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  1. Renal functions in pediatric patients with beta-thalassemia major: relation to chelation therapy: original prospective study

    Directory of Open Access Journals (Sweden)

    ElMelegy Nagla T

    2010-05-01

    Full Text Available Abstract Background In β-thalassemia, profound anemia and severe hemosiderosis cause functional and physiological abnormalities in various organ systems. In recent years, there have been few published studies mainly in adult demonstrating renal involvement in β-thalassemia. This prospective study was aimed to investigate renal involvement in pediatric patients with transfusion dependant beta-thalassemia major (TD-βTM, using both conventional and early markers of glomerular and tubular dysfunctions, and to correlate findings to oxidative stress and iron chelation therapy. Methods Sixty-nine TD-βTM patients (aged 1-16 years and 15 healthy controls (aged 3-14 years were enrolled in this study. Based on receiving chelation therapy (deferoxamine, DFO, patients were divided into two groups: group [I] with chelation (n = 34 and group [II] without chelation (n = 35. Levels of creatinine (Cr, calcium (Ca, inorganic phosphorus (PO4, uric acid (UA and albumin were measured by spectrophotometer. Serum (S levels of cystatin-C (SCysC and total antioxidant capacity (STAC and urinary (U levels of β2-microglobulin (Uβ2MG were measured by immunosorbent assay (ELISA. Urinary N-acetyl-beta-D-glucosaminidase (UNAG activity and malondialdehyde (UMDA were measured by chemical methods. Estimated glomerular filtration rate (eGFR was determined from serum creatinine. Results In patient with and without chelation, glomerular [elevated SCysC, SCr, Ualbumin/Cr and diminished eGFR]; and tubular dysfunctions [elevated SUA, SPO4, UNAG/Cr, Uβ2MG/Cr] and oxidative stress marker disturbances [diminished STAC and elevated UMDA/Cr] were reported than controls. In patients with chelation, SCysC was significantly higher while, STAC was significantly lower than those without chelation. In all patients, SCysC showed significant positive correlation with SCr and negative correlation with eGFR; STAC showed significant positive correlation with eGFR and negative correlation with

  2. Modern human origins: progress and prospects.

    OpenAIRE

    Stringer, Chris

    2002-01-01

    The question of the mode of origin of modern humans (Homo sapiens) has dominated palaeoanthropological debate over the last decade. This review discusses the main models proposed to explain modern human origins, and examines relevant fossil evidence from Eurasia, Africa and Australasia. Archaeological and genetic data are also discussed, as well as problems with the concept of 'modernity' itself. It is concluded that a recent African origin can be supported for H. sapiens, morphologically, be...

  3. Therapy using radiopharmaceuticals: prospects and status

    International Nuclear Information System (INIS)

    Pillai, M.R.A.

    2011-01-01

    Radionuclide therapy with artificially produced radionuclides started in 1936 with the administration of the cyclotron produced 32 P as orthophosphate for the treatment of leukemia by J.H. Lawrence. Thanks to the availability of nuclear reactors for peaceful applications post World War II, the treatment of thyroid cancer using Na 131 I was introduced in the late forties thereby beginning the successful use of radionuclides for targeted therapy. Though radionuclide therapy is only a small fraction of the current nuclear medicine practice, it is expected to grow significantly in the coming decades. This paper discusses the prospects and status of therapy using radiopharmaceuticals

  4. Antiaging therapy: a prospective hypothesis

    Directory of Open Access Journals (Sweden)

    Shahidi Bonjar MR

    2015-01-01

    Full Text Available Mohammad Rashid Shahidi Bonjar,1 Leyla Shahidi Bonjar2 1School of Dentistry, Kerman University of Medical Sciences, Kerman Iran; 2Department of Pharmacology, College of Pharmacy, Kerman University of Medical Sciences, Kerman, Iran Abstract: This hypothesis proposes a new prospective approach to slow the aging process in older humans. The hypothesis could lead to developing new treatments for age-related illnesses and help humans to live longer. This hypothesis has no previous documentation in scientific media and has no protocol. Scientists have presented evidence that systemic aging is influenced by peculiar molecules in the blood. Researchers at Albert Einstein College of Medicine, New York, and Harvard University in Cambridge discovered elevated titer of aging-related molecules (ARMs in blood, which trigger cascade of aging process in mice; they also indicated that the process can be reduced or even reversed. By inhibiting the production of ARMs, they could reduce age-related cognitive and physical declines. The present hypothesis offers a new approach to translate these findings into medical treatment: extracorporeal adjustment of ARMs would lead to slower rates of aging. A prospective “antiaging blood filtration column” (AABFC is a nanotechnological device that would fulfill the central role in this approach. An AABFC would set a near-youth homeostatic titer of ARMs in the blood. In this regard, the AABFC immobilizes ARMs from the blood while blood passes through the column. The AABFC harbors antibodies against ARMs. ARM antibodies would be conjugated irreversibly to ARMs on contact surfaces of the reaction platforms inside the AABFC till near-youth homeostasis is attained. The treatment is performed with the aid of a blood-circulating pump. Similar to a renal dialysis machine, blood would circulate from the body to the AABFC and from there back to the body in a closed circuit until ARMs were sufficiently depleted from the blood. The

  5. A newly designed radiation therapy protocol in combination with prednisolone as treatment for meningoencephalitis of unknown origin in dogs: a prospective pilot study introducing magnetic resonance spectroscopy as monitor tool.

    Science.gov (United States)

    Beckmann, Katrin; Carrera, Inés; Steffen, Frank; Golini, Lorenzo; Kircher, Patrick R; Schneider, Uwe; Bley, Carla Rohrer

    2015-01-31

    A plethora of treatment options have been described for canine meningoencephalitis of unknown origin (MUO), yet a gold standard has not been established. The aim of this prospective pilot study was to document the effect of a newly designed 30 Gray (Gy) radiation therapy (RT) protocol plus corticosteroids as treatment for focal and multifocal MUO, to monitor clinical and imaging changes during the course of the disease with conventional magnetic resonance imaging (MRI) and proton MR Spectroscopy (H-1 MRS) and to detect the occurrence of radiation related side effects. Six dogs (3 with focal and 3 with multifocal lesions) were included in the study. The RT protocol used consisted of 30 Gy in 10 fractions. The neurological status of all six dogs improved during RT, with 3 of 6 cases returning to a normal condition. One dog was euthanized early during follow-up (dog and improved in 3 dogs and H-1 MRS normalized in 4. In the dog without improvement of the MRI lesions, the N-acetyl aspartate continued to decrease, while choline and creatine concentrations remained stable during that time. This dog was euthanized 18 month after the end of RT due to relapse. One dog was lost to follow up 12 month after completion of RT. The other 3 dogs are still alive at the time of writing. RT with 30 Gy in 10 fractions can provide an additional option for anti-inflammatory treatment of focal and multifocal MUO. The protocol used for treatment monitoring was feasible while no side effects of RT could be observed during the follow up period. Moreover, H-1 MRS could represent a new and non-invasive tool to control the progression of the disease during the treatment course.

  6. Original and cumulative prospect theory: a discussion of empirical differences

    NARCIS (Netherlands)

    Wakker, P.P.; Fennema, H.

    1997-01-01

    This note discusses differences between prospect theory and cumulative prospect theory. It shows that cumulative prospect theory is not merely a formal correction of some theoretical problems in prospect theory, but it also gives different predictions. Experiments are described that favor cumulative

  7. Rational Emotive Behavior Therapy: Origins, Constructs, and Applications.

    Science.gov (United States)

    Watson, Joshua C.

    In 1956, Dr. Albert Ellis presented his seminal work on Rational Therapy, subsequently renamed Rational Emotive Behavior Therapy (REBT) in 1993. This paper explores the origins, theoretical foundations, applications, and implications of REBT and provides a look at the empirical research available in support of the approach's efficacy. REBT is…

  8. The origins of electroconvulsive therapy in denmark.

    Science.gov (United States)

    Kragh, Jesper Vaczy

    2009-12-01

    In recent years, the history of electroconvulsive therapy (ECT) has received renewed attention from historical researchers, who have published thorough monographs and articles on the subject of ECT. In these studies, however, one of the important events in the history of ECT has been overlooked: the lectures by Cerletti and Bini at the Third International Neurological Congress in Copenhagen. The lectures at the congress were the first presentation of ECT before a large international audience and became the impetus to the first Danish ECT trials. The first part of this article outlines the events of the neurological congress in 1939 and provides a translation of the paper presented by Bini at the congress. In the last part of the article, the history of ECT in Denmark is summarized.

  9. [Origin and development of umbilical therapy in traditional Chinese medicine].

    Science.gov (United States)

    Zhang, Xue-Wei; Jia, Hong-Ling

    2014-06-01

    The origin and development of umbilical therapy in traditional Chinese medicine is explored from related literature in the history. As a result, the Shang period is regarded as initial period of umbilical therapy, while periods from Han Dynasty, Jin Dynasty and Southern-Northern Dynasties to Sui Dynasty and Tang Dynasty could be taken as stage of primary development. Time from Song Dynasty, Jin Dynasty and Yuan Dynasty to Ming and Qing Dynasties is believed as mature stage. Also the manipulation, application principle, indications and contraindications of umbilical therapy are explained. A brief overview of modern development of umbilical therapy is also described.

  10. ORIGINAL ARTICLE ORI ORI Radioiodine therapy in skeletal ...

    African Journals Online (AJOL)

    underwent thyroid surgery as the initial management – total thyroidec- tomy in 18, subtotal thyroidectomy in 3, and .... as part of the original treatment, whereas external radiation therapy was used to control symptoms, principally at .... There is a definite role for XRT, especially to control bone pain in patients with large bony ...

  11. ORIGINAL ARTICLES The BEST study - a prospective study to ...

    African Journals Online (AJOL)

    1.04-3.99. Table V. Regression analysis of potential hormonal factors contributing to the development of positive D·dimers in females. 95% confidence. Odds ratio P-value interval. Hormone replacement. 2.15. 0.083. 0.91-5.10 therapy. Oral contraceptive. 1.23. 0.707. 0.42-3.62. HRT or OCs (Table V). There were 382 female ...

  12. Vietnam's Garment Industry – Origins and Future Prospects

    OpenAIRE

    Phuong, Dung

    2017-01-01

    This paper investigates the origin and future of Vietnam's garment industry. Recent research has shown that garments business have been shifting from china to Vietnam because in Vietnam, comparatively labor costs are more cheaper than china. The rearrangement of production amenities to Vietnam - with strong government support to the garments industry, increasing exports if textile product, strong trade relations and selected goals have helped to expand of textile and apparel industry in Vietn...

  13. [PEDIATRIC GASTROENTEROLOGY: ORIGINS, PROBLEMS, AND PROSPECTS OF THE RESEARCH].

    Science.gov (United States)

    Zaprudnov, A M; Kharitonova, L A; Grigoriev, K I; Bogomaz, L V

    2015-01-01

    The nomenclature of digestive diseases in children was supplemented by the "new" diseases: of esophagus--gastroesophageal reflux disease (GERD), Barrett's esophagus, Zenker's diverticulum; of stomach and duodenum--gastroduodenitis, peptic ulcer disease, polyps, ectopic pancreas in the stomach wall; of the intestine--jejunitis, ileocolitis, Crohn's disease, celiac disease, bacterial overgrowth syndrome in the small intestine; of biliary tract--cholelithiasis, gallbladder cholesterosis, anomalies of the biliary tract; of pancreas--acute and chronic pancreatitis, annular pancreas (2). The features of gastrointestinal diseases in children experiencing the action of factors, not always positively affecting the growing organism, were established. These features include: presence of allergic background; high level of neuro-autonomous and psycho-emotional changes in modern children, not only in schoolchildren, but even in preschoolers; polymorbidity or a combination (syntropy) of lesions of the digestive system; adverse outcomes of certain diseases as chronization, complications development, and as a consequence--a high risk of disability in children; "rejuvenation" of certain diseases of the digestive system (cholelithiasis, gallbladder cholesterosis, Crohn's disease), typical for adults. It is important to emphasize the clinical and social importance of gastroenterological diseases in childhood. Axiomatic is that the origins of many diseases of the digestive organs in adults lie in childhood. Early manifestation of certain diseases such as peptic ulcer disease, gluten enteropathy, Crohn's disease, and others, significantly impact the quality of life of sick children and their parents. It is worth to emphasize high costs of medical and prophylactic (tertiary prevention) activities using the drugs of latest generations. All this causes problems in both applied and scientific pediatric gastroenterology.

  14. Where are we now? The strengthened safeguards system: Origins, aims, features, issues and prospects

    International Nuclear Information System (INIS)

    Schriefer, D.

    1998-01-01

    The present status of the strengthened safeguards system includes the origins, aims, features, issues and future prospects. The areas of emphasis concerning the strengthened safeguards system are: access to information (environmental sampling and improved information analysis), access to sites, rational use of resources (cost analysis of present safeguards, increased cooperation with state systems, cost savings in traditional safeguards activities)

  15. Multiple sclerosis: a review of existing therapy and future prospects.

    Science.gov (United States)

    Khan, O A

    1996-01-01

    demyelinating lesion. Regardless of the plausibility of this theory and without going into details, several aspects of immune mediated pathology of MS remain unexplained. This is an attempt to review the status of current therapy and future prospects in the treatment of MS.

  16. Original Article Failure of Bacillus Calmette Guerin (BCG) Therapy ...

    African Journals Online (AJOL)

    Administrator

    -up, 6 (3.8%) stopped BCG due to side-effects and were subsequently treated with intravesical chemotherapy, while another 5 (3.1%) died during BCG therapy ... patients with impaired renal function. Hematuria was the most common clinical.

  17. ORIGINAL ARTICLES Barriers to initiating insulin therapy in patients ...

    African Journals Online (AJOL)

    Nicky

    oral medication by MOs in community health centres (CHCs). Barriers to ... diabetes mellitus in public-sector primary health care centres in Cape .... responsibility for initiation of insulin therapy to tertiary hospitals. 'There's not always somebody to ask [for advice] and there's no protocol, so the easiest thing is to just send [the.

  18. Origin, state of the art and some prospects of the diamond CVD

    CERN Document Server

    Spitsyn, B V; Alexenko, A E

    2000-01-01

    A short review on the diamond CVD origin, together with its state of the art and some prospects was given. New hybrid methods of the diamond CVD permit to gain 1.2 to 6 times of growth rate in comparison with ordinary diamond CVD's. Recent results on n-type diamond film synthesis through phosphorus doping in the course of the CVD process are briefly discussed. In comparison with high-pressure diamond synthesis, the CVD processes open new facets of the diamond as ultimate crystal for science and technology evolution. It was stressed that, mainly on the basis of new CVDs of diamond, the properties of natural diamond are not only reproduced, but can be surpassed. As examples, mechanical (fracture resistance), physical (thermal conductivity), and chemical (oxidation stability) properties are mentioned. Some present issues in the field are considered.

  19. Prospective randomised trial of laser therapy only and laser therapy followed by endoscopic intubation for the palliation of malignant dysphagia.

    OpenAIRE

    Barr, H; Krasner, N; Raouf, A; Walker, R J

    1990-01-01

    Forty six consecutive patients admitted for the relief of malignant dysphagia were prospectively randomised to receive laser therapy only or initial laser therapy followed by endoscopic intubation. Twenty patients were treated in each group with six exclusions. The patients' swallowing ability was assessed before and during the remainder of their life on a 0-4 scale with 0 being normal swallowing and 4 total dysphagia. The patient's quality of life was measured at the same times, using a phys...

  20. The Academy of Cognitive Therapy: Purpose, History, and Future Prospects

    Science.gov (United States)

    Dobson, Keith S.; Beck, Judith S.; Beck, Aaron T.

    2005-01-01

    The Academy of Cognitive Therapy (ACT) was developed as a means to identify and credential mental health professionals who demonstrate competence in cognitive therapy. Its missions include certifying clinicians from all disciplines as competent cognitive therapists and educating the public about this empirically supported treatment. This article…

  1. Prospects for Gene Therapy in the Fragile X Syndrome

    Science.gov (United States)

    Rattazzi, Mario C.; LaFauci, Giuseppe; Brown, W. Ted

    2004-01-01

    Gene therapy is unarguably the definitive way to treat, and possibly cure, genetic diseases. A straightforward concept in theory, in practice it has proven difficult to realize, even when directed to easily accessed somatic cell systems. Gene therapy for diseases in which the central nervous system (CNS) is the target organ presents even greater…

  2. Sjogren Syndrome-Gene Therapy and its Prospective

    Directory of Open Access Journals (Sweden)

    R Rahpeyma

    2003-02-01

    Full Text Available Sjogren syndrome is one of the autoimmune diseases which is characterized by lymphocytic infiltration to exocrine glands and causes keratoconjunctivitis sicca and xerostomia. Today, a large population, with a majority of women over 40, suffer from this disease and have several complications regarding oral health and reduced life quality such as severe dental caries, painful eyes, olfactory and gustatory deficiency, speech, mastication and swallowing discomforts. Unfortunately, these patients do not respond to the conventional therapies. Nowadays in medical world, which its target is basic therapy and not symptomatic one, several gene therapy approaches, have gained importance in treatment of this apparently incurable diseases. Due to the facts that this disease is the second prevelant autoimmune disease, after rheumatoid arthritis, and the conventional therapies of the disease are all relative and symptomatic, researchers have insisted on the basic and causative therapy through gene transfer more than before. In the Present article, through reviewing 58 references containing recent scientific and investigatory findings it has been tried, to consider the pathogenesis and conventional therapies of this syndrome. Another purpose of this study was to investigate several and potentially very effective gene transfer systems and different theraputic genes (mainly membrane water channels, ione transporter molecules, transcription factors, antifungal proteins and free radical scavengers.

  3. CAR T-Cell Therapy: Progress and Prospects.

    Science.gov (United States)

    Wilkins, Olivia; Keeler, Allison M; Flotte, Terence R

    2017-04-01

    Lentivirus-mediated transduction of autologous T cells with a chimeric antigen receptor (CAR) to confer a desired epitope specificity as a targeted immunotherapy for cancer has been among the first human gene therapy techniques to demonstrate widespread therapeutic efficacy. Other approaches to using gene therapy to enhance antitumor immunity have been less specific and less effective. These have included amplification, marking, and cytokine transduction of tumor infiltrating lymphocytes, recombinant virus-based expression of tumor antigens as a tumor vaccine, and transduction of antigen-presenting cells with tumor antigens. Unlike any of those methods, the engineering of CAR T cells combine specific monoclonal antibody gene sequences to confer epitope specificity and other T-cell receptor and activation domains to create a self-contained single vector approach to produce a very specific antitumor response, as is seen with CD19-directed CAR T cells used to treat CD19-expressing B-cell malignancies. Recent success with these therapies is the culmination of a long step-wise iterative process of improvement in the design of CAR vectors. This review aims to summarize this long series of advances in the development of effective CAR vector since their initial development in the 1990s, and to describe emerging approaches to design that promise to enhance and widen the human gene therapy relevance of CAR T-cell therapy in the future.

  4. Targeted Radionuclide Therapy: Practical Applications and Future Prospects

    Directory of Open Access Journals (Sweden)

    Katherine Zukotynski

    2016-01-01

    Full Text Available In recent years, there has been a proliferation in the development of targeted radionuclide cancer therapy. It is now possible to use baseline clinical and imaging assessments to determine the most effective therapy and to tailor this therapy during the course of treatment based on radiation dosimetry and tumor response. Although this personalized approach to medicine has the advantage of maximizing therapeutic effect while limiting toxicity, it can be challenging to implement and expensive. Further, in order to use targeted radionuclide therapy effectively, there is a need for multidisciplinary awareness, education, and collaboration across the scientific, industrial, and medical communities. Even more important, there is a growing understanding that combining radiopharmaceuticals with conventional treatment such as chemotherapy and external beam radiotherapy may limit patient morbidity while improving survival. Developments in radiopharmaceuticals as biomarkers capable of predicting therapeutic response and targeting disease are playing a central role in medical research. Adoption of a practical approach to manufacturing and delivering radiopharmaceuticals, assessing patient eligibility, optimizing post-therapy follow-up, and addressing reimbursement issues will be essential for their success.

  5. Gene therapy prospects--intranasal delivery of therapeutic genes.

    Science.gov (United States)

    Podolska, Karolina; Stachurska, Anna; Hajdukiewicz, Karolina; Małecki, Maciej

    2012-01-01

    Gene therapy is recognized to be a novel method for the treatment of various disorders. Gene therapy strategies involve gene manipulation on broad biological processes responsible for the spreading of diseases. Cancer, monogenic diseases, vascular and infectious diseases are the main targets of gene therapy. In order to obtain valuable experimental and clinical results, sufficient gene transfer methods are required. Therapeutic genes can be administered into target tissues via gene carriers commonly defined as vectors. The retroviral, adenoviral and adeno-associated virus based vectors are most frequently used in the clinic. So far, gene preparations may be administered directly into target organs or by intravenous, intramuscular, intratumor or intranasal injections. It is common knowledge that the number of gene therapy clinical trials has rapidly increased. However, some limitations such as transfection efficiency and stable and long-term gene expression are still not resolved. Consequently, great effort is focused on the evaluation of new strategies of gene delivery. There are many expectations associated with intranasal delivery of gene preparations for the treatment of diseases. Intranasal delivery of therapeutic genes is regarded as one of the most promising forms of pulmonary gene therapy research. Gene therapy based on inhalation of gene preparations offers an alternative way for the treatment of patients suffering from such lung diseases as cystic fibrosis, alpha-1-antitrypsin defect, or cancer. Experimental and first clinical trials based on plasmid vectors or recombinant viruses have revealed that gene preparations can effectively deliver therapeutic or marker genes to the cells of the respiratory tract. The noninvasive intranasal delivery of gene preparations or conventional drugs seems to be very encouraging, although basic scientific research still has to continue.

  6. Prospects for Foamy Viral Vector Anti-HIV Gene Therapy

    Directory of Open Access Journals (Sweden)

    Arun K. Nalla

    2016-03-01

    Full Text Available Stem cell gene therapy approaches for Human Immunodeficiency Virus (HIV infection have been explored in clinical trials and several anti-HIV genes delivered by retroviral vectors were shown to block HIV replication. However, gammaretroviral and lentiviral based retroviral vectors have limitations for delivery of anti-HIV genes into hematopoietic stem cells (HSC. Foamy virus vectors have several advantages including efficient delivery of transgenes into HSC in large animal models, and a potentially safer integration profile. This review focuses on novel anti-HIV transgenes and the potential of foamy virus vectors for HSC gene therapy of HIV.

  7. [Prospects of the anti-cytokine therapy in rheumatoid arthritis].

    Science.gov (United States)

    Lukina, G V

    2003-01-01

    The development and introduction of the anti-cytokine therapy applicable to rheumatoid arthritis (RA) is a most significant achievement in RA therapy. A high degree of purpose-orientation and selectivity of the mentioned method ensuring a high therapeutic effect and providing, simultaneously, for defining a number of important chains in RA pathogenesis is an essential advantage of the discussed approach. The clinical use of neutralization of key cytokines TNF-alpha, IL-1 and IF-gamma is a serious progress within this trend. Possibilities of developing new directions of the cytokines therapy are preconditioned, to a great extent, by the role of new, including little-studied cytokines, in the evolution of immune inflammation. A search for more simple low-molecular inhibitors of cytokines, which do not cause any tolerance-related problems, is another important trend. Hopefully, a further study of anti-cytokines and of their application in combination with other antirheumatic drugs will improve the general treatment results and outline new opportunities in antirheumatic therapy.

  8. A therapy for oral cancer. The present status and prospects of surgical therapy

    Energy Technology Data Exchange (ETDEWEB)

    Fukutake, Kimio; Ohtsuru, Hiroshi [National Second Hospital of Tokyo (Japan)

    1995-09-01

    Surgery for carcinoma of the oral cavity has developed rapidly with recent advances in reconstruction. Particularly, in radical surgery for progressive and recurrent disease, safe and adequate resection has been made possible and postoperative cosmetic and functional recovery has been achieved. We reviewed 64 patients with progressive and recurrent cancer who had undergone reconstruction using microvascular techniques during the 12 years from 1983 to 1994. There were 19 patients with T3 disease, 25 with T4 disease, and 20 with recurrence. The free grafts used were radial forearm flaps, the jejunum, rectus abdominis musculocutaneous flaps, and scapular flaps. The survival of free flap grafts was 95.3%. The primary tumor control rate was 85.9%, and the 5-year cumulative survival rate was 61.1%, 60.1%, and 62.9% for patients with T3, T4, and recurrent disease, respectively. Twelve patients with T4 disease of the tongue and the floor of the mouth were treated with combined preoperative brachytherapy and surgery to alleviate postoperative dysfunction, and this treatment was found to be exceedingly effective for improving the postoperative quality of life. There are still many problems with mandibular reconstruction. Since cancer patients commonly undergo preoperative radiotherapy, transplantation of living vascularized bone grafts is frequently performed and is believed to be effective. Since it is important to reconstruct masticatory function as well as to achieve cosmetic improvement, various techniques have recently been used to fit the reconstructed mandible with dental prostheses in order to restore masticatory function. This paper describes the present status and the prospects of surgical therapy for oral cancer. (author).

  9. Prospects in folate receptor-targeted radionuclide therapy

    Directory of Open Access Journals (Sweden)

    Cristina eMüller

    2013-09-01

    Full Text Available Targeted radionuclide therapy is based on systemic application of particle-emitting radiopharmaceuticals which are directed towards a specific tumor-associated target. Accumulation of the radiopharmaceutical in targeted cancer cells results in high doses of absorbed radiation energy whereas toxicity to non-targeted healthy tissue is limited. This strategy has found widespread application in the palliative treatment of neuroendocrine tumors using somatostatin-based radiopeptides. The folate receptor (FR has been identified as a target associated with a variety of frequent tumor types (e.g. ovarian, lung, brain, renal and colorectal cancer. In healthy organs and tissue FR-expression is restricted to only a few sites such as for instance the kidneys. This demonstrates why FR-targeting is an attractive strategy for the development of new therapy concepts. Due to its high FR-binding affinity (KD < 10-9 M the vitamin folic acid has emerged as an almost ideal targeting agent. Therefore, a variety of folic acid radioconjugates for nuclear imaging have been developed. However, in spite of the large number of cancer patients who could benefit of a folate-based radionuclide therapy, a therapeutic concept with folate radioconjugates has not yet been envisaged for clinical application. The reason is the generally high accumulation of folate radioconjugates in the kidneys where emission of particle-radiation may result in damage to the renal tissue. Therefore, the design of more sophisticated folate radioconjugates providing improved tissue distribution profiles are needed.This review article summarizes recent developments with regard to a therapeutic application of folate radioconjugates. A new construct of a folate radioconjugate and an application protocol which makes use of a pharmacological interaction allowed the first preclinical therapy experiments with radiofolates. These results raise hope for future application of such new concepts also in the

  10. Gene therapy for PIDs: progress, pitfalls and prospects.

    Science.gov (United States)

    Mukherjee, Sayandip; Thrasher, Adrian J

    2013-08-10

    Substantial progress has been made in the past decade in treating several primary immunodeficiency disorders (PIDs) with gene therapy. Current approaches are based on ex-vivo transfer of therapeutic transgene via viral vectors to patient-derived autologous hematopoietic stem cells (HSCs) followed by transplantation back to the patient with or without conditioning. The overall outcome from all the clinical trials targeting different PIDs has been extremely encouraging but not without caveats. Malignant outcomes from insertional mutagenesis have featured prominently in the adverse events associated with these trials and have warranted intense pre-clinical investigation into defining the tendencies of different viral vectors for genomic integration. Coupled with issues pertaining to transgene expression, the therapeutic landscape has undergone a paradigm shift in determining safety, stability and efficacy of gene therapy approaches. In this review, we aim to summarize the progress made in the gene therapy trials targeting ADA-SCID, SCID-X1, CGD and WAS, review the pitfalls, and outline the recent advancements which are expected to further enhance favourable risk benefit ratios for gene therapeutic approaches in the future. Copyright © 2013 Elsevier B.V. All rights reserved.

  11. Targeted alpha anticancer therapies: update and future prospects

    Directory of Open Access Journals (Sweden)

    Allen BJ

    2014-11-01

    Full Text Available Barry J Allen,1,2 Chen-Yu Huang,3 Raymond A Clarke2 1Faculty of Physics, University of Sydney, Sydney, NSW, Australia; 2Faculty of Medicine, Ingham Institute, University of Western Sydney, Liverpool, NSW, Australia; 3Central Clinical School, University of Sydney, Sydney, NSW, AustraliaAbstract: Targeted alpha therapy (TAT is an emerging option for local and systemic cancer treatment. Preclinical research and clinical trials show that alpha-emitting radionuclides can kill targeted cancer cells while sparing normal cells, thus reducing toxicity. 223RaCl2 (Xofigo® is the first alpha emitting radioisotope to gain registration in the US for palliative therapy of prostate cancer bone metastases by indirect physiological targeting. The alpha emitting radioisotopes 211At, 213Bi, 225Ac and 227Th are being used to label targeting vectors such as monoclonal antibodies for specific cancer therapy indications. In this review, safety and tolerance aspects are considered with respect to microdosimetry, specific energy, Monte Carlo model calculations, biodosimetry, equivalent dose and mutagenesis. The clinical efficacy of TAT for solid tumors may also be enhanced by its capacity for tumor anti-vascular (TAVAT effects. This review emphasizes key aspects of TAT research with respect to the PAI2-uPAR complex and the monoclonal antibodies bevacizumab, C595 and J591. Clinical trial outcomes are reviewed for neuroendocrine tumors, leukemia, glioma, melanoma, non-Hodgkins lymphoma, and prostate bone metastases. Recommendations and future directions are proposed.Keywords: biodosimetry, microdosimetry, mutagenesis, PAI2, bevacizumab, C595, J591, tumors, cancer, metastases

  12. Aaron T. Beck's drawings and the psychoanalytic origin story of cognitive therapy.

    Science.gov (United States)

    Rosner, Rachael I

    2012-02-01

    In this essay the author challenges the standard origin story of cognitive therapy, namely, that its founder Aaron T. Beck broke with psychoanalysis to pursue a more pragmatic, parsimonious, and experimentalist cognitive model. It is true that Beck broke with psychoanalysis in large measure as a result of his experimental disconfirmation of key psychoanalytic ideas. His new school of cognitive therapy brought the experimental ethos into every corner of psychological life, extending outward into the largest multisite randomized controlled studies of psychotherapy ever attempted and inward into the deepest recesses of our private worlds. But newly discovered hand-sketched drawings from 1964 of the schema, a conceptual centerpiece of cognitive therapy, as well as unpublished personal correspondence show that Beck continued to think psychoanalytically even after he broke with psychoanalysis. The drawings urge us to consider an origin story much more complex than the one of inherited tradition. This new, multifaceted origin story of cognitive therapy reaches beyond sectarian disagreements and speaks to a broader understanding of the theoretical underpinnings of cognitive therapy.

  13. Current status and prospect of therapy with advanced cancer

    International Nuclear Information System (INIS)

    Watari, Tsutomu

    1979-01-01

    Symtomatic or palliative therapy of the patients with advanced cancer must be directed to the relief of specific distressing symptoms caused by or associated with neoplasm. The radiotherapy must have a clear concepts of the potential accomplishments of other treatment modalities, such as neurosurgery, anesthesiology, chemotherapy, pharmacology and psychotherapy, so that he may use his own method in proper perspective. I discussed following is an list of contents in this papers. Relief of pain, Psychotherapy, SVC obstruction, Obstructive jaundice, Brain and lung metastasis, prevention of fracture, Skin metastasis, Liver metastasis and treatment of advanced pediaric tumor etc. For the future: 1) Establishment of Stage and Grade of advanced cancer. 2) Development of new chemotherapeutic drug and immunotherapy. 3) Combination of multidisciplinary team and multidisciplinary treatment. (author)

  14. Current status and future prospects of radiation therapy and medical accelerator

    International Nuclear Information System (INIS)

    Nakagawa, K.

    2004-01-01

    Progress of radiation therapy is remarkable in cancer treatment. Ten years ago, one out of eight cancer patients in Japan received this, but nowadays, a quarter of cancer patients undergo this modality. Furthermore, in ten years, the ratio will be nearly half, which is similar to western countries. In particular highly precise irradiation is actualized to pinpoint a cancer lesion owing to technological innovations. Radiation therapy is expected to play a major role in aging society of this country. Some examples of ''hi-tech'' radiation therapy is presented. On the other hand, several malpractices in radiation therapy are reported recently. It is caused mainly be the lack of hospital physicists in this field. In addition to it, there is no domestic company who manufactures medical accelerators. Current status and future prospects of radiation therapy and medical accelerator are addressed. (author)

  15. Shoma Morita, founder of Morita therapy, and haiku poet Shiki: origin of Morita therapy.

    Science.gov (United States)

    Moriyama, N

    1991-12-01

    A hypothesis that Shiki's struggle for life probably influenced the creation of Morita therapy is presented. Although Morita had no personal acquaintance with Shiki, they did have three common friends in Terada, Wakao and Katori. Considering this, as well as the renown of Shiki's works, Morita likely knew much of Shiki and may have been deeply impressed by his approach to life. Several essential concepts of Morita therapy such as absolute bed-rest, anguish and deliverance, "Arugamama," "Jijitsu Yuishin," desire to live, and the importance of keeping a diary can be found in Shiki's lifestyle and in his literary theory.

  16. Congenital Cytomegalovirus Infection: New Prospects for Prevention and Therapy

    Science.gov (United States)

    Swanson, Elizabeth C.; Schleiss, Mark R.

    2013-01-01

    SYNOPSIS Cytomegalovirus (CMV) is the most common congenital viral infection in the developed world, with an overall birth prevalence of approximately 0.6%. Approximately 10% of congenitally infected infants have signs and symptoms of disease at birth, and these symptomatic infants have a high risk for demonstration of subsequent neurologic sequelae, including sensorineural hearing loss (SNHL), mental retardation, microcephaly, development delay, seizure disorders, and cerebral palsy. Antiviral therapy of children with symptomatic central nervous system (CNS) congenital CMV infection is effective at reducing the risk of long-term disabilities and should be offered to families with affected newborns. An effective pre-conceptual vaccine against CMV could, by preventing congenital infection, protect against long-term neurological sequelae and other disabilities. A variety of active and passive immunization strategies are in clinical trials and are likely to be licensed in the next few years. Until a vaccine is licensed, preventive strategies aimed at reducing transmission should be emphasized and public awareness increased, particularly among women of child-bearing age. PMID:23481104

  17. Compliance with therapeutic guidelines in Radiation Therapy Oncology Group prospective gastrointestinal clinical trials

    International Nuclear Information System (INIS)

    Willett, Christopher G.; Moughan, Jennifer; O’Meara, Elizabeth; Galvin, James M.; Crane, Christopher H.; Winter, Kathryn; Manfredi, Denise; Rich, Tyvin A.; Rabinovitch, Rachel; Lustig, Robert; Machtay, Mitchell; Curran, Walter J.

    2012-01-01

    Background: This report analyzes the adherence to radiation therapy protocol guidelines in contemporary Radiation Therapy Oncology Group (RTOG) gastrointestinal trials. We aim to provide insight into current standards and compliance of radiation therapy field design and administration. Methods: From 1994 to 2006, the Gastrointestinal Cancer Committee of the RTOG initiated and completed 15 phase I–III clinical trials utilizing radiation therapy in the multimodality treatment of gastrointestinal cancers. In each protocol, details for planning and executing radiation therapy were outlined and each protocol contained scoring criteria for these components of radiation therapy, characterized according to per-protocol, variation acceptable and deviation unacceptable. Review of treatment planning and implementation was performed in all studies following therapy completion. Results: Radiation therapy planning and implementation was reviewed in 2309 of 2312 (99.9%) patients. The mean rate of compliance over all for the 15 protocols was 65% (total of the 2309 analyzed patients). The mean variation acceptable rate was 21% whereas the mean deviation unacceptable rate was 5%. The mean “other” rate (no RT given or incomplete RT due to death, progression or refusal) was 8%. Two of the 15 trials (13%) had deviation unacceptable rates >10%. In four studies incorporating pre-treatment review of radiation therapy planning and treatment, compliance with protocol therapy was enhanced. Conclusions: The fidelity of radiation planning and execution detailed in protocol to actual therapy is heterogeneous, with a mean per-protocol rate of 65%. As clinical trials evolve, available technology should permit efficient pre-treatment review processes, thus facilitating compliance to protocol therapy. These analyses should also permit prospective analysis of outcome measures by compliance to therapy.

  18. Origin,

    Directory of Open Access Journals (Sweden)

    Artur de Vargas Giorgi

    2011-02-01

    Full Text Available This essay tightens the “origin” concept, its manifestation through puzzles and their relationship to techniques of reproduction. Contrary to the hegemonic critique of aesthetic and cultural objects – critique that, settled on the appearance and notions of identity, tradition, canon, etc., undervalues the reproductions of "originals" –, the aim is to deliver these objects from formal hierarchization dispositives, that is, release them of what is ideal and positively imposed, so that the reproducibility is potentiated as producer of singularities, of apparitions. The effort is to keep the undecided character of puzzles (bodies, texts, images in which the origin is manifest, so that the logic of the spectacle is reverted into sense opening, instance in which the aesthetic becomes a “performance” before contemporary complexity. With the reproducibility, an origin survives in passage: continually restored, but incomplete, present in trace, in absence.

  19. Uptake of combination antiretroviral therapy and HIV disease progression according to geographical origin in seroconverters in Europe, Canada, and Australia

    DEFF Research Database (Denmark)

    Jarrin, Inma; Pantazis, Nikos; Gill, M John

    2012-01-01

    We examined differences by geographical origin (GO) in time from HIV seroconversion (SC) to AIDS, death, and initiation of antiretroviral therapy (cART).......We examined differences by geographical origin (GO) in time from HIV seroconversion (SC) to AIDS, death, and initiation of antiretroviral therapy (cART)....

  20. A Pilot Prospective Randomized Control Trial Comparing Exercises Using Videogame Therapy to Standard Physical Therapy: 6 Months Follow-Up.

    Science.gov (United States)

    Parry, Ingrid; Painting, Lynda; Bagley, Anita; Kawada, Jason; Molitor, Fred; Sen, Soman; Greenhalgh, David G; Palmieri, Tina L

    2015-01-01

    Commercially available, interactive videogames that use body movements for interaction are used clinically in burn rehabilitation and have been shown to facilitate functional range of motion (ROM) but their efficacy with burn patients has not yet been proven. The purpose of this pilot randomized control study was to prospectively compare planar and functional ROM, compliance, pain, enjoyment, and exertion in pediatric burn patients receiving two types of rehabilitation therapy. Seventeen school-aged children with 31 affected limbs who demonstrated limited shoulder ROM from burn injury were randomized to receive exercises using either standard therapy ROM activities (ST) or interactive videogame therapy (VGT). Patients received 3 weeks of the designated therapy intervention twice daily. They were then given a corresponding home program of the same type of therapy to perform regularly for 6 months. Standard goniometry and three-dimensional motion analysis during functional tasks were used to assess ROM. Measures were taken at baseline, 3 weeks, 3 months, and 6 months. Pain was measured before and after each treatment session during the 3-week intervention. There was no difference in compliance, enjoyment, or exertion between the groups. Patients in both the ST and VGT groups showed significant improvement in shoulder flexion (P videogames were equally effective as traditional therapy for overall ROM gains and resulted in quicker recovery of motion with less pain experienced. Such videogames are a useful adjunct to therapy and should be considered as part of a holistic approach to rehabilitation within the hospital and at home after discharge in pediatric patients recovering from burn injury.

  1. Umbilical Cord as Prospective Source for Mesenchymal Stem Cell-Based Therapy

    Science.gov (United States)

    2016-01-01

    The paper presents current evidence on the properties of human umbilical cord-derived mesenchymal stem cells, including origin, proliferative potential, plasticity, stability of karyotype and phenotype, transcriptome, secretome, and immunomodulatory activity. A review of preclinical studies and clinical trials using this cell type is performed. Prospects for the use of mesenchymal stem cells, derived from the umbilical cord, in cell transplantation are associated with the need for specialized biobanking and transplant standardization criteria. PMID:27651799

  2. Osteosarcoma: Cells-of-Origin, Cancer Stem Cells, and Targeted Therapies

    Directory of Open Access Journals (Sweden)

    Ander Abarrategi

    2016-01-01

    Full Text Available Osteosarcoma (OS is the most common type of primary solid tumor that develops in bone. Although standard chemotherapy has significantly improved long-term survival over the past few decades, the outcome for those patients with metastatic or recurrent OS remains dismally poor and, therefore, novel agents and treatment regimens are urgently required. A hypothesis to explain the resistance of OS to chemotherapy is the existence of drug resistant CSCs with progenitor properties that are responsible of tumor relapses and metastasis. These subpopulations of CSCs commonly emerge during tumor evolution from the cell-of-origin, which are the normal cells that acquire the first cancer-promoting mutations to initiate tumor formation. In OS, several cell types along the osteogenic lineage have been proposed as cell-of-origin. Both the cell-of-origin and their derived CSC subpopulations are highly influenced by environmental and epigenetic factors and, therefore, targeting the OS-CSC environment and niche is the rationale for many recently postulated therapies. Likewise, some strategies for targeting CSC-associated signaling pathways have already been tested in both preclinical and clinical settings. This review recapitulates current OS cell-of-origin models, the properties of the OS-CSC and its niche, and potential new therapies able to target OS-CSCs.

  3. Methylprednisolone pulse therapy for patients with moderately severe Graves' orbitopathy: a prospective, randomized, placebo-controlled study

    NARCIS (Netherlands)

    van Geest, Rob J.; Sasim, Inna V.; Koppeschaar, Hans P. F.; Kalmann, Rachel; Stravers, Simone N.; Bijlsma, Ward R.; Mourits, Maarten P.

    2008-01-01

    Objective: To assess whether methylprednisolone (MP) pulse therapy is efficacious in the treatment of moderately severe Graves' orbitopathy (GO). Design: Prospective, placebo (PL)-controlled, double-blind, randomized study. Methods: Fifteen previously untreated patients with active, moderately

  4. Anthroposophic therapy for chronic depression: a four-year prospective cohort study.

    Science.gov (United States)

    Hamre, Harald J; Witt, Claudia M; Glockmann, Anja; Ziegler, Renatus; Willich, Stefan N; Kiene, Helmut

    2006-12-15

    Depressive disorders are common, cause considerable disability, and do not always respond to standard therapy (psychotherapy, antidepressants). Anthroposophic treatment for depression differs from ordinary treatment in the use of artistic and physical therapies and special medication. We studied clinical outcomes of anthroposophic therapy for depression. 97 outpatients from 42 medical practices in Germany participated in a prospective cohort study. Patients were aged 20-69 years and were referred to anthroposophic therapies (art, eurythmy movement exercises, or rhythmical massage) or started physician-provided anthroposophic therapy (counselling, medication) for depression: depressed mood, at least two of six further depressive symptoms, minimum duration six months, Center for Epidemiological Studies Depression Scale, German version (CES-D, range 0-60 points) of at least 24 points. Outcomes were CES-D (primary outcome) and SF-36 after 3, 6, 12, 18, 24, and 48 months. Data were collected from July 1998 to March 2005. Median number of art/eurythmy/massage sessions was 14 (interquartile range 12-22), median therapy duration was 137 (91-212) days. All outcomes improved significantly between baseline and all subsequent follow-ups. Improvements from baseline to 12 months were: CES-D from mean (standard deviation) 34.77 (8.21) to 19.55 (13.12) (p therapies were followed by long-term clinical improvement. Although the pre-post design of the present study does not allow for conclusions about comparative effectiveness, study findings suggest that the anthroposophic approach, with its recourse to non-verbal and artistic exercising therapies can be useful for patients motivated for such therapies.

  5. Anthroposophic therapy for chronic depression: a four-year prospective cohort study

    Directory of Open Access Journals (Sweden)

    Willich Stefan N

    2006-12-01

    Full Text Available Abstract Background Depressive disorders are common, cause considerable disability, and do not always respond to standard therapy (psychotherapy, antidepressants. Anthroposophic treatment for depression differs from ordinary treatment in the use of artistic and physical therapies and special medication. We studied clinical outcomes of anthroposophic therapy for depression. Methods 97 outpatients from 42 medical practices in Germany participated in a prospective cohort study. Patients were aged 20–69 years and were referred to anthroposophic therapies (art, eurythmy movement exercises, or rhythmical massage or started physician-provided anthroposophic therapy (counselling, medication for depression: depressed mood, at least two of six further depressive symptoms, minimum duration six months, Center for Epidemiological Studies Depression Scale, German version (CES-D, range 0–60 points of at least 24 points. Outcomes were CES-D (primary outcome and SF-36 after 3, 6, 12, 18, 24, and 48 months. Data were collected from July 1998 to March 2005. Results Median number of art/eurythmy/massage sessions was 14 (interquartile range 12–22, median therapy duration was 137 (91–212 days. All outcomes improved significantly between baseline and all subsequent follow-ups. Improvements from baseline to 12 months were: CES-D from mean (standard deviation 34.77 (8.21 to 19.55 (13.12 (p Conclusion In outpatients with chronic depression, anthroposophic therapies were followed by long-term clinical improvement. Although the pre-post design of the present study does not allow for conclusions about comparative effectiveness, study findings suggest that the anthroposophic approach, with its recourse to non-verbal and artistic exercising therapies can be useful for patients motivated for such therapies.

  6. Intensive insulin therapy in severely burned pediatric patients: a prospective randomized trial.

    Science.gov (United States)

    Jeschke, Marc G; Kulp, Gabriela A; Kraft, Robert; Finnerty, Celeste C; Mlcak, Ron; Lee, Jong O; Herndon, David N

    2010-08-01

    Hyperglycemia and insulin resistance have been shown to increase morbidity and mortality in severely burned patients, and glycemic control appears essential to improve clinical outcomes. However, to date no prospective randomized study exists that determines whether intensive insulin therapy is associated with improved post-burn morbidity and mortality. To determine whether intensive insulin therapy is associated with improved post-burn morbidity. A total of 239 severely burned pediatric patients with burns over greater than 30% of their total body surface area were randomized (block randomization 1:3) to intensive insulin treatment (n = 60) or control (n = 179). Demographics, clinical outcomes, sepsis, glucose metabolism, organ function, and inflammatory, acute-phase, and hypermetabolic responses were determined. Demographics were similar in both groups. Intensive insulin treatment significantly decreased the incidence of infections and sepsis compared with controls (P < 0.05). Furthermore, intensive insulin therapy improved organ function as indicated by improved serum markers, DENVER2 scores, and ultrasound (P < 0.05). Intensive insulin therapy alleviated post-burn insulin resistance and the vast catabolic response of the body (P < 0.05). Intensive insulin treatment dampened inflammatory and acute-phase responses by deceasing IL-6 and acute-phase proteins compared with controls (P < 0.05). Mortality was 4% in the intensive insulin therapy group and 11% in the control group (P = 0.14). In this prospective randomized clinical trial, we showed that intensive insulin therapy improves post-burn morbidity. Clinical trial registered with www.clinicaltrials.gov (NCT00673309).

  7. Intracellular delivery of potential therapeutic genes: prospects in cancer gene therapy.

    Science.gov (United States)

    Bakhtiar, Athirah; Sayyad, Mustak; Rosli, Rozita; Maruyama, Atsushi; Chowdhury, Ezharul H

    2014-01-01

    Conventional therapies for malignant cancer such as chemotherapy and radiotherapy are associated with poor survival rates owing to the development of cellular resistance to cancer drugs and the lack of targetability, resulting in unwanted adverse effects on healthy cells and necessitating the lowering of therapeutic dose with consequential lower efficacy of the treatment. Gene therapy employing different types of viral and non-viral carriers to transport gene(s) of interest and facilitating production of the desirable therapeutic protein(s) has tremendous prospects in cancer treatments due to the high-level of specificity in therapeutic action of the expressed protein(s) with diminished off-target effects, although cancer cell-specific delivery of transgene(s) still poses some challenges to be addressed. Depending on the potential therapeutic target genes, cancer gene therapy could be categorized into tumor suppressor gene replacement therapy, immune gene therapy and enzyme- or prodrug-based therapy. This review would shed light on the current progress of delivery of potentially therapeutic genes into various cancer cells in vitro and animal models utilizing a variety of viral and non-viral vectors.

  8. ORIGINAL ARTICLE: Preparedness of Prospective Nurses to Work as Midwives in Hospital and Community

    Directory of Open Access Journals (Sweden)

    Pratibha A Chandekar

    2012-01-01

    Full Text Available Background: It is desirable to have skilled midwives to provide competent care in hospital and community setting. Aims and Objectives: The objectives were to assess curriculum adequacy, preparedness and job preferences of prospective nurses. Materials and Methods: A descriptive survey was used for the study. Thestudy was carried out at nursing institutes in Ahmednagar District, Maharashtra, India. The participants were the 200 prospective Nurses(final year Nursing students of General Nursing and B.Sc Nursing Programme, who had undergone midwifery examination. A semi structured questionnaire with self report technique method was used. Results: 20.57% and 89.1% students respectively felt that, thetheory input and allotted clinical hours were adequate. During the clinical posting, 29.7% felt that they did not get the opportunity to work in midwifery sections. 33.1% students expressed that they did not get cases as per the requirement prescribed by Indian NursingCouncil.13.7% and 33.7% students respectively agreed that they lacked confidence to perform abdominal palpation of antenatal cases & conduct deliveries independently. A few (26.2% expressed their inability to resuscitate the newborn. 89.1% said that they needed more experience to work independently as midwives. Everyone felt the need of in-service education and majority (77.2% felt that its duration should be either three months or more. Conclusion: Present study reveals that only 7% of the prospective nurses are ready to work in midwifery section. Only 13.7% of the prospective nurses are ready to work in rural area. Since there is a shortfall of 70.02% forspeciality of obstetrics and gynecology in rural health (GOI, 1997, and there are only 40 qualified nurse midwives per 100,000 births inIndia or only one midwife for 2500 births in rural areas, it is imperative to strengthen midwifery training to bridge this gap.

  9. A VACUUM ASSISTED CLOSURE (VAC THERAPY IN ORTHOPAEDIC TRAUMA : A PROSPECTIVE STUDY

    Directory of Open Access Journals (Sweden)

    Suresh

    2015-10-01

    Full Text Available BACKGROUND: Management of open fractures and massive soft tissue injuries around leg ankle, foot and hand requires multi - disciplinary approach. VAC therapy is an innovative approach to the treatment of these wounds. VAC therapy facilitates granulation tissue formation, promotes healing, reduces infection and allows early skin grafting or flap closure. AIM: To describe our experience with VAC therapy for orthopaedics trauma around leg ankle, foot and hand. MATERIALS AND METHODS : 41 patients were included in Prospective Study performed at Preethi hospital, Madurai in years 2011 - 12. Only patients having t raumatic wound of leg, ankle, foot and hand were i ncluded. Patients with bleeding disorders were not included. VAC therapy was used as adjuvant to debridement in wound care. RESULTS: In 39 patients lower limb and in 2 patient hands was involved. The mean age was 39.3 years and 38 pateints were male 3 were female. Mean wound grade after VAC therapy decrease by 1 grade. Average wound area reduction was 10%. The mean duration of VAC therapy was 5.2 days. Plastic surgery was done in mean 6 days after removal of VAC dressing. Local flap was required in only 39% of patients. After VAC therapy all 10 patients having heel injury showed good granulation tissue. Complications like infection, bleeding and skin irritation were not seen in our study. CONCLUSION : VAC therapy is a viable adjuvant in the management of trau matic open wounds. It facilitates the rapid granulation tissue formation and wound healing. It reduces the duration of treatment, hospital stay and need of extensive plastic surgery

  10. Eurythmy therapy in chronic disease: a four-year prospective cohort study

    Directory of Open Access Journals (Sweden)

    Willich Stefan N

    2007-04-01

    Full Text Available Abstract Background Many patients with chronic diseases use complementary therapies, often provided by their physicians. In Germany, several physician-provided complementary therapies have been reimbursed by health insurance companies as part of health benefit programs. In most of these therapies, the patient has a predominantly passive role. In eurythmy therapy, however, patients actively exercise specific movements with the hands, the feet or the whole body. The purpose of this study was to describe clinical outcomes in patients practising eurythmy therapy exercises for chronic diseases. Methods In conjunction with a health benefit program, 419 outpatients from 94 medical practices in Germany, referred to 118 eurythmy therapists, participated in a prospective cohort study. Main outcomes were disease severity (Disease and Symptom Scores, physicians' and patients' assessment on numerical rating scales 0–10 and quality of life (adults: SF-36, children aged 8–16: KINDL, children 1–7: KITA. Disease Score was documented after 0, 6 and 12 months, other outcomes after 0, 3, 6, 12, 18, 24, and (SF-36 and Symptom Score 48 months. Results Most common indications were mental disorders (31.7% of patients; primarily depression, fatigue, and childhood emotional disorder and musculoskeletal diseases (23.4%. Median disease duration at baseline was 3.0 years (interquartile range 1.0–8.5. Median number of eurythmy therapy sessions was 12 (interquartile range 10–19, median therapy duration was 119 days (84–188. All outcomes improved significantly between baseline and all subsequent follow-ups (exceptions: KITA Psychosoma in first three months and KINDL. Improvements from baseline to 12 months were: Disease Score from mean (standard deviation 6.65 (1.81 to 3.19 (2.27 (p Adverse reactions to eurythmy therapy occurred in 3.1% (13/419 of patients. No patient stopped eurythmy therapy due to adverse reactions. Conclusion Patients practising eurythmy therapy

  11. Progress and prospects: gene therapy for genetic diseases with helper-dependent adenoviral vectors.

    Science.gov (United States)

    Brunetti-Pierri, N; Ng, P

    2008-04-01

    Preclinical studies in small and large animal models using helper-dependent adenoviral vectors (HDAds) have generated promising results for the treatment of genetic diseases. However, clinical translation is complicated by the dose-dependent, capsid-mediated acute toxic response following systemic vector injection. With the advancements in vectorology, a better understanding of vector-mediated toxicity, and improved delivery methods, HDAds may emerge as an important vector for gene therapy of genetic diseases and this report highlights recent progress and prospects in this field.

  12. Ultra-Early Combination Antiplatelet Therapy with Cilostazol for the Prevention of Branch Atheromatous Disease: A Multicenter Prospective Study

    OpenAIRE

    Teruo Kimura; Adam Tucker; Toshihide Sugimura; Toshitaka Seki; Shin Fukuda; Satoru Takeuchi; Shiro Miyata; Tsutomu Fujita; Akira Hashizume; Naoto Izumi; Kazutsune Kawasaki; Makoto Katsuno; Masaaki Hashimoto; Kazuhiro Sako

    2016-01-01

    Background and Purpose: The optimal use of antiplatelet therapy for intracranial branch atheromatous disease (BAD) is not known. Methods: We conducted a prospective multicenter, single-group trial of 144 consecutive patients diagnosed with probable BAD. All patients were treated within 12 h of symptom onset to prevent clinical progression using dual antiplatelet therapy with cilostazol plus one oral antiplatelet drug (aspirin or clopidogrel). Endpoints of progressive BAD in the dual therapy g...

  13. Subcutaneous immunoglobulin therapy for inflammatory neuropathy: current evidence base and future prospects.

    Science.gov (United States)

    Rajabally, Yusuf A

    2014-06-01

    Intravenous immunoglobulin therapy is of proven effect in chronic inflammatory neuropathies, including chronic inflammatory demyelinating polyneuropathy (CIDP) and multifocal motor neuropathy (MMN). In more recent years, there have been a number of anecdotal case reports and small series, followed by a few trials of variable design, of subcutaneous immunoglobulin therapy in these neuropathies. To date, limited evidence suggests that the subcutaneous route may be a more clinically effective, better-tolerated, at least cost-equivalent and a more patient-friendly option than the still more used intravenous alternative. Long-term efficacy is not as yet established in neuropathic indications by randomised controlled clinical trial evidence, and it is likely that the subcutaneous route may not be suitable in all cases with some hints to this effect appearing from the limited data available to date. Further studies are ongoing, including those of dose comparison, and more are likely to be planned in future. The literature on the use of subcutaneous immunoglobulin therapy in chronic inflammatory neuropathy is reviewed here. The current use in clinical practice, day-to-day benefits, including quality of life measures and health economics as published thus far, are evaluated. The limitations of this form of treatment in CIDP and MMN are also analysed in the light of current literature and taking into account the remaining unknowns. Future prospects and research with this mode of immunoglobulin therapy administration are discussed.

  14. The prospect of molecular therapy for Angelman syndrome and other monogenic neurologic disorders

    Science.gov (United States)

    2014-01-01

    Background Angelman syndrome is a monogenic neurologic disorder that affects 1 in 15,000 children, and is characterized by ataxia, intellectual disability, speech impairment, sleep disorders, and seizures. The disorder is caused by loss of central nervous system expression of UBE3A, a gene encoding a ubiquitin ligase. Current treatments focus on the management of symptoms, as there have not been therapies to treat the underlying molecular cause of the disease. However, this outlook is evolving with advances in molecular therapies, including artificial transcription factors a class of engineered DNA-binding proteins that have the potential to target a specific site in the genome. Results Here we review the recent progress and prospect of targeted gene expression therapies. Three main issues that must be addressed to advance toward human clinical trials are specificity, toxicity, and delivery. Conclusions Artificial transcription factors have the potential to address these concerns on a level that meets and in some cases exceeds current small molecule therapies. We examine the possibilities of such approaches in the context of Angelman syndrome, as a template for other single-gene, neurologic disorders. PMID:24946931

  15. Prospective randomized study for optimal insulin therapy in type 2 diabetic patients with secondary failure

    Directory of Open Access Journals (Sweden)

    Tojo Katsuyoshi

    2008-05-01

    Full Text Available Abstract Background The large clinical trials proved that Basal-Bolus (BB insulin therapy was effective in the prevention of diabetic complications and their progression. However, BB therapy needs multiple insulin injections per a day. In this regard, a biphasic insulin analogue needs only twice-daily injections, and is able to correct postprandial hyperglycemia. Therefore it may achieve the blood glucose control as same as that of BB therapy and prevent the diabetic complications including macroangiopathy. Methods In PROBE (Prospective, Randomized, Open, Blinded-Endpoint design, forty-two type 2 diabetic patients (male: 73.8%, median(inter quartile range age: 64.5(56.8~71.0years with secondary failure of sulfonylurea (SU were randomly assigned to BB therapy with a thrice-daily insulin aspart and once-daily basal insulin (BB group or to conventional therapy with a twice-daily biphasic insulin analogue (30 Mix group, and were followed up for 6 months to compare changes in HbA1c, daily glycemic profile, intima-media thickness (IMT of carotid artery, adiponectin levels, amounts of insulin used, and QOL between the two groups. Results After 6 months, HbA1c was significantly reduced in both groups compared to baseline (30 Mix; 9.3(8.1~11.3 → 7.4(6.9~8.7%, p Conclusion Both BB and 30 mix group produced comparable reductions in HbA1c in type 2 diabetic patients with secondary failure. There was no significant change in IMT as an indicator of early atherosclerotic changes between the two groups. The basal-bolus insulin therapy may not be necessarily needed if the type 2 diabetic patients have become secondary failure. Trial registration Current Controlled Trials number, NCT00348231

  16. Oncologic Therapy Support Via Means of a Dedicated Mobile App (OPTIMISE-1): Protocol for a Prospective Pilot Trial.

    Science.gov (United States)

    El Shafie, Rami A; Bougatf, Nina; Sprave, Tanja; Weber, Dorothea; Oetzel, Dieter; Machmer, Timo; Huber, Peter E; Debus, Jürgen; Nicolay, Nils H

    2018-03-06

    The increasing role of consumer electronics and Web-enabled mobile devices in the medical sector opens up promising possibilities for integrating novel technical solutions into therapy and patient support for oncologic illnesses. A recent survey carried out at Heidelberg University Hospital suggested a high acceptance among patients for an additional approach to patient care during radiotherapy based on patient-reported outcomes by a dedicated mobile app. The aim of this trial (OPTIMISE-1: Oncologic Therapy Support Via Means of a Dedicated Mobile App - A Prospective Feasibility Evaluation) is to prospectively evaluate the feasibility of employing a mobile app for the systematic support of radiooncological patients throughout the course of their radiotherapy by monitoring symptoms and patient performance, and facilitating the background-exchange of relevant information between patient and physician. The present single-center, prospective, exploratory trial, conducted at Heidelberg University Hospital, assesses the feasibility of integrating an app-based approach into patient-care during radiotherapy. Patients undergoing curative radiotherapy for thoracic or pelvic tumors will be surveyed regarding general performance, treatment-related quality of life (QoL) and symptoms, and their need to personally consult a physician by means of a mobile app during treatment. The primary endpoint of feasibility will be reached when 80% of the patients have successfully answered 80% of their respective questions scheduled for each treatment day. Furthermore, treatment-related patient satisfaction and health-related QoL is assessed by the Patient Satisfaction Questionnaire Short Form (PSQ-18) and the European Organization for Research and Treatment of Cancer (EORTC) questionnaires at the beginning (baseline) and end of radiotherapy, and at the first follow-up. This trial will recruit 50 patients over a period of 12 months. Follow-up will be completed after 18 months, and publication

  17. Chamomile Consumption and Mortality: A Prospective Study of Mexican Origin Older Adults.

    Science.gov (United States)

    Howrey, Bret T; Peek, M Kristen; McKee, Juliet M; Raji, Mukaila A; Ottenbacher, Kenneth J; Markides, Kyriakos S

    2016-12-01

    Approximately 20% of adults use some kind of herbal; however, little data exists from population-based study or clinical trials to support effectiveness of most herbal products. Chamomile is a commonly used herb among older adults of Mexican origin. We examined the effects of herbal chamomile consumption on mortality among older adults of Mexican origin. A sample from the Hispanic Established Populations for Epidemiologic Study of the Elderly, a population-based study of noninstitutionalized Mexican Americans aged 65 and older from five Southwestern states (Texas, California, New Mexico, Colorado, and Arizona). We included all men and women from 2000 to 2007 (n = 1,677). Chamomile was used by 14% of the sample. Cox proportional hazards regression analyses showed that chamomile was associated with a decreased risk of mortality in the total sample (hazard ratio [HR] 0.71, 95% confidence interval [CI] 0.55-0.92) and for women (HR 0.67, 95% CI 0.49-0.92) but not for men. In models adjusted for sociodemographic variables, health behaviors, and chronic conditions, chamomile remained significantly associated with reduced mortality in women (HR 0.72, 95% CI 0.53-0.98). The use of chamomile shows protective effects against mortality in this sample of older adults of Mexican origin for women. Further research is warranted in other populations to determine if these effects are consistent. © The Author 2015. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  18. Anthroposophic therapy for asthma: A two-year prospective cohort study in routine outpatient settings

    Directory of Open Access Journals (Sweden)

    Harald J Hamre

    2009-11-01

    .78. All improvements were maintained until last follow-up after 24 months.Conclusions: Patients with asthma under anthroposophic treatment had long-term improvements of symptoms and quality of life.Keywords: anthroposophy, art therapy, asthma, combined modality therapy, drug therapy, eurythmy therapy, prospective studies, quality of life

  19. Auditive stimulation therapy as an intervention in subacute and chronic tinnitus: a prospective observational study.

    Science.gov (United States)

    Kusatz, Martin; Ostermann, Thomas; Aldridge, David

    2005-01-01

    Tinnitus is a noise, a ringing, or a roaring sound in the affected ear and is becoming an increasingly serious problem for health care systems. Integrative treatment concepts are currently regarded as promising therapeutic approaches for managing tinnitus. The aim of this study was to present the results of auditive stimulation therapy, a program of music therapy developed specifically for tinnitus treatment. We collected data on outpatient treatment results from 155 tinnitus patients and evaluated them in a prospective observational study with three defined times of measurement (start, end, and 6 months after the end of treatment). Apart from anamnestic data and subjective evaluation of treatment, the major outcome parameter was the score of the tinnitus questionnaire. To evaluate effectiveness of the therapy, we calculated effect sizes (according to Cohen). Fifty-one percent of the patients were male, and the mean patient age was 49 years. Of the 155 patients, 137 (88%) were capable of gainful employment, which means that they fell in the age range between 18 and 65 years. The duration of tinnitus was more than 6 months for 80% of patients, and 43% had been suffering from tinnitus for more than 3 years. In general, all subscales of the tinnitus questionnaire showed highly significant changes (t-test, p observe a reduction to the level prior to treatment. The values for the effect sizes mostly ranged between medium (> 0.5) and high (> 0.8). Closer investigations indicated that a combination of music therapy and psychological training rendered the best effect sizes. This study demonstrated that music therapy is an effective integrated treatment approach and offers a way to make progress in tinnitus treatment.

  20. Origin of Tumor Recurrence After Intensity Modulated Radiation Therapy for Oropharyngeal Squamous Cell Carcinoma

    International Nuclear Information System (INIS)

    Raktoe, Sawan A.S.; Dehnad, Homan; Raaijmakers, Cornelis P.J.; Braunius, Weibel; Terhaard, Chris H.J.

    2013-01-01

    Purpose: To model locoregional recurrences of oropharyngeal squamous cell carcinomas (OSCC) treated with primary intensity modulated radiation therapy (IMRT) in order to find the origins from which recurrences grow and relate their location to original target volume borders. Methods and Materials: This was a retrospective analysis of OSCC treated with primary IMRT between January 2002 and December 2009. Locoregional recurrence volumes were delineated on diagnostic scans and coregistered rigidly with treatment planning computed tomography scans. Each recurrence was analyzed with two methods. First, overlapping volumes of a recurrence and original target were measured (‘volumetric approach’) and assessed as ‘in-field’, ‘marginal’, or ‘out-field’. Then, the center of mass (COM) of a recurrence volume was assumed as the origin from where a recurrence expanded, the COM location was compared with original target volume borders and assessed as ‘in-field’, ‘marginal’, or ‘out-field’. Results: One hundred thirty-one OSCC were assessed. For all patients alive at the end of follow-up, the mean follow-up time was 40 months (range, 12-83 months); 2 patients were lost to follow-up. The locoregional recurrence rate was 27%. Of all recurrences, 51% were local, 23% were regional, and 26% had both local and regional recurrences. Of all recurrences, 74% had imaging available for assessment. Regarding volumetric analysis of local recurrences, 15% were in-field gross tumor volume (GTV), and 65% were in-field clinical tumor volume (CTV). Using the COM approach, we found that 70% of local recurrences were in-field GTV and 90% were in-field CTV. Of the regional recurrences, 25% were volumetrically in-field GTV, and using the COM approach, we found 54% were in-field GTV. The COM of local out-field CTV recurrences were maximally 16 mm outside CTV borders, whereas for regional recurrences, this was 17 mm. Conclusions: The COM model is practical and specific for

  1. Origin of Tumor Recurrence After Intensity Modulated Radiation Therapy for Oropharyngeal Squamous Cell Carcinoma

    Energy Technology Data Exchange (ETDEWEB)

    Raktoe, Sawan A.S. [Department of Radiotherapy, University Medical Center Utrecht, Utrecht (Netherlands); Dehnad, Homan, E-mail: h.dehnad@umcutrecht.nl [Department of Radiotherapy, University Medical Center Utrecht, Utrecht (Netherlands); Raaijmakers, Cornelis P.J. [Department of Radiotherapy, University Medical Center Utrecht, Utrecht (Netherlands); Braunius, Weibel [Department of ENT Head and Neck Surgery, University Medical Center Utrecht, Utrecht (Netherlands); Terhaard, Chris H.J. [Department of Radiotherapy, University Medical Center Utrecht, Utrecht (Netherlands)

    2013-01-01

    Purpose: To model locoregional recurrences of oropharyngeal squamous cell carcinomas (OSCC) treated with primary intensity modulated radiation therapy (IMRT) in order to find the origins from which recurrences grow and relate their location to original target volume borders. Methods and Materials: This was a retrospective analysis of OSCC treated with primary IMRT between January 2002 and December 2009. Locoregional recurrence volumes were delineated on diagnostic scans and coregistered rigidly with treatment planning computed tomography scans. Each recurrence was analyzed with two methods. First, overlapping volumes of a recurrence and original target were measured ('volumetric approach') and assessed as 'in-field', 'marginal', or 'out-field'. Then, the center of mass (COM) of a recurrence volume was assumed as the origin from where a recurrence expanded, the COM location was compared with original target volume borders and assessed as 'in-field', 'marginal', or 'out-field'. Results: One hundred thirty-one OSCC were assessed. For all patients alive at the end of follow-up, the mean follow-up time was 40 months (range, 12-83 months); 2 patients were lost to follow-up. The locoregional recurrence rate was 27%. Of all recurrences, 51% were local, 23% were regional, and 26% had both local and regional recurrences. Of all recurrences, 74% had imaging available for assessment. Regarding volumetric analysis of local recurrences, 15% were in-field gross tumor volume (GTV), and 65% were in-field clinical tumor volume (CTV). Using the COM approach, we found that 70% of local recurrences were in-field GTV and 90% were in-field CTV. Of the regional recurrences, 25% were volumetrically in-field GTV, and using the COM approach, we found 54% were in-field GTV. The COM of local out-field CTV recurrences were maximally 16 mm outside CTV borders, whereas for regional recurrences, this was 17 mm. Conclusions: The

  2. Electromagnetic-Guided MLC Tracking Radiation Therapy for Prostate Cancer Patients: Prospective Clinical Trial Results.

    Science.gov (United States)

    Keall, Paul J; Colvill, Emma; O'Brien, Ricky; Caillet, Vincent; Eade, Thomas; Kneebone, Andrew; Hruby, George; Poulsen, Per R; Zwan, Benjamin; Greer, Peter B; Booth, Jeremy

    2018-02-06

    To report on the primary and secondary outcomes of a prospective clinical trial of electromagnetic-guided multileaf collimator (MLC) tracking radiation therapy for prostate cancer. Twenty-eight men with prostate cancer were treated with electromagnetic-guided MLC tracking with volumetric modulated arc therapy. A total of 858 fractions were delivered, with the dose per fraction ranging from 2 to 13.75 Gy. The primary outcome was feasibility, with success determined if >95% of fractions were successfully delivered. The secondary outcomes were (1) the improvement in beam-target geometric alignment, (2) the improvement in dosimetric coverage of the prostate and avoidance of critical structures, and (3) no acute grade ≥3 genitourinary or gastrointestinal toxicity. All 858 planned fractions were successfully delivered with MLC tracking, demonstrating the primary outcome of feasibility (P radiation therapy for prostate cancer is feasible. The patients received improved geometric targeting and delivered dose distributions that were closer to those planned than they would have received without electromagnetic-guided MLC tracking. No significant acute toxicity was observed. Copyright © 2018 Elsevier Inc. All rights reserved.

  3. Origin and prospectivity of heavy mineral enriched sand deposits along the Somaliland coastal areas

    Science.gov (United States)

    Ali, M. Y.; Hibberd, P.; Stoikovich, B.

    2018-04-01

    minerals, in particular ilmenite. It appears that prospects for development of the heavy mineral sands in the east of Berbera are better than those to the west of Berbera. In general, east of Berbera has wider beaches, better heavy mineral sands in the upper horizons and dune areas with heavier mineral sands. Furthermore, a series of raised paleo-beaches with high concentrations of heavy mineral sands are observed 1-2 km behind the shoreline. However, further investigation, including drilling and laboratory analyses, still needs to be carried out, particularly close to the entrance of Waaheen and Biyo Gure ephemeral rivers to evaluate the potential quality and scale of the deposits.

  4. Cultural Diversity as a Concept of Global Law: Origins, Evolution and Prospects

    Directory of Open Access Journals (Sweden)

    Mira Burri

    2010-08-01

    Full Text Available “Cultural diversity” has become one of the latest buzzwords on the international policymaking scene. It is employed in various contexts—sometimes as a term close to “biological diversity”, at other times as correlated to the “exception culturelle” and most often, as a generic concept that is mobilised to counter the perceived negative effects of economic globalisation. While no one has yet provided a precise definition of what cultural diversity is, what we can observe is the emergence of the notion of cultural diversity as incorporating a distinct set of policy objectives and choices at the global level. These decisions are not confined, as one might have expected, to cultural policymaking, but rather spill over to multiple governance domains because of the complex linkages inherent to the simultaneous pursuit of economic and other societal goals that cultural diversity encompasses and has effects on. Accounting for these intricate interdependencies, the present article clarifies the origins of the concept of cultural diversity as understood in global law and traces its evolution over time. Observing the dynamics of the concept and the surrounding political and legal developments in particular in the context of trade and culture, the article explores its justification and overall impact on the global legal regime, as well as its discrete effects on different domains of policymaking, such as media and intellectual property. While the analysis is legal in essence, the article is also meant to speak to a broader transdisciplinary public.

  5. The High Cost of Prescription Drugs in the United States: Origins and Prospects for Reform.

    Science.gov (United States)

    Kesselheim, Aaron S; Avorn, Jerry; Sarpatwari, Ameet

    The increasing cost of prescription drugs in the United States has become a source of concern for patients, prescribers, payers, and policy makers. To review the origins and effects of high drug prices in the US market and to consider policy options that could contain the cost of prescription drugs. We reviewed the peer-reviewed medical and health policy literature from January 2005 to July 2016 for articles addressing the sources of drug prices in the United States, the justifications and consequences of high prices, and possible solutions. Per capita prescription drug spending in the United States exceeds that in all other countries, largely driven by brand-name drug prices that have been increasing in recent years at rates far beyond the consumer price index. In 2013, per capita spending on prescription drugs was $858 compared with an average of $400 for 19 other industrialized nations. In the United States, prescription medications now comprise an estimated 17% of overall personal health care services. The most important factor that allows manufacturers to set high drug prices is market exclusivity, protected by monopoly rights awarded upon Food and Drug Administration approval and by patents. The availability of generic drugs after this exclusivity period is the main means of reducing prices in the United States, but access to them may be delayed by numerous business and legal strategies. The primary counterweight against excessive pricing during market exclusivity is the negotiating power of the payer, which is currently constrained by several factors, including the requirement that most government drug payment plans cover nearly all products. Another key contributor to drug spending is physician prescribing choices when comparable alternatives are available at different costs. Although prices are often justified by the high cost of drug development, there is no evidence of an association between research and development costs and prices; rather, prescription

  6. Comprehensive pelvic floor physical therapy program for men with idiopathic chronic pelvic pain syndrome: a prospective study

    OpenAIRE

    Masterson, Thomas A.; Masterson, John M.; Azzinaro, Jessica; Manderson, Lattoya; Swain, Sanjaya; Ramasamy, Ranjith

    2017-01-01

    Background Male chronic pelvic pain syndrome (CPPS) is a heterogeneous constellation of symptoms that causes significant impairment and is often challenging to treat. In this prospective study, we evaluated men with CPPS who underwent comprehensive pelvic floor physical therapy (PFPT) program. We used the previously validated Genitourinary Pain Index (GUPI) to measure outcomes. Methods We included 14 men who underwent physical therapy for idiopathic CPPS from October 2015 to October 2016. Men...

  7. Prospective Evaluation of Severe Skin Toxicity and Pain During Postmastectomy Radiation Therapy

    Energy Technology Data Exchange (ETDEWEB)

    Pignol, Jean-Philippe, E-mail: j.p.pignol@erasmusmc.nl [Department of Radiation Oncology, Erasmus University, Rotterdam (Netherlands); Vu, Thi Trinh Thuc [Department of Radiation Oncology, Centre Hospitalier de l' Université de Montréal, Montreal, Québec (Canada); Mitera, Gunita [Department of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario (Canada); Bosnic, Sandy [Department of Radiation Oncology, University of Toronto, Toronto, Ontario (Canada); Verkooijen, Helena M. [Imaging Division, University Medical Centre Utrecht, Utrecht (Netherlands); Truong, Pauline [Department of Radiation Oncology, BC Cancer Agency, Vancouver Island Centre, Victoria, British Columbia (Canada)

    2015-01-01

    Purpose: To prospectively capture acute toxicities and pain associated with postmastectomy radiation therapy (PMRT), to analyze patient and treatment risk factors for severe side effects. Methods and Materials: Women referred for PMRT were prospectively enrolled and assessed weekly during and after radiation therapy. The endpoint included severe National Cancer Institute Common Terminology Criteria for Adverse Effects grade 3 moist desquamation, other skin symptoms, and pain. Results: Of 257 patients, 73 (28.4%) experienced extensive moist desquamation, 84 (32.7%) Common Terminology Criteria for Adverse Effects skin toxicity grade 3, and 57 (22.2%) a pain impacting on daily life activities. Among symptoms only grade 3 moist desquamation was significantly associated with severe pain (P<.001). On multivariate analysis, smoking, high-energy photons, and skin bolus were significantly associated with severe moist desquamation. Skin toxicity doubled for smokers, with 40% severe pain, 48% grade 3 moist desquamation, and 64% grade 3 skin toxicity. Without skin bolus 4.2% had severe pain, none moist desquamation, and 2.1% grade 3 skin toxicity. When skin bolus was used on alternate days, the frequency increased to 15% for pain, 22% for moist desquamation, and 26% for grade 3 skin toxicity. When bolus was used daily, 32% had pain, 41% moist desquamation, and 47% grade 3 skin toxicity. Symptoms peaked 1 to 2 weeks after the end of PMRT. Conclusions: The present cohort study suggests excessive radiation toxicity after PMRT. Among factors associated with an increase of toxicity are smoking habits and the use of skin bolus.

  8. Prospective evaluation of severe skin toxicity and pain during postmastectomy radiation therapy.

    Science.gov (United States)

    Pignol, Jean-Philippe; Vu, Thi Trinh Thuc; Mitera, Gunita; Bosnic, Sandy; Verkooijen, Helena M; Truong, Pauline

    2015-01-01

    To prospectively capture acute toxicities and pain associated with postmastectomy radiation therapy (PMRT), to analyze patient and treatment risk factors for severe side effects. Women referred for PMRT were prospectively enrolled and assessed weekly during and after radiation therapy. The endpoint included severe National Cancer Institute Common Terminology Criteria for Adverse Effects grade 3 moist desquamation, other skin symptoms, and pain. Of 257 patients, 73 (28.4%) experienced extensive moist desquamation, 84 (32.7%) Common Terminology Criteria for Adverse Effects skin toxicity grade 3, and 57 (22.2%) a pain impacting on daily life activities. Among symptoms only grade 3 moist desquamation was significantly associated with severe pain (Pmultivariate analysis, smoking, high-energy photons, and skin bolus were significantly associated with severe moist desquamation. Skin toxicity doubled for smokers, with 40% severe pain, 48% grade 3 moist desquamation, and 64% grade 3 skin toxicity. Without skin bolus 4.2% had severe pain, none moist desquamation, and 2.1% grade 3 skin toxicity. When skin bolus was used on alternate days, the frequency increased to 15% for pain, 22% for moist desquamation, and 26% for grade 3 skin toxicity. When bolus was used daily, 32% had pain, 41% moist desquamation, and 47% grade 3 skin toxicity. Symptoms peaked 1 to 2 weeks after the end of PMRT. The present cohort study suggests excessive radiation toxicity after PMRT. Among factors associated with an increase of toxicity are smoking habits and the use of skin bolus. Copyright © 2015 Elsevier Inc. All rights reserved.

  9. Prospective Evaluation of Severe Skin Toxicity and Pain During Postmastectomy Radiation Therapy

    International Nuclear Information System (INIS)

    Pignol, Jean-Philippe; Vu, Thi Trinh Thuc; Mitera, Gunita; Bosnic, Sandy; Verkooijen, Helena M.; Truong, Pauline

    2015-01-01

    Purpose: To prospectively capture acute toxicities and pain associated with postmastectomy radiation therapy (PMRT), to analyze patient and treatment risk factors for severe side effects. Methods and Materials: Women referred for PMRT were prospectively enrolled and assessed weekly during and after radiation therapy. The endpoint included severe National Cancer Institute Common Terminology Criteria for Adverse Effects grade 3 moist desquamation, other skin symptoms, and pain. Results: Of 257 patients, 73 (28.4%) experienced extensive moist desquamation, 84 (32.7%) Common Terminology Criteria for Adverse Effects skin toxicity grade 3, and 57 (22.2%) a pain impacting on daily life activities. Among symptoms only grade 3 moist desquamation was significantly associated with severe pain (P<.001). On multivariate analysis, smoking, high-energy photons, and skin bolus were significantly associated with severe moist desquamation. Skin toxicity doubled for smokers, with 40% severe pain, 48% grade 3 moist desquamation, and 64% grade 3 skin toxicity. Without skin bolus 4.2% had severe pain, none moist desquamation, and 2.1% grade 3 skin toxicity. When skin bolus was used on alternate days, the frequency increased to 15% for pain, 22% for moist desquamation, and 26% for grade 3 skin toxicity. When bolus was used daily, 32% had pain, 41% moist desquamation, and 47% grade 3 skin toxicity. Symptoms peaked 1 to 2 weeks after the end of PMRT. Conclusions: The present cohort study suggests excessive radiation toxicity after PMRT. Among factors associated with an increase of toxicity are smoking habits and the use of skin bolus

  10. Adverse reactions due to directly observed treatment strategy therapy in Chinese tuberculosis patients: a prospective study.

    Directory of Open Access Journals (Sweden)

    Xiaozhen Lv

    Full Text Available BACKGROUND: More than 1 million tuberculosis (TB patients are receiving directly observed treatment strategy (DOTS therapy in China every year. As to the profile of adverse drug reactions (ADRs due to DOTS therapy, no consensus has been reached. There is no report regarding ADRs due to DOTS therapy with a large Chinese TB population. This study aimed to determine the incidence and prognosis of ADRs due to DOTS therapy, and to evaluate their impact on anti-TB treatment in China. METHODS: A prospective population-based cohort study was performed during 2007-2008. Sputum smear positive pulmonary TB patients who received DOTS therapy were included and followed up for six to nine months in 52 counties of four regions in China. The suspected ADRs were recorded and reviewed by Chinese State Food and Drug Administration. RESULTS: A total of 4304 TB patients were included in this study. 649 patients (15.08% showed at least one ADR and 766 cases in total were detected. The incidence (count of ADR based on affected organ was: liver dysfunction 6.34% (273, gastrointestinal disorders 3.74% (161, arthralgia 2.51% (108, allergic reactions 2.35% (101, neurological system disorders 2.04% (88, renal impairment 0.07% (3 and others 0.05% (2. Most cases of ADRs (95% had a good clinical outcome, while two with hepatotoxicity and one with renal impairment died. Compared with patients without ADRs, patients with ADRs were more likely to have positive smear test results at the end of the intensive phase (adjusted OR, 2.00; 95%CI, 1.44-2.78 and unsuccessful anti-TB outcomes (adjusted OR, 2.58; 95%CI, 1.43-4.68. CONCLUSIONS: The incidence of ADRs due to DOTS therapy was 15.08%. Those ADRs had a substantial impact on TB control in China. This highlighted the importance of developing strategies to ameliorate ADRs both to improve the quality of patient care and to control TB safely.

