WorldWideScience

Sample records for human clinical studies

  1. Muscle pain: animal and human experimental and clinical studies.

    Science.gov (United States)

    Marchettini, P

    1993-10-01

    The search for the identification of the sensory apparatus encoding muscle pain sensation in humans is recounted. Basic neurophysiologic animal studies, leading to a description of slowly conducting afferent from muscle and definition of high threshold polymodal muscle nociceptors, and pioneer psychophysic human studies together with recent microneurographic experiments in humans are described. The phenomena of muscle pain broad localization and distant referral are discussed, and clinical implications are extrapolated to interpret muscle pain as a localizing sign of mononeuropathy or radiculopathy. The identification of human muscle nociceptors has defined the scientific standard to test emerging clinical descriptions having muscle pain as a symptom.

  2. Human reporter genes: potential use in clinical studies

    Energy Technology Data Exchange (ETDEWEB)

    Serganova, Inna [Department of Neurology, Memorial Sloan-Kettering Cancer Center, New York, NY 10021 (United States); Ponomarev, Vladimir [Department of Radiology, Memorial Sloan-Kettering Cancer Center, New York, NY 10021 (United States); Blasberg, Ronald [Department of Neurology, Memorial Sloan-Kettering Cancer Center, New York, NY 10021 (United States); Department of Radiology, Memorial Sloan-Kettering Cancer Center, New York, NY 10021 (United States)], E-mail: blasberg@neuro1.mskcc.org

    2007-10-15

    The clinical application of positron-emission-tomography-based reporter gene imaging will expand over the next several years. The translation of reporter gene imaging technology into clinical applications is the focus of this review, with emphasis on the development and use of human reporter genes. Human reporter genes will play an increasingly more important role in this development, and it is likely that one or more reporter systems (human gene and complimentary radiopharmaceutical) will take leading roles. Three classes of human reporter genes are discussed and compared: receptors, transporters and enzymes. Examples of highly expressed cell membrane receptors include specific membrane somatostatin receptors (hSSTrs). The transporter group includes the sodium iodide symporter (hNIS) and the norepinephrine transporter (hNET). The endogenous enzyme classification includes human mitochondrial thymidine kinase 2 (hTK2). In addition, we also discuss the nonhuman dopamine 2 receptor and two viral reporter genes, the wild-type herpes simplex virus 1 thymidine kinase (HSV1-tk) gene and the HSV1-tk mutant (HSV1-sr39tk). Initial applications of reporter gene imaging in patients will be developed within two different clinical disciplines: (a) gene therapy and (b) adoptive cell-based therapies. These studies will benefit from the availability of efficient human reporter systems that can provide critical monitoring information for adenoviral-based, retroviral-based and lenteviral-based gene therapies, oncolytic bacterial and viral therapies, and adoptive cell-based therapies. Translational applications of noninvasive in vivo reporter gene imaging are likely to include: (a) quantitative monitoring of gene therapy vectors for targeting and transduction efficacy in clinical protocols by imaging the location, extent and duration of transgene expression; (b) monitoring of cell trafficking, targeting, replication and activation in adoptive T-cell and stem/progenitor cell therapies

  3. Recombinant human thrombopoietin: basic biology and evaluation of clinical studies.

    Science.gov (United States)

    Kuter, David J; Begley, C Glenn

    2002-11-15

    Thrombocytopenia is a common medical problem for which the main treatment is platelet transfusion. Given the increasing use of platelets and the declining donor population, identification of a safe and effective platelet growth factor could improve the management of thrombocytopenia. Thrombopoietin (TPO), the c-Mpl ligand, is the primary physiologic regulator of megakaryocyte and platelet development. Since the purification of TPO in 1994, 2 recombinant forms of the c-Mpl ligand--recombinant human thrombopoietin (rhTPO) and pegylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF)--have undergone extensive clinical investigation. Both have been shown to be potent stimulators of megakaryocyte growth and platelet production and are biologically active in reducing the thrombocytopenia of nonmyeloablative chemotherapy. However, neither TPO has demonstrated benefit in stem cell transplantation or leukemia chemotherapy. Other clinical studies have investigated the use of TPO in treating chronic nonchemotherapy-induced thrombocytopenia associated with myelodysplastic syndromes, idiopathic thrombocytopenic purpura, thrombocytopenia due to human immunodeficiency virus, and liver disease. Based solely on animal studies, TPO may be effective in reducing surgical thrombocytopenia and bleeding, ex vivo expansion of pluripotent stem cells, and as a radioprotectant. Ongoing and future studies will help define the clinical role of recombinant TPO and TPO mimetics in the treatment of chemotherapy- and nonchemotherapy-induced thrombocytopenia.

  4. Human transcriptome array for high-throughput clinical studies.

    Science.gov (United States)

    Xu, Weihong; Seok, Junhee; Mindrinos, Michael N; Schweitzer, Anthony C; Jiang, Hui; Wilhelmy, Julie; Clark, Tyson A; Kapur, Karen; Xing, Yi; Faham, Malek; Storey, John D; Moldawer, Lyle L; Maier, Ronald V; Tompkins, Ronald G; Wong, Wing Hung; Davis, Ronald W; Xiao, Wenzhong

    2011-03-01

    A 6.9 million-feature oligonucleotide array of the human transcriptome [Glue Grant human transcriptome (GG-H array)] has been developed for high-throughput and cost-effective analyses in clinical studies. This array allows comprehensive examination of gene expression and genome-wide identification of alternative splicing as well as detection of coding SNPs and noncoding transcripts. The performance of the array was examined and compared with mRNA sequencing (RNA-Seq) results over multiple independent replicates of liver and muscle samples. Compared with RNA-Seq of 46 million uniquely mappable reads per replicate, the GG-H array is highly reproducible in estimating gene and exon abundance. Although both platforms detect similar expression changes at the gene level, the GG-H array is more sensitive at the exon level. Deeper sequencing is required to adequately cover low-abundance transcripts. The array has been implemented in a multicenter clinical program and has generated high-quality, reproducible data. Considering the clinical trial requirements of cost, sample availability, and throughput, the GG-H array has a wide range of applications. An emerging approach for large-scale clinical genomic studies is to first use RNA-Seq to the sufficient depth for the discovery of transcriptome elements relevant to the disease process followed by high-throughput and reliable screening of these elements on thousands of patient samples using custom-designed arrays.

  5. Parasitological and clinical studies on human scabies in Cairo.

    Science.gov (United States)

    Sarwat, M A; el Okbi, L M; el Sayed, M M; el Okbi, S M; el Deeb, H K

    1993-12-01

    This study is a parasitological and clinical study on human scabies. This study was carried out on 100 patients attending the Dermatology Outpatient Clinic at Ain Shams University Hospitals, including 54 males and 46 females. All patients were subjected to detailed history taking, complete dermatological examination including Skin Scraping Test and Burrow Ink Test. Younger patients attended the dermatology clinic earlier than older patients, who usually delayed their visits until complications occurred. Scratching, erythematous papules and secondary infected lesions were the commonest lesions. The hands, wrist and external genitalia were the most frequently affected sites while the feet, ankles, knees and back were the least affected. Burrows could only be detected in 40% of patients. The most frequent sites were the web spaces, external genitalia, and finger sides. Burrow Ink Test was positive among 85% of patients with burrows while mites could be identified by Skin Scraping Test in 55% of patients. The most frequent clinical manifestations in the parasitologically positive patients were itching, burrows, and papules, and the most frequent sites were the web spaces, and the finger sides. Multiple sites affection was the characteristic feature among the preschool age children who represented 14% of cases.

  6. Comparative study of clinical grade human tolerogenic dendritic cells

    Directory of Open Access Journals (Sweden)

    Martínez-Cáceres E

    2011-06-01

    Full Text Available Abstract Background The use of tolerogenic DCs is a promising therapeutic strategy for transplantation and autoimmune disorders. Immunomodulatory DCs are primarily generated from monocytes (MDDCs for in vitro experiments following protocols that fail to fulfil the strict regulatory rules of clinically applicable products. Here, we compared the efficacy of three different tolerance-inducing agents, dexamethasone, rapamycin and vitamin D3, on DC biology using GMP (Good Manufacturing Practice or clinical grade reagents with the aim of defining their use for human cell therapy. Methods Tolerogenic MDDCs were generated by adding tolerogenic agents prior to the induction of maturation using TNF-α, IL-β and PGE2. We evaluated the effects of each agent on viability, efficiency of differentiation, phenotype, cytokine secretion and stability, the stimulatory capacity of tol-DCs and the T-cell profiles induced. Results Differences relevant to therapeutic applicability were observed with the cellular products that were obtained. VitD3-induced tol-DCs exhibited a slightly reduced viability and yield compared to Dexa-and Rapa-tol-DCs. Phenotypically, while Dexa-and VitD3-tol-DCs were similar to immature DCs, Rapa-tol-DCs were not distinguishable from mature DCs. In addition, only Dexa-and moderately VitD3-tol-DCs exhibited IL-10 production. Interestingly, in all cases, the cytokine secretion profiles of tol-DCs were not modified by a subsequent TLR stimulation with LPS, indicating that all products had stable phenotypes. Functionally, clearly reduced alloantigen T cell proliferation was induced by tol-DCs obtained using any of these agent. Also, total interferon-gamma (IFN-γ secretion by T cells stimulated with allogeneic tol-DCs was reduced in all three cases, but only T cells co-cultured with Rapa-tol-DCs showed impaired intracellular IFN-γ production. In addition, Rapa-DCs promoted CD4+ CD127 low/negative CD25high and Foxp3+ T cells. Conclusions Our

  7. Human C-peptide. Part II: Clinical studies.

    Science.gov (United States)

    Beischer, W; Heinze, E; Keller, L; Raptis, S; Kerner, W; Pfeiffer, E F

    1976-08-01

    Human C-peptide is determined by radioimmunoassay. On gel filtration of serum from a healthy subject and from a patient with islet cell carcinoma, C-peptide (MW 3025) appears ahead of insulin (MW 5808) and shows much higher molar concentrations than the hormone. Human proinsulin cross-reacts with our antiserum to synthetic human C-peptide. On direct determination of immunomeasurable C-peptide (IMCP) in fasting serum of 25 healthy subjects we find an average of 1.8 (+/- 0.4) ng/ml, corresponding to 60.4 X 10(-11) Mol/l. The molar concentration is about five-fold as compared to IMI (immuno-measurable insulin). IMCP and IMI patterns are not identical on stimulation of beta-cell secretion in healthy subjects by i.v. glucose or glucose-glibenclamide. This is probably due to differences in peripheral metabolism of both compounds. We conclude from our results that C-peptide determined in peripheral venous serum is a better indicator of beta-cell secretion than is insulin. Among 26 insulin-treated juvenile diabetics 15 show not measurable and 11 subnormal IMCP levels in fasting serum. No rise in IMCP is found 1-2 h following breakfast. Four juvenile patients receiving no insulin in a phase of total diabetes remission have normal or raised fasting IMCP concentrations. Only 2 out of 24 adult diabetics (16 treated with insulin and 8 with tablets) show non-measurable fasting IMCP concentrations, in another 4 patients values are below and in the remaining 18 cases above 1 ng/ml serum. Stimulation of beta-cell secretion through glucose-glibenclamide is more or less impaired in all adult diabetics compared to the healthy subjects.

  8. Functional MRI in human motor control studies and clinical applications

    Energy Technology Data Exchange (ETDEWEB)

    Toma, Keiichiro [Kyoto Univ. (Japan). Graduate School of Medicine; Nakai, Toshiharu [Inst. of Biomedical Research and Innovation, Kobe (Japan)

    2002-07-01

    Functional magnetic resonance imaging (fMRI) has been a useful tool for the noninvasive mapping of brain function associated with various motor and cognitive tasks. Because fMRI is based on the blood oxygenation level dependent (BOLD) effect, it does not directly record neural activity. With the fMRI technique, distinguishing BOLD signals creased by cortical projection neurons from those created by intracortical neurons appears to be difficult. Two major experimental designs are used in fMRI studies: block designs and event-related designs. Block-designed fMRI presupposes the steady state of regional cerebral blood flow and has been applied to examinations of brain activation caused by tasks requiring sustained or repetitive movements. By contrast, the more recently developed event-related fMRI with time resolution of a few seconds allows the mapping of brain activation associated with a single movement according to the transient aspects of the hemodynamic response. Increasing evidence suggests that multiple motor areas are engaged in a networked manner to execute various motor acts. In order to understand functional brain maps, it is important that one understands sequential and parallel organizations of anatomical connections between multiple motor areas. In fMRI studies of complex motor tasks, elementary parameters such as movement length, force, velocity, acceleration and frequency should be controlled, because inconsistency in those parameters may alter the extent and intensity of motor cortical activation, confounding interpretation of the findings obtained. In addition to initiation of movements, termination of movements plays an important role in the successful achievement of complex movements. Brain areas exclusively related to the termination of movements have been, for the first time, uncovered with an event-related fMRI technique. We propose the application of fMRI to the elucidation of the pathophysiology of movement disorders, particularly dystonia

  9. Correlating preclinical animal studies and human clinical trials of a multifunctional, polymeric nanoparticle.

    Science.gov (United States)

    Eliasof, Scott; Lazarus, Douglas; Peters, Christian G; Case, Roy I; Cole, Roderic O; Hwang, Jungyeon; Schluep, Thomas; Chao, Joseph; Lin, James; Yen, Yun; Han, Han; Wiley, Devin T; Zuckerman, Jonathan E; Davis, Mark E

    2013-09-10

    Nanoparticles are currently being investigated in a number of human clinical trials. As information on how nanoparticles function in humans is difficult to obtain, animal studies that can be correlative to human behavior are needed to provide guidance for human clinical trials. Here, we report correlative studies on animals and humans for CRLX101, a 20- to 30-nm-diameter, multifunctional, polymeric nanoparticle containing camptothecin (CPT). CRLX101 is currently in phase 2 clinical trials, and human data from several of the clinical investigations are compared with results from multispecies animal studies. The pharmacokinetics of polymer-conjugated CPT (indicative of the CRLX101 nanoparticles) in mice, rats, dogs, and humans reveal that the area under the curve scales linearly with milligrams of CPT per square meter for all species. Plasma concentrations of unconjugated CPT released from CRLX101 in animals and humans are consistent with each other after accounting for differences in serum albumin binding of CPT. Urinary excretion of polymer-conjugated CPT occurs primarily within the initial 24 h after dosing in animals and humans. The urinary excretion dynamics of polymer-conjugated and unconjugated CPT appear similar between animals and humans. CRLX101 accumulates into solid tumors and releases CPT over a period of several days to give inhibition of its target in animal xenograft models of cancer and in the tumors of humans. Taken in total, the evidence provided from animal models on the CRLX101 mechanism of action suggests that the behavior of CRLX101 in animals is translatable to humans.

  10. A tool to facilitate clinical biomarker studies - a tissue dictionary based on the Human Protein Atlas

    Directory of Open Access Journals (Sweden)

    Kampf Caroline

    2012-09-01

    Full Text Available Abstract The complexity of tissue and the alterations that distinguish normal from cancer remain a challenge for translating results from tumor biological studies into clinical medicine. This has generated an unmet need to exploit the findings from studies based on cell lines and model organisms to develop, validate and clinically apply novel diagnostic, prognostic and treatment predictive markers. As one step to meet this challenge, the Human Protein Atlas project has been set up to produce antibodies towards human protein targets corresponding to all human protein coding genes and to map protein expression in normal human tissues, cancer and cells. Here, we present a dictionary based on microscopy images created as an amendment to the Human Protein Atlas. The aim of the dictionary is to facilitate the interpretation and use of the image-based data available in the Human Protein Atlas, but also to serve as a tool for training and understanding tissue histology, pathology and cell biology. The dictionary contains three main parts, normal tissues, cancer tissues and cells, and is based on high-resolution images at different magnifications of full tissue sections stained with H & E. The cell atlas is centered on immunofluorescence and confocal microscopy images, using different color channels to highlight the organelle structure of a cell. Here, we explain how this dictionary can be used as a tool to aid clinicians and scientists in understanding the use of tissue histology and cancer pathology in diagnostics and biomarker studies.

  11. 3D virtual human atria: A computational platform for studying clinical atrial fibrillation.

    Science.gov (United States)

    Aslanidi, Oleg V; Colman, Michael A; Stott, Jonathan; Dobrzynski, Halina; Boyett, Mark R; Holden, Arun V; Zhang, Henggui

    2011-10-01

    Despite a vast amount of experimental and clinical data on the underlying ionic, cellular and tissue substrates, the mechanisms of common atrial arrhythmias (such as atrial fibrillation, AF) arising from the functional interactions at the whole atria level remain unclear. Computational modelling provides a quantitative framework for integrating such multi-scale data and understanding the arrhythmogenic behaviour that emerges from the collective spatio-temporal dynamics in all parts of the heart. In this study, we have developed a multi-scale hierarchy of biophysically detailed computational models for the human atria--the 3D virtual human atria. Primarily, diffusion tensor MRI reconstruction of the tissue geometry and fibre orientation in the human sinoatrial node (SAN) and surrounding atrial muscle was integrated into the 3D model of the whole atria dissected from the Visible Human dataset. The anatomical models were combined with the heterogeneous atrial action potential (AP) models, and used to simulate the AP conduction in the human atria under various conditions: SAN pacemaking and atrial activation in the normal rhythm, break-down of regular AP wave-fronts during rapid atrial pacing, and the genesis of multiple re-entrant wavelets characteristic of AF. Contributions of different properties of the tissue to mechanisms of the normal rhythm and arrhythmogenesis were investigated. Primarily, the simulations showed that tissue heterogeneity caused the break-down of the normal AP wave-fronts at rapid pacing rates, which initiated a pair of re-entrant spiral waves; and tissue anisotropy resulted in a further break-down of the spiral waves into multiple meandering wavelets characteristic of AF. The 3D virtual atria model itself was incorporated into the torso model to simulate the body surface ECG patterns in the normal and arrhythmic conditions. Therefore, a state-of-the-art computational platform has been developed, which can be used for studying multi

  12. Resveratrol and Clinical Trials: The Crossroad from In Vitro Studies to Human Evidence

    Science.gov (United States)

    Tomé-Carneiro, Joao; Larrosa, Mar; González-Sarrías, Antonio; Tomás-Barberán, Francisco A.; García-Conesa, María Teresa; Espín, Juan Carlos

    2013-01-01

    Resveratrol (3,5,4’-trihydroxy-trans-stilbene) is a non-flavonoid polyphenol that may be present in a limited number of food-stuffs such as grapes and red wine. Resveratrol has been reported to exert a plethora of health benefits through many different mechanisms of action. This versatility and presence in the human diet have drawn the worldwide attention of many research groups over the past twenty years, which has resulted in a huge output of in vitro and animal (preclinical) studies. In line with this expectation, many resveratrol-based nutraceuticals are consumed all over the world with questionable clinical/scientific support. In fact, the confirmation of these benefits in humans through randomized clinical trials is still very limited. The vast majority of preclinical studies have been performed using assay conditions with a questionable extrapolation to humans, i.e. too high concentrations with potential safety concerns (adverse effects and drug interactions), short-term exposures, in vitro tests carried out with non-physiological metabolites and/or concentrations, etc. Unfortunately, all these hypothesis-generating studies have contributed to increased the number of ‘potential’ benefits and mechanisms of resveratrol but confirmation in humans is very limited. Therefore, there are many issues that should be addressed to avoid an apparent endless loop in resveratrol research. The so-called ‘Resveratrol Paradox’, i.e., low bioavailability but high bioactivity, is a conundrum not yet solved in which the final responsible actor (if any) for the exerted effects has not yet been unequivocally identified. It is becoming evident that resveratrol exerts cardioprotective benefits through the improvement of inflammatory markers, atherogenic profile, glucose metabolism and endothelial function. However, safety concerns remain unsolved regarding chronic consumption of high RES doses, specially in medicated people. This review will focus on the currently

  13. Integration of preclinical and clinical knowledge to predict intravenous PK in human: bilastine case study.

    Science.gov (United States)

    Vozmediano, Valvanera; Ortega, Ignacio; Lukas, John C; Gonzalo, Ana; Rodriguez, Monica; Lucero, Maria Luisa

    2014-03-01

    Modern pharmacometrics can integrate and leverage all prior proprietary and public knowledge. Such methods can be used to scale across species or comparators, perform clinical trial simulation across alternative designs, confirm hypothesis and potentially reduce development burden, time and costs. Crucial yet typically lacking in integration is the pre-clinical stage. Prediction of PK in man, using in vitro and in vivo studies in different animal species, is increasingly well theorized but could still find wider application in drug development. The aim of the present work was to explore methods for bridging pharmacokinetic knowledge from animal species (i.v. and p.o.) and man (p.o.) into i.v. in man using the antihistamine drug bilastine as example. A model, predictive of i.v. PK in man, was developed on data from two pre-clinical species (rat and dog) and p.o. in man bilastine trials performed earlier. In the knowledge application stage, two different approaches were used to predict human plasma concentration after i.v. of bilastine: allometry (several scaling methods) and a semi-physiological method. Both approaches led to successful predictions of key i.v. PK parameters of bilastine in man. The predictive i.v. PK model was validated using later data from a clinical study of i.v. bilastine. Introduction of such knowledge in development permits proper leveraging of all emergent knowledge as well as quantification-based exploration of PK scenario, e.g. in special populations (pediatrics, renal insufficiency, comedication). In addition, the methods permit reduction or elimination and certainly optimization of learning trials, particularly those concerning alternative off-label administration routes.

