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Sample records for therapy clinical trials

  1. Biomarkers in T cell therapy clinical trials

    Directory of Open Access Journals (Sweden)

    Kalos Michael

    2011-08-01

    Full Text Available Abstract T cell therapy represents an emerging and promising modality for the treatment of both infectious disease and cancer. Data from recent clinical trials have highlighted the potential for this therapeutic modality to effect potent anti-tumor activity. Biomarkers, operationally defined as biological parameters measured from patients that provide information about treatment impact, play a central role in the development of novel therapeutic agents. In the absence of information about primary clinical endpoints, biomarkers can provide critical insights that allow investigators to guide the clinical development of the candidate product. In the context of cell therapy trials, the definition of biomarkers can be extended to include a description of parameters of the cell product that are important for product bioactivity. This review will focus on biomarker studies as they relate to T cell therapy trials, and more specifically: i. An overview and description of categories and classes of biomarkers that are specifically relevant to T cell therapy trials, and ii. Insights into future directions and challenges for the appropriate development of biomarkers to evaluate both product bioactivity and treatment efficacy of T cell therapy trials.

  2. Bacteriophage Therapy: Advances in Formulation Strategies and Human Clinical Trials.

    Science.gov (United States)

    Vandenheuvel, Dieter; Lavigne, Rob; Brüssow, Harald

    2015-11-01

    Recently, a number of phage therapy phase I and II safety trials have been concluded, showing no notable safety concerns associated with the use of phage. Though hurdles for efficient treatment remain, these trials hold promise for future phase III clinical trials. Interestingly, most phage formulations used in these clinical trials are straightforward phage suspensions, and not much research has focused on the processing of phage cocktails in specific pharmaceutical dosage forms. Additional research on formulation strategies and the stability of phage-based drugs will be of key importance, especially with phage therapy advancing toward phase III clinical trials.

  3. The National Clinical Trials Network: Conducting Successful Clinical Trials of New Therapies for Rare Cancers

    Science.gov (United States)

    Schott, Anne F.; Welch, John J.; Verschraegen, Claire F.; Kurzrock, Razelle

    2015-01-01

    Rare cancers account for 27% of neoplasms diagnosed each year, and 25% of cancer-related deaths in the United States. However, rare cancers show some of the highest response rates to targeted therapies, probably due to identification of oncogenic drivers with little inter-patient variability. Although the low incidence of rare cancers make large scale randomized trials involving single histologies difficult to perform, drugs have been successfully developed in rare cancers utilizing clinical trial designs that combine microscopic anatomies. Such trials are being pursued within the National Clinical Trials Network (NCTN), which possesses unique qualifications to perform widespread molecular screening of tumors for patient enrollment onto therapeutic clinical trials. When larger clinical trials are needed to determine optimum treatment strategies in rare cancers, the NCTN's broad reach in North America and internationally, and ability to partner with both US-based and international research organizations, can make these challenging studies feasible. PMID:26433554

  4. Core journals that publish clinical trials of physical therapy interventions.

    Science.gov (United States)

    Costa, Leonardo Oliveira Pena; Moseley, Anne M; Sherrington, Catherine; Maher, Christopher G; Herbert, Robert D; Elkins, Mark R

    2010-11-01

    The objective of this study was to identify core journals in physical therapy by identifying those that publish the most randomized controlled trials of physical therapy interventions, provide the highest-quality reports of randomized controlled trials, and have the highest journal impact factors. This study was an audit of a bibliographic database. All trials indexed in the Physiotherapy Evidence Database (PEDro) were analyzed. Journals that had published at least 80 trials were selected. The journals were ranked in 4 ways: number of trials published; mean total PEDro score of the trials published in the journal, regardless of publication year; mean total PEDro score of the trials published in the journal from 2000 to 2009; and 2008 journal impact factor. The top 5 core journals in physical therapy, ranked by the total number of trials published, were Archives of Physical Medicine and Rehabilitation, Clinical Rehabilitation, Spine, British Medical Journal (BMJ), and Chest. When the mean total PEDro score was used as the ranking criterion, the top 5 journals were Journal of Physiotherapy, Journal of the American Medical Association (JAMA), Stroke, Spine, and Clinical Rehabilitation. When the mean total PEDro score of the trials published from 2000 to 2009 was used as the ranking criterion, the top 5 journals were Journal of Physiotherapy, JAMA, Lancet, BMJ, and Pain. The most highly ranked physical therapy-specific journals were Physical Therapy (ranked eighth on the basis of the number of trials published) and Journal of Physiotherapy (ranked first on the basis of the quality of trials). Finally, when the 2008 impact factor was used for ranking, the top 5 journals were JAMA, Lancet, BMJ, American Journal of Respiratory and Critical Care Medicine, and Thorax. There were no significant relationships among the rankings on the basis of trial quality, number of trials, or journal impact factor. Physical therapists who are trying to keep up-to-date by reading the best

  5. Comparison of manual therapy and exercise therapy in osteoarthritis of the hip: a randomized clinical trial.

    NARCIS (Netherlands)

    Hoeksma, H.L.; Dekker, J.; Ronday, H.K.; Heering, A.; Lubbe, N. van der; Vel, C.; Breedveld, F.C.; Ende, C.H.M. van den

    2004-01-01

    OBJECTIVE: To determine the effectiveness of a manual therapy program compared with an exercise therapy program in patients with osteoarthritis (OA) of the hip. METHODS: A single-blind, randomized clinical trial of 109 hip OA patients was carried out in the outpatient clinic for physical therapy of

  6. Design Issues in Randomized Clinical Trials of Maintenance Therapies.

    Science.gov (United States)

    Freidlin, Boris; Little, Richard F; Korn, Edward L

    2015-11-01

    A potential therapeutic strategy for patients who respond (or have stable disease) on a fixed-duration induction therapy is to receive maintenance therapy, typically given for a prolonged period of time. To enable patients and clinicians to make informed treatment decisions, the designs of phase III randomized clinical trials (RCTs) assessing maintenance strategies need to be such that their results will provide clear assessment of the relevant risks and benefits of these strategies. We review the key aspects of maintenance RCT designs. Important design considerations include choice of first-line and second-line therapies, minimizing between-arm differences in follow-up schedules, and choice of the primary endpoint. In order to change clinical practice, RCTs should be designed to accurately isolate and quantify the clinical benefit of maintenance as compared with the standard approach of fixed-duration induction followed by the second-line treatment at progression. To accomplish this, RCTs need to utilize an overall survival (or quality of life) endpoint or, in settings where this is not feasible, endpoints that incorporate the effects of the subsequent line of therapy (eg, time from randomization to second progression or death). Toxicity and symptom information over both the study treatment (maintenance) and the second-line treatment should also be collected and reported. Published by Oxford University Press 2015. This work is written by (a) US Government employee(s) and is in the public domain in the US.

  7. Randomized clinical trial: group counseling based on tinnitus retraining therapy

    National Research Council Canada - National Science Library

    Henry, James A; Loovis, Carl; Montero, Melissa; Kaelin, Christine; Anselmi, Kathryn-Anne; Coombs, Rebecca; Hensley, June; James, Kenneth E

    2007-01-01

    .... We conducted a randomized clinical trial to test the hypothesis that group educational counseling based on TRT principles would effectively treat veterans who have clinically significant tinnitus...

  8. 75 FR 54351 - Cell and Gene Therapy Clinical Trials in Pediatric Populations; Public Workshop

    Science.gov (United States)

    2010-09-07

    ... HUMAN SERVICES Food and Drug Administration Cell and Gene Therapy Clinical Trials in Pediatric... public workshop entitled ``Cell and Gene Therapy Clinical Trials in Pediatric Populations.'' The purpose... therapy clinical researchers, and other stakeholders regarding best practices related to cell and gene...

  9. Clinical Trials

    Medline Plus

    Full Text Available ... The results from other clinical trials show what doesn't work or may cause harm. For example, the NHLBI Women's Health Initiative tested whether hormone therapy (HT) reduced the risk of heart disease in postmenopausal women. (When the trial began, HT was already in common ...

  10. Clinical trial registration in physical therapy journals: a cross-sectional study.

    Science.gov (United States)

    Babu, Abraham Samuel; Veluswamy, Sundar Kumar; Rao, Pratiksha Tilak; Maiya, Arun G

    2014-01-01

    Clinical trial registration has become an important part of editorial policies of various biomedical journals, including a few physical therapy journals. However, the extent to which editorial boards enforce the need for trial registration varies across journals. The purpose of this study was to identify editorial policies and reporting of trial registration details in MEDLINE-indexed English-language physical therapy journals. This study was carried out using a cross-sectional design. Editorial policies on trial registration of MEDLINE-indexed member journals of the International Society of Physiotherapy Journal Editors (ISPJE) (Journal of Geriatric Physical Therapy, Journal of Hand Therapy, Journal of Neurologic Physical Therapy, Journal of Orthopaedic and Sports Physical Therapy, Journal of Physiotherapy [formerly Australian Journal of Physiotherapy], Journal of Science and Medicine in Sport, Manual Therapy, Physical Therapy, Physical Therapy in Sport, Physiotherapy, Physiotherapy Research International, Physiotherapy Theory and Practice, and Revista Brasileira de Fisioterapia) were reviewed in April 2013. Full texts of reports of clinical trials published in these journals between January 1, 2008, and December 31, 2012, were independently assessed for information on trial registration. Among the 13 journals, 8 recommended trial registration, and 6 emphasized prospective trial registration. As of April 2013, 4,618 articles were published between January 2008 and December 2012, of which 9% (417) were clinical trials and 29% (121/417) of these reported trial registration details. A positive trend in reporting of trial registration was observed from 2008 to 2012. The study was limited to MEDLINE-indexed ISPJE member journals. Editorial policies on trial registration of physical therapy journals and a rising trend toward reporting of trial registration details indicate a positive momentum toward trial registration. Physical therapy journal editors need to show

  11. Psychotherapy for depression: a randomized clinical trial comparing schema therapy and cognitive behavior therapy.

    Science.gov (United States)

    Carter, Janet D; McIntosh, Virginia V; Jordan, Jennifer; Porter, Richard J; Frampton, Christopher M; Joyce, Peter R

    2013-11-01

    The efficacy of Cognitive Behavior Therapy (CBT) for depression has been robustly supported, however, up to fifty percent of individuals do not respond fully. A growing body of research indicates Schema Therapy (ST) is an effective treatment for difficult and entrenched problems, and as such, may be an effective therapy for depression. In this randomized clinical trial the comparative efficacy of CBT and ST for depression was examined. 100 participants with major depression received weekly cognitive behavioral therapy or schema therapy sessions for 6 months, followed by monthly therapy sessions for 6 months. Key outcomes were comparisons over the weekly and monthly sessions of therapy along with remission and recovery rates. Additional analyses examined outcome for those with chronic depression and comorbid personality disorders. ST was not significantly better (nor worse) than CBT for the treatment of depression. The therapies were of comparable efficacy on all key outcomes. There were no differential treatment effects for those with chronic depression or comorbid personality disorders. This study needs replication. This preliminary research indicates that ST may provide an effective alternative therapy for depression. © 2013 Elsevier B.V. All rights reserved.

  12. Mitochondrial Replacement Therapy: Halachic Considerations for Enrolling in an Experimental Clinical Trial

    Directory of Open Access Journals (Sweden)

    Rabbi Moshe D. Tendler

    2015-07-01

    Full Text Available The transition of new biotechnologies into clinical trials is a critical step in approving a new drug or therapy in health care. Ethically recruiting appropriate volunteers for these clinical trials can be a challenging task for both the pharmaceutical companies and the US Food and Drug Administration. In this paper we analyze the Jewish halachic perspectives of volunteering for clinical trials by focusing on an innovative technology in reproductive medicine, mitochondrial replacement therapy. The halachic perspective encourages individuals to volunteer for such clinical trials under the ethical principles of beneficence and social responsibility, when animal studies have shown that health risks are minimal.

  13. Cupping therapy for acute and chronic pain management: a systematic review of randomized clinical trials

    OpenAIRE

    Cao, Huijuan; Li, Xun; Yan, Xue; Wang, Nissi S.; Bensoussan, Alan; Liu, Jianping

    2014-01-01

    Objective: Cupping as a traditional therapy is used to treat a myriad of health conditions, including pain. This systematic review assessed the effectiveness and safety of cupping for different types of pain. Methods: Thirteen databases and four trial registries were searched for randomized clinical trials. Meta-analysis of data was conducted if there was non-significant clinical and statistical heterogeneity (measured by I2 test) among trials. Results: Sixteen trials with 921 participa...

  14. Cellular Therapies Clinical Research Roadmap: lessons learned on how to move a cellular therapy into a clinical trial.

    Science.gov (United States)

    Ouseph, Stacy; Tappitake, Darah; Armant, Myriam; Wesselschmidt, Robin; Derecho, Ivy; Draxler, Rebecca; Wood, Deborah; Centanni, John M

    2015-04-01

    A clinical research roadmap has been developed as a resource for researchers to identify critical areas and potential pitfalls when transitioning a cellular therapy product from the research laboratory, by means of an Investigational New Drug (IND) application, into early-phase clinical trials. The roadmap describes four key areas: basic and preclinical research, resource development, translational research and Good Manufacturing Practice (GMP) and IND assembly and submission. Basic and preclinical research identifies a new therapeutic concept and demonstrates its potential value with the use of a model of the relevant disease. During resource development, the appropriate specialists and the required expertise to bring this product into the clinic are identified (eg, researchers, regulatory specialists, GMP manufacturing staff, clinicians and clinical trials staff, etc). Additionally, the funds required to achieve this goal (or a plan to procure them) are identified. In the next phase, the plan to translate the research product into a clinical-grade therapeutic is developed. Finally regulatory approval to start the trial must be obtained. In the United States, this is done by filing an IND application with the Food and Drug Administration. The National Heart, Lung and Blood Institute-funded Production Assistance for Cellular Therapies program has facilitated the transition of a variety of cellular therapy products from the laboratory into Phase1/2 trials. The five Production Assistance for Cellular Therapies facilities have assisted investigators by performing translational studies and GMP manufacturing to ensure that cellular products met release specifications and were manufactured safely, reproducibly and at the appropriate scale. The roadmap resulting from this experience is the focus of this article. Copyright © 2015 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

  15. CLINICAL PROGRESS IN INHERITED RETINAL DEGENERATIONS: GENE THERAPY CLINICAL TRIALS AND ADVANCES IN GENETIC SEQUENCING.

    Science.gov (United States)

    Hafler, Brian P

    2017-03-01

    Inherited retinal dystrophies are a significant cause of vision loss and are characterized by the loss of photoreceptors and the retinal pigment epithelium (RPE). Mutations in approximately 250 genes cause inherited retinal degenerations with a high degree of genetic heterogeneity. New techniques in next-generation sequencing are allowing the comprehensive analysis of all retinal disease genes thus changing the approach to the molecular diagnosis of inherited retinal dystrophies. This review serves to analyze clinical progress in genetic diagnostic testing and implications for retinal gene therapy. A literature search of PubMed and OMIM was conducted to relevant articles in inherited retinal dystrophies. Next-generation genetic sequencing allows the simultaneous analysis of all the approximately 250 genes that cause inherited retinal dystrophies. Reported diagnostic rates range are high and range from 51% to 57%. These new sequencing tools are highly accurate with sensitivities of 97.9% and specificities of 100%. Retinal gene therapy clinical trials are underway for multiple genes including RPE65, ABCA4, CHM, RS1, MYO7A, CNGA3, CNGB3, ND4, and MERTK for which a molecular diagnosis may be beneficial for patients. Comprehensive next-generation genetic sequencing of all retinal dystrophy genes is changing the paradigm for how retinal specialists perform genetic testing for inherited retinal degenerations. Not only are high diagnostic yields obtained, but mutations in genes with novel clinical phenotypes are also identified. In the era of retinal gene therapy clinical trials, identifying specific genetic defects will increasingly be of use to identify patients who may enroll in clinical studies and benefit from novel therapies.

  16. Description of interventions is under-reported in physical therapy clinical trials.

    Science.gov (United States)

    Hariohm, K; Jeyanthi, S; Kumar, J Saravan; Prakash, V

    Amongst several barriers to the application of quality clinical evidence and clinical guidelines into routine daily practice, poor description of interventions reported in clinical trials has received less attention. Although some studies have investigated the completeness of descriptions of non-pharmacological interventions in randomized trials, studies that exclusively analyzed physical therapy interventions reported in published trials are scarce. To evaluate the quality of descriptions of interventions in both experimental and control groups in randomized controlled trials published in four core physical therapy journals. We included all randomized controlled trials published from the Physical Therapy Journal, Journal of Physiotherapy, Clinical Rehabilitation, and Archives of Physical Medicine and Rehabilitation between June 2012 and December 2013. Each randomized controlled trial (RCT) was analyzed and coded for description of interventions using the checklist developed by Schroter et al. Out of 100 RCTs selected, only 35 RCTs (35%) fully described the interventions in both the intervention and control groups. Control group interventions were poorly described in the remaining RCTs (65%). Interventions, especially in the control group, are poorly described in the clinical trials published in leading physical therapy journals. A complete description of the intervention in a published report is crucial for physical therapists to be able to use the intervention in clinical practice. Copyright © 2017 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Publicado por Elsevier Editora Ltda. All rights reserved.

  17. Cell Therapies in Cardiomyopathy: Current Status of Clinical Trials

    Directory of Open Access Journals (Sweden)

    Ming Hao

    2017-01-01

    Full Text Available Because the human heart has limited potential for regeneration, the loss of cardiomyocytes during cardiac myopathy and ischaemic injury can result in heart failure and death. Stem cell therapy has emerged as a promising strategy for the treatment of dead myocardium, directly or indirectly, and seems to offer functional benefits to patients. The ideal candidate donor cell for myocardial reconstitution is a stem-like cell that can be easily obtained, has a robust proliferation capacity and a low risk of tumour formation and immune rejection, differentiates into functionally normal cardiomyocytes, and is suitable for minimally invasive clinical transplantation. The ultimate goal of cardiac repair is to regenerate functionally viable myocardium after myocardial infarction (MI to prevent or heal heart failure. This review provides a comprehensive overview of treatment with stem-like cells in preclinical and clinical studies to assess the feasibility and efficacy of this novel therapeutic strategy in ischaemic cardiomyopathy.

  18. Brain Malignancy Steering Committee clinical trials planning workshop: Report from the Targeted Therapies Working Group

    OpenAIRE

    Alexander, Brian M; Galanis, Evanthia; Yung, W.K. Alfred; Ballman, Karla V.; Boyett, James M.; Cloughesy, Timothy F.; Degroot, John F.; Huse, Jason T.; Mann, Bhupinder; Mason, Warren; Ingo K Mellinghoff; Mikkelsen, Tom; Mischel, Paul S.; O'Neill, Brian P.; Prados, Michael D.

    2014-01-01

    Glioblastoma is the most common primary brain malignancy and is associated with poor prognosis despite aggressive local and systemic therapy, which is related to a paucity of viable treatment options in both the newly diagnosed and recurrent settings. Even so, the rapidly increasing number of targeted therapies being evaluated in oncology clinical trials offers hope for the future. Given the broad range of possibilities for future trials, the Brain Malignancy Steering Committee convened a cli...

  19. Therapist-rated outcomes in a randomized clinical trial comparing cognitive behavioral therapy and psychodynamic therapy for major depression

    NARCIS (Netherlands)

    Driessen, E.; Van, H.L.; Peen, J.; Don, F.J.; Kool, S.; Westra, D.; Hendriksen, M.; Cuijpers, P.; Twisk, J.W.R.; Dekker, J.J.M.

    2015-01-01

    Background The efficacy of psychodynamic therapy (PDT) for depression is debated due to a paucity of high-quality studies. We compared short psychodynamic supportive psychotherapy (SPSP) to cognitive behavioral therapy (CBT) in a randomized clinical trial. We used therapist-rated outcomes to examine

  20. Weight loss therapy for clinical management of patients with some atherosclerotic diseases: a randomized clinical trial.

    Science.gov (United States)

    Oshakbayev, Kuat; Dukenbayeva, Bibazhar; Otarbayev, Nurzhan; Togizbayeva, Gulnar; Tabynbayev, Nariman; Gazaliyeva, Meruyert; Idrisov, Alisher; Oshakbayev, Pernekul

    2015-11-25

    The prevalence and burden of atherosclerotic (AS) diseases are increasing during the last twenty years. Some studies show a close relationship between overweight and AS, but influence on AS diseases of different weight loss methods are still studying. The purpose of the research was to study the effectiveness of a weight loss program in AS patients in randomized controlled trial, and to develop a conception of evolution of AS. A randomized controlled prospective clinical trial including 97 people, from them 71 patients with various AS manifestations. Patients were divided in 2 subgroups for non-drug weight loss program, and conventional drug therapy. The weight loss program included calorie restriction with 100-150 kcal/day, fat-free vegetables, salt diet, and optimum physical activity. Statistical analysis was performed using SPSS for Windows version 17.0. The weight loss subgroup lost ranging between 7-20% from an initial weight (P = 0.016). Weight loss was achieved due to fatty mass reduction only (P = 0.005). Hemoglobin levels (P bone mineral density (P water (P = 0.006) and muscle masses (P = 0.0038) were increased in weight loss subgroup. Ejection fraction (P body fat. ClinicalTrials.gov NCT01700075. State registration is # 0109RK000079, code is O.0475 at the National Center for Scientific and Technical Information of the Republic of Kazakhstan.

  1. Reported characteristics of participants in physical therapy-related clinical trials.

    Science.gov (United States)

    Chevan, Julia; Haskvitz, Esther M

    2015-06-01

    The inclusion of sociodemographic and anthropometric variables in published clinical trials enables physical therapists to determine the applicability of trial results to patients in their clinics. The aim of this study was to examine the reporting of participant sociodemographic and anthropometric characteristics in published physical therapy-related clinical trials. This was a retrospective review of clinical trials from 2 samples drawn from literature applicable to physical therapy. Two reviewers independently extracted data from a random sample of 152 clinical trials from the Physiotherapy Evidence Database (PEDro) and a purposive sample of 85 clinical trials published in the journal Physical Therapy (PTJ). A database containing the occurrence of sociodemographic (age, sex, race/ethnicity, level of education, marital status) and anthropometric variables (height, weight, body mass index) in each article was created to generate descriptive statistics about both samples. Among the sociodemographic variables, at least 90% of articles reported the sex and age of trial participants. Additional sociodemographic characteristics that were reported in 20% to 26% of articles were participant level of education and participant race/ethnicity. The reporting of anthropometric data differed between the 2 samples, with body mass index being most commonly reported in the PEDro sample (48.0%) and weight being most commonly reported in the PTJ sample (38.8%). Articles reviewed were limited by year of publication (from 2008 to 2012 for PTJ articles and 2010 for clinical trials from PEDro) and to English-language-only literature. The physical therapy literature would benefit from enhanced reporting requirements for both sociodemographic and anthropometric data about participants. © 2015 American Physical Therapy Association.

  2. Clinical Trials

    Medline Plus

    Full Text Available ... also requires DSMBs for large trials comparing alternative strategies for diagnosis or treatment. In addition, the NIH requires DSMBs for some earlier phase trials that involve high-risk procedures (such as gene therapy) or ...

  3. Oncolytic virus therapy for cancer: the first wave of translational clinical trials.

    Science.gov (United States)

    Patel, Manish R; Kratzke, Robert A

    2013-04-01

    The field of oncolytic virus therapy, the use of live, replicating viruses for the treatment of cancer, has expanded rapidly over the past decade. Preclinical models have clearly demonstrated anticancer activity against a number of different cancer types. Several agents have entered clinical trials and promising results have led to late stage clinical development for some viruses. The early clinical trials have demonstrated that oncolytic viruses by themselves have potential to result in tumor regression. Engineering of viruses to express novel genes have also led to the use of these vectors as a novel form of gene therapy. As a result, interest in oncolytic virus therapy has gained traction. The following review will focus on the first wave of clinical translation of oncolytic virus therapy, what has been learned so far, and potential challenges ahead for advancing the field. Copyright © 2013 Mosby, Inc. All rights reserved.

  4. Feasibility of a clinical trial of vision therapy for treatment of amblyopia.

    Science.gov (United States)

    Lyon, Don W; Hopkins, Kristine; Chu, Raymond H; Tamkins, Susanna M; Cotter, Susan A; Melia, B Michele; Holmes, Jonathan M; Repka, Michael X; Wheeler, David T; Sala, Nicholas A; Dumas, Janette; Silbert, David I

    2013-05-01

    We conducted a pilot randomized clinical trial of office-based active vision therapy for the treatment of childhood amblyopia to determine the feasibility of conducting a full-scale randomized clinical trial. A training and certification program and manual of procedures were developed to certify therapists to administer a standardized vision therapy program in ophthalmology and optometry offices consisting of weekly visits for 16 weeks. Nineteen children, aged 7 to less than 13 years, with amblyopia (20/40-20/100) were randomly assigned to receive either 2 hours of daily patching with active vision therapy or 2 hours of daily patching with placebo vision therapy. Therapists in diverse practice settings were successfully trained and certified to perform standardized vision therapy in strict adherence with protocol. Subjects completed 85% of required weekly in-office vision therapy visits. Eligibility criteria based on age, visual acuity, and stereoacuity, designed to identify children able to complete a standardized vision therapy program and judged likely to benefit from this treatment, led to a high proportion of screened subjects being judged ineligible, resulting in insufficient recruitment. There were difficulties in retrieving adherence data for the computerized home therapy procedures. This study demonstrated that a 16-week treatment trial of vision therapy was feasible with respect to maintaining protocol adherence; however, recruitment under the proposed eligibility criteria, necessitated by the standardized approach to vision therapy, was not successful. A randomized clinical trial of in-office vision therapy for the treatment of amblyopia would require broadening of the eligibility criteria and improved methods to gather objective data regarding the home therapy. A more flexible approach that customizes vision therapy based on subject age, visual acuity, and stereopsis might be required to allow enrollment of a broader group of subjects.

  5. Clinical Trials

    Medline Plus

    Full Text Available ... they work. The U.S. Food and Drug Administration (FDA) oversees these clinical trials. The NIH may partner ... the United States, the Food and Drug Administration (FDA) provides oversight for clinical trials that are testing ...

  6. Clinical Trials

    Science.gov (United States)

    Clinical trials are research studies that test how well new medical approaches work in people. Each study answers ... prevent, screen for, diagnose, or treat a disease. Clinical trials may also compare a new treatment to a ...

  7. Clinical Trials

    Medline Plus

    Full Text Available ... comparison groups by chance, rather than choice. This method helps ensure that any differences observed during a ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ...

  8. Clinical Trials

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    Full Text Available ... are research studies that explore whether a medical strategy, treatment, or device is safe and effective for ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ...

  9. Clinical Trials

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    Full Text Available ... and Centers sponsor clinical trials. Many other groups, companies, and organizations also sponsor clinical trials. Examples include ... U.S. Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and Centers ( ...

  10. Clinical Trials

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    Full Text Available ... treatment, or device is safe and effective for humans. What Are Clinical Trials? Clinical trials are research ... are required to have an IRB. Office for Human Research Protections The U.S. Department of Health and ...

  11. Clinical Trials

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    Full Text Available ... and groups sponsor clinical trials that test the safety of products, such as medicines, and how well they work. The U.S. Food and Drug Administration (FDA) oversees these clinical trials. ...

  12. Clinical Trials

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    Full Text Available ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ... lung, and blood disorders. By engaging the research community and a broad group of stakeholders and advisory ...

  13. Clinical Trials

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    Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... care providers might be part of your treatment team. They will monitor your health closely. You may ...

  14. Clinical Trials

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    Full Text Available ... harm. In later phases of clinical trials, researchers learn more about the new approach's risks and benefits. ... Clinical Studies Web page. Children and Clinical Studies Learn more about Children and Clinical Studies Importance of ...

  15. Establishing Evidence-Based Indications for Proton Therapy: An Overview of Current Clinical Trials

    Energy Technology Data Exchange (ETDEWEB)

    Mishra, Mark V., E-mail: mmishra@umm.edu [Department of Radiation Oncology, University of Maryland School of Medicine, Baltimore, Maryland (United States); Aggarwal, Sameer [Department of Internal Medicine, University of Maryland School of Medicine, Baltimore, Maryland (United States); Bentzen, Soren M. [Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland (United States); Knight, Nancy [Department of Radiation Oncology, University of Maryland School of Medicine, Baltimore, Maryland (United States); Mehta, Minesh P. [Miami Cancer Institute at Baptist Health South Florida, Miami, Florida (United States); Regine, William F. [Department of Radiation Oncology, University of Maryland School of Medicine, Baltimore, Maryland (United States)

    2017-02-01

    Purpose: To review and assess ongoing proton beam therapy (PBT) clinical trials and to identify major gaps. Methods and Materials: Active PBT clinical trials were identified from (clinicaltrials.gov) and the World Health Organization International Clinical Trials Platform Registry. Data on clinical trial disease site, age group, projected patient enrollment, expected start and end dates, study type, and funding source were extracted. Results: A total of 122 active PBT clinical trials were identified, with target enrollment of >42,000 patients worldwide. Ninety-six trials (79%), with a median planned sample size of 68, were classified as interventional studies. Observational studies accounted for 21% of trials but 71% (n=29,852) of planned patient enrollment. The most common PBT clinical trials focus on gastrointestinal tract tumors (21%, n=26), tumors of the central nervous system (15%, n=18), and prostate cancer (12%, n=15). Five active studies (lung, esophagus, head and neck, prostate, breast) will randomize patients between protons and photons, and 3 will randomize patients between protons and carbon ion therapy. Conclusions: The PBT clinical trial portfolio is expanding rapidly. Although the majority of ongoing studies are interventional, the majority of patients will be accrued to observational studies. Future efforts should focus on strategies to encourage optimal patient enrollment and retention, with an emphasis on randomized, controlled trials, which will require support from third-party payers. Results of ongoing PBT studies should be evaluated in terms of comparative effectiveness, as well as incremental effectiveness and value offered by PBT in comparison with conventional radiation modalities.

  16. Establishing Evidence-Based Indications for Proton Therapy: An Overview of Current Clinical Trials.

    Science.gov (United States)

    Mishra, Mark V; Aggarwal, Sameer; Bentzen, Soren M; Knight, Nancy; Mehta, Minesh P; Regine, William F

    2017-02-01

    To review and assess ongoing proton beam therapy (PBT) clinical trials and to identify major gaps. Active PBT clinical trials were identified from clinicaltrials.gov and the World Health Organization International Clinical Trials Platform Registry. Data on clinical trial disease site, age group, projected patient enrollment, expected start and end dates, study type, and funding source were extracted. A total of 122 active PBT clinical trials were identified, with target enrollment of >42,000 patients worldwide. Ninety-six trials (79%), with a median planned sample size of 68, were classified as interventional studies. Observational studies accounted for 21% of trials but 71% (n=29,852) of planned patient enrollment. The most common PBT clinical trials focus on gastrointestinal tract tumors (21%, n=26), tumors of the central nervous system (15%, n=18), and prostate cancer (12%, n=15). Five active studies (lung, esophagus, head and neck, prostate, breast) will randomize patients between protons and photons, and 3 will randomize patients between protons and carbon ion therapy. The PBT clinical trial portfolio is expanding rapidly. Although the majority of ongoing studies are interventional, the majority of patients will be accrued to observational studies. Future efforts should focus on strategies to encourage optimal patient enrollment and retention, with an emphasis on randomized, controlled trials, which will require support from third-party payers. Results of ongoing PBT studies should be evaluated in terms of comparative effectiveness, as well as incremental effectiveness and value offered by PBT in comparison with conventional radiation modalities. Copyright © 2016 Elsevier Inc. All rights reserved.

  17. Clinical Trials

    Medline Plus

    Full Text Available ... for trials with cutting-edge approaches, such as gene therapy or new biological treatments. Health insurance and health ... trials that involve high-risk procedures (such as gene therapy) or vulnerable patients (such as children). A DSMB's ...

  18. The efficacy of maggot debridement therapy - a review of comparative clinical trials

    DEFF Research Database (Denmark)

    Zarchi, K.; Jemec, G.B.

    2012-01-01

    in a variety of ulcers. However, comparative clinical trials and in particular randomized controlled trials investigating the efficacy of MDT are sparse. A systematic search in the literature showed three randomized clinical trials and five non randomized studies evaluating the efficacy of sterile Lucilia...... sericata applied on ulcers with various aetiologies. Of these, seven studies had debridement and/or healing as an outcome variable. When evaluating maggots as debriding agents, the studies report MDT as being significantly more effective than hydrogel or a mixture of conventional therapy modalities...

  19. Brain Malignancy Steering Committee clinical trials planning workshop: report from the Targeted Therapies Working Group.

    Science.gov (United States)

    Alexander, Brian M; Galanis, Evanthia; Yung, W K Alfred; Ballman, Karla V; Boyett, James M; Cloughesy, Timothy F; Degroot, John F; Huse, Jason T; Mann, Bhupinder; Mason, Warren; Mellinghoff, Ingo K; Mikkelsen, Tom; Mischel, Paul S; O'Neill, Brian P; Prados, Michael D; Sarkaria, Jann N; Tawab-Amiri, Abdul; Trippa, Lorenzo; Ye, Xiaobu; Ligon, Keith L; Berry, Donald A; Wen, Patrick Y

    2015-02-01

    Glioblastoma is the most common primary brain malignancy and is associated with poor prognosis despite aggressive local and systemic therapy, which is related to a paucity of viable treatment options in both the newly diagnosed and recurrent settings. Even so, the rapidly increasing number of targeted therapies being evaluated in oncology clinical trials offers hope for the future. Given the broad range of possibilities for future trials, the Brain Malignancy Steering Committee convened a clinical trials planning meeting that was held at the Udvar-Hazy Center in Chantilly, Virginia, on September 19 and 20, 2013. This manuscript reports the deliberations leading up to the event from the Targeted Therapies Working Group and the results of the meeting. © The Author(s) 2014. Published by Oxford University Press on behalf of the Society for Neuro-Oncology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  20. A TWELVE MONTH CLINICAL TRIAL OF CHIROPRACTIC SPINAL MANIPULATIVE THERAPY FOR MIGRAINE

    OpenAIRE

    Tuchin, Peter J.

    1999-01-01

    Objective: To assess the efficacy of Chiropractic spinal manipulative therapy (SMT) in the treatment of migraine. Design: A prospective clinical trial of twelve months duration. The trial consisted of 3 stages: two month pre-treatment, two month treatment, and two months post treatment. Comparison of outcomes to the initial baseline factors was made and also 6 months after the cessation of the study. Setting: Chiropractic Research Centre of Macquarie University. Participants: Thirty two volun...

  1. Clinical Trials

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    Full Text Available ... participants. Children and Clinical Studies Learn about the importance of children in clinical studies and get answers to common questions. NIH Clinical Research Trials and You Get additional guidance on participating ...

  2. Clinical Trials

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    Full Text Available ... the same scientific safeguards as clinical trials for adults. For more information, go to "How Do Clinical ... based on what is known to work in adults. To improve clinical care of children, more studies ...

  3. Clinical Trials

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    Full Text Available ... you to explore NIH Clinical Center for patient recruitment and clinical trial information. For more information, please email the NIH Clinical Center Office of Patient Recruitment at cc-prpl@cc.nih.gov or call ...

  4. Clinical Trials

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    Full Text Available ... and devices specific to children. Resources for a Wide Range of Audiences The Children and Clinical Studies ... medical centers, and hospitals. ClinicalTrials.gov View a database of clinical studies (past and present) funded or ...

  5. Clinical Trials

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    Full Text Available ... help produce reliable study results. Clinical trials are one of the final stages of a long and ... trials that test principles or strategies. For example, one NHLBI study explored whether the benefits of lowering ...

  6. Development of a manualized protocol of massage therapy for clinical trials in osteoarthritis

    Directory of Open Access Journals (Sweden)

    Ali Ather

    2012-10-01

    Full Text Available Abstract Background Clinical trial design of manual therapies may be especially challenging as techniques are often individualized and practitioner-dependent. This paper describes our methods in creating a standardized Swedish massage protocol tailored to subjects with osteoarthritis of the knee while respectful of the individualized nature of massage therapy, as well as implementation of this protocol in two randomized clinical trials. Methods The manualization process involved a collaborative process between methodologic and clinical experts, with the explicit goals of creating a reproducible semi-structured protocol for massage therapy, while allowing some latitude for therapists’ clinical judgment and maintaining consistency with a prior pilot study. Results The manualized protocol addressed identical specified body regions with distinct 30- and 60-min protocols, using standard Swedish strokes. Each protocol specifies the time allocated to each body region. The manualized 30- and 60-min protocols were implemented in a dual-site 24-week randomized dose-finding trial in patients with osteoarthritis of the knee, and is currently being implemented in a three-site 52-week efficacy trial of manualized Swedish massage therapy. In the dose-finding study, therapists adhered to the protocols and significant treatment effects were demonstrated. Conclusions The massage protocol was manualized, using standard techniques, and made flexible for individual practitioner and subject needs. The protocol has been applied in two randomized clinical trials. This manualized Swedish massage protocol has real-world utility and can be readily utilized both in the research and clinical settings. Trial registration Clinicaltrials.gov NCT00970008 (18 August 2009

  7. Cognitive-Behavioral Therapy for Intermittent Explosive Disorder: A Pilot Randomized Clinical Trial

    Science.gov (United States)

    McCloskey, Michael S.; Noblett, Kurtis L.; Deffenbacher, Jerry L.; Gollan, Jackie K.; Coccaro, Emil F.

    2008-01-01

    No randomized clinical trials have evaluated the efficacy of psychotherapy for intermittent explosive disorder (IED). In the present study, the authors tested the efficacy of 12-week group and individual cognitive-behavioral therapies (adapted from J. L. Deffenbacher & M. McKay, 2000) by comparing them with a wait-list control in a randomized…

  8. Moving from Efficacy to Effectiveness in Cognitive Behavioral Therapy for Psychosis: A Randomized Clinical Practice Trial

    Science.gov (United States)

    Lincoln, Tania M.; Ziegler, Michael; Mehl, Stephanie; Kesting, Marie-Luise; Lullmann, Eva; Westermann, Stefan; Rief, Winfried

    2012-01-01

    Objective: Randomized controlled trials have attested the efficacy of cognitive behavioral therapy (CBT) in reducing psychotic symptoms. Now, studies are needed to investigate its effectiveness in routine clinical practice settings. Method: Eighty patients with schizophrenia spectrum disorders who were seeking outpatient treatment were randomized…

  9. Improving participation in clinical trials of novel therapies: going back to basics.

    Science.gov (United States)

    Choi, Chan-Bum; Bae, Sang-Cheol; Gupta, Samar; Rogers, Malcolm P; Liang, Matthew H

    2014-08-01

    Clinical trials in many diseases are experiencing more difficulties in achieving sufficient or timely enrollment of participants; anecdotal reports from trials of novel therapies for systemic lupus erythematosus (SLE) seem to be facing the same challenges. General factors associated with this trend include the growth of the contract research industry, increasing oversight, and high-profile accounts of scientific misconduct and fraud in research. Complicated protocols that increase participant burden, overly restrictive entry criteria, the fear of an SLE flare may also affect enrollment in SLE trials. Published by Elsevier Inc.

  10. Accreditation and quality assurance for Radiation Therapy Oncology Group: Multicenter clinical trials using Stereotactic Body Radiation Therapy in lung cancer.

    Science.gov (United States)

    Timmerman, Robert; Galvin, James; Michalski, Jeff; Straube, William; Ibbott, Geoffrey; Martin, Elizabeth; Abdulrahman, Ramzi; Swann, Suzanne; Fowler, Jack; Choy, Hak

    2006-01-01

    Starting in 2002, the Radiation Therapy Oncology Group in North America began the process of developing multicenter prospective trials in lung cancer using Stereotactic Body Radiation Therapy (SBRT). Much of the work was based on the prospective single institution trials from Indiana University that had been presented and published. In late 2004, RTOG 0236 using SBRT for medically inoperable patients with clinical stage I non-small cell lung cancer (NSCLC) was activated for accrual. Prior to activation, representatives from the Lung, Image-Guided Therapy, Physics, and Radiobiology Committees met on regular occasions to design the multicenter study and quality assurance measures. SBRT is not a black box, and the essence of the therapy had to be distilled via guidelines. Issues related to patient selection, method of dosimetry construction, equipment requirements, motion assessments and control, site accreditation, data exchange, and follow-up policies were worked out by compromise and consensus. RTOG 0236 has nearly completed its accrual. The Lung Committee has initiated the development of several other trials, each building on the last, to investigate the therapy in central tumors, in combinations with systemic therapy, in operable patients, and in lung metastases patients. The guidelines developed for RTOG 0236 will be refined to take advantage of more modern innovations including heterogeneity corrections and intensity modulation when appropriate. The development of RTOG 0618 using SBRT in operable patients with early stage NSCLC is a testament to both the enthusiasm from already published works and prospective multicenter clinical testing using SBRT techniques.

  11. Comparative effectiveness of initial antiretroviral therapy regimens: ACTG 5095 and 5142 clinical trials relative to ART-CC cohort study

    NARCIS (Netherlands)

    Mugavero, Michael J.; May, Margaret; Ribaudo, Heather J.; Gulick, Roy M.; Riddler, Sharon A.; Haubrich, Richard; Napravnik, Sonia; Abgrall, Sophie; Phillips, Andrew; Harris, Ross; Gill, M. John; de Wolf, Frank; Hogg, Robert; Günthard, Huldrych F.; Chêne, Geneviève; D'Arminio Monforte, Antonella; Guest, Jodie L.; Smith, Colette; Murillas, Javier; Berenguer, Juan; Wyen, Christoph; Domingo, Pere; Kitahata, Mari M.; Sterne, Jonathan A. C.; Saag, Michael S.; Shikuma, Cecilia M.; Ribaudo, Heather; Lalama, Christina; Klingman, Karin K.; Bastow, Barbara; Kmack, Anne; Meyer, William A.; Kutitzkes, Daniel R.; Acosta, Edward P.; Hughes, Valery; Squires, Kathleen E.; Shackman, Bruce R.; Schouten, Jeffrey T.; Parrillo, Vincent; Martinez, Ana I.; Fallis, Richard; Storfer, Stephen P.; Giordano, Michael; McDonough, Marita; Rooney, James; Rugh, Lynn; Ryan, Kirk; Tolson, Jerry; van Kempen, Amy S.; Schnizlein Bick, Carol; Webb, Nancy; DiRienzo, A. Gregory; Peeples, Lynne; Powderly, William G.; Klingman, Karin L.; Garren, Kevin W.; George, Tania; Rooney, James F.; Brizz, Barbara; Lalloo, Umesh G.; Murphy, Robert L.; Swindells, Susan; Havlir, Diane; Mellors, John W.

    2011-01-01

    The generalizability of antiretroviral therapy (ART) clinical trial efficacy findings to routine care settings is not well studied. We compared the relative effectiveness of initial ART regimens estimated in AIDS Clinical Trial Group (ACTG) randomized controlled trials with that among patients

  12. 'Third wave' cognitive therapy versus mentalization-based therapy for major depressive disorder. A protocol for a randomised clinical trial

    DEFF Research Database (Denmark)

    Jakobsen, Janus Christian; Gluud, Christian Nyfeldt; Kongerslev, Mickey Toftkjær

    2012-01-01

    Background: Most interventions for depression have shown small or no effects. 'Third wave' cognitive therapy and mentalization-based therapy have both gained some ground as treatments of psychological problems. No randomised trial has compared the effects of these two interventions for patients...... with major depression.Methods/ design: We plan a randomised, parallel group, assessor-blinded superiority clinical trial. During two years we will include 84 consecutive adult participants diagnosed with major depressive disorder. The participants will be randomised to either 'third wave' cognitive therapy...... versus mentalization-based therapy. The primary outcome will be the Hamilton Rating Scale for Depression at cessation of treatment at 18 weeks. Secondary outcomes will be the proportion of patients with remission, Symptom Checklist 90 Revised, Beck's Depression Inventory, and The World Health...

  13. Clinical Trials

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    Full Text Available ... Clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and ... drugs, and devices specific to children. Resources for a Wide Range of Audiences The Children and Clinical ...

  14. Clinical Trials

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    Full Text Available ... you may get tests or treatments in a hospital, clinic, or doctor's office. In some ways, taking ... people will need to travel or stay in hospitals to take part in clinical trials. For example, ...

  15. 'Third wave' cognitive therapy versus mentalization-based therapy for major depressive disorder. A protocol for a randomised clinical trial.

    Science.gov (United States)

    Jakobsen, Janus Christian; Gluud, Christian; Kongerslev, Mickey; Larsen, Kirsten Aaskov; Sørensen, Per; Winkel, Per; Lange, Theis; Søgaard, Ulf; Simonsen, Erik

    2012-12-19

    Most interventions for depression have shown small or no effects. 'Third wave' cognitive therapy and mentalization-based therapy have both gained some ground as treatments of psychological problems. No randomised trial has compared the effects of these two interventions for patients with major depression. We plan a randomised, parallel group, assessor-blinded superiority clinical trial. During two years we will include 84 consecutive adult participants diagnosed with major depressive disorder. The participants will be randomised to either 'third wave' cognitive therapy versus mentalization-based therapy. The primary outcome will be the Hamilton Rating Scale for Depression at cessation of treatment at 18 weeks. Secondary outcomes will be the proportion of patients with remission, Symptom Checklist 90 Revised, Beck's Depression Inventory, and The World Health Organisation-Five Well-being Index 1999. Interventions for depression have until now shown relatively small effects. Our trial results will provide knowledge about the effects of two modern psychotherapeutic interventions. ClinicalTrials: NCT01070134.

  16. Physiotherapy and Occupational Therapy vs No Therapy in Mild to Moderate Parkinson Disease: A Randomized Clinical Trial.

    Science.gov (United States)

    Clarke, Carl E; Patel, Smitaa; Ives, Natalie; Rick, Caroline E; Dowling, Francis; Woolley, Rebecca; Wheatley, Keith; Walker, Marion F; Sackley, Catherine M

    2016-03-01

    It is unclear whether physiotherapy and occupational therapy are clinically effective and cost-effective in Parkinson disease (PD). To perform a large pragmatic randomized clinical trial to evaluate the clinical effectiveness of individualized physiotherapy and occupational therapy in PD. The PD REHAB Trial was a multicenter, open-label, parallel group, controlled efficacy trial. A total of 762 patients with mild to moderate PD were recruited from 38 sites across the United Kingdom. Recruitment took place between October 2009 and June 2012, with 15 months of follow-up. Participants with limitations in activities of daily living (ADL) were randomized to physiotherapy and occupational therapy or no therapy. The primary outcome was the Nottingham Extended Activities of Daily Living (NEADL) Scale score at 3 months after randomization. Secondary outcomes were health-related quality of life (assessed by Parkinson Disease Questionnaire-39 and EuroQol-5D); adverse events; and caregiver quality of life. Outcomes were assessed before trial entry and then 3, 9, and 15 months after randomization. Of the 762 patients included in the study (mean [SD] age, 70 [9.1] years), 381 received physiotherapy and occupational therapy and 381 received no therapy. At 3 months, there was no difference between groups in NEADL total score (difference, 0.5 points; 95% CI, -0.7 to 1.7; P = .41) or Parkinson Disease Questionnaire-39 summary index (0.007 points; 95% CI, -1.5 to 1.5; P = .99). The EuroQol-5D quotient was of borderline significance in favor of therapy (-0.03; 95% CI, -0.07 to -0.002; P = .04). The median therapist contact time was 4 visits of 58 minutes over 8 weeks. Repeated-measures analysis showed no difference in NEADL total score, but Parkinson Disease Questionnaire-39 summary index (diverging 1.6 points per annum; 95% CI, 0.47 to 2.62; P = .005) and EuroQol-5D score (0.02; 95% CI, 0.00007 to 0.03; P = .04) showed small differences in favor of therapy. There was no difference in

  17. [Bibliometrics study on indications of acupuncture therapy based on foreign acupuncture clinical trials].

    Science.gov (United States)

    He, Wei; Tong, Yuan-Yuan; Zhao, Ying-Kai; Rong, Pei-Jing; Wang, Hong-Cai

    2012-10-01

    In the present paper, the authors make a bibliometrics study on clinical indications of acupuncture therapy based on the published foreign articles about acupuncture clinical trials collected from PubMed database and Excerpta Medica database (EMbase). In 1996, 64 acupuncture indications were declared by WHO in Milan conference. But in recent 15 years, clinical trials have been conducted extensively in the foreign countries. Till now, 77 new indications for acupuncture therapy have been found in the foreign journals. The authors recommended that 29 indications (knee osteoarthritis, critique age problems, muscular fasciae ache, anxiety, etc.) should be added to the first class, 4 indications (irritable bowel syndrome, malposition, backache, simple obesity) should be upgraded from the second class to the first class, and the other 3 indications (childbirth pain, male and female barren) should be upgraded from the third class to the first class due to their application frequency in clinical trials. Increase of clinical indications reflects extensive application of acupuncture therapy and may help providing a better service for people's health.

  18. Experience with and potential of Cf-252 therapy for other tumors: Lexington clinical trials

    Energy Technology Data Exchange (ETDEWEB)

    Maruyama, Y.

    1986-01-01

    Clinical observations of tumor response in a variety of sites to Cf-252 (Cf) neutron brachytherapy (NT) are described. Many tumors which are accessible and easily implanted are suitable for Cf-NT, but in advanced stages, must be integrated into a more comprehensive program of local, regional and systemic therapy. With local tumor clearance and control, there should be treatment for regional disease using conventional photon radiotherapy; adjuvant therapies for disseminated disease using systemic therapy is also needed. While potential for therapy exists for Cf-NT treatment of many tumors, additional clinical trials carried out in a variety of global settings are needed where different tumors are common and are available for studies. Tumors suitable for study include e.g. cervix, uterus, vagina, tonsil-oropharynx, anterior oral cavity, prostate, female urethra, nasopharynx, anus and rectum, malignant glioma, parotid, perhaps esophagus, bladder, non-oat cell lung, localized sarcoma and melanoma, etc.

  19. Requirements for Clinical Trials with Gene Therapy and Transplant Products in Switzerland.

    Science.gov (United States)

    Marti, Andreas

    2015-01-01

    This chapter aims to describe and summarize the regulation of gene and cell therapy products in Switzerland and its legal basis. Product types are briefly described, as are Swiss-specific terminologies such as the term "transplant product," which means products manufactured from cells, tissues, or even whole organs. Although some parts of this chapter may show a guideline character, they are not legally binding, but represent the current thinking of Swissmedic, the Swiss Agency for Therapeutic Products. As so far the experience with marketing approval of gene therapy and cell therapy products in Switzerland is limited, this chapter focuses on the regulation of clinical trials conducted with these products. Quality, nonclinical, and clinical aspects are summarized separately for gene therapy products and transplant products.

  20. The clinical trial landscape in oncology and connectivity of somatic mutational profiles to targeted therapies.

    Science.gov (United States)

    Patterson, Sara E; Liu, Rangjiao; Statz, Cara M; Durkin, Daniel; Lakshminarayana, Anuradha; Mockus, Susan M

    2016-01-16

    Precision medicine in oncology relies on rapid associations between patient-specific variations and targeted therapeutic efficacy. Due to the advancement of genomic analysis, a vast literature characterizing cancer-associated molecular aberrations and relative therapeutic relevance has been published. However, data are not uniformly reported or readily available, and accessing relevant information in a clinically acceptable time-frame is a daunting proposition, hampering connections between patients and appropriate therapeutic options. One important therapeutic avenue for oncology patients is through clinical trials. Accordingly, a global view into the availability of targeted clinical trials would provide insight into strengths and weaknesses and potentially enable research focus. However, data regarding the landscape of clinical trials in oncology is not readily available, and as a result, a comprehensive understanding of clinical trial availability is difficult. To support clinical decision-making, we have developed a data loader and mapper that connects sequence information from oncology patients to data stored in an in-house database, the JAX Clinical Knowledgebase (JAX-CKB), which can be queried readily to access comprehensive data for clinical reporting via customized reporting queries. JAX-CKB functions as a repository to house expertly curated clinically relevant data surrounding our 358-gene panel, the JAX Cancer Treatment Profile (JAX CTP), and supports annotation of functional significance of molecular variants. Through queries of data housed in JAX-CKB, we have analyzed the landscape of clinical trials relevant to our 358-gene targeted sequencing panel to evaluate strengths and weaknesses in current molecular targeting in oncology. Through this analysis, we have identified patient indications, molecular aberrations, and targeted therapy classes that have strong or weak representation in clinical trials. Here, we describe the development and disseminate

  1. Evolutionary cognitive therapy versus standard cognitive therapy for depression: a protocol for a blinded, randomized, superiority clinical trial

    Science.gov (United States)

    2014-01-01

    Background Depression is estimated to become the leading cause of disease burden globally by 2030. Despite existing efficacious treatments (both medical and psychotherapeutic), a large proportion of patients do not respond to therapy. Recent insights from evolutionary psychology suggest that, in addition to targeting the proximal causes of depression (for example, targeting dysfunctional beliefs by cognitive behavioral therapy), the distal or evolutionary causes (for example, inclusive fitness) should also be addressed. A randomized superiority trial is conducted to develop and test an evolutionary-driven cognitive therapy protocol for depression, and to compare its efficacy against standard cognitive therapy for depression. Methods/design Romanian-speaking adults (18 years or older) with elevated Beck Depression Inventory (BDI) scores (>13), current diagnosis of major depressive disorder or major depressive episode (MDD or MDE), and MDD with comorbid dysthymia, as evaluated by the Structured Clinical Interview for DSM-IV (SCID), are included in the study. Participants are randomized to one of two conditions: 1) evolutionary-driven cognitive therapy (ED-CT) or 2) cognitive therapy (CT). Both groups undergo 12 psychotherapy sessions, and data are collected at baseline, mid-treatment, post-treatment, and the 3-month follow-up. Primary outcomes are depressive symptomatology and a categorical diagnosis of depression post-treatment. Discussion This randomized trial compares the newly proposed ED-CT with a classic CT protocol for depression. To our knowledge, this is the first attempt to integrate insights from evolutionary theories of depression into the treatment of this condition in a controlled manner. This study can thus add substantially to the body of knowledge on validated treatments for depression. Trial registration Current Controlled Trials ISRCTN64664414 The trial was registered in June 2013. The first participant was enrolled on October 3, 2012. PMID

  2. Current status of clinical trials assessing oncolytic virus therapy for urological cancers.

    Science.gov (United States)

    Taguchi, Satoru; Fukuhara, Hiroshi; Homma, Yukio; Todo, Tomoki

    2017-05-01

    Oncolytic virus therapy has recently been recognized as a promising new option for cancer treatment. Oncolytic viruses replicate selectively in cancer cells, thus killing them without harming normal cells. Notably, T-VEC (talimogene laherparepvec, formerly called OncoVEX(GM)(-)(CSF) ), an oncolytic herpes simplex virus type 1, was approved by the US Food and Drug Administration for the treatment of inoperable melanoma in October 2015, and was subsequently approved in Europe and Australia in 2016. The efficacies of many types of oncolytic viruses against urological cancers have been investigated in preclinical studies during the past decade, and some have already been tested in clinical trials. For example, a phase I trial of the third-generation oncolytic Herpes simplex virus type 1, G47Δ, in patients with prostate cancer was completed in 2016. We summarize the current status of clinical trials of oncolytic virus therapy in patients with the three major urological cancers: prostate, bladder and renal cell cancers. In addition to Herpes simplex virus type 1, adenoviruses, reoviruses, vaccinia virus, Sendai virus and Newcastle disease virus have also been used as parental viruses in these trials. We believe that oncolytic virus therapy is likely to become an important and major treatment option for urological cancers in the near future. © 2017 The Japanese Urological Association.

  3. Independent evaluation of a clinical prediction rule for spinal manipulative therapy: a randomised controlled trial.

    Science.gov (United States)

    Hancock, Mark J; Maher, Christopher G; Latimer, Jane; Herbert, Robert D; McAuley, James H

    2008-07-01

    A clinical prediction rule to identify patients most likely to respond to spinal manipulation has been published and widely cited but requires further testing for external validity. We performed a pre-planned secondary analysis of a randomised controlled trial investigating the efficacy of spinal manipulative therapy in 239 patients presenting to general practice clinics for acute, non-specific, low back pain. Patients were randomised to receive spinal manipulative therapy or placebo 2 to 3 times per week for up to 4 weeks. All patients received general practitioner care (advice and paracetamol). Outcomes were pain and disability measured at 1, 2, 4 and 12 weeks. Status on the clinical prediction rule was measured at baseline. The clinical prediction rule performed no better than chance in identifying patients with acute, non-specific low back pain most likely to respond to spinal manipulative therapy (pain P = 0.805, disability P = 0.600). At 1-week follow-up, the mean difference in effect of spinal manipulative therapy compared to placebo in patients who were rule positive rather than rule negative was 0.3 points less on a 10-point pain scale (95% CI -0.8 to 1.4). The clinical prediction rule proposed by Childs et al. did not generalise to patients presenting to primary care with acute low back pain who received a course of spinal manipulative therapy.

  4. Clinical Trials

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    Full Text Available ... review data from a clinical trial for safety problems or differences in results among different groups. The DSMB also reviews research results from other relevant studies. These results may ...

  5. Clinical Trials

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    Full Text Available ... or treatment is having harmful effects. Food and Drug Administration In the United States, the Food and Drug Administration (FDA) provides oversight for clinical trials that ...

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    Full Text Available ... treatment is having harmful effects. Food and Drug Administration In the United States, the Food and Drug Administration (FDA) provides oversight for clinical trials that are ...

  7. Clinical Trials

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    Full Text Available ... always, parents must give legal consent for their child to take part in a clinical trial. When ... minimal, both parents must give permission for their child to enroll. Also, children aged 7 and older ...

  8. Clinical Trials

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    Full Text Available ... A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders ... to fill an important gap in information and education for parents, clinicians, researchers, children, and the general ...

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    Full Text Available ... to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be ... the new approach. You also will have the support of a team of health care providers, who ...

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    Full Text Available ... States, the Food and Drug Administration (FDA) provides oversight for clinical trials that are testing new medicines or medical devices. The FDA reviews applications for new medicines ...

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    Full Text Available ... care providers might be part of your treatment team. They will monitor your health closely. You may ... taking part in a clinical trial. Your treatment team also may ask you to do other tasks. ...

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    Full Text Available Skip to main content U.S. Department of Health & Human Services Health Topics Health Topics A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders ...

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    Full Text Available ... Diseases Heart and Vascular Diseases Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies ... always, parents must give legal consent for their child to take part in a clinical trial. When ...

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    Full Text Available ... clinical trials are required to have an IRB. Office for Human Research Protections The U.S. Department of Health and Human Services’ (HHS’) Office for Human Research Protections (OHRP) oversees all research ...

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    Full Text Available ... include factors such as a patient's age and gender, the type and stage of disease, and whether ... in a clinical trial, find out ahead of time about costs and coverage. You should learn about ...

  16. Global Harmonization of Quality Assurance Naming Conventions in Radiation Therapy Clinical Trials

    Energy Technology Data Exchange (ETDEWEB)

    Melidis, Christos, E-mail: christos.melidis@eortc.be [European Organization for the Research and Treatment of Cancer–Radiation Oncology Group (EORTC-ROG), Radiation Therapy Quality Assurance (RTQA), Brussels (Belgium); Bosch, Walther R. [Washington University, representing Advanced Technology Consortium, Radiation Oncology, St. Louis, Missouri (United States); Izewska, Joanna [Dosimetry Laboratory, International Atomic Energy Agency, Vienna (Austria); Fidarova, Elena; Zubizarreta, Eduardo [Applied Radiation Biology and Radiotherapy Section, International Atomic Energy Agency, Vienna (Austria); Ulin, Kenneth [Department of Radiation Oncology, University of Massachusetts Medical School, Representing Quality Assurance Review Center, Worcester, Massachusetts (United States); Ishikura, Satoshi [Department of Radiation Oncology, Juntendo University, Representing Japan Clinical Oncology Group, RTQA, Tokyo (Japan); Followill, David [Department of Radiation Physics, The University of Texas MD Anderson Cancer Center, Representing Radiological Physics Center, RTQA, Houston, Texas (United States); Galvin, James [Department of Radiation Oncology, Thomas Jefferson University, Representing Radiation Therapy Oncology Group, RTQA, Philadelphia, Pennsylvania (United States); Haworth, Annette [Department of Physical Sciences, Peter MacCallum Cancer Centre, Melbourne, representing TransTasman Radiation Oncology Group (TROG) Cancer Research, Newcastle (Australia); Besuijen, Deidre [North West Cancer Centre, Representing TROG Cancer Research, Newcastle (Australia); Clark, Clark H. [Department of Medical Physics, St. Luke' s Cancer Centre, Royal Surrey County Hospital, Guildford, Surrey and National Physical Laboratory, Teddington, Middlesex, representing Radiation Therapy Trials Quality Assurance (RTTQA) (United Kingdom); Miles, Elizabeth; Aird, Edwin [Mount Vernon Cancer Centre, Northwood, Middlesex representing RTTQA (United Kingdom); and others

    2014-12-01

    Purpose: To review the various radiation therapy quality assurance (RTQA) procedures used by the Global Clinical Trials RTQA Harmonization Group (GHG) steering committee members and present the harmonized RTQA naming conventions by amalgamating procedures with similar objectives. Methods and Materials: A survey of the GHG steering committee members' RTQA procedures, their goals, and naming conventions was conducted. The RTQA procedures were classified as baseline, preaccrual, and prospective/retrospective data capture and analysis. After all the procedures were accumulated and described, extensive discussions took place to come to harmonized RTQA procedures and names. Results: The RTQA procedures implemented within a trial by the GHG steering committee members vary in quantity, timing, name, and compliance criteria. The procedures of each member are based on perceived chances of noncompliance, so that the quality of radiation therapy planning and treatment does not negatively influence the trial measured outcomes. A comparison of these procedures demonstrated similarities among the goals of the various methods, but the naming given to each differed. After thorough discussions, the GHG steering committee members amalgamated the 27 RTQA procedures to 10 harmonized ones with corresponding names: facility questionnaire, beam output audit, benchmark case, dummy run, complex treatment dosimetry check, virtual phantom, individual case review, review of patients' treatment records, and protocol compliance and dosimetry site visit. Conclusions: Harmonized RTQA harmonized naming conventions, which can be used in all future clinical trials involving radiation therapy, have been established. Harmonized procedures will facilitate future intergroup trial collaboration and help to ensure comparable RTQA between international trials, which enables meta-analyses and reduces RTQA workload for intergroup studies.

  17. "My Whole Life is Ethics!" Ordinary Ethics and Gene Therapy Clinical Trials.

    Science.gov (United States)

    Addison, Courtney; Lassen, Jesper

    2017-10-01

    What and where is ethics in gene therapy? Historical debates have identified a set of ethical issues with the field, and current regulatory systems presume a discrete ethics that can be achieved or protected. Resisting attempts at demarcation or resolution, we use the notions of "ordinary" or "everyday" ethics to develop a better understanding of the complexities of experimental gene therapy for patients, families, and practitioners and create richer imaginings of ethics in the gene therapy sphere. Drawing on ethnographic research in several clinical trials, we show that patients/parents can acquire some control in difficult medical situations, and practitioners can attune their care to their patients' needs. The human provenance of gene therapy practice, and the irreducible sociality of ethics, means that understanding the ethics of this medical field also requires understanding the everyday worlds and relationships of those at its heart.

  18. “My whole life is ethics!” Ordinary ethics and gene therapy clinical trials

    DEFF Research Database (Denmark)

    Addison, Courtney; Lassen, Jesper

    2017-01-01

    What and where is ethics in gene therapy? Historical debates have identified a set of ethical issues with the field, and current regulatory systems presume a discrete ethics that can be achieved or protected. Resisting attempts at demarcation or resolution, we use the notions of “ordinary......” or “everyday” ethics to develop a better understanding of the complexities of experimental gene therapy for patients, families, and practitioners and create richer imaginings of ethics in the gene therapy sphere. Drawing on ethnographic research in several clinical trials, we show that patients/parents can...... acquire some control in difficult medical situations, and practitioners can attune their care to their patients’ needs. The human provenance of gene therapy practice, and the irreducible sociality of ethics, means that understanding the ethics of this medical field also requires understanding the everyday...

  19. Evolutionary cognitive therapy versus standard cognitive therapy for depression: a protocol for a blinded, randomized, superiority clinical trial.

    Science.gov (United States)

    Giosan, Cezar; Cobeanu, Oana; Mogoase, Cristina; Muresan, Vlad; Malta, Loretta S; Wyka, Katarzyna; Szentagotai, Aurora

    2014-03-19

    Depression is estimated to become the leading cause of disease burden globally by 2030. Despite existing efficacious treatments (both medical and psychotherapeutic), a large proportion of patients do not respond to therapy. Recent insights from evolutionary psychology suggest that, in addition to targeting the proximal causes of depression (for example, targeting dysfunctional beliefs by cognitive behavioral therapy), the distal or evolutionary causes (for example, inclusive fitness) should also be addressed. A randomized superiority trial is conducted to develop and test an evolutionary-driven cognitive therapy protocol for depression, and to compare its efficacy against standard cognitive therapy for depression. Romanian-speaking adults (18 years or older) with elevated Beck Depression Inventory (BDI) scores (>13), current diagnosis of major depressive disorder or major depressive episode (MDD or MDE), and MDD with comorbid dysthymia, as evaluated by the Structured Clinical Interview for DSM-IV (SCID), are included in the study. Participants are randomized to one of two conditions: 1) evolutionary-driven cognitive therapy (ED-CT) or 2) cognitive therapy (CT). Both groups undergo 12 psychotherapy sessions, and data are collected at baseline, mid-treatment, post-treatment, and the 3-month follow-up. Primary outcomes are depressive symptomatology and a categorical diagnosis of depression post-treatment. This randomized trial compares the newly proposed ED-CT with a classic CT protocol for depression. To our knowledge, this is the first attempt to integrate insights from evolutionary theories of depression into the treatment of this condition in a controlled manner. This study can thus add substantially to the body of knowledge on validated treatments for depression. Current Controlled Trials ISRCTN64664414The trial was registered in June 2013. The first participant was enrolled on October 3, 2012.

  20. Clinical Trials

    Medline Plus

    Full Text Available ... taking the same treatment the same way. These patients are closely watched by Data and Safety Monitoring Boards. Even if you don't directly ... risk procedures (such as gene therapy) or vulnerable patients (such as ... trial for safety problems or differences in results among different groups. ...

  1. RNA interference for glioblastoma therapy: Innovation ladder from the bench to clinical trials.

    Science.gov (United States)

    Lozada-Delgado, Eunice L; Grafals-Ruiz, Nilmary; Vivas-Mejía, Pablo E

    2017-11-01

    Glioblastoma multiforme (GBM) is the most common and deadliest type of primary brain tumor with a prognosis of 14months after diagnosis. Current treatment for GBM patients includes "total" tumor resection, temozolomide-based chemotherapy, radiotherapy or a combination of these options. Although, several targeted therapies, gene therapy, and immunotherapy are currently in the clinic and/or in clinical trials, the overall survival of GBM patients has hardly improved over the last two decades. Therefore, novel multitarget modalities are urgently needed. Recently, RNA interference (RNAi) has emerged as a novel strategy for the treatment of most cancers, including GBM. RNAi-based therapies consist of using small RNA oligonucleotides to regulate protein expression at the post-transcriptional level. Despite the therapeutic potential of RNAi molecules, systemic limitations including short circulatory stability and low release into the tumor tissue have halted their progress to the clinic. The effective delivery of RNAi molecules through the blood-brain barrier (BBB) represents an additional challenge. This review focuses on connecting the translational process of RNAi-based therapies from in vitro evidence to pre-clinical studies. We delineate the effect of RNAi in GBM cell lines, describe their effectiveness in glioma mouse models, and compare the proposed drug carriers for the effective transport of RNAi molecules through the BBB to reach the tumor in the brain. Furthermore, we summarize the most important obstacles to overcome before RNAi-based therapy becomes a reality for GBM treatment. Published by Elsevier Inc.

  2. Optimizing Radiation Therapy Quality Assurance in Clinical Trials: A TROG 08.03 RAVES Substudy

    Energy Technology Data Exchange (ETDEWEB)

    Trada, Yuvnik, E-mail: yuvnik@gmail.com [Calvary Mater Newcastle, Waratah, New South Wales (Australia); Kneebone, Andrew [Royal North Shore Hospital, St Lenoards, New South Wales (Australia); Paneghel, Andrea [Peter MacCallum Cancer Centre, Melbourne, Victoria (Australia); Pearse, Maria [Auckland Hospital, Auckland (New Zealand); Sidhom, Mark [Liverpool Hospital, Liverpool, New South Wales (Australia); Tang, Colin [Sir Charles Gairdner Hospital, Nedlands, Western Australia (Australia); Wiltshire, Kirsty; Haworth, Annette [Peter MacCallum Cancer Centre, Melbourne, Victoria (Australia); Fraser-Browne, Carol [Auckland Hospital, Auckland (New Zealand); Martin, Jarad [Calvary Mater Newcastle, Waratah, New South Wales (Australia)

    2015-12-01

    Purpose: To explore site- and clinician-level factors associated with protocol violations requiring real-time-review (RTR) resubmission in a multicenter clinical trial to help tailor future quality assurance (QA) protocols. Methods and Materials: RAVES (Radiation Therapy–Adjuvant vs Early Salvage) (Trans-Tasman Radiation Oncology Group 08.03) is a randomized trial comparing adjuvant with early salvage radiation therapy in men with positive surgical margins or pT3 disease after prostatectomy. Quality assurance in RAVES required each clinician and site to submit a credentialing dummy run (DR) and for each patient's radiation therapy plan to undergo external RTR before treatment. Prospectively defined major violations from trial protocol required remedy and resubmission. Site and clinician factors associated with RTR resubmission were examined using hierarchical modeling. Results: Data were collected from 171 consecutive patients, treated by 46 clinicians at 32 hospitals. There were 47 RTR resubmissions (27%) due to 65 major violations. The relative rate of resubmission decreased by 29% per year as the study progressed (odds ratio OR. 0.71, P=.02). The majority of resubmissions were due to contouring violations (39 of 65) and dosimetric violations (22 of 65). For each additional patient accrued, significant decreases in RTR resubmission were seen at both clinician level (OR 0.75, P=.02) and site level (OR 0.72, P=.01). The rate of resubmission due to dosimetric violations was only 1.6% after the first 5 patients. Use of IMRT was associated with lower rates of resubmission compared with 3-dimensional conformal radiation therapy (OR 0.38, P=.05). Conclusion: Several low- and high-risk factors that may assist with tailoring future clinical trial QA were identified. Because the real-time resubmission rate was largely independent of the credentialing exercise, some form of RTR QA is recommended. The greatest benefit from QA was derived early in trial activation

  3. Effects of music therapy on intravitreal injections: a randomized clinical trial.

    Science.gov (United States)

    Chen, Xuejing; Seth, Rajeev K; Rao, Veena S; Huang, John J; Adelman, Ron A

    2012-08-01

    To investigate the effects of music therapy on anxiety, perceived pain, and satisfaction in patients undergoing intravitreal injections in the outpatient setting. This is a randomized clinical trial. Seventy-three patients were recruited from the retina clinic at 1 institution and randomized into a music therapy (n=37) or control (n=36) group. Prior to injection, patients completed the state portion of the Spielberger State Trait Anxiety Inventory (STAI-S). The music therapy group listened to classical music through computer speakers while waiting for and during the injection. The control group underwent the injection in the same setting without music. Afterward, all patients completed another STAI-S and a satisfaction and pain questionnaire. The main outcome measures were objective anxiety derived from STAI-S scores and subjective pain and anxiety from the post procedure questionnaire. The music therapy group had a greater decrease in anxiety than the control group (P=0.0480). Overall, 73% of all patients requested music for future injections (P=0.0001). The music therapy group (84%) requested music in future injections more frequently than the control group (61%) (P=0.0377). Both groups reported similar levels of pain (P=0.5879). Classical music before and during intravitreal injections decreases anxiety in patients without decreasing pain. Most patients desire to have music during future injections. Music therapy is a low-cost, easy, safe intervention that reduces anxiety during intravitreal injections in the outpatient setting.