  11. Use of Play Therapy in Nursing Process: A Prospective Randomized Controlled Study.

    Science.gov (United States)

    Sezici, Emel; Ocakci, Ayse Ferda; Kadioglu, Hasibe

    2017-03-01

    Play therapy is a nursing intervention employed in multidisciplinary approaches to develop the social, emotional, and behavioral skills of children. In this study, we aim to determine the effects of play therapy on the social, emotional, and behavioral skills of pre-school children through the nursing process. A single-blind, prospective, randomized controlled study was undertaken. The design, conduct, and reporting of this study adhere to the Consolidated Standards of Reporting Trials (CONSORT) guidelines. The participants included 4- to 5-year-old kindergarten children with no oral or aural disabilities and parents who agreed to participate in the study. The Pre-school Child and Family Identification Form and Social Competence and the Behavior Evaluation Scale were used to gather data. Games in the play therapy literature about nursing diagnoses (fear, social disturbance, impaired social interactions, ineffective coping, anxiety), which were determined after the preliminary test, constituted the application of the study. There was no difference in the average scores of the children in the experimental and control groups in their Anger-Aggression (AA), Social Competence (SC), and Anxiety-Withdrawal (AW) scores beforehand (t = 0.015, p = .988; t = 0.084, p = .933; t = 0.214, p = .831, respectively). The difference between the average AA and SC scores in the post-test (t = 2.041, p = .045; t = 2.692, p = .009, respectively), and the retests were statistically significant in AA and SC average scores in the experimental and control groups (t = 4.538, p = .000; t = 4.693; p = .000, respectively). In AW average scores, no statistical difference was found in the post-test (t = 0.700, p = .486), whereas in the retest, a significant difference was identified (t = 5.839, p = .000). Play therapy helped pre-school children to improve their social, emotional, and behavioral skills. It also provided benefits for the children to decrease their fear and anxiety levels, to improve

  12. Fetal and life course origins of serum lipids in mid-adulthood: results from a prospective cohort study

    Directory of Open Access Journals (Sweden)

    Gustafsson Per E

    2010-08-01

    Full Text Available Abstract Background During the past two decades, the hypothesis of fetal origins of adult disease has received considerable attention. However, critique has also been raised regarding the failure to take the explanatory role of accumulation of other exposures into consideration, despite the wealth of evidence that social circumstances during the life course impact on health in adulthood. The aim of the present prospective cohort study was to examine the contributions of birth weight and life course exposures (cumulative socioeconomic disadvantage and adversity to dyslipidemia and serum lipids in mid-adulthood. Methods A cohort (effective n = 824, 77% was prospectively examined with respect to self-reported socioeconomic status as well as stressors (e.g., financial strain, low decision latitude, separation, death or illness of a close one, unemployment at the ages of 16, 21, 30 and 43 years; summarized in cumulative socioeconomic disadvantage and cumulative adversity. Information on birth weight was collected from birth records. Participants were assessed for serum lipids (total cholesterol, low- and high-density lipoprotein cholesterol and triglycerides, apolipoproteins (A1 and B and height and weight (for the calculation of body mass index, BMI at age 43. Current health behavior (alcohol consumption, smoking and snuff use was reported at age 43. Results Cumulative life course exposures were related to several outcomes; mainly explained by cumulative socioeconomic disadvantage in the total sample (independently of current health behaviors but attenuated by current BMI and also by cumulative adversity in women (partly explained by current health behavior but not by BMI. Birth weight was related only to triglycerides in women, independently of life course exposures, health behaviors and BMI. No significant association of either exposure was observed in men. Conclusions Social circumstances during the life course seem to be of greater importance

  13. Radiation therapy in patients with implanted cardiac pacemakers and implantable cardioverter defibrillators. A prospective survey in Japan

    International Nuclear Information System (INIS)

    Soejima, Toshinori; Yoden, Eisaku; Nishimura, Yasumasa

    2011-01-01

    Patients with implanted cardiac pacemakers (ICPs) or implantable cardioverter defibrillators (ICDs) are increasing in number, and the incidence of treating these patients with radiation therapy also is increasing. Thus, a prospective survey was conducted of patients with these devices receiving radiation therapy. A prospective survey of patients with ICPs or ICDs treated with radiation therapy was conducted on methods of radiation therapy, status of ICP/ICD, and management of patients before, during, and after radiation therapy. After completion of radiation therapy, study participants were registered via mail, fax, or e-mail. Sixty-two patients from 29 institutions were registered from September 2006 to December 2008. Sixty patients had an ICP and 2 had an ICD. The total dose was estimated before radiation therapy by dose-volume histogram in 26 patients (42%) and by measurement of actual doses in 9 (15%). In one patient, the maximum total dose was 2069 cGy; however, in the other patients, the ICP/ICD dose did not exceed 478 cGy. Function of ICPs and ICDs was checked before radiation therapy in 38 patients (61%), after radiation therapy in 32 (52%), and both before and after radiation therapy in 29 (47%). ICP malfunction occurred in a patient with prostate cancer treated by intensity-modulated radiation therapy to the prostate. Even when an ICP or ICD is not within the field of radiation, malfunction of the device may still occur. To minimize the risk to patients, precautions must be taken during the planning and administration of radiation therapy. (author)

  14. Discontinuation of anti-tumor necrosis factor therapy in inflammatory bowel disease patients: a prospective observation.

    Science.gov (United States)

    Bortlik, Martin; Duricova, Dana; Machkova, Nadezda; Hruba, Veronika; Lukas, Martin; Mitrova, Katarina; Romanko, Igor; Bina, Vladislav; Malickova, Karin; Kolar, Martin; Lukas, Milan

    2016-01-01

    Discontinuation of anti-TNF therapy in patients with inflammatory bowel diseases (IBD) in remission remains a controversial issue. The aims of our study were to assess the proportion of patients who relapse after cessation of biological treatment, and to identify potential risk factors of disease relapse. Consecutive IBD patients who discontinued anti-TNF therapy in steroid-free clinical and endoscopic remission were prospectively followed. Multiple logistic regression and Cox proportional-hazards models were used to assess the predictors of disease relapse. Seventy-eight IBD patients (Crohn's disease, CD 61; ulcerative colitis, UC 17) were included and followed for a median of 30 months (range 7-47). A total of 32 (53%) CD patients and nine (53%) UC patients relapsed by the end of the follow-up with a median time to relapse of 8 months (range 1-25) in CD patients and 14 months (range 4-37) in UC patients, respectively. The cumulative probabilities of maintaining remission at 6, 12, and 24 months were 82%, 59%, and 51% in CD patients, and 77%, 77%, and 64% in UC patients, respectively. Survival of CD patients who were in deep remission (clinical and endoscopic healing; faecal calprotectin disease relapse. Approximately half of the IBD patients relapsed within 2 years after anti-TNF discontinuation. In CD patients, no difference between those who were or were not in deep remission was found. Colonic localization protected patients from relapse.

  15. Proton Therapy for Breast Cancer After Mastectomy: Early Outcomes of a Prospective Clinical Trial

    Energy Technology Data Exchange (ETDEWEB)

    MacDonald, Shannon M., E-mail: smacdonald@partners.org [Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts (United States); Patel, Sagar A.; Hickey, Shea [Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts (United States); Specht, Michelle [Department of Surgical Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts (United States); Isakoff, Steven J. [Division of Hematology and Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts (United States); Gadd, Michele; Smith, Barbara L. [Department of Surgical Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts (United States); Yeap, Beow Y. [Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts (United States); Adams, Judith; DeLaney, Thomas F.; Kooy, Hanne; Lu, Hsiao-Ming; Taghian, Alphonse G. [Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts (United States)

    2013-07-01

    Purpose: Dosimetric planning studies have described potential benefits for the use of proton radiation therapy (RT) for locally advanced breast cancer. We report acute toxicities and feasibility of proton delivery for 12 women treated with postmastectomy proton radiation with or without reconstruction. Methods and Materials: Twelve patients were enrolled in an institutional review board-approved prospective clinical trial. The patients were assessed for skin toxicity, fatigue, and radiation pneumonitis during treatment and at 4 and 8 weeks after the completion of therapy. All patients consented to have photographs taken for documentation of skin toxicity. Results: Eleven of 12 patients had left-sided breast cancer. One patient was treated for right-sided breast cancer with bilateral implants. Five women had permanent implants at the time of RT, and 7 did not have immediate reconstruction. All patients completed proton RT to a dose of 50.4 Gy (relative biological effectiveness [RBE]) to the chest wall and 45 to 50.4 Gy (RBE) to the regional lymphatics. No photon or electron component was used. The maximum skin toxicity during radiation was grade 2, according to the Common Terminology Criteria for Adverse Events (CTCAE). The maximum CTCAE fatigue was grade 3. There have been no cases of RT pneumonitis to date. Conclusions: Proton RT for postmastectomy RT is feasible and well tolerated. This treatment may be warranted for selected patients with unfavorable cardiac anatomy, immediate reconstruction, or both that otherwise limits optimal RT delivery using standard methods.

  16. EFFICACY OF SPINAL-CORD STIMULATION AS ADJUVANT THERAPY FOR INTRACTABLE ANGINA-PECTORIS - A PROSPECTIVE, RANDOMIZED CLINICAL-STUDY

    NARCIS (Netherlands)

    DEJONGSTE, MJL; HAUTVAST, RWM; HILLEGE, HL; LIE, KI

    Objectives. In a prospective, randomized study with an 8-week follow-up period, we evaluated the efficacy of spinal cord stimulation an exercise capacity and quality of life in patients with intractable angina. Background. Despite important achievements in therapy for ischemic heart disease, there

  17. PRELIMINARY RESULTS OF COMPARATIVE PHARMACOECONOMIC PROSPECTIVE STUDY OF DIFFERENT THERAPIES OF ARTERIAL HYPERTENSION

    Directory of Open Access Journals (Sweden)

    E. I. Tarlovskaya

    2015-12-01

    Full Text Available Aim. To carry out a comparative pharmacoeconomic analysis of two different types of antihypertensive therapy in patients with arterial hypertension (HT. Material and methods. 38 patients with essential HT (aged 18 to 70 years, 11 males and 27 females associated with metabolic syndrome, and having a history of previous ineffective antihypertensive therapy were included into the study. The patients were randomized into 2 groups. Patients of V/A group received a fixed combination of valsartan and amlodipine (Exforge, Novartis in dose of 5/160 and 10/160 mg depending on blood pressure (BP level. Patients of L/A group received losartan (Lorista, KRKA in dose of 100 mg and amlodipine (Tenox, KRKA in dose of 5 and 10 mg. Treatment duration was 24 weeks. If target level of BP was not achieved during 12 weeks, indapamide retard was added to the therapies (Ravel SR, KRKA. Dinamics of BP and left ventricular mass index (LVMI were considered. Cost-effectiveness method of analysis was used. Results. In V/A group 75% of patients achieved target BP levels for 24 weeks, while in L/A group — 33.3% of patients, and 16.7% of patients more after indapamide addition. L/A therapy cost was lower in comparison with this of V/A therapy: 57864.24 vs 156671.0 rubles per 24 weeks, respectively. Calculation shows that additional cost of 669.23 rubles during 24 weeks is needed to achieve BP target level in every next patient when V/A therapy is used instead of L/A therapy. LVMI reduction by 1% took 1015.13 rubles cost in V/A group and almost 6 times more in L/A group. Conclusion. Pharmacoeconomic analysis revealed that generic combination of L/A is the most cost-effective for BP reduction. Very low cost is required to achieve additional effect with original fixed V/A combination. V/A combination is the most economical for the left ventricular hypertrophy reduction. Thus, V/A combination is rational for use in HT patients with severe target-organs damage.

  18. Early Outcomes From Three Prospective Trials of Image-Guided Proton Therapy for Prostate Cancer

    International Nuclear Information System (INIS)

    Mendenhall, Nancy P.; Li Zuofeng; Hoppe, Bradford S.; Marcus, Robert B.; Mendenhall, William M.; Nichols, R. Charles; Morris, Christopher G.; Williams, Christopher R.; Costa, Joseph; Henderson, Randal

    2012-01-01

    Purpose: To report early outcomes with image-guided proton therapy for prostate cancer. Methods and Materials: We accrued 211 prostate cancer patients on prospective Institutional Review Board-approved trials of 78 cobalt gray equivalent (CGE) in 39 fractions for low–risk disease, dose escalation from 78 to 82 CGE for intermediate-risk disease, and 78 CGE with concomitant docetaxel followed by androgen deprivation for high-risk disease. Minimum follow-up was 2 years. Results: One intermediate-risk patient and 2 high-risk patients had disease progression. Pretreatment genitourinary (GU) symptom management was required in 38% of patients. A cumulative 88 (42%) patients required posttreatment GU symptom management. Four transient Grade 3 GU toxicities occurred, all among patients requiring pretreatment GU symptom management. Multivariate analysis showed correlation between posttreatment GU 2+ symptoms and pretreatment GU symptom management (p < 0.0001) and age (p = 0.0048). Only 1 Grade 3+ gastrointestinal (GI) symptom occurred. The prevalence of Grade 2+ GI symptoms was 0 (0%), 10 (5%), 12 (6%), and 8 (4%) at 6, 12, 18, and 24 months, with a cumulative incidence of 20 (10%) patients at 2 years after proton therapy. Univariate and multivariate analyses showed significant correlation between Grade 2+ rectal bleeding and proctitis and the percentage of rectal wall (rectum) receiving doses ranging from 40 CGE (10 CGE) to 80 CGE. Conclusions: Early outcomes with image-guided proton therapy suggest high efficacy and minimal toxicity with only 1.9% Grade 3 GU symptoms and <0.5% Grade 3 GI toxicities.

  19. Helicobacter Pylori Eradication Therapy in both Erosive and Non-erosive Gastritis — A Prospective Study

    Directory of Open Access Journals (Sweden)

    Mohammad Quamrul Hasan

    2014-01-01

    Full Text Available Background: Infection with Helicobacter pylori (H. pylori is a recognized cause of peptic ulcer and gastritis. Persistence of infection is a definite risk factor for gastric malignancy. Healing of gastritis after eradication of H. pylori reduces the risks of peptic ulcer disease and gastric malignancy. Objectives: To find out the relationship of H. pylori with erosive and nonerosive gastritis, the effect of anti-H. pylori therapy and to compare the effects of anti-H. pylori therapy between two types of gastritis. Materials and Methods: This prospective study was done in the Gastroenterology department of Bangabandhu Sheikh Mujib Medical University, Dhaka from June 2008 to May 2009. One hundred eighty dyspeptic patients were enrolled for the study. Patients with gastritis diagnosed by endoscopy underwent rapid urease test (RUT. RUT positive patients were considered to have H. pylori infection and were treated with triple therapy (omeprazole, amoxycillin and metronidiazole for 14 days. Treatment responses were assessed by clinical history and also by endoscopic biopsy and RUT. Results of endoscopic findings and RUT after treatment were compared with pretreatment status. Results: Seventy patients completed the treatment and finally could be assessed. Endoscopic findings of 70 patients revealed that 56 (80% patients had erosive gastritis and 14 (20% patients had nonerosive gastritis. After treatment, 47 (67.1% lesions became normal, 16 (22.9% remained erosive and 7 (10% non-erosive as before. Out of 14 non-erosive diseases, 7 became normal, while out of 56 erosive diseases 40 became normal. The erosive group responded significantly better than the non-erosive group (c2=32.766, p<0.001. Fifty nine (84.3% patients with gastritis showed negative urease test after treatment. Conclusion: Strong relation between H. pylori infection and gastritis was found. Majority were antral erosive gastritis. Erosive group responded better than non-erosive group.

  20. Anthroposophic therapy for attention deficit hyperactivity: A two-year prospective study in outpatients

    Directory of Open Access Journals (Sweden)

    Harald J Hamre

    2010-08-01

    were maintained until last follow-up after 24 months.Conclusion: Children with ADHD symptoms receiving anthroposophic treatment had ­long-term improvement of symptoms and quality of life.Keywords: anthroposophy, attention deficit disorder with hyperactivity, combined modality therapy, prospective studies, quality of life

  1. Treatment of therapy-refractive ulcera cruris of various origins with autologous keratinocytes in fibrin sealant.

    Science.gov (United States)

    Johnsen, S; Ermuth, T; Tanczos, E; Bannasch, H; Horch, R E; Zschocke, I; Peschen, M; Schöpf, E; Vanscheidt, W; Augustin, M

    2005-02-01

    Evaluation of the effects of cultivated, subconfluent, autologous keratinocytes in fibrin sealant (BioSeed-S) on the healing of therapy-refractive chronic wounds. Open observational study in 60 patients with chronic leg ulcers and impaired wound healing of various origins. After whole-skin excision and cultivation of the autologous keratinocytes, the suspended cells were applied to the preconditioned wound in fibrin sealant. Wound epithelization and wound size were recorded at defined times. Fifty-two of the 60 participating patients could be evaluated. After 6 weeks, 29 ulcers (55.8%) were healed. The mean epithelization increased between the 8th and 42nd postoperative day from 23% to 62.5%. In 50.0% of the patients, global assessment of the wound showed a high degree of epithelization or healing after 42 days. In 32.6% of treated patients, improvement was observed, while no healing tendency was to be found in 17.4%. The present observational study indicates that the transplantation of autologous keratinocytes suspended in fibrin sealant could be of advantage in the treatment of refractive leg ulcers.

  2. Uptake of combination antiretroviral therapy and HIV disease progression according to geographical origin in seroconverters in Europe, Canada, and Australia

    NARCIS (Netherlands)

    Jarrin, Inma; Pantazis, Nikos; Gill, M. John; Geskus, Ronald; Perez-Hoyos, Santiago; Meyer, Laurence; Prins, Maria; Touloumi, Giota; Johnson, Anne; Hamouda, Osamah; de Olalla, Patricia García; Porter, Kholoud; del Amo, Julia; Bucher, Heiner C.; Chêne, Geneviève; Pillay, Deenan; Rosinska, Magda; Sabin, Caroline; Olson, Ashley; Coughlin, Kate; Walker, Sarah; Babiker, Abdel; de Luca, Andrea; Fisher, Martin; Muga, Roberto; Zangerle, Robert; Kelleher, A. D.; Cooper, D. A.; Grey, Pat; Finlayson, Robert; Bloch, Mark; Kelleher, Tony; Ramacciotti, Tim; Gelgor, Linda; Cooper, David; Smith, Don; Gill, John; Tartu, Ülikool; Lutsar, Irja; Dabis, Francois; Thiebaut, Rodolphe; Masquelier, Bernard; Costagliola, Dominique; Guiguet, Marguerite; Vanhems, Philippe; Chaix, Marie-Laure; Ghosn, Jade; Boufassa, Faroudy; Ku, Claudia; Bartmeyer, Barbara; Katsarou, Olga; Paparizos, V.; Gargalianos-Kakolyris, P.; Lazanas, M.; Rezza, Giovanni; Dorrucci, Maria; D'Arminio Monforte, Antonella; van der Helm, Jannie; Sannes, Mette; Brubakk, Oddbjorn; Kran, Anne-Marte Bakken; Rosinska, Magdalena; Tor, Jordi; de Olalla, Patricia Garcia; Cayla, Joan; Moreno, Santiago; Monge, Susana; del Romero, Jorge; Pérez, Santiago; Rickenbach, Martin; Francioli, Patrick; Malyuta, Ruslan; Murphy, Gary; Phillips, Andrew; Morrison, Charles; Salata, Robert; Mugerwa, Roy; Chipato, Tsungai; Amornkul, Pauli; Giaquinto, Carlo; Gibb, Di; Grarup, Jesper; Kirk, Ole; Ledergerber, Bruno; Panteleev, Alex; Thorne, Claire; Welch, Stephen; Aboulker, Jean-Pierre; Albert, Jan; Asandi, Silvia; DeWit, Stéphane; de Wolf, Frank; Gatell, José; Koch, Robert; Karpov, Igor; Lundgren, Jens; Møller, Claus; Rakhmanova, Aza; Rockstroh, Jürgen; Volny Anne, Alain; Dedes, Nikos; Fenton, Kevin; Pizzuti, David; Vitoria, Marco; Ellefson, Michelle; Faggion, Silvia; Frost, Richard; Reynolds, Marie; Schwimmer, Christine; Scott, Martin

    2012-01-01

    We examined differences by geographical origin (GO) in time from HIV seroconversion (SC) to AIDS, death, and initiation of antiretroviral therapy (cART). Data from HIV seroconverter cohorts in Europe, Australia and Canada (CASCADE) was used; GO was classified as: western countries (WE), North Africa

  3. [Conservative therapy for metatarsal 5 basis fractures - retrospective and prospective analysis].

    Science.gov (United States)

    Schmoz, S; Voelcker, A L; Burchhardt, H; Tezval, M; Schleikis, A; Stürmer, K M; Sehmisch, S

    2014-12-01

    Approximately 30 % of all bone injuries are foot metatarsal fractures. Metatarsal V basis fractures occur most frequently. The classification is done into the tuberosity avulsion fractures, Jones fractures and stress fractures of the proximal diaphysis. The treatments of non-displaced fractures are generally conservative. The indication for surgical treatment depends on the load and the associated refracture rate. There are different types of treatment of these fractures. We present a possible approach to conservative treatments and show how different therapies affect healing of metatarsal V basis fractures and social reintegration of patients. A retrospective study consisted of 68 patients analysed during a 9-year period, whereas for a prospective analysis 18 patients were included for a period of 3 years. The treatment was performed using either a splint, closed bandage of the ankle or special Göttinger Anklesplint bandage, with immediate pain-oriented full load in all groups. The subjective and objective treatment results were analysed accoding the Göttinger Phillips score. In retrospect, the fracture consolidation was observed after 8.1 weeks full load-bearing was achieved after 6.3 weeks on average. In the prospective analysis, the osseous consolidation occurred after 6.2 weeks, and the full load was applied after 1.7 weeks. After 10 weeks the treatment with the Anklesplint bandage was assessed with 105 points of a maximum 110 points of the Phillips score. The Anklesplint bandage was also the cheapest option in the cost comparison. Using the immobilisation of the metatarsal supination with the Anklesplint bandage the metatarsal V basis fractures can heal in a regular way. The functional outcome is better in comparison to the that with other treatments and it is a cost-effective treatment. © Georg Thieme Verlag KG Stuttgart · New York.

  4. A prospective study of pelvic floor physical therapy: pain and psychosexual outcomes in provoked vestibulodynia.

    Science.gov (United States)

    Goldfinger, Corrie; Pukall, Caroline F; Gentilcore-Saulnier, Evelyne; McLean, Linda; Chamberlain, Susan

    2009-07-01

    Research suggests that increased tension in the pelvic floor muscles of women with provoked vestibulodynia (PVD, the most common form of chronic vulvar pain) may play an important role in maintaining and exacerbating their pain. However, no prospective studies of pelvic floor physical therapy (PFPT) for PVD have been carried out. This study prospectively examined the effectiveness of a PFPT intervention in treating the pain and sexual and psychological components of PVD, and determined predictors of greater treatment success. Thirteen women with PVD completed eight sessions of PFPT. Participants were assessed at pre- and post-treatment via gynecological examinations, vestibular pain threshold testing, structured interviews, and standardized questionnaires. A 3-month follow-up interview assessed any further changes. Outcome measures included: vestibular pain thresholds, gynecological examination and intercourse pain ratings, sexual function and intercourse frequency, mental health, negative pain cognitions, and success rates. Following treatment, participants had significantly higher vestibular pain thresholds and significantly lower pain ratings during the gynecological examination. Participants reported significant reductions in pain intensity during intercourse and were able to engage in significantly more pain-free activities. Although overall sexual function significantly improved, various components of sexual function and frequency of intercourse did not. Participants' mental health did not significantly improve; however, pain catastrophizing and pain-related anxiety significantly decreased. The treatment was considered to be successful for 10 of the 13 participants, and predictors of greater treatment success included greater reductions in helplessness and a longer period of time in treatment. Results provide preliminary support for the effectiveness of PFPT in treating the pain of PVD, as well as some of the sexual and cognitive correlates of PVD. The

  5. Prospective study of proton-beam radiation therapy for limited-stage small cell lung cancer.

    Science.gov (United States)

    Rwigema, Jean-Claude M; Verma, Vivek; Lin, Liyong; Berman, Abigail T; Levin, William P; Evans, Tracey L; Aggarwal, Charu; Rengan, Ramesh; Langer, Corey; Cohen, Roger B; Simone, Charles B

    2017-11-01

    Existing data supporting the use of proton-beam therapy (PBT) for limited-stage small cell lung cancer (LS-SCLC) are limited to a single 6-patient case series. This is the first prospective study to evaluate clinical outcomes and toxicities of PBT for LS-SCLC. This study prospectively analyzed patients with primary, nonrecurrent LS-SCLC definitively treated with PBT and concurrent chemotherapy from 2011 to 2016. Clinical backup intensity-modulated radiotherapy (IMRT) plans were generated for each patient and were compared with PBT plans. Outcome measures included local control (LC), recurrence-free survival (RFS), and overall survival (OS) rates and toxicities. Thirty consecutive patients were enrolled and evaluated. The median dose was 63.9 cobalt gray equivalents (range, 45-66.6 cobalt gray equivalents) in 33 to 37 fractions delivered daily (n = 18 [60.0%]) or twice daily (n = 12 [40.0%]). The concurrent chemotherapy was cisplatin/etoposide (n = 21 [70.0%]) or carboplatin/etoposide (n = 9 [30.0%]). In comparison with the backup IMRT plans, PBT allowed statistically significant reductions in the cord, heart, and lung mean doses and the volume receiving at least 5 Gy but not in the esophagus mean dose or the lung volume receiving at least 20 Gy. At a median follow-up of 14 months, the 1-/2-year LC and RFS rates were 85%/69% and 63%/42%, respectively. The median OS was 28.2 months, and the 1-/2-year OS rates were 72%/58%. There was 1 case each (3.3%) of grade 3 or higher esophagitis, pneumonitis, anorexia, and pericardial effusion. Grade 2 pneumonitis and esophagitis were seen in 10.0% and 43.3% of patients, respectively. In the first prospective registry study and largest analysis to date of PBT for LS-SCLC, PBT was found to be safe with a limited incidence of high-grade toxicities. Cancer 2017;123:4244-4251. © 2017 American Cancer Society. © 2017 American Cancer Society.

  6. From mutation identification to therapy: discovery and origins of the first approved gene therapy in the Western world

    NARCIS (Netherlands)

    Kastelein, John J. P.; Ross, Colin J. D.; Hayden, Michael R.

    2013-01-01

    On November 2, 2012, Glybera® (alipogene tipovarvec) was the first human gene therapy to receive long awaited market approval in the Western world. This important milestone is expected to open the door to additional gene therapies for the treatment of many diseases in the future. The development of

  7. Tamsulosin versus tadalafil as a medical expulsive therapy for distal ureteral stones: A prospective randomized study.

    Science.gov (United States)

    Kc, Hari Bahadur; Shrestha, Anil; Acharya, Ganesh Bhakta; Basnet, Robin Bahadur; Shah, Arvind Kumar; Shrestha, Parash Mani

    2016-09-01

    This study aimed to compare the safety and efficacy of tamsulosin and tadalafil as medical expulsive therapy for distal ureteral stones. This prospective randomized study was conducted at the Department of Urology of Bir Hospital over a period of 12 months in patients with distal ureteral stones sized 5 to 10 mm. Patients were randomly divided into 2 groups: group A received tamsulosin 0.4 mg and group B received tadalafil 10 mg at bedtime for 2 weeks. Stone expulsion rate, number of ureteric colic episodes and pain score, analgesic requirements, and adverse drug effects were noted in both groups. Statistical analyses were performed by using Student t-test and chi-square test. Altogether 85 patients, 41 in group A and 44 in group B, were enrolled in the study. The patients' average age was 31.72±12.63 years, and the male-to-female ratio was 1.5:1. Demographic profiles, stone size, and baseline investigations were comparable between the 2 groups. The stone expulsion rate was significantly higher in the tadalafil group than in the tamsulosin group (84.1% vs. 61.0%, p=0.017). Although the occurrence of side effects was higher with tadalafil, this difference was not significant (p=0.099). There were no serious adverse effects. Tadalafil has a significantly higher stone expulsion rate than tamsulosin when used as a medical expulsive therapy for distal ureteral stones sized 5-10 mm. Both drugs are safe, effective, and well tolerated with minor side effects.

  8. Monte Carlo fluence simulation for prospective evaluation of interstitial photodynamic therapy treatment plans

    Science.gov (United States)

    Cassidy, Jeffrey; Betz, Vaughn; Lilge, Lothar

    2015-03-01

    Photodynamic therapy (PDT) delivers a localized cytotoxic dose that is a function of tissue oxygen availability, photosensitive drug concentration, and light fluence. Providing safe and effective PDT requires an understanding of all three elements and the physiological response to the radicals generated. Interstitial PDT (IPDT) for solid tumours poses particular challenges due to complex organ geometries and the associated limitations for diffusion theory based fluence rate prediction, in addition to restricted access for light delivery and dose monitoring. As a first step towards enabling a complete prospective IPDT treatment-planning platform, we demonstrate use of our previously developed FullMonte tetrahedral Monte Carlo simulation engine for modeling of the interstitial fluence field due to intravesicular insertion of brief light sources. The goal is to enable a complete treatment planning and monitoring work flow analogous to that used in ionizing radiation therapy, including plan evaluation through dose-volume histograms and algorithmic treatment plan optimization. FullMonte is to our knowledge the fastest open-source tetrahedral MC light propagation software. Using custom hardware acceleration, we achieve 4x faster computing with 67x better power efficiency for limited-size meshes compared to the software. Ongoing work will improve the performance advantage to 16x with unlimited mesh size, enabling algorithmic plan optimization in reasonable time. Using FullMonte, we demonstrate significant new plan-evaluation capabilities including fluence field visualization, generation of organ dose-volume histograms, and rendering of isofluence surfaces for a representative bladder cancer mesh from a real patient. We also discuss the advantages of MC simulations for dose-volume histogram generation and the need for online personalized fluence-rate monitoring.

  9. CRRTnet: a prospective, multi-national, observational study of continuous renal replacement therapy practices.

    Science.gov (United States)

    Heung, Michael; Bagshaw, Sean M; House, Andrew A; Juncos, Luis A; Piazza, Robin; Goldstein, Stuart L

    2017-07-06

    Continuous renal replacement therapy (CRRT) is the recommended modality of dialysis for critically ill patients with hemodynamic instability. Yet there remains significant variability in how CRRT is prescribed and delivered, and limited evidence-basis to guide practice. This is a prospective, multi-center observational study of patients undergoing CRRT. Initial enrollment phase will occur at 4 academic medical centers in North America over 5 years, with a target enrollment of 2000 patients. All adult patients (18-89 years of age) receiving CRRT will be eligible for inclusion; patients who undergo CRRT for less than 24 h will be excluded from analysis. Data collection will include patient characteristics at baseline and at time of CRRT initiation; details of CRRT prescription and delivery, including machine-generated treatment data; and patient outcomes. The goal of this study is to establish a large comprehensive registry of critically ill adults receiving CRRT. Specific aims include describing variations in CRRT prescription and delivery across quality domains; validating quality measures for CRRT care by correlating processes and outcomes; and establishing a large registry for use in quality improvement and benchmarking efforts. For initial analyses, some particular areas of interest are anticoagulation protocols; approach to fluid overload; CRRT-related workload; and patient safety. Registered on ClinicalTrials.gov 1/10/2014: NCT02034448.

  10. Anterograde Amnesia during Electroconvulsive Therapy: A Prospective Pilot-Study in Patients with Major Depressive Disorder.

    Directory of Open Access Journals (Sweden)

    Elvira Boere

    Full Text Available Electroconvulsive therapy (ECT is considered an effective treatment for major depression with melancholic features. However, neurocognitive side-effects such as anterograde amnesia still regularly occur. The present study aims to evaluate the severity and course of anterograde amnesia in severely depressed patients undergoing ECT. In a prospective naturalistic study, anterograde memory function was assessed among inpatients who underwent ECT (n = 11. Subjects met DSM-IV criteria for major depressive disorder. Recruitment took place between March 2010-March 2011 and March 2012-March 2013. Controls treated with antidepressants (n = 9 were matched for age, gender and depression severity. Primary outcome measure was immediate recall; secondary outcome measures were delayed recall, recognition, and visual association. Differences were tested using repeated measures ANOVA and paired t-tests. Correlations with hypothesized covariates were calculated. In patients with major depressive disorder, ECT had a significant effect on delayed memory function (p<0.01 with large effect sizes. Findings on immediate recall were less consistent. Four weeks after treatment discontinuation, these memory functions had recovered. Age was identified as a very important covariate. The main limitations of our study are its naturalistic design, possibly compromising internal validity, and its small sample size. However, if these findings can be reproduced in a more comprehensive study group, then the possible induction of anterograde amnesia is not a justifiable reason for clinicians to disregard ECT as a treatment option.

  11. Value of CT scanning in radiation therapy treatment planning: a prospective study

    International Nuclear Information System (INIS)

    Goitein, M.; Wittenberg, J.; Mendiondo, M.; Doucette, J.; Friedberg, C.; Ferrucci, J.; Gunderson, L.; Linggood, R.; Shipley, W.U.; Fineberg, H.V.

    1979-01-01

    We report the results of a prospective study in which we assessed the value of computed tomography (CT) scanning in planning radiation therapy for 77 patients. First, conventional studies were performed, treatment fields were designed and simulated and, where appropriate, computer generated treatment plans drawn up. Then a CT scan was performed to delineate the location of the tumor and adjacent uninvolved tissues. The treatment goals and plans were reevaluated and changed when necessary. Forty of the 77 patients (52%) had their treatment changed as a result of the CT scan. Of these, four (5%) had a change of treatment modality. Thirty-two patients (42%) had changes in the radiotherapy technique because of inadequate tumor coverage (in 24 patients (31%) part of the tumor was outside one or more of the fields and in the other 8 patients (10%) the tumor coverage was marginal). Field changes resulting only from considerations of normal tissue coverage were made for 4 of these patients (5%). In total, normal tissue coverage was affected in 36 patients (47%). When the significance of these changes was evaluated, CT scanning was judged to be of major value for 28 of the 77 patients (36%) and of minor value in a further 12 patients

  12. Mutations in Epigenetic Modifiers in Myeloid Malignancies and the Prospect of Novel Epigenetic-Targeted Therapy

    Directory of Open Access Journals (Sweden)

    Amir T. Fathi

    2012-01-01

    Full Text Available In the recent years, the discovery of a series of mutations in patients with myeloid malignancies has provided insight into the pathogenesis of myelodysplastic syndromes (MDSs, myeloproliferative neoplasms (MPNs, and acute myeloid leukemia (AML. Among these alterations have been mutations in genes, such as IDH1/2, TET2, DNMT3A, and EZH2, which appear to affect DNA and/or histone lysine methylation. Large clinical correlative studies are beginning to decipher the clinical importance, prevalence, and potential prognostic significance of these mutations. Additionally, burgeoning insight into the role of epigenetics in the pathogenesis of myeloid malignancies has prompted increased interest in development of novel therapies which target DNA and histone posttranslational modifications. DNA demethylating agents have been demonstrated to be clinically active in a subset of patients with MDS and AML and are used extensively. However, newer, more specific agents which alter DNA and histone modification are under preclinical study and development and are likely to expand our therapeutic options for these diseases in the near future. Here, we review the current understanding of the clinical importance of these newly discovered mutations in AML and MDS patients. We also discuss exciting developments in DNA methyltransferase inhibitor strategies and the prospect of novel histone lysine methyltransferase inhibitors.

  13. Prospective study of use of perioperative antimicrobial therapy in general surgery.

    LENUS (Irish Health Repository)

    Fennessy, Brendan G

    2012-02-03

    BACKGROUND: Perioperative antimicrobial therapy has demonstrated efficacy in reducing the rate of surgical site infections in clinical trials. With the emergence of antibiotic resistance, the risk of reaction, and the inevitable financial repercussions, use of prophylactic antibiotics is not a panacea, and their misuse may have considerable implications. The aim of this study was to assess the use of antibiotics in the perioperative period in both general and vascular surgery procedures. METHODS: A prospective study was undertaken of 131 patients with a mean age of 43 years (range one month-88 years), of whom 68 (51%) were male, who underwent twenty-seven different general or vascular surgery procedures over a four-week period. Each patient was evaluated from the time of antibiotic commencement through their operative procedure until the treatment was discontinued. RESULTS: A total of 73 patients (54%) received ten antibiotics, with 71 (97%) of these uses being prophylactic. Of the 15 appendectomies performed for uncomplicated appendicitis, the mean number of prophylactic antibiotic doses was 5.3 (range 1-12). Where they were documented, written postoperative directives were not adhered to in 18\\/27 prescriptions (66%). CONCLUSION: This study has demonstrated a lack of adherence to guidelines in the perioperative administration of antimicrobial agents. In addition, it calls attention to the economic implications of unnecessary prophylaxis.

  14. Clinical Outcomes With Dose-Escalated Adaptive Radiation Therapy for Urinary Bladder Cancer: A Prospective Study

    International Nuclear Information System (INIS)

    Murthy, Vedang; Masodkar, Renuka; Kalyani, Nikhil; Mahantshetty, Umesh; Bakshi, Ganesh; Prakash, Gagan; Joshi, Amit; Prabhash, Kumar; Ghonge, Sujata; Shrivastava, Shyamkishore

    2016-01-01

    Purpose: The purpose of this study was to assess feasibility, clinical outcomes, and toxicity in patients with bladder cancer treated with adaptive, image guided radiation therapy (IGRT) for bladder preservation as a part of trimodality treatment. The role of dose escalation was also studied. Methods and Materials: Forty-four patients with localized bladder cancer were enrolled in a prospective study. They underwent maximal safe resection of bladder tumor and concurrent platinum-based chemotherapy. Patients with large tumors were offered induction chemotherapy. Radiation therapy planning was done using either 3 (n=34) or 6 (n=10) concentrically grown planning target volumes (PTV). Patients received 64 Gy in 32 fractions to the whole bladder and 55 Gy to the pelvic nodes and, if appropriate, a simultaneous integrated boost to the tumor bed to 68 Gy (equivalent dose for 2-Gy fractions assuming α/β of 10 [EQD2] 10  = 68.7 Gy). Daily megavoltage (MV) imaging helped to choose the most appropriate PTV encompassing bladder for the particular day (using plan-of-the-day approach). Results: Most patients (88%) had T2 disease. Sixteen patients (36%) received neoadjuvant chemotherapy. A majority of the patients (73%) received prophylactic nodal irradiation, whereas 55% of the patients received escalated dose to the tumor bed. With a median follow-up of 30 months, the 3-year locoregional control (LRC), disease-free survival, and overall survival (OS) were 78%, 66%, and 67%, respectively. The bladder preservation rate was 83%. LRC (87% vs 68%, respectively, P=.748) and OS (74% vs 60%, respectively, P=.36) rates were better in patients receiving dose escalation. Instances of acute and late Radiation Therapy Oncology Group (RTOG) grade 3 genitourinary toxicity was seen in 5 (11%) and 2 (4%) patients, respectively. There was no acute or late RTOG grade 3 or higher gastrointestinal toxicity. Conclusions: Adaptive IGRT using plan-of-the-day approach for bladder preservation

  15. Pain management in photodynamic therapy using a nitrous oxide/oxygen mixture: a prospective, within-patient, controlled clinical trial.

    Science.gov (United States)

    Fink, C; Uhlmann, L; Enk, A; Gholam, P

    2017-01-01

    Photodynamic therapy is an effective treatment for actinic keratoses. Nevertheless, severe pain during the procedure is a serious adverse effect, which leads to interruption or even termination. Complete pain relief remains a difficult challenge. To evaluate the effect of a nitrous oxide/oxygen mixture on pain intensity during photodynamic therapy. This clinical trial has been designed as a prospective, single-centre, explorative, controlled, observational study. We were able to detect a significant overall pain reduction of 55.2% after application of a nitrous oxide/oxygen mixture by means of an intra-individual comparison. Furthermore, the total number of therapy interruption significantly decreased by 82% after the inhalation analgesia. Additionally, treatment satisfaction ranged from 'extremely to very satisfied'. This study shows that analgesia by means of a nitrous oxide/oxygen mixture is a very effective and well-tolerated method for achieving significant pain reduction during photodynamic therapy. © 2016 European Academy of Dermatology and Venereology.

  16. Anthroposophic medical therapy in chronic disease: a four-year prospective cohort study

    Directory of Open Access Journals (Sweden)

    Willich Stefan N

    2007-04-01

    Full Text Available Abstract Background The short consultation length in primary care is a source of concern, and the wish for more consultation time is a common reason for patients to seek complementary medicine. Physicians practicing anthroposophic medicine have prolonged consultations with their patients, taking an extended history, addressing constitutional, psychosocial, and biographic aspect of patients' illness, and selecting optimal therapy. In Germany, health benefit programs have included the reimbursement of this additional physician time. The purpose of this study was to describe clinical outcomes in patients with chronic diseases treated by anthroposophic physicians after an initial prolonged consultation. Methods In conjunction with a health benefit program in Germany, 233 outpatients aged 1–74 years, treated by 72 anthroposophic physicians after a consultation of at least 30 min participated in a prospective cohort study. Main outcomes were disease severity (Disease and Symptom Scores, physicians' and patients' assessment on numerical rating scales 0–10 and quality of life (adults: SF-36, children aged 8–16: KINDL, children 1–7: KITA. Disease Score was documented after 0, 6 and 12 months, other outcomes after 0, 3, 6, 12, 18, 24, and (Symptom Score and SF-36 48 months. Results Most common indications were mental disorders (17.6% of patients; primarily depression and fatigue, respiratory diseases (15.5%, and musculoskeletal diseases (11.6%. Median disease duration at baseline was 3.0 years (interquartile range 0.5–9.8 years. The consultation leading to study enrolment lasted 30–60 min in 51.5% (120/233 of patients and > 60 min in 48.5%. During the following year, patients had a median of 3.0 (interquartile range 1.0–7.0 prolonged consultations with their anthroposophic physicians, 86.1% (167/194 of patients used anthroposophic medication. All outcomes except KITA Daily Life subscale and KINDL showed significant improvement between

  17. Rhythm and orthopedics: The effect of music therapy in cast room procedures, a prospective clinical trial.

    Science.gov (United States)

    Tolunay, Tolga; Bicici, Vedat; Tolunay, Hatice; Akkurt, Mehmet Orcun; Arslan, Arslan Kagan; Aydogdu, Ali; Bingol, Izzet

    2018-02-07

    Cast room procedures generally cause anxiety in patients. Anxiety complicates the procedure as well as increases the risk of a complication. Listening to music was found to be the safest and most common non-drug treatment method. The aim of this study is to evaluate the effect of listening to music on adult patients in cast room procedures. This study points out the relation between anxiety and anxiety relevant cardiac arrhythmia. The study was performed on 199 patients with stable general condition, aged above 18. The patients were divided into two groups. Randomization method used in the study was coin flip. The first group (Group 1) listened to music during cast room procedures whereby the second group (Group 2) did not listen to music. Length of the procedure, complication, blood pressure and heart rate evaluations before and after the procedure, Visual Analogue Scale (VAS scores for pain), State-Trait Anxiety Inventory (STAI) anxiety score, patient satisfaction, willingness of the patient to repeat the procedure, P wave dispersion (Pd) and corrected QT interval dispersion (QTcd) as electrocardiographic arrhythmia predictors were evaluated. The Clinical Research Ethics Committee approval was obtained for this study. Significant difference was shown between the two groups for the following criteria: VAS scores (p = 0.005), anxiety scores (p = 0.032), processing time (p = 0.027), and QTcd values (p = 0.031). Patient satisfaction (p < 0.001) and willingness to repeat the procedure (p < 0.001) were higher for the group who listened to music. No significant difference in Pd values, blood pressure and heart rate was reported within the groups. Music therapy is a non-invasive, safe, nonpharmacologic, anxiolytic, and analgesic treatment. Music therapy should become standard protocol in cast room procedures. One of the most important achievements of this study was the fact that music decreases anxiety and anxiety-related cardiac arrhythmia

  18. The use of adaptive radiation therapy to reduce setup error: a prospective clinical study

    International Nuclear Information System (INIS)

    Yan Di; Wong, John; Vicini, Frank; Robertson, John; Horwitz, Eric; Brabbins, Donald; Cook, Carla; Gustafson, Gary; Stromberg, Jannifer; Martinez, Alvaro

    1996-01-01

    Purpose: Adaptive Radiation Therapy (ART) is a closed-loop feedback process where each patients treatment is adaptively optimized according to the individual variation information measured during the course of treatment. The process aims to maximize the benefits of treatment for the individual patient. A prospective study is currently being conducted to test the feasibility and effectiveness of ART for clinical use. The present study is limited to compensating the effects of systematic setup error. Methods and Materials: The study includes 20 patients treated on a linear accelerator equipped with a computer controlled multileaf collimator (MLC) and a electronic portal imaging device (EPID). Alpha cradles are used to immobilize those patients treated for disease in the thoracic and abdominal regions, and thermal plastic masks for the head and neck. Portal images are acquired daily. Setup error of each treatment field is quantified off-line every day. As determined from an earlier retrospective study of different clinical sites, the measured setup variation from the first 4 to 9 days, are used to estimate systematic setup error and the standard deviation of random setup error for each field. Setup adjustment is made if estimated systematic setup error of the treatment field was larger than or equal to 2 mm. Instead of the conventional approach of repositioning the patient, setup correction is implemented by reshaping MLC to compensate for the estimated systematic error. The entire process from analysis of portal images to the implementation of the modified MLC field is performed via computer network. Systematic and random setup errors of the treatment after adjustment are compared with those prior to adjustment. Finally, the frequency distributions of block overlap cumulated throughout the treatment course are evaluated. Results: Sixty-seven percent of all treatment fields were reshaped to compensate for the estimated systematic errors. At the time of this writing

  19. Predictors of response to cardiac resynchronization therapy: A prospective cohort study.

    Science.gov (United States)

    Abreu, Ana; Oliveira, Mário; Silva Cunha, Pedro; Santa Clara, Helena; Santos, Vanessa; Portugal, Guilherme; Rio, Pedro; Soares, Rui; Moura Branco, Luísa; Alves, Marta; Papoila, Ana Luísa; Ferreira, Rui; Mota Carmo, Miguel

    2017-06-01

    Cardiac resynchronization therapy (CRT) has modified the prognosis of chronic heart failure (HF) with left ventricular systolic dysfunction. However, 30% of patients do not have a favorable response. The big question is how to determine predictors of response. To identify baseline characteristics that might influence echocardiographic response to CRT. We performed a prospective single-center hospital-based cohort study of consecutive HF patients selected to CRT (NYHA class II-IV, left ventricular ejection fraction (LVEF) <35% and QRS complex ≥120 ms). Responders were defined as those with a ≥5% absolute increase in LVEF at six months. Clinical, electrocardiographic, laboratory, echocardiographic, autonomic, endothelial and cardiopulmonary function parameters were assessed before CRT device implantation. Logistic regression models were used. Seventy-nine patients were included, 54 male (68.4%), age 68.1 years (standard deviation 10.2), 19 with ischemic etiology (24%). At six months, 51 patients (64.6%) were considered responders. Although by univariate analysis baseline tricuspid annular plane systolic excursion (TAPSE) and serum creatinine were significantly different in responders, on multivariate analysis only TAPSE was independently associated with response, with higher values predicting a positive response to CRT (OR=1.13; 95% CI: 1.02-1.26; p=0.020). TAPSE ≥15 mm was strongly associated with response, and TAPSE <15 mm with non-response (p=0.005). Responders had no TAPSE values below 10 mm. From a range of clinical and technical baseline characteristics, multivariate analysis only identified TAPSE as an independent predictor of CRT response, with TAPSE <15 mm associated with non-response. This study highlights the importance of right ventricular dysfunction in CRT response. ClinicalTrials.gov identifier: NCT02413151. Copyright © 2017 Sociedade Portuguesa de Cardiologia. Publicado por Elsevier España, S.L.U. All rights reserved.

  20. Nutritional status and clinical outcome of children on continuous renal replacement therapy: a prospective observational study.

    Science.gov (United States)

    Castillo, Ana; Santiago, Maria J; López-Herce, Jesús; Montoro, Sandra; López, Jorge; Bustinza, Amaya; Moral, Ramón; Bellón, Jose M

    2012-09-27

    No studies on continuous renal replacement therapy (CRRT) have analyzed nutritional status in children. The objective of this study was to assess the association between mortality and nutritional status of children receiving CRRT. Prospective observational study to analyze the nutritional status of children receiving CRRT and its association with mortality. The variables recorded were age, weight, sex, diagnosis, albumin, creatinine, urea, uric acid, severity of illness scores, CRRT-related complications, duration of admission to the pediatric intensive care unit, and mortality. The sample comprised 174 critically ill children on CRRT. The median weight of the patients was 10 kg, 35% were under percentile (P) 3, and 56% had a weight/P50 ratio of less than 0.85. Only two patients were above P95. The mean age for patients under P3 was significantly lower than that of the other patients (p = 0.03). The incidence of weight under P3 was greater in younger children (p = 0.007) and in cardiac patients and in those who had previous chronic renal insufficiency (p = 0.047). The mortality analysis did not include patients with pre-existing renal disease. Mortality was 38.9%. Mortality for patients with weight P3 (51% vs 33%; p = 0.037). In the univariate and multivariate logistic regression analyses, the only factor associated with mortality was protein-energy wasting (malnutrition) (OR, 2.11; 95% CI, 1.067-4.173; p = 0.032). The frequency of protein-energy wasting in children who require CRRT is high, and the frequency of obesity is low. Protein-energy wasting is more frequent in children with previous end-stage renal disease and heart disease. Underweight children present a higher mortality rate than patients with normal body weight.

  1. Metronomic therapy with oral 6-mercaptopurine in elderly acute myeloid leukemia: A prospective pilot study

    Directory of Open Access Journals (Sweden)

    Akhil Kapoor

    2016-01-01

    Full Text Available Introduction: Acute myeloid leukemia (AML in elderly patients differs biologically from that in younger patients and is known to have unfavorable chromosomal rearrangements, higher resistance, and lower tolerance to chemotherapy. In such circumstances, instead of giving full-blown chemotherapy, palliative metronomic chemotherapy (MCT could be a treatment option. Patients and Methods: We performed a prospective pilot study of old AML patients (age >60 years not amenable to curative treatment. Thirty-two patients were enrolled into the study and were treated with daily oral 6-mercaptopurine 75 mg/m 2 . The following inclusion criteria were used: age >60 years, nonpromyelocytic AML, the absence of uncontrolled comorbidities, and patient not amenable to curative treatment. Overall survival (OS was calculated using Kaplan-Meier method and Cox regression analysis were used to calculate the hazards ratio of significant factors. Results: The median age of the patients was 69 years (range: 61-86 years with male: female ratio of 2.5:1. About 59.4% of patients had Eastern Cooperative Oncology Group performance status of 2 while rest had the status of 3. The median OS was 6 months (95% confidence interval [CI]: 4.4-7.6. Males had median OS of 7 months (95% CI: 5.4-8.6 versus females with OS of 3 months (95% CI: 1.5-4.4; P = 0.008. There was no survival difference on the basis of baseline hemoglobin or French-American-British class. There were no Grade 4 toxicities and no episode of febrile neutropenia. Conclusions: MCT with oral 6-mercaptopurine is an attractive treatment option in elderly AML patients who are not amenable to curative therapy with minimal toxicities.

  2. An assessment of early Child Life Therapy pain and anxiety management: A prospective randomised controlled trial.

    Science.gov (United States)

    Hyland, Ela J; D'Cruz, Rachel; Harvey, John G; Moir, Jordyn; Parkinson, Christina; Holland, Andrew J A

    2015-12-01

    Burns remain extremely painful and distressing in young children. The consequences of poorly managed pain and anxiety can be life-long. Whilst Child Life Therapy (CLT) has been shown to be effective in many situations, few studies have looked at the effectiveness of CLT in regard to reducing pain and anxiety in children undergoing burn dressing changes. A prospective, randomised controlled trial was conducted, comparing CLT versus standard care in relation to pain and anxiety scores of children undergoing their initial burn dressing change. Pain and anxiety were assessed by an independent observer and questionnaires completed by the child, parent/caregiver and nursing staff. 50 subjects were recruited in each treatment group; median age 2.3 years (CLT) and 2.2 years (standard care). The median total body surface area (TBSA) burnt was 0.8% (CLT) and 0.5% (standard care). The majority were partial thickness dermal burns (88% CLT, 94% standard care). Rates of parent anxiety and pre-procedural child pain and anxiety were similar. Combined and scaled pain and anxiety scores in the CLT group were significantly less than in the standard treatment group (p=0.03). Whilst pain was significantly better in the CLT group (p=0.02), fear scores, wound outcomes and the need for skin grafting were not statistically different in either group. The presence of a Child Life Therapist, with their ability to adapt to the environment, the child and their family, significantly reduced the experience of pain during paediatric burn dressings. Copyright © 2015 Elsevier Ltd and ISBI. All rights reserved.

  3. THE DEVELOPMENT OF THE ELECTRIC POWER INDUSTRY AFTER THE OCTOBER REVOLUTION OF 1917: ORIGINS, PROSPECTS AND PROBLEMS

    Directory of Open Access Journals (Sweden)

    A. A. Gibadullin

    2018-01-01

    implementation of the plans ahead of schedule. In the post-war period, from 1950–1985, there was an increase in the construction of production capacities, The development of the electric power industry after the October Revolution of 1917: origins, prospects and problems  at the same time, both heat and hydro and nuclear power plants were built, thereby increasing the installed capacity by more than 10 times in thirty years. After the collapse of the Soviet Union, there has been a halt in the pace of development of the Russian electric power industry, and now the deprecation of the fixed assets increase, the degradation of energy equipment, the aging of power generation technologies, the fall in investment attractiveness and the efficiency of management of generating capacities, which can lead to mass failure equipment and emergency consequences.The conclusion. Based on the results of the study, we have the following conclusions in the need to search for new mechanisms to improve the sustainability of the electricity industry in the absence of financial resources. In the author's opinion, it is advisable to implement them on three interrelated mechanisms: revising production capacities, eliminating potentially worn-out fixed assets; the formation of common programs for the development of the electric power industry within the framework of the General Electricity Market of the Eurasian Economic Union; the construction of power plants in the border areas, due to which several national states will provide electric power. 

  4. The Combination of Laser Therapy and Metal Nanoparticles in Cancer Treatment Originated From Epithelial Tissues: A Literature Review.

    Science.gov (United States)

    Fekrazad, Reza; Naghdi, Nafiseh; Nokhbatolfoghahaei, Hanieh; Bagheri, Hossein

    2016-01-01

    Several methods have been employed for cancer treatment including surgery, chemotherapy and radiation therapy. Today, recent advances in medical science and development of new technologies, have led to the introduction of new methods such as hormone therapy, Photodynamic therapy (PDT), treatments using nanoparticles and eventually combinations of lasers and nanoparticles. The unique features of LASERs such as photo-thermal properties and the particular characteristics of nanoparticles, given their extremely small size, may provide an interesting combined therapeutic effect. The purpose of this study was to review the simultaneous application of lasers and metal nanoparticles for the treatment of cancers with epithelial origin. A comprehensive search in electronic sources including PubMed, Google Scholar and Science Direct was carried out between 2000 and 2013. Among the initial 400 articles, 250 articles applied nanoparticles and lasers in combination, in which more than 50 articles covered the treatment of cancer with epithelial origin. In the future, the combination of laser and nanoparticles may be used as a new or an alternative method for cancer therapy or diagnosis. Obviously, to exclude the effect of laser's wavelength and nanoparticle's properties more animal studies and clinical trials are required as a lack of perfect studies.

  5. Implementation of three dimensional conformal radiation therapy: prospects, opportunities, and challenges

    International Nuclear Information System (INIS)

    Vijayakumar, Srinivasan; Chen, George T.Y.

    1995-01-01

    Purpose: To briefly review scientific rationale of 3D conformal radiation therapy (3DCRT) and discuss the prospects, opportunities, and challenges in the implementation of 3DCRT. Some of these ideas were discussed during a workshop on 'Implementation of Three-Dimensional Conformal Radiation Therapy' in April 1994 at Bethesda, MD, and others have been discussed elsewhere in the literature. Methods and Materials: Local-regional control of cancer is an important component in the overall treatment strategy in any patient with cancer. It has been shown that failure to achieve local-regional control can lead to (a) an increase in chances of distant metastases, and (b) a decrease in the survival. In many disease sites, the doses delivered currently are inadequate to achieve satisfactory local tumor control rates; this is because in many sites, only limited doses of radiotherapy can be delivered due to the proximity of cancer to radiosensitive normal tissues. By conforming the radiotherapy beams to the tumor, doses to the tumors can be enhanced and doses to the normal tissues can be reduced. With the advances in 3DCRT, such conformation is possible now and is the rationale for using 3DCRT. However, a number of questions do remain that are not limited to the following: (a) What are the implications in terms of target volume definitions when implementing 3DCRT? (b) Are there some sites where research efforts can be focused to document the efficacy and cost effectiveness of 3DCRT? (c) How do we implement day-to-day 3DCRT treatment efficiently? (d) How do we transfer the technology from the university centers to the community without compromising quality? (e) What are all the quality assurance/quality improvement questions that need to be addressed and how do we ascertain quality assurance of 3DCRT? (f) Have we looked at cost-benefit ratios and quality of life (QOL) issues closely? Results: There is a need for defining multiple target volumes: gross tumor volume, clinical

  6. Discontinuation of continuous renal replacement therapy: A post hoc analysis of a prospective multicenter observational study

    NARCIS (Netherlands)

    Uchino, Shigehiko; Bellomo, Rinaldo; Morimatsu, Hiroshi; Morgera, Stanislao; Schetz, Miet; Tan, Ian; Bouman, Catherine; Macedo, Ettiene; Gibney, Noel; Tolwani, Ashita; Oudemans-van Straaten, Heleen; Ronco, Claudio; Kellum, John A.

    2009-01-01

    Objectives: To describe current practice for the discontinuation of continuous renal replacement therapy in a multinational setting and to identify variables associated with successful discontinuation. The approach to discontinue continuous renal replacement therapy may affect patient outcomes.

  7. A prospective study of quality of life in breast cancer patients undergoing radiation therapy

    Directory of Open Access Journals (Sweden)

    Canhua Xiao, PhD, RN

    2016-01-01

    Conclusions: Radiation therapy did not worsen QOL in breast cancer patients. However, pre-radiation therapy patient characteristics including BMI and perceived stress may be used to identify women who may experience decreased physical and mental function during and up to 1 year after radiation therapy.

  8. Antimicrobial photodynamic therapy-A discovery originating from the pre-antibiotic era in a novel periodontal therapy.

    Science.gov (United States)

    Oruba, Zuzanna; Łabuz, Przemysław; Macyk, Wojciech; Chomyszyn-Gajewska, Maria

    2015-12-01

    Antimicrobial photodynamic therapy (aPDT) involves pathogens' destruction caused by means of toxic Reactive Oxygen Species (ROS) that are generated upon the interaction of a photoactivatable substance (photosensitizer), light of the appropriate wavelength and oxygen. Among many clinical applications, it is also used as a supplementary method of treatment of periodontal disease. Many in vitro studies confirmed, that a major periopathogenic bacterium, Porphyromonas gingivalis is susceptible to this method. Several animal model studies pointed, that even a single application of aPDT adjunctive to conventional scaling and root planning (SRP) promotes better tissue healing, reduces the inflammatory infiltrate and bone loss. The outcomes of clinical trials are, however, inconsistent. Although in several the superiority of combined treatment protocol (SRP+aPDT) over the conventional (SRP alone) was reported, it was not confirmed in other trials. Nonetheless, the reduction of bleeding indices favoring the combined therapy was observed in the majority of the studies. It indicates, that aPDT has an influence on the extent of inflammation and further studies are needed to establish an optimal protocol of treatment combining mechanical debridement with photochemotherapy in order to obtain good treatment outcomes in our patients. Copyright © 2015 Elsevier B.V. All rights reserved.

  9. [Prospective multicenter study on long-term ketogenic diet therapy for intractable childhood epilepsy].

    Science.gov (United States)

    2013-04-01

    To evaluate the efficacy and safety of long-term ketogenic diet (KD) on the children with intractable epilepsy. This was a prospective, open-label study of intractable epilepsy patients treated with the classic KD with a lipid-to-nonlipid ratio 4:1 between October 2004 and July 2011 at five Chinese epilepsy centers. A total of 299 patients were enrolled. The patients were divided into different groups according to age (including the below-1-year-old group, 1-to-3-year-old group, 3-to-6-year-old group, 6-to-10-year-old group, and over-10-year-old group), etiology (cryptogenic epilepsy, symptomatic epilepsy, and idiopathic epilepsy), and the seizure types (included infantile spasm, Lennox-Gastaut syndrome, Ohtahara syndrome, tuberous sclerosis, Dravet syndrome, generalized epilepsy, and partial epilepsy). Parents were assigned to write seizure diaries which recorded the seizure presentations, tolerability, and complications associated with the KD. Patients' weight and height were measured every week. Blood β-hydroxybutyric acid, blood sugar, and urinary ketone bodies were monitored closely. Patients were followed up through telephone calls by the nutritionists every month and regular outpatient visits or hospitalizations were recommended at all time-points which included the third, sixth and twelfth month after initiation. Efficacy was measured through seizure frequency. The variables related to the efficacy were also analyzed. SPSS 17.0 was used for all statistical analysis. At 3, 6, and 12 months after initiation, 65.9%, 44.8%, and 26.4% patients remained on the diet, and 37.4%, 26.1%, and 20.4% had a > 50% reduction in their seizure frequency, including 21.7%, 10.7%, and 11.0% who became seizure free, respectively. At 24 months after initiation, 29 patients remained on the diet, and 28 patients had a > 90% seizure reduction, including five became seizure free. At 36 months after initiation, 7 patients remained on the diet, and all of them had a > 90% seizure

  10. Multimodal Therapy for Stage III Retinoblastoma (International Retinoblastoma Staging System): A Prospective Comparative Study.

    Science.gov (United States)

    Chawla, Bhavna; Hasan, Fahmi; Seth, Rachna; Pathy, Sushmita; Pattebahadur, Rajesh; Sharma, Sanjay; Upadhyaya, Ashish; Azad, Rajvardhan

    2016-09-01

    To compare the efficacy of 2 chemotherapeutic drug combinations as part of multimodal therapy for orbital retinoblastoma. Prospective, comparative, study. Patients with stage III retinoblastoma (International Retinoblastoma Staging System). Demographic and clinical features were recorded at presentation. Treatment consisted of a multimodal protocol with neoadjuvant chemotherapy, enucleation, orbital external-beam radiotherapy, and adjuvant chemotherapy. For chemotherapy, patients were randomized into 2 groups: group A patients were treated with vincristine, etoposide, and carboplatin (VEC) and group B patients were treated with carboplatin and etoposide, alternating with cyclophosphamide, idarubicin, and vincristine. Treatment outcomes and adverse effects were recorded. Efficacy parameters were compared between the groups. Survival probability, cause of death, and chemotherapy-related toxicity. A total of 54 children were recruited (27 in each group). The mean ± SD follow-up was 21.3±11.34 months. The overall Kaplan-Meier survival probability was 80% (95% confidence interval [CI], 0.67-0.89) and 42% (95% CI, 0.24-0.59) at 1 year and 4 years, respectively. There were 9 deaths in group A and 15 deaths in group B. The Kaplan-Meier survival probability at 1 year was similar between the groups: 81% (95% CI, 0.60-0.91) and 79% (95% CI, 0.58-0.9) for groups A and B, respectively. At 4 years, the survival probability for group A was higher (63% [95% CI, 0.41-0.79] vs. 25% [95% CI, 0.08-0.46] for groups A and B, respectively), with a strong trend of better survival in group A over time (P = 0.05). The major cause of death was central nervous system relapse (8 patients in group A and 7 patients in group B). Two patients in group B died of sepsis after febrile neutropenia. Grade 3 and grade 4 hematologic toxicities were more common in group B, with a significant difference in grade 4 neutropenia (P = 0.002). This study compared the outcomes of VEC chemotherapy with a 5

  11. Postoperative Intensity-Modulated Arc Therapy for Cervical and Endometrial Cancer: A Prospective Report on Toxicity

    Energy Technology Data Exchange (ETDEWEB)

    Vandecasteele, Katrien, E-mail: Katrien.Vandecasteele@uzgent.be [Department of Radiation Oncology, Ghent University Hospital, Ghent (Belgium); Tummers, Philippe; Makar, Amin [Department of Gynecologic Oncology, Ghent University Hospital, Ghent (Belgium); Eijkeren, Marc van [Department of Radiation Oncology, Ghent University Hospital, Ghent (Belgium); Delrue, Louke [Department of Radiology, Ghent University Hospital, Ghent (Belgium); Denys, Hannelore [Department of Medical Oncology, Ghent University Hospital, Ghent (Belgium); Lambert, Bieke [Department of Nuclear Medicine, Ghent University Hospital, Ghent (Belgium); Beerens, Anne-Sophie [Department of Pathology, Ghent University Hospital, Ghent (Belgium); Van den Broecke, Rudy [Department of Gynecologic Oncology, Ghent University Hospital, Ghent (Belgium); Lambein, Kathleen [Department of Pathology, Ghent University Hospital, Ghent (Belgium); Fonteyne, Valerie; De Meerleer, Gert [Department of Radiation Oncology, Ghent University Hospital, Ghent (Belgium)

    2012-10-01

    Purpose: To report on toxicity after postoperative intensity-modulated arc therapy (IMAT) for cervical (CC) and endometrial cancer (EC). Methods and Materials: Twenty-four CC and 41 EC patients were treated with postoperative IMAT. If indicated, para-aortic lymph node irradiation (preventive or when affected, PALN) and/or concomitant cisplatin (40 mg/m Superscript-Two , weekly) was administered. The prescribed dose for IMAT was 45 Gy (CC, 25 fractions) and 46 Gy (EC, 23 fractions), followed by a brachytherapeutic boost if possible. Radiation-related toxicity was assessed prospectively. The effect of concomitant cisplatin and PALN irradiation was evaluated. Results: Regarding acute toxicity (n = 65), Grade 3 and 2 acute gastrointestinal toxicity was observed in zero and 63% of patients (79% CC, 54% EC), respectively. Grade 3 and 2 acute genitourinary toxicity was observed in 1% and 18% of patients, respectively. Grade 2 (21%) and 3 (12%) hematologic toxicity (n = 41) occurred only in CC patients. Seventeen percent of CC patients and 2% of EC patients experienced Grade 2 fatigue and skin toxicity, respectively. Adding cisplatin led to an increase in Grade >2 nausea (57% vs. 9%; p = 0.01), Grade 2 nocturia (24% vs. 4%; p = 0.03), Grade {>=}2 hematologic toxicity (38% vs. nil, p = 0.003), Grade {>=}2 leukopenia (33% vs. nil, p = 0.009), and a strong trend toward more fatigue (14% vs. 2%; p = 0.05). Para-aortic lymph node irradiation led to an increase of Grade 2 nocturia (31% vs. 4%, p = 0.008) and a strong trend toward more Grade >2 nausea (44% vs. 18%; p = 0.052). Regarding late toxicity (n = 45), no Grade 3 or 4 late toxicity occurred. Grade 2 gastrointestinal toxicity, genitourinary toxicity, and fatigue occurred in 4%, 9%, and 1% of patients. Neither concomitant cisplatin nor PALN irradiation increased late toxicity rates. Conclusions: Postoperative IMAT for EC or CC is associated with low acute and late toxicity. Concomitant chemotherapy and PALN irradiation

  12. Outcomes and toxicity from a prospective study of moderately hypofractionated radiation therapy for prostate cancer

    Directory of Open Access Journals (Sweden)

    Wei Gang Wang, MD

    2018-04-01

    Full Text Available Purpose: The purpose of this study is to report the long-term outcomes and toxicity results of a prospective trial of moderately hypofractionated, image guided radiation therapy (RT for localized prostate cancer. Methods and materials: Patients were enrolled between December 2006 and February 2012. Patients in group 1 were stage T1-T2b, had a Gleason score (GS of 2 to 6 or 7 (3 + 4 with only 1 lobe involved, and had prostate-specific antigen levels ≤10 ng/mL. Group 2 patients were stage ≥T2c, had a GS ≥7 (4 + 3, a GS 7 (3 + 4 involving both lobes, or a PSA >10 ng/mL and ≤30 ng/mL. All patients underwent transrectal ultrasound guided fiducial (Visicoil placement prior to computed tomography/magnetic resonance imaging simulation. Daily cone beam computed tomography with online correction was used. The prescribed dose was 64 Gy in 20 fractions. The primary endpoint was acute and late toxicity. The secondary endpoint was biochemical control. Results: A total of 40 patients with a median age of 70 years were recruited for the study. Twenty-two patients (55% were in group 1, and 18 patients (45% were in group 2. Thirteen patients (32.5% were classified as low, 26 patients (65% as intermediate, and 1 patient (2.5% as high risk per the National Comprehensive Cancer Network criteria. The median follow-up time was 59 months. Five-year biochemical control was 100% and 94.4% for groups 1 and 2, respectively. Thirteen patients (32.5% developed acute gastrointestinal (GI toxicities grade ≥2 and 3 (7.5% developed acute grade 3 GI toxicity. A total of 17 patients (42.5% developed grade ≥2 acute genitourinary toxicities and 1 (2.5% developed acute grade 3 dysuria. Two patients (5% developed late GI toxicities grade ≥2. There was 1 case (2.5% of grade 4 fistula requiring sigmoid resection. Seven patients (17.5% developed grade ≥2 late genitourinary toxicities; 2 patients (5% late grade 3 urinary frequency/urgency. Conclusions

  13. Prospective comparison of preference and efficacy of adalimumab and infliximab for treating ulcerative colitis naive to antitumor necrosis factor therapy.

    Science.gov (United States)

    Mizoshita, Tsutomu; Katano, Takahito; Tanida, Satoshi; Hirano, Atsuyuki; Miyaki, Tomokatsu; Ozeki, Keiji; Suzuki, Yuka; Sugimura, Naomi; Kataoka, Hiromi; Joh, Takashi

    2017-08-01

    There have been few reports on 2 tumor necrosis factor alpha inhibitors, infliximab and adalimumab, with respect to patient preference and efficacy in ulcerative colitis (UC).We used questionnaires to evaluate the preference and reasons for drug choice between infliximab and adalimumab in UC patients naive to antitumor necrosis factor alpha therapy. We also analyzed the efficacy of infliximab and adalimumab prospectively and endoscopically before treatment and at 14 and 54 weeks.Of the 25 UC patients, infliximab and adalimumab were chosen by 10 (40%) and 15 (60%), respectively. Patients who favored infliximab considered "fear of syringes" (7/10, 70%) as the most important influencing factor, whereas patients who favored adalimumab considered "ease of administration" (10/15, 66.7%) and "time required for therapy" (10/15, 66.7%) as the most important factors. There were no statistical differences in remission induction and maintenance between the infliximab and adalimumab groups with regard to response, remission, mucosal healing, steroid-free, and steroid-free remission rates at weeks 14 and 54.The efficacy of adalimumab in remission induction and maintenance was equivalent to that of infliximab in UC patients naive to antitumor necrosis factor alpha therapy in this prospective study, but more patients preferred adalimumab.

  14. Treatment facilities, human resource development, and future prospect of particle beam therapy

    International Nuclear Information System (INIS)

    Tamaki, Tomoaki; Nakano, Takashi

    2015-01-01

    The number of particle beam therapy facilities is increasing globally. Among the countries practicing particle beam therapy, Japan is one of the leading countries in the field with four operating carbon-ion therapy facilities and ten operating proton therapy facilities. With the increasing number of particle beam therapy facilities, the human resource development is becoming extremely important, and there has been many such efforts including the Gunma University Program for Cultivating Global Leaders in Heavy Ion Therapeutics and Engineering, which aimed to educate and train the radiation oncologists, medical physicists, accelerator engineers, and radiation biologists to become global leaders in the field of particle beam therapy. In the future, the benefit and effectiveness of particle beam therapy should be discussed and elucidated objectively in a framework of comprehensive cancer care. (author)

  15. Polaprezinc combined with clarithromycin-based triple therapy for Helicobacter pylori-associated gastritis: A prospective, multicenter, randomized clinical trial.

    Science.gov (United States)

    Tan, Bei; Luo, Han-Qing; Xu, Hong; Lv, Nong-Hua; Shi, Rui-Hua; Luo, He-Sheng; Li, Jian-Sheng; Ren, Jian-Lin; Zou, Yi-You; Li, Yan-Qing; Ji, Feng; Fang, Jing-Yuan; Qian, Jia-Ming

    2017-01-01

    The efficacy and safety of polaprezinc combined with triple therapy was compared with triple therapy alone in the eradication of Helicobacter pylori. A randomized, parallel-group, open-label, controlled, prospective multicenter study was conducted in 11 cities in China. Treatment-naive patients with H. pylori-associated gastritis were randomly assigned to one of three arms for a 14-day treatment: Arm A triple therapy (omeprazole 20 mg, amoxicillin 1 g, and clarithromycin 500 mg, each twice daily) plus polaprezinc 75 mg twice daily; Arm B triple therapy plus polaprezinc 150 mg twice daily, or Arm C triple therapy alone. The rate of H. pylori eradication was the primary endpoint. Secondary endpoints were symptom improvement and lower incidence of adverse events. 303 patients completed the study- 106, 96, and 101 patients in Arms A, B, and C, respectively. Intention-to-treat (ITT) analysis showed that the rate of H. pylori eradication was significantly higher for Arms A (77.0%) and B (75.9%) compared to Arm C (58.6%) (P pylori eradication was significantly higher for Arms A (81.1%) and B (83.3%) compared to Arm C (61.4%) (P pylori eradication rate, without an increase in toxicity.

  16. Effects of different steps in gender reassignment therapy on psychopathology: a prospective study of persons with a gender identity disorder.

    Science.gov (United States)

    Heylens, Gunter; Verroken, Charlotte; De Cock, Sanne; T'Sjoen, Guy; De Cuypere, Griet

    2014-01-01

    At the start of gender reassignment therapy, persons with a gender identity disorder (GID) may deal with various forms of psychopathology. Until now, a limited number of publications focus on the effect of the different phases of treatment on this comorbidity and other psychosocial factors. The aim of this study was to investigate how gender reassignment therapy affects psychopathology and other psychosocial factors. This is a prospective study that assessed 57 individuals with GID by using the Symptom Checklist-90 (SCL-90) at three different points of time: at presentation, after the start of hormonal treatment, and after sex reassignment surgery (SRS). Questionnaires on psychosocial variables were used to evaluate the evolution between the presentation and the postoperative period. The data were statistically analyzed by using SPSS 19.0, with significance levels set at P difference in SCL-90 overall psychoneurotic distress was observed at the different points of assessments (P = 0.003), with the most prominent decrease occurring after the initiation of hormone therapy (P differences between pre- and postoperative assessments. A marked reduction in psychopathology occurs during the process of sex reassignment therapy, especially after the initiation of hormone therapy. © 2013 International Society for Sexual Medicine.

  17. Original paper Influence of biologic therapy on growth in children with chronic inflammatory connective tissue diseases

    Directory of Open Access Journals (Sweden)

    Joanna Świdrowska

    2015-04-01

    Full Text Available Objectives: Connective tissue diseases (CTD are a heterogeneous group of chronic inflammatory conditions. One of their complications in children is the inhibition of growth velocity. Due to direct inflammation within the musculoskeletal system as well as glucocorticoid therapy, this feature is the most essential and is mainly expressed in the course of juvenile spondyloarthropathies and juvenile idiopathic arthritis (JIA. Duration of the disease, but predominantly the activity of the inflammatory process, seems to have a significant impact on the abnormal growth profile in children. Effective biological therapy leads to improvement of the patient’s clinical condition and also, through the extinction of disease activity and reduction of daily doses of glucocorticosteroids (GCS, it gradually accelerates and normalizes the growth rate in children with CTD. Our objective was to evaluate the impact of biological therapy on growth in children with chronic inflammatory CTD. Material and methods: Data from 24 patients with CTD treated with tumor necrosis factor--blockers (etanercept, adalimumab, golimumab and an interleukin-6 receptor blocker (tocilizumab were reviewed at the time of disease onset, biological treatment initiation and at least 12 up to 24 months onwards. The rate of growth was correlated with the daily doses of GCS, and the type and duration of biological therapy. Results : Patient median height, measured as the change in height standard deviation score, was 0.36 ±1.07 at disease onset and –0.13 ±1.02 at biologic therapy initiation. The growth velocity accelerated in 17 patients (70.1% during the biological treatment. Mean height-SDS improvement between biological treatment initiation up to two years was 0.51 ±0.58. In 47% of patients daily doses of GCS were reduced to 0 mg/kg/day. Conclusions : In the treatment of CTD, biological agents restore growth velocity not only by inflammation inhibition, but also through limiting GCS

  18. Anthroposophic therapy for children with chronic disease: a two-year prospective cohort study in routine outpatient settings.

    Science.gov (United States)

    Hamre, Harald J; Witt, Claudia M; Kienle, Gunver S; Meinecke, Christoph; Glockmann, Anja; Willich, Stefan N; Kiene, Helmut

    2009-06-19

    Many children with chronic disease use complementary therapies. Anthroposophic treatment for paediatric chronic disease is provided by physicians and differs from conventional treatment in the use of special therapies (art therapy, eurythmy movement exercises, rhythmical massage therapy) and special medications. We studied clinical outcomes in children with chronic diseases under anthroposophic treatment in routine outpatient settings. In conjunction with a health benefit program, consecutive outpatients starting anthroposophic treatment for any chronic disease participated in a prospective cohort study. Main outcome was disease severity (Disease and Symptom Scores, physicians' and caregivers' assessment on numerical rating scales 0-10). Disease Score was documented after 0, 6, and 12 months, Symptom Score after 0, 3, 6, 12, 18, and 24 months. A total of 435 patients were included. Mean age was 8.2 years (standard deviation 3.3, range 1.0-16.9 years). Most common indications were mental disorders (46.2% of patients; primarily hyperkinetic, emotional, and developmental disorders), respiratory disorders (14.0%), and neurological disorders (5.7%). Median disease duration at baseline was 3.0 years (interquartile range 1.0-5.0 years). The anthroposophic treatment modalities used were medications (69.2% of patients), eurythmy therapy (54.7%), art therapy (11.3%), and rhythmical massage therapy (6.7%). Median number of eurythmy/art/massage therapy sessions was 12 (interquartile range 10-20), median therapy duration was 118 days (interquartile range 78-189 days).From baseline to six-month follow-up, Disease Score improved by average 3.00 points (95% confidence interval 2.76-3.24 points, p therapies within the first six study months. Children under anthroposophic treatment had long-term improvement of chronic disease symptoms. Although the pre-post design of the present study does not allow for conclusions about comparative effectiveness, study findings suggest that

  19. Can probiotics improve efficiency and safety profile of triple Helicobacter pylori eradication therapy? A prospective randomized study.

    Science.gov (United States)

    Grgov, Saša; Tasić, Tomislav; Radovanović-Dinić, Biljana; Benedeto-Stojanov, Daniela

    2016-11-01

    Some studies suggest the benefit of applying different probiotic strains in combination with antibiotics in the eradication of Helicobacter pylori (H. pylori) infection. The aim of this study was to evaluate the effect of co-administration of multiple probiotic strains with triple H. pylori eradication therapy. This prospective study included 167 patients with dyspeptic symptoms and chronic gastritis who were diagnosed with H. pylori infection and randomized into two groups. The group I of 77 patients underwent triple eradication therapy, for 7 days, with lansoprazole, 2 × 30 mg half an hour before the meal, amoxicillin 2 × 1.000 mg per 12 hours and clarithromycin 2 × 500 mg per 12 hours. After the 7th day of the therapy, lansoprazole continued at a dose of 30 mg for half an hour before breakfast for 4 weeks. The group II of 90 patients received the same treatment as the patients of the group I, with the addition of the probiotic cultures in the form of a capsule comprising Lactobacillus Rosell-52, Lactobacillus Rosell-11, Bifidobacterium Rosell-1755 and Saccharomyces boulardii, since the beginning of eradication for 4 weeks. Eradication of H. pylori infection control was performed 8 weeks after the therapy by rapid urease test and histopathologic evaluation of endoscopic biopsies or by stool antigen test for H. pylori. Eradication of H. pylori infection was achieved in 93.3% of the patients who received probiotics with eradication therapy and in 81.8% of patients who were only on eradication therapy without probiotics. The difference in eradication success was statistically significant, (p probiotic (28.6%) than in the group that received probiotic (17.7%), but the difference was not statistically significant. Multiple probiotic strains addition to triple eradication therapy of H. pylori achieves a significantly better eradication success, with fewer side effects of antibiotics.

  20. Uncovering the Origin of Skin Side Effects from EGFR-Targeted Therapies | Center for Cancer Research

    Science.gov (United States)

    The epidermal growth factor receptor (EGFR), a key regulator of cell proliferation, is often mutated or overexpressed in a variety of cancer types. EGFR-targeted therapies, including monoclonal antibodies and small molecule inhibitors, can effectively treat patients whose tumors depend on aberrant EGFR signaling. Within a few weeks of initiating therapy, however, patients develop a characteristic rash with leukocyte infiltration into the skin accompanied by pruritus (itching), scaling of the skin, hair loss, and even changes in skin cell differentiation. The side effects can become so severe that patients take reduced doses, which can limit efficacy, or stop treatment altogether. To understand how EGFR inhibitors cause these skin changes in the hopes of identifying a means of preventing them, Stuart Yuspa, M.D., of CCR’s Laboratory of Cancer Biology and Genetics, and his colleagues examined patient samples and generated a mouse model of EGFR loss in the skin.

  1. The Impact of Radiation Therapy on the Risk of Lymphedema After Treatment for Breast Cancer: A Prospective Cohort Study

    Energy Technology Data Exchange (ETDEWEB)

    Warren, Laura E.G.; Miller, Cynthia L. [Department of Radiation Oncology, Massachusetts General Hospital, Boston, Massachusetts (United States); Horick, Nora [Department of Biostatistics, Massachusetts General Hospital, Boston, Massachusetts (United States); Skolny, Melissa N.; Jammallo, Lauren S.; Sadek, Betro T.; Shenouda, Mina N. [Department of Radiation Oncology, Massachusetts General Hospital, Boston, Massachusetts (United States); O' Toole, Jean A. [Department of Physical and Occupational Therapy, Massachusetts General Hospital, Boston, Massachusetts (United States); MacDonald, Shannon M. [Department of Radiation Oncology, Massachusetts General Hospital, Boston, Massachusetts (United States); Specht, Michelle C. [Division of Surgical Oncology, Massachusetts General Hospital, Boston, Massachusetts (United States); Taghian, Alphonse G., E-mail: ataghian@partners.org [Department of Radiation Oncology, Massachusetts General Hospital, Boston, Massachusetts (United States)

    2014-03-01

    Purpose/Objective: Lymphedema after breast cancer treatment can be an irreversible condition with a negative impact on quality of life. The goal of this study was to identify radiation therapy-related risk factors for lymphedema. Methods and Materials: From 2005 to 2012, we prospectively performed arm volume measurements on 1476 breast cancer patients at our institution using a Perometer. Treating each breast individually, 1099 of 1501 patients (73%) received radiation therapy. Arm measurements were performed preoperatively and postoperatively. Lymphedema was defined as ≥10% arm volume increase occurring >3 months postoperatively. Univariate and multivariate Cox proportional hazard models were used to evaluate risk factors for lymphedema. Results: At a median follow-up time of 25.4 months (range, 3.4-82.6 months), the 2-year cumulative incidence of lymphedema was 6.8%. Cumulative incidence by radiation therapy type was as follows: 3.0% no radiation therapy, 3.1% breast or chest wall alone, 21.9% supraclavicular (SC), and 21.1% SC and posterior axillary boost (PAB). On multivariate analysis, the hazard ratio for regional lymph node radiation (RLNR) (SC ± PAB) was 1.7 (P=.025) compared with breast/chest wall radiation alone. There was no difference in lymphedema risk between SC and SC + PAB (P=.96). Other independent risk factors included early postoperative swelling (P<.0001), higher body mass index (P<.0001), greater number of lymph nodes dissected (P=.018), and axillary lymph node dissection (P=.0001). Conclusions: In a large cohort of breast cancer patients prospectively screened for lymphedema, RLNR significantly increased the risk of lymphedema compared with breast/chest wall radiation alone. When considering use of RLNR, clinicians should weigh the potential benefit of RLNR for control of disease against the increased risk of lymphedema.