  14. A Pilot Clinical Study to Investigate the Human Whole Blood Spectrum Characteristics in the Sub-THz Region

    CERN Document Server

    Tseng, Tzu-Fang; Gao, Hao-Cheng; Wang, Tzung-Dau; Sun, Chi-Kuang

    2014-01-01

    We have conducted a pilot clinical study to not only investigate the THz spectra of ex-vivo fresh human whole blood of 28 patients following 8-hours fasting guideline, but also to find out the critical blood ingredients of which the concentration dominantly affects those THz spectra. A great difference between the THz absorption properties of human blood among different people was observed, while the difference can be up to ~15% of the averaged absorption coefficient of the 28 samples. Our pilot clinical study indicates that triglyceride and red blood cell were two dominant factors to have significant clinically defined negative correlation to the sub-THz absorption coefficients.

  15. Clinical Studies

    DEFF Research Database (Denmark)

    Pallesen, Ulla

    and repair? Have new materials improved longevity? Are there still clinical and material problems to be solved? And what has the highest impact on longevity of posterior resin restorations – the material, the dentist, the patient or the tooth? These matters will be discussed on the basis of the literature......Within the last 25 years composite resin materials have in many countries successively replaced amalgam as a restorative for posterior teeth. Resin materials and bonding systems are continuously being improved by the manufactures, adhesive procedures are now included in the curriculum of most...... universities and practicing dentists restore millions of teeth throughout the World with composite resin materials. Do we know enough about the clinical performance of these restorations over time? Numerous in vitro studies are being published on resin materials and adhesion, some of them attempting to imitate...

  16. Clinical studies of pigmented lesions in human skin by using a multiphoton tomograph

    Science.gov (United States)

    Balu, Mihaela; Kelly, Kristen M.; Zachary, Christopher B.; Harris, Ronald M.; Krasieva, Tatiana B.; König, Karsten; Tromberg, Bruce J.

    2013-02-01

    In vivo imaging of pigmented lesions in human skin was performed with a clinical multiphoton microscopy (MPM)-based tomograph (MPTflex, JenLab, Germany). Two-photon excited fluorescence was used for visualizing endogenous fluorophores such as NADH/FAD, keratin, melanin in the epidermal cells and elastin fibers in the dermis. Collagen fibers were imaged by second harmonic generation. Our study involved in vivo imaging of benign melanocytic nevi, atypical nevi and melanoma. The goal of this preliminary study was to identify in vivo the characteristic features and their frequency in pigmented lesions at different stages (benign, atypical and malignant) and to evaluate the ability of in vivo MPM to distinguish atypical nevi from melanoma. Comparison with histopathology was performed for the biopsied lesions. Benign melanocytic nevi were characterized by the presence of nevus cell nests at the epidermal-dermal junction. In atypical nevi, features such as lentiginous hyperplasia, acanthosis and architectural disorder were imaged. Cytological atypia was present in all the melanoma lesions imaged, showing the strongest correlation with malignancy. The MPM images demonstrated very good correlation with corresponding histological images, suggesting that MPM could be a promising tool for in vivo non-invasive pigmented lesion diagnosis, particularly distinguishing atypical nevi from melanoma.

  17. XB130 expression in human osteosarcoma: a clinical and experimental study.

    Science.gov (United States)

    Wang, Xiaohui; Wang, Ruiguo; Liu, Zhaolong; Hao, Fengyun; Huang, Hai; Guo, Wenchen

    2015-01-01

    Identifying prognostic factors for osteosarcoma (OS) aids in the selection of patients who require more aggressive management. XB130 is a newly characterized adaptor protein that was reported to be a prognostic factor of certain tumor types. However, the association between XB130 expression and the prognosis of OS remains unknown. In the present study, we investigated the association between XB130 expression and clinicopathologic features and prognosis in patients suffering OS, and further investigated its potential role on OS cells in vitro and vivo. A retrospective immunohistochemical study of XB130 was performed on archival formalin-fixed paraffin-embedded specimens from 60 pairs of osteosarcoma and noncancerous bone tissues, and compared the expression of XB130 with clinicopathological parameters. We then investigate the effect of XB130 sliencing on invasion in vitro and lung metastasis in vivo of the human OS cell line. Immunohistochemical assays revealed that XB130 expression in OS tissues was significantly higher than that in corresponding noncancerous bone tissues (P=0.001). In addition, high XB130 expression more frequently occurred in OS tissues with advanced clinical stage (P=0.002) and positive distant metastasis (P=0.001). Moreover, OS patients with high XB130 expression had significantly shorter overall survival and disease-free survival (both Ptreatments. Furthermore, XB130 is the potential molecular target for OS therapy.

  18. Stereomicroscopic study of the human tooth caries: clinical and morphological correlations

    Science.gov (United States)

    Oancea, Roxana; Vasile, Liliana; Marchese, Cristian; Sava-Rosianu, Ruxandra

    2012-06-01

    loss that is very useful in grading the progression of the carious lesion. Conclusions: The stereomicroscopic study correlated with clinical and morphological data allowed to appreciate the extent of tissue involved in the carious process, but also the understanding of the enamel, dentine and cement matrix demineralization process, in proximity with the morpho-embryological markings of the human tooth structure.

  19. A clinical pilot study of fresh frozen plasma versus human albumin in paediatric craniofacial repair

    NARCIS (Netherlands)

    Kerner, T.; Machottas, A.; Kerner, S.; Ahlers, O.; Haberl, H.; Riess, H.; Hildebrandt, B.

    2008-01-01

    Poediatric craniofacial surgery (pCFS) regularly requires transfusion of packed red blood cells (pRBC). In this clinical pilot study two different transfusion regimens were prospectively compared concerning pRBC transfusions, postoperative bleeding and other clinical parameters. Thirty infants (aged

  20. Clinical Exposure Boost Predictions by Integrating Cytochrome P450 3A4-Humanized Mouse Studies With PBPK Modeling.

    Science.gov (United States)

    Zhang, Jin; Heimbach, Tycho; Scheer, Nico; Barve, Avantika; Li, Wenkui; Lin, Wen; He, Handan

    2016-04-01

    NVS123 is a poorly water-soluble protease 56 inhibitor in clinical development. Data from in vitro hepatocyte studies suggested that NVS123 is mainly metabolized by CYP3A4. As a consequence of limited solubility, NVS123 therapeutic plasma exposures could not be achieved even with high doses and optimized formulations. One approach to overcome NVS123 developability issues was to increase plasma exposure by coadministrating it with an inhibitor of CYP3A4 such as ritonavir. A clinical boost effect was predicted by using physiologically based pharmacokinetic (PBPK) modeling. However, initial boost predictions lacked sufficient confidence because a key parameter, fraction of drug metabolized by CYP3A4 (fmCYP3A4), could not be estimated with accuracy on account of disconnects between in vitro and in vivo preclinical data. To accurately estimate fmCYP3A4 in human, an in vivo boost effect study was conducted using CYP3A4-humanized mouse model which showed a 33- to 56-fold exposure boost effect. Using a top-down approach, human fmCYP3A4 for NVS123 was estimated to be very high and included in the human PBPK modeling to support subsequent clinical study design. The combined use of the in vivo boost study in CYP3A4-humanized mouse model mice along with PBPK modeling accurately predicted the clinical outcome and identified a significant NVS123 exposure boost (∼42-fold increase) with ritonavir.

  1. How to avoid risks for patients in minimal-access trials: Avoiding complications in clinical first-in-human studies by example of the ADBEE study.

    Science.gov (United States)

    Cezar, Cristina; Korell, Matthias; Tchartchian, Garri; Ziegler, Nicole; Senshu, Kazuhisa; Herrmann, Anja; Larbig, Angelika; De Wilde, Rudy Leon

    2016-08-01

    A clinical trial is a prospective study designed to establish the safety and efficacy of investigational devices in humans, in accordance with the strict guidelines of the Food and Drug Administration (FDA; USA) or European Medicines Agency (EMA; Europe). Before a clinical first-in-human study is initiated, preclinical studies of the investigational product are mandatory, and the results should be sufficient to indicate that the investigational device is acceptably safe for the proposed evaluation in human subjects. The present paper describes an experience of clinical trials, highlighting ways of avoiding possible complications in clinical first-in-human studies. For a better approach to our aim, we exemplified a prospective, randomized, single-blind study, ADBEE. The primary objective was to assess the safety of the ADBLOCK system when used as an adjunct to laparoscopic primary removal of myomas in women wishing to improve pregnancy outcomes.

  2. A tool to facilitate clinical biomarker studies--a tissue dictionary based on the Human Protein Atlas.

    Science.gov (United States)

    Kampf, Caroline; Bergman, Julia; Oksvold, Per; Asplund, Anna; Navani, Sanjay; Wiking, Mikaela; Lundberg, Emma; Uhlén, Mathias; Ponten, Fredrik

    2012-09-12

    The complexity of tissue and the alterations that distinguish normal from cancer remain a challenge for translating results from tumor biological studies into clinical medicine. This has generated an unmet need to exploit the findings from studies based on cell lines and model organisms to develop, validate and clinically apply novel diagnostic, prognostic and treatment predictive markers. As one step to meet this challenge, the Human Protein Atlas project has been set up to produce antibodies towards human protein targets corresponding to all human protein coding genes and to map protein expression in normal human tissues, cancer and cells. Here, we present a dictionary based on microscopy images created as an amendment to the Human Protein Atlas. The aim of the dictionary is to facilitate the interpretation and use of the image-based data available in the Human Protein Atlas, but also to serve as a tool for training and understanding tissue histology, pathology and cell biology. The dictionary contains three main parts, normal tissues, cancer tissues and cells, and is based on high-resolution images at different magnifications of full tissue sections stained with H & E. The cell atlas is centered on immunofluorescence and confocal microscopy images, using different color channels to highlight the organelle structure of a cell. Here, we explain how this dictionary can be used as a tool to aid clinicians and scientists in understanding the use of tissue histology and cancer pathology in diagnostics and biomarker studies.

  3. Ethical Issues for Clinical Studies That use Human Embryonic Stem Cells: The 2014 Revisions to the Japanese Guidelines.

    Science.gov (United States)

    Mizuno, Hiroshi

    2015-10-01

    The use of human embryonic stem cells (hESCs) in clinical studies has been expanding in recent years. The application of hESCs in clinical studies raises ethical issues from a different standpoint compared with the use of other types of stem cells. In Japan, the Guidelines on the Derivation of Human Embryonic Stem Cells, and Guidelines on the Distribution and Utilization of Human Embryonic Stem Cells had been revised for clinical studies in 2014. In the revised guidelines, the method for protection of personal information was changed to offer the choice between unlinkable anonymization and linkable anonymization, to enable the use of information on diseases suffered by donors and the assurance of traceability for safety. Procedures for re-consent are generally prohibited out of consideration for donors' feelings. However, obtaining re-consent is permitted when consent for re-consent has been received in advance and approval has been given by an ethical review board, in which case the donors may be contacted. Incidental findings obtained from hESCs are not disclosed individually to donors, while the research results should be actively published for the common good. These guidelines have enabled the derivation, distribution, and use of hESCs for clinical studies.

  4. 78 FR 12664 - Human Subject Protection; Acceptance of Data From Clinical Studies for Medical Devices

    Science.gov (United States)

    2013-02-25

    ... documenting the review and approval of the study by an independent ethics committee (IEC) and obtaining and... for acceptance of a PMA application for marketing approval based solely on foreign clinical data, and... this document) identifying ethical and other principles that provide assurance of the quality...

  5. Historic images in nuclear medicine: 1976: the first issue of clinical nuclear medicine and the first human FDG study.

    Science.gov (United States)

    Hess, Søren; Høilund-Carlsen, Poul Flemming; Alavi, Abass

    2014-08-01

    In 1976, 2 major molecular imaging events coincidentally took place: Clinical Nuclear Medicine was first published in June, and in August researchers at the Hospital of the University of Pennsylvania created the first images in humans with F-FDG. FDG was initially developed as part of an evolution set in motion by fundamental research studies with positron-emitting tracers in the 1950s by Michel Ter-Pegossian and coworkers at the Washington University. Today, Clinical Nuclear Medicine is a valued scientific contributor to the molecular imaging community, and FDG PET is considered the backbone of this evolving and exciting discipline.

  6. Clinical Trials: A Crucial Key to Human Health Research

    Science.gov (United States)

    Skip Navigation Bar Home Current Issue Past Issues Clinical Trials: A Crucial Key to Human Health Research Past ... the forefront of human health research today are clinical trials—studies that use human volunteers to help medical ...

  7. Mathematical modeling of human glioma growth based on brain topological structures: study of two clinical cases.

    Directory of Open Access Journals (Sweden)

    Cecilia Suarez

    Full Text Available Gliomas are the most common primary brain tumors and yet almost incurable due mainly to their great invasion capability. This represents a challenge to present clinical oncology. Here, we introduce a mathematical model aiming to improve tumor spreading capability definition. The model consists in a time dependent reaction-diffusion equation in a three-dimensional spatial domain that distinguishes between different brain topological structures. The model uses a series of digitized images from brain slices covering the whole human brain. The Talairach atlas included in the model describes brain structures at different levels. Also, the inclusion of the Brodmann areas allows prediction of the brain functions affected during tumor evolution and the estimation of correlated symptoms. The model is solved numerically using patient-specific parametrization and finite differences. Simulations consider an initial state with cellular proliferation alone (benign tumor, and an advanced state when infiltration starts (malign tumor. Survival time is estimated on the basis of tumor size and location. The model is used to predict tumor evolution in two clinical cases. In the first case, predictions show that real infiltrative areas are underestimated by current diagnostic imaging. In the second case, tumor spreading predictions were shown to be more accurate than those derived from previous models in the literature. Our results suggest that the inclusion of differential migration in glioma growth models constitutes another step towards a better prediction of tumor infiltration at the moment of surgical or radiosurgical target definition. Also, the addition of physiological/psychological considerations to classical anatomical models will provide a better and integral understanding of the patient disease at the moment of deciding therapeutic options, taking into account not only survival but also life quality.

  8. Fundamental and clinical study of direct immunoradiometric assay in human renin concentration

    Energy Technology Data Exchange (ETDEWEB)

    Kurimoto, Fumihiko; Horiuchi, Junko; Sakurai, Hyoichiro; Suzuki, Hiromichi; Takita, Takashi; Saruta, Takao.

    1988-05-01

    'Renin RIA Pasteur' kit for directly measuring renin concentration in human plasma (PRC) was fundamentally and clinically evaluated. A standard curve for PRC was linear in the range of 10 - 640 pg/ml. Reproducibility, recovery, and stability were satisfactory. There was a significantly positive correlation between direct PRC and conventional plasma renin activity (PRA) and indirect PRC. PRC was directly measured in 119 healthy volunteers and 15 patients with primary aldosteronism (4), Cushing's syndrome (6), or non-functioning tumor (5). The basal PRC was 32.4 +- 18.8 pg/ml for men and 37.9 +- 22.6 pg/ml for women. PRC for primary aldosteronism was below detectable levels, and remained unchanged even after the administratin of ACTH. In the case of Cushing's syndrome, mean PRC and PRA were 19 pg/ml and 1.2 ng/ml/hr, and did not respond to ACTH. Although the administration of ATCH was significantly associated with a decreased PRC, there was only tendency toward the decreased PRA in the case of non-functioning tumors. The results indicate the usefulness of the present kit in terms of its ability to directly measure PRC without any complicated procedures. (Namekawa, K.).

  9. Predicted levels of human radiation tolerance extrapolated from clinical studies of radiation effects

    Science.gov (United States)

    Lushbaugh, C. C.

    1972-01-01

    Results of clinical studies of radiation effects on man are used to evaluate space radiation hazards encountered during manned space travel. Considered are effects of photons as well as of mixed fission neutrons and gamma irradiations in establishing body radiosensitivity and tolerance levels. Upper and lower dose-response-time relations for acute radiation syndromes in patients indicate that man is more than sufficiently radioresistant to make the risks of an early radiation effect during one short space mission intangibly small in relation to the other nonradiation risks involved.

  10. [Implantation of collagen coated hydroxyapatite particles. A clinical-histological study in humans].

    Science.gov (United States)

    Sanz, M; Bascones, A; Kessler, A; García Nuñez, J; Newman, M G; Robertson, M A; Carranza, F A

    1989-05-01

    In this study, histologic behaviour of collagen coated hydroxylapatite particles implanted in human periodontal osseous defects has been analyzed. This material was surgically implanted in four patients, and reentry and block biopsies were carried out 4 and 6 months later. The histologic results demonstrate that this material is well tolerated by surrounding tissues, not eliciting an inflammatory reaction. At four months, the hydroxylapatite particles appear encapsulated by a very cellular connective tissue and at 6 months are found in direct contact with osteoid and mature bone. This material acts as a filler material, being fully biocompatible and stimulating an osseoconductive reaction of the adjacent alveolar bone.