  4. Novel therapies for resistant focal segmental glomerulosclerosis (FONT phase II clinical trial: study design

    Directory of Open Access Journals (Sweden)

    Joy Melanie

    2011-02-01

    Full Text Available Abstract Background The lack of adequate randomized clinical trials (RCT has hindered identification of new therapies that are safe and effective for patients with primary focal segmental glomerulosclerosis (FSGS, especially in patients who fail to respond to corticosteroids and immunosuppressive therapies. Recent basic science advances have led to development of alternative treatments that specifically target aberrant pathways of fibrosis which are relevant to disease progression in FSGS. There is a need for a flexible Phase II study design which will test such novel antifibrotic strategies in order to identify agents suitable for phase III testing. Methods/Design The Novel Therapies for Resistant Focal Segmental Glomerulosclerosis (FONT project is a multicenter Phase I/II RCT designed to investigate the potential efficacy of novel therapies for resistant FSGS. Adalimumab and galactose will be evaluated against conservative therapy consisting of the combination of lisinopril, losartan and atorvastatin. The sample size is defined to assure that if one of the treatments has a superior response rate compared to that of the other treatments, it will be selected with high probability for further evaluation. Comparison of primary and secondary endpoints in each study arm will enable a choice to be made of which treatments are worthy of further study in future Phase III RCT. Discussion This report highlights the key features of the FONT II RCT including the two-step outcome analysis that will expedite achievement of the study objectives. The proposed phase II study design will help to identify promising agents for further testing while excluding ineffective agents. This staged approach can help to prevent large expenditures on unworthy therapeutic agents in the management of serious but rare kidney diseases Trial Registration ClinicalTrials.gov, NCT00814255

  5. Weight loss therapy for clinical management of patients with some atherosclerotic diseases: a randomized clinical trial

    OpenAIRE

    Oshakbayev, Kuat; Dukenbayeva, Bibazhar; Otarbayev, Nurzhan; Togizbayeva, Gulnar; Tabynbayev, Nariman; Gazaliyeva, Meruyert; Idrisov, Alisher; Oshakbayev, Pernekul

    2015-01-01

    Background The prevalence and burden of atherosclerotic (AS) diseases are increasing during the last twenty years. Some studies show a close relationship between overweight and AS, but influence on AS diseases of different weight loss methods are still studying. The purpose of the research was to study the effectiveness of a weight loss program in AS patients in randomized controlled trial, and to develop a conception of evolution of AS. Methods A randomized controlled prospective clinical tr...

  6. Reported rates of diarrhea following oral penicillin therapy in pediatric clinical trials.

    Science.gov (United States)

    Kuehn, Jemima; Ismael, Zareen; Long, Paul F; Barker, Charlotte I S; Sharland, Mike

    2015-01-01

    Antibiotic-associated diarrhea (AAD) is a well-recognized adverse reaction to oral penicillins. This review analyzed the literature to determine the incidence of AAD following amoxicillin, amoxicillin/clavulanate, and penicillin V oral therapy in pediatric clinical trials. An advanced search was conducted in MEDLINE and Embase databases for articles in any language reporting the incidence of AAD following oral penicillin therapy for any indicated infection in children (0-17 years). The search was limited to clinical trials. Articles were excluded if treatment was related to chronic conditions, involved concomitant antimicrobials, or if the dose or number of patients was not specified. Four hundred thirty-five articles relating to clinical trials were identified (307 from Embase; 128 from MEDLINE). Thirty-five articles reporting on 42 studies were included for analysis. The indications included acute otitis media, sinusitis, pharyngitis, and pneumonia. Thirty-three trials reported on amoxicillin/clavulanate, 6 on amoxicillin, and 3 on penicillin V. In total, the 42 trials included 7729 children who were treated with an oral penicillin. On average, 17.2% had AAD. Data were pooled for each penicillin. The AAD incidence was 19.8% for amoxicillin/clavulanate, 8.1% for amoxicillin, and 1.2% for penicillin V. The amoxicillin/clavulanate data were analyzed according to formulation: pooled-average. The incidence of ADD was 24.6% for the 4:1 formulation, 12.8% for the 7:1 formulation, 19.0% for the 8:1 formulation, and 20.2% for the 14:1 formulation. These results demonstrate substantially increased incidence of AAD following use of amoxicillin/clavulanate, compared to use of amoxicillin and penicillin V, as well as varying AAD rates with diffierent amoxicillin/clavulanate formulations. These findings warrant consideration when prescribing. The underlying mechanisms of AAD in children remain unclear.

  7. Role of cerebrospinal fluid biomarkers in clinical trials for Alzheimer's disease modifying therapies.

    Science.gov (United States)

    Kang, Ju-Hee; Ryoo, Na-Young; Shin, Dong Wun; Trojanowski, John Q; Shaw, Leslie M

    2014-12-01

    Until now, a disease-modifying therapy (DMT) that has an ability to slow or arrest Alzheimer's disease (AD) progression has not been developed, and all clinical trials involving AD patients enrolled by clinical assessment alone also have not been successful. Given the growing consensus that the DMT is likely to require treatment initiation well before full-blown dementia emerges, the early detection of AD will provide opportunities to successfully identify new drugs that slow the course of AD pathology. Recent advances in early detection of AD and prediction of progression of the disease using various biomarkers, including cerebrospinal fluid (CSF) Aβ1-42, total tau and p-tau181 levels, and imagining biomarkers, are now being actively integrated into the designs of AD clinical trials. In terms of therapeutic mechanisms, monitoring these markers may be helpful for go/no-go decision making as well as surrogate markers for disease severity or progression. Furthermore, CSF biomarkers can be used as a tool to enrich patients for clinical trials with prospect of increasing statistical power and reducing costs in drug development. However, the standardization of technical aspects of analysis of these biomarkers is an essential prerequisite to the clinical uses. To accomplish this, global efforts are underway to standardize CSF biomarker measurements and a quality control program supported by the Alzheimer's Association. The current review summarizes therapeutic targets of developing drugs in AD pathophysiology, and provides the most recent advances in the.

  8. Implementation of Remote 3-Dimensional Image Guided Radiation Therapy Quality Assurance for Radiation Therapy Oncology Group Clinical Trials

    Energy Technology Data Exchange (ETDEWEB)

    Cui Yunfeng [Department of Radiation Oncology, Jefferson Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania (United States); Galvin, James M. [Department of Radiation Oncology, Jefferson Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania (United States); Radiation Therapy Oncology Group, American College of Radiology, Philadelphia, Pennsylvania (United States); Parker, William [Department of Medical Physics, McGill University Health Center, Montreal, QC (Canada); Breen, Stephen [Department of Radiation Physics, Princess Margaret Hospital, Toronto, ON (Canada); Yin Fangfang; Cai Jing [Department of Radiation Oncology, Duke University Medical Center, Durham, North Carolina (United States); Papiez, Lech S. [Department of Radiation Oncology, University of Texas Southwestern Medical Center, Dallas, Texas (United States); Li, X. Allen [Department of Radiation Oncology, Medical College of Wisconsin, Milwaukee, Wisconsin (United States); Bednarz, Greg [Department of Radiation Oncology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania (United States); Chen Wenzhou [Department of Radiation Oncology, Jefferson Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania (United States); Xiao Ying, E-mail: ying.xiao@jefferson.edu [Department of Radiation Oncology, Jefferson Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania (United States); Radiation Therapy Oncology Group, American College of Radiology, Philadelphia, Pennsylvania (United States)

    2013-01-01

    Purpose: To report the process and initial experience of remote credentialing of three-dimensional (3D) image guided radiation therapy (IGRT) as part of the quality assurance (QA) of submitted data for Radiation Therapy Oncology Group (RTOG) clinical trials; and to identify major issues resulting from this process and analyze the review results on patient positioning shifts. Methods and Materials: Image guided radiation therapy datasets including in-room positioning CT scans and daily shifts applied were submitted through the Image Guided Therapy QA Center from institutions for the IGRT credentialing process, as required by various RTOG trials. A centralized virtual environment is established at the RTOG Core Laboratory, containing analysis tools and database infrastructure for remote review by the Physics Principal Investigators of each protocol. The appropriateness of IGRT technique and volumetric image registration accuracy were evaluated. Registration accuracy was verified by repeat registration with a third-party registration software system. With the accumulated review results, registration differences between those obtained by the Physics Principal Investigators and from the institutions were analyzed for different imaging sites, shift directions, and imaging modalities. Results: The remote review process was successfully carried out for 87 3D cases (out of 137 total cases, including 2-dimensional and 3D) during 2010. Frequent errors in submitted IGRT data and challenges in the review of image registration for some special cases were identified. Workarounds for these issues were developed. The average differences of registration results between reviewers and institutions ranged between 2 mm and 3 mm. Large discrepancies in the superior-inferior direction were found for megavoltage CT cases, owing to low spatial resolution in this direction for most megavoltage CT cases. Conclusion: This first experience indicated that remote review for 3D IGRT as part of QA

  9. Towards more successful gene therapy clinical trials for β-thalassemia.

    Science.gov (United States)

    Drakopoulou, E; Papanikolaou, E; Georgomanoli, M; Anagnou, N P

    2013-09-01

    β-thalassemias constitute hereditary blood disorders characterized by reduced or absence of β-globin synthesis resulting in mild to severe anemia, depending on the genotype. More than 200 mutations in the β-globin gene are responsible for their specific features leading to a very heterogeneous phenotype. Current therapies for β-thalassemia include blood transfusions, usually along with iron chelation and in selected cases with bone marrow transplantation (BMT) of HLA-matched hematopoietic stem cells (HSCs). However, these approaches are limited by factors, such as iron overload and donor availability, respectively. Since 2000, when globin lentiviral vectors (LVs) were first successfully tested for transfer efficiency of the therapeutic transgene, which led to disease amelioration in murine models, attention was drawn towards the improvement of such vectors for β-thalassemia gene therapy. Constantly improving vector design and efficient HSC manipulation led recently to the first successful clinical trial in France, which further proved that this genetic approach can be curative. Furthermore, improved new efficient vectors and methods to safely monitor integration sites and therapeutic transgene position effects, promise a new era for β-thalassemia gene therapy, with more and safer clinical trials yet to come.

  10. Clinical Trials of Immunogene Therapy for Spontaneous Tumors in Companion Animals

    Science.gov (United States)

    Glikin, Gerardo Claudio; Finocchiaro, Liliana María Elena

    2014-01-01

    Despite the important progress obtained in the treatment of some pets' malignancies, new treatments need to be developed. Being critical in cancer control and progression, the immune system's appropriate modulation may provide effective therapeutic options. In this review we summarize the outcomes of published immunogene therapy veterinary clinical trials reported by many research centers. A variety of tumors such as canine melanoma, soft tissue sarcomas, osteosarcoma and lymphoma, feline fibrosarcoma, and equine melanoma were subjected to different treatment approaches. Both viral and mainly nonviral vectors were used to deliver gene products as cytokines, xenogeneic tumor associated antigens, specific ligands, and proapoptotic regulatory factors. In some cases autologous, allogenic, or xenogeneic transgenic cytokine producing cells were assayed. In general terms, minor or no adverse collateral effects appeared during this kind of therapies and treated patients usually displayed a better course of the disease (longer survival, delayed or suppressed recurrence or metastatic spread, and improvement of the quality of life). This suggests the utility of these methodologies as standard adjuvant treatments. The encouraging outcomes obtained in companion animals support their ready application in veterinary clinical oncology and serve as preclinical proof of concept and safety assay for future human gene therapy trials. PMID:25506617

  11. Clinical Trials

    Medline Plus

    Full Text Available ... This shows how the approach affects a living body and whether it's harmful. However, an approach that works well in the lab or animals doesn't always work well in people. Thus, research in humans is needed. For safety purposes, clinical trials start ...

  12. Clinical Trials

    Medline Plus

    Full Text Available ... educational programs and materials, and offer advice on research-related issues. Data Safety Monitoring Board Every National Institutes of Health ( ... III clinical trial is required to have a Data and Safety Monitoring Board ... of a group of research and study topic experts. The NIH also requires ...

  13. Clinical Trials

    Medline Plus

    Full Text Available ... examples of clinical trials that test principles or strategies include studies that explore whether surgery or other medical treatments ... board consists of a group of research and study topic experts. The NIH also ... alternative strategies for diagnosis or treatment. In addition, the NIH ...

  14. A Randomized Clinical Trial of an Integrative Group Therapy for Children With Severe Mood Dysregulation

    Science.gov (United States)

    Waxmonsky, James G.; Waschbusch, Daniel A.; Belin, Peter; Li, Tan; Babocsai, Lysett; Humphrey, Hugh; Pariseau, Meaghan E.; Babinski, Dara E.; Hoffman, Martin T.; Haak, Jenifer L.; Mazzant, Jessica A.; Fabiano, Gregory A.; Pettit, Jeremy W.; Fallahazad, Negar; Pelham, William E.

    2015-01-01

    Objective Non-episodic irritability is a common and impairing problem, leading to the development of the diagnoses severe mood dysregulation (SMD) and disruptive mood dysregulation disorder (DMDD). No psychosocial therapies have been formally evaluated for either, with medication being the most common treatment. This study examined the feasibility and efficacy of a joint parent–child intervention for SMD. Method Sixty-eight particpants ages 7–12 with attention-deficit/hyperactivity disorder (ADHD) and SMD were randomly assigned to the 11-week therapy or community-based psychosocial treatment. All participants were first stabilized on psychostimulant medication by study physicians. Fifty-six still manifested impairing SMD symptoms and entered the therapy phase. Masked evaluators assessed participants at baseline, midpoint, and endpoint, with therapy participants reassessed 6 weeks later. Results All but two therapy participants attended the majority of sessions (n=29), with families reporting high levels of satisfaction. The primary outcome of change in mood symptoms using the Mood Severity Index (MSI) did not reach significance except in the subset attending the majority of sessions (effect size [ES]=0.53). Therapy was associated with significantly greater improvement in parent-rated irritability (ES=0.63). Treatment effects for irritability but not MSI diminished after therapy stopped. Little impact on ADHD symptoms was seen. Results may not be generalizable to youth with SMD and different comorbidities than seen in this sample of children with ADHD and are limited by the lack of a gold standard for measuring change in SMD symptoms. Conclusion While failing to significantly improve mood symptoms versus community treatment, the integrative therapy was found to be a feasible and efficacious treatment for irritability in participants with SMD and ADHD. Clinical trial registration information Group-Based Behavioral Therapy Combined With Stimulant Medication for

  15. Perspectives on the design of clinical trials combining transarterial chemoembolization and molecular targeted therapy.

    Science.gov (United States)

    Hsu, Chiun; Po-Ching-Liang; Morita, Satoshi; Hu, Fu-Chang; Cheng, Ann-Lii

    2012-11-01

    Transarterial chemoembolization (TACE) moderately prolongs the survival of patients with intermediate-stage hepatocellular carcinoma. Molecular targeted therapy (MTT) may improve the efficacy of TACE. However, the findings of clinical trials evaluating the efficacy of a combination of TACE and MTT are conflicting. We hypothesized that this disparity can be prevented using alternative study designs. In this review, we classify the pertinent issues of study designs into five domains: primary endpoints, patients, TACE procedures, timing of randomization, and drug administration. Furthermore, we discuss the methods for increasing the success rate by minimizing potentially confounding factors within these five domains. Transarterial chemoembolization (TACE) is the current standard therapy for patients with Barcelona Clinic Liver Cancer (BCLC) intermediate-stage hepatocellular carcinoma (HCC) [1, 2, 3]. The survival benefit of TACE is supported by the results of meta-analysis of clinical trials comparing TACE with other conservative treatments in patients with inoperable HCC [4]. The results showed that the median survival of patients improved from approximately 16 to 20 months following TACE [4, 5]. Although advances in TACE techniques and the use of new embolization agents may improve the efficacy of TACE [6, 7], other approaches are needed to further improve the outcome in HCC patients treated using TACE. Molecular targeted therapy (MTT) has improved the survival of patients with advanced-stage HCC [5, 8]. Therefore, combining MTT and TACE may additionally improve the survival in patients with intermediate-stage HCC. Many molecular targeted agents (MTA) are currently undergoing evaluation in randomized trials (table 1). However, the designs of these trials differ significantly. The results of two trials combining sorafenib and TACE were recently reported. Both trials failed to demonstrate a therapeutic benefit of the combination therapy for time to tumor progression

  16. Using PET for therapy monitoring in oncological clinical trials: challenges ahead

    Energy Technology Data Exchange (ETDEWEB)

    Deroose, C.M. [UZ Leuven, Nuclear Medicine, Leuven (Belgium); KU Leuven, Nuclear Medicine and Molecular Imaging, Department of Imaging and Pathology, Leuven (Belgium); European Organisation for Research and Treatment of Cancer (EORTC) Imaging Group, Leuven (Belgium); Stroobants, S. [European Organisation for Research and Treatment of Cancer (EORTC) Imaging Group, Leuven (Belgium); University Hospital, Department of Nuclear Medicine, Antwerp, Edegem (Belgium); Liu, Y. [European Organisation for Research and Treatment of Cancer (EORTC) Imaging Group, Leuven (Belgium); EORTC Headquarters, Brussels (Belgium); Shankar, L.K. [National Cancer Institute, Diagnostic Imaging Branch, Cancer Imaging Program, Bethesda, MD (United States); Bourguet, P. [European Organisation for Research and Treatment of Cancer (EORTC) Imaging Group, Leuven (Belgium); University of Rennes 1, Department of Nuclear Medicine, Rennes (France)

    2017-08-15

    Molecular imaging with PET has emerged as a powerful imaging tool in the clinical care of oncological patients. Assessing therapy response is a prime application of PET and so the integration of PET into multicentre trials can offer valuable scientific insights and shape future clinical practice. However, there are a number of logistic and methodological challenges that have to be dealt with. These range from availability and regulatory compliance of the PET radiopharmaceutical to availability of scan time for research purposes. Standardization of imaging and reconstruction protocols, quality control, image processing and analysis are of paramount importance. Strategies for harmonization of the final image and the quantification result are available and can be implemented within the scope of multicentre accreditation programmes. Data analysis can be performed either locally or by centralized review. Response assessment can be done visually or using more quantitative approaches, depending on the research question. Large-scale real-time centralized review can be achieved using web-based solutions. Specific challenges for the future are inclusion of PET/MRI scanners in multicentre trials and the incorporation of radiomic analyses. Inclusion of PET in multicentre trials is a necessity to guarantee the further development of PET for routine clinical care and may yield very valuable scientific insights. (orig.)

  17. Gene therapy using retrovirus vectors: vector development and biosafety at clinical trials.

    Science.gov (United States)

    Doi, Knayo; Takeuchi, Yasuhiro

    2015-01-01

    Retrovirus vectors (gammaretroviral and lentiviral vectors) have been considered as promising tools to transfer therapeutic genes into patient cells because they can permanently integrate into host cellular genome. To treat monogenic, inherited diseases, retroviral vectors have been used to add correct genes into patient cells. Conventional gammaretroviral vectors achieved successful results in clinical trials: treated patients had therapeutic gene expression in target cells and had improved symptoms of diseases. However, serious side-effects of leukemia occurred, caused by retroviral insertional mutagenesis (IM). These incidences stressed the importance of monitoring vector integration sites in patient cells as well as of re-consideration on safer vectors. More recently lentiviral vectors which can deliver genes into non-dividing cells started to be used in clinical trials including neurological disorders, showing their efficacy. Vector integration site analysis revealed that lentiviruses integrate less likely to near promoter regions of oncogenes than gammaretroviruses and no adverse events have been reported in lentiviral vector-mediated gene therapy clinical trials. Therefore lentiviral vectors have promises to be applied to a wide range of common diseases in near future. For example, T cells from cancer patients were transduced to express chimeric T cell receptors recognizing their tumour cells enhancing patients' anti-cancer immunity.

  18. Ear Acupuncture Therapy for Masticatory Myofascial and Temporomandibular Pain: A Controlled Clinical Trial

    Directory of Open Access Journals (Sweden)

    Luciano Ambrosio Ferreira

    2015-01-01

    Full Text Available Ear acupuncture works by reducing painful sensations with analgesic effect through microsystem therapy and has been demonstrated to be as effective as conventional therapies in the control of facial pain. This clinical trial aimed to evaluate the adjuvant action of auricular acupuncture through an observation of the evolution of temporomandibular and masticatory myofascial symptoms in two groups defined by the therapies elected: auricular acupuncture associated with occlusal splint (study and the use of the occlusal splint plate alone (control. We have selected 20 patients, who were randomly allocated into two groups of ten individuals. Symptoms were evaluated in five different moments, every seven days. We analyzed the orofacial muscle and joint palpation in order to measure the intensity of the experienced pain. Both groups showed a statistically significant decrease in muscle and joint symptoms (p<0.05. However, comparisons between the groups showed an expressive and significant reduction of symptomatology in the study group (p<0.05 already on the first week of therapy. According to the results, to the methodological criteria developed and statistical analysis applied, the conclusion is that auricular acupuncture therapy has synergistic action on conventional occlusal splint treatment. It was demonstrated to be effective in the reduction of symptoms in the short term.

  19. Overcoming challenges to initiating cell therapy clinical trials in rapidly developing countries: India as a model.

    Science.gov (United States)

    Viswanathan, Sowmya; Rao, Mahendra; Keating, Armand; Srivastava, Alok

    2013-08-01

    Increasingly, a number of rapidly developing countries, including India, China, Brazil, and others, are becoming global hot spots for the development of regenerative medicine applications, including stem cell-based therapies. Identifying and overcoming regulatory and translational research challenges and promoting scientific and ethical clinical trials with cells will help curb the growth of stem cell tourism for unproven therapies. It will also enable academic investigators, local regulators, and national and international biotechnology and biopharmaceutical companies to accelerate stem cell-based clinical research that could lead to effective innovative treatments in these regions. Using India as a model system and obtaining input from regulators, clinicians, academics, and industry representatives across the stem cell field in India, we reviewed the role of key agencies and processes involved in this field. We have identified areas that need attention and here provide solutions from other established and functioning models in the world to streamline and unify the regulatory and ethics approval processes for cell-based therapies. We also make recommendations to check the growth and functioning of clinics offering unproven treatments. Addressing these issues will remove considerable hurdles to both local and international investigators, accelerate the pace of research and development, and create a quality environment for reliable products to emerge. By doing so, these countries would have taken one important step to move to the forefront of stem cell-based therapeutics.

  20. Stem cell therapy for type 1 diabetes mellitus: a review of recent clinical trials

    Directory of Open Access Journals (Sweden)

    Couri Carlos

    2009-10-01

    Full Text Available Abstract Stem cell therapy is one of the most promising treatments for the near future. It is expected that this kind of therapy can ameliorate or even reverse some diseases. With regard to type 1 diabetes, studies analyzing the therapeutic effects of stem cells in humans began in 2003 in the Hospital das Clínicas of the Faculty of Medicine of Ribeirão Preto - SP USP, Brazil, and since then other centers in different countries started to randomize patients in their clinical trials. Herein we summarize recent data about beta cell regeneration, different ways of immune intervention and what is being employed in type 1 diabetic patients with regard to stem cell repertoire to promote regeneration and/or preservation of beta cell mass. The Diabetes Control and Complications Trial (DCCT was a 7-year longitudinal study that demonstrated the importance of the intensive insulin therapy when compared to conventional treatment in the development of chronic complications in patients with type 1 diabetes mellitus (T1DM. This study also demonstrated another important issue: there is a reverse relationship between C-peptide levels (endogenous indicator of insulin secretion chronic complications - that is, the higher the C-peptide levels, the lower the incidence of nephropathy, retinopathy and hypoglycemia. From such data, beta cell preservation has become an additional target in the management of T1DM 1.

  1. Hepatitis C antiviral treatment outcomes are comparable between clinical trial participants and recipients of standard-of-care therapy: an analysis of trial effect.

    Science.gov (United States)

    Kelly, Erin M; Cooper, Curtis L

    2013-10-01

    Trial effect refers to the impact of clinical trial participation on treatment outcomes. Little literature exists evaluating the magnitude and direction of trial effect in hepatitis C virus (HCV). A single-center, retrospective study on HCV antiviral therapy recipients was conducted. Sustained virologic response (SVR), virologic response at treatment weeks 4 and 12, dose interruptions, and adverse events were compared between clinical trial participants and standard-of-care antiviral recipients between September 2000 and November 2011. A total of 449 patients were evaluated (trial: 89, nontrial: 360). Patients were matched for age (trial: 47 years, nontrial: 45 years), sex (male: trial, 74%; nontrial, 72%), and ethnicity (white: trial, 87%; nontrial, 78%). The groups differed in the incidence of genotype 1 infection (trial: 83%, nontrial 53%; Panalysis, SVR rates were found to be similar (trial: 51%, nontrial: 54%; P=0.86), even when stratified for genotype (G1: trial, 47%; nontrial, 47%; P=0.78). Interferon dose reductions (trial: 18%, nontrial: 6%; P<0.01) were more likely in trial patients, whereas treatment discontinuation because of side effects (trial: 8%, nontrial: 18%; P<0.02) was less likely in them. No differences in safety issues were identified. Overall, a trial effect resulting in improved or diminished SVR rates was not identified. Other potential positive and negative variables should be focused upon for HCV patients deliberating between clinical trial participation and receiving standard-of-care treatment.

  2. Meropenem in children receiving continuous renal replacement therapy: clinical trial simulations using realistic covariates.

    Science.gov (United States)

    Nehus, Edward J; Mouksassi, Samer; Vinks, Alexander A; Goldstein, Stuart

    2014-12-01

    Meropenem is frequently prescribed in children receiving continuous renal replacement therapy (CRRT). Fluid overload is often present in critically ill children and affects drug disposition. The purpose of this study was to develop a pharmacokinetic model to (1) evaluate target attainment of meropenem dosing regimens against P. aeruginosa in children receiving CRRT and (2) estimate the effect of fluid overload on target attainment. Clinical trial simulations were employed to evaluate target attainment of meropenem in various age groups and degrees of fluid overload in children receiving CRRT. Pharmacokinetic parameters were extracted from published literature, and 287 patients from the prospective pediatric CRRT registry database provided realistic clinical covariates including patient weight, fluid overload, and CRRT prescription characteristics. Target attainment at 40% and 75% time above the minimum inhibitory concentration was evaluated. Clinical trial simulations demonstrated that children greater than 5 years of age achieved acceptable target attainment with a dosing regimen of 20 mg/kg every 12 hours. In children less than 5, however, increased dosing of 20 mg/kg every 8 hours was needed to optimize target attainment. Fluid overload did not affect target attainment. These in silico model predictions will need to be verified in vivo in children receiving meropenem and CRRT. © 2014, The American College of Clinical Pharmacology.

  3. Clinical Research and Clinical Trials

    Science.gov (United States)

    ... Contracts section of the NIH website. Find NICHD Clinical Trials NIH maintains the ClinicalTrials.gov website as the main database of publicly and privately funded clinical trials. Each trial has its own pre-defined research ...

  4. Functional relaxation as complementary therapy in irritable bowel syndrome: a randomized, controlled clinical trial.

    Science.gov (United States)

    Lahmann, Claas; Röhricht, Frank; Sauer, Nina; Noll-Hussong, Michael; Ronel, Joram; Henrich, Gerhard; von Arnim, Angela; Loew, Thomas

    2010-01-01

    Irritable bowel syndrome (IBS) is a frequently disabling and almost invariably distressing disease with a high overall prevalence. Numerous trials identified the importance of psychogenic and emotional etiological factors, and this is obvious in clinical practice. Although relaxation techniques are frequently recommended, there is still a lack of evidence for their efficacy in the management of IBS. This study therefore aims to determine the efficacy of functional relaxation (FR) in IBS. The subjects were 80 patients with IBS. Participants were randomly allocated either to FR or to enhanced medical care (EMC: treatment as usual plus two counseling interviews) as control intervention with 2 weekly sessions over the 5-week trial each. Thirty-nine (39) patients completed FR and 39 received EMC. An impairment-severity score (IS) was employed as the primary outcome parameter with assessment at baseline, after treatment, and again after 3-month follow-up. FR was significantly superior to EMC with a standardized effect size of 0.85. The achieved effects through FR remained stable in terms of psychic and bodily impairment after 3-month follow-up. The results of our trial suggest a positive effect of FR training on subjective functional impairment in the IS, if provided in addition to treatment as usual (TAU). There appears to be a clinically relevant long-term benefit of FR as a nonpharmacological and complementary therapy approach in IBS.

  5. Complement in clinical medicine: Clinical trials, case reports and therapy monitoring.

    Science.gov (United States)

    Ricklin, Daniel; Barratt-Due, Andreas; Mollnes, Tom Eirik

    2017-09-01

    Research during past decades made it evident that complement is involved in more tasks than fighting infections, but has important roles in other immune surveillance and housekeeping functions. If the balance between complement activation and regulation is out of tune, however, complement can quickly turn against the host and contribute to adverse processes that result in various clinical conditions. Whereas clinical awareness was initially focused on complement deficiencies, excessive activation and insufficient regulation are frequently the dominant factors in complement-related disorders. The individual complement profile of a patient often determines the course and severity of the disease, and the pathophysiological involvement of complement may be highly diverse. As a consequence, complement assays have evolved as essential tools not only in initial diagnosis but also for following disease progression and for monitoring complement-targeted therapies, which become increasingly available in routine clinical use. We herein review the current state of complement-directed drug candidates in clinical evaluation and provide an overview of extended indications considered for the FDA-approved inhibitor eculizumab. Furthermore we review the literature describing cases reports and case series where eculizumab has been used "off-label". Finally, we give a summary of the currently available tests to measure complement profiles and discuss their suitability in diagnostics and treatment monitoring. With complement finally entering the clinical arena, there are intriguing opportunities for treating complement-mediated diseases. However, this progress also requires a new awareness about complement pathophysiology, adequate diagnostic tools and suitable treatment options among clinicians treating patients with such disorders. Copyright © 2017 The Author(s). Published by Elsevier Ltd.. All rights reserved.

  6. Effect of photodynamic therapy for the treatment of halitosis in adolescents - a controlled, microbiological, clinical trial.

    Science.gov (United States)

    Costa da Mota, Ana Carolina; França, Cristiane Miranda; Prates, Renato; Deana, Alessandro Melo; Costa Santos, Larissa; Lopes Garcia, Rubia; Leal Gonçalves, Marcela Letícia; Mesquita Ferrari, Raquel Agnelli; Porta Santos Fernandes, Kristianne; Kalil Bussadori, Sandra

    2016-12-01

    Halitosis can exert a negative influence on the social relations of adolescents and affect one's self-image. The aim of this study was to evaluate the clinical and microbiological effect of antimicrobial photodynamic therapy (aPDT) on halitosis in adolescents. Forty-six individuals aged 12 to 19 years were randomly allocated: Group 1 - treatment with photodynamic therapy; Group 2 - treatment with a tongue scraper and Group 3 - treatment with a tongue scraper and photodynamic therapy. The count of bacterial colony-forming units per milliliter was used for the microbiological analysis. Statistical analysis involved the Kruskal-Wallis test followed by the Student-Newman-Keuls test. ANOVA was used for the determination of colony-forming units after treatment. The level of significance for all statistical tests was 5% (p halitosis in adolescents, with an immediate effect and without the mechanical aggression to the toungue. Clinical Trials: NCT02007993. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  7. Critical Aspects of Clinical Trial Design for Novel Cell and Gene Therapies

    Directory of Open Access Journals (Sweden)

    Zinovia Kefalopoulou

    2011-01-01

    Full Text Available Neural cell transplantation and gene therapy have attracted considerable interest as promising therapeutic alternatives for patients with Parkinson's disease (PD. Preclinical and open-label studies have suggested that grafted fetal neural tissue or viral vector gene transfer can achieve considerable biochemical and clinical improvements, whereas subsequent double-blind, placebo-controlled protocols have produced rather more modest and variable results. Detailed evaluation of these discordant findings has highlighted several crucial issues such as patient selection criteria, details surrounding transplantation or gene therapy methodologies, as well as the study designs themselves that ought to be carefully considered in the planning phases of future clinical trials. Beyond the provision of symptomatic efficacy and safety data, it also remains to be identified whether the possibilities offered by stem cell and gene therapy technological advances might translate to meaningful neuroprotection and/or disease-modifying effects or alleviate the nonmotor aspects of PD and thus offer additional benefits beyond those achieved through conventional pharmacotherapy or deep brain stimulation (DBS.

  8. May spa therapy be a valid opportunity to treat hand osteoarthritis? A review of clinical trials and mechanisms of action.

    Science.gov (United States)

    Fortunati, Nicola Angelo; Fioravanti, Antonella; Seri, Gina; Cinelli, Simone; Tenti, Sara

    2016-01-01

    Osteoarthritis (OA) is the most common form of arthritis and its current treatment includes non-pharmacological and pharmacological modalities. Spa therapy represents a popular treatment for many rheumatic diseases. The aim of this review was to summarize the currently available information on clinical effects and mechanisms of action of spa therapy in OA of the hand. We conducted a search of the literature to extract articles describing randomized clinical trials (RCTs) in hand OA published in the period 1952-2015. We identified three assessable articles reporting RCTs on spa therapy in hand OA. Data from these clinical trials support a beneficial effect of spa therapy on pain, function and quality of life in hand OA. Spa therapy seems to have a role in the treatment of hand OA. However, additional RCTs are necessary to clarify the mechanisms of action and the effects of the application of thermal treatments.

  9. Comparison of manual therapy and exercise therapy for postural hyperkyphosis: A randomized clinical trial.

    Science.gov (United States)

    Kamali, Fahimeh; Shirazi, Sara Abolahrari; Ebrahimi, Samaneh; Mirshamsi, Maryam; Ghanbari, Ali

    2016-01-01

    To compare the efficacy of a manual therapy and an exercise therapy program in improving postural hyperkyphosis among young adults. Forty-six women between the ages of 18 to 30 years with thoracic kyphosis diagnosed by flexicurve ruler were randomly assigned to either an exercise therapy or a manual therapy group. The exercise therapy program focused on stretching and strengthening exercises in 15 sessions over 5 weeks. The manual therapy group received 15 sessions of manual techniques including massage, mobilization, muscle energy and myofascial release. Kyphosis angle and back extensor muscle strength were measured with a motion analysis system and a dynamometer at the baseline and after treatment. The data were analyzed with paired and independent t-tests. After treatment, the angle of thoracic kyphosis was smaller and back extensor muscle strength was significantly greater in both the exercise and manual therapy groups (p 0.05). Manual therapy was as effective as exercise therapy in reducing kyphosis angle and increasing back extensor muscle strength in young women with postural hyperkyphosis.

  10. Contribution of Dry Needling to Individualized Physical Therapy Treatment of Shoulder Pain: A Randomized Clinical Trial.

    Science.gov (United States)

    Pérez-Palomares, Sara; Oliván-Blázquez, Bárbara; Pérez-Palomares, Ana; Gaspar-Calvo, Elena; Pérez-Benito, Marina; López-Lapeña, Elena; de la Torre-Beldarraín, Maria Luisa; Magallón-Botaya, Rosa

    2017-01-01

    Study Design Multicenter, parallel randomized clinical trial. Background Myofascial trigger points (MTrPs) are implicated in shoulder pain and functional limitations. An intervention intended to treat MTrPs is dry needling. Objectives To investigate the effectiveness of dry needling in addition to evidence-based personalized physical therapy treatment in the treatment of shoulder pain. Methods One hundred twenty patients with nonspecific shoulder pain were randomly allocated into 2 parallel groups: (1) personalized, evidencebased physical therapy treatment; and (2) trigger point dry needling in addition to personalized, evidence-based physical therapy treatment. Patients were assessed at baseline, posttreatment, and 3-month follow-up. The primary outcome measure was pain assessed by a visual analog scale at 3 months, and secondary variables were joint range-of-motion limitations, Constant-Murley score for pain and function, and number of active MTrPs. Clinical efficacy was assessed using intention-to-treat analysis. Results Of the 120 enrolled patients, 63 were randomly assigned to the control group and 57 to the intervention group. There were no significant differences in outcome between the 2 treatment groups. Both groups showed improvement over time. Conclusion Dry needling did not offer benefits in addition to personalized, evidencebased physical therapy treatment for patients with nonspecific shoulder pain. Level of Evidence Therapy, level 1b. Registered February 11, 2009 at www.isrctn.com (ISRCTN30907460). J Orthop Sports Phys Ther 2017;47(1):11-20. Epub 9 Dec 2016. doi:10.2519/jospt.2017.6698.

  11. Hospitalizations During Systemic Therapy for Metastatic Lung Cancer: A Systematic Review of Real World vs Clinical Trial Outcomes.

    Science.gov (United States)

    Prince, Rebecca M; Atenafu, Eshetu G; Krzyzanowska, Monika K

    2015-12-01

    Understanding the risk of hospitalization due to treatment-related toxic effects is essential for patients, their clinicians, and health systems. Unplanned hospitalizations represent potential gaps in patient care; definition of these gaps allows characterization and identification of areas for quality improvement. To compare the rates of hospitalization in patients with metastatic non-small-cell lung cancer (mNSCLC) receiving chemotherapy in the "real world" vs clinical trial settings and to identify factors associated with hospitalization. A systematic review of Medline and EMBASE was conducted for records dating from database inception (1946 and 1974, respectively) through December 2014 to identify articles reporting rates of hospitalization during chemotherapy in patients with cancer. Both observational studies and clinical trials were eligible. This report focuses on patients with mNSCLC receiving chemotherapy because data were available for this clinical scenario in both the clinical trial and observational setting, allowing comparison. Summary statistics were used to describe results, and the χ2 test was used to compare hospitalization rates. Of the 74 articles reporting hospitalization rates during chemotherapy, 10 studies, all published after 2004, examined chemotherapy in mNSCLC, 5 randomized clinical trials (3962 patients) and 5 observational studies (8624 patients). Chemotherapy regimens included doublet therapy, single-agent therapy, or chemotherapy type unspecified. The real world cohort was older (71 vs 63 years). All real world studies reported on comorbidities, while clinical trials reported performance status. The aggregate hospitalization rate among real world patients was significantly higher than among trial patients (51% vs 16%) (odds ratio, 7.7; 95% CI, 7.0-8.4; P chemotherapy were associated with hospitalization during chemotherapy in clinical trials, while type of chemotherapy was a risk factor in observational studies. Clinical trials in

  12. Nicotine therapy sampling to induce quit attempts among smokers unmotivated to quit: a randomized clinical trial.

    Science.gov (United States)

    Carpenter, Matthew J; Hughes, John R; Gray, Kevin M; Wahlquist, Amy E; Saladin, Michael E; Alberg, Anthony J

    2011-11-28

    Rates of smoking cessation have not changed in a decade, accentuating the need for novel approaches to prompt quit attempts. Within a nationwide randomized clinical trial (N = 849) to induce further quit attempts and cessation, smokers currently unmotivated to quit were randomized to a practice quit attempt (PQA) alone or to nicotine replacement therapy (hereafter referred to as nicotine therapy), sampling within the context of a PQA. Following a 6-week intervention period, participants were followed up for 6 months to assess outcomes. The PQA intervention was designed to increase motivation, confidence, and coping skills. The combination of a PQA plus nicotine therapy sampling added samples of nicotine lozenges to enhance attitudes toward pharmacotherapy and to promote the use of additional cessation resources. Primary outcomes included the incidence of any ever occurring self-defined quit attempt and 24-hour quit attempt. Secondary measures included 7-day point prevalence abstinence at any time during the study (ie, floating abstinence) and at the final follow-up assessment. Compared with PQA intervention, nicotine therapy sampling was associated with a significantly higher incidence of any quit attempt (49% vs 40%; relative risk [RR], 1.2; 95% CI, 1.1-1.4) and any 24-hour quit attempt (43% vs 34%; 1.3; 1.1-1.5). Nicotine therapy sampling was marginally more likely to promote floating abstinence (19% vs 15%; RR, 1.3; 95% CI, 1.0-1.7); 6-month point prevalence abstinence rates were no different between groups (16% vs 14%; 1.2; 0.9-1.6). Nicotine therapy sampling during a PQA represents a novel strategy to motivate smokers to make a quit attempt. clinicaltrials.gov Identifier: NCT00706979.

  13. [Benefits of cognitive behavior therapy and acupressure therapy in obese patients: a randomized clinical trial].

    Science.gov (United States)

    Torres, V; Castro Sánchez, A Ma; Matarán Peñarocha, G A; Lara Palomo, I; Aguilar Ferrándiz, Ma E; Moreno Lorenzo, C

    2011-01-01

    The purpose of this study was to analyze change of lifestyle in obese patients with cognitive behavior therapy and acupressure. An experimental study was performed with placebo control group. Forty patients were randomly assigned to intervention group (cognitive behaviour therapy + acupressure) and control group (information session). Outcome measure was a questionnaire for the assessment and quantification of obesity related lifestyles. Measures were performed at baseline and, after 3-months intervention. After 3 months of treatment, the intervention group showed significant differences (pobese patient, cognitive behavior therapy and acupressure, it has lost at least three kilograms over three months and has changed lifestyles related to obesity.

  14. Cognitive-behavioral group therapy in obsessive-compulsive disorder: a clinical trial

    Directory of Open Access Journals (Sweden)

    Cordioli Aristides V

    2002-01-01

    Full Text Available Objective: To develop a cognitive-behavioral group therapy protocol and to verify its efficacy to reduce obsessive-compulsive symptoms. Methods: An open clinical trial with 32 obsessive-compulsive patients was performed, in which a cognitive-behavioral group therapy protocol of 12 weekly sessions of two hours, in 5 consecutive groups, was applied. The severity of symptoms was rated with the Yale-Brown Obsessive-Compulsive (Y-BOCS, Hamilton Anxiety (HAM A and Hamilton Depression (HAM D scales. The patients were followed up for 3 months after the end of the treatment. Results: There was a significant reduction in the scores of Y-BOCS, HAM A and HAM D scales with the treatment regardless the use of anti-obsessive medications. The rate of improved patients (decrease of > or = 35% in Y-BOCS was 78.1%. Two patients (6.25% dropped out from the study. The effect size calculated for the Y-BOCS scale was 1.75. Conclusions: This study suggests that cognitive-behavioral group therapy reduces obsessive-compulsive symptoms. In addition, patients presented good compliance.

  15. Meet Clinical Trial Participants

    Science.gov (United States)

    ... page please turn JavaScript on. Feature: Clinical Trials Meet Clinical Trial Participants Past Issues / Fall 2016 Table ... Articles Clinical Trials, A Healthier Future for All / Meet Clinical Trial Participants / North Carolinians Volunteer for Knee ...

  16. Textbook of clinical trials

    National Research Council Canada - National Science Library

    Day, Simon; Machin, David; Green, Sylvan B

    2006-01-01

    ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xix INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1 The Development of Clinical Trials Simon...

  17. Eslicarbazepine acetate: its effectiveness as adjunctive therapy in clinical trials and open studies.

    Science.gov (United States)

    Shorvon, S D; Trinka, E; Steinhoff, B J; Holtkamp, M; Villanueva, V; Peltola, J; Ben-Menachem, E

    2017-03-01

    Eslicarbazepine acetate (ESL) is a once-daily antiepileptic drug that is approved as adjunctive therapy in adults with focal-onset seizures. Following oral administration, ESL is rapidly metabolized to its active metabolite, eslicarbazepine, which acts primarily by enhancing slow inactivation of voltage-gated sodium channels. The efficacy and safety/tolerability of ESL in the adjunctive setting were established in a comprehensive Phase III program (n = 1702 randomized patients) and this evidence has been supported by several open studies (n = 864). ESL treatment has demonstrated improvements in health-related quality of life, in both randomized clinical trials and open studies. ESL has also been shown to be usually well tolerated and efficacious when used in the adjunctive setting in elderly patients. The effectiveness of ESL as the only add-on to antiepileptic drug monotherapy has been demonstrated in a multinational study (n = 219), subgroup analyses of which have also shown it to be efficacious and generally well tolerated in patients who had previously not responded to carbamazepine therapy. Open studies have also demonstrated improvements in tolerability in patients switched overnight from oxcarbazepine to ESL. Due to differences in pharmacokinetics, pharmacodynamics, and metabolism, there may be clinical situations in which it is appropriate to consider switching patients from oxcarbazepine or carbamazepine to ESL.

  18. Clinical Trials

    Medline Plus

    Full Text Available ... under way. For example, some trials are stopped early if benefits from a strategy or treatment are ... stop a trial, or part of a trial, early if the strategy or treatment is having harmful ...

  19. Clinical Trials

    Medline Plus

    Full Text Available ... criteria differ from trial to trial. They include factors such as a patient's age and gender, the ... bias. "Bias" means that human choices or other factors not related to the protocol affect the trial's ...

  20. The Effect of Cognitive Behavior Therapy in Insomnia due to Methadone Maintenance Therapy: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Robabeh Soleimani

    2015-09-01

    Full Text Available Background: Sleep disturbance is a common complaint of patients undergoing methadone maintenance therapy (MMT. There are limited studies about the effect of different treatments on insomnia due to MMT. In this study, we evaluated the effect of cognitive-behavioral treatment for insomnia (CBTI on sleep disorders in patients undergoing MMT. Methods: Twenty-two patients with insomnia due to MMT (aged 18-60 years participated in this randomized double-blind clinical trial. The intervention group received CBTI from a clinical psychologist for 8 weeks, whereas the control group received behavioral placebo therapy (BPT. The duration of individual sessions was 45 minutes, which was conducted once a week. The primary outcome was sleep disturbance assessed with Pittsburgh Sleep Quality Index (PSQI. Data were analyzed using SPSS software version 19. Results: Eleven patients were assigned to each group. Two groups were matched according to demographic characteristics (age, marital status, education, and daily methadone doses. Although PSQI score was significantly reduced during weeks 5 and 8 after both interventions, there was a significant difference in intervention versus time interaction (P<0.02. The effects of CBTI versus placebo were significantly different (P<0.001. The time course was also significant (P<0.001. Conclusion: This study showed that CBTI is more effective than BPT in overall sleep quality. We recommend further studies, with a larger sample, on CBTI in patients undergoing MMT.

  1. Effect of Adjunctive Raloxifene Therapy on Severity of Refractory Schizophrenia in Women: A Randomized Clinical Trial.

    Science.gov (United States)

    Kulkarni, Jayashri; Gavrilidis, Emorfia; Gwini, Stella M; Worsley, Roisin; Grigg, Jasmin; Warren, Annabelle; Gurvich, Caroline; Gilbert, Heather; Berk, Michael; Davis, Susan R

    2016-09-01

    A substantial proportion of women with schizophrenia experience debilitating treatment-refractory symptoms. The efficacy of estrogen in modulating brain function in schizophrenia has to be balanced against excess exposure of peripheral tissue. Raloxifene hydrochloride is a selective estrogen receptor modulator (mixed estrogen agonist/antagonist) with potential psychoprotective effects and fewer estrogenic adverse effects. To determine whether adjunctive raloxifene therapy reduces illness severity in women with refractory schizophrenia. This 12-week, double-blind, placebo-controlled, randomized clinical trial with fortnightly assessments was performed at an urban tertiary referral center and a regional center from January 1, 2006, to December 31, 2014. Participants included 56 women with schizophrenia or schizoaffective disorder and marked symptom severity despite substantial and stable antipsychotic doses. Data were analyzed using intention to treat as the basis. Adjunctive raloxifene hydrochloride, 120 mg/d, or placebo for 12 weeks. The primary outcome was the change in the Positive and Negative Syndrome Scale (PANSS) total score. Clinical response (defined as a ≥20% decrease in PANSS total score from baseline) and change in PANSS subscale scores, mood, cognition, reproductive hormone levels, and adverse events were also assessed. Of the 56 participants (mean [SD] age, 53 [7.7] years; age range, 40-70 years; mean [SD] duration of psychotic illness, 24 [11] years), 26 were randomized to raloxifene and 30 were randomized to placebo. Raloxifene produced a greater reduction in the PANSS total score relative to placebo (β = -6.37; 95% CI, -11.64 to -1.10; P = .02) and resulted in an increased probability of a clinical response (hazard ratio, 5.79; 95% CI, 1.46 to 22.97; P = .01). A significant reduction was found in the PANSS general symptom scores for the raloxifene compared with the placebo (β = -3.72; 95% CI, -6.83 to -0.61; P = .02) groups

  2. Evaluation of Wet Cupping Therapy: Systematic Review of Randomized Clinical Trials.

    Science.gov (United States)

    Al Bedah, Abdullah M N; Khalil, Mohamed K M; Posadzki, Paul; Sohaibani, Imen; Aboushanab, Tamer Shaaban; AlQaed, Meshari; Ali, Gazzaffi I M

    2016-10-01

    Wet cupping is a widely used traditional therapy in many countries, which justifies a continuous scientific evaluation of its efficacy and safety. To perform a systematic review to critically evaluate and update the available evidence of wet cupping in traditional and complementary medicine. Ten electronic databases were searched from their inceptions to February 2016. Included studies were randomized clinical trials (RCTs) that evaluated wet cupping against any type of control interventions in patients with any clinical condition, as well as healthy individuals. Cochrane risk of bias tool was used to appraise the included RCTs. Fourteen RCTs met the eligibility criteria. The included studies evaluated the following clinical conditions: nonspecific low back pain (NSLBP), hypertension, brachialgia, carpal tunnel syndrome (CTS), chronic neck pain, metabolic syndrome, migraine headaches, oxygen saturation in smokers with chronic obstructive pulmonary disease (COPD), and oral and genital ulcers due to Behçet disease. Two RCTs evaluated physiologic and biochemical parameters of healthy individuals. Overall, 9 RCTs favored wet cupping over various control interventions in NSLBP (n = 2), hypertension (n = 1), brachialgia (n = 1), CTS (n = 1), chronic neck pain (n = 2), oxygen saturation in smokers with COPD (n = 1), and oral and genital ulcers due to Behçet disease (n = 1). Five RCTs showed no statistically significant between-group differences: NSLBP (n = 1), metabolic syndrome (n = 1), migraine headaches (n = 1), and physiologic and biochemical parameters of healthy individuals (n = 2). Included RCTs had a variable risk of bias across all domains and suffered methodologic limitations. There is a promising evidence in favor of the use of wet cupping for musculoskeletal pain, specifically NSLBP, neck pain, CTS, and brachialgia. Better-quality trials are needed to generate solid evidence and firmly inform policy makers.

  3. Ozone as an adjunct to conventional nonsurgical therapy in chronic periodontitis: a randomized controlled clinical trial.

    Science.gov (United States)

    Al Habashneh, R; Alsalman, W; Khader, Y

    2015-02-01

    Currently, only limited data are available from controlled clinical trials regarding the effect of irrigation by ozonated water in the treatment of periodontitis. The aim of the present study was to determine the clinical and biological effects of the adjunctive use of ozone in nonsurgical periodontal treatment. Forty-one patients with chronic periodontitis were randomized to treatment with either subgingival scaling and root planing (SRP) followed by irrigation with ozonated water (test) or subgingival SRP followed by irrigation with distilled water irrigation (control). The following parameters were evaluated at baseline (T0), 3 mo (T1): plaque index; gingival index; bleeding on probing; probing pocket depth; gingival recession; and clinical attachment loss. In addition, the serum concentrations of high sensitivity C-reactive protein were measured at T0 and T1. Forty-one patients with chronic periodontitis were included in the analysis (20 in the test group and 21 in the control group). There was statistically significant improvement in the study parameters in both groups between T0 and T1, except for gingival index. However, there were no significant differences in any study parameter between test and control groups. Irrigation with ozonated water as an adjunctive therapy to SRP produces no statistically significant benefit compared with SRP plus distilled water irrigation. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  4. The effect of manual therapy with augmentative exercises for neck pain: a randomised clinical trial.

    Science.gov (United States)

    Petersen, Shannon Bravo; Cook, Chad; Donaldson, Megan; Hassen, Amy; Ellis, Alyson; Learman, Ken

    2015-12-01

    To compare the effect of manual therapy (MT) and an augmentative exercise programme (AEP) versus MT and general neck range of motion (ROM) on functional outcomes for patients with neck pain. A secondary objective was to examine changes in self-report measures and quantitative sensory testing (QST) following MT and AEP. This was a randomised clinical trial. Seventy-two patients with neck pain were recruited. All patients received a single session of MT. Patients were randomly assigned to MT+AEP or MT+ROM. Clinical self-report outcome measures for disability and pain, and QST measures (pain and vibration thresholds) were collected at baseline, post MT treatment, at ∼48 hours, and at ∼96 hours. Repeated measures ANOVA and MANOVA were used to analyse within and between-group effects for clinical and QST measures. There were no between-group differences for disability, pain and QST measures. There was, however, a significant difference between groups for Global Rating of Change (GRoC) scores (P = 0.037). Patients in both groups showed improvements in pain, disability and trapezius pressure-pain threshold (PPT) (all P < 0.001). Augmentative exercise programme does not significantly improve disability, pain or QST measures in patients with chronic neck pain although it may enhance their GRoC scores. Over a 96-hour period, patients benefitted from MT plus exercise whether the exercise was general or specific.

  5. Brief Behavioral Therapy for Pediatric Anxiety and Depression in Primary Care: A Randomized Clinical Trial.

    Science.gov (United States)

    Weersing, V Robin; Brent, David A; Rozenman, Michelle S; Gonzalez, Araceli; Jeffreys, Megan; Dickerson, John F; Lynch, Frances L; Porta, Giovanna; Iyengar, Satish

    2017-06-01

    Anxiety and depression affect 30% of youth but are markedly undertreated compared with other mental disorders, especially in Hispanic populations. To examine whether a pediatrics-based behavioral intervention targeting anxiety and depression improves clinical outcome compared with referral to outpatient community mental health care. This 2-center randomized clinical trial with masked outcome assessment conducted between brief behavioral therapy (BBT) and assisted referral to care (ARC) studied 185 youths (aged 8.0-16.9 years) from 9 pediatric clinics in San Diego, California, and Pittsburgh, Pennsylvania, recruited from October 6, 2010, through December 5, 2014. Youths who met DSM-IV criteria for full or probable diagnoses of separation anxiety disorder, generalized anxiety disorder, social phobia, major depression, dysthymic disorder, and/or minor depression; lived with a consenting legal guardian for at least 6 months; and spoke English were included in the study. Exclusions included receipt of alternate treatment for anxiety or depression, presence of a suicidal plan, bipolar disorder, psychosis, posttraumatic stress disorder, substance dependence, current abuse, intellectual disability, or unstable serious physical illness. The BBT consisted of 8 to 12 weekly 45-minute sessions of behavioral therapy delivered in pediatric clinics by master's-level clinicians. The ARC families received personalized referrals to mental health care and check-in calls to support accessing care from master's-level coordinators. The primary outcome was clinically significant improvement on the Clinical Global Impression-Improvement scale (score ≤2). Secondary outcomes included the Pediatric Anxiety Rating Scale, Children's Depression Rating Scale-Revised, and functioning. A total of 185 patients were enrolled in the study (mean [SD] age, 11.3 [2.6] years; 107 [57.8%] female; 144 [77.8%] white; and 38 [20.7%] Hispanic). Youths in the BBT group (n = 95), compared with those in

  6. 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.

  7. Clinical Trials

    Medline Plus

    Full Text Available ... research—that is, who is eligible. Each trial must include only people who fit the patient traits ... to take part in the study. Each trial must include only people who fit the patient traits ...

  8. A Randomized Clinical Trial of Multisystemic Therapy with Juvenile Sexual Offenders: Effects on Youth Social Ecology and Criminal Activity

    Science.gov (United States)

    Borduin, Charles M.; Schaeffer, Cindy M.; Heiblum, Naamith

    2009-01-01

    A randomized clinical trial evaluated the efficacy of multisystemic therapy (MST) versus usual community services (UCS) for 48 juvenile sexual offenders at high risk of committing additional serious crimes. Results from multiagent assessment batteries conducted before and after treatment showed that MST was more effective than UCS in improving key…

  9. Marital Status and Satisfaction Five Years Following a Randomized Clinical Trial Comparing Traditional versus Integrative Behavioral Couple Therapy

    Science.gov (United States)

    Christensen, Andrew; Atkins, David C.; Baucom, Brian; Yi, Jean

    2010-01-01

    Objective: To follow distressed married couples for 5 years after their participation in a randomized clinical trial. Method: A total of 134 chronically and seriously distressed married couples were randomly assigned to approximately 8 months of either traditional behavioral couple therapy (TBCT; Jacobson & Margolin, 1979) or integrative…

  10. The effectiveness of exercise therapy in patients with osteoarthritis of the hip or knee: a randomized clinical trial.

    NARCIS (Netherlands)

    Baar, M.E. van; Dekker, J.; Oostendorp, R.A.B.; Bijl, D.; Voorn, T.B.; Lemmens, J.A.M.; Bijlsma, J.W.J.

    1998-01-01

    Objective: To determine the effectiveness of exercise therapy in patients with osteoarthritis (OA) of the hip or knee. Methods: A randomized single blind, clinical trial was conducted in a primary care setting. Patients with hip or knee OA by American College of Rheumatology criteria were

  11. Hyperbaric oxygen therapy can diminish fibromyalgia syndrome--prospective clinical trial.

    Directory of Open Access Journals (Sweden)

    Shai Efrati

    Full Text Available Fibromyalgia Syndrome (FMS is a persistent and debilitating disorder estimated to impair the quality of life of 2-4% of the population, with 9:1 female-to-male incidence ratio. FMS is an important representative example of central nervous system sensitization and is associated with abnormal brain activity. Key symptoms include chronic widespread pain, allodynia and diffuse tenderness, along with fatigue and sleep disturbance. The syndrome is still elusive and refractory. The goal of this study was to evaluate the effect of hyperbaric oxygen therapy (HBOT on symptoms and brain activity in FMS.A prospective, active control, crossover clinical trial. Patients were randomly assigned to treated and crossover groups: The treated group patients were evaluated at baseline and after HBOT. Patients in the crossover-control group were evaluated three times: baseline, after a control period of no treatment, and after HBOT. Evaluations consisted of physical examination, including tender point count and pain threshold, extensive evaluation of quality of life, and single photon emission computed tomography (SPECT imaging for evaluation of brain activity. The HBOT protocol comprised 40 sessions, 5 days/week, 90 minutes, 100% oxygen at 2ATA. Sixty female patients were included, aged 21-67 years and diagnosed with FMS at least 2 years earlier. HBOT in both groups led to significant amelioration of all FMS symptoms, with significant improvement in life quality. Analysis of SPECT imaging revealed rectification of the abnormal brain activity: decrease of the hyperactivity mainly in the posterior region and elevation of the reduced activity mainly in frontal areas. No improvement in any of the parameters was observed following the control period.The study provides evidence that HBOT can improve the symptoms and life quality of FMS patients. Moreover, it shows that HBOT can induce neuroplasticity and significantly rectify abnormal brain activity in pain related areas

  12. Antimicrobial photodynamic therapy suppresses dental plaque formation in healthy adults: a randomized controlled clinical trial.

    Science.gov (United States)

    Ichinose-Tsuno, Akiko; Aoki, Akira; Takeuchi, Yasuo; Kirikae, Teruo; Shimbo, Takuro; Lee, Masaichi-Chang-Il; Yoshino, Fumihiko; Maruoka, Yutaka; Itoh, Toshiyuki; Ishikawa, Isao; Izumi, Yuichi

    2014-12-15

    Oral care is important for oral and systemic health, especially for elderly institutionalized individuals and compromised patients. However, conventional mechanical plaque control is often difficult for these patients because of the pain or the risk of aspiration. Although antimicrobial photodynamic therapy (aPDT), which is considered an alternative or adjunct to mechanical approaches, has potential application as a less stressful method of daily plaque control, no clinical application of this technique has been reported. We investigated the inhibitory effect of a combination of toluidine blue O (TBO), and a red light-emitting diode (LED) on dental plaque formation in healthy volunteers. The optimal concentration of TBO was determined in preliminary in vitro experiments to evaluate the bactericidal effect of aPDT on Streptococcus oralis and to clarify its safety in fibroblast cells. To survey the mechanism of TBO-mediated aPDT, the quality and quantity of reactive oxygen species (ROS) generated during aPDT were also examined using electron spin resonance (ESR) spectroscopy. Subsequently, the inhibitory effect of aPDT on dental plaque formation was investigated in eleven subjects as a clinical pilot study. The right or left mandibular premolars were randomly assigned to the treatment (with aPDT) or control (without aPDT) groups. In total, aPDT was applied six times (twice per day) to the teeth in the test group over a period of four days. On the fourth day, the study concluded and the analyses were performed. A combination of 500 or 1000 μg/ml TBO and LED irradiation for 20 s significantly decreased the number of colony forming units of Streptococcus oralis. The cytotoxicity of aPDT was comparable to that of standard antiseptics used in the oral cavity. Hydroxyl radicals were detected by ESR analysis, but singlet oxygen was not. A randomized controlled trial demonstrated that aPDT with 1000 μg/ml TBO and red LED irradiation significantly suppressed dental plaque

  13. Sphingosine-1-phosphate receptor therapies: Advances in clinical trials for CNS-related diseases.

    Science.gov (United States)

    O'Sullivan, Sinead; Dev, Kumlesh K

    2017-02-01

    The family of sphingosine-1-phosphate receptors (S1PRs) are G protein-coupled and comprise of five subtypes, S1P1-S1P5. These receptors are activated by the sphingolipid ligand, S1P, which is produced from the phosphorylation of sphingosine by sphingosine kinases. The activation of S1PRs modulates a host of cellular processes such as cell proliferation, migration and survival. These receptors are targeted by the drug fingolimod, a first in class oral therapy for multiple sclerosis. Importantly, S1PRs have also been implicated, in cellular experiments, pre-clinical studies and clinical trials in a range of other neurodegenerative diseases, neurological disorders and psychiatric illnesses, where S1PR drugs are proving beneficial. Overall, studies now highlight the importance of S1PRs as targets for modulating a variety of debilitating brain-related diseases. Here, we review the role of S1PRs in these illnesses. This article is part of the Special Issue entitled 'Lipid Sensing G Protein-Coupled Receptors in the CNS'. Copyright © 2016 Elsevier Ltd. All rights reserved.

  14. Long-term clinical effect of adjunctive antimicrobial photodynamic therapy in periodontal treatment: a randomized clinical trial.

    Science.gov (United States)

    Alwaeli, Haider A; Al-Khateeb, Susan N; Al-Sadi, Amani

    2015-02-01

    Mechanical removal of microbial biofilm dental plaque from tooth surfaces is important for treatment of periodontal diseases. However, the effectiveness of conventional scaling and root planing (SRP) is affected by the local conditions and residual bacteria which may affect the healing process. We performed a randomized clinical trial to test our hypothesis that adjunctive antimicrobial photodynamic therapy (aPDT) plus SRP has significant effect compared with SRP alone, which can last for 1 year. The study included 136 sites in 16 patients with previously untreated chronic periodontitis, at least one premolar and one molar in every quadrant (minimum, four teeth/quadrant) and at least one tooth with attachment loss of ≥4 mm in every quadrant. In all patients, two randomly assigned quadrants were treated with SRP and the other two were treated with SRP + aPDT. The clinical parameters of probing pocket depth (PPD), bleeding on probing (BOP), and clinical attachment level (CAL) were evaluated at baseline and after 3, 6, and 12 months. There were no significant differences between the two groups at baseline. PPD and BOP showed significant reduction, and CAL showed significant gain from baseline for all three time points in both groups. In addition, there were significantly greater reduction and gain for SRP + aPDT than for SRP at all three time points. No adverse effects of aPDT were observed. These data demonstrate significant improvement in all evaluated clinical parameters for at least 1 year and suggest that aPDT as an adjunctive therapy to SRP represents a promising therapeutic concept for persistent periodontitis.

  15. Proctitis 1 Week after Stereotactic Body Radiation Therapy for Prostate Cancer: Implications for Clinical Trial Design.

    Science.gov (United States)

    Paydar, Ima; Cyr, Robyn A; Yung, Thomas M; Lei, Siyuan; Collins, Brian Timothy; Chen, Leonard N; Suy, Simeng; Dritschilo, Anatoly; Lynch, John H; Collins, Sean P

    2016-01-01

    Proctitis following prostate cancer radiation therapy is a primary determinant of quality of life (QOL). While previous studies have assessed acute rectal morbidity at 1 month after stereotactic body radiotherapy (SBRT), little data exist on the prevalence and severity of rectal morbidity within the first week following treatment. This study reports the acute bowel morbidity 1 week following prostate SBRT. Between May 2013 and August 2014, 103 patients with clinically localized prostate cancer were treated with 35-36.25 Gy in five fractions using robotic SBRT delivered on a prospective clinical trial. Bowel toxicity was graded using the Common Terminology Criteria for Adverse Events version 4.0 (CTCAEv.4). Bowel QOL was assessed using the EPIC-26 questionnaire bowel domain at baseline, 1 week, 1 month, and 3 months. Time-dependent changes in bowel symptoms were statistically compared using the Wilcoxon signed-rank test. Clinically significant change was assessed by the minimally important difference (MID) in EPIC score. This was defined as a change of 1/2 standard deviation (SD) from the baseline score. One-hundred and three patients with a minimum of 3 months of follow-up were analyzed. The cumulative incidence of acute grade 2 gastrointestinal (GI) toxicity was 23%. There were no acute ≥ grade 3 bowel toxicities. EPIC bowel summary scores maximally declined at 1 week after SBRT (-13.9, p big problem. This increased to 28.4% (p < 0.0001) 1 week after SBRT and returned to baseline at 3 months after SBRT (0.0%, p = 0.66). Only the bowel summary and bowel bother score declines at 1 week met the MID threshold for clinically significant change. The rate and severity of acute proctitis following prostate SBRT peaked at 1 week after treatment and returned to baseline by 3 months. Toxicity assessment at 1 week can therefore minimize recall bias and should aid in the design of future clinical trials focused on accurately capturing

  16. PROCTITIS ONE WEEK AFTER STEREOTACTIC BODY RADIATION THERAPY FOR PROSTATE CANCER: IMPLICATIONS FOR CLINICAL TRIAL DESIGN

    Directory of Open Access Journals (Sweden)

    Ima Paydar

    2016-07-01

    Full Text Available Background: Proctitis following prostate cancer radiation therapy is a primary determinant of quality of life (QOL. While previous studies have assessed acute rectal morbidity at 1 month after stereotactic body radiotherapy (SBRT, little data exist on the prevalence and severity of rectal morbidity within the first week following treatment. This study reports the acute bowel morbidity one week following prostate SBRT. Materials and methods: Between May 2013 and August 2014, 103 patients with clinically localized prostate cancer were treated with 35 to 36.25 Gy in five fractions using robotic SBRT delivered on a prospective clinical trial. Bowel toxicity was graded using the Common Terminology Criteria for Adverse Events version 4.0 (CTCAEv.4. Bowel QOL was assessed using EPIC-26 questionnaire bowel domain at baseline, one week, one month, and three months. Time-dependent changes in bowel symptoms were statistically compared using the Wilcoxon signed-rank test. Clinically significant change was assessed by the minimally important difference (MID in EPIC score. This was defined as a change of one-half standard deviation (SD from the baseline score. Results: One hundred and three patients with a minimum of three months of follow-up were analyzed. The cumulative incidence of acute grade 2 GI toxicity was 23%. There were no acute ≥ grade 3 bowel toxicities. EPIC bowel summary scores maximally declined at 1 week after SBRT (-13.9, p<0.0001 before returning to baseline at three months after SBRT (+0.03, p=0.94. Prior to treatment, 4.9% of men reported that their bowel bother was a moderate to big problem. This increased to 28.4% (p<0.0001 one week after SBRT and returned to baseline at three months after SBRT (0.0%, p=0.66. Only the bowel summary and bowel bother score declines at 1 week met the MID threshold for clinically significant change. Conclusion: The rate and severity of acute proctitis following prostate SBRT peaked at one week after

  17. The Incremental Effects of Manual Therapy or Booster Sessions in Addition to Exercise Therapy for Knee Osteoarthritis: A Randomized Clinical Trial.

    Science.gov (United States)

    Abbott, J Haxby; Chapple, Catherine M; Fitzgerald, G Kelley; Fritz, Julie M; Childs, John D; Harcombe, Helen; Stout, Kirsten

    2015-12-01

    therapy in addition to exercise therapy improved treatment effectiveness compared to providing 12 consecutive exercise therapy sessions alone. Trial registered with the Australian New Zealand Clinical Trials Registry (ACTRN12612000460808).

  18. Clinical Trials

    Medline Plus

    Full Text Available ... trial's potential risks are greater than minimal, both parents must give permission for their child to enroll. Also, children aged 7 and older ... trial's potential risks are greater than minimal, both parents must give permission for their child to enroll. Also, children aged 7 and older ...

  19. 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.

  20. Clinical trial of cancer therapy with heavy ions at heavy ion research facility in lanzhou

    Science.gov (United States)

    Zhang, Hong

    With collaborative efforts of scientists from the Institute of Modern Physics (IMP), Chinese Academy of Sciences and hospitals in Gansu, initial clinical trial on cancer therapy with heavy ions has been successfully carried out in China. From November 2006 to December 2007, 51 patients with superficially-placed tumors were treated with carbon ions at Heavy Ion Research Facility in Lanzhou (HIRFL) within four beam time blocks of 6-11 days, collaborating with the General Hospital of Lanzhou Command and the Tumor Hospital of Gansu Province. Patients and Methods: There were 51 patients (31 males and 20 females) with superficially-placed tumors (squamous cell carcinoma of the skin, basal cell carcinoma of the skin, malignant skin melanoma, sarcoma, lymphoma, breast cancer, metastatic lymph nodes of carcinomas and other skin lesions). The tumors were less than 2.1 cm deep to the skin surface. All patients had histological confirmation of their tumors. Karnofsky Performance Scale (KPS) of all patients was more than 70. The majority of patients were with failures or recurrences of conventional therapies. Median age at the time of radiotherapy (RT) was 55.5 years (range 5-85 years). Patients were immobilized with a vacuum cushion or a head mask and irradiated by carbon ion beams with energy 80-100 MeV/u at spread-out Bragg peak field generated from HIRFL, with two and three-dimensional conformal irradiation methods. Target volume was defined by physical palpation [ultrasonography and Computerized tomography (CT), for some cases]. The clinical target volume (CTV) was defined as the gross total volume GTV with a 0.5-1.0cm margin axially. Field placement for radiation treatment planning was done based on the surface markings. RBE of 2.5-3 within the target volume, and 40-75 GyE with a weekly fractionation of 7 × 3-15 GyE/fraction were used in the trial. Patients had follow-up examinations performed 1 month after treatment, in 1 or 2 months for the first 6 months, and 3

  1. Clinical Trials

    Medline Plus

    Full Text Available ... a laboratory (lab), where scientists first develop and test new ideas. If an approach seems promising, the ... Centers (including the NHLBI) usually sponsor trials that test principles or strategies. For example, one NHLBI study ...