  2. Anthroposophic therapy for children with chronic disease: a two-year prospective cohort study in routine outpatient settings

    Directory of Open Access Journals (Sweden)

    Willich Stefan N

    2009-06-01

    Full Text Available Abstract Background Many children with chronic disease use complementary therapies. Anthroposophic treatment for paediatric chronic disease is provided by physicians and differs from conventional treatment in the use of special therapies (art therapy, eurythmy movement exercises, rhythmical massage therapy and special medications. We studied clinical outcomes in children with chronic diseases under anthroposophic treatment in routine outpatient settings. Methods In conjunction with a health benefit program, consecutive outpatients starting anthroposophic treatment for any chronic disease participated in a prospective cohort study. Main outcome was disease severity (Disease and Symptom Scores, physicians' and caregivers' assessment on numerical rating scales 0–10. Disease Score was documented after 0, 6, and 12 months, Symptom Score after 0, 3, 6, 12, 18, and 24 months. Results A total of 435 patients were included. Mean age was 8.2 years (standard deviation 3.3, range 1.0–16.9 years. Most common indications were mental disorders (46.2% of patients; primarily hyperkinetic, emotional, and developmental disorders, respiratory disorders (14.0%, and neurological disorders (5.7%. Median disease duration at baseline was 3.0 years (interquartile range 1.0–5.0 years. The anthroposophic treatment modalities used were medications (69.2% of patients, eurythmy therapy (54.7%, art therapy (11.3%, and rhythmical massage therapy (6.7%. Median number of eurythmy/art/massage therapy sessions was 12 (interquartile range 10–20, median therapy duration was 118 days (interquartile range 78–189 days. From baseline to six-month follow-up, Disease Score improved by average 3.00 points (95% confidence interval 2.76–3.24 points, p Conclusion Children under anthroposophic treatment had long-term improvement of chronic disease symptoms. Although the pre-post design of the present study does not allow for conclusions about comparative effectiveness, study

  3. Properties of films obtained from biopolymers of different origins for skin lesions therapy

    Directory of Open Access Journals (Sweden)

    Márcia Zilioli Bellini

    2015-04-01

    Full Text Available In this study, the effects of the origin of xanthan used, in combination with chitosan, to prepare films for the treatment of skin lesions were evaluated. The characteristics of the films obtained with xanthan commercially available for the food industry sector and xanthan originated from a fermentation process conducted in a pilot plant were compared. Results showed that the source did not strongly interfere in many of the properties of the films, such as the mechanical properties, cytotoxicity to L929 cells, absorption of simulated body fluid and culture medium, stability in water and saline solution. Hence, even though the properties of biopolymers of different sources might vary, the films prepared with two distinct types of xanthan gum could be considered as potentially safe and similar in terms of relevant characteristics considering the aimed application.

  4. Current status and future prospects of multi-dimensional image-guided particle therapy

    NARCIS (Netherlands)

    Mori, Shinichiro; Zenklusen, Silvan; Knopf, Antje-Christin

    In this review article we emphasize the importance of "imaging" and "image guidance" in advanced particle therapy from a clinical point of view. Although the image-guided radiotherapy (IGRT) technology used for photon and particle therapy is closely similar, the focus of its application in the two

  5. An Empirical vs Risk-Based Approach Algorithm to Intracavernosal Injection Therapy: A Prospective Study

    Directory of Open Access Journals (Sweden)

    Helen Levey Bernie, DO, MPH

    2017-03-01

    Conclusion: Empiric and risk-based strategies for ICI therapy resulted in significant improvements across multiple domains of sexual function. Complication rates, satisfaction, and efficacy overall were similar between the two approaches. Clinicians can be reassured that no one approach to ICI therapy for ED management appears inferior to another.

  6. The cost of molecular-guided therapy in oncology: a prospective cost study alongside the MOSCATO trial.

    Science.gov (United States)

    Pagès, Arnaud; Foulon, Stéphanie; Zou, Zhaomin; Lacroix, Ludovic; Lemare, François; de Baère, Thierry; Massard, Christophe; Soria, Jean-Charles; Bonastre, Julia

    2017-06-01

    There is increasing use of molecular technologies to guide cancer treatments, but few cost data are available. Our objective was to assess the costs of molecular-guided therapy for patients with advanced solid tumors alongside the Molecular Screening for Cancer Treatment and Optimization (MOSCATO) trial. The study population consisted of 529 patients. The molecular diagnosis included seven steps from tumor biopsy to the multidisciplinary molecular tumor board. The cost of a complete molecular diagnosis was assessed by micro-costing. Direct costs incurred from enrollment until progression were assessed from the French National Health Insurance perspective. The patients' mean age was 54 years (range: 3-82) and the mean follow-up period was 145 days (range: 1-707 days). A complete molecular diagnosis cost [euro ]2,396. There were 220 patients with an actionable target (42%), among whom 105 (20%) actually received a targeted therapy. The cost of molecular-guided therapy per patient was [euro ]31,269. The main cost drivers were anticancer drugs (54%) and hospitalizations (35%). This prospective cost analysis showed that molecular diagnosis accounts for only 6% of the cost of molecular-guided therapy per patient. The costs of drugs and hospitalizations are the main cost drivers.Genet Med advance online publication 01 December 2016.

  7. The Impact of the Prospective Payment System for Skilled Nursing Facilities on Therapy Service Provision: A Transaction Cost Approach

    Science.gov (United States)

    Zinn, Jacqueline S; Mor, Vincent; Intrator, Orna; Feng, Zhanlian; Angelelli, Joseph; Davis, Jullet A

    2003-01-01

    Objective To examine skilled nursing facilities (SNFs) “make-or-buy” decisions with respect to rehabilitation therapy service provision in the 1990s, both before and after implementation of Medicare's Prospective Payment System (PPS) for SNFs. Data Sources Longitudinal On-line Survey Certification and Reporting (OSCAR) data (1992–2001) on a sample of 10,241 freestanding urban SNFs. Study Design We estimated a longitudinal multinomial logistic regression model derived from transaction cost economic theory to predict the probability of the outcome in each of four service provision categories (all employed staff, all contract, mixed, and no services provided). Principal Findings Transaction frequency, uncertainty, and complexity result in greater control over therapy services through employment as opposed to outside contracting. For-profit status and chain affiliation were associated with greater control over therapy services. Following PPS, nursing homes acted to limit transaction costs by either exiting the rehabilitation market or exerting greater control over therapy services by managing rehabilitation services in-house. Conclusions The financial incentives associated with changes in reimbursement methodology have implications that extend beyond the boundaries of the health care industry segment directly affected. Unintended quality and access consequences need to be carefully monitored by the Medicare program. PMID:14727783

  8. Outcomes and Prognostic Features of Patients With Influenza Requiring Hospitalization and Receiving Early Antiviral Therapy: A Prospective Multicenter Cohort Study.

    Science.gov (United States)

    Maruyama, Takaya; Fujisawa, Takao; Suga, Shigeru; Nakamura, Haruna; Nagao, Mizuho; Taniguchi, Kiyosu; Tsutsui, Kiyoyuki; Ihara, Toshiaki; Niederman, Michael S

    2016-02-01

    In Japan, the routine use of early antiviral therapy for patients with influenza is standard. This multicenter prospective cohort evaluation of hospitalized patients with laboratory-confirmed influenza identified prognostic factors among the patients receiving antiviral therapy. Of 1,345 patients with influenza (766 pediatric, 579 adult), excluding those aged antiviral therapy), 97.7% (1,224 of 1,253) received antiviral therapy. Among the adult patients, 24 (4.1%) died within 30 days, whereas none of the pediatric patients died. Five hundred twenty-eight (91.2%) adult patients had influenza A, 509 (87.9%) had a chronic underlying illness, and 211 (36.4%) had radiographically confirmed pneumonia. Twenty of the 24 patients who died had pneumonia of the following etiologies: Streptococcus pneumoniae (12.3%); Staphylococcus aureus (10.9%), including methicillin-resistant S aureus (MRSA) 3.3%; Enterobacteriaceae (8.1%); and Pseudomonas aeruginosa (3.3%). Of the adult patients, 151 were classified as having community-acquired pneumonia (CAP) and 60 as having health-care-associated pneumonia (HCAP). Inappropriate therapy was more common in HCAP than in CAP (15.2% vs 2%, P = .001). Potential multidrug-resistant (MDR) pathogens were more common (21.7% vs 2.6%, P therapy for patients with HCAP and influenza. Japan Medical Association Center for Clinical Trials; No.: JMA-IIA00123; URL: http://www.jmacct.med.or.jp/en/. Copyright © 2016 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.

  9. Glucagon-like peptide-1 analogue therapy for psoriasis patients with obesity and type 2 diabetes: a prospective cohort study.

    LENUS (Irish Health Repository)

    Ahern, T

    2012-06-13

    Background  Diabetes and obesity are more prevalent amongst psoriasis patients as is disturbance of the innate immune system. GLP-1 analogue therapy considerably improves weight and glycaemic control in people with type 2 diabetes and its receptor is present on innate immune cells. Objective  We aimed to determine the effect of liraglutide, a GLP-1 analogue, on psoriasis severity. Methods  Before and after 10 weeks of liraglutide therapy (1.2 mg subcutaneously daily) we determined the psoriasis area and severity index (PASI) and the dermatology life quality index (DLQI) in seven people with both psoriasis and diabetes (median age 48 years, median body mass index 48.2 kg\\/m(2) ). We also evaluated the immunomodulatory properties of liraglutide by measuring circulating lymphocyte subset numbers and monocyte cytokine production. Results  Liraglutide therapy decreased the median PASI from 4.8 to 3.0 (P = 0.03) and the median DLQI from 6.0 to 2.0 (P = 0.03). Weight and glycaemic control improved significantly. Circulating invariant natural killer T (iNKT) cells increased from 0.13% of T lymphocytes to 0.40% (P = 0.03). Liraglutide therapy also effected a non-significant 54% decrease in the proportion of circulating monocytes that produced tumour necrosis factor alpha (P = 0.07). Conclusion  GLP-1 analogue therapy improves psoriasis severity, increases circulating iNKT cell number and modulates monocyte cytokine secretion. These effects may result from improvements in weight and glycaemic control as well as from direct immune effects of GLP-1 receptor activation. Prospective controlled trials of GLP-1 therapies are warranted, across all weight groups, in psoriasis patients with and without type 2 diabetes.

  10. Comparing complementary alternative treatment for chronic shoulder pain of myofascial origin: Collateral meridian therapy versus local tender area-related meridians therapy.

    Science.gov (United States)

    Pan, Ru-Yu; Hsu, Yung-Chi; Wong, Chih-Shung; Lin, Shinn-Long; Li, Tsung-Ying; Cherng, Chen-Hwan; Ko, Shan-Chi; Yeh, Chun-Chang

    2016-08-01

    The aim of this study was to compare the short-term outcomes between 2 different treatments for unilateral chronic shoulder pain of myofascial origin, that is, local tender area related meridians (LTARMs) treatment and collateral meridian therapy (CMT), which were performed 6 times over a period of 4 weeks.Seventy patients with unilateral shoulder pain of chronic myofascial origin were enrolled. The patients were randomly assigned to 2 different treatment groups: 1 group received CMT (n = 35) and the other received LTARM (n = 35). Before and after the 2 treatment processes, all patients rated their overall pain intensity on a visual analogue scale (VAS) and a validated 13-question shoulder pain and disability index (SPADI) questionnaire was used to measure shoulder pain and functional impairment after therapy for 4 weeks.After CMT, the pain intensity was reduced after CMT. VAS score is reduced from 5.90 ± 2.07 (a mean of 5.90 and standard deviation of 2.07) to 3.39 ± 1.2. This was verified by the SPADI pain subscale scores (from 0.58 ± 0.193 to 0.33 ± 0.14). The pain-relief effect of CMT was significantly better than that of LTARM (VAS score from 5.78 ± 1.64 to 4.58 ± 1.40; P pain subscale score from 0.58 ± 0.16 to 0.45 ± 0.14, P pain, whereas the VAS scores for moderate pain were even higher in the LTARM group in 75% of patients (P chronic shoulder pain of myofascial origin than the LTARM treatment, where treatment with the former resulted in better functional recovery after 4 weeks than the latter.

  11. Ashkenazi Jewish Origin Protects Against Formation of Antibodies to Infliximab and Therapy Failure

    Science.gov (United States)

    Ungar, Bella; Haj-Natour, Ola; Kopylov, Uri; Yavzori, Miri; Fudim, Ella; Picard, Orit; Loebstein, Ronen; Lahat, Adi; Maor, Yaakov; Avidan, Benjamin; Lang, Alon; Weiss, Batia; Chowers, Yehuda; Eliakim, Rami; Ben-Horin, Shomron

    2015-01-01

    Abstract Infliximab is an anti-tumor necrosis factor (TNF) used for treatment of inflammatory bowel disease (IBD) as well as rheumatoid arthritis, psoriasis, and other inflammatory conditions. Antibodies to infliximab (ATI) develop in approximately 45% of infliximab-treated IBD patients and are correlated with loss of clinical response. Scarce data exist as to factors which predict infliximab immunogenicity. To investigate factors that may predict formation of antibodies to infliximab (ATI) and infliximab therapy failure an observational study of consecutive IBD patients treated with infliximab between 2009 and 2013 was performed. Trough levels of ATI were measured. Patients were monitored for disease activity using clinical activity indexes and were classified according to ATI formation and clinical response. All clinical and demographic parameters were analyzed for association with the designated outcomes. One hundred fifty-nine patients were included and 1505 sera were tested. On multivariate analysis, Jewish Ashkenazi ethnicity was protective against both development of ATI (odds ratio [OR] 0.35, 95% confidence interval [CI] 0.17–0.7, P = 0.005) and treatment failure (OR 0.29, 95% CI 0.13–0.66, P = 0.003). Concomitant immunomodulator therapy was also negatively associated with immunogenicity and infliximab therapy failure (OR 0.31, 95% CI 0.15–0.65, P = 0.002; OR 0.42 95% CI 0.18−0.99, p = 0.04, respectively), whereas episodic therapy was positively associated with both outcomes (OR 4.2 95% CI 1.07−16.1, p = 0.04, OR 4.45 95% CI 1.2−16.6, p = 0.026 respectively). All other variables, including IBD type, gender, weight, age, smoking status and disease duration, were not predictive of ATI formation or clinical failure. However, among Crohn's disease patients, a non-stricturing non-penetrating phenotype was protective against ATI formation (OR 0.4, 95% CI 0.14−0.96, p = 0.04). P = 0.04, respectively), whereas episodic

  12. Health psychology in Ghana: A review of the multidisciplinary origins of a young sub-field and its future prospects.

    Science.gov (United States)

    de-Graft Aikins, Ama

    2018-03-01

    This article presents a historical overview of psychology applied to health and health psychology in Ghana. A brief history of health, illness and healthcare in Ghana is introduced. Then, the history of psychology in Ghana is presented, with signposts of the major turns in the field in relation to psychology and other disciplines applied to health and the emergence of health psychology as a sub-field. Selected health psychology studies are reviewed to highlight ideological trends in the field. Finally, future prospects are considered in terms of how the sub-field can transition into an established critical field with unique contributions to make to global health psychology.

  13. Multinational Prospective Study of Patient-Reported Outcomes After Prostate Radiation Therapy: Detailed Assessment of Rectal Bleeding

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Jae Y.; Daignault-Newton, Stephanie; Heath, Gerard; Scarlett, Sarah [University of Michigan, Ann Arbor, Michigan (United States); Sanda, Martin G. [Emory University Department of Urology, Atlanta, Georgia (United States); Chang, Peter [Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts (United States); Regan, Meredith M. [Dana-Farber Cancer Institute, Boston, Massachusetts (United States); Michalski, Jeff M. [Washington University School of Medicine, St. Louis, Missouri (United States); Sandler, Howard M. [Cedars-Sinai Medical Center, Los Angeles, California (United States); Feng, Felix Y. [University of Michigan, Ann Arbor, Michigan (United States); Kuban, Deborah A. [MD Anderson Cancer Center, Houston, Texas (United States); Zietman, Anthony L. [Massachusetts General Hospital, Boston, Massachusetts (United States); Ciezki, Jay P. [Cleveland Clinic, Cleveland, Ohio (United States); Kaplan, Irving D.; Crociani, Catrina [Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts (United States); McLaughlin, William P. [University of Michigan, Ann Arbor, Michigan (United States); Mantz, Constantine A. [21st Century Oncology, Fort Myers, Florida (United States); Finkelstein, Steven E. [21st Century Oncology, Scottsdale, Arizona (United States); Suy, Simeng; Collins, Sean P. [Georgetown University Medical Center, Washington, DC (United States); and others

    2016-11-15

    Purpose: The new short Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) patient-reported health-related quality of life (HRQOL) tool has removed the rectal bleeding question from the previous much longer version, EPIC-26. Herein, we assess the impact of losing the dedicated rectal bleeding question in 2 independent prospective multicenter cohorts. Methods and Materials: In a prospective multicenter test cohort (n=865), EPIC-26 patient-reported HRQOL data were collected for 2 years after treatment from patients treated with prostate radiation therapy from 2003 to 2011. A second prospective multicenter cohort (n=442) was used for independent validation. A repeated-effects model was used to predict the change from baseline in bowel summary scores from longer EPIC instruments using the change in EPIC-CP bowel summary scores with and without rectal bleeding scores. Results: Two years after radiation therapy, 91% of patients were free of bleeding, and only 2.6% reported bothersome bleeding problems. Correlations between EPIC-26 and EPIC-CP bowel scores were very high (r{sup 2}=0.90-0.96) and were statistically improved with the addition of rectal bleeding information (r{sup 2}=0.94-0.98). Considering all patients, only 0.2% of patients in the test cohort and 0.7% in the validation cohort reported bothersome bleeding and had clinically relevant HRQOL changes missed with EPIC-CP. However, of the 2.6% (n=17) of men with bothersome rectal bleeding in the test cohort, EPIC-CP failed to capture 1 patient (6%) as experiencing meaningful declines in bowel HRQOL. Conclusions: Modern prostate radiation therapy results in exceptionally low rates of bothersome rectal bleeding, and <1% of patients experience bothersome bleeding and are not captured by EPIC-CP as having meaningful HRQOL declines after radiation therapy. However, in the small subset of patients with bothersome rectal bleeding, the longer EPIC-26 should strongly be considered, given its superior

  14. Concomitant boost radiation therapy for inoperable non-small-cell lung cancer: preliminary report of a prospective randomized study

    International Nuclear Information System (INIS)

    Sun, L.-M.; Leung, Stephen Wan; Wang, C.-J.; Chen, H.-C.; Fang, F.-M.; Huang, E.-Y.; Hsu, H.-C.; Yeh, S.-A.; Hsiung, C.-Y.; Huang, David T.

    2000-01-01

    Purpose: The radiation therapy results for patients with inoperable non-small-cell lung cancer (NSCLC) have been disappointing. Tumor dose escalation using concomitant boost technique (CBT) has been shown to improve local control in a few prospective studies. This trial was carried out to prospectively assess the radiation response and acute toxicity of CBT in comparison to the conventional treatment technique (CTT). Methods and Materials: Ninety-seven consecutive eligible patients were entered in this prospective clinical trial between November 1994 and February 1998. Patients were randomized to receive either CBT (43 patients) or CTT (54 patients) radiation therapy. These patients either refused chemotherapy or were judged as unsuitable for chemotherapy. Patients in the CBT group received 46.8 Gy in 26 fractions using large fields that encompassed the gross and occult disease. A concomitant boost of 18.2 Gy (0.7 Gy per fraction) was delivered to the gross disease using small fields with 1.5-cm margins. The small fields were treated concurrently with the large fields and the total dose to the tumor area was 65 Gy in 26 fractions. Patients in the CTT group received 70.8 Gy in 38 fractions. The acute toxicity between each group was compared. The response rate was analyzed and compared by treatment group, gender, age, stage, histology, initial Karnofsky performance score (KPS), severity of acute toxicity, and maximum body weight loss (MBWL) during treatment course. Results: The demographic parameters such as sex, age, and stage were evenly distributed in each treatment group. The majority of these patients had Stage IIIA and IIIB disease. Overall median treatment times were 39 days for the CBT group of patients and 62 days for the CTT group. No treatment-related mortality was found. There were 2 patients in the CTT group with acute RTOG Grade 3 lung toxicity, and no Grade 3 lung or esophageal toxicity was observed in CBT group. The response rates, assessed by

  15. A prospective study of dexamethasone therapy in refractory epileptic encephalopathy with continuous spike-and-wave during sleep.

    Science.gov (United States)

    Chen, Jin; Cai, Fangcheng; Jiang, Li; Hu, Yue; Feng, Chenggong

    2016-02-01

    Epileptic encephalopathy with continuous spike-and-wave during sleep (CSWS) is an intractable form of epilepsy that has no consensus protocol for corticosteroid therapy. This prospective study aimed to evaluate the efficacy and tolerability of dexamethasone for the treatment of CSWS. Patients (age: 4 years to 12 years and 5 months) with CSWS that failed to respond to several antiepileptic drugs and prednisolone at our pediatric neurology outpatient clinic between 2007 and 2015 were treated with dexamethasone and prospectively analyzed. An initial 4-week dexamethasone (0.15 mg/kg/day p.o.) scheme was employed, and response was assessed. If effective, dexamethasone was maintained for 2-3 months and then slowly weaned over several months, depending on individual patient response at each follow-up. Systemic evaluations (clinical evaluations, electroencephalography recordings, and analysis of side effects) were performed regularly thereafter. Among 15 patients, 7 were defined as initial responders after 4-week dexamethasone treatment based on comprehensive clinical and electroencephalogram evaluations. The duration of dexamethasone treatment (including weaning) in these 7 patients was 6 to 10 months, and the follow-up duration was 6 months to 7 years. Three patients had no relapse after dexamethasone withdrawal at last follow-up. Among the other 4 patients, relapse was observed during dexamethasone withdrawal (n=1) or at 2-6 months after discontinuation of dexamethasone therapy (n=3). There were no serious or life-threatening side effects, and all observed side effects were reversible after discontinuation of dexamethasone. Continuous oral dexamethasone treatment is an effective and tolerable therapy and should be an option for the treatment of CSWS. Copyright © 2015 Elsevier Inc. All rights reserved.

  16. Chronic shoulder pain of myofascial origin: a randomized clinical trial using ischemic compression therapy.

    Science.gov (United States)

    Hains, Guy; Descarreaux, Martin; Hains, François

    2010-06-01

    The aim of this clinical trial was to evaluate the effect of 15 myofascial therapy treatments using ischemic compression on shoulder trigger points in patients with chronic shoulder pain. Forty-one patients received 15 experimental treatments, which consisted of ischemic compressions on trigger points located in the supraspinatus muscle, the infraspinatus muscle, the deltoid muscle, and the biceps tendon. Eighteen patients received the control treatment involving 15 ischemic compression treatments of trigger points located in cervical and upper thoracic areas. Of the 18 patients forming the control group, 16 went on to receive 15 experimental treatments after having received their initial control treatments. Outcome measures included a validated 13-question questionnaire measuring shoulder pain and functional impairment. A second questionnaire was used to assess patients' perceived amelioration, using a scale from 0% to 100%. Outcome measure evaluation was completed for both groups at baseline after 15 treatments, 30 days after the last treatment, and finally for the experimental group only, 6 months later. A significant group x time interval interaction was observed after the first 15 treatments, indicating that the experimental group had a significant reduction in their Shoulder Pain and Disability Index (SPADI) score compared with the control group (62% vs 18% amelioration). Moreover, the patients perceived percentages of amelioration were higher in the experimental group after 15 treatments (75% vs 29%). Finally, the control group subjects significantly reduced their SPADI scores after crossover (55%). The results of this study suggest that myofascial therapy using ischemic compression on shoulder trigger points may reduce the symptoms of patients experiencing chronic shoulder pain. Copyright (c) 2010 National University of Health Sciences. Published by Mosby, Inc. All rights reserved.

  17. A comparison of medication administration errors from original medication packaging and multi-compartment compliance aids in care homes: A prospective observational study.

    Science.gov (United States)

    Gilmartin-Thomas, Julia Fiona-Maree; Smith, Felicity; Wolfe, Rory; Jani, Yogini

    2017-07-01

    No published study has been specifically designed to compare medication administration errors between original medication packaging and multi-compartment compliance aids in care homes, using direct observation. Compare the effect of original medication packaging and multi-compartment compliance aids on medication administration accuracy. Prospective observational. Ten Greater London care homes. Nurses and carers administering medications. Between October 2014 and June 2015, a pharmacist researcher directly observed solid, orally administered medications in tablet or capsule form at ten purposively sampled care homes (five only used original medication packaging and five used both multi-compartment compliance aids and original medication packaging). The medication administration error rate was calculated as the number of observed doses administered (or omitted) in error according to medication administration records, compared to the opportunities for error (total number of observed doses plus omitted doses). Over 108.4h, 41 different staff (35 nurses, 6 carers) were observed to administer medications to 823 residents during 90 medication administration rounds. A total of 2452 medication doses were observed (1385 from original medication packaging, 1067 from multi-compartment compliance aids). One hundred and seventy eight medication administration errors were identified from 2493 opportunities for error (7.1% overall medication administration error rate). A greater medication administration error rate was seen for original medication packaging than multi-compartment compliance aids (9.3% and 3.1% respectively, risk ratio (RR)=3.9, 95% confidence interval (CI) 2.4 to 6.1, ppackaging (from original medication packaging-only care homes) and multi-compartment compliance aids (RR=2.3, 95%CI 1.1 to 4.9, p=0.03), and between original medication packaging and multi-compartment compliance aids within care homes that used a combination of both medication administration

  18. Can probiotics improve efficiency and safety profile of triple Helicobacter pylori eradication therapy? A prospective randomized study

    Directory of Open Access Journals (Sweden)

    Grgov Saša

    2016-01-01

    Full Text Available Background/Aim. Some studies suggest the benefit of applying different probiotic strains in combination with antibiotics in the eradication of Helicobacter pylori (H. pylori infection. The aim of this study was to evaluate the effect of co-administration of multiple probiotic strains with triple H. pylori eradication therapy. Methods. This prospective study included 167 patients with dyspeptic symptoms and chronic gastritis who were diagnosed with H. pylori infection and randomized into two groups. The group I of 77 patients underwent triple eradication therapy, for 7 days, with lansoprazole, 2 × 30 mg half an hour before the meal, amoxicillin 2 × 1.000 mg per 12 hours and clarithromycin 2 × 500 mg per 12 hours. After the 7th day of the therapy, lansoprazole continued at a dose of 30 mg for half an hour before breakfast for 4 weeks. The group II of 90 patients received the same treatment as the patients of the group I, with the addition of the probiotic cultures in the form of a capsule comprising Lactobacillus Rosell-52, Lactobacillus Rosell-11, Bifidobacterium Rosell-1755 and Saccharomyces boulardii, since the beginning of eradication for 4 weeks. Eradication of H. pylori infection control was performed 8 weeks after the therapy by rapid urease test and histopathologic evaluation of endoscopic biopsies or by stool antigen test for H. pylori. Results. Eradication of H. pylori infection was achieved in 93.3% of the patients who received probiotics with eradication therapy and in 81.8% of patients who were only on eradication therapy without probiotics. The difference in eradication success was statistically significant, (p < 0.05. The incidence of adverse effects of eradication therapy was higher in the group of patients who were not on probiotic (28.6% than in the group that received probiotic (17.7%, but the difference was not statistically significant. Conclusion. Multiple probiotic strains addition to triple eradication therapy of H

  19. Disordered eating behaviors in youth with type 1 diabetes: prospective pilot assessment following initiation of insulin pump therapy.

    Science.gov (United States)

    Markowitz, Jessica T; Alleyn, Cielo A; Phillips, Roxanne; Muir, Andrew; Young-Hyman, Deborah; Laffel, Lori M B

    2013-05-01

    There is risk for disordered eating behaviors in type 1 diabetes, especially related to insulin manipulation. Implementation of insulin pump therapy may encourage either normalization of eating behaviors or a greater focus on food intake due to renewed emphasis on carbohydrate counting. There is need for prospective studies to assess disordered eating behaviors upon implementation of pump therapy using diabetes-specific measurement tools. In a multicenter pilot study, 43 youth with type 1 diabetes, 10-17 years old, were assessed prior to pump initiation and after 1 and 6 months of pump therapy. Youth completed the Diabetes-specific Eating Problems Survey-Revised (DEPS-R), a validated measure of risk for both diabetes-specific and general disordered eating behaviors. Youth (45% female), 13.3 years old with diabetes for 2.1 years, had a mean hemoglobin A1c of 8.3±1.3% (68±14.5 mmol/mol) at baseline. DEPS-R scores decreased over time (P=0.01). Overall rate of high risk for eating disorders was low. Overweight/obese youth endorsed more disordered eating behaviors than normal-weight participants. DEPS-R scores were correlated with z-score for body mass index at all three time points and with hemoglobin A1c after 1 and 6 months. Hemoglobin A1c did not change significantly over the 6 months and was higher in overweight/obese compared with normal-weight participants. Initiation of insulin pump therapy was associated with diminished endorsement of disordered eating behaviors in youth with type 1 diabetes. Longer follow-up studies are needed to assess the impact of insulin pump therapy on glycemic control, weight status, and disordered eating behaviors in this vulnerable population.

  20. [Tones and being tuned. Suggestions for the common origins of music therapy and hypnotherapy].

    Science.gov (United States)

    Vas, József Pál

    2013-01-01

    Sound vibrations are viewed to play an important role in embryonic development. Before the cochlea evolves, the haptic and mechanic skin-receptors detect the amniotic fluid's pressure-waves produced by sounds in uterus. Touching and hearing are seen as primordial and the most relevant stimuli both of mother-fetus attunement and development of fetal nervous system. Man is attuned to environmental stimuli, mainly to human speaking since the embryonic period. Attunement is secured by energy zones (chakras) circling around body. It is considered to be base of our music capacity. Origin of hypnotic susceptibility is viewed as being in embryonic period as well. Movements, experiences supposed, bonding and communication patterns of both of fetus and hypnotized person are suggested to show similarities. Prenatal audio-somatosensory stimulating program facilitates newborn babies' cognitive, emotional and bonding capacities. As a matter of fact, by virtue of regressive fetus-like experiences, hypnotherapy contributes to the restart of personality development halted by trauma.

  1. A Prospective Clinical Trial Combining Radiation Therapy With Systemic Immunotherapy in Metastatic Melanoma

    Energy Technology Data Exchange (ETDEWEB)

    Hiniker, Susan M., E-mail: shiniker@stanford.edu [Department of Radiation Oncology, Stanford University Medical Center and Cancer Institute, Stanford, California (United States); Reddy, Sunil A. [Division of Oncology, Department of Medicine, Stanford University Medical Center and Cancer Institute, Stanford, California (United States); Maecker, Holden T.; Subrahmanyam, Priyanka B.; Rosenberg-Hasson, Yael [Human Immune Monitoring Center, Institute for Immunity, Transplantation, and Infection, Stanford University Medical Center, Stanford, California (United States); Swetter, Susan M. [Department of Dermatology, Pigmented Lesion and Melanoma Program, Stanford University Medical Center and Cancer Institute, Stanford, California (United States); Dermatology Service, Veterans Affairs Palo Alto Health Care System, Palo Alto, California (United States); Saha, Saurabh [Atlas Venture, Cambridge, Massachusetts (United States); Shura, Lei; Knox, Susan J. [Department of Radiation Oncology, Stanford University Medical Center and Cancer Institute, Stanford, California (United States)

    2016-11-01

    Purpose: Local radiation therapy (RT) combined with systemic anti-cytotoxic T-lymphocyte–associated protein-4 immunotherapy may enhance induction of systemic antimelanoma immune responses. The primary objective of the present trial was to assess the safety and efficacy of combining ipilimumab with RT in patients with stage IV melanoma. The secondary objectives included laboratory assessment of induction of antimelanoma immune responses. Methods and Materials: In our prospective clinical trial, 22 patients with stage IV melanoma were treated with palliative RT and ipilimumab for 4 cycles. RT to 1 to 2 disease sites was initiated within 5 days after starting ipilimumab. Patients had ≥1 nonirradiated metastasis measuring ≥1.5 cm available for response assessment. Tumor imaging studies were obtained at baseline, 2 to 4 weeks after cycle 4 of ipilimumab, and every 3 months until progression. Laboratory immune response parameters were measured before and during treatment. Results: Combination therapy was well-tolerated without unexpected toxicities. Eleven patients (50.0%) experienced clinical benefit from therapy, including complete and partial responses and stable disease at median follow-up of 55 weeks. Three patients (27.3%) achieved an ongoing systemic complete response at a median follow-up of 55 weeks (range 32-65), and 3 (27.3%) had an initial partial response for a median of 40 weeks. Analysis of immune response data suggested a relationship between elevated CD8-activated T-cells and response. Conclusion: This is the second prospective clinical trial of treatment of metastatic melanoma using the combination of RT and systemic immunotherapy and the first using this sequence of therapy. The results from the present trial demonstrate that a subset of patients may benefit from combination therapy, arguing for continued clinical investigation of the use of RT combined with immunotherapy, including programmed cell death 1 inhibitors, which might have the

  2. A Prospective Clinical Trial Combining Radiation Therapy With Systemic Immunotherapy in Metastatic Melanoma.

    Science.gov (United States)

    Hiniker, Susan M; Reddy, Sunil A; Maecker, Holden T; Subrahmanyam, Priyanka B; Rosenberg-Hasson, Yael; Swetter, Susan M; Saha, Saurabh; Shura, Lei; Knox, Susan J

    2016-11-01

    Local radiation therapy (RT) combined with systemic anti-cytotoxic T-lymphocyte-associated protein-4 immunotherapy may enhance induction of systemic antimelanoma immune responses. The primary objective of the present trial was to assess the safety and efficacy of combining ipilimumab with RT in patients with stage IV melanoma. The secondary objectives included laboratory assessment of induction of antimelanoma immune responses. In our prospective clinical trial, 22 patients with stage IV melanoma were treated with palliative RT and ipilimumab for 4 cycles. RT to 1 to 2 disease sites was initiated within 5 days after starting ipilimumab. Patients had ≥1 nonirradiated metastasis measuring ≥1.5 cm available for response assessment. Tumor imaging studies were obtained at baseline, 2 to 4 weeks after cycle 4 of ipilimumab, and every 3 months until progression. Laboratory immune response parameters were measured before and during treatment. Combination therapy was well-tolerated without unexpected toxicities. Eleven patients (50.0%) experienced clinical benefit from therapy, including complete and partial responses and stable disease at median follow-up of 55 weeks. Three patients (27.3%) achieved an ongoing systemic complete response at a median follow-up of 55 weeks (range 32-65), and 3 (27.3%) had an initial partial response for a median of 40 weeks. Analysis of immune response data suggested a relationship between elevated CD8-activated T-cells and response. This is the second prospective clinical trial of treatment of metastatic melanoma using the combination of RT and systemic immunotherapy and the first using this sequence of therapy. The results from the present trial demonstrate that a subset of patients may benefit from combination therapy, arguing for continued clinical investigation of the use of RT combined with immunotherapy, including programmed cell death 1 inhibitors, which might have the potential to be even more effective in combination with

  3. Fractionated stereotactic radiation therapy and single high-dose radiosurgery for acoustic neuroma: early results of a prospective clinical study

    International Nuclear Information System (INIS)

    Meijer, O.W.M.; Wolbers, J.G.; Baayen, J.C.; Slotman, B.J.

    2000-01-01

    Purpose: To prospectively assess the local control and toxicity rate in acoustic neuroma patients treated with linear accelerator-based radiosurgery and fractionated stereotactic radiation therapy. Methods and Materials: We evaluated 37 consecutive patients treated with stereotactic radiation therapy for acoustic neuroma. All patients had progressive tumors, progressive symptoms, or both. Mean tumor diameter was 2.3 cm (range 0.8-3.3) on magnetic resonance (MR) scan. Dentate patients were given a dose of 5 x 4 Gy or 5 x 5 Gy and edentate patients were given a dose of 1 x 10 Gy or 1 x 12.50 Gy prescribed to the 80% isodose. All patients were treated with a single isocenter. Results: With a mean follow-up period of 25 months (range 12-61), the actuarial local control rate at 5 years was 91% (only 1 patient failed). The actuarial rate of hearing preservation at 5 years was 66% in previously-hearing patients. The actuarial rate of freedom from trigeminal nerve toxicity was 97% at 5 years. No patient developed facial nerve toxicity or other complications. Conclusion: In this unselected series, fractionated stereotactic radiation therapy and linear accelerator-based radiosurgery give excellent local control in acoustic neuroma. It combines a high rate of preservation of hearing with a very low rate of other toxicity, although follow-up is relatively short

  4. Immunosuppressive therapy of LGL leukemia: prospective multicenter phase II study by the Eastern Cooperative Oncology Group (E5998).

    Science.gov (United States)

    Loughran, T P; Zickl, L; Olson, T L; Wang, V; Zhang, D; Rajala, H L M; Hasanali, Z; Bennett, J M; Lazarus, H M; Litzow, M R; Evens, A M; Mustjoki, S; Tallman, M S

    2015-04-01

    Failure to undergo activation-induced cell death due to global dysregulation of apoptosis is the pathogenic hallmark of large granular lymphocyte (LGL) leukemia. Consequently, immunosuppressive agents are rational choices for treatment. This first prospective trial in LGL leukemia was a multicenter, phase 2 clinical trial evaluating methotrexate (MTX) at 10 mg/m(2) orally weekly as initial therapy (step 1). Patients failing MTX were eligible for treatment with cyclophosphamide at 100 mg orally daily (step 2). The overall response in step 1 was 38% with 95% confidence interval (CI): 26 and 53%. The overall response in step 2 was 64% with 95% CI: 35 and 87%. The median overall survival for patients with anemia was 69 months with a 95% CI lower bound of 46 months and an upper bound not yet reached. The median overall survival for patients with neutropenia has not been reached 13 years from study activation. Serum biomarker studies confirmed the inflammatory milieu of LGL but were not a priori predictive of response. We identify a gene expression signature that correlates with response and may be STAT3 mutation driven. Immunosuppressive therapies have efficacy in LGL leukemia. Gene signature and mutational profiling may be an effective tool in determining whether MTX is an appropriate therapy.

  5. A prospective, open-label study of low-dose total skin electron beam therapy in mycosis fungoides

    DEFF Research Database (Denmark)

    Kamstrup, Maria R; Specht, Lena; Skovgaard, Gunhild L

    2008-01-01

    causes and did not complete treatment. Acute side effects included desquamation, xerosis, and erythema of the skin. No severe side effects were observed. CONCLUSION: Low-dose total skin electron beam therapy can induce complete and partial responses in Stage IB-II mycosis fungoides; however, the duration......PURPOSE: To determine the effect of low-dose (4 Gy) total skin electron beam therapy as a second-line treatment of Stage IB-II mycosis fungoides in a prospective, open-label study. METHODS AND MATERIALS: Ten patients (6 men, 4 women, average age 68.7 years [range, 55-82 years......]) with histopathologically confirmed mycosis fungoides T2-T4 N0-N1 M0 who did not achieve complete remission or relapsed within 4 months after treatment with psoralen plus ultraviolet-A were included. Treatment consisted of low-dose total skin electron beam therapy administered at a total skin dose of 4 Gy given in 4...

  6. Physiotherapy and behavior therapy for the treatment of overactive bladder syndrome: a prospective cohort study.

    Science.gov (United States)

    Wolz-Beck, Martina; Reisenauer, Christl; Kolenic, Giselle E; Hahn, Sabine; Brucker, Sara Y; Huebner, Markus

    2017-05-01

    To determine the efficacy of physiotherapy and behavior therapy and to find specific subgroups of women with overactive bladder syndrome that might gain increased benefit from this therapy. Women with ≥10 micturitions per 24-h period were included. Six to nine therapy sessions were held within a 14-day interval. Efficacy end point was a reduction in micturitions and in episodes of nocturia. Secondary outcomes included ICIQ-OAB, ICIQ-OABqol and visual analog scales. Follow-up was 6 months. Levene test, Student's t test, Pearson´s and Spearman's correlations were utilized as well as the Friedman test and a multivariable-multilevel model. 32 women were included. Mean age was 51 ± 15.9 (years ± standard deviation, sd). Mean body mass index (BMI) was 24.4 ± 4.8 (kg/m 2  ± sd). There was a 22.9% reduction in the number of micturitions per 24 h (11.7 ± 1.6 vs. 9.0 ± 1.3 p physiotherapy and behavior therapy in women with overactive bladder syndrome with a post-therapy effect especially for women with no prior treatment.

  7. [Theoretical origin and clinical application of wrist-ankle acupuncture therapy].

    Science.gov (United States)

    Wang, Qiong; Zhou, Qinghui

    2017-05-12

    The theory of wrist-ankle acupuncture is consistent with traditional meridian-collateral theory. For example, the body divisions of wrist-ankle acupuncture are corresponding to the distribution of 12 cutaneous regions of meridians, the needling sites of it are to the running courses of 12 meridians; the indications of it are to those of 12 meridians. The needling sites of wrist-ankle acupuncture are relevant with some special acupoints of acupuncture theory. For example, the 12-needling sites of wrist-ankle acupuncture are located similar to those of 12 meridian points and have very similar indications. The needling sites of it are located in the wrist and ankle regions, in which the five- shu points are located nearby, for meridian disorders. Most luo -connecting points are located near to the needling sites of wrist-ankle acupuncture or the needle tip points to. Additionally, the needling method of wrist-ankle acupuncture is consistent with some of the subcutaneous needling methods in traditional acupuncture therapy. On the basis of the aspects mentioned above, it is explained that wrist-ankle acupuncture is the development of traditional acupuncture and cannot be independent from the traditional theories of acupuncture and meridians. It is necessary to seek for the evidence from the traditional theories of TCM. The traditional theories of TCM are summarized from clinical practice, which can be newly verified from the practice of wrist-ankle acupuncture.

  8. Oxygen-ozone therapy for degenerative spine disease in the elderly: a prospective study.

    Science.gov (United States)

    Bonetti, Matteo; Fontana, Alessandro; Martinelli, Francesco; Andreula, Cosma

    2011-01-01

    We describe our experience of oxygen-ozone therapy to treat degenerative spine disease in the elderly. From April 2004 to March 2008 we selected 129 patients with CT and/or MR evidence of spondyloarthrosis and disc degeneration of the lumbar spine. All patients enrolled in the study had contraindications to the administration of commonly used analgesic and anti-inflammatory drugs.Oxygen-ozone therapy was given by CT-guided intraforaminal injection as the first treatment followed by 4 weekly paralumbar infiltrations on an outpatient basis. The full treatment lasted a month. Clinical outcome was assessed 3 months and 1 year after treatment. The good results obtained indicate that oxygen-ozone therapy is an ideal treatment with no side-effects in elderly patients with degenerative spine disease.

  9. The Prospect of Immunoglobulin Y for Therapy of Canine parvovirus Infection in Dogs

    Directory of Open Access Journals (Sweden)

    I Gusti Ayu Agung Suartini

    2015-06-01

    Full Text Available Canine parvovirus (CPV is a highly infectious virus. The virus causes death in dogs worldwide. The mortality rate due to infection of CPV in dog reaches 91%. Prevention of CPV infection in puppies has been done by vaccination which is effectively proven. Protective mechanisms of maternal antibodies contribute to the failure of vaccination. Highly stable characteristics of parvovirus enable the virus still exist in the environment. Various therapies are performed only to suppress the clinical symptoms but can not reduce puppy mortalities. This review discusses CPV alternative therapy and the advantages using immunoglobulin Y (IgY specific antibodies isolated from chicken egg yolk. Immunoglobulin Y will neutralize the virus, so it can not infect host cells. Intravenous IgY therapy has shown to suppress the spread of CPV infection and prevent death.

  10. Shorter Maintenance Therapy in Childhood Acute Lymphoblastic Leukemia: The Experience of the Prospective, Randomized Brazilian GBTLI ALL-93 Protocol.

    Science.gov (United States)

    Brandalise, Silvia R; Viana, Marcos B; Pinheiro, Vitória R P; Mendonça, Núbia; Lopes, Luiz F; Pereira, Waldir V; Lee, Maria L M; Pontes, Elitânia M; Zouain-Figueiredo, Gláucia P; Azevedo, Alita C A C; Pimentel, Nilma; Fernandes, Maria Z; Oliveira, Hilda M; Vianna, Sônia R; Scrideli, Carlos A; Werneck, Fernando A; Álvares, Maria N; Boldrini, Érica; Loggetto, Sandra R; Bruniera, Paula; Mastellaro, Maria J; Souza, Eni M; Araújo, Rogério A; Bandeira, Flávia; Tan, Doralice M; Carvalho, Nelson A; Salgado, Maria A S

    2016-01-01

    Maintenance therapy is an important phase of the childhood ALL treatment, requiring 2-year long therapy adherence of the patients and families. Weekly methotrexate with daily 6-mercaptopurine (6MP) constitutes the backbone of maintenance therapy. Reduction in the maintenance therapy could overweight problems related with poverty of children with ALL living in limited-income countries (LIC). To compare, prospectively, the EFS rates of children with ALL treated according to two maintenance regimens: 18 vs. 24 months duration. From October 1993 to September 1999, 867 consecutive untreated ALL patients Childhood ALL Treatment (GBTLI) ALL-93 protocol. Risk classification was based exclusively on patient's age and leukocyte count (NCI risk group) and clinical extra medullary involvement of the disease. Data were analyzed by the intention-to-treat approach. Fourteen patients (1.6%) were excluded: wrong diagnosis ( n  = 7) and previous corticosteroid ( n  = 7). Of the 853 eligible patients, 421 were randomly allocated, at study enrollment, to receive 18-month (group 1) and 432 to receive 24-month (group 2) maintenance therapy. Complete remission rate was achieved in 96% of the patients (817/853). Twenty-eight patients (3.4%) died during the induction phase. Thirty-four patients (4.0%) were lost to follow-up. The overall EFS was 66.1 ± 1.7% at 15 years. No difference was seen according to maintenance: EFS 15y was 65.8 ± 2.3% (group 1) and 66.3 ± 2.3% (group 2; p  = 0.79). No difference between regimens was detected after stratifying the analyses according to factors associated with adverse prognosis in this study (age group 10 years and high WBC at diagnosis). Overall death in remission rate was 6.85% (56 patients). Deaths during maintenance were 13 in group 1 and 12 in group 2, all due to infection. Over 15 years of follow-up, two patients both from group 2 presented a second malignancy (Hodgkin's disease and thyroid carcinoma) after 8

  11. A Prospective Comparison of the Effects of Interfractional Variations on Proton Therapy and Intensity Modulated Radiation Therapy for Prostate Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Moteabbed, Maryam, E-mail: mmoteabbed@partners.org; Trofimov, Alexei; Sharp, Gregory C.; Wang, Yi; Zietman, Anthony L.; Efstathiou, Jason A.; Lu, Hsiao-Ming

    2016-05-01

    Purpose: To quantify and compare the impact of interfractional setup and anatomic variations on proton therapy (PT) and intensity modulated radiation therapy (IMRT) for prostate cancer. Methods and Materials: Twenty patients with low-risk or intermediate-risk prostate cancer randomized to receive passive-scattering PT (n=10) and IMRT (n=10) were selected. For both modalities, clinical treatment plans included 50.4 Gy(RBE) to prostate and proximal seminal vesicles, and prostate-only boost to 79.2 Gy(RBE) in 1.8 Gy(RBE) per fraction. Implanted fiducials were used for prostate localization and endorectal balloons were used for immobilization. Patients in PT and IMRT arms received weekly computed tomography (CT) and cone beam CT (CBCT) scans, respectively. The planned dose was recalculated on each weekly image, scaled, and mapped onto the planning CT using deformable registration. The resulting accumulated dose distribution over the entire treatment course was compared with the planned dose using dose-volume histogram (DVH) and γ analysis. Results: The target conformity index remained acceptable after accumulation. The largest decrease in the average prostate D{sub 98} was 2.2 and 0.7 Gy for PT and IMRT, respectively. On average, the mean dose to bladder increased by 3.26 ± 7.51 Gy and 1.97 ± 6.84 Gy for PT and IMRT, respectively. These values were 0.74 ± 2.37 and 0.56 ± 1.90 for rectum. Differences between changes in DVH indices were not statistically significant between modalities. All volume indices remained within the protocol tolerances after accumulation. The average pass rate for the γ analysis, assuming tolerances of 3 mm and 3%, for clinical target volume, bladder, rectum, and whole patient for PT/IMRT were 100/100, 92.6/99, 99.2/100, and 97.2/99.4, respectively. Conclusion: The differences in target coverage and organs at risk dose deviations for PT and IMRT were not statistically significant under the guidelines of this protocol.

  12. Pulmonary recurrence predominates after combined modality therapy for rectal cancer: an original retrospective study.

    Science.gov (United States)

    Ding, Peirong; Liska, David; Tang, Peter; Shia, Jinru; Saltz, Leonard; Goodman, Karyn; Downey, Robert J; Nash, Garrett M; Temple, Larissa K; Paty, Philip B; Guillem, José G; Wong, W Douglas; Weiser, Martin R

    2012-07-01

    To characterize patterns of recurrence in locally advanced rectal cancer treated with combined modality therapy (CMT): neoadjuvant chemoradiation + total mesorectal excision + adjuvant chemotherapy. A total of 593 consecutive rectal cancer patients (1998 to 2007) with locally advanced (stage II/III) disease (noted on endorectal ultrasound or magnetic resonance imaging) who received CMT were analyzed for patterns of recurrence. After median 44-month follow-up (interquartile range, 25 to 64 months), 119 patients (20%) recurred: 105 distant, 7 local, 7 local and distant, and 112 distant-only recurrence. Ninety-three (78%) had single-organ recurrence, and 26 (22%) had multiple-organ recurrence. The most common site of distant recurrence was lung (69% of all patients with distant relapse); 20% had liver recurrence. Fourteen patients (2.4%) recurred locally. Pulmonary metastases were most commonly identified by computed tomographic scan versus abnormal positron emission tomographic (PET) scan or carcinoembryonic antigen (CEA). Risk factors associated with pulmonary recurrence were the following: pathologic stage, tumor distance from anal verge, lymphovascular or perineural invasion. Five-year freedom from pulmonary recurrence for patients with 0, 1, 2, or 3 risk factors was 99%, 90%, 61%, and 42%, respectively. Thirty of 59 patents with pulmonary recurrence underwent lung metastasectomy; 3-year freedom from recurrence was 37%. Unlike colon cancer, which most frequently recurs in the liver, locally advanced rectal cancer treated with CMT relapses most frequently in the lung. Pulmonary metastasis was associated with advanced pathologic stage, low-lying tumor, lymphovascular invasion, or perineural invasion. Confirmation of pulmonary metastasis usually requires serial imaging because metastases are often small when initially detected, well below the resolution of PET, and not necessarily associated with elevated CEA. Individualized risk-based surveillance strategies are

  13. Anterograde amnesia during electroconvulsive therapy: A prospective pilot-study in patients with major depressive disorder

    NARCIS (Netherlands)

    I.A. Boere (Ingrid); A.M. Kamperman (Astrid); Van't Hoog, A.E. (Arianne E.); W.W. van den Broek (Walter); T.K. Birkenhäger (Tom)

    2016-01-01

    textabstractElectroconvulsive therapy (ECT) is considered an effective treatment for major depression with melancholic features. However, neurocognitive side-effects such as anterograde amnesia still regularly occur. The present study aims to evaluate the severity and course of anterograde amnesia

  14. [Intraperitoneal photodynamic therapy for peritoneal metastasis of epithelial ovarian cancer. Limits and future prospects].

    Science.gov (United States)

    Azaïs, H; Mordon, S; Collinet, P

    2017-04-01

    High peritoneal recurrence rate in advanced epithelial ovarian cancer after complete macroscopic cytoreductive surgery and platinum-based chemotherapy, raises the issue of peritoneal microscopic disease management and requires the development of additional locoregional treatment strategies. Photodynamic therapy is an effective treatment already applied in other medical and surgical indications. After administration of a photosensitizer which accumulates in cancer cells, illumination with a light of adequate wavelength may induce photochemical reaction between photosensitizer and tissue oxygen which lead to reactive oxygen species production and cytotoxic phenomenon. Photodynamic therapy's ability to treat superficial lesions disseminated on large area makes it an excellent candidate to insure destruction of microscopic peritoneal metastases in addition to macroscopic cytoreductive surgery in order to decrease peritoneal recurrence rate. Development of intraperitoneal photodynamic therapy has been limited by its poor tolerance related to the lack of specificity of photosensitizers and the location of the metastases in proximity to adjacent intraperitoneal organs. Our aim is to review clinical data concerning intraperitoneal photodynamic therapy and epithelial ovarian cancer to identify the limits of this strategy and to provide solutions which may be applied to solve these barriers and enable safe and effective treatment. Targeted photosensitizers and innovative illumination solutions are mandatory to continue research in this field and to consider the feasibility of clinical trials. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

  15. Vibration therapy reduces CPAP need in a prospective randomised controlled trial

    NARCIS (Netherlands)

    K. Helder MScN (Onno); W.C.J. Hop (Wim); J.B. van Goudoever (Hans)

    2008-01-01

    textabstractBackground: Increased mucus production is a common phenomena following ventilatory support, which might increase morbidity. In order to reduce airway obstruction we tested the effect of vibration therapy on the duration of ventilatory support. Methodology: We conducted a randomised

  16. Prospects for the Use of Artificial Chromosomes and Minichromosome-Like Episomes in Gene Therapy

    Directory of Open Access Journals (Sweden)

    Sara Pérez-Luz

    2010-01-01

    Full Text Available Artificial chromosomes and minichromosome-like episomes are large DNA molecules capable of containing whole genomic loci, and be maintained as nonintegrating, replicating molecules in proliferating human somatic cells. Authentic human artificial chromosomes are very difficult to engineer because of the difficulties associated with centromere structure, so they are not widely used for gene-therapy applications. However, OriP/EBNA1-based episomes, which they lack true centromeres, can be maintained stably in dividing cells as they bind to mitotic chromosomes and segregate into daughter cells. These episomes are more easily engineered than true human artificial chromosomes and can carry entire genes along with all their regulatory sequences. Thus, these constructs may facilitate the long-term persistence and physiological regulation of the expression of therapeutic genes, which is crucial for some gene therapy applications. In particular, they are promising vectors for gene therapy in inherited diseases that are caused by recessive mutations, for example haemophilia A and Friedreich's ataxia. Interestingly, the episome carrying the frataxin gene (deficient in Friedreich's ataxia has been demonstrated to rescue the susceptibility to oxidative stress which is typical of fibroblasts from Friedreich's ataxia patients. This provides evidence of their potential to treat genetic diseases linked to recessive mutations through gene therapy.

  17. Effectiveness and safety of Chinese massage therapy (Tui Na) on post-stroke spasticity: a prospective multicenter randomized controlled trial.

    Science.gov (United States)

    Yang, Yu-Jie; Zhang, Jun; Hou, Ying; Jiang, Bao-Yin; Pan, Hua-Fei; Wang, Jian; Zhong, Da-Yong; Guo, Hai-Ying; Zhu, Yi; Cheng, Jie

    2017-07-01

    To evaluate the effectiveness and safety of Chinese massage therapy (Tui Na) for patients with post-stroke spasticity. A prospective, multicenter, blinded, randomized, placebo-controlled intervention trial. A total of 90 patients with post-stroke spasticity were randomly assigned to the experimental (Tui Na therapy) group ( n = 45) or control (placebo Tui Na therapy) group ( n = 45). Participants in the experimental group received Tui Na therapy, while those in the control group received placebo-Tai Na (gentle rubbing) for 20-25 minutes per limb, once per day, five days per week for a total of four weeks. All participants in both groups received conventional rehabilitation. The Modified Ashworth Scale, the Fugl-Meyer Assessment and the Modified Barthel Index were used to assess the severity of spasticity, motor function of limbs and activities of daily living, respectively. Assessments were performed at baseline, at four weeks and at three months. Tui Na group had a significantly greater reduction in Modified Ashworth Scale in only four muscle groups than the control did (elbow flexors, P = 0.026; wrist flexors, P = 0.005; knee flexors, P = 0.023; knee extensors, P = 0.017). Improvements were sustained at three months follow-up. There was no significant difference between the two groups in Fugl-Meyer Assessment ( P = 0.503) and Modified Barthel Index ( P = 0.544). No adverse reaction was recorded in any of the cases mentioned at all study sites. Tui Na might be a safe and effective treatment to reduce post-stroke spasticity of several muscle groups.

  18. Five-Year Outcomes from 3 Prospective Trials of Image-Guided Proton Therapy for Prostate Cancer

    International Nuclear Information System (INIS)

    Mendenhall, Nancy P.; Hoppe, Bradford S.; Nichols, Romaine C.; Mendenhall, William M.; Morris, Christopher G.; Li, Zuofeng; Su, Zhong; Williams, Christopher R.; Costa, Joseph; Henderson, Randal H.

    2014-01-01

    Purpose: To report 5-year clinical outcomes of 3 prospective trials of image-guided proton therapy for prostate cancer. Methods and Materials: A total of 211 prostate cancer patients (89 low-risk, 82 intermediate-risk, and 40 high-risk) were treated in institutional review board-approved trials of 78 cobalt gray equivalent (CGE) in 39 fractions for low-risk disease, 78 to 82 CGE for intermediate-risk disease, and 78 CGE with concomitant docetaxel therapy followed by androgen deprivation therapy for high-risk disease. Toxicities were graded according to Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Median follow-up was 5.2 years. Results: Five-year rates of biochemical and clinical freedom from disease progression were 99%, 99%, and 76% in low-, intermediate-, and high-risk patients, respectively. Actuarial 5-year rates of late CTCAE, version 3.0 (or version 4.0) grade 3 gastrointestinal and urologic toxicity were 1.0% (0.5%) and 5.4% (1.0%), respectively. Median pretreatment scores and International Prostate Symptom Scores at >4 years posttreatment were 8 and 7, 6 and 6, and 9 and 8, respectively, among the low-, intermediate-, and high-risk patients. There were no significant changes between median pretreatment summary scores and Expanded Prostate Cancer Index Composite scores at >4 years for bowel, urinary irritative and/or obstructive, and urinary continence. Conclusions: Five-year clinical outcomes with image-guided proton therapy included extremely high efficacy, minimal physician-assessed toxicity, and excellent patient-reported outcomes. Further follow-up and a larger patient experience are necessary to confirm these favorable outcomes

  19. Five-Year Outcomes from 3 Prospective Trials of Image-Guided Proton Therapy for Prostate Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Mendenhall, Nancy P., E-mail: menden@shands.ufl.edu [University of Florida Proton Therapy Institute, Jacksonville, Florida (United States); Hoppe, Bradford S.; Nichols, Romaine C.; Mendenhall, William M.; Morris, Christopher G.; Li, Zuofeng; Su, Zhong [University of Florida Proton Therapy Institute, Jacksonville, Florida (United States); Williams, Christopher R.; Costa, Joseph [Division of Urology, College of Medicine, University of Florida, Jacksonville, Florida (United States); Henderson, Randal H. [University of Florida Proton Therapy Institute, Jacksonville, Florida (United States)

    2014-03-01

    Purpose: To report 5-year clinical outcomes of 3 prospective trials of image-guided proton therapy for prostate cancer. Methods and Materials: A total of 211 prostate cancer patients (89 low-risk, 82 intermediate-risk, and 40 high-risk) were treated in institutional review board-approved trials of 78 cobalt gray equivalent (CGE) in 39 fractions for low-risk disease, 78 to 82 CGE for intermediate-risk disease, and 78 CGE with concomitant docetaxel therapy followed by androgen deprivation therapy for high-risk disease. Toxicities were graded according to Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Median follow-up was 5.2 years. Results: Five-year rates of biochemical and clinical freedom from disease progression were 99%, 99%, and 76% in low-, intermediate-, and high-risk patients, respectively. Actuarial 5-year rates of late CTCAE, version 3.0 (or version 4.0) grade 3 gastrointestinal and urologic toxicity were 1.0% (0.5%) and 5.4% (1.0%), respectively. Median pretreatment scores and International Prostate Symptom Scores at >4 years posttreatment were 8 and 7, 6 and 6, and 9 and 8, respectively, among the low-, intermediate-, and high-risk patients. There were no significant changes between median pretreatment summary scores and Expanded Prostate Cancer Index Composite scores at >4 years for bowel, urinary irritative and/or obstructive, and urinary continence. Conclusions: Five-year clinical outcomes with image-guided proton therapy included extremely high efficacy, minimal physician-assessed toxicity, and excellent patient-reported outcomes. Further follow-up and a larger patient experience are necessary to confirm these favorable outcomes.

  20. Neuropsychiatric manifestations after mefloquine therapy for Plasmodium falciparum malaria: comparing a retrospective and a prospective study

    DEFF Research Database (Denmark)

    Rønn, A M; Rønne-Rasmussen, J; Gøtzsche, P C

    1998-01-01

    Mefloquine has been increasingly used for treatment of chloroquine-resistant malaria since its introduction in the late 1970s. In 1987 the first case of toxic encephalopathy was published, and in 1989 the WHO initiated reporting and investigation of neuropsychiatric adverse reactions of mefloquine....... Neuropsychiatric adverse drug reactions are now well documented. We compared an open prospective 3 year study including all patients with P. falciparum treated with mefloquine with an earlier published, retrospective study on a comparable population from our department covering the period up to 1989...

  1. Magnetic Resonance Imaging–Guided versus Surrogate-Based Motion Tracking in Liver Radiation Therapy: A Prospective Comparative Study

    Energy Technology Data Exchange (ETDEWEB)

    Paganelli, Chiara, E-mail: chiara.paganelli@polimi.it [Dipartimento di Elettronica, Informazione e Bioingegneria, Politecnico di Milano, Milano (Italy); Seregni, Matteo; Fattori, Giovanni [Dipartimento di Elettronica, Informazione e Bioingegneria, Politecnico di Milano, Milano (Italy); Summers, Paul [Division of Radiology, Istituto Europeo di Oncologia, Milano (Italy); Bellomi, Massimo [Division of Radiology, Istituto Europeo di Oncologia, Milano (Italy); Department of Health Sciences, Università degli Studi di Milano, Milano (Italy); Baroni, Guido; Riboldi, Marco [Dipartimento di Elettronica, Informazione e Bioingegneria, Politecnico di Milano, Milano (Italy); Bioengineering Unit, CNAO Foundation, Pavia (Italy)

    2015-03-15

    Purpose: This study applied automatic feature detection on cine–magnetic resonance imaging (MRI) liver images in order to provide a prospective comparison between MRI-guided and surrogate-based tracking methods for motion-compensated liver radiation therapy. Methods and Materials: In a population of 30 subjects (5 volunteers plus 25 patients), 2 oblique sagittal slices were acquired across the liver at high temporal resolution. An algorithm based on scale invariant feature transform (SIFT) was used to extract and track multiple features throughout the image sequence. The position of abdominal markers was also measured directly from the image series, and the internal motion of each feature was quantified through multiparametric analysis. Surrogate-based tumor tracking with a state-of-the-art external/internal correlation model was simulated. The geometrical tracking error was measured, and its correlation with external motion parameters was also investigated. Finally, the potential gain in tracking accuracy relying on MRI guidance was quantified as a function of the maximum allowed tracking error. Results: An average of 45 features was extracted for each subject across the whole liver. The multi-parametric motion analysis reported relevant inter- and intrasubject variability, highlighting the value of patient-specific and spatially-distributed measurements. Surrogate-based tracking errors (relative to the motion amplitude) were were in the range 7% to 23% (1.02-3.57mm) and were significantly influenced by external motion parameters. The gain of MRI guidance compared to surrogate-based motion tracking was larger than 30% in 50% of the subjects when considering a 1.5-mm tracking error tolerance. Conclusions: Automatic feature detection applied to cine-MRI allows detailed liver motion description to be obtained. Such information was used to quantify the performance of surrogate-based tracking methods and to provide a prospective comparison with respect to MRI

  2. Present state and prospects of fast neutrons application in cancer therapy in Krakow

    International Nuclear Information System (INIS)

    Skolyszewski, J.; Huczkowski, J.

    1986-01-01

    The results of the therapy in the group of 89 patients with advanced head and neck cancer treated with fast neutrons (5.6MeV mean neutron energy) are presented. Fifteen patients (16.9%) survived two years and fourteen from them (15.7%) without any symptons of cancer. The pilot results of radiobiological experiments performed on clinical neutron beam are also included. These are: RBE determination with the use of Withers-Elkind microcolony assay (acute radiation effects on the survival of crypt cells in the mouse intestine) and the RBE determination for late large bowel stenosis in Wistar rats after local irradiation (Trott-Kiszel assay). Both assays will be used to study the RBE neutron beams from new isochronic cyclotron (accelerating deuterons up to 25 MeV and protons up to 50 MeV). Such cyclotron was built in Cracow and will be used also in neutron cancer therapy. 26 refs., 7 figs. (author)

  3. Prospects and implications of using chromatin insulators in gene therapy and transgenesis.

    Science.gov (United States)

    Recillas-Targa, Félix; Valadez-Graham, Viviana; Farrell, Catherine M

    2004-07-01

    Gene therapy has emerged from the idea of inserting a wild-type copy of a gene in order to restore the proper expression and function of a damaged gene. Initial efforts have focused on finding the proper vector and delivery method to introduce a corrected gene to the affected tissue or cell type. Even though these first attempts are clearly promising, several problems remain unsolved. A major problem is the influence of chromatin structure on transgene expression. To overcome chromatin-dependent repressive transgenic states, researchers have begun to use chromatin regulatory elements to drive transgene expression. Insulators or chromatin boundaries are able to protect a transgene against chromatin position effects at their genomic integration sites, and they are able to maintain transgene expression for long periods of time. Therefore, these elements may be very useful tools in gene therapy applications for ensuring high-level and stable expression of transgenes. Copyright 2004 Wiley Periodicals, Inc.

  4. Anthroposophic therapy for attention deficit hyperactivity: a two-year prospective study in outpatients.

    Science.gov (United States)

    Hamre, Harald J; Witt, Claudia M; Kienle, Gunver S; Meinecke, Christoph; Glockmann, Anja; Ziegler, Renatus; Willich, Stefan N; Kiene, Helmut

    2010-08-30

    Anthroposophic treatment for attention deficit hyperactivity disorder (ADHD) includes special artistic and physical therapies and special medications. We studied 61 consecutive children starting anthroposophic treatment for ADHD symptoms under routine outpatient conditions. Primary outcome was FBB-HKS (a parents' questionnaire for ADHD core symptoms, 0-3), and secondary outcomes were disease and symptom scores (physicians' and parents' assessment, 0-10) and quality of life (KINDL(®) total score, 0-100). A total of 67% of patients fulfilled the DSM-IV criteria for ADHD, 15% had an exclusion diagnosis such as pervasive developmental disorders, while 18% did not fulfill ADHD criteria for another reason. Anthroposophic treatment modalities used were eurythmy therapy (in 56% of patients), art therapy (20%), rhythmical massage therapy (8%), and medications (51%). From baseline to six-month follow-up, all outcomes improved significantly; average improvements were FBB-HKS total score 0.30 points (95% confidence interval [CI]: 0.18-0.43; P < 0.001), FBB-HKS inattention 0.36 (95% CI: 0.21-0.50; P < 0.001), FBB-HKS hyperactivity 0.29 (95% CI: 0.14-0.44; P < 0.001), FBB-HKS impulsivity 0.22 (95% CI: 0.03-0.40; P < 0.001), disease score 2.33 (95% CI: 1.84-2.82; P < 0.001), symptom score 1.66 (95% CI: 1.17-2.16; P < 0.001), and KINDL 5.37 (95% CI: 2.27-8.47; P = 0.001). Improvements were similar in patients not using stimulants (90% of patients at months 0-6) and were maintained until last follow-up after 24 months. Children with ADHD symptoms receiving anthroposophic treatment had long-term improvement of symptoms and quality of life.

  5. Prospective evaluation of two different physical therapies in the treatment of female urinary incontinence

    OpenAIRE

    Seibt, Elisa

    2015-01-01

    Objective: To evaluate the effectiveness of two different physical therapies in the treatment of female urinary incontinence. Study design: 58 women with stress, urge or mixed urinary incontinence participated in the study. Individual treatment programs were selected according to the dysfunction evaluated by vaginal palpation and perineal ultrasound. 22 women in group 1 were treated by electrical stimulation followed by an EMG-assisted PFMT program including training at home for 2-12 mon...

  6. [Current status and future prospects of stem cell gene therapy for primary immunodeficiency].

    Science.gov (United States)

    Uchiyama, Toru; Onodera, Masafumi

    2013-01-01

    Patients affected by primary immunodeficiency (PID) can be cured by allogeneic hematopoietic stem cell transplantation (HSCT). In the absence of HLA-matched donors, however, incidence of HSCT-related complications is observed. Therefore, gene therapy has been developed as a highly desirable alternative treatment for patients lacking suitable donors. Retrovirus-based gene therapy was begun in 1990 for the patients of adenosine deaminase deficiency, followed by X-linked severe combined immunodeficiency, Wiskott-Aldrich syndrome and chronic granulomatous disease. Although treated patients have had excellent immune reconstitution and resolution of ongoing infections, complications such as a lymphoproliferative syndrome and a disappearance of gene-modified cells were observed in some clinical trials. To overcome these, ongoing and upcoming clinical trials use some new strategies. The use of preconditioning chemotherapy makes space in the bone marrow for the gene-treated stem cells and allows engraftment of multi lineage stem/progenitor cells. Self-inactivating vectors in which strong enhancers of long terminal repeat are eliminated may reduce the risk of insertional activation of proto-oncogene resulting in leukemia. These modifications will surely increase the safety and efficacy of stem cell gene therapy for PID.

  7. Human induced pluripotent stem cells and neurodegenerative disease: prospects for novel therapies.

    Science.gov (United States)

    Jung, Yong Wook; Hysolli, Eriona; Kim, Kun-Yong; Tanaka, Yoshiaki; Park, In-Hyun

    2012-04-01

    The lack of effective treatments for various neurodegenerative disorders has placed huge burdens on society. We review the current status in applying induced pluripotent stem cell (iPSC) technology for the cellular therapy, drug screening, and in-vitro modeling of neurodegenerative diseases. iPSCs are generated from somatic cells by overexpressing four reprogramming factors (Oct4, Sox2, Klf4, and Myc). Like human embryonic stem cells, iPSCs have features of self-renewal and pluripotency, and allow in-vitro disease modeling, drug screening, and cell replacement therapy. Disease-specific iPSCs were derived from patients of several neurodegenerative diseases, including Parkinson's disease, Alzheimer's disease, amyotrophic lateral sclerosis, and spinal muscular atrophy. Neurons differentiated from these iPSCs recapitulated the in-vivo phenotypes, providing platforms for drug screening. In the case of Parkinson's disease, iPSC-derived dopaminergic neurons gave positive therapeutic effect on a rodent Parkinson's disease model as a proof of principle in using iPSCs as sources of cell replacement therapy. Beyond iPSC technology, much effort is being made to generate neurons directly from dermal fibroblasts with neuron-specific transcription factors, which does not require making iPSCs as an intermediate cell type. We summarize recent progress in using iPSCs for modeling the progress and treatment of neurodegenerative diseases and provide evidence for future perspectives in this field.

  8. Suan Zao Ren Tang as an Original Treatment for Sleep Difficulty in Climacteric Women: A Prospective Clinical Observation

    Science.gov (United States)

    Yeh, Chia-Hao; Arnold, Christof K.; Chen, Yen-Hui; Lai, Jung-Nein

    2011-01-01

    Little scientific evidence supports the efficacy of herbal medicines in the treatment of women with sleep difficulty during the climacteric period. The purpose of this study is to evaluate the efficacy and safety of Suan Zao Ren Tang (SZRT) in reducing the impact of sleep disturbance on climacteric women, as measured by Pittsburg sleep quality index (PSQI) and the World Health Organization quality of life (WHOQOL). Sixty-seven climacteric women with sleep difficulty intending to treat received SZRT at a rate of 4.0 g, thrice daily for four weeks (MRS < 16, n = 34; MRS ≥ 16, n = 33). After taking into account potential confounding factors, the mean PSQI total scores had fallen from 13.0 (±2.9) to 9.0 (±3.2) (95% confidence interval −4.93, −3.10). Further analyses showed that SZRT produced superior benefit of daytime dysfunction in women with severe menopausal symptoms (MRS ≥ 16). There were three of the withdrawals involved treatment-related adverse events (stomachache, diarrhea, and dizziness). Excluding women with a past history of stomachache, diarrhea, or dizziness, four weeks of therapy with SZRT appears to be a relatively safe and effective short-term therapeutic option in improving daytime function of climacteric women with poor sleep quality. PMID:21660310

  9. Suan Zao Ren Tang as an Original Treatment for Sleep Difficulty in Climacteric Women: A Prospective Clinical Observation

    Directory of Open Access Journals (Sweden)

    Chia-Hao Yeh

    2011-01-01

    Full Text Available Little scientific evidence supports the efficacy of herbal medicines in the treatment of women with sleep difficulty during the climacteric period. The purpose of this study is to evaluate the efficacy and safety of Suan Zao Ren Tang (SZRT in reducing the impact of sleep disturbance on climacteric women, as measured by Pittsburg sleep quality index (PSQI and the World Health Organization quality of life (WHOQOL. Sixty-seven climacteric women with sleep difficulty intending to treat received SZRT at a rate of 4.0 g, thrice daily for four weeks (MRS<16, n=34; MRS≥16, n=33. After taking into account potential confounding factors, the mean PSQI total scores had fallen from 13.0 (±2.9 to 9.0 (±3.2 (95% confidence interval −4.93, −3.10. Further analyses showed that SZRT produced superior benefit of daytime dysfunction in women with severe menopausal symptoms (MRS≥16. There were three of the withdrawals involved treatment-related adverse events (stomachache, diarrhea, and dizziness. Excluding women with a past history of stomachache, diarrhea, or dizziness, four weeks of therapy with SZRT appears to be a relatively safe and effective short-term therapeutic option in improving daytime function of climacteric women with poor sleep quality.

  10. A prospective study of the effects of radioiodine therapy for hyperthyroidism in patients with minimally active graves' ophthalmopathy.

    Science.gov (United States)

    Perros, Petros; Kendall-Taylor, Pat; Neoh, Chris; Frewin, Sarah; Dickinson, Jane

    2005-09-01

    Radioiodine is an effective and safe treatment for hyperthyroidism but has been implicated as a risk factor for deterioration or new presentation of Graves' ophthalmopathy (GO). Prophylactic glucocorticoids appear to prevent this effect. The objective of this study was to document the course of GO after radioiodine therapy. This was a prospective observational study. Patients were assessed at baseline and 2, 4, 6, and 12 months after radioiodine therapy. The study was conducted at a tertiary referral center. Seventy-two GO patients with minimally active eye disease participated in the study. A fixed dose of radioiodine was administered. T(4) was commenced 2 wk later to prevent hypothyroidism. Change in activity and severity of GO were analyzed. Exophthalmometer readings, the width of the palpebral aperture, diplopia scores, and the clinical activity score improved significantly. By clinically significant criteria, the eye disease improved in four patients (transiently in three of the four cases), most likely attributable to the natural course of the disease. No patient's eyes deteriorated. Radioiodine is not associated with deterioration of GO in patients with minimally active eye disease when postradioiodine hypothyroidism is prevented.

  11. Highly active antiretroviral therapy (HAART) among HIV-infected drug users: a prospective cohort study of sexual risk and injecting behaviour

    NARCIS (Netherlands)

    Smit, Colette; Lindenburg, Karen; Geskus, Ronald B.; Brinkman, Kees; Coutinho, Roel A.; Prins, Maria

    2006-01-01

    AIMS: To study sexual risk and injecting behaviour among HIV-infected drug users (DU) receiving highly active antiretroviral therapy (HAART). DESIGN AND SETTING: As part of an ongoing prospective cohort study, HIV-infected DU who commenced HAART (n=67) were matched with those not starting HAART

  12. Efficacy of low-level laser therapy in the management of stage III decubitus ulcers: a prospective, observer-blinded multicentre randomised clinical trial

    NARCIS (Netherlands)

    Lucas, C.; van Gemert, M. J. C.; de Haan, R. J.

    2003-01-01

    Low-level laser therapy (LLLT) has been suggested as a promising treatment option for open wounds. In view of the absence of randomised studies with sufficiently large sample sizes, we assessed the efficacy of LLLT in the treatment of stage III decubitus ulcers. We performed a prospective,

  13. Outcome of radioiodine therapy without, on or 3 days off carbimazole: a prospective interventional three-group comparison

    Energy Technology Data Exchange (ETDEWEB)

    Walter, Martin A. [University Hospital, Institute of Nuclear Medicine, Basel (Switzerland); University Hospital Basel, Division of Endocrinology, Diabetology and Clinical Nutrition, Basel (Switzerland); Christ-Crain, Mirjam; Mueller, Beat [University Hospital Basel, Division of Endocrinology, Diabetology and Clinical Nutrition, Basel (Switzerland); Schindler, Christian [University Hospital Basel, Institute of Social and Preventive Medicine, Basel (Switzerland); Mueller-Brand, Jan [University Hospital, Institute of Nuclear Medicine, Basel (Switzerland)

    2006-06-15

    Carbimazole ameliorates hyperthyroidism but reduces radioiodine uptake and adversely affects the outcome of simultaneous radioiodine therapy. We explored whether withdrawal of carbimazole for 3 days can restore the outcome of radioiodine treatment without concurrent exacerbation of hyperthyroidism. By generating three groups with comparable radioiodine uptake, we also investigated whether the effect of carbimazole depends on the radioiodine uptake. Stratified by a radioiodine uptake >30%, 227 consecutive adult patients were prospectively assigned to radioiodine therapy (target dose 200 Gy) without, on or 3 days off carbimazole. Patients were clinically (Crooks-Wayne score) and biochemically (T{sub 3}, fT{sub 4}, TSH) followed up after 3, 6 and 12 months. Primary endpoint was outcome 12 months after radioiodine therapy. A total of 207 patients completed follow-up (toxic nodular goitre, n=117; Graves' disease, n=90). The overall success rate was 71.5%. Patients without and 3 days off carbimazole had similar biochemical (81.4% and 83.3%, respectively; p=0.82) and clinical outcomes [median (range) Crooks-Wayne score 0 (0-16) and 1 (0-10), respectively; p=0.73], which were both higher than in patients on carbimazole [42.6%, p<0.001; Crooks-Wayne score 3 (0-30), p<0.03]. Time to achieve cure was delayed on carbimazole. No changes in thyroid hormone levels occurred after 3 days' discontinuation of carbimazole. Logistic regression revealed that all observed cure rates were independent of entity, sex, age, thyroid volume, radioiodine uptake, radioiodine half-life, fT{sub 4}, T{sub 3} and TSH. (orig.)

  14. A prospective study of conservative surgery without radiation therapy in select patients with Stage I breast cancer

    International Nuclear Information System (INIS)

    Lim, May; Bellon, Jennifer R.; Gelman, Rebecca; Silver, Barbara B.A.; Recht, Abram; Schnitt, Stuart J.; Harris, Jay R.

    2006-01-01

    Purpose: The effectiveness of radiation therapy (RT) in reducing local recurrence after breast-conserving surgery (BCS) in unselected patients with early stage invasive breast cancer has been demonstrated in multiple randomized trials. Whether a subset of women can achieve local control without RT is unknown. In 1986, we initiated a prospective one-arm trial of BCS alone for highly selected breast-cancer patients. This report updates those results. Methods and Materials: Eighty-seven (of 90 planned) patients enrolled from 1986 until closure in 1992, when a predefined stopping boundary was crossed. Patients were required to have a unicentric, T1, pathologic node-negative invasive ductal, mucinous, or tubular carcinoma without an extensive intraductal component or lymphatic-vessel invasion. Surgery included local excision with margins of at least 1 cm or a negative re-excision. No RT or systemic therapy was given. Results: Results are available on 81 patients (median follow-up, 86 months). Nineteen patients (23%) had local recurrence (LR) as a first site of failure (average annual LR: 3.5 per 100 patient-years of follow-up). Other sites of first failure included 1 ipsilateral axilla, 2 contralateral breast cancers, and 4 distant metastases. Six patients developed other (nonbreast) malignancies. Nine patients have died, 4 of metastatic breast cancer and 5 of unrelated causes. Conclusions: Even in this highly selected cohort, a substantial risk of local recurrence occurred after BCS alone with margins of 1.0 cm or more. These results suggest that with the possible exception of elderly women with comorbid conditions, radiation therapy after BCS remains standard treatment

  15. Prospective randomized trial to assess effects of continuing hormone therapy on cerebral function in postmenopausal women at risk for dementia.

    Directory of Open Access Journals (Sweden)

    Natalie L Rasgon

    Full Text Available The objective of this study was to examine the effects of estrogen-based hormone therapy (HT on regional cerebral metabolism in postmenopausal women (mean age = 58, SD = 5 at risk for development of dementia. The prospective clinical trial design included pre- and post-intervention neuroimaging of women randomized to continue (HT+ or discontinue (HT- therapy following an average of 10 years of use. The primary outcome measure was change in brain metabolism during the subsequent two years, as assessed with fluorodeoxyglucose-18 positron emission tomography (FDG-PET. Longitudinal FDG-PET data were available for 45 study completers. Results showed that women randomized to continue HT experienced relative preservation of frontal and parietal cortical metabolism, compared with women randomized to discontinue HT. Women who discontinued 17-β estradiol (17βE-based HT, as well as women who continued conjugated equine estrogen (CEE-based HT, exhibited significant decline in metabolism of the precuneus/posterior cingulate cortical (PCC area. Significant decline in PCC metabolism was additionally seen in women taking concurrent progestins (with either 17βE or CEE. Together, these findings suggest that among postmenopausal subjects at risk for developing dementia, regional cerebral cortical metabolism is relatively preserved for at least two years in women randomized to continue HT, compared with women randomized to discontinue HT. In addition, continuing unopposed 17βE therapy is associated specifically with preservation of metabolism in PCC, known to undergo the most significant decline in the earliest stages of Alzheimer's disease.ClinicalTrials.gov NCT00097058.

  16. Helical tomo-therapy of ORL cancers: prospective scintigraphic assessment of parotid gland protection

    International Nuclear Information System (INIS)

    Berges, O.; Zefkili, S.; Bolle, S.; Giraud, P.; Belin, L.; Savignoni, A.; Benamor, M.; Petras, S.; Jouffroy, T.; Rodriguez, J.; Giraud, P.

    2010-01-01

    The authors discuss data and results of treatments performed on 19 patients suffering from ORL cancers and submitted to helical tomo-therapy in order to protect their parotid glands. They discuss the planning target volume coverage and the assessment of the salivary excretion fraction by scintigraphy before, and six months and twelve months after the tomography. It appears that the helical tomography protects the parotid glands, thus reducing the incidence and severity of xerostomia by 6 and 12 months. The authors indicate a threshold average dose for the protection of gland functionality. Short communication

  17. A Prospective Cohort Study of Gated Stereotactic Liver Radiation Therapy Using Continuous Internal Electromagnetic Motion Monitoring

    DEFF Research Database (Denmark)

    Worm, Esben S; Høyer, Morten; Hansen, Rune

    2018-01-01

    PURPOSE: Intrafraction motion can compromise the treatment accuracy in liver stereotactic body radiation therapy (SBRT). Respiratory gating can improve treatment delivery; however, gating based on external motion surrogates is inaccurate. The present study reports the use of Calypso-based internal.......0 percentage points (range 0.7-22.0) without gating and 0.8 percentage point (range 0.2-2.0) with gating. CONCLUSIONS: Gating using internal motion monitoring was successfully applied for liver SBRT. It markedly improved the geometric and dosimetric accuracy compared with nongated standard treatment....

  18. Prospects of radical-interacting porphyrin photosensitizers and their possible use in photodynamic therapy

    Science.gov (United States)

    Gal, Dezso; Shuliakovskaya, T.; Vidoczy, Tamas; Elzemzam, Saleh; Vasvari, Gabor; Suemegi, L.; Kuti, Zsolt

    1994-03-01

    Based on literature data obtained in various fields with respect to studies on the role of free radicals in biology and on the kinetics of triplet-doublet interactions, it is suggested that excited photosensitizers react in vivo with free radicals formed in malignant tissues during photodynamic therapy (PDT) and this interaction competes with sensitizer-radical + molecule and the singlet oxygen mediated effects. Experimental results by laser flash photolysis and electron spin resonance revealed that sensitizer applied in PDT react with stable free radicals presumably both by energy transfer and electron transfer.