  11. Optical properties of human tendons characterized by PSOCT and their relation to tendinopathy: a clinical study

    Science.gov (United States)

    Bagnaninchi, P. O.; Churmakov, D.; Bonesi, M.; Yang, Y.; Phelan, C.; Maffulli, N.; Meglinski, I.; El Haj, A.

    2008-02-01

    Polarisation-sensitive optical coherence tomography (PSOCT) is a non destructive technique with great potential for tendinopathy diagnosis. Functional optical assessment can be used in operating theatres to delineate in depth the margin of the non-healthy area, and limit the amount of tissue to be removed. A clinical study of 21 patients has been undertaken to correlate the optical properties of tendons to their clinical conditions. Tendons were scanned ex vivo with a fibre based time domain PSOCT. The beam from a superluminescent diode with a bandwidth of 52nm is sent through a polarizer and a polarizer modulator, and split into a sample and reference arm. After passing through polarization beam splitter, the interferences fringes are detected with two balanced detectors, for horizontal and vertical polarization. Scattering, birefringence and in depth stokes vectors are extracted from the measurements. Direct microstructural variation and changes in scattering properties are correlated with different tendinopathy and presence of scar tissue, which is cross-validated by histology. Lack of tissue organization, detected as the disappearance of the bands of birefringence, is representative of tendon degeneration. Special attention is paid to the difference between crimp patterns of different patient's tendons. As in polarization microscopy, the crimp pattern appears as extinction bands, and is particularly important as its alteration is generally symptomatic and could be used as an early diagnosis. Its optical origin is investigated by varying polarization and scanning conditions.

  12. Study on human chondrocyte culture viability for autologous transplantation in clinical application

    Directory of Open Access Journals (Sweden)

    Christiane Lombello

    2003-06-01

    Full Text Available Objective: The limited regenerative capacity of the cartilage tissuemakes the treatment of chondral lesions difficult. The techniquescurrently available to treat cartilage lesions may relieve symptoms,but do not regenerate the injured tissue. Autologous chondrocytetransplantation uses cell biology and cell culture techniques toregenerate the hyaline cartilage. Methods: In this study, we analyzechondrocyte biopsy collection and culture for autologoustransplantation. Ultrastructural analyses of hyaline cartilage biopsieswere performed 0, 6, 24 and 48 hours after collection. The tissue evenafter 48 hours. Eleven cell culture assays were performed to evaluateisolation, viability, morphology, proliferation and absence ofcontaminants. Results: The cell culture techniques used allowedchondrocyte proliferation. Rates on cell viability were maintained abovethe acceptable patterns (above 90. Control of cell culture laboratoryconditions showed absence of contaminants, assuring safety of theprocess. The chondrocytes obtained presented the morphology typicalof cultured cell monolayers. Conclusion: The results indicate viabilityof chondrocyte culture technique for clinical application in autologoustransplantation.

  13. A learning activity to introduce undergraduate students to bioethics in human clinical research: a case study.

    Science.gov (United States)

    Segarra, Ignacio; Gomez, Manuel

    2014-12-01

    We developed a pharmacology practicum assignment to introduce students to the research ethics and steps involved in a clinical trial. The assignment included literature review, critical analysis of bioethical situations, writing a study protocol and presenting it before a simulated ethics committee, a practice interview with a faculty member to obtain informed consent, and a student reflective assessment and self-evaluation. Students were assessed at various steps in the practicum; the learning efficiency of the activity was evaluated using an independent survey as well as students' reflective feedback. Most of the domains of Bloom's and Fink's taxonomies of learning were itemized and covered in the practicum. Students highly valued the translatability of theoretical concepts into practice as well as the approach to mimic professional practice. This activity was within a pharmacy program, but may be easily transferable to other medical or health sciences courses.

  14. Human clinical studies of tea polyphenols in allergy or life style-related diseases.

    Science.gov (United States)

    Maeda-Yamamoto, Mari

    2013-01-01

    Many previous epidemiological studies have revealed that green tea or green tea catechins contributed to the preveintion of lifestyle-related diseases. Several cohort studies on the relationship between green tea consumption and cardiovascular disease (CVD) risk/type 2 diabetes mellitus risk have been conducted. The results showed that green tea consumption (5 or more cups/day) was inversely associated with mortality from CVD and all causes. Within CVD mortality, the strongest inverse association was observed for stroke mortality. Furthermore, consumption of green tea, coffee, and total caffeine was associated with a reduced risk for type 2 diabetes. On the other hand, the analysis of randomized clinical trial (RCT) studies showed that the administration of green tea beverages or extracts resulted in significant reductions in serum total cholesterol and LDL-cholesterol concentrations, but had no apparent effect on HDL-cholesterol. Green tea reduced fasting blood glucose levels in a small intervention trial, although no improvements in HbA1c levels were seen. Continuous intake of green tea containing catechins and caffeine (5 or more cups per day) may be beneficial for body weight management, vascular disease risk reduction via LDL-cholesterol improvement, and type 2 diabetes risk reduction through the lowering of fasting blood glucose levels. Epigallocatechin-3-O-(3-O-methyl) gallate (EGCG3"Me) isolated from cv. "Benifuuki" green tea has been shown to strongly inhibit mast cell activation and histamine release after FcepsilonRI cross-linking through the suppression of tyrosine phosphorylation (Lyn) of cellular protein kinase, and the suppression of myosin light chain phosphorylation and high-affinity IgE receptor expression via the binding to 67 kDa laminin receptors. A double-blind clinical study on subjects with Japanese cedar pollinosis was carried out. At the eleventh week after starting intake, which was coincident with the most severe period of cedar pollen

  15. The Fibularis (Peroneus Tertius Muscle in Humans: A Meta-Analysis of Anatomical Studies with Clinical and Evolutionary Implications

    Directory of Open Access Journals (Sweden)

    Kaissar Yammine

    2017-01-01

    Full Text Available Being considered an exclusive human structure for a long time, fibularis tertius (FT is believed to have a secondary function of foot dorsiflexion and eversion. This study is an attempt to approach the issue from an anatomical perspective. A systematic literature search identified 35 studies (7601 legs which met the inclusion criteria. The weighted results of FT presence were as follows: an “adult cadaveric” frequency of 93.2% and a clinical frequency of 80%. The most common FT origin and insertion sites were the distal half of fibula and the base of the 5th metatarsal, respectively. In 95% of cases, an accessory fibular muscle was detected when FT was lacking. We demonstrated that the discrepancy found between the adult cadaveric and clinical frequency values would point out a probable bias in interpreting previous kinesiological results. On an evolutionary level, comparative anatomy demonstrated a very low FT prevalence among monkeys while reaching a frequency of 30% in gorillas, the only non-human apes having an almost exclusive terrestrial locomotion. The consistent prevalence among humans and the presence of similar functional muscles when it is missing would support an essential role of FT during the phylogenetic development of the erect bipedal posture and probably during gait.

  16. Effectiveness of human amnion as a graft material in lower anterior ridge vestibuloplasty: a clinical study.

    Science.gov (United States)

    Sharma, Yogesh; Maria, Anisha; Kaur, Preeti

    2011-12-01

    The aim of this study is to evaluate the clinical use of amnion as a biodegradable graft material for lower anterior ridge vestibuloplasty. Ten patients who had been referred for preprosthetic surgery underwent mandibular anterior ridge vestibuloplasty using Clark's technique and amniotic membrane as a graft material. Preoperative vestibular depth was measured. Fresh amniotic membrane was placed in the surgical site and sutured with 4-0 vicryl. In all ten cases suction catheter stent was used and was secured in the depth of the vestibule by using 1-0 mersilk percutaneous sutures. Vestibular depths were measured using a divider and a scale. Post operative measurements were taken at the end of 10th day, 1st month and 3rd month. And an average gain of 4-6 mm in the depth of the labial vestibule was noted. Amniotic membrane can be a favorable graft material for vestibuloplasty, promoting healing and preventing relapse. It is easily available and preserved and a cost effective material.

  17. [Pseudo-tumoral human African trypanosomiasis due to Trypanosoma gambiense. Clinical and tomodensitometry study (author's transl)].

    Science.gov (United States)

    Poisson, M; Bleibel, J M; Regnier, A; Mashaly, R; Le Bigot, P; Danis, M; Buge, A

    The authors report an observation of african trypanosomiasis due to Trypanosoma Gambiense, clinical signs included massive and progressive hemiplegia, papillary edema and vascular shift from median line at arteriography. These pseudo tumoral clinical features are unusual in this disease. Asymetrical heterogenous hypodensities of the centrum semioval are dominant in the initial CT scanner aspect. The confrontation of CT scanner images to the clinical and evolutive data suggests the presence of associated cerebral edema and demyelination. With treatment, hypodensities were regressing while images of subcortical atrophy appeared. Lastly, in spite of severe general signs and the importance of neurological deficit, arsenical treatment associated with high doses of corticotherapy lead to a rapid improvement.

  18. Stem cell-based treatments against stroke: observations from human proof-of-concept studies and considerations regarding clinical applicability

    Directory of Open Access Journals (Sweden)

    Thorsten Roland Doeppner

    2014-10-01

    Full Text Available Ischemic stroke remains a heavy burden for industrialized countries. The only causal therapy is the recanalization of occluded vessels via thrombolysis, which due to a narrow time window still can be offered only to a minority of patients. Since the majority of patients continues to exhibit neurological deficits even following successful thrombolysis, restorative therapies are urgently needed that promote brain remodeling and repair once stroke injury has occurred. Due to their unique properties of action, stem cell-based strategies gained increasing interest during recent years. Using various stroke models in both rodents and primates, the transplantation of stem cells, namely of bone marrow derived mesenchymal stem cells (MSCs or neural progenitor cells (NPCs, has been shown to promote neurological recovery most likely via indirect bystander actions. In view of promising observations, clinical proof-of-concept studies are currently under way, in which effects of stem and precursor cells are evaluated in human stroke patients. In this review we summarize already published studies, which due to the broad experience in other medical contexts mostly employed bone marrow-derived MSCs by means of intravenous transplantation. With the overall number of clinical trials limited in number, only a fraction of these studies used non-treated control groups, and only single studies were adequately blinded. Despite these limitations, first promising results justify the need for more elaborate clinical trials in order to make stem cell transplantation a success for stroke treatment in the future.

  19. Implementing human factors in clinical practice

    Science.gov (United States)

    Timmons, Stephen; Baxendale, Bryn; Buttery, Andrew; Miles, Giulia; Roe, Bridget; Browes, Simon

    2015-01-01

    Objectives To understand whether aviation-derived human factors training is acceptable and useful to healthcare professionals. To understand whether and how healthcare professionals have been able to implement human factors approaches to patient safety in their own area of clinical practice. Methods Qualitative, longitudinal study using semi-structured interviews and focus groups, of a multiprofessional group of UK NHS staff (from the emergency department and operating theatres) who have received aviation-derived human factors training. Results The human factors training was evaluated positively, and thought to be both acceptable and relevant to practice. However, the staff found it harder to implement what they had learned in their own clinical areas, and this was principally attributed to features of the informal organisational cultures. Conclusions In order to successfully apply human factors approaches in hospital, careful consideration needs to be given to the local context and informal culture of clinical practice. PMID:24631959

  20. A MORPHOLOGICAL STUDY OF PONTICULI OF THE HUMAN ATLAS VERTEBRAE AND ITS CLINICAL SIGNIFICANCE

    Directory of Open Access Journals (Sweden)

    Md. Jawed Akhtar

    2015-12-01

    Full Text Available BACKGROUND: The first cervical vertebra, atlas plays a vital role in the movement of skull & neck. The anatomy of atlas is complex due to its three dimensional structure. There is a groove on superior surface of posterior arch of atlas for passage of 3rd part of vertebral artery and first cervical spinal nerve (suboccipital nerve. Sometimes the oblique ligament of atlas which is present at the lower border of posterior atlanto-occipital membrane may ossify and convert this groove into a foramen. This foramen may be complete or incomplete, which is commonly known as ponticulus posterior or retroarticular canal. In some cases a bony bridge also extends from lateral masses of atlas to the posterior root of transverse process and form an additional foramen through which vertebral artery travels which is known as ponticulus lateralis. The vertebral artery is prone to compression in its entire course between foramen transversarium and foramen magnum during extreme rotation movement of head & neck. This condition may be aggravated by the presence of these ponticuli & results in compromised blood flow and causes vertebrobasilar insufficiency presenting with dizziness, fainting, vertigo, transient diplopia & various neurological disturbances. AIMS & OBJECTIVES: To study the incidence of ponticulus posterior as well as lateralis on atlas vertebra in the population of Bihar and compare the incidence of such type of variation in atlases of various races of world. MATERIALS & METHODS: The present study was carried out on 118 (Male-62, Female-56 dried fully ossified adult human atlas of known sex for the presence of complete or incomplete ring for vertebral artery i.e. different ponticuli on the superior surface of the atlas vertebra. RESULTS: We observed 21.17% cases of ponticulus posterior in which 7.62% specimens had complete ring while 13.55% specimens had incomplete ring & ponticulus lateralis was reported only in 5.93% cases (unilateral: 2

  1. On improving human clinical trials to the level of animal ischemic stroke studies.

    Science.gov (United States)

    Stein, Donald G

    2015-04-01

    This is a response to Jickling and Sharp's paper discussing the near-complete failure of clinical trials for stroke interventions. While they propose a paradigm shift in the way preclinical research is conducted, I propose that it is clinical trial design that needs an overhaul. Clinical trials could be designed to reduce variance, prevent data entry errors, and encompass less ambitious enrollment criteria limited to fewer centers which have demonstrated expertise in the treatment of stroke (and TBI). Statistical fundamentalism is another soluble problem: clinical trial designs tend to address what is medically significant as opposed to what is primarily statistically significant. Adaptive Design is an alternative to current protocols that needs urgent consideration if we are to get through the Valley of Death between bench and bedside. Maybe it is time to change the clinical trial paradigm to adopt the precise modeling used in good laboratory research rather than asking scientists to give up well-established procedures for producing reliable and reproducible results.

  2. Actigraphy in human African trypanosomiasis as a tool for objective clinical evaluation and monitoring: a pilot study.

    Science.gov (United States)

    Njamnshi, Alfred K; Seke Etet, Paul F; Perrig, Stephen; Acho, Alphonse; Funsah, Julius Y; Mumba, Dieudonné; Muyembe, Jean-Jacques; Kristensson, Krister; Bentivoglio, Marina

    2012-01-01

    Human African trypanosomiasis (HAT) or sleeping sickness leads to a complex neuropsychiatric syndrome with characteristic sleep alterations. Current division into a first, hemolymphatic stage and second, meningoencephalitic stage is primarily based on the detection of white blood cells and/or trypanosomes in the cerebrospinal fluid. The validity of this criterion is, however, debated, and novel laboratory biomarkers are under study. Objective clinical HAT evaluation and monitoring is therefore needed. Polysomnography has effectively documented sleep-wake disturbances during HAT, but could be difficult to apply as routine technology in field work. The non-invasive, cost-effective technique of actigraphy has been widely validated as a tool for the ambulatory evaluation of sleep disturbances. In this pilot study, actigraphy was applied to the clinical assessment of HAT patients. Actigraphy was recorded in patients infected by Trypanosoma brucei gambiense, and age- and sex-matched control subjects. Simultaneous nocturnal polysomnography was also performed in the patients. Nine patients, including one child, were analyzed at admission and two of them also during specific treatment. Parameters, analyzed with user-friendly software, included sleep time evaluated from rest-activity signals, rest-activity rhythm waveform and characteristics. The findings showed sleep-wake alterations of various degrees of severity, which in some patients did not parallel white blood cell counts in the cerebrospinal fluid. Actigraphic recording also showed improvement of the analyzed parameters after treatment initiation. Nocturnal polysomnography showed alterations of sleep time closely corresponding to those derived from actigraphy. The data indicate that actigraphy can be an interesting tool for HAT evaluation, providing valuable clinical information through simple technology, well suited also for long-term follow-up. Actigraphy could therefore objectively contribute to the clinical

  3. Actigraphy in human African trypanosomiasis as a tool for objective clinical evaluation and monitoring: a pilot study.

    Directory of Open Access Journals (Sweden)

    Alfred K Njamnshi

    Full Text Available Human African trypanosomiasis (HAT or sleeping sickness leads to a complex neuropsychiatric syndrome with characteristic sleep alterations. Current division into a first, hemolymphatic stage and second, meningoencephalitic stage is primarily based on the detection of white blood cells and/or trypanosomes in the cerebrospinal fluid. The validity of this criterion is, however, debated, and novel laboratory biomarkers are under study. Objective clinical HAT evaluation and monitoring is therefore needed. Polysomnography has effectively documented sleep-wake disturbances during HAT, but could be difficult to apply as routine technology in field work. The non-invasive, cost-effective technique of actigraphy has been widely validated as a tool for the ambulatory evaluation of sleep disturbances. In this pilot study, actigraphy was applied to the clinical assessment of HAT patients.Actigraphy was recorded in patients infected by Trypanosoma brucei gambiense, and age- and sex-matched control subjects. Simultaneous nocturnal polysomnography was also performed in the patients. Nine patients, including one child, were analyzed at admission and two of them also during specific treatment. Parameters, analyzed with user-friendly software, included sleep time evaluated from rest-activity signals, rest-activity rhythm waveform and characteristics. The findings showed sleep-wake alterations of various degrees of severity, which in some patients did not parallel white blood cell counts in the cerebrospinal fluid. Actigraphic recording also showed improvement of the analyzed parameters after treatment initiation. Nocturnal polysomnography showed alterations of sleep time closely corresponding to those derived from actigraphy.The data indicate that actigraphy can be an interesting tool for HAT evaluation, providing valuable clinical information through simple technology, well suited also for long-term follow-up. Actigraphy could therefore objectively contribute to

  4. Distinguishing malaria and influenza: early clinical features in controlled human experimental infection studies.

    Science.gov (United States)

    Lillie, Patrick J; Duncan, Christopher J A; Sheehy, Susanne H; Meyer, Joel; O'Hara, Geraldine A; Gilbert, Sarah C; Hill, Adrian V S

    2012-07-01

    During the H1N1 influenza pandemic (pH1N1/09) diagnostic algorithms were developed to guide antiviral provision. However febrile illnesses are notoriously difficult to distinguish clinically. Recent evidence highlights the importance of incorporating travel history into diagnostic algorithms to prevent the catastrophic misdiagnosis of life-threatening infections such as malaria. We applied retrospectively the UK pH1N1/09 case definition to a unique cohort of healthy adult volunteers exposed to Plasmodium falciparum malaria or influenza to assess the predictive value of this case definition, and to explore the distinguishing clinical features of early phase infection with these pathogens under experimental conditions. For influenza exposure the positive predictive value of the pH1N1/09 case definition was only 0.38 (95% CI: 0.06-0.60), with a negative predictive value of 0.27 (95% CI: 0.02-0.51). Interestingly, 8/11 symptomatic malaria-infected adults would have been inappropriately classified with influenza by the pH1N1/09 case definition, while 5/8 symptomatic influenza-exposed volunteers would have been classified without influenza (P = 0.18 Fisher's exact). Cough (P = 0.005) and nasal symptoms (P = 0.001) were the only clinical features that distinguished influenza-exposed from malaria-exposed volunteers. An open mind regarding the clinical cause of undifferentiated febrile illness, particularly in the absence of upper respiratory tract symptoms, remains important even during influenza pandemic settings. These data support incorporating travel history into pandemic algorithms.