  2. Clinical Trials

    Medline Plus

    Full Text Available ... get special protection as research subjects. Almost always, parents must give legal consent for their child to ... trial's potential risks are greater than minimal, both parents must give permission for their child to enroll. ...

  3. Clinical Trials

    Medline Plus

    Full Text Available ... scale phase III trials begin, the FDA provides input on how these studies should be done. Patient ... of stakeholders and advisory groups, NHLBI has received input and has established a multi-pronged approach to ...

  4. Clinical Trials

    Medline Plus

    Full Text Available ... long and careful research process. The process often begins in a laboratory (lab), where scientists first develop ... IRB reviews the trial's protocol before the study begins. An IRB will only approve research that deals ...

  5. Clinical Trials

    Medline Plus

    Full Text Available ... Masking, or "blinding," helps avoid bias. For this reason, researchers also may not be told which treatments ... from a study at any time, for any reason. Also, during the trial, you have the right ...

  6. Adjunctive Non-Surgical Therapy of Inflamed Periodontal Pockets During Maintenance Therapy Using Diode Laser: A Randomized Clinical Trial.

    Science.gov (United States)

    Nguyen, Naomi-Trang; Byarlay, Matthew R; Reinhardt, Richard A; Marx, David B; Meinberg, Trudy A; Kaldahl, Wayne B

    2015-10-01

    Numerous studies have documented the clinical outcomes of laser therapy for untreated periodontitis, but very few have reported on lasers treating inflamed pockets during maintenance therapy. The aim of this study is to compare the effectiveness of scaling and root planing (SRP) plus the adjunctive use of diode laser therapy to SRP alone on changes in the clinical parameters of disease and on the gingival crevicular fluid (GCF) inflammatory mediator interleukin-1β (IL-1β) in patients receiving regular periodontal maintenance therapy. This single-masked and randomized, controlled, prospective study includes 22 patients receiving regular periodontal maintenance therapy who had one or more periodontal sites with a probing depth (PD) ≥ 5 mm with bleeding on probing (BOP). Fifty-six sites were treated with SRP and adjunctive laser therapy (SRP + L). Fifty-eight sites were treated with SRP alone. Clinical parameters, including PD, clinical attachment level (CAL), and BOP, and GCF IL-1β levels were measured immediately before treatment (baseline) and 3 months after treatment. Sites treated with SRP + L and SRP alone resulted in statistically significant reductions in PD and BOP and gains in CAL. These changes were not significantly different between the two therapies. Similarly, differences in GCF IL-1β levels between SRP + L and SRP alone were not statistically significant. In periodontal maintenance patients, SRP + L did not enhance clinical outcomes compared to SRP alone in the treatment of inflamed sites with ≥ 5 mm PD.

  7. ‘Third wave’ cognitive therapy versus mentalization-based therapy for major depressive disorder. A protocol for a randomised clinical trial

    Directory of Open Access Journals (Sweden)

    Jakobsen Janus Christian

    2012-12-01

    Full Text Available Abstract Background Most interventions for depression have shown small or no effects. ‘Third wave‘ cognitive therapy and mentalization-based therapy have both gained some ground as treatments of psychological problems. No randomised trial has compared the effects of these two interventions for patients with major depression. Methods/ design We plan a randomised, parallel group, assessor-blinded superiority clinical trial. During two years we will include 84 consecutive adult participants diagnosed with major depressive disorder. The participants will be randomised to either ‘third wave‘ cognitive therapy versus mentalization-based therapy. The primary outcome will be the Hamilton Rating Scale for Depression at cessation of treatment at 18 weeks. Secondary outcomes will be the proportion of patients with remission, Symptom Checklist 90 Revised, Beck’s Depression Inventory, and The World Health Organisation-Five Well-being Index 1999. Discussion Interventions for depression have until now shown relatively small effects. Our trial results will provide knowledge about the effects of two modern psychotherapeutic interventions. Trial registration ClinicalTrials: NCT01070134

  8. Clinical Trials

    Medline Plus

    Full Text Available ... Diseases Heart and Vascular Diseases Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies ... the NHLBI's Children and Clinical Studies Web page. Children and Clinical Studies Learn more about Children and ...

  9. Safety and effects of the vector for the Leber hereditary optic neuropathy gene therapy clinical trial.

    Science.gov (United States)

    Koilkonda, Rajeshwari D; Yu, Hong; Chou, Tsung-Han; Feuer, William J; Ruggeri, Marco; Porciatti, Vittorio; Tse, David; Hauswirth, William W; Chiodo, Vince; Boye, Sanford L; Lewin, Alfred S; Neuringer, Martha; Renner, Lauren; Guy, John

    2014-04-01

    IMPORTANCE We developed a novel strategy for treatment of Leber hereditary optic neuropathy (LHON) caused by a mutation in the nicotinamide adenine dinucleotide dehydrogenase subunit IV (ND4) mitochondrial gene. OBJECTIVE To demonstrate the safety and effects of the gene therapy vector to be used in a proposed gene therapy clinical trial. DESIGN AND SETTING In a series of laboratory experiments, we modified the mitochondrial ND4 subunit of complex I in the nuclear genetic code for import into mitochondria. The protein was targeted into the organelle by agency of a targeting sequence (allotopic expression). The gene was packaged into adeno-associated viral vectors and then vitreally injected into rodent, nonhuman primate, and ex vivo human eyes that underwent testing for expression and integration by immunohistochemical analysis and blue native polyacrylamide gel electrophoresis. During serial follow-up, the animal eyes underwent fundus photography, optical coherence tomography, and multifocal or pattern electroretinography. We tested for rescue of visual loss in rodent eyes also injected with a mutant G11778A ND4 homologue responsible for most cases of LHON. EXPOSURE Ocular infection with recombinant adeno-associated viral vectors containing a wild-type allotopic human ND4 gene. MAIN OUTCOMES AND MEASURES Expression of human ND4 and rescue of optic neuropathy induced by mutant human ND4. RESULTS We found human ND4 expressed in almost all mouse retinal ganglion cells by 1 week after injection and ND4 integrated into the mouse complex I. In rodent eyes also injected with a mutant allotopic ND4, wild-type allotopic ND4 prevented defective adenosine triphosphate synthesis, suppressed visual loss, reduced apoptosis of retinal ganglion cells, and prevented demise of axons in the optic nerve. Injection of ND4 in the ex vivo human eye resulted in expression in most retinal ganglion cells. Primates undergoing vitreal injection with the ND4 test article and followed up for 3

  10. A Randomized Clinical Trial of Cognitive Enhancement Therapy for Adults with Autism Spectrum Disorders

    Science.gov (United States)

    2015-10-01

    of the neuroplastic effects of CET on brain function in support of cognitive enhancement in adult autism . Analyses of treatment effects to date...the need and potential for CET to be a significant treatment advance for verbal adults with autism . Importantly, improvements were found in daily life function and in brain circuitry supporting core abilities....This project is focused on conducting the first randomized-controlled trial of Cognitive Enhancement Therapy (CET) in 54 verbal adults with autism

  11. The implementation and evaluation of cognitive milieu therapy for dual diagnosis inpatients: A pragmatic clinical trial

    DEFF Research Database (Denmark)

    Lykke, Jørn; Oestrich, Irene; Austin, Stephen

    2010-01-01

    milieu therapy (CMT) among a group of dual diagnosis inpatients. CMT is an integrated treatment for both mental illness and substance abuse based on cognitive behavioral principles and carried out within a supportive inpatient environment. A convenience sample of dual diagnosis inpatients (N = 136......Dual diagnosis is chronic psychiatric condition involving serious mental illness and substance abuse. Experts recommend the integration of treatment for concurrent substance abuse and serious psychiatric problems. The following pragmatic trial examined the implementation and outcomes of cognitive...

  12. Chemotherapy and targeted therapy in advanced biliary tract carcinoma: a pooled analysis of clinical trials.

    Science.gov (United States)

    Eckel, Florian; Schmid, Roland M

    2014-01-01

    In biliary tract cancer, gemcitabine platinum (GP) doublet palliative chemotherapy is the current standard treatment. The aim of this study was to analyze recent trials, even those small and nonrandomized, and identify superior new regimens. Trials published in English between January 2000 and January 2014 were analyzed, as well as ASCO abstracts from 2010 to 2013. In total, 161 trials comprising 6,337 patients were analyzed. The pooled results of standard therapy GP (no fluoropyrimidine, F, or other drug) were as follows: the median response rate (RR), tumor control rate (TCR), time to tumor progression (TTP) and overall survival (OS) were 25.9 and 63.5%, and 5.3 and 9.5 months, respectively. GFP triplets as well as G-based chemotherapy plus targeted therapy were significantly superior to GP concerning tumor control (TCR, TTP) and OS, with no difference in RR. Triplet combinations of GFP as well as G-based chemotherapy with (predominantly EGFR) targeted therapy are most effective concerning tumor control and survival.

  13. Amiodarone: clinical trials.

    Science.gov (United States)

    Naccarelli, G V; Wolbrette, D L; Patel, H M; Luck, J C

    2000-01-01

    Amiodarone is an antiarrhythmic agent commonly used in the treatment of supraventricular and ventricular tachyarrhythmias. This article reviews the results and clinical implications of primary and secondary prevention trials in which amiodarone was used in one of the treatment arms. Key post-myocardial infarction primary prevention trials include the European Myocardial Infarct Amiodarone Trial (EMIAT) and the Canadian Amiodarone Myocardial Infarction Trial (CAMIAT), both of which demonstrated that amiodarone reduced arrhythmic but not overall mortality. In congestive heart failure patients, amiodarone was studied as a primary prevention strategy in two pivotal trials: Grupo de Estudio de la Sobrevida en la Insuficiencia Cardiac en Argentina (GESICA) and Amiodarone in Patients With Congestive Heart Failure and Asymptomatic Ventricular Arrhythmia (CHF-STAT). Amiodarone was associated with a neutral overall survival and a trend toward improved survival in nonischemic cardiomyopathy patients in CHF/STAT and improved survival in GESICA. In post-myocardial infarction patients with nonsustained ventricular tachycardia and a depressed ejection fraction, the Multicenter Automatic Defibrillator Implantation Trial (MADIT) demonstrated that implantable cardioverter-defibrillators (ICD) statistically improved survival compared to the antiarrhythmic drug arm, most of whose patients were taking amiodarone. In patients with histories of sustained ventricular tachycardia or ventricular fibrillation, the Cardiac Arrest Study in Seattle: Conventional Versus Amiodarone Drug Evaluation (CASCADE) trial demonstrated that empiric amiodarone lowered arrhythmic recurrence rates compared to other drugs guided by serial Holter or electrophysiologic studies. However, arrhythmic death rates were high in both treatment arms of the study. Several secondary prevention trials, including the Antiarrhythmics Versus Implantable Defibrillators Study (AVID), the Canadian Implantable Defibrillator Study

  14. Group Versus Individual Physical Therapy for Veterans With Knee Osteoarthritis: Randomized Clinical Trial.

    Science.gov (United States)

    Allen, Kelli D; Bongiorni, Dennis; Bosworth, Hayden B; Coffman, Cynthia J; Datta, Santanu K; Edelman, David; Hall, Katherine S; Lindquist, Jennifer H; Oddone, Eugene Z; Hoenig, Helen

    2016-05-01

    Efficient approaches are needed for delivering nonpharmacological interventions for management of knee osteoarthritis (OA). This trial compared group-based versus individual physical therapy interventions for management of knee OA. Three hundred twenty patients with knee OA at the VA Medical Center in Durham, North Carolina, (mean age=60 years, 88% male, 58% nonwhite) were randomly assigned to receive either the group intervention (group physical therapy; six 1-hour sessions, typically 8 participants per group) or the individual intervention (individual physical therapy; two 1-hour sessions). Both programs included instruction in home exercise, joint protection techniques, and individual physical therapist evaluation. The primary outcome measure was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC; range=0-96, higher scores indicate worse symptoms), measured at baseline, 12 weeks, and 24 weeks. The secondary outcome measure was the Short Physical Performance Battery (SPPB; range=0-12, higher scores indicate better performance), measured at baseline and 12 weeks. Linear mixed models assessed the difference in WOMAC scores between arms. At 12 weeks, WOMAC scores were 2.7 points lower in the group physical therapy arm compared with the individual physical therapy arm (95% confidence interval [CI]=-5.9, 0.5; P=.10), indicating no between-group difference. At 24 weeks, WOMAC scores were 1.3 points lower in the group physical therapy arm compared with the individual physical therapy arm (95% CI=-4.6, 2.0; P=.44), indicating no significant between-group difference. At 12 weeks, SPPB scores were 0.1 points lower in the group physical therapy arm compared with the individual physical therapy arm (95% CI=-0.5, 0.2; P=.53), indicating no difference between groups. This study was conducted in one VA medical center. Outcome assessors were blinded, but participants and physical therapists were not blinded. Group physical therapy was not more effective

  15. A systematic review of orthopaedic manual therapy randomized clinical trials quality.

    Science.gov (United States)

    Riley, Sean P; Swanson, Brian; Brismée, Jean-Michel; Sawyer, Steven F

    2016-12-01

    Study Design: Systematic review and meta-analysis. Objectives: To conduct a systematic review and meta-analysis of randomized clinical trials (RCTs) in the orthopaedic manual therapy (OMT) literature from January 2010 to June 2014 in order to determine if the CONSORT checklist and Cochrane Risk of Bias (RoB) assessment tools: (1) are reliable; (2) have improved the reporting and decreased the risk of bias in RCTs in the OMT literature; (3) differ based on journal impact factor (JIF); and (4) scores are associated with each other. Background: The CONSORT statement is used to improve the accuracy of reporting within RCTs. The Cochrane RoB tool was designed to assess the risk of bias within RCTs. To date, no evaluation of the quality of reporting and risk of bias in OMT RCTs has been published. Methods: Relevant RCTs were identified by a literature review from January 2010 to June 2014. The identified RCTs were assessed by two individual reviewers utilizing the 2010 CONSORT checklist and the RoB tool. Agreement and a mean composite total score for each tool were attained in order to determine if the CONSORT and RoB tools were reliable and varied by year and impact factor. Results: A total of 72 RCTs in the OMT literature were identified. A number of categories within the CONSORT and RoB tools demonstrated prevalence-adjusted bias-adjusted kappa (PABAK) scores of less than 0.20 and from 0.20 to 0.40. The total CONSORT and RoB scores were correlated to each other (r = 0.73; 95% CI 0.60 to 0.82; p < 0.0001). There were no statistically significant differences in CONSORT or RoB scores by year. There was a statistically significant correlation between both CONSORT scores and JIF (r = 0.64, 95% CI 0.47 to 0.76; p < 0.0001), and between RoB scores and JIF (r = 0.42, 95% confidence interval 0.21-0.60; p < 0.001). There was not a statistically significant correlation between JIF and year of publication. Conclusion: Our findings suggest that the CONSORT and RoB have

  16. A Randomized Clinical Trial of Cognitive-Behavioral Therapy and Applied Relaxation for Adults With Generalized Anxiety Disorder

    OpenAIRE

    Dugas, Michel J.; Brillon, Pascale; Savard, Pierre; Turcotte, Julie; Gaudet, Adrienne; Ladouceur, Robert; Leblanc, Renée; Gervais, Nicole J.

    2009-01-01

    This randomized clinical trial compared cognitive-behavioral therapy (CBT), applied relaxation (AR), and wait-list control (WL) in a sample of 65 adults with a primary diagnosis of generalized anxiety disorder (GAD). The CBT condition was based on the intolerance of uncertainty model of GAD, whereas the AR condition was based on general theories of anxiety. Both manualized treatments were administered over 12 weekly 1-hour sessions. Standardized clinician ratings and self-report questionnaire...

  17. Cognitive Function and Treatment Response in a Randomized Clinical Trial of Computer-Based Training in Cognitive-Behavioral Therapy

    OpenAIRE

    Carroll, Kathleen M.; Kiluk, Brian D.; Nich, Charla; Babuscio, Theresa A.; Brewer, Judson A.; Marc N. Potenza; Ball, Samuel A.; Martino, Steve; Rounsaville, Bruce J.; Lejuez, Carl W.

    2011-01-01

    Cognitive-behavioral therapy (CBT), because of its comparatively high level of cognitive demand, is likely to be challenging for substance users with limitations in cognitive function. However, it is not known whether computer-assisted versions of CBT will be particularly helpful (e.g., allowing individualized pace and repetition) or difficult (e.g., via complexity of computerized delivery) for such patients. In this secondary analysis of data collected from a randomized clinical trial evalua...

  18. A virtual clinical trial comparing static versus dynamic PET imaging in measuring response to breast cancer therapy

    Science.gov (United States)

    Wangerin, Kristen A.; Muzi, Mark; Peterson, Lanell M.; Linden, Hannah M.; Novakova, Alena; Mankoff, David A.; E Kinahan, Paul

    2017-05-01

    We developed a method to evaluate variations in the PET imaging process in order to characterize the relative ability of static and dynamic metrics to measure breast cancer response to therapy in a clinical trial setting. We performed a virtual clinical trial by generating 540 independent and identically distributed PET imaging study realizations for each of 22 original dynamic fluorodeoxyglucose (18F-FDG) breast cancer patient studies pre- and post-therapy. Each noise realization accounted for known sources of uncertainty in the imaging process, such as biological variability and SUV uptake time. Four definitions of SUV were analyzed, which were SUVmax, SUVmean, SUVpeak, and SUV50%. We performed a ROC analysis on the resulting SUV and kinetic parameter uncertainty distributions to assess the impact of the variability on the measurement capabilities of each metric. The kinetic macro parameter, K i , showed more variability than SUV (mean CV K i   =  17%, SUV  =  13%), but K i pre- and post-therapy distributions also showed increased separation compared to the SUV pre- and post-therapy distributions (mean normalized difference K i   =  0.54, SUV  =  0.27). For the patients who did not show perfect separation between the pre- and post-therapy parameter uncertainty distributions (ROC AUC  definitions and uptake time scenarios (p  <  0.05). For the patient cohort in this study, which is comprised of non-high-grade ER+  tumors, K i outperformed SUV in an ROC analysis of the parameter uncertainty distributions pre- and post-therapy. This methodology can be applied to different scenarios with the ability to inform the design of clinical trials using PET imaging.

  19. Association of clinical trial enrollment and survival using contemporary therapy for pediatric acute lymphoblastic leukemia.

    Science.gov (United States)

    Moke, Diana J; Oberley, Matthew J; Bhojwani, Deepa; Parekh, Chintan; Orgel, Etan

    2018-02-01

    While early studies reported superior survival for cancer patients enrolled on clinical trials, recent findings are inconclusive. We investigated the association between enrollment on contemporary trials and event-free survival (EFS) in pediatric B-cell acute lymphoblastic leukemia (B-ALL). In a retrospective cohort of 274 children (1-21 years) treated for B-ALL from 2008 to 2015, 55.5% enrolled with no disparity in enrollment by age, sex, or ethnicity. Three-year EFS was similar for enrolled and not enrolled patients (90.1% [95% CI, 82.5-94.5] versus 86.5% [95% CI, 77.7-92.0]). Clinical trial enrollment did not affect pediatric B-ALL survival, albeit in a limited-size cohort treated at a single academic institution. © 2017 Wiley Periodicals, Inc.

  20. Clinical Trials

    Medline Plus

    Full Text Available ... preexisting differences between the patients. Usually, a computer program makes the group assignments. Masking The term "masking" ... Range of Audiences The Children and Clinical Studies Program has been successfully developed and evaluated to fill ...

  1. Clinical Trials

    Medline Plus

    Full Text Available ... the strategy or treatment is having harmful effects. Food and Drug Administration In the United States, the Food and Drug Administration (FDA) provides oversight for clinical ...

  2. Clinical Trials

    Medline Plus

    Full Text Available ... and devices specific to children. Resources for a Wide Range of Audiences The Children and Clinical Studies ... have not only shaped medical practice around the world, but have improved the health of millions of ...

  3. Clinical Trials

    Medline Plus

    Full Text Available ... works well in the lab or animals doesn't always work well in people. Thus, research in ... Clinical research is done only if doctors don't know whether a new approach works well in ...

  4. Timed Light Therapy for Sleep and Daytime Sleepiness Associated With Parkinson Disease: A Randomized Clinical Trial.

    Science.gov (United States)

    Videnovic, Aleksandar; Klerman, Elizabeth B; Wang, Wei; Marconi, Angelica; Kuhta, Teresa; Zee, Phyllis C

    2017-04-01

    Impaired sleep and alertness are some of the most common nonmotor manifestations of Parkinson disease (PD) and currently have only limited treatment options. Light therapy (LT), a widely available treatment modality in sleep medicine, has not been systematically studied in the PD population. To determine the safety and efficacy of LT on excessive daytime sleepiness (EDS) associated with PD. This randomized, placebo-controlled, clinical intervention study was set in PD centers at Northwestern University and Rush University. Participants were 31 patients with PD receiving stable dopaminergic therapy with coexistent EDS, as assessed by an Epworth Sleepiness Scale score of 12 or greater, and without cognitive impairment or primary sleep disorder. Participants were randomized 1:1 to receive bright LT or dim-red LT (controlled condition) twice daily in 1-hour intervals for 14 days. This trial was conducted between March 1, 2007, and October 31, 2012. Data analysis of the intention-to-treat population was conducted from November 1, 2012, through April 30, 2016. The primary outcome measure was the change in the Epworth Sleepiness Scale score comparing the bright LT with the dim-red LT. Secondary outcome measures included the Pittsburgh Sleep Quality Index score, the Parkinson's Disease Sleep Scale score, the visual analog scale score for daytime sleepiness, and sleep log-derived and actigraphy-derived metrics. Among the 31 patients (13 males and 18 females; mean [SD] disease duration, 5.9 [3.6] years), bright LT resulted in significant improvements in EDS, as assessed by the Epworth Sleepiness Scale score (mean [SD], 15.81 [3.10] at baseline vs 11.19 [3.31] after the intervention). Both bright LT and dim-red LT were associated with improvements in sleep quality as captured by mean (SD) scores on the Pittsburg Sleep Quality Index (7.88 [4.11] at baseline vs 6.25 [4.27] after bright LT, and 8.87 [2.83] at baseline vs 7.33 [3.52] after dim-red LT) and the Parkinson's Disease

  5. Statistical significance versus clinical importance: trials on exercise therapy for chronic low back pain as example.

    NARCIS (Netherlands)

    van Tulder, M.W.; Malmivaara, A.; Hayden, J.; Koes, B.

    2007-01-01

    STUDY DESIGN. Critical appraisal of the literature. OBJECIVES. The objective of this study was to assess if results of back pain trials are statistically significant and clinically important. SUMMARY OF BACKGROUND DATA. There seems to be a discrepancy between conclusions reported by authors and

  6. The efficacy of herbal therapy on quality of life in patients with breast cancer: self-control clinical trial.

    Science.gov (United States)

    Wong, Lai Yi Eliza; Wong, Chun Kwok; Leung, Ping Chung; Lam, Wei Kei Christopher

    2010-07-21

    Mounting evidence indicates that herbal therapy is effective in alleviating anxiety, lessening cancer treatment-related side-effects, and facilitating rehabilitation. This is the first trial to examine the herbal therapy of combined yunzhi and danshen on quality of life among breast cancer patients. A multicenter, longitudinal, and self-control study was used. Eighty-two breast cancer patients were given combined yunzhi and danshen capsules for six months on a daily basis. Data collection including quality of life, vitality status and adverse effects were taken. Results showed a significant improvement in physical function, role-physical, role-emotion and health transition (P cancer patients. Therefore, herbal therapy has a potentially important role to play in managing psychological distress in cancer patients. This study also suggests that herbal therapy is clinically acceptable and can be used safely with breast cancer patients.

  7. [Randomized Controlled Clinical Trials of Eye-acupuncture Therapy for Patients with Post-stroke Insomnia].

    Science.gov (United States)

    Liu, Lu-Yang; Wang, Peng-Qin

    2017-02-25

    To observe the therapeutic effect of eye-acupuncture therapy for post-stroke insomnia. Sixty patients (45-70 years in age) with post-stroke insomnia were randomized into eye-acupuncture group and routine acupuncture (body acupuncture) group (30 cases in each). Patients of the eye-acupuncture group were treated by acupuncture stimulation of bilateral Shangjiao (Upper-energizer) and Xin (Heart) regions and those of the routine acupuncture group treated by acupuncture stimulation of Baihui (GV 20), Sishencong (EX-HN 1), Anmian (EX-HN 16), etc. After Deqi, the filiform needles were retained for 20 min, and the treatment in both groups was conducted once a day, with 15 days being one therapeutic course and 2 courses altogether. The Pittsburgh Sleep Quality Index (PSQI) including the subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, daytime dysfunction, and total PSQI score was used to evaluate the overall sleep quality. The clinical efficacy was assessed according to the "Guiding Principles of Clinical Trials for New Drugs of Traditional Chinese Medicine" formulated by Chinese Ministry of Health. Following the treatment, of the two 30 cases in the eye-and routine acupuncture groups, 21 and 9 experienced a marked improvement in their symptoms, 8 and 17 were effective, and 1 and 4 invalid, with the effective rate being 96.7% and 86.7%, respectively. The PSQI scores of the subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, daytime dysfunction, and the total PSQI score were all significantly decreased in comparison with pre-treatment in each group (Pacupuncture was markedly superior to those of routine acupuncture in reducing sleep latency, sleep disturbances and daytime dysfunction (Pefficiency and total PSQI score (P>0.05). Both eye-acupuncture and routine acupunture are effective in the treatment of post-stroke insomnia, and the eye-acupuncture is better than

  8. VEGF gene therapy for angiogenesis in refractory angina: phase I/II clinical trial.

    Science.gov (United States)

    Kalil, Renato A K; Salles, Felipe Borsu de; Giusti, Imarilde Inês; Rodrigues, Clarissa Garcia; Han, Sang Won; Sant'Anna, Roberto Tofani; Ludwig, Eduardo; Grossman, Gabriel; Prates, Paulo Roberto Lunardi; Sant'anna, João Ricardo Michelin; Teixeira Filho, Guaracy Fernandes; Nardi, Nance Beyer; Nesralla, Ivo Abrahão

    2010-01-01

    Safety, feasibility and early myocardial angiogenic effects evaluation of transthoracic intramyocardial phVEGF165 administration for refractory angina in no option patients. Cohort study, in which 13 patients with refractory angina under optimized clinical treatment where included, after cineangiograms had been evaluated and found unfeasible by surgeon and interventional cardiologist. Intramyocardial injections of 5 mL solution containing plasmidial VEGF165 where done over the ischemic area of myocardium identified by previous SPECT/Sestamibi scan. Evaluations included a SPECT scan, stress test, Minnesota QOL questionnaire and NYHA functional class and CCS angina class determinations. There were no deaths or new interventions during the study period. There were no significant variations in SPECT scans, QOL scores and stress tests results during medical treatment in the included patients. After the 3rd post operative month, there was improvement in SPECT segmental scores, SSS (18.38 ± 7.51 vs. 15.31 ± 7.29, P = 0.003) and SRS (11.92 ± 7.49 vs. 8.53 ± 6.68, P = 0.002). The ischemic area extension, however, had non-significant variation (23.38 ± 13.12% vs. 20.08 ± 13.88%, P = 0.1). Stress tests METs varied from 7.66 ± 4.47 pre to 10.29 ± 4.36 METs post-op (P = 0.08). QOL score improved from 48.23 ± 18.35 pre to 30.15 ± 20.13 post-op points (P = 0.02). NYHA class was 3.15 ± 0.38 pre vs. 1.77 ± 0.83 post-op (P = 0.001) and angina CCS class, 3.08 ± 0.64 vs. 1.77 ± 0.83 (P = 0.001). Intramyocardial VEGF165 therapy for refractory angina, in this small trial of no option patients, resulted feasible and safe. Early clinical and scintilographic data showed improvements in symptoms and myocardial perfusion, with regression of ischemia severity in treated areas.

  9. Clinical Trials

    Science.gov (United States)

    ... and her initial results. Nueva Esperanza Para Las Enfermedades Del Corazón 09/23/2014 Milena tuvo un ... Story 09/23/2014 Nueva Esperanza Para Las Enfermedades Del Corazón 09/23/2014 Children and Clinical ...

  10. Dialectical Behavior Therapy (DBT) Applied to College Students: A Randomized Clinical Trial

    Science.gov (United States)

    Pistorello, Jacqueline; Fruzzetti, Alan E.; MacLane, Chelsea; Gallop, Robert; Iverson, Katherine M.

    2012-01-01

    Objective: College counseling centers (CCCs) are increasingly being called upon to treat highly distressed students with complex clinical presentations. This study compared the effectiveness of Dialectical Behavior Therapy (DBT) for suicidal college students with an optimized control condition and analyzed baseline global functioning as a…

  11. Randomized controlled trial of oral vs intravenous therapy for the clinically diagnosed acute uncomplicated diverticulitis.

    LENUS (Irish Health Repository)

    Ridgway, P F

    2009-11-01

    Despite the high prevalence of hospitalization for left iliac fossa tenderness, there is a striking lack of randomized data available to guide therapy. The authors hypothesize that an oral antibiotic and fluids are not inferior to intravenous (IV) antibiotics and \\'bowel rest\\' in clinically diagnosed acute uncomplicated diverticulitis.

  12. Comparative Effectiveness of Initial Antiretroviral Therapy Regimens: ACTG 5095 and 5142 Clinical Trials Relative to ART-CC Cohort Study

    Science.gov (United States)

    Mugavero, Michael J.; May, Margaret; Ribaudo, Heather J.; Gulick, Roy M.; Riddler, Sharon A.; Haubrich, Richard; Napravnik, Sonia; Abgrall, Sophie; Phillips, Andrew; Harris, Ross; Gill, M. John; de Wolf, Frank; Hogg, Robert; Günthard, Huldrych F.; Chêne, Geneviève; D'Arminio Monforte, Antonella; Guest, Jodie L.; Smith, Colette; Murillas, Javier; Berenguer, Juan; Wyen, Christoph; Domingo, Pere; Kitahata, Mari M.; Sterne, Jonathan A. C.; Saag, Michael S.

    2011-01-01

    Background The generalizability of antiretroviral therapy (ART) clinical trial efficacy findings to routine care settings is not well studied. We compared the relative effectiveness of initial ART regimens estimated in AIDS Clinical Trial Group (ACTG) randomized controlled trials with that among patients receiving ART at Antiretroviral Therapy Cohort Collaboration (ART-CC) study sites. Methods Treatment-naive HIV-infected patients initiating identical ART regimens in ACTG trials (A5095 and A5142) and at 15 ART-CC cohort study sites were included. Virological failure (HIV-1 RNA >200 copies/ml) at 24- and 48-weeks, incident AIDS-defining events and mortality were measured according to study design (ART-CC cohort vs. ACTG trial) and stratified by 3rd drug [Abacavir (ABC), Efavirenz (EFV), and Lopinavir/r (LPV/r)]. We used logistic regression to estimate and compare odds ratios for virological failure between different regimens and study designs, and used Cox models to estimate and compare hazard ratios for AIDS and death. Results Compared with patients receiving ABC, those receiving EFV had roughly half the odds of 24-week virologic failure (>200 copies/mL) in both ACTG 5095 (OR=0.53, 95% CI 0.36–0.79) and ART-CC (0.46, 0.37–0.57). Virologic superiority of EFV (vs. ABC) appeared comparable in ART-CC and ACTG 5095 (ratio of ORs 0.86, 95% CI 0.54–1.35). Odds ratios for 48-week virologic failure, comparing EFV with LPV/r, were also comparable in ACTG 5142 and ART-CC (ratio of ORs 0.87, 0.45–1.69). Conclusions Between ART regimen virologic efficacy of 3rd drugs ABC, EFV, and LPV/r observed in the ACTG 5095 and 5142 trials appear generalizable to the routine care setting of ART-CC clinical cohorts. PMID:21857357

  13. From first class to third class: recent upheaval in antiarrhythmic therapy--lessons from clinical trials.

    Science.gov (United States)

    Lazzara, R

    1996-08-29

    In recent years, the results of large randomized and controlled trials of antiarrhythmic agents for primary and secondary prevention of ventricular tachycardia and ventricular fibrillation have changed perceptions of the actions of antiarrhythmic agents regarding both efficacy and risk. The premature termination of the CAST trials of primary prevention in postinfarct patients highlighted the proarrhythmic risk and inefficacy of the sodium channel blockers (class I action), encainide, flecainide, and moricizine, in patients at relatively low risk for death in the long term. The excess mortality with therapy was attributed to proarrhythmia due to facilitation of reentry, especially during acute ischemia. About the same time, European trials with amiodarone, a complex agent with antiadrenergic action and powerful action to prolong refractoriness (class III action), indicated enhanced survival after infarction with amiodarone but not with agents with class I action. Recent verbal reports of larger and placebo-controlled trials (EMIAT and CAM-IAT) confirm a significant reduction in arrhythmia mortality, possibly with a favorable trend in total mortality. While an older trial with dl-sotalol (class III and beta-blocking actions) showed a trend toward improved survival after infarction, a recent trial with d-sotalol in patients with recent infarction or remote infarction and heart failure was prematurely terminated because of excess mortality attributed to proarrhythmia (torsades de pointes), indicating the importance of beta-blocking properties of a class III agent. A secondary prevention trial (ESVEM) in patients surviving an episode of VT or VF showed significant superiority of dl-sotalol compared to an array of agents that block sodium channels with respect to both efficacy and tolerance. Occurrence rates of arrhythmias treated with drugs tested for efficacy either by suppression of inducible arrhythmias or by suppression of spontaneous ectopy were higher and

  14. Efficacy of a specific model for cognitive-behavioral therapy among panic disorder patients with agoraphobia: a randomized clinical trial.

    Science.gov (United States)

    King, Anna Lucia Spear; Valença, Alexandre Martins; de Melo-Neto, Valfrido Leão; Freire, Rafael Christophe; Mezzasalma, Marco André; Silva, Adriana Cardoso de Oliveira e; Nardi, Antonio Egidio

    2011-01-01

    Cognitive-behavioral therapy is frequently indicated for panic disorder. The aim here was to evaluate the efficacy of a model for cognitive-behavioral therapy for treating panic disorder with agoraphobia. Randomized clinical trial at Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro. A group of 50 patients with a diagnosis of panic disorder with agoraphobia was randomized into two groups to receive: a) cognitive-behavioral therapy with medication; or b) medication (tricyclic antidepressants or selective serotonin reuptake inhibitors). Although there was no difference between the groups after the treatment in relation to almost all variables with the exception of some items of the Sheehan disability scale and the psychosocial and environmental problems scale, the patients who received the specific therapy presented significant reductions in panic attacks, anticipatory anxiety, agoraphobia avoidance and fear of body sensations at the end of the study, in relation to the group without the therapy. On the overall functioning assessment scale, overall wellbeing increased from 60.8% to 72.5% among the patients in the group with therapy, thus differing from the group without therapy. Although both groups responded to the treatment and improved, we only observed significant differences between the interventions on some scales. The association between specific cognitive-behavioral therapy focusing on somatic complaints and pharmacological treatment was effective among this sample of patients with panic disorder and the response was similar in the group with pharmacological treatment alone.

  15. Efficacy of a specific model for cognitive-behavioral therapy among panic disorder patients with agoraphobia: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Anna Lucia Spear King

    Full Text Available CONTEXT AND OBJECTIVE: Cognitive-behavioral therapy is frequently indicated for panic disorder. The aim here was to evaluate the efficacy of a model for cognitive-behavioral therapy for treating panic disorder with agoraphobia. DESIGN AND SETTING: Randomized clinical trial at Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro. METHODS: A group of 50 patients with a diagnosis of panic disorder with agoraphobia was randomized into two groups to receive: a cognitive-behavioral therapy with medication; or b medication (tricyclic antidepressants or selective serotonin reuptake inhibitors. RESULTS: Although there was no difference between the groups after the treatment in relation to almost all variables with the exception of some items of the Sheehan disability scale and the psychosocial and environmental problems scale, the patients who received the specific therapy presented significant reductions in panic attacks, anticipatory anxiety, agoraphobia avoidance and fear of body sensations at the end of the study, in relation to the group without the therapy. On the overall functioning assessment scale, overall wellbeing increased from 60.8% to 72.5% among the patients in the group with therapy, thus differing from the group without therapy. CONCLUSION: Although both groups responded to the treatment and improved, we only observed significant differences between the interventions on some scales. The association between specific cognitive-behavioral therapy focusing on somatic complaints and pharmacological treatment was effective among this sample of patients with panic disorder and the response was similar in the group with pharmacological treatment alone.

  16. Adapting preclinical concepts for use in clinical trials of serosal and interstitial photodynamic therapy.

    Science.gov (United States)

    Cengel, Keith

    2012-10-01

    Photodynamic therapy (PDT) requires an optimal combination of drug and light. To achieve the ideal conditions, a tight bond between the research laboratory and the clinic is essential. This continual 2-way street allows preclinical ideas and concepts to be tested in the clinic and refinements in technique to be made. This article clearly illustrates the close connection between the bench and the bedside, exploring intraoperative pleural PDT, challenges in matching fluence and photosensitizer, improvements in animal models that lead to adjustments in the operating room, and clinical applications for interstitial PDT in prostate cancer and beyond.

  17. A systematic review and meta-analysis of clinical trials of mesenchymal stem cell therapy for cartilage repair.

    Science.gov (United States)

    Borakati, A; Mafi, Reza; Mafi, P; Khan, Wasim

    2017-09-15

    Osteoarthritis (OA) is a major global burden creating significant morbidity worldwide. Current curative therapies are expensive, challenging to access and have significant risks, making them infeasible and difficult in many cases. Mesenchymal stem cells (MSCs) can be applied to joints and may regenerate the cartilage damaged in OA, this therapy may be advantageous to existing treatments. We systematically reviewed clinical trials of MSCs for cartilage repair and provide an overview of the literature in this area here. MEDLINE, Embase, CENTRAL, clinicaltrials.gov and OpenGrey were searched for controlled trials and case series with >5 patents involving MSC therapy for cartilage repair. The controlled trials were meta-analysed and the primary outcome measure was improvement in pain over the control group. A narrative synthesis was composed for the case series. A significant reduction in pain was found with the use of MSCs over controls: Standardised mean difference= -1.27 (95% Confidence intervals -1.95 to -0.58). However, the data was extremely heterogeneous with I2=95%, this may be attributed to differing therapies, clinical indication for treatment and joints treated amongst others. Case series showed improvements in treated patients with a variety of differing treatments and by many outcomes. There were no severe adverse outcomes found across all studies that could be attributed to MSCs, implying their safety. We conclude that MSCs have significant potential for the treatment of OA, however, larger, more consistent trials are needed for conclusive analysis. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  18. Efficacy of Cellular Therapy for Diabetic Foot Ulcer: A Meta-Analysis of Randomized Controlled Clinical Trials.

    Science.gov (United States)

    Zhang, Ye; Deng, Hong; Tang, Zhouping

    2017-12-01

    Diabetes mellitus is a widely spread chronic disease with growing incidence worldwide, and diabetic foot ulcer is one of the most serious complications of diabetes. Cellular therapy has shown promise in the management of diabetic foot ulcer in many preclinical experiments and clinical researches. Here, we performed a meta-analysis to evaluate the efficacy and safety of cellular therapy in the management of diabetic foot ulcer. We systematically searched PubMed, MEDLINE, EMBASE, and Cochrane Library databases from inception to May 2017 for randomized controlled trials assessing the efficacy of cellular therapy in diabetic foot ulcer, and a meta-analysis was conducted. A total of 6 randomized controlled clinical trials involving 241 individuals were included in this meta-analysis. The results suggested that cellular therapy could help accelerating the healing of diabetic foot ulcer, presented as higher ankle-brachial index (mean difference = 0.17, 95% confidence interval [CI] = 0.11 to 0.23), higher transcutaneous oxygen pressure (standardized mean difference [SMD] = 1.43; 95% CI, 1.09- to 1.78), higher ulcer healing rate (relative risk [RR] = 1.78; 95% CI, 1.41 to 2.25), higher amputation-free survival (RR = 1.25; 95% CI, 1.11 to 1.40), and lower scale of pain (SMD = -1.69; 95% CI, -2.05 to -1.33). Furthermore, cellular therapy seemed to be safe, with no serious complications and low risk of short-term slight complications. Cellular therapy could accelerate the rate of diabetic foot ulcer healing and may be more efficient than standard therapy for diabetic foot treatment.

  19. [PARAMOUNT trial: clinical meaning of continuous maintenance therapy in lung cancer].

    Science.gov (United States)

    Gridelli, Cesare

    2015-05-01

    Non-small cell lung cancer (NSCLC) remains one of the leading causes of cancer related deaths worldwide across both sex. Patients with Advanced -NSCLC (A-NSCLC) do not have curative treatment options, so the primary endpoint of every therapeutic decision aims to prolong survival, improving or maintain a good Quality of Life (QoL). Histology could represent a positive predictive factor for patients with Non squamous NSCLC (Nsq-NSCLC) respect to pemetrexed treatment. Pemetrexed is an antifolate that inhibits primarily thymidylate synthase (TS), together with dihydrofolate reductase and glycinamide ribonucleotide formyl transferase. Pemetrexed in combination with cisplatin is approved in the first line setting and as monotherapy in the switch or continuous maintenance of Non Squamous A-NSCLC. Maintenance therapy is a widely used therapeutic option in other solid and hematologic malignancies, but in the A-NSCLC represent an innovative approach. The rationale in this new setting of patients is based on the evidence that patients who benefit from an initial induction therapy platinum based may benefit from maintenance therapy with the third generation agent dropping the platinum drug after four to six cycles. We can define two types of maintenance therapy: continuation maintenance and switch maintenance. Major results in prolonging Overall Survival (OS) was reported with the continuation maintenance strategy as in the PARAMOUNT trial.

  20. Description of leprosy classification at baseline among patients enrolled at the uniform multidrug therapy clinical trial for leprosy patients in Brazil

    National Research Council Canada - National Science Library

    Moura, Rodrigo Scaliante; Penna, Gerson Oliveira; Cardoso, Ludimila Paula Vaz; de Andrade Pontes, Maria Araci; Cruz, Rossilene; de Sá Gonçalves, Heitor; Fernandes Penna, Maria Lúcia; de Araújo Stefani, Mariane Martins; Bührer-Sékula, Samira

    2015-01-01

    The uniform multidrug therapy clinical trial, Brazil (U-MDT/CT-BR), database was used to describe and report the performance of available tools to classify 830 leprosy patients as paucibacillary (PB...

  1. How Do Clinical Trials Work?

    Science.gov (United States)

    ... Back To Health Topics / About Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical ... is safe and effective for humans. What Are Clinical Trials? Clinical trials are research studies that explore whether ...

  2. Comparison of the Effect of Transdiagnostic Therapy and Cognitive-Behavior Therapy on Patients with Emotional Disorders: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Mozhgan Lotfi

    2014-08-01

    Full Text Available Background: Transdiagnostic cognitive-behavioral treatments for emotional disorders are a new approach that empirically supported. Despite this most of the researches in this field have no control group and so there is a little information about comparing of the effect of transdiagnostic approach to others. The current study was compared transdiagnostic with cognitive-behavior therapy on patients with depression and anxiety disorders. Materials and Methods: This study was a pretest-post test randomized control trial. A diagnostically heterogeneous clinical sample of 23 patients with a principal depression and anxiety disorders that randomly assigned in two groups and participated in eight sessions. Participants were recruited from clinical psychology and psychiatry clinics of Taleghani hospital, Tehran, Iran. Beck Depression Inventory (BDI-II, Beck Anxiety Inventory (BAI, and Quality of life Scale (IRQL were completed pre and post intervention by participants. The results were analyzed by dependent sample t-test and analyses of covariance (ANCOVA. Results: Data analyses showed that transdiagnostic therapy was effective for decreasing anxiety and depression symptoms, and have more effect for anxiety in comparing to cognitive-behavior therapy. Conclusion: Transdiagnostic therapy was confirmed in decreasing depressive and anxiety symptoms and improving quality of life in patients with depression and anxiety disorders and transdiagnostic therapy was more effective than cognitive-behavior therapy for decrease anxiety symptoms.

  3. Cognitive enhancement therapy for adult autism spectrum disorder: Results of an 18-month randomized clinical trial.

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    Eack, Shaun M; Hogarty, Susan S; Greenwald, Deborah P; Litschge, Maralee Y; Porton, Shannondora A; Mazefsky, Carla A; Minshew, Nancy J

    2017-12-29

    Cognitive remediation is a promising approach to treating core cognitive deficits in adults with autism, but rigorously controlled trials of comprehensive interventions that target both social and non-social cognition over a sufficient period of time to impact functioning are lacking. This study examined the efficacy of cognitive enhancement therapy (CET) for improving core cognitive and employment outcomes in adult autism. Verbal adult outpatients with autism spectrum disorder (N = 54) were randomized to an 18-month, single-blind trial of CET, a cognitive remediation approach that integrates computer-based neurocognitive training with group-based training in social cognition, or an active enriched supportive therapy (EST) comparison focused on psychoeducation and condition management. Primary outcomes were composite indexes of neurocognitive and social-cognitive change. Competitive employment was a secondary outcome. Intent-to-treat analyses indicated that CET produced significant differential increases in neurocognitive function relative to EST (d = .46, P = .013). Both CET and EST were associated with large social-cognitive improvements, with CET demonstrating an advantage at 9 (d = .58, P = 0.020), but not 18 months (d = .27, P = 0.298). Effects on employment indicated that participants treated with CET were significantly more likely to gain competitive employment than those in EST, OR = 6.21, P = 0.023, which was mediated by cognitive improvement. CET is a feasible and potentially effective treatment for core cognitive deficits in adult autism spectrum disorder. The treatment of cognitive impairments in this population can contribute to meaningful improvements in adult outcomes. Autism Res 2017. © 2017 International Society for Autism Research, Wiley Periodicals, Inc. Cognitive enhancement therapy (CET), an 18-month cognitive remediation intervention designed to improve thinking and social understanding, was found to be

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

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    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

  5. Acupuncture-movement therapy for acute lumbar sprain: a randomized controlled clinical trial.

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    Lin, Ruizhu; Zhu, Ning; Liu, Jian; Li, Xinjian; Wang, Yue; Zhang, Jie; Xi, Chaolei

    2016-02-01

    Several studies have reported that acupuncture is effective for treatment of acute lumbar sprain, but they neglected to consider that acupuncture cannot remarkably improve lumbar activity. We performed a randomized controlled trial to evaluate the effect of acupuncture-movement therapy versus conventional acupuncture in the treatment of acute lumbar sprain. Sixty patients were randomized into four groups: the acupuncture-movement (AM) group, sham acupuncture-movement (SAM) group, conventional acupuncture (CA) group, and physical therapy (PT) group. Patients in the AM group were treated with acupuncture at Yintang (EX-HN 3) and exercise of the lumbar region during acupuncture. Patients in the SAM group were treated with sham acupuncture at Yintang (EX-HN 3) and exercise of the lumbar region during sham acupuncture. Conventional acupuncture was performed in the CA group, and physical therapy was applied in the PT group. Each treatment lasted for 20 min. Patients were assessed before and after treatment using a visual analogue scale (VAS) and the Roland Morris Questionnaire (RMQ). The VAS and RMQ scores in the AM group were significantly lower after than before treatment (P lumbar sprain with a persistent pain-relief and remarkable improvement of lumbar activity. Movement, that is, lumbar exercise during acupuncture, enhances the effect of acupuncture.

  6. Comparison of 2 manual therapy and exercise protocols for cervical radiculopathy: a randomized clinical trial evaluating short-term effects.

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    Langevin, Pierre; Desmeules, François; Lamothe, Mélanie; Robitaille, Simon; Roy, Jean-Sébastien

    2015-01-01

    Participant- and assessor-blinded randomized clinical trial. To compare a rehabilitation program thought to increase the size of the intervertebral foramen (IVF) of the affected nerve root to a rehabilitation program that doesn't include any specific techniques thought to increase the size of the IVF in patients presenting with cervical radiculopathy (CR). Clinical approaches for the treatment of CR commonly include exercises and manual therapy techniques thought to increase the size of the IVF, but evidence regarding the effectiveness of these specific manual therapy techniques is scarce. Thirty-six participants with CR were randomly assigned either to a group that received a manual therapy and exercise program aimed at increasing the size of the IVF of the affected nerve root (experimental group, n=18) or to a group that received a manual therapy and exercise program without the specific goal of increasing the size of the IVF of the affected level and side (comparison group, n=18). Primary (Neck Disability Index) and secondary (shortened version of the Disabilities of the Arm, Shoulder and Hand questionnaire [QuickDASH] and numeric pain-rating scale) outcomes were evaluated at baseline, at the end of the 4-week program (week 4), and 4 weeks later (week 8). A mixed-model, 2-way analysis of variance was used to analyze treatment effects. No significant group-by-time interaction or group effect was observed for Neck Disability Index, QuickDASH, and numeric pain-rating scale scores (P≥.14) following the intervention. However, both groups showed statistically and clinically significant improvement from baseline to week 4 and to week 8 in Neck Disability Index, QuickDASH, and numeric pain-rating scale scores (Pmanual therapy and exercises are effective in reducing pain and functional limitations related to CR. The addition of techniques thought to increase the size of the IVF of the affected nerve root yielded no significant additional benefits. Given the absence of

  7. The effectiveness of mangosteen rind extract as additional therapy on chronic periodontitis (Clinical trials

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    Ina Hendiani

    2017-03-01

    Full Text Available ABSTRACT   Introduction: Periodontitis is an inflammatory disease that attacks the periodontal tissue comprises the gingiva, periodontal ligament, cementum and alveolar bone caused mainly by plaque bacteriophage or other specific dominant type of bacteria. The purpose of this study was to determine the therapeutic effect of clinical application of mangosteen peel extract gel as adjunctive therapy scaling and root planing in patients with chronic periodontitis. This research was expected to developed new treatment in the field of dentistry, particularly in periodontics, which can be used as supporting material for the treatment of chronic periodontitis. Methods: Quasi-experimental research, split mouth, with as many as 14 chronic periodontitis patients. Mangosteen rind was prepared to be formed into extract gel, dried at room temperature, then the dried samples were macerated by using ethanol, then evaporated and decanted for 3 days until obtained condensed extract. The samples were patients with chronic periodontitis in at least 2 teeth with pockets ≥ 5 mm. Clinical parameters of pocket depth, gingival bleeding, and clinical epithelial attachment level were measured at baseline and 1 month after treatment. Analysis of data using the t-test. Results: The comparison of average gap ratio of pockets depth, gingival index, gingival bleeding and epithelium attachment levels, before and after treatment showed significant differences, such as in the test and control sides. Conclusion: The mangosteen rind gel as adjunctive therapy for scaling and root planing is able to reduce pockets depth, gingival index, and gingival bleeding, and improve clinical epithelial attachment.

  8. Phase I clinical trial of fibronectin CH296-stimulated T cell therapy in patients with advanced cancer.

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    Takeshi Ishikawa

    Full Text Available BACKGROUND: Previous studies have demonstrated that less-differentiated T cells are ideal for adoptive T cell transfer therapy (ACT and that fibronectin CH296 (FN-CH296 together with anti-CD3 resulted in cultured cells that contain higher amounts of less-differentiated T cells. In this phase I clinical trial, we build on these prior results by assessing the safety and efficacy of FN-CH296 stimulated T cell therapy in patients with advanced cancer. METHODS: Patients underwent fibronectin CH296-stimulated T cell therapy up to six times every two weeks and the safety and antitumor activity of the ACT were assessed. In order to determine immune function, whole blood cytokine levels and the number of peripheral regulatory T cells were analyzed prior to ACT and during the follow up. RESULTS: Transferred cells contained numerous less-differentiated T cells greatly represented by CD27+CD45RA+ or CD28+CD45RA+ cell, which accounted for approximately 65% and 70% of the total, respectively. No ACT related severe or unexpected toxicities were observed. The response rate among patients was 22.2% and the disease control rate was 66.7%. CONCLUSIONS: The results obtained in this phase I trial, indicate that FN-CH296 stimulated T cell therapy was very well tolerated with a level of efficacy that is quite promising. We also surmise that expanding T cell using CH296 is a method that can be applied to other T- cell-based therapies. TRIAL REGISTRATION: UMIN UMIN000001835.

  9. Effectiveness of cognitive behavioural therapy in a community-based pulmonary rehabilitation programme: A controlled clinical trial.

    Science.gov (United States)

    Luk, Edwin K; Gorelik, Alexandra; Irving, Louis; Khan, Fary

    2017-03-06

    To investigate whether the use of cognitive behavioural therapy in pulmonary rehabilitation addresses the depression and anxiety burden and thereby improves rehabilitation outcomes. Prospective controlled clinical trial. A total of 70 patients with chronic obstructive pulmonary disease who were referred to a community centre for pulmonary rehabilitation. Patients were allocated to either the control group, consisting of pulmonary rehabilitation alone, or to the treatment group, receiving pulmonary rehabilitation and an additional 6 sessions of group-based cognitive behavioural therapy. Assessments consisting of questionnaires and walk tests were conducted pre- and post-pulmonary rehabilitation. A total of 28 patients were enrolled. The cognitive behavioural therapy group had significant improvements in exercise capacity following pulmonary rehabilitation (mean change 32.9 m, p = 0.043), which was maintained at 3 months post-pulmonary rehabilitation (mean change 23.4 m, p = 0.045). Patients in the cognitive behavioural therapy group showed significant short-term improvements in fatigue, stress and depression (mean change 2.4, p = 0.016, 3.9, p = 0.024 and 4.3, p = 0.047, respectively) and a 3-month post-pulmonary rehabilitation improvement in anxiety score (mean change 3.1, p = 0.01). No significant changes were seen in the control group. The addition of cognitive behavioural therapy improved patients' physical, psychological and quality of life results. Cognitive behavioural therapy should be considered for inclusion in a pulmonary rehabilitation programme to enhance outcomes.

  10. TU-G-BRB-01: Topic Introduction: Do We Need Clinical Trials in Particle Therapy and How Can Medical Physics Support Them?

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    Schulte, R. [Loma Linda Univ. (United States)

    2015-06-15

    Proton therapy, in particular, and ion therapy, just beginning, are becoming an increasing focus of attention in clinical radiation oncology and medical physics. Both modalities have been criticized of lacking convincing evidence from randomized trials proving their efficacy, justifying the higher costs involved in these therapies. This session will provide an overview of the current status of clinical trials in proton therapy, including recent developments in ion therapy. As alluded to in the introductory talk by Dr. Schulte, opinions are diverging widely as to the usefulness and need for clinical trials in particle therapy and the challenge of equipoise. The lectures will highlight some of the challenges that surround clinical trials in particle therapy. One, presented by Dr. Choy from UT Southwestern, is that new technology and even different types of particles such as helium and carbon ions are introduced into this environment, increasing the phase space of clinical variables. The other is the issue of medical physics quality assurance with physical phantoms, presented by Mrs. Taylor from IROC Houston, which is more challenging because 3D and 4D image guidance and active delivery techniques are in relatively early stages of development. The role of digital phantoms in developing clinical treatment planning protocols and as a QA tool will also be highlighted by Dr. Lee from NCI. The symposium will be rounded off by a panel discussion among the Symposium speakers, arguing pro or con the need and readiness for clinical trials in proton and ion therapy. Learning Objectives: To get an update on the current status of clinical trials allowing or mandating proton therapy. Learn about the status of planned clinical trials in the U.S. and worldwide involving ion therapy. Discuss the challenges in the design and QA of clinical trials in particle therapy. Learn about existing and future physical and computational anthropomorphic phantoms for charged particle clinical trial

  11. Directly administered antiretroviral therapy for HIV-infected individuals in opioid treatment programs: results from a randomized clinical trial.

    Directory of Open Access Journals (Sweden)

    Gregory M Lucas

    Full Text Available Data regarding the efficacy of directly administered antiretroviral therapy (DAART are mixed. Opioid treatment programs (OTPs provide a convenient framework for DAART. In a randomized controlled trial, we compared DAART and self-administered therapy (SAT among HIV-infected subjects attending five OTPs in Baltimore, MD.HIV-infected individuals attending OTPs were eligible if they were not taking antiretroviral therapy (ART or were virologically failing ART at last clinical assessment. In subjects assigned to DAART, we observed one ART dose per weekday at the OTP for up to 12 months. SAT subjects administered ART at home. The primary efficacy comparison was the between-arm difference in the average proportions with HIV RNA <50 copies/mL during the intervention phase (3-, 6-, and 12-month study visits, using a logistic regression model accounting for intra-person correlation due to repeated observations. Adherence was measured with electronic monitors in both arms.We randomized 55 and 52 subjects from five Baltimore OTPs to DAART and SAT, respectively. The average proportions with HIV RNA <50 copies/mL during the intervention phase were 0.51 in DAART and 0.40 in SAT (difference 0.11, 95% CI: -0.020 to 0.24. There were no significant differences between arms in electronically-measured adherence, average CD4 cell increase from baseline, average change in log10 HIV RNA from baseline, opportunistic conditions, hospitalizations, mortality, or the development of new drug resistance mutations.In this randomized trial, we found little evidence that DAART provided clinical benefits compared to SAT among HIV-infected subjects attending OTPs.ClinicalTrials.gov NCT00279110 NCT00279110?term = NCT00279110&rank = 1.

  12. The implementation and evaluation of cognitive milieu therapy for dual diagnosis inpatients: A pragmatic clinical trial

    DEFF Research Database (Denmark)

    Lykke, Jørn; Oestrich, I.; Austin, Stephen

    2010-01-01

    ) was assessed pre- and post-intervention from an inpatient setting where CMT was the mode of treatment. Psychopathology was measured using the Brief Psychiatric Rating Scale and substance abuse measured with the DrugCheck scale, breath/urine samples, and the Severity of Dependence Scale. Functioning......Dual diagnosis is chronic psychiatric condition involving serious mental illness and substance abuse. Experts recommend the integration of treatment for concurrent substance abuse and serious psychiatric problems. The following pragmatic trial examined the implementation and outcomes of cognitive...... milieu therapy (CMT) among a group of dual diagnosis inpatients. CMT is an integrated treatment for both mental illness and substance abuse based on cognitive behavioral principles and carried out within a supportive inpatient environment. A convenience sample of dual diagnosis inpatients (N = 136...

  13. Randomised clinical trial of manipulative therapy and physiotherapy for persistent back and neck complaints: results of one year follow up.

    Science.gov (United States)

    Koes, B W; Bouter, L M; van Mameren, H; Essers, A H; Verstegen, G M; Hofhuizen, D M; Houben, J P; Knipschild, P G

    1992-03-07

    To compare the effectiveness of manipulative therapy, physiotherapy, treatment by the general practitioner, and placebo therapy in patients with persistent non-specific back and neck complaints. Randomised clinical trial. Primary health care in the Netherlands. 256 patients with non-specific back and neck complaints of at least six weeks' duration who had not received physiotherapy or manipulative therapy in the past two years. At the discretion of the manipulative therapists, physiotherapists, and general practitioners. Physiotherapy consisted of exercises, massage, and physical therapy (heat, electrotherapy, ultrasound, shortwave diathermy). Manipulative therapy consisted of manipulation and mobilisation of the spine. Treatment by general practitioners consisted of drugs (for example, analgesics), advice about posture, home exercises, and (bed)rest. Placebo treatment consisted of detuned shortwave diathermy (10 minutes) and detuned ultrasound (10 minutes). Changes in severity of the main complaint and limitation of physical functioning measured on 10 point scales by a blinded research assistant and global perceived effect measured on a 6 point scale by the patients. Many patients in the general practitioner and placebo groups received other treatment during follow up. Improvement in the main complaint was larger with manipulative therapy (4.5) than with physiotherapy (3.8) after 12 months' follow up (difference 0.9; 95% confidence interval 0.1 to 1.7). Manipulative therapy also gave larger improvements in physical functioning (difference 0.6; -0.1 to 1.3). The global perceived effect after six and 12 months' follow up was similar for both treatments. Manipulative therapy and physiotherapy are better than general practitioner and placebo treatment. Furthermore, manipulative therapy is slightly better than physiotherapy after 12 months.

  14. Clinical trial methodology

    National Research Council Canada - National Science Library

    Peace, Karl E; Chen, Ding-Geng

    2011-01-01

    "Now viewed as its own scientific discipline, clinical trial methodology encompasses the methods required for the protection of participants in a clinical trial and the methods necessary to provide...

  15. Informed Consent (Clinical Trials)

    Science.gov (United States)

    ... Cancer Treatment Types of Cancer Treatment Side Effects Clinical Trials Information A to Z List of Cancer Drugs ... Staging Prognosis Treatment Types of Treatment Side Effects Clinical Trials Cancer Drugs Complementary & Alternative Medicine Coping Feelings & Cancer ...

  16. Research Areas - Clinical Trials

    Science.gov (United States)

    Information about NCI programs and initiatives that sponsor, conduct, develop, or support clinical trials, including NCI’s Clinical Trial Network (NCTN) and NCI Community Oncology Research Program (NCORP) initiatives.

  17. Cognitive function and treatment response in a randomized clinical trial of computer-based training in cognitive-behavioral therapy.

    Science.gov (United States)

    Carroll, Kathleen M; Kiluk, Brian D; Nich, Charla; Babuscio, Theresa A; Brewer, Judson A; Potenza, Marc N; Ball, Samuel A; Martino, Steve; Rounsaville, Bruce J; Lejuez, Carl W

    2011-01-01

    Cognitive-behavioral therapy (CBT), because of its comparatively high level of cognitive demand, is likely to be challenging for substance users with limitations in cognitive function. However, it is not known whether computer-assisted versions of CBT will be particularly helpful (e.g., allowing individualized pace and repetition) or difficult (e.g., via complexity of computerized delivery) for such patients. In this secondary analysis of data collected from a randomized clinical trial evaluating computer-assisted CBT, four aspects of cognitive functioning were evaluated among 77 participants. Those with higher levels of risk taking completed fewer sessions and homework assignments and had poorer substance use outcomes.

  18. A randomized clinical trial of cognitive behavioral therapy and interpersonal psychotherapy for panic disorder with agoraphobia.

    Science.gov (United States)

    Vos, S P F; Huibers, M J H; Diels, L; Arntz, A

    2012-12-01

    Interpersonal psychotherapy (IPT) seems to be as effective as cognitive behavioral therapy (CBT) in the treatment of major depression. Because the onset of panic attacks is often related to increased interpersonal life stress, IPT has the potential to also treat panic disorder. To date, a preliminary open trial yielded promising results but there have been no randomized controlled trials directly comparing CBT and IPT for panic disorder. This study aimed to directly compare the effects of CBT versus IPT for the treatment of panic disorder with agoraphobia. Ninety-one adult patients with a primary diagnosis of DSM-III or DSM-IV panic disorder with agoraphobia were randomized. Primary outcomes were panic attack frequency and an idiosyncratic behavioral test. Secondary outcomes were panic and agoraphobia severity, panic-related cognitions, interpersonal functioning and general psychopathology. Measures were taken at 0, 3 and 4 months (baseline, end of treatment and follow-up). Intention-to-treat (ITT) analyses on the primary outcomes indicated superior effects for CBT in treating panic disorder with agoraphobia. Per-protocol analyses emphasized the differences between treatments and yielded larger effect sizes. Reductions in the secondary outcomes were equal for both treatments, except for agoraphobic complaints and behavior and the credibility ratings of negative interpretations of bodily sensations, all of which decreased more in CBT. CBT is the preferred treatment for panic disorder with agoraphobia compared to IPT. Mechanisms of change should be investigated further, along with long-term outcomes.

  19. Recent Advances in Dipeptidyl-Peptidase-4 Inhibition Therapy: Lessons from the Bench and Clinical Trials

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    Jixin Zhong

    2015-01-01

    Full Text Available DPP4 inhibitors (DPP4i are a class of newly developed antidiabetic drugs which preserve incretin hormones and promote postprandial insulin secretion. Although the cardiovascular effect of DPP4 inhibition has been substantially studied, the exact role of DPP4 in cardiovascular disease especially in humans remains elusive. Previous small studies and meta-analyses have suggested a benefit in both surrogate outcomes and cardiovascular events for these agents. However, there was growing evidence in recent years questioning the cardioprotective effect of DPP4i. Further, a signal of heart failure hospitalization in a recent large scale clinical trial SAVOR-TIMI 53 has called into question the safety of these agents and their utility in the treatment of cardiovascular disease. In this review, we will revisit the physiologic function of DPP4 and discuss its role in cardiometabolic disease based on recent experimental and clinical studies.

  20. Effectiveness of manual therapy or pulsed shortwave diathermy in addition to advice and exercise for neck disorders: a pragmatic randomized controlled trial in physical therapy clinics.

    Science.gov (United States)

    Dziedzic, Krysia; Hill, Jonathan; Lewis, Martyn; Sim, Julius; Daniels, Jane; Hay, Elaine M

    2005-04-15

    To determine whether manual therapy or pulsed shortwave diathermy, in addition to advice and exercise, provide better clinical outcome at 6 months than advice and exercise alone in primary care patients with nonspecific neck disorders. This was a multicenter, 3-arm randomized controlled trial in 15 physical therapy departments. Of the 735 screened patients, 350 were recruited to the study (mean age 51 years) from July 2000 to June 2002. Participants were randomized to advice and exercise plus manual therapy, advice and exercise plus pulsed shortwave, or advice and exercise alone. Assessments were undertaken at baseline, 6 weeks, and 6 months. The primary outcome was the Northwick Park Neck Pain Questionnaire. Analysis was by intention to treat. Of the participants, 115 were allocated to advice and exercise, 114 to advice and exercise plus manual therapy, and 121 to advice and exercise plus pulsed shortwave; 98% received the allocated treatment. There was 93% followup at 6 months. The mean +/- SD fall in Northwick Park score at 6 months was 11.5 +/- 15.7 for advice and exercise alone, 10.2 +/- 14.1 for advice and exercise plus manual therapy, and 10.3 +/- 15.0 for advice and exercise plus pulsed shortwave. There were no statistically significant differences in mean changes between groups. The addition of pulsed shortwave or manual therapy to advice and exercise did not provide any additional benefits in the physical therapy treatment of neck disorders.

  1. Cognitive behavioural therapy versus supportive therapy for persistent positive symptoms in psychotic disorders: The POSITIVE Study, a multicenter, prospective, single-blind, randomised controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Sartory Gudrun

    2010-12-01

    Full Text Available Abstract Background It has been demonstrated that cognitive behavioural therapy (CBT has a moderate effect on symptom reduction and on general well being of patients suffering from psychosis. However, questions regarding the specific efficacy of CBT, the treatment safety, the cost-effectiveness, and the moderators and mediators of treatment effects are still a major issue. The major objective of this trial is to investigate whether CBT is specifically efficacious in reducing positive symptoms when compared with non-specific supportive therapy (ST which does not implement CBT-techniques but provides comparable therapeutic attention. Methods/Design The POSITIVE study is a multicenter, prospective, single-blind, parallel group, randomised clinical trial, comparing CBT and ST with respect to the efficacy in reducing positive symptoms in psychotic disorders. CBT as well as ST consist of 20 sessions altogether, 165 participants receiving CBT and 165 participants receiving ST. Major methodological aspects of the study are systematic recruitment, explicit inclusion criteria, reliability checks of assessments with control for rater shift, analysis by intention to treat, data management using remote data entry, measures of quality assurance (e.g. on-site monitoring with source data verification, regular query process, advanced statistical analysis, manualized treatment, checks of adherence and competence of therapists. Research relating the psychotherapy process with outcome, neurobiological research addressing basic questions of delusion formation using fMRI and neuropsychological assessment and treatment research investigating adaptations of CBT for adolescents is combined in this network. Problems of transfer into routine clinical care will be identified and addressed by a project focusing on cost efficiency. Discussion This clinical trial is part of efforts to intensify psychotherapy research in the field of psychosis in Germany, to contribute to the

  2. Value of Prophylactic Postoperative Antibiotic Therapy after Bimaxillary Orthognathic Surgery: A Clinical Trial

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    Majid Eshghpour

    2014-10-01

    Full Text Available Introduction: Antibiotic therapy before or after orthognathic surgery is commonly recommended by surgeons to minimize the risk of wound infection. This article evaluates the value of Prophylactic antibiotic therapy in order to diminish the incidence of postoperative wound infection after orthognathic surgery.   Materials and Methods: Fifty candidates for bimaxillary orthognathic surgery were divided into cases and controls. Cefazolin (1g was administered intravenously to all participants 30 mins prior to surgery followed by a similar dose 4 hours later. Case-group patients ingested amoxicillin (500 mg orally for 7 days after surgery. Postoperative wound infection was assessed using clinical features, and the P-value significance was set at P  Results: Both groups were similar according to gender, age, and operating time. During the follow-up period no infection was observed in either the case or control group.   Conclusion:  The results of this study suggest that long-term postoperative antibiotic therapy is not essential for the prevention of postoperative infection, and that application of aseptic surgical technique and hygiene instruction after surgery are sufficient.

  3. Immediate results of photodynamic therapy for the treatment of halitosis in adolescents: a randomized, controlled, clinical trial.

    Science.gov (United States)

    Lopes, Rubia Garcia; da Mota, Ana Carolina Costa; Soares, Carolina; Tarzia, Olinda; Deana, Alessandro Melo; Prates, Renato Araújo; França, Cristiane Miranda; Fernandes, Kristianne Porta Santos; Ferrari, Raquel Agnelli Mesquita; Bussadori, Sandra Kalil

    2016-01-01

    Light with or without chemical agents has been used to induce therapeutic and antimicrobial effects. With photodynamic therapy, the antimicrobial effect is confined to areas covered by a photosensitive dye and irradiated with light. The aim of the present study was to evaluate the effect of photodynamic therapy for the treatment of halitosis in adolescents through the analysis of volatile sulfur compounds, especially sulfide. A controlled, clinical trial was conducted with 45 adolescents randomly allocated to three groups: group 1, photodynamic therapy administered to the dorsum of the tongue; group 2, treatment with a tongue scraper; and group 3, treatment with a tongue scraper combined with photodynamic therapy. The diagnosis of halitosis was performed using gas chromatography before and after treatment. Comparisons were made using the Kruskal-Wallis test followed by the Student-Newman-Keuls test, with the level of significance set at 5 % (p halitosis was found in all groups (p halitosis in adolescents with an immediate effect that does not involve the mechanical aggression of the lingual papillae that occurs with conventional treatment. Photodynamic Therapy in Adolescents Halitosis ( https://clinicaltrials.gov/ct2/show/NCT02007993?term=NCT02007993&rank=1 )Number: NCT02007993FUNDING:FAPESPNumber: 2013/13032-8.