  19. The behavior analytic perspective: its nature, prospects, and limitations for behavior therapy.

    Science.gov (United States)

    Hawkins, R P; Forsyth, J P

    1997-03-01

    Behavior analysis is defined as a natural science approach to behavior--with both basic and applied branches--and contrasted with cognitive psychology. Behavior analysis is described as an integrated science that views a person's interactions with the environment as selecting certain behaviors--or rather, environment-behavior relations--making them more probable, given certain subsequent stimulus situations. It seeks an understanding that promotes effective action, which fits the clinical interests of behavior therapy. It promotes persistent searching for environmental causes, which has resulted in a remarkable range of successes, clinical and other. We explore the reasons that all behavior therapists are not behavior analysts and suggest needed future developments.

  20. Comprehensive pelvic floor physical therapy program for men with idiopathic chronic pelvic pain syndrome: a prospective study.

    Science.gov (United States)

    Masterson, Thomas A; Masterson, John M; Azzinaro, Jessica; Manderson, Lattoya; Swain, Sanjaya; Ramasamy, Ranjith

    2017-10-01

    Male chronic pelvic pain syndrome (CPPS) is a heterogeneous constellation of symptoms that causes significant impairment and is often challenging to treat. In this prospective study, we evaluated men with CPPS who underwent comprehensive pelvic floor physical therapy (PFPT) program. We used the previously validated Genitourinary Pain Index (GUPI) to measure outcomes. We included 14 men who underwent physical therapy for idiopathic CPPS from October 2015 to October 2016. Men with clearly identifiable causes of pelvic pain, such as previous surgery, chronic infection, trauma, prostatitis and epididymitis were excluded. Treatment included: (I) manual therapy (internal and external) of pelvic floor and abdominal musculature to facilitate relaxation of muscles; (II) therapeutic exercises to promote range of motion, improve mobility/flexibility and strengthen weak muscles; (III) biofeedback to facilitate strengthening and relaxation of pelvic floor musculature; (IV) neuromodulation for pelvic floor muscle relaxation and pain relief. GUPI questionnaires were collected at initial evaluation and after the 10th visit. Higher scores reflect worse symptoms. Previous validation of the GUPI calculated a reduction of 7 points to robustly predict being a treatment responder (sensitivity 100%, specificity 76%) and a change in 4 points to predict modest response. Data are presented as medians (ranges). A total of 10 patients completed 10 visits, and the remaining four patients completed between 5 and 9 visits. The median National Institute of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) score at initial evaluation was 30.8 [16-39] and decreased to 22.2 [7-37] at the tenth visit. Five of the 10 patients (50%) in the study had a reduction of greater than 7 points indicating a robust treatment response, and two (20%) had a change of greater than 4 indicating moderate response. Three patients (30%) did not have any meaningful change in NIH-CPSI and the remaining four are in the

  1. Late Side Effects After Image Guided Intensity Modulated Radiation Therapy Compared to 3D-Conformal Radiation Therapy for Prostate Cancer: Results From 2 Prospective Cohorts

    Energy Technology Data Exchange (ETDEWEB)

    Wortel, Ruud C.; Incrocci, Luca [Department of Radiation Oncology, Erasmus Medical Center Cancer Institute, Rotterdam (Netherlands); Pos, Floris J.; Heide, Uulke A. van der; Lebesque, Joos V. [Department of Radiation Oncology, Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam (Netherlands); Aluwini, Shafak [Department of Radiation Oncology, Erasmus Medical Center Cancer Institute, Rotterdam (Netherlands); Witte, Marnix G. [Department of Radiation Oncology, Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam (Netherlands); Heemsbergen, Wilma D., E-mail: w.heemsbergen@nki.nl [Department of Radiation Oncology, Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam (Netherlands)

    2016-06-01

    Purpose: Technical developments in the field of external beam radiation therapy (RT) enabled the clinical introduction of image guided intensity modulated radiation therapy (IG-IMRT), which improved target conformity and allowed reduction of safety margins. Whether this had an impact on late toxicity levels compared to previously applied three-dimensional conformal radiation therapy (3D-CRT) is currently unknown. We analyzed late side effects after treatment with IG-IMRT or 3D-CRT, evaluating 2 prospective cohorts of men treated for localized prostate cancer to investigate the hypothesized reductions in toxicity. Methods and Materials: Patients treated with 3D-CRT (n=189) or IG-IMRT (n=242) to 78 Gy in 39 fractions were recruited from 2 Dutch randomized trials with identical toxicity scoring protocols. Late toxicity (>90 days after treatment) was derived from self-assessment questionnaires and case report forms, according to Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer (RTOG-EORTC) scoring criteria. Grade ≥2 endpoints included gastrointestinal (GI) rectal bleeding, increased stool frequency, discomfort, rectal incontinence, proctitis, and genitourinary (GU) obstruction, increased urinary frequency, nocturia, urinary incontinence, and dysuria. The Cox proportional hazards regression model was used to compare grade ≥2 toxicities between both techniques, adjusting for other modifying factors. Results: The 5-year cumulative incidence of grade ≥2 GI toxicity was 24.9% for IG-IMRT and 37.6% following 3D-CRT (adjusted hazard ratio [HR]: 0.59, P=.005), with significant reductions in proctitis (HR: 0.37, P=.047) and increased stool frequency (HR: 0.23, P<.001). GU grade ≥2 toxicity levels at 5 years were comparable with 46.2% and 36.4% following IG-IMRT and 3D-CRT, respectively (adjusted HR: 1.19, P=.33). Other strong predictors (P<.01) of grade ≥2 late toxicity were baseline complaints, acute toxicity, and age

  2. Bacteriophages of Pseudomonas aeruginosa: long-term prospects for use in phage therapy.

    Science.gov (United States)

    Krylov, Victor N

    2014-01-01

    Bacteria Pseudomonas aeruginosa, being opportunistic pathogens, are the major cause of nosocomial infections and, in some cases, the primary cause of death. They are virtually untreatable with currently known antibiotics. Phage therapy is considered as one of the possible approaches to the treatment of P. aeruginosa infections. Difficulties in the implementation of phage therapy in medical practice are related, for example, to the insufficient number and diversity of virulent phages that are active against P. aeruginosa. Results of interaction of therapeutic phages with bacteria in different conditions and environments are studied insufficiently. A little is known about possible interactions of therapeutic phages with resident prophages and plasmids in clinical strains in the foci of infections. This chapter highlights the different approaches to solving these problems and possible ways to expand the diversity of therapeutic P. aeruginosa phages and organizational arrangements (as banks of phages) to ensure long-term use of phages in the treatment of P. aeruginosa infections. © 2014 Elsevier Inc. All rights reserved.

  3. Emotional aspects of anorexia nervosa: results of prospective naturalistic cognitive behavioral group therapy.

    Science.gov (United States)

    Ohmann, Susanne; Popow, Christian; Wurzer, Marcus; Karwautz, Andreas; Sackl-Pammer, Petra; Schuch, Bibiana

    2013-01-01

    Anorexic girls have difficulties in handling their emotions. We examined emotional problems of adolescent girls with anorexia nervosa (AN) during the course of cognitive behavioral group therapy (G-CBT). Overall, 29 girls with AN (age 13-17 years) participated in four groups of manual based G-CBT. We assessed the body mass index (BMI), eating behavior psychopathology, emotions, depression, hedonistic activities, self-care and-efficacy, social phobia, sense of coherence (SOC), and alexithymia before, during and up to 1 year after therapy. Out of 29, 16 (55 %, intent to treat, or 76 %, per protocol) girls were successfully treated, 5 (17 or 24 %) had a "poor outcome", and 8 (28 %) dropped out. BMI, eating behavior, mood, social anxiety, self-care, and self-efficacy persistently improved. Anorexic girls had multiple emotional deficits, low self-confidence, and exaggerated needs of control and of being accepted. Emotional deficits were resistant to change. Hedonistic activities, social skills, and recovery from depression were positive, comorbid disorders and parental psychopathology negative prognostic factors.

  4. Hypofractionated radiation therapy in the treatment of epidemic Kaposi sarcoma - A prospective randomized trial

    International Nuclear Information System (INIS)

    Singh, Niveditha B.; Lakier, Roy H.; Donde, Bernard

    2008-01-01

    Purpose: To compare a conventional fractionation regimen with a hypofractionated regimen in the treatment of Epidemic Kaposi sarcoma with radiation therapy. Materials and methods: Sixty patients were randomized to receive a standard regimen of 24 Gy in 12 fractions (ARM A) or the study regimen of 20 Gy in five fractions (ARM B). Radiation technique was individualized. Treatment response, local control and toxicity were recorded. Results: Thirty five sites were treated in ARM A and 30 sites in ARM B. Treatment arms were similar for gender, ECOG performance score, treated site, antiretroviral therapy usage, T stage, I stage and S stage. The overall survival using the Kaplan Meier method was 37% at 1 year. Complete responses were recorded at 28 sites (13 Arm A, 15 Arm B), partial responses at 19 sites (8 Arm A, 11 Arm B) and stable disease at three sites (2 Arm A, 1 Arm B). The mean time to maximum objective response was 3 months (range: 1-14 months). Response rates and local control were equal in the two arms (p = 0.73 and 0.77, respectively, log rank test). Acute skin toxicity (p = 0.77) and late skin toxicity (p = 0.24) were equal in the two arms. Conclusion: The two treatment regimens produced equivalent results for treatment response, local recurrence-free survival and toxicity

  5. A Prospective Outcomes Study of Proton Therapy for Chordomas and Chondrosarcomas of the Spine

    Energy Technology Data Exchange (ETDEWEB)

    Indelicato, Daniel J., E-mail: dindelicato@floridaproton.org [Department of Radiation Oncology, University of Florida College of Medicine, Jacksonville, Florida (United States); Rotondo, Ronny L.; Begosh-Mayne, Dustin [Department of Radiation Oncology, University of Florida College of Medicine, Jacksonville, Florida (United States); Scarborough, Mark T.; Gibbs, C. Parker [Department of Orthopedics and Rehabilitation, University of Florida College of Medicine, Gainesville, Florida (United States); Morris, Christopher G.; Mendenhall, William M. [Department of Radiation Oncology, University of Florida College of Medicine, Jacksonville, Florida (United States)

    2016-05-01

    Purpose: To evaluate the effectiveness of definitive or adjuvant external beam proton therapy on survival in patients with chordomas and chondrosarcomas of the spine. Methods and Materials: Between March 2007 and May 2013, 51 patients with a median age of 58 years (range, 22-83 years) with chordoma (n=34) or chondrosarcomas (n=17) of the sacrum (n=21), the cervical spine (n=20), and the thoracolumbar spine (n=10) were treated with external beam proton therapy to a median dose of 70.2 Gy(RBE) [range, 64.2-75.6 Gy(RBE)] at our institution. Distant metastases, overall survival, cause-specific survival, local control, and disease-free survival were calculated. Results: The mean follow-up time was 3.7 years (range, 0.3-7.7 years). Across all time points, 25 patients experienced disease recurrence: 18 local recurrences, 6 local and distant recurrences, and 1 distant metastasis. The 4-year rates of overall survival and cause-specific survival were 72%; disease-free survival was 57%, local control was 58%, and freedom from distant metastases was 86%. The median time to local progression was 1.7 years (range, 0.2-6.0 years), and the median time to distant progression was 1.6 years (range, 0.2-6.0 years). The risk factors for local recurrence were age ≤58 years (62% vs 26%; P=.04) and recurrence after prior surgery (29% vs 81%; P=.01). Secondary cancers developed in 2 patients: B-cell lymphoma 5.5 years after treatment and bladder cancer 2 years after treatment. We observed the following toxicities: sacral soft tissue necrosis requiring surgery (n=2), T1 vertebral fracture requiring fusion surgery (n=1), chronic urinary tract infections (n=1), surgery for necrotic bone cyst (n=1), and grade 2 bilateral radiation nephritis (n=1). Conclusion: High-dose proton therapy controls more than half of spinal chordomas and chondrosarcomas and compares favorably with historic photon data. Local progression is the dominant mode of treatment failure and may be reduced by

  6. Membranoproliferative glomerulonephritis. A prospective clinical trial of platelet-inhibitor therapy

    International Nuclear Information System (INIS)

    Donadio, J.V. Jr.; Anderson, C.F.; Mitchell, J.C.; Holley, K.E.; Ilstrup, D.M.; Fuster, V.; Chesebro, J.H.

    1984-01-01

    Forty patients with Type I membranoproliferative glomerulonephritis were treated for one year with dipyridamole, 225 mg per day, and aspirin, 975 mg per day, in a prospective, randomized, double-blind, placebo-controlled study. At the base line, the half-life of 51 Cr-labeled platelets was reduced in 12 of 17 patients. The platelet half-life became longer and renal function stabilized in the treated group, as compared with the placebo group, suggesting a relation between platelet consumption and the glomerulopathy. The glomerular filtration rate, determined by iothalamate clearance, was better maintained in the treated group (average decrease, 1.3 ml per minute per 1.73 m 2 of body-surface area per 12 months) than in the placebo group (average decrease, 19.6). Fewer patients in the treated group than in the placebo group had progression to end-stage renal disease (3 of 21 after 62 months as compared with 9 of 19 after 33 months). The data suggest that dipyridamole and aspirin slowed the deterioration of renal function and the development of end-stage renal disease

  7. Challenges and Future Prospects of Antibiotic Therapy: From Peptides to Phages Utilization

    Directory of Open Access Journals (Sweden)

    Santi M. Mandal

    2014-05-01

    Full Text Available Bacterial infections are raising serious concern across the globe. The effectiveness of conventional antibiotics is decreasing due to global emergence of multi-drug-resistant (MDR bacterial pathogens. This process seems to be primarily caused by an indiscriminate and inappropriate use of antibiotics in non-infected patients and in the food industry. New classes of antibiotics with different actions against MDR pathogens need to be developed urgently. In this context, this review focuses on several ways and future directions to search for the next generation of safe and effective antibiotics compounds including antimicrobial peptides, phage therapy, phytochemicals, metalloantibiotics, LPS and efflux pump inhibitors to control the infections caused by MDR pathogens.

  8. Placenta and Placental Derivatives in Regenerative Therapies: Experimental Studies, History, and Prospects

    Directory of Open Access Journals (Sweden)

    Olena Pogozhykh

    2018-01-01

    Full Text Available Placental structures, capable to persist in a genetically foreign organism, are a natural model of allogeneic engraftment carrying a number of distinctive properties. In this review, the main features of the placenta and its derivatives such as structure, cellular composition, immunological and endocrine aspects, and the ability to invasion and deportation are discussed. These features are considered from a perspective that determines the placental material as a unique source for regenerative cell therapies and a lesson for immunological tolerance. A historical overview of clinical applications of placental extracts, cells, and tissue components is described. Empirically accumulated data are summarized and compared with modern research. Furthermore, we define scopes and outlooks of application of placental cells and tissues in the rapidly progressing field of regenerative medicine.

  9. Placenta and Placental Derivatives in Regenerative Therapies: Experimental Studies, History, and Prospects.

    Science.gov (United States)

    Pogozhykh, Olena; Prokopyuk, Volodymyr; Figueiredo, Constança; Pogozhykh, Denys

    2018-01-01

    Placental structures, capable to persist in a genetically foreign organism, are a natural model of allogeneic engraftment carrying a number of distinctive properties. In this review, the main features of the placenta and its derivatives such as structure, cellular composition, immunological and endocrine aspects, and the ability to invasion and deportation are discussed. These features are considered from a perspective that determines the placental material as a unique source for regenerative cell therapies and a lesson for immunological tolerance. A historical overview of clinical applications of placental extracts, cells, and tissue components is described. Empirically accumulated data are summarized and compared with modern research. Furthermore, we define scopes and outlooks of application of placental cells and tissues in the rapidly progressing field of regenerative medicine.

  10. Challenges and Prospects for Helper-Dependent Adenoviral Vector-Mediated Gene Therapy

    Directory of Open Access Journals (Sweden)

    Pasquale Piccolo

    2014-04-01

    Full Text Available Helper-dependent adenoviral (HDAd vectors that are devoid of all viral coding sequences are promising non-integrating vectors for gene therapy because they efficiently transduce a variety of cell types in vivo, have a large cloning capacity, and drive long-term transgene expression without chronic toxicity. The main obstacle preventing clinical applications of HDAd vectors is the host innate inflammatory response against the vector capsid proteins that occurs shortly after intravascular vector administration and result in acute toxicity, the severity of which is dose dependent. Intense efforts have been focused on elucidating adenoviral vector–host interactions and the factors involved in the acute toxicity. This review focuses on the recent acquisition of data on such interactions and on strategies investigated to improve the therapeutic index of HDAd vectors.

  11. Atopic dermatitis in children: prospects of using innovation products as an external therapy

    Directory of Open Access Journals (Sweden)

    M. M. Tlish

    2016-01-01

    Full Text Available Goal of the research: to determine the efficacy of a new line of Atopic cosmetic products for skin care in children suffering from atopic dermatitis. Materials and methods: The study involved three groups of 15 children aged 3-12 suffering from atopic dermatitis in each group. Subjects from Group 1 were treated with Atopic Soothing Cream, from Group 2 with Atopic Soothing Stick Cream and from Group 3 with Atopic Everyday Care Cream. Different inclusion and exclusion criteria were developed for each group, and the algorithm for the product application and efficacy criteria were determined. According to recommendations, Atopic Soothing Cream and Atopic Soothing Stick Cream were applied to clean and dry skin in the morning and in the evening for the study period of 14 days. The patients’ skin condition was assessed prior to the study and on Day 14 of the therapy; the assessment covered parameters necessary for calculating the SCORAD Index. Atopic Everyday Care Cream was applied to clean and dry skin in the morning and in the evening for 28 days. The patients’ skin condition was assessed prior to the study and on Days 14 and 28 of the therapy including the SCORAD Index and assessments of the skin hydration level of the epidermal corneous layer and transepidermal waster loss (TEWL using the DermaLabCombo CORTEX device. According to the study results, the line of Atopic cosmetic products fully complies with the properties specified by the manufacturer, reliably improves the skin condition in children suffering from atopic dermatitis, has no irritant or sensitizing effect, and can be recommended for the complex treatment and rehabilitation of patients suffering from the pathology.

  12. Macroscopic Hematuria After Conventional or Hypofractionated Radiation Therapy: Results From a Prospective Phase 3 Study

    Energy Technology Data Exchange (ETDEWEB)

    Sanguineti, Giuseppe, E-mail: sanguineti@ifo.it [Department of Radiation Oncology, Regina Elena National Cancer Institute, Rome (Italy); Arcidiacono, Fabio [Department of Radiation Oncology, Regina Elena National Cancer Institute, Rome (Italy); Landoni, Valeria [Department of Physics, Regina Elena National Cancer Institute, Rome (Italy); Saracino, Bianca Maria; Farneti, Alessia; Arcangeli, Stefano; Petrongari, Maria Grazia; Gomellini, Sara [Department of Radiation Oncology, Regina Elena National Cancer Institute, Rome (Italy); Strigari, Lidia [Department of Physics, Regina Elena National Cancer Institute, Rome (Italy); Arcangeli, Giorgio [Department of Radiation Oncology, Regina Elena National Cancer Institute, Rome (Italy)

    2016-10-01

    Purpose: To assess the macroscopic hematuria rates within a single-institution randomized phase 3 trial comparing dose-escalated, conventionally fractionated radiation therapy (CFRT) and moderately hypofractionated radiation therapy (MHRT) for localized prostate cancer. Methods and Materials: Patients with intermediate- to high-risk localized prostate cancer were treated with conformal RT and short-course androgen deprivation. Both the prostate and the entire seminal vesicles were treated to 80 Gy in 40 fractions over 8 weeks (CFRT) or 62 Gy in 20 fractions over 5 weeks (MHRT). The endpoint of the present study was the development of any episode or grade of macroscopic hematuria. The median follow-up period was 93 months (range 6-143). Results: Macroscopic hematuria was reported by 25 of 168 patients (14.9%). The actuarial estimate of hematuria at 8 years was 17.0% (95% confidence interval [CI] 10.7%-23.3%). The number of patients with hematuria was 6 and 19 in the CFRT and MHRT arms, respectively, for an actuarial 8-year estimate of 9.7% and 24.3%, respectively (hazard ratio 3.468, 95% CI 1.385-8.684; P=.008). Overall, 8 of 25 patients were found to have biopsy-proven urothelial carcinoma (3 in the CFRT arm and 5 in the MHRT arm; P=.27). Thus, the 8-year actuarial incidence of macroscopic hematuria (after censoring urothelial cancer–related episodes) was 4.1% and 18.2% after CFRT and MHRT, respectively (hazard ratio 4.961, 95% CI 1.426-17.263; P=.012). The results were confirmed by multivariate analysis after accounting for several patient-, treatment-, and tumor-related covariates. Conclusions: MHRT was associated with a statistically significant increased risk of macroscopic hematuria compared with CFRT.

  13. Macroscopic Hematuria After Conventional or Hypofractionated Radiation Therapy: Results From a Prospective Phase 3 Study

    International Nuclear Information System (INIS)

    Sanguineti, Giuseppe; Arcidiacono, Fabio; Landoni, Valeria; Saracino, Bianca Maria; Farneti, Alessia; Arcangeli, Stefano; Petrongari, Maria Grazia; Gomellini, Sara; Strigari, Lidia; Arcangeli, Giorgio

    2016-01-01

    Purpose: To assess the macroscopic hematuria rates within a single-institution randomized phase 3 trial comparing dose-escalated, conventionally fractionated radiation therapy (CFRT) and moderately hypofractionated radiation therapy (MHRT) for localized prostate cancer. Methods and Materials: Patients with intermediate- to high-risk localized prostate cancer were treated with conformal RT and short-course androgen deprivation. Both the prostate and the entire seminal vesicles were treated to 80 Gy in 40 fractions over 8 weeks (CFRT) or 62 Gy in 20 fractions over 5 weeks (MHRT). The endpoint of the present study was the development of any episode or grade of macroscopic hematuria. The median follow-up period was 93 months (range 6-143). Results: Macroscopic hematuria was reported by 25 of 168 patients (14.9%). The actuarial estimate of hematuria at 8 years was 17.0% (95% confidence interval [CI] 10.7%-23.3%). The number of patients with hematuria was 6 and 19 in the CFRT and MHRT arms, respectively, for an actuarial 8-year estimate of 9.7% and 24.3%, respectively (hazard ratio 3.468, 95% CI 1.385-8.684; P=.008). Overall, 8 of 25 patients were found to have biopsy-proven urothelial carcinoma (3 in the CFRT arm and 5 in the MHRT arm; P=.27). Thus, the 8-year actuarial incidence of macroscopic hematuria (after censoring urothelial cancer–related episodes) was 4.1% and 18.2% after CFRT and MHRT, respectively (hazard ratio 4.961, 95% CI 1.426-17.263; P=.012). The results were confirmed by multivariate analysis after accounting for several patient-, treatment-, and tumor-related covariates. Conclusions: MHRT was associated with a statistically significant increased risk of macroscopic hematuria compared with CFRT.

  14. Prospective study of exercise intervention in prostate cancer patients on androgen deprivation therapy

    International Nuclear Information System (INIS)

    Beydoun, Nadine; Bucci, Joseph A.; Chin, Yaw S.; Spry, Nigel; Newton, Robert; Galvão, Daniel A.

    2014-01-01

    Androgen deprivation therapy (ADT) is an important component of modern prostate cancer treatment. Survival benefits from neo-adjuvant and adjuvant hormones may take years to manifest, and balancing this with potential morbidity of therapy can be challenging. This study aimed to assess whether education and short-term combined aerobic and resistance exercises could help to ameliorate the adverse side effects of ADT. Eight hundred fifty-nine patients with relapsed or metastatic prostate cancer on leuprorelin acetate were allocated to three interventional streams based on patient preference and medical fitness: supervised group (Face-to-Face) exercise sessions, home-based (At Home) exercise or a support programme for those incapable of exercising (Support). Patients enrolled onto Face to Face underwent measurement of body composition and cardiorespiratory fitness variables at baseline and programme completion. Patients in the exercise streams were surveyed to determine the programme's impact on physical fitness and well-being. Statistically significant improvements (p<0.001) were seen in all measured cardiorespiratory fitness and strength variables. Programme attrition rates were low (75/859; 8.7%), the primary reason for withdrawal being discontinuation of hormones (70%). Programme satisfaction was high, with 98% of surveyed patients reporting a positive impact on fitness and 97% planning to continue exercising after programme completion. At 6 months, improved physical and emotional well-being was reported by 93 and 79% of patients, respectively. A short-term structured exercise intervention results in high compliance and significant improvements in muscle strength and cardiorespiratory fitness in prostate cancer patients on ADT.

  15. Hyperbaric oxygen therapy as salvage treatment for sudden sensorineural hearing loss: a prospective controlled study.

    Science.gov (United States)

    Pezzoli, M; Magnano, M; Maffi, L; Pezzoli, L; Marcato, P; Orione, M; Cupi, D; Bongioannini, G

    2015-07-01

    The most commonly used treatment for sensorineural sudden hearing loss (SSHL) in clinical practice is the administration of steroids; however, a favorable result is not always obtained. We studied 58 patients who failed to recover after primary treatment with IV steroids, 44 of these met our inclusion criteria (mean age 50.7, 27 males, range 30-74). We treated 23 patients (mean age 47.3, 16 males, age range 22-74) with hyperbaric oxygen therapy (HBO) (2.5 ATA for 60 min for 15 treatments), while 21 (mean age 54.5, 11 males, age range 22-71) patients refused to be treated and served as a non-randomized control group. Patients treated with HBO had a mean improvement of 15.6 dB (SD ± 15.3), with 1 of them completely healed, 5 with a good recovery, 10 with a fair recovery and 7 unchanged. Patients who were not treated had a spontaneous mean improvement of 5.0 dB (SD ± 11.4) with 3 patients with a good recovery, 1 patient with a fair recovery and 17 patients unchanged. Mean improvement was significantly better in patients treated with HBO compared to controls (p = 0.0133). Patients with worst hearing had the greater degree of improvement whether or not they were treated in the first 10 days after the onset of the hearing loss or between 11 and 30 days. In conclusion, hyperbaric oxygen therapy can lead to significant improvement of pure tone hearing thresholds in patients with SSHL who failed primary corticosteroid treatment and are within 4 weeks of the onset of deafness.

  16. Efficacy of steroid therapy based on symptomatic and functional improvement in patients with vestibular neuritis: a prospective randomized controlled trial.

    Science.gov (United States)

    Yoo, Myung Hoon; Yang, Chan Joo; Kim, Shin Ae; Park, Marn Joon; Ahn, Joong Ho; Chung, Jong Woo; Park, Hong Ju

    2017-06-01

    The aim of this study was to examine the efficacy of methylprednisolone in vestibular neuritis (VN) by objective and subjective measures. This prospective controlled randomized study was conducted at one tertiary hospital. Twenty-nine VN patients were randomized to either the steroid (n = 15) or the control (n = 14) group. The steroid group received methylprednisolone for 2 weeks, whereas control patients did not; both groups underwent regular vestibular exercises and were prescribed a Ginkgo biloba. Vestibular function tests including caloric test, video head impulse test (vHIT), and sensory organization test (SOT) were performed, and dizziness handicap index (DHI) was determined at enrollment; all tests were repeated at 1 and 6 months after enrollment. Both groups showed statistically significant improvements in caloric weakness and vHIT gain at 1- and 6-month follow-up evaluations compared to the initial examination; however, differences were not significant. The rates of normalization of canal paresis at 1 and 6 months were 50 and 64% in the control group and 33 and 60% in the steroid group, respectively, with no differences between the two groups. The rates of vHIT normalization at 1 and 6 months after treatment were 57 and 78% in the control group and 53 and 87% in the steroid group, respectively, with no differences between the two groups. Finally, there were no significant differences in the improvement of composite scores of SOT and the DHI scores between the two groups. In this prospective RCT, methylprednisolone had no additional benefit in patients with VN who underwent vestibular exercises and received a Ginkgo biloba. Clinicaltrials.gov Identifier, NCT02098330; Trial title, The Efficacy of Steroid Therapy in Vestibular Neuritis.

  17. Prospective Longitudinal Assessment of Quality of Life for Liver Cancer Patients Treated With Stereotactic Body Radiation Therapy

    Energy Technology Data Exchange (ETDEWEB)

    Klein, Jonathan, E-mail: jonathan.klein@rmp.uhn.on.ca [Department of Radiation Oncology, University of Toronto, Toronto, Ontario (Canada); Radiation Medicine Program, Princess Margaret Cancer Centre, Toronto, Ontario (Canada); Dawson, Laura A. [Department of Radiation Oncology, University of Toronto, Toronto, Ontario (Canada); Radiation Medicine Program, Princess Margaret Cancer Centre, Toronto, Ontario (Canada); Jiang, Haiyan [Department of Biostatistics, Princess Margaret Cancer Centre, Toronto, Ontario (Canada); Kim, John; Dinniwell, Rob; Brierley, James; Wong, Rebecca [Department of Radiation Oncology, University of Toronto, Toronto, Ontario (Canada); Radiation Medicine Program, Princess Margaret Cancer Centre, Toronto, Ontario (Canada); Lockwood, Gina [Department of Biostatistics, Princess Margaret Cancer Centre, Toronto, Ontario (Canada); Ringash, Jolie [Department of Radiation Oncology, University of Toronto, Toronto, Ontario (Canada); Radiation Medicine Program, Princess Margaret Cancer Centre, Toronto, Ontario (Canada)

    2015-09-01

    Purpose: To evaluate quality of life (QoL), an important outcome owing to poor long-term survival, after stereotactic body radiation therapy (SBRT) to the liver. Methods and Materials: Patients (n=222) with hepatocellular carcinoma (HCC), liver metastases, or intrahepatic cholangiocarcinoma and Child-Pugh A liver function received 24-60 Gy of 6-fraction image-guided SBRT. Prospective QoL assessment was completed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (QLQ-C30) and/or Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep, version 4) questionnaires at baseline and 1, 3, 6, and 12 months after treatment. Ten HCC patients with Child-Pugh B liver function were also treated. Results: The QLQ-C30 was available for 205 patients, and 196 completed the FACT-Hep. No difference in baseline QoL (P=.17) or overall survival (P=.088) was seen between the HCC, liver metastases, and intrahepatic cholangiocarcinoma patients. Appetite loss and fatigue measured by the QLQ-C30 clinically and statistically worsened by 1 month after treatment but recovered by 3 months. At 3 and 12 months after treatment, respectively, the FACT-Hep score had improved relative to baseline in 13%/19%, worsened in 36%/27%, and remained stable in 51%/54%. Using the QLQ-C30 Global Health score, QoL improved in 16%/23%, worsened in 34%/39%, and remained stable in 50%/38% at 3 and 12 months, respectively. Median survival was 17.0 months (95% confidence interval [CI] 12.3-19.8 months). Higher baseline scores on both FACT-Hep and QLQ-C30 Global Health were associated with improved survival. Hazard ratios for death, per 10-unit decrease in QoL, were 0.90 (95% CI 0.83-0.98; P=.001) and 0.88 (95% CI 0.82-0.95; P=.001), respectively. Tumor size was inversely correlated with survival. Conclusions: Liver SBRT temporarily worsens appetite and fatigue, but not overall QoL. Stereotactic body radiation therapy is well tolerated and warrants

  18. Hyperfractionated external radiation therapy in stage IIIB carcinoma of uterine cervix: a prospective pilot study

    International Nuclear Information System (INIS)

    Faria, Sergio L.; Ferrigno, Robson

    1997-01-01

    Purpose: Brazil has one of the highest incidence of carcinoma of the cervix in the world. Half of the patients have advanced stages at the diagnosis. Due to this large number of patients we decided to conduct a prospective pilot study to investigate the tolerance to and survival rate with hyperfractionated external radiotherapy only in patients with Stage IIIB carcinoma of the uterine cervix. Methods and Materials: Between January 1991 and December 1993, 23 patients underwent hyperfractionated external beam radiotherapy without brachytherapy. All cases were biopsy proven squamous cell carcinoma of cervix clinically Staged as IIIB (FIGO). Hyperfractionation (HFX) was given with 1.2 Gy doses, twice daily at 6-h interval, 5 days/week, to the whole pelvis up to 72 Gy within 30 working days. Complications were evaluated by an adaptation of the RTOG Radiation Morbidity Scoring Table graded as 1 = none/mild; 2 = moderate, and 3 = severe. Results: Follow-up ranged from 27 to 50 months (median 40 months) on the 9 to 23 living patients at the time of the analysis in December 1995. There was no severe acute toxicity, but moderate acute reaction was high: 74%. The commonest site of complication was the intestine where severe late toxicity occurred in 2 of 23 (9%). Overall survival rate at 27 months was 48% and at 40 months was 43%. Discussion: There is little information in literature about HFX in carcinoma of the cervix. This is the third published study about it and the one that gave the highest total dose with external HFX of 60 x 1.2 Gy = 72 Gy. Theoretically, through the linear quadratic formula this schedule of HFX would be equivalent to 30 x 2 Gy = 60 Gy of standard fractionation, both treatments given in 30 working days. HFX schedules must be tested to establish their safety. Present results suggest being possible to further increase the total dose in the pelvis with hyperfractionated irradiation

  19. External Beam Radiation Therapy or Brachytherapy With or Without Short-course Neoadjuvant Androgen Deprivation Therapy: Results of a Multicenter, Prospective Study of Quality of Life

    International Nuclear Information System (INIS)

    Gay, Hiram A.; Sanda, Martin G.; Liu, Jingxia; Wu, Ningying; Hamstra, Daniel A.; Wei, John T.; Dunn, Rodney L.; Klein, Eric A.; Sandler, Howard M.; Saigal, Christopher S.; Litwin, Mark S.; Kuban, Deborah A.; Hembroff, Larry; Regan, Meredith M.; Chang, Peter; Michalski, Jeff M.; Regan, Meredith; Hembroff, Larry; Wei, John T.; Hamstra, Dan

    2017-01-01

    Purpose: The long-term effects of neoadjuvant androgen deprivation therapy (NADT) with radiation therapy on participant-reported health-related quality of life (HRQOL) have not been characterized in prospective multicenter studies. We evaluated HRQOL for 2 years among participants undergoing radiation therapy (RT) with or without NADT for newly diagnosed, early-stage prostate cancer. Methods and Materials: We analyzed longitudinal cohort data from the Prostate Cancer Outcomes and Satisfaction with Treatment Quality Assessment Consortium to ascertain the HRQOL trajectory of men receiving NADT with external beam RT (EBRT) or brachytherapy. HRQOL was measured using the expanded prostate cancer index composite 26-item questionnaire at 2, 6, 12, and 24 months after the initiation of NADT. We used the χ 2 or Fisher exact test to compare the shift in percentages between groups that did or did not receive NADT. Analyses were conducted at the 2-sided 5% significance level. Results: For subjects receiving EBRT, questions regarding the ability to have an erection, ability to reach an orgasm, quality of erections, frequency of erections, ability to function sexually, and lack of energy were in a significantly worse dichotomized category for the patients receiving NADT. Comparing the baseline versus 24-month outcomes, 24%, 23%, and 30% of participants receiving EBRT plus NADT shifted to the worse dichotomized category for the ability to reach an orgasm, quality of erections, and ability to function sexually compared with 14%, 13%, and 16% in the EBRT group, respectively. Conclusions: Compared with baseline, at 2 years, participants receiving NADT plus EBRT compared with EBRT alone had worse HRQOL, as measured by the ability to reach orgasm, quality of erections, and ability to function sexually. However, no difference was found in the ability to have an erection, frequency of erections, overall sexual function, hot flashes, breast tenderness/enlargement, depression, lack of

  20. External Beam Radiation Therapy or Brachytherapy With or Without Short-course Neoadjuvant Androgen Deprivation Therapy: Results of a Multicenter, Prospective Study of Quality of Life

    Energy Technology Data Exchange (ETDEWEB)

    Gay, Hiram A., E-mail: hiramgay@wustl.edu [Department of Radiation Oncology, Washington University School of Medicine, St. Louis, Missouri (United States); Sanda, Martin G. [Department of Urology, Emory University School of Medicine, Atlanta, Georgia (United States); Liu, Jingxia; Wu, Ningying [Division of Public Health Sciences, Washington University School of Medicine, St. Louis, Missouri (United States); Hamstra, Daniel A. [Texas Center for Proton Therapy, Irving, Texas (United States); Wei, John T.; Dunn, Rodney L. [Department of Urology, University of Michigan, Ann Arbor, Michigan (United States); Klein, Eric A. [Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, Ohio (United States); Sandler, Howard M. [Department of Radiation Oncology, Cedars-Sinai Medical Center, Los Angeles, California (United States); Saigal, Christopher S. [Department of Urology, University of California at Los Angeles, Los Angeles, California (United States); Litwin, Mark S. [Department of Urology, University of California at Los Angeles, Los Angeles, California (United States); Health Policy and Management, University of California at Los Angeles, Los Angeles, California (United States); Kuban, Deborah A. [Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Hembroff, Larry [Institute for Public Policy and Social Research, Michigan State University, East Lansing, Michigan (United States); Regan, Meredith M. [Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts (United States); Chang, Peter [Department of Surgery, Beth Israel-Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts (United States); Michalski, Jeff M. [Department of Radiation Oncology, Washington University School of Medicine, St. Louis, Missouri (United States); Regan, Meredith; Hembroff, Larry; Wei, John T.; Hamstra, Dan; and others

    2017-06-01

    Purpose: The long-term effects of neoadjuvant androgen deprivation therapy (NADT) with radiation therapy on participant-reported health-related quality of life (HRQOL) have not been characterized in prospective multicenter studies. We evaluated HRQOL for 2 years among participants undergoing radiation therapy (RT) with or without NADT for newly diagnosed, early-stage prostate cancer. Methods and Materials: We analyzed longitudinal cohort data from the Prostate Cancer Outcomes and Satisfaction with Treatment Quality Assessment Consortium to ascertain the HRQOL trajectory of men receiving NADT with external beam RT (EBRT) or brachytherapy. HRQOL was measured using the expanded prostate cancer index composite 26-item questionnaire at 2, 6, 12, and 24 months after the initiation of NADT. We used the χ{sup 2} or Fisher exact test to compare the shift in percentages between groups that did or did not receive NADT. Analyses were conducted at the 2-sided 5% significance level. Results: For subjects receiving EBRT, questions regarding the ability to have an erection, ability to reach an orgasm, quality of erections, frequency of erections, ability to function sexually, and lack of energy were in a significantly worse dichotomized category for the patients receiving NADT. Comparing the baseline versus 24-month outcomes, 24%, 23%, and 30% of participants receiving EBRT plus NADT shifted to the worse dichotomized category for the ability to reach an orgasm, quality of erections, and ability to function sexually compared with 14%, 13%, and 16% in the EBRT group, respectively. Conclusions: Compared with baseline, at 2 years, participants receiving NADT plus EBRT compared with EBRT alone had worse HRQOL, as measured by the ability to reach orgasm, quality of erections, and ability to function sexually. However, no difference was found in the ability to have an erection, frequency of erections, overall sexual function, hot flashes, breast tenderness/enlargement, depression

  1. MYOPATHY AS A SIDE EFFECT OF STATIN THERAPY: MECHANISMS OF DEVELOPMENT AND PROSPECTS FOR TREATMENT

    Directory of Open Access Journals (Sweden)

    O. M. Drapkina

    2015-01-01

    Full Text Available Statins are lipid-lowering drugs with proven efficacy that reduce cardiovascular risk and are well tolerated by most patients. Myopathy as a side effect of statin therapy is one of the most common reasons for their withdrawal. Its severity can range from asymptomatic increase of serum CPK to life-threatening rhabdomyolysis. Therefore it is necessary to remember about the possibility of its occurrence.The exact molecular mechanisms of muscle damage by statins are still unknown. Various hypotheses are suggested in this respect: fatty acid oxidation disorders, mitochondrial dysfunction, increased protein degradation in myocytes due to changes in atrogin-1 and ubiquitin activity, activation of autoimmune processes, intracellular depletion of essential metabolites, destabilization of cell membranes, impaired expression of genes involved in apoptosis and protein degradation. The theory that the reduction of intramuscular CoQ10 level is the cause of myopathy prevails. Additional intake of CoQ10 seems promising, but is not evidence-based.

  2. MYOPATHY AS A SIDE EFFECT OF STATIN THERAPY: MECHANISMS OF DEVELOPMENT AND PROSPECTS FOR TREATMENT

    Directory of Open Access Journals (Sweden)

    O. M. Drapkina

    2015-09-01

    Full Text Available Statins are lipid-lowering drugs with proven efficacy that reduce cardiovascular risk and are well tolerated by most patients. Myopathy as a side effect of statin therapy is one of the most common reasons for their withdrawal. Its severity can range from asymptomatic increase of serum CPK to life-threatening rhabdomyolysis. Therefore it is necessary to remember about the possibility of its occurrence.The exact molecular mechanisms of muscle damage by statins are still unknown. Various hypotheses are suggested in this respect: fatty acid oxidation disorders, mitochondrial dysfunction, increased protein degradation in myocytes due to changes in atrogin-1 and ubiquitin activity, activation of autoimmune processes, intracellular depletion of essential metabolites, destabilization of cell membranes, impaired expression of genes involved in apoptosis and protein degradation. The theory that the reduction of intramuscular CoQ10 level is the cause of myopathy prevails. Additional intake of CoQ10 seems promising, but is not evidence-based.

  3. Properties and uses of embryonic stem cells: prospects for application to human biology and gene therapy.

    Science.gov (United States)

    Rathjen, P D; Lake, J; Whyatt, L M; Bettess, M D; Rathjen, J

    1998-01-01

    Embryonic stem cells are pluripotent cells derived from the early mouse embryo that can be propagated stably in the undifferentiated state in vitro. They retain the ability to differentiate into all cell types found in an embryonic and adult mouse in vivo, and can be induced to differentiate into many cell types in vitro. Exploitation of ES cell technology for the creation of mice bearing predetermined genetic alterations has received widespread attention because of the sophistication that it brings to the study of gene function in mammals. Analysis of cell differentiation in vitro has also been of value, leading to the identification of novel bioactive factors and the elucidation of cell specification mechanisms. In this paper, we summarise the features of pluripotent cell lines and their applications, foreshadowing the impact that these systems may have on human biology. While the isolation of definitive human pluripotent cell lines has not yet been achieved, potential applications for these cells in the study of human biology, particularly cell specification, can be envisaged. Of particular interest is the possibility that human embryonic stem cells with properties similar to mouse embryonic stem cells might provide a generic system for gene therapy.

  4. Weight loss in patients receiving radical radiation therapy for head and neck cancer: a prospective study

    International Nuclear Information System (INIS)

    Johnston, C.A.; Keane, T.J.; Prudo, S.M.

    1982-01-01

    Thirty-one patients receiving radiation therapy for localized cancer of the head and neck areas were systematically assessed before, during, and after treatment. The pathogenesis of weight loss and its association with treatment morbidity and other determinants were sought. The serial data collected consisted of a food frequency questionnaire based on Canada's Food Guide, anthropometric measurements, 10 Linear Analogue Self Assessment questions on morbidity, and biochemical and hematological indices. Twenty of 31 patients (68%) lost over 5% of their presenting weight within one month after completing treatment. The mean weight loss was 10% and the range of weight loss in this group was 5.4 to 18.9%. Pretreatment dietary habits, serum albumin, absolute lymphocyte count, serum creatinine, creatinine height index, and anthropometric measurements did not predict for weight loss. However, weight loss can be predicted on the basis of field size and site irradiated. Treatment-related morbidity involving dysguesia, xerostomia, dysphagia of solids, and mouth pain was greater and of longer duration in patients with weight loss. The sequence of development of these symptoms during treatment and their duration provide a rational basis for the timing and methods of nutritional intervention in this patient population

  5. Predictors of mortality in HIV-1 infected children on antiretroviral therapy in Kenya: a prospective cohort

    Directory of Open Access Journals (Sweden)

    Mbori-Ngacha Dorothy A

    2010-05-01

    Full Text Available Abstract Background Among children, early mortality following highly active antiretroviral therapy (HAART remains high. It is important to define correlates of mortality in order to improve outcome. Methods HIV-1-infected children aged 18 months-12 years were followed up at Kenyatta National Hospital, Nairobi after initiating NNRTI-based HAART. Cofactors for mortality were determined using multivariate Cox regression models. Results Between August 2004 and November 2008, 149 children were initiated on HAART of whom 135 were followed for a total of 238 child-years (median 21 months after HAART initiation. Baseline median CD4% was 6.8% and median HIV-1-RNA was 5.98-log10 copies/ml. Twenty children (13.4% died at a median of 35 days post-HAART initiation. Mortality during the entire follow-up period was 8.4 deaths per 100 child-years (46 deaths/100 child-years in first 4 months and 1.0 deaths/100 child-years after 4 months post-HAART initiation. On univariate Cox regression, baseline hemoglobin (Hb Conclusion High early mortality was observed in this cohort of Kenyan children receiving HAART, and low baseline hemoglobin was an independent risk factor for death.

  6. Transgenic Studies with a Keratin Promoter-Driven Growth Hormone Transgene: Prospects for Gene Therapy

    Science.gov (United States)

    Wang, Xiaoming; Zinkel, Sandra; Polonsky, Kenneth; Fuchs, Elaine

    1997-01-01

    Keratinocytes are potentially appealing vehicles for the delivery of secreted gene products because they can be transferred to human skin by the relatively simple procedure of grafting. Adult human keratinocytes can be efficiently propagated in culture with sufficient proliferative capacity to produce enough epidermis to cover the body surface of an average adult. However, the feasibility of delivering secreted proteins through skin grafting rests upon (i) the strength of the promoter in keratinocytes and (ii) the efficiency of protein transport through the basement membrane of the stratified epithelium and into the bloodstream. In this paper, we use transgenic technology to demonstrate that the activity of the human keratin 14 promoter remains high in adult skin and that keratinocyte-derived human growth hormone (hGH) can be produced, secreted, and transported to the bloodstream of mice with efficiency that is sufficient to exceed by an order of magnitude the circulating hGH concentration in growing children. Transgenic skin grafts from these adults continue to produce and secrete hGH stably, at ≈ 1/10 physiological levels in the bloodstream of nontransgenic recipient mice. These studies underscore the utility of the keratin 14 promoter for expressing foreign transgenes in keratinocytes and demonstrate that keratinocytes can be used as effective vehicles for transporting factors to the bloodstream and for eliciting metabolic changes. These findings have important implications for considering the keratinocyte as a possible vehicle for gene therapy.

  7. Commentary on Zohar's "Prospects for 'genetic therapy' -- can a person benefit from being altered?

    Science.gov (United States)

    Kahn, Jeffrey P

    1991-10-01

    In his paper on the effects of Prenatal Genetic Intervention (PGI) on personal identity, Noam Zohar comes to a conclusion about genetic makeup and the uses of gene therapy quite different from the one I reach in another piece in this issue. Zohar's argument rests on the contention that personal identity changes with alteration of the genome, following what I have identified as the "constitutive" view. To see that this is the pillar supporting the weight of his argument, consider the following. Questions of identity aside, how can it be that altering the genome of children suffering from Lesch-Nyhan syndrome or Tay-Sachs disease so that they now produce the enzyme that they formerly lacked does not benefit them? Clearly, if their identities were not changed, such individuals would in fact realize great benefit from PGI, since the devastating bad effects of the genetic flaw would be avoided. Such a change would certainly make the altered individuals better off, that is, it would benefit them. On this, Zohar and I do not disagree. Persistence of identity through such genetic change is the sticking point.

  8. Prospects of Bacteriotherapy with Nanotechnology in Nanoparticledrug Conjugation Approach for Cancer Therapy.

    Science.gov (United States)

    Raj, Ritu; Das, Surajit

    2016-01-01

    Bacteriotherapy and nanotechnology have shown remarkable potential in diagnostic and therapeutic applications for various diseases. Individual impacts of these micro-nano systems over different aspects of human health are well studied; however, an integrated system of bacteria-nanoparticle (NP) conjugation is less explored. The untamed potential of bacteria-NP conjugation could be a new tool for diagnosis and treatment of invasive diseases like malaria, tuberculosis and cancer. Mammalian cells exhibit cytosis as their defense mechanism when they encounter foreign elements such as bacteria. In these mammalian cells, during phagocytosis, bacteria are ruptured and lysed by lysozymes. A bacterium carrying the drug-tagged NP would be engulfed in the same manner and ultimately reaches the target cells. Rapid and continuous cell divisions in the cancer tissues lead to defective vessels, underdeveloped cellcell interconnects, development of hypoxic areas and heterogeneous population of tumor cells. This unorganized and poorly developed angiogenesis in tumor cells makes it difficult for conventional chemotherapeutic drugs to localize the tumors selectively. In the present scenario of diagnosis and treatment of cancer/tumor cells, it could be expected that the existing bacteriotherapy with the advanced nanotechnology would be a way further in the targeted drug delivery for cancer therapy. This review emphasizes the potential applications of bacteriotherapy with nanotechnology for the diagnosis and treatment of cancer.

  9. Treatment of Obstructive Sleep Apnea. Prospects for Personalized Combined Modality Therapy.

    Science.gov (United States)

    Deacon, Naomi L; Jen, Rachel; Li, Yanru; Malhotra, Atul

    2016-01-01

    Obstructive sleep apnea (OSA) is a common sleep disorder with serious associated morbidities. Although several treatment options are currently available, variable efficacy and adherence result in many patients either not being treated or receiving inadequate treatment long term. Personalized treatment based on relevant patient characteristics may improve adherence to treatment and long-term clinical outcomes. Four key traits of upper airway anatomy and neuromuscular control interact to varying degrees within individuals to cause OSA. These are: (1) the pharyngeal critical closing pressure, (2) the stability of ventilator chemoreflex feedback control (loop gain), (3) the negative intraesophageal pressure that triggers arousal (arousal threshold), and (4) the level of stimulus required to activated upper airway dilator muscles (upper airway recruitment threshold). Simplified diagnostic methods are being developed to assess these pathophysiological traits, potentially allowing prediction of which treatment would best suit each patient. In contrast to current practice of using various treatment modes alone, model predictions and pilot clinical trials show improved outcomes by combining several treatments targeted to each patient's pathophysiology profile. These developments could theoretically improve efficacy and adherence to treatment and in turn reduce the social and economic health burden of OSA and the associated life-threatening morbidities. This article reviews OSA pathophysiology and identifies currently available and investigational treatments that may be combined in the future to optimize therapy based on individual profiles of key patient pathophysiological traits.

  10. Periodontal regenerative therapy with enamel matrix derivative in the treatment of intrabony defects: a prospective 2-year study.

    Science.gov (United States)

    Seshima, Fumi; Aoki, Hideto; Takeuchi, Takahiro; Suzuki, Eiichi; Irokawa, Daisuke; Makino-Oi, Asako; Sugito, Hiroki; Tomita, Sachiyo; Saito, Atsushi

    2017-07-06

    To date, enamel matrix derivative (EMD) has been considered to be one of the few biomaterials for clinical use capable of demonstrating true periodontal regeneration. The aim of this two-center prospective clinical study was to evaluate 2-year outcome of periodontal regenerative therapy using EMD in the treatment of intrabony defects, performed as an 'advanced medical treatment' under the national healthcare system in Japan. Patients with chronic periodontitis who have completed initial periodontal therapy at either of the two dental school clinics were enrolled. Each contributed at least one intrabony defect of ≥3 mm in depth. During surgery, EMD was applied to the defect following debridement. Twenty-two participants (mean age 55.2 years old, 9 men and 13 women) completed 2-year reevaluation, and a total of 42 defects were subjected to data analysis. Mean gains in clinical attachment level (CAL) at 1 and 2 years were 2.9 mm (38% of baseline CAL) and 3.1 mm (41%), respectively, both showing a significant improvement from baseline. There was also a significant reduction in probing depth (PD): mean reductions at 1 and 2 years were 3.2 and 3.3 mm, respectively. There was a progressive improvement in the mean percentages of bone fill from 26% at 1 year to 36% at 2 years. No significant difference in CAL gain at 2 years was found between 3-wall bone defects and other defect types combined. In multiple regression analysis, the baseline PD was significantly associated with CAL gain at 2 years. In this population of patients, the treatment of intrabony defects with EMD yielded clinically favorable outcomes, as assessed by periodontal and radiographical parameters, over a period of 2 years.

  11. Gram-negative bacteraemia; a multi-centre prospective evaluation of empiric antibiotic therapy and outcome in English acute hospitals.

    Science.gov (United States)

    Fitzpatrick, J M; Biswas, J S; Edgeworth, J D; Islam, J; Jenkins, N; Judge, R; Lavery, A J; Melzer, M; Morris-Jones, S; Nsutebu, E F; Peters, J; Pillay, D G; Pink, F; Price, J R; Scarborough, M; Thwaites, G E; Tilley, R; Walker, A S; Llewelyn, M J

    2016-03-01

    Increasing antibiotic resistance makes choosing antibiotics for suspected Gram-negative infection challenging. This study set out to identify key determinants of mortality among patients with Gram-negative bacteraemia, focusing particularly on the importance of appropriate empiric antibiotic treatment. We conducted a prospective observational study of 679 unselected adults with Gram-negative bacteraemia at ten acute english hospitals between October 2013 and March 2014. Appropriate empiric antibiotic treatment was defined as intravenous treatment on the day of blood culture collection with an antibiotic to which the cultured organism was sensitive in vitro. Mortality analyses were adjusted for patient demographics, co-morbidities and illness severity. The majority of bacteraemias were community-onset (70%); most were caused by Escherichia coli (65%), Klebsiella spp. (15%) or Pseudomonas spp. (7%). Main foci of infection were urinary tract (51%), abdomen/biliary tract (20%) and lower respiratory tract (14%). The main antibiotics used were co-amoxiclav (32%) and piperacillin-tazobactam (30%) with 34% receiving combination therapy (predominantly aminoglycosides). Empiric treatment was inappropriate in 34%. All-cause mortality was 8% at 7 days and 15% at 30 days. Independent predictors of mortality (p antibiotic therapy was not associated with mortality at either time-point (adjusted OR 0.82; 95% CI 0.35-1.94 and adjusted OR 0.92; 95% CI 0.50-1.66, respectively). Although our study does not exclude an impact of empiric antibiotic choice on survival in Gram-negative bacteraemia, outcome is determined primarily by patient and disease factors. Copyright © 2015 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

  12. Everolimus and reduced calcineurin inhibitor therapy in pediatric liver transplant recipients: Results from a multicenter, prospective study.

    Science.gov (United States)

    Ganschow, Rainer; Ericzon, Bo-Goran; Dhawan, Anil; Sharif, Khalid; Martzloff, El-Djouher; Rauer, Barbara; Ng, Jennifer; Lopez, Patricia

    2017-11-01

    In a 24-month, multicenter, single-arm, prospective study, 56 pediatric liver transplant patients with or without basiliximab induction were converted at 1-6 months post-transplant from standard calcineurin inhibitor (CN) therapy (± mycophenolic acid), to everolimus with reduced exposure to CNI (tacrolimus n=50, cyclosporine n=6). Steroid therapy was optional. Recruitment was stopped prematurely due to high rates of PTLD, treatment-related serious infections leading to hospitalization and premature study drug discontinuation. Subsequently, patients aged <7 years reverted to local standard-of-care immunosuppression. Mean tacrolimus concentration was above or near the upper end of the maintenance target range (2-5 ng/mL) until after month 6 post-enrollment. The primary variable, mean (SD) change in eGFR from baseline to month 12 (last observation carried forward), was +6.2 (19.5) mL/min/1.73 m 2 . Two patients experienced treated biopsy-proven acute rejection. No graft losses or deaths occurred. PTLD occurred in five patients (8.9%) (3/25 [12.0%] patients <2 years, 2/31 aged 2-18 years [6.5%]). Adverse events, serious adverse events, and discontinuation due to adverse events were reported in 100.0%, 76.8%, and 44.6% of patients, respectively. In conclusion, everolimus with reduced CNI improved renal function while maintaining antirejection potency in pediatric liver transplant patients but safety outcomes suggest that patients were overimmunosuppressed. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  13. Mechanism-based classification and physical therapy management of persons with cancer pain: A prospective case series

    Directory of Open Access Journals (Sweden)

    Senthil P Kumar

    2013-01-01

    Full Text Available Context: Mechanism-based classification (MBC was established with current evidence and physical therapy (PT management methods for both cancer and for noncancer pain. Aims: This study aims to describe the efficacy of MBC-based PT in persons with primary complaints of cancer pain. Settings and Design: A prospective case series of patients who attended the physiotherapy department of a multispecialty university-affiliated teaching hospital. Material and Methods: A total of 24 adults (18 female, 6 male aged 47.5 ± 10.6 years, with primary diagnosis of heterogeneous group of cancer, chief complaints of chronic disabling pain were included in the study on their consent for participation The patients were evaluated and classified on the basis of five predominant mechanisms for pain. Physical therapy interventions were recommended based on mechanisms identified and home program was prescribed with a patient log to ensure compliance. Treatments were given in five consecutive weekly sessions for five weeks each of 30 min duration. Statistical Analysis Used: Pre-post comparisons for pain severity (PS and pain interference (PI subscales of Brief pain inventory-Cancer pain (BPI-CP and, European organization for research and treatment in cancer-quality of life questionnaire (EORTC-QLQ-C30 were done using Wilcoxon signed-rank test at 95% confidence interval using SPSS for Windows version 16.0 (SPSS Inc, Chicago, IL. Results: There were statistically significant ( P < 0.05 reduction in pain severity, pain interference and total BPI-CP scores, and the EORTC-QLQ-C30. Conclusion: MBC-PT was effective for improving BPI-CP and EORTC-QLQ-C30 scores in people with cancer pain.

  14. Predictors of neurocognitive outcomes on antiretroviral therapy after cryptococcal meningitis: a prospective cohort study.

    Science.gov (United States)

    Carlson, Renee Donahue; Rolfes, Melissa A; Birkenkamp, Kate E; Nakasujja, Noeline; Rajasingham, Radha; Meya, David B; Boulware, David R

    2014-06-01

    Cryptococcal meningitis is the most common cause of adult meningitis in Africa, yet neurocognitive outcomes are unknown. We investigated the incidence and predictors of neurologic impairment among cryptococcal survivors. HIV-infected, antiretroviral-naive Ugandans with cryptococcal meningitis underwent standardized neuropsychological testing at 1, 3, 6, and 12 months. A quantitative neurocognitive performance z-score (QNPZ) was calculated based on population z-scores from HIV-negative Ugandans (n = 100). Comparison was made with an HIV-infected, non-meningitis cohort (n = 110). Among 78 cryptococcal meningitis survivors with median CD4 count of 13 cells/μL (interquartile range: 6-44), decreased global cognitive function occurred through 12 months compared with the HIV-infected, non-cryptococcosis cohort (QNPZ-6 at 12 months, P = 0.036). Tests of performance in eight cognitive domains was impaired 1 month after cryptococcal diagnosis; however, cryptococcal meningitis survivors improved their global neurocognitive function over 12 months with residual impairment (mean z-scores meningitis severity. Paradoxically, persons with sterile CSF cultures after 14 days of induction amphotericin therapy had worse neurocognitive outcomes than those still culture-positive at 14 days (P = 0.002). Cryptococcal meningitis survivors have significant short-term neurocognitive impairment with marked improvement over the first 12 months. Few characteristics related to severity of cryptococcosis, including Cryptococcus burden, were associated with neurocognitive outcome.

  15. Mortality in an antiretroviral therapy programme in Jinja, south-east Uganda: a prospective cohort study

    Directory of Open Access Journals (Sweden)

    Coutinho Alex

    2011-10-01

    Full Text Available Abstract Background There have been few reports of long-term survival of HIV-infected patients on antiretroviral therapy (ART in Africa managed under near normal health service conditions. Methods Participants starting ART between February 2005 and December 2006 in The AIDS Support (TASO clinic in Jinja, Uganda, were enrolled into a cluster-randomised trial of home versus facility-based care and followed up to January 2009. The trial was integrated into normal service delivery with patients managed by TASO staff according to national guidelines. Rates of survival, virological failure, hospital admissions and CD4 count over time were similar between the two arms. Data for the present analysis were analysed using Cox regression analyses. Results 1453 subjects were enrolled with baseline median count of 108 cells/μl. Over time, 119 (8% withdrew and 34 (2% were lost to follow-up. 197/1453 (14% died. Mortality rates (95% CI per 100 person-years were 11.8 (10.1, 13.8 deaths in the first year and 2.4 (1.8, 3.2 deaths thereafter. The one, two and three year survival probabilities (95% CI were 0.89 (0.87 - 0.91, 0.86 (0.84 - 0.88 and 0.85 (0.83 - 0.87 respectively. Low baseline CD4 count, low body weight, advanced clinical condition (WHO stages III and IV, not being on cotrimoxazole prophylaxis and male gender were associated independently with increased mortality. Tuberculosis, cryptococcal meningitis and diarrhoeal disease were estimated to be major causes of death. Conclusion Practical and affordable interventions are needed to enable earlier initiation of ART and to reduce mortality risk among those who present late for treatment with advanced disease.

  16. Radiation exposure in 90Y-Zevalin therapy. Results of a prospective multicentre trial

    International Nuclear Information System (INIS)

    Geworski, L.; Sandrock, D.; Zander, A.; Munz, D.L.; Zoephel, K.; Halm, T.; Rimpler, A.; Barth, I.; Lassmann, M.; Haenscheid, H.; Reiners, C.; Hofmann, M.

    2006-01-01

    Aim of this study was the assessment of the radiation exposure from preparation and application of 90 Y-Zevalin, the measurement of the dose rate at the patient, the exposure of family members as well as the determination of the activity concentration in urine of patients. Methods: Overall data from 31 therapeutic administrations carried out in four institutions were evaluated. During preparation and application of 90 Y-Zevalin the finger exposures of radiochemists, technicians, and physicians were measured. The dose rate of the patient was measured immediately after radioimmunotherapy. In patients treated in a nuclear medicine therapy unit, urine was collected over a two day period and the corresponding activity was determined. Family members of outpatients were asked to wear a dosimeter over a seven day period. Results: during the preparation we found a maximum skin dose of 6 mSv at the average, and during application of 3 mSv, respectively. After administration of 90 Y the dose rate was 0.4 ± 0.1 μSv/h at 2 m distance. Urine measurements yielded a cumulated 24 h excretion of 3.9 ± 1.4% and 4.4 ± 1.4% within 48 h, respectively, that is equivalent to 43 ± 18 and 50 ± 20 MBq of 90 Y, respectively. Family members received a radiation exposure of 40 ± 14 μSv over seven days. Conclusion: during preparation and application of 90 Y-Zevalin appropriate radiation shielding is necessary. For family members as well as nursing staff no additional special radiation protection measures beyond those being common for other nuclear medicine procedures are necessary. (orig.)

  17. ROLE OF NON-DRUG THERAPIES OF METABOLIC SYNDROME: CHALLENGES AND PROSPECTS

    Directory of Open Access Journals (Sweden)

    S. N. Strelkova

    2016-01-01

    Full Text Available Abdominal obesity (and the closely related metabolic syndrome is one of the most common diseases in the world. The urgency of the problem of the progression of abdominal obesity is not only in its high prevalence, but also in the formation of a high risk of developing cardiovascular disease and diabetes type 2. The main reasons for the rapid development of obesity are considered high-calorie food (which includes not only the quantity but also the quality of edible products, sedentary lifestyle and genetic predisposition. Until now there are underway great controversies about the procedures of fast and trouble-free weight loss. There are many studies on the treatment of various components of metabolic syndrome. Despite a number of different pharmaceutical drugs developed for the treatment of abdominal obesity, non-drug therapies come first as well as the organization of the right way of life, which is difficult and sometimes impossible task for the clinician. One of the main reasons is the lack of time in doctor during outpatient consultations. To resolve this issue the role of "School of Health" is considered in order to effectively reduce the body weight of patients with metabolic syndrome and maintaining long-term results. It is expected that the implementation of the "School of Health" in the complex treatment of patients with metabolic syndrome will more broadly inform patients about their disease, improve the motivational and cognitive components of plants, and increase compliance to carry out the doctor's prescription. A review of the prevalence and root causes of abdominal obesity is presented, as well as analysis of the effectiveness of existing “Schools of Health” in the clinical practice for the treatment of various chronic diseases.

  18. The pivotal roles of mitochondria in cancer: Warburg and beyond and encouraging prospects for effective therapies.

    Science.gov (United States)

    Mathupala, Saroj P; Ko, Young H; Pedersen, Peter L

    2010-01-01

    Tumors usurp established metabolic steps used by normal tissues for glucose utilization and ATP production that rely heavily on mitochondria and employ a route that, although involving mitochondria, includes a much greater dependency on glycolysis. First described by Otto Warburg almost nine decades ago [1], this aberrant phenotype becomes more pronounced with increased tumor malignancy [2]. Thus, while maintaining their capacity for respiration, tumors "turn more parasitic" by enhancing their ability to scavenge glucose from their surroundings. With excess glucose at hand, tumors shunt their metabolic flux more toward glycolysis than do their normal cells of origin, a strategy that allows for their survival when oxygen is limiting while providing them a mechanism to poison their extra-cellular environment with acid, thus paving the way for invasion and metastasis. Significantly, tumors harness a crucial enzyme to regulate and support this destructive path--to entrap and channel glucose toward glycolysis. This enzyme is an isoform of hexokinase, referred to as hexokinase type II, and also in abbreviated form as HK-2 or HK II. Due to many-faceted molecular features at genetic, epigenetic, transcriptional, and enzymatic levels, including sub-cellular localization to mitochondria, HK-2 facilitates and promotes the high glycolytic tumor phenotype [3]. Thus, HK-2 represents a pivotal model gene or enzyme that tumors "select for" during tumorigenesis in order to facilitate their destructive path. In this review, we examine the roles played by mitochondrial bound HK-2 within the context of the highly choreographed metabolic roulette of malignant tumors. Recent studies that outline how the aberrant glycolytic flux can be subverted toward a more "normal" metabolic phenotype, and how the glycolytic flux affects the tumor microenvironment to facilitate tumor dissemination are also described, including how these very features can be harnessed in new metabolic targeting

  19. Procalcitonin guided antibiotic therapy and hospitalization in patients with lower respiratory tract infections: a prospective, multicenter, randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Henzen Christoph

    2007-07-01

    Full Text Available Abstract Background: Lower respiratory tract infections like acute bronchitis, exacerbated chronic obstructive pulmonary disease and community-acquired pneumonia are often unnecessarily treated with antibiotics, mainly because of physicians' difficulties to distinguish viral from bacterial cause and to estimate disease-severity. The goal of this trial is to compare medical outcomes, use of antibiotics and hospital resources in a strategy based on enforced evidence-based guidelines versus procalcitonin guided antibiotic therapy in patients with lower respiratory tract infections. Methods and design: We describe a prospective randomized controlled non-inferiority trial with an open intervention. We aim to randomize over a fixed recruitment period of 18 months a minimal number of 1002 patients from 6 hospitals in Switzerland. Patients must be >18 years of age with a lower respiratory tract infections Discussion: Use of and prolonged exposure to antibiotics in lower respiratory tract infections is high. The proposed trial investigates whether procalcitonin-guidance may safely reduce antibiotic consumption along with reductions in hospitalization costs and antibiotic resistance. It will additionally generate insights for improved prognostic assessment of patients with lower respiratory tract infections. Trial registration: ISRCTN95122877

  20. Extracorporeal shock wave therapy for the treatment of poststroke plantar-flexor muscles spasticity: a prospective open-label study.

    Science.gov (United States)

    Santamato, Andrea; Micello, Maria Francesca; Panza, Francesco; Fortunato, Francesca; Logroscino, Giancarlo; Picelli, Alessandro; Manganotti, Paolo; Smania, Nicola; Fiore, Pietro; Ranieri, Maurizio

    2014-01-01

    To assess the use of extracorporeal shock wave therapy (ESWT) for the treatment of equinus foot after stroke and to correlate the ESWT effect on spastic plantar-flexor muscles with echo intensity on the Heckmatt scale. The prospective open-label study examined 23 patients with poststroke lower limb spasticity. Adults with spastic equinus foot after stroke received one ESWT session on hypertonic plantar-flexor muscles. The effect on spasticity, degree of passive ankle dorsiflexion, and neurophysiological values were evaluated. Before treatment, participants underwent a sonography evaluation of calf muscles to identify echo intensity on the Heckmatt scale. Immediately after the session, ESWT induced a statistically significant reduction in muscle tone, increasing passive ankle dorsiflexion motion. At 30 days of follow-up, the effect persisted only in patients with echo intensity of spastic plantar-flexor muscles graded I, II, or III on the Heckmatt scale without any action related to spinal excitability. Mild adverse events were reported after the treatment but were resolved in a few days. ESWT is safe and efficacious for the treatment of poststroke plantar-flexor muscles spasticity, reducing muscle tone and improving passive ankle dorsiflexion motion. The effect was long lasting in subjects with echo intensity of calf muscles graded I, II, or III but was brief for echo intensity graded IV on the Heckmatt scale. The ESWT effect did not appear to be related to spinal excitability.

  1. Prospective Study of Functional Bone Marrow-Sparing Intensity Modulated Radiation Therapy With Concurrent Chemotherapy for Pelvic Malignancies

    International Nuclear Information System (INIS)

    Liang Yun; Bydder, Mark; Yashar, Catheryn M.; Rose, Brent S.; Cornell, Mariel; Hoh, Carl K.; Lawson, Joshua D.; Einck, John; Saenz, Cheryl; Fanta, Paul; Mundt, Arno J.; Bydder, Graeme M.

    2013-01-01

    Purpose: To test the hypothesis that intensity modulated radiation therapy (IMRT) can reduce radiation dose to functional bone marrow (BM) in patients with pelvic malignancies (phase IA) and estimate the clinical feasibility and acute toxicity associated with this technique (phase IB). Methods and Materials: We enrolled 31 subjects (19 with gynecologic cancer and 12 with anal cancer) in an institutional review board-approved prospective trial (6 in the pilot study, 10 in phase IA, and 15 in phase IB). The mean age was 52 years; 8 of 31 patients (26%) were men. Twenty-one subjects completed 18 F-fluorodeoxyglucose (FDG)-positron emission tomography (PET)/computed tomography (CT) simulation and magnetic resonance imaging by use of quantitative IDEAL (IDEAL IQ; GE Healthcare, Waukesha, WI). The PET/CT and IDEAL IQ were registered, and BM subvolumes were segmented above the mean standardized uptake value and below the mean fat fraction within the pelvis and lumbar spine; their intersection was designated as functional BM for IMRT planning. Functional BM-sparing vs total BM-sparing IMRT plans were compared in 12 subjects; 10 were treated with functional BM-sparing pelvic IMRT per protocol. Results: In gynecologic cancer patients, the mean functional BM V 10 (volume receiving ≥10 Gy) and V 20 (volume receiving ≥20 Gy) were 85% vs 94% (P 18 F-fluorodeoxyglucose-PET/CT and IDEAL IQ. The efficacy of BM-sparing IMRT is being tested in a phase II trial.

  2. Negative pressure wound therapy for serious dog bites of extremities: a prospective randomized trial.

    Science.gov (United States)

    Rui-Feng, Chen; Li-Song, Huang; Ji-Bo, Zheng; Yi-Qing, Jia; Yu-Jie, Liu; Yi, Shan

    2016-06-01

    The objectives were to investigate the emergency treatment of serious dog bite lacerations on limbs and to identify whether negative pressure wound therapy (NPWT) was beneficial in these instances. A total of 580 cases with serious limb lacerations due to dog bites were randomly divided into 2 groups. After thorough debridement, the limb lacerations of group A (n = 329) were left open. The remaining cases (n = 251) were randomly divided into 2 subgroups, group B and group C, which were treated with 125 and 75 mm Hg of continuous negative pressure, respectively. Antibiotics were only used in cases where there were systemic signs of wound infection, and were not given prophylactically. The infection rate, infection time, and healing time were analyzed. The wound infection rates of groups A, B, and C were 9.1%, 4.1%, and 3.9%, respectively. The infection times of the 3 groups were 26.3 ± 11.6, 159.8 ± 13.4, and 166.4 ± 16.2 hours, respectively. The recovery times of the infection patients in the 3 groups were 19.2 ± 4.6, 13.2 ± 2.1, and 12.7 ± 2.3 days, respectively, and in the noninfection patients, the recovery times were 15.6 ± 2.7, 10.1 ± 2.3, and 10.5 ± 1.9 days, respectively. In groups B (-125 mm Hg) and C (-75 mm Hg), the infection rate, infection time, and healing time showed no significant differences. Patients with serious dog bite laceration on limbs could benefit from NPWT. Compared with the traditional treatment of leaving the wounds open, NPWT reduced the infection rate and shortened recovery time. When NPWT was performed, low negative pressure (-75 mm Hg) had the same positive effects as high pressure (-125 mm Hg). Prophylactic antibiotics administration is not recommended for treating this kind of laceration. Therapeutic/care management, level II. Copyright © 2016 Elsevier Inc. All rights reserved.

  3. A Prospective Cohort Study of Gated Stereotactic Liver Radiation Therapy Using Continuous Internal Electromagnetic Motion Monitoring.

    Science.gov (United States)

    Worm, Esben S; Høyer, Morten; Hansen, Rune; Larsen, Lars P; Weber, Britta; Grau, Cai; Poulsen, Per R

    2018-02-13

    Intrafraction motion can compromise the treatment accuracy in liver stereotactic body radiation therapy (SBRT). Respiratory gating can improve treatment delivery; however, gating based on external motion surrogates is inaccurate. The present study reports the use of Calypso-based internal electromagnetic motion monitoring for gated liver SBRT. Fifteen patients were included in a study of 3-fraction respiratory gated liver SBRT guided by 3 implanted electromagnetic transponders. The planning target volume was created by a 5-mm axial and 7-mm (n = 12) or 10-mm (n = 3) craniocaudal expansion of the clinical target volume (CTV) and covered with 67% of the prescribed CTV mean dose. Treatment was gated to the end-exhale phase of the respiratory cycle with beam-on when the target deviated 1 to 2 mm occurred. Log files of transponder motion were used to determine the geometric error and reconstruct the delivered CTV dose in the actual gated treatments and in simulated nongated treatments. No severe side effects were observed in relation to transponder implantation. All 45 treatment fractions were successfully guided using the Calypso system. The mean number of couch corrections during each gated fraction was 2.8 (range 0-7). The mean duty cycle during gated treatment was 62.5% (range 29.1%-84.9%). Without gating, the mean 3-dimensional geometric error during a fraction would have been 5.4 mm (range 2.7-12.1). Gating reduced this error to 2.0 mm (range 1.2-3.0). The patient mean reduction in minimum dose to 95% of the CTV relative to the planned dose was 6.0 percentage points (range 0.7-22.0) without gating and 0.8 percentage point (range 0.2-2.0) with gating. Gating using internal motion monitoring was successfully applied for liver SBRT. It markedly improved the geometric and dosimetric accuracy compared with nongated standard treatment. Copyright © 2018 Elsevier Inc. All rights reserved.

  4. EFFICACY OF INTRAVENOUS METHYLPREDNISOLONE THERAPY IN TRAUMATIC OPTIC NEUROPATHY WITH ORBITAL WALL FRACTURES: A PROSPECTIVE COHORT STUDY

    Directory of Open Access Journals (Sweden)

    Srinivasan

    2016-05-01

    Full Text Available BACKGROUND Craniofacial injury due to road traffic accidents, blunt trauma and other accidents leading to traumatic optic neuropathy were managed with high dose of steroids rather than wait and observation and surgical decompression of optic nerve or nerve sheath (in case of sheath hematoma. Motor vehicles and bikes are most frequent causes for traumatic optic neuropathy, accounting for 17%-63% of cases. Our study was conducted to assess the visual loss due to traumatic optic neuropathy in association with orbital bone and wall fracture due to various types of ocular injuries and the response to medical line of management by intravenous methylprednisolone was observed. MATERIALS AND METHODS The prospective cohort study conducted at Department of Ophthalmology, Government Vellore Medical College Hospital, Vellore. Total number of ocular injury cases included in this study were 200. The study period was from November 2014 to December 2015. The ocular injury patients reported as outpatients in eye department as well as referred patients from Trauma Ward. RESULTS In our study, the ocular injuries of age group between 21-40 years is (121/200 60.5%. All cases of traumatic optic neuropathy manifestation individuals fall in that age group with severe form of ocular injuries. But the visual recovery reported with intravenous methylprednisolone and oral prednisolone alone because of neuropraxia and surrounding oedema of tissues as well as incomplete fracture of orbital wall without extending into optic canal level and without impingement of bone chips to the optic nerve. With improvement of colour vision apart from visual acuity improvement, visual field changes disappeared with the treatment. In our study, instead of wait and observation management where there was danger for total loss of vision or surgical decompression which carried the risk of orbital apex structure and other intracranial structure damage, iatrogenic direct and indirect optic nerve

  5. Fluid therapy and outcome: a prospective observational study in 65 German intensive care units between 2010 and 2011.

    Science.gov (United States)

    Ertmer, Christian; Zwißler, Bernhard; Van Aken, Hugo; Christ, Michael; Spöhr, Fabian; Schneider, Axel; Deisz, Robert; Jacob, Matthias

    2018-02-17

    Outcome data on fluid therapy in critically ill patients from randomised controlled trials may be different from data obtained by observational studies under "real-life" conditions. We conducted this prospective, observational study to investigate current practice of fluid therapy (crystalloids and colloids) and associated outcomes in 65 German intensive care units (ICUs). In total, 4545 adult patients who underwent intravenous fluid therapy were included. The main outcome measures were 90-day mortality, ICU mortality and acute kidney injury (AKI). Data were analysed using logistic and Cox regression models, as appropriate. In the predominantly post-operative overall cohort, unadjusted 90-day mortality was 20.1%. Patients who also received colloids (54.6%) had a higher median Simplified Acute Physiology Score II [25 (interquartile range 11; 41) vs. 17 (7; 31)] and incidence of severe sepsis (10.2 vs. 7.4%) on admission compared to patients who received exclusively crystalloids (45.4%). 6% hydroxyethyl starch (HES 130/0.4) was the most common colloid (57.0%). Crude rates of 90-day mortality were higher for patients who received colloids (OR 1.845 [1.560; 2.181]). After adjustment for baseline variables, the HR was 1.666 [1.405; 1.976] and further decreased to indicate no associated risk (HR 1.003 [0.980; 1.027]) when it was adjusted for vasopressor use, severity of disease and transfusions. Similarly, the crude risk of AKI was higher in the colloid group (crude OR 3.056 [2.528; 3.694]), after adjustment for baseline variables OR 1.941 [1.573; 2.397], and after full adjustment OR 0.696 [0.629; 0.770]), the risk of AKI turned out to be reduced. The same was true for the subgroup of patients treated with 6% HES 130/0.4 (crude OR 1.931 [1.541; 2.419], adjusted for baseline variables OR 2.260 [1.730; 2.953] and fully adjusted OR 0.800 [0.704; 0.910]) as compared to crystalloids only. The present analysis of mostly post-operative patients in routine clinical care did not

  6. 78 FR 26794 - Prospective Grant of Start-Up Exclusive Evaluation Option License Agreement: Gene Therapy and...

    Science.gov (United States)

    2013-05-08

    ...-Up Exclusive Evaluation Option License Agreement: Gene Therapy and Cell-Based Therapy for Cardiac... the field of use may be limited to ``Gene therapy and cell-based therapy for cardiac arrhythmias in... normal heart rhythm. These pacemakers include viral vectors suitable for gene therapy that incorporate Ca...

  7. Prospective Qualitative and Quantitative Analysis of Real-Time Peer Review Quality Assurance Rounds Incorporating Direct Physical Examination for Head and Neck Cancer Radiation Therapy.

    Science.gov (United States)

    Cardenas, Carlos E; Mohamed, Abdallah S R; Tao, Randa; Wong, Andrew J R; Awan, Mussadiq J; Kuruvila, Shirly; Aristophanous, Michalis; Gunn, G Brandon; Phan, Jack; Beadle, Beth M; Frank, Steven J; Garden, Adam S; Morrison, William H; Fuller, Clifton D; Rosenthal, David I

    2017-07-01

    Our department has a long-established comprehensive quality assurance (QA) planning clinic for patients undergoing radiation therapy (RT) for head and neck cancer. Our aim is to assess the impact of a real-time peer review QA process on the quantitative and qualitative radiation therapy plan changes in the era of intensity modulated RT (IMRT). Prospective data for 85 patients undergoing head and neck IMRT who presented at a biweekly QA clinic after simulation and contouring were collected. A standard data collection form was used to document alterations made during this process. The original pre-QA clinical target volumes (CTVs) approved by the treating-attending physicians were saved before QA and compared with post-QA consensus CTVs. Qualitative assessment was done according to predefined criteria. Dice similarity coefficients (DSC) and other volume overlap metrics were calculated for each CTV level and were used for quantitative comparison. Changes are categorized as major, minor, and trivial according to the degree of overlap. Patterns of failure were analyzed and correlated to plan changes. All 85 patients were examined by at least 1 head and neck subspecialist radiation oncologist who was not the treating-attending physician; 80 (94%) were examined by ≥3 faculty members. New clinical findings on physical examination were found in 12 patients (14%) leading to major plan changes. Quantitative DSC analysis revealed significantly better agreement in CTV1 (0.94 ± 0.10) contours than in CTV2 (0.82 ± 0.25) and CTV3 (0.86 ± 0.2) contours (P=.0002 and P=.03, respectively; matched-pair Wilcoxon test). The experience of the treating-attending radiation oncologist significantly affected DSC values when all CTV levels were considered (P=.012; matched-pair Wilcoxon text). After a median follow-up time of 38 months, only 10 patients (12%) had local recurrence, regional recurrence, or both, mostly in central high-dose areas. Comprehensive peer review planning

  8. Periodontal Regenerative Therapy of Intrabony Defects Using Deproteinized Bovine Bone Mineral in Combination with Collagen Barrier Membrane: A Multicenter Prospective Case-Series Study.

    Science.gov (United States)

    Irokawa, Daisuke; Okubo, Nobuki; Nikaido, Masahiko; Shimizu, Hiroyasu; Konobu, Hiroyuki; Matsui, Tokuo; Fujita, Takahisa; Goto, Hiroaki; Takeuchi, Takahiro; Ishii, Yoshihito; Saito, Atsushi

    This multicenter prospective case series study aimed to evaluate the outcome of periodontal regenerative therapy using a deproteinized bovine bone mineral (DBBM) in combination with a collagen barrier (CB) in the treatment of intrabony defects. A total of 36 nonsmoking patients with chronic periodontitis were recruited in five centers in Japan. All patients had at least one intrabony defect of ≥ 3 mm. The surgical procedures included access for debridement using a papilla preservation technique. Defects were filled with DBBM and covered with CB. Clinical evidence after 6 months supported the effectiveness of the combination therapy in the treatment of intrabony defects.

  9. A prospective, randomized multicenter trial of the empirical addition of antifungal therapy for febrile neutropenic cancer patients: results of the Paul Ehrlich Society for Chemotherapy (PEG) Multicenter Trial II.