  5. DNA vaccines targeting human papillomavirus-associated diseases: progresses in animal and clinical studies

    OpenAIRE

    Han, Kyusun Torque; Sin, Jeong-Im

    2013-01-01

    Human papillomavirus (HPV) infection is a major cause of cervical cancer and its precancerous diseases. Cervical cancer is the second deadliest cancer killer among women worldwide. Moreover, HPV is also known to be a causative agent of oral, pharyngeal, anal and genital cancer. Recent application of HPV structural protein (L1)-targeted prophylactic vaccines (Gardasil® and Cervarix®) is expected to reduce the incidence of HPV infection and cervical cancer, and possibly other HPV-associated can...

  6. Magnetic resonance imaging tracking of ferumoxytol-labeled human neural stem cells: studies leading to clinical use.

    Science.gov (United States)

    Gutova, Margarita; Frank, Joseph A; D'Apuzzo, Massimo; Khankaldyyan, Vazgen; Gilchrist, Megan M; Annala, Alexander J; Metz, Marianne Z; Abramyants, Yelena; Herrmann, Kelsey A; Ghoda, Lucy Y; Najbauer, Joseph; Brown, Christine E; Blanchard, M Suzette; Lesniak, Maciej S; Kim, Seung U; Barish, Michael E; Aboody, Karen S; Moats, Rex A

    2013-10-01

    Numerous stem cell-based therapies are currently under clinical investigation, including the use of neural stem cells (NSCs) as delivery vehicles to target therapeutic agents to invasive brain tumors. The ability to monitor the time course, migration, and distribution of stem cells following transplantation into patients would provide critical information for optimizing treatment regimens. No effective cell-tracking methodology has yet garnered clinical acceptance. A highly promising noninvasive method for monitoring NSCs and potentially other cell types in vivo involves preloading them with ultrasmall superparamagnetic iron oxide nanoparticles (USPIOs) to enable cell tracking using magnetic resonance imaging (MRI). We report here the preclinical studies that led to U.S. Food and Drug Administration approval for first-in-human investigational use of ferumoxytol to label NSCs prior to transplantation into brain tumor patients, followed by surveillance serial MRI. A combination of heparin, protamine sulfate, and ferumoxytol (HPF) was used to label the NSCs. HPF labeling did not affect cell viability, growth kinetics, or tumor tropism in vitro, and it enabled MRI visualization of NSC distribution within orthotopic glioma xenografts. MRI revealed dynamic in vivo NSC distribution at multiple time points following intracerebral or intravenous injection into glioma-bearing mice that correlated with histological analysis. Preclinical safety/toxicity studies of intracerebrally administered HPF-labeled NSCs in mice were also performed, and they showed no significant clinical or behavioral changes, no neuronal or systemic toxicities, and no abnormal accumulation of iron in the liver or spleen. These studies support the clinical use of ferumoxytol labeling of cells for post-transplant MRI visualization and tracking.

  7. Ultrastructural study of the mycelial phase of clinical isolates of Sporothrix schenckii obtained from feline, canine and human cases of sporotrichosis

    Directory of Open Access Journals (Sweden)

    Isabel Martins Madrid

    2011-09-01

    Full Text Available Using transmission electron microscopy, we studied the presence of melanin and cell wall thickness of clinical isolates of Sporothrix schenckii obtained from cats, dogs and humans as compared to reference strains. We detected differences regarding presence of the melanin among the clinical isolates of S. schenckii and a correlation between presence of melanin and cell wall thickness.

  8. In vitro study of RRS HA injectable mesotherapy/biorevitalization product on human skin fibroblasts and its clinical utilization

    Directory of Open Access Journals (Sweden)

    Deglesne PA

    2016-02-01

    Full Text Available Pierre-Antoine Deglesne,* Rodrigo Arroyo,* Evgeniya Ranneva, Philippe Deprez Research and Development, SKIN TECH PHARMA GROUP, Castelló d'Empúries, Spain  *These authors contributed equally to this work Abstract: Mesotherapy/biorevitalization with hyaluronic acid (HA is a treatment approach currently used for skin rejuvenation. Various products with a wide range of polycomponent formulations are available on the market. Most of these formulations contain noncross-linked HA in combination with a biorevitalization cocktail, formed by various amounts of vitamins, minerals, amino acids, nucleotides, coenzymes, and antioxidants. Although ingredients are very similar among the different products, in vitro and clinical effects may vary substantially. There is a real need for better characterization of these products in terms of their action on human skin or in vitro skin models. In this study, we analyzed the effect of the RRS® (Repairs, Refills, Stimulates HA injectable medical device on human skin fibroblasts in vitro. Skin fibroblast viability and its capacity to induce the production of key extracellular matrix were evaluated in the presence of different concentrations of RRS HA injectable. Viability was evaluated through colorimetric MTT (3-[4,5-dimethylthiazol-2-yl]-2,5 diphenyl tetrazolium bromide assay, and key extracellular matrix genes, type I collagen and elastin, were quantified by quantitative polymerase chain reaction. Results demonstrated that RRS HA injectable could promote human skin fibroblast viability (+15% and increase fibroblast gene expression of type I collagen and elastin by 9.7-fold and 14-fold in vitro, respectively. These results demonstrate that mesotherapy/biorevitalization products can, at least in vitro, effectively modulate human skin fibroblasts.Keywords: mesotherapy, medical device, RRS, collagen, elastin, extracellular matrix

  9. [Epidemiological and clinical characteristics of infants admitted to hospital due to human parechovirus infections: A prospective study in Spain].

    Science.gov (United States)

    Martín Del Valle, Fernando; Calvo, Cristina; Martinez-Rienda, Inés; Cilla, Amaia; Romero, María P; Menasalvas, Ana Isabel; Reis-Iglesias, Leticia; Roda, Diana; Pena, María J; Rabella, Nuria; Portugués de la Red, María Del Mar; Megías, Gregoria; Moreno-Docón, Antonio; Otero, Almudena; Cabrerizo, María

    2017-03-29

    Human parechovirus (HPeV) is one of the recently described picornaviridae viruses that have been associated with fever of unknown origin (FUO), clinical sepsis, gastroenteritis, meningitis, or encephalitis in very young infants. The aim of this study is to describe the epidemiology and clinical features of these viruses. A prospective multicentre 3-year study was conducted in 12 hospitals in Spain. Out of 850 specimens examined, 47 were positive (5.52%), with HPeV-3 being the most frequent (29 cases). Infections occurred throughout the year, but mainly in May and July, and a biennial distribution was observed. More than half (57%) were neonates, and only 2 children were older than 3 months. Fever was present in all children, with irritability in 45%, rash in 18.6%, and diarrhoea in 14%. The results of biochemical tests were all in normal range. The most common final diagnosis was FUO (61%), followed by clinical sepsis (29%). Up to 29% of infants were admitted to the intensive care unit, but only one patient had sequelae. Out of 850 specimens examined, 47 were positive (5.52%) for HPeV, with HPeV-3 being the most frequent (29 cases). Infections occurred throughout the year, but mainly in May and July, and a biennial distribution was observed. More than half (57%) were neonates, and only 2 children were older than 3 months. Fever was present in all children, with irritability in 45%, rash in 18.6%, and diarrhoea in 14%. The results of biochemical tests were all in normal range. The most common final diagnosis was FUO (61%), followed by clinical sepsis (29%). Up to 29% of infants were admitted to the intensive care unit, but only one patient had sequelae CONCLUSIONS: HPeV circulates in our country, mainly during spring and summer, and affects young infants with a FUO and clinical sepsis. Molecular diagnostic techniques in all hospitals could help in improving the management of patients with these infections. Copyright © 2017. Publicado por Elsevier España, S.L.U.

  10. Light penetration in the human prostate: a whole prostate clinical study at 763 nm

    Science.gov (United States)

    Moore, Caroline M.; Mosse, C. Alexander; Allen, Clare; Payne, Heather; Emberton, Mark; Bown, Stephen G.

    2011-01-01

    Photodynamic therapy (PDT) is being investigated as a treatment for localized prostate cancer. Photodynamic therapy uses a photosensitizing drug which is activated by a specific wavelength of light, in the presence of oxygen. The activated drug reacts with tissue oxygen to produce reactive oxygen species which are responsible for localized tissue necrosis. One of the determinants of the PDT effect is the penetration of light in the prostate. This study assesses the penetration depth of 763 nm light throughout the prostate. Eight men undergoing multiple hollow needle insertion for high dose rate brachytherapy were recruited. 763 nm light, produced by a diode laser, was delivered to the prostate using cylindrically diffusing optical fibers within the plastic needles. Light was detected at different distances from the source, using an isotropic detector within nearby needles. Penetration depth was calculated using the Boltzmann approximation to the diffusion equation. Delivery detector fiber separation was measured on computed tomography. The mean penetration depth was 0.57 cm, but there was within patient variation of a mean factor of 4.3. Further work is ongoing to assess the effect of such variability in light penetration, on the PDT effect.

  11. Does enriched acoustic environment in humans abolish chronic tinnitus clinically and electrophysiologically? A double blind placebo controlled study.

    Science.gov (United States)

    Vanneste, Sven; van Dongen, Marijn; De Vree, Bjorn; Hiseni, Senad; van der Velden, Eddy; Strydis, Christos; Joos, Kathleen; Norena, Arnaud; Serdijn, Wouter; De Ridder, Dirk

    2013-02-01

    Animal research has shown that loss of normal acoustic stimulation can increase spontaneous firing in the central auditory system and induce cortical map plasticity. Enriched acoustic environment after noise trauma prevents map plasticity and abolishes neural signs of tinnitus. In humans, the tinnitus spectrum overlaps with the area of hearing loss. Based on these findings it can be hypothesized that stimulating the auditory system by presenting music compensating specifically for the hearing loss might also suppress chronic tinnitus. To verify this hypothesis, a study was conducted in three groups of tinnitus patients. One group listened just to unmodified music (i.e. active control group), one group listened to music spectrally tailored to compensate for their hearing loss, and a third group received music tailored to overcompensate for their hearing loss, associated with one (in presbycusis) or two notches (in audiometric dip) at the edge of hearing loss. Our data indicate that applying overcompensation to the hearing loss worsens the patients' tinnitus loudness, the tinnitus annoyance and their depressive feelings. No significant effects were obtained for the control group or for the compensation group. These clinical findings were associated with an increase in current density within the left dorsal anterior cingulate cortex in the alpha2 frequency band and within the left pregenual anterior cingulate cortex in beta1 and beta2 frequency band. In addition, a region of interest analysis also demonstrated an associated increase in gamma band activity in the auditory cortex after overcompensation in comparison to baseline measurements. This was, however, not the case for the control or the compensation groups. In conclusion, music therapy compensating for hearing loss is not beneficial in suppressing tinnitus, and overcompensating hearing loss actually worsens tinnitus, both clinically and electrophysiologically.

  12. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Children & Clinical Studies NHLBI Trials Clinical Trial Websites Children and Clinical Studies Learn more about Children and Clinical Studies Importance of Children in Clinical Studies Children have often had to ...

  13. International Conference on Harmonisation; Guidance on M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals; availability. Notice.

    Science.gov (United States)

    2010-01-21

    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance, which is a revision of an existing guidance, discusses the types of nonclinical studies, their scope and duration, and their relation to the conduct of human clinical trials and marketing authorization for pharmaceuticals. The guidance is intended to facilitate the timely conduct of clinical trials and reduce the unnecessary use of animals and other drug development resources.

  14. Comparative case control study of clinical features and human leukocyte antigen susceptibility between familial and nonfamilial vitiligo

    Directory of Open Access Journals (Sweden)

    Misri Rachita

    2009-01-01

    Full Text Available Background: Various studies worldwide suggest that human leukocyte antigen (HLA region may be involved in the genetic susceptibility of vitiligo but little information is available from India. Aim: To find the HLA associated susceptibility to develop vitiligo in Indian patients and to detect role of HLA in familial vitiligo. Methods: This was a case controlled study which included all patients suffering from vitiligo over a period of one and half years. Clinical details were noted and sera collected from these patients were screened for the presence of HLA class I antibodies. The clinical features and HLA antigens were assessed and comparison was made between patients with familial and nonfamilial vitiligo. Results: Out of 114 patients studied, 84 had family history and 30 had no family history. Patients with family history of vitiligo have higher chances of acquiring vitiligo if first degree relatives are affected compared to if second degree relatives are affected. Family history of vitiligo is associated with an early onset of vitiligo (< 20 years. There was no statistically significant difference in the type, stability, and severity of vitiligo in both the groups. HLA results in both the groups revealed increase in HLA A2, A11, A31, A33, B17, B35, B40, and B44 alleles while HLA A9, B13, and B53 alleles were decreased. Family history was associated with HLA A2, A28, A31, and B44 alleles. Early onset of vitiligo (< 20 years was significantly associated with HLA A2, A11, B17, B35, and B44 alleles. The patients with severe affection (> 10% area showed in significant association with HLA A10 and B8. Conclusion: Family history of vitiligo is associated with an early onset of vitiligo. There is no correlation of family history with the type of vitiligo, stability of lesions, and areas involved. Severity is not associated with family history. Apart from other alleles, alleles A2, and B44 play a significant role in vitiligo in the Indian patients.

  15. [Human papillomavirus infection and its correlates with clinically relevant gynecological and obstetric conditions: A cross-sectional study].

    Science.gov (United States)

    López-Hernández, Daniel; Beltrán-Lagunes, Luis; Brito-Aranda, Leticia; López-Hernández, Maria de la Luz

    2016-08-05

    To analyze the prevalence of human papillomavirus (HPV) infection and the possible epidemiological association with conditions of clinical relevance in women. A cross-sectional study from Mexico City was conducted from January 2012 to December 2014. HPV molecular detection was performed on cervical samples. Data were analyzed with appropriated statistic tests. A total of 1,604 females (median 47, interquartile range 38-54) were analyzed. Global prevalence of infection for any HPV is 9.91% (95% CI 8.6-11.3). An association between infection with 16-HPV and number of abortions (NA) (OR=1.427; 95% CI 1.091-1.866), by univariate regression model (UVRM) was estimated. Moreover, menarche (OR=1.566; 95% CI 1.079-2.272), NA (OR=1.570; 95% CI 1.106-2.227) and number of pregnancies (NP) (OR=0.461; 95% CI 0.260-0.818) have a direct and inverse association with infection by genotype 18 of HPV, respectively. Also, infection with HR-HPV genotypes has an inverse association with NP (OR=0.791; 95% CI 0.707-0.884) by normal labor (OR=0.867; 95% CI 0.767-0.979) and NA (OR=0.715; 95% CI 0.534-0.959) (UVRM), and a direct association with number of sexual partners (OR=1.082; 95% CI 1.015-1.154). Onset of sexual activity has an inverse association with infection by genotype 16- (UVRM: OR=0.814; 95% CI 0.715-0.926; multinomial regression model (MNRM): OR=0.803; 95% CI 0.702-0.918) and HR-HPV (UVRM: OR=0.933; 95% CI 0.889-0.980, and MNRM: OR=0.912; 95% CI 0.867-0.959), all P values were lower than .03. Prevalence of HPV cervical infection is different according to age and it is associated with several medical conditions of clinical relevance in women. Copyright © 2016 Elsevier España, S.L.U. All rights reserved.

  16. Missing osteoconductive effect of a resorbable PEO/PBT copolymer in human bone defects: a clinically relevant pilot study with contrary results to previous animal studies.

    Science.gov (United States)

    Roessler, M; Wilke, A; Griss, P; Kienapfel, H

    2000-01-01

    PEO/PBT 70/30 (POLYACTIVE(R) 70/30), a degradable porous copolymer with elastic properties, was found to be osteoconductive in many animal studies. The aim of this study was to determine the osteoconductive effect in a human paired control iliac defect model. In seven patients undergoing anterior spinal interbody fusion surgery, two bicortical iliac defects for autograft harvesting were created. The defect size was identical for both defects measuring about 40 x 15 mm (group I). One defect was filled with the degradable implants, whereas the remaining one was left untreated as a control. The defect site for treatment was chosen randomly. In three further patients, only one defect measuring about 40 x 35 mm was created (group II). All patients were examined clinically and radiologically by spiral-CT after 1, 6, 12, 24, and 52 weeks. Three-dimensional reconstructions as well as CT-volumetric measurements using 1 mm sections were used as evaluation methods. In group I, a two-tailed paired t-test showed that the treated defects had significantly less formation of new bone than the untreated ones (p < 0.05 after 12 weeks, p < 0.01 after 52 weeks). Also, in group II, not much bone ingrowth could be observed. The histological evaluation of one patient in group I revealed no bone within the pores, and a fibrous layer between bone and implant was always present. Therefore, PEO/PBT 70/30 cannot be recommended as a bone substitute for clinical use. Differences in bone regeneration between humans and certain animal species as well as inapplicable defect models in previous animal studies are discussed as possible reasons for the failure.

  17. Quality assurance for accuracy of anthropometric measurements in clinical and epidemiological studies [Errare humanum est = to err is human

    Directory of Open Access Journals (Sweden)

    Prem K Mony

    2016-01-01

    Full Text Available Anthropometry involves the external measurement of morphologic traits of human beings. High quality anthropometric measurements are fundamental to clinical and epidemiological research. The measurements for each method have inherent variations, either due to biologic variation or due to error in measurement. Errors in measurement cannot be avoided completely but they can be minimized to a large extent. We define methods to estimate measurement error in anthropometry, offer guidelines for acceptable error, and suggest ways to minimize measurement error; thereby improving anthropometry quality in health assessments. We propose that special attention be paid to the following six key parameters for quality assurance of anthropometric measurements: (i Identification of certified lead anthropometrist and trainer, (ii manual of standard operating procedures, (iii choice of robust equipment, (iv equipment calibration, (v standardization training and certification, and (vi measurements resampling.

  18. Quality Assurance for Accuracy of Anthropometric Measurements in Clinical and Epidemiological Studies: [Errare humanum est = to err is human].

    Science.gov (United States)

    Mony, Prem K; Swaminathan, Sumathi; Gajendran, Jayachitra K; Vaz, Mario

    2016-01-01

    Anthropometry involves the external measurement of morphologic traits of human beings. High quality anthropometric measurements are fundamental to clinical and epidemiological research. The measurements for each method have inherent variations, either due to biologic variation or due to error in measurement. Errors in measurement cannot be avoided completely but they can be minimized to a large extent. We define methods to estimate measurement error in anthropometry, offer guidelines for acceptable error, and suggest ways to minimize measurement error; thereby improving anthropometry quality in health assessments. We propose that special attention be paid to the following six key parameters for quality assurance of anthropometric measurements: (i) Identification of certified lead anthropometrist and trainer, (ii) manual of standard operating procedures, (iii) choice of robust equipment, (iv) equipment calibration, (v) standardization training and certification, and (vi) measurements resampling.