  4. Early report of randomized double blind clinical trial of hormonal therapy of carcinoma of prostate (CAP stage D2

    Directory of Open Access Journals (Sweden)

    Jagdeesh N Kulkarni

    2003-01-01

    Full Text Available Objectives: We herein report our experience of double blind randomized clinical trial comparing combined an-drogen blockade vs monotherapy in stage D2 CaP. Patients and Methods: Through June 1999 and May 2001, 100 patients of stage D2 CaP were randomized into placebo (44 and flutamide (42 group after orchiectomy in double blind fashion using the strictest criteria. All men and histological proof of CaP with bone metastasis dem-onstrated on imaging: bone scan and skeletal survey. These patients were further substratified according to number o f bony metastases into high volume disease (HVD>5 sites and low volume disease (LVD< 5 sites. The follow-up was at 3 month intervals. Criteria for decoding were clinical or serological progression and serious adverse effects. Results: Of the 100 patients recruited in the trial, 48 had HVD and 52 LVD. Treatmentwise they were almost equally distributed in flutamide group and placebo group. In the follow-up ranging front 6 to 24 months, 30 out of 100 patients (30% required decoding, reasons for decod-ing were progression of disease in 25 and serious adverse effects in remaining 5. These 25 patients were further analyzed according to treatment group, volume of metas-tasis pre -orchiectomy PSA and Gleason score. We observed that number of bony metastases had impact over the dura-tion of response to hormonal therapy. Discussion: We initiated this simple trial to address the issue of benefit of total androgen blockade over monotherapy in Indian population. In the initial analysis, we observed that treatment group did not make any impact over the response. While subset of prostate cancer with large number of bony metastases has higher propensity to convert into hormone refractory cancer Conclusions: Addition of flutamide did not provide ben-efit. We observed that large number of bony metastases had poor response to hormonal therapy, hence it requires large trial to substantiate this initial observation.

  5. Planning an Academic Clinical Trial.

    Science.gov (United States)

    Champion, Kim M; Jones, Gemma R

    2015-01-01

    Clinical trials are performed to discover or verify the efficacy and safety of one or more investigational medicinal product (IMP). Biological medicinal products, including gene therapies, offer groundbreaking new opportunities for the treatment of disease and injury, but they are also highly regulated and trials with these products can be logistically challenging to set up and execute. To ensure a compliant and successful trial, it is important to know and understand the regulatory framework, and to be aware of available guidance documents published to advise the different stakeholders on how to develop, manufacture, handle, administer, or destroy these products safely and legally. This chapter summarizes the standard requirements and considerations applicable for clinical trials with IMPs and also describes additional requirements for trials with gene therapies or genetically modified microorganisms (GMM).This chapter has been written from the perspective of a UK noncommercial (academic) sponsor. As such, the discussion and guidance has its basis in gene therapy research as governed by UK law. Nevertheless, European legislation and guidance documents are also referenced; most of the following recommendations will be applicable to clinical trials with a gene therapy medicinal product in any European Member State, and the overriding principles would be applicable to any trial.

  6. Transcranial laser therapy in acute stroke treatment: results of neurothera effectiveness and safety trial 3, a phase III clinical end point device trial.

    Science.gov (United States)

    Hacke, Werner; Schellinger, Peter D; Albers, Gregory W; Bornstein, Natan M; Dahlof, Bjorn L; Fulton, Rachael; Kasner, Scott E; Shuaib, Ashfaq; Richieri, Steven P; Dilly, Stephen G; Zivin, Justin; Lees, Kennedy R

    2014-11-01

    On the basis of phase II trials, we considered that transcranial laser therapy could have neuroprotective effects in patients with acute ischemic stroke. We studied transcranial laser therapy in a double-blind, sham-controlled randomized clinical trial intended to enroll 1000 patients with acute ischemic stroke treated ≤24 hours after stroke onset and who did not undergo thrombolytic therapy. The primary efficacy measure was the 90-day functional outcome as assessed by the modified Rankin Scale, with hierarchical Bayesian analysis incorporating relevant previous data. Interim analyses were planned after 300 and 600 patients included. The study was terminated on recommendation by the Data Monitoring Committee after a futility analysis of 566 completed patients found no difference in the primary end point (transcranial laser therapy 140/282 [49.6%] versus sham 140/284 [49.3%] for good functional outcome; modified Rankin Scale, 0-2). The results remained stable after inclusion of all 630 randomized patients (adjusted odds ratio, 1.024; 95% confidence interval, 0.705-1.488). Once the results of the interim futility analysis became available, all study support was immediately withdrawn by the capital firms behind PhotoThera, and the company was dissolved. Proper termination of the trial was difficult but was finally achieved through special efforts by former employees of PhotoThera, the CRO Parexel and members of the steering and the safety committees. We conclude that transcranial laser therapy does not have a measurable neuroprotective effect in patients with acute ischemic stroke when applied within 24 hours after stroke onset. http://www.clinicaltrials.gov. Unique identifier: NCT01120301. © 2014 American Heart Association, Inc.

  7. Effects of music therapy on anxiety of patients with breast cancer after radical mastectomy: a randomized clinical trial.

    Science.gov (United States)

    Li, Xiao-Mei; Zhou, Kai-Na; Yan, Hong; Wang, Duo-Lao; Zhang, Yin-Ping

    2012-05-01

      This paper is a report of a clinical trial of the effects of music therapy on anxiety of female breast cancer patients following radical mastectomy.   There is insufficient evidence on the effects of music therapy on state anxiety of breast cancer patients following radical mastectomy.   A Hall's Core, Care, and Cure Model-based clinical trial was conducted in 120 female breast cancer patients from March to November 2009. A randomized controlled design was utilized. The patients were randomly allocated to the experimental group (n = 60) received music therapy in addition to routine nursing care, and the control group (n = 60) only received routine nursing care. A standardized questionnaire and the State Anxiety Inventory were applied. The primary endpoint was the state anxiety score measured at pretest (on the day before radical mastectomy) and at three post-tests (on the day before patients were discharged from hospital, the second and third time of admission to hospital for chemotherapy respectively).   The pretest score revealed that the majority of the patients had a moderate level (77·5%) and 15% had severe level of state anxiety. The repeated-measure ancova model analysis indicated that the mean state anxiety score was significantly lower in the experimental group than those in the control group at each of the three post-test measurements. The mean difference between the experimental and control group together with 95% confidence intervals were -4·57 (-6·33, -2·82), -8·91 (-10·75, -7·08) and -9·69 (-11·52, -7·85) at the 1st post-test, 2nd post-test and 3rd post-test respectively.   Music therapy is found to have positive effects on decreasing state anxiety score. © 2011 The Authors. Journal of Advanced Nursing © 2011 Blackwell Publishing Ltd.

  8. Effect of Prolonged Exposure Therapy Delivered Over 2 Weeks vs 8 Weeks vs Present-Centered Therapy on PTSD Symptom Severity in Military Personnel: A Randomized Clinical Trial.

    Science.gov (United States)

    Foa, Edna B; McLean, Carmen P; Zang, Yinyin; Rosenfield, David; Yadin, Elna; Yarvis, Jeffrey S; Mintz, Jim; Young-McCaughan, Stacey; Borah, Elisa V; Dondanville, Katherine A; Fina, Brooke A; Hall-Clark, Brittany N; Lichner, Tracey; Litz, Brett T; Roache, John; Wright, Edward C; Peterson, Alan L

    2018-01-23

    Effective and efficient treatment is needed for posttraumatic stress disorder (PTSD) in active duty military personnel. To examine the effects of massed prolonged exposure therapy (massed therapy), spaced prolonged exposure therapy (spaced therapy), present-centered therapy (PCT), and a minimal-contact control (MCC) on PTSD severity. Randomized clinical trial conducted at Fort Hood, Texas, from January 2011 through July 2016 and enrolling 370 military personnel with PTSD who had returned from Iraq, Afghanistan, or both. Final follow-up was July 11, 2016. Prolonged exposure therapy, cognitive behavioral therapy involving exposure to trauma memories/reminders, administered as massed therapy (n = 110; 10 sessions over 2 weeks) or spaced therapy (n = 109; 10 sessions over 8 weeks); PCT, a non-trauma-focused therapy involving identifying/discussing daily stressors (n = 107; 10 sessions over 8 weeks); or MCC, telephone calls from therapists (n = 40; once weekly for 4 weeks). Outcomes were assessed before and after treatment and at 2-week, 12-week, and 6-month follow-up. Primary outcome was interviewer-assessed PTSD symptom severity, measured by the PTSD Symptom Scale-Interview (PSS-I; range, 0-51; higher scores indicate greater PTSD severity; MCID, 3.18), used to assess efficacy of massed therapy at 2 weeks posttreatment vs MCC at week 4; noninferiority of massed therapy vs spaced therapy at 2 weeks and 12 weeks posttreatment (noninferiority margin, 50% [2.3 points on PSS-I, with 1-sided α = .05]); and efficacy of spaced therapy vs PCT at posttreatment. Among 370 randomized participants, data were analyzed for 366 (mean age, 32.7 [SD, 7.3] years; 44 women [12.0%]; mean baseline PSS-I score, 25.49 [6.36]), and 216 (59.0%) completed the study. At 2 weeks posttreatment, mean PSS-I score was 17.62 (mean decrease from baseline, 7.13) for massed therapy and 21.41 (mean decrease, 3.43) for MCC (difference in decrease, 3.70 [95% CI,0.72 to 6.68]; P = .02

  9. Automated Text Messaging as an Adjunct to Cognitive Behavioral Therapy for Depression: A Clinical Trial.

    Science.gov (United States)

    Aguilera, Adrian; Bruehlman-Senecal, Emma; Demasi, Orianna; Avila, Patricia

    2017-05-08

    Cognitive Behavioral Therapy (CBT) for depression is efficacious, but effectiveness is limited when implemented in low-income settings due to engagement difficulties including nonadherence with skill-building homework and early discontinuation of treatment. Automated messaging can be used in clinical settings to increase dosage of depression treatment and encourage sustained engagement with psychotherapy. The aim of this study was to test whether a text messaging adjunct (mood monitoring text messages, treatment-related text messages, and a clinician dashboard to display patient data) increases engagement and improves clinical outcomes in a group CBT treatment for depression. Specifically, we aim to assess whether the text messaging adjunct led to an increase in group therapy sessions attended, an increase in duration of therapy attended, and reductions in Patient Health Questionnaire-9 item (PHQ-9) symptoms compared with the control condition of standard group CBT in a sample of low-income Spanish speaking Latino patients. Patients in an outpatient behavioral health clinic were assigned to standard group CBT for depression (control condition; n=40) or the same treatment with the addition of a text messaging adjunct (n=45). The adjunct consisted of a daily mood monitoring message, a daily message reiterating the theme of that week's content, and medication and appointment reminders. Mood data and qualitative responses were sent to a Web-based platform (HealthySMS) for review by the therapist and displayed in session as a tool for teaching CBT skills. Intent-to-treat analyses on therapy attendance during 16 sessions of weekly therapy found that patients assigned to the text messaging adjunct stayed in therapy significantly longer (median of 13.5 weeks before dropping out) than patients assigned to the control condition (median of 3 weeks before dropping out; Wilcoxon-Mann-Whitney z=-2.21, P=.03). Patients assigned to the text messaging adjunct also generally

  10. Randomized trial of nicotine replacement therapy (NRT), bupropion and NRT plus bupropion for smoking cessation: effectiveness in clinical practice

    Science.gov (United States)

    Stapleton, John; West, Robert; Hajek, Peter; Wheeler, Jenny; Vangeli, Eleni; Abdi, Zeinab; O’Gara, Colin; McRobbie, Hayden; Humphrey, Kirsty; Ali, Rachel; Strang, John; Sutherland, Gay

    2013-01-01

    Background and aims Bupropion was introduced for smoking cessation following a pivotal trial showing that it gave improved efficacy over the nicotine patch and also suggesting combination treatment was beneficial. We tested in clinical practice for an effectiveness difference between bupropion and nicotine replacement therapy (NRT), whether the combination improves effectiveness and whether either treatment might be more beneficial for certain subgroups of smokers. Design Open-label randomized controlled trial with 6-month follow-up. Setting Four UK National Health Service (NHS) smoking cessation clinics. Participants Smokers (n = 1071) received seven weekly behavioural support sessions and were randomized to an NRT product of their choice (n = 418), bupropion (n = 409) or NRT plus bupropion (n = 244). Measures The primary outcome was self-reported cessation over 6 months, with biochemical verification at 1 and 6 months. Also measured were baseline demographics, health history, smoking characteristics and unwanted events during treatment. Findings Abstinence rates for bupropion (27.9%) and NRT (24.2%) were not significantly different (odds ratio = 1.21, 95% confidence interval = 0.883–1.67), and the combination rate (24.2%) was similar to that for either treatment alone. There was some evidence that the relative effectiveness of bupropion and NRT differed according to depression (χ2 = 2.86, P = 0.091), with bupropion appearing more beneficial than NRT in those with a history of depression (29.8 versus 18.5%). Several unwanted symptoms were more common with bupropion. Conclusion There is no difference in smoking cessation effectiveness among bupropion, nicotine replacement therapy and their combination when used with behavioural support in clinical practice. There is some evidence that bupropion is more beneficial than nicotine replacement therapy for smokers with a history of depression. PMID:23859696

  11. Exercise, education, manual-therapy and taping compared to education for patellofemoral osteoarthritis: a blinded, randomised clinical trial.

    Science.gov (United States)

    Crossley, K M; Vicenzino, B; Lentzos, J; Schache, A G; Pandy, M G; Ozturk, H; Hinman, R S

    2015-09-01

    Patellofemoral joint osteoarthritis (PFJ OA) contributes considerably to knee OA symptoms. This study aimed to determine the efficacy of a PFJ-targeted exercise, education manual-therapy and taping program compared to OA education alone, in participants with PFJ OA. A randomised, participant-blinded and assessor-blinded clinical trial was conducted in primary-care physiotherapy. 92 people aged ≥40 years with symptomatic and radiographic PFJ OA participated. Physiotherapists delivered the PFJ-targeted exercise, education, manual-therapy and taping program, or the OA-education (control condition) in eight sessions over 12 weeks. Primary outcomes at 3-month (primary) and 9-month follow-up: (1) patient-perceived global rating of change (2) pain visual analogue scale (VAS) (100 mm); and (3) activities of daily living (ADL) subscale of the Knee injury and Osteoarthritis Outcome Score (KOOS). 81 people (88%) completed the 3-month follow-up and data analysed on an intention-to-treat basis. Between-group baseline similarity for participant characteristics was observed. The exercise, education, manual-therapy and taping program resulted in more people reporting much improvement (20/44) than the OA-education group (5/48) (number needed to treat 3 (95% confidence interval (CI) 2 to 5)) and greater pain reduction (mean difference: -15.2 mm, 95% CI -27.0 to -3.4). No significant effects on ADL were observed (5.8; 95% CI -0.6 to 12.1). At 9 months there were no significant effects for self-report of improvement, pain (-10.5 mm, 95% CI -22.7 to 1.8) or ADL (3.0, 95% CI -3.7 to 9.7). Exercise, education, manual-therapy and taping can be recommended to improve short-term patient rating of change and pain severity. However over 9-months, both options were equivalent. Australian New Zealand Clinical Trials Registry (ACTRN12608000288325): https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=82878. Copyright © 2015 Osteoarthritis Research Society International. Published

  12. Randomized clinical trial of the effectiveness of complementary therapies for recurrent aphthous stomatitis.

    Science.gov (United States)

    Rodríguez-Archilla, Alberto; Raissouni, Tarik

    2017-07-21

    Despite the high prevalence of recurrent aphthous stomatitis (RAS), its etiology is not yet completely clear and there is no completely remedial treatment available at present. The objective of this study was to evaluate the clinical efficacy and safety of 4 treatments (silver nitrate, propolis, rhubarb and walnut) for RAS. A randomized clinical trial was conducted with 125 patients with minor aphthae, including 25 patients per group: cauterization with silver nitrate, propolis, rhubarb extract, walnut extract and placebo. No patient reported adverse effects related to the treatment received. There were significant (P<.001) differences in the time elapsed until symptom resolution. The fastest treatment was silver nitrate (1.16 days), followed by the 3 alternative treatments (1.60 days with propolis, 1.84 with rhubarb and 2.00 with walnut; with no differences between them), and finally the placebo (4.64 days). The mean healing time of the lesions was statistically higher (8.96 days) for the placebo than for the 4 treatments: silver nitrate (7.32 days), propolis (6.80), rhubarb (7.72) and walnut (8.00). Copyright © 2017 Elsevier España, S.L.U. All rights reserved.

  13. Comparing self-management of oral anticoagulant therapy with clinic management: a randomized trial.

    Science.gov (United States)

    Menéndez-Jándula, Bárbara; Souto, Juan Carlos; Oliver, Arturo; Montserrat, Isabel; Quintana, Mireia; Gich, Ignasi; Bonfill, Xavier; Fontcuberta, Jordi

    2005-01-04

    Control of oral anticoagulant treatment has been reported to be suboptimal, but previous studies suggest that patient self-management improves control. To compare the quality of control and the clinical outcomes of oral anticoagulant treatment in self-managed patients versus patients following conventional management. Randomized, controlled trial. University-affiliated hospital in Spain. 737 patients with indications for anticoagulant treatment. The self-management group (n = 368) received simple instructions for using a portable coagulometer weekly and self-adjusting treatment dose. The conventional management group (n = 369) received usual care in an anticoagulation clinic (monthly measurement and control of international normalized ratio [INR], managed by hematologists). Percentage of INR values within the target range and major related complications. The median follow-up period was 11.8 months (range, 0.3 to 16.9 months). The unadjusted percentages of in-range INRs were 58.6% in the self-management group and 55.6% in the conventional management group (difference, 3.0 percentage points [95% CI, 0.4 to 5.4 percentage points]). Twenty-seven patients (7.3%) in the conventional management group and 8 (2.2%) in the self-management group had major complications related to anticoagulant treatment. The unadjusted risk difference for major complications between groups was 5.1 percentage points (exact 95% CI, 1.7 to 8.5 percentage points). Fewer patients had minor hemorrhages in the self-management group (14.9%) than in the conventional management group (36.4%). Fifteen patients (4.1%) in the conventional management group and 6 (1.6%) in the self-management group died (unadjusted risk difference, 2.5 percentage points [exact 95% CI, 0.0 to 5.1 percentage points]). The trial was performed at only 1 center and was not blinded. The dropout rate in the intervention group was 21%. Compared with conventional management by an anticoagulation clinic, self-management of oral

  14. Two-year results of vital pulp therapy in permanent molars with irreversible pulpitis: an ongoing multicenter randomized clinical trial.

    Science.gov (United States)

    Asgary, Saeed; Eghbal, Mohammad Jafar; Ghoddusi, Jamileh

    2014-01-01

    Oral healthcare expenses are increasing rapidly as a result of the growth of high-cost health technologies worldwide. In many developing/developed countries, low-cost tooth extraction is the alternative treatment option for a high-cost root canal therapy (RCT) for management of human molars with irreversible pulpitis. Vital pulp therapy with calcium-enriched mixture cement (VPT/CEM) as a new alternative treatment option has demonstrated excellent treatment outcomes up to 1 year; if 2-year radiographic/clinical effectiveness as well as cost-effectiveness of the VPT/CEM is also non-inferior compared with RCT, it can serve as a viable treatment for mature molars with irreversible pulpitis. In this prospective, multicenter (n = 23), non-inferiority clinical trial, 407 patients were randomized to either one-visit RCT (n = 202) or VPT/CEM (n = 205) for 27 months. In this part of study, the primary outcome measure was the 2-year clinical and radiographic treatment outcomes. Cost-effectiveness was also analyzed. Mean follow-up times were 24.62 ± 0.72 and 24.61 ± 0.69 months in RCT (n = 166) and VPT/CEM (n = 166) arms, respectively. Clinical success rates in the two study arms were equal (98.19%); however, radiographic success rates were 79.5 and 86.7% in RCT and VPT/CEM arms, respectively, with no statistical difference (P = 0.053). The treatment time span mean was approximately three times greater in the RCT than in the VPT/CEM arm (94.07 vs. 31.09 min; P irreversible pulpitis. Vital pulp therapy with CEM is a cost-effective and reliable biological technique for endodontic treatment of permanent molar teeth with irreversible pulpitis and can be recommended for general clinical practice.

  15. Nabiximols combined with motivational enhancement/cognitive behavioral therapy for the treatment of cannabis dependence: A pilot randomized clinical trial.

    Directory of Open Access Journals (Sweden)

    Jose M Trigo

    Full Text Available The current lack of pharmacological treatments for cannabis use disorder (CUD warrants novel approaches and further investigation of promising pharmacotherapy. We previously showed that nabiximols (27 mg/ml Δ9-tetrahydrocannabinol (THC/ 25 mg/ml cannabidiol (CBD, Sativex® can decrease cannabis withdrawal symptoms. Here, we assessed in a pilot study the tolerability and safety of self-titrated nabiximols vs. placebo among 40 treatment-seeking cannabis-dependent participants.Subjects participated in a double blind randomized clinical trial, with as-needed nabiximols up to 113.4 mg THC/105 mg CBD or placebo daily for 12 weeks, concurrently with Motivational Enhancement Therapy and Cognitive Behavioral Therapy (MET/CBT. Primary outcome measures were tolerability and abstinence, secondary outcome measures were days and amount of cannabis use, withdrawal, and craving scores. Participants received up to CDN$ 855 in compensation for their time.Medication was well tolerated and no serious adverse events (SAEs were observed. Rates of adverse events did not differ between treatment arms (F1,39 = 0.205, NS. There was no significant change in abstinence rates at trial end. Participants were not able to differentiate between subjective effects associated with nabiximols or placebo treatments (F1,40 = 0.585, NS. Cannabis use was reduced in the nabiximols (70.5% and placebo groups (42.6%. Nabiximols reduced cannabis craving but no significant differences between the nabiximols and placebo groups were observed on withdrawal scores.Nabiximols in combination with MET/CBT was well tolerated and allowed for reduction of cannabis use. Future clinical trials should explore the potential of high doses of nabiximols for cannabis dependence.

  16. Hepatitis C: Clinical Trials

    Science.gov (United States)

    ... and Public Home » Hepatitis C » Treatment Decisions Viral Hepatitis Menu Menu Viral Hepatitis Viral Hepatitis Home For ... can I find out about participating in a hepatitis C clinical trial? Many trials are being conducted ...

  17. Characteristics and outcomes of breast cancer patients enrolled in the National Cancer Institute Cancer Therapy Evaluation Program sponsored phase I clinical trials.

    Science.gov (United States)

    Lynce, Filipa; Blackburn, Matthew J; Cai, Ling; Wang, Heping; Rubinstein, Larry; Harris, Pamela; Isaacs, Claudine; Pohlmann, Paula R

    2017-11-08

    Breast cancer (BC) is the most commonly diagnosed cancer and the second leading cause of cancer-related death among women. Given the availability of approved therapies and abundance of phase II and III clinical trials, historically few BC patients have been referred for consideration of participation on a phase I trial. We were interested in determining whether clinical benefit rates differed in patients with BC from other patients enrolled in phase I trials. We performed a retrospective analysis of all Cancer Therapy Evaluation Program (CTEP) sponsored phase I trials from 1993 to 2012. We report an analysis of demographic variables, rates of response to treatment, grade 4 toxicities, and treatment-related deaths. De-identified data from 8087 patients were analyzed, with 1,376 having a diagnosis of BC. The median time from initial cancer diagnosis to enrollment in a CTEP-sponsored phase I clinical trial was 614 days for all patients. Breast cancer patients were enrolled on average 790 days after initial diagnosis, while non-BC patients had a median enrollment time of 582 days (p enrolled on phase I clinical trials, BC patients tend to derive clinical benefit from these therapies with similar toxicity profile. This evidence further supports enrollment of BC patients on phase I trials.

  18. A randomized, controlled clinical trial: the effect of mindfulness-based cognitive therapy on generalized anxiety disorder among Chinese community patients: protocol for a randomized trial.

    Science.gov (United States)

    Wong, Samuel Y S; Mak, Winnie W S; Cheung, Eliza Y L; Ling, Candy Y M; Lui, Wacy W S; Tang, W K; Wong, Rebecca L P; Lo, Herman H M; Mercer, Stewart; Ma, Helen S W

    2011-11-29

    Research suggests that an eight-week Mindfulness-Based Cognitive Therapy (MBCT) program may be effective in the treatment of generalized anxiety disorders. Our objective is to compare the clinical effectiveness of the MBCT program with a psycho-education programme and usual care in reducing anxiety symptoms in people suffering from generalized anxiety disorder. A three armed randomized, controlled clinical trial including 9-month post-treatment follow-up is proposed. Participants screened positive using the Structure Clinical Interview for DSM-IV (SCID) for general anxiety disorder will be recruited from community-based clinics. 228 participants will be randomly allocated to the MBCT program plus usual care, psycho-education program plus usual care or the usual care group. Validated Chinese version of instruments measuring anxiety and worry symptoms, depression, quality of life and health service utilization will be used. Our primary end point is the change of anxiety and worry score (Beck Anxiety Inventory and Penn State Worry Scale) from baseline to the end of intervention. For primary analyses, treatment outcomes will be assessed by ANCOVA, with change in anxiety score as the baseline variable, while the baseline anxiety score and other baseline characteristics that significantly differ between groups will serve as covariates. This is a first randomized controlled trial that compare the effectiveness of MBCT with an active control, findings will advance current knowledge in the management of GAD and the way that group intervention can be delivered and inform future research. Unique Trail Number (assigned by Centre for Clinical Trails, Clinical Trials registry, The Chinese University of Hong Kong): CUHK_CCT00267.

  19. A randomized, controlled clinical trial: the effect of mindfulness-based cognitive therapy on generalized anxiety disorder among Chinese community patients: protocol for a randomized trial

    Directory of Open Access Journals (Sweden)

    Wong Samuel YS

    2011-11-01

    Full Text Available Abstract Background Research suggests that an eight-week Mindfulness-Based Cognitive Therapy (MBCT program may be effective in the treatment of generalized anxiety disorders. Our objective is to compare the clinical effectiveness of the MBCT program with a psycho-education programme and usual care in reducing anxiety symptoms in people suffering from generalized anxiety disorder. Methods A three armed randomized, controlled clinical trial including 9-month post-treatment follow-up is proposed. Participants screened positive using the Structure Clinical Interview for DSM-IV (SCID for general anxiety disorder will be recruited from community-based clinics. 228 participants will be randomly allocated to the MBCT program plus usual care, psycho-education program plus usual care or the usual care group. Validated Chinese version of instruments measuring anxiety and worry symptoms, depression, quality of life and health service utilization will be used. Our primary end point is the change of anxiety and worry score (Beck Anxiety Inventory and Penn State Worry Scale from baseline to the end of intervention. For primary analyses, treatment outcomes will be assessed by ANCOVA, with change in anxiety score as the baseline variable, while the baseline anxiety score and other baseline characteristics that significantly differ between groups will serve as covariates. Conclusions This is a first randomized controlled trial that compare the effectiveness of MBCT with an active control, findings will advance current knowledge in the management of GAD and the way that group intervention can be delivered and inform future research. Unique Trail Number (assigned by Centre for Clinical Trails, Clinical Trials registry, The Chinese University of Hong Kong: CUHK_CCT00267

  20. Manual and manipulative therapy compared to night splint for symptomatic hallux abducto valgus: an exploratory randomised clinical trial.

    Science.gov (United States)

    du Plessis, Morne; Zipfel, Bernhard; Brantingham, James W; Parkin-Smith, Gregory F; Birdsey, Paul; Globe, Gary; Cassa, Tammy K

    2011-06-01

    Hallux abducto valgus (HAV) is a frequent cause of great toe pain and disability, yet common treatments are only supported by mixed or equivocal research findings. Surgery often only provides modest improvement and post-surgery complications may significantly hamper outcomes, implying the need for trials testing conservative treatment, such as manual and manipulative therapy, particularly in cases where surgery may be contraindicated or premature. The purpose of this exploratory trial was to test an innovative protocol of manual and manipulative therapy (MMT) and compare it to standard care of a night splint(s) for symptomatic mild to moderate HAV, with a view gather insight into the effectiveness of MMT and inform the design of a definitive trial. Parallel-group randomised trial set in an out-patient teaching clinic. A convenience sample of 75 patients was assessed for eligibility, with 30 participants (15 per group) being consented and randomly allocated to either the control group (standard care with a night splint) or the experimental group (MMT). Participants in the control group used a night splint(s) and those in the experimental group (MMT) received a structured protocol of MMT, with the participants in the experimental group receiving 4 treatments over a 2-week period. Visual analogue scale (HAV-related pain), foot function index (HAV-related disability) and hallux dorsiflexion (goniometry). There were no participant dropouts and no data was missing. There were no statistical (pmanipulative therapy (experimental group) is equivalent to standard care of a night splint(s) (control group) for symptomatic mild to moderate HAV in the short term. The protocol of MMT maintains its treatment effect from 1-week to 1-month follow-up without further treatment, while patients receiving standard care seem to regress when not using the night splint. Insights from this study support further testing of MMT for symptomatic mild to moderate HAV, particularly where surgery

  1. Supportive Nursing Care and Satisfaction of Patients Receiving Electroconvulsive Therapy: A Randomized Controlled Clinical Trial.

    Science.gov (United States)

    Navidian, Ali; Ebrahimi, Hossein; Keykha, Roghaieh

    2015-09-01

    Patient satisfaction is the most important criterion in evaluating the quality of care. Besides, its assessment in patients with severe mental disorder treated by electroconvulsive therapy (ECT) is highly appropriate. The ECT is accompanied by lower satisfaction and may exacerbate the patients' condition. The current study aimed to determine the effect of supportive nursing care on the satisfaction of patients receiving ECT. This randomized controlled trial was conducted in the education center of Baharan psychiatric hospital, Zahedan, Iran. Seventy hospitalized patients receiving ECT were randomly divided into two groups of control (n = 35) and intervention (n = 35).The socio-personal and Webster Satisfaction Questionnaire were used as data collection tools. The intervention group received supportive nursing care by nurses trained in informational, emotional, and physical aspects. The control group received only regular nursing care. The levels of satisfaction were measured and compared between groups, before and after the intervention. Data were analyzed using the SPSS software, and Chi-square, independent and paired t tests, as well as covariance analysis were performed. The results showed similarities in socio-personal characteristics of both groups. However, there was a significant difference (P satisfaction in the groups, predominantly for the intervention group. In other words, a significant difference (P satisfaction of the intervention (54.71 ± 5.27) and control (36.28 ± 7.00) groups after intervention by controlling the effect of socio-personal variables. Results of the current study confirmed the effect of supportive nursing care on increasing the level of satisfaction in ECT receiving patients, recommending the use of this therapeutic method.

  2. Failure to Integrate Quantitative Measurement Methods of Ocular Inflammation Hampers Clinical Practice and Trials on New Therapies for Posterior Uveitis.

    Science.gov (United States)

    Herbort, Carl P; Tugal-Tutkun, Ilknur; Neri, Piergiorgio; Pavésio, Carlos; Onal, Sumru; LeHoang, Phuc

    2017-05-01

    Uveitis is one of the fields in ophthalmology where a tremendous evolution took place in the past 25 years. Not only did we gain access to more efficient, more targeted, and better tolerated therapies, but also in parallel precise and quantitative measurement methods developed allowing the clinician to evaluate these therapies and adjust therapeutic intervention with a high degree of precision. Objective and quantitative measurement of the global level of intraocular inflammation became possible for most inflammatory diseases with direct or spill-over anterior chamber inflammation, thanks to laser flare photometry. The amount of retinal inflammation could be quantified by using fluorescein angiography to score retinal angiographic signs. Indocyanine green angiography gave imaging insight into the hitherto inaccessible choroidal compartment, rendering possible the quantification of choroiditis by scoring indocyanine green angiographic signs. Optical coherence tomography has enabled measurement and objective monitoring of retinal and choroidal thickness. This multimodal quantitative appraisal of intraocular inflammation represents an exquisite security in monitoring uveitis. What is enigmatic, however, is the slow pace with which these improvements are integrated in some areas. What is even more difficult to understand is the fact that clinical trials to assess new therapeutic agents still mostly rely on subjective parameters such as clinical evaluation of vitreous haze as a main endpoint; whereas a whole array of precise, quantitative, and objective modalities are available for the design of clinical studies. The scope of this work was to review the quantitative investigations that improved the management of uveitis in the past 2-3 decades.

  3. Photodynamic therapy as adjunct to non-surgical periodontal treatment in patients on periodontal maintenance: a randomized controlled clinical trial.

    Science.gov (United States)

    Chondros, Panos; Nikolidakis, Dimitris; Christodoulides, Nicos; Rössler, Ralf; Gutknecht, Norbert; Sculean, Anton

    2009-09-01

    Recent preclinical and clinical data have suggested the potential benefit of photodynamic therapy (PDT) in the treatment of periodontitis. However, currently, there are very limited data from controlled clinical trials evaluating the effect of PDT in the treatment of periodontitis. The aim of the present study was to evaluate the clinical and microbiological effects of the adjunctive use of PDT in non-surgical periodontal treatment in patients receiving supportive periodontal therapy. Twenty-four patients receiving regularly supportive periodontal therapy were randomly treated with either subgingival scaling and root planing followed by a single episode of PDT (test) or subgingival scaling and root planing alone (control). The following parameters were evaluated at baseline and at 3 months and 6 months after therapy: full mouth plaque score (FMPS), full mouth bleeding score (FMBS), bleeding on probing (BOP) at experimental sites, probing pocket depth (PPD), gingival recession (REC), and clinical attachment level (CAL). Primary outcome variables were changes in PPD and CAL. Microbiological evaluation of Aggregatibacter actinomycetemcomitans (A.a.), Porphyromonas gingivalis (P.g.), Prevotella intermedia (P.i.), Tannerella forsythensis (T.f.), Treponema denticola (T.d.), Peptostreptococcus micros (P.m.), Fusobacterium nucleatum (F.n.), Campylobacter rectus (C.r.), Eubacterium nodatum (E.n.), Eikenella corrodens (E.c.), and Capnocytophaga species (C.s.) was also performed at baseline and at 3 months and 6 months after therapy, using a commercially available polymerase chain reaction test. No differences in any of the investigated parameters were observed at baseline between the two groups. At 3 months and 6 months after treatment, there were no statistically significant differences between the groups in terms of PPD, CAL and FMPS. At 3 months and 6 months, a statistically significantly higher improvement of BOP was found in the test group. At 3 months after therapy

  4. Computer Enabled Neuroplasticity Treatment: A Clinical Trial of a Novel Design for Neurofeedback Therapy in Adult ADHD.

    Science.gov (United States)

    Cowley, Benjamin; Holmström, Édua; Juurmaa, Kristiina; Kovarskis, Levas; Krause, Christina M

    2016-01-01

    We report a randomized controlled clinical trial of neurofeedback therapy intervention for ADHD/ADD in adults. We focus on internal mechanics of neurofeedback learning, to elucidate the primary role of cortical self-regulation in neurofeedback. We report initial results; more extensive analysis will follow. Trial has two phases: intervention and follow-up. The intervention consisted of neurofeedback treatment, including intake and outtake measurements, using a waiting-list control group. Treatment involved ~40 h-long sessions 2-5 times per week. Training involved either theta/beta or sensorimotor-rhythm regimes, adapted by adding a novel "inverse-training" condition to promote self-regulation. Follow-up (ongoing) will consist of self-report and executive function tests. Intake and outtake measurements were conducted at University of Helsinki. Treatment was administered at partner clinic Mental Capital Care, Helsinki. We randomly allocated half the sample then adaptively allocated the remainder to minimize baseline differences in prognostic variables. Waiting-list control design meant trial was not blinded. Fifty-four adult Finnish participants (mean age 36 years; 29 females) were recruited after screening by psychiatric review. Forty-four had ADHD diagnoses, 10 had ADD. Symptoms were assessed by computerized attention test (T.O.V.A.) and self-report scales, at intake and outtake. Performance during neurofeedback trials was recorded. PARTICIPANTS were recruited and completed intake measurements during summer 2012, before assignment to treatment and control, September 2012. Outtake measurements ran April-August 2013. After dropouts, 23 treatment and 21 waiting-list participants remained for analysis. Initial analysis showed that, compared to waiting-list control, neurofeedback promoted improvement of self-reported ADHD symptoms, but did not show transfer of learning to T.O.V.A. Comprehensive analysis will be reported elsewhere. "Computer Enabled Neuroplasticity

  5. Limited clinical utility of genotype-guided warfarin initiation dosing algorithms versus standard therapy: a meta-analysis and trial sequential analysis of 11 randomized controlled trials.

    Science.gov (United States)

    Tang, H L; Shi, W L; Li, X G; Zhang, T; Zhai, S D; Xie, H G

    2015-12-01

    In terms of inconsistent conclusions across all relevant randomized controlled trials (RCTs) and available meta-analyses, we aimed to use a meta-analysis and trial sequential analysis (TSA) to evaluate whether clinical utility of a genotype-guided warfarin initiation dosing algorithm could be better than that of a standard therapy regimen, and whether currently relevant evidence could be reliable and conclusive. Overall, 11 eligible RCTs involving 2677 patients were included for further analyses. Compared with fixed dose or clinically adjusted warfarin initiation dosing regimens, genotype-guided algorithms significantly increased time in therapeutic range, shortened time to first therapeutic international normalized ratio (INR) and time to stable doses, but did not show any marked improvements in excessive anticoagulation, bleeding events, thromboembolism, or all-cause mortality. Subgroup analyses revealed that, genotype-guided algorithms showed better control in the outcomes of time in therapeutic range or excessive anticoagulation than fixed-dose regimens rather than clinically adjusted regimens. Except for excessive anticoagulation, currently available evidence of all other outcomes was unreliable and inconclusive as determined with TSA. Our findings suggest that genotype-guided warfarin initiation dosing algorithms have superiority in the improvement of surrogate quality markers for anticoagulation control, but that this does not translate into statistically significant differences in clinical outcomes, which is largely because of the insufficient sample size in the RCTs analyzed.

  6. Low-level laser therapy for treatment of neurosensory disorders after orthognathic surgery: A systematic review of randomized clinical trials.

    Science.gov (United States)

    Bittencourt, M-A-V; Paranhos, L-R; Martins-Filho, P-R-S

    2017-11-01

    Low-level laser has been widely used in Dentistry and many studies have focused on its application in oral surgeries. This study was conducted with the aim of searching for scientific evidence concerning the effectiveness of laser to reduce pain or paresthesia related to orthognathic surgery. An electronic search was performed in PubMed, Scopus, Science Direct, LILACS, SciELO, CENTRAL, Google Scholar, OpenGrey, and ClinicalTrials.gov, up to November 2016, with no restrictions on language or year of publication. Additionally, a hand search of the reference list of the selected studies was carried out. The PICOS strategy was used to define the eligibility criteria and only randomized clinical trials were selected. Out of 1,257 identified citations, three papers fulfilled the criteria and were included in the systematic review. The risk of bias was assessed according to the Cochrane Guidelines for Clinical Trials and results were exposed based on a descriptive analysis. One study showed that laser therapy was effective to reduce postoperative pain 24 hours (P=0.007) and 72 hours (P=0.007) after surgery. Other study revealed the positive effect of laser to improve neurosensory recovery 60 days after surgery, evaluated also by the two-point discrimination (P=0.005) and sensory (P=0.008) tests. The third study reported an improvement for general sensibility of 68.75% for laser group, compared with 21.43% for placebo (P=0.0095), six months after surgery. Individual studies suggested a positive effect of low-level laser therapy on reduction of postoperative pain and acceleration of improvement of paresthesia related to orthognathic surgery. However, due to the insufficient number and heterogeneity of studies, a meta-analysis evaluating the outcomes of interest was not performed, and a pragmatic recommendation about the use of laser therapy is not possible. This systematic review was conducted according to the statements of PRISMA and was registered at PROSPERO under the

  7. Efficacy of Laser Therapy in Ankle Sprains : Design of a Randomized Clinical Trial

    NARCIS (Netherlands)

    de Bie, Robert A.; de Vet, Henrica CW; Knipschild, Paul G.; van den Wildenberg, Frans AJM; Lenssen, Ton F.; Bouter, Lex

    1997-01-01

    Studies on low intensity 904 nm laser therapy in the treatment of musculoskeletal disorders show conflicting results. Yet, on the basis of a systematic review we concluded that 904 nm laser therapy for musculoskeletal disorders seems to be promising, when compared to placebo laser therapy. Quick

  8. Results of a multicenter randomized controlled trial of the clinical effectiveness of schema therapy for personality disorders

    NARCIS (Netherlands)

    Bamelis, L.L.M.; Evers, S.M.A.A.; Spinhoven, P.; Arntz, A.

    2014-01-01

    Objective: The authors compared the effectiveness of 50 sessions of schema therapy with clarification-oriented psychotherapy and with treatment as usual among patients with cluster C, paranoid, histrionic, or narcissistic personality disorder. Method: A multicenter randomized controlled trial, with

  9. Photodynamic Therapy treatment of onychomycosis with Aluminium-Phthalocyanine Chloride nanoemulsions: A proof of concept clinical trial.

    Science.gov (United States)

    Morgado, Luciano Ferreira; Trávolo, Ana Regina Franchi; Muehlmann, Luís Alexandre; Narcizo, Paulo Souza; Nunes, Rodrigo Barbosa; Pereira, Pedro Alencar Gomes; Py-Daniel, Karen Rapp; Jiang, Cheng-Shi; Gu, Jinsong; Azevedo, Ricardo Bentes; Longo, João Paulo Figueiró

    2017-08-01

    The conventional treatment of onychomycosis, a common fungal infection, consists in the use of local and systemic drugs for 4-6 months. This long protocol is often ineffective due to patient compliance, and usually promotes important collateral effects such as liver and kidney failure. As the alternative, Photodynamic Therapy (PDT) has been used as a noninvasive alternative local treatment for onychomycosis due to the reduction of systemic side effects, fact indicates their use for patients undergoing other systemic treatments. In the present article, we evaluated the effectiveness, as well as the safety of PDT mediated by Aluminium-Phthalocyanine Chloride, entrapped in nanoemulsions, as a drug carrier, to treat onychomycosis in a proof of concept clinical trial. To the date, this is the first published clinical trial that uses PDT mediated by nanomedicines to treat onychomycosis. As main results, we can highlight the safety of the clinical protocol and the antifungal effectiveness similar to the conventional treatments. We observed the (1) clinical cure of 60% of treated lesions; (2) the absence of local and systemic adverse effects; (3) from these clinically healed lesions, 40% were negative for fungal infection in laboratorial exams; and (4) nails that presented negative fungal culture were kept without fungal infection for at least four weeks. The innovation of this approach is the absence of collateral effects, due to the local therapeutically treatment, and the possibility to repeat the treatment without inducing fungal resistance, a fact that indicates this approach as a possible alternative protocol for onychomycosis management. Copyright © 2017 Elsevier B.V. All rights reserved.

  10. Prospective evaluation of patients with early-/intermediate-stage hepatocellular carcinoma with disease progression following arterial locoregional therapy: candidacy for systemic treatment or clinical trials.

    Science.gov (United States)

    Memon, Khairuddin; Kulik, Laura; Lewandowski, Robert J; Gupta, Ramona; Ryu, Robert K; Miller, Frank H; Vouche, Michael; Atassi, Rohi; Ganger, Daniel; Mulcahy, Mary F; Salem, Riad

    2013-08-01

    During the course of cancer treatment, patients whose disease progresses despite therapy are offered alternative options. Similarly, patients with hepatocellular carcinoma (HCC) whose disease progresses following arterial locoregional therapies (LRTs) cross over to undergo systemic therapies or participate in clinical trials. Per current guidelines, patients must meet inclusion criteria (most importantly Child-Pugh class A status) to qualify for systemic options. The present study analyzed the candidacy for systemic agents or clinical trials of patients whose disease progresses despite LRTs. A total of 245 patients with HCC were treated with LRTs (chemoembolization, n = 123; yttrium-90 [(90)Y] radioembolization, n = 122) as part of a previously published comparative effectiveness study; 96 patients exhibiting disease progression were followed prospectively. Modes of progression (cancer stage, Child-Pugh class) were analyzed to determine candidacy for systemic therapy or clinical trials, as well as assess ultimate treatment(s) received. Among the 96 patients with disease progression, 52% and 48% had Child-Pugh class A and class B/C disease, respectively, thereby substantially limiting the latter group's eligibility for systemic therapy and/or clinical trials. Of those whose disease progressed who had advanced-stage HCC, 63% had Child-Pugh class B/C disease. By size and necrosis criteria, the local disease progression rate was higher with chemoembolization than with (90)Y radioembolization (P = .006 and P = .016, respectively). Of the 96 patients with disease progression, only 13 (13%) ultimately received systemic agents or entered clinical trials. Most patients with advanced HCC that progresses following LRTs were not candidates for clinical trials or systemic agents. There is a need for future research efforts directed at treatment options or novel trial designs that will permit inclusion of patients with progressive liver disease and suboptimal liver function

  11. Low-level laser therapy for pain relief after episiotomy: a double-blind randomised clinical trial.

    Science.gov (United States)

    Santos, Jaqueline de O; de Oliveira, Sonia M J V; da Silva, Flora M B; Nobre, Moacyr R C; Osava, Ruth H; Riesco, Maria L G

    2012-12-01

    To evaluate the effectiveness of a low-level laser therapy for pain relief in the perineum following episiotomy during childbirth. Laser irradiation is a painless and non-invasive therapy for perineal pain treatment and its effects have been investigated in several studies, with no clear conclusion on its effectiveness. A double-blind randomised controlled clinical trial. One hundred and fourteen women who underwent right mediolateral episiotomies during vaginal birth in an in-hospital birthing centre in São Paulo, Brazil and reported pain ≥ 3 on a numeric scale (0-10) were randomised into three groups of 38 women each: two experimental groups (treated with red and infrared laser) and a control group. The experimental groups were treated with laser applied at three points directly on the episiotomy after suturing in a single session between 6-56 hours postpartum. We used a diode laser with wavelengths of 660 nm (red laser) and 780 nm (infrared laser). The control group participants underwent all laser procedures, excluding the emission of irradiation. The participants and the pain scores evaluator were blinded to the type of intervention. The perineal pain scores were assessed at three time points: before, immediately after and 30 minutes after low-level laser therapy. The comparison of perineal pain between the three groups showed no significant differences in the three evaluations (p = 0.445), indicating that the results obtained in the groups treated with low-level laser therapy were equivalent to the control group. Low-level laser therapy did not decrease the intensity of perineal pain reported by women who underwent right mediolateral episiotomy. The effect of laser in perineal pain relief was not demonstrated in this study. The dosage may not have been sufficient to provide relief from perineal pain after episiotomy during a vaginal birth. © 2012 Blackwell Publishing Ltd.

  12. Long-term effects of cognitive therapy on biological rhythms and depressive symptoms: A randomized clinical trial.

    Science.gov (United States)

    Mondin, Thaíse Campos; Cardoso, Taiane de Azevedo; Jansen, Karen; Silva, Giovanna Del Grande da; Souza, Luciano Dias de Mattos; Silva, Ricardo Azevedo da

    2015-11-15

    To evaluate the effect of cognitive therapy on biological rhythm and depressive and anxious symptoms in a twelve-month follow-up period. In addition, correlations between the reduction of depression and anxiety symptoms and the regulation of biological rhythm were observed. This was a randomized clinical trial with young adults from 18 to 29 years of age who were diagnosed with depression. Two models of psychotherapy were used: Cognitive Behavioral Therapy (CBT) and Narrative Cognitive Therapy (NCT). Biological rhythm was assessed with the Biological Rhythm Interview of Assessment in Neuropsychiatry (BRIAN). Severity of depressive and anxious symptoms was assessed by the Hamilton Depression Rating Scale (HDRS) and the Hamilton Anxiety Rating Scale (HARS), respectively. The sample included 97 patients who were divided within the protocols of psychotherapy. There was a significant reduction in depressive and anxious symptoms (pbiological rhythm (pbiological rhythm (r=0.638; pbiological rhythm (r=0.438; pbiological rhythm at a twelve-month follow-up evaluation. This study highlights the association between biological rhythm and symptoms of depression and anxiety. We did not assess genetic, hormonal or neurochemical factors and we did not include patients under pharmaceutical treatment or those with severe symptomatology. Copyright © 2015 Elsevier B.V. All rights reserved.

  13. Randomised, double-blinded, placebo-controlled, clinical trial of ozone therapy as treatment of sudden sensorineural hearing loss.

    Science.gov (United States)

    Ragab, A; Shreef, E; Behiry, E; Zalat, S; Noaman, M

    2009-01-01

    To investigate the safety and efficacy of ozone therapy in adult patients with sudden sensorineural hearing loss. Prospective, randomised, double-blinded, placebo-controlled, parallel group, clinical trial. Forty-five adult patients presented with sudden sensorineural hearing loss, and were randomly allocated to receive either placebo (15 patients) or ozone therapy (auto-haemotherapy; 30 patients). For the latter treatment, 100 ml of the patient's blood was treated immediately with a 1:1 volume, gaseous mixture of oxygen and ozone (from an ozone generator) and re-injected into the patient by intravenous infusion. Treatments were administered twice weekly for 10 sessions. The following data were recorded: pre- and post-treatment mean hearing gains; air and bone pure tone averages; speech reception thresholds; speech discrimination scores; and subjective recovery rates. Significant recovery was observed in 23 patients (77 per cent) receiving ozone treatment, compared with six (40 per cent) patients receiving placebo (p ozone-treated patients compared with placebo-treated patients (p Ozone therapy is a significant modality for treatment of sudden sensorineural hearing loss; no complications were observed.

  14. The effectiveness of ibuprofen and lorazepam combination therapy in treating the symptoms of acute Migraine: A randomized clinical trial

    Science.gov (United States)

    Rad, Reza Ebrahimi; Ghaffari, Fatemeh; Fotokian, Zahra; Ramezani, Azadeh

    2017-01-01

    Background Migraine is a common, episodic and debilitating disease. The migraineur not only suffers from pain, but also lives with a diminished to poor quality of life. Several medicinal therapies are used to abate the debilitating symptoms of this disease. Objective The present study was conducted to determine the effectiveness of Ibuprofen and Lorazepam combination therapy in treating the symptoms of acute migraine. Methods The present randomized clinical trial study used the pretest-posttest design with three comparison treatments, to examine 90 patients with an average of two to six attacks per month and an initial diagnosis of migraine based on the International Headache Society (HIS) criteria. The study was conducted on patients during the first half of 2014 with a diagnosis of acute migraine attack who were referred to Babol Ayatollah Rouhani Hospital in Iran. The patients were randomly divided into three groups of 30. The first group was administered 200 mg Ibuprofen capsules, the second group 400 mg Ibuprofen capsules and the third group a combination of 200 mg Ibuprofen capsules and 1 mg Lorazepam tablets. The medications were taken in the presence of the researcher. A checklist was used to assess the severity of headache and other migraine symptoms such as nausea, vomiting, photophobia and phonophobia in the patients, before and two hours after the intervention. Data were analyzed in SPSS-18 using the Mann-Whitney test, the McNemar test, Wilcoxon’s test, the NOVA and the Chi-squared test at the significance level of p<0.05, and power analysis with 30 patients in each group to perform this study was 0.8(1-β). Results The mean age of participants was reported as 52±8 years and the condition was more frequent in women (56%). All three treatment regimens reduced the severity of headache significantly in the patients (p<0.001); nevertheless, the combination therapy used, produced the lowest mean severity of headache (p<0.001). The highest reduction in

  15. Design of a multicentered randomized controlled trial on the clinical and cost effectiveness of schema therapy for personality disorders

    Directory of Open Access Journals (Sweden)

    Bamelis Lotte LM

    2012-01-01

    Full Text Available Abstract Background Despite international guidelines describing psychotherapy as first choice for people with personality disorders (PDs, well-designed research on the effectiveness and cost-effectiveness of psychotherapy for PD is scarce. Schema therapy (ST is a specific form of psychological treatment that proved to be effective for borderline PD. Randomized controlled studies on the effectiveness of ST for other PDs are lacking. Another not yet tested new specialized treatment is Clarification Oriented Psychotherapy (COP. The aim of this project is to perform an effectiveness study as well as an economic evaluation study (cost effectiveness as well as cost-utility comparing ST versus COP versus treatment as usual (TAU. In this study, we focus on avoidant, dependent, obsessive-compulsive, paranoid, histrionic and narcissistic PD. Methods/Design In a multicentered randomized controlled trial, ST, and COP as an extra experimental condition, are compared to TAU. Minimal 300 patients are recruited in 12 mental health institutes throughout the Netherlands, and receive an extensive screening prior to enrolment in the study. When eligible, they are randomly assigned to one of the intervention groups. An economic evaluation and a qualitative research study on patient and therapist perspectives on ST are embedded in this trial. Outcome assessments (both for clinical effectiveness and economic evaluation take place at 6,12,18,24 and 36 months after start of treatment. Primary outcome is recovery from PD; secondary measures include general psychopathological complaints, social functioning and quality of life. Data for the cost-effectiveness and cost-utility analyses are collected by using a retrospective cost interview. Information on patient and therapist perspectives is gathered using in-depth interviews and focus groups, and focuses on possible helpful and impeding aspects of ST. Discussion This trial is the first to compare ST and COP head

  16. An approach to personalized cell therapy in chronic complete paraplegia: The Puerta de Hierro phase I/II clinical trial.

    Science.gov (United States)

    Vaquero, Jesús; Zurita, Mercedes; Rico, Miguel A; Bonilla, Celia; Aguayo, Concepcion; Montilla, Jesús; Bustamante, Salvador; Carballido, Joaquin; Marin, Esperanza; Martinez, Francisco; Parajon, Avelino; Fernandez, Cecilia; Reina, Laura De

    2016-08-01

    Cell transplantation in patients suffering spinal cord injury (SCI) is in its initial stages, but currently there is confusion about the results because of the disparity in the techniques used, the route of administration, and the criteria for selecting patients. We conducted a clinical trial involving 12 patients with complete and chronic paraplegia (average time of chronicity, 13.86 years; SD, 9.36). The characteristics of SCI in magnetic resonance imaging (MRI) were evaluated for a personalized local administration of expanded autologous bone marrow mesenchymal stromal cells (MSCs) supported in autologous plasma, with the number of MSCs ranging from 100 × 10(6) to 230 × 10(6). An additional 30 × 10(6) MSCs were administered 3 months later by lumbar puncture into the subarachnoid space. Outcomes were evaluated at 3, 6, 9 and 12 months after surgery through clinical, urodynamic, neurophysiological and neuroimaging studies. Cell transplantation is a safe procedure. All patients experienced improvement, primarily in sensitivity and sphincter control. Infralesional motor activity, according to clinical and neurophysiological studies, was obtained by more than 50% of the patients. Decreases in spasms and spasticity, and improved sexual function were also common findings. Clinical improvement seems to be dose-dependent but was not influenced by the chronicity of the SCI. Personalized cell therapy with MSCs is safe and leads to clear improvements in clinical aspects and quality of life for patients with complete and chronically established paraplegia. Copyright © 2016 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

  17. Relaxation Therapy on Fetal Outcomes in Complicated Pregnancies Suffering Sleep Disorders: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    azar nematollahi

    2016-10-01

    Full Text Available Background: Sleep disorders like snoring, mouth breathing, and insomnia are frequent in pregnancy and studies have shown that poor sleep is linked to obstetric complications. Muscle relaxation technique is an effective method used for improving sleep quality. The purpose of this study was to determine the effect of muscle relaxation technique on fetal outcomes in complicated pregnancies with sleep disorders. Methods: This study was performed as a clinical trial on 160 pregnant women who suffered from preeclampsia and gestational diabetes. The participants filled the Pittsburgh Sleep Quality Index (PSQI in order to measure the quality and patterns of their sleep. The participants with the total score of 5 or more were included in the present study. Intervention group were asked to use muscle relaxation technique twice a week at home for 8 weeks alongside the routine care. Study variables included sleep quality, Apgar scores, birth weight, levels of Interleukin- 6 (IL- 6, as well as umbilical cord PH and PO2. Results: The mean score of PSQI before the intervention was 9.28±4.16 and 9.18±3.06 in the intervention and control groups without a significant difference (P=0.6, respectively. However, PSQI global score of the experimental group was smaller than the control group at the end of the study (P<0.001. Also, birth weight (P=0.04, Apgar score (P=0.01, and umbilical cord blood po2 (P=0.03 and PH (P=0.01 were higher, and IL-6 (P=0.04 was smaller in the experimental group compared to the control group. Conclusion: The results of this study showed that muscle relaxation, as a simple, inexpensive and safe method, can improve the fetal outcomes such as birth weight, Apgar score, cord blood po2, and cord blood PH, and also it leads to lower IL-6 in complicated pregnancies.

  18. Manual Therapy, Exercise, and Traction for Patients With Cervical Radiculopathy: A Randomized Clinical Trial

    National Research Council Canada - National Science Library

    Ian A. Young; Lori A. Michener; Joshua A. Cleland; Arnold J. Aguilera; Alison R. Snyder

    2009-01-01

    .... Preliminary evidence suggests that a multimodal treatment program consisting of manual therapy, exercise, and cervical traction may result in positive outcomes for patients with cervical radiculopathy...

  19. Psychosocial and Clinical Outcomes of a Cognitive Behavioral Therapy for Asians and Pacific Islanders with Type 2 Diabetes: A Randomized Clinical Trial.

    Science.gov (United States)

    Inouye, Jillian; Li, Dongmei; Davis, James; Arakaki, Richard

    2015-11-01

    Asian Americans and Pacific Islanders are twice as likely to be diagnosed with type 2 diabetes compared to Caucasians. The objective was to determine the effect of cognitive behavioral therapy on quality of life, general health perceptions, depressive symptoms, and glycemia in Asians and Pacific Islanders with type 2 diabetes. The design was a randomized controlled clinical trial comparing cognitive behavioral therapy to diabetes education and support for six weekly sessions. Participants were recruited from two endocrinology practices; 207 were enrolled. The cognitive behavioral therapy group was provided self-management tools which included biofeedback, breathing exercises, and stress relievers, while the diabetes education and support group included diabetes education and group discussions. Assessments of psychosocial and clinical outcomes were obtained before and after sessions and 12 months PostSession. Differences between the two groups were examined using linear mixed-effects models with linear contrasts. The cognitive behavioral therapy group had improved depressive symptom scores from PreSession to EndSession compared to the diabetes education and support group (P < .03), but the improvement did not extend to 12 months PostSession. Similar results were observed with misguided support scores in the Multidimensional Diabetes Questionnaire (P < .03) and susceptibility in health beliefs (P < .01), but no significant differences in HbA1c improvement were found between the two groups. Both interventions improved outcomes from baseline but were not sustained for 1 year.

  20. Effects of massage therapy and occlusal splint therapy on mandibular range of motion in individuals with temporomandibular disorder: a randomized clinical trial.

    Science.gov (United States)

    Gomes, Cid André Fidelis de Paula; Politti, Fabiano; Andrade, Daniel Ventura; de Sousa, Dowglas Fernando Magalhães; Herpich, Carolina Marciela; Dibai-Filho, Almir Vieira; Gonzalez, Tabajara de Oliveira; Biasotto-Gonzalez, Daniela Aparecida

    2014-01-01

    The purpose of this study was to investigate the effects of massage therapy compared with occlusal splint therapy on mandibular range of motion (ROM) in individuals with temporomandibular disorder (TMD) and compare the results with ROM obtained in a group of individuals without this disorder. A blinded randomized clinical trial was conducted. Twenty-eight volunteers with TMD were randomly distributed into either a massage therapy group or an occlusal splint group. Both treatments were provided for 4 weeks. Fourteen individuals without TMD were consecutively allocated to a comparison group. Fonseca anamnestic index was used to characterize TMD and allocate the volunteers to either of the intervention groups or asymptomatic comparison group. Mandibular ROM was evaluated before and after treatment using a digital caliper. Two-way repeated-measures analysis of variance with a post hoc Bonferroni testing was used for intergroup and intragroup comparisons (level of significance was set to 5%). Cohen d was used to calculate the effect size. In the intragroup analysis, significant increases in ROM were found for all measures in both the massage and occlusal splint groups (P < .05). A small to moderate clinical effect of treatment with the occlusal splint was found regarding right and left lateral excursion in comparison with the massage therapy and asymptomatic comparison groups (0.2 therapy on the masticatory muscles and the use of an occlusal splint lead to an increase in mandibular ROM similar to that of the asymptomatic comparison group with regard to maximum active mouth opening and both right and left excursion in individuals with TMD. © 2013. Published by National University of Health Sciences All rights reserved.

  1. Dialectical Behavior Therapy (DBT) Applied to College Students: A Randomized Clinical Trial

    Science.gov (United States)

    Pistorello, Jacqueline; Fruzzetti, Alan E.; MacLane, Chelsea; Gallop, Robert; Iverson, Katherine M.

    2012-01-01

    Objective College counseling centers (CCCs) are increasingly being called upon to treat highly distressed students with complex clinical presentations. This study compared the effectiveness of Dialectical Behavior Therapy (DBT) for suicidal college students to an optimized control condition, and analyzed baseline global functioning as a moderator. Method The intent-to-treat (ITT) sample included 63 college students between the ages of 18 and 25 who were suicidal at baseline, reported at least one lifetime non-suicidal self-injurious (NSSI) act or suicide attempt, and met three or more borderline personality disorder (BPD) diagnostic criteria. Participants were randomly assigned to DBT (n = 31) or an optimized Treatment as Usual (O-TAU) control condition (n = 32). Treatment was provided by trainees, supervised by experts in both treatments. Both treatments lasted 7–12 months and included both individual and group components. Assessments were conducted at pretreatment, 3-months, 6-months, 9-months, 12-months, and 18-months (follow-up). Results Mixed effects analyses (ITT sample) revealed that DBT, compared to the control condition, showed significantly greater decreases in suicidality, depression, number of NSSI events (if participant had self-injured), BPD criteria, and psychotropic medication use, and significantly greater improvements in social adjustment. Most of these treatment effects were observed at follow-up. No treatment differences were found for treatment dropout. Moderation analyses showed that DBT was particularly effective for suicidal students who were lower functioning at pretreatment. Conclusions DBT is an effective treatment for suicidal, multi-problem college students. Future research should examine the implementation of DBT in CCCs in a stepped care approach. PMID:22730955

  2. Dialectical behavior therapy (DBT) applied to college students: a randomized clinical trial.

    Science.gov (United States)

    Pistorello, Jacqueline; Fruzzetti, Alan E; Maclane, Chelsea; Gallop, Robert; Iverson, Katherine M

    2012-12-01

    College counseling centers (CCCs) are increasingly being called upon to treat highly distressed students with complex clinical presentations. This study compared the effectiveness of Dialectical Behavior Therapy (DBT) for suicidal college students with an optimized control condition and analyzed baseline global functioning as a moderator. The intent-to-treat (ITT) sample included 63 college students between the ages of 18 and 25 years who were suicidal at baseline, reported at least 1 lifetime nonsuicidal self-injurious (NSSI) act or suicide attempt, and met 3 or more borderline personality disorder (BPD) diagnostic criteria. Participants were randomly assigned to DBT (n = 31) or an optimized treatment-as-usual (O-TAU) control condition (n = 32). Treatment was provided by trainees, supervised by experts in both treatments. Both treatments lasted 7-12 months and included both individual and group components. Assessments were conducted at pretreatment, 3 months, 6 months, 9 months, 12 months, and 18 months (follow-up). Mixed effects analyses (ITT sample) revealed that DBT, compared with the control condition, showed significantly greater decreases in suicidality, depression, number of NSSI events (if participant had self-injured), BPD criteria, and psychotropic medication use and significantly greater improvements in social adjustment. Most of these treatment effects were observed at follow-up. No treatment differences were found for treatment dropout. Moderation analyses showed that DBT was particularly effective for suicidal students who were lower functioning at pretreatment. DBT is an effective treatment for suicidal, multiproblem college students. Future research should examine the implementation of DBT in CCCs in a stepped care approach.

  3. Cognitive Behavioral Insomnia Therapy for Those With Insomnia and Depression: A Randomized Controlled Clinical Trial.

    Science.gov (United States)

    Carney, Colleen E; Edinger, Jack D; Kuchibhatla, Maragatha; Lachowski, Angela M; Bogouslavsky, Olya; Krystal, Andrew D; Shapiro, Colin M

    2017-04-01

    To compare cognitive behavioral therapy for insomnia (CBT-I) + antidepressant medication (AD) against treatments that target solely depression or solely insomnia. A blinded, randomized split-plot experimental study. Two urban academic clinical centers. 107 participants (68% female, mean age 42 ± 11) with major depressive disorder and insomnia. Randomization was to one of three groups: antidepressant (AD; escitalopram) + CBT-I (4 sessions), CBT-I + placebo pill, or AD + 4-session sleep hygiene control (SH). Subjective sleep was assessed via 2 weeks of daily sleep diaries (use of medication was covaried in all analyses); although there were no statistically significant group differences detected, all groups improved from baseline to posttreatment on subjective sleep efficiency (SE) and total wake time (TWT) and the effect sizes were large. Objective sleep was assessed via overnight polysomnographic monitoring at baseline and posttreatment; analyses revealed both CBT groups improved on TWT (p = .03), but the AD + SH group worsened. There was no statistically significant effect for PSG SE (p = .07). There was a between groups medium effect observed for the AD + SH and CBT + placebo group differences on diary TWT and both PSG variables. All groups improved significantly from baseline to posttreatment on the Hamilton Rating Scale for Depression (HAMD-17); the groups did not differ. Although all groups self-reported sleeping better after treatment, only the CBT-I groups improved on objective sleep, and AD + SH's sleep worsened. This suggests that we should be treating sleep in those with depression with an effective insomnia treatment and relying on self-report obscures sleep worsening effects. All groups improved on depression, even a group with absolutely no depression-focused treatment component (CBT-I + placebo). The depression effect in CBT-I only group has been reported in other studies, suggesting that we should further investigate the antidepressant properties of

  4. Adjunctive effect of antimicrobial photodynamic therapy to nonsurgical periodontal treatment in smokers: a randomized clinical trial.

    Science.gov (United States)

    Queiroz, Adriana C; Suaid, Flávia Adelino; de Andrade, Patrícia Freitas; Oliveira, Fabíola S; Novaes, Arthur B; Taba, Mário; Palioto, Daniela B; Grisi, Márcio F M; Souza, Sérgio L S

    2015-02-01

    The aim of this study was to investigate the adjunctive effect of antimicrobial photodynamic therapy (aPDT) to scaling and root planing (SRP) in smokers with chronic periodontitis. Twenty subjects had two contralateral teeth randomly assigned to receive SRP (SRP group) or SRP + a single episode of aPDT (SRP + aPDT group), with a diode laser and a phenothiazine photosensitizer. Plaque index, bleeding on probing, probing depth (PD), clinical attachment level (CAL), and gingival recession were recorded, and gingival crevicular fluid was collected for assay of IL-1β and matrix metalloproteinase (MMP)-8 levels. There was a significant PD reduction (SRP 1.81 ± 0.52 mm/SRP + aPDT 1.58 ± 1.28 mm; p < 0.001) and a significant CAL gain (SRP 1.60 ± 0.92 mm/SRP + aPDT 1.41 ± 1.58 mm; p < 0.001) for both groups. Significant differences were not observed in between-group comparisons. IL-1β level in gingival crevicular fluid was higher in SRP group after 1 week (SRP 24.65 ± 18.85 pg/μL/SRP + aPDT 34.07 ± 24.81 pg/μL; p = 0.048), and MMP-8 level was higher in SRP group after 12 weeks (SRP 303.31 ± 331.62 pg/μL/SRP + aPDT 534.23 ± 647.37 pg/μL; p = 0.024). There were no statistically significant differences in intragroup comparisons. The adjunctive effect of aPDT did not warrant improvements on clinical parameters in smokers. However, it resulted in a suppression of IL-1β and MMP-8 when compared with SRP alone.

  5. Evaluating clinical trial design: systematic review of randomized vehicle-controlled trials for determining efficacy of benzoyl peroxide topical therapy for acne.

    Science.gov (United States)

    Lamel, Sonia A; Sivamani, Raja K; Rahvar, Maral; Maibach, Howard I

    2015-11-01

    Determined efficacies of benzoyl peroxide may be affected by study design, implementation, and vehicle effects. We sought to elucidate areas that may allow improvement in determining accurate treatment efficacies by determining rates of active treatment and vehicle responders in randomized controlled trials assessing the efficacy of topical benzoyl peroxide to treat acne. We conducted a systematic review of randomized vehicle-controlled trials evaluating the efficacy of topical benzoyl peroxide for the treatment of acne. We compared response rates of vehicle treatment arms versus those in benzoyl peroxide arms. Twelve trials met inclusion criteria with 2818 patients receiving benzoyl peroxide monotherapy treatment and 2004 receiving vehicle treatment. The average percent reduction in total number of acne lesions was 44.3 (SD = 9.2) and 27.8 (SD = 21.0) for the active and vehicle treatment groups, respectively. The average reduction in non-inflammatory lesions was 41.5 % (SD = 9.4) in the active treatment group and 27.0 % (SD = 20.9) in the vehicle group. The average percent decrease in inflammatory lesions was 52.1 (SD = 10.4) in the benzoyl peroxide group and 34.7 (SD = 22.7) in the vehicle group. The average percentage of participants achieving success per designated study outcomes was 28.6 (SD = 17.3) and 15.2 (SD = 9.5) in the active treatment and vehicle groups, respectively. Patient responses in randomized controlled trials evaluating topical acne therapies may be affected by clinical trial design, implementation, the biologic effects of vehicles, and natural disease progression. "No treatment" groups may facilitate determination of accurate treatment efficacies.

  6. Clinical effectiveness of cognitive therapy v. interpersonal psychotherapy for depression: results of a randomized controlled trial

    NARCIS (Netherlands)

    Lemmens, L.H.J.M.; Arntz, A.; Peeters, F.; Hollon, S.D.; Roefs, A.; Marcus, J.H.; Huibers, M.J.H.

    2015-01-01

    Background: Although both cognitive therapy (CT) and interpersonal psychotherapy (IPT) have been shown to be effective treatments for major depressive disorder (MDD), it is not clear yet whether one therapy outperforms the other with regard to severity and course of the disorder. This study examined

  7. Clinical effectiveness of cognitive therapy v. interpersonal psychotherapy for depression: results of a randomized controlled trial

    NARCIS (Netherlands)

    Lemmens, L.H.J.M.; Arntz, A.; Peeters, F.; Hollon, S.D.; Roefs, A.; Huibers, M.J.H.

    2015-01-01

    Background Although both cognitive therapy (CT) and interpersonal psychotherapy (IPT) have been shown to be effective treatments for major depressive disorder (MDD), it is not clear yet whether one therapy outperforms the other with regard to severity and course of the disorder. This study examined

  8. Effects of Coping-Oriented Couples Therapy on Depression: A Randomized Clinical Trial

    Science.gov (United States)

    Bodenmann, Guy; Plancherel, Bernard; Beach, Steven R. H.; Widmer, Kathrin; Gabriel, Barbara; Meuwly, Nathalie; Charvoz, Linda; Hautzinger, Martin; Schramm, Elisabeth

    2008-01-01

    The aim of this study was to evaluate the effectiveness of treating depression with coping-oriented couples therapy (COCT) as compared with cognitive-behavioral therapy (CBT; A. T. Beck, C. Ward, & M. Mendelson, 1961) and interpersonal psychotherapy (IPT; M. M. Weissman, J. C. Markowitz, & G. L. Klerman, 2000). Sixty couples, including 1…

  9. The Clinical and Theoretical Impact of a Controlled Trial of Family Therapy in Anorexia Nervosa.

    Science.gov (United States)

    Dare, Christopher; And Others

    1990-01-01

    Compared family therapy with individual, supportive psychotherapy for management of severe eating disorder. Findings showed family therapy more effective for patients with early onset, short duration disorder but not in other subgroups (early onset, duration more than 3 years; late onset, after age of 18 years; and those with bulimia nervosa).…

  10. Randomized Clinical Trial of Cognitive Behavioral Therapy (CBT) versus Acceptance and Commitment Therapy (ACT) for Mixed Anxiety Disorders

    Science.gov (United States)

    Arch, Joanna J.; Eifert, Georg H.; Davies, Carolyn; Vilardaga, Jennifer C. Plumb; Rose, Raphael D.; Craske, Michelle G.