    Science.gov (United States)

    Schiel, X; Link, H; Maschmeyer, G; Glass, B; Cornely, O A; Buchheidt, D; Wilhelm, M; Silling, G; Helmerking, M; Hiddemann, W; Ostermann, H; Hentrich, M

    2006-06-01

    The aim of the study was to compare the efficacy of empirical antifungals in combination with broad spectrum antibiotics with that of antibiotics alone in high risk febrile neutropenic cancer patients not responding to initial antibacterial therapy. A prospective, randomized controlled trial was conducted at 22 cancer centers in Germany. Patients with fever of unknown origin were randomized to either piperacillin (Pip) plus an aminoglycoside (AMG) (arm A) or a third generation cephalosporin (Ceph) plus AMG (arm B). Patients not responding after 4-6 days were randomized to either imipenem (Imi) plus glycopeptide (GLP) (arm C), or Imi/GLP plus amphotericin B deoxycholate (AmB) plus 5-flucytosine (5-FC) (arm D), or Imi/GLP plus fluconazole (Fluco) (arm E). A successful outcome was defined as resolution of fever. In arm A, 192 of 373 patients (51.5%) responded as compared to 176 of 344 patients (51.2%) in arm B. The response rates of 155 patients randomized for further empirical treatment were 55.6%, 77.8% and 62.5% in arm C, D and E, respectively. The difference between arm C and D was of borderline statistical significance (p = 0.06) after correction for multiple testing. In neutropenic cancer patients with persistent fever the combination of antibiotics with AmB/5-FC is superior to salvage antibacterial therapy alone. There is no difference in efficacy between Pip and third generation Ceph given as initial empirical therapy in combination with an AMG.

  10. [Do diabetologists choose a therapy rationally? Basic results of the PROROK project (a prospective observation project to assess the relevance of the difference between fasting glycemia and postprandial glycemia to estimation of success of type 2 diabetes therapy)].

    Science.gov (United States)

    Žďarská, Denisa Janíčková; Piťhová, Pavlína; Pavlík, Tomáš; Kvapil, Milan

    2015-04-01

    The PROROK project (A prospective observation project to assess the relevance of the difference between fasting glycemia and postprandial glycemia to estimation of success of type 2 diabetes therapy) had a character of a non-interventional, prospective, multicentric observation project conducted for a period of 6 months, whose aim was to quantify the relevance of the difference between fasting and postprandial glycemia to the success of GLP1 receptor agonist treatment, or insulin therapy with basal or premixed insulin, or a combination of basal and bolus insulin. Physicians chose therapy for inadequately compensated patients at their own discretion, with 4 972 patients included. The study aimed at the assessment of the differences in basic anthropometric and biochemical parameters between the patient cohorts included in the PROROK project with regard to the therapy selected by the treating diabetologist. The patients treated with GLP1 receptor agonists were quite young, they have suffered from diabetes for a shorter period of time and at the same time were more obese and had the highest concentration of triacylglycerols. The patients who underwent basal insulin therapy, had the highest fasting glycemia. The patients for whom premixed insulin therapy or basal/bolus insulin regimen were chosen, manifested the highest postprandial glycemia, those with basal/bolus insulin regimen had the highest initial glycated haemoglobin. The difference between fasting and postprandial glycemia was the smallest in the cohort for which basal insulin therapy was chosen and the greatest in the cohort chosen for the therapy with premixed insulin, or with the basal/bolus insulin combination. Average improvement in glycated haemoglobin values reached 1.6 % within the whole cohort, a median of the resulting glycated haemoglobin reached 5.9 % or 5.8 % (GLP1 receptor agonist treatment). All the differences amounted to p project choose their therapy in a rational manner.

  11. Early detection and prediction of cardiotoxicity after radiation therapy for breast cancer: the BACCARAT prospective cohort study

    International Nuclear Information System (INIS)

    Jacob, Sophie; Pathak, Atul; Franck, Denis; Latorzeff, Igor; Jimenez, Gaelle; Fondard, Olivier; Lapeyre, Matthieu; Colombier, Daniel; Bruguiere, Eric; Lairez, Olivier; Fontenel, Benoit; Milliat, Fabien; Tamarat, Radia; Broggio, David; Derreumaux, Sylvie; Ducassou, Marianne; Ferrières, Jean; Laurier, Dominique; Benderitter, Marc; Bernier, Marie-Odile

    2016-01-01

    Radiotherapy (RT) for breast cancer presents a benefit in terms of reducing local recurrence and deaths resulting from breast cancer but it can lead to secondary effects due to the presence of neighboring cardiac normal tissues within the irradiation field. Breast RT has been shown to be associated with long-term increased risk of heart failure, coronary artery disease, myocardial infarction and finally cardiovascular death more than 10 years after RT. However, there is still a lack of knowledge for early cardiotoxicity induced by breast RT that can appear long before the onset of clinically significant cardiac events. Based on a 2-year follow-up prospective cohort of patients treated with breast RT, the BACCARAT (BreAst Cancer and CArdiotoxicity Induced by RAdioTherapy) study aims to enhance knowledge on detection and prediction of early subclinical cardiac dysfunction and lesions induced by breast RT and on biological mechanisms potentially involved, based on functional and anatomical cardiac imaging combined with simultaneous assessment of multiple circulating biomarkers and accurate heart dosimetry. BACCARAT study consists in a monocentric prospective cohort study that will finally include 120 women treated with adjuvant 3D CRT for breast cancer, and followed for 2 years after RT. Women aged 50 to 70 years, treated for breast cancer and for whom adjuvant 3D CRT is indicated, without chemotherapy are eligible for the study. Baseline (before RT) and follow-up data include measurements of functional myocardial dysfunction including strain and strain rate based on 2D-speckle tracking echocardiography, anatomical coronary lesions including description of plaques in segments of coronary arteries based on Coronary computed tomography angiography, and a wide panel of circulating biomarkers. The absorbed dose is evaluated for the whole heart and its substructures, in particular the coronary arteries. Analysis on occurrence and evolution of subclinical cardiac lesions

  12. Efficacy of Insulin Pump Therapy on Diabetes Treatment Satisfaction and Glycemic Control Among Patients with Type 1 Diabetes Mellitus in Saudi Arabia: A Prospective Study

    OpenAIRE

    Al Hayek, Ayman A.; Robert, Asirvatham A.; Al Dawish, Mohamed A.; Braham, Rim B.; Goudeh, Hanouf S.; Al Sabaan, Fahad S.

    2015-01-01

    Introduction The aim of this study was to explore the impact of insulin pump therapy on diabetes treatment satisfaction and glycemic control among patients with type 1 diabetes mellitus (T1DM) in Saudi Arabia. Methods A 6-month, prospective study was conducted among 47 patients (aged 17?24?years) with T1DM who attended the Insulin Pump Clinic at Prince Sultan Military Medical City, Riyadh, Saudi Arabia, between April 2014 and November 2014. The respondents were purposively and conveniently se...

  13. Preoperative physical therapy treatment did not influence postoperative pain and disability outcomes in patients undergoing shoulder arthroscopy: a prospective study

    Directory of Open Access Journals (Sweden)

    Valencia C

    2016-07-01

    contrast, age, pain intensity, disability, and pain-associated psychological factors did not differ between pre-op PT treatment groups (P>0.05. Subacromial bursectomies were more commonly performed in patients having pre-op PT treatment (P<0.05. Pre-op PT treatment did not influence length of post-op PT treatment and did not affect 3-month and 6-month pain intensity and disability outcomes. Differences in distribution of pre-op PT for males and females and subacromial bursectomy did not influence 3-month or 6-month postsurgical outcomes. Conclusion: Receiving pre-op PT treatment did not influence post-op PT treatment or pain and disability outcomes at 3 months and 6 months. This prospective cohort study provides no evidence of benefit for pre-op PT on post-op PT treatment or postsurgical outcomes. Females or patients receiving certain surgical procedures are more likely to undergo pre-op PT treatment. However, these differences did not influence postoperative outcomes in this cohort. Keywords: preoperative physical therapy, postoperative pain, postoperative disability, shoulder arthroscopy

  14. ORIGINAL ARTICLES

    African Journals Online (AJOL)

    ORIGINAL ARTICLES. UNPAID COMMUNITY. VOLUNTEERS - EFFECTIVE. PROVIDERS OF DIRECTLY. OBSERVED THERAPY (DOT) IN. RURAL SOUTH AFRICA. R D Barker, F J C Millard, M E Nthangeni. Objective. To il).ustrate successes and difficulties for the South. African National Tuberculosis Progranune in a ...

  15. Predictors of adherence to antiretroviral therapy among HIV-infected persons: a prospective study in Southwest Ethiopia

    Directory of Open Access Journals (Sweden)

    Girma Belaineh

    2008-07-01

    Full Text Available Abstract Background The devastating impact of AIDS in the world especially in sub-Saharan Africa has led to an unprecedented global effort to ensure access to antiretroviral (ARV drugs. Given that medication-taking behavior can immensely affect an individual's response; ART adherence is now widely recognized as an 'Achilles heel' for the successful outcome. The present study was undertaken to investigate the rate and predictors of adherence to antiretroviral therapy among HIV-infected persons in southwest Ethiopia. Methods The study was conducted in the antiretroviral therapy unit of Jimma University Specialized Hospital. A prospective study was undertaken on a total of 400 HIV infected person. Data were collected using a pre-tested interviewer-administered structured questionnaire at first month (M0 and third month (M3 follow up visits. Results A total of 400 and 383 patients at baseline (M0 and at follow up visit (M3 respectively were interviewed. Self-reported dose adherence in the study area was 94.3%. The rate considering the combined indicator (dose, time and food was 75.7%. Within a three month follow up period, dose adherence decreased by 2% and overall adherence rate decreased by more than 3%. Adherence was common in those patients who have a social support (OR, 1.82, 95%CI, 1.04, 3.21. Patients who were not depressed were two times more likely to be adherent than those who were depressed (OR, 2.13, 95%CI, 1.18, 3.81. However, at the follow up visit, social support (OR, 2.42, 95%CI, 1.29, 4.55 and the use of memory aids (OR, 3.29, 95%CI, 1.44, 7.51 were found to be independent predictors of adherence. The principal reasons reported for skipping doses in this study were simply forgetting, feeling sick or ill, being busy and running out of medication in more than 75% of the cases. Conclusion The self reported adherence rate was high in the study area. The study showed that adherence is a dynamic process which changes overtime and cannot

  16. Fractionated Boron Neutron Capture Therapy in Locally Recurrent Head and Neck Cancer: A Prospective Phase I/II Trial.

    Science.gov (United States)

    Wang, Ling-Wei; Chen, Yi-Wei; Ho, Ching-Yin; Hsueh Liu, Yen-Wan; Chou, Fong-In; Liu, Yuan-Hao; Liu, Hong-Ming; Peir, Jinn-Jer; Jiang, Shiang-Huei; Chang, Chi-Wei; Liu, Ching-Sheng; Lin, Ko-Han; Wang, Shyh-Jen; Chu, Pen-Yuan; Lo, Wen-Liang; Kao, Shou-Yen; Yen, Sang-Hue

    2016-05-01

    To investigate the efficacy and safety of fractionated boron neutron capture therapy (BNCT) for recurrent head and neck (H&N) cancer after photon radiation therapy. In this prospective phase 1/2 trial, 2-fraction BNCT with intravenous L-boronophenylalanine (L-BPA, 400 mg/kg) was administered at a 28-day interval. Before each fraction, fluorine-18-labeled-BPA-positron emission tomography was conducted to determine the tumor/normal tissue ratio of an individual tumor. The prescription dose (D80) of 20 Gy-Eq per fraction was selected to cover 80% of the gross tumor volume by using a dose volume histogram, while minimizing the volume of oral mucosa receiving >10 Gy-Eq. Tumor responses and adverse effects were assessed using the Response Evaluation Criteria in Solid Tumors v1.1 and the Common Terminology Criteria for Adverse Events v3.0, respectively. Seventeen patients with a previous cumulative radiation dose of 63-165 Gy were enrolled. All but 2 participants received 2 fractions of BNCT. The median tumor/normal tissue ratio was 3.4 for the first fraction and 2.5 for the second, whereas the median D80 for the first and second fraction was 19.8 and 14.6 Gy-Eq, respectively. After a median follow-up period of 19.7 months (range, 5.2-52 mo), 6 participants exhibited a complete response and 6 exhibited a partial response. Regarding acute toxicity, 5 participants showed grade 3 mucositis and 1 participant showed grade 4 laryngeal edema and carotid hemorrhage. Regarding late toxicity, 2 participants exhibited grade 3 cranial neuropathy. Four of six participants (67%) receiving total D80 > 40 Gy-Eq had a complete response. Two-year overall survival was 47%. Two-year locoregional control was 28%. Our results suggested that 2-fraction BNCT with adaptive dose prescription was effective and safe in locally recurrent H&N cancer. Modifications to our protocol may yield more satisfactory results in the future. Copyright © 2016 Elsevier Inc. All rights reserved.

  17. The Combination of Laser Therapy and Metal Nanoparticles in Cancer Treatment Originated From Epithelial Tissues: A Literature Review

    OpenAIRE

    Fekrazad, Reza; Naghdi, Nafiseh; Nokhbatolfoghahaei, Hanieh; Bagheri, Hossein

    2016-01-01

    Several methods have been employed for cancer treatment including surgery, chemotherapy and radiation therapy. Today, recent advances in medical science and development of new technologies, have led to the introduction of new methods such as hormone therapy, Photodynamic therapy (PDT), treatments using nanoparticles and eventually combinations of lasers and nanoparticles. The unique features of LASERs such as photo-thermal properties and the particular characteristics of nanoparticles, given ...

  18. Sorafenib after combination therapy with gemcitabine plus doxorubicine in patients with sarcomatoid renal cell Carcinoma: a prospective evaluation

    Directory of Open Access Journals (Sweden)

    Staehler M

    2010-07-01

    Full Text Available Abstract Background Sarcomatoid renal cell cancer (RCC is a distinct histological variant of RCC that is associated with rapid progression and a poor prognosis. The optimal treatment for patients with sarcomatoid RCC remains to be defined. Gemcitabine plus doxorubicine (GD has shown some efficacy, however durability of response is limited. We carried out a prospective, open-label study to investigate the efficacy and safety of sorafenib in patients after GD failure in sarcomatoid RCC. Methods Fifteen patients with pure sarcomatoid RCC and objective progressive disease were treated with GD (gemcitabine 1500 mg/m2, doxorubicine 50 mg/m2 administered by weekly intravenous infusion until progression of disease. Subsequently 9 patients were switched to sorafenib (400 mg twice daily. Tumor response was measured by physical examination and computerized tomography scans and evaluated according to Response Evaluation Criteria in Solid Tumors criteria. Results Median time to progression (TTP under GD was 6.6 months (range 0.8 - 8 months. During GD treatment there were no remissions and 6 patients died from progressive disease. Median TTP for the 9 patients switched to sorafenib was 10.9 months (range 0.6 - 25.5 months. During sorafenib therapy one patient had a partial remission lasting for 3 months and 4 patients experienced stable disease with a duration of 3 to 9 months. Four patients immediately progressed on sorafenib treatment but had a slower dynamic of tumor progression than under GD. Dosing in both treatment phases was generally well tolerated with manageable toxicities and no requirement for dose reduction. Conclusions Chemotherapy with GD was ineffective in our patients with pure sarcomatoid RCC. Subsequent anti-angiogenic treatment using the multi-tyrosine kinase inhibitor sorafenib resulted in additional progression-free survival in 5 of 9 patients. Further evaluation of targeted anti-angiogenic agents for the treatment of sarcomatoid RCC is

  19. Serum phosphate predicts early mortality in adults starting antiretroviral therapy in Lusaka, Zambia: a prospective cohort study.

    Directory of Open Access Journals (Sweden)

    Douglas C Heimburger

    Full Text Available BACKGROUND: Patients starting antiretroviral therapy (ART for acquired immunodeficiency syndrome (AIDS in sub-Saharan Africa have high rates of mortality in the initial weeks of treatment. We assessed the association of serum phosphate with early mortality among HIV-infected adults with severe malnutrition and/or advanced immunosuppression. METHODOLOGY/PRINCIPAL FINDINGS: An observational cohort of 142 HIV-infected adults initiating ART in Lusaka, Zambia with body mass index (BMI <16 kg/m(2 or CD4(+ lymphocyte count <50 cells/microL, or both, was followed prospectively during the first 12 weeks of ART. Detailed health and dietary intake history, review of systems, physical examination, serum metabolic panel including phosphate, and serum ferritin and high-sensitivity C-reactive protein (hsCRP were monitored. The primary outcome was mortality. Baseline serum phosphate was a significant predictor of mortality; participants alive at 12 weeks had a median value of 1.30 mmol/L (interquartile range [IQR]: 1.04, 1.43, compared to 1.06 mmol/L (IQR: 0.89, 1.27 among those who died (p<0.01. Each 0.1 mmol/L increase in baseline phosphate was associated with an incremental decrease in mortality (AHR 0.83; 95% CI 0.72 to 0.95. The association was independent of other metabolic parameters and known risk factors for early ART-associated mortality in sub-Saharan Africa. While participant attrition represented a limitation, it was consistent with local program experience. CONCLUSIONS/SIGNIFICANCE: Low serum phosphate at ART initiation was an independent predictor of early mortality among HIV patients starting ART with severe malnutrition or advanced immunosuppression. This may represent a physiologic phenomenon similar to refeeding syndrome, and may lead to therapeutic interventions that could reduce mortality.

  20. A prospective controlled study: Minimally invasive stereotactic puncture therapy versus conventional craniotomy in the treatment of acute intracerebral hemorrhage

    Directory of Open Access Journals (Sweden)

    Tang Yuping

    2011-06-01

    Full Text Available Abstract Background Spontaneous intracerebral hemorrhage (ICH is a devastating form of stroke with the high mortality twofold to sixfold higher than that for ischemic stroke. But the treatment of haematomas within the basal ganglia continues to be a matter of debate among neurologists and neurosurgeons. The purpose of this study is to judge the clinical value of minimally invasive stereotactic puncture therapy (MISPT on acute ICH. Methods A prospective controlled study was undertaken. The clinical trial was in compliance with the WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects. According to the enrollment criterion, there were 168 acute ICH cases analyzed, of which 90 cases were performed by MISPT ( MISPT group, MG and 78 cases by Conventional craniotomy (CC group, CG, by means of compare of Glasgow Coma Scale(GCS score, postoperative complications(PC and rebleeding incidence(RI, moreover, long-term outcome of 1 year postoperation judged by Glasgow Outcome Scale (GOS, Barthel Index (BI, modified Rankin Scale (mRS and case fatality(CF. Results MG patients showed obvious amelioration in GCS score compared with that of CG. The total incidence of PC in MG decreased obviously compared with that of CG. The incidences of rebleeding in MG and CG were 10.0% and 15.4% respectively. There was no obvious difference between CFs of MG and CG. For three parameters representing long-term outcome, the GOS, BI and mRS in MG were ameliorated significantly than that of CG. Conclusion These data suggested that the advantage of MISPT was displayed in minute trauma and safety, and seemed to be feasible and to had a trend towards improved long-term outcome. Trial Registration The Australian New Zealand Clinical Trials Registry (ANZCTR, the registration number:ACTRN12610000945022.

  1. A prospective assessment of the effect of aminophylline therapy on urine output and inflammation in critically ill children

    Directory of Open Access Journals (Sweden)

    Robert F Tamburro

    2014-06-01

    Full Text Available Background: Aminophylline, an established bronchodilator, is also purported to be an effective diuretic and anti-inflammatory agent. However, the data to support these contentions are scant. We conducted a prospective, open-label, single arm, single center study to assess the hypothesis that aminophylline increases urine output and decreases inflammation in critically ill children. Methods: Children less than 18 years of age admitted to the pediatric intensive care unit who were prescribed aminophylline over a 24-hour period were eligible for study. The use and dosing of aminophylline was independent of the study and was at the discretion of the clinical team. Data analyzed consisted of demographics, diagnoses, medications, and markers of pulmonary function, renal function and inflammation. Data were collected at baseline and at 24-hours after aminophylline initiation with primary outcomes of change in urine output and inflammatory cytokine concentrations. Results: Thirty-five patients were studied. Urine output increased significantly with aminophylline use (median increase 0.5 mL/kg/hour ([IQR:-0.3,1.3], p=0.05 while BUN and creatinine concentrations remained unchanged. Among patients with elevated C-reactive protein concentrations, levels of both interleukin-6 (IL-6 and IL-10 decreased at 24-hours of aminophylline therapy. There were no significant differences in pulmonary compliance or resistance among patients invasively ventilated at both time points. Side effects of aminophylline were detected in 7 of 35 patients. Conclusions: Although no definitive conclusions can be drawn from this study, aminophylline may be a useful diuretic and effective anti-inflammatory medication in critically ill children. Given the incidence of side effects, the small sample size and the uncontrolled study design, further study is needed to inform the appropriate use of aminophylline in these children.

  2. A prospective controlled study: Minimally invasive stereotactic puncture therapy versus conventional craniotomy in the treatment of acute intracerebral hemorrhage

    Science.gov (United States)

    2011-01-01

    Background Spontaneous intracerebral hemorrhage (ICH) is a devastating form of stroke with the high mortality twofold to sixfold higher than that for ischemic stroke. But the treatment of haematomas within the basal ganglia continues to be a matter of debate among neurologists and neurosurgeons. The purpose of this study is to judge the clinical value of minimally invasive stereotactic puncture therapy (MISPT) on acute ICH. Methods A prospective controlled study was undertaken. The clinical trial was in compliance with the WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects. According to the enrollment criterion, there were 168 acute ICH cases analyzed, of which 90 cases were performed by MISPT ( MISPT group, MG) and 78 cases by Conventional craniotomy (CC group, CG), by means of compare of Glasgow Coma Scale(GCS) score, postoperative complications(PC) and rebleeding incidence(RI), moreover, long-term outcome of 1 year postoperation judged by Glasgow Outcome Scale (GOS), Barthel Index (BI), modified Rankin Scale (mRS) and case fatality(CF). Results MG patients showed obvious amelioration in GCS score compared with that of CG. The total incidence of PC in MG decreased obviously compared with that of CG. The incidences of rebleeding in MG and CG were 10.0% and 15.4% respectively. There was no obvious difference between CFs of MG and CG. For three parameters representing long-term outcome, the GOS, BI and mRS in MG were ameliorated significantly than that of CG. Conclusion These data suggested that the advantage of MISPT was displayed in minute trauma and safety, and seemed to be feasible and to had a trend towards improved long-term outcome. Trial Registration The Australian New Zealand Clinical Trials Registry (ANZCTR), the registration number:ACTRN12610000945022. PMID:21699716

  3. Pathophysiology and therapy of irinotecan-induced delayed-onset diarrhea in patients with advanced colorectal cancer: a prospective assessment.

    Science.gov (United States)

    Saliba, F; Hagipantelli, R; Misset, J L; Bastian, G; Vassal, G; Bonnay, M; Herait, P; Cote, C; Mahjoubi, M; Mignard, D; Cvitkovic, E

    1998-08-01

    Irinotecan (CPT-11), a camptothecin derivative, has shown efficacy against colorectal cancer. Delayed-onset diarrhea is its main limiting toxicity. The aim of this study was to determine the pathophysiology of CPT-11-induced delayed-onset diarrhea and assess the efficacy of combined antidiarrheal medication in a phase II, prospective, successive-cohorts, open study. Twenty-eight patients with advanced colorectal cancer refractory to fluorouracil (5-FU) therapy received CPT-11 350 mg/m2 every 3 weeks. The first cohort of 14 consecutive patients explored for the mechanism of diarrhea received acetorphan (a new enkephalinase inhibitor) 100 mg three times daily; the second 14-patient cohort received, in addition to acetorphan, loperamide 4 mg three times daily. Before treatment, and if late diarrhea occurred, patients underwent colon mucosal biopsies for CPT-11 and topoisomerase I levels; intestinal transit time; fecalogram; fat and protein excretion; alpha1-antitrypsin clearance; D-xylose test; blood levels for vasoactive intestinal polypeptide, glucagon, gastrin, somatostatin, prostaglandin E2, and carboxylesterase; CPT-11/SN-38 and SN-38 glucuronide pharmacokinetics; and stool cultures. Delayed-onset diarrhea occurred during the first three treatment cycles in 23 patients (82%). Electrolyte fecal measurements showed a negative or small osmotic gap in nine of nine patients and an increased alpha1-antitrypsin clearance in six of six patients. There were no modifications in stool cultures or hormonal dysfunction. Four of 11 patients (36%) with delayed-onset diarrhea in the first cohort responded to acetorphan, whereas nine of 10 patients (90%) responded to the combination of acetorphan and loperamide (P diarrhea is caused by a secretory mechanism with an exudative component. Early combined treatment with loperamide and acetorphan seems effective in controlling the diarrheal episodes.

  4. Role and interpretation of fluorodeoxyglucose-positron emission tomography/computed tomography in HIV-infected patients with fever of unknown origin: a prospective study.

    Science.gov (United States)

    Martin, C; Castaigne, C; Tondeur, M; Flamen, P; De Wit, S

    2013-09-01

    The aim of the study was to evaluate prospectively the usefulness of fluorodeoxyglucose-positron emission tomography/computed tomography (FDG-PET/CT) in investigation of fever of unknown origin (FUO) in HIV-positive patients and to determine whether HIV viraemia impacts on FDG-PET/CT performance. The FDG-PET/CT results of 20 HIV-infected patients with FUO were analysed and compared with the FDG-PET/CT results of 10 HIV-infected viraemic patients without FUO. The performance of FDG-PET/CT for identifying the aetiology of FUO was assessed. Final diagnosis for FUO was based on histopathology, microbiological assays, or clinical and imaging follow-up. FDG-PET/CT contributed to the diagnosis or exclusion of a focal aetiology of the febrile state in 80% of patients with FUO. The presence of increased FDG uptake in the central lymph node has 100% specificity for focal aetiology of fever, even in viraemic patients. The absence of hypermetabolic central lymph nodes in FUO patients has 100% negative predictive value for focal disease. Lymph node biopsy in central hypermetabolic areas allowed, in 100% of cases, identification of underlying disease in patients with FUO. Biopsy of peripheral lymph nodes should be performed in lymph nodes with maximum standardized uptake value (SUVmax) ≥ 6-8 (sensitivity 62.5%; specificity 75%) and avoided in lymph nodes with SUVmax = 0-4 (specificity 0%). High HIV viraemia does not prevent correct interpretation of FDG-PET/CT. As in HIV-negative patients, we confirm the usefulness of FDG-PET/CT in investigation of FUO in HIV-positive patients even if they are viraemic. © 2013 British HIV Association.

  5. Timing of radiotherapy in breast-conserving therapy: a large prospective cohort study of node-negative breast cancer patients without adjuvant systemic therapy

    NARCIS (Netherlands)

    Jobsen, J.J.; van der Palen, Jacobus Adrianus Maria; Baum, M.; Brinkhuis, M.; Struikmans, H.

    2013-01-01

    Background: To investigate the issue of timing of radiation therapy (RT) after lumpectomy in relation to recurrences and outcome. Methods: Analysis was done on 1107 breast-conserving therapies (BCT) with 1070 women, all without lymph node metastasis and without any adjuvant systemic therapy. Timing

  6. A prospective study predicting the outcome of chronic low back pain and physical therapy: the role of fear-avoidance beliefs and extraspinal pain.

    Science.gov (United States)

    Feitosa, Aloma S A; Lopes, Jaqueline Barros; Bonfa, Eloisa; Halpern, Ari S R

    To identify the prognostic factors for conventional physical therapy in patients with chronic low back pain (CLBP). Prospective observational study. One hundred thirteen patients with CLBP selected at the Spinal Disease Outpatient Clinic. Pain intensity was scored using the Numeric Rating Scale (NRS), and function was measured using the Roland-Morris Disability Questionnaire (RMDQ). The Fear-Avoidance Beliefs Questionnaire work subscale results (FABQ-work; odds ratio [OR]=0.27, 95% confidence interval [CI] 0.13-0.56, p<0.001) and extraspinal pain (OR=0.35, 95% CI 0.17-0.74, p=0.006) were independently associated with a decreased response to conventional physical therapy for CLBP. We identified high FABQ-work and extraspinal pain scores as key determinants of a worse response to physical therapy among CLBP patients, supporting the need for a special rehabilitation program for this subgroup. Copyright © 2016 Elsevier Editora Ltda. All rights reserved.

  7. A prospective observational study of early intervention with erythropoietin therapy and renal survival in non-dialysis chronic kidney disease patients with anemia: JET-STREAM Study.

    Science.gov (United States)

    Akizawa, Tadao; Tsubakihara, Yoshiharu; Hirakata, Hideki; Watanabe, Yuzo; Hase, Hiroki; Nishi, Shinichi; Babazono, Tetsuya; Kumagai, Michiko; Katakura, Shingo; Uemura, Yukari; Ohashi, Yasuo

    2016-12-01

    There is limited data showing that early treatment for anemia could prolong renal survival in non-dialysis chronic kidney disease (CKD) patients. We therefore investigated the relationship between hemoglobin (Hb) levels at initiation of epoetin beta therapy and renal outcome in non-dialysis CKD patients with anemia. In this prospective, multi-center, observational study, non-dialysis CKD patients with anemia who were naïve to erythropoiesis-stimulating agents (ESAs) were divided into three groups based on their Hb levels at initiation of epoetin beta therapy (Group I: 10 ≤ Hb anemia compared with initiation of ESA therapy at below 9 g/dL or even 10 g/dL.

  8. Prospective study to determine early hypertrophy of the contra-lateral liver lobe after unilobar, Yttrium-90, selective internal radiation therapy in patients with hepatocellular carcinoma.

    Science.gov (United States)

    Teo, Jin Yao; Allen, John Carson; Ng, David Chee Eng; Abdul Latiff, Julianah Bee; Choo, Su Pin; Tai, David Wai-Meng; Low, Albert Su Chong; Cheah, Foong Koon; Chang, Jason Pik Eu; Kam, Juinn Huar; Lee, Victor T W; Chung, Alexander Yaw Fui; Chan, Chung Yip; Chow, Pierce Kah Hoe; Goh, Brian K P

    2018-01-03

    Liver resection is a major curative option in patients presenting with hepatocellular carcinoma. An inadequate functional liver remnant is a major limiting factor precluding liver resection. In recent years, hypertrophy of the functional liver remnant after selective internal radiation therapy hypertrophy has been observed, but the degree of hypertrophy in the early postselective internal radiation therapy period has not been well studied. We conducted a prospective study on patients undergoing unilobar, Yttrium-90 selective internal radiation therapy for hepatocellular carcinoma to evaluate early hypertrophy at 4-6 weeks and 8-12 weeks after selective internal radiation therapy. In the study, 24 eligible patients were recruited and had serial volumetric measurements performed. The median age was 66 years (38-75 years). All patients were either Child-Pugh Class A or B, and 6/24 patients had documented, clinically relevant portal hypertension; 15 of the 24 patients were hepatitis B positive. At 4-6 weeks, modest hypertrophy was seen (median 3%; range -12 to 42%) and this increased at 8-12 weeks (median 9%; range -12 to 179%). No preprocedural factors predictive of hypertrophy were identified. Hypertrophy of the functional liver remnant after selective internal radiation therapy with Yttrium-90 occurred in a subset of patients but was modest and unpredictable in the early stages. Selective internal radiation therapy cannot be recommended as a standard treatment modality to induce early hypertrophy for patients with hepatocellular carcinoma. (Surgery 2017;160:XXX-XXX.). Copyright © 2017 Elsevier Inc. All rights reserved.

  9. The mechanisms of inter-effect about gene therapy and radiotherapy to tumor and the prospect of therapeutic alliance

    International Nuclear Information System (INIS)

    Zhao Yanzhi; Li Jin; Wang Qin; Mu Chuanjie

    2006-01-01

    The way about therapy include radio therapy and gene therapy in the recent years there are some improve about the therapy alliance, by the mechanism of improving the efficiency of the gene transfering, the recombination and conform of the DNA and induction the expression of the gene et. The radiotherapy can enhance the effect of the gene therapy. By the mechanism of improving of radiosensitivity some, reducing the radiation damage of radiotherapy, repairing the radiation impaired gene the gene therapy can enhance the effect of the radiotherapy. (authors)

  10. Original Research: Metabolic alterations from early life thyroxine replacement therapy in male Ames dwarf mice are transient.

    Science.gov (United States)

    Darcy, Justin; Fang, Yimin; Hill, Cristal M; McFadden, Sam; Sun, Liou Y; Bartke, Andrzej

    2016-10-01

    Ames dwarf mice are exceptionally long-lived due to a Prop1 loss of function mutation resulting in deficiency of growth hormone, thyroid-stimulating hormone and prolactin. Deficiency in thyroid-stimulating hormone and growth hormone leads to greatly reduced levels of circulating thyroid hormones and insulin-like growth factor 1, as well as a reduction in insulin secretion. Early life growth hormone replacement therapy in Ames dwarf mice significantly shortens their longevity, while early life thyroxine (T4) replacement therapy does not. Possible mechanisms by which early life growth hormone replacement therapy shortens longevity include deleterious effects on glucose homeostasis and energy metabolism, which are long lasting. A mechanism explaining why early life T4 replacement therapy does not shorten longevity remains elusive. Here, we look for a possible explanation as to why early life T4 replacement therapy does not impact longevity of Ames dwarf mice. We found that early life T4 replacement therapy increased body weight and advanced the age of sexual maturation. We also find that early life T4 replacement therapy does not impact glucose tolerance or insulin sensitivity, and any deleterious effects on oxygen consumption, respiratory quotient and heat production are transient. Lastly, we find that early life T4 replacement therapy has long-lasting effects on bone mineral density and bone mineral content. We suggest that the transient effects on energy metabolism and lack of effects on glucose homeostasis are the reasons why there is no shortening of longevity after early life T4 replacement therapy in Ames dwarf mice. © 2016 by the Society for Experimental Biology and Medicine.

  11. A Prospective, Randomized, Blinded, Controlled Trial Comparing Transdermal Continuous Oxygen Delivery to Moist Wound Therapy for the Treatment of Diabetic Foot Ulcers.

    Science.gov (United States)

    Driver, Vickie R; Reyzelman, Alexander; Kawalec, Jill; French, Michael

    2017-04-01

    Worldwide, diabetic foot ulcers (DFUs) continue to exact a major burden on patients and health care providers. Although hyperbaric oxygen therapy is well-known as an adjunct option, less is known about the efficacy of transdermal continuous oxygen therapy (TCOT). A prospective, randomized, blinded, multicenter, parallel study was conducted from October 2009 to November 2012 to evaluate healing time and the proportion of DFUs healed after 12 weeks of moist wound therapy (MWT) with or without TCOT. Study participants (persons with type 1 or type 2 diabetes and a nonhealing [>1-month but treatment consisted of continuous administration of 98+% oxygen to the wound site using a 15-day device with dressings changed every 3 to 7 days per care plan or more often when clinically required. Potential participants completed demographic and clinical screening and wound and laboratory evaluations at baseline, and wound evaluations, evaluation of adverse events, debridement, and treatment once weekly until the wound healed or up to 12 weeks. The primary endpoint was defined as complete wound closure by week 12. Wound measurements were made utilizing acetate tracings. Original tracings were collected at approximately 6-week intervals and analyzed upon study closure. Data were collected via paper Case Report Forms and entered into an electronic database after the patient's final visit. Statistical analysis was performed on datasets exported from the electronic database. Wound measurement data were analyzed using chi-squared. Time to complete closure was analyzed using Kaplan-Meier analysis in conjunction with the log-rank test. Of the 130 potential participants, 8 with protocol violations were excluded from analysis. In the intent-to-treat (ITT) population (N = 122, average age 59 years [range 28-85 years]), the majority were male (74%), Caucasian (81%), and had a plantar ulcer (76%). Mean baseline wound area was 2.3 ± 1.7 cm² (range 0.4-8.9 cm2) and 2.0 ± 1.7 cm² (range 0

  12. VESPRO: An Individual Patient Data Prospective Meta-Analysis of Selective Internal Radiation Therapy Versus Sorafenib for Advanced, Locally Advanced, or Recurrent Hepatocellular Carcinoma of the SARAH and SIRveNIB Trials.

    Science.gov (United States)

    Gebski, Val; Gibbs, Emma; Gandhi, Mihir; Chatellier, Gilles; Dinut, Aurelia; Pereira, Helena; Chow, Pierce Kh; Vilgrain, Valérie

    2017-02-15

    Untreated advanced hepatocellular carcinoma (HCC) has an overall poor prognosis. Currently there are 2 ongoing prospective randomized controlled trials that are evaluating the efficacy and safety of sorafenib and selective internal radiation therapy (SIRT) with yttrium-90 resin microspheres in patients with advanced HCC. The SorAfenib versus Radioembolisation in Advanced Hepatocellular carcinoma (SARAH; 459 patients) trial is being performed in Europe and the SIRt VErsus SorafeNIB (SIRveNIB; 360 patients) trial in the Asia Pacific region. Prospectively combining the results, these trials will not only allow for increased precision to estimate efficacy (in terms of survival), but will also provide increased statistical power for subgroup analyses. To ensure the prospectivity and transparency of the meta-analysis. The sirVEnib and SARAH merge PROject (VESPRO) is an individual, patient-data prospective meta-analysis of the SIRveNIB and SARAH randomized trials. The VESPRO protocol includes prespecified hypotheses, inclusion criteria, and outcome measures. The primary outcome measure is overall survival and secondary outcomes include tumor response rate, progression-free survival, progression in the liver as first event, and disease control in the liver. Pooling of toxicity results will allow for robust safety profiles to be established for both therapies, and provides increased statistical power to investigate treatment effects in key subgroups. Analyses will be performed in the intent-to-treat population stratified by trial. Both studies are expected to demonstrate a survival benefit for SIRT together with a better toxicity profile compared with sorafenib. It is also anticipated that liver progression as the first event would be longer in the intervention compared with the control. As the results of the 2 trials are not yet known, the methodological strength is enhanced, as biases inherent in conventional meta-analyses are avoided. This has the effect of providing

  13. Intraoperative Photodynamic Diagnosis Using Talaporfin Sodium Simultaneously Applied for Photodynamic Therapy against Malignant Glioma: A Prospective Clinical Study

    Directory of Open Access Journals (Sweden)

    Kazuhide Shimizu

    2018-01-01

    Full Text Available ObjectiveThe goal of this study was to demonstrate the feasibility of intraoperative photodynamic diagnosis (PDD of malignant glioma using the fluorescence from talaporfin sodium (TS, which is used simultaneously for photodynamic therapy (PDT.MethodsPatients with suspected primary malignant glioma who were eligible for surgical removal of the tumor and PDT with TS were enrolled in this prospective study. Tissue samples were obtained from the contrast-enhanced (CE region and from the surrounding non-contrast-enhanced (NCE marginal tissue at the boundary between the tumor and normal tissue. The excised samples were set into a fluorescence measurement system, which consisted of a semiconductor laser with a 400-nm wavelength for excitation, and a compact spectrometer for detection, which were applied and received through a custom-made probe consisting of coaxial optical fibers. The fluorescence spectrum was obtained, and peak intensity was calculated. Tumor cellularity was histopathologically analyzed and semi-quantitatively classified into four (0–3 categories.Results86 samples from 17 surgical cases were available for fluorescence measurement and analysis. The fluorescence from TS had a single peak at 664 nm that was easily distinguished from the 400-nm excitation light. Samples from the CE regions showed higher fluorescence intensity than those from the NCE regions (P < 0.001. DAPI staining and fluorescence microscopy confirmed that cells in the CE regions showed red fluorescence in their cytoplasm. The fluorescence was notably strong along vascular endothelium. CE samples from newly diagnosed versus recurrent cases showed no difference in fluorescence intensity (P = 0.26. Among all samples (CE and NCE combined, the fluorescence intensity was very high in those of histopathological class 3, and a trend of increased fluorescence according to histopathological class (P < 0.001 was shown. Differences between class 0 and 3 (P < 0

  14. High incidence of unplanned pregnancy after antiretroviral therapy initiation: findings from a prospective cohort study in South Africa.

    Directory of Open Access Journals (Sweden)

    Sheree R Schwartz

    Full Text Available Increased fertility rates in HIV-infected women receiving antiretroviral therapy (ART have been attributed to improved immunological function; it is unknown to what extent the rise in pregnancy rates is due to unintended pregnancies.Non-pregnant women ages 18-35 from four public-sector ART clinics in Johannesburg, South Africa, were enrolled into a prospective cohort and followed from August 2009-March 2011. Fertility intentions, contraception and pregnancy status were measured longitudinally at participants' routine ART clinic visits.Of the 850 women enrolled, 822 (97% had at least one follow-up visit and contributed 745.2 person-years (PY at-risk for incident pregnancy. Overall, 170 pregnancies were detected in 161 women (incidence rate [IR]: 21.6/100 PY [95% confidence interval (CI: 18.5-25.2]. Of the 170 pregnancies, 105 (62% were unplanned. Unmet need for contraception was 50% higher in women initiating ART in the past year as compared to women on ART>1 year (prevalence ratio 1.5 [95% CI: 1.1-2.0]; by two years post-ART initiation, nearly one quarter of women had at least one unplanned pregnancy. Cumulative incidence of pregnancy was equally high among recent ART initiators and ART experienced participants: 23.9% [95% CI: 16.4-34.1], 15.9% [12.0-20.8], and 21.0% [16.8-26.1] for women on ART 0-1 yr, >1 yr-2 yrs, and >2 yrs respectively (log-rank, p = 0.54. Eight hormonal contraceptive failures were detected [IR: 4.4 [95% CI: 2.2-8.9], 7/8 among women using injectable methods. Overall 47% (80/170 of pregnancies were not carried to term.Rates of unintended pregnancies among women on ART are high, including women recently initiating ART with lower CD4 counts and higher viral loads. A substantial burden of pregnancy loss was observed. Integration of contraceptive services and counselling into ART care is necessary to reduce maternal and child health risks related to mistimed and unwanted pregnancies. Further research into injectable

  15. Excess Mortality Associated With Colistin-Tigecycline Compared With Colistin-Carbapenem Combination Therapy for Extensively Drug-Resistant Acinetobacter baumannii Bacteremia: A Multicenter Prospective Observational Study.

    Science.gov (United States)

    Cheng, Aristine; Chuang, Yu-Chung; Sun, Hsin-Yun; Sheng, Wang-Huei; Yang, Chia-Jui; Liao, Chun-Hsing; Hsueh, Po-Ren; Yang, Jia-Ling; Shen, Ni-Jiin; Wang, Jann-Tay; Hung, Chien-Ching; Chen, Yee-Chun; Chang, Shan-Chwen

    2015-06-01

    Since few therapeutic options exist for extensively drug resistant Acinetobacter baumannii, an emerging threat in ICUs worldwide, and comparative prospective studies of colistin-based combination therapies are lacking, our objective was to compare the outcomes of patients with extensively drug-resistant A. baumannii bacteremia, treated with colistin-carbapenem and colistin-tigecycline combinations. Prospective, observational, multicenter study. Adults with extensively drug-resistant A. baumannii bacteremia were prospectively followed from 2010 to 2013 at three hospitals in Taiwan. Extensively drug-resistant A. baumannii was defined as A. baumannii (genospecies 2) nonsusceptible to all drug classes except for colistin and tigecycline, and standard combination therapy as use of parenteral colistin-carbapenem or colistin-tigecycline for at least 48 hours after onset of bacteremia. Primary outcome measure was 14-day mortality. Of the 176 episodes of extensively drug-resistant A. baumannii bacteremia evaluated, 55 patients with a median (interquartile range) age of 62 years (44-79 yr) and Sequential Organ Failure Assessment score of 9 (5-13) points received standard combination therapy: colistin-tigecycline in 29 patients and colistin-carbapenem in 26. Crude 14-day and in-hospital mortality rates for patients receiving colistin-tigecycline versus patients receiving colistin-carbapenem were 35% versus 15% (p=0.105) and 69% versus 50% (p=0.152), respectively. Breakthrough extensively drug-resistant A. baumannii bacteremia under steady state concentrations of combination therapy for colistin-tigecycline group was 18% and for colistin-carbapenem group was 0% (p=0.059). Eleven patients (20.0%) developed nephrotoxicity. After adjusting for age, sex, comorbidity, initial disease severity, loading colistin dose, polymicrobial infection, and primary infection site, excess 14-day mortality was associated with the use of colistin-tigecycline in the subgroup with tigecycline

  16. Prenatal Metformin Therapy Attenuates Hypertension of Developmental Origin in Male Adult Offspring Exposed to Maternal High-Fructose and Post-Weaning High-Fat Diets

    Directory of Open Access Journals (Sweden)

    You-Lin Tain

    2018-04-01

    Full Text Available Widespread consumption of a Western diet, comprised of highly refined carbohydrates and fat, may play a role in the epidemic of hypertension. Hypertension can take origin from early life. Metformin is the preferred treatment for type 2 diabetes. We examined whether prenatal metformin therapy can prevent maternal high-fructose plus post-weaning high-fat diets-induced hypertension of developmental origins via regulation of nutrient sensing signals, uric acid, oxidative stress, and the nitric oxide (NO pathway. Gestating Sprague–Dawley rats received regular chow (ND or chow supplemented with 60% fructose diet (HFR throughout pregnancy and lactation. Male offspring were onto either the ND or high-fat diet (HFA from weaning to 12 weeks of age. A total of 40 male offspring were assigned to five groups (n = 8/group: ND/ND, HFR/ND, ND/HFA, HFR/HFA, and HFR/HFA+metformin. Metformin (500 mg/kg/day was administered via gastric gavage for three weeks during the pregnancy period. Combined maternal HFR plus post-weaning HFA induced hypertension in male adult offspring, which prenatal metformin therapy prevented. The protective effects of prenatal metformin therapy on HFR/HFA-induced hypertension, including downregulation of the renin-angiotensin system, decrease in uric acid level, and reduction of oxidative stress. Our results highlighted that the programming effects of metformin administered prenatally might be different from those reported in adults, and that deserves further elucidation.

  17. The effectiveness of low laser therapy in subacromial impingement syndrome: a randomized placebo controlled double-blind prospective study

    Directory of Open Access Journals (Sweden)

    Sebnem Koldas Dogan

    2010-01-01

    Full Text Available OBJECTIVES: Conflicting results were reported about the effectiveness of Low level laser therapy on musculoskeletal disorders. The aim of this study was to investigate the effectiveness of 850-nm gallium arsenide aluminum (Ga-As-Al laser therapy on pain, range of motion and disability in subacromial impingement syndrome. METHODS: A total of 52 patients (33 females and 19 males with a mean age of 53.59±11.34 years with subacromial impingement syndrome were included. The patients were randomly assigned into two groups. Group I (n = 30, laser group received laser therapy (5 joule/cm² at each point over maximum 5-6 painful points for 1 minute. Group II (n = 22, placebo laser group received placebo laser therapy. Initially cold pack (10 minutes was applied to all of the patients. Also patients were given an exercise program including range of motion, stretching and progressive resistive exercises. The therapy program was applied 5 times a week for 14 sessions. Pain severity was assessed by using visual analogue scale. Range of motion was measured by goniometer. Disability was evaluated by using Shoulder Pain and Disability Index. RESULTS: In group I, statistically significant improvements in pain severity, range of motion except internal and external rotation and SPADI scores were observed compared to baseline scores after the therapy (p0.05. CONCLUSIONS: The Low level laser therapy seems to have no superiority over placebo laser therapy in reducing pain severity, range of motion and functional disability.

  18. Tuberculosis associated mortality in a prospective cohort in Sub Saharan Africa: Association with HIV and antiretroviral therapy

    Directory of Open Access Journals (Sweden)

    Tumaini J. Nagu

    2017-03-01

    CONCLUSION: Meticulously planned and supervised antiretroviral therapy reduces mortality among TB/HIV patients. Among patients with TB/HIV naïve of ART, withholding ART until the third week of anti-tuberculosis therapy will likely reduce TB mortality in Tanzania. Patients on ART and later develop tuberculosis should be closely monitored.

  19. Faster Wound Healing With Topical Negative Pressure Therapy in Difficult-to-Heal Wounds: A Prospective Randomized Controlled Trial

    NARCIS (Netherlands)

    Laat, E.H. de; Boogaard, M.H.W.A. van den; Spauwen, P.H.M.; Kuppevelt, D.H. van; Goor, H. van; Schoonhoven, L.

    2011-01-01

    OBJECTIVE: : A randomized clinical trial was conducted to determine the effectiveness and safety of topical negative pressure therapy in patients with difficult-to-heal wounds. METHODS: : A total of 24 patients were randomly assigned to either treatment with topical negative pressure therapy or

  20. Predictors of outcome after 6 and 12 months following anthroposophic therapy for adult outpatients with chronic disease: a secondary analysis from a prospective observational study

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    Willich Stefan N

    2010-08-01

    Full Text Available Abstract Background Anthroposophic medicine is a physician-provided complementary therapy system involving counselling, artistic and physical therapies, and special medications. The purpose of this analysis was to identify predictors of symptom improvement in patients receiving anthroposophic treatment for chronic diseases. Methods 913 adult outpatients from Germany participated in a prospective cohort study. Patients were starting anthroposophic treatment for mental (30.4% of patients, n = 278/913, musculoskeletal (20.2%, neurological (7.6%, genitourinary (7.4% or respiratory disorders (7.2% or other chronic indications. Stepwise multiple linear regression analysis was performed with the improvement of Symptom Score (patients' assessment, 0: not present, 10: worst possible after 6 and 12 months as dependent variables. 61 independent variables pertaining to socio-demographics, life style, disease status, co-morbidity, health status (SF-36, depression, and therapy factors were analysed. Results Compared to baseline, Symptom Score improved by average 2.53 points (95% confidence interval 2.39-2.68, p Conclusion In adult outpatients receiving anthroposophic treatment for chronic diseases, symptom improvement after 6 and 12 months was predicted by baseline symptoms, health status, disease duration, education, and therapy goal. Other variables were not associated with the outcome. This secondary predictor analysis of data from a pre-post study does not allow for causal conclusions; the results are hypothesis generating and need verification in subsequent studies.

  1. A new strategy for healthcare-associated pneumonia: a 2-year prospective multicenter cohort study using risk factors for multidrug-resistant pathogens to select initial empiric therapy.

    Science.gov (United States)

    Maruyama, Takaya; Fujisawa, Takao; Okuno, Masataka; Toyoshima, Hirokazu; Tsutsui, Kiyoyuki; Maeda, Hikaru; Yuda, Hisamichi; Yoshida, Masamichi; Kobayashi, Hiroyasu; Taguchi, Osamu; Gabazza, Esteban C; Takei, Yoshiyuki; Miyashita, Naoyuki; Ihara, Toshiaki; Brito, Veronica; Niederman, Michael S

    2013-11-01

    Optimal empiric therapy for hospitalized patients with healthcare-associated pneumonia (HCAP) is uncertain. We prospectively applied a therapeutic algorithm, based on the presence of risk factors for multidrug-resistant (MDR) pathogens in a multicenter cohort study of 445 pneumonia patients, including both community-acquired pneumonia (CAP; n = 124) and HCAP (n = 321). MDR pathogens were more common (15.3% vs 0.8%, P risk factors, one of which was severity of illness (n = 170), vs HCAP patients with 0-1 risk factor (n = 151) had a significantly higher frequency of MDR pathogens (27.1% vs 2%, P risk factor, mortality was lower than with ≥2 MDR risk factors (8.6% vs 18.2%, P = .012). In multivariate analysis, initial treatment failure, but not inappropriate empiric antibiotic therapy, was a mortality risk factor (odds ratio, 72.0). Basing empiric HCAP therapy on its severity and the presence of risk factors for MDR pathogens is a potentially useful approach that achieves good outcomes without excessive use of broad-spectrum antibiotic therapy. Japan Medical Association Center for Clinical Trials, JMA-IIA00054.

  2. Prospective observer and software-based assessment of magnetic resonance imaging quality in head and neck cancer: Should standard positioning and immobilization be required for radiation therapy applications?

    Science.gov (United States)

    Ding, Yao; Mohamed, Abdallah S R; Yang, Jinzhong; Colen, Rivka R; Frank, Steven J; Wang, Jihong; Wassal, Eslam Y; Wang, Wenjie; Kantor, Michael E; Balter, Peter A; Rosenthal, David I; Lai, Stephen Y; Hazle, John D; Fuller, Clifton D

    2015-01-01

    The purpose of this study was to investigate the potential of a head and neck magnetic resonance simulation and immobilization protocol on reducing motion-induced artifacts and improving positional variance for radiation therapy applications. Two groups (group 1, 17 patients; group 2, 14 patients) of patients with head and neck cancer were included under a prospective, institutional review board-approved protocol and signed informed consent. A 3.0-T magnetic resonance imaging (MRI) scanner was used for anatomic and dynamic contrast-enhanced acquisitions with standard diagnostic MRI setup for group 1 and radiation therapy immobilization devices for group 2 patients. The impact of magnetic resonance simulation/immobilization was evaluated qualitatively by 2 observers in terms of motion artifacts and positional reproducibility and quantitatively using 3-dimensional deformable registration to track intrascan maximum motion displacement of voxels inside 7 manually segmented regions of interest. The image quality of group 2 (29 examinations) was significantly better than that of group 1 (50 examinations) as rated by both observers in terms of motion minimization and imaging reproducibility (P quality of head and neck MRI in terms of motion-related artifacts and positional reproducibility was greatly improved by use of radiation therapy immobilization devices. Consequently, immobilization with external and intraoral fixation in MRI examinations is required for radiation therapy application. Copyright © 2015 American Society for Radiation Oncology. Published by Elsevier Inc. All rights reserved.

  3. Tadalafil once daily and extracorporeal shock wave therapy in the management of patients with Peyronie's disease and erectile dysfunction: results from a prospective randomized trial.

    Science.gov (United States)

    Palmieri, A; Imbimbo, C; Creta, M; Verze, P; Fusco, F; Mirone, V

    2012-04-01

    Extracorporeal shock wave therapy improves erectile function in patients with Peyronie's disease. However, erectile dysfunction still persists in many cases. We aimed to investigate the effects of extracorporeal shock wave therapy plus tadalafil 5 mg once daily in the management of patients with Peyronie's disease and erectile dysfunction not previously treated. One hundred patients were enrolled in a prospective, randomized, controlled study. Patients were randomly allocated to receive either extracorporeal shock wave therapy alone for 4 weeks (n = 50) or extracorporeal shock wave therapy plus tadalafil 5 mg once daily for 4 weeks (n = 50). Main outcome measures were: erectile function (evaluated through the shortened version of the International Index of Erectile Function), pain during erection (evaluated through a Visual Analog Scale), plaque size, penile curvature and quality of life (evaluated through an internal questionnaire). Follow-up evaluations were performed after 12 and 24 weeks. In both groups, at 12 weeks follow-up, mean Visual Analog Scale score, mean International Index of Erectile Function score and mean quality of life score ameliorated significantly while mean plaque size and mean curvature degree were unchanged. Intergroup analysis revealed a significantly higher mean International Index of Erectile Function score and quality of life score in patients receiving the combination. After 24 weeks, intergroup analysis revealed a significantly higher mean International Index of Erectile Function score and mean quality of life score in patients that received extracorporeal shock wave therapy plus tadalafil. In conclusion extracorporeal shock wave therapy plus tadalafil 5 mg once daily may represent a valid conservative strategy for the management of patients with Peyronie's disease and erectile dysfunction. © 2011 The Authors. International Journal of Andrology © 2011 European Academy of Andrology.

  4. Prospective evaluation of early treatment outcome in patients with meningiomas treated with particle therapy based on target volume definition with MRI and {sup 68}Ga-DOTATOC-PET

    Energy Technology Data Exchange (ETDEWEB)

    Combs, Stephanie E.; Welzel, Thomas; Habermehl, Daniel; Rieken, Stefan; Dittmar, Jan-Oliver; Kessel, Kerstin; Debus, Juergen [Univ. Hospital of Heidelberg, Dept. of Radiation Oncology, Heidelberg (Germany)], e-mail: Stephanie.Combs@med.uni-heidelberg.de; Jaekel, Oliver [Heidelberg Ion Therapy Center (HIT), Heidelberg (Germany); Haberkorn, Uwe [Univ. Hospital of Heidelberg, Dept. of Nuclear Medicine, Heidelberg (Germany)

    2013-04-15

    Purpose: To evaluate early treatment results and toxicity in patients with meningiomas treated with particle therapy. Material and methods: Seventy patients with meningiomas were treated with protons (n = 38) or carbon ion radiotherapy (n = 26). Median age was 49 years. Median age at treatment was 55 years, 24 were male (34%), and 46 were female (66%). Histology was benign meningioma in 26 patients (37%), atypical in 23 patients (33%) and anaplastic in four patients (6%). In 17 patients (24%) with skull base meningiomas diagnosis was based on the typical appearance of a meningioma. For benign meningiomas, total doses of 52.2-57.6 GyE were applied with protons. For high-grade lesions, the boost volume was 18 GyE carbon ions, with a median dose of 50 GyE applied as highly conformal radiation therapy. Nineteen patients were treated as re-irradiation. Treatment planning with MRI and 68-Ga-DOTATOC-PET was evaluated. Results: Very low rates of side effects developed, including headaches, nausea and dizziness. No severe treatment-related toxicity was observed. Local control for benign meningiomas was 100%. Five of 27 patients (19%) developed tumor recurrence during follow-up. Of these, four patients had been treated as re-irradiation for recurrent high-risk meningiomas. Actuarial local control after re-irradiation of high-risk meningiomas was therefore 67% at six and 12 months. In patients treated with primary radiotherapy, only one of 13 patients (8%) developed tumor recurrence 17 months after radiation therapy (photon and carbon ion boost). Conclusion: Continuous prospective follow-up and development of novel study concepts are required to fully exploit the long-term clinical data after particle therapy for meningiomas. To date, it may be concluded that when proton therapy is available, meningioma patients can be offered a treatment at least comparable to high-end photon therapy.

  5. Empirical and targeted therapy of candidemia with fluconazole versus echinocandins: a propensity score-derived analysis of a population-based, multicentre prospective cohort.

    Science.gov (United States)

    López-Cortés, L E; Almirante, B; Cuenca-Estrella, M; Garnacho-Montero, J; Padilla, B; Puig-Asensio, M; Ruiz-Camps, I; Rodríguez-Baño, J

    2016-08-01

    We compared the clinical efficacy of fluconazole and echinocandins in the treatment of candidemia in real practice. The CANDIPOP study is a prospective, population-based cohort study on candidemia carried out between May 2010 and April 2011 in 29 Spanish hospitals. Using strict inclusion criteria, we separately compared the impact of empirical and targeted therapy with fluconazole or echinocandins on 30-day mortality. Cox regression, including a propensity score (PS) for receiving echinocandins, stratified analysis on the PS quartiles and PS-based matched analyses, were performed. The empirical and targeted therapy cohorts comprised 316 and 421 cases, respectively; 30-day mortality was 18.7% with fluconazole and 33.9% with echinocandins (p 0.02) in the empirical therapy group and 19.8% with fluconazole and 27.7% with echinocandins (p 0.06) in the targeted therapy group. Multivariate Cox regression analysis including PS showed that empirical therapy with fluconazole was associated with better prognosis (adjusted hazard ratio 0.38; 95% confidence interval 0.17-0.81; p 0.01); no differences were found within each PS quartile or in cases matched according to PS. Targeted therapy with fluconazole did not show a significant association with mortality in the Cox regression analysis (adjusted hazard ratio 0.77; 95% confidence interval 0.41-1.46; p 0.63), in the PS quartiles or in PS-matched cases. The results were similar among patients with severe sepsis and septic shock. Empirical or targeted treatment with fluconazole was not associated with increased 30-day mortality compared to echinocandins among adults with candidemia. Copyright © 2016 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

  6. Evaluation of multiple image-based modalities for image-guided radiation therapy (IGRT) of prostate carcinoma: A prospective study

    International Nuclear Information System (INIS)

    Mayyas, Essa; Chetty, Indrin J.; Chetvertkov, Mikhail; Wen, Ning; Neicu, Toni; Nurushev, Teamor; Ren Lei; Pradhan, Deepak; Movsas, Benjamin; Elshaikh, Mohamed A.; Lu Mei; Stricker, Hans

    2013-01-01

    Purpose: Setup errors and prostate intrafraction motion are main sources of localization uncertainty in prostate cancer radiation therapy. This study evaluates four different imaging modalities 3D ultrasound (US), kV planar images, cone-beam computed tomography (CBCT), and implanted electromagnetic transponders (Calypso/Varian) to assess inter- and intrafraction localization errors during intensity-modulated radiation therapy based treatment of prostate cancer. Methods: Twenty-seven prostate cancer patients were enrolled in a prospective IRB-approved study and treated to a total dose of 75.6 Gy (1.8 Gy/fraction). Overall, 1100 fractions were evaluated. For each fraction, treatment targets were localized using US, kV planar images, and CBCT in a sequence defined to determine setup offsets relative to the patient skin tattoos, intermodality differences, and residual errors for each patient and patient cohort. Planning margins, following van Herk's formalism, were estimated based on error distributions. Calypso-based localization was not available for the first eight patients, therefore centroid positions of implanted gold-seed markers imaged prior to and immediately following treatment were used as a motion surrogate during treatment. For the remaining 19 patients, Calypso transponders were used to assess prostate intrafraction motion. Results: The means (μ), and standard deviations (SD) of the systematic (Σ) and random errors (σ) of interfraction prostate shifts (relative to initial skin tattoo positioning), as evaluated using CBCT, kV, and US, averaged over all patients and fractions, were: [μ CBCT = (−1.2, 0.2, 1.1) mm, Σ CBCT = (3.0, 1.4, 2.4) mm, σ CBCT = (3.2, 2.2, 2.5) mm], [μ kV = (−2.9, −0.4, 0.5) mm, Σ kV = (3.4, 3.1, 2.6) mm, σ kV = (2.9, 2.0, 2.4) mm], and [μ US = (−3.6, −1.4, 0.0) mm, Σ US = (3.3, 3.5, 2.8) mm, σ US = (4.1, 3.8, 3.6) mm], in the anterior–posterior (A/P), superior–inferior (S/I), and the left–right (L

  7. Evaluation of multiple image-based modalities for image-guided radiation therapy (IGRT) of prostate carcinoma: A prospective study

    Energy Technology Data Exchange (ETDEWEB)

    Mayyas, Essa; Chetty, Indrin J.; Chetvertkov, Mikhail; Wen, Ning; Neicu, Toni; Nurushev, Teamor; Ren Lei; Pradhan, Deepak; Movsas, Benjamin; Elshaikh, Mohamed A. [Department of Radiation Oncology, Henry Ford Health System, 2799 West Grand Boulevard, Detroit, Michigan 48202 (United States); Lu Mei [Department of Public Health Sciences, Henry Ford Health System, 2799 West Grand Boulevard, Detroit Michigan 48202 (United States); Stricker, Hans [Department of Urology, Henry Ford Health System, 2799 West Grand Boulevard, Detroit Michigan 48202 (United States)

    2013-04-15

    Purpose: Setup errors and prostate intrafraction motion are main sources of localization uncertainty in prostate cancer radiation therapy. This study evaluates four different imaging modalities 3D ultrasound (US), kV planar images, cone-beam computed tomography (CBCT), and implanted electromagnetic transponders (Calypso/Varian) to assess inter- and intrafraction localization errors during intensity-modulated radiation therapy based treatment of prostate cancer. Methods: Twenty-seven prostate cancer patients were enrolled in a prospective IRB-approved study and treated to a total dose of 75.6 Gy (1.8 Gy/fraction). Overall, 1100 fractions were evaluated. For each fraction, treatment targets were localized using US, kV planar images, and CBCT in a sequence defined to determine setup offsets relative to the patient skin tattoos, intermodality differences, and residual errors for each patient and patient cohort. Planning margins, following van Herk's formalism, were estimated based on error distributions. Calypso-based localization was not available for the first eight patients, therefore centroid positions of implanted gold-seed markers imaged prior to and immediately following treatment were used as a motion surrogate during treatment. For the remaining 19 patients, Calypso transponders were used to assess prostate intrafraction motion. Results: The means ({mu}), and standard deviations (SD) of the systematic ({Sigma}) and random errors ({sigma}) of interfraction prostate shifts (relative to initial skin tattoo positioning), as evaluated using CBCT, kV, and US, averaged over all patients and fractions, were: [{mu}{sub CBCT}= (-1.2, 0.2, 1.1) mm, {Sigma}{sub CBCT}= (3.0, 1.4, 2.4) mm, {sigma}{sub CBCT}= (3.2, 2.2, 2.5) mm], [{mu}{sub kV}= (-2.9, -0.4, 0.5) mm, {Sigma}{sub kV}= (3.4, 3.1, 2.6) mm, {sigma}{sub kV}= (2.9, 2.0, 2.4) mm], and [{mu}{sub US}= (-3.6, -1.4, 0.0) mm, {Sigma}{sub US}= (3.3, 3.5, 2.8) mm, {sigma}{sub US}= (4.1, 3.8, 3.6) mm], in the anterior

  8. Detailed analysis of the clinical effects of cell therapy for thoracolumbar spinal cord injury: an original study

    Directory of Open Access Journals (Sweden)

    Sharma A

    2013-07-01

    Full Text Available Alok Sharma,1 Nandini Gokulchandran,1 Hemangi Sane,2 Prerna Badhe,1 Pooja Kulkarni,2 Mamta Lohia,3 Anjana Nagrajan,3 Nancy Thomas3 1Department of Medical Services and Clinical Research, 2Department of Research and Development, 3Department of Neurorehabilitation, NeuroGen Brain and Spine Institute, Surana Sethia Hospital and Research Centre, Chembur, Mumbai, India Background: Cell therapy is amongst the most promising treatment strategies in spinal cord injury (SCI because it focuses on repair. There are many published animal studies and a few human trials showing remarkable results with various cell types. The level of SCI determines whether paraplegia or quadriplegia is present, and greatly influences recovery. The purpose of this study was to determine the significance of the clinical effects and long-term safety of intrathecal administration of autologous bone marrow-derived mononuclear cells, along with changes in functional independence and quality of life in patients with thoracolumbar SCI. Methods: We undertook a retrospective analysis of a clinical study in which a nonrandomized sample of 110 patients with thoracolumbar SCI underwent autologous bone marrow-derived mononuclear cell transplantation intrathecally and subsequent neurorehabilitation, with a mean follow-up of 2 years ± 1 month. Changes on any parameters were recorded at follow-up. The data were analyzed using the Wilcoxon's signed-rank test and McNemar's test. Functional Independence Measure and American Spinal Injury Association (ASIA scores were recorded, and a detailed neurological assessment was performed. Results: Overall improvement was seen in 91% of patients, including reduction in spasticity, partial sensory recovery, and improvement in trunk control, postural hypotension, bladder management, mobility, activities of daily living, and functional independence. A significant association of these symptomatic improvements with the cell therapy intervention was established

  9. The prevalence of microcystic macular changes on optical coherence tomography of the macular region in optic nerve atrophy of non-neuritis origin : a prospective study

    NARCIS (Netherlands)

    Pott, J. W. R.; de Vries-Knoppert, W. A. E. J.; Petzold, A.

    2015-01-01

    Background Microcystic macular changes, also called microcystic macular oedema, have recently been reported in patients with multiple sclerosis, particularly after optic neuritis. But it has since emerged that the finding is not specific for optic neuritis. This study was designed to prospectively

  10. Sexual functioning in women after mastectomy versus breast conserving therapy for early-stage breast cancer: A prospective controlled study

    NARCIS (Netherlands)

    Aerts, L.; Christiaens, M. R.; Enzlin, P.; Neven, P.; Amant, F.

    2014-01-01

    Introduction: Breast cancer (BC) and/or its treatments may affect sexual functioning based on physiological and psychosocial mechanisms. The aim of this study was to prospectively investigate sexual adjustment of BC patients during a follow-up period of one year after mastectomy (ME) or breast

  11. Tri-length laser therapy associated to tecar therapy in the treatment of low-back pain in adults: a preliminary report of a prospective case series.

    Science.gov (United States)

    Osti, Raffaella; Pari, Carlotta; Salvatori, Giada; Massari, Leo

    2015-01-01

    Low-back pain is very frequent, especially in active adult population. There are several different orthopaedic condition that can cause low-back pain, and the pain worsen the quality of life significantly. The treatments vary from drugs, physical therapies, kinesiology, local infiltrations, and so on. Laser therapy has an important role in the treatment of the inflammatory causes of pain, with several studies that demonstrate the efficacy of low and high energy laser therapy in the treatment of low-back pain. Sixty-six consecutive patients with low-back pain with or without leg pain were treated using a combination of Tri-length laser I-Triax® (Mectronic Medicale, Bergamo, Italy) and Pharon® tecar therapy (Mectronic Medicale, Bergamo, Italy). The patients were treated three times a week, every other day, for a total of 10 sessions. Clinical results were evaluated using visual analogic scale for individual pain (0 to 10) and the Oswestry disability scale (ODS). Tests started before the beginning of therapies and 8 weeks after the end of the therapies. Visual analogic scale (VAS) score significantly improved from an average value of 8.1 ± 1.58 pre-treatment to an average value 8-weeks post-treatment of 2.63 ± 2.74 (P treatment average value of 53.0 ± 13.0 to a post-treatment average value of 23.5 ± 19.8 (P low-back pain and leg pain (respectively, VAS from 8.66 ± 1.58 to 2.86 ± 2.94 and ODS from 57.8 ± 15.5 to 23.7 ± 19.5). Low-back pain, associated or not with leg pain, is a very common clinical situation. The treatments of this condition are different, and an important role can be given to the laser therapy. The conclusion of this study is that the association between laser therapy iLux-Triax® and tecar therapy Pharon® in the treatment of low-back pain, with or without leg pain, can significantly reduce pain and improve the quality of life in patients with degenerative and inflammatory problems.

  12. The effectiveness of low laser therapy in subacromial impingement syndrome: a randomized placebo controlled double‐blind prospective study

    Science.gov (United States)

    Dogan, Sebnem Koldas; AY, Saime; Evcik, Deniz

    2010-01-01

    OBJECTIVES: Conflicting results were reported about the effectiveness of Low level laser therapy on musculoskeletal disorders. The aim of this study was to investigate the effectiveness of 850‐nm gallium arsenide aluminum (Ga‐As‐Al) laser therapy on pain, range of motion and disability in subacromial impingement syndrome. METHODS: A total of 52 patients (33 females and 19 males with a mean age of 53.59±11.34 years) with subacromial impingement syndrome were included. The patients were randomly assigned into two groups. Group I (n = 30, laser group) received laser therapy (5 joule/cm2 at each point over maximum 5‐6 painful points for 1 minute). Group II (n = 22, placebo laser group) received placebo laser therapy. Initially cold pack (10 minutes) was applied to all of the patients. Also patients were given an exercise program including range of motion, stretching and progressive resistive exercises. The therapy program was applied 5 times a week for 14 sessions. Pain severity was assessed by using visual analogue scale. Range of motion was measured by goniometer. Disability was evaluated by using Shoulder Pain and Disability Index. RESULTS: In group I, statistically significant improvements in pain severity, range of motion except internal and external rotation and SPADI scores were observed compared to baseline scores after the therapy (p0.05). CONCLUSIONS: The Low level laser therapy seems to have no superiority over placebo laser therapy in reducing pain severity, range of motion and functional disability. PMID:21120304

  13. A Prospective, Randomized Trial of Intravenous Prochlorperazine Versus Subcutaneous Sumatriptan in Acute Migraine Therapy in the Emergency Department(Preprint)

    Science.gov (United States)

    2009-01-01

    migraine abortive therapy.1-5 It is often given in conjunction with diphenhydramine to minimize the risk of akathisia.6 Subcutaneously injected...subcutaneous sumatriptan (Imitrex, GlaxoSmithKline, Philadelphia, PA) in migraine abortive therapy in ED patients. The primary outcome measure was the mean...to our knowledge Prochlorperazine was superior to sumatriptan in relieving pain, whereas adverse effects (nausea and sedation) were similar. How this

  14. Growth factor-based therapies provide additional benefit beyond physical therapy in resistant elbow tendinopathy: a prospective, single-blind, randomised trial of autologous blood injections versus platelet-rich plasma injections.

    Science.gov (United States)

    Creaney, Leon; Wallace, Andrew; Curtis, Mark; Connell, David

    2011-09-01

    Growth factor technologies are increasingly used to enhance healing in musculoskeletal injuries, particularly in sports medicine. Two such products; platelet-rich plasma (PRP) and autologous blood, have a growing body of supporting evidence. No previous trial has directly compared the efficacy of these two methods. Growth factor administration improves tissue regeneration in patients who have failed to respond to conservative therapy. A prospective, double-blind, randomised trial. Elbow tendinopathy patients who had failed conservative physical therapy were divided into two patient groups: PRP injection (N=80) and autologous blood injection (ABI) (N=70). Each patient received two injections at 0 and 1 month. Patient-related tennis elbow evaluation (PRTEE) was recorded by a blinded investigator at 0, 1, 3 and 6 months. The main outcome measure was PRTEE, a validated composite outcome for pain, activities of daily living and physical function, utilising a 0-100 scale. At 6 months the authors observed a 66% success rate in the PRP group versus 72% in the ABI group, p=NS. There was a higher rate of conversion to surgery in the ABI group (20%) versus the PRP group (10%). In patients who are resistant to first-line physical therapy such as eccentric loading, ABI or PRP injections are useful second-line therapies to improve clinical outcomes. In this study, up to seven out of 10 additional patients in this difficult to treat cohort benefit from a surgery-sparing intervention.

  15. EFFICIENCY OF ANTI-INFLAMMATORY THERAPY IN PATIENTS WITH ANKYLOSING SPONDYLITIS ACCORDING TO THE RESULTS OF A PROSPECTIVE FOLLOW-UP STUDY

    Directory of Open Access Journals (Sweden)

    T. A. Raskina

    2016-01-01

    Full Text Available In accordance  with the Ankylosing Spondylitis Assessments (ASAS International Working Group guidelines, tumor necrosis factor-α  inhibitors are recommended in patients with ankylosing spondylitis (AS refractory to at least two nonsteroidal  anti-inflammatory drugs (NSAIDs  and in those with the peripheral form of the disease. Previous investigations suggest that when long used, infliximab (INF shows a steady-state efficacy in the vast majority of patients with active AS. Works evaluating the efficiency of combined therapy using NSAIDs and INF are scarce. Objective: to evaluate the efficiency of therapy with NSAIDs and INF in patients with AS from the results of a prospective study.Subjects and methods. A total of 72 men with a valid diagnosis of AS were followed up. All the patients were allocated to two groups according to the option of basic therapy: 1 29 patients received combined therapy with INF and NSAIDs; 2 43 had NSAID monotherapy. Clinical, laboratory, and instrumental  examinations were performed every 12 months. Results and discussion. At 12 months of INF therapy, there were significant reductions in the values of BASDAI, BASFI, back pain, fatigue, and patient-rated global activity assessment. High BASDAI values remained in only 10 patients.At 24-month follow-up, the above measures did not significantly change as compared to the results obtained at 12 months and remained stable at 36 months. At 12 months of NSAID therapy, there were significant reductions in the values of BASDAI, back pain, fatigue, and patient-rated global activity assessment (p < 0.05. The reduction in BASFI values was insignificant. At 24 months of treatment all the measures versus those obtained after 12 months did not significantly change, except pain in the examined region of the spine, which became significantly severer than that at the 12-month follow-up. These results were also preserved at 36 months. There were more patients achieving 20% and 40

  16. Effect of Helicobacter pylori eradication and antisecretory maintenance therapy on peptic ulcer recurrence in cirrhotic patients: a prospective, cohort 2-year follow-up study.

    Science.gov (United States)

    Tzathas, Charalambos; Triantafyllou, Konstantinos; Mallas, Elias; Triantafyllou, George; Ladas, Spiros D

    2008-07-01

    The role of Helicobacter pylori eradication to cure peptic ulcer disease in patients with cirrhosis is not clear. To investigate the course of peptic ulcer disease in cirrhotics, first after healing with either H. pylori eradication or omeprazole therapy and second while on omeprazole maintenance therapy after recurrence. Prospective cohort study in a tertiary-care hospital in Greece. Out of 365 consecutive cirrhotic patients who underwent endoscopy, 67 had peptic ulcer and 30 were enrolled. H. pylori positive patients received eradication therapy and H. pylori negative patients received omeprazole treatment. Follow-up endoscopies were performed at 12 and 24 months or when symptoms recurred. Patients with ulcer recurrence were treated with omeprazole maintenance therapy. The main outcome measurement of the study was peptic ulcer relapse rate during follow-up. Twenty-eight patients with healed ulcers were followed for up to 2 years. During follow-up, ulcer relapsed in 17 patients (8/18 H. pylori positive and 9/10 H. pylori negative at study entry, P=0.041), including 2 patients who died from ulcer bleeding. No further ulcer relapse was observed in the remaining 15 patients who received omeprazole maintenance therapy for the rest of follow-up. H. pylori negative status (P=0.002) and severity of cirrhosis (P=0.015) at study entry were independently related to shorter peptic ulcer relapse-free time. H. pylori eradication does not protect all cirrhotics from ulcer recurrence and the majority of ulcers recur in H. pylori negative patients. Therefore, omeprazole maintenance treatment is mandatory, irrespectively of H. pylori status.

  17. Prospective analysis of tiopronin in prevention of sorafenib and antiviral therapy inducing liver toxicity in advanced hepatitis B virus-related hepatocellular carcinoma.

    Science.gov (United States)

    Li, Jianhua; Qiu, Xinguang; Guo, Wenzhi; Yan, Bing; Zhang, Shuijun

    2015-10-01

    Hepatotoxicity induced by sorafenib and antiviral therapy is a limitation for its continuation treatment for patients with advanced hepatitis B virus-related hepatocellular carcinoma (HCC). This prospective study determined the efficacy of tiopronin in hepatotoxicity prevention of HBV-related HCC treatment. Eighty-two patients (median age, 50 years; 71 % male) of advanced HCC treated with sorafenib and antiviral therapy were included, of whom 40 were given the supplementation of tiopronin. The primary endpoint was liver function which was checked before the treatment and every week during the therapy. Besides, course discontinuations, dose reductions, HBV DNA levels and treatment efficacy were evaluated. Patient characteristics and liver function were comparable (p > 0.05). The proportion of abnormal liver function was significantly lower in tiopronin group than in control group including alanine transaminase (ALT, p = 0.035), aspartate aminotransferase (AST, p = 0.041), total bilirubin (TBIL, p = 0.021) and albumin (ALB, p = 0.001). Rates of course discontinuations (p = 0.024) and dose reductions (p = 0.046) were significantly lower in tiopronin groups, and disease control rate (p = 0.036) was higher. No difference was found in HBV DNA level. Multivariate regression analysis showed that sorafenib (OR 7.837; 95 % CI 3.845-15.333; p = 0.004), antiviral therapy (OR 3.871; 95 % CI 1.572-9.569; p = 0.044) and hepatoprotective drug (OR 3.007; 95 % CI 1.321-6.308; p = 0.046) played important roles in clinical outcome. Tiopronin tends to prevent the HCC patients from the treatment-induced hepatotoxicity, enhance patients' tolerance to sorafenib and antiviral therapy and even improve the cancer treatment efficacy.

  18. Antiviral therapy improves post-hepatectomy survival in patients with hepatitis B virus-related hepatocellular carcinoma: a prospective-retrospective study.

    Science.gov (United States)

    Chong, C C N; Wong, G L H; Wong, V W S; Ip, P C T; Cheung, Y S; Wong, J; Lee, K F; Lai, P B S; Chan, H L Y

    2015-01-01

    The effect of antiviral therapy on the post-hepatectomy long-term survival in patients with hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC) remains uncertain. To evaluate the effect of antiviral therapy on post-hepatectomy survival and recurrence in patients with HBV-related HCC. This was a prospective-retrospective study of a total of 404 patients who underwent hepatectomy for HBV-related HCC in a tertiary academic hospital. Data on patient and tumour characteristics, tumour recurrence, treatment for recurrence and survival were compared between antiviral and no antiviral groups. Patient's and tumour characteristics were comparable between the two groups, except a higher proportion of patients with cirrhosis in the antiviral group. With a mean follow-up time of 52.4 months, antiviral group had a better 5-year overall survival (66.7% vs. 56.0%, P = 0.001) while there was no significant difference in the 5-year disease-free survival (44.7% vs. 38.1%, P = 0.166). Use of antiviral therapy was associated with better liver function reserve at the time of recurrence and a greater proportion of patients could receive curative treatment for recurrence (38.5% vs. 24.3%, P = 0.041). There was no significant different in the hazard ratios of patients who started antiviral therapy before or after operation (P = 0.054). Use of antiviral therapy improves the long-term post-hepatectomy survival in patients with HBV-related HCC. With a better liver function reserve at the time of recurrence, a greater proportion of patients in antiviral group could receive curative treatment for recurrence. © 2014 John Wiley & Sons Ltd.

  19. A prospective randomized cohort study evaluating 3 weeks vs 6 weeks of oral antibiotic treatment in the setting of "maximal medical therapy" for chronic rhinosinusitis.

    Science.gov (United States)

    Sreenath, Satyan B; Taylor, Robert J; Miller, Justin D; Ambrose, Emily C; Rawal, Rounak B; Ebert, Charles S; Senior, Brent A; Zanation, Adam M

    2015-09-01

    Surprisingly, little literature exists evaluating the optimal duration of antibiotic treatment in "maximal medical therapy" for chronic rhinosinusitis (CRS). As such, we investigated whether 3 weeks vs 6 weeks of antibiotic therapy resulted in significant differences in clinical response. A prospective, randomized cohort study was performed with patients assigned to 3-week or 6-week cohorts. Our primary outcome was failure of "maximal medical therapy" and surgical recommendation. Secondary outcomes included changes in pretherapy and posttherapy scores for the Rhinosinusitis Disability Index (RSDI), Chronic Sinusitis Survey (CSS), and computed tomography (CT)-based Lund-Mackay (LM) evaluation. Analyses were substratified based on presence of nasal polyps. Forty patients were randomized to the 3-week or 6-week treatment cohorts, with near-complete clinical follow-up achieved. No significant difference was found between the proportion of patients who failed medical therapy and were deemed surgical candidates between the 2 cohorts (71% vs 68%, p = 1.000). No significant difference was found in the change of RSDI or CSS scores in the 3 vs 6 weeks of treatment groups (mean ± standard error of the mean [SEM]; RSDI: 9.62 ± 4.14 vs 1.53 ± 4.01, p = 0.868; CSS: 5.75 ± 4.36 vs 9.65 ± 5.34, p = 0.573). Last, no significant difference was found in the change of LM scores (3.35 ± 1.11 vs 1.53 ± 0.81, p = 0.829). Based on this data, there is little difference in clinical outcomes between 3 weeks vs 6 weeks of antibiotic treatment as part of "maximal medical therapy" for CRS. Increased duration of antibiotic treatment theoretically may increase risk from side effects and creates higher healthcare costs. © 2015 ARS-AAOA, LLC.

  20. Original geochemical types and epigenetic alteration of rocks in prospecting target stratum for uranium deposit in the southeast of Songliao basin

    International Nuclear Information System (INIS)

    Lin Jinrong; Tian Hua; Dong Wenming; Xia Yuliang; Qi Daneng; Yao Shancong; Zheng Jiwei

    2009-01-01

    By comprehensive analysis on informations of regional geology and evaluating drillhole works of uranium resources in the southeast of Songliao basin, lithofacies-palaeogeography features, lithologies and sandbody characteristics of target layes in Quantou formation, Yaojia formation and Sifangtai formation have been basically found out. By research on geochemical environment of rocks in target layez, types of original geochemistry and epigenetic alteration have been identified and classified. The types of original geochemistry have been divided into types of original oxidation and original reduction, and the types of epigenetic alteration have been divided into types of reduction by oil-gas and coalbed gas and epigenetic oxidation. By comparative study on mineral and chemical characteristics of original geochemistry and epigenetic oxidation, identification marks for oil-gas and coalbed gas reduced epigenetic oxidation have been proposed. It is proposed that uranium was strongly pre-concentrated in original sandstone that bearing carboniferous matter, and reduction by oil-gas and coalbed gas made uranium superimpose and concentrate in alterated rocks. (authors)

  1. A prospective study predicting the outcome of chronic low back pain and physical therapy: the role of fear-avoidance beliefs and extraspinal pain.