  19. Prolactinomas : clinical studies

    NARCIS (Netherlands)

    Kars, Marleen

    2008-01-01

    Prolactinoma are treated with dopamine agonists, which are effective in reducing prolactin and tumor size. Studies reporting clinical and radiological outcome are scarce. The study described in chapter 2, assesses long-term outcome in patients treated with dopamine agonists for macroprolactinoma. An

  20. Prolactinomas : clinical studies

    NARCIS (Netherlands)

    Kars, Marleen

    2008-01-01

    Prolactinoma are treated with dopamine agonists, which are effective in reducing prolactin and tumor size. Studies reporting clinical and radiological outcome are scarce. The study described in chapter 2, assesses long-term outcome in patients treated with dopamine agonists for macroprolactinoma. An

  1. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... Guidelines Resources Continuing Education Researchers Funding Training & Career Development Division of Intramural Research Research Resources Research Meeting Summaries Technology Transfer Clinical Trials What Are Clinical Trials? Children & Clinical Studies NHLBI Trials Clinical Trial Websites News & ...

  2. Determination of roxatidine in human plasma by liquid chromatography/electrospray mass spectrometry and application to a clinical pharmacokinetic study.

    Science.gov (United States)

    Shin, Beom Soo; Choi, Jin Won; Balthasar, Joseph P; Hong, Deok Ki; Kim, Jung Jun; Yoo, Sun Dong

    2007-01-01

    A rapid and sensitive liquid chromatography/mass spectrometry (LC/MS) method was developed and validated for the determination of roxatidine in human plasma. Roxatidine was extracted by single liquid-liquid extraction with tert-butyl methyl ether, and the chromatographic separation was performed on a C8 column. The total analytical run time was relatively short (5 min), and the limit of assay quantification was 2 ng/mL using 0.1 mL of human plasma. Roxatidine and the internal standard, propranolol, were monitored in selected ion monitoring (SIM) mode at m/z 307.3 and 260.3, respectively. The standard curve was linear over a concentration range from 2-500 ng/mL, and the correlation coefficients were >0.999. The mean intra- and inter-day assay accuracy ranged from 103.4-108.8% and 102.3-110.0%, respectively, and the mean intra- and inter-day precision was between 3.3-8.8% and 5.3-6.2%, respectively. The developed assay method was successfully applied to a pharmacokinetic study in human volunteers after oral administration of roxatidine acetate hydrochloride at a dose of 75 mg.

  3. Clinical science and human behavior.

    Science.gov (United States)

    Plaud, J J

    2001-09-01

    The debate between mentalism/cognitivism and behaviorism is analyzed, and it is concluded that behaviorism is the philosophy more closely associated with psychology as a behavioral science, the cognitive approach being more closely aligned with biological science. Specific objections to mentalistic interpretations of behavioral phenomena are detailed, and examples from clinical psychology are used to show the importance of behavioral approaches in applied domains. It is argued that the relation between behavior theory and clinical psychology is critical to the continued advancement of applied psychology. Behavior analysis is offered as a direct, applied extension of behavior theory as well as a highly practical and effective approach for understanding, explaining, and modifying the factors that contribute to and maintain maladaptive behaviors.

  4. Bovine pericardium based non-cross linked collagen matrix for successful root coverage, a clinical study in human

    Directory of Open Access Journals (Sweden)

    Schlee Markus

    2012-03-01

    Full Text Available Abstract Introduction The aim of this study was to clinically assess the capacity of a novel bovine pericardium based, non-cross linked collagen matrix in root coverage. Methods 62 gingival recessions of Miller class I or II were treated. The matrix was adapted underneath a coronal repositioned split thickness flap. Clinical values were assessed at baseline and after six months. Results The mean recession in each patient was 2.2 mm at baseline. 6 Months after surgery 86.7% of the exposed root surfaces were covered. On average 0,3 mm of recession remained. The clinical attachment level changed from 3.5 ± 1.3 mm to 1,8 ( ± 0,7 mm during the observational time period. No statistically significant difference was found in the difference of probing depth. An increase in the width of gingiva was significant. With a baseline value of 1.5 ± 0.9 mm an improvement of 2.4 ± 0.8 mm after six month could be observed. 40 out of 62 recessions were considered a thin biotype at baseline. After 6 months all 62 sites were assessed thick. Conclusions The results demonstrate the capacity of the bovine pericardium based non-cross linked collagen matrix for successful root coverage. This material was able to enhance gingival thickness and the width of keratinized gingiva. The percentage of root coverage achieved thereby is comparable to existing techniques. This method might contribute to an increase of patient's comfort and an enhanced aesthetical outcome.

  5. Bovine pericardium based non-cross linked collagen matrix for successful root coverage, a clinical study in human

    Science.gov (United States)

    2012-01-01

    Introduction The aim of this study was to clinically assess the capacity of a novel bovine pericardium based, non-cross linked collagen matrix in root coverage. Methods 62 gingival recessions of Miller class I or II were treated. The matrix was adapted underneath a coronal repositioned split thickness flap. Clinical values were assessed at baseline and after six months. Results The mean recession in each patient was 2.2 mm at baseline. 6 Months after surgery 86.7% of the exposed root surfaces were covered. On average 0,3 mm of recession remained. The clinical attachment level changed from 3.5 ± 1.3 mm to 1,8 ( ± 0,7) mm during the observational time period. No statistically significant difference was found in the difference of probing depth. An increase in the width of gingiva was significant. With a baseline value of 1.5 ± 0.9 mm an improvement of 2.4 ± 0.8 mm after six month could be observed. 40 out of 62 recessions were considered a thin biotype at baseline. After 6 months all 62 sites were assessed thick. Conclusions The results demonstrate the capacity of the bovine pericardium based non-cross linked collagen matrix for successful root coverage. This material was able to enhance gingival thickness and the width of keratinized gingiva. The percentage of root coverage achieved thereby is comparable to existing techniques. This method might contribute to an increase of patient's comfort and an enhanced aesthetical outcome. PMID:22390875

  6. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... about Children and Clinical Studies Importance of Children in Clinical Studies Children have often had to accept ... treatments based on what is known to work in adults. To improve clinical care of children, more ...

  7. Review of In Vivo Bone Strain Studies and Finite Element Models of the Zygomatic Complex in Humans and Nonhuman Primates: Implications for Clinical Research and Practice.

    Science.gov (United States)

    Prado, Felippe Bevilacqua; Freire, Alexandre Rodrigues; Cláudia Rossi, Ana; Ledogar, Justin A; Smith, Amanda L; Dechow, Paul C; Strait, David S; Voigt, Tilman; Ross, Callum F

    2016-12-01

    The craniofacial skeleton is often described in the clinical literature as being comprised of vertical bony pillars, which transmit forces from the toothrow to the neurocranium as axial compressive stresses, reinforced transversely by buttresses. Here, we review the literature on bony microarchitecture, in vivo bone strain, and finite-element modeling of the facial skeleton of humans and nonhuman primates to address questions regarding the structural and functional existence of facial pillars and buttresses. Available bone material properties data do not support the existence of pillars and buttresses in humans or Sapajus apella. Deformation regimes in the zygomatic complex emphasize bending and shear, therefore conceptualizing the zygomatic complex of humans or nonhuman primates as a pillar obscures its patterns of stress, strain, and deformation. Human fossil relatives and chimpanzees exhibit strain regimes corroborating the existence of a canine-frontal pillar, but the notion of a zygomatic pillar has no support. The emerging consensus on patterns of strain and deformation in finite element models (FEMs) of the human facial skeleton corroborates hypotheses in the clinical literature regarding zygomatic complex function, and provide new insights into patterns of failure of titanium and resorbable plates in experimental studies. It is suggested that the "pillar and buttress" model of human craniofacial skeleton function be replaced with FEMs that more accurately and precisely represent in vivo function, and which can serve as the basis for future research into implants used in restoration of occlusal function and fracture repair. Anat Rec, 299:1753-1778, 2016. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  8. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... of Intramural Research Research Resources Research Meeting Summaries Technology Transfer Clinical Trials What Are Clinical Trials? Children & ... Clinical Studies Children have often had to accept medicines and treatments based on what is known to ...

  9. Humanities, Digital Humanities, Media studies, Internet studies

    DEFF Research Database (Denmark)

    Brügger, Niels

    the interplay between four areas which until now to a certain extent have been separated: Traditional Hu- manities, Digital Humanities, Media studies, and Internet studies. The vision is followed by an outline of how it can be unfolded in concrete activities, in the form of research projects, research...

  10. A study on the incidence of retromolar foramen in South Indian adult dried human mandibles and its clinical relevance

    Directory of Open Access Journals (Sweden)

    Suman Tiwari

    2015-06-01

    Full Text Available Background: The retromolar foramen is one of the most important non-metrical anatomical variants in the mandible. The present study describes the incidence of retromolar foramen in South Indian adult dried mandibles and its clinical relevance. Methods: One hundred South Indian adult dried mandibles of unknown sex were studied at the Department of Anatomy, MVJ Medical College, Bangalore for the presence of retromolar foramen. Its location, size, shape, distance of the foramen if present from the posterior border of socket for 3rd molar tooth, anterior border of ramus of the mandible were measured. Results: Retromolar foramen was present in 16 (16% of the mandibles. Out of the 16 mandibles, it was present bilaterally in 3 (3% mandibles and unilaterally in 13 (13% mandibles (In 3 (3% on the right side and in 10 (10% on the left side. The mean diameter of the foramen was 1.33mm (range - 1.10-1.92 mm. It was oval in shape in 9 (9% and rounded in shape in 7 (7% mandibles. The mean distance of retromolar foramen from the posterior border of socket for 3rd molar tooth and anterior border of ramus were 6.15 mm (2.23-12.10 and 8.02 mm (3.24-13.12 respectively. Conclusions: The knowledge about the incidence of the retromolar foramen is important for dental surgeons during various anaesthetic, implantation and surgical procedures of the mandible, especially during extraction of the lower last molar tooth. [Int J Res Med Sci 2015; 3(6.000: 1383-1387

  11. Humanities, Digital Humanities, Media studies, Internet studies

    DEFF Research Database (Denmark)

    Brügger, Niels

    the interplay between four areas which until now to a certain extent have been separated: Traditional Hu- manities, Digital Humanities, Media studies, and Internet studies. The vision is followed by an outline of how it can be unfolded in concrete activities, in the form of research projects, research......Todays expanding digital landscape constitutes an important research object as well as the research environment for the Humanities at the beginning of the 21st century. Taking this state of affairs as a starting point this inaugural lecture presents a vision for how the digital affects...

  12. Outcome of surgical treatment of peri-implantitis: results from a 2-year prospective clinical study in humans.

    Science.gov (United States)

    Serino, Giovanni; Turri, Alberto

    2011-11-01

    The aim of the present study was to evaluate the outcome of a surgical procedure based on pocket elimination and bone re-contouring for the treatment of peri-implantitis. The 31 subjects involved in this study presented clinical signs of peri-implantitis at one or more dental implants (i.e. ≥6 mm pockets, bleeding on probing and/or suppuration and radiographic evidence of ≥2 mm bone loss). The patients were treated with a surgical procedure based on pocket elimination and bone re-contouring and plaque control before and following the surgery. At the time of surgery, the amount of bone loss at implants was recorded. Two years following treatment, 15 (48%) subjects had no signs of peri-implant disease; 24 patients (77%) had no implants with a probing pocket depth of ≥6 mm associated with bleeding and/or suppuration following probing. A total of 36 implants (42%) out of the 86 with initial diagnosis of peri-implantitis presented peri-implant disease despite treatment. The proportion of implants that became healthy following treatment was higher for those with minor initial bone loss (2-4 mm bone loss as assessed during surgery) compared with the implants with a bone loss of ≥5 mm (74% vs. 40%). Among the 18 implants with bone loss of ≥7 mm, seven were extracted. Between the 6-month and the 2-year examination, healthy implants following treatment tended to remain stable, while deepening of pockets was observed for those implants with residual pockets. The results of this study indicated that a surgical procedure based on pocket elimination and bone re-contouring and plaque control before and following surgery was an effective therapy for treatment of peri-implantitis for the majority of subjects and implants. However, complete disease resolution at the site level seems to depend on the initial bone loss at implants. Implants with no signs of peri-implantitis following treatment tended to remain healthy during the 2-year period, while a tendency for disease

  13. Ridge preservation comparing socket allograft alone to socket allograft plus facial overlay xenograft: a clinical and histologic study in humans.

    Science.gov (United States)

    Poulias, Evmenios; Greenwell, Henry; Hill, Margaret; Morton, Dean; Vidal, Ricardo; Shumway, Brian; Peterson, Thomas L

    2013-11-01

    Previous studies of ridge preservation showed a loss of ≈18% or 1.5 mm of crestal ridge width in spite of treatment. The primary aim of this randomized, controlled, masked clinical trial is to compare a socket graft to the same treatment plus a buccal overlay graft, both with a polylactide membrane, to determine if loss of ridge width can be prevented by use of an overlay graft. Twelve patients who served as positive controls received an intrasocket mineralized cancellous allograft (socket group), and 12 patients received the same socket graft procedure plus buccal overlay cancellous xenograft (overlay group). Horizontal ridge dimensions were measured with a digital caliper, and vertical ridge changes were measured from a stent. Before implant placement, at 4 months, a trephine core was obtained for histologic analysis. The mean horizontal ridge width at the crest for the socket group decreased from 8.7 ± 1.0 to 7.1 ± 1.5 mm for a mean loss of 1.6 ± 0.8 mm (P overlay group decreased from 8.4 ± 1.4 to 8.1 ± 1.4 mm for a mean loss of 0.3 ± 0.9 mm (P >0.05). The overlay group was significantly different from the socket group (P overlay group had 40% ± 16% (P >0.05). The overlay treatment significantly prevented loss of ridge width and preserved or augmented the buccal contour. The socket and overlay groups healed with a high percentage of vital bone.

  14. Patient-specific finite-element simulation of the human cornea: a clinical validation study on cataract surgery.

    Science.gov (United States)

    Studer, Harald P; Riedwyl, Hansjörg; Amstutz, Christoph A; Hanson, James V M; Büchler, Philippe

    2013-02-22

    The planning of refractive surgical interventions is a challenging task. Numerical modeling has been proposed as a solution to support surgical intervention and predict the visual acuity, but validation on patient specific intervention is missing. The purpose of this study was to validate the numerical predictions of the post-operative corneal topography induced by the incisions required for cataract surgery. The corneal topography of 13 patients was assessed preoperatively and postoperatively (1-day and 30-day follow-up) with a Pentacam tomography device. The preoperatively acquired geometric corneal topography - anterior, posterior and pachymetry data - was used to build patient-specific finite element models. For each patient, the effects of the cataract incisions were simulated numerically and the resulting corneal surfaces were compared to the clinical postoperative measurements at one day and at 30-days follow up. Results showed that the model was able to reproduce experimental measurements with an error on the surgically induced sphere of 0.38D one day postoperatively and 0.19D 30 days postoperatively. The standard deviation of the surgically induced cylinder was 0.54D at the first postoperative day and 0.38D 30 days postoperatively. The prediction errors in surface elevation and curvature were below the topography measurement device accuracy of ±5μm and ±0.25D after the 30-day follow-up. The results showed that finite element simulations of corneal biomechanics are able to predict post cataract surgery within topography measurement device accuracy. We can conclude that the numerical simulation can become a valuable tool to plan corneal incisions in cataract surgery and other ophthalmosurgical procedures in order to optimize patients' refractive outcome and visual function.

  15. Unavoidable Human Errors of Tumor Size Measurement during Specimen Attachment after Endoscopic Resection: A Clinical Prospective Study

    Science.gov (United States)

    Mori, Hirohito; Kobara, Hideki; Tsushimi, Takaaki; Nishiyama, Noriko; Fujihara, Shintaro; Masaki, Tsutomu

    2015-01-01

    Objective Objective evaluation of resected specimen and tumor size is critical because the tumor diameter after endoscopic submucosal dissection affects therapeutic strategies. In this study, we investigated whether the true tumor diameter of gastrointestinal cancer specimens measured by flexible endoscopy is subjective by testing whether the specimen is correctly attached to the specimen board after endoscopic submucosal dissection resection and whether the size differs depending on the endoscopist who attached the specimen. Methods Seventy-two patients diagnosed with early gastric cancer who satisfied the endoscopic submucosal dissection expanded-indication guideline were enrolled. Three endoscopists were randomly selected before every endoscopic submucosal dissection. Each endoscopist separately attached the same resected specimen, measured the maximum resection diameter and tumor size, and removed the lesion from the attachment board. Results The resected specimen diameters of the 3 endoscopists were 44.5±13.9 mm (95% Confidence Interval (CI): 23–67), 37.4±12.0 mm (95% CI: 18–60), and 41.1±13.3 mm (95% CI: 20–63) mm. Comparison among 3 groups (Kruskal Wallis H- test), there were significant differences (H = 6.397, P = 0.040), and recorded tumor sizes were 38.3±13.1 mm (95% CI: 16–67), 31.1±11.2 mm (95% CI: 12.5–53.3), and 34.8±12.8 (95% CI: 11.5–62.3) mm. Comparison among 3 groups, there were significant differences (H = 6.917, P = 0.031). Conclusions Human errors regarding the size of attached resected specimens are unavoidable, but it cannot be ignored because it affects the patient’s additional treatment and/or surgical intervention. We must develop a more precise methodology to obtain accurate tumor size. Trial Registration University hospital Medical Information Network UMIN No. 000012915 PMID:25856397

  16. The human minor histocompatibility antigen HA-1 as target for stem cell based immunotherapy of cancer : pre-clinical and clinical studies

    NARCIS (Netherlands)

    Hambach, Lothar Wolfgang Heinrich

    2012-01-01

    Human leukocyte antigen (HLA) matched allogeneic stem cell transplantation (SCT) is an established curative treatment for hematopoietic malignancies and an investigative immunotherapeutic approach for solid tumors. The curative effect of allogeneic SCT is based on so called graft versus-tumor (GvT)

  17. Non-clinical immuno-toxicological evaluation of HER1 cancer vaccine in non-human primates: a 12-month study.

    Science.gov (United States)

    Barro, Ana M Bada; Rivero, Arianna Iglesias; Goñi, Avelina León; Navarro, Bárbara O González; Angarica, Meilis Mesa; Ramírez, Belinda Sánchez; Bedoya, Darel Martínez; Triana, Consuelo González; Rodríguez, Axel Mancebo; Parada, Ángel Casacó

    2012-12-17

    Human epidermal growth factor receptor (HER1) constitutes a tumor associated antigen. Its overexpression in many epithelial tumors has been associated with bad prognosis and poor survival. Cancer vaccine based on the extracellular domain (ECD) of HER1 and adjuvated in very small sized proteoliposomes (VSSP) and Montanide ISA 51-VG is a new and complementary approach for the treatment of epithelial tumors. The present study deals with the immunogenicity of this vaccine in Macaca fascicularis monkeys and evaluation of its toxicity during 12 months. Twelve monkeys were randomized into two groups of 3 animals per sex: control and vaccinated. Treated monkeys received 9 doses of vaccination and were daily inspected for clinical signs. Body weight, rectal temperature, cardiac and respiratory rates were measured during the study. Humoral immune response, clinical pathology parameters and delayed type hypensensitivity were analyzed. Skin biopsy was performed at the end of the study in all animals. Animal's survival in the study was 100% (n=12). Local reactions were observed at the administration site of four treated animals (n=6), with two showing slight inflammatory cutaneous damage. Clinical pathology parameters were not affected. HER1 vaccine induced high IgG antibodies titers in the treated animals even when DTH was not observed. The induced antibodies recognized HER1+ tumor cell lines, decreased HER1 phosphorylation and showed anti-proliferative and pro-apoptotic effects in H125 cells. In general the present study showed that HER1 vaccine induced specific immune response in M. fascicularis monkeys and was well tolerated, suggesting it could be safely used in clinical studies in epithelial cancer patients.