    2012-01-01

    Objective: Randomized comparisons of acceptance-based treatments with traditional cognitive behavioral therapy (CBT) for anxiety disorders are lacking. To address this gap, we compared acceptance and commitment therapy (ACT) to CBT for heterogeneous anxiety disorders. Method: One hundred twenty-eight individuals (52% female, mean age = 38, 33%…

  11. Clinical trial structures

    OpenAIRE

    Evans, Scott R.

    2010-01-01

    Most errors in clinical trials are a result of poor planning. Fancy statistical methods cannot rescue design flaws. Thus careful planning with clear foresight is crucial. The selection of a clinical trial design structure requires logic and creativity. Common structural designs are discussed.

  12. Trial end points and natural history in patients with G11778A Leber hereditary optic neuropathy : preparation for gene therapy clinical trial.

    Science.gov (United States)

    Lam, Byron L; Feuer, William J; Schiffman, Joyce C; Porciatti, Vittorio; Vandenbroucke, Ruth; Rosa, Potyra R; Gregori, Giovanni; Guy, John

    2014-04-01

    IMPORTANCE Establishing the natural history of G11778A Leber hereditary optic neuropathy (LHON) is important to determine the optimal end points to assess the safety and efficacy of a planned gene therapy trial. OBJECTIVE To use the results of the present natural history study of patients with G11778A LHON to plan a gene therapy clinical trial that will use allotopic expression by delivering a normal nuclear-encoded ND4 gene into the nuclei of retinal ganglion cells via an adeno-associated virus vector injected into the vitreous. DESIGN, SETTING, AND PARTICIPANTS A prospective observational study initiated in 2008 was conducted in primary and referral institutional practice settings. Participants included 44 individuals with G11778A LHON, recruited between September 2008 and March 2012, who were evaluated every 6 months and returned for 1 or more follow-up visits (6-36 months) as of August 2012. EXPOSURES Complete neuro-ophthalmic examination and main measures. MAIN OUTCOMES AND MEASURES Visual acuity, automated visual field testing, pattern electroretinogram, and spectral-domain optical coherence tomography. RESULTS Clinical measures were stable during the follow-up period, and visual acuity was as good as or better than the other visual factors used for monitoring patients. Based on a criterion of 15 or more letters from the Early Treatment Diabetic Retinopathy Study chart, 13 eyes of 8 patients (18%) improved, but 24 months after the onset of symptoms, any further improvements were to no better than 20/100. Acuity recovery occurred in some patients despite continued marked retinal nerve fiber layer thinning indistinguishable from that in patients who did not recover visual acuity. CONCLUSIONS AND RELEVANCE Spontaneous improvement of visual acuity in patients with G11778A LHON is not common and is partial and limited when it occurs, so improvements in vision with adeno-associated virus-mediated gene therapy of a synthetic wild-type ND4 subunit gene should be

  13. Computer Enabled Neuroplasticity Treatment: a Clinical Trial of a Novel Design for Neurofeedback Therapy in Adult ADHD

    Directory of Open Access Journals (Sweden)

    Benjamin eCowley

    2016-05-01

    Full Text Available BackgroundWe report a randomised controlled clinical trial of neurofeedback therapy intervention for ADHD/ADD in adults. We focus on internal mechanics of neurofeedback learning, to elucidate the primary role of cortical self-regulation in neurofeedback. We report initial results; more extensive analysis will follow.MethodsTrial has two phases: intervention and follow-up. The intervention consisted of neurofeedback treatment, including intake and outtake measurements, using a waiting-list control group. Treatment involved $sim$40 hour-long sessions 2-5 times per week. Training involved either theta/beta or sensorimotor-rhythm regimes, adapted by adding a novel 'inverse-training' condition to promote self-regulation. Follow-up (ongoing will consist of self-report and executive function tests.SettingIntake and outtake measurements were conducted at University of Helsinki. Treatment was administered at partner clinic Mental Capital Care, Helsinki.RandomisationWe randomly allocated half the sample then adaptively allocated the remainder to minimise baseline differences in prognostic variables.BlindingWaiting-list control design meant trial was not blinded.Participants54 adult Finnish participants (mean age 36 years; 29 females were recruited after screening by psychiatric review. 44 had ADHD diagnoses, 10 had ADD.MeasurementsSymptoms were assessed by computerised attention test (T.O.V.A. and self-report scales, at intake and outtake. Performance during neurofeedback trials was recorded.ResultsParticipants were recruited and completed intake measurements during summer 2012, before assignment to treatment and control, September 2012. Outtake measurements ran April-August 2013. After dropouts, 23 treatment and 21 waiting-list participants remained for analysis.Initial analysis showed that, compared to waiting-list control, neurofeedback promoted improvement of self-reported ADHD symptoms, but did not show transfer of learning to T.O.V.A. Comprehensive

  14. Design of a multicentered randomized controlled trial on the clinical and cost effectiveness of schema therapy for personality disorders.

    Science.gov (United States)

    Bamelis, Lotte L M; Evers, Silvia M A A; Arntz, Arnoud

    2012-01-24

    Despite international guidelines describing psychotherapy as first choice for people with personality disorders (PDs), well-designed research on the effectiveness and cost-effectiveness of psychotherapy for PD is scarce. Schema therapy (ST) is a specific form of psychological treatment that proved to be effective for borderline PD. Randomized controlled studies on the effectiveness of ST for other PDs are lacking. Another not yet tested new specialized treatment is Clarification Oriented Psychotherapy (COP). The aim of this project is to perform an effectiveness study as well as an economic evaluation study (cost effectiveness as well as cost-utility) comparing ST versus COP versus treatment as usual (TAU). In this study, we focus on avoidant, dependent, obsessive-compulsive, paranoid, histrionic and narcissistic PD. In a multicentered randomized controlled trial, ST, and COP as an extra experimental condition, are compared to TAU. Minimal 300 patients are recruited in 12 mental health institutes throughout the Netherlands, and receive an extensive screening prior to enrolment in the study. When eligible, they are randomly assigned to one of the intervention groups. An economic evaluation and a qualitative research study on patient and therapist perspectives on ST are embedded in this trial. Outcome assessments (both for clinical effectiveness and economic evaluation) take place at 6,12,18,24 and 36 months after start of treatment. Primary outcome is recovery from PD; secondary measures include general psychopathological complaints, social functioning and quality of life. Data for the cost-effectiveness and cost-utility analyses are collected by using a retrospective cost interview. Information on patient and therapist perspectives is gathered using in-depth interviews and focus groups, and focuses on possible helpful and impeding aspects of ST. This trial is the first to compare ST and COP head-to-head with TAU for people with a cluster C, paranoid, histrionic and

  15. Recent advances in the biologic therapy of lupus: the 10 most important areas to look for common pitfalls in clinical trials.

    Science.gov (United States)

    Medina-Rosas, Jorge; Al-Rayes, Hanan; Moustafa, Ahmed T; Touma, Zahi

    2016-10-01

    Systemic lupus erythematosus (SLE) is an autoimmune disease affecting different organs. The improved knowledge of the disease's pathogenesis has contributed to the emergence of immune targets and new biologic drugs directed at them. Although rheumatologists continue to use off-label biologics in SLE resistant to other immunosuppressants, only belimumab has been approved as a biological therapy since 2011. In this review, an overview is provided on: 1) the classification of the biologic drugs in clinical trials and of those under research; 2) the results of clinical trials of biologic therapy with an interpretation of pitfalls and syntheses of potential approaches to overcome these pitfalls and, 3) the commonly used disease activity metrics and composite indices for assessing response to drugs. Some drugs that have failed in previous drug trials have shown to be efficacious in the treatment of lupus in observational studies. Moreover, the post-hoc analyses of the data of negative drug trials have shown that results of the same trials could be altered with the modification of some pitfalls. For future clinical trials, the consideration of these pitfalls is crucial when designing clinical trials. This could potentially enhance the approval of novel drugs for SLE.

  16. Phase II clinical trial of peptide cocktail therapy for patients with advanced pancreatic cancer: VENUS-PC study.

    Science.gov (United States)

    Suzuki, Nobuaki; Hazama, Shoichi; Iguchi, Haruo; Uesugi, Kazuhiro; Tanaka, Hiroaki; Hirakawa, Kosei; Aruga, Atsushi; Hatori, Takashi; Ishizaki, Hidenobu; Umeda, Yuzo; Fujiwara, Toshiyoshi; Ikemoto, Tetsuya; Shimada, Mitsuo; Yoshimatsu, Kazuhiko; Shimizu, Ryoichi; Hayashi, Hiroto; Sakata, Koichiro; Takenouchi, Hiroko; Matsui, Hiroto; Shindo, Yoshitaro; Iida, Michihisa; Koki, Yasunobu; Arima, Hideki; Furukawa, Hiroyuki; Ueno, Tomio; Yoshino, Shigefumi; Nakamura, Yusuke; Oka, Masaaki; Nagano, Hiroaki

    2017-01-01

    We previously conducted a phase I clinical trial combining the HLA-A*2402-restricted KIF20A-derived peptide vaccine with gemcitabine for advanced pancreatic cancer (PC) and confirmed its safety and immunogenicity in cancer patients. In this study, we conducted a multicenter, single-armed, phase II trial using two antiangiogenic cancer vaccines targeting VEGFR1 and VEGFR2 in addition to the KIF20A peptide. We attempted to evaluate the clinical benefit of the cancer vaccination in combination with gemcitabine. Chemotherapy naïve PC patients were enrolled to evaluate primarily the 1-year survival rate, and secondarily overall survival (OS), progression free survival (PFS), response rate (RR), disease control rate (DCR) and the peptide-specific immune responses. All enrolled patients received therapy without the HLA-A information, and the HLA genotypes were used for classification of the patients. Between June 2012 and May 2013, a total of 68 patients were enrolled. No severe systemic adverse effects of Grade 3 or higher related to these three peptides were observed. The 1-year survival rates between the HLA-A*2402-matched and -unmatched groups were not significantly different. In the HLA-A*2402 matched group, patients showing peptide-specific CTL induction for KIF20A or VEGFR1 showed a better prognosis compared to those without such induction (P = 0.023, P = 0.009, respectively). In the HLA-A*2402-matched group, the patients who showed a strong injection site reaction had a better survival rate (P = 0.017) compared to those with a weak or no injection site reaction. This phase II study demonstrated that this therapeutic peptide cocktail might be effective in patients who demonstrate peptide-specific immune reactions although predictive biomarkers are needed for patient selection in its further clinical application. © 2016 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association.

  17. Different bismuth-based therapies for eradicating Helicobacter pylori: Randomized clinical trial of efficacy and safety.

    Science.gov (United States)

    Gokcan, Hale; Oztas, Erkin; Onal, Ibrahim Koral

    2016-02-01

    Bismuth salts are used for treating dyspepsia, and they exert antibacterial effects on Helicobacter pylori. This study aimed to compare the efficacy and safety of three bismuth-containing combination regimens for H. pylori eradication in a Turkish population. In this single-center study, 149 patients, who were diagnosed with H. pylori infection with urea breath test and histopathological examination, were randomized to receive the following therapies for 14 days: (1) bismuth-containing clarithromycin-based triple therapy (CBS-LAC), (2) bismuth-containing levofloxacin-based triple therapy (CBS-LAL), and (3) bismuth-containing quadruple therapy (BCQT). Eradication rates were evaluated six weeks after the treatment by performing intention to treat (ITT) and per protocol (PP) analyses. In addition, data on side effect profiles and patient compliance were collected. PP and ITT analyses showed that eradication rates were 86% and 81.1%, respectively, with BCQT; 68.3% and 66.7%, respectively, with CBS-LAL therapy; and 65.3% and 59.3%, respectively, with CBS-LAC therapy. Eradication rates obtained using PP and ITT analyses were statistically significant for all the regimens. Addition of bismuth to standard triple and levofloxacin-based regimen did not show an acceptable increase in eradication rates. Therefore, BCQT may be preferred for the first-line treatment of H. pylori infection. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  18. Medical expulsive therapy in urolithiasis: a mixed treatment comparison network meta-analysis of randomized controlled clinical trials.

    Science.gov (United States)

    Sridharan, Kannan; Sivaramakrishnan, Gowri

    2017-10-01

    Medical expulsive therapy (MET) using alpha blockers, calcium channel blockers (CCB), phosphodiesterase inhibitors (PDEI) and spasmolytics have been shown to be effective in clinical trials on urolithiasis. The present study is a network meta-analysis comparing the above mentioned drug classes. Electronic databases were searched for randomized controlled trials comparing the above mentioned drug classes in patients with urolithiasis using appropriate search strategy. Inverse variance heterogeneity model was used for the mixed treatment comparisons. Stone expulsion rate (SER) was the primary and stone expulsion time (SET) was the main secondary outcome measure. We included a total of 114 studies for systematic review and 108 studies for the network meta-analysis. Alpha blockers, PDEI, and combined alpha blockers and corticosteroids had significantly increased SER and shorter SET than placebo or standard of care. Alpha blockers have the highest probability of being the 'best' in the pool with regard to SER. This effect persisted in patients with stones ≥ 5 mm, children, after shockwave lithotripsy, proximal ureteric stones and distal ureteric stones. To conclude, we observed a statistically significant increase in the expulsion rate and shorter expulsion time with alpha blockers, PDEI and combined alpha blockers with corticosteroids. Of these interventions, alpha blockers have the high probability of being the 'best'.

  19. A phase III clinical trial of exercise modalities on treatment side-effects in men receiving therapy for prostate cancer

    Directory of Open Access Journals (Sweden)

    Wall Bradley

    2009-06-01

    exercise in this patient population specifically targeting bone density, cardiovascular function, lean and fat mass, physical function and falls risk as primary study endpoints. In terms of advancement of prostate cancer care, we expect dissemination of the knowledge gained from this project to reduce fracture risk, improve physical and functional ability, quality of life and ultimately survival rate in this population. Clinical Trial Registry A Phase III clinical trial of exercise modalities on treatment side-effects in men receiving therapy for prostate cancer; ACTRN12609000200280

  20. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Kraus, V B; Blanco, F J; Englund, M

    2015-01-01

    The objective of this work was to describe requirements for inclusion of soluble biomarkers in osteoarthritis (OA) clinical trials and progress toward OA-related biomarker qualification. The Guidelines for Biomarkers Working Group, representing experts in the field of OA biomarker research from...... both academia and industry, convened to discuss issues related to soluble biomarkers and to make recommendations for their use in OA clinical trials based on current knowledge and anticipated benefits. This document summarizes current guidance on use of biomarkers in OA clinical trials...... and their utility at five stages, including preclinical development and phase I to phase IV trials. As demonstrated by this summary, biomarkers can provide value at all stages of therapeutics development. When resources permit, we recommend collection of biospecimens in all OA clinical trials for a wide variety...

  1. Dialectical behaviour therapy skills training compared to standard group therapy in borderline personality disorder: a 3-month randomised controlled clinical trial.

    Science.gov (United States)

    Soler, Joaquim; Pascual, Juan Carlos; Tiana, Thaïs; Cebrià, Anabel; Barrachina, Judith; Campins, M Josefa; Gich, Ignasi; Alvarez, Enrique; Pérez, Víctor

    2009-05-01

    Dialectical behaviour therapy (DBT) has proven to be an effective treatment in borderline personality disorder (BPD). However, the effectiveness in BPD of DBT skills training (DBT-ST) alone is not known. This study aimed at comparing the efficacy of DBT-ST and standard group therapy (SGT) for outpatients with BPD. Sixty patients meeting the DSM-IV diagnostic criteria for BPD, as assessed by two semi-structured diagnostic interviews, were included in a 3-month, single-blind randomised controlled trial. A total of 13 weekly group psychotherapy sessions of 120 min of either SGT or DBT-ST were conducted. Assessments were carried out every 2 weeks by two blinded evaluators. Observer-rater, self-report scales and behavioural reports were used as outcome measures. DBT-ST was associated with lower dropout rates, 34.5% compared to 63.4% with SGT. It was superior to SGT in improving several mood and emotion areas, such as: depression, anxiety, irritability, anger and affect instability. A reduction in general psychiatric symptoms was also observed. Three-months weekly DBT-ST proved useful. This therapy was associated with greater clinical improvements and lower dropout rates than SGT. DBT-ST seems to play a role in the overall improvement of BPD seen with standard DBT intervention. It allows straightforward implementation in a wide range of mental health settings and provides the additional advantage that it is cost effective.

  2. Customized Versus Noncustomized Sound Therapy for Treatment of Tinnitus: A Randomized Crossover Clinical Trial.

    Science.gov (United States)

    Mahboubi, Hossein; Haidar, Yarah M; Kiumehr, Saman; Ziai, Kasra; Djalilian, Hamid R

    2017-10-01

    To determine the effectiveness of a customized sound therapy and compare its effectiveness to that of masking with broadband noise. Subjects were randomized to receive either customized sound therapy or broadband noise for 2 hours per day for 3 months and then switched to the other treatment after a washout period. The outcome variables were tinnitus loudness (scored 0-10), Tinnitus Handicap Inventory (THI), Beck Anxiety Inventory (BAI), minimum masking levels (MML), and residual inhibition (RI). Eighteen subjects completed the study. Mean age was 53 ± 11 years, and mean tinnitus duration was 118 ± 99 months. With customized sound therapy, mean loudness decreased from 6.4 ± 2.0 to 4.9 ± 1.9 ( P = .001), mean THI decreased from 42.8 ± 21.6 to 31.5 ± 20.3 ( P tinnitus patients, and the results may be superior to broadband noise.

  3. Randomised controlled trial of non-directive counselling, cognitive-behaviour therapy, and usual general practitioner care for patients with depression. I: Clinical effectiveness

    OpenAIRE

    Ward, Elaine; King, Michael; Lloyd, Margaret; Bower, Peter; Sibbald, Bonnie; Farrelly, Sharon; Gabbay, Mark; Tarrier, Nicholas; Addington-Hall, Julia

    2000-01-01

    Objective: To compare the clinical effectiveness of general practitioner care and two general practice based psychological therapies for depressed patients. Design: Prospective, controlled trial with randomised and patient preference allocation arms. Setting: General practices in London and greater Manchester. Participants: 464 of 627 patients presenting with depression or mixed anxiety and depression were suitable for inclusion. Interventions: Usual general practitioner care ...

  4. Physical therapy plus general practitioners' care versus general practitioners' care alone for sciatica: a randomised clinical trial with a 12-month follow-up.

    NARCIS (Netherlands)

    Luijsterburg, P.A.; Verhagen, A.P.; Ostelo, R.W.J.G.; Hoogen, H.J.M. van den; Peul, W.C.; Avezaat, C.J.; Koes, B.W.

    2008-01-01

    A randomised clinical trial in primary care with a 12-months follow-up period. About 135 patients with acute sciatica (recruited from May 2003 to November 2004) were randomised in two groups: (1) the intervention group received physical therapy (PT) added to the general practitioners' care, and (2)

  5. Cost-Effectiveness of Primary Care Management With or Without Early Physical Therapy for Acute Low Back Pain: Economic Evaluation of a Randomized Clinical Trial.

    Science.gov (United States)

    Fritz, Julie M; Kim, Minchul; Magel, John S; Asche, Carl V

    2017-03-01

    Economic evaluation of a randomized clinical trial. Compare costs and cost-effectiveness of usual primary care management for patients with acute low back pain (LBP) with or without the addition of early physical therapy. Low back pain is among the most common and costly conditions encountered in primary care. Early physical therapy after a new primary care consultation for acute LBP results in small clinical improvement but cost-effectiveness of a strategy of early physical therapy is unknown. Economic evaluation was conducted alongside a randomized clinical trial of patients with acute, nonspecific LBP consulting a primary care provider. All patients received usual primary care management and education, and were randomly assigned to receive four sessions of physical therapy or usual care of delaying referral consideration to permit spontaneous recovery. Data were collected in a randomized trial involving 220 participants age 18 to 60 with LBP Early physical therapy resulted in higher total 1-year costs (mean difference in adjusted total costs = $580, 95% CI: $175, $984, P = 0.005) and better quality of life (mean difference in QALYs = 0.02, 95% CI: 0.005, 0.35, P = 0.008) after 1-year. The incremental cost-effectiveness ratio was $32,058 (95% CI: $10,629, $151,161) per QALY. Our results support early physical therapy as cost-effective relative to usual primary care after 1 year for patients with acute, nonspecific LBP. 2.

  6. Virtual Reality Cognitive Behavior Therapy for Public Speaking Anxiety: A Randomized Clinical Trial

    Science.gov (United States)

    Wallach, Helene S.; Safir, Marilyn P.; Bar-Zvi, Margalit

    2009-01-01

    Public speaking anxiety (PSA) is a common phobia. Although cognitive behavior therapy (CBT) is preferred, difficulties arise with the exposure component (lack of therapist control, patient's inability to imagine, self-flooding, loss of confidentiality resulting from public exposure). Virtual reality CBT (VRCBT) enables a high degree of therapist…

  7. Cognitive-Behavioral Therapy to Promote Smoking Cessation among African American Smokers: A Randomized Clinical Trial

    Science.gov (United States)

    Webb, Monica S.; de Ybarra, Denise Rodriguez; Baker, Elizabeth A.; Reis, Isildinha M.; Carey, Michael P.

    2010-01-01

    Objective: The health consequences of tobacco smoking disproportionately affect African Americans, but research on whether efficacious interventions can be generalized to this population is limited. This study examined the efficacy of group-based cognitive-behavioral therapy (CBT) for smoking cessation among African Americans. Method: Participants…

  8. Parent-Child Interaction Therapy for Mexican Americans: A Randomized Clinical Trial

    Science.gov (United States)

    McCabe, Kristen; Yeh, May

    2009-01-01

    This study compared the effectiveness of a culturally modified version of Parent-Child Interaction Therapy (PCIT), called Guiando a Ninos Activos (GANA), to the effectiveness of standard PCIT and Treatment as Usual (TAU) for young Mexican American children with behavior problems. Fifty-eight Mexican American families whose 3- to 7-year-old child…

  9. Effect of General Anesthesia and Conscious Sedation During Endovascular Therapy on Infarct Growth and Clinical Outcomes in Acute Ischemic Stroke: A Randomized Clinical Trial

    DEFF Research Database (Denmark)

    Simonsen, Claus Ziegler; Yoo, Albert J; Sørensen, Leif Hougaard

    2018-01-01

    (GA) is associated with worse outcomes compared with conscious sedation (CS). Objective: To examine the effect of type of anesthesia during EVT on infarct growth and clinical outcome. Design, Setting, and Participants: The General or Local Anesthesia in Intra Arterial Therapy (GOLIATH) trial......: Of 128 patients included in the trial, 65 were randomized to GA, and 63 were randomized to CS. For the entire cohort, the mean (SD) age was 71.4 (11.4) years, and 62 (48.4%) were women. Baseline demographic and clinical variables were balanced between the GA and CS treatment arms. The median National...... among patients treated under GA or CS did not reach statistical significance (median [IQR] growth, 8.2 [2.2-38.6] mL vs 19.4 [2.4-79.0] mL; P = .10). There were better clinical outcomes in the GA group, with an odds ratio for a shift to a lower modified Rankin Scale score of 1.91 (95% CI, 1...

  10. Nifurtimox-eflornithine combination therapy for second-stage Trypanosoma brucei gambiense sleeping sickness: a randomized clinical trial in Congo.

    Science.gov (United States)

    Priotto, Gerardo; Kasparian, Serena; Ngouama, Daniel; Ghorashian, Sara; Arnold, Ute; Ghabri, Salah; Karunakara, Unni

    2007-12-01

    Human African trypanosomiasis caused by Trypanosoma brucei gambiense is a fatal disease. Current treatment options for patients with second-stage disease are either highly toxic or impracticable in field conditions. We compared the efficacy and safety of the nifurtimox-eflornithine drug combination with the standard eflornithine regimen for the treatment of second-stage disease. A randomized, open-label, active-control, phase III clinical trial comparing 2 arms was conducted at the Sleeping Sickness Treatment Center, which was run by Medecins Sans Frontieres, in Nkayi, Bouenza Province, Republic of Congo. Patients were screened for inclusion and randomly assigned to receive eflornithine alone (400 mg/kg per day given intravenously every 6 h for 14 days) or eflornithine (400 mg/kg per day given intravenously every 12 h for 7 days) plus nifurtimox (15 mg/kg per day given orally every 8 h for 10 days). Patients were observed for 18 months. The study's outcomes were cure and adverse events attributable to treatment. A total of 103 patients with second-stage disease were enrolled. Cure rates were 94.1% for the eflornithine group and 96.2% for the nifurtimox-eflornithine group. Drug reactions were frequent in both arms, and severe reactions affected 25.5% of patients in the eflornithine group and 9.6% of those in the nifurtimox-eflornithine group, resulting in 2 and 1 treatment suspensions, respectively. There was 1 death in the eflornithine arm and no deaths in the nifurtimox-eflornithine arm. The nifurtimox-eflornithine combination appears to be a promising first-line therapy for second-stage sleeping sickness. If our findings are corroborated by ongoing findings from additional sites (a multicenter extension of this study), the new nifurtimox-eflornithine combination therapy will mark a major and multifaceted advance over current therapies.

  11. Chiropractic spinal manipulative therapy for migraine: a study protocol of a single-blinded placebo-controlled randomised clinical trial.

    Science.gov (United States)

    Chaibi, Aleksander; Šaltytė Benth, Jūratė; Tuchin, Peter J; Russell, Michael Bjørn

    2015-11-19

    Migraine affects 15% of the population, and has substantial health and socioeconomic costs. Pharmacological management is first-line treatment. However, acute and/or prophylactic medicine might not be tolerated due to side effects or contraindications. Thus, we aim to assess the efficacy of chiropractic spinal manipulative therapy (CSMT) for migraineurs in a single-blinded placebo-controlled randomised clinical trial (RCT). According to the power calculations, 90 participants are needed in the RCT. Participants will be randomised into one of three groups: CSMT, placebo (sham manipulation) and control (usual non-manual management). The RCT consists of three stages: 1 month run-in, 3 months intervention and follow-up analyses at the end of the intervention and 3, 6 and 12 months. The primary end point is migraine frequency, while migraine duration, migraine intensity, headache index (frequency x duration x intensity) and medicine consumption are secondary end points. Primary analysis will assess a change in migraine frequency from baseline to the end of the intervention and follow-up, where the groups CSMT and placebo and CSMT and control will be compared. Owing to two group comparisons, p values below 0.025 will be considered statistically significant. For all secondary end points and analyses, a p value below 0.05 will be used. The results will be presented with the corresponding p values and 95% CIs. The RCT will follow the clinical trial guidelines from the International Headache Society. The Norwegian Regional Committee for Medical Research Ethics and the Norwegian Social Science Data Services have approved the project. Procedure will be conducted according to the declaration of Helsinki. The results will be published at scientific meetings and in peer-reviewed journals. NCT01741714. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  12. Early Physical Therapy vs Usual Care in Patients With Recent-Onset Low Back Pain: A Randomized Clinical Trial.

    Science.gov (United States)

    Fritz, Julie M; Magel, John S; McFadden, Molly; Asche, Carl; Thackeray, Anne; Meier, Whitney; Brennan, Gerard

    2015-10-13

    Low back pain (LBP) is common in primary care. Guidelines recommend delaying referrals for physical therapy. To evaluate whether early physical therapy (manipulation and exercise) is more effective than usual care in improving disability for patients with LBP fitting a decision rule. Randomized clinical trial with 220 participants recruited between March 2011 and November 2013. Participants with no LBP treatment in the past 6 months, aged 18 through 60 years (mean age, 37.4 years [SD, 10.3]), an Oswestry Disability Index (ODI) score of 20 or higher, symptom duration less than 16 days, and no symptoms distal to the knee in the past 72 hours were enrolled following a primary care visit. All participants received education. Early physical therapy (n = 108) consisted of 4 physical therapy sessions. Usual care (n = 112) involved no additional interventions during the first 4 weeks. Primary outcome was change in the ODI score (range: 0-100; higher scores indicate greater disability; minimum clinically important difference, 6 points) at 3 months. Secondary outcomes included changes in the ODI score at 4-week and 1-year follow-up, and change in pain intensity, Pain Catastrophizing Scale (PCS) score, fear-avoidance beliefs, quality of life, patient-reported success, and health care utilization at 4-week, 3-month, and 1-year follow-up. One-year follow-up was completed by 207 participants (94.1%). Using analysis of covariance, early physical therapy showed improvement relative to usual care in disability after 3 months (mean ODI score: early physical therapy group, 41.3 [95% CI, 38.7 to 44.0] at baseline to 6.6 [95% CI, 4.7 to 8.5] at 3 months; usual care group, 40.9 [95% CI, 38.6 to 43.1] at baseline to 9.8 [95% CI, 7.9 to 11.7] at 3 months; between-group difference, -3.2 [95% CI, -5.9 to -0.47], P = .02). A significant difference was found between groups for the ODI score after 4 weeks (between-group difference, -3.5 [95% CI, -6.8 to -0.08], P = .045

  13. Impact of early personal-history characteristics on the Pace of Aging: implications for clinical trials of therapies to slow aging and extend healthspan.

    Science.gov (United States)

    Belsky, Daniel W; Caspi, Avshalom; Cohen, Harvey J; Kraus, William E; Ramrakha, Sandhya; Poulton, Richie; Moffitt, Terrie E

    2017-08-01

    Therapies to extend healthspan are poised to move from laboratory animal models to human clinical trials. Translation from mouse to human will entail challenges, among them the multifactorial heterogeneity of human aging. To inform clinical trials about this heterogeneity, we report how humans' pace of biological aging relates to personal-history characteristics. Because geroprotective therapies must be delivered by midlife to prevent age-related disease onset, we studied young-adult members of the Dunedin Study 1972-73 birth cohort (n = 954). Cohort members' Pace of Aging was measured as coordinated decline in the integrity of multiple organ systems, by quantifying rate of decline across repeated measurements of 18 biomarkers assayed when cohort members were ages 26, 32, and 38 years. The childhood personal-history characteristics studied were known predictors of age-related disease and mortality, and were measured prospectively during childhood. Personal-history characteristics of familial longevity, childhood social class, adverse childhood experiences, and childhood health, intelligence, and self-control all predicted differences in cohort members' adulthood Pace of Aging. Accumulation of more personal-history risks predicted faster Pace of Aging. Because trials of anti-aging therapies will need to ascertain personal histories retrospectively, we replicated results using cohort members' retrospective personal-history reports made in adulthood. Because many trials recruit participants from clinical settings, we replicated results in the cohort subset who had recent health system contact according to electronic medical records. Quick, inexpensive measures of trial participants' early personal histories can enable clinical trials to study who volunteers for trials, who adheres to treatment, and who responds to anti-aging therapies. © 2017 The Authors. Aging Cell published by the Anatomical Society and John Wiley & Sons Ltd.

  14. Initiating Antiretroviral Therapy for HIV at a Patient's First Clinic Visit: The RapIT Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Sydney Rosen

    2016-05-01

    Full Text Available High rates of patient attrition from care between HIV testing and antiretroviral therapy (ART initiation have been documented in sub-Saharan Africa, contributing to persistently low CD4 cell counts at treatment initiation. One reason for this is that starting ART in many countries is a lengthy and burdensome process, imposing long waits and multiple clinic visits on patients. We estimated the effect on uptake of ART and viral suppression of an accelerated initiation algorithm that allowed treatment-eligible patients to be dispensed their first supply of antiretroviral medications on the day of their first HIV-related clinic visit.RapIT (Rapid Initiation of Treatment was an unblinded randomized controlled trial of single-visit ART initiation in two public sector clinics in South Africa, a primary health clinic (PHC and a hospital-based HIV clinic. Adult (≥18 y old, non-pregnant patients receiving a positive HIV test or first treatment-eligible CD4 count were randomized to standard or rapid initiation. Patients in the rapid-initiation arm of the study ("rapid arm" received a point-of-care (POC CD4 count if needed; those who were ART-eligible received a POC tuberculosis (TB test if symptomatic, POC blood tests, physical exam, education, counseling, and antiretroviral (ARV dispensing. Patients in the standard-initiation arm of the study ("standard arm" followed standard clinic procedures (three to five additional clinic visits over 2-4 wk prior to ARV dispensing. Follow up was by record review only. The primary outcome was viral suppression, defined as initiated, retained in care, and suppressed (≤400 copies/ml within 10 mo of study enrollment. Secondary outcomes included initiation of ART ≤90 d of study enrollment, retention in care, time to ART initiation, patient-level predictors of primary outcomes, prevalence of TB symptoms, and the feasibility and acceptability of the intervention. A survival analysis was conducted comparing attrition

  15. Fundamentals of clinical trials

    CERN Document Server

    Friedman, Lawrence M; DeMets, David L; Reboussin, David M; Granger, Christopher B

    2015-01-01

    This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise.  Most chapters have been revised considerably from the fourth edition.  A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded.  Many contemporary clinical trial examples have been added.  There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing, and international trials.  This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of ...

  16. Randomized clinical trial of artemisinin versus non-artemisinin combination therapy for uncomplicated falciparum malaria in Madagascar

    Directory of Open Access Journals (Sweden)

    Ratsimbasoa Arsène

    2007-05-01

    Full Text Available Abstract Background Data concerning antimalarial combination treatment for uncomplicated malaria in Madagascar are largely lacking. Randomized clinical trial was designed to assess therapeutic efficacies of chloroquine (CQ, amodiaquine (AQ, sulphadoxine-pyrimethamine (SP, amodiaquine plus sulphadoxine-pyrimethamine combination (AQ+SP and artesunate plus amodiaquine combination (AQ+AS. Methods 287 children between 6 months and 15 years of age, with uncomplicated falciparum malaria, were enrolled in the study. Primary endpoints were the day-14 and day-28 risks of parasitological failure, either unadjusted or adjusted by genotyping. Results All treatment regimens, except for CQ treatment, gave clinical cure rates above 97% by day-14 and 92% by day-28 (PCR-corrected. AQ+SP was as effective as AQ+AS. The risk of new infection within the month after therapy was generally higher for AQ+AS than AQ+SP. Conclusion These findings show that the inexpensive and widely available combination AQ+SP may be valuable in for the treatment of uncomplicated malaria in Madagascar and could have an important role in this country, where much of the drugs administered go to patients who do not have malaria.

  17. Current Molecular Targeted Therapy in Advanced Gastric Cancer: A Comprehensive Review of Therapeutic Mechanism, Clinical Trials, and Practical Application

    Directory of Open Access Journals (Sweden)

    Kaichun Li

    2016-01-01

    Full Text Available Despite the great progress in the treatment of gastric cancer, it is still the third leading cause of cancer death worldwide. Patients often miss the opportunity for a surgical cure, because the cancer has already developed into advanced cancer when identified. Compared to best supportive care, chemotherapy can improve quality of life and prolong survival time, but the overall survival is often short. Due to the molecular study of gastric cancer, new molecular targeted drugs have entered the clinical use. Trastuzumab, an antibody targeting human epidermal growth factor receptor 2 (HER2, can significantly improve survival in advanced gastric cancer patients with HER2 overexpression. Second-line treatment of advanced gastric cancer with ramucirumab, an antibody targeting VEGFR-2, alone or in combination with paclitaxel, has been proved to provide a beneficial effect. The VEGFR-2 tyrosine kinase inhibitor, apatinib, can improve the survival of advanced gastric cancer patients after second-line chemotherapy failure. Unfortunately, none of the EGFR targeting antibodies (cetuximab or panitumumab, VEGF targeting monoclonal antibodies (bevacizumab, mTOR inhibitor (everolimus, or HGF/MET pathway targeting drugs has a significant survival benefit. Many other clinical trials based on molecular markers are underway. This review will summarize targeted therapies for advanced gastric cancer.

  18. Laser Therapy and Occlusal Stabilization Splint for Temporomandibular Disorders in Patients With Fibromyalgia Syndrome: A Randomized, Clinical Trial.

    Science.gov (United States)

    Molina-Torres, Guadalupe; Rodríguez-Archilla, Alberto; Matarán-Peñarrocha, Guillermo; Albornoz-Cabello, Manuel; Aguilar-Ferrándiz, María Encarnación; Castro-Sánchez, Adelaida María

    2016-09-01

    Context • Patients with fibromyalgia syndrome (FMS) report frequent and severe symptoms from temporomandibular disorders (TMDs). The appropriate treatment of TMDs remains controversial. No studies have occurred on the efficacy of therapy with a laser or an occlusal stabilization splint in the treatment of TMDs in patients with FMS. Objective • The study intended to investigate the therapeutic effects of laser therapy and of an occlusal stabilization splint for reducing pain and dysfunction and improving the quality of sleep in patients with TMDs and FMS. Design • The research team designed a single-blinded, randomized clinical trial. Setting • The study took place in the research laboratory at the University of Granada (Granada, Spain). Participants • Participants were 58 women and men who had been diagnosed with FMS and TMDs and who were referred from the clinical setting. Intervention • Participants were randomly assigned to the occlusal-splint or the laser group. The laser group received a treatment protocol in which laser therapy was applied to the participant's tender points, and the occlusal-splint group underwent a treatment protocol in which an occlusal stabilization splint was used. Both groups underwent treatment for 12 wk. Outcomes Measures • Pain intensity, widespread pain, quality of sleep, severity of symptoms, active and passive mouth opening, and joint sounds were assessed in both groups at baseline and after the last intervention. The measurements used were (1) a visual analogue scale (VAS), (2) the Widespread Pain Index (WPI), (3) the Symptom Severity Scale (SSS), (4) the Patient's Global Impression of Change (PGIC), (5) the Pittsburgh Quality of Sleep Questionnaire Index (PSQI), (6) an assessment of the number of tender points, (7) a measurement of the active mouth opening, (8) a measurement of the vertical overlap of the incisors, and (9) the measurement of joint sounds during mouth opening and closing. Results • The group X time

  19. Randomized Clinical Trial Comparing Proton Beam Radiation Therapy with Transarterial Chemoembolization for Hepatocellular Carcinoma: Results of an Interim Analysis

    Energy Technology Data Exchange (ETDEWEB)

    Bush, David A., E-mail: dbush@llu.edu [Department of Radiation Medicine, Loma Linda University Medical Center, Loma Linda, California (United States); Smith, Jason C. [Department of Diagnostic Radiology, Loma Linda University Medical Center, Loma Linda, California (United States); Slater, Jerry D. [Department of Radiation Medicine, Loma Linda University Medical Center, Loma Linda, California (United States); Volk, Michael L. [Transplantation Institute and Liver Center, Loma Linda University Medical Center, Loma Linda, California (United States); Reeves, Mark E. [VA Loma Linda Health Care System, Loma Linda, California (United States); Cheng, Jason [Transplantation Institute and Liver Center, Loma Linda University Medical Center, Loma Linda, California (United States); Grove, Roger [Department of Radiation Medicine, Loma Linda University Medical Center, Loma Linda, California (United States); Vera, Michael E. de [Transplantation Institute and Liver Center, Loma Linda University Medical Center, Loma Linda, California (United States)

    2016-05-01

    Purpose: To describe results of a planned interim analysis of a prospective, randomized clinical trial developed to compare treatment outcomes among patients with newly diagnosed hepatocellular carcinoma (HCC). Methods and Materials: Eligible subjects had either clinical or pathologic diagnosis of HCC and met either Milan or San Francisco transplant criteria. Patients were randomly assigned to transarterial chemoembolization (TACE) or to proton beam radiation therapy. Patients randomized to TACE received at least 1 TACE with additional TACE for persistent disease. Proton beam radiation therapy was delivered to all areas of gross disease to a total dose of 70.2 Gy in 15 daily fractions over 3 weeks. The primary endpoint was progression-free survival, with secondary endpoints of overall survival, local tumor control, and treatment-related toxicities as represented by posttreatment days of hospitalization. Results: At the time of this analysis 69 subjects were available for analysis. Of these, 36 were randomized to TACE and 33 to proton. Total days of hospitalization within 30 days of TACE/proton was 166 and 24 days, respectively (P<.001). Ten TACE and 12 proton patients underwent liver transplantation after treatment. Viable tumor identified in the explanted livers after TACE/proton averaged 2.4 and 0.9 cm, respectively. Pathologic complete response after TACE/proton was 10%/25% (P=.38). The 2-year overall survival for all patients was 59%, with no difference between treatment groups. Median survival time was 30 months (95% confidence interval 20.7-39.3 months). There was a trend toward improved 2-year local tumor control (88% vs 45%, P=.06) and progression-free survival (48% vs 31%, P=.06) favoring the proton beam treatment group. Conclusions: This interim analysis indicates similar overall survival rates for proton beam radiation therapy and TACE. There is a trend toward improved local tumor control and progression-free survival with proton beam. There are

  20. Cognitive behavioral therapy for patients with primary insomnia or insomnia associated predominantly with mixed psychiatric disorders: a randomized clinical trial.

    Science.gov (United States)

    Edinger, Jack D; Olsen, Maren K; Stechuchak, Karen M; Means, Melanie K; Lineberger, Margaret D; Kirby, Angela; Carney, Colleen E

    2009-04-01

    This study was conducted to evaluate the efficacy of cognitive behavioral therapy (CBT) against a sleep hygiene education control therapy in patients with primary or comorbid insomnia. Randomized, parallel-group, clinical trial conducted at a single Veterans Affairs medical center, with recruitment from March 2001 to June 2005. Eighty-one adults (n = 11 women; mean age, 54.2 years) with chronic primary (n = 40) or comorbid insomnia associated predominantly with mixed psychiatric disorders (n = 41). Patients, screened via structured interviews and diagnostic polysomnography, were randomly assigned to receive CBT (sleep education, stimulus control, and time-in-bed restrictions; 20 patients with primary and 21 with comorbid insomnia), or sleep hygiene (SH: education about aspects of lifestyle and the bedroom environment that affect sleep; 20 patients with primary and 20 with comorbid insomnia). Outpatient treatment included 4 biweekly sessions with a posttreatment assessment and a follow-up conducted at 6 months. Participants completed actigraphy and sleep diaries for 2 weeks prior to therapy, during a 2-week posttreatment assessment, and during 2 weeks at follow-up. They also completed questionnaires measuring global insomnia symptoms, general sleep quality, and sleep-disruptive beliefs before treatment, immediately following treatment, and at the follow-up time point. Consistent with previous studies, CBT outperformed sleep hygiene across several study outcome measures for the sample as a whole. Statistical analyses showed no significant 3-way interaction of treatment group, time, and insomnia type for any of the sleep or questionnaire measures, suggesting the benefits of CBT over sleep hygiene were comparable for patients with primary insomnia and comorbid insomnia. Moreover, only 1 of several indexes of clinically notable improvement suggested a significantly better response to CBT by patients with primary insomnia, as compared with those with comorbid insomnia. A

  1. Psycho-education with problem solving (PEPS) therapy for adults with personality disorder: a pragmatic multi-site community-based randomised clinical trial.

    Science.gov (United States)

    McMurran, Mary; Crawford, Mike J; Reilly, Joseph G; McCrone, Paul; Moran, Paul; Williams, Hywel; Adams, Clive E; Duggan, Conor; Delport, Juan; Whitham, Diane; Day, Florence

    2011-08-24

    Impairment in social functioning is a key component of personality disorder. Therefore psycho-education and problem solving (PEPS) therapy may benefit people with this disorder. Psycho-education aims to educate, build rapport, and motivate people for problem solving therapy. Problem solving therapy aims to help clients solve interpersonal problems positively and rationally, thereby improving social functioning and reducing distress. PEPS therapy has been evaluated with community adults with personality disorder in an exploratory trial. At the end of treatment, compared to a wait-list control group, those treated with PEPS therapy showed better social functioning, as measured by the Social Functioning Questionnaire (SFQ). A definitive evaluation is now being conducted to determine whether PEPS therapy is a clinically and cost-effective treatment for people with personality disorder This is a pragmatic, two-arm, multi-centre, parallel, randomised controlled clinical trial. The target population is community-dwelling adults with one or more personality disorder, as identified by the International Personality Disorder Examination (IPDE). Inclusion criteria are: Living in the community (including residential or supported care settings); presence of one or more personality disorder; aged 18 or over; proficiency in spoken English; capacity to provide informed consent. Exclusion criteria are: Primary diagnosis of a functional psychosis; insufficient degree of literacy, comprehension or attention to be able to engage in trial therapy and assessments; currently engaged in a specific programme of psychological treatment for personality disorder or likely to start such treatment during the trial period; currently enrolled in any other trial. Suitable participants are randomly allocated to PEPS therapy plus treatment as usual (TAU) or TAU only. We aim to recruit 340 men and women. The primary outcome is social functioning as measured by the SFQ. A reduction (i.e., an

  2. A Randomized Clinical Trial of Cognitive Enhancement Therapy for Adults with Autism Spectrum Disorders

    Science.gov (United States)

    2013-10-01

    Mayer-Salovey-Caruso Emotional Intelligence Test, and the Penn Emotion Recognition Test, both performance-based measures of social cognition that... Autism Spectrum Disorders PRINCIPAL INVESTIGATOR: Nancy J. Minshew, M.D. CONTRACTING ORGANIZATION: University of Pittsburgh...Enhancement Therapy for Adults with Autism Spectrum Disorders 5a. CONTRACT NUMBER W81XWH-11-1-0665 5b. GRANT NUMBER W81XWH-11-1-0665 5c. PROGRAM

  3. Randomized clinical trial examining the effect of music therapy in stress response to day surgery.

    Science.gov (United States)

    Leardi, S; Pietroletti, R; Angeloni, G; Necozione, S; Ranalletta, G; Del Gusto, B

    2007-08-01

    Music therapy could reduce stress and the stress response. The aim of this study was to investigate the role of music therapy in alleviating stress during day surgery. Sixty patients undergoing day surgery were randomized to one of three groups, each containing 20 patients. Before and during surgery, patients in group 1 listened to new age music and those in group 2 listened to a choice of music from one of four styles. Patients in group 3 (control group) heard the normal sounds of the operating theatre. Plasma levels of cortisol and subpopulations of lymphocytes were evaluated before, during and after operation. Plasma cortisol levels decreased during operation in both groups of patients who listened to music, but increased in the control group. Postoperative cortisol levels were significantly higher in group 1 than in group 2 (mean(s.d.) 14.21(6.96) versus 8.63(2.72) ng/dl respectively; P music therapy changed the neurohormonal and immune stress response to day surgery, especially when the type of music was selected by the patient. Copyright (c) 2007 British Journal of Surgery Society Ltd.

  4. Multileaf Collimator Tracking Improves Dose Delivery for Prostate Cancer Radiation Therapy: Results of the First Clinical Trial

    DEFF Research Database (Denmark)

    Colvill, Emma; Booth, Jeremy T; O'Brien, Ricky T

    2015-01-01

    collimator tracking was implemented for 15 patients in a prostate cancer radiation therapy trial; in total, 513 treatment fractions were delivered. During each treatment fraction, the prostate trajectory and treatment MLC positions were collected. These data were used as input for dose reconstruction......PURPOSE: To test the hypothesis that multileaf collimator (MLC) tracking improves the consistency between the planned and delivered dose compared with the dose without MLC tracking, in the setting of a prostate cancer volumetric modulated arc therapy trial. METHODS AND MATERIALS: Multileaf...

  5. The PEX study – Exercise therapy for patellofemoral pain syndrome: design of a randomized clinical trial in general practice and sports medicine [ISRCTN83938749

    Science.gov (United States)

    van Linschoten, Robbart; van Middelkoop, Marienke; Berger, Marjolein Y; Heintjes, Edith M; Koopmanschap, Mark A; Verhaar, Jan AN; Koes, Bart W; Bierma-Zeinstra, Sita MA

    2006-01-01

    Background Patellofemoral complaints are frequently seen in younger and active patients. Clinical strategy is usually based on decreasing provoking activities as sports and demanding knee activities during work and leisure and reassuring the patient on the presumed good outcome. Exercise therapy is also often prescribed although evidence on effectiveness is lacking. The objective of this article is to present the design of a randomized clinical trial that examines the outcome of exercise therapy supervised by a physical therapist versus a clinically accepted "wait and see" approach (information and advice about the complaints only). The research will address to both effectiveness and cost effectiveness of supervised exercise therapy in patients with patellofemoral pain syndrome (PFPS). Methods/design 136 patients (adolescents and young adults) with patellofemoral pain syndrome are recruited in general practices and sport medicine centers. They will be randomly allocated receiving either 3 months of exercise therapy (or usual care. The primary outcome measures are pain, knee function and perception of recovery after 3 months and 12 months of follow up and will be measured by self reporting. Measurements will take place at baseline, 6 weeks, and 3 monthly until 1 year after inclusion in the study. Secondary outcome measurements include an economic evaluation. A cost-utility analysis will be performed that expresses health improvements in Quality Adjusted Life Years (QALYs) and incorporates direct medical costs and productivity costs Discussion This study has been designed after reviewing the literature on exercise therapy for patellofemoral pain syndrome. It was concluded that to merit the effect of exercise therapy a trial based on correct methodological concept needed to be executed. The PEX study is a randomized clinical trial where exercise therapy is compared to usual care. This trial started in April 2005 and will finish in June 2007. The first results will be

  6. The PEX study - Exercise therapy for patellofemoral pain syndrome: design of a randomized clinical trial in general practice and sports medicine [ISRCTN83938749].

    Science.gov (United States)

    van Linschoten, Robbart; van Middelkoop, Marienke; Berger, Marjolein Y; Heintjes, Edith M; Koopmanschap, Mark A; Verhaar, Jan A N; Koes, Bart W; Bierma-Zeinstra, Sita M A

    2006-03-17

    Patellofemoral complaints are frequently seen in younger and active patients. Clinical strategy is usually based on decreasing provoking activities as sports and demanding knee activities during work and leisure and reassuring the patient on the presumed good outcome. Exercise therapy is also often prescribed although evidence on effectiveness is lacking. The objective of this article is to present the design of a randomized clinical trial that examines the outcome of exercise therapy supervised by a physical therapist versus a clinically accepted "wait and see" approach (information and advice about the complaints only). The research will address to both effectiveness and cost effectiveness of supervised exercise therapy in patients with patellofemoral pain syndrome (PFPS). 136 patients (adolescents and young adults) with patellofemoral pain syndrome are recruited in general practices and sport medicine centers. They will be randomly allocated receiving either 3 months of exercise therapy (or usual care. The primary outcome measures are pain, knee function and perception of recovery after 3 months and 12 months of follow up and will be measured by self reporting. Measurements will take place at baseline, 6 weeks, and 3 monthly until 1 year after inclusion in the study. Secondary outcome measurements include an economic evaluation.A cost-utility analysis will be performed that expresses health improvements in Quality Adjusted Life Years (QALYs) and incorporates direct medical costs and productivity costs This study has been designed after reviewing the literature on exercise therapy for patellofemoral pain syndrome. It was concluded that to merit the effect of exercise therapy a trial based on correct methodological concept needed to be executed. The PEX study is a randomized clinical trial where exercise therapy is compared to usual care. This trial started in April 2005 and will finish in June 2007. The first results will be available around December 2007.

  7. The PEX study – Exercise therapy for patellofemoral pain syndrome: design of a randomized clinical trial in general practice and sports medicine [ISRCTN83938749

    Directory of Open Access Journals (Sweden)

    Verhaar Jan AN

    2006-03-01

    Full Text Available Abstract Background Patellofemoral complaints are frequently seen in younger and active patients. Clinical strategy is usually based on decreasing provoking activities as sports and demanding knee activities during work and leisure and reassuring the patient on the presumed good outcome. Exercise therapy is also often prescribed although evidence on effectiveness is lacking. The objective of this article is to present the design of a randomized clinical trial that examines the outcome of exercise therapy supervised by a physical therapist versus a clinically accepted "wait and see" approach (information and advice about the complaints only. The research will address to both effectiveness and cost effectiveness of supervised exercise therapy in patients with patellofemoral pain syndrome (PFPS. Methods/design 136 patients (adolescents and young adults with patellofemoral pain syndrome are recruited in general practices and sport medicine centers. They will be randomly allocated receiving either 3 months of exercise therapy (or usual care. The primary outcome measures are pain, knee function and perception of recovery after 3 months and 12 months of follow up and will be measured by self reporting. Measurements will take place at baseline, 6 weeks, and 3 monthly until 1 year after inclusion in the study. Secondary outcome measurements include an economic evaluation. A cost-utility analysis will be performed that expresses health improvements in Quality Adjusted Life Years (QALYs and incorporates direct medical costs and productivity costs Discussion This study has been designed after reviewing the literature on exercise therapy for patellofemoral pain syndrome. It was concluded that to merit the effect of exercise therapy a trial based on correct methodological concept needed to be executed. The PEX study is a randomized clinical trial where exercise therapy is compared to usual care. This trial started in April 2005 and will finish in June 2007

  8. Clinical Trials - Multiple Languages

    Science.gov (United States)

    ... clínicos: Tema de salud de MedlinePlus - español (Spanish) National Library of Medicine Clinical Trials - English ... PDF American Cancer Society Characters not displaying correctly on this page? See language ...

  9. ClinicalTrials.gov

    Data.gov (United States)

    U.S. Department of Health & Human Services — Provides patients, family members, health care professionals, and members of the public easy access to information on clinical trials for a wide range of diseases...

  10. The Right Therapy for Neurological Disorders: From Randomized Trials to Clinical Practice - Patients versus Investigator Expectations and Needs.

    Science.gov (United States)

    Bruijn, Lucie I; Kolb, Steve

    2016-01-01

    People living with amyotrophic lateral sclerosis (ALS) are now more proactive in making decisions about their treatment options, in particular with increased awareness through social media and the Internet. Together with increased awareness about the disease comes increased frustration that there is still only one Food and Drug Administration (FDA)-approved drug that modestly improves survival. While efforts are underway to improve clinical trial design, patient involvement in trial design, clinical outcomes, and risk/benefit evaluations have become more recognized and will play a major role in the future success of clinical trials. This chapter addresses the perspective of people living with ALS and their perceptions of clinical trials. We describe various organizations and programs available that provide increased education and patient involvement. Stronger partnerships between those living with ALS, clinicians, government, nonprofit organizations, and regulatory agencies will significantly impact treatment development. © 2016 S. Karger AG, Basel.

  11. Effects of physical therapy on quality of life in osteoporosis patients - a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Schröder Guido

    2012-08-01

    Full Text Available Abstract Summary The aim of this prospective randomized single-center study was to investigate whether sling exercise therapy is superior to conventional exercises in osteoporosis patients. Background Patients with osteoporosis frequently experience fractures of the vertebral body, which may cause chronic back pain and other symptoms. These, in turn, may lead to immobilization, muscular atrophy, and restrictions in activities of daily living. The situation can be improved with specific medication and physiotherapy. We explored the effects of a variety of physical treatments on activities of daily living in patients with osteoporosis. Method Fifty patients were randomly allocated to two treatment groups. Group A received traditional physiotherapy (PT while group B underwent sling exercise therapy (ST. Both treatments were given twice a week for three months. The results of the treatment were registered on the quality of life questionnaire (Qualeffo-41 devised by the International Osteoporosis Foundation. After a further three months with no specific exercise treatment, we again tested all patients in order to draw conclusions about the long-term effects of both types of exercise. Results Forty-four patients (88% completed the study. Patients were assigned to small groups (a maximum of 5 patients in each group and thus received individual attention and motivation. Quality of life was improved in both groups; a significantly greater improvement was registered in patients who performed sling exercises (Global score Qualeffo: p = 0.002. Conclusion The test results confirm the known positive effects of physical therapy on the quality of life of osteoporosis patients, as well as the fact that sling exercises are a sound alternative treatment for this condition.

  12. Behavioral couples therapy for smoking cessation: A pilot randomized clinical trial.

    Science.gov (United States)

    LaChance, Heather; Cioe, Patricia A; Tooley, Erin; Colby, Suzanne M; O'Farrell, Timothy J; Kahler, Christopher W

    2015-09-01

    Behavioral couples therapy (BCT) has been found to improve long-term abstinence rates in alcohol- and substance-dependent populations but has not been tested for smoking cessation. This pilot study examined the feasibility and acceptability of BCT for smoking-discordant couples. Forty-nine smokers (smoking >10 cigarettes/day) with nonsmoking partners were randomized to receive a couples social support (BCT-S) intervention or an individually delivered, standard smoking cessation treatment (ST). The couples were married or had been cohabiting for at least 1 year, with partners who had never smoked or had not used tobacco in 1 year. Both treatments included 7 weekly sessions and 8 weeks of nicotine replacement therapy. Participants were followed for 6 months posttreatment. The Partner Interaction Questionnaire was used to measure perceived smoking-specific partner support. Participants were 67% male and 88% White. Biochemically verified cessation rates were 40.9%, 50%, and 45% in BCT-S and 59.1%, 50%, and 55% in ST at end of treatment, after 3 month, and after 6 months, respectively, and did not differ significantly between treatment conditions at any time point. Perceived smoking-specific partner support at posttreatment did not significantly differ between treatment groups. Results of this pilot study do not provide support for the efficacy of BCT in smoking-discordant couples. (c) 2015 APA, all rights reserved).

  13. Cell-Based Therapies Used to Treat Lumbar Degenerative Disc Disease: A Systematic Review of Animal Studies and Human Clinical Trials

    Directory of Open Access Journals (Sweden)

    David Oehme

    2015-01-01

    Full Text Available Low back pain and degenerative disc disease are a significant cause of pain and disability worldwide. Advances in regenerative medicine and cell-based therapies, particularly the transplantation of mesenchymal stem cells and intervertebral disc chondrocytes, have led to the publication of numerous studies and clinical trials utilising these biological therapies to treat degenerative spinal conditions, often reporting favourable outcomes. Stem cell mediated disc regeneration may bridge the gap between the two current alternatives for patients with low back pain, often inadequate pain management at one end and invasive surgery at the other. Through cartilage formation and disc regeneration or via modification of pain pathways stem cells are well suited to enhance spinal surgery practice. This paper will systematically review the current status of basic science studies, preclinical and clinical trials utilising cell-based therapies to repair the degenerate intervertebral disc. The mechanism of action of transplanted cells, as well as the limitations of published studies, will be discussed.

  14. A randomized clinical trial of Acceptance and Commitment Therapy vs. Progressive Relaxation Training for obsessive compulsive disorder

    Science.gov (United States)

    Twohig, Michael P.; Hayes, Steven C.; Plumb, Jennifer C.; Pruitt, Larry D.; Collins, Angela B.; Hazlett-Stevens, Holly; Woidneck, Michelle R.

    2010-01-01

    Objective Effective treatments for adult OCD exist, but refusal and drop-out rates are high and treatments are not effective for all individuals who complete them. Thus, additional treatment options are needed. This study investigated the effectiveness of eight sessions of Acceptance and Commitment Therapy (ACT) for adult obsessive compulsive disorder (OCD) compared to Progressive Relaxation Training (PRT). Method 79 adults (66% Female) diagnosed with OCD (M age=37, 89% Caucasian) participated in a randomized clinical trial of 8 sessions of ACT or PRT with no in-session exposure. The following assessments were completed at pretreatment, posttreatment, and three month follow-up by an assessor who was unaware of treatment conditions: Yale-Brown Obsessive Compulsive Scale (Y-BOCS), Beck Depression Inventory-II, Quality of Life Scale, Acceptance and Action Questionnaire, Thought Action Fusion Scale, and Thought Control Questionnaire. The Treatment Evaluation Inventory-Short Form was completed at posttreatment. Results ACT produced greater changes at posttreatment and follow-up over PRT on OCD severity (Y-BOCS: ACT pre=24.22, post=12.76, follow-up=11.79; PRT pre=25.4, post=18.67, follow-up=16.23), and produced greater change on depression among those reporting at least mild depression before treatment. Clinically significant change in OCD severity occurred more in the ACT condition than PRT using multiple criteria (clinical response rates: ACT post=46-56%, follow-up 46-66%; PRT post=13%-18%, follow-up 16-18%). Quality of life improved in both conditions but was marginally in favor of ACT at post. Finally, treatment refusal (2.4% ACT, 7.8% PRT) and drop-out (9.8% ACT, 13.2% PRT) were low in both conditions. Conclusions ACT is worth exploring further as a treatment for OCD. PMID:20873905

  15. Cost-effectiveness and cost-utility of cognitive therapy, rational emotive behavioral therapy, and fluoxetine (Prozac) in treating depression: a randomized clinical trial.

    Science.gov (United States)

    Sava, Florin A; Yates, Brian T; Lupu, Viorel; Szentagotai, Aurora; David, Daniel

    2009-01-01

    Cost-effectiveness and cost-utility of cognitive therapy (CT), rational emotive behavioral therapy (REBT), and fluoxetine (Prozac) for major depressive disorder (MDD) were compared in a randomized clinical trial with a Romanian sample of 170 clients. Each intervention was offered for 14 weeks, plus three booster sessions. Beck Depression Inventory (BDI) scores were obtained prior to intervention, 7 and 14 weeks following the start of intervention, and 6 months following completion of intervention. CT, REBT, and fluoxetine did not differ significantly in changes in the BDI, depression-free days (DFDs), or Quality-Adjusted Life Years (QALYs). Average BDI scores decreased from 31.1 before treatment to 9.7 six months following completion of treatment. Due to lower costs, both psychotherapies were more cost-effective, and had better cost-utility, than pharmacotherapy: median $26.44/DFD gained/month for CT and $23.77/DFD gained/month for REBT versus $34.93/DFD gained/month for pharmacotherapy, median $/QALYs=$1,638, $1,734, and $2,287 for CT, REBT, and fluoxetine (Prozac), respectively. (c) 2008 Wiley Periodicals, Inc.

  16. Novel devices for individualized controlled inhalation can optimize aerosol therapy in efficacy, patient care and power of clinical trials

    Directory of Open Access Journals (Sweden)

    Fischer A

    2009-12-01

    Full Text Available Abstract In the treatment of pulmonary diseases the inhalation of aerosols plays a key role - it is the preferred route of drug delivery in asthma, chronic obstructive pulmonary disease (COPD and cystic fibrosis. But, in contrast to oral and intravenous administration drug delivery to the lungs is controlled by additional parameters. Beside its pharmacology the active agent is furthermore determined by its aerosol characteristics as particle diameter, particle density, hygroscopicity and electrical charge. The patient related factors like age and stage of pulmonary disease will be additionally affected by the individual breathing pattern and morphometry of the lower airways. A number of these parameters with essential impact on the pulmonary drug deposition can be influenced by the performance of the inhalation system. Therefore, the optimization of nebulisation technology was a major part of aerosol science in the last decade. At this time the control of inspiration volume and air flow as well as the administration of a defined aerosol bolus was in the main focus. Up to date a more efficient and a more targeted pulmonary drug deposition - e.g., in the alveoli - will be provided by novel devices which also allow shorter treatment times and a better reproducibility of the administered lung doses. By such means of precise dosing and drug targeting the efficacy of inhalation therapy can be upgraded, e.g., the continuous inhalation of budesonide in asthma. From a patients' perspective an optimized inhalation manoeuvre means less side effects, e.g., in cystic fibrosis therapy the reduced oropharyngeal tobramycin exposure causes fewer bronchial irritations. Respecting to shorter treatment times also, this result in an improved quality of life and compliance. For clinical trials the scaling down of dose variability in combination with enhanced pulmonary deposition reduces the number of patients to be included and the requirement of pharmaceutical

  17. Intraoperative stress and anxiety reduction with music therapy: a controlled randomized clinical trial of efficacy and safety.

    Science.gov (United States)

    Jiménez-Jiménez, Maria; García-Escalona, Alma; Martín-López, Alejandra; De Vera-Vera, Raquel; De Haro, Joaquin

    2013-09-01

    The purpose of this study was to investigate the music therapy (MT) effect in levels of intraoperative anxiety in patients undergoing crossectomy with stripping of the great saphenous vein and to assess the efficacy, safety, and feasibility of this alternative therapy as a complement of standard intraoperative care. The study is a simple blind, controlled, parallel groups, prospective randomized clinical trial. Patients were allocated by means of randomized controlled sampling. The study was performed in the surgery room of Getafe University Hospital in Madrid. The study was carried out in 40 patients, 20 randomized to the experimental group and 20 randomized to the control group, with an age range from 27 to 70 years. The control group was given intraoperative routine attention, and the experimental group was given an MT passive intervention that consisted of audition of musical fragments during varicose veins surgery. These pieces previously showed relaxing actions on the cardiovascular system. The anxiety levels were measured by means of pre- and postsurgical questionnaires by a blinded investigator for the study arm to which the patients had been randomized. Heart rate and systolic and diastolic blood pressures were determined during the intervention, and adrenaline and noradrenaline plasma levels were determined before and after the surgical procedure. The majority of the patients in the MT group (95%) and standard care group (90%) completed the study. There were no statistical differences between the control and experimental groups in heart rate gradient or systolic and diastolic blood pressures measured after the intervention. The anxiety state and the stress feeling scale score after surgery were significantly inferior in the MT group (94.7% vs 57.9% decrease in anxiety levels, P stress score of 1.31 vs 2.36, P reduce anxiety and stress in the study patients. Copyright © 2013 Society for Vascular Nursing, Inc. Published by Mosby, Inc. All rights reserved.

  18. Fast Neutron Radiotherapy for Locally Advanced Prostate Cancer. Final Report of Radiation Therapy Oncology Group Randomized Clinical Trial.

    Energy Technology Data Exchange (ETDEWEB)

    Laramore, G. E. [Washington U.; Krall, J. M. [Unlisted, US, PA; Thomas, F. J. [Unlisted, US, OH; Russell, K. J. [Washington U.; Maor, M. H. [Unlisted, US, TX; Hendrickson, F. R. [Fermilab; Martz, K. L. [Unlisted, US, PA; Griffin, T. W. [Washington U.

    1993-01-01

    Between June 1977 and April 1983 the Radiation Therapy Oncology Group (RTOG) sponsored a Phase III randomized trial investigating the use of fast neutron radiotherapy for patients with locally advanced (Stages C and D1) adenocarcinoma of the prostate gland. Patients were randomized to receive either conventional photon radiation or fast neutron radiation used in a mixed-beam (neutron/photon) treatment schedule. A total of 91 analyzable patients were entered into the study, and the two patient groups were balanced with respect to the major prognostic variables. Actuarial curves are presented for local/regional control and "overall" survival. Ten-year results for clinically assessed local control are 70% for the mixed-beam group versus 58% for the photon group (p = 0.03) and for survival are 46% for the mixed-beam group versus 29% for the photon group (p = 0.04). This study suggests that a regional method of treatment can influence both local tumor control and survival in patients with locally advanced adenocarcinoma of the prostate gland.

  19. Gene therapy for mitochondrial diseases: Leber Hereditary Optic Neuropathy as the first candidate for a clinical trial.

    Science.gov (United States)

    Cwerman-Thibault, Hélène; Augustin, Sébastien; Ellouze, Sami; Sahel, José-Alain; Corral-Debrinski, Marisol

    2014-03-01

    Mitochondrial disorders cannot be ignored anymore in most medical disciplines; indeed their minimum estimated prevalence is superior to 1 in 5000 births. Despite the progress made in the last 25 years on the identification of gene mutations causing mitochondrial pathologies, only slow progress was made towards their effective treatments. Ocular involvement is a frequent feature in mitochondrial diseases and corresponds to severe and irreversible visual handicap due to retinal neuron loss and optic atrophy. Interestingly, three clinical trials for Leber Congenital Amaurosis due to RPE65 mutations are ongoing since 2007. Overall, the feasibility and safety of ocular Adeno-Associated Virus delivery in adult and younger patients and consistent visual function improvements have been demonstrated. The success of gene-replacement therapy for RPE65 opens the way for the development of similar approaches for a broad range of eye disorders, including those with mitochondrial etiology such as Leber Hereditary Optic Neuropathy (LHON). Copyright © 2013 Académie des sciences. Published by Elsevier SAS. All rights reserved.

  20. The Effect of Debriefing and Brief Cognitive-Behavioral Therapy on Postpartum Depression in Traumatic Childbirth: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Sedigheh Abdollahpour

    2018-01-01

    Full Text Available Background & aim: Childbirth is a stressful event in women’s lives, and if a mother perceives it as an unpleasant event, it can influence her postpartum mental health. Depression is a common mental disorder, which can has serious consequences depending on its severity. Therefore, this study aimed to investigate the effect of debriefing and brief cognitive-behavioral therapy on postpartum depression in traumatic childbirth. Methods: This clinical trial was performed on 179 mothers who experienced a traumatic childbirth and were admitted in postnatal ward of Nohom Dey Hospital in Torbat-e Heydarieh, North East of Iran in 2016. The subjects were randomly allocated into three groups, including two intervention groups of debriefing and brief cognitive-behavioral counseling and a control group. The intervention groups received appropriate counseling for 40-60 minutes in the first 48 postpartum hours and the control group received the routine postpartum care. Edinburgh Postnatal Depression Scale was used to evaluate postpartum depression 4-6 weeks and also three months after the intervention. Post-traumatic stress symptoms in were compared in three groups using t-test, chi-square test, and repeated measures analysis of variance. Results: No significant differences were observed between the mean depression scores of the two intervention groups and that of the control group 4-6 weeks after childbirth. However, three months after delivery, the mean depression scores of the two intervention groups was lower than the control group (P

  1. Hypoalgesic effects of three different manual therapy techniques on cervical spine and psychological interaction: A randomized clinical trial.

    Science.gov (United States)

    Alonso-Perez, Jose Luis; Lopez-Lopez, Almudena; La Touche, Roy; Lerma-Lara, Sergio; Suarez, Emilio; Rojas, Javier; Bishop, Mark D; Villafañe, Jorge Hugo; Fernández-Carnero, Josué

    2017-10-01

    The purpose of this study was to evaluate the extent to which psychological factors interact with a particular manual therapy (MT) technique to induce hypoalgesia in healthy subjects. Seventy-five healthy volunteers (36 female, 39 males), were recruited in this double-blind, controlled and parallel study. Subjects were randomly assigned to receive: High velocity low amplitude technique (HVLA), joint mobilization, or Cervical Lateral glide mobilization (CLGM). Pressure pain threshold (PPT) over C7 unilaterally, trapezius muscle and lateral epicondyle bilaterally, were measured prior to single technique MT was applied and immediately after to applied MT. Pain catastrophizing, depression, anxiety and kinesiophobia were evaluated before treatment. The results indicate that hypoalgesia was observed in all groups after treatment in the neck and elbow region (P techniques studied produced local and segmental hypoalgesic effects, supporting the results of previous studies studying the individual interventions. Interaction between catastrophizing and HVLA technique suggest that whether catastrophizing level is low or medium, the chance of success is high, but high levels of catastrophizing may result in poor outcome after HVLA intervention. ClinicalTrials.gov Registration Number: NCT02782585. Copyright © 2016 Elsevier Ltd. All rights reserved.

  2. A randomized clinical trial of cognitive-behavioral therapy and applied relaxation for adults with generalized anxiety disorder.

    Science.gov (United States)

    Dugas, Michel J; Brillon, Pascale; Savard, Pierre; Turcotte, Julie; Gaudet, Adrienne; Ladouceur, Robert; Leblanc, Renée; Gervais, Nicole J

    2010-03-01

    This randomized clinical trial compared cognitive-behavioral therapy (CBT), applied relaxation (AR), and wait-list control (WL) in a sample of 65 adults with a primary diagnosis of generalized anxiety disorder (GAD). The CBT condition was based on the intolerance of uncertainty model of GAD, whereas the AR condition was based on general theories of anxiety. Both manualized treatments were administered over 12 weekly 1-hour sessions. Standardized clinician ratings and self-report questionnaires were used to assess GAD and related symptoms at pretest, posttest, and at 6-, 12-, and 24-month follow-ups. At posttest, CBT was clearly superior to WL, AR was marginally superior to WL, and CBT was marginally superior to AR. Over follow-up, CBT and AR were equivalent, but only CBT led to continued improvement. Thus, direct comparisons of CBT and AR indicated that the treatments were comparable; however, comparisons of each treatment with another point of reference (either waiting list or no change over follow-up) provided greater support for the efficacy of CBT than AR. 2009. Published by Elsevier Ltd.