    Science.gov (United States)

    Feitosa, Aloma S A; Lopes, Jaqueline Barros; Bonfa, Eloisa; Halpern, Ari S R

    2016-03-16

    To identify the prognostic factors for conventional physical therapy in patients with chronic low back pain (CLBP). Prospective observational study. One hundred thirteen patients with CLBP selected at the Spinal Disease Outpatient Clinic. Pain intensity was scored using the Numeric Rating Scale (NRS), and function was measured using the Roland-Morris Disability Questionnaire (RMDQ). The Fear-Avoidance Beliefs Questionnaire work subscale results (FABQ-work; odds ratio [OR]=0.27, 95% confidence interval [CI] 0.13 to 0.56, p<0.001) and extraspinal pain (OR=0.35, 95% CI 0.17 to 0.74, p=0.006) were independently associated with a decreased response to conventional physical therapy for CLBP. We identified high FABQ-work and extraspinal pain scores as key determinants of a worse response to physical therapy among CLBP patients, supporting the need for a special rehabilitation program for this subgroup. Copyright © 2016 Elsevier Editora Ltda. All rights reserved.

  2. Early tumor necrosis factor α antagonist therapy in everyday practice for inflammatory back pain suggesting axial spondyloarthritis: results from a prospective multicenter french cohort.

    Science.gov (United States)

    Canouï-Poitrine, Florence; Poulain, Cécile; Molto, Anna; Le Thuaut, Aurélie; Lafon, Cécile; Farrenq, Valérie; Ferkal, Salah; Le Corvoisier, Philippe; Ghaleh, Bijan; Bastuji-Garin, Sylvie; Fautrel, B; Dougados, Maxime; Claudepierre, Pascal

    2014-09-01

    To determine the frequency of and factors associated with early tumor necrosis factor α (TNFα) antagonist therapy in everyday clinical practice in patients with suspected axial spondyloarthropathy (SpA). We used data from the prospective observational study in the French Devenir des Spondylarthropathies Indifférenciées Récentes (DESIR; Outcome of Recent Undifferentiated Spondylarthropathies) cohort of 708 patients with recent-onset (50 (OR 1.88, 95% CI 1.24-2.87, P = 0.003), current or past disease-modifying antirheumatic drug use (OR 2.09, 95% CI 1.22-3.59, P = 0.008), systemic corticosteroid use (OR 2.48, 95% CI 1.43-4.34, P = 0.002), and mild to severe radiographic hip abnormalities (OR 9.43, 95% CI 2.11-42.09, P = 0.003). After adjustment on these factors, Achilles enthesis hypervascularization by power Doppler and number of work days missed were associated with TNFα antagonist therapy. In the DESIR cohort, approximately one-fourth of patients with recent IBP suggestive of axial SpA were under anti-TNFα therapy after 1 year of followup. All factors associated with this early initiation reflected higher disease activity, refractoriness, or severity, which suggests compliance of French rheumatologists with current treatment guidelines. Copyright © 2014 by the American College of Rheumatology.

  3. Efficacy of a static progressive stretch device as an adjunct to physical therapy in treating adhesive capsulitis of the shoulder: a prospective, randomised study.

    Science.gov (United States)

    Ibrahim, M; Donatelli, R; Hellman, M; Echternach, J

    2014-09-01

    Stress relaxation and static progressive stretch are techniques used for non-surgical restoration of shoulder range of motion for patients with adhesive capsulitis. To compare a static progressive stretch device plus traditional therapy with traditional therapy alone for the treatment of adhesive capsulitis of the shoulder. Prospective, randomised controlled trial. Sixty patients with adhesive capsulitis of the shoulder were assigned at random to an experimental group or a control group. Both groups received three traditional therapy sessions per week for 4 weeks. In addition, the experimental group used a static progressive stretch device for 4 weeks. The primary outcome measure was shoulder range of motion (active and passive shoulder abduction, and passive shoulder external rotation). The secondary outcome measures were function [measured by the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire] and pain [measured using a visual analogue scale (VAS)]. At baseline, there were no differences between the two groups. However, after the intervention, there were significant (Padhesive capsulitis of the shoulder. At 12-month follow-up, the experimental group had continued to improve, while the control group had relapsed. Copyright © 2013 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

  4. Antiviral therapy with nucleotide/nucleoside analogues in chronic hepatitis B: A meta-analysis of prospective randomized trials.

    Science.gov (United States)

    Bedre, Renesh H; Raj, Utkarsh; Misra, Sri Prakash; Varadwaj, Pritish Kumar

    2016-03-01

    Nucleotide/nucleoside analogues (antiviral therapy) are used in the therapy of HBeAg positive and HBeAg negative chronic hepatitis B. We analyzed ten selected randomized controlled with 2557 patients to estimate the effect of antiviral drugs in chronic hepatitis B with compared to placebo. Virological response, biochemical response, histological response, seroconversion of HBeAg, and loss of HBeAg were estimated as primary efficacy measures. The included studies were subjected for heterogeneity and publication bias. The heterogeneity was assessed with χ2 and I(2) statistics. Publication bias was assessed by funnel plot. Greater rates of improvement obtained in antiviral group for virological response [43.96 % vs. 3.15 %, RR = 0.57, 95 % CI = 0.54-0.61, p-value Antiviral therapy provided significant benefit for the treatment of chronic hepatitis B with no measurable adverse effects.

  5. Prospective Randomized Comparison of the Effectiveness of Radiation Therapy and Local Steroid Injection for the Treatment of Plantar Fasciitis

    International Nuclear Information System (INIS)

    Canyilmaz, Emine; Canyilmaz, Fatih; Aynaci, Ozlem; Colak, Fatma; Serdar, Lasif; Uslu, Gonca Hanedan; Aynaci, Osman; Yoney, Adnan

    2015-01-01

    Purpose: The purpose of this study was to conduct a randomized trial of radiation therapy for plantar fasciitis and to compare radiation therapy with local steroid injections. Methods and Materials: Between March 2013 and April 2014, 128 patients with plantar fasciitis were randomized to receive radiation therapy (total dose of 6.0 Gy applied in 6 fractions of 1.0 Gy three times a week) or local corticosteroid injections a 1 ml injection of 40 mg methylprednisolone and 0.5 ml 1% lidocaine under the guidance of palpation. The results were measured using a visual analog scale, a modified von Pannewitz scale, and a 5-level function score. The fundamental phase of the study was 3 months, with a follow-up period of up to 6 months. Results: The median follow-up period for all patients was 12.5 months (range, 6.5-18.6 months). For the radiation therapy patients, the median follow-up period was 13 months (range, 6.5-18.5 months), whereas in the palpation-guided (PG) steroid injection arm, it was 12.1 months (range, 6.5-18.6 months). After 3 months, results in the radiation therapy arm were significantly superior to those in the PG steroid injection arm (visual analog scale, P<.001; modified von Pannewitz scale, P<.001; 5-level function score, P<.001). Requirements for a second treatment did not significantly differ between the 2 groups, but the time interval for the second treatment was significantly shorter in the PG steroid injection group (P=.045). Conclusion: This study confirms the superior analgesic effect of radiation therapy compared to mean PG steroid injection on plantar fasciitis for at least 6 months after treatment

  6. Prospective Randomized Comparison of the Effectiveness of Radiation Therapy and Local Steroid Injection for the Treatment of Plantar Fasciitis

    Energy Technology Data Exchange (ETDEWEB)

    Canyilmaz, Emine, E-mail: dremocan@ktu.edu.tr [Department of Radiation Oncology, Faculty of Medicine, Karadeniz Technical University, Trabzon (Turkey); Canyilmaz, Fatih [Department of Orthopaedics and Traumatology, Yavuz Selim Bone Disease and Rehabilitation Hospital, Trabzon (Turkey); Aynaci, Ozlem; Colak, Fatma; Serdar, Lasif [Department of Radiation Oncology, Faculty of Medicine, Karadeniz Technical University, Trabzon (Turkey); Uslu, Gonca Hanedan [Department of Radiation Oncology, Kanuni Research and Education Hospital, Trabzon (Turkey); Aynaci, Osman [Department of Orthopaedics and Traumatology, Faculty of Medicine, Karadeniz Technical University, Trabzon (Turkey); Yoney, Adnan [Department of Radiation Oncology, Faculty of Medicine, Karadeniz Technical University, Trabzon (Turkey)

    2015-07-01

    Purpose: The purpose of this study was to conduct a randomized trial of radiation therapy for plantar fasciitis and to compare radiation therapy with local steroid injections. Methods and Materials: Between March 2013 and April 2014, 128 patients with plantar fasciitis were randomized to receive radiation therapy (total dose of 6.0 Gy applied in 6 fractions of 1.0 Gy three times a week) or local corticosteroid injections a 1 ml injection of 40 mg methylprednisolone and 0.5 ml 1% lidocaine under the guidance of palpation. The results were measured using a visual analog scale, a modified von Pannewitz scale, and a 5-level function score. The fundamental phase of the study was 3 months, with a follow-up period of up to 6 months. Results: The median follow-up period for all patients was 12.5 months (range, 6.5-18.6 months). For the radiation therapy patients, the median follow-up period was 13 months (range, 6.5-18.5 months), whereas in the palpation-guided (PG) steroid injection arm, it was 12.1 months (range, 6.5-18.6 months). After 3 months, results in the radiation therapy arm were significantly superior to those in the PG steroid injection arm (visual analog scale, P<.001; modified von Pannewitz scale, P<.001; 5-level function score, P<.001). Requirements for a second treatment did not significantly differ between the 2 groups, but the time interval for the second treatment was significantly shorter in the PG steroid injection group (P=.045). Conclusion: This study confirms the superior analgesic effect of radiation therapy compared to mean PG steroid injection on plantar fasciitis for at least 6 months after treatment.

  7. [Evaluation of an original tool for carbohydrate counting, aimed at facilitating the implementation of functional insulin therapy].

    Science.gov (United States)

    Reach, Gérard; Choleau, Carine

    2013-01-01

    Carbohydrate counting is the most difficult component of functional insulin therapy. We thus designed a tool to facilitate carbohydrate counting of meals. The tool consists of an illustrated directory (16 x 10 cm, 119 pages) presenting 389 pictures of food, classified in 12 categories (breads, fruits, vegetables, etc.). For each photo, the name and mode of preparation of the foods are given, with the weight of the illustrated portion and its carbohydrate content as a multiple of 5 g. During the first phase of the study (3 days a week for 12 weeks), twelve patients with type 1 diabetes completed a precise food diary using a list and weight of all consumed foods. We were thus able to determine, for each of three meals (breakfast, lunch and dinner), the variability of their carbohydrate content. During the second phase of the study (2 weeks), the patients were given the possibility of using the illustrated food directory. We asked them first to estimate, from the photos, the global carbohydrate content of their meals, and then to weigh each food. This allowed us to calculate the true carbohydrate content of the meals from nutritional tables. During the first phase, the carbohydrate contents of breakfast, lunch and dinner were 67 +/- 29, 72 +/- 30 and 74 +/- 30 g, respectively (mean +/- SD, n = 12). For a given patient, the variability in the carbohydrate content of each meal was expressed by its standard deviation (SD). For the 12 patients, this variability was 18+/-+ 8, 25+/-+ 8 and 27+/-+ 11 g, respectively, for breakfast, lunch and dinner, and represented on the average about one-quarter of the total carbohydrate content. During the second phase, carbohydrate content, estimated by the patients using the illustrated food directory, correlated well with the retrospective evaluation based on nutritional tables (y = 0.95 x + 5 g, r2 = 0.8 ; n = 12, 235 meals). This new illustrated food repertory allows accurate evaluation of the highly variable carbohydrate content of

  8. ‘Great ease and simplicity of action’: Dr Nelson’s Inhaler and the origins of modern inhalation therapy

    Directory of Open Access Journals (Sweden)

    Barry Murnane

    2017-11-01

    Full Text Available Unveiled at the conclusion of a meeting of the Royal Medical and Chirurgical Society in 1861,[1] ‘Dr Nelson’s Improved Inhaler’ was one of the most important milestones in the genesis of reliable treatment of respiratory ailments in the modern era. Affordable and suitable for self-medication, the Dr Nelson’s Inhaler offered simple and reliable relief for patients with respiratory and pulmonary ailments. Conspicuous for its modesty and simplicity, it was one of the most widely produced, reproduced, and used inhalation devices in the final third of the nineteenth century. By reconstructing the ‘biography’ of the Nelson Inhaler, this article will attempt to sketch a network of medical and commercial interests and expertise in London which aligned in the 1860s to help establish inhalation as a popular, inexpensive, and trusted form of medical therapy for pulmonary ailments. This article will look at what connects physicians, apothecaries, and patients in the era: the medicines and technologies that were prescribed, made, bought, and which caused wellness, side-effects, and even death. This approach allows us to develop a narrative of respiratory illness as it was experienced by practitioners and patients alike.

  9. The prospects of application of natural antioxidants in correction of blood coagulation in patients with breast cancer during radiation therapy

    International Nuclear Information System (INIS)

    Syimonova, L.Yi.; Byilogurova, L.V.; Gertman, V.Z.; Pushkar, S.M.; Muzikant, P.M.; Nesterenko, G.Yi.

    2008-01-01

    As an accompanying therapy of the patients with BC Bipolan produced positive effect on coagulation homeostasis. By the end of the course of treatment the indices of homeostasis normalized in the experimental group of the patients; manifestations of DIC syndrome and thromboembolic complications were controlled

  10. Triple antiviral therapy in hepatitis C virus infection with or without mixed cryoglobulinaemia: a prospective, controlled pilot study.

    Science.gov (United States)

    Gragnani, Laura; Fabbrizzi, Alessio; Triboli, Elisa; Urraro, Teresa; Boldrini, Barbara; Fognani, Elisa; Piluso, Alessia; Caini, Patrizio; Ranieri, Jessica; Monti, Monica; Laffi, Giacomo; Zignego, Anna Linda

    2014-09-01

    Mixed cryoglobulinaemia is strongly related to hepatitis C virus infection. Treatment with peg-interferon and ribavirin has been indicated as first-line therapy for mild/moderate hepatitis C virus-related mixed cryoglobulinaemia. To evaluate the safety and efficacy of triple boceprevir-based antiviral therapy in patients with or without mixed cryoglobulinaemia previously treated with peg-interferon and ribavirin, and with advanced liver disease. Thirty-five hepatitis C virus-positive patients (17 with asymptomatic mixed cryoglobulinaemia, 5 with symptomatic mixed cryoglobulinaemia, and 11 without mixed cryoglobulinaemia) were treated with triple boceprevir-based antiviral therapy. In 19/22 cryoglobulinaemic subjects (86%), the addition of boceprevir induced cryocrit disappearance. Cryocrit behaviour was related to virological response, with improvement of symptoms upon undetectable viraemia and reappearance after virological breakthrough. The rate of sustained virological response was lower in cryoglobulinaemic patients than in patients without mixed cryoglobulinaemia (23.8% vs 70% respectively, p=0.01). Boceprevir-based therapy was safe and effective in cryoglobulinaemic patients. The correlation between direct inhibition of hepatitis C virus replication and clinical improvement in mixed cryoglobulinaemic patients is definitive proof of the key pathogenetic role played by viral replication. Further studies are needed to confirm and clarify the reduced virological response in patients with mixed cryoglobulinaemia. Copyright © 2014 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

  11. Short- and long-term neurocognitive functioning after electroconvulsive therapy in depressed elderly: a prospective naturalistic study

    NARCIS (Netherlands)

    Verwijk, E.; Comijs, H.C.; Kok, R.M.; Spaans, H.P.; Tielkes, C.E.M.; Scherder, E.J.A.; Stek, M.L.

    2014-01-01

    Background: It is generally assumed that the elderly patients are more vulnerable to cognitive side effects after electroconvulsive therapy (ECT) than younger depressed patients. The current study aims to evaluate the nature and extent of changes across multiple domains of neurocognitive functioning

  12. Menopausal hormone therapy and breast cancer risk : impact of different treatments. The European Prospective Investigation into Cancer and Nutrition

    NARCIS (Netherlands)

    Bakken, Kjersti; Fournier, Agnes; Lund, Eiliv; Waaseth, Marit; Dumeaux, Vanessa; Clavel-Chapelon, Francoise; Fabre, Alban; Hemon, Bertrand; Rinaldi, Sabina; Chajes, Veronique; Slimani, Nadia; Allen, Naomi E.; Reeves, Gillian K.; Bingham, Sheila; Khaw, Kay-Tee; Olsen, Anja; Tjonneland, Anne; Rodriguez, Laudina; Sanchez, Maria-Jose; Amiano Etxezarreta, Pilar; Ardanaz, Eva; Tormo, Maria-Jose; Peeters, Petra H.; van Gils, Carla H.; Steffen, Annika; Schulz, Mandy; Chang-Claude, Jenny; Kaaks, Rudolf; Tumino, Rosario; Gallo, Valentina; Norat, Teresa; Riboli, Elio; Panico, Salvatore; Masala, Giovanna; Gonzalez, Carlos A.; Berrino, Franco

    2011-01-01

    Menopausal hormone therapy (MHT) is characterized by use of different constituents, regimens and routes of administration. We investigated the association between the use of different types of MHT and breast cancer risk in the EPIC cohort study. The analysis is based on data from 133,744

  13. Social Learning Family Therapy and the Treatment of Conduct Disorder in Early Childhood: Premise, Procedures and Prospects.

    Science.gov (United States)

    Mpofu, Elias

    1997-01-01

    Discusses social learning family therapy hypotheses on the development and sustenance of conduct disorder in early childhood, together with treatment approaches that use parents as the primary agents of change. Reviews research showing that parent training procedures hold much promise for the treatment of conduct disorder in childhood. (JPB)

  14. The timing of tuberculosis after isoniazid preventive therapy among gold miners in South Africa: a prospective cohort study

    NARCIS (Netherlands)

    Hermans, Sabine M.; Grant, Alison D.; Chihota, Violet; Lewis, James J.; Vynnycky, Emilia; Churchyard, Gavin J.; Fielding, Katherine L.

    2016-01-01

    The durability of isoniazid preventive therapy (IPT) in preventing tuberculosis (TB) is limited in high-prevalence settings. The underlying mechanism (reactivation of persistent latent TB or reinfection) is not known. We aimed to investigate the timing of TB incidence during and after IPT and

  15. Original Research Original Research

    African Journals Online (AJOL)

    RAGHAVENDRA

    When the quantitative method was a dominant approach to address the research problem, the qualitative one was used to substantiate the quantitative data. In this study which was conducted at Bahir Dar. University, subjects of the study included 445 the summer modality secondary education prospective teachers of 10.

  16. Prospective controlled cohort study to evaluate changes of function, activity and participation in patients with bilateral spastic cerebral palsy after Robot-enhanced repetitive treadmill therapy.

    Science.gov (United States)

    Schroeder, A S; Homburg, M; Warken, B; Auffermann, H; Koerte, I; Berweck, S; Jahn, K; Heinen, F; Borggraefe, I

    2014-07-01

    Robot-enhanced therapies are increasingly being used to improve gross motor performance in patients with cerebral palsy. To evaluate gross motor function, activity and participation in patients with bilateral spastic cerebral palsy (BS-CP) after Robot-enhanced repetitive treadmill therapy (ROBERT) in a prospective, controlled cohort study. Participants trained for 30-60 min in each of 12 sessions within a three-week-period. Changes in Gross Motor Function Measure (GMFM 66) scores, standardized walking distance, self-selected and maximum walking speed (ICF domain "Activity"), and Canadian Occupational Performance Measure (COPM; "Participation") were measured. Outcome measures were assessed three weeks in advance (V1), the day before (V2) as well as the day after, and 8 weeks after ROBERT (V3 + V4). 18 patients with BS-CP participated; age 11.5 (mean, range: 5.0-21.8) years, body weight 36.4 (15.0-72.0) kg. GMFCS levels I-IV were: n = 4; 5; 8; 1. There was no significant difference comparing V1 and V2. GMFM 66 (total +2.5 points, Dimension D +3.8 and E +3.2) and COPM (Performance +2.1 points, Satisfaction +1.8 points) showed statistically significant improvements for V3 or V4 compared to V1 or V2 representing clinically meaningful effect sizes. Age, GMFCS level, and repeated ROBERT blocks correlated negatively with GMFM improvement, but not with COPM improvement. Following ROBERT, this prospective controlled cohort study showed significant and clinically meaningful improvements of function in ICF domains of "activity" and "participation" in patients with BS-CP. Further assessment in a larger cohort is necessary to allow more specific definition of factors that influence responsiveness to ROBERT program. Copyright © 2014. Published by Elsevier Ltd.

  17. Dose–Volume Modeling of Brachial Plexus-Associated Neuropathy After Radiation Therapy for Head-and-Neck Cancer: Findings From a Prospective Screening Protocol

    International Nuclear Information System (INIS)

    Chen, Allen M.; Wang, Pin-Chieh; Daly, Megan E.; Cui, Jing; Hall, William H.; Vijayakumar, Srinivasan; Phillips, Theodore L.; Farwell, D. Gregory; Purdy, James A.

    2014-01-01

    Purpose: Data from a prospective screening protocol administered for patients previously irradiated for head-and-neck cancer was analyzed to identify dosimetric predictors of brachial plexus-associated neuropathy. Methods and Materials: Three hundred fifty-two patients who had previously completed radiation therapy for squamous cell carcinoma of the head and neck were prospectively screened from August 2007 to April 2013 using a standardized self-administered instrument for symptoms of neuropathy thought to be related to brachial plexus injury. All patients were disease-free at the time of screening. The median time from radiation therapy was 40 months (range, 6-111 months). A total of 177 patients (50%) underwent neck dissection. Two hundred twenty-one patients (63%) received concurrent chemotherapy. Results: Fifty-one patients (14%) reported brachial plexus-related neuropathic symptoms with the most common being ipsilateral pain (50%), numbness/tingling (40%), and motor weakness and/or muscle atrophy (25%). The 3- and 5-year estimates of freedom from brachial plexus-associated neuropathy were 86% and 81%, respectively. Clinical/pathological N3 disease (P<.001) and maximum radiation dose to the ipsilateral brachial plexus (P=.01) were significantly associated with neuropathic symptoms. Cox regression analysis revealed significant dose–volume effects for brachial plexus-associated neuropathy. The volume of the ipsilateral brachial plexus receiving >70 Gy (V70) predicted for symptoms, with the incidence increasing with V70 >10% (P<.001). A correlation was also observed for the volume receiving >74 Gy (V74) among patients treated without neck dissection, with a cutoff of 4% predictive of symptoms (P=.038). Conclusions: Dose–volume guidelines were developed for radiation planning that may limit brachial plexus-related neuropathies

  18. Dose–Volume Modeling of Brachial Plexus-Associated Neuropathy After Radiation Therapy for Head-and-Neck Cancer: Findings From a Prospective Screening Protocol

    Energy Technology Data Exchange (ETDEWEB)

    Chen, Allen M., E-mail: amchen@mednet.ucla.edu [Department of Radiation Oncology, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, California (United States); Wang, Pin-Chieh [Department of Radiation Oncology, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, California (United States); Daly, Megan E.; Cui, Jing; Hall, William H. [Department of Radiation Oncology, University of California, Davis, Comprehensive Cancer Center, Sacramento, California (United States); Vijayakumar, Srinivasan [Department of Radiation Oncology, University of Mississippi School of Medicine, Jackson, Mississippi (United States); Phillips, Theodore L. [Department of Radiation Oncology, University of California, Davis, Comprehensive Cancer Center, Sacramento, California (United States); Farwell, D. Gregory [Department of Otolaryngology–Head and Neck Surgery, University of California, Davis, Comprehensive Cancer Center, Sacramento, California (United States); Purdy, James A. [Department of Radiation Oncology, University of California, Davis, Comprehensive Cancer Center, Sacramento, California (United States)

    2014-03-15

    Purpose: Data from a prospective screening protocol administered for patients previously irradiated for head-and-neck cancer was analyzed to identify dosimetric predictors of brachial plexus-associated neuropathy. Methods and Materials: Three hundred fifty-two patients who had previously completed radiation therapy for squamous cell carcinoma of the head and neck were prospectively screened from August 2007 to April 2013 using a standardized self-administered instrument for symptoms of neuropathy thought to be related to brachial plexus injury. All patients were disease-free at the time of screening. The median time from radiation therapy was 40 months (range, 6-111 months). A total of 177 patients (50%) underwent neck dissection. Two hundred twenty-one patients (63%) received concurrent chemotherapy. Results: Fifty-one patients (14%) reported brachial plexus-related neuropathic symptoms with the most common being ipsilateral pain (50%), numbness/tingling (40%), and motor weakness and/or muscle atrophy (25%). The 3- and 5-year estimates of freedom from brachial plexus-associated neuropathy were 86% and 81%, respectively. Clinical/pathological N3 disease (P<.001) and maximum radiation dose to the ipsilateral brachial plexus (P=.01) were significantly associated with neuropathic symptoms. Cox regression analysis revealed significant dose–volume effects for brachial plexus-associated neuropathy. The volume of the ipsilateral brachial plexus receiving >70 Gy (V70) predicted for symptoms, with the incidence increasing with V70 >10% (P<.001). A correlation was also observed for the volume receiving >74 Gy (V74) among patients treated without neck dissection, with a cutoff of 4% predictive of symptoms (P=.038). Conclusions: Dose–volume guidelines were developed for radiation planning that may limit brachial plexus-related neuropathies.

  19. Anti-TNF Therapy Is Associated With an Increased Risk of Postoperative Morbidity After Surgery for Ileocolonic Crohn Disease: Results of a Prospective Nationwide Cohort.

    Science.gov (United States)

    Brouquet, Antoine; Maggiori, Léon; Zerbib, Philippe; Lefevre, Jérémie H; Denost, Quentin; Germain, Adeline; Cotte, Eddy; Beyer-Berjot, Laura; Munoz-Bongrand, Nicolas; Desfourneaux, Véronique; Rahili, Amine; Duffas, Jean-Pierre; Pautrat, Karine; Denet, Christine; Bridoux, Valérie; Meurette, Guillaume; Faucheron, Jean-Luc; Loriau, Jérome; Guillon, Françoise; Vicaut, Eric; Benoist, Stéphane; Panis, Yves

    2018-02-01

    To determine the risk factors of morbidity after surgery for ileocolonic Crohn disease (CD). The risk factors of morbidity after surgery for CD, particularly the role of anti-TNF therapy, remain controversial and have not been evaluated in a large prospective cohort study. From 2013 to 2015, data on 592 consecutive patients who underwent surgery for CD in 19 French specialty centers were collected prospectively. Possible relationships between anti-TNF and postoperative overall morbidity were tested by univariate and multivariate analyses. Because treatment by anti-TNF is possibly dependent on the characteristics of the patients and disease, a propensity score was calculated and introduced in the analyses using adjustment of the inverse probability of treatment-weighted method. Postoperative mortality, overall and intra-abdominal septic morbidity rates in the entire cohort were 0%, 29.7%, and 8.4%, respectively; 143 (24.1%) patients had received anti-TNF risk factor of the overall postoperative morbidity (odds-ratio [OR] =1.99; confidence interval [CI] 95% = 1.17-3.39, P = 0.011), with preoperative hemoglobin 180 min (OR = 2.71; CI 95% = 1.54-4.78, P risk of overall (OR = 2.98; CI 95% = 2.04-4.35, P risk of morbidity after surgery for ileocolonic CD. This information should be considered in the surgical management of these patients, particularly with regard to the preoperative preparation and indication of temporary defunctioning stoma.

  20. Ten-day bismuth-containing quadruple therapy is effective as first-line therapy for Helicobacter pylori-related chronic gastritis: a prospective randomized study in China.

    Science.gov (United States)

    Wang, L; Lin, Z; Chen, S; Li, J; Chen, C; Huang, Z; Ye, B; Ding, J; Li, W; Wu, L; Jiang, Y; Meng, L; Du, Q; Si, J

    2017-06-01

    To investigate the effectiveness of 10-day bismuth-containing quadruple (B-quadruple) treatment as first-line therapy in patients with Helicobacter pylori-related chronic gastritis. A randomized controlled trial was conducted from October 2011 to December 2013 in Zhejiang, China, including patients with H. pylori-related chronic gastritis who were randomly provided either 10-day omeprazole-based triple therapy (OM-triple; omeprazole 20 mg twice daily, clarithromycin 500 mg twice daily and amoxicillin 1 g twice daily) or 10-day B-quadruple therapy (OM-triple + bismuth subcitrate 120 mg four times daily). H. pylori status, pathologic findings and dyspeptic symptoms were assessed at baseline and after 3 months. The primary outcome was H. pylori eradication rates by intention-to-treat (ITT) and per-protocol (PP) analyses. The secondary outcomes were the histologic and symptomatic benefits from H. pylori eradication. A total of 351 patients with H. pylori-related chronic gastritis were recruited. The eradication rates of the OM-triple and B-quadruple groups were 58.4% (108/185) and 86.1% (143/166) respectively according to ITT analysis (p pylori eradication were 63.2% (108/171) and 92.3% (143/155) respectively (p gastritis and intestinal metaplasia did not regress in both groups (n=326). The reduction of dyspeptic symptoms score was significantly higher in the B-quadruple group than in the OM-triple group (0.59±0.057 vs. 0.39±0.046) (p pylori-induced chronic gastritis in China. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  1. Rectal Toxicity After Proton Therapy For Prostate Cancer: An Analysis of Outcomes of Prospective Studies Conducted at the University of Florida Proton Therapy Institute

    Energy Technology Data Exchange (ETDEWEB)

    Colaco, Rovel J.; Hoppe, Bradford S.; Flampouri, Stella [The University of Florida Proton Therapy Institute, Jacksonville, Florida (United States); McKibben, Brian T. [Baptist Health Medical Center, Department of Surgery, Jacksonville, Florida (United States); Henderson, Randal H.; Bryant, Curtis; Nichols, Romaine C.; Mendenhall, William M.; Li, Zuofeng; Su, Zhong [The University of Florida Proton Therapy Institute, Jacksonville, Florida (United States); Morris, Christopher G. [Baptist Health Medical Center, Department of Surgery, Jacksonville, Florida (United States); Mendenhall, Nancy P., E-mail: menden@floridaproton.org [The University of Florida Proton Therapy Institute, Jacksonville, Florida (United States)

    2015-01-01

    Purpose: Study goals were to characterize gastrointestinal effects of proton therapy (PT) in a large cohort of patients treated for prostate cancer, identify factors associated with rectal bleeding (RB), and compare RB between patients receiving investigational protocols versus those in outcome-tracking protocols. Methods and Materials: A total of 1285 consecutive patients were treated with PT between August 2006 and May 2010. Potential pre-existing clinical and treatment-related risk factors for rectal toxicity were recorded. Common Terminology Criteria for Adverse Events version 3.0 was used to score toxicity. Results: Transient RB was the predominant grade 2 or higher (GR2+) toxicity after PT, accounting for 95% of gastrointestinal events. GR1 RB occurred in 217 patients (16.9%), GR2 RB in 187 patients (14.5%), and GR3 in 11 (0.9%) patients. There were no GR4 or GR5 events. Univariate analyses showed correlations between GR2+ RB and anticoagulation therapy (P=.008) and rectal and rectal wall dose-volume histogram (DVH) parameters (P<.001). On multivariate analysis, anticoagulation therapy (P=.0034), relative volume of rectum receiving 75 Gy (V75; P=.0102), and relative rectal wall V75 (P=.0017) were significant predictors for G2+ RB. Patients treated with investigational protocols had toxicity rates similar to those receiving outcome-tracking protocols. Conclusions: PT was associated with a low rate of GR2+ gastrointestinal toxicity, predominantly transient RB, which was highly correlated with anticoagulation and rectal DVH parameters. Techniques that limit rectal exposure should be used when possible.

  2. Rectal toxicity after proton therapy for prostate cancer: an analysis of outcomes of prospective studies conducted at the university of Florida Proton Therapy Institute.

    Science.gov (United States)

    Colaco, Rovel J; Hoppe, Bradford S; Flampouri, Stella; McKibben, Brian T; Henderson, Randal H; Bryant, Curtis; Nichols, Romaine C; Mendenhall, William M; Li, Zuofeng; Su, Zhong; Morris, Christopher G; Mendenhall, Nancy P

    2015-01-01

    Study goals were to characterize gastrointestinal effects of proton therapy (PT) in a large cohort of patients treated for prostate cancer, identify factors associated with rectal bleeding (RB), and compare RB between patients receiving investigational protocols versus those in outcome-tracking protocols. A total of 1285 consecutive patients were treated with PT between August 2006 and May 2010. Potential pre-existing clinical and treatment-related risk factors for rectal toxicity were recorded. Common Terminology Criteria for Adverse Events version 3.0 was used to score toxicity. Transient RB was the predominant grade 2 or higher (GR2+) toxicity after PT, accounting for 95% of gastrointestinal events. GR1 RB occurred in 217 patients (16.9%), GR2 RB in 187 patients (14.5%), and GR3 in 11 (0.9%) patients. There were no GR4 or GR5 events. Univariate analyses showed correlations between GR2+ RB and anticoagulation therapy (P=.008) and rectal and rectal wall dose-volume histogram (DVH) parameters (P<.001). On multivariate analysis, anticoagulation therapy (P=.0034), relative volume of rectum receiving 75 Gy (V75; P=.0102), and relative rectal wall V75 (P=.0017) were significant predictors for G2+ RB. Patients treated with investigational protocols had toxicity rates similar to those receiving outcome-tracking protocols. PT was associated with a low rate of GR2+ gastrointestinal toxicity, predominantly transient RB, which was highly correlated with anticoagulation and rectal DVH parameters. Techniques that limit rectal exposure should be used when possible. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

  3. Rectal Toxicity After Proton Therapy For Prostate Cancer: An Analysis of Outcomes of Prospective Studies Conducted at the University of Florida Proton Therapy Institute

    International Nuclear Information System (INIS)

    Colaco, Rovel J.; Hoppe, Bradford S.; Flampouri, Stella; McKibben, Brian T.; Henderson, Randal H.; Bryant, Curtis; Nichols, Romaine C.; Mendenhall, William M.; Li, Zuofeng; Su, Zhong; Morris, Christopher G.; Mendenhall, Nancy P.

    2015-01-01

    Purpose: Study goals were to characterize gastrointestinal effects of proton therapy (PT) in a large cohort of patients treated for prostate cancer, identify factors associated with rectal bleeding (RB), and compare RB between patients receiving investigational protocols versus those in outcome-tracking protocols. Methods and Materials: A total of 1285 consecutive patients were treated with PT between August 2006 and May 2010. Potential pre-existing clinical and treatment-related risk factors for rectal toxicity were recorded. Common Terminology Criteria for Adverse Events version 3.0 was used to score toxicity. Results: Transient RB was the predominant grade 2 or higher (GR2+) toxicity after PT, accounting for 95% of gastrointestinal events. GR1 RB occurred in 217 patients (16.9%), GR2 RB in 187 patients (14.5%), and GR3 in 11 (0.9%) patients. There were no GR4 or GR5 events. Univariate analyses showed correlations between GR2+ RB and anticoagulation therapy (P=.008) and rectal and rectal wall dose-volume histogram (DVH) parameters (P<.001). On multivariate analysis, anticoagulation therapy (P=.0034), relative volume of rectum receiving 75 Gy (V75; P=.0102), and relative rectal wall V75 (P=.0017) were significant predictors for G2+ RB. Patients treated with investigational protocols had toxicity rates similar to those receiving outcome-tracking protocols. Conclusions: PT was associated with a low rate of GR2+ gastrointestinal toxicity, predominantly transient RB, which was highly correlated with anticoagulation and rectal DVH parameters. Techniques that limit rectal exposure should be used when possible

  4. Prospective Randomized Phase 2 Trial of Intensity Modulated Radiation Therapy With or Without Oncolytic Adenovirus-Mediated Cytotoxic Gene Therapy in Intermediate-Risk Prostate Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Freytag, Svend O., E-mail: sfreyta1@hfhs.org [Department of Radiation Oncology, Henry Ford Health System, Detroit, Michigan (United States); Stricker, Hans [Vattikuti Urology Institute, Henry Ford Health System, Detroit, Michigan (United States); Lu, Mei [Public Health Sciences, Henry Ford Health System, Detroit, Michigan (United States); Elshaikh, Mohamed; Aref, Ibrahim; Pradhan, Deepak; Levin, Kenneth; Kim, Jae Ho [Department of Radiation Oncology, Henry Ford Health System, Detroit, Michigan (United States); Peabody, James [Vattikuti Urology Institute, Henry Ford Health System, Detroit, Michigan (United States); Siddiqui, Farzan; Barton, Kenneth; Pegg, Jan; Zhang, Yingshu; Cheng, Jingfang [Department of Radiation Oncology, Henry Ford Health System, Detroit, Michigan (United States); Oja-Tebbe, Nancy; Bourgeois, Renee [Public Health Sciences, Henry Ford Health System, Detroit, Michigan (United States); Gupta, Nilesh; Lane, Zhaoli [Pathology, Henry Ford Health System, Detroit, Michigan (United States); Rodriguez, Ron [Urology, Johns Hopkins University School of Medicine, Baltimore, Maryland (United States); DeWeese, Theodore [Department of Radiation Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland (United States); and others

    2014-06-01

    Purpose: To assess the safety and efficacy of combining oncolytic adenovirus-mediated cytotoxic gene therapy (OAMCGT) with intensity modulated radiation therapy (IMRT) in intermediate-risk prostate cancer. Methods and Materials: Forty-four men with intermediate-risk prostate cancer were randomly assigned to receive either OAMCGT plus IMRT (arm 1; n=21) or IMRT only (arm 2; n=23). The primary phase 2 endpoint was acute (≤90 days) toxicity. Secondary endpoints included quality of life (QOL), prostate biopsy (12-core) positivity at 2 years, freedom from biochemical/clinical failure (FFF), freedom from metastases, and survival. Results: Men in arm 1 exhibited a greater incidence of low-grade influenza-like symptoms, transaminitis, neutropenia, and thrombocytopenia than men in arm 2. There were no significant differences in gastrointestinal or genitourinary events or QOL between the 2 arms. Two-year prostate biopsies were obtained from 37 men (84%). Thirty-three percent of men in arm 1 were biopsy-positive versus 58% in arm 2, representing a 42% relative reduction in biopsy positivity in the investigational arm (P=.13). There was a 60% relative reduction in biopsy positivity in the investigational arm in men with <50% positive biopsy cores at baseline (P=.07). To date, 1 patient in each arm exhibited biochemical failure (arm 1, 4.8%; arm 2, 4.3%). No patient developed hormone-refractory or metastatic disease, and none has died from prostate cancer. Conclusions: Combining OAMCGT with IMRT does not exacerbate the most common side effects of prostate radiation therapy and suggests a clinically meaningful reduction in positive biopsy results at 2 years in men with intermediate-risk prostate cancer.

  5. Effectiveness and side-effects of peptide receptor radionuclide therapy for neuroendocrine neoplasms in Germany: A multi-institutional registry study with prospective follow-up.

    Science.gov (United States)

    Hörsch, Dieter; Ezziddin, Samer; Haug, Alexander; Gratz, Klaus Friedrich; Dunkelmann, Simone; Miederer, Matthias; Schreckenberger, Mathias; Krause, Bernd Joachim; Bengel, Frank M; Bartenstein, Peter; Biersack, Hans-Jürgen; Pöpperl, Gabriele; Baum, R P

    2016-05-01

    Monocentric and retrospective studies indicate effectiveness of peptide receptor radionuclide therapy targeting somatostatin receptors of neuroendocrine neoplasms. We assessed overall and progression-free survival and adverse events of peptide receptor radionuclide therapy by a multi-institutional, board certified registry with prospective follow-up in five centres in Germany. A total of 450 patients were included and followed for a mean of 24.4 months. Most patients had progressive low- or intermediate grade neuroendocrine neoplasms and 73% were pretreated with at least one therapy. Primary neuroendocrine neoplasms were mainly derived of pancreas (38%), small bowel (30%), unknown primary (19%) or bronchial system (4%). Patients were treated with Lutetium-177 in 54%, with Yttrium-90 in 17% and with both radionuclides in 29%. Overall and progression-free survival was determined with Kaplan-Meier curves and uni-variate log rank test Cox models. Median overall survival of all patients was 59 (95% confidence interval [CI] 49-68.9) months. Overall survival was significantly inferior in the patients treated with Yttrium-90 solely (hazard ratio, 3.22; 95% CI, 1.83-5.64) compared to any peptide receptor radionuclide therapy with Lutetium-177. Grade II (hazard ratio, 2.06; 95% CI, 0.79-5.32) and grade III (hazard ratio, 4.22; 95% CI, 1.41-12.06) neuroendocrine neoplasms had significantly worse overall survival than grade I neuroendocrine neoplasms. Patients with small neuroendocrine neoplasms of small bowel had significantly increased survival (hazard ratio, 0.39; 95% CI, 0.18-0.87) compared to neuroendocrine neoplasms of other locations. Median progression-free survival was 41 (35.9-46.1) months and significantly inferior in patients treated with Yttrium solely (hazard ratio, 2.7; 95% CI, 1.71-4.55). Complete remission was observed in 5.6% of patients, 22.4% had a partial remission, 47.3% were stable and 4% were progressive as best response. Adverse events of bone marrow

  6. Determinants of survival in adult HIV patients on antiretroviral therapy in Eastern Uttar Pradesh: A prospective study

    Directory of Open Access Journals (Sweden)

    Jaya Chakravarty

    2014-01-01

    Full Text Available Background & objectives: The National AIDS Control Organization (NACO of India has been providing free ARV (antiretroviral drugs since 2004. b0 y 2012, 486,173 patients had received treatment through the antiretroviral therapy (ART centres. The objective of this observational study was to assess the factors determining survival of patients on ART under routine programme conditions in an ART centre in north India five years after its inception. Methods: Treatment naive HIV positive patients who were enrolled in the ART centre between May 2009 and May 2010 and started on ART as per the Revised NACO guidelines 2009, were included in the study and outcome was assessed after two years of follow up. Results: A total of 1689 patients were included in the analysis, of whom 272 (16.10% expired, 205 (12.13% were lost to follow up (LFU, 526 (31.14% were transferred out to other facilities and 686 (40.63% were alive at the end of two years. Majority (92% of the deaths occurred in the first six months of therapy. Age >30 yr, male gender, poor functional status, haemoglobin level <11 g/dl, body weight <45 kg and CD4 count <100/μl at baseline had significantly higher relative hazard of death. Most LFU also occurred in the first six months and these patients had significantly low CD4 count, weight, haemoglobin level and higher number of patients in Stages III and IV as compared to those who survived. Interpretation & conclusions: The study findings revealed poor survival in the first six months of therapy especially in those with severe immunosuppression. This emphasizes the need for early enrolment into the programme. The high LFU occurring early after initiation of therapy suggests the urgent need to build an efficient patient retrieval system in the programme.

  7. [Establishment of an Animal Based Therapy at a University Hospital for Psychiatry: Results of a Preliminary Study and Future Prospects].

    Science.gov (United States)

    Hartfiel, Cajetan; Bodatsch, Mitja; Klosterkötter, Joachim; Kuhn, Jens

    2017-01-01

    Objective: Dogs have been integrated in human society over centuries. This process has selected unique social and communicative skills. Dogs are thus able to represent social substitutes for human counterparts in cases of social withdrawal. Furthermore, dogs act as "social catalysts" in promoting interhuman encounters. Thus, the integration of dogs in psychotherapeutic concepts addressing social and interpersonal deficits may be of special interest. Methods: The present investigation reports the results of a pilot study to establish animal-assisted therapy (dogs) at a psychiatric department. The animal-assisted intervention straddled the following areas: (1) contact making, communication and orientation to needs, (2) recreation and play, (3) outward orientation, (4) release and farewell. The sample comprised 22 subjects. Results: The results demonstrated in particular that the animal-assisted intervention significantly promoted unspecific aspects of positive affectivity and wellbeing. Evaluation of the overall acceptance of the dog on the psychiatric ward revealed very positive feedback. Conclusions: We conclude that animal-assisted therapies represent a significant enchrichment of the therapeutic context, that may be used to enhance the patients' openness and adherence to conventional therapies. © Georg Thieme Verlag KG Stuttgart · New York.

  8. Treatment of severe glaucomatous visual field deficit by chiropractic spinal manipulative therapy: a prospective case study and discussion.

    Science.gov (United States)

    Wingfield, B R; Gorman, R F

    2000-01-01

    To discuss the case of a patient with severely reduced visual fields arising from terminal glaucomatous retinal damage and the treatment of this condition by spinal manipulation. A 25-year-old uniocular female patient with congenital glaucoma sought chiropractic treatment for spinal pain, headache, and classic migraine. Advanced optic disk cupping was present, and loss of vision was near complete. A 3-degree island of central vision and a small area of peripheral light sensitivity had remained relatively stable for 3 years after a trabeculectomy procedure that had resulted in intraocular hypotony. It was considered possible that chiropractic spinal manipulative therapy may have a positive outcome in visual performance. Before commencing chiropractic spinal manipulative therapy, an ophthalmologic examination was performed, and visual performance was monitored through a course of treatment. Immediately after the first treatment, significant visual field improvement was recorded in the remaining eye. Maximal improvement of vision was achieved after 1 week (4 treatment sessions). Total monocular visual field had increased from approximately 2% to approximately 20% of normal. Corrected central acuity had improved from 6/12 to 6/9. Independent reexamination by the patient's regular ophthalmic surgeon confirmed the results. Recovery of vision in this patient was an unexpected and remarkable outcome, raising the question of whether chiropractic spinal manipulative therapy may be of value in the management of glaucomatous visual field loss. More intensive research is required.

  9. Therapeutic efficacy of nonsteroidal anti-inflammatory drug therapy versus exercise therapy in patients with chronic nonspecific low back pain: a prospective study.

    Science.gov (United States)

    Takahashi, Naoto; Omata, Jun-Ichi; Iwabuchi, Masumi; Fukuda, Hironari; Shirado, Osamu

    2017-04-28

    Therapy for chronic, nonspecific low back pain is mainly conservative: medication and/or exercise. Pharmacotherapy, however, has side effects, and the quantities of concomitant drugs in older persons require attention. Although exercise promises improved function, its use to alleviate pain is controversial. Thus, we compared the efficacy of pharmacotherapy versus exercise for treating chronic nonspecific low back pain. The pharmacotherapy group (n=18: 8 men, 10 women) were prescribed celecoxib monotherapy. The exercise group (n=22: 10 men, 12 women) undertook stretching exercises. Because of drop-outs, the NSAID group (n=15: 7 men, 8 women) and the exercise group (n =18: 8 men, 10 women) were finally analyzed. We applied a visual analog scale, Roland-Morris disability scores, and the 36-Item Short Form Health Survey. We used a paired t-test for within-group analyses and an unpaired t-test for between-group analyses. Pain relief was achieved after 3 months of pharmacotherapy or exercise. Quality of life improved only in the exercise group. Recovery outcomes for the two groups were not significantly different. Efficacy of exercise therapy for strictly defined low back pain was almost equivalent to that of pharmacotherapy and provided better quality of life.

  10. No influence of parental origin of intact X chromosome and/or Y chromosome sequences on three-year height response to growth hormone therapy in Turner syndrome

    Directory of Open Access Journals (Sweden)

    Hye Jin Lee

    2014-09-01

    Full Text Available PurposeWhether parental origin of the intact X chromosome and/or the presence of Y chromosome sequences (Yseq play a role in three-year height response to growth hormone (GH were investigated.MethodsPaternal (Xp or maternal (Xm origin of X chromosome was assessed by microsatellite marker analysis and the presence of hidden Yseq was analyzed. The first-, second-, and third-year GH response was measured as a change in height z-score (Z_Ht in Turner syndrome (TS patients with 45,Xp (n=10, 45,Xm (n=15, and 45,X/46,X,+mar(Y (Xm_Yseq (n=8.ResultsThe mean baseline Z_Ht did not differ according to Xp or Xm origin, however the mean baseline Z_Ht was higher in the Xm_Yseq group than in Xm group, after adjusting for bone age delay and midparental Z_Ht (P=0.04. There was no difference in the height response to GH between the 3 groups. The height response to GH decreased progressively each year (P<0.001, such that the third-year increase in Z_Ht was not significant. This third-year decrease in treatment response was unaffected by Xp, Xm, and Xm_Yseq groups. Increasing GH dosage from the second to third-year of treatment positively correlated with the increase in Z_Ht (P=0.017.ConclusionThere was no evidence of X-linked imprinted genes and/or Yseq affecting height response to 3 years of GH therapy. Increasing GH dosages may help attenuate the decrease in third-year GH response in TS patients with 45,X and/or 46,X/+mar(Y.

  11. Diffusion-weighted MR enterography to monitor bowel inflammation after medical therapy in Crohn's disease: A prospective longitudinal study

    Energy Technology Data Exchange (ETDEWEB)

    Huh, Jimi; Park, Seong Ho; Park, So Hyun; Kim, Ah Young; Kim, Kyung Jo; Ye, Byong Duk; Park, Sang Hyoung [University of Ulsan College of Medicine, Asan Medical Center, Seoul (Korea, Republic of); Han, Kyung Hwa [Dept. of Radiology and Research Institute of Radiological Science, Yonsei University College of Medicine, Seoul (Korea, Republic of)

    2017-01-15

    To prospectively evaluate the performance of diffusion-weighted imaging (DWI) to monitor bowel inflammation after medical therapy for Crohn's disease (CD). Before and following 1–2 years of medical therapy, between October 2012 and May 2015, 18 randomly selected adult CD patients (male:female, 13:5; mean age ± SD, 25.8 ± 7.9 years at the time of enrollment) prospectively underwent MR enterography (MRE) including DWI (b = 900 s/mm2) and ileocolonoscopy. Thirty-seven prospectively defined index lesions (one contiguous endoscopy-confirmed inflamed area chosen from each inflamed anatomical bowel segment; 1–4 index lesions per patient; median, 2 lesions) were assessed on pre- and post-treatment MRE and endoscopy. Visual assessment of treatment responses on DWI in 4 categories including complete remission and reduced, unchanged or increased inflammation, and measurements of changes in apparent diffusion coefficient (ΔADC), i.e., pre-treatment–post-treatment, were performed by 2 independent readers. Endoscopic findings and CD MRI activity index (CDMI) obtained using conventional MRE served as reference standards. ΔADC significantly differed between improved (i.e., complete remission and reduced inflammation) and unimproved (i.e., unchanged or increased inflammation) lesions: mean ± SD (× 10-3 mm2/s) of -0.65 ± 0.58 vs. 0.06 ± 0.15 for reader 1 (p = 0.022) and -0.68 ± 0.56 vs. 0.10 ± 0.26 for reader 2 (p = 0.025). DWI accuracy for diagnosing complete remission or improved inflammation ranged from 76% (28/37) to 84% (31/37). A significant negative correlation was noted between ΔADC and ΔCDMI for both readers with correlation coefficients of -0.438 and -0.461, respectively (p < 0.05). DWI is potentially a feasible tool to monitor quantitatively and qualitatively bowel inflammation of CD after medical treatment.

  12. Original research paper. Switching antipsychotics: Results of 16-month non-interventional, prospective, observational clinical research of inpatients with schizophrenia spectrum disorders.

    Science.gov (United States)

    Bole, Cvetka Bačar; Pišlar, Mitja; Šen, Metka; Tavčar, Rok; Mrhar, Aleš

    2017-03-01

    The study aims to identify prescribing and switching patterns of antipsychotics in clinical practice. A 16-month, prospective study was conducted at the Psychiatric Hospital Idrija, Slovenia. Inpatients (N = 311) with schizophrenia spectrum disorders were observed. The causes for switching antipsychotics and switching strategies were analyzed. Analyzing a total of 3954 prescriptions, the collected data confirmed that treatment strategies in this psychiatric hospital are very complex. It was found that 37 percent of inpatients had at least one switch. Moreover, switches that included three or more antipsychotics were detected. The most common causes for switching antipsychotics were adverse reactions and inefficacy or lack of efficacy. Among switching options, abrupt switch was recorded several times. As some patients are receiving several antipsychotics at the same time, it is possible that unusual switching occurs in clinical practice. It seems that the choice of switching strategy is also affected by the cause and urgency for switching an antipsychotic.

  13. Prospective study of sequential volumetric changes of parotid gland in early oropharyngeal carcinoma patients treated by intensity-modulated radiation therapy: An institutional experience.

    Science.gov (United States)

    Patel, Pooja Nandwani; Goyal, Sumit; Shah, Anand; Gohel, Mehul; Suryanarayana, Unnikrishnan

    2018-01-01

    During course of radiation therapy, anatomical variations occur risking overdose of parotid gland. We tried to quantify volume of parotid gland and mean dose to parotid gland after every 10 fractions (#). We conducted the prospective study from July 2016 to May 2017 in 25 patients of early-stage oropharyngeal carcinoma. Patients had Karnofsy Performance Score of 80-100, median age was 54 years, and 18 patients were males. Patients were planned with intensity-modulated radiation therapy planning with dose as 66 Gy/30# to planning target volume (PTV) including primary and 54 Gy/30# to PTV-nodal including elective neck irradiation. After each 10#, replanning was done, and variations in parotid volume were studied including D mean (mean dose to parotids) and D 50 (the dose delivered to 50% of volume). Other tumor characteristic like PTV of primary was also assessed and minimum PTV volume covered by 95% isodose line was kept as 95%. Average parotid volumes decreased by the mean value of 10% and 6% for the left and right parotids, respectively, and PTV of primary target decreased by mean of 13%. The difference in D mean doses to parotid glands was 32% and 42% and difference in D 50 dose was 30% and 35% on the left and right side, respectively. The parotid volumes differ considerably during adaptive planning done after every ten fractions. These differences in parotid volumes and doses received to parotid glands play a significant role in the risk of xerostomia observed during later follow-up.

  14. Prospective, randomized, investigator-blinded study of the efficacy and safety of meropenem vs. cefotaxime therapy in bacterial meningitis in children. Meropenem Meningitis Study Group.

    Science.gov (United States)

    Odio, C M; Puig, J R; Feris, J M; Khan, W N; Rodriguez, W J; McCracken, G H; Bradley, J S

    1999-07-01

    To compare the efficacy and safety of meropenem with cefotaxime for the treatment of infants and children with bacterial meningitis. Infants and children with strongly suspected or documented bacterial meningitis were randomly assigned in a prospective multicenter study to receive either meropenem or cefotaxime. Patients were assessed at the end of therapy and at 5 to 7 weeks and 5 to 7 months after the end of treatment for the presence of neurologic and sensory neural sequelae. A total of 258 children were randomized to either treatment group. A further 8 patients with suspected pneumococcal meningitis were treated with meropenem without randomization. Of the randomized patients 154 were fully evaluable, 79 in the meropenem group and 75 in the cefotaxime group. At the end of treatment there were no significant differences in clinical outcome between the two treatment groups. Clinical cure with or without sequelae was achieved in 97 and 96% of the meropenem- and cefotaxime-treated patients, respectively. At the end of treatment and at 5 to 7 weeks, 46 and 54% of meropenem patients were cured with no sequelae, respectively. Corresponding results for cefotaxime patients were 56 and 58%. All pathogens were eradicated. In total 37 patients had seizures during treatment, 15 (12%) in the meropenem and 22 (17%) in the cefotaxime group. None of the seizures was considered to be drug-related. This trial shows that meropenem is suitable therapy for bacterial meningitis in infants and children and that it offers an efficacy and safety profile similar to that of cefotaxime.

  15. Severe metabolic or mixed acidemia on intensive care unit admission: incidence, prognosis and administration of buffer therapy. A prospective, multiple-center study.

    Science.gov (United States)

    Jung, Boris; Rimmele, Thomas; Le Goff, Charlotte; Chanques, Gérald; Corne, Philippe; Jonquet, Olivier; Muller, Laurent; Lefrant, Jean-Yves; Guervilly, Christophe; Papazian, Laurent; Allaouchiche, Bernard; Jaber, Samir

    2011-01-01

    In this study, we sought describe the incidence and outcomes of severe metabolic or mixed acidemia in critically ill patients as well as the use of sodium bicarbonate therapy to treat these illnesses. We conducted a prospective, observational, multiple-center study. Consecutive patients who presented with severe acidemia, defined herein as plasma pH below 7.20, were screened. The incidence, sodium bicarbonate prescription and outcomes of either metabolic or mixed severe acidemia were analyzed. Among 2, 550 critically ill patients, 200 (8%) presented with severe acidemia, and 155 (6% of the total admissions) met the inclusion criteria. Almost all patients needed mechanical ventilation and vasopressors during their ICU stay, and 20% of them required renal replacement therapy within the first 24 hours of their ICU stay. Severe metabolic or mixed acidemia was associated with a mortality rate of 57% in the ICU. Delay of acidemia recovery as opposed to initial pH value was associated with increased mortality in the ICU. The type of acidemia did not influence the decision to administer sodium bicarbonate. The incidence of severe metabolic or mixed acidemia in critically ill patients was 6% in the present study, and it was associated with a 57% mortality rate in the ICU. In contradistinction with the initial acid-base parameters, the rapidity of acidemia recovery was an independent risk factor for mortality. Sodium bicarbonate prescription was very heterogeneous between ICUs. Further studies assessing specific treatments may be of interest in this population.

  16. Severe metabolic or mixed acidemia on intensive care unit admission: incidence, prognosis and administration of buffer therapy. a prospective, multiple-center study

    Science.gov (United States)

    2011-01-01

    Introduction In this study, we sought describe the incidence and outcomes of severe metabolic or mixed acidemia in critically ill patients as well as the use of sodium bicarbonate therapy to treat these illnesses. Methods We conducted a prospective, observational, multiple-center study. Consecutive patients who presented with severe acidemia, defined herein as plasma pH below 7.20, were screened. The incidence, sodium bicarbonate prescription and outcomes of either metabolic or mixed severe acidemia were analyzed. Results Among 2, 550 critically ill patients, 200 (8%) presented with severe acidemia, and 155 (6% of the total admissions) met the inclusion criteria. Almost all patients needed mechanical ventilation and vasopressors during their ICU stay, and 20% of them required renal replacement therapy within the first 24 hours of their ICU stay. Severe metabolic or mixed acidemia was associated with a mortality rate of 57% in the ICU. Delay of acidemia recovery as opposed to initial pH value was associated with increased mortality in the ICU. The type of acidemia did not influence the decision to administer sodium bicarbonate. Conclusions The incidence of severe metabolic or mixed acidemia in critically ill patients was 6% in the present study, and it was associated with a 57% mortality rate in the ICU. In contradistinction with the initial acid-base parameters, the rapidity of acidemia recovery was an independent risk factor for mortality. Sodium bicarbonate prescription was very heterogeneous between ICUs. Further studies assessing specific treatments may be of interest in this population. PMID:21995879

  17. Psychological Stress and Coping Resources during Primary Systemic Therapy for Breast Cancer. Results of a Prospective Study.

    Science.gov (United States)

    Tschuschke, Volker; Karadaglis, Georgios; Evangelou, Kalliopi; Gräfin von Schweinitz, Clara; Schwickerath, Jürgen

    2017-02-01

    Introduction This prospective study reports on the impact of psychological factors on women with primary breast cancer undergoing neoadjuvant chemotherapy. These women are in a special situation, where they not only have to deal with the shock of the cancer diagnosis but also with the fact that the malignant tumor will not be removed immediately but only after completing chemotherapy. A situation like this is stressful and requires a personal strength which not every woman may have. Methods In a prospective study 53 patients were assessed using various psychological and psycho-oncological questionnaires which aimed to evaluate their psychological stress and their coping resources. The women were evaluated before starting systemic treatment (t-1) and again immediately after completing chemotherapy but prior to surgery (t-2). The patients were also asked about their coping strategies at t-1 and t-2. Using the Ulm Coping Manual (UCM) the interviews were rated by independent assessors blinded to the respective patient's medical data. Patients were followed up for 3.7-5.5 years after completing chemotherapy. Results Patients with poor psychosocial adjustment to the situation were identified prior to starting treatment (at t-1). The social coping strategies of these women were found to be inadequate. Their coping behavior was characterized by resignation and they did not attempt to seek social support. This was found to increase their overall risk of recurrence or of developing another type of malignancy during the follow-up period. The study also identified patients who coped significantly better with primary systemic treatment by strengthening their coping strategies. Conclusion Careful psychological screening of women's vulnerabilities or strengths immediately after the diagnosis and prior to any oncological treatment is strongly recommended. This would help to identify those patients early on who will require additional psycho-oncological support due to their

  18. A prospective study of hepatitis B virus markers in patients with chronic HBV infection from Brazilian families of Western and Asian origin

    Directory of Open Access Journals (Sweden)

    F.J. Carrilho

    2005-09-01

    Full Text Available The purpose of the present study was to determine the frequency of hepatitis B virus (HBV markers in families of HBsAg-positive patients with chronic liver disease. Serum anti-HBc, HBsAg and anti-HBs were determined by enzyme immunoassay and four subpopulations were considered: genetically related (consanguineous and non-genetically related (non-consanguineous Asian subjects and genetically related and non-genetically related Western subjects. A total of 165 and 186 relatives of Asian and Western origin were enrolled, respectively. The occurrence of HBsAg and anti-HBs antibodies was significantly higher (P < 0.0001 in family members of Asian origin (81.8% than in family members of Western origin (36.5%. HBsAg was also more frequent among brothers (79.6 vs 8.5%; P < 0.0001, children (37.9 vs 3.3%; P < 0.0001 and other family members (33.9 vs 16.7%; P < 0.0007 of Asian than Western origin, respectivelly. No difference between groups was found for anti-HBs, which was more frequently observed in fathers, spouses and other non-genetic relatives. HBV infection was significantly higher in children of Asian than Western mothers (P < 0.0004. In both ethnic groups, the mothers contributed more to their children's infection than the fathers (P < 0.0001. Furthermore, HBsAg was more frequent among consanguineous members and anti-HBs among non-consanguineous members. These results suggest the occurrence of vertical transmission of HBV among consanguineous members and probably horizontal sexual transmission among non-consanguineous members of a family cluster. Thus, the high occurrence of dissemination of HBV infection characterizes family members as a high-risk group that calls for immunoprophylaxis. Finally, the study showed a high familial aggregation rate for both ethnic groups, 18/19 (94.7% and 23/26 (88.5% of the Asian and Western origin, respectively.

  19. Relationship Between Radiation-Induced Apoptosis of T Lymphocytes and Chronic Toxicity in Patients With Prostate Cancer Treated by Radiation Therapy: A Prospective Study

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    Foro, Palmira, E-mail: pforo@parcdesalutmar.cat [Department of Radiation Oncology, Parc de Salut Mar, Barcelona (Spain); Universitat Pompeu Fabra, Barcelona (Spain); Algara, Manuel [Department of Radiation Oncology, Parc de Salut Mar, Barcelona (Spain); Universitat Pompeu Fabra, Barcelona (Spain); Lozano, Joan [Department of Radiation Oncology, Parc de Salut Mar, Barcelona (Spain); Rodriguez, Nuria; Sanz, Xavier [Department of Radiation Oncology, Parc de Salut Mar, Barcelona (Spain); Universitat Pompeu Fabra, Barcelona (Spain); Torres, Erica [Pathology Department, Parc de Salut Mar, Barcelona (Spain); Carles, Joan [Universitat Autonoma de Barcelona, Barcelona (Spain); Department of Oncology, Hospital Vall d' Hebron, Barcelona (Spain); Reig, Anna; Membrive, Ismael [Department of Radiation Oncology, Parc de Salut Mar, Barcelona (Spain); Quera, Jaume [Department of Radiation Oncology, Parc de Salut Mar, Barcelona (Spain); Universitat Pompeu Fabra, Barcelona (Spain); Fernandez-Velilla, Enric; Pera, Oscar [Department of Radiation Oncology, Parc de Salut Mar, Barcelona (Spain); Lacruz, Marti [Universitat Pompeu Fabra, Barcelona (Spain); Radiation Protection Department, Parc de Salut Mar, Barcelona (Spain); Bellosillo, Beatriz [Universitat Pompeu Fabra, Barcelona (Spain); Pathology Department, Parc de Salut Mar, Barcelona (Spain)

    2014-04-01

    Purpose: To assess the correlation of radiation-induced apoptosis in vitro of CD4 and CD8 T lymphocytes with late toxicity of prostate cancer patients treated with radiation therapy. Methods and Materials: 214 patients were prospectively included in the study. Peripheral blood was drawn from patients before treatment and irradiated with 8 Gy. The percentage of CD4+ and CD8+ T lymphocytes that underwent radiation-induced apoptosis was assessed by flow cytometry. Toxicity and mortality were correlated in 198 cases with pretreatment apoptosis and clinical and biological variables by use of a Cox proportional hazards model. Results: The mean percentage of CD4+ and CD8+ T lymphocyte radiation-induced apoptosis was 28.58% (±14.23) and 50.76% (±18.9), respectively. Genitourinary (GU) toxicity was experienced by 39.9% of patients, while gastrointestinal (GI) toxicity was experienced by 19.7%. The probability of development of GU toxicity was nearly doubled (hazard ratio [HR] 1.99, P=.014) in those patients in whom the percentage of in vitro radiation-induced apoptosis of CD4+ T-lymphocytes was ≤28.58%. It was also almost double in patients who received doses ≥50 Gy in 65% of the bladder volume (V65 ≥50) (HR 1.92, P=.048). No correlation was found between GI toxicity and any of the variables studied. The probability of death during follow-up, after adjustment for different variables, was 2.7 times higher in patients with a percentage of CD8+ T lymphocyte apoptosis ≤50.76% (P=.022). Conclusions: In conclusion, our study shows, in the largest prospective cohort of prostate cancer patients undergoing radiation therapy, that in vitro radiation-induced apoptosis of CD4+ T lymphocytes assessed before radiation therapy was associated with the probability of developing chronic GU toxicity. In addition, the radiation dose received in the urinary bladder (V65 ≥50) affected the occurrence of GU toxicity. Finally, we also demonstrate that radiation-induced apoptosis of

  20. Searching for existential security: a prospective qualitative study on the influence of mindfulness therapy on experienced stress and coping strategies among patients with somatoform disorders.

    Science.gov (United States)

    Lind, Annemette Bondo; Delmar, Charlotte; Nielsen, Klaus

    2014-12-01

    The aim was to explore how mindfulness group therapy for somatoform disorders influenced the patients' stress experiences, coping strategies and contextual psychosocial processes. A longitudinal pre- and post-treatment design, using 22 semi-structured individual pre- and post-treatment interviews. Data-analysis was based on a thematic methodology. Pre-treatment patients were struggling in an existential crisis, feeling existentially insecure about their social identity, the causes, consequences and management of their illness; experiencing difficulties identifying and expressing stress-related cognitions, emotions and feelings, and low bodily and emotional self-contact; often leading to avoidant coping, making these individuals highly stress-vulnerable. Post-treatment, the overall change was conceptualized as increased existential security, defined by patients being more self-confident; more clarified with their social identity, the nature, management and future prospects of their illness; generally using more flexible coping strategies to reduce their daily stress experiences. Four related subthemes were identified contributing to increased existential security: 1) more secure illness perceptions - feeling existentially recognized as "really" ill, 2) enhanced relaxation ability - using mindfulness techniques, 3) increased awareness - connecting differently to mind and body 4) improved ability to identify and express needs and feelings of distress - more active communicating. Patients suggested that mindfulness therapy could be expanded with more time for group-discussions followed by additional individual therapy. Generally, treatment positively influenced the patients' illness perceptions, stress-experiences, body- and self-awareness, coping strategies, self-image, social identity and social functioning. However, patients identified potentials for treatment improvements, and they needed further treatment to fully recover. Copyright © 2014 Elsevier Inc. All

  1. Incidence of Opportunistic Infections among HIV-Positive Adults on Highly Active Antiretroviral Therapy in a Teaching Hospital, India: Prospective Study.

    Science.gov (United States)

    Shenoy, Nandita; Ramapuram, John T; Shenoy, Ashok; Ahmed, Junaid; Srikant, N

    Oral manifestations in HIV infections are numerous and some of these are acknowledged as being of great importance in the early diagnosis of the disease. Many HIV-associated oral infections occur early in HIV disease, not infrequently as the presenting sign or symptom. Thus, early detection of the associated oral opportunistic infections should, in many cases, result in earlier diagnosis of HIV infection. Cytology, a simple, painless, and inexpensive method, has become a preferred method and was used in our study for early diagnosis of certain lesions. To determine the effect of highly active antiretroviral therapy on incidence rate of opportunistic infections among HIV-positive adults in a teaching hospital in India, a prospective study was conducted and the required sample size was 40. Study participants were selected randomly from the outpatient department of an HIV clinic who were currently on for antiretroviral therapy (ART). Data on age, gender, form of contagion, antiretroviral therapy at the time of review, number of CD4 lymphocytes per milliliter, and viral load were collected. Oral cytologic investigation was carried out and then stained for histopathological examination. A total of 40 individuals were examined and the incidence of opportunistic infections was 66.7% in individuals with CD4 counts less than 200, 55.6% in individuals with CD4 counts of 200 to 499, and 40.0% in individuals with CD4 counts more than 500. The incidence of opportunistic infection was higher in individuals with low CD4 counts in spite of being on ART.

  2. Prospective Clinical Trial of 18F-Fluciclovine PET/CT for Determining the Response to Neoadjuvant Therapy in Invasive Ductal and Invasive Lobular Breast Cancers.

    Science.gov (United States)

    Ulaner, Gary A; Goldman, Debra A; Corben, Adriana; Lyashchenko, Serge K; Gönen, Mithat; Lewis, Jason S; Dickler, Maura

    2017-07-01

    18 F-labeled 1-amino-3-fluorocyclobutane-1-carboxylic acid ( 18 F-fluciclovine) is a leucine analog radiotracer that depicts amino acid transport into cells. 18 F-fluciclovine PET/CT visualizes malignancy, including prostate cancer, invasive ductal breast cancer, and invasive lobular breast cancer. Whether changes in 18 F-fluciclovine avidity reflect changes in tumor burden resulting from treatment has not been shown. In this prospective clinical trial (clinical trials.gov: NCT01864083), changes in 18 F-fluciclovine avidity after neoadjuvant therapy were compared to breast cancer therapy response, as determined by residual tumor burden on pathology, were evaluated. Methods: Twenty-four women with a new diagnosis of locally advanced invasive ductal breast cancer ( n = 18) or invasive lobular breast cancer ( n = 6) underwent 18 F-fluciclovine PET/CT before and after the completion of neoadjuvant systemic therapy. SUV max , SUV mean , metabolic tumor volume, and total lesion avidity were obtained for the primary breast tumor, axillary lymph nodes, and extraaxillary lymph nodes on each examination and corrected for background 18 F-fluciclovine avidity. The relationship between changes in 18 F-fluciclovine avidity and the percentage of reduction of tumor on pathology was assessed with the Spearman rank correlation. Results: The median decrease in the corrected SUV max of the primary breast lesions was 99% (range, 33%-100%). The median reduction of tumor on pathology was 92% (range, 10%-100%). Changes in 18 F-fluciclovine avidity were strongly correlated with the percentage of reduction of tumor on pathology (Spearman ρ, 0.79; 95% CI, 0.56-0.90; P < 0.001). Conclusion: Changes in 18 F-fluciclovine avidity strongly correlated with the tumor response on pathology in this pilot study. © 2017 by the Society of Nuclear Medicine and Molecular Imaging.

  3. Attenuation of mania-like behavior in Na(+),K(+)-ATPase α3 mutant mice by prospective therapies for bipolar disorder: melatonin and exercise.

    Science.gov (United States)

    Kirshenbaum, G S; Burgess, C R; Déry, N; Fahnestock, M; Peever, J H; Roder, J C

    2014-02-28

    Bipolar disorder is a neuropsychiatric disease characterized by states of mania with or without depression. Pharmacological treatments can be inadequate at regulating mood for many individuals. Melatonin therapy and aerobic exercise are independent prospective therapies for bipolar disorder that have shown potential as mood stabilizers in humans. Myshkin mice (Myk/+) carry a heterozygous missense mutation in the neuronal Na(+),K(+)-ATPase α3 and model mania-related symptoms of bipolar disorder including increased activity, risk-taking behavior and reductions in sleep. One cohort of Myk/+ and wild-type littermates (+/+) was treated with melatonin and a separate cohort was treated with voluntary exercise. Mania-related behavior was assessed in both cohorts. The effect of melatonin on sleep and the effect of exercise on brain-derived neurotrophic factor (BDNF) expression in the hippocampus were assayed. Melatonin and voluntary wheel running were both effective at reducing mania-related behavior in Myk/+ but did not affect behavior in +/+. Melatonin increased sleep in Myk/+ and did not change sleep in +/+. Myk/+ showed higher baseline levels of BDNF protein in the hippocampus than +/+. Exercise increased BDNF protein in +/+ hippocampus, while it did not significantly affect BDNF levels in Myk/+ hippocampus. These findings support initial studies in humans indicating that melatonin and exercise are useful independent adjunct therapies for bipolar disorder. Their effects on mood regulation should be further examined in randomized clinical trials. Our results also suggest that hippocampal BDNF may not mediate the effects of exercise on mania-related behavior in the Myk/+ model of mania. Copyright © 2013 IBRO. Published by Elsevier Ltd. All rights reserved.

  4. Mortality Implications of Appropriate Implantable Cardioverter Defibrillator Therapy in Secondary Prevention Patients: Contrasting Mortality in Primary Prevention Patients From a Prospective Population-Based Registry.

    Science.gov (United States)

    Almehmadi, Fahad; Porta-Sánchez, Andreu; Ha, Andrew C T; Fischer, Hadas D; Wang, Xuesong; Austin, Peter C; Lee, Douglas S; Nanthakumar, Kumaraswamy

    2017-08-19

    We sought to examine the mortality impact of appropriate implantable cardioverter defibrillator (ICD) therapy between patients who received ICD for primary versus secondary prevention purposes. From a prospective, population-based registry, we identified 7020 patients who underwent de novo ICD implantation between February 2007 and May 2012 in Ontario, Canada. The primary outcome was all-cause mortality. We used multivariable Cox proportional hazard modeling to adjust for differences in baseline characteristics and analyzed the mortality impact of first appropriate ICD therapy (shock and antitachycardia pacing [ATP]) as a time-varying covariate. There were 1929 (27.5%) patients who received ICDs for secondary prevention purposes. The median follow-up period was 5.02 years. Compared with those with secondary prevention ICDs, patients with primary prevention ICDs had more medical comorbidities, and lower ejection fraction. Patients who experienced appropriate ICD shock or ATP had greater risk of death compared with those who did not, irrespective of implant indication. In the primary prevention group, the adjusted hazard ratios of death for appropriate shock and ATP were 2.00 (95% CI: 1.72-2.33) and 1.73 (95% CI: 1.52-1.97), respectively. In the secondary prevention group, the adjusted hazard ratios of death for appropriate ICD shock and ATP were 1.46 (95% CI: 1.20-1.77) and 1.38 (95% CI: 1.16-1.64), respectively. Despite having a more favorable clinical profile, occurrence of appropriate ICD shock or ATP in patients with secondary prevention ICDs was associated with similar magnitudes of mortality risk as those with primary prevention ICDs. A heightened degree of care is warranted for all patients who experience appropriate ICD shock or ATP therapy. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

  5. Stereotactic Body Radiation Therapy Can Be Used Safely to Boost Residual Disease in Locally Advanced Non-Small Cell Lung Cancer: A Prospective Study

    Energy Technology Data Exchange (ETDEWEB)

    Feddock, Jonathan, E-mail: jmfedd0@uky.edu [Department of Radiation Medicine, University of Kentucky, Lexington, Kentucky (United States); Arnold, Susanne M. [Department of Radiation Medicine, University of Kentucky, Lexington, Kentucky (United States); Department of Medical Oncology, University of Kentucky, Lexington, Kentucky (United States); Shelton, Brent J. [Department of Biostatistics, University of Kentucky, Lexington, Kentucky (United States); Sinha, Partha; Conrad, Gary [Department of Radiology, University of Kentucky, Lexington, Kentucky (United States); Chen, Li [Department of Biostatistics, University of Kentucky, Lexington, Kentucky (United States); Rinehart, John [Department of Medical Oncology, University of Kentucky, Lexington, Kentucky (United States); McGarry, Ronald C. [Department of Radiation Medicine, University of Kentucky, Lexington, Kentucky (United States)

    2013-04-01

    Purpose: To report the results of a prospective, single-institution study evaluating the feasibility of conventional chemoradiation (CRT) followed by stereotactic body radiation therapy (SBRT) as a means of dose escalation for patients with stage II-III non-small cell lung cancer (NSCLC) with residual disease. Methods and Materials: Patients without metastatic disease and with radiologic evidence of limited residual disease (≤5 cm) within the site of the primary tumor and good or complete nodal responses after standard CRT to a target dose of 60 Gy were considered eligible. The SBRT boost was done to achieve a total combined dose biological equivalent dose >100 Gy to the residual primary tumor, consisting of 10 Gy × 2 fractions (20 Gy total) for peripheral tumors, and 6.5 Gy × 3 fractions (19.5 Gy total) for medial tumors using the Radiation Therapy Oncology Group protocol 0813 definitions. The primary endpoint was the development of grade ≥3 radiation pneumonitis (RP). Results: After a median follow-up of 13 months, 4 patients developed acute grade 3 RP, and 1 (2.9%) developed late and persistent grade 3 RP. No patients developed grade 4 or 5 RP. Mean lung dose, V2.5, V5, V10, and V20 values were calculated for the SBRT boost, and none were found to significantly predict for RP. Only advancing age (P=.0147), previous smoking status (P=.0505), and high CRT mean lung dose (P=.0295) were significantly associated with RP development. At the time of analysis, the actuarial local control rate at the primary tumor site was 82.9%, with only 6 patients demonstrating recurrence. Conclusions: Linear accelerator-based SBRT for dose escalation of limited residual NSCLC after definitive CRT was feasible and did not increase the risk for toxicity above that for standard radiation therapy.

  6. Health-Related Quality of Life After Stereotactic Body Radiation Therapy for Localized Prostate Cancer: Results From a Multi-institutional Consortium of Prospective Trials

    Energy Technology Data Exchange (ETDEWEB)

    King, Christopher R., E-mail: crking@mednet.ucla.edu [Department of Radiation Oncology, University of California, Los Angeles, California (United States); Collins, Sean [Department of Radiation Oncology, Georgetown University, Washington, District of Columbia (United States); Fuller, Donald [Genesis Healthcare Partners, San Diego, California (United States); Wang, Pin-Chieh; Kupelian, Patrick; Steinberg, Michael [Department of Radiation Oncology, University of California, Los Angeles, California (United States); Katz, Alan [Flushing Radiation Oncology, Flushing, New York (United States)

    2013-12-01

    Purpose: To evaluate the early and late health-related quality of life (QOL) outcomes among prostate cancer patients following stereotactic body radiation therapy (SBRT). Methods and Materials: Patient self-reported QOL was prospectively measured among 864 patients from phase 2 clinical trials of SBRT for localized prostate cancer. Data from the Expanded Prostate Cancer Index Composite (EPIC) instrument were obtained at baseline and at regular intervals up to 6 years. SBRT delivered a median dose of 36.25 Gy in 4 or 5 fractions. A short course of androgen deprivation therapy was given to 14% of patients. Results: Median follow-up was 3 years and 194 patients remained evaluable at 5 years. A transient decline in the urinary and bowel domains was observed within the first 3 months after SBRT which returned to baseline status or better within 6 months and remained so beyond 5 years. The same pattern was observed among patients with good versus poor baseline function and was independent of the degree of early toxicities. Sexual QOL decline was predominantly observed within the first 9 months, a pattern not altered by the use of androgen deprivation therapy or patient age. Conclusion: Long-term outcome demonstrates that prostate SBRT is well tolerated and has little lasting impact on health-related QOL. A transient and modest decline in urinary and bowel QOL during the first few months after SBRT quickly recovers to baseline levels. With a large number of patients evaluable up to 5 years following SBRT, it is unlikely that unexpected late adverse effects will manifest themselves.

  7. Bleeding tendency in dual antiplatelet therapy with aspirin/clopidogrel: rescue of the template bleeding time in a single-center prospective study

    Directory of Open Access Journals (Sweden)

    Altman Raul

    2012-01-01

    Full Text Available Abstract Background Patients with heightened platelet reactivity in response to antiplatelet agents are at an increased risk of recurrent ischemic events. However, there is a lack of diagnostic criteria for increased response to combined aspirin/clopidogrel therapy. The challenge is to identify patients at risk of bleeding. This study sought to characterize bleeding tendency in patients treated with aspirin and clopidogrel. Patients/methods In a single-center prospective study, 100 patients under long-term aspirin/clopidogrel treatment, the effect of therapy was assayed by template bleeding time (BT and the inhibition of platelet aggregation (IPA by light transmission aggregometry (LTA. Arachidonic acid (0.625 mmol/L and adenosine diphosphate (ADP; 2, 4, and 8 μmol/L were used as platelet agonists. Results Bleeding episodes (28 nuisance, 2 hematuria [1 severe], 1 severe proctorrhagia, 1 severe epistaxis were significantly more frequent in patients with longer BT. Template BT ≥ 24 min was associated with bleeding episodes (28 of 32. Risk of bleeding increased 17.4% for each 1 min increase in BT. Correlation was found between BT and IPAmax in response to ADP 2 μmol/L but not to ADP 4 or 8 μmol/L. Conclusion In patients treated with dual aspirin/clopidogrel therapy, nuisance and internal bleeding were significantly associated with template BT and with IPAmax in response to ADP 2 μmol/L but not in response to ADP 4 μmol/L or 8 μmol/L.

  8. Accuracy of Consecutive Fecal Calprotectin Measurements to Predict Relapse in Inflammatory Bowel Disease Patients Under Maintenance With Anti-TNF Therapy: A Prospective Longitudinal Cohort Study.

    Science.gov (United States)

    Ferreiro-Iglesias, Rocio; Barreiro-de Acosta, Manuel; Lorenzo-Gonzalez, Aurelio; Dominguez-Muñoz, Juan E

    2018-03-01

    Predicting relapse in inflammatory bowel disease (IBD) patients could allow early changes in therapy. We aimed at evaluating the accuracy of consecutive fecal calprotectin (FC) measurements to predict flares in IBD patients under maintenance treatment with anti-tumor necrosis factor (TNF) drugs. A prospective longitudinal cohort study with 16-month follow-up period was designed. IBD patients in clinical remission for at least 6 months under anti-TNF therapy were included. FC was quantified at 4-month intervals for 1 year, and patients were clinically evaluated for relapse at 2-month intervals. Diagnostic accuracy of FC for predicting relapse was evaluated by receiver-operating characteristic curve analysis. In total, 95 of 106 included patients finalized the study and were analyzed (median age 44 y, 50.5% female, 75% with Crohn's disease). A total of 30 patients (31.6%) had a relapse over follow-up. FC concentration was significantly higher in patients who relapsed (477 μg/g) than in patients who maintained in remission (65 μg/g) (Ppredict remission was 130 μg/g (negative predictive value of 100%), and 300 μg/g to predict relapse (positive predictive value of 78.3%). FC is a good predictor of clinical relapse and a particularly good predictor of remission over the following 4 months in patients with IBD on maintenance therapy with anti-TNF drugs. FC levels 300 μg/g allow predicting relapse with a high probability at any time over the following 4 months.