  18. Brincidofovir Is Not a Substrate for the Human Organic Anion Transporter 1: A Mechanistic Explanation for the Lack of Nephrotoxicity Observed in Clinical Studies

    Science.gov (United States)

    Morrison, Marion E.; Brundage, Thomas M.; Momméja-Marin, Hervé

    2016-01-01

    Background: Brincidofovir (BCV) is an orally bioavailable lipid conjugate of cidofovir (CDV) with increased in vitro potency relative to CDV against all 5 families of double-stranded DNA viruses that cause human disease. After intravenous (IV) administration of CDV, the organic anion transporter 1 (OAT1) transports CDV from the blood into the renal proximal tubule epithelial cells with resulting dose-limiting nephrotoxicity. Objective: To study whether OAT1 transports BCV and to evaluate the pharmacokinetic and renal safety profile of oral BCV compared with IV CDV. Methods: The cellular uptake of BCV and its major metabolites was assessed in vitro. Renal function at baseline and during and after treatment in subjects in BCV clinical studies was examined. Results: In OAT1-expressing cells, uptake of BCV and its 2 major metabolites (CMX103 and CMX064) was the same as in mock-transfected control cells and was not inhibited by the OAT inhibitor probenecid. In human pharmacokinetic studies, BCV administration at therapeutic doses resulted in detection of CDV as a circulating metabolite; peak CDV plasma concentrations after oral BCV administration in humans were <1% of those observed after IV CDV administration at therapeutic doses. Analysis of renal function and adverse events from 3 BCV clinical studies in immunocompromised adult and pediatric subjects indicated little to no evidence of associated nephrotoxicity. Over 80% of subjects who switched from CDV or foscarnet to BCV experienced an improvement in renal function as measured by maximum on-treatment estimated glomerular filtration rate. Conclusions: The lack of BCV uptake through OAT1, together with lower CDV concentrations after oral BCV compared with IV CDV administration, likely explains the superior renal safety profile observed in immunocompromised subjects receiving BCV compared with CDV. PMID:27851688

  19. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... of Intramural Research Research Resources Research Meeting Summaries Technology Transfer Clinical Trials What Are Clinical Trials? Children & ... the general public. Last Updated: August 3, 2015 Resources Educational Website - English / Spanish ... FEAR ACT OIG CONTACT US National Institutes of Health Department of Health and Human Services USA.gov

  20. Clinical and epidemiologic characteristics of human bocavirus in Danish infants: results from a prospective birth cohort study

    DEFF Research Database (Denmark)

    von Linstow, Marie-Louise; Høgh, Mette; Høgh, Birthe

    2008-01-01

    BACKGROUND: Human bocavirus (HBoV) is a recently discovered parvovirus that has been detected in respiratory samples from children with acute respiratory tract infection (ARTI) and in feces from children with gastroenteritis. However, its role as a causative agent of respiratory disease is not de......BACKGROUND: Human bocavirus (HBoV) is a recently discovered parvovirus that has been detected in respiratory samples from children with acute respiratory tract infection (ARTI) and in feces from children with gastroenteritis. However, its role as a causative agent of respiratory disease...

  1. Paralytic shellfish toxins in clinical matrices: Extension of AOAC official method 2005.06 to human urine and serum and application to a 2007 case study in Maine

    Science.gov (United States)

    DeGrasse, Stacey; Rivera, Victor; Roach, John; White, Kevin; Callahan, John; Couture, Darcie; Simone, Karen; Peredy, Tamas; Poli, Mark

    2014-05-01

    Paralytic shellfish poisoning (PSP), a potentially fatal foodborne illness, is often diagnosed anecdotally based on symptoms and dietary history. The neurotoxins responsible for PSP, collectively referred to as the saxitoxins or paralytic shellfish toxins (PSTs), are natural toxins, produced by certain dinoflagellates, that may accumulate in seafood, particularly filter-feeding bivalves. Illnesses are rare because of effective monitoring programs, yet occasional poisonings occur. Rarely are contaminated food and human clinical samples (e.g., urine and serum) available for testing. There are currently few methods, none of which are validated, for determining PSTs in clinical matrices. This study evaluated AOAC (Association of Analytical Communities) Official Method of Analysis (OMA) 2005.06. [AOAC Official Method 2005.06 Paralytic Shellfish Poisoning Toxins in Shellfish: Prechormatographic Oxidation and Liquid Chromatography with Fluorescence Detection. In Official Methods of Analysis of AOAC International aoac.org>], validated only for shellfish extracts, for its extension to human urine and serum samples. Initial assessment of control urine and serum matrices resulted in a sample cleanup modification when working with urine to remove hippuric acid, a natural urinary compound of environmental/dietary origin, which co-eluted with saxitoxin. Commercially available urine and serum matrices were then quantitatively spiked with PSTs that were available as certified reference materials (STX, dcSTX, B1, GTX2/3, C1/2, NEO, and GTX1/4) to assess method performance characteristics. The method was subsequently applied successfully to a PSP case study that occurred in July 2007 in Maine. Not only were PSTs identified in the patient urine and serum samples, the measured time series also led to the first report of human PST-specific urinary elimination rates. The LC-FD data generated from this case study compared remarkably well to results obtained using AOAC OMA 2011.27 [AOAC

  2. [Adaptive clinical study methodologies in drug development].

    Science.gov (United States)

    Antal, János

    2015-11-29

    The evolution of drug development in human, clinical phase studies triggers the overview of those technologies and procedures which are labelled as adaptive clinical trials. The most relevant procedural and operational aspects will be discussed in this overview from points of view of clinico-methodological aspect.

  3. Translational research into species differences of endocrine toxicity via steroidogenesis inhibition by SMP-028 — For human safety in clinical study

    Energy Technology Data Exchange (ETDEWEB)

    Nishizato, Yohei, E-mail: yohei-nishizato@ds-pharma.co.jp [Preclinical Research Laboratories, Dainippon Sumitomo Pharma Co., Ltd., 33-94, Enoki-cho, Suita, Osaka 564-0053 (Japan); Imai, Satoki [Preclinical Research Laboratories, Dainippon Sumitomo Pharma Co., Ltd., 33-94, Enoki-cho, Suita, Osaka 564-0053 (Japan); Okahashi, Noriko [Research Planning and Intelligence, Dainippon Sumitomo Pharma Co., Ltd., 33-94, Enoki-cho, Suita, Osaka 564-0053 (Japan); Yabunaka, Atsushi; Kunimatsu, Takeshi [Preclinical Research Laboratories, Dainippon Sumitomo Pharma Co., Ltd., 33-94, Enoki-cho, Suita, Osaka 564-0053 (Japan); Kikuchi, Kaoru [Innovative Drug Discovery Laboratories, Dainippon Sumitomo Pharma Co., Ltd., 33-94, Enoki-cho, Suita, Osaka 564-0053 (Japan); Yabuki, Masashi [Preclinical Research Laboratories, Dainippon Sumitomo Pharma Co., Ltd., 33-94, Enoki-cho, Suita, Osaka 564-0053 (Japan)

    2014-05-01

    SMP-028 is a drug candidate developed for the treatment of asthma. In a 13-week repeated dose toxicity study of SMP-028 in rats and monkeys, differences of endocrine toxicological events between rats and monkeys were observed. In rats, these toxicological events mainly consisted of pathological changes in the adrenal, testis, ovary, and the other endocrine-related organs. On the other hand, in monkeys, no toxicological events were observed. The goal of this study is to try to understand the reason why only rats, but not monkeys, showed toxicological events following treatment with SMP-028 and to eventually predict the possible toxicological effect of this compound on human endocrine organs. Our results show that SMP-028 inhibits neutral cholesterol esterase more strongly than other steroidogenic enzymes in rats. Although SMP-028 also inhibits monkeys and human neutral cholesterol esterase, this inhibition is much weaker than that of rat neutral cholesterol esterase. These results indicate (1) that the difference in endocrine toxicological events between rats and monkeys is mainly due to inhibition of steroidogenesis by SMP-028 in rats, not in monkeys, and (2) that SMP-028 may not affect steroidogenesis in humans and therefore might cause no endocrine toxicological events in clinical studies. - Highlights: • SMP-028 inhibits neutral CEase more strongly than other steroidogenic enzymes in rats. • Inhibition of neutral CEase in rats by SMP-028 suppresses steroidogenesis in vivo. • SMP-028 does not inhibit neutral CEase in monkeys in vivo. • Steroidogenesis pathway in monkeys treated with SMP-028 was not suppressed. • SMP-028 may not inhibit LIPE in humans in vivo.

  4. A clinical comparative study on treatment of severe newly diagnosed immune thrombocytopenia by recombinant human thrombopoietin combined with glucocorticoid

    Institute of Scientific and Technical Information of China (English)

    顾史洋

    2013-01-01

    Objective To evaluate the efficacy and safety of recombinant human thrombopoietin (rhTPO) combined with glucocorticoid in treatment of severe newly diagnosed primary immune thrombocytopenia (ITP) .Methods From June 2009 to December 2012,24 male patients and 38female patients with the diagnosis of severe primary ITP in our hospital were randomized into trial group (31cases) or control group (31 cases) ,the median age was 50 years (range:21-84 years) .Trial group was treated with rhTPO combined with glucocorticoid,and control group was

  5. Clinical study on the combined effect of capsaicin, green tea extract and essence of chicken on body fat content in human subjects.

    Science.gov (United States)

    Tsi, Daniel; Nah, Agatha Khow Hui; Kiso, Yoshinobu; Moritani, Toshio; Ono, Hiroyuki

    2003-12-01

    This study was conducted to assess the body fat content of free-living healthy human subjects taking a health supplement containing 0.4 mg capsaicin, 625 mg green tea extract (125 mg catechins and 50 mg caffeine) and 800 mg essence of chicken (CGTE). Subjects were advised to maintain their regular dietary habits and routine physical activity throughout study duration. Their body fat content was measured before and throughout the trial duration using a hand-grip body fat monitor. After 2 wk of supplementation with CGTE, the mean body fat percentage of males and female subjects was significantly less than the initial value (p essence of chicken could translate to a positive clinical effect by reducing approximately 460 g of body fat, following 2 wk of supplementation and the application of this natural health supplement for excess fat regulation, should be considered.

  6. Derivation of vascular endothelial cells from human embryonic stem cells under GMP-compliant conditions: towards clinical studies in ischaemic disease.

    Science.gov (United States)

    Kaupisch, A; Kennedy, L; Stelmanis, V; Tye, B; Kane, N M; Mountford, J C; Courtney, A; Baker, A H

    2012-10-01

    Revascularisation of ischaemic tissue remains an area of substantial unmet clinical need in cardiovascular disease. Strategies to induce therapeutic angiogenesis are therefore attractive. Our recent focus has been on human embryonic stem cell (hESC) strategies since hESC can be maintained in a pluripotent state or differentiated into any desired cell type, including endothelial cells (EC), under defined differentiation culture conditions. We recently published a protocol for non-good manufacturing practice (GMP) feeder- and serum-free hESC-EC-directed monolayer differentiation to vascular EC demonstrating the potential to generate hESC-derived EC in a GMP-compliant manner suitable for use in clinical trials. In this study we modified that laboratory protocol to GMP compliance. EC production was confirmed by flow cytometry, qRT-PCR and production of vascular structures in Matrigel®, yielding approximately 30 % mature VE-cadherin(+)/PECAM-1(+) cells using the GMP-compliant hESC line RC13. In conclusion, we have successfully demonstrated the production of vascular EC under GMP-compliant conditions suitable for clinical evaluation.

  7. Effect of a dentifrice containing aloe vera on plaque and gingivitis control: a double-blind clinical study in humans

    Directory of Open Access Journals (Sweden)

    Sílvia Morgana Araújo de Oliveira

    2008-08-01

    Full Text Available The effect of Aloe vera on the reduction of plaque and gingivitis was evaluated in a randomized, parallel and double-blind clinical trial. Subjects were randomly allocated to the test group (n=15 - dentifrice containing Aloe vera - or the control group (n=15 - fluoridated dentifrice. Plaque index (PI and gingival bleeding index (GBI were assessed at days 0 and 30. Subjects were asked to brush their teeth with the control or test dentifrice, three times a day, during a 30-day period. There was a significant reduction on plaque and gingivitis in both groups, but no statistically significant difference was observed among them (p>0.01. The dentifrice containing Aloe vera did not show any additional effect on plaque and gingivitis control compared to the fluoridated dentifrice.

  8. EFFECT OF A DENTIFRICE CONTAINING ALOE VERA ON PLAQUE AND GINGIVITIS CONTROL. A DOUBLE-BLIND CLINICAL STUDY IN HUMANS

    Science.gov (United States)

    de Oliveira, Sílvia Morgana Araújo; Torres, Ticiana Carneiro; Pereira, Sérgio Luís da Silva; Mota, Olívia Morais de Lima; Carlos, Márlio Ximenes

    2008-01-01

    The effect of Aloe vera on the reduction of plaque and gingivitis was evaluated in a randomized, parallel and double-blind clinical trial. Subjects were randomly allocated to the test group (n=15) – dentifrice containing Aloe vera - or the control group (n=15) – fluoridated dentifrice. Plaque index (PI) and gingival bleeding index (GBI) were assessed at days 0 and 30. Subjects were asked to brush their teeth with the control or test dentifrice, three times a day, during a 30-day period. There was a significant reduction on plaque and gingivitis in both groups, but no statistically significant difference was observed among them (p>0.01). The dentifrice containing Aloe vera did not show any additional effect on plaque and gingivitis control compared to the fluoridated dentifrice. PMID:19089263

  9. Clinical studies involving probiotics

    OpenAIRE

    Degnan, Fred H

    2012-01-01

    Researchers from a diverse array of scientific disciplines have focused and continue to focus on opportunities and areas for responsible clinical research involving the possible beneficial health effects of “probiotics.” Investigators and researchers should be aware that not all clinical research involving probiotics reasonably falls within the requirements of the “investigational new drug” (IND) rubric administered and enforced by the US Food and Drug Administration. In determining whether a...

  10. Clinical Nursing Records Study

    Science.gov (United States)

    1991-08-01

    for Sam Houston, Texas MAJ Joanne Burton , AN, Clinical Head Nurse, Psychiatry MAJ Shelby Christian, AN, Clinical Head Nurse, OB/GYN MAJ Melissa Opio...Specify Level) Parenting, Potential Alteration In Decubitus Ulcer Self-Care Deficit, Total (Specify Level) Social Isolation Fluid Volume Deficit. Potential...METABOLIC PATTERN Self-Care Dieficit. Total (Specify Level) SiX alizaticni Alterations ifl Decubitus ulcer S-If-Batingrla.v~qene Oeticit 601?Cif Levet

  11. Human Polymorphisms as Clinical Predictors in Leprosy

    Directory of Open Access Journals (Sweden)

    Ernesto Prado Montes de Oca

    2011-01-01

    Full Text Available Genetic and serum markers in human host can predict leprosy susceptibility per se as well as be useful in classification and/or prediction of clinical variants and immunological responses in leprosy. Adequate and timely assessment of potential risks associated with these 38 host leprosy genes could diminish epidemiological burden and improve life quality of patients with this still prevalent mycobacterial disease.

  12. Clinical and epidemiological study of human papillomavirus infection in women with systemic lupus erythematosus in eastern brazilian amazon

    Directory of Open Access Journals (Sweden)

    Juliana Lasmar Ayres do Amaral

    2017-01-01

    Full Text Available Cervical cancer, the second most common cancer affecting women in Northern Brazil, is strongly associated with human papillomavirus (HPV infection. Diseases affecting the immune state of a patient, including autoimmune diseases like systemic lupus erythematosus (SLE, can lead to persistent HPV infection and cancer. We evaluated cervical HPV prevalence and the associated risk factors in 70 women with SLE in the city of Belém, located in Brazilian Amazon. HPV DNA was detected by PCR using primers MY9 and MY11. HPV subtypes were determined by real-time PCR, using specific probes. Overall, prevalence of cervical HPV in women with SLE was 22.8%. HPV prevalence was significantly higher in younger women (aged 18–25 years; 75%, p< 0.0001, in women who had not given birth (50%, p = 0.01, and in women with no prior pregnancy (57%, p = 0.003. Five women (7.1% had Pap smears with a cytopathological outcome suggestive of HPV; four of these women were HPV-positive. No women with both, SLE and HPV, had a normal Pap smear. Of the women diagnosed with SLE in the last 1–5 years, 75% was HPV-positive (p = 0.04. The two most prevalent HPV subtypes were HPV 58 (37.5% and HPV 31 (31.3%. These results are important for understanding HPV infection in women with SLE and are valuable tools for developing cervical cancer prevention strategies and health management policies.

  13. An ultra-sensitive LC-MS/MS method to determine midazolam levels in human plasma: development, validation and application to a clinical study.

    Science.gov (United States)

    Chen, Mu; Lu, Wenzhe; Lu, Yang; Kang, Lijuan; Zhao, Harry; Lin, Zhongping John; Wang, Weimin; Fraier, Daniela; Ottaviani, Giorgio

    2017-02-01

    Midazolam is a commonly used marker substrate for the in vivo assessment of CYP3A activity. Reliable pharmacokinetic assessment at sub-pharmacological doses of midazolam requires an ultra-sensitive analytical method. A new, ultra-sensitive LC-MS/MS method for the determination of midazolam in human plasma using SPE was developed and fully validated. The lowest limit of quantitation is 0.1 pg/ml with a sample volume of 500 μl. The following parameters were validated: sensitivity, assay accuracy and precision, linearity, selectivity, and stability of midazolam at pertinent analytical and storage conditions. The validated method was utilized successfully for the sample assay during a midazolam microdosing study for the evaluation of CYP3A4 activity of a clinical candidate.

  14. First Human Implantation of a Bioresorbable Polymer Scaffold for Acute Traumatic Spinal Cord Injury: A Clinical Pilot Study for Safety and Feasibility.