  3. Low-level laser therapy and anesthetic infiltration for orofacial pain in patients with fibromyalgia: a randomized clinical trial.

    Science.gov (United States)

    de Souza, R-C-V; de Sousa, E; Scudine, K-O; Meira, U; de Oliveira E Silva, E; Gomes, A; Limeira-Junior, F-A

    2017-12-23

    To compare the analgesic effect of anesthetic infiltration of lidocaine 2% and low-level laser therapy (LLLT) by GaAlAs into tender points of patients with orofacial pain and fibromyalgia (FM). A randomized clinical trial was performed with adults (N=66) that were allocated into two groups (1:1): Group A received LLLT irradiation by Diode Laser GaAlAs (780nm) with expositions twice a week during six weeks and Group B was treated with anesthetic infiltration of lidocaine 2% without vasoconstrictor once a week for four weeks. The pain assessment included the Visual Analogic Scale (VAS) and tenderness to palpation. No dropout and adverse effect was observed during the study. The pain decreased significantly in each group after the treatment (p=0.0001, β=1.0), even though no statistical difference was found between both treatments (p=0.46, β= 0.82). The presence of tender points decreased after both treatments, with responsively in some types of masticatory muscles (p<0.05) except posterior temporalis muscle. The patients perception showed that both treatments were effective and a few patients reported that the treatment did not improve welfare. The LLLT by GaAlAs and anesthetic infiltration of lidocaine 2% were equally effective to control orofacial pain in FM individuals.

  4. Efficacy of cognitive behavioral therapy training using brief e-mail sessions in the workplace: a controlled clinical trial.

    Science.gov (United States)

    Kojima, Reiko; Fujisawa, Daisuke; Tajima, Miyuki; Shibaoka, Michi; Kakinuma, Mitsuru; Shima, Satoru; Tanaka, Katsutoshi; Ono, Yutaka

    2010-01-01

    In the present study, we conducted a clinical controlled trial to evaluate the effects of cognitive behavioral therapy (CBT) training in improving depression and self-esteem in workers. A total of 261 workers were assigned to either an intervention group (n=137) or a waiting-list group (n=124). The intervention group was offered participation in a group session with CBT specialists and three e-mail sessions with occupational health care staff. Between-group differences in the change in Center for Epidemiologic Studies Depression Scale (CES-D) and Self-Esteem Scale from baseline to three months after the end of training were assessed by analysis of covariance. All subjects in the intervention group completed the group session and 114 (83%) completed the three e-mail sessions. CES-D score decreased by 2.21 points in the intervention group but increased by 0.12 points in the control group, a significant difference of -2.33 points (95% confidence interval: -3.89 to-0.77; pself-esteem scores was not significant. Results of the present study suggest that CBT training cooperatively provided by CBT specialists and occupational health care staff using brief e-mail is effective in improving feelings of depression in workers.

  5. Nominal effective radiation doses delivered during clinical trials of boron neutron capture therapy

    Energy Technology Data Exchange (ETDEWEB)

    Capala, J.; Diaz, A.Z.; Chanana, A.D.

    1997-12-31

    Boron neutron capture therapy (BNCT) is a binary system that, in theory, should selectively deliver lethal, high linear energy transfer (LET) radiation to tumor cells dispersed within normal tissues. It is based on the nuclear reaction 10-B(n, {alpha})7-Li, which occurs when the stable nucleus of boron-10 captures a thermal neutron. Due to the relatively high cross-section of the 10-B nucleus for thermal neutron capture and short ranges of the products of this reaction, tumor cells in the volume exposed to thermal neutrons and containing sufficiently high concentration of 10-B would receive a much higher radiation dose than the normal cells contained within the exposed volume. Nevertheless, radiation dose deposited in normal tissue by gamma and fast neutron contamination of the neutron beam, as well as neutron capture in nitrogen, 14-N(n,p)14-C, hydrogen, 1-H(n,{gamma})2-H, and in boron present in blood and normal cells, limits the dose that can be delivered to tumor cells. It is, therefore, imperative for the success of the BNCT the dosed delivered to normal tissues be accurately determined in order to optimize the irradiation geometry and to limit the volume of normal tissue exposed to thermal neutrons. These are the major objectives of BNCT treatment planning.

  6. Randomized Clinical Trial of Family-Based Treatment and Cognitive-Behavioral Therapy for Adolescent Bulimia Nervosa.

    Science.gov (United States)

    Le Grange, Daniel; Lock, James; Agras, W Stewart; Bryson, Susan W; Jo, Booil

    2015-11-01

    There is a paucity of randomized clinical trials (RCTs) for adolescents with bulimia nervosa (BN). Prior studies suggest cognitive-behavioral therapy adapted for adolescents (CBT-A) and family-based treatment for adolescent bulimia nervosa (FBT-BN) could be effective for this patient population. The objective of this study was to compare the relative efficacy of these 2 specific therapies, FBT-BN and CBT-A. In addition, a smaller participant group was randomized to a nonspecific treatment (supportive psychotherapy [SPT]), whose data were to be used if there were no differences between FBT-BN and CBT-A at end of treatment. This 2-site (Chicago and Stanford) randomized controlled trial included 130 participants (aged 12-18 years) meeting DSM-IV criteria for BN or partial BN (binge eating and purging once or more per week for 6 months). Outcomes were assessed at baseline, end of treatment, and 6 and 12 months posttreatment. Treatments involved 18 outpatient sessions over 6 months. The primary outcome was defined as abstinence from binge eating and purging for 4 weeks before assessment, using the Eating Disorder Examination. Participants in FBT-BN achieved higher abstinence rates than in CBT-A at end of treatment (39% versus 20%; p = .040, number needed to treat [NNT] = 5) and at 6-month follow-up (44% versus 25%; p = .030, NNT = 5). Abstinence rates between these 2 groups did not differ statistically at 12-month follow-up (49% versus 32%; p = .130, NNT = 6). In this study, FBT-BN was more effective in promoting abstinence from binge eating and purging than CBT-A in adolescent BN at end of treatment and 6-month follow-up. By 12-month follow-up, there were no statistically significant differences between the 2 treatments. Study of Treatment for Adolescents With Bulimia Nervosa; http://clinicaltrials.gov/; NCT00879151. Copyright © 2015 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

  7. Photodynamic therapy in non-surgical treatment of chronic periodontitis: short term randomized clinical trial study

    Science.gov (United States)

    Russo, C.; Palaia, G.; Loskutova, E.; Libotte, F.; Kornblit, R.; Gaimari, G.; Tenore, G.; Romeo, U.

    2016-03-01

    Introduction: Periodontitis is a chronic inflammatory disease due to exposition to plaque and tartar. Conventional treatments consist of scaling and root planing (SRP) and antibiotics administration. Among them encouraging results have been obtained using alternative protocols, like the antimicrobial photodynamic therapy (PDT). Aim of the Study: Evaluation of PDT effects added to conventional methods. Materials and Methods: 11 patients (4M/7F, 37-67 years aged, non-smoking) affected by untreated chronic periodontal disease, with >3mm pockets in at least 4 teeth were divided in two groups, test and control group. Each patient had to made full-intraoral before and after the treatment. The test group received SRP+PDT, while the control group was subjected to SRP. The PDT was performed through the HELBO®TheraLite (Bredent Medical), diode laser battery powered 670nm with an output of 75mW/cm2. The Helbo Blue photosensitizer, containing methylene blue, was used. The exposure time to the laser effect was of 10'' for each site, for a total of 60'' at 3J/cm2. Results: Both groups had a significant improvement in the reduction of pocket depth (PD), above all in the test group. Statistical analysis was performed through the T-test, evaluating PD between the two groups p=0.96 (p> 0.05), resulting not statistically significant. Conclusion: PDT is a promising support to SRP, achieving a significant reduction in the pocket depth, but more cases are needed to confirm the validity of the used protocol.

  8. Exercise, manual therapy, and use of booster sessions in physical therapy for knee osteoarthritis: a multi-center, factorial randomized clinical trial.

    Science.gov (United States)

    Fitzgerald, G K; Fritz, J M; Childs, J D; Brennan, G P; Talisa, V; Gil, A B; Neilson, B D; Abbott, J H

    2016-08-01

    (1) Do treatment effects differ between participants receiving manual therapy (MT) with exercise compared to subjects who don't, (2) are treatment effects sustained better when participants receive booster sessions compared to those who don't over a one year period in subjects with knee osteoarthritis (KOA)? Multi-center, 2 × 2 factorial randomized clinical trial. 300 participants with knee OA were randomized to four groups: exercise-no boosters (Ex), exercise-with boosters (Ex+B), manual therapy+exercise-no boosters (MT+Ex), manual therapy+exercise-with boosters (MT+Ex+B). The primary outcome was the Western Ontario and McMaster osteoarthritis index (WOMAC) at 1 year. Secondary outcomes included knee pain, physical performance tests, and proportions of participants meeting treatment responder criteria. There were no differences between groups on the WOMAC at 1 year or on any performance-based measures. Secondary analyses indicated a) better scores on the WOMAC and greater odds of being a treatment responder at 9 weeks for participants receiving MT, b) greater odds of being a treatment responder at 1 year for participants receiving boosters. Exploratory interaction analysis suggested knee pain decreases for participants receiving boosters and increases for participants not receiving boosters from 9 weeks to 1 year. MT or use of boosters with exercise did not result in additive improvement in the primary outcome at 1 year. Secondary outcomes suggest MT may have some short term benefit, and booster sessions may improve responder status and knee pain at 1 year. However, the role of booster sessions remains unclear in sustaining treatment effects and warrants further study. gov (NCT01314183). Copyright © 2016 Osteoarthritis Research Society International. All rights reserved.

  9. Nanoformulations and Clinical Trial Candidates as Probably ...

    African Journals Online (AJOL)

    Nanoformulations and Clinical Trial Candidates as Probably Effective and Safe Therapy for Tuberculosis. Madeeha Laghari, Yusrida Darwis, Abdul Hakeem Memon, Arshad Ali Khan, Ibrahim Mohammed Tayeb Abdulbaqi, Reem Abou Assi ...

  10. Recruitment of HIV/AIDS treatment-naïve patients to clinical trials in the highly active antiretroviral therapy era: influence of gender, sexual orientation and race.

    Science.gov (United States)

    Menezes, P; Eron, J J; Leone, P A; Adimora, A A; Wohl, D A; Miller, W C

    2011-03-01

    In the USA, women, racial/ethnic minorities and persons who acquire HIV infection through heterosexual intercourse represent an increasing proportion of HIV-infected persons, and yet are frequently underrepresented in clinical trials. We assessed the demographic predictors of trial participation in antiretroviral-naïve patients. Patients were characterized as trial participants if highly active antiretroviral therapy (HAART) was initiated within a clinical trial. Prevalence ratios (PRs) were obtained using binomial regression. Between 1996 and 2006, 30% of 738 treatment-naïve patients initiated HAART in a clinical trial. Trial participation rates for men who have sex with men (MSM), heterosexual men, and women were respectively 36.5, 29.6 and 24.3%. After adjustment for other factors, heterosexual men appeared less likely to participate in trials compared with MSM [PR 0.79, 95% confidence interval (CI) 0.57, 1.11], while women were as likely to participate as MSM (PR 0.97, 95% CI 0.68, 1.39). The participation rate in Black patients (25.9%) was lower compared with non-Black patients (37.5%) (adjusted PR 0.80, 95% CI 0.60, 1.06). In our clinical setting, gender did not appear to impact participation in HIV treatment trials, but Black patients were slightly less likely to participate in these trials. Considering the substantial proportion of HIV-infected patients who are Black, future trials need to consider strategies to incorporate such underrepresented populations. © 2010 British HIV Association.

  11. Efficacy of low-level laser therapy in the management of tinnitus due to noise-induced hearing loss: a double-blind randomized clinical trial.

    Science.gov (United States)

    Mollasadeghi, Abolfazl; Mirmohammadi, Seyyed Jalil; Mehrparvar, Amir Houshang; Davari, Mohammad Hossein; Shokouh, Pedram; Mostaghaci, Mehrdad; Baradaranfar, Mohammad Hossein; Bahaloo, Maryam

    2013-01-01

    Background. Several remedial modalities for the treatment of tinnitus have been proposed, but an effective standard treatment is still to be confirmed. In the present study, we aimed to evaluate the effect of low-level laser therapy on tinnitus accompanied by noise-induced hearing loss. Methods. This was a double-blind randomized clinical trial on subjects suffering from tinnitus accompanied by noise-induced hearing loss. The study intervention was 20 sessions of low-level laser therapy every other day, 20 minutes each session. Tinnitus was assessed by three methods (visual analog scale, tinnitus handicap inventory, and tinnitus loudness) at baseline, immediately and 3 months after the intervention. Results. All subjects were male workers with age range of 30-51 years. The mean tinnitus duration was 1.85 ± 0.78 years. All three measurement methods have shown improved values after laser therapy compared with the placebo both immediately and 3 months after treatment. Laser therapy revealed a U-shaped efficacy throughout the course of follow-up. Nonresponse rate of the intervention was 57% and 70% in the two assessment time points, respectively. Conclusion. This study found low-level laser therapy to be effective in alleviating tinnitus in patients with noise-induced hearing loss, although this effect has faded after 3 months of follow-up. This trial is registered with the Australian New Zealand clinical trials registry with identifier ACTRN12612000455864).

  12. Effectiveness of Trauma-Focused Cognitive Behavioral Therapy Among Trauma-Affected Children in Lusaka, Zambia: A Randomized Clinical Trial.

    Science.gov (United States)

    Murray, Laura K; Skavenski, Stephanie; Kane, Jeremy C; Mayeya, John; Dorsey, Shannon; Cohen, Judy A; Michalopoulos, Lynn T M; Imasiku, Mwiya; Bolton, Paul A

    2015-08-01

    Orphans and vulnerable children (OVC) are at high risk for experiencing trauma and related psychosocial problems. Despite this, no randomized clinical trials have studied evidence-based treatments for OVC in low-resource settings. To evaluate the effectiveness of lay counselor-provided trauma-focused cognitive behavioral therapy (TF-CBT) to address trauma and stress-related symptoms among OVC in Lusaka, Zambia. This randomized clinical trial compared TF-CBT and treatment as usual (TAU) (varying by site) for children recruited from August 1, 2012, through July 31, 2013, and treated until December 31, 2013, for trauma-related symptoms from 5 community sites within Lusaka, Zambia. Children were aged 5 through 18 years and had experienced at least one traumatic event and reported significant trauma-related symptoms. Analysis was with intent to treat. The intervention group received 10 to 16 sessions of TF-CBT (n = 131). The TAU group (n = 126) received usual community services offered to OVC. The primary outcome was mean item change in trauma and stress-related symptoms using a locally validated version of the UCLA Posttraumatic Stress Disorder Reaction Index (range, 0-4) and functional impairment using a locally developed measure (range, 0-4). Outcomes were measured at baseline and within 1 month after treatment completion or after a waiting period of approximately 4.5 months after baseline for TAU. At follow-up, the mean item change in trauma symptom score was -1.54 (95% CI, -1.81 to -1.27), a reduction of 81.9%, for the TF-CBT group and -0.37 (95% CI, -0.57 to -0.17), a reduction of 21.1%, for the TAU group. The mean item change for functioning was -0.76 (95% CI, -0.98 to -0.54), a reduction of 89.4%, and -0.54 (95% CI, -0.80 to -0.29), a reduction of 68.3%, for the TF-CBT and TAU groups, respectively. The difference in change between groups was statistically significant for both outcomes (P trauma symptoms and 0.34 for functioning. Lay counselors participated in

  13. Building the rationale and structure for a complex physical therapy intervention within the context of a clinical trial: a multimodal individualized treatment for patients with hip osteoarthritis.

    Science.gov (United States)

    Bennell, Kim L; Egerton, Thorlene; Pua, Yong-Hao; Abbott, J Haxby; Sims, Kevin; Buchbinder, Rachelle

    2011-10-01

    Evaluating the efficacy of complex interventions such as multimodal, impairment-based physical therapy treatments in randomized controlled trials is essential to inform practice and compare relative benefits of available treatment options. Studies of physical therapy interventions using highly standardized intervention protocols, although methodologically rigorous, do not necessarily reflect "real-world" clinical practice, and in many cases results have been disappointing. Development of a complex intervention that includes multiple treatment modalities and individualized treatment technique selection requires a systematic approach to designing all aspects of the intervention based on theory, evidence, and practical constraints. This perspective article outlines the development of the rationale and structure of a multimodal physical therapy program for painful hip osteoarthritis to be assessed in a clinical trial. The resulting intervention protocol comprises a semi-structured program of exercises and manual therapy, advice, physical activity, and optional prescription of a gait aid that is standardized, yet can be individualized according to physical assessment and radiographic findings. The program is evidence based and reflects contemporary physical therapist practice, while also being reproducible and reportable. This perspective article aims to encourage physical therapy researchers involved in evaluation of complex interventions to better document their own intervention development, as well as the outcomes, thus generating a body of knowledge about the development processes and protocols that is generalizable to the real-world complexity of providing physical therapy to individual patients.

  14. Dialectical behavior therapy for high suicide risk in individuals with borderline personality disorder: a randomized clinical trial and component analysis.

    Science.gov (United States)

    Linehan, Marsha M; Korslund, Kathryn E; Harned, Melanie S; Gallop, Robert J; Lungu, Anita; Neacsiu, Andrada D; McDavid, Joshua; Comtois, Katherine Anne; Murray-Gregory, Angela M

    2015-05-01

    Dialectical behavior therapy (DBT) is an empirically supported treatment for suicidal individuals. However, DBT consists of multiple components, including individual therapy, skills training, telephone coaching, and a therapist consultation team, and little is known about which components are needed to achieve positive outcomes. To evaluate the importance of the skills training component of DBT by comparing skills training plus case management (DBT-S), DBT individual therapy plus activities group (DBT-I), and standard DBT which includes skills training and individual therapy. We performed a single-blind randomized clinical trial from April 24, 2004, through January 26, 2010, involving 1 year of treatment and 1 year of follow-up. Participants included 99 women (mean age, 30.3 years; 69 [71%] white) with borderline personality disorder who had at least 2 suicide attempts and/or nonsuicidal self-injury (NSSI) acts in the last 5 years, an NSSI act or suicide attempt in the 8 weeks before screening, and a suicide attempt in the past year. We used an adaptive randomization procedure to assign participants to each condition. Treatment was delivered from June 3, 2004, through September 29, 2008, in a university-affiliated clinic and community settings by therapists or case managers. Outcomes were evaluated quarterly by blinded assessors. We hypothesized that standard DBT would outperform DBT-S and DBT-I. The study compared standard DBT, DBT-S, and DBT-I. Treatment dose was controlled across conditions, and all treatment providers used the DBT suicide risk assessment and management protocol. Frequency and severity of suicide attempts and NSSI episodes. All treatment conditions resulted in similar improvements in the frequency and severity of suicide attempts, suicide ideation, use of crisis services due to suicidality, and reasons for living. Compared with the DBT-I group, interventions that included skills training resulted in greater improvements in the frequency of NSSI

  15. Efficacy and safety of metformin and sitagliptin based triple antihyperglycemic therapy (STRATEGY): a multicenter, randomized, controlled, non-inferiority clinical trial.

    Science.gov (United States)

    Xu, Wen; Mu, Yiming; Zhao, Jiajun; Zhu, Dalong; Ji, Qiuhe; Zhou, Zhiguang; Yao, Bin; Mao, Anhua; Engel, Samuel S; Zhao, Bin; Bi, Yan; Zeng, Longyi; Ran, Xingwu; Lu, Juming; Ji, Linong; Yang, Wenying; Jia, Weiping; Weng, Jianping

    2017-03-01

    Despite the current guideline's recommendation of a timely stepwise intensification therapy, the "clinical inertia", termed as the delayed treatment intensification, commonly exists in the real world, which may be partly due to the relatively little substantial evidence and no clear consensus regarding the efficacy and safety of triple oral agents in patients inadequately controlled with dual therapy. In this clinical trial performed in 237 centers in China, 5,535 type 2 diabetic patients inadequately controlled by previous therapies were treated with a stable metformin/sitagliptin dual therapy for 20 weeks. The patients who did not reach the glycated hemoglobin A1c (HbA1c) goal were then further randomized into glimepiride, gliclazide, repaglinide, or acarbose group for an additional 24-week triple therapy. A mean HbA1c reduction of 0.85% was observed when sitagliptin was added to the patients inadequately controlled with metformin in 16 weeks. Further HbA1c reductions in the 24-week triple therapy stage were 0.65% in glimepiride group, 0.70% in gliclazide group, 0.61% in repaglinide group, and 0.45% in acarbose group. The non-inferiority criterion for primary hypotheses was met for gliclazide and repaglinide, but not for acarbose, compared with glimepiride, when added to metformin/sitagliptin dual therapy. The incidences of adverse events (AEs) were 29.2% in the dual therapy stage and 30.3% in the triple therapy stage. Metformin/sitagliptin as baseline therapy, with the addition of a third oral antihyperglycemic agent, including glimepiride, gliclazide, repaglinide, or acarbose, was effective, safe and well-tolerated for achieving an HbA1c <7.0% goal in type 2 diabetic patients inadequately controlled with previous therapies. The timely augmentation of up to three oral antihyperglycemic agents is valid and of important clinical benefit to prevent patients from exposure to unnecessarily prolonged hyperglycemia.

  16. Randomized Clinical Trial of Dialectical Behavior Therapy for Preadolescent Children With Disruptive Mood Dysregulation Disorder: Feasibility and Outcomes.

    Science.gov (United States)

    Perepletchikova, Francheska; Nathanson, Donald; Axelrod, Seth R; Merrill, Caitlin; Walker, Amy; Grossman, Meredith; Rebeta, James; Scahill, Lawrence; Kaufman, Joan; Flye, Barbara; Mauer, Elizabeth; Walkup, John

    2017-10-01

    Persistent irritability and behavior outbursts in disruptive mood dysregulation disorder (DMDD) are associated with severe impairment in childhood and with negative adolescent and adult outcomes. There are no empirically established treatments for DMDD. This study examined the feasibility and preliminary efficacy of dialectical behavior therapy adapted for preadolescent children (DBT-C) with DMDD. Children 7 to 12 years old with DMDD (N = 43) were randomly assigned 1:1 to DBT-C or treatment as usual (TAU). The 6 domains of feasibility included recruitment, randomization, retention, attendance, participants' satisfaction, and therapist adherence. Blinded raters assessed participants at baseline, after 8, 16, 24, and 32 weeks, and at 3-month follow-up. The primary efficacy outcome was the positive response rate on the Clinical Global Impression-Improvement scale. Improvements in behavior outbursts and angry/irritable mood were assessed by the Clinical Global Impression-Severity scale. Mean number of participants randomized per month was 2.53 ± 2.72. Participants in DBT-C (n = 21) attended 89% of sessions compared with 48.6% in TAU (n = 22). Eight TAU participants (36.4%) dropped out compared with none in DBT-C. Parents and children in DBT-C expressed significantly higher treatment satisfaction than those in TAU. The rate of positive response was 90.4% in DBT-C compared with 45.5% in TAU, despite 3 times as many participants in TAU receiving psychiatric medications. Remission rates were 52.4% for DBT-C and 27.3% for TAU. Improvements were maintained at 3-month follow-up. Therapists showed adherence to DBT-C. DBT-C demonstrated feasibility in all prespecified domains. Outcomes also indicated preliminary efficacy of DBT-C. Clinical trial registration information-Adapting DBT for Children With DMDD: Pilot RCT; http://clinicaltrials.gov/; NCT01862549. Copyright © 2017 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

  17. Rapid Antiretroviral Therapy Initiation for Women in an HIV-1 Prevention Clinical Trial Experiencing Primary HIV-1 Infection during Pregnancy or Breastfeeding.

    Science.gov (United States)

    Morrison, Susan; John-Stewart, Grace; Egessa, John J; Mubezi, Sezi; Kusemererwa, Sylvia; Bii, Dennis K; Bulya, Nulu; Mugume, Francis; Campbell, James D; Wangisi, Jonathan; Bukusi, Elizabeth A; Celum, Connie; Baeten, Jared M

    2015-01-01

    During an HIV-1 prevention clinical trial in East Africa, we observed 16 cases of primary HIV-1 infection in women coincident with pregnancy or breastfeeding. Nine of eleven pregnant women initiated rapid combination antiretroviral therapy (ART), despite having CD4 counts exceeding national criteria for ART initiation; breastfeeding women initiated ART or replacement feeding. Rapid ART initiation during primary HIV-1 infection during pregnancy and breastfeeding is feasible in this setting.

  18. Rapid Antiretroviral Therapy Initiation for Women in an HIV-1 Prevention Clinical Trial Experiencing Primary HIV-1 Infection during Pregnancy or Breastfeeding.

    Directory of Open Access Journals (Sweden)

    Susan Morrison

    Full Text Available During an HIV-1 prevention clinical trial in East Africa, we observed 16 cases of primary HIV-1 infection in women coincident with pregnancy or breastfeeding. Nine of eleven pregnant women initiated rapid combination antiretroviral therapy (ART, despite having CD4 counts exceeding national criteria for ART initiation; breastfeeding women initiated ART or replacement feeding. Rapid ART initiation during primary HIV-1 infection during pregnancy and breastfeeding is feasible in this setting.

  19. Ethics and social acceptability of a proposed clinical trial using maternal gene therapy to treat severe early-onset fetal growth restriction

    OpenAIRE

    Sheppard, M.; Spencer, R. N.; Ashcroft, R.; David, A. L.; Everrest Consortium

    2016-01-01

    OBJECTIVE: To evaluate the ethical and social acceptability of a proposed clinical trial using maternal uterine artery vascular endothelial growth factor (VEGF) gene therapy to treat severe early-onset fetal growth restriction (FGR) in pregnant women. METHODS: We conducted a literature review on the ethics and legality of experimental treatments in pregnant women, in particular advanced therapeutics. Issues that were identified from the literature helped develop interview guides for semistruc...

  20. A preliminary study of individual cognitive behavior therapy for social anxiety disorder in Japanese clinical settings: a single-arm, uncontrolled trial

    OpenAIRE

    Yoshinaga, Naoki; Ohshima, Fumiyo; Matsuki, Satoshi; Tanaka, Mari; Kobayashi, Tomomi; Ibuki, Hanae; Asano, Kenichi; Kobori, Osamu; Shiraishi , Tetsuya; Ito, Emi; Nakazato, Michiko; Nakagawa, Akiko; Iyo, Masaomi; Shimizu, Eiji

    2013-01-01

    Background Cognitive behavior therapy (CBT) is regarded as an effective treatment for social anxiety disorder (SAD) in Europe and North America. Individual CBT might be acceptable and effective for patients with SAD even in non-Western cultures; therefore, we conducted a feasibility study of individual CBT for SAD in Japanese clinical settings. We also examined the baseline predictors of outcomes associated with receiving CBT. Methods This single-arm trial employed a 14-week individual CBT in...

  1. A randomized trial of family focused therapy with populations at clinical high risk for psychosis: effects on interactional behavior.

    Science.gov (United States)

    O'Brien, Mary P; Miklowitz, David J; Candan, Kristin A; Marshall, Catherine; Domingues, Isabel; Walsh, Barbara C; Zinberg, Jamie L; De Silva, Sandra D; Woodberry, Kristen A; Cannon, Tyrone D

    2014-02-01

    This study investigated whether family focused therapy (FFT-CHR), an 18-session intervention that consisted of psychoeducation and training in communication and problem solving, brought about greater improvements in family communication than enhanced care (EC), a 3-session psychoeducational intervention, among individuals at clinical high risk for developing psychosis. This study was conducted within a randomized controlled trial across 8 sites. We examined 10-min problem-solving discussions at baseline and 6-month reassessment among 66 adolescents and young adults and their parents. Trained coders who were blind to treatment and time of assessment achieved high levels of interrater reliability when evaluating family discussions on categories of calm-constructive and critical-conflictual behavior. Individuals at high risk and their family members who participated in FFT-CHR demonstrated greater improvement from baseline to 6-month reassessment in constructive communication and decreases in conflictual behaviors during family interactions than those in EC. Participants in FFT-CHR showed greater increases from baseline to 6 months in active listening and calm communication and greater decreases in irritability and anger, complaints and criticism, and off-task comments compared to participants in EC. These changes occurred equally in high-risk participants and their family members. A 6-month family skills training treatment can bring about significant improvement in family communication among individuals at high risk for psychosis and their parents. Future studies should examine the association between enhancements in family communication and reduced risk for the onset of psychosis among individuals at high risk. PsycINFO Database Record (c) 2014 APA, all rights reserved.

  2. A Randomized Trial of Family Focused Therapy With Populations at Clinical High Risk for Psychosis: Effects on Interactional Behavior

    Science.gov (United States)

    O’Brien, Mary P.; Miklowitz, David J.; Candan, Kristin A.; Marshall, Catherine; Domingues, Isabel; Walsh, Barbara C.; Zinberg, Jamie L.; De Silva, Sandra D.; Woodberry, Kristen A.; Cannon, Tyrone D.

    2013-01-01

    Objective This study investigated whether family focused therapy (FFT-CHR), an 18-session intervention that consisted of psychoeducation and training in communication and problem solving, brought about greater improvements in family communication than enhanced care (EC), a 3-session psychoeducational intervention, among individuals at clinical high risk for developing psychosis. Method This study was conducted within a randomized controlled trial across 8 sites. We examined 10-min problem-solving discussions at baseline and 6-month reassessment among 66 adolescents and young adults and their parents. Trained coders who were blind to treatment and time of assessment achieved high levels of interrater reliability when evaluating family discussions on categories of calm–constructive and critical– conflictual behavior. Results Individuals at high risk and their family members who participated in FFT-CHR demonstrated greater improvement from baseline to 6-month reassessment in constructive communication and decreases in conflictual behaviors during family interactions than those in EC. Participants in FFT-CHR showed greater increases from baseline to 6 months in active listening and calm communication and greater decreases in irritability and anger, complaints and criticism, and off-task comments compared to participants in EC. These changes occurred equally in high-risk participants and their family members. Conclusions A 6-month family skills training treatment can bring about significant improvement in family communication among individuals at high risk for psychosis and their parents. Future studies should examine the association between enhancements in family communication and reduced risk for the onset of psychosis among individuals at high risk. PMID:24188511

  3. Microbiological Efficacy of Photodynamic Therapy as an Adjunct to Non-surgical Periodontal Treatment: A Clinical Trial

    Science.gov (United States)

    Talebi, Mohammadreza; Taliee, Rojin; Mojahedi, Masoud; Meymandi, Mansour; Torshabi, Maryam

    2016-01-01

    Introduction: The efficiency of routine scaling and root planning is negatively influenced by the tooth anatomy and residual bacteria all possibly affecting the treatment outcomes in future. The present study compared the microbiologic effectiveness of the photodynamic therapy (PDT) as an adjunctive treatment modality for nonsurgical treatment in chronic periodontitis. Methods: In this randomized controlled clinical trial, 18 chronic periodontitis patients were selected. Four quadrants were randomly treated by scaling and root planning (SRP), diode laser (810n m wavelength, 1.5 W and 320 μm fiber, contact and sweeping technique), SRP + PDT (with diode laser 808 nm, 0.5 W) and laser + SRP (with diode laser 808 nm, 1 W) in each patient. Presence of periodontal pathogen species in the treated areas were measured before the treatment, at 1 and 3 months afterwards. The identification and reproduction of the specific genes of pathogen bacteria were done by means of polymerase chain reaction (PCR) technique. Presence of oral pathogen bacteria in the treatment groups were analyzed by chi-square test. A semi quantitative analysis was used to measure the intensity of white light in each band. This was calculated by number of pixels in each band. Results: In the qualitative analysis, Fusobacterium nucleatum (Fn) and Treponema denticola (Td) species were killed after 1 month in all treatment modalities. PDT had more effects to decrease Prevotella intermedia (Pi) species than SRP while Tannerella forsythensis count (Tf) species increased in all treatments. Furthermore, Actinobacillus actinomycetemcomitans (Aa) species decreased in all treatments and Porphyromonas gingivalis (P.g) species increased in all treatments after 1 and 3 months. Conclusion: It can be concluded that PDT was more effective as an adjunctive treatment to SRP than SRP alone; however, no distinct differences were found between both treatment modalities regarding reduction of certain pathogen bacteria. PMID

  4. Omeprazole versus doxycycline combination therapy with topical erythromycin the treatment of acne vulgaris: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Fariba Jaffary

    2017-04-01

    Full Text Available Background: Acne vulgaris is self-limiting, multifactorial disease involving sebaceous glands. Omeprazole is a proton pump inhibitor with in vitro antibacterial effects against staphylococcus aureus and anti-androgen that can be potential treatment of acne vulgaris. This study was designed to evaluate the efficacy of oral omeprazole and erythromycin 4% compared to doxycycline combination therapy in the treatment of acne vulgaris. Methods: In this clinical trial study, patients with moderate acne were referred to Skin Diseases and Leishmaniasis Research Center, Isfahan University of Medical Science, Iran, during August 2014 until November 2015 and were randomized into two groups receiving topical erythromycin 4% plus omeprazole (34 patients or doxycycline (35 patients for 3 months. Moderate acne, lack of sensitivity to proton pump inhibitors, lack of warfarin, phenytoin, diazepam consumption, lack of active liver or kidney disease, being older than 12 years, were considered as inclusion criteria. Pregnant or lactating patients, patients with drug allergy history, patients taking oral contraceptives, acne topical medications (including retinoids or systemic treatment within 30 days of study, patients with oligomenorrhea, hirsutism, acne conglobata, acne fulminant or body acne alone were excluded from the study. All patients were tested for Helicobacter pylori test at the beginning of the study. Results: Both inflammatory and non-inflammatory lesions decreased in both groups with negative correlation with age (P< 0.05. There was no significant correlation between positive Helicobacter pylori test and inflammatory or non-inflammatory lesion reduction (P= 0.794, P= 0.514. Also, patient satisfaction and rate of total drug side effects was not different between two treatment groups. Rate of skin reactions was 20.58% in omeprazole treated group and 11.42% in doxycycline group. For side effects, other than skin it was 2.94% versus 14.28% respectively

  5. Internet and In-Person Cognitive Behavioral Therapy for Insomnia in Military Personnel: A Randomized Clinical Trial.

    Science.gov (United States)

    Taylor, Daniel J; Peterson, Alan L; Pruiksma, Kristi E; Young-McCaughan, Stacey; Nicholson, Karin; Mintz, Jim

    2017-06-01

    Compare in-person and unguided Internet-delivered cognitive behavioral therapy for insomnia (CBTi) with a minimal contact control condition in military personnel. A three-arm parallel randomized clinical trial of 100 active duty US Army personnel at Fort Hood, Texas. Internet and in-person CBTi were comparable, except for the delivery format. The control condition consisted of phone call assessments. Internet and in-person CBTi performed significantly better than the control condition on diary-assessed sleep efficiency (d = 0.89 and 0.53, respectively), sleep onset latency (d = -0.68 and -0.53), number of awakenings (d = -0.42 and -0.54), wake time after sleep onset (d = -0.88 and -0.50), the Insomnia Severity Index (d = -0.98 and -0.51), and the Dysfunctional Beliefs and Attitudes About Sleep Scale (d = -1.12 and -0.54). In-person treatment was better than Internet treatment on self-reported sleep quality (d = 0.80) and dysfunctional beliefs and attitudes about sleep (d = -0.58). There were no differences on self-reported daytime sleepiness or actigraphy-assessed sleep parameters (except total sleep time; d = -0.55 to -0.60). There were technical difficulties with the Internet treatment which prevented tailored sleep restriction upward titration for some participants. Despite the unique, sleep-disrupting occupational demands of military personnel, in-person and Internet CBTi are efficacious treatments for this population. The effect sizes for in-person were consistently better than Internet and both were similar to those found in civilians. Dissemination of CBTi should be considered for maximum individual and population benefits, possibly in a stepped-care model.

  6. Nuclear medicine therapy principles and clinical applications

    CERN Document Server

    Aktolun, Cumali

    2012-01-01

    This book reviews nuclear medicine techniques and technology for therapy of malignant and benign diseases, covering scientific principles and clinical applications, and trials of experimental agents for treating tumors involving virtually every organ system.

  7. Immunotherapy Shown Safe in Type 1 Diabetes Clinical Trial

    Science.gov (United States)

    ... Immunotherapy Shown Safe in Type 1 Diabetes Clinical Trial Next step is to see if it works ... Aug. 9, 2017 (HealthDay News) -- A small clinical trial showed an immune system therapy was safe for ...

  8. [Controlled randomized clinical trials].

    Science.gov (United States)

    Jaillon, Patrice

    2007-01-01

    It is generally agreed that the first comparative clinical trial in history was done by James Lind in 1747, in the treatment of scurvy. The general bases of modern experimental medicine were published by Claude Bernard in 1865. However, it is the development of new drugs and the evolution of methodological concepts that led to the first randomized controlled clinical trial, in 1948, which showed that the effects of streptomycin on pulmonary tuberculosis were significantly different from those of a placebo. Today, "evidence-based" medicine aims to rationalize the medical decision-making process by taking into account, first and foremost, the results of controlled randomized clinical trials, which provide the highest level of evidence. In the second half of the 20th century it became clear that different kinds of clinical trials might not provide the same level of evidence. Practitioners' intimate convictions must be challenged by the results of controlled clinical trials. Take the CAST trial for example, which, in 1989, tested antiarrhythmic drugs versus placebo in patients with myocardial infarction. It was well known that ventricular arrhythmias were a factor of poor prognosis in coronary heart disease, and it was therefore considered self-evident that drug suppression of these ventricular arrhythmias would reduce the mortality rate. In the event, the CAST trial showed the exact opposite, with an almost 3-fold increase in total mortality among patients with coronary heart disease who were treated with antiarrhythmic drugs. These results had a profound impact on the use of antiarrythmic drugs, which became contraindicated after myocardial infarction. A clinical trial has to fulfill certain methodological standards to be accepted as evidence-based medicine. First, a working hypothesis has to be formulated, and then the primary outcome measure must be chosen before beginning the study. An appropriate major endpoint for efficacy must be selected, in keeping with the

  9. THE EFFICACY AND SAFETY OF CARMOLIS GEL IN THE COMBINATION THERAPY OF KNEE OSTEOARTHRITIS: RESULTS OF A MULTICENTER CLINICAL TRIAL

    Directory of Open Access Journals (Sweden)

    I. N. Denisov

    2015-01-01

    Full Text Available Osteoarthritis (OA is one of the most common rheumatic diseases. Knee OA is particularly frequently encountered among all forms of OA, the prevalence of knee OA being about 25% in the general population. Despite multiple guidelines for the management of knee OA, which have been prepared by the European League Against Rheumatism (EULAR, the American College of Rheumatology (ACR, and the Osteoarthritis Research Society International (OARSI, many problems of its treatment policy remain to be solved. The same holds true for not only the symptomatic and disease-modifying effects of chondroprotectors, but also topical therapy options.Objective: to evaluate the clinical efficacy and safety of Carmolis gel in patients with knee OA.Subjects and methods.The trial included 280 patients with knee OA (a study group consisted of 190 patents; a control group comprised 90 patients. The mean age was 58.3±9.3 years in the study group and 59±10.5 years in the control group. The disease duration was 10.3±5.5 and 10.1±4.1 years, respectively. Carmolis gel was applied to the region of the most painful knee joint up to 4–5 times daily, followed by massage of this skin area. The treatment cycle lasted for 2 weeks. No therapy was performed in the control patients. The clinical efficacy was determined by the changes in joint pains at rest or on movement and palpation, according to a visual analogue scale (VAS, WOMAC questionnaire, the synovitis intensity (assessed by ultrasonography, patient and physician global assessments of disease activity (Likert scale, and the possibility of reducing the daily dosage of nonsteroidal anti-inflammatory drugs (NSAIDs. The onset the therapeutic effect of the gel and the duration of its action were recorded.Results and discussion. The topical application of Carmolis gel caused a statistically significant reduction in joint pain at rest and on movement from 57.7±6.8 to 12±1.8 mm (р < 0.01 and from 52±5.3 to 17±2.7 mm

  10. Oral dexamethasone pulse therapy versus daily prednisolone in sub-acute onset myositis, a randomised clinical trial

    NARCIS (Netherlands)

    Van de Vlekkert, J.; Hoogendijk, J. E.; de Haan, R. J.; Algra, A.; van der Tweel, I.; van der Pol, W. L.; Uijtendaal, E. V.; de Visser, M.

    2010-01-01

    To determine if high-dose pulsed dexamethasone is more effective and safer than daily high-dose prednisolone in treatment-naive adult patients with inflammatory myopathies (sporadic inclusion body myositis excluded) we performed a multicenter, double-blind randomised controlled clinical trial with

  11. A randomized clinical trial of cognitive behavioural therapy versus short-term psychodynamic psychotherapy versus no intervention for patients with hypochondriasis

    DEFF Research Database (Denmark)

    Sørensen, Per; Birket-Smith, M; Wattar, U

    2011-01-01

    Hypochondriasis is common in the clinic and in the community. Cognitive behavioural therapy (CBT) has been found to be effective in previous trials. Psychodynamic psychotherapy is a treatment routinely offered to patients with hypochondriasis in many countries, including Denmark. The aim...... of this study was to test CBT for hypochondriasis in a centre that was not involved in its development and compare both CBT and short-term psychodynamic psychotherapy (STPP) to a waiting-list control and to each other. CBT was modified by including mindfulness and group therapy sessions, reducing the therapist...

  12. Music therapy as an adjunct to standard treatment for obsessive compulsive disorder and co-morbid anxiety and depression: A randomized clinical trial.

    Science.gov (United States)

    Shirani Bidabadi, Shahrzad; Mehryar, Amirhooshang

    2015-09-15

    Previous studies have highlighted the potential therapeutic benefits of music therapy as an adjunct to standard care, in a variety of psychiatric ailments including mood and anxiety disorders. However, the role of music in the treatment of obsessive-compulsive disorder (OCD) have not been investigated to date. In a single-center, parallel-group, randomized clinical trial (NCT02314195) 30 patients with OCD were randomly assigned to standard treatment (pharmacotherapy and cognitive-behavior therapy) plus 12 sessions of individual music therapy (n = 15) or standard treatment only (n = 15) for one month. Maudsley Obsessive-Compulsive Inventory, Beck Anxiety Inventory, and Beck Depression Inventory-Short Form were administered baseline and after one month. Thirty patients completed the study. Music therapy resulted in a greater decrease in total obsessive score (post-intervention score: music therapy+standard treatment: 12.4 ± 1.9 vs standard treatment only: 15.1 ± 1.7, p Music therapy was significantly more effective in reducing anxiety (post-intervention score: music therapy + standard treatment: 16.9 ± 7.4 vs standard treatment only: 22.9 ± 4.6, p music therapy + standard treatment: 10.8 ± 3.8 vs standard treatment: 17.1 ± 3.7, p music therapy, as an adjunct to standard care, seems to be effective in reducing obsessions, as well as co-morbid anxiety and depressive symptoms. Copyright © 2015. Published by Elsevier B.V.

  13. Results of a multicenter randomized controlled trial of the clinical effectiveness of schema therapy for personality disorders.

    Science.gov (United States)

    Bamelis, Lotte L M; Evers, Silvia M A A; Spinhoven, Philip; Arntz, Arnoud

    2014-03-01

    The authors compared the effectiveness of 50 sessions of schema therapy with clarification-oriented psychotherapy and with treatment as usual among patients with cluster C, paranoid, histrionic, or narcissistic personality disorder. A multicenter randomized controlled trial, with a single-blind parallel design, was conducted between 2006 and 2011 in 12 Dutch mental health institutes. A total of 323 patients with personality disorders were randomly assigned (schema therapy, N=147; treatment as usual, N=135; clarification-oriented psychotherapy, N=41). There were two cohorts of schema therapy therapists, with the first trained primarily with lectures and the second primarily with exercises. The primary outcome was recovery from personality disorder 3 years after treatment started (assessed by blinded interviewers). Secondary outcomes were dropout rates and measures of personality disorder traits, depressive and anxiety disorders, general psychological complaints, general and social functioning, self-ideal discrepancy, and quality of life. A significantly greater proportion of patients recovered in schema therapy compared with treatment as usual and clarification-oriented psychotherapy. Second-cohort schema therapists had better results than first-cohort therapists. Clarification-oriented psychotherapy and treatment as usual did not differ. Findings did not vary with specific personality disorder diagnosis. Dropout was lower in the schema therapy and clarification-oriented psychotherapy conditions. All treatments showed improvements on secondary outcomes. Schema therapy patients had less depressive disorder and higher general and social functioning at follow-up. While interview-based measures demonstrated significant differences between treatments, differences were not found with self-report measures. Schema therapy was superior to treatment as usual on recovery, other interview-based outcomes, and dropout. Exercise-based schema therapy training was superior to

  14. TELEHEALTH ALLOWS FOR CLINICAL TRIAL PARTICIPATION AND MULTIMODALITY THERAPY IN A RURAL PATIENT WITH STAGE 4 NON-SMALL CELL LUNG CANCER.

    Science.gov (United States)

    Clark, James M; Heifetz, Laurence J; Palmer, Daphne; Brown, Lisa M; Cooke, David T; David, Elizabeth A

    2016-01-01

    Oligometastatic non-small cell lung cancer (NSCLC) has a poor prognosis for rural patients with traditional therapies. Implementation of multi-modality systemic therapy in conjunction with surgical resection can dramatically improve overall survival, leading to clinical complete remission. The currently accepted indications for resection in oligometastatic NSCLC include brain and adrenal metastases. Rural populations are known to have disparities in care of complex malignancies and the use of telehealth has been shown to improve outcomes. We present a case of a rural patient with stage IV NSCLC, who was able to participate in two clinical trials, undergo trimodality therapy, and remain disease-free for 18 months, whose care was facilitated via telehealth video conferencing with a tertiary care center.

  15. Effect of systemic antibiotics on clinical and patient-reported outcomes of implant therapy - a multicenter randomized controlled clinical trial.

    Science.gov (United States)

    Tan, Wah Ching; Ong, Marianne; Han, Jie; Mattheos, Nikos; Pjetursson, Bjarni E; Tsai, Alex Yi-Min; Sanz, Ignacio; Wong, May C M; Lang, Niklaus P

    2014-02-01

    To determine the effect of various systemic antibiotic prophylaxis regimes on patient-reported outcomes and postsurgical complications in patients undergoing conventional implant installation. Three hundred and twenty-nine healthy adults in need of conventional implant installation were randomly assigned to one of four groups: (i) preoperatively 2 g of amoxycillin 1 h before surgery (positive control, PC), (ii) postoperatively 2 g of amoxycillin immediately following surgery (test 1, T1), (iii) preoperatively 2 g of amoxycillin 1 h before and 500 mg thrice daily on days 2 and 3 after surgery (test 2, T2), (iv) preoperatively 2 g of placebo 1 h before surgery (negative control, NC). Subjects were examined clinically by blinded examiners over 8 weeks after implant installation. In addition, Visual Analogue Scales (VAS) for pain, swelling, bruising and bleeding were obtained over 14 days. ANOVA was performed for the VAS. Chi-square tests were applied for postsurgical complications. All VAS scores were low for all groups and decreased over time (P 0.05). There was only a significant difference in flap closure at week 4, where NC had 5% of the subjects not achieving complete wound closure compared to 0% for the three other groups (P = 0.01), with no other significant differences for any postsurgical complications (P > 0.05). For standard single implant placement, prophylactic systemic antibiotics either before or after, or before and after the surgical procedure do not improve patient-reported outcomes or prevalence of postsurgical complications. © 2013 John Wiley & Sons A/S. Published by Blackwell Publishing Ltd.

  16. Efficiency of photodynamic therapy in the treatment of peri-implantitis: A three-month randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Rakašević Dragana

    2016-01-01

    Full Text Available Introduction. Peri-implantitis is an inflammatory lesion of peri-implant tissues. Eradication of the causative bacteria and decontamination of the implant surface is essential in achieving predictable and stabile clinical results. Photodynamic therapy (PDT is non-invasive adjuvant therapeutic method to surgery in the treatment of bacterial infection. Objective. The aim of this study was to evaluate early clinical and microbiological outcomes of periimplantitis after surgical therapy with adjuvant PDT. Methods. Fifty-two diagnosed peri-implantitis sites were divided into two groups. PDT was used for decontamination of implant surface in the study group; in the control group, chlorhexidine gel (CHX followed by saline irrigation was applied. Several clinical parameters were recorded before the treatment (baseline values and three months after surgical treatment. Samples for microbiological identification were collected before therapy, during the surgical therapy (before and after decontamination of implant surface, and three months thereafter, and analyzed with identification systems using biochemical analysis. Results. The use of PDT resulted in significant decrease of bleeding on probing in comparison to CHX (p < 0.001. It showed significant decontamination of implant surfaces with complete elimination of anaerobic bacteria immediately after surgical procedure and three months later. Conclusion. The results indicate that PDT can be used as an adjuvant therapy to surgery for decontamination of implant surface and surrounding peri-implant tissues within the treatment of peri-implantitis. [Projekat Ministarstva nauke Republike Srbije, br. 41008

  17. Identification of potential neuromotor mechanisms of manual therapy in patients with musculoskeletal disablement: rationale and description of a clinical trial

    Directory of Open Access Journals (Sweden)

    Kulig Kornelia

    2009-05-01

    Full Text Available Abstract Background Many health care practitioners use a variety of hands-on treatments to improve symptoms and disablement in patients with musculoskeletal pathology. Research to date indirectly suggests a potentially broad effect of manual therapy on the neuromotor processing of functional behavior within the supraspinal central nervous system (CNS in a manner that may be independent of modification at the level of local spinal circuits. However, the effect of treatment speed, as well as the specific mechanism and locus of CNS changes, remain unclear. Methods/Design We developed a placebo-controlled, randomized study to test the hypothesis that manual therapy procedures directed to the talocrural joint in individuals with post-acute ankle sprain induce a change in corticospinal excitability that is relevant to improve the performance of lower extremity functional behavior. Discussion This study is designed to identify potential neuromotor changes associated with manual therapy procedures directed to the appendicular skeleton, compare the relative effect of treatment speed on potential neuromotor effects of manual therapy procedures, and determine the behavioral relevance of potential neuromotor effects of manual therapy procedures. Trial Registration http://www.clinicaltrials.gov identifier NCT00847769.

  18. Preladenant as an Adjunctive Therapy With Levodopa in Parkinson Disease: Two Randomized Clinical Trials and Lessons Learned.

    Science.gov (United States)

    Hauser, Robert A; Stocchi, Fabrizio; Rascol, Olivier; Huyck, Susan B; Capece, Rachel; Ho, Tony W; Sklar, Peter; Lines, Christopher; Michelson, David; Hewitt, David

    2015-12-01

    Preladenant is an adenosine 2A receptor antagonist that reduced "off" time in a placebo-controlled phase 2b trial in patients with Parkinson disease (PD). We sought to confirm its efficacy in phase 3 trials. To evaluate preladenant as an adjunct to levodopa in patients with PD and motor fluctuations. Two 12-week, phase 3, randomized, placebo-controlled, double-blind trials performed from July 15, 2010, to April 16, 2013. The setting included neurology clinics, clinical research centers, and hospitals in the Americas, the European Union, Eastern Europe, India, and South Africa. Participants included patients with moderate to severe PD taking levodopa who were experiencing motor fluctuations. In trial 1, a total of 778 eligible patients were randomized to the addition of preladenant (2 mg, 5 mg, or 10 mg twice daily), placebo, or rasagiline mesylate (1 mg/d) in a 1:1:1:1:1 ratio. In trial 2, a total of 476 eligible patients were randomized to the addition of preladenant (2 mg or 5 mg twice daily) or placebo in a 1:1:1 ratio. The primary outcome measure was change in off time from baseline to week 12. In trial 1, neither preladenant nor rasagiline was superior to placebo in reducing off time from baseline to week 12. The differences vs placebo were -0.10 hour (95% CI, -0.69 to 0.46 hour) for preladenant 2 mg twice daily, -0.20 hour (95% CI, -0.75 to 0.41 hour) for preladenant 5 mg twice daily, -0.00 hour (95% CI, -0.62 to 0.53 hour) for preladenant 10 mg twice daily, and -0.30 hour (95% CI, -0.90 to 0.26 hour) for rasagiline mesylate 1 mg/d. In trial 2, preladenant was not superior to placebo in reducing off time from baseline to week 12. The differences vs placebo were -0.20 hour (95% CI, -0.72 to 0.35 hour) for preladenant 2 mg twice daily and -0.30 hour (95% CI, -0.86 to 0.21 hour) for preladenant 5 mg twice daily. Preladenant was well tolerated, with the most common adverse event that showed an increase over placebo in both trials being constipation (6%-8% for

  19. A randomized controlled trial on the effectiveness of strength training on clinical and muscle cellular outcomes in patients with prostate cancer during androgen deprivation therapy: rationale and design

    Directory of Open Access Journals (Sweden)

    Thorsen Lene

    2012-03-01

    Full Text Available Abstract Background Studies indicate that strength training has beneficial effects on clinical health outcomes in prostate cancer patients during androgen deprivation therapy. However, randomized controlled trials are needed to scientifically determine the effectiveness of strength training on the muscle cell level. Furthermore, close examination of the feasibility of a high-load strength training program is warranted. The Physical Exercise and Prostate Cancer (PEPC trial is designed to determine the effectiveness of strength training on clinical and muscle cellular outcomes in non-metastatic prostate cancer patients after high-dose radiotherapy and during ongoing androgen deprivation therapy. Methods/design Patients receiving androgen deprivation therapy for 9-36 months combined with external high-dose radiotherapy for locally advanced prostate cancer are randomized to an exercise intervention group that receives a 16 week high-load strength training program or a control group that is encouraged to maintain their habitual activity level. In both arms, androgen deprivation therapy is continued until the end of the intervention period. Clinical outcomes are body composition (lean body mass, bone mineral density and fat mass measured by Dual-energy X-ray Absorptiometry, serological outcomes, physical functioning (muscle strength and cardio-respiratory fitness assessed with physical tests and psycho-social functioning (mental health, fatigue and health-related quality of life assessed by questionnaires. Muscle cellular outcomes are a muscle fiber size b regulators of muscle fiber size (number of myonuclei per muscle fiber, number of satellite cells per muscle fiber, number of satellite cells and myonuclei positive for androgen receptors and proteins involved in muscle protein degradation and muscle hypertrophy and c regulators of muscle fiber function such as proteins involved in cellular stress and mitochondrial function. Muscle cellular outcomes

  20. Clinical effectiveness of online computerised cognitive-behavioural therapy without support for depression in primary care: randomised trial

    NARCIS (Netherlands)

    Graaf, de L.E.; Gerhards, S.A.H.; Arntz, A.; Riper, H.; Metsemakers, J.F.M.; Evers, S.M.; Severens, J.L.; Widdershoven, G.A.M.; Huibers, M.J.H.

    2009-01-01

    BACKGROUND: Computerised cognitive-behavioural therapy (CCBT) might offer a solution to the current undertreatment of depression. AIMS: To determine the clinical effectiveness of online, unsupported CCBT for depression in primary care. METHOD: Three hundred and three people with depression were

  1. Trichuris suis ova therapy for allergic rhinitis: a randomized, double-blind, placebo-controlled clinical trial

    DEFF Research Database (Denmark)

    Bager, Peter; Arnved, John; Rønborg, Steen

    2010-01-01

    Parasitic helminth infections can protect against allergic airway inflammation in experimental models and have been associated with a reduced risk of atopy and a reduced course of asthma in some observational studies. Although no clinical evidence exists to support the use of helminth therapy...

  2. Cognitive-behavioral therapy (CBT) versus acceptance and commitment therapy (ACT) for dementia family caregivers with significant depressive symptoms: Results of a randomized clinical trial.

    Science.gov (United States)

    Losada, Andrés; Márquez-González, María; Romero-Moreno, Rosa; Mausbach, Brent T; López, Javier; Fernández-Fernández, Virginia; Nogales-González, Celia

    2015-08-01

    The differential efficacy of acceptance and commitment therapy (ACT) and cognitive-behavioral therapy (CBT) for dementia family caregivers' is analyzed through a randomized controlled trial. Participants were 135 caregivers with high depressive symptomatology who were randomly allocated to the intervention conditions or a control group (CG). Pre-, postintervention, and follow-up measurements assessed depressive symptomatology, anxiety, leisure, dysfunctional thoughts, and experiential avoidance. Depression: Significant effects of interventions compared with CG were found for CBT (p dementia caregivers. (c) 2015 APA, all rights reserved).

  3. Lapatinib versus hormone therapy in patients with advanced renal cell carcinoma: a randomized phase III clinical trial

    DEFF Research Database (Denmark)

    Ravaud, Alain; Hawkins, Robert; Gardner, Jason P

    2008-01-01

    of metastatic sites--were randomly assigned to lapatinib 1,250 mg daily or HT. The primary end point was time to progression (TTP); secondary end points included overall survival (OS), safety, and biomarker analyses. RESULTS: Four hundred sixteen patients were enrolled onto the study. Median TTP was 15.3 weeks......PURPOSE: Lapatinib is an orally reversible inhibitor of epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor 2 (HER-2) tyrosine kinases with demonstrated activity in patients with HER-2-positive breast cancer. In the current phase III open-label trial, lapatinib...... was compared with hormone therapy (HT) in patients with advanced renal cell carcinoma (RCC) that express EGFR and/or HER-2. PATIENTS AND METHODS: Patients with advanced RCC who had experienced disease progression through first-line cytokine therapy--stratified by Karnofsky performance status and number...

  4. Fundamentals of clinical trial design

    OpenAIRE

    Evans, Scott R.

    2010-01-01

    Most errors in clinical trials are a result of poor planning. Fancy statistical methods cannot rescue design flaws. Thus careful planning with clear foresight is crucial. Issues in trial conduct and analyses should be anticipated during trial design and thoughtfully addressed. Fundamental clinical trial design issues are discussed.

  5. An open-label clinical trial of agalsidase alfa enzyme replacement therapy in children with Fabry disease who are naïve to enzyme replacement therapy

    Directory of Open Access Journals (Sweden)

    Goker-Alpan O

    2016-05-01

    .975. No change occurred in secondary efficacy endpoints: mean (95% CI change from baseline at week 55 in LVMI, 0.16 (-3.3, 3.7 g/m2.7; midwall fractional shortening, -0.62% (-2.7%, 1.5%; estimated glomerular filtration rate, 0.15 (-11.4, 11.7 mL/min/1.73 m2; urine protein, -1.8 (-6.0, 2.4 mg/dL; urine microalbumin, 0.6 (-0.5, 1.7 mg/dL; plasma globotriaosylceramide (Gb3, -5.71 (-10.8, -0.6 nmol/mL; urinary Gb3, -1,403.3 (-3,714.0, 907.4 nmol/g creatinine, or clinical quality-of-life outcomes. Conclusion: Fifty-five weeks’ agalsidase alfa ERT at 0.2 mg/kg every other week was well tolerated. Disease progression may be slowed when ERT is started prior to major organ dysfunction. Trial registration: https://ClinicalTrials.gov identifier NCT01363492. Keywords: agalsidase alfa, efficacy, enzyme replacement therapy, Fabry disease, pediatric study, safety

  6. Effects of kinesiotaping versus non-steroidal anti-inflammatory drugs and physical therapy for treatment of pes anserinus tendino-bursitis: A randomized comparative clinical trial.

    Science.gov (United States)

    Homayouni, Kaynoosh; Foruzi, Shima; Kalhori, Fereshte

    2016-09-01

    Pes anserinus tendino-bursitis is a condition caused by repetitive friction over the bursa or direct trauma to knee joint and it presents with proximal medial tibial pain and swelling. The aim of this study is to determine the effects of kinesiotaping in comparison with naproxen and physical therapy in treatment of pes anserinus tendino-bursitis. In a randomized comparative clinical trial 56 patients with clinical diagnosis of pes anserinus tendino-bursitis were randomly assigned to kinesiotaping and naproxen/physical therapy (28 patients in each group). Kinesiotaping on the tender area in the form of space-correction (lifting) technique was used and repeated for three times with a one-week interval. Another group received naproxen (250mg TID for 10 days) and ten sessions of daily physical therapy. The visual analog scale (VAS) was used for evaluation of pain. The depth of swelling of the area was measured with sonography before and after treatment. Wilcoxon signed ranks test has been used for determining the influence of interventions on pain (VAS) and swelling scores in each group. The ANCOVA (Analysis of covariance) test was applied for comparing the influence of interventions on VAS and swelling scores after adjustment for co-variables. At end of the study, 27 patients remained in the kinesiotaping group and 19 patients in naproxen/physical therapy group. Treatment with kinesiotaping significantly decreased the pain (P=0.0001) and swelling scores (P=0.0001) in comparison with naproxen/physical therapy after adjustment for baseline characteristics. Kinesiotaping was safe without any complications except for a mild local skin irritation in one patient. Kinesiotaping is more effective than naproxen plus physical therapy in reduction of pain and swelling in patients with pes anserinus tendino-bursitis. www.ClinicalTrials.gov identifier is NCT01680263.

  7. Ethics and social acceptability of a proposed clinical trial using maternal gene therapy to treat severe early-onset fetal growth restriction.

    Science.gov (United States)

    Sheppard, M; Spencer, R N; Ashcroft, R; David, A L

    2016-04-01

    To evaluate the ethical and social acceptability of a proposed clinical trial using maternal uterine artery vascular endothelial growth factor (VEGF) gene therapy to treat severe early-onset fetal growth restriction (FGR) in pregnant women. We conducted a literature review on the ethics and legality of experimental treatments in pregnant women, in particular advanced therapeutics. Issues that were identified from the literature helped develop interview guides for semistructured, qualitative interviews, carried out in four European countries, with 34 key stakeholders (disability groups, professional bodies and patient support groups) and 24 women/couples who had experienced a pregnancy affected by severe early-onset FGR. The literature review identified two main questions: 'is it ethical to give a pregnant woman a potentially risky treatment from which she does not benefit directly?' and 'is it ethical to treat a condition of the unborn child, who may then be born with a serious disability when, without treatment, they would have died?'. The review concluded that there were no ethical or legal objections to the intervention, or to a trial of this intervention. Overall, respondents viewed the proposed trial in positive terms. Women were generally interested in participating in clinical trials that conferred a potential benefit to their unborn child. The risk of disability of the premature child was a concern, but not considered a major stumbling block for maternal VEGF gene therapy. This study did not identify any fundamental or insurmountable objections to a trial of maternal gene therapy for severe early-onset FGR. Copyright © 2016 ISUOG. Published by John Wiley & Sons Ltd. Copyright © 2016 ISUOG. Published by John Wiley & Sons Ltd.

  8. Clinical characteristics predict benefits from eptifibatide therapy during coronary stenting: insights from the Enhanced Suppression of the Platelet IIb/IIIa Receptor With Integrilin Therapy (ESPRIT) trial.

    Science.gov (United States)

    Puma, Joseph A; Banko, Lesan T; Pieper, Karen S; Sacchi, Terrence J; O'Shea, J Conor; Dery, Jean Pierre; Tcheng, James E

    2006-02-21

    In order to determine a differential benefit from treatment, we compared the long-term outcome of high-risk versus low-risk patients and evaluated survival free from death or myocardial infarction at one year. Newer anticoagulant strategies during percutaneous coronary intervention have necessitated a reanalysis of the role of intravenous GP IIb/IIIa inhibitors. The Enhanced Suppression of the Platelet IIb/IIIa Receptor with Integrilin Therapy trial randomized 2,064 patients undergoing nonurgent coronary stent implantation to eptifibatide or placebo. High-risk characteristics were defined as age >75 years, diabetes, elevated cardiac markers, ST-segment elevation myocardial infarction within 7 days, or unstable angina within 48 h of randomization. Age <5 years, absence of diabetes, and any other reason for admission were considered low risk characterstics. There were 1,018 patients in the high-risk group (50.8% eptifibatide, 49.2% placebo) and 1,045 patients in the low-risk group (50.0% eptifibatide, 50.0% placebo). Baseline demographics were similar in both groups except for more hypertension (63% vs. 55%, respectively), peripheral vascular disease (8.2% vs. 5.2%, respectively), prior stroke (5.5% vs. 3.2%, respectively), and female gender (33% vs. 22%, respectively) in the high-risk than the low-risk group. At one year, the composite end point of death or myocardial infarction occurred in 15.89% of placebo patients and 7.99% of eptifibatide patients in the high-risk group and 9.02% of the placebo and 8.11% of eptifibatide patients in the low-risk group. Although eptifibatide treatment improved outcomes for all patients, preprocedural clinical characteristics can define a subgroup of patients who may derive greatest benefit from its use during coronary stent placement.

  9. Impact of Global Geographic Region on Time in Therapeutic Range on Warfarin Anticoagulant Therapy: Data From the ROCKET AF Clinical Trial

    Science.gov (United States)

    Singer, Daniel E.; Hellkamp, Anne S.; Piccini, Jonathan P.; Mahaffey, Kenneth W.; Lokhnygina, Yuliya; Pan, Guohua; Halperin, Jonathan L.; Becker, Richard C.; Breithardt, Günter; Hankey, Graeme J.; Hacke, Werner; Nessel, Christopher C.; Patel, Manesh R.; Califf, Robert M.; Fox, Keith A. A.

    2013-01-01

    Background Vitamin K antagonist (VKA) therapy remains the most common method of stroke prevention in patients with atrial fibrillation. Time in therapeutic range (TTR) is a widely cited measure of the quality of VKA therapy. We sought to identify factors associated with TTR in a large, international clinical trial. Methods and Results TTR (international normalized ratio [INR] 2.0 to 3.0) was determined using standard linear interpolation in patients randomized to warfarin in the ROCKET AF trial. Factors associated with TTR at the individual patient level (i‐TTR) were determined via multivariable linear regression. Among 6983 patients taking warfarin, recruited from 45 countries grouped into 7 regions, the mean i‐TTR was 55.2% (SD 21.3%) and the median i‐TTR was 57.9% (interquartile range 43.0% to 70.6%). The mean time with INR 3 was 15.7%. While multiple clinical features were associated with i‐TTR, dominant determinants were previous warfarin use (mean i‐TTR of 61.1% for warfarin‐experienced versus 47.4% in VKA‐naïve patients) and geographic region where patients were managed (mean i‐TTR varied from 64.1% to 35.9%). These effects persisted in multivariable analysis. Regions with the lowest i‐TTRs had INR distributions shifted toward lower INR values and had longer inter‐INR test intervals. Conclusions Independent of patient clinical features, the regional location of medical care is a dominant determinant of variation in i‐TTR in global studies of warfarin. Regional differences in mean i‐TTR are heavily influenced by subtherapeutic INR values and are associated with reduced frequency of INR testing. Clinical Trial Registration URL: ClinicalTrials.gov. Unique identifier: NCT00403767. PMID:23525418

  10. Comparing the effects of treatment with sildenafil and cognitive-behavioral therapy on treatment of sexual dysfunction in women: a randomized controlled clinical trial

    Science.gov (United States)

    Omidi, Abdollah; Ahmadvand, Afshin; Najarzadegan, Mohammad Reza; Mehrzad, Fateme

    2016-01-01

    Background Sexual dysfunction in women is prevalent and common in women after menopause. Many attempts to treat patients with sexual dysfunction by cognitive-behavioral therapy (CBT) methods. But to the best of our knowledge, there has been no study that compared these two methods. Objective The aim of this study was to assess and compare the effects of sildenafil and cognitive-behavioral therapy on treatment of sexual dysfunction in women. Methods In this randomized, controlled, clinical trial, 86 women with arousal and orgasm dysfunction were surveyed. The patients were divided into two groups, i.e., sildenafil and CBT groups. The patients in the sildenafil group were treated by 50 mg of oral sildenafil one hour before intercourse, and the other group had weekly sessions of CBT for eight weeks. Sexual dysfunctions were evaluated by the Female Sexual Function Index (FSFI), a sexual satisfaction questionnaire, and the Enrich marital satisfaction scale. Results The mean age of the participants was 33.14 ± 7.34 years. The mean scores for female sexual function index, sexual satisfaction, and the Enrich marital satisfaction scale were increased in both groups during treatment (p orgasm, and lubrication. Conclusion Cognitive-behavioral therapy is more effective than treatment with sildenafil for improving female sexual function. Clinical trial registration The trial was registered at the Iranian Registry of Clinical Trials (http://www.irct.ir) with the IRCT ID: IRCT2014070318338N1. Funding The authors received no financial support for the research, authorship, and/or publication of this article. PMID:27382439

  11. Effectiveness of manual therapy compared to usual care by the general practitioner for chronic tension-type headache: design of a randomised clinical trial

    Directory of Open Access Journals (Sweden)

    Dekker Joost

    2009-02-01

    Full Text Available Abstract Background Patients with Chronic Tension Type Headache (CTTH report functional and emotional impairments (loss of workdays, sleep disturbances, emotional well-being and are at risk for overuse of medication. Manual therapy may improve symptoms through mobilisation of the spine, correction of posture, and training of cervical muscles. We present the design of a randomised clinical trial (RCT evaluating the effectiveness of manual therapy (MT compared to usual care by the general practitioner (GP in patients with CTTH. Methods and design Patients are eligible for participation if they present in general practice with CTTH according to the classification of the International Headache Society (IHS. Participants are randomised to either usual GP care according to the national Dutch general practice guidelines for headache, or manual therapy, consisting of mobilisations (high- and low velocity techniques, exercise therapy for the cervical and thoracic spine and postural correction. The primary outcome measures are the number of headache days and use of medication. Secondary outcome measures are severity of headache, functional status, sickness absence, use of other healthcare resources, active cervical range of motion, algometry, endurance of the neckflexor muscles and head posture. Follow-up assessments are conducted after 8 and 26 weeks. Discussion This is a pragmatic trial in which interventions are offered as they are carried out in everyday practice. This increases generalisability of results, but blinding of patients, GPs and therapists is not possible. The results of this trial will contribute to clinical decision making of the GP regarding referral to manual therapy in patients with chronic tension headache.

  12. Route of Delivery Modulates the Efficacy of Mesenchymal Stem Cell Therapy for Myocardial Infarction: A Meta-Analysis of Preclinical Studies and Clinical Trials.