  9. Promising prospects for 44Sc-/47Sc-based theragnostics: application of 47Sc for radionuclide tumor therapy in mice.

    Science.gov (United States)

    Müller, Cristina; Bunka, Maruta; Haller, Stephanie; Köster, Ulli; Groehn, Viola; Bernhardt, Peter; van der Meulen, Nicholas; Türler, Andreas; Schibli, Roger

    2014-10-01

    In recent years, (47)Sc has attracted attention because of its favorable decay characteristics (half-life, 3.35 d; average energy, 162 keV; Eγ, 159 keV) for therapeutic application and for SPECT imaging. The aim of the present study was to investigate the suitability of (47)Sc for radionuclide therapy in a preclinical setting. For this purpose a novel DOTA-folate conjugate (cm10) with an albumin-binding entity was used. (47)Sc was produced via the (46)Ca(n,γ)(47)Ca[Formula: see text](47)Sc nuclear reaction at the high-flux reactor at the Institut Laue-Langevin. Separation of the (47)Sc from the target material was performed by a semi-automated process using extraction chromatography and cation exchange chromatography. (47)Sc-labeled cm10 was tested on folate receptor-positive KB tumor cells in vitro. Biodistribution and SPECT imaging experiments were performed in KB tumor-bearing mice. Radionuclide therapy was conducted with two groups of mice, which received either (47)Sc-cm10 (10 MBq) or only saline. Tumor growth and survival time were compared between the two groups of mice. Irradiation of (46)Ca resulted in approximately 1.8 GBq of (47)Ca, which subsequently decayed to (47)Sc. Separation of (47)Sc from (47)Ca was obtained with 80% yield in only 10 min. The (47)Sc was then available in a small volume (∼500 μL) of an ammonium acetate/HCl (pH 4.5) solution suitable for direct radiolabeling. (47)Sc-cm10 was prepared with a radiochemical yield of more than 96% at a specific activity of up to 13 MBq/nmol. In vitro (47)Sc-cm10 showed folate receptor-specific binding and uptake into KB tumor cells. In vivo SPECT/CT images allowed the visualization of accumulated radioactivity in KB tumors and in the kidneys. The therapy study showed a significantly delayed tumor growth in mice, which received (47)Sc-cm10 (10 MBq, 10 Gy) resulting in a more than 50% increase in survival time, compared with untreated control mice. With this study, we demonstrated the suitability of

  10. Radiation therapy of prostate cancer: rationale, pitfalls and the continuing prospect of success forged by medical physics.

    Science.gov (United States)

    Williams, S G

    2009-09-01

    Radiation therapy aimed at curing prostate cancer forms a considerable workload in most contemporary radiation oncology departments. The wide range of currently available therapeutic strategies for this cancer and their increasing complexity further increases the impact these patients have within the treating unit. Grounded in basic anatomy, physiology and pathology, the rationale for the division of prostate cancers into different prognostic and therapeutic groups is discussed, and put into clinical context using the current research evidence base. Weaknesses in this evidence base are highlighted in relation to areas directly impacted on by the work of medical physics.

  11. Onychomycosis in patients of nail psoriasis on biologic therapy: a randomized, prospective open label study comparing Etanercept, Infliximab and Adalimumab.

    Science.gov (United States)

    Al-Mutairi, Nawaf; Nour, Tarek; Al-Rqobah, Duha

    2013-05-01

    The association between patients of psoriasis on anti TNF therapy and onychomycosis has not been explored. The aim of this study was to determine the rate of onychomycosis in patients of psoriasis with nail involvement on anti TNF therapy. All patients of psoriasis with nail involvement seen between February 2007 - July 2012 were examined. All the patients with negative nail scrapings for fungus were enrolled. Patients found fit for biologics after investigations were randomly divided into 3 groups (Group A: Infliximab, Group B: Etanercept and Group C: Adalimumab). The patients were followed up every 4 weeks for 24 weeks. Repeat nail scrapings were done at week 24. The results were compared with controls. In total, 315 (178 males and 137 females) patients were enrolled. The mean age was 37.5 ± 11.4 years. The results for scraping for fungus at the end of 24 weeks were as follows: 33% (33/100) in patients on Infliximab followed by 15.45% (17/110), 13.33% (14/105) in patients on treatment with Etanercept and Adalimumab respectively as compared to 13.89% (25/180) among controls. Onychomycosis in association with nail psoriasis was more common in males. This study revealed statistically significant association between fungal infections of the nail in patients of psoriasis on treatment with Infliximab.

  12. Aliskiren add-on therapy effectively reduces proteinuria in chronic kidney disease: an open-label prospective trial.

    Science.gov (United States)

    Wu, Men-Tai; Tung, Shi-Cheng; Hsu, Kao-Tai; Lee, Chien-Te

    2014-09-01

    The combination therapy of aliskiren and renin-angiotensin-aldosterone system (RAAS) blocker in chronic kidney disease (CKD) is controversial. Whether such dual blockade can effectively apply to patients with CKD irrespective of stage and amount of proteinuria remains uncertain. We added aliskiren at a dosage of 150 mg/day for six months in 103 Chinese CKD patients who had been treated with angiotensin converting enzyme inhibitors (ACEis) or angiotensin receptor blockers (ARBs) and still had significant proteinuria or uncontrolled hypertension. Blood pressure, serum creatinine, estimated glomerular filtration rate (eGFR), potassium, and spot urine protein-to-creatinine ratio (UPCR) were measured at three and six months after aliskiren add-on therapy and compared with baseline. The combination of aliskiren and ACEi or ARB significantly reduced UPCR by 23% (p=0.001) and mean arterial pressure by 7.9 ± 13.8 mmHg (pproteinuria and inadequately controlled blood pressure. © The Author(s) 2012.

  13. Addiction treatment intervention: an uncontrolled prospective pilot study of Spiritual Self-Schema therapy with Latina women.

    Science.gov (United States)

    Amaro, Hortensia; Magno-Gatmaytan, Cielo; Meléndez, Michael; Cortés, Dharma E; Arevalo, Sandra; Margolin, Arthur

    2010-04-01

    Spiritual Self-Schema (3-S) is a weekly 8-session, mindfulness-based, manual-guided, individual intervention targeting addiction and human immunodeficiency virus (HIV) risk behaviors that integrates cognitive behavioral strategies with Buddhist principles and clients' religious/spiritual beliefs. 3-S is efficacious for reducing drug use and HIV risk behaviors among mixed-gender, methadone-maintained outpatients. The study goal was to conduct a preliminary evaluation of 3-S therapy among urban, low-income Latinas (n = 13) in residential addiction treatment. Data gathered via in-person interviews (baseline, 8 and 20 weeks postentry) showed high rates of 3-S acceptability and positive changes in a number of outcomes relevant to recovery from addiction and to HIV prevention, including impulsivity, spirituality, motivation for change, and HIV prevention knowledge. The study findings are promising; however, a controlled study with longer follow-up is needed to rigorously assess the efficacy of 3-S therapy with Latinas in substance abuse treatment.

  14. Association of hemolysis with high dose intravenous immunoglobulin therapy in pediatric patients: An open-label prospective trial.

    Science.gov (United States)

    Akman, Alkim Oden; Kara, Fatma Karaca; Koksal, Tulin; Cakir, Bahar Cuhaci; Karagol, Cuneyt; Sayli, Tulin

    2017-08-01

    Immunoglobulin therapy can be used to treat a wide variety of diseases. However, intravenous immunoglobin products can cause several adverse reactions, including hemolysis. The objective of this study was to determine the extent of anemia and hemolysis after high dose intravenous immunoglobin (2g/kg) and its relationship to the ABO blood type system and hemolytic anemia blood parameters in pediatric patients. Incidence of 'Intravenous immunoglobulin related hemolysis' was %19 (6/31) after high dose intravenous immunoglobulin therapy. The blood parameters were measured before IVIG infusion (1-24h before infusion) and 3-10 days after the first day of infusion. In terms of decrease in Hb levels; decline of 2g/dL (severe hemolysis) in 4 patients (12.9%) after infusion. The decrease in hemoglobin, haptoglobin levels, the increase of reticulocyte count or direct bilirubin were statistically significant after infusion. Five of 6 hemolysis patients had non-O blood group, however statistically significant difference was not noted between these two groups. Also, intravenous immunoglobulin-related hemolysis was determined significantly higher in female than male patients. Mild to moderate hemolysis may be undetected after infusion and the true incidence of such reactions is difficult to document without careful clinical and laboratory follow-up. A careful risk assessment analysis should be performed before intravenous immunoglobulin infusion. Copyright © 2017 Elsevier Ltd. All rights reserved.

  15. Serum lipid profile changes after successful treatment with electroconvulsive therapy in major depression: A prospective pilot trial.

    Science.gov (United States)

    Aksay, Suna Su; Bumb, Jan Malte; Janke, Christoph; Biemann, Ronald; Borucki, Katrin; Lederbogen, Florian; Deuschle, Michael; Sartorius, Alexander; Kranaster, Laura

    2016-01-01

    Cholesterol is reduced in depressed patients, however, these patients have a higher risk for cardiovascular diseases. Electroconvulsive therapy (ECT) is a highly effective treatment option for specific forms of depression. Like for other non-pharmacological therapies targeting depression such as psychotherapy or sleep deprivation, there is a lack of evidence about the effects on peripheral lipid parameters. Our objective was to study the impact of ECT as a non-pharmacological treatment on the peripheral lipid pattern in depressive patients. Peripheral lipid profile composition before and after a course of ECT was analysed in 27 non-fasting inpatients at a university psychiatric hospital with DSM-IV major depressive episode. For the impact of ECT treatment on each lipid parameter a multivariate repeated measurement regression analysis was performed and computed separately for every dependent variable. Total Cholesterol and the cholesterol subtypes HDL and LDL were increased after the treatment compared to baseline. Apolipoprotein A1 was also increased after ECT, whereas apolipoprotein B was not. Indices for the prediction of cardiovascular diseases were unchanged after successful treatment by ECT. The reduction of depressive psychopathology negatively correlated with increases of HDL cholesterol and apolipoprotein A1. Subjects received several antidepressants and other psychotropic medication before and during the ECT. In our preliminary pilot study ECT as a non-pharmacological, effective treatment of depression led to distinct effects on the peripheral lipid pattern. Copyright © 2015 Elsevier B.V. All rights reserved.

  16. Changes in oral health-related quality of life during fixed orthodontic appliance therapy: an 18-month prospective longitudinal study.

    Science.gov (United States)

    Liu, Zhijian; McGrath, Colman; Hägg, Urban

    2011-02-01

    There is an increasing research interest in quality of life issues in orthodontics. In this study, we aimed to investigate changes in oral health related quality of life (OHRQoL) among adults during fixed orthodontic appliance therapy (FOAT). Two hundred thirty-two adult patients were enrolled from a consecutive sample at a university dental hospital. OHRQoL was assessed by 2 standardized instruments (OHIP-14 and OHQoL-UK) at 4 times: before treatment (T0), 6 months after bonding and banding (T1), 12 months after bonding and banding (T2), and 18 months after bonding and banding (T3). Friedman 2-way analysis of variance (ANOVA) and Wilcoxon signed rank tests were used to compare the relative changes of OHRQoL among the different time points. Significant changes in the summary scores of both the OHIP-14 and OHQoL-UK were observed during fixed orthodontic treatment (P orthodontic appliance therapy. In the early phase of treatment, the greatest deterioration in OHRQoL occurs. With ongoing treatment, the detrimental effects to OHRQoL are reduced. Copyright © 2011 American Association of Orthodontists. Published by Mosby, Inc. All rights reserved.

  17. Effects of Levothyroxine Replacement Therapy on Parameters of Metabolic Syndrome and Atherosclerosis in Hypothyroid Patients: A Prospective Pilot Study

    Directory of Open Access Journals (Sweden)

    Zoran Gluvic

    2015-01-01

    Full Text Available The aim of this study was to investigate the effect of levothyroxine (LT4 replacement therapy during three months on some parameters of metabolic syndrome and atherosclerosis in patients with increased thyroid-stimulating hormone (TSH level. This study included a group of 30 female patients with TSH level >4 mIU/L and 15 matched healthy controls. Intima media complex thickness (IMCT and peak systolic flow velocity (PSFV of superficial femoral artery were determined by Color Doppler scan. In hypothyroid subjects, BMI, SBP, DBP, and TSH were significantly increased versus controls and decreased after LT4 administration. FT4 was significantly lower in hypothyroid subjects compared with controls and significantly higher by treatment. TC, Tg, HDL-C, and LDL-C were similar to controls at baseline but TC and LDL-C were significantly decreased by LH4 treatment. IMCT was significantly increased versus controls at baseline and significantly reduced by treatment. PSFV was similar to controls at baseline and significantly decreased on treatment. In this study, we have demonstrated the effects of LT4 replacement therapy during three months of treatment on correction of risk factors of metabolic syndrome and atherosclerosis.

  18. The Experience of Electroconvulsive Therapy in the 1980s: A Prospective Study of the Knowledge, Opinions, and Experience of California Electroconvulsive Therapy Patients in the Berkeley Years.

    Science.gov (United States)

    Baxter, Lewis R.; Roy-Byrne, Peter; Liston, Edward H.; Fairbanks, Lynn

    1986-01-01

    In 1982, the city of Berkeley, California voted to make the use of electroconvulsive therapy (ECT) a crime. Though later overturned, this ordinance generated much publicity and underscored the public's general negative view of ECT. In this climate, the authors surveyed first-time ECT recipients (n = 35), and a group with prior ECT (n = 20) to examine patient knowledge, experience, and opinions of ECT in California in the 1980s. Patients in both groups believed ECT should be available and did not think it was used for punishment or control. First-time ECT patients showed good understanding of the ECT process, thought that they had adequate information with which to decide about ECT, and were optimistic about the outcome. In comparison, those with prior ECT were less knowledgeable, less sure about the ECT process, less optimistic about the outcome, and more frightened of the procedure. After treatment, first-time ECT patients believed they had made a good decision to have ECT and that they were helped. Complaints of memory dysfunction were common. Patients who received ECT in the past may have had a more negative experience with ECT than those undergoing the procedure in the 1980s. These more negative experiences may have determined present media presentations and, therefore, had an influence on present day public attitudes against ECT. Accurate portrayals of ECT, as it is done today, may improve public attitudes toward ECT and forestall adverse legislation.

  19. Therapy of Hypoparathyroidism With PTH(1-84): A Prospective Six Year Investigation of Efficacy and Safety.

    Science.gov (United States)

    Rubin, Mishaela R; Cusano, Natalie E; Fan, Wen-Wei; Delgado, Yasmine; Zhang, Chengchen; Costa, Aline G; Cremers, Serge; Dworakowski, Elzbieta; Bilezikian, John P

    2016-07-01

    Human recombinant (rh)PTH(1-84) was recently approved for the treatment of refractory hypoparathyroidism, based upon a short-term phase 3 clinical trial. Long-term data are needed, because no time limit was placed on the treatment period. We studied the effect of long-term rhPTH(1-84) treatment in hypoparathyroidism for up to 6 years. Prospective open-label study. Referral center. A total of 33 subjects with hypoparathyroidism. rhPTH(1-84) treatment was initiated at a starting dose of 100 μg every other day for 6 years. Due to the availability of new dosages during the 6-year time period of the study, the dose could be and was adjusted for most patients to a daily dosing regimen. Supplemental calcium and vitamin D requirements, serum and urinary calcium (monthly for 6 mo and then biannually), serum phosphorus, bone turnover markers, and bone mineral density (BMD) biannually. Treatment with rhPTH(1-84) progressively reduced supplemental calcium requirements over 6 years by 53% (P hypoparathyroidism for 6 years with rhPTH(1-84) is associated with reductions in supplemental calcium and calcitriol requirements, stable serum calcium concentration, and reduced urinary calcium excretion. The safety profile remains good. These data represent the longest experience with the therapeutic use of PTH for any condition and demonstrate its long-term efficacy and safety in hypoparathyroidism.

  20. Therapy of Hypoparathyroidism With PTH(1–84): A Prospective Six Year Investigation of Efficacy and Safety

    Science.gov (United States)

    Cusano, Natalie E.; Fan, Wen-Wei; Delgado, Yasmine; Zhang, Chengchen; Costa, Aline G.; Cremers, Serge; Dworakowski, Elzbieta; Bilezikian, John P.

    2016-01-01

    Context: Human recombinant (rh)PTH(1–84) was recently approved for the treatment of refractory hypoparathyroidism, based upon a short-term phase 3 clinical trial. Long-term data are needed, because no time limit was placed on the treatment period. Objective: We studied the effect of long-term rhPTH(1–84) treatment in hypoparathyroidism for up to 6 years. Design: Prospective open-label study. Setting: Referral center. Patients: A total of 33 subjects with hypoparathyroidism. Interventions: rhPTH(1–84) treatment was initiated at a starting dose of 100 μg every other day for 6 years. Due to the availability of new dosages during the 6-year time period of the study, the dose could be and was adjusted for most patients to a daily dosing regimen. Main Outcome Measures: Supplemental calcium and vitamin D requirements, serum and urinary calcium (monthly for 6 mo and then biannually), serum phosphorus, bone turnover markers, and bone mineral density (BMD) biannually. Results: Treatment with rhPTH(1–84) progressively reduced supplemental calcium requirements over 6 years by 53% (P hypoparathyroidism for 6 years with rhPTH(1–84) is associated with reductions in supplemental calcium and calcitriol requirements, stable serum calcium concentration, and reduced urinary calcium excretion. The safety profile remains good. These data represent the longest experience with the therapeutic use of PTH for any condition and demonstrate its long-term efficacy and safety in hypoparathyroidism. PMID:27144931

  1. Quality of life, fatigue and local response of patients with unstable spinal bone metastases under radiation therapy - a prospective trial

    International Nuclear Information System (INIS)

    Rief, Harald; Heinhold, Maximiliane; Bruckner, Thomas; Schlampp, Ingmar; Förster, Robert; Welzel, Thomas; Bostel, Tilman; Debus, Jürgen; Rieken, Stefan

    2014-01-01

    To evaluate the local response according to stability after radiotherapy (RT) with a special focus on quality-of-life (QoL), fatigue, pain and emotional distress in patients with unstable spinal bone metastases. In this prospective trial, 30 patients were treated from September 2011 until March 2013. The stability of osteolytic metastases in the thoracic and lumbar spine was evaluated on the basis of the Taneichi-score after three and six months. EORTC QLQ-BM22, EORTC QLQ-FA13, and QSC-R10 were assessed at baseline, and three months after RT. After 3 months, 25% (n = 6) and after 6 months 33.3% (n = 8) were classified as stable. QoL, fatigue, and emotional distress showed no difference over the course. The pain response 3 months after RT showed a significant difference (p < 0.001). Pathological fractures occurred in 8.3% of the patients (n = 2) within six months following RT. Our trial demonstrated that RT can improve stability in one third of patients over a 6-months period with unstable spinal metastases. Importantly, for these patients pain relief was detected but RT had no impact on QoL, fatigue, and emotional distress

  2. Natural conception in HIV-serodiscordant couples with the infected partner in suppressive antiretroviral therapy: A prospective cohort study.

    Science.gov (United States)

    Del Romero, Jorge; Baza, María Begoña; Río, Isabel; Jerónimo, Adrián; Vera, Mar; Hernando, Victoria; Rodríguez, Carmen; Castilla, Jesús

    2016-07-01

    The potential of antiretroviral treatment (ART) to prevent the sexual transmission of HIV has increased the number of serodiscordant couples who are considering natural conception. We aim to describe the results of a protocol for reproductive counseling aimed at HIV serodiscordant couples who desire natural conception, in which the infected partner, the index case, is receiving suppressive antiretroviral treatment.A prospective cohort included all HIV serodiscordant couples attended a counseling program in the period 2002 to 2013 who opted for natural conception and met the following criteria: index case on ART with persistent plasma viral suppression for at least the previous 6 months, ART compliance over 95%, preserved immune status, undetectable HIV viral and proviral load in semen in male index cases, and absence of genitourinary infections and fertility problems in both members of the couple.Of the 161 HIV serodiscordant couples included, 133 with male index cases, 66% achieved at least 1 pregnancy, 18% a second one, and 5% a third pregnancy. A total of 144 natural pregnancies occurred and 107 babies were born. The pregnancy rate was 1.9 for each 100 acts of vaginal intercourse, and the mean time to conception was 6.1 months, both independently of the sex of the index case. No case of sexual or vertical HIV transmission occurred.In the absence of fertility problems and under controlled conditions, natural conception might be a safe and effective reproductive method for those HIV serodiscordant couples who choose this reproductive option.

  3. Comparative effectiveness of medical and surgical therapy on olfaction in chronic rhinosinusitis: a prospective, multi-institutional study

    Science.gov (United States)

    DeConde, Adam S.; Mace, Jess C.; Alt, Jeremiah A.; Schlosser, Rodney J.; Smith, Timothy L.; Soler, Zachary M.

    2014-01-01

    Background Evidence comparing the impact of medical and surgical management of chronic rhinosinusitis on olfactory function is limited. This study evaluates olfactory outcomes in patients who failed initial medical management and elect either continued medical management or endoscopic sinus surgery (ESS) followed by medical management. Methods Adult subjects were prospectively enrolled into a non-randomized, multi-institutional cohort. Baseline characteristics, quality-of-life and objective clinical findings were collected along with two quality-of-life disease-specific measures, the Rhinosinusitis Disability Index (RSDI) and Sinonasal Outcome Test (SNOT-22). The primary outcome measure was the post-treatment change (≥6 months) in the Brief Smell Identification Test (B-SIT). Bivariate and multivariate analyses compared B-SIT changes by treatment type while controlling for baseline cofactors. Results Subjects (n=280) were enrolled between March, 2011 and May, 2013. Baseline B-SIT scores were comparable between medical and surgical treatment groups (8.8(3.2) vs 9.0(3.2); p=0.703). Subjects with baseline impaired olfaction (n=83; 29.6%) experienced mean B-SIT improvement in both the medical (n=17, 2.3(2.8), p=0.005) and surgical (n=66, 2.1(3.0), p0.050). Conclusion Subjects electing ESS experienced gains in olfaction comparable to subjects electing continued medical management. Further study with larger sample size and more sensitive measures of olfaction are needed to determine differences between treatment groups. PMID:25044658

  4. Endovascular therapy for Acute ischemic Stroke Trial (EAST): study protocol for a prospective, multicentre control trial in China.

    Science.gov (United States)

    Miao, Zhongrong; Huo, Xiaochuan; Gao, Feng; Liao, Xiaoling; Wang, Chunjuan; Peng, Ya; Cao, Yibin; Chen, Shengli; Zhang, Meng; Jiang, Changchun; Peng, Xiaoxiang; Song, Cunfeng; Wei, Liping; Zhu, Qiyi; Guo, Zaiyu; Liu, Li; Lin, Hang; Yang, Hua; Wu, Wei; Liang, Hui; Xu, Anding; Chen, Kangning; Zhao, Xingquan; Pan, Yuesong; Li, Hao; Liu, Liping; Wang, Yilong; Wang, Yongjun

    2016-06-01

    5 recent trials have shown the benefit of endovascular treatment for acute ischaemic stroke (AIS) due to large vessel occlusion of the anterior circulation. This study aims to evaluate the safety and efficacy of Solitaire thrombectomy in patients with moderate-to-severe stroke in the Chinese population, which has a high prevalence of intracranial atherosclerosis. This multicentre prospective control study will involve 17 stroke centres in China, and plans to recruit 150 patients in the intervention group, and 150 patients in the medical group, in which patients meet enrolment criteria but refuse intervention. Patients with AIS due to large vessel occlusion indicated for treatment with Solitaire stent retriever within 12 hours of symptom onset, and who meet the inclusion and exclusion criteria, will be enrolled in this study. The primary efficacy endpoint is functional independence as defined by a modified Rankin Scale (mRS) score ≤2 at 90 days or by functional improvement as defined by mRS, using shift analysis. The procedural efficacy endpoint is arterial recanalisation of the occluded target vessel measured by a modified Thrombolysis in Cerebral Infarction (mTICI) score equal or superior to 2b right following the use of the study device. The primary safety endpoint is symptomatic intracranial haemorrhage (sICH) within 24±3 hours postprocedure. The protocol was approved by the Ethics Committee at the coordinating centre and by the local Institutional Review Board of each participating centre. NCT02350283.

  5. A randomized prospective study of rehabilitation therapy in the treatment of radiation-induced dysphagia and trismus

    International Nuclear Information System (INIS)

    Tang, Y.; Shen, Q.; Lu, K.; Peng, Y.; Wang, Y.; Wang, Y.

    2011-01-01

    Purpose: To evaluate the therapeutic effect of rehabilitation therapy on radiation-induced dysphagia and trismus in nasopharyngeal carcinoma (NPC) patients after radiotherapy. Patients and Methods: 43 NPC patients after radiotherapy were included. Patients were randomly assigned to either the rehabilitation group or a control group. Both groups were subjected to routine treatment, while the rehabilitation group also received rehabilitation therapy for 3 months. The severity of dysphagia was assessed using the water swallow test, while trismus was evaluated with the LENT/SOMA score and the interincisor distance (IID). The water swallow test, the LENT/SOMA score, as well as IID for both groups before and after treatment were analyzed and compared. Results: After treatment, the rehabilitation group displayed a significant improvement in swallowing function, while the control group did not. The efficacy rate (percentage of patients with excellent or effective results) of rehabilitation group was higher than that of control group (77% vs. 43%), and the difference was statistically significant (χ 2 = 5.32, p = 0.02). IID pretreatment and posttreatment did not show much difference in the rehabilitation group, while in the control group IID significantly decreased posttreatment (1.1 ± 0.36 cm vs.1.8 ± 0.56 cm, p = 0.001). Although the mean IID in patients of both groups decreased after the 3 month follow-up, the decrease in the rehabilitation group was less than that of the control group (0.19 ± 0.5 cm vs. 0.69 ± 0.56 cm, p = 0.004). The efficacy rate of trismus in the rehabilitation group was significantly higher than that of the control group (64% vs. 28%, χ 2 = 5.31, p = 0.02). Conclusions: Rehabilitation training can improve swallow function and slow down the progress of trismus in NPC patients following radiotherapy. (orig.)

  6. A randomized prospective study of rehabilitation therapy in the treatment of radiation-induced dysphagia and trismus

    Energy Technology Data Exchange (ETDEWEB)

    Tang, Y.; Shen, Q.; Lu, K.; Peng, Y. [Sun Yat-sen Univ., Guangzhou (China). Dept. of Neurology; Wang, Y. [Sun Yat-sen Univ., Guangzhou (China). Dept. of Internal Medicine; Wang, Y. [Sun Yat-sen Univ., Guangzhou (China). Dept. of Neurosurgery

    2011-01-15

    Purpose: To evaluate the therapeutic effect of rehabilitation therapy on radiation-induced dysphagia and trismus in nasopharyngeal carcinoma (NPC) patients after radiotherapy. Patients and Methods: 43 NPC patients after radiotherapy were included. Patients were randomly assigned to either the rehabilitation group or a control group. Both groups were subjected to routine treatment, while the rehabilitation group also received rehabilitation therapy for 3 months. The severity of dysphagia was assessed using the water swallow test, while trismus was evaluated with the LENT/SOMA score and the interincisor distance (IID). The water swallow test, the LENT/SOMA score, as well as IID for both groups before and after treatment were analyzed and compared. Results: After treatment, the rehabilitation group displayed a significant improvement in swallowing function, while the control group did not. The efficacy rate (percentage of patients with excellent or effective results) of rehabilitation group was higher than that of control group (77% vs. 43%), and the difference was statistically significant ({chi}{sup 2} = 5.32, p = 0.02). IID pretreatment and posttreatment did not show much difference in the rehabilitation group, while in the control group IID significantly decreased posttreatment (1.1 {+-} 0.36 cm vs.1.8 {+-} 0.56 cm, p = 0.001). Although the mean IID in patients of both groups decreased after the 3 month follow-up, the decrease in the rehabilitation group was less than that of the control group (0.19 {+-} 0.5 cm vs. 0.69 {+-} 0.56 cm, p = 0.004). The efficacy rate of trismus in the rehabilitation group was significantly higher than that of the control group (64% vs. 28%, {chi}{sup 2} = 5.31, p = 0.02). Conclusions: Rehabilitation training can improve swallow function and slow down the progress of trismus in NPC patients following radiotherapy. (orig.)

  7. Original Researc Original Research

    African Journals Online (AJOL)

    RAGHAVENDRA

    equalizer and tasseled cap transformation were employed to the image data. RGB to IHS conversions and color combination of the original image data have also been made. The Vegetation index, NDVI, has also been used to measure the presence and state of vegetation so as to distinguish vegetated areas from others.

  8. Original Research Original Research

    African Journals Online (AJOL)

    User

    2013-03-28

    Mar 28, 2013 ... food production in sub-Saharan Africa coun. (Sanchez, 2010). Soil is the most precious vital natural resource and it must be mana. Original Research .... Exchangeable K and Na were measured by fl photometer. Exchangeable acidity determined by saturating the samples with. KCl solution and titrated with ...

  9. Original Research Original Research

    African Journals Online (AJOL)

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  10. Original Research Original Research

    African Journals Online (AJOL)

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    2013-06-20

    Jun 20, 2013 ... great value in Ethiopian socio-economic growt requires small capital, promote inter linkages as it is a base for medium and large enterprises, increased domestic saving investment. Also they help for bal development provision of goods and services. Original Research. 123. 3327 (Online) esearch Journal.

  11. Original Research Original Research

    African Journals Online (AJOL)

    User

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  12. Original Research Original Research

    African Journals Online (AJOL)

    User

    2013-06-25

    Jun 25, 2013 ... the feeding practices (Kassahun, 2000). This involves the use of fodder bank, f trees, agro-industrial by-products such as, seed cake and urea to overcome CP shor. (ILCA, 1990). Supplementation of poor q roughage feed with suitable energy and p. Original Research. 38. 3327 (Online) esearch Journal.

  13. Original Research Original Research

    African Journals Online (AJOL)

    User

    2013-03-24

    Mar 24, 2013 ... approach is to create a pseudo alignment by taking random positions of the original alignment. Some columns of the alignment ... Table 1: Sequences selected for MSA: Inform contains the organism name from wh sequences. Sequence format. Sequence number. Sequence 1. Sequence 2. Sequence 3.

  14. Fever of unknown origin: prospective comparison of diagnostic value of 18F-FDG PET and 111In-granulocyte scintigraphy

    DEFF Research Database (Denmark)

    Kjaer, Andreas; Lebech, Anne-Mette; Eigtved, Annika

    2004-01-01

    The diagnostic work-up in patients with fever of unknown origin (FUO) is often challenging and frequently includes nuclear medicine procedures. Whereas a role for leucocyte or granulocyte scintigraphy in FUO is generally accepted, a possible role of fluorine-18 fluorodeoxyglucose (FDG) positron....../inflammatory or malignant cause of FUO. The sensitivity of granulocyte scintigraphy and FDG-PET were 71% [95% confidence interval (CI): 37-85%] and 50% (CI: 16-84%), respectively. The specificity of granulocyte scintigraphy was 92% (71-100%), which was significantly higher than that of FDG-PET, at 46% (34-62%). Positive....../inflammatory or neoplastic cause of FUO. The poorer performance of FDG-PET is in particular attributable to a high percentage of false positive scans, leading to low specificity....

  15. The iBRA-2 (immediate breast reconstruction and adjuvant therapy audit) study: protocol for a prospective national multicentre cohort study to evaluate the impact of immediate breast reconstruction on the delivery of adjuvant therapy.

    Science.gov (United States)

    Dave, Rajiv; O'Connell, Rachel; Rattay, Tim; Tolkien, Zoe; Barnes, Nicola; Skillman, Joanna; Williamson, Paula; Conroy, Elizabeth; Gardiner, Matthew; Harnett, Adrian; O'Brien, Ciara; Blazeby, Jane; Potter, Shelley; Holcombe, Chris

    2016-10-07

    Immediate breast reconstruction (IBR) is routinely offered to improve quality of life for women with breast cancer requiring a mastectomy, but there are concerns that more complex surgery may delay the delivery of adjuvant oncological treatments and compromise long-term oncological outcomes. High-quality evidence, however, is lacking. iBRA-2 is a national prospective multicentre cohort study that aims to investigate the effect of IBR on the delivery of adjuvant therapy. Breast and plastic surgery centres in the UK performing mastectomy with or without (±) IBR will be invited to participate in the study through the trainee research collaborative network. All women undergoing mastectomy ± IBR for breast cancer between 1 July and 31 December 2016 will be included. Patient demographics, operative, oncological and complication data will be collected. Time from last definitive cancer surgery to first adjuvant treatment for patients undergoing mastectomy ± IBR will be compared to determine the impact that IBR has on the time of delivery of adjuvant therapy. Prospective data on 3000 patients from ∼50 centres are anticipated. Research ethics approval is not required for this study. This has been confirmed using the online Health Research Authority decision tool. This novel study will explore whether IBR impacts the time to delivery of adjuvant therapy. The study will provide valuable information to help patients and surgeons make more informed decisions about their surgical options. Dissemination of the study protocol will be via the Mammary Fold Academic and Research Collaborative (MFAC) and the Reconstructive Surgery Trials Network (RSTN), the Association of Breast Surgery (ABS) and the British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS). Participating units will have access to their own data and collective results will be presented at relevant surgical conferences and published in appropriate peer-reviewed journals. Published by

  16. Fully Automated Simultaneous Integrated Boosted-Intensity Modulated Radiation Therapy Treatment Planning Is Feasible for Head-and-Neck Cancer: A Prospective Clinical Study

    Energy Technology Data Exchange (ETDEWEB)

    Wu Binbin, E-mail: binbin.wu@gunet.georgetown.edu [Department of Radiation Oncology and Molecular Radiation Science, Johns Hopkins University, Baltimore, Maryland (United States); Department of Radiation Medicine, Georgetown University Hospital, Washington, DC (United States); McNutt, Todd [Department of Radiation Oncology and Molecular Radiation Science, Johns Hopkins University, Baltimore, Maryland (United States); Zahurak, Marianna [Department of Oncology Biostatistics, Johns Hopkins University, Baltimore, Maryland (United States); Simari, Patricio [Autodesk Research, Toronto, ON (Canada); Pang, Dalong [Department of Radiation Medicine, Georgetown University Hospital, Washington, DC (United States); Taylor, Russell [Department of Computer Science, Johns Hopkins University, Baltimore, Maryland (United States); Sanguineti, Giuseppe [Department of Radiation Oncology and Molecular Radiation Science, Johns Hopkins University, Baltimore, Maryland (United States)

    2012-12-01

    Purpose: To prospectively determine whether overlap volume histogram (OVH)-driven, automated simultaneous integrated boosted (SIB)-intensity-modulated radiation therapy (IMRT) treatment planning for head-and-neck cancer can be implemented in clinics. Methods and Materials: A prospective study was designed to compare fully automated plans (APs) created by an OVH-driven, automated planning application with clinical plans (CPs) created by dosimetrists in a 3-dose-level (70 Gy, 63 Gy, and 58.1 Gy), head-and-neck SIB-IMRT planning. Because primary organ sparing (cord, brain, brainstem, mandible, and optic nerve/chiasm) always received the highest priority in clinical planning, the study aimed to show the noninferiority of APs with respect to PTV coverage and secondary organ sparing (parotid, brachial plexus, esophagus, larynx, inner ear, and oral mucosa). The sample size was determined a priori by a superiority hypothesis test that had 85% power to detect a 4% dose decrease in secondary organ sparing with a 2-sided alpha level of 0.05. A generalized estimating equation (GEE) regression model was used for statistical comparison. Results: Forty consecutive patients were accrued from July to December 2010. GEE analysis indicated that in APs, overall average dose to the secondary organs was reduced by 1.16 (95% CI = 0.09-2.33) with P=.04, overall average PTV coverage was increased by 0.26% (95% CI = 0.06-0.47) with P=.02 and overall average dose to the primary organs was reduced by 1.14 Gy (95% CI = 0.45-1.8) with P=.004. A physician determined that all APs could be delivered to patients, and APs were clinically superior in 27 of 40 cases. Conclusions: The application can be implemented in clinics as a fast, reliable, and consistent way of generating plans that need only minor adjustments to meet specific clinical needs.

  17. Targeted Physician Education Positively Affects Delivery of Nutrition Therapy and Patient Outcomes: Results of a Prospective Clinical Trial.

    Science.gov (United States)

    Hurt, Ryan T; McClave, Stephen A; Evans, David C; Jones, Chris; Miller, Keith R; Frazier, Thomas H; Minhas, Mahad A; Lowen, Cynthia C; Stout, Allyson; Edakkanambeth Varayil, Jithinraj; Matheson, Paul J; Franklin, Glen A

    2015-11-01

    Malnutrition is a continuing epidemic among hospitalized patients. We hypothesize that targeted physician education should help reduce caloric deficits and improve patient outcomes. We performed a prospective trial of patients (n = 121) assigned to 1 of 2 trauma groups. The experimental group (EG) received targeted education consisting of strategies to increase delivery of early enteral nutrition. Strategies included early enteral access, avoidance of nil per os (NPO) and clear liquid diets (CLD), volume-based feeding, early resumption of feeds postprocedure, and charting caloric deficits. The control group (CG) did not receive targeted education but was allowed to practice in a standard ad hoc fashion. Both groups were provided with dietitian recommendations on a multidisciplinary nutrition team per standard practice. The EG received a higher percentage of measured goal calories (30.1 ± 18.5%, 22.1 ± 23.7%, P = .024) compared with the CG. Mean caloric deficit was not significantly different between groups (-6796 ± 4164 kcal vs -8817 ± 7087 kcal, P = .305). CLD days per patient (0.1 ± 0.5 vs 0.6 ± 0.9), length of stay in the intensive care unit (3.5 ± 5.5 vs 5.2 ± 6.8 days), and duration of mechanical ventilation (1.6 ± 3.7 vs 2.8 ± 5.0 days) were all reduced in the EG compared with the CG (P affected patient care and outcomes. © 2014 American Society for Parenteral and Enteral Nutrition.

  18. Impact of more intensive written information in patients having radical radiation therapy: Results of a prospective randomized phase III trial

    International Nuclear Information System (INIS)

    Zissiadis, Yvonne; Harper, Emily; Kearney, Elizabeth

    2010-01-01

    Background and purpose: A diagnosis of malignancy and its treatment is a very stressful time for patients and their families. This study was conducted to determine the impact of more intensive written information on patients' anxiety levels. The secondary aim was to determine the impact of this information on patients' satisfaction levels. Materials and methods: This prospective randomized trial consisted of patients with a pathological diagnosis of cancer having radical radiotherapy (RT). Patients were randomized to receive the more intensive information (including written information and a telephone call from the research nurse) or not to receive the more intensive information at the time of their initial consultation with the radiation oncologist. Study questionnaires measuring anxiety (STAI form) were completed prior to their first consultation (baseline) at the time of simulation (pre-RT) and at the completion of radiotherapy. A second questionnaire assessing satisfaction with the information given (ISQ) was completed at the time of simulation prior to commencing RT. Results: One hundred and ninety-four patients were enrolled in the study. The mean age of the patients was 58.5 years and 70% of patients were female. Breast cancer (67%) was the commonest cancer. One hundred and two patients were randomized to receive the intensive information package and 92 patients received the standard consultation. There was no significant difference in mean State or Trait anxiety scores between any of the time intervals and no difference between the two information groups. There was no significant difference between the groups with regard to mean satisfaction scores with the overall information given, nor with any individual question. The satisfaction scores with lifestyle information given were lower than those for any other type of information in both randomization arms. Conclusion: More intensive information did not significantly change patients' anxiety scores or

  19. A prospective study of ocular toxicity in patients receiving ethambutol as a part of directly observed treatment strategy therapy

    Directory of Open Access Journals (Sweden)

    Pragati Garg

    2015-01-01

    Full Text Available Background and Objectives: India is among the largest countries to implement the revised National Tuberculosis Control Program (RNTCP. This program provides intermittent regimens to the patients, where the doses of isoniazid and ethambutol are more as compared to the daily regimen, which is a cause of concern, particularly with regard to the ocular toxicity of ethambutol. The present study was undertaken to explore the ocular toxicity in the patients registered under the program. Materials and Methods: This was a prospective single center cohort study of 64 patients of categories I and II, coming to the RNTCP-Directly Observed Treatment Strategy (DOTS center at a tertiary care referral hospital. The detailed history, best corrected visual acuity, fundus examination, and color vision test were carried out in all patients at the start of treatment and then at the first and second month of treatment. Results: Loss in visual acuity from the baseline was noted at the second month follow up in 12 (9.4% eyes (P = 0.001, visual field defects were seen in eight (6.3% eyes (P = 0.0412, and optic disc abnormalities were observed in six (4.7% (P = 0.013 eyes. Color vision abnormalities were noted in 16 (12.6% eyes (P = 0.003, four eyes showed impairment in red-green color perception, and the others showed impairment in blue-yellow color perception as well. Patients with ocular symptoms were advised to stop ethambutol and they showed improvement in visual acuity after follow up of one to two months. The overall outcome of treatment was not affected by discontinuation of ethambutol in these patients. Conclusion: Ethambutol when taken according to program could cause ocular toxicity. The early recognition of ocular symptoms is important to prevent unnecessary delay in diagnosis and probable irreversible visual loss.

  20. Can low-intensity extracorporeal shockwave therapy improve erectile dysfunction?

    DEFF Research Database (Denmark)

    Olsen, Anne B.; Persiani, Marie; Boie, Sidsel

    2015-01-01

    OBJECTIVE: The aim of this study was to investigate whether low-intensity extracorporeal shockwave therapy (LI-ESWT) can be used as a treatment for men with erectile dysfunction of organic origin. MATERIALS AND METHODS: This prospective, randomized, blinded, placebo-controlled study included 112 ...... are needed. KEYWORDS: Erectile dysfunction; extracorporeal shockwave; penis...

  1. Comparison between noninvasive mechanical ventilation and standard oxygen therapy in children up to 3 years old with respiratory failure after extubation: a pilot prospective randomized clinical study.

    Science.gov (United States)

    Fioretto, José R; Ribeiro, Cristiane F; Carpi, Mario F; Bonatto, Rossano C; Moraes, Marcos A; Fioretto, Eduardo B; Fagundes, Djalma J

    2015-02-01

    The effectiveness of noninvasive positive-pressure ventilation in preventing reintubation due to respiratory failure in children remains uncertain. A pilot study was designed to evaluate the frequency of extubation failure, develop a randomization approach, and analyze the feasibility of a powered randomized trial to compare noninvasive positive-pressure ventilation and standard oxygen therapy post extubation for preventing reintubation within 48 hours in children with respiratory failure. Prospective pilot study. PICU at a university-affiliated hospital. Children aged between 28 days and 3 years undergoing invasive mechanical ventilation for greater than or equal to 48 hours with respiratory failure after programmed extubation. Patients were prospectively enrolled and randomly assigned into noninvasive positive-pressure ventilation group and inhaled oxygen group after programmed extubation from May 2012 to May 2013. Length of stay in PICU and hospital, oxygenation index, blood gas before and after tracheal extubation, failure and reason for tracheal extubation, complications, mechanical ventilation variables before tracheal extubation, arterial blood gas, and respiratory and heart rates before and 1 hour after tracheal extubation were analyzed. One hundred eight patients were included (noninvasive positive-pressure ventilation group, n = 55 and inhaled oxygen group, n = 53), with 66 exclusions. Groups did not significantly differ for gender, age, disease severity, Pediatric Risk of Mortality at admission, tracheal intubation, and mechanical ventilation indications. There was no statistically significant difference in reintubation rate (noninvasive positive-pressure ventilation group, 9.1%; inhaled oxygen group, 11.3%; p > 0.05) and length of stay (days) in PICU (noninvasive positive-pressure ventilation group, 3 [1-16]; inhaled oxygen group, 2 [1-25]; p > 0.05) or hospital (noninvasive positive-pressure ventilation group, 19 [7-141]; inhaled oxygen group, 17 [8

  2. Decline of Cosmetic Outcomes Following Accelerated Partial Breast Irradiation Using Intensity Modulated Radiation Therapy: Results of a Single-Institution Prospective Clinical Trial

    International Nuclear Information System (INIS)

    Liss, Adam L.; Ben-David, Merav A.; Jagsi, Reshma; Hayman, James A.; Griffith, Kent A.; Moran, Jean M.; Marsh, Robin B.; Pierce, Lori J.

    2014-01-01

    Purpose: To report the final cosmetic results from a single-arm prospective clinical trial evaluating accelerated partial breast irradiation (APBI) using intensity modulated radiation therapy (IMRT) with active-breathing control (ABC). Methods and Materials: Women older than 40 with breast cancer stages 0-I who received breast-conserving surgery were enrolled in an institutional review board-approved prospective study evaluating APBI using IMRT administered with deep inspiration breath-hold. Patients received 38.5 Gy in 3.85-Gy fractions given twice daily over 5 consecutive days. The planning target volume was defined as the lumpectomy cavity with a 1.5-cm margin. Cosmesis was scored on a 4-category scale by the treating physician. Toxicity was scored according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE version 3.0). We report the cosmetic and toxicity results at a median follow-up of 5 years. Results: A total of 34 patients were enrolled. Two patients were excluded because of fair baseline cosmesis. The trial was terminated early because fair/poor cosmesis developed in 7 of 32 women at a median follow-up of 2.5 years. At a median follow-up of 5 years, further decline in the cosmetic outcome was observed in 5 women. Cosmesis at the time of last assessment was 43.3% excellent, 30% good, 20% fair, and 6.7% poor. Fibrosis according to CTCAE at last assessment was 3.3% grade 2 toxicity and 0% grade 3 toxicity. There was no correlation of CTCAE grade 2 or greater fibrosis with cosmesis. The 5-year rate of local control was 97% for all 34 patients initially enrolled. Conclusions: In this prospective trial with 5-year median follow-up, we observed an excellent rate of tumor control using IMRT-planned APBI. Cosmetic outcomes, however, continued to decline, with 26.7% of women having a fair to poor cosmetic result. These results underscore the need for continued cosmetic assessment for patients treated with APBI by technique

  3. Decline of Cosmetic Outcomes Following Accelerated Partial Breast Irradiation Using Intensity Modulated Radiation Therapy: Results of a Single-Institution Prospective Clinical Trial

    Energy Technology Data Exchange (ETDEWEB)

    Liss, Adam L. [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan (United States); Ben-David, Merav A. [Department of Radiation Oncology, The Sheba Medical Center, Ramat Gan (Israel); Jagsi, Reshma; Hayman, James A. [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan (United States); Griffith, Kent A. [Biostatistics Unit, University of Michigan, Ann Arbor, Michigan (United States); Moran, Jean M.; Marsh, Robin B. [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan (United States); Pierce, Lori J., E-mail: ljpierce@umich.edu [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan (United States)

    2014-05-01

    Purpose: To report the final cosmetic results from a single-arm prospective clinical trial evaluating accelerated partial breast irradiation (APBI) using intensity modulated radiation therapy (IMRT) with active-breathing control (ABC). Methods and Materials: Women older than 40 with breast cancer stages 0-I who received breast-conserving surgery were enrolled in an institutional review board-approved prospective study evaluating APBI using IMRT administered with deep inspiration breath-hold. Patients received 38.5 Gy in 3.85-Gy fractions given twice daily over 5 consecutive days. The planning target volume was defined as the lumpectomy cavity with a 1.5-cm margin. Cosmesis was scored on a 4-category scale by the treating physician. Toxicity was scored according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE version 3.0). We report the cosmetic and toxicity results at a median follow-up of 5 years. Results: A total of 34 patients were enrolled. Two patients were excluded because of fair baseline cosmesis. The trial was terminated early because fair/poor cosmesis developed in 7 of 32 women at a median follow-up of 2.5 years. At a median follow-up of 5 years, further decline in the cosmetic outcome was observed in 5 women. Cosmesis at the time of last assessment was 43.3% excellent, 30% good, 20% fair, and 6.7% poor. Fibrosis according to CTCAE at last assessment was 3.3% grade 2 toxicity and 0% grade 3 toxicity. There was no correlation of CTCAE grade 2 or greater fibrosis with cosmesis. The 5-year rate of local control was 97% for all 34 patients initially enrolled. Conclusions: In this prospective trial with 5-year median follow-up, we observed an excellent rate of tumor control using IMRT-planned APBI. Cosmetic outcomes, however, continued to decline, with 26.7% of women having a fair to poor cosmetic result. These results underscore the need for continued cosmetic assessment for patients treated with APBI by technique.

  4. Treating trismus: A prospective study on effect and compliance to jaw exercise therapy in head and neck cancer.

    Science.gov (United States)

    Pauli, Nina; Andréll, Paulin; Johansson, Mia; Fagerberg-Mohlin, Bodil; Finizia, Caterina

    2015-12-01

    Trismus after head and neck cancer is a symptom associated with pain and negatively affected health-related quality of life. The purpose of this study was to compare two different jaw exercise devices and the compliance to exercise. Fifty patients with head and neck cancer were randomized to jaw exercise with either the TheraBite or Engström jaw device in a 10-week exercise program. Patients were regularly assessed by an oral surgeon, filled in exercise diaries, and answered the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Head and Neck 35-questions (EORTC QLQ H&N35) and the Gothenburg Trismus Questionnaire (GTQ). Both groups improved their mouth opening, 7.2 mm (22.9%) and 5.5 mm (17.6%) for TheraBite and Engström, respectively. The largest increase in mouth opening and highest compliance to exercise was seen during the 4 first weeks. Jaw exercise therapy effectively improved mouth opening capacity and led to less trismus-related symptoms. Both jaw devices were proved efficient and compliance to exercise was comparable. © 2014 Wiley Periodicals, Inc.

  5. Spinal Manipulative Therapy for Chronic Lower Back Pain in Older Veterans: A Prospective, Randomized, Placebo-Controlled Trial.

    Science.gov (United States)

    Dougherty, Paul E; Karuza, Jurgis; Dunn, Andrew S; Savino, Dorian; Katz, Paul

    2014-12-01

    Chronic lower back pain (CLBP) is problematic in older veterans. Spinal manipulative therapy (SMT) is commonly utilized for CLBP in older adults, yet there are few randomized placebo-controlled trials evaluating SMT. The purpose of the study was to compare the effectiveness of SMT to a sham intervention on pain (Visual Analogue Scale, SF-36 pain subscale), disability (Oswestry Disability Index), and physical function (SF-36 subscale, Timed Up and Go) by performing a randomized placebo-controlled trial at 2 Veteran Affairs Clinics. Older veterans (≥ 65 years of age) who were naive to chiropractic were recruited. A total of 136 were included in the study with 69 being randomly assigned to SMT and 67 to sham intervention. Patients were treated 2 times per week for 4 weeks assessing outcomes at baseline, 5, and 12 weeks postbaseline. Both groups demonstrated significant decrease in pain and disability at 5 and 12 weeks. At 12 weeks, there was no significant difference in pain and a statistically significant decline in disability scores in the SMT group when compared to the sham intervention group. There were no significant differences in adverse events between the groups. The SMT did not result in greater improvement in pain when compared to our sham intervention; however, SMT did demonstrate a slightly greater improvement in disability at 12 weeks. The fact that patients in both groups showed improvements suggests the presence of a nonspecific therapeutic effect.

  6. Original Researc Original Research

    African Journals Online (AJOL)

    RAGHAVENDRA

    introdution of defects during the synthesis proces growth of the films. But, still the origin of ferromag is in debate. ... se (Mn), cobalt (Co) and nickel (Ni) doped zinc oxide (ZnO) ndidates for variety of practical application due to their spin of ... hexhydrate (Zn (NO3)26H2O), mangane hydrate (Co(NO3)2.6H2O), cobalt nitrate he.

  7. Comparison of early quality of life in patients treated with radiotherapy following mastectomy or breast conservation therapy: A prospective study

    International Nuclear Information System (INIS)

    Munshi, Anusheel; Dutta, Debnarayan; Kakkar, Sajal; Budrukkar, Ashwini; Jalali, Rakesh; Sarin, Rajiv; Gupta, Sudeep; Parmar, Vani; Badwe, Rajendra

    2010-01-01

    Introduction: To compare quality of life (QOL) in breast cancer patients from a developing country after breast conservation surgery (BCS) or mastectomy and adjuvant radiotherapy (RT). Materials and methods: In a 6-month period, all consecutive early and locally advanced breast cancer patients treated with either BCS or mastectomy and treated with RT were analyzed. All patients who underwent mastectomy were treated with 45 Gray/20/4 weeks. Patients with BCS were treated with a dose of 45-50 Gray/25/5 weeks to whole breast followed by tumor bed boost (15 Gray/6/6 days with suitable energy electrons). Prospective evaluation of QOL using EORTC QLQ C30 and breast cancer specific QLQ BR23 was done before starting RT (baseline), at mid-RT and at RT conclusion for all patients. Results: One hundred and thirteen patients had mastectomy and 142 patients underwent BCS. Reliability test (Cronbach alpha) for questionnaire filling was 0.669-0.886. At pre-RT assessment, global QOL scores in mastectomy and BCS groups were 71.1 and 71.3, respectively. There was no significant difference in pre-RT EORTC QLQ C30 functional and symptom domains between mastectomy and BCS patients. However, social function domain score was higher in patients who underwent mastectomy (83 versus 73.9; p = 0.018). In QLQ BR23 domains, body image and sexual functioning domains were similar between the two groups. However, sexual enjoyment (10.9 versus 47.6; p = 0.006) and future perspective (7.4 versus 37.1; p = 0.036) domains were significantly better in BCS arm. There was no difference between systemic side effect (BRSSE), breast symptom (BRBS) and arm symptom (BRAS) domain scores between the groups. There was no significant difference in change of QOL scores between mastectomy and BCS patients at RT completion as compared to baseline. Conclusions: There was no significant difference in quality of life in patients with BCS versus those with mastectomy. However, patients who underwent BCS had better

  8. Continuous passive motion and physical therapy (CPM) versus physical therapy (PT) versus delayed physical therapy (DPT) after surgical release for elbow contractures; a study protocol for a prospective randomized controlled trial

    NARCIS (Netherlands)

    Viveen, Jetske; Doornberg, Job N.; Kodde, Izaak F.; Goossens, Pjotr; Koenraadt, Koen L. M.; The, Bertram; Eygendaal, Denise

    2017-01-01

    The elbow is prone to stiffness after trauma. To regain functional elbow motion several conservative- and surgical treatment options are available. Conservative treatment includes physical therapy, intra-articular injections with corticosteroids and a static progressive or dynamic splinting program.

  9. Recovery of Toxoplasma gondii DNA in experimentally mummified skin and bones: Prospects for paleoparasitological studies to unveil the origin of toxoplasmosis.

    Science.gov (United States)

    Leles, Daniela; Lobo, Amanda; Rhodes, Taís; Millar, Patrícia Riddell; Amendoeira, Maria Regina Reis; Araújo, Adauto

    2016-09-01

    Paleoparasitology studies parasite infections by finding the parasites' remains in preserved organic remains such as natural or artificial mummy tissues, skeletons, teeth, and coprolites, among others. However, some currently important infections like toxoplasmosis have not been studied by paleoparasitology. The reasons include this parasite's complex life cycle, the resulting difficulties in locating this protozoan in the intermediate host tissues, and the limitation of coprolite studies to felines, the protozoan's definitive host. The current study thus aimed to produce an experimental model for molecular diagnosis of toxoplasmosis, prioritizing its study in bones and skin, the most abundant materials in archeological collections and sites. The study demonstrated the feasibility of recovering Toxoplasma gondii DNA from desiccated material, including bones and skin, in experimental models both with circulating tachyzoites (RH strain), characteristic of acute infection, and with cysts (ME49 cystogenic strain), characteristic of chronic infection. At present, most individuals with T. gondii infection are in the chronic phase, and the same was probably true in the past. The current study thus expands the odds of finding the parasite in archeological material, enhanced by the nature of the material in which the diagnosis was made. Finding the parasite may help answer questions that are widely debated in the literature on this protozoan's origin (Old World versus New World). In addition, when conditions do not allow ideal storage of samples for molecular tests, the methodology creates the possibility of testing oven-dried samples transported at room temperature. Copyright © 2016 Elsevier Inc. All rights reserved.

  10. A long-term prospective follow-up study of incident RLS in the course of chronic DAergic therapy in newly diagnosed untreated patients with Parkinson's disease.

    Science.gov (United States)

    Calzetti, Stefano; Angelini, Monica; Negrotti, Anna; Marchesi, Elena; Goldoni, Matteo

    2014-05-01

    It is currently controversial if and in which terms Parkinson's disease (PD) and restless legs syndrome (RLS) are linked in co-morbid association. In a cohort of 106 de novo PD patients (67 male and 39 female, aged 42-83 years), 15 of them developed RLS, which was prospectively assessed at 6-month intervals from the starting of dopamine(DA)ergic therapy. The incidence rate of total RLS was 47 per 1,000 case/person per year and 37 per 1,000 case/person per year after the exclusion of possible "secondary" forms of the disorder (n = 3). These figures are higher than those reported in an incidence study conducted in German general population (Study of Health in Pomerania), in which the method of ascertainment of RLS similar to ours has been used. An incidence rate of total RLS significantly higher than that reported in the above-mentioned study was found in the age ranges 55-64 years and in the age range 45-74 years standardized to European general population 2013  (70 and 53 per 1,000 case/person per year, respectively, p RLS within 24 months from the starting of DAergic medication (median latency 7.5 months). These findings support the view that sustained DAergic therapy could represent the critical factor inducing an increased incidence of RLS in patients with PD and that the latter disease should be regarded as the condition predisposing to the occurrence of the former and not viceversa as previously hypothesized. The mechanism underlying the increased incidence of RLS remains unclear and deserves further investigation.

  11. Prospective study of sequential volumetric changes of parotid gland in early oropharyngeal carcinoma patients treated by intensity-modulated radiation therapy: An institutional experience

    Directory of Open Access Journals (Sweden)

    Pooja Nandwani Patel

    2018-01-01

    Full Text Available Aims and Objectives: During course of radiation therapy, anatomical variations occur risking overdose of parotid gland. We tried to quantify volume of parotid gland and mean dose to parotid gland after every 10 fractions (#. Materials and Methods: We conducted the prospective study from July 2016 to May 2017 in 25 patients of early-stage oropharyngeal carcinoma. Patients had Karnofsy Performance Score of 80–100, median age was 54 years, and 18 patients were males. Patients were planned with intensity-modulated radiation therapy planning with dose as 66 Gy/30# to planning target volume (PTV including primary and 54 Gy/30# to PTV-nodal including elective neck irradiation. After each 10#, replanning was done, and variations in parotid volume were studied including Dmean(mean dose to parotids and D50(the dose delivered to 50% of volume. Other tumor characteristic like PTV of primary was also assessed and minimum PTV volume covered by 95% isodose line was kept as 95%. Results: Average parotid volumes decreased by the mean value of 10% and 6% for the left and right parotids, respectively, and PTV of primary target decreased by mean of 13%. The difference in Dmeandoses to parotid glands was 32% and 42% and difference in D50dose was 30% and 35% on the left and right side, respectively. Conclusions: The parotid volumes differ considerably during adaptive planning done after every ten fractions. These differences in parotid volumes and doses received to parotid glands play a significant role in the risk of xerostomia observed during later follow-up.

  12. A multicenter, randomized, prospective study of 14-day ranitidine bismuth citrate- vs. lansoprazole-based triple therapy for the eradication of Helicobacter pylori in dyspeptic patients.

    Science.gov (United States)

    Avşar, Erol; Tiftikçi, Arzu; Poturoğlu, Sule; Erzin, Yusuf; Kocakaya, Ozan; Dinçer, Dinç; Yıldırım, Bulut; Güliter, Sefa; Türkay, Cansel; Yılmaz, Uğur; Onuk, Mehmet Derya; Bölükbaş, Cengiz; Ellidokuz, Ender; Bektaş, Ahmet; Taşan, Güralp; Aytuğ, Necip; Ateş, Yüksel; Kaymakoğlu, Sabahattin

    2013-01-01

    Proton-pump inhibitor and ranitidine bismuth citrate-based triple regimens are the two recommended first line treatments for the eradication of Helicobacter pylori. We aimed to compare the effectiveness and tolerability of these two treatments in a prospective, multicentric, randomized study. Patients with dyspeptic complaints were recruited from 15 study centers. Presence of Helicobacter pylori was investigated by both histology and rapid urease test. The patients were randomized to either ranitidine bismuth citrate 400 mg bid plus amoxicillin 1 g bid plus clarithromycin 500 mg bid (n=149) or lansoprazole 30 mg bid plus amoxicillin 1 g bid plus clarithromycin 500 mg bid (n=130) treatment arm for 14 days. Adverse events have been recorded during the treatment phase. A 13 C urea breath test was performed 6 weeks after termination of treatment to assess the efficacy of the therapy. Eradication rate was calculated by intention-to-treat and per-protocol analysis. Two hundred seventy-nine patients (123 male, 156 female) were eligible for randomization. In per-protocol analysis (n=247), Helicobacter pylori was eradicated with ranitidine bismuth citrate- and lansoprazole-based regimens in 74,6% and 69,2% of cases, respectively (p>0,05). Intention-to-treat analysis (n=279) revealed that eradication rates were 65,1% and 63,6% in ranitidine bismuth citrate and in lansoprazole-based regimens, respectively (p>0,05). Both regimes were well-tolerated, and no serious adverse event was observed during the study. Ranitidine bismuth citrate-based regimen is at least as effective and tolerable as the classical proton-pump inhibitor-based regimen, but none of the therapies could achieve the recommendable eradication rate.

  13. Trends in antimicrobial resistance and empiric antibiotic therapy of bloodstream infections at a general hospital in Mid-Norway: a prospective observational study.

    Science.gov (United States)

    Mehl, Arne; Åsvold, Bjørn Olav; Kümmel, Angela; Lydersen, Stian; Paulsen, Julie; Haugan, Ingvild; Solligård, Erik; Damås, Jan Kristian; Harthug, Stig; Edna, Tom-Harald

    2017-02-02

    The occurrence of bloodstream infection (BSI) and antimicrobial resistance have been increasing in many countries. We studied trends in antimicrobial resistance and empiric antibiotic therapy at a medium-sized general hospital in Mid-Norway. Between 2002 and 2013, 1995 prospectively recorded episodes of BSI in 1719 patients aged 16-99 years were included. We analyzed the antimicrobial non-susceptibility according to place of acquisition, site of infection, microbe group, and time period. There were 934 community-acquired (CA), 787 health care-associated (HCA) and 274 hospital-acquired (HA) BSIs. The urinary tract was the most common site of infection. Escherichia coli was the most frequently isolated infective agent in all three places of acquisition. Second in frequency was Streptococcus pneumoniae in CA and Staphylococcus aureus in both HCA and HA. Of the BSI microbes, 3.5% were non-susceptible to the antimicrobial regimen recommended by the National Professional Guidelines for Use of Antibiotics in Hospitals, consisting of penicillin, gentamicin, and metronidazole (PGM). In contrast, 17.8% of the BSI microbes were non-susceptible to cefotaxime and 27.8% were non-susceptible to ceftazidime. Antimicrobial non-susceptibility differed by place of acquisition. For the PGM regimen, the proportions of non-susceptibility were 1.4% in CA, 4.8% in HCA, and 6.9% in HA-BSI (p antibiotic therapy could be achieved to a larger extent by replacing second- and third-generation cephalosporins with penicillin-gentamicin or piperacillin-tazobactam.

  14. A prospective randomized study concerning the point a dose in high-dose rate intracavitary therapy for carcinoma of the uterine cervix. The final results

    International Nuclear Information System (INIS)

    Chatani, M.; Matayoshi, Y.; Masaki, N.; Teshima, T.; Inoue, T.

    1994-01-01

    Between January 1983 and February 1989, a total of 165 patients with carcinoma of the unterine cervix was entered in a prospective randomized study concerning the point A dose of HDR therapy (6 Gy/fraktion vs 7.5 Gy/fraction) and external irradiation dose at Department of Radiation Therapy, The Center for Adult Diseases, Osaka. UICC stage distribution of patients was as follows: Stage IA=4, stage IB=33, stage IIA=18, stage IIB=38, stage III=57, stage IV=15. Overall 5-year cause specific survivals were as follows: Stage IA=100%, stage IB=96%, stage IIA=92%, stage IIB=79%, stage III=57%, stage IV=27%. In each stage, 5-year survival rates in groups A and B were 100%, 93% in stage I, 82% and 85% in stage II, 62% and 52% in stage II and 22% and 31% in stage IV, respectively. There were no statistically significant differences among these survival curves in each stage. Five-year local failure rates were 16% in group A and 16% in group B (p=0.9096), and corresponding distant failure rates were 23% in group A and 19% in group B (p=0.2955). Moderate-to-severe complications requiring treatment (Kottmeier's grade 2 or more) were noted in 6 patients (7%) in group A and 6 patients (7%) in group B. All of the bladder and rectal complications needed medical treatment (Kottmeier's grade 2). Severe complications receiving surgery were noted in 4 patients (A: 1; B: 3), i.e., small intestine 3 and sigmoid colon 1 patient. Another 1 patient (A) was dead of ileus. There were no statistically significant differences between 2 treatment schedules in survival rates, failure patterns and complications rates. This fact suggests that small number of fractions (7.5 Gy/fraction) may be advantageous because of short duration and a low load of treatment. (orig.) [de

  15. Prospective Randomized Trial of Prone Accelerated Intensity Modulated Breast Radiation Therapy With a Daily Versus Weekly Boost to the Tumor Bed

    Energy Technology Data Exchange (ETDEWEB)

    Cooper, Benjamin T.; Formenti-Ujlaki, George F. [Department of Radiation Oncology, New York University School of Medicine and Langone Medical Center, New York, New York (United States); Li, Xiaochun [Division of Biostatistics, Departments of Population Health and Environmental Medicine, New York University School of Medicine, New York, New York (United States); Shin, Samuel M.; Fenton-Kerimian, Maria [Department of Radiation Oncology, New York University School of Medicine and Langone Medical Center, New York, New York (United States); Guth, Amber; Roses, Daniel F. [Department of Surgery, New York University School of Medicine and Langone Medical Center, New York, New York (United States); Hitchen, Christine J. [Department of Radiation Oncology, New York University School of Medicine and Langone Medical Center, New York, New York (United States); Rosenstein, Barry S. [Department of Radiation Oncology, New York University School of Medicine and Langone Medical Center, New York, New York (United States); Department of Radiation Oncology, Icahn School of Medicine at Mount Sinai, New York, New York (United States); Dewyngaert, J. Keith [Department of Radiation Oncology, New York University School of Medicine and Langone Medical Center, New York, New York (United States); Goldberg, Judith D. [Division of Biostatistics, Departments of Population Health and Environmental Medicine, New York University School of Medicine, New York, New York (United States); Formenti, Silvia C., E-mail: formenti@med.cornell.edu [Department of Radiation Oncology, New York University School of Medicine and Langone Medical Center, New York, New York (United States)

    2016-06-01

    Purpose: To report the results of a prospective randomized trial comparing a daily versus weekly boost to the tumor cavity during the course of accelerated radiation to the breast with patients in the prone position. Methods and Materials: From 2009 to 2012, 400 patients with stage 0 to II breast cancer who had undergone segmental mastectomy participated in an institutional review board–approved trial testing prone breast radiation therapy to 40.5 Gy in 15 fractions 5 d/wk to the whole breast, after randomization to a concomitant daily boost to the tumor bed of 0.5 Gy, or a weekly boost of 2 Gy, on Friday. The present noninferiority trial tested the primary hypothesis that a weekly boost produced no more acute toxicity than did a daily boost. The recurrence-free survival was estimated for both treatment arms using the Kaplan-Meier method; the relative risk of recurrence or death was estimated, and the 2 arms were compared using the log-rank test. Results: At a median follow-up period of 45 months, no deaths related to breast cancer had occurred. The weekly boost regimen produced no more grade ≥2 acute toxicity than did the daily boost regimen (8.1% vs 10.4%; noninferiority Z = −2.52; P=.006). No statistically significant difference was found in the cumulative incidence of long-term fibrosis or telangiectasia of grade ≥2 between the 2 arms (log-rank P=.923). Two local and two distant recurrences developed in the daily treatment arm and three local and one distant developed in the weekly arm. The 4-year recurrence-free survival rate was not different between the 2 treatment arms (98% for both arms). Conclusions: A tumor bed boost delivered either daily or weekly was tolerated similarly during accelerated prone breast radiation therapy, with excellent control of disease and comparable cosmetic results.

  16. The beneficial use of ultramicronized palmitoylethanolamide as add-on therapy to Tapentadol in the treatment of low back pain: a pilot study comparing prospective and retrospective observational arms.

    Science.gov (United States)

    Passavanti, Maria Beatrice; Fiore, Marco; Sansone, Pasquale; Aurilio, Caterina; Pota, Vincenzo; Barbarisi, Manlio; Fierro, Daniela; Pace, Maria Caterina

    2017-12-19

    This pilot study was designed to compare the efficacy of ultramicronized palmitoylethanolamide (um-PEA) as add-on therapy to tapentadol (TP) with TP therapy only in patients suffering from chronic low back pain (LBP). This pilot observational study consists in two arms: the prospective arm and the retrospective one. In the prospective arm patients consecutively selected received um-PEA as add-on therapy to TP for 6 months; in the retrospective arm patients were treated with TP only for 6 months. Pain intensity and neuropathic component were evaluated at baseline, during and after 6 months. The degree of disability and TP dosage assumption were evaluated at baseline and after 6 months. Statistical analysis performed with generalized linear mixed model on 55 patients (30 in the prospective group and 25 in the retrospective group) demonstrated that um-PEA as add-on treatment to TP in patients with chronic LBP, in comparison to TP alone, led to a significantly higher reduction in pain intensity, in the neuropathic component, the degree of disability and TP dosage assumption. No serious side effects were observed. Overall, the present findings suggest that um-PEA may be an innovative therapeutic intervention as add-on therapy to TP for the management of chronic LBP with a neuropathic component, as well as to improve patient quality of life. Additionally, this combination treatment allowed a reduction in TP dose over time and did not show any serious side effects.

  17. Effectiveness of enhanced cognitive behavioral therapy (CBT-E in the treatment of anorexia nervosa: a prospective multidisciplinary study

    Directory of Open Access Journals (Sweden)

    Yngvild S. Danielsen

    2016-10-01

    Full Text Available Abstract Background Anorexia nervosa (AN is a debilitating psychiatric disorder associated with a wide array of negative health complications and psychiatric comorbidity. Existing evidence for AN treatment in adults is weak, and no empirically supported treatment has been reliably established. The primary objective of this study is to gain knowledge about the effectiveness of enhanced cognitive behavioral therapy (CBT-E for anorexia nervosa delivered in a public hospital setting. Baseline predictors of treatment outcome and dropout are studied. Furthermore, there will be collected blood and stool samples for a general biobank to be able to initiate research on possible pathophysiological mechanisms underlying AN. Methods The study will assess the potency of outpatient CBT-E in a sample of patients suffering from AN (age >16 admitted to the Section for Eating Disorders at the Department for Psychosomatic Medicine, Haukeland University Hospital in Bergen, Norway. The study has a longitudinal design with five main assessment time points: before treatment, at 3 months, at the end of treatment, at 20 weeks, and at 12 months follow-up including biobank samples. A control group without an eating disorder will also be recruited. Discussion Treatment research in a public hospital setting is important for gaining knowledge about the transportability of treatments evaluated in research clinics into ordinary clinical practice. Furthermore, biological material from the thoroughly described patient cohort will serve as a basis for further research on the pathophysiological mechanisms in AN. Trial registration ClinicalTrials.gov Identifier: NCT02745067 . Registered 14 April 2016. 

  18. Retinal characteristics during 1 year of insulin pump therapy in type 1 diabetes: a prospective, controlled, observational study.

    Science.gov (United States)

    Klefter, Oliver Niels; Hommel, Eva; Munch, Inger Christine; Nørgaard, Kirsten; Madsbad, Sten; Larsen, Michael

    2016-09-01

    To investigate changes in retinal metabolism, function, structure and morphology in relation to initiation of insulin pump therapy (continuous subcutaneous insulin infusion, CSII). Visual acuity, retinopathy level, dark adaptation kinetics, retinal and subfoveal choroidal thickness, macular perfusion velocities, retinal vessel diameters and blood oxygen saturations were measured at baseline and after 1, 4, 16, 32 and 52 weeks in 31 patients with type 1 diabetes who started CSII and 20 patients who continued multiple daily insulin injections (MDI). One year of CSII reduced haemoglobin A1c (HbA1c ) by 1.6% (17.8 mmol/mol) compared with 0.3% (3.1 mmol/mol) in the MDI group (p < 0.0001). Central retinal thickness increased by 1.5% in the CSII group (within-group p = 0.0098; between-group p = 0.063) without producing macular oedema. No detectable change was found in any other primary outcome measure. The proportion of patients with retinopathy worsening did not differ between groups. At baseline, longer disease duration was associated with higher retinal artery oxygen saturation (p = 0.014) and lower macular venous perfusion velocity (p = 0.045). One year of CSII led to an HbA1c reduction relative to continued MDI and a small increase in retinal thickness but not to early retinopathy worsening or to changes in retinal vascular, structural or functional characteristics. Longer duration of type 1 diabetes appears to be associated with lower macular venous perfusion velocity and higher retinal artery oxygen saturation. The latter could potentially reflect cumulative glycaemia. © 2016 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

  19. Preoperative low level laser therapy in dogs undergoing tibial plateau levelling osteotomy: A blinded, prospective, randomized clinical trial.

    Science.gov (United States)

    Rogatko, Cleo P; Baltzer, Wendy I; Tennant, Rachel

    2017-01-16

    To evaluate the influence of preoperative low-level laser therapy (LLLT) on therapeutic outcomes of dogs undergoing tibial plateau levelling osteotomy (TPLO). Healthy dogs undergoing TPLO were randomly assigned to receive either a single preoperative LLLT treatment (800-900 nm dual wavelength, 6 W, 3.5 J/cm 2 , 100 cm 2 area) or a sham treatment. Lameness assessment and response to manipulation, as well as force plate analysis, were performed preoperatively, then again at 24 hours, two weeks, and eight weeks postoperatively. Radiographic signs of healing of the osteo-tomy were assessed at eight weeks postoperatively. Twenty-seven dogs (27 stifles) were included and no major complications occurred. At eight weeks postoperatively, a significant difference in peak vertical force analysis was noted between the LLLT (39.6% ± 4.7%) and sham groups (28.9% ± 2.6%), (p dogs in the LLLT group (6.6 ± 1.6 years) was greater than that for the sham group (4.5 ± 2.0, p dogs (5/8) had healed at the eight-week time point than in the sham group (3/12) despite the age difference (p = 0.11) Clinical significance: The results of this study demonstrate that improved peak vertical force could be related to the preoperative use of LLLT for dogs undergoing TPLO at eight weeks postoperatively. The use of LLLT may improve postoperative return to function following canine osteotomies and its use is recommended.

  20. Hyperbaric oxygen therapy for late radiation-induced tissue toxicity: prospectively patient-reported outcome measures in breast cancer patients

    International Nuclear Information System (INIS)

    Teguh, David N.; Bol Raap, René; Struikmans, Henk; Verhoef, Cees; Koppert, Linetta B.; Koole, Arne; Huang, Yadi; Hulst, Rob A. van

    2016-01-01

    This study examines patient reported outcome measures of women undergoing hyperbaric oxygen treatment (HBOT) after breast-conserving therapy. Included were 57 women treated with HBOT for late radiation-induced tissue toxicity (LRITT) referred in the period January 2014-December 2015. HBOT consisted of (on average) 47 sessions. In total, 80 min of 100 % O 2 was administered under increased pressure of 2.4 ATA. Quality of life was assessed before and after treatment using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-BR23, and a NRS pain score. Fifty-seven women were available for evaluation before and after treatment. Before HBOT, patients had severe complaints of pain in the arm/shoulder (46 %), swollen arm/hand (14 %), difficulty to raise arm or move it sideways (45 %), pain in the area of the affected breast (67 %), swollen area of the affected breast (45 %), oversensitivity of the affected breast (54 %), and skin problems on/in the area of the affected breast (32 %); post HBOT, severe complaints were still experienced in 17, 7, 22, 15, 13, 15, and 11 % of the women, respectively. Differences were all significant. The NRS pain score improved at least 1 point (range 0–10) in 81 % of the patients (p < 0.05). In these breast cancer patients treated with HBOT for LRITT, the patient-reported outcomes were positive and improvements were observed. HBOT was a well-tolerated treatment for LRITT and its side-effects were both minimal and reversible

  1. Antibody levels to tetanus, diphtheria, measles and varicella in patients with primary immunodeficiency undergoing intravenous immunoglobulin therapy: a prospective study.

    Science.gov (United States)

    Nobre, Fernanda Aimée; Gonzalez, Isabela Garrido da Silva; Simão, Raquel Maria; de Moraes Pinto, Maria Isabel; Costa-Carvalho, Beatriz Tavares

    2014-06-21

    Patients with antibody deficiencies depend on the presence of a variety of antibody specificities in intravenous immunoglobulin (IVIG) to ensure continued protection against pathogens. Few studies have examined levels of antibodies to specific pathogens in IVIG preparations and little is known about the specific antibody levels in patients under regular IVIG treatment. The current study determined the range of antibodies to tetanus, diphtheria, measles and varicella in IVIG products and the levels of these antibodies in patients undergoing IVIG treatment. We selected 21 patients with primary antibody deficiencies who were receiving regular therapy with IVIG. Over a period of one year, we collected four blood samples from each patient (every 3 months), immediately before immunoglobulin infusion. We also collected samples from the IVIG preparation the patients received the month prior to blood collection. Antibody levels to tetanus, diphtheria, measles and varicella virus were measured in plasma and IVIG samples. Total IgG levels were determined in plasma samples. Antibody levels to tetanus, diphtheria, varicella virus and measles showed considerable variation in different IVIG lots, but they were similar when compared between commercial preparations. All patients presented with protective levels of antibodies specific for tetanus, measles and varicella. Some patients had suboptimal diphtheria antibody levels. There was a significant correlation between serum and IVIG antibodies to all pathogens, except tetanus. There was a significant correlation between diphtheria and varicella antibodies with total IgG levels, but there was no significant correlation with antibodies to tetanus or measles. The study confirmed the variation in specific antibody levels between batches of the same brand of IVIG. Apart from the most common infections to which these patients are susceptible, health care providers must be aware of other vaccine preventable diseases, which still exist

  2. Acute toxicity profile of craniospinal irradiation with intensity-modulated radiation therapy in children with medulloblastoma: A prospective analysis

    International Nuclear Information System (INIS)

    Cox, Maurice C.; Kusters, Johannes M.; Gidding, Corrie E.; Schieving, Jolanda H.; Lindert, Erik J. van; Kaanders, Johannes H.; Janssens, Geert O.

    2015-01-01

    To report on the acute toxicity in children with medulloblastoma undergoing intensity-modulated radiation therapy (IMRT) with daily intrafractionally modulated junctions. Newly diagnosed patients, aged 3–21, with standard-risk (SR) or high-risk (HR) medulloblastoma were eligible. A dose of 23.4 or 36.0Gy in daily fractions of 1.8Gy was prescribed to the craniospinal axis, followed by a boost to the primary tumor bed (54 or 55.8Gy) and metastases (39.6–55.8Gy), when indicated. Weekly, an intravenous bolus of vincristine was combined for patients with SR medulloblastoma and patients participating in the COG-ACNS-0332 study. Common toxicity criteria (CTC, version 2.0) focusing on skin, alopecia, voice changes, conjunctivitis, anorexia, dysphagia, gastro-intestinal symptoms, headache, fatigue and hematological changes were scored weekly during radiotherapy. From 2010 to 2014, data from 15 consecutive patients (SR, n = 7; HR, n = 8) were collected. Within 72 h from onset of treatment, vomiting (66 %) and headache (46 %) occurred. During week 3 of treatment, a peak incidence in constipation (33 %) and abdominal pain/cramping (40 %) was observed, but only in the subgroup of patients (n = 9) receiving vincristine (constipation: 56 vs 0 %, P = .04; pain/cramping: 67 vs 0 %, P = .03). At week 6, 73 % of the patients developed faint erythema of the cranial skin with dry desquamation (40 %) or moist desquamation confined to the skin folds of the auricle (33 %). No reaction of the skin overlying the spinal target volume was observed. Headache at onset and gastro-intestinal toxicity, especially in patients receiving weekly vincristine, were the major complaints of patients with medulloblastoma undergoing craniospinal irradiation with IMRT

  3. Cognitive Function Before and After Intensity-Modulated Radiation Therapy in Patients With Nasopharyngeal Carcinoma: A Prospective Study

    International Nuclear Information System (INIS)

    Hsiao, Kuan-Yin; Yeh, Shyh-An; Chang, Chiung-Chih

    2010-01-01

    Purpose: To evaluate the effects of radiation therapy (RT) on neurocognitive function in patients with nasopharyngeal carcinoma (NPC). Methods and Materials: Thirty patients with NPC treated with intensity-modulated RT were included. Dose-volume histograms of the temporal lobes were obtained in every patient. Neurocognitive tests were administered individually to each patient 1 day before initiation of RT and at least 12 months after completion of RT. Cognitive functioning status was evaluated as change in scores over time. Results: Among the total of 30 patients, 23 patients (76.7%) had significantly lower post-RT cognitive functioning scores compared with their pre-RT scores (p = 0.033). The cognitive functioning scores had significantly declined in the domains of short-term memory, language abilities, and list-generating fluency (p = 0.020, 0.023, and 0.001, respectively). Compared with patients with a mean dose to the temporal lobes of 36 Gy or less, patients with a mean dose of greater than 36 Gy had a significantly greater reduction in cognitive functioning scores (p = 0.017). Patients in whom V60 of the temporal lobes (i.e., the percentage of the temporal lobe volume that had received >60 Gy) was greater than 10% also had a greater reduction in cognitive functioning scores than those in whom V60 was 10% or less (p = 0.039). Conclusions: The results of our study indicated that RT could have deleterious effects on cognitive function in patients with NPC. Efforts should be made to reduce the radiation dose and irradiated volume of temporal lobes without compromising the coverage of target volume.

  4. 2B4 expression on natural killer cells increases in HIV-1 infected patients followed prospectively during highly active antiretroviral therapy

    DEFF Research Database (Denmark)

    Ostrowski, S R; Ullum, H; Pedersen, Bente Klarlund

    2005-01-01

    by highly active antiretroviral therapy (HAART), low-level viraemia, proviral-DNA or immune activation in HIV-1 infected patients. A total of 101 HAART-treated HIV-1 infected patients with HIV-RNA copies/ml were followed prospectively for 24 months. HIV-RNA was investigated 3-monthly and 2B4...... expression on CD3- CD16+ NK cells and CD3+ CD8+ cells, proviral-DNA and plasma soluble tumour necrosis factor receptor (sTNFr)-II were investigated 6-monthly. For comparison, 2B4 expression was investigated in 20 healthy individuals. The concentration of 2B4+ NK cells was initially reduced in HIV-1 infected...... follow-up (both P DNA carrying cells and plasma sTNFrII were associated with reductions in the concentration of 2B4+ NK cells (all P HIV-RNA had no effect on 2B4 expression on NK cells or CD3+ CD8+ cells. These findings demonstrate that the concentration of 2B...

  5. Prospective Preference Assessment of Patients' Willingness to Participate in a Randomized Controlled Trial of Intensity-Modulated Radiotherapy Versus Proton Therapy for Localized Prostate Cancer

    International Nuclear Information System (INIS)

    Shah, Anand; Efstathiou, Jason A.; Paly, Jonathan J.; Halpern, Scott D.; Bruner, Deborah W.; Christodouleas, John P.; Coen, John J.; Deville, Curtiland; Vapiwala, Neha; Shipley, William U.; Zietman, Anthony L.; Hahn, Stephen M.; Bekelman, Justin E.

    2012-01-01

    Purpose: To investigate patients’ willingness to participate (WTP) in a randomized controlled trial (RCT) comparing intensity-modulated radiotherapy (IMRT) with proton beam therapy (PBT) for prostate cancer (PCa). Methods and Materials: We undertook a qualitative research study in which we prospectively enrolled patients with clinically localized PCa. We used purposive sampling to ensure a diverse sample based on age, race, travel distance, and physician. Patients participated in a semi-structured interview in which they reviewed a description of a hypothetical RCT, were asked open-ended and focused follow-up questions regarding their motivations for and concerns about enrollment, and completed a questionnaire assessing characteristics such as demographics and prior knowledge of IMRT or PBT. Patients’ stated WTP was assessed using a 6-point Likert scale. Results: Forty-six eligible patients (33 white, 13 black) were enrolled from the practices of eight physicians. We identified 21 factors that impacted patients’ WTP, which largely centered on five major themes: altruism/desire to compare treatments, randomization, deference to physician opinion, financial incentives, and time demands/scheduling. Most patients (27 of 46, 59%) stated they would either “definitely” or “probably” participate. Seventeen percent (8 of 46) stated they would “definitely not” or “probably not” enroll, most of whom (6 of 8) preferred PBT before their physician visit. Conclusions: A substantial proportion of patients indicated high WTP in a RCT comparing IMRT and PBT for PCa.