    Science.gov (United States)

    Theodore, Nicholas; Hlubek, Randall; Danielson, Jill; Neff, Kristin; Vaickus, Lou; Ulich, Thomas R; Ropper, Alexander E

    2016-08-01

    A porous bioresorbable polymer scaffold has previously been tested in preclinical animal models of spinal cord contusion injury to promote appositional healing, spare white matter, decrease posttraumatic cysts, and normalize intraparenchymal tissue pressure. This is the first report of its human implantation in a spinal cord injury patient during a pilot study testing the safety and feasibility of this technique (ClinicalTrials.gov Identifier: NCT02138110). A 25-year-old man had a T11-12 fracture dislocation sustained in a motocross accident that resulted in a T11 American Spinal Injury Association Impairment Scale (AIS) grade A traumatic spinal cord injury. He was treated with acute surgical decompression and spinal fixation with fusion, and enrolled in the spinal scaffold study. A 2 × 10 mm bioresorbable scaffold was placed in the spinal cord parenchyma at T12. The scaffold was implanted directly into the traumatic cavity within the spinal cord through a dorsal root entry zone myelotomy at the caudal extent of the contused area. By 3 months, his neurological examination improved to an L1 AIS grade C incomplete injury. At 6-month postoperative follow-up, there were no procedural complications or apparent safety issues related to the scaffold implantation. Although longer-term follow-up and investigation are required, this case demonstrates that a polymer scaffold can be safely implanted into an acutely contused spinal cord. This is the first human surgical implantation, and future outcomes of other patients in this clinical trial will better elucidate the safety and possible efficacy profile of the scaffold. AIS, American Spinal Injury Association Impairment ScaleSCI, spinal cord injurytSCI, traumatic spinal cord injury.

  15. Dietary Supplementation with a Combination of Lactoferrin, Fish Oil, and Enterococcus faecium WB2000 for Treating Dry Eye: A Rat Model and Human Clinical Study.

    Science.gov (United States)

    Kawashima, Motoko; Nakamura, Shigeru; Izuta, Yusuke; Inoue, Sachiko; Tsubota, Kazuo

    2016-04-01

    To examine the effect of a combined dietary supplement containing fish oil, lactoferrin, zinc, vitamin C, lutein, vitamin E, γ-aminobutanoic acid, and Enterococcus faecium WB2000 on dry eye. A preliminary study in a rat model and a prospective, randomized, double-blind, placebo-controlled study in humans were conducted. Forty Japanese volunteers aged 22 to 59 years were randomized into combined dietary supplement (2 capsules/day; 20 participants) and placebo (vehicle; 19 participants) groups and treated once daily for 8 weeks. Rats received the combined dietary supplement components (10 or 50 mg/kg orally) or vehicle (2% DMSO), and dry eye was mechanically induced for 2 days. Tear production was measured in rats after dry eye was induced. Humans were assessed at baseline and weeks 4 and 8 post-supplementation based on keratoconjunctival epithelial damage; fluorescein tear film breakup time; tear production; biochemical data; information regarding subjective dry eye symptoms by answering a questionnaire; and information regarding adverse events via medical interviews. Supplementation dose-dependently mitigated the decrease in tear production in rats. Among subjects with confirmed dry eye, clinical symptoms improved at weeks 4 and 8 more significantly in the supplementation group than in the placebo group (P<.05). The rate of increase in the Schirmer value was greater in the supplementation group. No adverse events occurred. Supplementation improved objective and subjective dry eye symptoms. Copyright © 2016 Elsevier Inc. All rights reserved.

  16. Development of a high-performance liquid chromatography-based assay for carotenoids in human red blood cells: application to clinical studies.

    Science.gov (United States)

    Nakagawa, Kiyotaka; Kiko, Takehiro; Hatade, Keijiro; Asai, Akira; Kimura, Fumiko; Sookwong, Phumon; Tsuduki, Tsuyoshi; Arai, Hiroyuki; Miyazawa, Teruo

    2008-10-01

    Peroxidized phospholipid-mediated cytotoxicity is involved in the pathophysiology of many diseases; for example, there is an abnormal increase of phospholipid hydroperoxides in red blood cells (RBCs) of dementia patients. Dietary carotenoids have gained attention as potent inhibitors of RBC phospholipid hydroperoxidation, thereby making them plausible candidates for preventing disease. However, the occurrence of carotenoids in human RBCs is still unclear. This is in contradistinction to plasma carotenoids, which have been investigated thoroughly for analytical methods as well as biological significance. In this study, we developed a method to analyze RBC carotenoids using high-performance liquid chromatography (HPLC) coupled with ultraviolet (UV) diode array detection (DAD) and atmospheric pressure chemical ionization (APCI) mass spectrometry (MS). Under optimized conditions that included extraction, separation, and detection procedures, six carotenoids (lutein, zeaxanthin, beta-cryptoxanthin, alpha-carotene, beta-carotene, and lycopene) were separated, detected by DAD, and concurrently identified based on APCI/MS and UV spectra profiles when an extract from human RBCs was subjected to HPLC-DAD-APCI/MS. The amounts of carotenoids varied markedly (1.3-70.2 nmol/L packed cells), and polar oxygenated carotenoids (xanthophylls) were predominant in RBCs. The HPLC-DAD-APCI/MS method would be a useful tool for clinical studies for evaluating the bioavailability of RBC carotenoids.

  17. Determination of Clarithromycin in Human Plasma by Liquid Chromatography-Tandem Mass Spectrometry: Validation and Application in Clinical Pharmacokinetic Study

    Institute of Scientific and Technical Information of China (English)

    ZHANGXiang-rong; CHENXiao-yan; LIXiao-yan; ZHONGDa-fang

    2004-01-01

    Aim To develop a liquid chromatographic-tandem mass spectrometric (LC-MS-MS) method to determine clarithromycin in human plasma. Methods The analyte and internal standard roxithromycin were extracted from plasma samples by n-nexane-dichloromethane-isopropanel (300:150:15, V/V/V) and chromatographed on a C18 column. The mobile phase consisted of methanol-water-formic acid (80:20:1, V/V/V). Detection was performed on a triple quadrupole tandem mass spectrometer via electrospray ionization source (ESI) in the positive mode. Results The method had a lower limit of quantification of 10.0 ng·mL-1 when 0.2 mL plasma was used. The linear calibration curves were obtained in the concentration range of 10.0-5000 ng·mL-1. The intra-and inter-rum precisions were lower than 3.3% in terms of relative standard deviation (RSD), and the accuracy ranged±0.7% in terms of relative error (RE). Tmax, Cmax, T1/2 and AUC0-24h values were found to be (3.1±2.7)h, (8 750±4 734)ng·mL-1, (5.3±2.2)h, and (5932±2 449)ng·mL-1, respectively, after a single oral dose of 250 mg clarithromycin tablet to 18 volunteers. Conclusion This validated method was successful in the evaluation of pharmacokinetic profiles of clarithromycin tablets administered to 18 healthy male volubteers.

  18. Study of association and molecular analysis of human papillomavirus in breast cancer of Indian patients: Clinical and prognostic implication

    Science.gov (United States)

    Islam, Saimul; Dasgupta, Hemantika; Roychowdhury, Anirban; Bhattacharya, Rittwika; Mukherjee, Nupur; Roy, Anup; Mandal, Gautam Kumar; Alam, Neyaz; Biswas, Jaydip; Mandal, Shyamsundar; Roychoudhury, Susanta

    2017-01-01

    Objectives Human papillomavirus (HPV) causes tumors primarily Cervical cancer. Recently, inconsistent reports came up in Breast cancer (BC) too. In India, despite treatment 70,218 BC patients die each year. So, we explored the association of HPV, if any, with BC prognosis in Indian pre-therapeutic (PT) and Neo-adjuvant chemotherapy (NACT) patients with subsequent analysis of HPV profile. Methods HPV prevalence was checked and analysis of physical status, copy number, genome variation, promoter methylation and expression (mRNA and protein) of the prevalent subtype was done. Results High prevalence of HPV was observed in both PT (64.0%) and NACT (71.0%) cases with significant association with younger (20–45 yrs) PT patients. Interestingly, HPV infection was significantly increased from adjacent normal breast (9.5%, 2/21), fibro adenomas (30%, 3/10) to tumors (64.8%, 203/313) samples. In both PT and NACT cases, HPV16 was the most prevalent subtype (69.0%) followed by HPV18 and HPV33. Survival analysis illustrated hrHPV infected PT patients had worst prognosis. So, detailed analysis of HPV16 profile was done which showed Europian-G350 as the most frequent HPV16 variant along with high rate of integration. Moreover, low copy number and hyper-methylation of P97 early promoter were concordant with low HPV16 E6 and E7 mRNA and protein expression. Notably, four novel variations (KT020838, KT020840, KT020841 and KT020839) in the LCR region and two (KT020836 and KT020837) in the E6 region were identified for the first time along with two novel E6^E7*I (KU199314) and E6^E7*II (KU199315) fusion transcript variants. Conclusion Thus, significant association of hrHPV with prognosis of Indian BC patients led to additional investigation of HPV16 profile. Outcomes indicated a plausible role of HPV in Indian BC patients. PMID:28245287

  19. Silver percutaneous absorption after exposure to silver nanoparticles: a comparison study of three human skin graft samples used for clinical applications.

    Science.gov (United States)

    Bianco, C; Adami, G; Crosera, M; Larese, F; Casarin, S; Castagnoli, C; Stella, M; Maina, G

    2014-11-01

    Silver nanoparticles (AgNPs) are increasingly applied to a wide range of materials for biomedical use. These enable a close contact with human skin, thanks to the large release of silver ions that is responsible for a broad spectrum of antimicrobial activity. Silver can permeate the skin; however, there are no data available on silver permeation through skin grafts commonly used in burns recovery. The aim of our study was to evaluate silver penetration using fresh, cryopreserved, and glycerolized human skin grafts after exposure to a suspension of AgNPs in synthetic sweat using a Franz diffusion cell apparatus for 24 h. Silver permeation profiles revealed a significantly higher permeation through glycerolized skin compared with both fresh and cryopreserved skin: 24-h silver flux penetration was 0.2 ng cm(-2) h(-1) (lag time: 8.2 h) for fresh skin, 0.3 ng cm(-2) h(-1) (lag time: 10.9 h) for cryopreserved skin, and 3.8 ng cm(-2) h(-1) (lag time: 6.3 h) for glycerolized skin. Permeation through glycerolized skin is significantly higher compared to both fresh and cryopreserved skin. This result can generate relevant clinical implications for burns treatment with products containing AgNPs.

  20. A whey-protein supplement increases fat loss and spares lean muscle in obese subjects: a randomized human clinical study

    Directory of Open Access Journals (Sweden)

    Ward Loren S

    2008-03-01

    Full Text Available Abstract Background This study evaluated a specialized whey fraction (Prolibra™, high in leucine, bioactive peptides and milk calcium for use as a dietary supplement to enhance weight loss. Methods This was a randomized, double-blind, parallel-arm, 12-week study. Caloric intake was reduced 500 calories per day. Subjects consumed Prolibra or an isocaloric ready-to-mix beverage 20 minutes before breakfast and 20 minutes before dinner. Body fat and lean muscle tissue were measured by dual-energy x-ray absorptiometry (DEXA. Body weight and anthropometric measurements were recorded every 4 weeks. Blood samples were taken at the beginning and end of the study. Statistical analyses were performed on all subjects that completed (completer analysis and all subjects that lost at least 2.25 kg of body weight (responder analysis. Within group significance was determined at P Results Both groups lost a significant amount of weight and the Prolibra group tended to lose more weight than the control group; however the amount of weight loss was not significantly different between groups after 12 weeks. Prolibra subjects lost significantly more body fat compared to control subjects for both the completer (2.81 vs. 1.62 kg P = 0.03 and responder (3.63 vs. 2.11 kg, P = 0.01 groups. Prolibra subjects lost significantly less lean muscle mass in the responder group (1.07 vs. 2.41 kg, P = 0.02. The ratio of fat to lean loss (kg fat lost/kg lean lost was much larger for Prolibra subjects for both completer (3.75 vs. 1.05 and responder (3.39 vs. 0.88 groups. Conclusion Subjects in both the control and treatment group lost a significant amount of weight with a 500 calorie reduced diet. Subjects taking Prolibra lost significantly more body fat and showed a greater preservation of lean muscle compared to subjects consuming the control beverage. Because subjects taking Prolibra lost 6.1% of their body fat mass, and because a 5% reduction of body fat mass has been shown to

  1. Eggshell membrane: A possible new natural therapeutic for joint and connective tissue disorders. Results from two open-label human clinical studies

    Directory of Open Access Journals (Sweden)

    Kevin J Ruff

    2009-05-01

    Full Text Available Kevin J Ruff1, Dale P DeVore2, Michael D Leu3, Mark A Robinson41ESM Technologies, LLC, Carthage, MO, USA; 2Membrell, LLC, Carthage, MO, USA; 3Private Practice, Jenks, OK, USA; 4Robinson Family Health Center, Carthage, MO, USABackground: Natural Eggshell Membrane (NEM® is a novel dietary supplement that contains naturally occurring glycosaminoglycans and proteins essential for maintaining healthy joint and connective tissues. Two single center, open-label human clinical studies were conducted to evaluate the efficacy and safety of NEM® as a treatment for pain and inflexibility associated with joint and connective tissue disorders. Methods: Eleven (single-arm trial and 28 (double-arm trial patients received oral NEM® 500 mg once daily for four weeks. The primary outcome measure was to evaluate the change in general pain associated with the treatment joints/areas (both studies. In the single-arm trial, range of motion (ROM and related ROM-associated pain was also evaluated. The primary treatment response endpoints were at seven and 30 days. Both clinical assessments were performed on the intent-to-treat (ITT population within each study.Results: Single-arm trial: Supplementation with NEM® produced a significant treatment response at seven days for flexibility (27.8% increase; P = 0.038 and at 30 days for general pain (72.5% reduction; P = 0.007, flexibility (43.7% increase; P = 0.006, and ROM-associated pain (75.9% reduction; P = 0.021. Double-arm trial: Supplementation with NEM® produced a significant treatment response for pain at seven days for both treatment arms (X: 18.4% reduction; P = 0.021. Y: 31.3% reduction; P = 0.014. There was no clinically meaningful difference between treatment arms at seven days, so the Y arm crossed over to the X formulation for the remainder of the study. The significant treatment response continued through 30 days for pain (30.2% reduction; P = 0.0001. There were no adverse events reported during either

  2. Bilateral Transplantation of Allogenic Adult Human Bone Marrow-Derived Mesenchymal Stem Cells into the Subventricular Zone of Parkinson’s Disease: A Pilot Clinical Study

    Directory of Open Access Journals (Sweden)

    N. K. Venkataramana

    2012-01-01

    Full Text Available The progress of PD and its related disorders cannot be prevented with the medications available. In this study, we recruited 8 PD and 4 PD plus patients between 5 to 15 years after diagnosis. All patients received BM-MSCs bilaterally into the SVZ and were followed up for 12 months. PD patients after therapy reported a mean improvement of 17.92% during “on” and 31.21% during “off” period on the UPDRS scoring system. None of the patients increased their medication during the follow-up period. Subjectively, the patients reported clarity in speech, reduction in tremors, rigidity, and freezing attacks. The results correlated with the duration of the disease. Those patients transplanted in the early stages of the disease (less than 5 years showed more improvement and no further disease progression than the later stages (11–15 years. However, the PD plus patients did not show any change in their clinical status after stem cell transplantation. This study demonstrates the safety of adult allogenic human BM-MSCs transplanted into the SVZ of the brain and its efficacy in early-stage PD patients.

  3. Human Defensins: Potential Tools for Clinical Applications

    Directory of Open Access Journals (Sweden)

    Matthias Wenghoefer

    2012-02-01

    Full Text Available As components of the innate immune system, antimicrobial peptides in the form of human defensins play an important role in host defense by serving as the epithelial layer’s biochemical barrier against local infections. Recent studies have shown these molecules to have far more additional cellular functions besides their antimicrobial activity. Defensins play a role in cell division, attraction and maturation of immune cells, differentiation and reorganization of epithelial tissues, wound healing and tumor suppression. This multitude of function makes human defensins appear to be excellent tools for therapeutic approaches. These antimicrobial peptides may be used directly as a remedy against bacterial and viral infections. Furthermore, the application of human defensins can be used to promote wound healing and epithelial reorganization. In particular, human β-defensins have a strong impact on osteoblast proliferation and differentiation. Human β-defensins have already been applied as a vaccination against HIV-1. Another potentially useful characteristic of defensins is their suitability as diagnostic markers in cancer therapy. In particular, α-defensins have already been used for this purpose. Human α-defensin-3, for example, has been described as a tumor marker for lymphocytes. High gene expression levels of α-defensin-3 and -4 have been detected in benign oral neoplasia, α-defensin-6 is considered to be a tumor marker for colon cancer.

  4. HUMAN OCULAR DIROFILARIOSIS: CLINICAL AND EPIDEMIOLOGICAL FEATURES

    Directory of Open Access Journals (Sweden)

    Marija Trenkić-Božinović

    2014-03-01

    Full Text Available Dirofilarioses are zoonoses caused by filaria of the genus Dirofilaria, the parasites of domestic and wild animals. People are just random carriers of this parasite. In Europe, human dirofilariosis is caused by two species: Dirofilaria repens ( D. repens, also known as a species of The Old World , usually with the superficial localization of infection, and D. immitis, which is present throughout the world, and causes, beside superficial, visceral dirofilariosis. So far, based on the data from reference literature, it can be observed that in Serbia about 34 cases of human dirofilariosis have been diagnosed and published. It is assumed that the prevalence of this parasitosis is significantly higher as our country is an endemic area for dirofilariosis in dogs and the region where species of mosquitoes, which are transitory hosts and vectors of Dirofilaria spp., are present. The clinical picture of dirofilariosis depends on the type and location of the parasite in the human body. In our country, patients diagnosed with dirofilariosis had subcutaneous or subconjunctival infection in the majority of cases. Ocular dirofilariosis may affect the orbit and the periorbital region, the skin of the eyelids, the conjunctiva, the Tenon membrane, a retrobulbar space or has an intrabulbar localization. These patients may have a severe disability, and surgery alone can be complicated due to localization. The aim of this review is to highlight the importance of this unexpected important zoonoses, with special emphasis on the importance within the ophthalmic practice.

  5. Learn about Clinical Studies

    Science.gov (United States)

    ... is to make sure that the study is ethical and that the rights and welfare of participants ... trials provide the basis for the development and marketing of new drugs, biological products, and medical devices. ...