    Science.gov (United States)

    Kanelidis, Anthony J; Premer, Courtney; Lopez, Juan; Balkan, Wayne; Hare, Joshua M

    2017-03-31

    Accumulating data support a therapeutic role for mesenchymal stem cell (MSC) therapy; however, there is no consensus on the optimal route of delivery. We tested the hypothesis that the route of MSC delivery influences the reduction in infarct size and improvement in left ventricular ejection fraction (LVEF). We performed a meta-analysis investigating the effect of MSC therapy in acute myocardial infarction (AMI) and chronic ischemic cardiomyopathy preclinical studies (58 studies; n=1165 mouse, rat, swine) which revealed a reduction in infarct size and improvement of LVEF in all animal models. Route of delivery was analyzed in AMI swine studies and clinical trials (6 clinical trials; n=334 patients). In AMI swine studies, transendocardial stem cell injection reduced infarct size (n=49, 9.4% reduction; 95% confidence interval, -15.9 to -3.0), whereas direct intramyocardial injection, intravenous infusion, and intracoronary infusion indicated no improvement. Similarly, transendocardial stem cell injection improved LVEF (n=65, 9.1% increase; 95% confidence interval, 3.7 to 14.5), as did direct intramyocardial injection and intravenous infusion, whereas intracoronary infusion demonstrated no improvement. In humans, changes of LVEF paralleled these results, with transendocardial stem cell injection improving LVEF (n=46, 7.0% increase; 95% confidence interval, 2.7 to 11.3), as did intravenous infusion, but again intracoronary infusion demonstrating no improvement. MSC therapy improves cardiac function in animal models of both AMI and chronic ischemic cardiomyopathy. The route of delivery seems to play a role in modulating the efficacy of MSC therapy in AMI swine studies and clinical trials, suggesting the superiority of transendocardial stem cell injection because of its reduction in infarct size and improvement of LVEF, which has important implications for the design of future studies. © 2016 American Heart Association, Inc.

  13. Opicapone as Adjunct to Levodopa Therapy in Patients With Parkinson Disease and Motor Fluctuations: A Randomized Clinical Trial.

    Science.gov (United States)

    Lees, Andrew J; Ferreira, Joaquim; Rascol, Olivier; Poewe, Werner; Rocha, José-Francisco; McCrory, Michelle; Soares-da-Silva, Patricio

    2017-02-01

    Catechol O-methyltransferase (COMT) inhibitors are an established treatment for end-of-dose motor fluctuations associated with levodopa therapy in patients with Parkinson disease (PD). Current COMT inhibitors carry a high risk for toxic effects to hepatic cells or show moderate improvement. Opicapone was designed to be effective without the adverse effects. To evaluate the efficacy and safety of 25- and 50-mg/d dosages of opicapone compared with placebo as adjunct to levodopa therapy in patients with PD experiencing end-of-dose motor fluctuations. This phase 3 international, multicenter outpatient study evaluated a 25- and a 50-mg/d dosage of opicapone in a randomized, double-blind, 14- to 15-week, placebo-controlled clinical trial, followed by a 1-year open-label phase during which all patients received active treatment with opicapone. Patients with PD who experienced signs of end-of-dose deterioration and had a mean total awake off-time (state of akinesia or decreased mobility) of at least 1.5 hours, not including morning akinesia, were enrolled. Data were collected from March 18, 2011, through June 25, 2013. Data from the evaluable population were analyzed from July 31, 2013, to July 31, 2014. The primary efficacy outcome of the double-blind phase was the change from baseline in absolute off-time vs placebo based on patient diaries. The open-label phase focused on maintenance of treatment effect in off-time. A total of 427 patients (258 men [60.4%] and 169 women [39.6%]; mean [SD] age, 63.1 [8.8] years) were randomized to a 25-mg/d (n = 129) or a 50-mg/d (n = 154) dosage of opicapone or to placebo (n = 144). Of these, 376 patients completed the double-blind phase and entered the open-label phase, of whom 286 completed 1 year of open-label treatment. At the end of the double-blind phase, the least squares mean change (SE) in off-time was -64.5 (14.4) minutes for the placebo group, -101.7 (14.9) minutes for the 25-mg/d opicapone group, and -118.8

  14. Cognitive Behavior Therapy for Depression and Self-Care in Heart Failure Patients: A Randomized Clinical Trial.

    Science.gov (United States)

    Freedland, Kenneth E; Carney, Robert M; Rich, Michael W; Steinmeyer, Brian C; Rubin, Eugene H

    2015-11-01

    Depression and inadequate self-care are common and interrelated problems that increase the risks of hospitalization and mortality in patients with heart failure (HF). To determine the efficacy of an integrative cognitive behavior therapy (CBT) intervention for depression and HF self-care. Randomized clinical trial with single-blind outcome assessments. Eligible patients were enrolled at Washington University Medical Center in St Louis between January 4, 2010, and June 28, 2013. The primary data analyses were conducted in February 2015. The participants were 158 outpatients in New York Heart Association Class I, II, and III heart failure with comorbid major depression. Cognitive behavior therapy delivered by experienced therapists plus usual care (UC), or UC alone. Usual care was enhanced in both groups with a structured HF education program delivered by a cardiac nurse. The primary outcome was severity of depression at 6 months as measured by the Beck Depression Inventory. The Self-Care of Heart Failure Index Confidence and Maintenance subscales were coprimary outcomes. Secondary outcomes included measures of anxiety, depression, physical functioning, fatigue, social roles and activities, and quality of life. Hospitalizations and deaths were exploratory outcomes. One hundred fifty-eight patients were randomized to UC (n = 79) or CBT (n = 79). Within each arm, 26 (33%) of the patients were taking an antidepressant at baseline. One hundred thirty-two (84%) of the participants completed the 6-month posttreatment assessments; 60 (76%) of the UC and 58 (73%) of the CBT participants completed every follow-up assessment (P = .88). Six-month depression scores were lower in the CBT than the UC arm on the Beck Depression Inventory (BDI-II) (12.8 [10.6] vs 17.3 [10.7]; P = .008). Remission rates differed on the BDI-II (46% vs 19%; number needed to treat [NNT] = 3.76; 95% CI, 3.62-3.90; P Beck Depression Inventory scores 6 months after randomization were lower in the CBT

  15. Evaluation of a modified clinical prediction rule for use with spinal manipulative therapy in patients with chronic low back pain: a randomized clinical trial.

    Science.gov (United States)

    Dougherty, Paul E; Karuza, Jurgis; Savino, Dorian; Katz, Paul

    2014-01-01

    Spinal Manipulative Therapy (SMT) and Active Exercise Therapy (AET) have both demonstrated efficacy in the treatment of Chronic Lower Back Pain (CLBP). A Clinical Prediction Rule (CPR) for responsiveness to SMT has been validated in a heterogeneous lower back pain population; however there is a need to evaluate this CPR specifically for patients with CLBP, which is a significant source of disability. We conducted a randomized controlled trial (RCT) in Veteran Affairs and civilian outpatient clinics evaluating a modification of the original CPR (mCPR) in CLBP, eliminating acute low back pain and altering the specific types of SMT to improve generalizability. We enrolled and followed 181 patients with CLBP from 2007 to 2010. Patients were randomized by status on the mCPR to undergo either SMT or AET twice a week for four weeks. Providers and statisticians were blinded as to mCPR status. We collected outcome measures at 5, 12 and 24-weeks post baseline. We tested our study hypotheses by a general linear model repeated measures procedure following a univariate analysis of covariance approach. Outcome measures included, Visual Analogue Scale, Bodily pain subscale of SF-36 and the Oswestry Disability Index, Patient Satisfaction and Patient Expectation. Of the 89 AET patients, 69 (78%) completed the study and of the 92 SMT patients, 76 (83%) completed the study. As hypothesized, we found main effects of time where the SMT and AET groups showed significant improvements in pain and disability from baseline. There were no differences in treatment outcomes between groups in response to the treatment, given the lack of significant treatment x time interactions. The mCPR x treatment x time interactions were not significant. The differences in outcomes between treatment groups were the same for positive and negative on the mCPR groups, thus our second hypothesis was not supported. We found no evidence that a modification of the original CPR can be used to discriminate CLBP

  16. Prediction of treatment response at 5-year follow-up in a randomized clinical trial of behaviorally based couple therapies.

    Science.gov (United States)

    Baucom, Brian R; Atkins, David C; Rowe, Lorelei Simpson; Doss, Brian D; Christensen, Andrew

    2015-02-01

    Building on earlier work examining predictors of short- and moderate-term treatment response, demographic, intrapersonal, communication, and interpersonal variables were examined as predictors of clinically significant outcomes 5 years after couples completed 1 of 2 behaviorally based couple therapies. One hundred and thirty-four couples were randomly assigned to Integrative Behavioral Couple Therapy (IBCT; Jacobson & Christensen, 1998) or Traditional Behavioral Couple Therapy (TBCT; Jacobson & Margolin, 1979) and followed for 5 years after treatment. Outcomes include clinically significant change categories of relationship satisfaction and marital status at 5-year follow-up. Optimal subsets of predictors were selected using an automated, bootstrapped selection procedure based on Bayesian information criterion. Higher levels of commitment and being married for a longer period of time were associated with decreased likelihood of divorce or separation (odds ratio [OR] = 1.39, p = .004; OR = 0.91, p = .015). Being married for a longer period of time was also associated with increased likelihood of positive, clinically significant change (OR = 1.12, p = .029). Finally, higher levels of wife-desired closeness were associated with increased odds of positive, clinically significant change and decreased odds of divorce for moderately distressed, IBCT couples (OR = 1.16, p = .002; OR = 0.85, p = .007, respectively), whereas the opposite was true for moderately distressed, TBCT couples (OR = 0.77, p < .001; OR = 1.17, p = .002, respectively). Commitment-related variables are associated with clinically significant outcomes at 5-year follow-up as well as at termination and moderate-term follow-up. (PsycINFO Database Record (c) 2015 APA, all rights reserved).

  17. Comparable benefit of β-blocker therapy in heart failure across regions of the world: meta-analysis of randomized clinical trials.

    Science.gov (United States)

    Chatterjee, Saurav; Udell, Jacob A; Sardar, Partha; Lichstein, Edgar; Ryan, John J

    2014-08-01

    There is a concern about geographical region heterogeneity regarding clinical benefit of β-blocker (BB) therapy in heart failure with reduced ejection fraction (HFrEF). This study sought to compare benefits of BB use within randomized controlled trials (RCTs) that enrolled patients with HFrEF from North America (NA) compared with other regions of the world (ROW). We conducted a meta-analysis using MEDLINE, EMBASE, Cochrane Library, Web of Science, and Scopus (inceptions-December 2012) of BB RCTs stratified according to NA vs ROW. The primary end point was all-cause mortality and secondary end points were cardiovascular death, sudden death, death due to pump failure, and premature drug discontinuation. Summary odds ratios (ORs) and 95% confidence intervals (CIs) for each outcome were calculated with interaction terms for region. Two-sided P values were calculated with P analysis included 16 RCTs with 14,452 patients; 7 trials were conducted in NA and 9 trials in ROW with follow-up durations of 3-58 months. All-cause mortality was consistently reduced in NA (OR, 0.82; 95% CI, 0.71-0.96; P = 0.01) and ROW (OR, 0.76; 95% CI, 0.69-0.84; P < 0.001; P-interaction = 0.40). Overall and according to region, all secondary end points including premature drug discontinuation were also less with BB therapy (P-interactions all ≥ 0.10). For the regions represented in the included trials, there is no evidence to suggest that geographic region is a significant moderator of clinical outcomes with BB therapy in HFrEF patients. Copyright © 2014 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

  18. Enhancing CBT for Chronic Insomnia: A Randomised Clinical Trial of Additive Components of Mindfulness or Cognitive Therapy.

    Science.gov (United States)

    Wong, Mei Yin; Ree, Melissa J; Lee, Christopher W

    2016-09-01

    Although cognitive behavioural therapy (CBT) for insomnia has resulted in significant reductions in symptoms, most patients are not classified as good sleepers after treatment. The present study investigated whether additional sessions of cognitive therapy (CT) or mindfulness-based therapy (MBT) could enhance CBT in 64 participants with primary insomnia. All participants were given four sessions of standard CBT as previous research had identified this number of sessions as an optimal balance between therapist guidance and patient independence. Participants were then allocated to further active treatment (four sessions of CT or MBT) or a no further treatment control. The additional treatments resulted in significant improvements beyond CBT on self-report and objective measures of sleep and were well tolerated as evidenced by no dropouts from either treatment. The effect sizes for each of these additional treatments were large and clinically significant. The mean scores on the primary outcome measure, the Insomnia Severity Index, were 5.74 for CT and 6.69 for MBT, which are within the good-sleeper range. Treatment effects were maintained at follow-up. There were no significant differences between CT and MBT on any outcome measure. These results provide encouraging data on how to enhance CBT for treatment of insomnia. Copyright © 2015 John Wiley & Sons, Ltd. CBT treatments for insomnia can be enhanced using recent developments in cognitive therapy. CBT treatments for insomnia can be enhanced using mindfulness-based treatments. Both cognitive therapy and mindfulness produce additional clinically significant change. Copyright © 2015 John Wiley & Sons, Ltd.

  19. The impact of metrifonate therapy on caregivers of patients with Alzheimer's disease: results from the MALT clinical trial. Metrifonate in Alzheimer's Disease Trial.

    Science.gov (United States)

    Shikiar, R; Shakespeare, A; Sagnier, P P; Wilkinson, D; McKeith, I; Dartigues, J F; Dubois, B

    2000-03-01

    To assess the impact on burden reported by caregivers of patients with mild to moderate Alzheimer's disease (AD) who were treated with metrifonate during a randomized double blind clinical trial. Randomized clinical trial, with a 2-week screening period and a 26-week double blind, placebo controlled, treatment phase. Caregivers were assessed at baseline, at 12 weeks, and at end of trial. Caregivers were interviewed at clinics as part of the assessment of the patients. Six hundred and three caregivers of AD patients who were enrolled in the MALT trial; 591 (98%) provided data suitable for analysis at baseline, and 546 (91%) provided data allowing for inclusion in the analysis of change scores. The Caregiver Burden Assessment consisted of the Screen for Caregiver Burden, including both subjective (SCB-subj) and objective (SCB-obj) scores; the cognitive subscale of Poulshock and Deimling (PD); an abridged version of the Relatives Stress Scale (aRSS); assessments of time spent in providing care, including the Caregiver Activity Time Scale (CATS); and demographic and background variables on both the patient and caregiver. Treatment of mild to moderate AD patients with metrifonate for a duration of 26 weeks significantly reduced the psychological burden of care to the caregivers, as measured by the SCB-subj, the PD, and the aRSS. There were no statistically significant differences on the measures assessing the time spent in caregiving, except for the caregiver's subjective impression of the change in time spent providing care during the trial. When comparing individual dose groups, most of the measures of burden showed the largest benefits in burden for the 60/80 mg group, followed by the 40/50 mg group, and then the placebo group. However, there was no statistically significant dose effect. This study provides the first evidence from a randomized clinical trial of any acetylcholinesterase inhibitor used in the treatment of AD demonstrating a positive impact on the

  20. The role of amputation as an outcome measure in cellular therapy for critical limb ischemia: implications for clinical trial design

    Science.gov (United States)

    2011-01-01

    Background Autologous bone marrow-derived stem cells have been ascribed an important therapeutic role in No-Option Critical limb Ischemia (NO-CLI). One primary endpoint for evaluating NO-CLI therapy is major amputation (AMP), which is usually combined with mortality for AMP-free survival (AFS). Only a trial which is double blinded can eliminate physician and patient bias as to the timing and reason for AMP. We examined factors influencing AMP in a prospective double-blinded pilot RCT (2:1 therapy to control) of 48 patients treated with site of service obtained bone marrow cells (BMAC) as well as a systematic review of the literature. Methods Cells were injected intramuscularly in the CLI limbs as either BMAC or placebo (peripheral blood). Six month AMP rates were compared between the two arms. Both patient and treating team were blinded of the assignment in follow-up examinations. A search of the literature identified 9 NO-CLI trials, the control arms of which were used to determine 6 month AMP rates and the influence of tissue loss. Results Fifteen amputations occurred during the 6 month period, 86.7% of these during the first 4 months. One amputation occurred in a Rutherford 4 patient. The difference in amputation rate between patients with rest pain (5.6%) and those with tissue loss (46.7%), irrespective of treatment group, was significant (p = 0.0029). In patients with tissue loss, treatment with BMAC demonstrated a lower amputation rate than placebo (39.1% vs. 71.4%, p = 0.1337). The Kaplan-Meier time to amputation was longer in the BMAC group than in the placebo group (p = 0.067). Projecting these results to a pivotal trial, a bootstrap simulation model showed significant difference in AFS between BMAC and placebo with a power of 95% for a sample size of 210 patients. Meta-analysis of the literature confirmed a difference in amputation rate between patients with tissue loss and rest pain. Conclusions BMAC shows promise in improving AMP-free survival if the

  1. Efficacy of manual and manipulative therapy in the perception of pain and cervical motion in patients with tension-type headache: a randomized, controlled clinical trial.

    Science.gov (United States)

    Espí-López, Gemma V; Gómez-Conesa, Antonia

    2014-03-01

    The purpose of this study was to evaluate the efficacy of manipulative and manual therapy treatments with regard to pain perception and neck mobility in patients with tension-type headache. A randomized clinical trial was conducted on 84 adults diagnosed with tension-type headache. Eighty-four subjects were enrolled in this study: 68 women and 16 men. Mean age was 39.76 years, ranging from 18 to 65 years. A total of 57.1% were diagnosed with chronic tension-type headache and 42.9% with tension-type headache. Participants were divided into 3 treatment groups (manual therapy, manipulative therapy, a combination of manual and manipulative therapy) and a control group. Four treatment sessions were administered during 4 weeks, with posttreatment assessment and follow-up at 1 month. Cervical ranges of motion pain perception, and frequency and intensity of headaches were assessed. All 3 treatment groups showed significant improvements in the different dimensions of pain perception. Manual therapy and manipulative treatment improved some cervical ranges of motion. Headache frequency was reduced with manipulative treatment (P therapy (P efficacy for patients with tension-type headache with regard to pain perception. As for cervical ranges of motion, treatments produced greater effect when separately administered.

  2. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    McAlindon, T. E.; Driban, J. B.; Henrotin, Y.

    2015-01-01

    the members voted we calculated the median score among the nine members of the working group who completed the score. The document includes 25 recommendations regarding randomization, blocking and stratification, blinding, enhancing accuracy of patient-reported outcomes (PRO), selecting a study population......The goal of this document is to update the original OARSI recommendations specifically for the design, conduct, and reporting of clinical trials that target symptom or structure modification among individuals with knee osteoarthritis (OA). To develop recommendations for the design, conduct...

  3. Prediction of Treatment Response at 5-year Follow-up in a Randomized Clinical Trial of Behaviorally Based Couple Therapies

    Science.gov (United States)

    Baucom, Brian R.; Atkins, David C.; Rowe, Lorelei Simpson; Doss, Brian D.; Christensen, Andrew

    2014-01-01

    Objective Building on earlier work examining predictors of short- and moderate-term treatment response, demographic, intrapersonal, communication, and interpersonal variables were examined as predictors of clinically significant outcomes five years after couples completed one of two behaviorally based couple therapies. Method One hundred and thirty-four couples were randomly assigned to Integrative Behavioral Couple Therapy (IBCT; Jacobson & Christensen, 1998) or Traditional Behavioral Couple Therapy (TBCT; Jacobson & Margolin, 1979) and followed for 5 years after treatment. Outcomes include clinically significant change categories of relationship satisfaction and marital status at 5-year follow-up. Optimal subsets of predictors were selected using an automated, bootstrapped selection procedure based on Bayesian Information Criterion. Results Higher levels of commitment and being married for a longer period of time were associated with decreased likelihood of divorce/separation (Odds Ratio [OR] = 1.39, p = .004; OR = 0.91, p = .015). Being married for a longer period of time was also associated with increased likelihood of positive, clinically significant change (OR = 1.12, p = .029). Finally, higher levels of wife desired closeness were associated with increased odds of positive, clinically significant change and decreased odds of divorce for moderately distressed, IBCT couples (OR = 1.16, p = 0.002; OR = 0.85, p = 0.007, respectively) whereas the opposite was true for moderately distressed, TBCT couples (OR = 0.77, p divorced and most likely to report improvements in relationship satisfaction five years after ending treatment. In addition, it appears that the impact of wives’ desired closeness depended on the type of treatment moderately distressed couple received. PMID:25265544

  4. Analyzing the short-term effect of placebo therapy in pulmonary arterial hypertension: potential implications for the design of future clinical trials.

    Science.gov (United States)

    Helman, Donald L; Brown, Alexander W; Jackson, Jeffrey L; Shorr, Andrew F

    2007-09-01

    Placebo is commonly used in short-term randomized trials for pulmonary arterial hypertension (PAH). Currently, outcome data regarding placebo are lacking. We conducted a systematic review and performed a metaanalysis to assess its effect. Articles were identified via a query of MEDLINE and EMBASE using the following terms: "pulmonary hypertension"; "clinical trial"; "six minute walk"; "pulmonary hemodynamic"; and "survival." A manual bibliography search of selected trials, reviews, and guidelines was performed. The inclusion criteria were as follows: randomized, placebo-controlled with data reported at baseline and at 12 to 18 weeks. Two reviewers independently abstracted: 6-min walk distance, pulmonary hemodynamic measures and frequency of death, clinical worsening, and change in New York Heart Association/World Health Organization functional class. The data were pooled using a random-effects model. Thirteen of the 688 articles identified met the inclusion criteria (a total of 868 placebo-treated patients). After 12 to 18 weeks, the 6-min walk distance decreased by 8.4 m (95% confidence interval [CI], -14.6 to -2.2) and pulmonary vascular resistance increased by 58.9 dyne (.) s (.) cm(-5) (95% CI, 27.6 to 90.1). Placebo-treated patients were 1.81 times more likely to experience a clinical worsening (95% CI, 1.30 to 2.53). Placebo treatment was not associated with a difference in mortality. Patients with PAH who receive placebo are more likely to experience clinical deteriorations. Further debate is needed regarding the design of future clinical trials. Research efforts should focus on evaluating existing medications against one another and comparing novel therapies with currently accepted ones.

  5. An Update on Randomized Clinical Trials in Breast Cancer.

    Science.gov (United States)

    Barnard, Kayla; Klimberg, V Suzanne

    2017-10-01

    Numerous clinical trials reveal new innovations and therapies that continually change the treatment and prevention of breast cancer. Earlier trials have changed the standard of care from radical mastectomy to breast conservation therapy and individualized treatment based on tumor-specific biology. As research continues and long-term follow-up results become available, updated reviews on randomized clinics trials become exceedingly important in discerning the most effective and oncologically safe therapies to provide optimal outcomes. Published by Elsevier Inc.

  6. The clinical efficacy of reminiscence therapy in patients with mild-to-moderate Alzheimer disease: Study protocol for a randomized parallel-design controlled trial.

    Science.gov (United States)

    Li, Mo; Lyu, Ji-Hui; Zhang, Yi; Gao, Mao-Long; Li, Wen-Jie; Ma, Xin

    2017-12-01

    Alzheimer disease (AD) is one of the most common diseases among the older adults. Currently, various nonpharmacological interventions are used for the treatment of AD. Such as reminiscence therapy is being widely used in Western countries. However, it is often used as an empirical application in China; the evidence-based efficacy of reminiscence therapy in AD patients remains to be determined. Therefore, the aim of this research is to assess the effectives of reminiscence therapy for Chinese elderly. This is a randomized parallel-design controlled trial. Mild and moderate AD patients who are in the Beijing Geriatric Hospital, China will be randomized into control and intervention groups (n = 45 for each group). For the intervention group, along with conventional drug therapy, participants will be exposed to a reminiscence therapy of 35 to 45 minutes, 2 times/wk for 12 consecutive weeks. Patients in the control group will undergo conventional drug therapy only. The primary outcome measure will be the differences in Alzheimer disease Assessment Scale-Cognitive Section Score. The secondary outcome measures will be the differences in the Cornell scale for depression in dementia, Neuropsychiatric Inventory score, and Barthel Index scores at baseline, at 4 and 12 weeks of treatment, and 12 weeks after treatment. The protocols have been approved by the ethics committee of Beijing Geriatric Hospital of China (approval no. 2015-010). Findings will be disseminated through presentation at scientific conferences and in academic journals. Chinese Clinical Trial Registry identifier ChiCTR-INR-16009505. Copyright © 2017 The Authors. Published by Wolters Kluwer Health, Inc. All rights reserved.

  7. Ankle manual therapy for individuals with post-acute ankle sprains: description of a randomized, placebo-controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Fisher Beth E

    2010-10-01

    Full Text Available Abstract Background Ankle sprains are common within the general population and can result in prolonged disablement. Limited talocrural dorsiflexion range of motion (DF ROM is a common consequence of ankle sprain. Limited talocrural DF ROM may contribute to persistent symptoms, disability, and an elevated risk for re-injury. As a result, many health care practitioners use hands-on passive procedures with the intention of improving talocrural joint DF ROM in individuals following ankle sprains. Dosage of passive hands-on procedures involves a continuum of treatment speeds. Recent evidence suggests both slow- and fast-speed treatments may be effective to address disablement following ankle sprains. However, these interventions have yet to be longitudinally compared against a placebo study condition. Methods/Design We developed a randomized, placebo-controlled clinical trial designed to test the hypotheses that hands-on treatment procedures administered to individuals following ankle sprains during the post-acute injury period can improve short-, intermediate-, and long-term disablement, as well as reduce the risk for re-injury. Discussion This study is designed to measure the clinical effects of hands-on passive stretching treatment procedures directed to the talocrural joint that vary in treatment speed during the post-acute injury period, compared to hands-on placebo control intervention. Trial Registration http://www.clinicaltrials.gov identifier NCT00888498.

  8. Study Protocol for a randomized controlled trial of mentalization based therapy against specialist supportive clinical management in patients with both eating disorders and symptoms of borderline personality disorder.

    Science.gov (United States)

    Robinson, Paul; Barrett, Barbara; Bateman, Anthony; Hakeem, Az; Hellier, Jennifer; Lemonsky, Fenella; Rutterford, Clare; Schmidt, Ulrike; Fonagy, Peter

    2014-02-21

    The NOURISHED study: Nice OUtcomes for Referrals with Impulsivity, Self Harm and Eating Disorders.Eating Disorders (ED) and Borderline Personality Disorder (BPD) are both difficult to treat and the combination presents particular challenges. Both are associated with vulnerability to loss of mentalization (awareness of one's own and others' emotional state). In BPD, Mentalization Based therapy (MBT) has been found effective in reducing symptoms. In this trial we investigate the effectiveness and cost-effectiveness of MBT adapted for Eating disorders (Mentalization Based Therapy for Eating Disorders (MBT-ED)) compared to a standard comparison treatment, Specialist Supportive Clinical Management (SSCM-ED) in patients with a combination of an Eating Disorder and either a diagnosis of BPD or a history of self-harm and impulsivity in the previous 12 months. We will complete a multi-site single-blind randomized controlled trial (RCT) of MBT-ED vs SSCM-ED. Participants will be recruited from three Eating Disorder Services and two Borderline Personality Disorder Services in London. Participants allocated to MBT-ED will receive one year of weekly group and individual therapy and participants allocated to SSCM-ED will receive 20 sessions of individual therapy over 1 year. In addition, participants in both groups will have access to up to 5 hours of dietetic advice. The primary outcome measure is the global score on the Eating Disorders Examination. Secondary outcome measures include total score on the Zanarini BPD scale, the Object Relations Inventory, the Depression Anxiety Stress Scales, quality of life and cost-effectiveness. Measures are taken at recruitment and at 6 month intervals up to 18 months. This is the first Randomised Controlled Trial of MBT-ED in patients with eating disorders and symptoms of BPD and will provide evidence to inform therapy decisions in this group of patients. During MBT-ED mentalization is encouraged, while in SSCM-ED it is not overtly

  9. [Effectiveness of microcurrent therapy as a constituent of post-hospital rehabilitative treatment in patients after total knee alloarthroplasty - a randomized clinical trial].

    Science.gov (United States)

    Rockstroh, G; Schleicher, W; Krummenauer, F

    2010-06-01

    This trial compared the clinical effectiveness of a combination of microcurrent therapy (M) with conventional postoperative physiotherapy treatment versus the combination of the latter with a sham (S) treatment after total knee arthroplasty (TKA) in terms of patient-related functional outcome parameters. A total of 78 inpatients after TKA was randomized into the active versus the sham treatment samples; all patients received ten applications of their respective therapy assignment. The primary clinical endpoint of the investigation was defined as the three-months intraindividual change (%) in a patient's OSWESTRY total function score after start of treatment. Secondary endpoints were the WOMAC osteoarthritis index as well as a patient's pain profile as assessed by a visual analogue scale before start of treatment, after five and ten therapeutic applications, and three months after discharge from hospital. The M sample showed a median increase of 31% (22-38%) in the OSWESTRY total score from 53% before start of treatment to 91% three months afterwards; the control sample showed an increase of 18% (3-31%) in median from 56 % to 78%; the samples differed significantly in this three-months increase (pmicrocurrent therapy embedded in conventional postoperative rehabilitation treatment after TKA versus the combination with a sham treatment. The results indicate an early introduction of microcurrent therapy concepts into postoperative treatment. Georg Thieme Verlag KG Stuttgart New York.

  10. The effects of topical heat therapy on chest pain in patients with acute coronary syndrome: a randomised double-blind placebo-controlled clinical trial.

    Science.gov (United States)

    Mohammadpour, Ali; Mohammadian, Batol; Basiri Moghadam, Mehdi; Nematollahi, Mahmoud Reza

    2014-12-01

    To investigate the effects of local heat therapy on chest pain in patients with acute coronary syndrome. Chest pain is a very common complaint in patients with acute coronary syndrome. It is managed both pharmacologically and nonpharmacologically. Pharmacological pain management is associated with different side effects. This was a randomised double-blind placebo-controlled clinical trial conducted in 2013. A convenience sample of 66 patients with acute coronary syndrome was selected from a coronary care unit of a local teaching hospital affiliated to Gonabad University of Medical Sciences, Gonabad, Iran. Patients were randomly assigned to either the experimental or the placebo group. Patients in the experimental and the placebo groups received local heat therapy using a hot pack warmed to 50 and 37 °C, respectively. We assessed chest pain intensity, duration and frequency as well as the need for opioid analgesic therapy both before and after the study. The study instrument consisted of a demographic questionnaire, the McGill Pain Questionnaire, and a data sheet for documenting pain frequency and duration as well as the need for analgesic therapy. The placebo heat therapy did not significantly decrease the intensity, the duration and the frequency of pain episodes. However, pain intensity, duration and frequency in the experimental group decreased significantly after the study. Moreover, the groups differed significantly in terms of the need for opioid analgesic therapy neither before nor after the intervention. Local heat therapy is an effective intervention for preventing and relieving chest pain in patients with acute coronary syndrome. Effective pain management using local heat therapy could help nurses play an important role in providing effective care to patients with acute coronary syndrome and in minimising adverse effects associated with pain medications. © 2014 John Wiley & Sons Ltd.

  11. Effects of Improvisational Music Therapy vs Enhanced Standard Care on Symptom Severity Among Children With Autism Spectrum Disorder: The TIME-A Randomized Clinical Trial.

    Science.gov (United States)

    Bieleninik, Lucja; Geretsegger, Monika; Mössler, Karin; Assmus, Jörg; Thompson, Grace; Gattino, Gustavo; Elefant, Cochavit; Gottfried, Tali; Igliozzi, Roberta; Muratori, Filippo; Suvini, Ferdinando; Kim, Jinah; Crawford, Mike J; Odell-Miller, Helen; Oldfield, Amelia; Casey, Órla; Finnemann, Johanna; Carpente, John; Park, A-La; Grossi, Enzo; Gold, Christian

    2017-08-08

    Music therapy may facilitate skills in areas affected by autism spectrum disorder (ASD), such as social interaction and communication. To evaluate effects of improvisational music therapy on generalized social communication skills of children with ASD. Assessor-blinded, randomized clinical trial, conducted in 9 countries and enrolling children aged 4 to 7 years with ASD. Children were recruited from November 2011 to November 2015, with follow-up between January 2012 and November 2016. Enhanced standard care (n = 182) vs enhanced standard care plus improvisational music therapy (n = 182), allocated in a 1:1 ratio. Enhanced standard care consisted of usual care as locally available plus parent counseling to discuss parents' concerns and provide information about ASD. In improvisational music therapy, trained music therapists sang or played music with each child, attuned and adapted to the child's focus of attention, to help children develop affect sharing and joint attention. The primary outcome was symptom severity over 5 months, based on the Autism Diagnostic Observation Schedule (ADOS), social affect domain (range, 0-27; higher scores indicate greater severity; minimal clinically important difference, 1). Prespecified secondary outcomes included parent-rated social responsiveness. All outcomes were also assessed at 2 and 12 months. Among 364 participants randomized (mean age, 5.4 years; 83% boys), 314 (86%) completed the primary end point and 290 (80%) completed the last end point. Over 5 months, participants assigned to music therapy received a median of 19 music therapy, 3 parent counseling, and 36 other therapy sessions, compared with 3 parent counseling and 45 other therapy sessions for those assigned to enhanced standard care. From baseline to 5 months, mean ADOS social affect scores estimated by linear mixed-effects models decreased from 14.08 to 13.23 in the music therapy group and from 13.49 to 12.58 in the standard care group (mean difference, 0

  12. Dialectical behaviour therapy for women with borderline personality disorder: 12-month, randomised clinical trial in The Netherlands.

    Science.gov (United States)

    Verheul, Roel; Van Den Bosch, Louise M C; Koeter, Maarten W J; De Ridder, Maria A J; Stijnen, Theo; Van Den Brink, Wim

    2003-02-01

    Dialectical behaviour therapy (DBT) is widely considered to be a promising treatment for borderline personality disorder (BPD). However, the evidence for its efficacy published thus far should be regarded as preliminary. To compare the effectiveness of DBT with treatment as usual for patients with BPD and to examine the impact of baseline severity on effectiveness. Fifty-eight women with BPD were randomly assigned to either 12 months of DBT or usual treatment in a randomised controlled study. Participants were recruited through clinical referrals from both addiction treatment and psychiatric services. Outcome measures included treatment retention and the course of suicidal, self-mutilating and self-damaging impulsive behaviours. Dialectical behaviour therapy resulted in better retention rates and greater reductions of self-mutilating and self-damaging impulsive behaviours compared with usual treatment, especially among those with a history of frequent self-mutilation. Dialectical behaviour therapy is superior to usual treatment in reducing high-risk behaviours in patients with BPD.

  13. [Physical therapy intervention during hospitalization in patients with acute exacerbation of chronic obstructive pulmonary disease and pneumonia: A randomized clinical trial].

    Science.gov (United States)

    Martín-Salvador, Adelina; Colodro-Amores, Gloria; Torres-Sánchez, Irene; Moreno-Ramírez, M Paz; Cabrera-Martos, Irene; Valenza, Marie Carmen

    2016-04-01

    Respiratory infections involve not only hospitalization due to pneumonia, but also acute exacerbations of COPD (AECOPD). The objective of the present study was to evaluate the effectiveness of a physical therapy intervention during hospitalization in patients admitted due to community-acquired pneumonia (CAP) and AECOPD. Randomized clinical trial, 44 patients were randomized into 2 groups: a control group which received standard medical therapy (oxygen therapy and pharmacotherapy) and an experimental group that received standard treatment and a physical therapy intervention (breathing exercises, electrostimulation, exercises with elastic bands and relaxation). Between-groups analysis showed that after the intervention (experimental vs. control) significant differences were found in perceived dyspnoea (P=.041), and right and left quadriceps muscle strength (P=.008 and P=.010, respectively). In addition, the subscale of "domestic activities" of the functional ability related to respiratory symptoms questionnaire showed significant differences (P=.036). A physical therapy intervention during hospitalization in patients with AECOPD and CAP can generate skeletal muscle level gains that exceed the deterioration caused by immobilization during hospitalization. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.

  14. COMPliance and Arthralgia in Clinical Therapy: the COMPACT trial, assessing the incidence of arthralgia, and compliance within the first year of adjuvant anastrozole therapy.

    Science.gov (United States)

    Hadji, P; Jackisch, C; Bolten, W; Blettner, M; Hindenburg, H J; Klein, P; König, K; Kreienberg, R; Rief, W; Wallwiener, D; Zaun, S; Harbeck, N

    2014-02-01

    This prospective study evaluated the relationship between arthralgia and compliance during the first year of adjuvant anastrozole therapy in postmenopausal women with hormone receptor-positive early breast cancer. COMPliance and Arthralgia in Clinical Therapy (COMPACT) was an open-label, multicenter, noninterventional study conducted in Germany. Patients had started adjuvant anastrozole 3-6 months before the study start. The primary end points were arthralgia, compliance, and the relationship between compliance and arthralgia, assessed at specific time points. Overall, 1916 patients received upfront anastrozole. Mean arthralgia scores were increased from baseline at each visit up to 9 months. Compliance with anastrozole therapy gradually decreased over time from baseline to 9 months (P95% of patients were compliant versus patient reports of <70%. There was a significant association between arthralgia mean scores and noncompliance at 6 months (P<0.0001), 9 months (P<0.0001), and overall (P<0.0001). Over time, new events or impairment of existing arthralgias were reported in 14% (3 months), 11% (6 months), and 9% (9 months) of patients. Arthralgia is important in the clinical management of women with early breast cancer and may contribute to noncompliance and clinical outcomes. NCT00857012.

  15. Effects of neuromuscular electrical stimulation, laser therapy and LED therapy on the masticatory system and the impact on sleep variables in cerebral palsy patients: a randomized, five arms clinical trial

    Directory of Open Access Journals (Sweden)

    Giannasi Lilian

    2012-05-01

    Full Text Available Abstract Background Few studies demonstrate effectiveness of therapies for oral rehabilitation of patients with cerebral palsy (CP, given the difficulties in chewing, swallowing and speech, besides the intellectual, sensory and social limitations. Due to upper airway obstruction, they are also vulnerable to sleep disorders. This study aims to assess the sleep variables, through polysomnography, and masticatory dynamics, using electromiography, before and after neuromuscular electrical stimulation, associated or not with low power laser (Gallium Arsenide- Aluminun, =780 nm and LED (= 660 nm irradiation in CP patients. Methods/design 50 patients with CP, both gender, aged between 19 and 60 years will be enrolled in this study. The inclusion criteria are: voluntary participation, patient with hemiparesis, quadriparesis or diparetic CP, with ability to understand and respond to verbal commands. The exclusion criteria are: patients undergoing/underwent orthodontic, functional maxillary orthopedic or botulinum toxin treatment. Polysomnographic and surface electromyographic exams on masseter, temporalis and suprahyoid will be carry out in all sample. Questionnaire assessing oral characteristics will be applied. The sample will be divided into 5 treatment groups: Group 1: neuromuscular electrical stimulation; Group 2: laser therapy; Group 3: LED therapy; Group 4: neuromuscular electrical stimulation and laser therapy and Group 5: neuromuscular electrical stimulation and LED therapy. All patients will be treated during 8 consecutive weeks. After treatment, polysomnographic and electromiographic exams will be collected again. Discussion This paper describes a five arm clinical trial assessing the examination of sleep quality and masticatory function in patients with CP under non-invasive therapies. Trial registration The protocol for this study is registered with the Brazilian Registry of Clinical Trials - ReBEC RBR-994XFS Descriptors Cerebral Palsy

  16. Boric acid irrigation as an adjunct to mechanical periodontal therapy in patients with chronic periodontitis: a randomized clinical trial.

    Science.gov (United States)

    Sağlam, Mehmet; Arslan, Uğur; Buket Bozkurt, Şerife; Hakki, Sema S

    2013-09-01

    The purpose of this single-masked, randomized, controlled clinical trial was to evaluate the effects of boric acid irrigation as an adjunct to scaling and root planing (SRP) on clinical and microbiologic parameters and compare this method with chlorhexidine irrigation and SRP alone in patients with chronic periodontitis (CP). Forty-five systemically healthy patients with CP are included in this study. They were divided into three groups: 1) SRP + saline irrigation (C); 2) SRP + chlorhexidine irrigation (CHX); and 3) SRP + boric acid irrigation (B). To determine an ideal concentration of boric acid, a preclinical analysis was conducted. At baseline, 1 month, and 3 months after treatment, clinical measurements, including plaque index (PI), gingival index (GI), probing depth (PD), clinical attachment level (CAL), and bleeding on probing (BOP), were performed, and subgingival plaque samples were taken. Quantitative analysis of Porphyromonas gingivalis (Pg), Tannerella forsythia (Tf), and Treponema denticola (Td) was performed using real-time polymerase chain reaction (PCR) procedures. The concentration of boric acid is 0.75% in this study. All clinical parameters showed statistically significant reduction at all time points compared to baseline in all groups (P 0.05). The PD and CAL reductions for moderately deep pockets (PD ≥5 and 0.05). BOP (percentage) was significantly lower in the B group compared with the CHX and C groups in the first month after treatment (P 0.05). The results of this study suggest that boric acid could be an alternative to chlorhexidine, and it might be more favorable because boric acid was superior in whole-mouth BOP as well as PD and CAL reduction for moderate pockets in early time periods.

  17. Clinical trials and gender medicine

    Directory of Open Access Journals (Sweden)

    Mariarita Cassese

    2011-01-01

    Full Text Available Women use more medicines than men because they fall ill more often and suffer more from chronic diseases, but also because women pay more attention to their health and have more consciousness and care about themselves. Although medicines can have different effects on women and men, women still represent a small percentage in the first phases of trials (22% which are essential to verify drugs dosage, side effects, and safety. Even though women are more present in trials, studies results are not presented with a gender approach. This situation is due to educational, social, ethical and economical factors. The scientific research must increase feminine presence in clinical trials in order to be equal and correct, and all the key stakeholder should be involved in this process. We still have a long way to cover and it doesn't concern only women but also children and old people. The aim is to have a medicine not only illness-focused but patient-focused: a medicine able to take into consideration all the patient characteristics and so to produce a really personalized therapy. What above described is part of the reasons why in 2005 was founded the National Observatory for Women's Health (Osservatorio Nazionale sulla Salute della Donna, ONDa which promotes a gender health awareness and culture in Italy, at all the levels of the civil and scientific society.

  18. Massage as adjuvant therapy in the management of post-cesarean pain and anxiety: A randomized clinical trial.

    Science.gov (United States)

    Saatsaz, Sussan; Rezaei, Rozita; Alipour, Abbas; Beheshti, Zahra

    2016-08-01

    The present study was conducted to determine the effect of massage on post-cesarean pain and anxiety. The present single-blind clinical trial was conducted on 156 primiparous women undergone elective cesarean section. The participants were randomly divided into three groups, including a hand and foot massage group, a foot massage group and a control group (n = 52 per group). The patients' intensity of pain, vital signs and anxiety level were measured before, immediately after and 90 min after the massage. A significant reduction was observed in the intensity of pain immediately and 90 min after massage (P anxiety (P management of postoperative pain and stress. Copyright © 2016 Elsevier Ltd. All rights reserved.

  19. Clinical Differences between Younger and Older Adults with HIV/AIDS Starting Antiretroviral Therapy in Uganda and Zimbabwe: A Secondary Analysis of the DART Trial

    Science.gov (United States)

    Parikh, Sujal M.; Obuku, Ekwaro A.; Walker, Sarah A.; Semeere, Aggrey S.; Auerbach, Brandon J.; Hakim, James G.; Mayanja-Kizza, Harriet; Mugyenyi, Peter N.; Salata, Robert A.; Kityo, Cissy M.

    2013-01-01

    Objective Clinical and immunological data about HIV in older adults from low and middle income countries is scarce. We aimed to describe differences between younger and older adults with HIV starting antiretroviral therapy in two low–income African countries. Methods Setting: HIV clinics in Uganda and Zimbabwe. Design: Secondary exploratory cross-sectional analysis of the DART randomized controlled trial. Outcome Measures: Clinical and laboratory characteristics were compared between adults aged 18-49 years (younger) and ≥ 50 years (older), using two exploratory multivariable logistic regression models, one with HIV viral load (measured in a subset pre-ART) and one without. Results A total of 3316 eligible participants enrolled in DART were available for analysis; 219 (7%) were ≥ 50 years and 1160 (35%) were male. Across the two adjusted regression models, older adults had significantly higher systolic blood pressure, lower creatinine clearance and were consistently less likely to be females compared to younger adults with HIV. Paradoxically, the models separately suggested that older adults had statistically significant (but not clinically important) higher CD4+ cell counts and higher plasma HIV–1 viral copies at initiation. Crude associations between older age and higher baseline hemoglobin, body mass index, diastolic blood pressure and lower WHO clinical stage were not sustained in the adjusted analysis. Conclusions Our study found clinical and immunological differences between younger and older adults, in a cohort of Africans starting antiretroviral therapy. Further investigations should explore how these differences could be used to ensure equity in service delivery and affect outcomes of antiretroviral therapy. PMID:24098434

  20. Restricted Crystalloid Fluid Therapy during Orthotopic Liver Transplant Surgery and its Effect on Respiratory and Renal Insufficiency in the Early Post-operative Period: A Randomized Clinical Trial.

    Science.gov (United States)

    Sahmeddini, M A; Janatmakan, F; Khosravi, M B; Ghaffaripour, S; Eghbal, M H; Nickeghbalian, S; Malek-Hosseini, S A

    2014-01-01

    Respiratory and renal insufficiencies are common dysfunctions during post-liver transplantation period that increase post-operative mortality and morbidity rates. Intra-operative fluid therapy is an important factor associated with pulmonary and renal insufficiency. To evaluate the relation between intra-operative fluid therapy and early renal and respiratory insufficiency after liver transplantation. In this randomized clinical study, 67 adult patients with end-stage liver disease who underwent orthotopic deceased donor liver transplantation were randomly allocated into two groups. The restricted fluid group, which received a controlled fluid administration of normal saline, 5 mL/kg/hr during anesthesia, and non-restricted fluid group received a controlled infusion of normal saline 10 mL/kg/hr during anesthesia. Early post-operative respiratory and renal insufficiency in both groups were assessed. The patients were monitored during the three stages of liver transplantation for their hemodynamic indices. The trial is registered with the Iranian Randomized Clinical Trial Registry, number IRCT2013101811662N4. The baseline demographic and clinical characteristics were similar in both studied groups. The prevalence of respiratory insufficiency in the non-restricted fluid group (15%) significantly (p=0.01) higher than that in the restricted fluid group (0%). The post-operative mean±SD serum creatinine was 1.0±0.1 mg/dL in the non-restricted fluid group and 1.1±0.2 in the restricted fluid group (p=0.43). No patients in the studied groups required post-operative continuous renal replacement therapy. Restricted crystalloid fluid administration during orthotropic liver transplantation though decreased post-operative chance of pulmonary insufficiency, did not increase renal dysfunction.

  1. Placebo and nocebo effects in randomized double-blind clinical trials of agents for the therapy for fatigue in patients with advanced cancer.

    Science.gov (United States)

    de la Cruz, Maxine; Hui, David; Parsons, Henrique A; Bruera, Eduardo

    2010-02-01

    A significant response to placebo in randomized controlled trials of treatments for cancer-related fatigue (CRF) had been reported. A retrospective study was conducted to determine the frequency and predictors of response to placebo effect and nocebo effects in patients with CRF treated in those trials. The records of 105 patients who received placebo in 2 previous randomized clinical trials conducted by this group were reviewed. The proportion of patients who demonstrated clinical response to fatigue, defined as an increase in Functional Assessment of Chronic Illness Therapy-Fatigue score of > or = 7 from baseline to Day 8, and the proportion of patients with a nocebo effect, defined as those reporting >2 side effects, were determined. Baseline patient characteristics and symptoms recorded using the Edmonton Symptom Assessment Scale (ESAS) were analyzed to determine their association with placebo and nocebo effects. Fifty-nine (56%) patients had a placebo response. Worse baseline anxiety and well-being subscale score (univariate) and well-being (multivariate) were significantly associated with placebo response. Commonly reported side effects were insomnia (79%), anorexia (53%), nausea (38%), and restlessness (34%). Multivariate analysis indicated that worse baseline (ESAS) sleep, appetite, and nausea were associated with increased reporting of the corresponding side effects. Greater than half of advanced cancer patients enrolled in CRF trials had a placebo response. Worse baseline physical well-being score was associated with placebo response. Patients experiencing specific symptoms at baseline were more likely to report these as side effects of the medication. These findings should be considered in the design of future CRF trials. Copyright 2009 American Cancer Society.

  2. Effectiveness of core stabilization exercises and routine exercise therapy in management of pain in chronic non-specific low back pain: A randomized controlled clinical trial.

    Science.gov (United States)

    Akhtar, Muhammad Waseem; Karimi, Hossein; Gilani, Syed Amir

    2017-01-01

    Low back pain is a frequent problem faced by the majority of people at some point in their lifetime. Exercise therapy has been advocated an effective treatment for chronic low back pain. However, there is lack of consensus on the best exercise treatment and numerous studies are underway. Conclusive studies are lacking especially in this part of the world. Thisstudy was designed to compare the effectiveness of specific stabilization exercises with routine physical therapy exerciseprovided in patients with nonspecific chronic mechanical low back pain. This is single blinded randomized control trial that was conducted at the department of physical therapy Orthopedic and Spine Institute, Johar Town, Lahore in which 120 subjects with nonspecific chronic low back pain participated. Subjects with the age between 20 to 60 years and primary complaint of chronic low back pain were recruited after giving an informed consent. Participants were randomly assigned to two treatment groups A & B which were treated with core stabilization exercise and routine physical therapy exercise respectively. TENS and ultrasound were given as therapeutic modalities to both treatment groups. Outcomes of the treatment were recorded using Visual Analogue Scale (VAS) pretreatment, at 2 nd , 4 th and 6 th week post treatment. The results of this study illustrate that clinical and therapeutic effects of core stabilization exercise program over the period of six weeks are more effective in terms of reduction in pain, compared to routine physical therapy exercise for similar duration. This study found significant reduction in pain across the two groups at 2 nd , 4 th and 6 th week of treatment with p value less than 0.05. There was a mean reduction of 3.08 and 1.71 on VAS across the core stabilization group and routine physical therapy exercise group respectively. Core stabilization exercise is more effective than routine physical therapy exercise in terms of greater reduction in pain in patients with

  3. Effectiveness of core stabilization exercises and routine exercise therapy in management of pain in chronic non-specific low back pain: A randomized controlled clinical trial

    Science.gov (United States)

    Akhtar, Muhammad Waseem; Karimi, Hossein; Gilani, Syed Amir

    2017-01-01

    Background & Objective: Low back pain is a frequent problem faced by the majority of people at some point in their lifetime. Exercise therapy has been advocated an effective treatment for chronic low back pain. However, there is lack of consensus on the best exercise treatment and numerous studies are underway. Conclusive studies are lacking especially in this part of the world. Thisstudy was designed to compare the effectiveness of specific stabilization exercises with routine physical therapy exerciseprovided in patients with nonspecific chronic mechanical low back pain. Methods: This is single blinded randomized control trial that was conducted at the department of physical therapy Orthopedic and Spine Institute, Johar Town, Lahore in which 120 subjects with nonspecific chronic low back pain participated. Subjects with the age between 20 to 60 years and primary complaint of chronic low back pain were recruited after giving an informed consent. Participants were randomly assigned to two treatment groups A & B which were treated with core stabilization exercise and routine physical therapy exercise respectively. TENS and ultrasound were given as therapeutic modalities to both treatment groups. Outcomes of the treatment were recorded using Visual Analogue Scale (VAS) pretreatment, at 2nd, 4th and 6th week post treatment. Results: The results of this study illustrate that clinical and therapeutic effects of core stabilization exercise program over the period of six weeks are more effective in terms of reduction in pain, compared to routine physical therapy exercise for similar duration. This study found significant reduction in pain across the two groups at 2nd, 4th and 6th week of treatment with p value less than 0.05. There was a mean reduction of 3.08 and 1.71 on VAS across the core stabilization group and routine physical therapy exercise group respectively. Conclusion: Core stabilization exercise is more effective than routine physical therapy exercise in terms

  4. Clinical outcomes in clinical trials of anti-HIV treatment

    DEFF Research Database (Denmark)

    Reekie, J; Mocroft, A; J, Neaton

    2007-01-01

    and knowledge of HIV led to short-term trials using surrogate outcomes such as viral load and CD4 count. This established a faster drug approval process that complimented the rapid need to evaluate and provide access to drugs based on short-term trials. However, no treatment has yet been found that eradicates......Since the introduction of combination antiretroviral therapy, there has been a decrease in both AIDS-defining illnesses and deaths. This decrease meant that performing clinical trials with clinical outcomes in HIV infection became more time consuming and hence costly. Improved understanding...... the infection, so when treatment is started it is currently a lifelong commitment. Is it reasonable then that guidelines are based almost completely on short-term randomized trials and observational studies of surrogate markers, or is there still a need for trials with clinical outcomes?...

  5. Clinical outcomes in clinical trials of anti-HIV treatment

    DEFF Research Database (Denmark)

    Reekie, J; Mocroft, A; J, Neaton

    2007-01-01

    Since the introduction of combination antiretroviral therapy, there has been a decrease in both AIDS-defining illnesses and deaths. This decrease meant that performing clinical trials with clinical outcomes in HIV infection became more time consuming and hence costly. Improved understanding...... the infection, so when treatment is started it is currently a lifelong commitment. Is it reasonable then that guidelines are based almost completely on short-term randomized trials and observational studies of surrogate markers, or is there still a need for trials with clinical outcomes?...... and knowledge of HIV led to short-term trials using surrogate outcomes such as viral load and CD4 count. This established a faster drug approval process that complimented the rapid need to evaluate and provide access to drugs based on short-term trials. However, no treatment has yet been found that eradicates...

  6. Comparison of the Effect of Massage Therapy and Isometric Exercises on Primary Dysmenorrhea: A Randomized Controlled Clinical Trial.

    Science.gov (United States)

    Azima, Sara; Bakhshayesh, Hajar Rajaei; Kaviani, Maasumeh; Abbasnia, Keramatallah; Sayadi, Mehrab

    2015-12-01

    Dysmenorrhea is the most common cyclic pelvic pain, and it affects the quality of life of many women. We sought to compare the effects of massage and isometric exercises on primary dysmenorrhea. We conducted a randomized controlled trial at the dormitories of Shiraz University among 102 students with primary dysmenorrheal. The student groups were randomly divided into massage, isometric exercises, and control groups. The first group received 2 consecutive cycles of effleurage massage with lavender oil. The second group had 8 weeks of isometric exercises. No intervention was performed for the control group. Pain intensity was measured and recorded by using a visual analog scale. In addition, the duration of pain was measured in hours, and Spielberger's questionnaire was used to measure the anxiety level. Pain intensity had significantly reduced in the massage and exercises groups; the reduction was more significant in the massage group (P massage group after the third cycle (P = .017). Based on the present findings, it seems that massage therapy and isometric exercises were effective in reducing some symptoms of dysmenorrhea. Copyright © 2015 North American Society for Pediatric and Adolescent Gynecology. Published by Elsevier Inc. All rights reserved.

  7. Adjunctive Systemic Antimicrobial Therapy vs Asepsis in Conjunction with Guided Tissue Regeneration: A Randomized, Controlled Clinical Trial.

    Science.gov (United States)

    Abu-Ta'a, Mahmoud

    2016-01-01

    This randomized clinical trial compares the usefulness of adjunctive antibiotics, while strict asepsis was followed during periodontal surgery involving guided tissue regeneration. Two groups of 20 consecutive patients each with advanced periodontal disease were randomly assigned to treatment. They displayed one angular defect each with an intrabony component ≥3 mm, probing pocket depth and probing attachment level (PAL) ≥7 mm. Test group included 13 males, mean age 60 years, treated with enamel matrix derivative (EMD) and demineralized freeze-dried bone allograft with modified papilla preservation technique, received oral amoxicillin 1 gm, 1 hour preoperatively and 2 gm for 2 days postoperatively. Control group included 10 males, mean age 57 years, treated with EMD and demineralized freeze-dried bone allograft with modified papilla preservation technique, received no antibiotics. Outcome measures were clinical attachment level (CAL) gain, residual periodontal pocket depth (res. PD), gingival recession (GR), bleeding on probing (BOP), adverse events and postoperative complications. Patients were followed up to 12 months after periodontal surgery involving guided tissue regeneration. There were no significant differences between both groups for CAL gain, res. PD, GR, BOP nor other clinical parameters, though patients' subjective perception of postoperative discomfort was significantly smaller in the group receiving antibiotics. Antibiotics do not provide significant advantages concerning clinical periodontal parameters nor concerning postoperative infections in case of proper asepsis. It does, on the contrary, reduce postoperative discomfort. Regarding the results of this study, adjunc-tive systemic antibiotics in combination with guided tissue regeneration may be useful in reducing postoperative discomfort but may not be helpful for improving periodontal regeneration outcomes.

  8. A randomized clinical trial of manual therapy and physiotherapy for persistent back and neck complaints: subgroup analysis and relationship between outcome measures.

    Science.gov (United States)

    Koes, B W; Bouter, L M; van Mameren, H; Essers, A H; Verstegen, G J; Hofhuizen, D M; Houben, J P; Knipschild, P G

    1993-05-01

    To study the efficacy of manual therapy and physiotherapy in subgroups of patients with persistent back and neck complaints. The second objective was to determine the correlation between three important outcome measures used in this trial. Randomized clinical trial (subgroup analysis). Primary health care in the Netherlands. Two hundred fifty-six patients with nonspecific back and neck complaints of at least 6 wk duration who had not received physiotherapy or manual therapy in the past 2 yr. At the discretion of the manual therapists, physiotherapists and general practitioners. Physiotherapy consisted of exercises, massage and physical therapy (heat, electrotherapy, ultrasound, shortwave diathermy). Manual therapy consisted of manipulation and mobilization of the spine. Treatment by the general practitioner consisted of drugs (e.g., analgesics), advice about posture, home exercises and (bed)rest. Placebo treatment consisted of detuned shortwave diathermy (10 min) and detuned ultrasound (10 min). Changes in severity of the main complaint and limitation of physical functioning measured on 10-point scales by a blinded research assistant and global perceived effect measured on a 6-point scale by the patients. Improvement in the main complaint was larger with manual therapy (4.3) than with physiotherapy (2.5) for patients with chronic conditions (duration complaint of 1 yr or longer). Also, improvement in the main complaint was larger with manual therapy (5.5) than with physiotherapy (4.0) for patients younger than 40 yr (both were measured after 12-mo follow-up). Labeling of patients by the treating manual therapists as "suitable" or "not suitable" for treatment with manual therapy did not predict differences in outcomes. Generally, there was a moderate to strong correlation between the three outcome measures, although a considerable number of patients gave a relatively low score for perceived benefit, while the research assistant gave a high improvement score for the

  9. Effect of nonsurgical periodontal therapy and strict plaque control on preterm/low birth weight: a randomized controlled clinical trial.

    Science.gov (United States)

    Weidlich, Patricia; Moreira, Carlos Heitor C; Fiorini, Tiago; Musskopf, Marta L; da Rocha, José M; Oppermann, Maria Lucia R; Aass, Anne M; Gjermo, Per; Susin, Cristiano; Rösing, Cassiano K; Oppermann, Rui V

    2013-01-01

    This randomized controlled clinical trial was carried out to assess the effect of comprehensive nonsurgical periodontal treatment and strict plaque control performed during pregnancy on the reduction of preterm and/or low birth weight rates (PTLBW). Three hundred and three women were randomly allocated to receive periodontal treatment either during pregnancy (n = 147, test group) or after delivery (n = 156, control group). During pregnancy, the control group received only one session of supragingival scaling and oral hygiene instruction. In contrast, the test group received comprehensive periodontal treatment including multiple sessions of scaling and root planing, oral hygiene instructions, and frequent maintenance visits. At baseline, periodontal inflammation was observed in approximately 50% of sites and attachment loss affected controls, women in the test group had significant reductions in the percentage of sites with plaque (48.5% vs. 10.3%, p control significantly improved periodontal health; however, no reduction of PTLBW rates was observed. Thus, remaining periodontal inflammation posttreatment cannot explain the lack of effect of periodontal treatment on PTLBW. Clinical relevance This study demonstrated that periodontal diseases may be successfully treated during pregnancy. Our results do not support a potential beneficial effect of periodontal treatment on PTLBW.

  10. Ankle manual therapy for individuals with post-acute ankle sprains: description of a randomized, placebo-controlled clinical trial.

    Science.gov (United States)

    Davenport, Todd E; Kulig, Kornelia; Fisher, Beth E

    2010-10-19

    Ankle sprains are common within the general population and can result in prolonged disablement. Limited talocrural dorsiflexion range of motion (DF ROM) is a common consequence of ankle sprain. Limited talocrural DF ROM may contribute to persistent symptoms, disability, and an elevated risk for re-injury. As a result, many health care practitioners use hands-on passive procedures with the intention of improving talocrural joint DF ROM in individuals following ankle sprains. Dosage of passive hands-on procedures involves a continuum of treatment speeds. Recent evidence suggests both slow- and fast-speed treatments may be effective to address disablement following ankle sprains. However, these interventions have yet to be longitudinally compared against a placebo study condition. We developed a randomized, placebo-controlled clinical trial designed to test the hypotheses that hands-on treatment procedures administered to individuals following ankle sprains during the post-acute injury period can improve short-, intermediate-, and long-term disablement, as well as reduce the risk for re-injury. This study is designed to measure the clinical effects of hands-on passive stretching treatment procedures directed to the talocrural joint that vary in treatment speed during the post-acute injury period, compared to hands-on placebo control intervention. http://www.clinicaltrials.gov identifier NCT00888498.

  11. The effects of scapular stabilization based exercise therapy on pain, posture, flexibility and shoulder mobility in patients with shoulder impingement syndrome: a controlled randomized clinical trial.

    Science.gov (United States)

    Moezy, Azar; Sepehrifar, Saeed; Solaymani Dodaran, Masoud

    2014-01-01

    Dysfunction in the kinetic chain caused by poor scapula stabilization can contribute to shoulder injuries and Shoulder Impingement Syndrome (SIS). The purpose of this study was to compare the effectiveness of two treatment approaches scapular stabilization based exercise therapy and physical therapy in patients with SIS. The study is a randomized clinical trial in which 68 patients with SIS were randomly assigned in two groups of exercise therapy (ET) and physical therapy (PT) and received 18 sessions of treatment. Pain, shoulders' range of abduction and external rotation, shoulder protraction, scapular rotation and symmetry as well as postural assessment and Pectoralis minor length were evaluated pre and post intervention. The paired-sample t test and the independent sample t test were applied respectively to determine the differences in each group and between two groups. Our findings indicated significant differences in abduction and external rotation range, improvement of forward shoulder translation and increase in the flexibility of the involved shoulder between the two groups (respectively ; p=0.024, p=0.001, ppain reduction between the groups (p=0.576). Protraction of the shoulder (pshoulder range, decreasing forward head and shoulder postures and Pectoralis minor flexibility.

  12. A comparison of cognitive-behavioral couple therapy and lidocaine in the treatment of provoked vestibulodynia: study protocol for a randomized clinical trial.

    Science.gov (United States)

    Corsini-Munt, Serena; Bergeron, Sophie; Rosen, Natalie O; Steben, Marc; Mayrand, Marie-Hélène; Delisle, Isabelle; McDuff, Pierre; Aerts, Leen; Santerre-Baillargeon, Marie

    2014-12-23

    Provoked vestibulodynia (PVD), a frequent form of chronic genital pain, is associated with decreased sexual function for afflicted women, as well as impoverished sexual satisfaction for women and their partners. Pain and sexuality outcomes for couples with PVD are influenced by interpersonal factors, such as pain catastrophizing, partner responses to pain, ambivalence over emotional expression, attachment style and perceived relationship and sexual intimacy. Despite recommendations in the literature to include the partner in cognitive-behavioral therapy targeted at improving pain and sexuality outcomes, no randomized clinical trial has tested the efficacy of this type of intervention and compared it to a first-line medical intervention. This bi-center, randomized clinical trial is designed to examine the efficacy of cognitive-behavioral couple therapy compared to topical lidocaine. It is conducted across two Canadian university-hospital centers. Eligible women diagnosed with PVD and their partners are randomized to one of the two interventions. Evaluations are conducted using structured interviews and validated self-report measures at three time points: Pre-treatment (T1: prior to randomization), post-treatment (T2), and 6-month follow-up (T3). The primary outcome is the change in reported pain during intercourse between T1 and T2. Secondary outcomes focus on whether there are significant differences between the two treatments at T2 and T3 on (a) the multidimensional aspects of women's pain and (b) women and partners' sexuality (sexual function and satisfaction), psychological adjustment (anxiety, depression, catastrophizing, self-efficacy, and quality of life), relationship factors (partner responses and dyadic adjustment) and self-reported improvement and treatment satisfaction. In order to detect an effect size as small as 0.32 for secondary outcomes, a sample of 170 couples is being recruited (27% dropout expected). A clinically significant decrease in pain is

  13. Clinical trials of homoeopathy

    NARCIS (Netherlands)

    Kleijnen, J.; Knipschild, P.; ter Riet, G.

    1991-01-01

    OBJECTIVE: To establish whether there is evidence of the efficacy of homoeopathy from controlled trials in humans. DESIGN: Criteria based meta-analysis. Assessment of the methodological quality of 107 controlled trials in 96 published reports found after an extensive search. Trials were scored using

  14. Effect of physical therapy on pain and function in patients with hip osteoarthritis: a randomized clinical trial.

    Science.gov (United States)

    Bennell, Kim L; Egerton, Thorlene; Martin, Joel; Abbott, J Haxby; Metcalf, Ben; McManus, Fiona; Sims, Kevin; Pua, Yong-Hao; Wrigley, Tim V; Forbes, Andrew; Smith, Catherine; Harris, Anthony; Buchbinder, Rachelle

    2014-05-21

    There is limited evidence supporting use of physical therapy for hip osteoarthritis. To determine efficacy of physical therapy on pain and physical function in patients with hip osteoarthritis. Randomized, placebo-controlled, participant- and assessor-blinded trial involving 102 community volunteers with hip pain levels of 40 or higher on a visual analog scale of 100 mm (range, 0-100 mm; 100 indicates worst pain possible) and hip osteoarthritis confirmed by radiograph. Forty-nine patients in the active group and 53 in the sham group underwent 12 weeks of intervention and 24 weeks of follow-up (May 2010-February 2013) INTERVENTIONS: Participants attended 10 treatment sessions over 12 weeks. Active treatment included education and advice, manual therapy, home exercise, and gait aid if appropriate. Sham treatment included inactive ultrasound and inert gel. For 24 weeks after treatment, the active group continued unsupervised home exercise while the sham group self-applied gel 3 times weekly. Primary outcomes were average pain (0 mm, no pain; 100 mm, worst pain possible) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index, 0 no difficulty to 68 extreme difficulty) at week 13. Secondary outcomes were these measures at week 36 and impairments, physical performance, global change, psychological status, and quality of life at weeks 13 and 36. Ninety-six patients (94%) completed week 13 measurements and 83 (81%) completed week 36 measurements. The between-group differences for improvements in pain were not significant. For the active group, the baseline mean (SD) visual analog scale score was 58.8 mm (13.3) and the week-13 score was 40.1 mm (24.6); for the sham group, the baseline score was 58.0 mm (11.6) and the week-13 score was 35.2 mm (21.4). The mean difference was 6.9 mm favoring sham treatment (95% CI, -3.9 to 17.7). The function scores were not significantly different between groups. The baseline mean (SD) physical function score

  15. Two-year outcomes after arthroscopic surgery compared to physical therapy for femoracetabular impingement: A protocol for a randomized clinical trial.

    Science.gov (United States)

    Mansell, Nancy S; Rhon, Daniel I; Marchant, Bryant G; Slevin, John M; Meyer, John L

    2016-02-04

    As the prevalence of hip pathology in the younger athletic population rises, the medical community continues to investigate effective intervention options. Femoracetabular impingement is the morphologically abnormal articulation of the femoral head against the acetabulum, and often implicated in pre-arthritic hip conditions of musculoskeletal nature. Arthroscopic surgical decompression and non-surgical rehabilitation programs focused on strengthening and stability are common interventions. However, they have never been directly compared in clinical trials. The primary purpose of this study will be to assess the difference in outcomes between these 2 commonly utilized interventions for femoracetabular impingement. The study will be a single site, non-inferiority, randomized controlled trial comparing two different treatment approaches (surgical and nonsurgical) for FAI. The enrollment goal is for a total of 80 subjects with a diagnosis of Femoracetabular impingement that are surgical candidates and have failed 6 weeks of conservative treatment. This will be a convenience sample of consecutive patients that are Tricare beneficiaries and seeking care at Madigan Army Medical Center. Patients that meet the criteria will be screened, provide written consent before enrollment, and then randomized into one of two arms (Group I = hip arthroscopy, Group II = physical therapy). Group I will undergo hip arthroscopy with or without labral repair. Group II will follow an impairment based physical therapy program consisting of 2 sessions per week for 6 weeks. The primary outcome will be the Hip Outcome Score and secondary measures will include the International Hip Outcome Tool and the Global Rating of Change. Measures will be taken at baseline, 6 months, 1 and 2 years. Hip-related healthcare utilization between both groups will also be assessed at the end of 2 years. The current evidence to support both surgical and conservative interventions for femoroacetabular impingement is

  16. Chiropractic spinal manipulative therapy for cervicogenic headache: a study protocol of a single-blinded placebo-controlled randomized clinical trial.

    Science.gov (United States)

    Chaibi, Aleksander; Benth, Jūratė Šaltytė; Tuchin, Peter J; Russell, Michael Bjørn

    2015-01-01

    Cervicogenic headache (CEH) is a secondary headache which affects 1.0-4.6 % of the population. Although the costs are unknown, the health consequences are substantial for the individual; especially considering that they often suffers chronicity. Pharmacological management has no or only minor effect on CEH. Thus, we aim to assess the efficacy of chiropractic spinal manipulative therapy (CSMT) for CEH in a single-blinded placebo-controlled randomized clinical trial (RCT). According to the power calculations, we aim to recruit 120 participants to the RCT. Participants will be randomized into one of three groups; CSMT, placebo (sham manipulation) and control (usual non-manual management). The RCT consists of three stages: 1 month run-in, 3 months intervention and follow-up analyses at the end of intervention and 3, 6 and 12 months. Primary end-point is headache frequency, while headache duration, headache intensity, headache index (frequency × duration × intensity) and medicine consumption are secondary end-points. Primary analysis will assess a change in headache frequency from baseline to the end of intervention and to follow-up, where the groups CSMT and placebo and CSMT and control will be compared. Due to two group-comparisons, the results with p values below 0.025 will be considered statistically significant. For all secondary end-points and analyses, the significance level of 0.05 will be used. The results will be presented with the corresponding p values and 95 % confidence intervals. To our knowledge, this is the first prospective manual therapy three-armed single-blinded placebo-controlled RCT to be conducted for CEH. Current RCTs suggest efficacy in headache frequency, duration and intensity. However a firm conclusion requires clinical single-blinded placebo-controlled RCTs with few methodological shortcomings. The present study design adheres to the recommendations for pharmacological RCTs as far as possible and follows the recommended clinical

  17. Clinical Trials in Vision Research

    Science.gov (United States)

    ... Clinical Trials in Vision Research Booklet for Nook, iPad and iPhone (EPUB - 1.6MB) Download the Clinical ... NEI Office of Science Communications, Public Liaison, and Education. Technical questions about this website can be addressed ...

  18. Comparison of sequential therapy and amoxicillin/tetracycline containing bismuth quadruple therapy for the first-line eradication of Helicobacter pylori: a prospective, multi-center, randomized clinical trial.