  6. Placebo controlled, prospectively randomized, double-blinded study for the investigation of the effectiveness and safety of the acoustic wave therapy (AWT(®)) for cellulite treatment.

    Science.gov (United States)

    Russe-Wilflingseder, Katharina; Russe-Wilfingsleder, Katharina; Russe, Elisabeth; Vester, Johannes C; Haller, Gerd; Novak, Pavel; Krotz, Alexander

    2013-06-01

    Placebo controlled double-blinded, prospectively randomized clinical trial with 17 patients (11 verum, 5 placebo) for evaluation of cellulite treatment with Acoustic Wave Therapy, (AWT(®)) was performed. The patients were treated once a week for 7 weeks, a total of 8 treatments with the D-ACTOR(®) 200 by Storz Medical AG. Data were collected at baseline, before 8th treatment, at 1 month (follow-up 1) and at 3 months (follow-up 2) after the last treatment with a patients' questionnaire, weight control, measurement of circumference and standardized photography. Treatment progress was further documented using a specially designed 3D imaging system (SkinSCAN(3D), 3D-Shape GmbH) providing an objective measure of cellulite (primary efficacy criteria). Patient's questionnaire in the verum group revealed an improvement in number and depth of dimples, skin firmness and texture, in shape and in reduction of circumference. The overall result (of skin waviness, Sq and Sz, surface and volume of depressions and elevations, Vvv and Vmp) at two follow-up visits indicates a more than medium sized superiority (MW = 0.6706) and is statistically significant (pWei-Lachin = 0.0106). The placebo group revealed no statistical significance. No side effects were seen. This indicates the efficacy and safety of AWT(®) for patients with cellulite.

  7. Low-Dose Total Skin Electron Beam Therapy as a Debulking Agent for Cutaneous T-Cell Lymphoma: An open-label prospective phase II study

    DEFF Research Database (Denmark)

    Kamstrup, M R; Lindahl, Lise Maria; Gniadecki, R

    2012-01-01

    Background: Total skin electron beam therapy (TSEBT) is a powerful treatment for cutaneous T-cell lymphomas (CTCL). Based on the occurrence of relapses with low radiation doses, doses of 30-36 Gy are commonly used but most patients still eventually relapse and repeat treatment courses are limited...... due to the cumulative toxicity. Complete response rates are about 60-90% for T2-4 stages with a 5-year relapse-free survival of 10-25% for stages IB-III. Objectives: To evaluate prospectively the efficacy of low-dose TSEBT (10 Gy) in terms of complete cutaneous response rate, overall response rate...... and response duration in CTCL. Methods: Ten patients with stage IB-IV mycosis fungoides (MF) were treated in an open-label manner with 4 fractions of 1 Gy/week TSEB to a total skin dose of 10 Gy. Treatment responses were assessed at 1 and 3 months after treatment and subsequently at least every 6 months...

  8. Prospective Analysis of Lipid Composition Changes with Antiretroviral Therapy and Immune Activation in Persons Living with HIV

    Directory of Open Access Journals (Sweden)

    Martha A. Belury

    2017-10-01

    Full Text Available Background: Lipid profiles are altered by HIV infection and antiretroviral therapy (ART. Among HIV-uninfected (HIV- populations the concentrations of various lipid classes (ie, lysophosphatidylcholine, LPC and their saturated (SaFA, monounsaturated (MUFA, and polyunsaturated fatty acid (PUFA composition are related to cardiometabolic disease risk. Associations between changes in the lipidome and immune activation in HIV-infected (HIV+ individuals beginning ART have not been described. Methods: Plasma lipid concentrations and their fatty acid composition were measured by differential mobility spectroscopy in samples from 35 treatment-naive HIV+ participants beginning raltegravir (RAL-based ART and from HIV- individuals (N=13 matched for age and sex. Results: The levels of SaFA, including palmitic (16:0 and stearic (18:0 acid were enriched in HIV+ participants (pre- and post-ART, and SaFA levels were often positively correlated with levels of immune activation (ie, IL-6, sCD14, and TNFR1 at baseline and week 48. Levels of PUFAs (including 18:3, 20:4, and 20:5 were lower in HIV+ participants at baseline compared to levels in HIV- participants (P<0.01, and levels of these PUFAs were increased following 48 weeks of ART. Levels of PUFAs were often inversely related to immune activation. Levels of LPC were increased in HIV+ participants, both pre- and post-ART vs HIV- participants, and the composition of LPC was enriched for SaFAs among HIV+ individuals. At week 48, several LPC molecules containing SaFAs were positively correlated with levels of sCD14, D-dimer, and TNFR1 (P<0.01, and levels of PUFA-containing LPC (18:3, 20:5, 22:5, 22:6 were positively correlated with CD4+ T cell counts and inversely correlated with sCD14 and IL-6 (P<0.01. Conclusions: The composition of the lipidome is altered in HIV infection and changes when ART is administered. Alterations in SaFAs were generally associated with inflammatory markers and may contribute to comorbid

  9. Prospective Phase II Study of Brachytherapy Boost as a Component of Neo-Adjuvant Chemotherapy and External Beam Radiation Therapy in Locally Advanced Rectal Cancer

    International Nuclear Information System (INIS)

    EL-SAYED, M.E.; EL-TAHER, Z.H.

    2008-01-01

    The aim of the current study is to assess the response rate and toxicity profile in patients with locally advanced rectal cancer using brachytherapy (BT) boost following external beam radiotherapy (EBRT), concomitant with chemotherapy as a component of the neoadjuvant treatment. Patients and Methods: This is a prospective phase II study of neoadjuvant chemo-radiation therapy for patients with locally advanced rectal cancer who presented to the department of radiation oncology, King Abdul-Aziz University Hospital, Jeddah, Kingdom of Saudi Arabia. Seventeen patients had been included in the study. Radiation therapy was given as: phase I,45 Gy/25 fractions/5 weeks of EBRT, followed by brachytherapy boost (within one week after the end of EBRT) using high dose rate iridium 192 (Ir 192 ) aiming at 800 c Gy given in 2 fractions (each 400 c Gy) separated by 1 week. All patients received the same concomitant chemotherapy in the form of Capecitabine and Oxaliplatin. The clinical and pathological response rates, together with the toxicity profile were assessed. Results: Seventeen patients had been studied; the majority (14; 82%) were males, while 3 only (18%) were females, their mean age was 57.4 years. All patients had low anterior resection (LAR). The clinical response rate, assessed by digital rectal examination ± endoscopy examination 4 weeks after the end of EBRT and BT, revealed that complete clinical response (cCR) was noted in 3 patients (18%), clinical partial response (cPR) in 14 patients (82%); while the pathological response rate was: complete pathological response (pCR) in 8 patients (47%), pathological partial response (pPR) in 9 patients (53%). The toxicity profile showed that grade III radiation proctitis was seen in one patient (6%), grade III dermatitis in 2 (12%), while no patients developed grade III cystitis. For chemotherapy toxicities, three patients (18%) developed grade III nausea and/or vomiting, 2 (12%) developed grade III diarrhea. Conclusion

  10. Treatment of Children With Central Nervous System Primitive Neuroectodermal Tumors/Pinealoblastomas in the Prospective Multicentric Trial HIT 2000 Using Hyperfractionated Radiation Therapy Followed by Maintenance Chemotherapy

    Energy Technology Data Exchange (ETDEWEB)

    Gerber, Nicolas U., E-mail: nicolas.gerber@kispi.uzh.ch [Department of Pediatric Oncology, University Children' s Hospital, Zurich (Switzerland); Hoff, Katja von; Resch, Anika [Department of Pediatric Hematology and Oncology, University Medical Center Hamburg-Eppendorf, Hamburg (Germany); Ottensmeier, Holger [Department of Pediatric Oncology, University of Wuerzburg, Wuerzburg (Germany); Kwiecien, Robert; Faldum, Andreas [Institute of Biostatistics and Clinical Research, University of Muenster (Germany); Matuschek, Christiane [Department of Radiation Oncology, Medical Faculty, Heinrich Heine University of Duesseldorf, Duesseldorf (Germany); Hornung, Dagmar [Department of Radiotherapy and Radio-Oncology, University Medical Center Hamburg-Eppendorf, Hamburg (Germany); Bremer, Michael [Institute for Radiation Therapy and Special Oncology, Hannover Medical School, Hannover (Germany); Benesch, Martin [Division of Pediatric Hematology and Oncology, Department of Pediatrics and Adolescent Medicine, Medical University of Graz, Graz (Austria); Pietsch, Torsten [Department of Neuropathology, University of Bonn, Bonn (Germany); Warmuth-Metz, Monika [Department of Neuroradiology, University of Wuerzburg, Wuerzburg (Germany); Kuehl, Joachim [Department of Pediatric Oncology, University of Wuerzburg, Wuerzburg (Germany); Rutkowski, Stefan [Department of Pediatric Hematology and Oncology, University Medical Center Hamburg-Eppendorf, Hamburg (Germany); Kortmann, Rolf D. [Department of Radiation Oncology, University of Leipzig, Leipzig (Germany)

    2014-07-15

    Purpose: The prognosis for children with central nervous system primitive neuroectodermal tumor (CNS-PNET) or pinealoblastoma is still unsatisfactory. Here we report the results of patients between 4 and 21 years of age with nonmetastatic CNS-PNET or pinealoblastoma diagnosed from January 2001 to December 2005 and treated in the prospective GPOH-trial P-HIT 2000-AB4. Methods and Materials: After surgery, children received hyperfractionated radiation therapy (36 Gy to the craniospinal axis, 68 Gy to the tumor region, and 72 Gy to any residual tumor, fractionated at 2 × 1 Gy per day 5 days per week) accompanied by weekly intravenous administration of vincristine and followed by 8 cycles of maintenance chemotherapy (lomustine, cisplatin, and vincristine). Results: Twenty-six patients (15 with CNS-PNET; 11 with pinealoblastoma) were included. Median age at diagnosis was 11.5 years old (range, 4.0-20.7 years). Gross total tumor resection was achieved in 6 and partial resection in 16 patients (indistinct, 4 patients). Median follow-up of the 15 surviving patients was 7.0 years (range, 5.2-10.0 years). The combined response rate to postoperative therapy was 17 of 20 (85%). Eleven of 26 patients (42%; 7 of 15 with CNS-PNET; 4 of 11 with pinealoblastoma) showed tumor progression or relapse at a median time of 1.3 years (range, 0.5-1.9 years). Five-year progression-free and overall survival rates (±standard error [SE]) were each 58% (±10%) for the entire cohort: CNS-PNET was 53% (±13); pinealoblastoma was 64% (±15%; P=.524 and P=.627, respectively). Conclusions: Postoperative hyperfractionated radiation therapy with local dose escalation followed by maintenance chemotherapy was feasible without major acute toxicity. Survival rates are comparable to those of a few other recent studies but superior to those of most other series, including the previous trial, HIT 1991.

  11. Transurethral Resection of the Prostate (TURP) Versus Original and PErFecTED Prostate Artery Embolization (PAE) Due to Benign Prostatic Hyperplasia (BPH): Preliminary Results of a Single Center, Prospective, Urodynamic-Controlled Analysis

    Energy Technology Data Exchange (ETDEWEB)

    Carnevale, Francisco C., E-mail: fcarnevale@uol.com.br [University of Sao Paulo Medical School, Interventional Radiology Unit (Brazil); Iscaife, Alexandre, E-mail: iscaifeboni@yahoo.com.br; Yoshinaga, Eduardo M., E-mail: dumuracca@ig.com.br [University of Sao Paulo Medical School, Division of Urology (Brazil); Moreira, Airton Mota, E-mail: motamoreira@gmail.com [University of Sao Paulo Medical School, Interventional Radiology Unit (Brazil); Antunes, Alberto A., E-mail: antunesuro@uol.com.br; Srougi, Miguel, E-mail: srougi@uol.com.br [University of Sao Paulo Medical School, Division of Urology (Brazil)

    2016-01-15

    PurposeTo compare clinical and urodynamic results of transurethral resection of the prostate (TURP) to original and PErFecTED prostate artery embolization (PAE) methods for benign prostatic hyperplasia.MethodsWe prospectively randomized 30 patients to receive TURP or original PAE (oPAE) and compared them to a cohort of patients treated by PErFecTED PAE, with a minimum of 1-year follow-up. Patients were assessed for urodynamic parameters, prostate volume, international prostate symptom score (IPSS), and quality of life (QoL).ResultsAll groups were comparable for all pre-treatment parameters except bladder contractility and peak urine flow rate (Q{sub max}), both of which were significantly better in the TURP group, and IIEF score, which was significantly higher among PErFecTED PAE patients than TURP patients. All groups experienced significant improvement in IPSS, QoL, prostate volume, and Q{sub max}. TURP and PErFecTED PAE both resulted in significantly lower IPSS than oPAE but were not significantly different from one another. TURP resulted in significantly higher Q{sub max} and significantly smaller prostate volume than either original or PErFecTED PAE but required spinal anesthesia and hospitalization. Two patients in the oPAE group with hypocontractile bladders experienced recurrence of symptoms and were treated with TURP. In the TURP group, urinary incontinence occurred in 4/15 patients (26.7 %), rupture of the prostatic capsule in 1/15 (6.7 %), retrograde ejaculation in all patients (100 %), and one patient was readmitted for temporary bladder irrigation due to hematuria.ConclusionsTURP and PAE are both safe and effective treatments. TURP and PErFecTED PAE yield similar symptom improvement, but TURP is associated with both better urodynamic results and more adverse events.

  12. Transurethral Resection of the Prostate (TURP) Versus Original and PErFecTED Prostate Artery Embolization (PAE) Due to Benign Prostatic Hyperplasia (BPH): Preliminary Results of a Single Center, Prospective, Urodynamic-Controlled Analysis.

    Science.gov (United States)

    Carnevale, Francisco C; Iscaife, Alexandre; Yoshinaga, Eduardo M; Moreira, Airton Mota; Antunes, Alberto A; Srougi, Miguel

    2016-01-01

    To compare clinical and urodynamic results of transurethral resection of the prostate (TURP) to original and PErFecTED prostate artery embolization (PAE) methods for benign prostatic hyperplasia. We prospectively randomized 30 patients to receive TURP or original PAE (oPAE) and compared them to a cohort of patients treated by PErFecTED PAE, with a minimum of 1-year follow-up. Patients were assessed for urodynamic parameters, prostate volume, international prostate symptom score (IPSS), and quality of life (QoL). All groups were comparable for all pre-treatment parameters except bladder contractility and peak urine flow rate (Q max), both of which were significantly better in the TURP group, and IIEF score, which was significantly higher among PErFecTED PAE patients than TURP patients. All groups experienced significant improvement in IPSS, QoL, prostate volume, and Q max. TURP and PErFecTED PAE both resulted in significantly lower IPSS than oPAE but were not significantly different from one another. TURP resulted in significantly higher Q max and significantly smaller prostate volume than either original or PErFecTED PAE but required spinal anesthesia and hospitalization. Two patients in the oPAE group with hypocontractile bladders experienced recurrence of symptoms and were treated with TURP. In the TURP group, urinary incontinence occurred in 4/15 patients (26.7 %), rupture of the prostatic capsule in 1/15 (6.7 %), retrograde ejaculation in all patients (100 %), and one patient was readmitted for temporary bladder irrigation due to hematuria. TURP and PAE are both safe and effective treatments. TURP and PErFecTED PAE yield similar symptom improvement, but TURP is associated with both better urodynamic results and more adverse events.

  13. Patient-Reported Voice and Speech Outcomes After Whole-Neck Intensity Modulated Radiation Therapy and Chemotherapy for Oropharyngeal Cancer: Prospective Longitudinal Study

    Energy Technology Data Exchange (ETDEWEB)

    Vainshtein, Jeffrey M. [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan (United States); Griffith, Kent A. [Center for Cancer Biostatistics, University of Michigan School of Public Health, Ann Arbor, Michigan (United States); Feng, Felix Y.; Vineberg, Karen A. [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan (United States); Chepeha, Douglas B. [Department of Otolaryngology–Head and Neck Surgery, University of Michigan, Ann Arbor, Michigan (United States); Eisbruch, Avraham, E-mail: eisbruch@umich.edu [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan (United States)

    2014-08-01

    Purpose: To describe voice and speech quality changes and their predictors in patients with locally advanced oropharyngeal cancer treated on prospective clinical studies of organ-preserving chemotherapy–intensity modulated radiation therapy (chemo-IMRT). Methods and Materials: Ninety-one patients with stage III/IV oropharyngeal cancer were treated on 2 consecutive prospective studies of definitive chemoradiation using whole-field IMRT from 2003 to 2011. Patient-reported voice and speech quality were longitudinally assessed from before treatment through 24 months using the Communication Domain of the Head and Neck Quality of Life (HNQOL-C) instrument and the Speech question of the University of Washington Quality of Life (UWQOL-S) instrument, respectively. Factors associated with patient-reported voice quality worsening from baseline and speech impairment were assessed. Results: Voice quality decreased maximally at 1 month, with 68% and 41% of patients reporting worse HNQOL-C and UWQOL-S scores compared with before treatment, and improved thereafter, recovering to baseline by 12-18 months on average. In contrast, observer-rated larynx toxicity was rare (7% at 3 months; 5% at 6 months). Among patients with mean glottic larynx (GL) dose ≤20 Gy, >20-30 Gy, >30-40 Gy, >40-50 Gy, and >50 Gy, 10%, 32%, 25%, 30%, and 63%, respectively, reported worse voice quality at 12 months compared with before treatment (P=.011). Results for speech impairment were similar. Glottic larynx dose, N stage, neck dissection, oral cavity dose, and time since chemo-IMRT were univariately associated with either voice worsening or speech impairment. On multivariate analysis, mean GL dose remained independently predictive for both voice quality worsening (8.1%/Gy) and speech impairment (4.3%/Gy). Conclusions: Voice quality worsening and speech impairment after chemo-IMRT for locally advanced oropharyngeal cancer were frequently reported by patients, underrecognized by clinicians, and

  14. Patient-Reported Voice and Speech Outcomes After Whole-Neck Intensity Modulated Radiation Therapy and Chemotherapy for Oropharyngeal Cancer: Prospective Longitudinal Study

    International Nuclear Information System (INIS)

    Vainshtein, Jeffrey M.; Griffith, Kent A.; Feng, Felix Y.; Vineberg, Karen A.; Chepeha, Douglas B.; Eisbruch, Avraham

    2014-01-01

    Purpose: To describe voice and speech quality changes and their predictors in patients with locally advanced oropharyngeal cancer treated on prospective clinical studies of organ-preserving chemotherapy–intensity modulated radiation therapy (chemo-IMRT). Methods and Materials: Ninety-one patients with stage III/IV oropharyngeal cancer were treated on 2 consecutive prospective studies of definitive chemoradiation using whole-field IMRT from 2003 to 2011. Patient-reported voice and speech quality were longitudinally assessed from before treatment through 24 months using the Communication Domain of the Head and Neck Quality of Life (HNQOL-C) instrument and the Speech question of the University of Washington Quality of Life (UWQOL-S) instrument, respectively. Factors associated with patient-reported voice quality worsening from baseline and speech impairment were assessed. Results: Voice quality decreased maximally at 1 month, with 68% and 41% of patients reporting worse HNQOL-C and UWQOL-S scores compared with before treatment, and improved thereafter, recovering to baseline by 12-18 months on average. In contrast, observer-rated larynx toxicity was rare (7% at 3 months; 5% at 6 months). Among patients with mean glottic larynx (GL) dose ≤20 Gy, >20-30 Gy, >30-40 Gy, >40-50 Gy, and >50 Gy, 10%, 32%, 25%, 30%, and 63%, respectively, reported worse voice quality at 12 months compared with before treatment (P=.011). Results for speech impairment were similar. Glottic larynx dose, N stage, neck dissection, oral cavity dose, and time since chemo-IMRT were univariately associated with either voice worsening or speech impairment. On multivariate analysis, mean GL dose remained independently predictive for both voice quality worsening (8.1%/Gy) and speech impairment (4.3%/Gy). Conclusions: Voice quality worsening and speech impairment after chemo-IMRT for locally advanced oropharyngeal cancer were frequently reported by patients, underrecognized by clinicians, and

  15. Questions for Your Prospective Massage Therapist

    Science.gov (United States)

    ... Your Prospective Massage Therapist Questions for Your Prospective Massage Therapist Searching for a massage therapist? Get the ... 1. Are you a member of the American Massage Therapy Association (AMTA)? AMTA members commit to the ...

  16. Bioactive glasses potential biomaterials for future therapy

    CERN Document Server

    Kaur, Gurbinder

    2017-01-01

    This book describes the history, origin and basic characteristics of bioactive materials. It includes a chapter dedicated to hydroxyapatite mineral, its formation and its bioactive properties. The authors address how cytotoxicity is a determining step for bioactivity. Applications of bioactive materials in the contexts of tissue regeneration, bone regeneration and cancer therapy are also covered. Silicate, metallic and mesoporous glasses are described, as well as the challenges and future prospects of research in this field.

  17. A Prospective Trial of Intensity Modulated Radiation Therapy (IMRT) Incorporating a Simultaneous Integrated Boost for Prostate Cancer: Long-term Outcomes Compared With Standard Image Guided IMRT

    Energy Technology Data Exchange (ETDEWEB)

    Schild, Michael H. [Midwestern University, Glendale, Arizona (United States); Schild, Steven E., E-mail: sschild@mayo.edu [Department of Radiation Oncology, Mayo Clinic Hospital, Phoenix, Arizona (United States); Wong, William W.; Vora, Sujay A.; Keole, Sameer R.; Vargas, Carlos E.; Daniels, Thomas B.; Ezzell, Gary A. [Department of Radiation Oncology, Mayo Clinic Hospital, Phoenix, Arizona (United States); Nguyen, Ba D.; Roarke, Michael C. [Department of Radiology, Mayo Clinic, Scottsdale, Arizona (United States)

    2017-04-01

    Purpose: This report describes the long-term outcomes of a prospective trial of intensity modulated radiation therapy (IMRT), integrating a {sup 111}In capromab pendetide (ProstaScint) scan-directed simultaneous integrated boost (SIB) for localized prostate cancer. Methods and Materials: Seventy-one patients with T1N0M0 to T4N0M0 prostate cancer were enrolled, and their ProstaScint and pelvic computed tomography scans were coregistered for treatment planning. The entire prostate received 75.6 Gy in 42 fractions with IMRT, whereas regions of increased uptake on ProstaScint scans received 82 Gy as an SIB. Patients with intermediate- and high-risk disease also received 6 months and 12 months of adjuvant hormonal therapy, respectively. Results: The study enrolled 31 low-, 30 intermediate-, and 10 high-risk patients. The median follow-up was 120 months (range, 24-150 months). The 10-year biochemical control rates were 85% for the entire cohort and 84%, 84%, and 90% for patients with low-, intermediate-, and high-risk disease, respectively. The 10-year survival rate of the entire cohort was 69%. Pretreatment prostate-specific antigen level >10 ng/mL and boost volume of >10% of the prostate volume were significantly associated with poorer biochemical control and survival. The outcomes were compared with those of a cohort of 302 patients treated similarly but without the SIB and followed up for a median of 91 months (range, 6-138 months). The 5- and 10-year biochemical control rates were 86% and 61%, respectively, in patients without the SIB compared with 94% and 85%, respectively, in patients in this trial who received the SIB (P=.02). The cohort that received an SIB did not have increased toxicity. Conclusions: The described IMRT strategy, integrating multiple imaging modalities to administer 75.6 Gy to the entire prostate with a boost dose of 82 Gy, was feasible. The addition of the SIB was associated with greater biochemical control but not toxicity. Modern

  18. Effects of Radiation Therapy on Immunological and Virological Status in HIV-Infected Cancer Patients in Thailand: A Multicenter Prospective Study.

    Science.gov (United States)

    Siraprapasiri, Pathomphorn; Tharavichitkul, Ekkasit; Suntornpong, Nan; Tovanabutra, Chowkaew; Meennuch, Ekapop; Panboon, Phimphun; Swangsilpa, Thiti; Siraprapasiri, Taweesap

    2016-02-01

    Radiation therapy (RT) is the core part of cancer multidisciplinary management which causes myelosuppression. The current standard or RT among HIV-positive cancer patients who are immuno-compromised does not differ from that of HIV-negative ones. To determine the effects of radiation therapy on immunological and virological status among HIV-infected cancer patients. A prospective observational study was conducted of HIV-infected cancer patients who received definitive RT in seven hospitals in Thailand. Blood samples were taken to determine immune status using CD4%, and virological status was identified using plasma HIV-RNA viral load (HIV-VL) assay: at baseline before RT at the last week of RT completion; and at the 6-month follow-up visit. Additional CD4% test was performed at the 3-month follow-up visit. Ninety HIV-infected cancer patients from seven hospitals in Thailand were included in the analysis. The median age was 40 years old (range 19-61). Seventy-six patients (84.4%) were female and 65 (72.2%) were cases of invasive cervical cancers. Eighty-seven percent of patients had been receiving antiretroviral treatment (ART) before RT The mean CD4% at baseline, RT completion, 3-month and 6-month follow-up visits, were 18.7%, 20.1%, 16.8% and 17.1%, respectively. The proportion of CD4% reduction in the non-ART group was higher than that of the ART group throughout the period, particularly at the 3-month follow-up visit (100% vs. 29.7%, p = 0.0004). Six cases had a HIV-VL increase of more than 10 times (1-log₁₀) at completion of RT: 3 of these were non-ART and 3 were ART-uncontrolled viral suppression. RT had a suppressive effect on immunological status in HIV-infected cancer patients, particularly in the subacute period among those who were not on ART HIV-disease progression was observed during radiation treatment in HIV-infected cancer patients without ART and those with ART-uncontrolled viral suppression.

  19. Renal insufficiency was correlated with 2-year mortality for rural female patients with ST-segment elevation acute myocardial infarction after reperfusion therapy: a multicenter, prospective study.

    Science.gov (United States)

    Gao, Yuan; Jiang, Daming; Zhang, Bo; Sun, Yujiao; Ren, Lina; Fan, Dandan; Qi, Guoxian

    2015-12-24

    Renal insufficiency (RI) following ST-segment elevation acute myocardial infarction (STEMI) is associated with a worse clinical prognosis. We investigated the impact of RI on long-term mortality in rural female patients with STEMI and evaluated prognostic factors. A prospective cohort study of 436 consecutive rural female patients who were successfully treated with reperfusion therapy for STEMI between May 2009 and August 2011 in secondary care hospitals in Liaoning province northeastern China and followed up for 2 years. Patients were divided into three groups by estimated glomerular filtration rate (eGFR): Normal group, eGFR ≥90 mL/min/1.73 m(2) (n = 233). Moderate group, eGFR 60-90 mL/min/1.73 m(2) (n = 108). RI group, eGFR <60 mL/min/1.73 m(2) (n = 95). The primary outcome was 2-year mortality. During follow-up (mean 741 ± 118 days), the RI group had a significantly higher mortality than the other groups (24.21 % vs. 6.87 % and 10.19 %, p < 0.001). The RI group had significantly higher hospital mortality (7.37 % p = 0.045 vs. Normal group). RI increased the risk of hospital mortality (hazard ratio (HR) 1.832, 95 % CI 1.017-3.091, p = 0.033), and increased the risk of 2-year mortality (HR 3.872, 95 % CI 2.004-6.131, p < 0.001). Multivariate analysis showed eGFR <90 ml/min/1.73 m(2) and age ≥75 years as independent predictors of mortality at 2 years. In detail these were eGFR 60-90 ml/min/1.73 m(2) with HR 2.081, 95%CI 1.250-2.842, p < 0.001; eGFR <60 ml/min/1.73 m(2) with HR 3.872, 95%CI 2.004-6.131, p < 0.001; age ≥75 with HR 1.461, 95%CI 1.011-1.952, p = 0.024. RI had a powerful correlation with long-term mortality for rural female patients with STEMI after reperfusion therapy.

  20. Fractionated Boron Neutron Capture Therapy in Locally Recurrent Head and Neck Cancer: A Prospective Phase I/II Trial

    Energy Technology Data Exchange (ETDEWEB)

    Wang, Ling-Wei, E-mail: lwwang@vghtpe.gov.tw [Department of Oncology, Taipei Veterans General Hospital, Taipei, Taiwan (China); National Yang-Ming University, Taiwan (China); Chen, Yi-Wei [Department of Oncology, Taipei Veterans General Hospital, Taipei, Taiwan (China); National Yang-Ming University, Taiwan (China); Ho, Ching-Yin [National Yang-Ming University, Taiwan (China); Department of Otolaryngology, Taipei Veterans General Hospital, Taiwan (China); Hsueh Liu, Yen-Wan [Institute of Nuclear Engineering and Science, National Tsing Hua University, Taiwan (China); Chou, Fong-In [Institute of Nuclear Engineering and Science, National Tsing Hua University, Taiwan (China); Nuclear Science and Technology Development Center, National Tsing Hua University, Taiwan (China); Liu, Yuan-Hao [Nuclear Science and Engineering Department, Nanjing University of Aeronautics and Astronautics, Nanjing (China); Liu, Hong-Ming; Peir, Jinn-Jer [Nuclear Science and Technology Development Center, National Tsing Hua University, Taiwan (China); Jiang, Shiang-Huei [Institute of Nuclear Engineering and Science, National Tsing Hua University, Taiwan (China); Chang, Chi-Wei [National Yang-Ming University, Taiwan (China); Department of Nuclear Medicine, Taipei Veterans General Hospital, Taiwan (China); Liu, Ching-Sheng [Department of Oncology, Taipei Veterans General Hospital, Taipei, Taiwan (China); National Yang-Ming University, Taiwan (China); Lin, Ko-Han [Taoyuan Veterans Hospital, Taiwan (China); Wang, Shyh-Jen [National Yang-Ming University, Taiwan (China); Department of Nuclear Medicine, Taipei Veterans General Hospital, Taiwan (China); Chu, Pen-Yuan [National Yang-Ming University, Taiwan (China); Department of Otolaryngology, Taipei Veterans General Hospital, Taiwan (China); Lo, Wen-Liang; Kao, Shou-Yen [National Yang-Ming University, Taiwan (China); Department of Stomatology, Taipei Veterans General Hospital, Taiwan (China); and others

    2016-05-01

    Purpose: To investigate the efficacy and safety of fractionated boron neutron capture therapy (BNCT) for recurrent head and neck (H&N) cancer after photon radiation therapy. Methods and Materials: In this prospective phase 1/2 trial, 2-fraction BNCT with intravenous L-boronophenylalanine (L-BPA, 400 mg/kg) was administered at a 28-day interval. Before each fraction, fluorine-18-labeled-BPA–positron emission tomography was conducted to determine the tumor/normal tissue ratio of an individual tumor. The prescription dose (D80) of 20 Gy-Eq per fraction was selected to cover 80% of the gross tumor volume by using a dose volume histogram, while minimizing the volume of oral mucosa receiving >10 Gy-Eq. Tumor responses and adverse effects were assessed using the Response Evaluation Criteria in Solid Tumors v1.1 and the Common Terminology Criteria for Adverse Events v3.0, respectively. Results: Seventeen patients with a previous cumulative radiation dose of 63-165 Gy were enrolled. All but 2 participants received 2 fractions of BNCT. The median tumor/normal tissue ratio was 3.4 for the first fraction and 2.5 for the second, whereas the median D80 for the first and second fraction was 19.8 and 14.6 Gy-Eq, respectively. After a median follow-up period of 19.7 months (range, 5.2-52 mo), 6 participants exhibited a complete response and 6 exhibited a partial response. Regarding acute toxicity, 5 participants showed grade 3 mucositis and 1 participant showed grade 4 laryngeal edema and carotid hemorrhage. Regarding late toxicity, 2 participants exhibited grade 3 cranial neuropathy. Four of six participants (67%) receiving total D80 > 40 Gy-Eq had a complete response. Two-year overall survival was 47%. Two-year locoregional control was 28%. Conclusions: Our results suggested that 2-fraction BNCT with adaptive dose prescription was effective and safe in locally recurrent H&N cancer. Modifications to our protocol may yield more satisfactory results in the future.

  1. Intensity-modulated radiation therapy reduces radiation-induced trismus in patients with nasopharyngeal carcinoma: a prospective study with >5 years of follow-up.

    Science.gov (United States)

    Chen, Yuan-Yuan; Zhao, Chong; Wang, Jin; Ma, Hong-Lian; Lai, Shu-Zheng; Liu, Yuan; Han, Fei; Lu, Li-Xia; Bao, Yong; Chen, Ming

    2011-07-01

    Intensity-modulated radiation therapy (IMRT) for nasopharyngeal carcinoma (NPC) provides better temporomandibular joint (TMJ) sparing and, thus, may reduce the incidence of radiation-induced trismus after radiotherapy. The objectives of this study were to evaluate radiation-induced trismus in patients with NPC who had received IMRT and to assess the pretreatment factors, relevant treatment factors, and dosimetry parameters associated with trismus. A prospective, single-arm measurement study with more than 5 years of follow-up was designed. Patients with newly diagnosed stage I through IVB NPC who received treatment with IMRT were eligible. Patients received 66 to 70 grays (Gy) to the gross tumor volume. The maximal interincisal distance (MID) was measured at baseline and 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years after they completed IMRT. The trial enrolled 211 consecutive patients from 2001 to 2004. The mean dose to the TMJ ranged from 6.18 Gy to 51.36 Gy (median dose, 29.88 Gy). Compared with baseline MID levels, normalized MID levels at 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years after IMRT were 94.6% ± 9.9%, 92.5% ± 10.5%, 92% ± 10.6%, 92.2% ± 10.5%, 92.1% ± 10.2%, and 90.3% ± 11.4%, respectively (P trismus was identified in 12 of 211 patients (5.7%), and no grade 3/4 trismus was observed. There was an increasing risk of trismus after IMRT when the MID was 40.5 mm (P = .007). No dosimetric parameter was associated with trismus. IMRT was able to reduce the radiation dose to the TMJ and likely reduced the incidence and severity of radiation-induced trismus after radiotherapy. Copyright © 2011 American Cancer Society.

  2. Prospective observational study of the effect of dual antiplatelet therapy with tranexamic acid treatment on platelet function and bleeding after cardiac surgery.

    Science.gov (United States)

    Amour, J; Garnier, M; Szymezak, J; Le Manach, Y; Helley, D; Bertil, S; Ouattara, A; Riou, B; Gaussem, P

    2016-12-01

    The bleeding impact of dual antiplatelet therapy (DAPT), aspirin and clopidogrel, maintained until coronary artery bypass graft surgery (CABG), is still a matter of debate. The lack of preoperative antiplatelet activity measurement and heterogeneity of antifibrinolytic protocols in prior studies make the conclusions questionable. The aim of this prospective study was to determine, after preoperative antiplatelet activity measurement, if the maintenance of DAPT until CABG increases bleeding in patients treated with tranexamic acid (TA). This observational study included 150 consecutive patients, 89 treated with aspirin and 61 treated with DAPT, undergoing a first-time planned on-pump CABG with TA treatment. Antiplatelet activity was measured with platelet aggregation tests and quantification of VASP phosphorylation. Postoperative bleeding at 24 h was recorded and propensity score analysis was performed. Based on VASP assay, 54% of patients showed high on-clopidogrel platelet activity inhibition. Postoperative bleeding at 24 h increased by 22% in the DAPT group, compared with the aspirin group (680 [95% CI: 360-1670] vs 558 [95%CI: 267-1270] ml, P < 0.01), consistent with increased blood transfusion (21% vs 7%, P = 0.01); a higher incidence of mediastinitis did not reach statistical significance (15% vs 4%, P = 0.05). Bleeding correlated with the extent of clopidogrel antiplatelet effect, with the best correlation for the VASP assay. Maintenance of DAPT until the day of CABG in patients treated with TA, increased postoperative bleeding at 24 h in parallel with preoperative antiplatelet activity induced by clopidogrel. © The Author 2016. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  3. A prospective study of XELIRI plus bevacizumab as a first-line therapy in Japanese patients with unresectable or recurrent colorectal cancer (KSCC1101).

    Science.gov (United States)

    Ando, Koji; Emi, Yasunori; Suenaga, Toyokuni; Hamanoue, Masahiro; Maekawa, Soichiro; Sakamoto, Yasuo; Kai, Seiichiro; Satake, Hironaga; Shimose, Takayuki; Shimokawa, Mototsugu; Saeki, Hiroshi; Oki, Eiji; Sakai, Kenji; Akagi, Yoshito; Baba, Hideo; Maehara, Yoshihiko

    2017-10-01

    This study was designed to evaluate the efficacy and toxicity of XELIRI plus bevacizumab for the treatment of Japanese patients with unresectable or recurrent colorectal cancer (CRC). This was a multicenter, single-arm, open-label prospective study. The major inclusion criteria were previously untreated unresectable or recurrent CRC, presence of measurable lesions, ≥20 years of age, Eastern Cooperative Oncology Group performance status 0 or 1, and adequate organ function. Patients received bevacizumab (7.5 mg/kg on day 1) and XELIRI (irinotecan 200 mg/m 2 on day 1 plus capecitabine 800 mg/m 2 b.i.d. on days 1-14) every 3 weeks. The primary endpoint was the objective tumor response rate. A total of 36 patients were enrolled in this study from July 2011 to September 2012. One patient did not fulfill the eligibility criteria and one patient withdrew their consent before the start of the treatment protocol. The confirmed objective response rate was 58.8% (95% CI 35.1-70.2%). The median progression-free survival was 9.6 months (95% CI 5.1-11.1 months) and the median overall survival was 23.1 months (95% CI 11.3-36.7 months). The grade ≥3 adverse events that were frequently encountered in this study were neutropenia (31.4%), leukopenia (22.9%), diarrhea (22.9%), anemia (20.0%), anorexia (20.0%) and febrile neutropenia (17.2%). The frequency of grade 3/4 adverse events, such as neutropenia and leukopenia, was much higher in patients with a UGT1A1 polymorphism. A first-line therapy comprising XELIRI plus bevacizumab yielded a promising response rate. However, careful attention should be given to adverse clinical events in Japanese patients receiving treatment with unresectable or recurrent CRC.

  4. A Prospective Pathologic Study to Define the Clinical Target Volume for Partial Breast Radiation Therapy in Women With Early Breast Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Nguyen, Brandon T., E-mail: Brandon.Nguyen@act.gov.au [Department of Radiation Oncology, Peter MacCallum Cancer Centre, East Melbourne, Victoria (Australia); Canberra Hospital, Radiation Oncology Department, Garran, ACT (Australia); Deb, Siddhartha [Department of Anatomical Pathology, Peter MacCallum Cancer Centre, East Melbourne, Victoria (Australia); Victorian Cancer Biobank, Cancer Council of Victoria, Carlton, Victoria (Australia); Fox, Stephen [Department of Anatomical Pathology, Peter MacCallum Cancer Centre, East Melbourne, Victoria (Australia); Hill, Prudence [Department of Anatomical Pathology, St. Vincent' s Hospital Melbourne, Fitzroy, Victoria (Australia); Collins, Marnie [Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, East Melbourne, Victoria (Australia); Chua, Boon H. [Department of Radiation Oncology, Peter MacCallum Cancer Centre, East Melbourne, Victoria (Australia); University of Melbourne, Parkville, Victoria (Australia)

    2012-12-01

    Purpose: To determine an appropriate clinical target volume for partial breast radiation therapy (PBRT) based on the spatial distribution of residual invasive and in situ carcinoma after wide local excision (WLE) for early breast cancer or ductal carcinoma in situ (DCIS). Methods and Materials: We performed a prospective pathologic study of women potentially eligible for PBRT who had re-excision and/or completion mastectomy after WLE for early breast cancer or DCIS. A pathologic assessment protocol was used to determine the maximum radial extension (MRE) of residual carcinoma from the margin of the initial surgical cavity. Women were stratified by the closest initial radial margin width: negative (>1 mm), close (>0 mm and {<=}1 mm), or involved. Results: The study population was composed of 133 women with a median age of 59 years (range, 27-82 years) and the following stage groups: 0 (13.5%), I (40.6%), II (38.3%), and III (7.5%). The histologic subtypes of the primary tumor were invasive ductal carcinoma (74.4%), invasive lobular carcinoma (12.0%), and DCIS alone (13.5%). Residual carcinoma was present in the re-excision and completion mastectomy specimens in 55.4%, 14.3%, and 7.2% of women with an involved, close, and negative margin, respectively. In the 77 women with a noninvolved radial margin, the MRE of residual disease, if present, was {<=}10 mm in 97.4% (95% confidence interval 91.6-99.5) of cases. Larger MRE measurements were significantly associated with an involved margin (P<.001), tumor size >30 mm (P=.03), premenopausal status (P=.03), and negative progesterone receptor status (P=.05). Conclusions: A clinical target volume margin of 10 mm would encompass microscopic residual disease in >90% of women potentially eligible for PBRT after WLE with noninvolved resection margins.

  5. [Efficacy, safety and comfort of compression therapy models in the immediate post-operative period after a greater saphenectomy. A prospective randomised study].

    Science.gov (United States)

    Collazo Chao, Eliseo; Luque, María Antonia; González-Ripoll, Carmen

    2010-10-01

    There is still controversy on the best compression therapy after performing a greater saphenectomy. The purpose of this study is to establish whether the use of a controlled compression stocking has the same level of safety and efficacy as a compression bandage in the immediate post-operative period after a greater saphenectomy. A prospective, randomised, open-labelled study, comparing three groups: a) a conventional compression bandage for one week, b) a conventional compression bandage replaced by a controlled tubular compression stocking at 5h of its putting in place, c) immediate direct use of the controlled tubular compression stocking, was conducted on fifty-five consecutive outpatients with a greater saphenectomy in one of their legs, and who fulfilled the inclusion criteria. The working hypothesis was that the controlled tubular compression stocking could replace, in terms of efficacy, safety and comfort, the usual controlled compression in the immediate post-operative period after saphenous vein stripping. The analysis variables were pain, control of bleeding, analgesics in the post-operative period, bruising, incapacity during the first week after the operation and comfort level. There were no statistically significant differences found between the three types of compressions studied as regards, safety, efficacy, comfort level, pain and analgesic consumption, but there was as regards the level of convenience in favour of the use of the stocking. The controlled tubular compression stocking can replace the compression bandage with more advantages after greater saphenous vein stripping in outpatients, having the same safety and efficacy. Copyright © 2009 AEC. Published by Elsevier Espana. All rights reserved.

  6. A prospective comparison of a noninvasive cardiac output monitor versus esophageal Doppler monitor for goal-directed fluid therapy in colorectal surgery patients.

    Science.gov (United States)

    Waldron, Nathan H; Miller, Timothy E; Thacker, Julie K; Manchester, Amy K; White, William D; Nardiello, John; Elgasim, Magdi A; Moon, Richard E; Gan, Tong J

    2014-05-01

    Goal-directed fluid therapy (GDFT) is associated with improved outcomes after surgery. The esophageal Doppler monitor (EDM) is widely used, but has several limitations. The NICOM, a completely noninvasive cardiac output monitor (Cheetah Medical), may be appropriate for guiding GDFT. No prospective studies have compared the NICOM and the EDM. We hypothesized that the NICOM is not significantly different from the EDM for monitoring during GDFT. One hundred adult patients undergoing elective colorectal surgery participated in this study. Patients in phase I (n = 50) had intraoperative GDFT guided by the EDM while the NICOM was connected, and patients in phase II (n = 50) had intraoperative GDFT guided by the NICOM while the EDM was connected. Each patient's stroke volume was optimized using 250-mL colloid boluses. Agreement between the monitors was assessed, and patient outcomes (postoperative pain, nausea, and return of bowel function), complications (renal, pulmonary, infectious, and wound complications), and length of hospital stay (LOS) were compared. Using a 10% increase in stroke volume after fluid challenge, agreement between monitors was 60% at 5 minutes, 61% at 10 minutes, and 66% at 15 minutes, with no significant systematic disagreement (McNemar P > 0.05) at any time point. The EDM had significantly more missing data than the NICOM. No clinically significant differences were found in total LOS or other outcomes. The mean LOS was 6.56 ± 4.32 days in phase I and 6.07 ± 2.85 days in phase II, and 95% confidence limits for the difference were -0.96 to +1.95 days (P = 0.5016). The NICOM performs similarly to the EDM in guiding GDFT, with no clinically significant differences in outcomes, and offers increased ease of use as well as fewer missing data points. The NICOM may be a viable alternative monitor to guide GDFT.

  7. Utility of Volume Assessment Using Bioelectrical Impedance Analysis in Critically Ill Patients Receiving Continuous Renal Replacement Therapy: A Prospective Observational Study

    Directory of Open Access Journals (Sweden)

    Ki Hyun Park

    2017-08-01

    Full Text Available Background Fluid overload prior to continuous renal replacement therapy (CRRT is an important prognostic factor. Thus, precise evaluation of fluid status is necessary to treat such patients. In this study, we investigated whether fluid assessment using bioelectrical impedance analysis (BIA can predict outcomes in critically ill patients requiring CRRT. Methods A prospective observational study was performed in patients who were admitted to the intensive care unit and who required CRRT. BIA was conducted before CRRT; then, the ratio of extracellular water to total body water (ECW/TBW was derived to estimate volume status. Results A total of 31 patients treated with CRRT were included. There were 18 men (58.1%, and the median age was 67 years (interquartile range, 51 to 78 years. Fourteen patients (45.2% died within 28 days after CRRT initiation. Patients were divided into 16 with ECW/TBW ≥0.41 and 15 with ECW/TBW <0.41. Survival rate within 28 days was different between the two groups (P = 0.044. Cox regression analysis revealed a relationship between ECW/TBW ≥0.41 and 28-day mortality, but it was not statistically significant (hazard ratio, 3.0; 95% confidence interval, 0.9 to 9.8; P = 0.061. Lastly, the area under the curve of ECW/TBW for 28-day mortality was analyzed. The area under the curve of ECW/TBW was 0.73 (95% confidence interval, 0.54 to 0.92, and this was significant (P = 0.037. Conclusions Fluid status can be assessed using BIA in critically ill patients requiring CRRT, and BIA can predict mortality. Further large trials are needed to confirm the usefulness of BIA in critically ill patients.

  8. Prospective Preference Assessment of Patients' Willingness to Participate in a Randomized Controlled Trial of Intensity-Modulated Radiotherapy Versus Proton Therapy for Localized Prostate Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Shah, Anand [Department of Radiation Oncology, University of Pennsylvania, Philadelphia, PA (United States); Efstathiou, Jason A.; Paly, Jonathan J. [Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA (United States); Halpern, Scott D. [Department of Medicine, University of Pennsylvania, Philadelphia, PA (United States); Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA (United States); Center for Bioethics, University of Pennsylvania, Philadelphia, PA (United States); Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA (United States); Bruner, Deborah W. [Winship Cancer Institute, Emory University, Atlanta, GA (United States); Christodouleas, John P. [Department of Radiation Oncology, University of Pennsylvania, Philadelphia, PA (United States); Coen, John J. [Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA (United States); Deville, Curtiland; Vapiwala, Neha [Department of Radiation Oncology, University of Pennsylvania, Philadelphia, PA (United States); Shipley, William U.; Zietman, Anthony L. [Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA (United States); Hahn, Stephen M. [Department of Radiation Oncology, University of Pennsylvania, Philadelphia, PA (United States); Bekelman, Justin E., E-mail: bekelman@uphs.upenn.edu [Department of Radiation Oncology, University of Pennsylvania, Philadelphia, PA (United States); Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA (United States)

    2012-05-01

    Purpose: To investigate patients' willingness to participate (WTP) in a randomized controlled trial (RCT) comparing intensity-modulated radiotherapy (IMRT) with proton beam therapy (PBT) for prostate cancer (PCa). Methods and Materials: We undertook a qualitative research study in which we prospectively enrolled patients with clinically localized PCa. We used purposive sampling to ensure a diverse sample based on age, race, travel distance, and physician. Patients participated in a semi-structured interview in which they reviewed a description of a hypothetical RCT, were asked open-ended and focused follow-up questions regarding their motivations for and concerns about enrollment, and completed a questionnaire assessing characteristics such as demographics and prior knowledge of IMRT or PBT. Patients' stated WTP was assessed using a 6-point Likert scale. Results: Forty-six eligible patients (33 white, 13 black) were enrolled from the practices of eight physicians. We identified 21 factors that impacted patients' WTP, which largely centered on five major themes: altruism/desire to compare treatments, randomization, deference to physician opinion, financial incentives, and time demands/scheduling. Most patients (27 of 46, 59%) stated they would either 'definitely' or 'probably' participate. Seventeen percent (8 of 46) stated they would 'definitely not' or 'probably not' enroll, most of whom (6 of 8) preferred PBT before their physician visit. Conclusions: A substantial proportion of patients indicated high WTP in a RCT comparing IMRT and PBT for PCa.

  9. Inadequate pain relief and large functional loss among patients with knee osteoarthritis: evidence from a prospective multinational longitudinal study of osteoarthritis real-world therapies.

    Science.gov (United States)

    Conaghan, Philip G; Peloso, Paul M; Everett, Sharlette V; Rajagopalan, Srinivasan; Black, Christopher M; Mavros, Panagiotis; Arden, Nigel K; Phillips, Ceri J; Rannou, François; van de Laar, Mart A F J; Moore, R Andrew; Taylor, Stephanie D

    2015-02-01

    To estimate the prevalence of inadequate pain relief (IPR) among patients with symptomatic knee OA prescribed analgesic therapy and to characterize patients with IPR. Patients ≥50 years old with physician-diagnosed knee OA who had taken topical or oral pain medication for at least 14 days were recruited for this prospective non-interventional study in six European countries. Pain and function were assessed using the Brief Pain Inventory (BPI) and the WOMAC; quality of life (QoL) was assessed using the 12-item short form. IPR was defined as an average pain score of >4 out of 10 on BPI question 5. Of 1187 patients enrolled, 68% were female and the mean age was 68 years (s.d. 9); 639 (54%) met the definition of IPR. Patient responses for the BPI average pain question were well correlated with responses on the WOMAC pain subscale (Spearman r = 0.64, P < 0.001). In multivariate logistic regression, patients with IPR had greater odds of being female [adjusted odds ratio (adjOR) 1.90 (95% CI 1.46, 2.48)] and having OA in both knees [adjOR 1.48 (95% CI 1.15, 1.90)], higher BMI, longer OA duration, depression or diabetes. Patients with IPR (vs non-IPR) were more likely to have worse QoL, greater function loss and greater pain interference. IPR is common among patients with knee OA requiring analgesics and is associated with large functional loss and impaired QoL. Patients at particular risk of IPR, as characterized in this study, may require greater attention towards their analgesic treatment options. https://clinicaltrials.gov/ (NCT01294696). © The Author 2014. Published by Oxford University Press on behalf of the British Society for Rheumatology.

  10. The MOTIV-HEART Study: A Prospective, Randomized, Single-Blind Pilot Study of Brief Strategic Therapy and Motivational Interviewing among Cardiac Rehabilitation Patients.

    Science.gov (United States)

    Pietrabissa, Giada; Manzoni, Gian Mauro; Rossi, Alessandro; Castelnuovo, Gianluca

    2017-01-01

    Background: Psychological distress, biomedical parameters, and unhealthy lifestyles contribute to a poorer prognosis for cardiac disease. Public health's challenge is to motivate patients to utilize self-care. Objective: This prospective, randomized, single-blind pilot study aimed at testing the incremental efficacy of Brief Strategic Therapy (BST) combined with Motivational Interviewing (MI) in improving selected biomedical and psychological outcomes over and beyond those of the stand-alone BST in a residential Cardiac Rehabilitation (CR) program. Method: Fourty-two inpatients (17 females), enrolled in a 1-month CR program, were randomly allocated into two conditions: (a) Three sessions of BST and (b) Three sessions of BST plus MI. Data were collected at baseline, discharge, and after 3 months through phone interviews. Results: At discharge, no significant between-group difference was found in any outcome variable. Changes from pre- to post-treatment within each condition showed significant improvements only in the BST group, where the level of external regulation diminished, and both the participants' self-regulation (Relative Autonomous Motivation Index, RAI) and willingness to change improved. At the 3-month follow-up, within-group analyses on responders (BST = 9; BST + MI = 11) showed a statistically significant improvement in the level of systolic blood pressure in both groups. Discussion: Findings showed no evidence of the incremental efficacy of combining BST and MI over and beyond BST alone on either selected biomedical or psychological outcomes among CR patients. Conclusions: Ends and limitations from the present pilot study should be considered and addressed in future investigations.

  11. Utility of Deep Inspiration Breath Hold for Left-Sided Breast Radiation Therapy in Preventing Early Cardiac Perfusion Defects: A Prospective Study

    Energy Technology Data Exchange (ETDEWEB)

    Zagar, Timothy M., E-mail: zagar@med.unc.edu [Department of Radiation Oncology, University of North Carolina, Chapel Hill, North Carolina (United States); Kaidar-Person, Orit [Department of Radiation Oncology, University of North Carolina, Chapel Hill, North Carolina (United States); Tang, Xiaoli [Memorial Sloan Kettering Cancer Center, West Harrison, New York (United States); Jones, Ellen E.; Matney, Jason; Das, Shiva K.; Green, Rebecca L. [Department of Radiation Oncology, University of North Carolina, Chapel Hill, North Carolina (United States); Sheikh, Arif [Department of Radiology, Columbia University, New York, New York (United States); Khandani, Amir H.; McCartney, William H.; Oldan, Jorge Daniel; Wong, Terence Z. [Department of Radiology, University of North Carolina, Chapel Hill, North Carolina (United States); Marks, Lawrence B. [Department of Radiation Oncology, University of North Carolina, Chapel Hill, North Carolina (United States)

    2017-04-01

    Purpose: To evaluate early cardiac single photon computed tomography (SPECT) findings after left breast/chest wall postoperative radiation therapy (RT) in the setting of deep inspiration breath hold (DIBH). Methods and Materials: We performed a prospective single-institution single-arm study of patients who were planned for tangential RT with DIBH to the left breast/chest wall (± internal mammary nodes). The DIBH was done by use of a controlled surface monitoring technique (AlignRT, Vision RT Ltd, London, UK). The RT was given with tangential fields and a heart block. Radiation-induced cardiac perfusion and wall motion changes were assessed by pre-RT and 6-month post-RT SPECT scans. A cumulative SPECT summed-rest score was used to quantify perfusion in predefined left ventricle segments. The incidence of wall motion abnormalities was assessed in each of these same segments. Results: A total of 20 patients with normal pre-RT scans were studied; their median age was 56 years (range, 39-72 years). Seven (35%) patients also received irradiation to the left internal mammary chain, and 5 (25%) received an additional RT field to supraclavicular nodes. The median heart dose was 94 cGy (range, 56-200 cGy), and the median V25{sub Gy} was zero (range, 0-0.1). None of the patients had post-RT perfusion or wall motion abnormalities. Conclusions: Our results suggest that DIBH and conformal cardiac blocking for patients receiving tangential RT for left-sided breast cancer is an effective means to avoid early RT-associated cardiac perfusion defects.

  12. Changes in regional body fat, lean body mass and body shape in trans persons using cross-sex hormonal therapy: results from a multicenter prospective study.

    Science.gov (United States)

    Klaver, M; de Blok, C J M; Wiepjes, C M; Nota, N M; Dekker, M J H J; de Mutsert, R; Schreiner, T; Fisher, A D; T'Sjoen, G; den Heijer, M

    2018-02-01

    Cross-sex hormonal therapy (CHT) in trans persons affects their total body fat and total lean body mass. However, it is unknown how separate body regions are affected and whether these changes alter body shape. Therefore, the aim of this study was to determine the effects on body fat and lean body mass in separate body regions and on body shape after one year of CHT. In a multicenter prospective study at university hospitals, 179 male-to-female gender dysphoric persons, referred to as transwomen, and 162 female-to-male gender dysphoric persons, referred to as transmen, were included. All underwent whole-body dual-energy X-ray absorptiometry and anthropometric measurements before and after one year of CHT. In transwomen, increases in body fat ranged from +18% (95% CI: 13%;23%) in the android region to +42% (95% CI: 37%;46%) in the leg region and +34% (95% CI: 29%;38%) in the gynoid region. In transmen, changes in body fat ranged from -16% (95% CI: -19;-14%) in the leg region and -14% in the gynoid region (95% CI: -16%;-12) to no change in the android region (+1%, 95% CI: -3%;5%). Waist-to-hip ratio (WHR) decreased in transwomen (-0.03, 95% CI: -0.04;-0.02) mainly due to an increase in hip circumference (+3.2 cm, 95% CI: 2.3;4.0). Transmen have a decrease in hip circumference (-1.9 cm, 95% CI: -3.1;-0.7) resulting in an increase in WHR (+0.01, 95% CI: 0.00;0.02). CHT causes a more feminine body fat distribution and a lower WHR in transwomen and a more masculine body fat distribution with a lower hip circumference in transmen. © 2018 European Society of Endocrinology.

  13. Prophylactic low-energy shock wave therapy improves wound healing after vein harvesting for coronary artery bypass graft surgery: a prospective, randomized trial.

    Science.gov (United States)

    Dumfarth, Julia; Zimpfer, Daniel; Vögele-Kadletz, Margit; Holfeld, Johannes; Sihorsch, Florian; Schaden, Wolfgang; Czerny, Martin; Aharinejad, Seyedhossein; Wolner, Ernst; Grimm, Michael

    2008-12-01

    Wound healing disorders after vein harvesting for coronary artery bypass graft surgery increase morbidity and lower patient satisfaction. Low-energy shock wave therapy (SWT) reportedly improves healing of diabetic and vascular ulcers by overexpression of vascular endothelial growth fractor and downregulation of necrosis factor kappaB. In this study, we investigate whether prophylactic low-energy SWT improves wound healing after vein harvesting for coronary artery bypass graft surgery. One hundred consecutive patients undergoing coronary artery bypass graft surgery were randomly assigned to either prophylactic low-energy SWT (n = 50) or control (n = 50). Low-energy SWT was applied to the site of vein harvesting after wound closure under sterile conditions using a commercially available SWT system (Dermagold; Tissue Regeneration Technologies, Woodstock, GA). A total of 25 impulses (0.1 mJ/mm(2); 5 Hz) were applied per centimeter wound length. Wound healing was evaluated and quantified using the ASEPSIS score. (ASEPSIS stands for Additional treatment, presence of Serous discharge, Erythema, Purulent exudate, Separation of the deep tissue, Isolation of bacteria, and duration of inpatient Stay). Patient demographics, operative data, and postoperative adverse events were monitored. Patient characteristics and operative data including wound length (SWT 39 +/- 13 cm versus control 37 +/- 11 cm, p = 0.342) were comparable between the two groups. We observed lower ASEPSIS scores indicating improved wound healing in the SWT group (4.4 +/- 5.3) compared with the control group (11.6 +/- 8.3, p = 0.0001). Interestingly, we observed a higher incidence of wound healing disorders necessitating antibiotic treatment in the control group (22%) as compared with the SWT group (4%, p = 0.015). No SWT-associated adverse events were observed in the treatment group. As shown in this prospective randomized study, prophylactic application of low-energy SWT improves wound healing after vein

  14. Interfractional and intrafractional errors assessed by daily cone-beam computed tomography in nasopharyngeal carcinoma treated with intensity-modulated radiation therapy. A prospective study

    International Nuclear Information System (INIS)

    Lu Heming; Lin Hui; Feng Guosheng

    2012-01-01

    This prospective study was to assess interfractional and intrafractional errors and to estimate appropriate margins for planning target volume (PTV) by using daily cone-beam computed tomography (CBCT) guidance in nasopharyngeal carcinoma (NPC). Daily pretreatment and post-treatment CBCT scans were acquired separately after initial patient setup and after the completion of each treatment fraction in 10 patients treated with intensity-modulated radiation therapy (IMRT). Online corrections were made before treatment if any translational setup error was found. Interfractional and intrafractional errors were recorded in the right-left (RL), superior-inferior (SI) and anterior-posterior (AP) directions. For the translational shifts, interfractional errors >2 mm occurred in 21.7% of measurements in the RL direction, 12.7% in the SI direction and 34.1% in the AP direction, respectively. Online correction resulted in 100% of residual errors ≤2 mm in the RL and SI directions, and 95.5% of residual errors ≤2 mm in the AP direction. No residual errors >3 mm occurred in the three directions. For the rotational shifts, a significant reduction was found in the magnitudes of residual errors compared with those of interfractional errors. A margin of 4.9 mm, 4.0 mm and 6.3 mm was required in the RL, SI and AP directions, respectively, when daily CBCT scans were not performed. With daily CBCT, the margins were reduced to 1.2 mm in all directions. In conclusion, daily CBCT guidance is an effective modality to improve the accuracy of IMRT for NPC. The online correction could result in a 70-81% reduction in margin size. (author)

  15. A novel schedule of accelerated partial breast radiation using intensity-modulated radiation therapy in elderly patients: survival and toxicity analysis of a prospective clinical trial

    Energy Technology Data Exchange (ETDEWEB)

    Sayan, Mutlay; Nelson, Carl; Gagne, Havaleh; Rubin, Deborah; Heimann, Ruth [Dept. of Radiation Oncology, University of Vermont Medical Center, Burlington (United States); Wilson, Karen [University of Vermont Cancer Center, Burlington (United States)

    2017-03-15

    Several accelerated partial breast radiation (APBR) techniques have been investigated in patients with early-stage breast cancer (BC); however, the optimal treatment delivery techniques remain unclear. We evaluated the feasibility and toxicity of APBR delivered using intensity-modulated radiation therapy (IMRT) in elderly patients with stage I BC, using a novel fractionation schedule. Forty-two patients aged ≥65 years, with stage I BC who underwent breast conserving surgery were enrolled in a phase I/II study evaluating APBR using IMRT. Forty eligible patients received 40 Gy in 4 Gy daily fractions. Patients were assessed for treatment related toxicities, and cosmesis, before APBR, during, and after completion of the treatment. The median age was 73 years, median tumor size 0.8 cm and the median follow-up was 54 months. The 5-year locoregional control was 97.5% and overall survival 90%. Erythema and skin pigmentation was the most common acute adverse event, reported by 27 patients (69%). Twenty-six patients (65%) reported mild pain, rated 1-4/10. This improved at last follow-up to only 2 (15%). Overall the patient and physician reported worst late toxicities were lower than the baseline and at last follow-up, patients and physicians rated cosmesis as excellent/good in 93% and 86 %, respectively. In this prospective trial, we observed an excellent rate of tumor control with daily APBR. The acceptable toxicity profile and cosmetic results of this study support the use of IMRT planned APBR with daily schedule in elderly patients with early stage BC.

  16. Endovascular therapy by CO2 angiography to prevent contrast-induced nephropathy in patients with chronic kidney disease: a prospective multicenter trial of CO2 angiography registry.

    Science.gov (United States)

    Fujihara, Masahiko; Kawasaki, Daizo; Shintani, Yoshiaki; Fukunaga, Masashi; Nakama, Tatsuya; Koshida, Ryouji; Higashimori, Akihiro; Yokoi, Yoshiaki

    2015-04-01

    To assess the safety and efficacy of carbon dioxide (CO2) angiography-guided endovascular therapy (EVT) for renal, iliofemoral artery disease. Patients with peripheral vascular disease (PVD) often have chronic kidney disease (CKD) and the use of iodinated contrast media may enhance the risk of contrast-induced nephropathy (CIN). Contrast volume reduction is an effective CIN preventive strategy. A prospective multicenter registry was developed and six clinical centers participated in the study. Patients with an estimated glomerular filtration rate (eGFR) of CO2 angiography-guided EVT was performed; incomplete CO2 angiograms were supplemented by intravascular ultrasound, pressure wire, and/or minimal iodinated contrast media. The primary endpoint was a composite of freedom from renal events and freedom from major CO2 angiography related complications. This study included 98 patients with 109 lesions. The mean eGFR baseline was 35.2±12.7 ml min(-1). CO2 angiography-guided angioplasty were performed in 16 renal arteries, 31 aortoiliac arteries, and 62 superficial femoral arteries. The technical success rate was 97.9%. Average CO2 consumption was 281.4±155.8 ml, average dose of iodinated contrast media was 15.0±18.1 ml. Primary endpoint was 92.8% (91/98). Incidence of CIN was 5.1% (5/98) and CO2 angiography-related complications occurred in 17.3% (17/98). Two cases (2%) developed severe, fatal, nonocclusive mesenteric ischemia (NOMI). This trial showed that CO2 angiography-guided angioplasty was effective for preventing CIN, however, CO2 angiography related complication was somewhat high. © 2014 Wiley Periodicals, Inc.

  17. The MOTIV-HEART Study: A Prospective, Randomized, Single-Blind Pilot Study of Brief Strategic Therapy and Motivational Interviewing among Cardiac Rehabilitation Patients

    Science.gov (United States)

    Pietrabissa, Giada; Manzoni, Gian Mauro; Rossi, Alessandro; Castelnuovo, Gianluca

    2017-01-01

    Background: Psychological distress, biomedical parameters, and unhealthy lifestyles contribute to a poorer prognosis for cardiac disease. Public health's challenge is to motivate patients to utilize self-care. Objective: This prospective, randomized, single-blind pilot study aimed at testing the incremental efficacy of Brief Strategic Therapy (BST) combined with Motivational Interviewing (MI) in improving selected biomedical and psychological outcomes over and beyond those of the stand-alone BST in a residential Cardiac Rehabilitation (CR) program. Method: Fourty-two inpatients (17 females), enrolled in a 1-month CR program, were randomly allocated into two conditions: (a) Three sessions of BST and (b) Three sessions of BST plus MI. Data were collected at baseline, discharge, and after 3 months through phone interviews. Results: At discharge, no significant between-group difference was found in any outcome variable. Changes from pre- to post-treatment within each condition showed significant improvements only in the BST group, where the level of external regulation diminished, and both the participants' self-regulation (Relative Autonomous Motivation Index, RAI) and willingness to change improved. At the 3-month follow-up, within-group analyses on responders (BST = 9; BST + MI = 11) showed a statistically significant improvement in the level of systolic blood pressure in both groups. Discussion: Findings showed no evidence of the incremental efficacy of combining BST and MI over and beyond BST alone on either selected biomedical or psychological outcomes among CR patients. Conclusions: Ends and limitations from the present pilot study should be considered and addressed in future investigations. PMID:28223950

  18. Early goal-directed therapy in pediatric septic shock: comparison of outcomes "with" and "without" intermittent superior venacaval oxygen saturation monitoring: a prospective cohort study*.

    Science.gov (United States)

    Sankar, Jhuma; Sankar, M Jeeva; Suresh, C P; Dubey, Nandkishore K; Singh, Archana

    2014-05-01

    To evaluate the effect of intermittent central venous oxygen saturation monitoring (ScvO(2)) on critical outcomes in children with septic shock, as continuous monitoring may not be feasible in most resource-restricted settings. Prospective cohort study. PICU of a tertiary care teaching hospital. Consecutive children younger than 17 years with fluid refractory septic shock admitted to our ICU from November 2010 to October 2012 were included. Enrolled children were subjected to subclavian/internal jugular catheter insertion. Those in whom it was successful formed the "exposed" group (ScvO(2) group), whereas the rest constituted the control group (no ScvO(2) group). In the former group, intermittent ScvO(2) monitoring at 1, 3, and 6 hours was used to guide resuscitation, whereas in the latter, only clinical variables were used. The major outcomes were in-hospital mortality and achievement of therapeutic goals within first 6 hours. One hundred twenty children were enrolled in the study-63 in the ScvO(2) group and 57 in the no ScvO(2) group. Baseline characteristics including the organ dysfunction and mortality risk scores were comparable between the groups. Children in the ScvO(2) group had significantly lower in-hospital mortality (33.3% vs 54%; relative risk, 0.61; 95% CI, 0.4, 0.93; number needed to treat, 5; 95% CI, 3, 27). A greater proportion of children in exposed group achieved therapeutic endpoints in first 6 hours (43% vs 23%, p = 0.02) and during entire ICU stay (71% vs 51%, p = 0.02). The mean number of dysfunctional organs was also significantly lesser in ScvO(2) group in comparison with no ScvO(2) group (2 vs 3, p therapy using intermittent ScvO(2) monitoring seemed to reduce the mortality rates and improved organ dysfunction in children with septic shock as compared with those without such monitoring.

  19. A prospective study on radiation pneumonitis following conformal radiation therapy in non-small-cell lung cancer: clinical and dosimetric factors analysis.

    Science.gov (United States)

    Claude, Line; Pérol, David; Ginestet, Chantal; Falchero, Lionel; Arpin, Dominique; Vincent, Michel; Martel, Isabelle; Hominal, Stéphane; Cordier, Jean-François; Carrie, Christian

    2004-05-01

    Clinical and dosimetric prognostic factors for radiation pneumonitis (RP) have been reported after three-dimensional conformal radiotherapy (3D-CRT) in patients with non-small cell lung cancer (NSCLC). Ninety-six patients who received 3D-CRT for stage IA to IIIB NSCLC were evaluated prospectively. Surgery was performed before radiation in 51% of the patients (n = 49). RP was diagnosed six-eight weeks after 3D-CRT using the Lent-Soma classification. Factors evaluated included treatment factors such as total mean lung dose (MLD), and dose-volume histogram (DVH) thresholds for several radiation dose steps. These thresholds were originally determined from the median of the irradiated lung volume at each step. Six patients could not be evaluated for RP six weeks after 3D-CRT. Of the 90 remaining patients, 40 (44%) had RP (i.e. grade > or =1) at 6 weeks, including 7 patients (7.8%) with severe RP (grade > or =2). Regarding the whole toxicity (grade > or =1), age (> or =60 years), MLD, V20 and V30 were significantly related to RP. DVH thresholds determined for radiation doses from 20 to 40 Gy were also predictive of RP. Considering only severe RP (grade > or =2), only MLD, V20 and V30 remained associated with increased acute pulmonary toxicity. In this study, dosimetric factors (MLD, V20, V30) and age (> or =60 years) were predictive of RP regarding the whole pulmonary toxicity (grade > or =1). In addition, thresholds from 20 to 40 Gy, based on a stratification according to the median of the percentage of irradiated lung volume, were also predictive factors. They may, therefore, help discriminate patients at high and low risk for RP. However, only MLD, V20 and V30 remained associated with severe RP (grade > or =2), probably due to the small number of severe events in our series.

  20. Developmental Cognitive Neuroscience: Origins, Issues, and Prospects

    Science.gov (United States)

    Pennington, Bruce F.; Snyder, Kelly A.; Roberts, Ralph J., Jr.

    2007-01-01

    This commentary explains how the field of developmental cognitive neuroscience (DCN) holds the promise of a much wider interdisciplinary integration across sciences concerned with development: psychology, molecular genetics, neurobiology, and evolutionary developmental biology. First we present a brief history of DCN, including the key theoretical…

  1. Origins of narcissism in children

    NARCIS (Netherlands)

    Brummelman, E.; Thomaes, S.; Nelemans, S.A.; Orobio de Castro, B.; Overbeek, G.; Bushman, B.J.

    2015-01-01

    Narcissism levels have been increasing among Western youth, and contribute to societal problems such as aggression and violence. The origins of narcissism, however, are not well understood. Here, we report, to our knowledge, the first prospective longitudinal evidence on the origins of narcissism in

  2. Results of a prospective phase 2 clinical trial of induction gemcitabine/capecitabine followed by stereotactic ablative radiation therapy in borderline resectable or locally advanced pancreatic adenocarcinoma.

    Science.gov (United States)

    Quan, Kimmen; Sutera, Philip; Xu, Karen; Bernard, Mark E; Burton, Steven A; Wegner, Rodney E; Zeh, Herbert; Bahary, Nathan; Stoller, Ronald; Heron, Dwight E

    Stereotactic ablative radiation therapy's (SABR's) great conformity and short duration has become an attractive treatment modality. We report a phase 2 clinical trial to evaluate efficacy and safety of induction chemotherapy (ICT) followed by SABR in patient with borderline resectable (BR) and locally advanced (LA) pancreatic ductal adenocarcinoma (PDAC). Patients with biopsy-proven BR or LA PDAC were treated with four 21-day cycles of intravenous gemcitabine and oral capecitabine. Patients were restaged within 4 weeks after ICT by computed tomography and treated by 3-fraction SABR if no metastasis or progressive disease was identified. Patients were restaged 4 weeks following SABR to determine resectability. Tumor response was assessed with carbohydrate antigen 19-9. Thirty-five patients (19 BR/16 LA) were enrolled. The median age was 71.8 years (range, 50.6-81.1). ICT was completed in 91.4% (n = 32) of patients. All patients who completed ICT completed SABR. Of those 32 patients, 34.3% (n = 12: 10 BR, 2 LA) underwent pancreaticoduodenectomy and 11 of 12 (91.7%) received R0 resection. Median overall survival was 18.8, 28.3, and 14.3 months for the entire cohort, BR, and LA, respectively. The 2-year local progression-free survival (LPFS) was 44.9%, 40%, and 52% for the entire cohort, BR, and LA, respectively. For BR patients, multivariate analysis showed surgery was associated with better overall survival and LPFS. One-year LPFS for patients with surgery was 80% and 44% without surgery. Within the 15.4-month follow-up, no grade 3+ toxicity from SABR was observed. No significant quality of life change was observed before and after ICT, SABR, or surgery for BR or LA patients. This is the first prospective phase 2 study to investigate the feasibility and efficacy of a 12-week gemcitabine/capecitabine ICT followed by SABR for BR or LA PDAC. The results suggest excellent tolerability, high R0 resection rates, and acceptable posttreatment complications. Copyright © 2017

  3. Early results of a prospective quality of life analysis using the lung cancer symptom scale (LCSS) in patients receiving radiation therapy (XRT) for lung cancer in the community hospital setting

    International Nuclear Information System (INIS)

    Lutz, Stephen T.; Norrell, Ruth; Johnson, Christopher R.; Kachnic, Lisa A.; Arthur, Douglas W.; Huang, David T.

    1997-01-01

    Purpose/Objective: To prospectively determine symptom response in patients receiving radiation therapy for primary lung cancer. Materials and Methods: Thirty-three consecutive lung cancer patients were evaluated between March 1996 and February 1997 at the Medical College of Virginia satellite facility which serves a local community hospital. The LCSS, a validated quality of life scale, was used prospectively during the consultation and upon subsequent follow-up. The scale allowed scoring of symptom improvement, worsening, or stability following therapy. One patient declined therapy, while another was not offered XRT. The 31 remaining patients received a median dose of 54 Gy. Eleven patients received radiotherapy with curative intent to doses between 60 and 70 Gy, 5 small cell lung carcinoma (SmCCa) patients received 54 Gy consolidative therapy, and 13 patients received 15 to 30 Gy with palliative intent. Eight patients received chemotherapy as part of their initial treatment course, including all of those diagnosed with SmCCa. Twenty-one patients completed the LCSS at least once in the three month interval after therapy, while 6 died prior to follow-up, 2 were under treatment at the time of this analysis, and 2 were lost to follow-up. Survival analysis was completed using the Kaplan-Meier method. Results: Median follow-up was 4 months (range = 1 to 14), with an estimated median survival of 5 months. Fourteen patients died of lung cancer, 12 are alive with disease, 6 are alive without disease, and 1 died without disease. Patient characteristics were median age of 69 years (range = 43 to 91), male to female ratio of 4.5 to 1, mean weight loss of 12 pounds (range = 0 to 27), and mean duration of symptoms of 3 months (range = 0 to 12). Stage was: I 9%, II = 0%, IIIA = 6%, IIIB = 43%, IV = 27%, and limited stage SmCCa = 15%. Histology was: squamous cell carcinoma = 21%, adenocarcinoma = 23%, large cell carcinoma = 23%, poorly differentiated carcinoma = 15%, mesothelioma

  4. ORIGINAL ARTICLES

    African Journals Online (AJOL)

    Bacterial food poisoning (Mx). Chronic skin ulcers (Mx /Sx). Elective circum,ion. Acute viral hepatitis (Mx) .... Diag: Benign neoplasm bone, articular cartilage and connective tissue. Proe: Excision, radiation therapy ... chemotherapy and radiation therapy. Non-superficial open wounds, non-life-threatening. Repair. Menstrual ...

  5. ORIGINAL ARTICLES

    African Journals Online (AJOL)

    Introduction. Quinine therapy for 7 days remains the mainstay for treating hospitalised malaria cases in South Africa. However, limited resources, including available beds and staff, often result in early discharge of non-severe cases, with quinine tablets for outpatient use. The effectiveness of shorter course quinine therapy ...

  6. ORIGINAL ARTICLE

    African Journals Online (AJOL)

    User

    therapy- Physics, Therapy and Oncolo- gy. 6th Ed. London Churchill Livingstone. Chang, L., Sheng-Yow, H., Jia-Ming W., Tainsong,. T., Yi-Chun (2007). An improved method to accurately calibrate the gantry angle in- dicators of the radiotherapy linear acceler- ators Nuclear Instruments and Methods in. Physics Research ...

  7. Lansoprazole for secondary prevention of gastric or duodenal ulcers associated with long-term non-steroidal anti-inflammatory drug (NSAID) therapy: results of a prospective, multicenter, double-blind, randomized, double-dummy, active-controlled trial.

    Science.gov (United States)

    Sugano, Kentaro; Kontani, Teiji; Katsuo, Shinichi; Takei, Yoshinori; Sakaki, Nobuhiro; Ashida, Kiyoshi; Mizokami, Yuji; Asaka, Masahiro; Matsui, Shigeyuki; Kanto, Tatsuya; Soen, Satoshi; Takeuchi, Tsutomu; Hiraishi, Hideyuki; Hiramatsu, Naoki

    2012-05-01

    Low-dose lansoprazole has not been intensively evaluated for its efficacy in the prevention of recurrent gastric or duodenal ulcers in patients receiving long-term non-steroidal anti-inflammatory drug (NSAID) therapy for pain relief in such diseases as rheumatoid arthritis, osteoarthritis, and low back pain. This multi-center, prospective, double-blind, randomized, active-controlled study involving 99 sites in Japan was designed to compare the efficacy of lansoprazole (15 mg daily) with gefarnate (50 mg twice daily). Patients with a history of gastric or duodenal ulcers who required long-term NSAID therapy were randomized to receive lansoprazole 15 mg daily (n = 185) or gefarnate 50 mg twice daily (n = 181) and followed up for 12 months or longer prospectively. The cumulative incidence of gastric or duodenal ulcer at days 91, 181, and 361 from the start of the study was calculated by the Kaplan-Meier method as 3.3, 5.9, and 12.7%, respectively, in the lansoprazole group versus 18.7, 28.5, and 36.9%, respectively, in the gefarnate group. The risk for ulcer development was significantly (log-rank test, P lansoprazole group than in the gefarnate group, with the hazard ratio being 0.2510 (95% CI 0.1400-0.4499). A long-term follow-up study showed an acceptable safety profile for low-dose lansoprazole therapy, with diarrhea as the most frequent adverse event. Lansoprazole was superior to gefarnate in reducing the risk of gastric or duodenal ulcer recurrence in patients with a definite history of gastric or duodenal ulcers who required long-term NSAID therapy.

  8. How to Make the Choice in the Retreatment of EGFR-TKI for Advanced NSCLC Patients Who Benefited from Prior Gefitinib Therapy: the Original Drug or Switching to A Second EGFR-TKI?

    Directory of Open Access Journals (Sweden)

    Chuanhao TANG

    2013-07-01

    Full Text Available Background and objective For advanced non-small cell lung cancer (NSCLC patients who benefited from prior epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI therapy, the choice of a second TKI therapy has gradually become a new strategy for the treatment. Some investigators recommend that the second therapy should be continued with the original TKI; however, other investigators recommend the administration of another TKI. The aim of this study is to explore which choice is more reasonable. Methods In retrospect, patients with advanced NSCLC or with postoperative relapse of advanced NSCLC achieved complete response (CR, partial response (PR or stable disease (SD in prior Gefitinib therapy, progression free survival (PFS ≥3 months. They received repeated Gefitinib or Erlotinib at an interval of at least one month. The analysis was carried out with respect to efficacy and optimal population of the two groups. Results A total of 61 patients were enrolled into the study, 30 in Gefitinib group and 31 in Erlotinib group. Baseline characteristics of the two groups were comparable. In the comparison between patients treated with Gefitinib and with Erlotinib, no statistical differences were seen for response rate (10% vs 22.6%, P=0.300,6, disease control rate (60% vs 74.2%, P=0.237,8, median PFS (3.0 vs 3.5 months, P=0.494,5, or median OS (8.3 vs 8.5 months, P=0.140,8. Multivariate analysis showed that in the initial dose of Gefitinib, PFS≥6 months (HR=0.317, 95%CI: 0.102-0.984, P=0.046,9. With an interval ≥3 months (HR=0.224, 95%CI: 0.071-0.713, P=0.011,3 between two doses of TKI, the risk of disease progression was reduced; but if with an interval ≥3 months (HR=0.262, 95%CI: 0.097-0.705, P=0.008,0, the risk of death was reduced. Conclusion Advanced NSCLC patients who benefited from prior Gefitinib therapy can benefit again either with the original drug Gefitinib or the alternative drug Erlotinib when a second TKI therapy is

  9. Evaluation of the prognostic value of liver stiffness in patients with hepatitis C virus treated with triple or dual antiviral therapy: A prospective pilot study.

    Science.gov (United States)

    Stasi, Cristina; Piluso, Alessia; Arena, Umberto; Salomoni, Elena; Montalto, Paolo; Monti, Monica; Boldrini, Barbara; Corti, Giampaolo; Marra, Fabio; Laffi, Giacomo; Milani, Stefano; Zignego, Anna Linda

    2015-03-14

    To evaluate the association between liver stiffness (LS) prior to the initiation of dual/triple therapy and viral response. LS was measured in all patients before treatment was administered. The therapeutic approach was based on hepatic, virological, and immunological evaluations and considered the fact that patients with severe fibrosis (F3) or compensated cirrhosis (F4) in Child-Pugh class A are the primary candidates for triple therapy. In total, 65 hepatitis C virus (HCV) patients were treated with Peg-interferon/ribavirin (Peg-IFN/RBV); 24 patients were classified as genotypes 1/4 (36.92%), and 41 patients were classified as genotypes 2/3 (63.08%) (dual therapy). In addition, 20 HCV treatment-experienced genotype 1 patients were treated with PegIFN-RBV and boceprevir (triple therapy). Wilcoxon rank-sum tests were used to compare the groups. LS significantly differed between dual therapy and triple therapy (P = 0.002). The mean LS value before dual therapy treatment was 8.61 ± 5.79 kPa and was significantly different between patients achieving a sustained virologic response (SVR) 24 weeks after therapy and those who did not (7.23 ± 5.18 kPa vs 11.72 ± 5.99 kPa, respectively, P = 0.0003). The relative risk of non-response to therapy was 4.45 (95%CI: 2.32-8.55). The attributable risk of non-response to therapy was 49%. The mean LS value before triple therapy treatment was 13.29 ± 8.57 kPa and was significantly different between patients achieving and not achieving SVR24 (9.41 ± 5.05 vs 19.11 ± 9.74, respectively; P = 0.008). The relative risk of non-response to therapy was 5.57% (95%CI: 1.50-20.65). The attributable risk of non-response to therapy (70%) was increased compared with dual therapy patients. Pre-treatment stiffness > 12 kPa was significantly associated with non-SVR (P < 0.025) in both groups. Pre-treatment liver stiffness may be useful for predicting the respo