    Science.gov (United States)

    Lee, Ju Yup; Kim, Nayoung; Park, Kyung Sik; Kim, Hyun Jin; Park, Seon Mee; Baik, Gwang Ho; Shim, Ki-Nam; Oh, Jung Hwan; Choi, Suck Chei; Kim, Sung Eun; Kim, Won Hee; Park, Seon-Young; Kim, Gwang Ha; Lee, Bong Eun; Jo, Yunju; Hong, Su Jin

    2016-07-26

    The amoxicillin, could be promising because H. pylori resistance to tetracycline or to amoxicillin is relatively low. A 14-day modified bismuth quadruple protocol as first-line H. pylori treatment was compared with 10-day sequential therapy. In total, 390 H. pylori-infected subjects participated in the randomized clinical trial: 10-day sequential therapy (40 mg pantoprazole plus 1 g amoxicillin twice a day for 5 days, then 40 mg pantoprazole and 500 mg clarithromycin twice a day and 500 mg metronidazole three times a day for 5 days) or 14-day modified bismuth quadruple therapy (40 mg pantoprazole, 600 mg bismuth subcitrate, 1 g tetracycline, and 1 g amoxicillin, twice a day). (13)C-urea breath test, rapid urease testing, or histology was performed to check for eradication. Intention-to-treat (ITT) eradication rates of 10-day sequential and 14-day quadruple therapy were 74.6 % and 68.7 %, respectively, and the per-protocol (PP) rates were 84.2 and 76.5 %, respectively. The eradication rate was higher in the sequential therapy group, but neither the ITT nor the PP analyses had a significant difference (P = 0.240 and P = 0.099, respectively). However, the adverse events were significantly lower in the modified bismuth quadruple therapy group than the sequential therapy group (36.9 vs. 47.7 %, P = 0.040). Ten-day sequential therapy appears to be more effective despite frequent adverse events. However, both 10-day SQT and 14-day PBAT did not reach the excellent eradication rates that exceed 90 %. Additional trials are needed to identify a more satisfactory first-line eradication therapy. ClinicalTrials.gov ( NCT02159976 ); Registration date: 2014-06-03, CRIS ( KCT0001176 ); Registration date: 2014-07-23.

  19. Economic evaluation of antibiotic therapy versus appendicectomy for the treatment of uncomplicated acute appendicitis from the APPAC randomized clinical trial.

    Science.gov (United States)

    Sippola, S; Grönroos, J; Tuominen, R; Paajanen, H; Rautio, T; Nordström, P; Aarnio, M; Rantanen, T; Hurme, S; Salminen, P

    2017-09-01

    An increasing amount of evidence supports antibiotic therapy for treating uncomplicated acute appendicitis. The objective of this study was to compare the costs of antibiotics alone versus appendicectomy in treating uncomplicated acute appendicitis within the randomized controlled APPAC (APPendicitis ACuta) trial. The APPAC multicentre, non-inferiority RCT was conducted on patients with CT-confirmed uncomplicated acute appendicitis. Patients were assigned randomly to appendicectomy or antibiotic treatment. All costs were recorded, whether generated by the initial visit and subsequent treatment or possible recurrent appendicitis during the 1-year follow-up. The cost estimates were based on cost levels for the year 2012. Some 273 patients were assigned to the appendicectomy group and 257 to antibiotic treatment. Most patients randomized to antibiotic treatment did not require appendicectomy during the 1-year follow-up. In the operative group, overall societal costs (€5989·2, 95 per cent c.i. 5787·3 to 6191·1) were 1·6 times higher (€2244·8, 1940·5 to 2549·1) than those in the antibiotic group (€3744·4, 3514·6 to 3974·2). In both groups, productivity losses represented a slightly higher proportion of overall societal costs than all treatment costs together, with diagnostics and medicines having a minor role. Those in the operative group were prescribed significantly more sick leave than those in the antibiotic group (mean(s.d.) 17·0(8·3) (95 per cent c.i. 16·0 to 18·0) versus 9·2(6·9) (8·3 to 10·0) days respectively; P appendicitis incurred lower costs than those who had surgery. © 2017 BJS Society Ltd Published by John Wiley & Sons Ltd.

  20. High remission and low relapse with prolonged intensive DMARD therapy in rheumatoid arthritis (PRINT): A multicenter randomized clinical trial.

    Science.gov (United States)

    Li, Ru; Zhao, Jin-Xia; Su, Yin; He, Jing; Chen, Li-Na; Gu, Fei; Zhao, Cheng; Deng, Xue-Rong; Zhou, Wei; Hao, Yan-Jie; Xue, Yu; Liu, Hua-Xiang; Zhao, Yi; Zou, Qing-Hua; Liu, Xiang-Yuan; Zhu, Ping; Sun, Ling-Yun; Zhang, Zhuo-Li; Zou, He-Jian; Li, Xing-Fu; Liu, Yi; Fang, Yong-Fei; Keystone, Edward; McInnes, Iain B; Li, Zhan-Guo

    2016-07-01

    To determine whether prolonged intensive disease-modifying antirheumatic drug (DMARD) treatment (PRINT) leads to high remission and low relapse rates in patients with severe rheumatoid arthritis (RA). In this multicenter, randomized and parallel treatment trial, 346 patients with active RA (disease activity score (28 joints) [DAS28] (erythrocyte sedimentation rate [ESR]) > 5.1) were enrolled from 9 centers. In phase 1, patients received intensive treatment with methotrexate, leflunomide, and hydroxychloroquine, up to 36 weeks, until remission (DAS28 ≤ 2.6) or a low disease activity (2.6 intensive treatment and the disease state retention rate during step-down maintenance treatment. Predictors of a good EULAR response in the intensive treatment period and disease flare in the maintenance period were sought. A good EULAR response was achieved in 18.7%, 36.9%, and 54.1% of patients at 12, 24, and 36 weeks, respectively. By 36 weeks, 75.4% of patients achieved good and moderate EULAR responses. Compared with those achieving low disease activity and a high health assessment questionnaire (HAQ > 0.5), patients achieving remission (DAS28 ≤ 2.6) and low HAQ (≤ 0.5) had a significantly higher retention rate when tapering the DMARDs treatment (P = 0.046 and P = 0.01, respectively). There was no advantage on tapering to combination rather than monotherapy. Remission was achieved in a proportion of patients with RA receiving prolonged intensive DMARD therapy. Low disease activity at the start of disease taper leads to less subsequent flares. Leflunomide is a good maintenance treatment as single treatment.

  1. The effects of combined sertraline and aspirin therapy on depression severity among patients with major depressive disorder: A randomized clinical trial.

    Science.gov (United States)

    Sepehrmanesh, Zahra; Fahimi, Hosein; Akasheh, Goudarz; Davoudi, Mohamadreza; Gilasi, Hamidreza; Ghaderi, Amir

    2017-11-01

    Different studies have been conducted to find the best adjuvant therapies for depression management. There are controversies over the effects of aspirin as an adjuvant therapy for depression. To determine the effects of combined sertraline and aspirin therapy on depression severity among patients with major depressive disorder. This randomized clinical trial was conducted at Kargarnejad Psychiatric Hospital in Kashan, Isfahan, Iran, from September 1, 2016 to November 1, 2016. The study participants included 100 patients with major depressive disorder who were assigned to aspirin and placebo groups by the use of computer-generated random numbers. Patients in these groups respectively received sertraline-aspirin and sertraline-placebo for eight consecutive weeks. Patients were prescribed 80 milligrams of aspirin twice a day. Also, sertraline was administered at a dose of 50-200 milligrams daily. Beck Depression Inventory was employed for depression severity assessment at four time points, namely before, two, four, and eight weeks after the beginning of the intervention. Medication side effects were also assessed eight weeks after the beginning of the intervention. Data were analyzed by SPSS version 12.0, using Chi-square and the Independent-samples t-test (α=0.05). Both groups were matched in terms of age (p=0.46), gender (p=0.539), and depression severity (p=0.509, with mean score 33.5±4.1 vs. 32.8±5.9) at baseline. However, depression scores were reduced significantly four and eight weeks after initiation of therapy just in the sertraline-aspirin group (pdepression severity among patients with major depressive disorder. Yet, further studies are needed to prove the effectiveness of aspirin and other anti-inflammatory agents in reducing depression severity. The trial was registered at the Iranian Registry of Clinical Trials (http://www.irct.ir) with the IRCT ID: IRCT2016082829556N1. The authors received financial support from Research Deputy of Kashan University

  2. Clinical and cost-effectiveness of therapist-guided internet-delivered cognitive behavior therapy for older adults with symptoms of anxiety: a randomized controlled trial.

    Science.gov (United States)

    Dear, Blake F; Zou, Judy B; Ali, Shehzad; Lorian, Carolyn N; Johnston, Luke; Sheehan, Joanne; Staples, Lauren G; Gandy, Milena; Fogliati, Vincent J; Klein, Britt; Titov, Nickolai

    2015-03-01

    There is preliminary support for internet-delivered cognitive behaviour therapy (iCBT) as a way of improving access to treatment among older adults with anxiety. The aim of this randomized controlled trial (RCT) was to examine the efficacy, long-term outcomes, and cost-effectiveness of an iCBT program for adults over 60 years of age with anxiety. Successful applicants were randomly allocated to either the treatment group (n=35) or the waitlist control group (n=37). The online treatment course was delivered over 8 weeks and provided with brief weekly contact with a clinical psychologist via telephone or secure email. Eighty-four percent of participants completed the iCBT course within the 8 weeks and 90% provided data at posttreatment. Significantly lower scores on measures of anxiety (Cohen's d=1.43; 95% CI: 0.89 - 1.93) and depression (Cohen's d=1.79; 95% CI: 1.21 - 2.32) were found among the treatment group compared to the control group at posttreatment. These lower scores were maintained at 3-month and 12-month follow-up and the treatment group rated the iCBT treatment as acceptable. The treatment group had slightly higher costs ($92.2; 95% CI: $38.7 to $149.2) and Quality-Adjusted Life-Years (QALYs=0.010; 95% CI: 0.003 to 0.018) than the control group at posttreatment and the intervention was found to have a greater than 95% probability of being cost-effective. The results support iCBT as an efficacious and cost-effective treatment option for older adults with symptoms of anxiety. Australian and New Zealand Clinical Trials Registry: ACTRN12611000929909; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12611000929909. Copyright © 2014. Published by Elsevier Ltd.

  3. PANCREATIC TOXICITY AS AN ADVERSE EFFECT INDUCED BY MEGLUMINE ANTIMONIATE THERAPY IN A CLINICAL TRIAL FOR CUTANEOUS LEISHMANIASIS

    Directory of Open Access Journals (Sweden)

    Marcelo Rosandiski LYRA

    Full Text Available SUMMARY American tegumentary leishmaniasis is an infectious disease caused by a protozoan of the genus Leishmania. Pentavalent antimonials are the first choice drugs for cutaneous leishmaniasis (CL, although doses are controversial. In a clinical trial for CL we investigated the occurrence of pancreatic toxicity with different schedules of treatment with meglumine antimoniate (MA. Seventy-two patients were allocated in two different therapeutic groups: 20 or 5 mg of pentavalent antimony (Sb5+/kg/day for 20 or 30 days, respectively. Looking for adverse effects, patients were asked about abdominal pain, nausea, vomiting or anorexia in each medical visit. We performed physical examinations and collected blood to evaluate serum amylase and lipase in the pre-treatment period, and every 10 days during treatment and one month post-treatment. Hyperlipasemia occurred in 54.8% and hyperamylasemia in 19.4% patients. Patients treated with MA 20 mg Sb5+ presented a higher risk of hyperlipasemia (p = 0.023. Besides, higher MA doses were associated with a 2.05 higher risk ratio (p = 0.003 of developing more serious (moderate to severe hyperlipasemia. The attributable fraction was 51% in this group. Thirty-six patients presented abdominal pain, nausea, vomiting or anorexia but only 47.2% of those had hyperlipasemia and/ or hyperamylasemia. These findings suggest the importance of the search for less toxic therapeutic regimens for the treatment of CL.

  4. Effect of Supportive Nursing Care on Self Esteem of Patients Receiving Electroconvulsive Therapy: A Randomized Controlled Clinical Trial

    Directory of Open Access Journals (Sweden)

    Hossein Ebrahimi

    2014-06-01

    Full Text Available Introduction: Self-esteem is an important potential indicator in etiology, diagnosis and treatment of patients with severe mental illness. ECT is a popular treatment for these patients that can effect on their self-esteem and reinforce their problems. The purpose of this study is to determine the effect of supportive nursing care in increasing self esteem of patients receiving ECT. Methods: This clinical trial was conducted in the Baharan psychiatric hospital of Zahedan. A total of 70 cases of patients who received ECT were randomly allocated to control (n=35 and intervention (n=35 groups. The data were collected by demographic characteristics questionnaire and Rosenberg Self Esteem Scale (RSES. Intervention group received the supportive nursing care. The control group received only routine treatment. Self esteem level was measured and compared before and after intervention for two groups. The data was analyzed by SPSS using the χ2, t-test and ANCOVA. Results: Results showed that both groups were homogeneous on the socio- demographic characteristics. The mean self esteem in the intervention group compared with the control group was significantly increased. While controlling the effects of individual and social variables, the result shows significant differences between two groups in the mean scores of self esteem after the intervention.Conclusion: The results suggest that supportive nursing care can have positive effect on self esteem of patients receiving ECT. It is recommended to use this method for increasing self esteem of these patients.

  5. Effect of supportive nursing care on self esteem of patients receiving electroconvulsive therapy: a randomized controlled clinical trial.

    Science.gov (United States)

    Ebrahimi, Hossein; Navidian, Ali; Keykha, Roghaieh

    2014-06-01

    Self-esteem is an important potential indicator in etiology, diagnosis and treatment of patients with severe mental illness. ECT is a popular treatment for these patients that can effect on their self-esteem and reinforce their problems. The purpose of this study is to determine the effect of supportive nursing care in increasing self esteem of patients receiving ECT. This clinical trial was conducted in the Baharan psychiatric hospital of Zahedan. A total of 70 cases of patients who received ECT were randomly allocated to control (n=35) and intervention (n=35) groups. The data were collected by demographic characteristics questionnaire and Rosenberg Self Esteem Scale (RSES). Intervention group received the supportive nursing care. The control group received only routine treatment. Self esteem level was measured and compared before and after intervention for two groups. The data was analyzed by SPSS using the χ(2), t-test and ANCOVA. RESULTS showed that both groups were homogeneous on the socio- demographic characteristics. The mean self esteem in the intervention group compared with the control group was significantly increased. While controlling the effects of individual and social variables, the result shows significant differences between two groups in the mean scores of self esteem after the intervention. The results suggest that supportive nursing care can have positive effect on self esteem of patients receiving ECT. It is recommended to use this method for increasing self esteem of these patients.

  6. Music therapy to reduce pain and anxiety in children with cancer undergoing lumbar puncture: a randomized clinical trial.

    Science.gov (United States)

    Nguyen, Thanh Nhan; Nilsson, Stefan; Hellström, Anna-Lena; Bengtson, Ann

    2010-01-01

    A nonpharmacological method can be an alternative or complement to analgesics.The aim of this study was to evaluate if music medicine influences pain and anxiety in children undergoing lumbar punctures. A randomized clinical trial was used in 40 children (aged 7-12 years) with leukemia, followed by interviews in 20 of these participants. The participants were randomly assigned to a music group (n = 20) or control group (n = 20). The primary outcome was pain scores and the secondary was heart rate, blood pressure, respiratory rate, and oxygen saturation measured before, during, and after the procedure. Anxiety scores were measured before and after the procedure. Interviews with open-ended questions were conducted in conjunction with the completed procedures. The results showed lower pain scores and heart and respiratory rates in the music group during and after the lumbar puncture. The anxiety scores were lower in the music group both before and after the procedure. The findings from the interviews confirmed the quantity results through descriptions of a positive experience by the children, including less pain and fear.

  7. Do clinical decision-support reminders for medical providers improve isoniazid preventative therapy prescription rates among HIV-positive adults? Study protocol for a randomized controlled trial.

    Science.gov (United States)

    Green, Eric P; Catalani, Caricia; Diero, Lameck; Carter, E Jane; Gardner, Adrian; Ndwiga, Charity; Keny, Aggrey; Owiti, Philip; Israelski, Dennis; Biondich, Paul

    2015-04-09

    This document describes a research protocol for a study designed to estimate the impact of implementing a reminder system for medical providers on the use of isoniazid preventative therapy (IPT) for adults living with HIV in western Kenya. People living with HIV have a 5% to 10% annual risk of developing active tuberculosis (TB) once infected with TB bacilli, compared to a 5% lifetime risk in HIV-negative people with latent TB infection. Moreover, people living with HIV have a 20-fold higher risk of dying from TB. A growing body of literature suggests that IPT reduces overall TB incidence and is therefore of considerable benefit to patients and the larger community. However, in 2009, of the estimated 33 million people living with HIV, only 1.7 million (5%) were screened for TB, and about 85,000 (0.2%) were offered IPT. This study will examine the use of clinical decision-support reminders to improve rates of initiation of preventative treatment in a TB/HIV co-morbid population living in a TB endemic area. This will be a pragmatic, parallel-group, cluster-randomized superiority trial with a 1:1 allocation to treatment ratio. For the trial, 20 public medical facilities that use clinical summary sheets generated from an electronic medical records system will participate as clusters. All HIV-positive adult patients who complete an initial encounter at a study cluster and at least one return encounter during the study period will be included in the study cohort. The primary endpoint will be IPT prescription at 3 months post the initial encounter. We will conduct both individual-level and cluster-level analyses. Due to the nature of the intervention, the trial will not be blinded. This study will contribute to the growing evidence base for the use of electronic health interventions in low-resource settings to promote high-quality clinical care, health system optimization and positive patient outcomes. Trial registration ClinicalTrials.gov NCT01934309, registered 29

  8. Highly Efficient Training, Refinement, and Validation of a Knowledge-based Planning Quality-Control System for Radiation Therapy Clinical Trials.

    Science.gov (United States)

    Li, Nan; Carmona, Ruben; Sirak, Igor; Kasaova, Linda; Followill, David; Michalski, Jeff; Bosch, Walter; Straube, William; Mell, Loren K; Moore, Kevin L

    2017-01-01

    To demonstrate an efficient method for training and validation of a knowledge-based planning (KBP) system as a radiation therapy clinical trial plan quality-control system. We analyzed 86 patients with stage IB through IVA cervical cancer treated with intensity modulated radiation therapy at 2 institutions according to the standards of the INTERTECC (International Evaluation of Radiotherapy Technology Effectiveness in Cervical Cancer, National Clinical Trials Network identifier: 01554397) protocol. The protocol used a planning target volume and 2 primary organs at risk: pelvic bone marrow (PBM) and bowel. Secondary organs at risk were rectum and bladder. Initial unfiltered dose-volume histogram (DVH) estimation models were trained using all 86 plans. Refined training sets were created by removing sub-optimal plans from the unfiltered sample, and DVH estimation models… and DVH estimation models were constructed by identifying 30 of 86 plans emphasizing PBM sparing (comparing protocol-specified dosimetric cutpoints V 10 (percentage volume of PBM receiving at least 10 Gy dose) and V 20 (percentage volume of PBM receiving at least 20 Gy dose) with unfiltered predictions) and another 30 of 86 plans emphasizing bowel sparing (comparing V 40 (absolute volume of bowel receiving at least 40 Gy dose) and V 45 (absolute volume of bowel receiving at least 45 Gy dose), 9 in common with the PBM set). To obtain deliverable KBP plans, refined models must inform patient-specific optimization objectives and/or priorities (an auto-planning "routine"). Four candidate routines emphasizing different tradeoffs were composed, and a script was developed to automatically re-plan multiple patients with each routine. After selection of the routine that best met protocol objectives in the 51-patient training sample (KBP FINAL ), protocol-specific DVH metrics and normal tissue complication probability were compared for original versus KBP FINAL plans across the 35-patient validation set

  9. Effect of Conservative vs Conventional Oxygen Therapy on Mortality Among Patients in an Intensive Care Unit: The Oxygen-ICU Randomized Clinical Trial.

    Science.gov (United States)

    Girardis, Massimo; Busani, Stefano; Damiani, Elisa; Donati, Abele; Rinaldi, Laura; Marudi, Andrea; Morelli, Andrea; Antonelli, Massimo; Singer, Mervyn

    2016-10-18

    Despite suggestions of potential harm from unnecessary oxygen therapy, critically ill patients spend substantial periods in a hyperoxemic state. A strategy of controlled arterial oxygenation is thus rational but has not been validated in clinical practice. To assess whether a conservative protocol for oxygen supplementation could improve outcomes in patients admitted to intensive care units (ICUs). Oxygen-ICU was a single-center, open-label, randomized clinical trial conducted from March 2010 to October 2012 that included all adults admitted with an expected length of stay of 72 hours or longer to the medical-surgical ICU of Modena University Hospital, Italy. The originally planned sample size was 660 patients, but the study was stopped early due to difficulties in enrollment after inclusion of 480 patients. Patients were randomly assigned to receive oxygen therapy to maintain Pao2 between 70 and 100 mm Hg or arterial oxyhemoglobin saturation (Spo2) between 94% and 98% (conservative group) or, according to standard ICU practice, to allow Pao2 values up to 150 mm Hg or Spo2 values between 97% and 100% (conventional control group). The primary outcome was ICU mortality. Secondary outcomes included occurrence of new organ failure and infection 48 hours or more after ICU admission. A total of 434 patients (median age, 64 years; 188 [43.3%] women) received conventional (n = 218) or conservative (n = 216) oxygen therapy and were included in the modified intent-to-treat analysis. Daily time-weighted Pao2 averages during the ICU stay were significantly higher (P < .001) in the conventional group (median Pao2, 102 mm Hg [interquartile range, 88-116]) vs the conservative group (median Pao2, 87 mm Hg [interquartile range, 79-97]). Twenty-five patients in the conservative oxygen therapy group (11.6%) and 44 in the conventional oxygen therapy group (20.2%) died during their ICU stay (absolute risk reduction [ARR], 0.086 [95% CI, 0.017-0.150]; relative risk [RR], 0

  10. DYNAMICS OF CLINICAL LABORATORY PARAMETER IN HIV-INFECTED CHILDREN UNDERGOING DIFFERENT PATTERNS OF INITIAL HIGHLY ACTIVE ANTIRETROVIRAL THERAPY: RANDOMIZED CONTROLLED TRIAL

    Directory of Open Access Journals (Sweden)

    V. B. Denisenko

    2016-01-01

    Full Text Available Background: Adverse course of HIV infection, rapid development of immunosuppression, severe opportunistic infections and malignant tumors and high mortality substantiate the importance of timely prescription of highly active antiretroviral therapy (HAART. The initial therapy pattern must remain efficient and safe in the long term.Objective: Our aim was to study effectiveness and safety of different patterns of initial HAART in HIV-infected children.Methods: The randomized controlled trial involved HIV-infected children aged 1–3 years. Clinical, immunological and virological examinations were conducted before and 12 months after HAART. The initial therapy pattern included 2 nucleoside HIV reverse transcriptase inhibitors — zidovudine and lamivudine. Children were randomized to the groups differing in the third therapy component: lopinavir/ritonavir or nevirapine.Results: 25 patients were randomized to the lopinavir/ritonavir group, 23 children — to the nevirapine group. After 12 months of treatment, HIV replication suppression (blood viral load < 50 copies/ml was achieved in 25 (100% lopinavir/ritonavir group patients and in 16 (70% nevirapine group patients (p = 0.003. HIV infection did not progress clinically regardless of the pattern. The median number of CD4+CD3+ lymphocytes in the lopinavir/ritonavir group increased from 20.5% (12; 23 to 30% (27; 34 (p < 0,001, in the nevirapine group — from 21.5% (17; 23 to 29% (27; 38 (p < 0.001. Adverse events developed in 13 (27% children. 3 and 2 children in the lopinavir/ritonavir group suffered from nausea and emesis, respectively. 1 and 1 patient in the nevirapine group suffered from allergic rash and drug-induced hepatitis, respectively.Conclusion: High effectiveness and safety of lopinavir/ritonavir allow recommending this drug as the third component of the initial HAART pattern for HIV-infected children.

  11. A Combination of Gestalt Therapy, Rosen Body Work, and Cranio Sacral Therapy did not help in Chronic Whiplash-Associated Disorders (WAD - Results of a Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Søren Ventegodt

    2004-01-01

    Full Text Available The chronic state of whiplash-associated disorder (WAD might be understood as a somatization of existential pain. Intervention aimed to improve quality of life (QOL seemed to be a solution for such situations. The basic idea behind the intervention was holistic, restoring quality of life and relationship with self, in order to diminish tension in the locomotion system, especially the neck. A psychosomatic theory for WAD is proposed. Our treatment was a short 2-day course with teachings in philosophy of life, followed by 6 to 10 individual sessions in gestalt psychotherapy and body therapy (Rosen therapy and Cranio Sacral therapy, followed by a 1-day course approximately 2 months later, closing the intervention. Two independent institutions did the intervention and the assessments. In a randomized, clinically controlled setting, 87 chronic WAD patients were included with a median duration of 37 months from their whiplash accidents. One patient never started. Forty-three had the above intervention (female/male = 36/7, ages 22–49, median 37 years and another 43 were assigned to a nontreated control group (female/male = 35/8, ages 1848, median 38. Six had disability pension and 27 had pending medicolegal issues in each group. Effect variables were pain in neck, arm, and/or head; measures of quality of life and daily activities; as well as general physical or mental health. Wilcoxon test for between-groups comparisons with intention-to-treat analyses was conducted; the square curve paradigm testing for immediate improvements of health and quality of life was also used. The groups were comparable at baseline. From the intervention group, 11 dropped out during the intervention (4 of those later joined the follow-up investigation, 22 of the remaining 32 graduated the course, and 35 of the 43 controls did as well. Approximately 3 months later, we found no clinically relevant or significant increase in any effect measure. The above version of a quality

  12. Reiki therapy for postoperative oral pain in pediatric patients: pilot data from a double-blind, randomized clinical trial.

    Science.gov (United States)

    Kundu, Anjana; Lin, Yuting; Oron, Assaf P; Doorenbos, Ardith Z

    2014-02-01

    To examine the effects of Reiki as an adjuvant therapy to opioid therapy for postoperative pain control in pediatric patients. This was a double-blind, randomized controlled study of children undergoing dental procedures. Participants were randomly assigned to receive either Reiki therapy or the control therapy (sham Reiki) preoperatively. Postoperative pain scores, opioid requirements, and side effects were assessed. Family members were also asked about perioperative care satisfaction. Multiple linear regressions were used for analysis. Thirty-eight children participated. The blinding procedure was successful. No statistically significant difference was observed between groups on all outcome measures. Our study provides a successful example of a blinding procedure for Reiki therapy among children in the perioperative period. This study does not support the effectiveness of Reiki as an adjuvant therapy to opioid therapy for postoperative pain control in pediatric patients. Copyright © 2013 Elsevier Ltd. All rights reserved.

  13. Ozone Gas Bath Combined with Endovenous Laser Therapy for Lower Limb Venous Ulcers: A Randomized Clinical Trial.

    Science.gov (United States)

    Zhou, Yi-Ting; Zhao, Xu-Dong; Jiang, Jian-Wei; Li, Xin-Sheng; Wu, Zhen-Hai

    2016-10-01

    Endovenous laser therapy (EVLT) is safe and effective for lower limb venous ulcers. However, severe necrosis and infection in the ulcer area are contraindications of puncture and EVLT. Local bath with ozone gas has been shown to improve the condition of ulcer areas. The aim of this study was to evaluate the clinical efficacy of ozone gas bath combined with EVLT in comparison with EVLT alone for the treatment for lower limb venous ulcers. Ninety-two patients with venous ulcers were randomized to receive ozone gas bath combined with EVLT (OEVLT group) or EVLT alone (EVLT group). In the OEVLT group, the venous ulcers were preconditioned with ozone gas bath prior to EVLT. The minimum follow-up time was 12 months. The two groups were compared in terms of complete occlusion of the treated veins, ulcer healing ratio, ratio of ulcer recurrence, patient satisfaction, complications, and side effects. There was no significant difference in venous occlusion between the two groups. The ratio of ulcer healing in the OEVLT group was significantly higher than the EVLT group at 12 months follow-up. Patients in the OEVLT group showed better satisfaction and a lower recurrence ratio than the OEVLT group. No severe complications or side effects occurred in either groups. Ozone gas bath combined with EVLT showed improved efficacy for the treatment of lower limb venous ulcers and lower recurrence ratio comparison with EVLT alone. This procedure is a safe and technically feasible.

  14. PR interval identifies clinical response in patients with non-left bundle branch block: a Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy substudy.

    Science.gov (United States)

    Kutyifa, Valentina; Stockburger, Martin; Daubert, James P; Holmqvist, Fredrik; Olshansky, Brian; Schuger, Claudio; Klein, Helmut; Goldenberg, Ilan; Brenyo, Andrew; McNitt, Scott; Merkely, Bela; Zareba, Wojciech; Moss, Arthur J

    2014-08-01

    In Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy (MADIT-CRT), patients with non-left bundle branch block (LBBB; including right bundle branch block, intraventricular conduction delay) did not have clinical benefit from cardiac resynchronization therapy with defibrillator (CRT-D). We hypothesized that baseline PR interval modulates clinical response to CRT-D therapy in patients with non-LBBB. Non-LBBB patients (n=537; 30%) were divided into 2 groups based on their baseline PR interval as normal (including minimally prolonged) PR (PR <230 ms) and prolonged PR (PR ≥230 ms). The primary end point was heart failure or death. Separate secondary end points included heart failure events and all-cause mortality. Cox proportional hazards regression models were used to compare risk of end point events by CRT-D to implantable cardioverter defibrillator therapy in the PR subgroups. There were 96 patients (22%) with a prolonged PR and 438 patients (78%) with a normal PR interval. In non-LBBB patients with a prolonged PR interval, CRT-D treatment was associated with a 73% reduction in the risk of heart failure/death (hazard ratio, 0.27; 95% confidence interval, 0.13-0.57; P<0.001) and 81% decrease in the risk of all-cause mortality (hazard ratio, 0.19; 95% confidence interval, 0.13-0.57; P<0.001) compared with implantable cardioverter defibrillator therapy. In non-LBBB patients with normal PR, CRT-D therapy was associated with a trend toward an increased risk of heart failure/death (hazard ratio, 1.45; 95% confidence interval, 0.96-2.19; P=0.078; interaction P<0.001) and a more than 2-fold higher mortality (hazard ratio, 2.14; 95% confidence interval, 1.12-4.09; P=0.022; interaction P<0.001) compared with implantable cardioverter defibrillator therapy. The data support the use of CRT-D in MADIT-CRT non-LBBB patients with a prolonged PR interval. In non-LBBB patients with a normal PR interval, implantation of a CRT-D may be deleterious

  15. A comparison of two manual physical therapy approaches and electrotherapy modalities for patients with knee osteoarthritis: A randomized three arm clinical trial.

    Science.gov (United States)

    Kaya Mutlu, Ebru; Ercin, Ersin; Razak Ozdıncler, Arzu; Ones, Nadir

    2018-01-08

    A broad spectrum of physical therapy exercise programs provides symptom relief and functional benefit for patients with knee OA. Manual physical therapy, including tailored exercise programs provide relatively higher level benefit that persists to one year. It is currently unknown if there are important differences in the effects of different manual physical therapy techniques for patients with knee OA and there are virtually no studies comparing manual physical therapy and electrotherapy modalities. The aim of the study was to compare long-term results between three treatment groups (mobilization with movements [MWMs], passive joint mobilization [PJM], and electrotherapy) to determine which treatment is most effective in patients with knee OA. A single-blind randomized clinical trial with parallel design was conducted in patients with knee OA. Seventy-two consecutive patients (mean age 56.11 ± 6.80 years) with bilateral knee OA were randomly assigned to one of three treatment groups: MWMs, PJM, and electrotherapy. All groups performed an exercise program and received 12 sessions. The primary outcome measures of the functional assessment were the Western Ontario and McMaster Universities Osteoarthritis index (WOMAC) and Aggregated Locomotor Function (ALF) test scores. The secondary outcome measures were pain level, measured using a pressure algometer and a visual analogue scale (VAS), range of motion (ROM), measured using a digital goniometer, and muscle strength, evaluated with a handheld dynamometer. Patients were assessed before treatment, after treatment and after 1 year of follow-up. Patients receiving the manual physical therapy interventions consisting of either MWM or PJM demonstrated a greater decrease in VAS scores at rest, during functional activities, and during the night compared to those in the electrotherapy group from baseline to after the treatment (p electrotherapy group from baseline to 1-year follow-up (p electrotherapy in terms of pain

  16. Occupational therapy for delirium management in elderly patients without mechanical ventilation in an intensive care unit: A pilot randomized clinical trial.

    Science.gov (United States)

    Álvarez, Evelyn A; Garrido, Maricel A; Tobar, Eduardo A; Prieto, Stephanie A; Vergara, Sebastian O; Briceño, Constanza D; González, Francisco J

    2017-02-01

    Delirium has negative consequences such as increased mortality, hospital expenses and decreased cognitive and functional status. This research aims to determine the impact of occupational therapy intervention in duration, incidence and severity of delirium in elderly patients in the intensive care unit; secondary outcome was to assess functionality at hospital discharge. This is a pilot randomized clinical trial of patients without mechanical ventilation for 60 years. Patients were assigned to a control group that received standard strategies of prevention (n=70) or to an experimental group that received standard strategies plus occupational therapy twice a day for 5 days (n=70). Delirium was valued with Confusion Assessment Method and Delirium Rating Scale, and functional outcomes at discharge with Functional Independence Measure, Hand Dynamometer, and Mini-Mental State Examination. A total of 140 participants were recruited. The experimental group had lower duration (risk incidence ratios, 0.15 [P=.000; 95% confidence interval, 0.12-0.19] vs 6.6 [P=.000, 95% confidence interval, 5.23-8.3]) and incidence of delirium (3% vs 20%, P=.001), and had higher scores in Motor Functional Independence Measure (59 vs 40 points, Phand (26 vs 18 kg, POccupational therapy is effective in decreasing duration and incidence of delirium in nonventilated elderly patients in the intensive care unit and improved functionality at discharge. Copyright © 2016 Elsevier Inc. All rights reserved.

  17. The clinical and sonographic effects of kinesiotaping and exercise in comparison with manual therapy and exercise for patients with subacromial impingement syndrome: a preliminary trial.

    Science.gov (United States)

    Kaya, Derya Ozer; Baltaci, Gul; Toprak, Ugur; Atay, Ahmet Ozgur

    2014-01-01

    The purpose of this study was to compare the effects of manual therapy with exercise to kinesiotaping with exercise for patients with subacromial impingement syndrome. Randomized clinical before and after trial was used. Fifty-four patients diagnosed as having subacromial impingement syndrome who were referred for outpatient treatment were included. Eligible patients (between 30 and 60 years old, with unilateral shoulder pain) were randomly allocated to 2 study groups: kinesiotaping with exercise (n = 28) or manual therapy with exercise (n = 26). In addition, patients were advised to use cold packs 5 times per day to control for pain. Visual analog scale for pain, Disability of Arm and Shoulder Questionnaire for function, and diagnostic ultrasound assessment for supraspinatus tendon thickness were used as main outcome measures. Assessments were applied at the baseline and after completing 6 weeks of related interventions. At the baseline, there was no difference between the 2 group characteristics (P > .05). There were significant differences in both groups before and after treatment in terms of pain decrease and improvement of Disability of Arm and Shoulder Questionnaire scores (P .05). The only difference between the groups was at night pain, resulting in favor of the kinesiotaping with exercise group (P < .05). For the group of subjects studied, no differences were found between kinesiotaping with exercise and manual therapy with exercise. Both treatments may have similar results in reducing pain and disability in subacromial impingement in 6 weeks. Copyright © 2014 National University of Health Sciences. Published by Elsevier Inc. All rights reserved.

  18. Randomized Trial of Interpersonal Psychotherapy and Cognitive Behavioral Therapy for Major Depressive Disorder in a Community-Based Psychiatric Outpatient Clinic.

    Science.gov (United States)

    Ekeblad, Annika; Falkenström, Fredrik; Andersson, Gerhard; Vestberg, Robert; Holmqvist, Rolf

    2016-12-01

    Interpersonal psychotherapy (IPT) and cognitive behavioral therapy (CBT) are both evidence-based treatments for major depressive disorder (MDD). Several head-to-head comparisons have been made, mostly in the United States. In this trial, we compared the two treatments in a small-town outpatient psychiatric clinic in Sweden. The patients had failed previous primary care treatment and had extensive Axis-II comorbidity. Outcome measures were reduction of depressive symptoms and attrition rate. Ninety-six psychiatric patients with MDD (DSM-IV) were randomized to 14 sessions of CBT (n = 48) or IPT (n = 48). A noninferiority design was used with the hypothesis that IPT would be noninferior to CBT. A three-point difference on the Beck Depression Inventory-II (BDI-II) was used as noninferiority margin. IPT passed the noninferiority test. In the ITT group, 53.5% (23/43) of the IPT patients and 51.0% (24/47) of the CBT patients were reliably improved, and 20.9% (9/43) and 19.1% (9/47), respectively, were recovered (last BDI score depressed psychiatric patients in a community-based outpatient clinic. CBT had significantly more dropouts than IPT, indicating that CBT may be experienced as too demanding. Since about half the patients did not recover, there is a need for further treatment development for these patients. The study should be considered an effectiveness trial, with strong external validity but some limitations in internal validity. © 2016 Wiley Periodicals, Inc.

  19. Registration of randomized clinical trials

    DEFF Research Database (Denmark)

    Østervig, R M; Sonne, A; Rasmussen, L S

    2015-01-01

    starting enrolment before 2010 to 63.2% after 2010 (24/38, P clinical trials were registered at clinicaltrials.gov. CONCLUSION: Many published randomized controlled trials from Acta Anaesthesiologica Scandinavica were not adequately registered but the requirement of trial registration has...... the proportion of correctly registered randomized controlled trials (RCTs) published in Acta from 2009 to 2014. METHODS: We manually searched all Acta issues from 2009 to 2014 for RCTs. Information about timing of data collection and registration in trial registries was extracted. We classified RCTs as correctly...... registered when it could be verified that patient enrolment was started after registration in a trial registry. RESULTS: We identified 200 RCTs. Dates for patient enrolment were not specified in 51 (25.5%). The proportion of correctly registered trials increased significantly from 17.1% (19/111) for trials...

  20. Oral Appliance Therapy in Patients With Daytime Sleepiness and Snoring or Mild to Moderate Sleep Apnea: A Randomized Clinical Trial.

    Science.gov (United States)

    Marklund, Marie; Carlberg, Bo; Forsgren, Lars; Olsson, Tommy; Stenlund, Hans; Franklin, Karl A

    2015-08-01

    Oral appliances that move the mandible forward during sleep are suggested as treatment for mild to moderate obstructive sleep apnea. To test whether an adjustable, custom-made oral appliance improves daytime sleepiness and quality of life in patients with daytime sleepiness and snoring or mild to moderate obstructive sleep apnea. Ninety-six patients with daytime sleepiness and an apnea-hypopnea index (AHI) lower than 30 were included in a randomized, placebo-controlled, parallel trial in Umeå, Sweden, from May 2007 through August 2011. Four months' intervention with an oral appliance or a placebo device. Daytime sleepiness was measured with the Epworth Sleepiness Scale, the Karolinska Sleepiness Scale, and the Oxford Sleep Resistance (OSLER) test. Quality of life was assessed with the Short-Form 36-Item Health Survey (SF-36) and the Functional Outcomes of Sleep Questionnaire (FOSQ). Secondary outcomes included the apnea-hypopnea index, headaches, symptoms of restless legs, and insomnia. Oral appliance therapy was not associated with improvements in daytime sleepiness from baseline to 4-month follow-up when compared with the placebo device; Epworth score >10: 53% at baseline to 24% at follow-up for the oral appliance group vs 54% at baseline to 40% at follow-up for the placebo device group, P = .11; median (IQR) for Karolinska score ≥7/wk: 10 (8 to 14) at baseline to 7 (4 to 9) at follow-up for the oral appliance group vs 12 (6 to 15) at baseline to 8 (5 to 12) at follow-up for the placebo device group, P = .11; mean between-group difference in OSLER test, -2.4 min (95% CI, -6.3 to 1.4). The mean between-group difference for the total FOSQ score was insignificant (-1.2 [95% CI, -2.5 to 0.1]). No domain of the SF-36 differed significantly between the groups. The AHI was below 5 in 49% of patients using the active appliance and in 11% using placebo, with an odds ratio of 7.8 (95% CI, 2.6-23.5) and a number needed to treat of 3. Snoring (P oral appliance

  1. The impact of trauma-focused group therapy upon HIV sexual risk behaviors in the NIDA Clinical Trials Network "Women and trauma" multi-site study.

    Science.gov (United States)

    Hien, Denise A; Campbell, Aimee N C; Killeen, Therese; Hu, Mei-Chen; Hansen, Cheri; Jiang, Huiping; Hatch-Maillette, Mary; Miele, Gloria M; Cohen, Lisa R; Gan, Weijin; Resko, Stella M; DiBono, Michele; Wells, Elizabeth A; Nunes, Edward V

    2010-04-01

    Women in drug treatment struggle with co-occurring problems, including trauma and post-traumatic stress disorder (PTSD), which can heighten HIV risk. This study examines the impact of two group therapy interventions on reduction of unprotected sexual occasions (USO) among women with substance use disorders (SUD) and PTSD. Participants were 346 women recruited from and receiving treatment at six community-based drug treatment programs participating in NIDA's Clinical Trials Network. Participants were randomized to receive 12-sessions of either seeking safety (SS), a cognitive behavioral intervention for women with PTSD and SUD, or women's health education (WHE), an attention control psychoeducational group. Participants receiving SS who were at higher sexual risk (i.e., at least 12 USO per month) significantly reduced the number of USO over 12-month follow up compared to WHE. High risk women with co-occurring PTSD and addiction may benefit from treatment addressing coping skills and trauma to reduce HIV risk.

  2. Immediate Effects of External Vibration vs Placebo on Vocal Function Therapy in Singers: A Randomized Clinical Trial.

    Science.gov (United States)

    Anderson, Jennifer; DeLuca, Marta; Haines, Mary-Enid; Merrick, Gwen

    2018-01-04

    External vibration therapy (EVT) has been widely used in chronic pain conditions, musculoskeletal rehabilitation, and athletic training. Vibration therapy has been suggested to enhance vocal performance and has been popularized in social media. However, there is no evidence to support its effect on vocal function. To evaluate the immediate effects of EVT in trained singers using acoustic and self-assessment parameters. Prospective, randomized, placebo-controlled interventional study at St Michael's Hospital Voice Clinic, affiliated with the University of Toronto. Data collection and analysis were performed by investigators who were blinded to the group assignment of the participants. Study participants were randomized to EVT or a placebo (control) group. The study dates were September 2015 to December 2016. Participants attended the voice laboratory at St Michael's Hospital, where a standardized data collection protocol was performed, including acoustic parameters, voice range profile, and soft voice tasks, followed by subjective rating of vocal effort or discomfort. The EVT group underwent EVT to 5 neck sites bilaterally. The placebo group underwent the same protocol with a modified device. After the intervention, the participants repeated the standardized data collection. The primary outcome in this study was acoustic analysis (jitter, shimmer, and pitch range) compared before and after treatment. In addition, secondary outcomes included perceived effort or discomfort evaluated by participants after 4 voice tasks proposed to investigate more subtle voice properties. Within and between groups, data sets were statistically analyzed for potential treatment effect. Among 27 participants (age range, 18-50 years; all female), 14 were randomized to the intervention group and 13 to the placebo group. Comparison of the treatment effect on the vowel token acoustic parameters evaluated showed that, after EVT, participants had a more cohesive change with a restricted 95% CI

  3. ArmAssist Robotic System versus Matched Conventional Therapy for Poststroke Upper Limb Rehabilitation: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Tijana J. Dimkić Tomić

    2017-01-01

    Full Text Available The ArmAssist is a simple low-cost robotic system for upper limb motor training that combines known benefits of repetitive task-oriented training, greater intensity of practice, and less dependence on therapist assistance. The aim of this preliminary study was to compare the efficacy of ArmAssist (AA robotic training against matched conventional arm training in subacute stroke subjects with moderate-to-severe upper limb impairment. Twenty-six subjects were enrolled within 3 months of stroke and randomly assigned to the AA group or Control group (n=13 each. Both groups were trained 5 days per week for 3 weeks. The primary outcome measure was Fugl-Meyer Assessment-Upper Extremity (FMA-UE motor score, and the secondary outcomes were Wolf Motor Function Test-Functional Ability Scale (WMFT-FAS and Barthel index (BI. The AA group, in comparison to the Control group, showed significantly greater increases in FMA-UE score (18.0 ± 9.4 versus 7.5 ± 5.5, p=0.002 and WMFT-FAS score (14.1 ± 7.9 versus 6.7 ± 7.8, p=0.025 after 3 weeks of treatment, whereas the increase in BI was not significant (21.2 ± 24.8 versus 13.1 ± 10.7, p=0.292. There were no adverse events. We conclude that arm training using the AA robotic device is safe and able to reduce motor deficits more effectively than matched conventional arm training in subacute phase of stroke. The study has been registered at the ClinicalTrials.gov, ID: NCT02729649.

  4. A manual physical therapy approach versus subacromial corticosteroid injection for treatment of shoulder impingement syndrome: a protocol for a randomised clinical trial

    Science.gov (United States)

    Boyles, Robert E; Cleland, Joshua A; Brown, David L

    2011-01-01

    Introduction Corticosteroid injections (CSI) are a recommended and often-used first-line intervention for shoulder impingement syndrome (SIS) in primary care and orthopaedic settings. Manual physical therapy (MPT) offers a non-invasive approach with negligible risk for managing SIS. There is limited evidence to suggest significant long-term improvements in pain, strength and disability with the use of MPT, and there are conflicting reports from systematic reviews that question the long-term efficacy of CSI. Specifically, the primary objective is to compare the effect of CSI and MPT on pain and disability in subjects with SIS at 12 months. Design This pragmatic randomised clinical trial will be a mixed-model 2×5 factorial design. The independent variables are treatment (MPT and CSI) and time with five levels from baseline to 1 year. The primary dependent variable is the Shoulder Pain and Disability Index, and the secondary outcome measures are the Global Rating of Change and the Numeric Pain Rating Scale. For each ANOVA, the hypothesis of interest will be the two-way group-by-time interaction. Methods and analysis The authors plan to recruit 104 participants meeting established impingement criteria. Following examination and enrolment, eligible participants will be randomly allocated to receive a pragmatic approach of either CSI or MPT. The MPT intervention will consist of six sessions, and the CSI intervention will consist of one to three sessions. All subjects will continue to receive usual care. Subjects will be followed for 12 months. Dissemination and ethics The protocol was approved by the Madigan Army Medical Center Institutional Review Board. The results may have an impact on clinical practice guidelines. This study was funded in part by the Orthopaedic Physical Therapy Products Grant through the American Academy of Orthopaedic Manual Physical Therapists. Trial Registration http://clinicaltrials.gov/ NCT01190891. PMID:22021870

  5. Photobiomodulation versus light-emitting diode (LED) therapy in the treatment of temporomandibular disorder: study protocol for a randomized, controlled clinical trial.

    Science.gov (United States)

    Langella, Luciana G; Silva, Paula F C; Costa-Santos, Larissa; Gonçalves, Marcela L L; Motta, Lara J; Deana, Alessandro M; Fernandes, Kristianne P S; Mesquita-Ferrari, Raquel A; Bussadori, Sandra Kalil

    2018-01-26

    Temporomandibular disorder (TMD) is described as a subgroup of orofacial pain with a set of signs and symptoms that involve the temporomandibular joint, masticatory muscles, ears, and neck. TMD can occur unilaterally or bilaterally and approximately 70% of the population is affected with at least one sign. The disorder progresses with orofacial pain, muscle pain involving the masticatory and cervical muscles, joint noises (clicks and pops), joint block, mandibular dysfunction, and headache. The etiology can be abnormal occlusion and/or posture, trauma involving local tissues, repetitive microtrauma, parafunctional habits, and an increase in emotional stress. Studies have demonstrated that phototherapy is an efficient option for the treatment of TMD, leading to improvements in pain and orofacial function. The aim of the proposed study is to compare the effects of two sources of photobiomodulation in individuals with TMD. A randomized, controlled, double-blind, clinical trial is proposed, which will involve 80 individuals aged 18-65 years allocated to either a laser group or light-emitting diode (LED) group submitted to 12 sessions of phototherapy. The Research Diagnostic Criteria for TMDs will be used to evaluate all participants. Pain will be measured using the visual analog scale and maximum vertical mandibular movement will be determined with the aid of digital calipers. This study compares the effects of two modalities of laser therapy on the pain and orofacial function of patients with TMD dysfunction. Photobiomodulation and LED therapy are treatment options for reducing the inflammatory process and pain as well as inducing the regeneration of the target tissue. ClinicalTrials.gov, NCT03257748 . Registered on 8 August 2017.

  6. Randomized Clinical Trial of Supervised Tapering and Cognitive Behavior Therapy to Facilitate Benzodiazepine Discontinuation in Older Adults With Chronic Insomnia

    National Research Council Canada - National Science Library

    Morin, Charles M; Bastien, Célyne; Guay, Bernard; Radouco-Thomas, Monelly; Leblanc, Jacinthe; Vallières, Annie

    2004-01-01

    OBJECTIVE: This study evaluated the effectiveness of a supervised benzodiazepine taper, singly and combined with cognitive behavior therapy, for benzodiazepine discontinuation in older adults with chronic insomnia. METHOD...

  7. Results of a Multicenter Randomized Controlled Trial of the Clinical Effectiveness of Schema Therapy for Personality Disorders

    National Research Council Canada - National Science Library

    Bamelis, Lotte L.M; Evers, Silvia M.A.A; Spinhoven, Philip; Arntz, Arnoud

    2014-01-01

    Schema therapy, an integrative psychotherapy that emphasizes processing negative experiences and using the therapeutic relationships as a way to fulfill unmet needs, was superior to treatment as usual...

  8. A Novel Biomarker Panel Examining Response to Gemcitabine with or without Erlotinib for Pancreatic Cancer Therapy in NCIC Clinical Trials Group PA.3.

    Directory of Open Access Journals (Sweden)

    David B Shultz

    Full Text Available NCIC Clinical Trials Group PA.3 was a randomized control trial that demonstrated improved overall survival (OS in patients receiving erlotinib in addition to gemcitabine for locally advanced or metastatic pancreatic cancer. Prior to therapy, patients had plasma samples drawn for future study. We sought to identify biomarkers within these samples.Using the proximity ligation assay (PLA, a probe panel was built from commercially available antibodies for 35 key proteins selected from a global genetic analysis of pancreatic cancers, and used to quantify protein levels in 20 uL of patient plasma. To determine if any of these proteins levels independently associated with OS, univariate and mulitbaraible Cox models were used. In addition, we examined the associations between biomarker expression and disease stage at diagnosis using Fisher's exact test. The correlation between Erlotinib sensitivity and each biomarkers was assessed using a test of interaction between treatment and biomarker.Of the 569 eligible patients, 480 had samples available for study. Samples were randomly allocated into training (251 and validation sets (229. Among all patients, elevated levels of interleukin-8 (IL-8, carcinoembryonic antigen (CEA, hypoxia-inducible factor 1-alpha (HIF-1 alpha, and interleukin-6 were independently associated with lower OS, while IL-8, CEA, platelet-derived growth factor receptor alpha and mucin-1 were associated with metastatic disease. Patients with elevated levels of receptor tyrosine-protein kinase erbB-2 (HER2 expression had improved OS when treated with erlotinib compared to placebo. In conclusion, PLA is a powerful tool for identifying biomarkers from archived, small volume serum samples. These data may be useful to stratify patient outcomes regardless of therapeutic intervention.ClinicalTrials.gov NCT00040183.

  9. A Sound Therapy-Based Intervention to Expand the Auditory Dynamic Range for Loudness among Persons with Sensorineural Hearing Losses: A Randomized Placebo-Controlled Clinical Trial.

    Science.gov (United States)

    Formby, Craig; Hawley, Monica L; Sherlock, LaGuinn P; Gold, Susan; Payne, JoAnne; Brooks, Rebecca; Parton, Jason M; Juneau, Roger; Desporte, Edward J; Siegle, Gregory R

    2015-05-01

    The primary aim of this research was to evaluate the validity, efficacy, and generalization of principles underlying a sound therapy-based treatment for promoting expansion of the auditory dynamic range (DR) for loudness. The basic sound therapy principles, originally devised for treatment of hyperacusis among patients with tinnitus, were evaluated in this study in a target sample of unsuccessfully fit and/or problematic prospective hearing aid users with diminished DRs (owing to their elevated audiometric thresholds and reduced sound tolerance). Secondary aims included: (1) delineation of the treatment contributions from the counseling and sound therapy components to the full-treatment protocol and, in turn, the isolated treatment effects from each of these individual components to intervention success; and (2) characterization of the respective dynamics for full, partial, and control treatments. Thirty-six participants with bilateral sensorineural hearing losses and reduced DRs, which affected their actual or perceived ability to use hearing aids, were enrolled in and completed a placebo-controlled (for sound therapy) randomized clinical trial. The 2 × 2 factorial trial design was implemented with or without various assignments of counseling and sound therapy. Specifically, participants were assigned randomly to one of four treatment groups (nine participants per group), including: (1) group 1-full treatment achieved with scripted counseling plus sound therapy implemented with binaural sound generators; (2) group 2-partial treatment achieved with counseling and placebo sound generators (PSGs); (3) group 3-partial treatment achieved with binaural sound generators alone; and (4) group 4-a neutral control treatment implemented with the PSGs alone. Repeated measurements of categorical loudness judgments served as the primary outcome measure. The full-treatment categorical-loudness judgments for group 1, measured at treatment termination, were significantly

  10. Designing clinical trials for amblyopia.

    Science.gov (United States)

    Holmes, Jonathan M

    2015-09-01

    Randomized clinical trial (RCT) study design leads to one of the highest levels of evidence, and is a preferred study design over cohort studies, because randomization reduces bias and maximizes the chance that even unknown confounding factors will be balanced between treatment groups. Recent randomized clinical trials and observational studies in amblyopia can be taken together to formulate an evidence-based approach to amblyopia treatment, which is presented in this review. When designing future clinical studies of amblyopia treatment, issues such as regression to the mean, sample size and trial duration must be considered, since each may impact study results and conclusions. Copyright © 2015 Elsevier Ltd. All rights reserved.

  11. Effect of a Matrix Therapy Agent on Corneal Epithelial Healing After Standard Collagen Cross-linking in Patients With Keratoconus: A Randomized Clinical Trial.

    Science.gov (United States)

    Bata, Ahmed M; Witkowska, Katarzyna J; Wozniak, Piotr A; Fondi, Klemens; Schmidinger, Gerald; Pircher, Niklas; Szegedi, Stephan; Aranha Dos Santos, Valentin; Pantalon, Anca; Werkmeister, René M; Garhofer, Gerhard; Schmetterer, Leopold; Schmidl, Doreen

    2016-10-01

    Corneal abrasions are frequent after standard (epithelium-off [epi-off]) corneal collagen cross-linking (CXL) in patients with progressive keratoconus. A new matrix therapy agent (ReGeneraTing Agent [RGTA]) has been developed to promote corneal wound healing. To assess the effect of the new type of matrix therapy agent on corneal wound healing after epi-off CXL in patients with keratoconus. This double-masked randomized clinical trial enrolled 40 patients with keratoconus undergoing epi-off CXL from July 18, 2014, to October 21, 2015, when the last follow-up was completed. The analysis of the intention-to-treat population was performed at the Department of Clinical Pharmacology in cooperation with the Center for Medical Physics and Biomedical Engineering and the Department of Ophthalmology and Optometry of the Medical University of Vienna. Patients were randomized to receive the matrix therapy agent or hyaluronic acid-containing eyedrops, 0.1%, every other day starting immediately after surgery. The size of the corneal defect was measured using ultrahigh-resolution optical coherence tomography (OCT) and slitlamp photography (SLP) with fluorescein staining. Corneal wound healing rate, defined as the size of the defect over time. Among the 40 patients undergoing epi-off CXL (31 men; 9 women; mean [SD] age, 31 [10] years), wound healing was significantly faster in the matrix therapy agent group compared with the hyaluronic acid group (4.4 vs 6.1 days; mean difference, 1.7 days; 95% CI, 0.25-3.15 days; P = .008). The defect size was smaller in the matrix therapy agent group than in the hyaluronic acid group as measured with OCT (12.4 vs 23.9 mm2; mean difference, 11.6 mm2; 95% CI, 0.8-23.5 mm2; P = .045) and SLP (11.9 vs 23.5 mm2; mean difference, 11. 6 mm2; 95% CI, 1.3-22.9 mm2; P = .03). A correlation between the defect size measured with OCT and SLP was found (r = 0.89; P matrix therapy agent appears to improve corneal wound healing after CXL in

  12. Comparison of conservative treatment with and without manual physical therapy for patients with shoulder impingement syndrome: a prospective, randomized clinical trial.

    Science.gov (United States)

    Senbursa, Gamze; Baltaci, Gul; Atay, Ahmet

    2007-07-01

    rotation in the manual therapy group improved significantly while ROM in the exercise group did not. There were statistically differences among the groups in function (P > 0.05). Group 2 showed significantly greater improvements in the Neer Questionnaire score and shoulder satisfaction score than Group 1. The patients treated with manual physical therapy applied by experienced physical therapists combined with supervised exercise in a brief clinical trial showed improvement of symptoms including increasing strength, decreasing pain and improving function earlier than with exercise program.

  13. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Katz, J N; Losina, E; Lohmander, L S

    2015-01-01

    To highlight methodological challenges in the design and conduct of randomized trials of surgical interventions and to propose strategies for addressing these challenges. This paper focuses on three broad areas: enrollment; intervention; and assessment including implications for analysis. For each...... relating to obsolescence, fidelity of intervention delivery, and adherence and crossover. Assessment and analysis raise questions regarding blinding and clustering of observations. This paper describes methodological problems in the design and conduct of surgical randomized trials and proposes strategies...

  14. Clinically meaningful differences in pain, disability and quality of life for chronic nonspecific neck pain - a reanalysis of 4 randomized controlled trials of cupping therapy.

    Science.gov (United States)

    Lauche, Romy; Langhorst, Jost; Dobos, Gustav J; Cramer, Holger

    2013-08-01

    The assessment of clinically meaningful differences in patients' self-reported outcomes has become increasingly important when interpreting the results of clinical studies. Although these assessments have become quite common there are hardly any data for nonspecific neck pain, especially in the context of complementary and alternative medicine. The aim of this analysis is the determination of minimal clinically important differences (MCID) and substantial clinical benefits (SCB) in patients with chronic nonspecific neck pain after cupping treatment. The data set comprised a total of 200 patients with chronic nonspecific neck pain participating in clinical trials on cupping therapy. The MCID and SCB for pain intensity (VAS), neck disability index (NDI) and the subscale bodily pain (SF-36-BP) as well as physical component summary (SF-36-PCS) of the SF-36 were determined using receiver operating characteristic (ROC) curve analysis with an adapted assessment of change in health status (SF-36), i.e. a 5-point Likert scale ranging from "much better" to "much worse", as anchor. MCID derived from the ROC was the score to distinguish "somewhat better" from "about the same", and the SCB was the score to distinguish "much better" from "somewhat better". The calculated MCIDs were: -8mm (-21%) for VAS, -3 points (-10.2%) for NDI, +10 points (+20.5%) for SF-36-BP and +2.6 points (+7.7%) for SF-36-PCS. The SCBs were: -26.5mm (-66.8%) for VAS, -8.4 points (-29%) for NDI, +15.5 points (+43.1%) for SF-36-BP and +5.1 points (+12.9%) for SF-36-PCS. Accuracy of the estimations was good for MCID in general and for SCB regarding VAS and NDI. The results support the assumption that patients' perceptions of treatment benefits measured by VAS in these trials might be comparable to others in conventional therapies. For NDI and SF-36-PCS the estimated differences were smaller than in previous reports indicating that context factors such as patient characteristics and specific treatment

  15. Antiretroviral effect of lovastatin on HIV-1-infected individuals without highly active antiretroviral therapy (The LIVE study: a phase-II randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Montoya Carlos J

    2009-06-01

    Full Text Available Abstract Background Highly active antiretroviral therapy produces a significant decrease in HIV-1 replication and allows an increase in the CD4 T-cell count, leading to a decrease in the incidence of opportunistic infections and mortality. However, the cost, side effects and complexity of antiretroviral regimens have underscored the immediate need for additional therapeutic approaches. Statins exert pleiotropic effects through a variety of mechanisms, among which there are several immunoregulatory effects, related and unrelated to their cholesterol-lowering activity that can be useful to control HIV-1 infection. Methods/design Randomized, double-blinded, placebo controlled, single-center, phase-II clinical trial. One hundred and ten chronically HIV-1-infected patients, older than 18 years and naïve for antirretroviral therapy (i.e., without prior or current management with antiretroviral drugs will be enrolled at the outpatient services from the most important centres for health insurance care in Medellin-Colombia. The interventions will be lovastatin (40 mg/day, orally, for 12 months; 55 patients or placebo (55 patients. Our primary aim will be to determine the effect of lovastatin on viral replication. The secondary aim will be to determine the effect of lovastatin on CD4+ T-cell count in peripheral blood. As tertiary aims we will explore differences in CD8+ T-cell count, expression of activation markers (CD38 and HLA-DR on CD4 and CD8 T cells, cholesterol metabolism, LFA-1/ICAM-1 function, Rho GTPases function and clinical evolution between treated and not treated HIV-1-infected individuals. Discussion Preliminary descriptive studies have suggested that statins (lovastatin may have anti HIV-1 activity and that their administration is safe, with the potential effect of controlling HIV-1 replication in chronically infected individuals who had not received antiretroviral medications. Considering that there is limited clinical data available on

  16. A Comparison of the Effects of Stabilization Exercises Plus Manual Therapy to Those of Stabilization Exercises Alone in Patients With Nonspecific Mechanical Neck Pain: A Randomized Clinical Trial.

    Science.gov (United States)

    Celenay, Seyda Toprak; Akbayrak, Turkan; Kaya, Derya Ozer

    2016-02-01

    Randomized clinical trial. Little is known about the efficacy of providing manual therapy in addition to cervical and scapulothoracic stabilization exercises in people with mechanical neck pain (MNP). Objectives To compare the effects of stabilization exercises plus manual therapy to those of stabilization exercises alone on disability, pain, range of motion (ROM), and quality of life in patients with MNP. One hundred two patients with MNP (18-65 years of age) were recruited and randomly allocated into 2 groups: stabilization exercise without (n = 51) and with (n = 51) manual therapy. The program was carried out 3 days per week for 4 weeks. The Neck Disability Index, visual analog pain scale, digital algometry of pressure pain threshold, goniometric measurements, and Medical Outcomes Study 36-Item Short-Form Health Survey were used to assess participants at baseline and after 4 weeks. Improvements in Neck Disability Index score, night pain, rotation ROM, and the Medical Outcomes Study 36-Item Short-Form Health Survey score were greater in the group that received stabilization exercise with manual therapy compared to the group that only received stabilization exercise. Between-group differences (95% confidence interval) were 2.2 (0.1, 4.3) points for the Neck Disability Index, 1.1 (0.0, 2.3) cm for pain at night measured on the visual analog scale, -4.3° (-8.1°, -0.5°) and -5.0° (-8.2°, -1.7°) for right and left rotation ROM, respectively, and -2.9 (-5.4, -0.4) points and -3.1 (-6.2, 0.0) points for the Medical Outcomes Study 36-Item Short-Form Health Survey physical and mental components, respectively. Changes in resting and activity pain, pressure pain threshold, and cervical extension or lateral flexion ROM did not differ significantly between the groups. Pressure pain threshold increased only in those who received stabilization exercise with manual therapy (Pmanual therapy may be superior to stabilization exercises alone for improving disability, pain

  17. Effectiveness of two physical therapy interventions, relative to dental treatment in individuals with bruxism: study protocol of a randomized clinical trial.

    Science.gov (United States)

    Santos Miotto Amorim, Cinthia; Firsoff, Eliete Ferreira Osses; Vieira, Glauco Fioranelli; Costa, Jecilene Rosana; Marques, Amélia Pasqual

    2014-01-07

    support the practice of evidence-based physical therapy for individuals with bruxism. Data will be published after study is completed. ClinicalTrials.gov, NCT01778881.

  18. Comparison of the effects of extracorporeal shock wave therapy and a vacuum erectile device on penile erectile dysfunction: a randomized clinical trial.

    Science.gov (United States)

    Qi, Tao; Ye, Lei; Wang, Bo; Zhang, Bin; Chen, Jun

    2017-11-01

    This randomized clinical trial (October 2012-December 2013) compared extracorporeal shock wave therapy (ESWT) and a vacuum erectile device (VED) for management of erectile dysfunction (ED). Consecutive Chinese patients (20-55 years) with ED, abnormal nocturnal penile tumescence and rigidity (NPTR), and international index of erectile function-5 items (IIEF-5) score <22 were randomized to receive ESWT or VED (twice weekly, 4 weeks). Primary outcomes were treatment efficacy and success rate 4 weeks after completion of therapy. Secondary outcomes included changes in IIEF-5 score, sex encounter profile (SEP) score, erection hardness score (EHS) and NPTR assessments 4 weeks post-therapy. All enrolled patients (n = 30 per group) completed the study. At baseline, age, IIEF-5 score, SEP score, EHS, and NPTR assessments were similar between groups. Four weeks post-therapy, IIEF-5 score increased in the ESWT (15.03 ± 3.00 vs. 11.60 ± 2.28) and VED (15.10 ± 3.06 vs. 11.53 ± 2.27) groups, as did SEP score, EHS, and NPTR measures (all P < .05). Efficacy in the ESWT and VED groups was excellent in 10% and 13.3%, respectively, and moderate in 63.3% and 53.3%, respectively. Treatment success rate in the ESWT and VED groups was 73.3% and 67.7%, respectively. VED use and ESWT have comparable efficacies in the treatment of ED in Chinese patients.

  19. Optimizing Rehabilitation for Phantom Limb Pain Using Mirror Therapy and Transcranial Direct Current Stimulation: A Randomized, Double–Blind Clinical Trial Study Protocol

    Science.gov (United States)

    Bolognini, Nadia; Crandell, David; Merabet, Lotfi B

    2016-01-01

    Background Despite the multiple available pharmacological and behavioral therapies for the management of chronic phantom limb pain (PLP) in lower limb amputees, treatment for this condition is still a major challenge and the results are mixed. Given that PLP is associated with maladaptive brain plasticity, interventions that promote cortical reorganization such as non-invasive brain stimulation and behavioral methods including transcranial direct current stimulation (tDCS) and mirror therapy (MT), respectively, may prove to be beneficial to control pain in PLP. Due to its complementary effects, a combination of tDCS and MT may result in synergistic effects in PLP. Objective The objective of this study is to evaluate the efficacy of tDCS and MT as a rehabilitative tool for the management of PLP in unilateral lower limb amputees. Methods A prospective, randomized, placebo-controlled, double-blind, factorial, superiority clinical trial will be carried out. Participants will be eligible if they meet the following inclusion criteria: lower limb unilateral traumatic amputees that present PLP for at least 3 months after the amputated limb has completely healed. Participants (N=132) will be randomly allocated to the following groups: (1) active tDCS and active MT, (2) sham tDCS and active MT, (3) active tDCS and sham MT, and (4) sham tDCS and sham MT. tDCS will be applied with the anodal electrode placed over the primary motor cortex (M1) contralateral to the amputation side and the cathode over the contralateral supraorbital area. Stimulation will be applied at the same time of the MT protocol with the parameters 2 mA for 20 minutes. Pain outcome assessments will be performed at baseline, before and after each intervention session, at the end of MT, and in 2 follow-up visits. In order to assess cortical reorganization and correlate with clinical outcomes, participants will undergo functional magnetic resonance imaging (fMRI) and transcranial magnetic stimulation (TMS

  20. Topics in clinical trial management

    NARCIS (Netherlands)

    B.A. Kirwan (Bridget Anne)

    2004-01-01

    textabstractThe aim of this thesis is to show how clinical trial conduct can be managed while respecting the underlying scientific principles. Chapter 2 describes the main results of PICO (PImobendan in COngestive heart failure), a trial which investigated a positive inotropic agent in patients

  1. Yohimbine Enhancement of Exposure Therapy for Social Anxiety Disorder: A Randomized Controlled Trial

    NARCIS (Netherlands)

    Smits, J.A.J.; Rosenfield, D.; Davis, M.L.; Julian, K.; Handelsman, P.R.; Otto, M.W.; Tuerk, P.; Shiekh, M.; Rosenfield, B.; Hofmann, S.G.; Powers, M.B.

    2014-01-01

    Background Preclinical and clinical trials suggest that yohimbine may augment extinction learning without significant side effects. However, previous clinical trials have only examined adults with specific phobias. Yohimbine has not yet been investigated in the augmentation of exposure therapy for

  2. Clinical outcomes and cost-effectiveness of brief guided parent-delivered cognitive behavioural therapy and solution-focused brief therapy for treatment of childhood anxiety disorders: a randomised controlled trial.

    Science.gov (United States)

    Creswell, Cathy; Violato, Mara; Fairbanks, Hannah; White, Elizabeth; Parkinson, Monika; Abitabile, Gemma; Leidi, Alessandro; Cooper, Peter J

    2017-07-01

    Half of all lifetime anxiety disorders emerge before age 12 years; however, access to evidence-based psychological therapies for affected children is poor. We aimed to compare the clinical outcomes and cost-effectiveness of two brief psychological treatments for children with anxiety referred to routine child mental health settings. We hypothesised that brief guided parent-delivered cognitive behavioural therapy (CBT) would be associated with better clinical outcomes than solution-focused brief therapy and would be cost-effective. We did this randomised controlled trial at four National Health Service primary child and mental health services in Oxfordshire, UK. Children aged 5-12 years referred for anxiety difficulties were randomly allocated (1:1), via a secure online minimisation tool, to receive brief guided parent-delivered CBT or solution-focused brief therapy, with minimisation for age, sex, anxiety severity, and level of parental anxiety. The allocation sequence was not accessible to the researcher enrolling participants or to study assessors. Research staff who obtained outcome measurements were masked to group allocation and clinical staff who delivered the intervention did not measure outcomes. The primary outcome was recovery, on the basis of Clinical Global Impressions of Improvement (CGI-I). Parents recorded patient-level resource use. Quality-adjusted life-years (QALYs) for use in cost-utility analysis were derived from the Child Health Utility 9D. Assessments were done at baseline (before randomisation), after treatment (primary endpoint), and 6 months after treatment completion. We did analysis by intention to treat. This trial is registered with the ISCRTN registry, number ISRCTN07627865. Between March 23, 2012, and March 31, 2014, we randomly assigned 136 patients to receive brief guided parent-delivered CBT (n=68) or solution-focused brief therapy (n=68). At the primary endpoint assessment (June, 2012, to September, 2014), 40 (59%) children in

  3. A Sound Therapy-Based Intervention to Expand the Auditory Dynamic Range for Loudness among Persons with Sensorineural Hearing Losses: A Randomized Placebo-Controlled Clinical Trial

    Science.gov (United States)

    Formby, Craig; Hawley, Monica L.; Sherlock, LaGuinn P.; Gold, Susan; Payne, JoAnne; Brooks, Rebecca; Parton, Jason M.; Juneau, Roger; Desporte, Edward J.; Siegle, Gregory R.

    2015-01-01

    The primary aim of this research was to evaluate the validity, efficacy, and generalization of principles underlying a sound therapy–based treatment for promoting expansion of the auditory dynamic range (DR) for loudness. The basic sound therapy principles, originally devised for treatment of hyperacusis