  6. 数字人在妇科手术学教学中的应用%The study of digital human in clinical teaching of gynecological operation

    Institute of Scientific and Technical Information of China (English)

    王中显; 祁晓晨; 高巧玲; 罗幼珍; 陈建玲

    2015-01-01

    Objective The study of digital human in intern's clinical teaching of gynecological operation and the assessment of teaching quality.Methods 78 clinical medical students from Grade 2010,China Three Gorges University,were selected as the research object.The interns of clinical medicine were randomly assigned into the digital human group and control group.The control group used the traditional method to teach gynecological operation according to patients preoperation.The digital group was used zygote body and 3D body software in preoperative explanation on the basis.Two groups of students were evaluated before and after surgery.A questionnaire survey was conducted and the analysis of teaching effect evaluation was processed for the two groups after operation.Results The understanding degree of the digital group were higher than that of control group in theoretical knowledge,anatomy,operation(P < 0.05);and this teaching method can enhancing the clinical thinking ability of the intern,the teaching content vivid and concrete,have obvious advantages in memory the teaching content more deeply.Conclusions Using digital software preoperative explanation combined with intraoperation process is helpful to improve the teaching effect on gynecological operation.%目的 探讨数字人在妇科手术学教学中的应用及其教学效果评估.方法 选择三峡大学2010级临床医学专业78名实习学生作为研究对象,将其随机分为实验组和对照组.对照组采用传统教学方法,在术前以患者病情为依据向实习学生讲解妇科手术;实验组在传统讲授的基础上将zygote body、3D body等数字人软件应用于教学之中.手术前后对两组学生进行测评,手术后对两组实习学生进行问卷调查以评价教学效果.结果 实验组学生对于妇科手术学相关理论知识、解剖层次、手术方式选择的理解度明显高于对照组学生,P<0.05,差异具有统计学意义.这种教学方法在增强实

  7. Human RAG mutations: biochemistry and clinical implications.

    Science.gov (United States)

    Notarangelo, Luigi D; Kim, Min-Sung; Walter, Jolan E; Lee, Yu Nee

    2016-04-01

    The recombination-activating gene 1 (RAG1) and RAG2 proteins initiate the V(D)J recombination process, which ultimately enables the generation of T cells and B cells with a diversified repertoire of antigen-specific receptors. Mutations of the RAG genes in humans are associated with a broad spectrum of clinical phenotypes, ranging from severe combined immunodeficiency to autoimmunity. Recently, novel insights into the phenotypic diversity of this disease have been provided by resolving the crystal structure of the RAG complex, by developing novel assays to test recombination activity of the mutant RAG proteins and by characterizing the molecular and cellular basis of immune dysregulation in patients with RAG deficiency.

  8. Consumption of an aqueous cyanophyta extract derived from Arthrospira platensis is associated with reduction of chronic pain: results from two human clinical pilot studies

    Directory of Open Access Journals (Sweden)

    Jensen GS

    2016-05-01

    Full Text Available Gitte S Jensen,1 Victoria L Attridge,1 Steve G Carter,1 Jesse Guthrie,2 Axel Ehmann,2 Kathleen F Benson1 1NIS Labs, 2Cerule LLC, Klamath Falls, OR, USA Objectives: The aim of this study was to evaluate the effects of consumption of an aqueous cyanophyta extract (ACE from Arthrospira platensis on chronic pain in humans, in two clinical pilot studies. Design and interventions: The two pilot studies each involved 12 subjects experiencing chronic pain. The initial study followed an open-label 4-week study design involving consumption of 1 g ACE per day. A subsequent placebo-controlled, single-blind, crossover study involved consumption of 500 mg ACE, 250 mg ACE, or 0 mg ACE (placebo per day for 1-week duration, separated by 1-week washout period. Subjects: Adult subjects of both sexes, with chronic joint-related pain for at least 6 months prior to enrollment, were recruited after obtaining written informed consent. Outcome measures: Visual analog scales were used to score pain at rest and during physical activity for each person's primary and secondary areas of chronic pain. An activities of daily living questionnaire was used to collect data on physical functioning. Results: The data showed rapid reduction of chronic pain in people consuming ACE, where the reduction in pain scores for each person's primary pain area reached a high level of statistical significance after 2 weeks of consumption (P<0.01, both when at rest and when being physically active. Secondary pain areas when physically active showed highly significant improvements within 1 week of consumption of 1 g/d (P<0.001 and borderline significant improvements within 1 week of consuming 500 mg/d (P<0.065 and 250 mg/d (P<0.05. This was accompanied by an increased ability to perform daily activities (P<0.05. A small but significant weight loss was observed during the 4-week study, as the average body mass index dropped from 31.4 to 29.4 (P<0.01. Conclusion: Consumption of ACE was associated

  9. Identities of Microbacterium spp. Encountered in Human Clinical Specimens▿

    OpenAIRE

    Gneiding, Kathrina; Frodl, Reinhard; Funke, Guido

    2008-01-01

    In the present study, 50 strains of yellow-pigmented gram-positive rods that had been isolated from human clinical specimens and collected over a 5-year period were further characterized by phenotypic and molecular genetic methods. All 50 strains belonged to the genus Microbacterium, and together they represented 18 different species. Microbacterium oxydans (n = 11), M. paraoxydans (n = 9), and M. foliorum (n = 7) represented more than half of the strains included in the present study. The is...

  10. VENOUS AIR-EMBOLISM, PRESERVATION REPERFUSION INJURY, AND THE PRESENCE OF INTRAVASCULAR AIR COLLECTIONS IN HUMAN DONOR LIVERS - A RETROSPECTIVE CLINICAL-STUDY

    NARCIS (Netherlands)

    WOLF, RFE; SLUITER, WJ; BALLAST, A; VANDAM, RM; SLOOFF, MJH

    In human liver transplantation, air embolism is seldom encountered after graft reperfusion. Nevertheless, despite adequate flushing and clamping routines, air emboli have been reported in transesophageal echocardiography (TEE) studies performed during the reperfusion phase, We retrospectively

  11. VENOUS AIR-EMBOLISM, PRESERVATION REPERFUSION INJURY, AND THE PRESENCE OF INTRAVASCULAR AIR COLLECTIONS IN HUMAN DONOR LIVERS - A RETROSPECTIVE CLINICAL-STUDY

    NARCIS (Netherlands)

    WOLF, RFE; SLUITER, WJ; BALLAST, A; VANDAM, RM; SLOOFF, MJH

    1995-01-01

    In human liver transplantation, air embolism is seldom encountered after graft reperfusion. Nevertheless, despite adequate flushing and clamping routines, air emboli have been reported in transesophageal echocardiography (TEE) studies performed during the reperfusion phase, We retrospectively invest

  12. Pre-clinical Orthotopic Murine Model of Human Prostate Cancer.

    Science.gov (United States)

    Shahryari, Varahram; Nip, Hannah; Saini, Sharanjot; Dar, Altaf A; Yamamura, Soichiro; Mitsui, Yozo; Colden, Melissa; Bucay, Nathan; Tabatabai, Laura Z; Greene, Kirsten; Deng, Guoren; Tanaka, Yuichiro; Dahiya, Rajvir; Majid, Shahana

    2016-08-29

    To study the multifaceted biology of prostate cancer, pre-clinical in vivo models offer a range of options to uncover critical biological information about this disease. The human orthotopic prostate cancer xenograft mouse model provides a useful alternative approach for understanding the specific interactions between genetically and molecularly altered tumor cells, their organ microenvironment, and for evaluation of efficacy of therapeutic regimens. This is a well characterized model designed to study the molecular events of primary tumor development and it recapitulates the early events in the metastatic cascade prior to embolism and entry of tumor cells into the circulation. Thus it allows elucidation of molecular mechanisms underlying the initial phase of metastatic disease. In addition, this model can annotate drug targets of clinical relevance and is a valuable tool to study prostate cancer progression. In this manuscript we describe a detailed procedure to establish a human orthotopic prostate cancer xenograft mouse model.

  13. Concept and benefits of the Inverted Classroom method for a competency-based biochemistry course in the pre-clinical stage of a human medicine course of studies

    Directory of Open Access Journals (Sweden)

    Kühl, Susanne J.

    2017-08-01

    Full Text Available Background: Medical students often have a problem recognising the relevance of basic science subjects for their later professional work in the pre-clinical stage of their studies. This can lead to a lower motivation to learn biochemical content and dissatisfaction in the courses amongst the students. Alternative teaching methods such as the Inverted Classroom (IC method can address this deficiency. The goal of this study was: We also investigated how a biochemistry course in the pre-clinical stage of a human medicine course of studies can be successfully organised according to the IC method. Furthermore, we examined the benefits of the IC method over conventional teaching formats. Method: The IC method was implemented in accordance with the guidelines of the GMA committee “New Media” in a biochemistry seminar for two student IC intervention groups with 42 students. A part of the factual knowledge from the on-site phase in the form of teaching videos together with self-learning control tasks were provided online before the seminar for both IC intervention groups. Exporting content to the self-learning phase creates new free time in the on-site phase, during which the content can be critically considered and processed and additional competency-based learning objectives can be taught. Identical biochemistry teaching content was taught in parallel control groups (14 student groups with n=299 students, but no material was handed out beforehand for a self-learning phase. These students only received the materials after the on-site phase. Motivation and satisfaction as well as the acceptance for the teaching methods were recorded by questionnaires, the acquisition of knowledge by MC exams.Results: On a Likert scale from 1 (strongly disagree to 6 (strongly agree, the students in the IC intervention groups could be seen to be much more motivated (5.53 than students in the control group (4.01. Students in the IC intervention groups also recognised the

  14. Herpes simplex encephalitis (HSE) and the immunocompromised: a clinical and autopsy study of HSE in the settings of cancer and human immunodeficiency virus-type 1 infection.

    Science.gov (United States)

    Schiff, D; Rosenblum, M K

    1998-03-01

    Although herpes simplex encephalitis (HSE) is not regarded as an opportunistic infection, the occurrence of HSE in immunocompromised patients has been documented and the suggestion made that unusual clinical and neuropathologic features characterize the disorder in this population. To further characterize HSE as it affects the immunodeficient, the authors reviewed the clinical and pathological findings in three immunocompromised patients with autopsy-proven HSE. Two patients had cancer (one with lymphoma and another with glioblastoma multiforme), one was known to be human immunodeficiency virus-type 1 (HIV-1)-seropositive and a second was suspected of harboring underlying HIV-1 infection. Two were receiving dexamethasone at onset of HSE. All had fever, mental status changes and new, focal neurological deficits or worsening of established deficits. Cerebrospinal fluid (CSF) pleocytosis was absent or minimal and head computerized tomographic (CT) scans, performed in all cases, were unrevealing. No patient was clinically suspected of having HSE, only one received acyclovir (for concurrent mucocutaneous herpes) and HSE played a major role in all deaths. Autopsy revealed an unusual form of HSE characterized by a noninflammatory, pseudoischemic histological presentation and the unexpected persistence of viral antigens in abundance despite survival beyond the clinical stage during which inflammatory responses usually peak and productive brain infection wanes. The incidence of HSE in the immunocompromised may be underestimated. Preexistent neurological disease, a noninflammatory CSF profile and negative CT scan may confound the diagnosis in this population, a typical clinical presentation notwithstanding. Increased clinical suspicion, the use of magnetic resonance imaging and polymerase chain reaction analysis of CSF for herpes simplex virus nucleic acid sequences may permit more rapid diagnosis and treatment. The absence of inflammatory infiltrates in some fatal cases of

  15. Identities of Microbacterium spp. encountered in human clinical specimens.

    Science.gov (United States)

    Gneiding, Kathrina; Frodl, Reinhard; Funke, Guido

    2008-11-01

    In the present study, 50 strains of yellow-pigmented gram-positive rods that had been isolated from human clinical specimens and collected over a 5-year period were further characterized by phenotypic and molecular genetic methods. All 50 strains belonged to the genus Microbacterium, and together they represented 18 different species. Microbacterium oxydans (n = 11), M. paraoxydans (n = 9), and M. foliorum (n = 7) represented more than half of the strains included in the present study. The isolation of strains belonging to M. hydrocarbonoxydans (n = 2), M. esteraromaticum (n = 1), M. oleivorans (n = 1), M. phyllosphaerae (n = 1), and M. thalassium (n = 1) from humans is reported for the first time. Microbacterium sp. strain VKM Ac-1389 (n = 1) and the previously uncultured Microbacterium sp. clone YJQ-29 (n = 1) probably represent new species. Comprehensive antimicrobial susceptibility data are given for the 50 Microbacterium isolates. This study is, so far, the largest on Microbacterium spp. encountered in human clinical specimens and outlines the heterogeneity of clinical Microbacterium strains.

  16. Identities of Microbacterium spp. Encountered in Human Clinical Specimens▿

    Science.gov (United States)

    Gneiding, Kathrina; Frodl, Reinhard; Funke, Guido

    2008-01-01

    In the present study, 50 strains of yellow-pigmented gram-positive rods that had been isolated from human clinical specimens and collected over a 5-year period were further characterized by phenotypic and molecular genetic methods. All 50 strains belonged to the genus Microbacterium, and together they represented 18 different species. Microbacterium oxydans (n = 11), M. paraoxydans (n = 9), and M. foliorum (n = 7) represented more than half of the strains included in the present study. The isolation of strains belonging to M. hydrocarbonoxydans (n = 2), M. esteraromaticum (n = 1), M. oleivorans (n = 1), M. phyllosphaerae (n = 1), and M. thalassium (n = 1) from humans is reported for the first time. Microbacterium sp. strain VKM Ac-1389 (n = 1) and the previously uncultured Microbacterium sp. clone YJQ-29 (n = 1) probably represent new species. Comprehensive antimicrobial susceptibility data are given for the 50 Microbacterium isolates. This study is, so far, the largest on Microbacterium spp. encountered in human clinical specimens and outlines the heterogeneity of clinical Microbacterium strains. PMID:18799696

  17. Rhodococcus equi human clinical isolates enter and survive within human alveolar epithelial cells.

    Science.gov (United States)

    Ramos-Vivas, J; Pilares-Ortega, L; Remuzgo-Martínez, S; Padilla, D; Gutiérrez-Díaz, J L; Navas-Méndez, J

    2011-05-01

    Rhodococcus equi is an emerging opportunistic human pathogen associated with immunosuppressed people, especially those infected with the human immunodeficiency virus (HIV). This pathogen resides primarily within lung macrophages of infected patients, which may explain in part its ability to escape normal pulmonary defense mechanisms. Despite numerous studies as a pulmonary pathogen in foals, where a plasmid seems to play an important role in virulence, information on the pathogenesis of this pathogen in humans is still scarce. In this study, fluorescence microscopy and vancomycin protection assays were used to investigate the ability of R. equi human isolates to adhere to and to invade the human alveolar epithelial cell line A549. Our findings indicate that some R. equi clinical strains are capable of adhering, entering and surviving within the alveolar cell line, which may contribute to the pathogen persistence in lung tissues. Copyright © 2011 Institut Pasteur. Published by Elsevier SAS. All rights reserved.

  18. A community study of clinical traits and risk factors for human metapneumovirus and respiratory syncytial virus infection during the first year of life

    DEFF Research Database (Denmark)

    von Linstow, Marie-Louise; Høgh, Mette; Nordbø, Svein;

    2008-01-01

    Human metapneumovirus (hMPV) and respiratory syncytial virus (RSV) are important respiratory pathogens with similar symptomatology. The aim of this prospective birth cohort study was to identify risk factors for an hMPV or RSV infection during the first year of life in unselected healthy children...

  19. Novel, broad-spectrum anticonvulsants containing a sulfamide group: advancement of N-((benzo[b]thien-3-yl)methyl)sulfamide (JNJ-26990990) into human clinical studies.

    Science.gov (United States)

    Parker, Michael H; Smith-Swintosky, Virginia L; McComsey, David F; Huang, Yifang; Brenneman, Douglas; Klein, Brian; Malatynska, Ewa; White, H Steve; Milewski, Michael E; Herb, Mark; Finley, Michael F A; Liu, Yi; Lubin, Mary Lou; Qin, Ning; Iannucci, Robert; Leclercq, Laurent; Cuyckens, Filip; Reitz, Allen B; Maryanoff, Bruce E

    2009-12-10

    In seeking broad-spectrum anticonvulsants to treat epilepsy and other neurological disorders, we synthesized and tested a group of sulfamide derivatives (4a-k, 5), which led to the clinical development of 4a (JNJ-26990990). This compound exhibited excellent anticonvulsant activity in rodents against audiogenic, electrically induced, and chemically induced seizures, with very weak inhibition of human carbonic anhydrase-II (IC(50) = 110 microM). The pharmacological profile for 4a supports its potential in the treatment of multiple forms of epilepsy, including pharmacoresistant variants. Mechanistically, 4a inhibited voltage-gated Na(+) channels and N-type Ca(2+) channels but was not effective as a K(+) channel opener. The pharmacokinetics and metabolic properties of 4a are discussed.

  20. [Clinical studies on pramipexol retard].

    Science.gov (United States)

    Klivényi, Péter; Vécsei, László

    2010-05-30

    Pramipexol retard is the newest drug for the treatment of Parkinson's disease. The prolonged release of the agent in this preparation allows a more continuous dopaminergic stimulation than previous preparations, without reducing the agent's already known and proven clinical efficiency. In addition, it has a more favourable adverse effect profile than previous preparations, and patient compliance can also be better as it needs to be taken only once daily. These benefits have been proven in recent clinical studies, of which the most important ones are reviewed here.

  1. 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.

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

    Science.gov (United States)

    Oehme, David; Goldschlager, Tony; Ghosh, Peter; Rosenfeld, Jeffrey V; Jenkin, Graham

    2015-01-01

    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.

  3. Mapping gene associations in human mitochondria using clinical disease phenotypes.

    Directory of Open Access Journals (Sweden)

    Curt Scharfe

    2009-04-01

    Full Text Available Nuclear genes encode most mitochondrial proteins, and their mutations cause diverse and debilitating clinical disorders. To date, 1,200 of these mitochondrial genes have been recorded, while no standardized catalog exists of the associated clinical phenotypes. Such a catalog would be useful to develop methods to analyze human phenotypic data, to determine genotype-phenotype relations among many genes and diseases, and to support the clinical diagnosis of mitochondrial disorders. Here we establish a clinical phenotype catalog of 174 mitochondrial disease genes and study associations of diseases and genes. Phenotypic features such as clinical signs and symptoms were manually annotated from full-text medical articles and classified based on the hierarchical MeSH ontology. This classification of phenotypic features of each gene allowed for the comparison of diseases between different genes. In turn, we were then able to measure the phenotypic associations of disease genes for which we calculated a quantitative value that is based on their shared phenotypic features. The results showed that genes sharing more similar phenotypes have a stronger tendency for functional interactions, proving the usefulness of phenotype similarity values in disease gene network analysis. We then constructed a functional network of mitochondrial genes and discovered a higher connectivity for non-disease than for disease genes, and a tendency of disease genes to interact with each other. Utilizing these differences, we propose 168 candidate genes that resemble the characteristic interaction patterns of mitochondrial disease genes. Through their network associations, the candidates are further prioritized for the study of specific disorders such as optic neuropathies and Parkinson disease. Most mitochondrial disease phenotypes involve several clinical categories including neurologic, metabolic, and gastrointestinal disorders, which might indicate the effects of gene defects

  4. The human genome project: Prospects and implications for clinical medicine

    Energy Technology Data Exchange (ETDEWEB)

    Green, E.D.; Waterston, R.H. (Washington Univ., St. Louis, MO (United States))

    1991-10-09

    The recently initiated human genome project is a large international effort to elucidate the genetic architecture of the genomes of man and several model organisms. The initial phases of this endeavor involve the establishment of rough blueprints (maps) of the genetic landscape of these genomes, with the long-term goal of determining their precise nucleotide sequences and identifying the genes. The knowledge gained by these studies will provide a vital tool for the study of many biologic processes and will have a profound impact on clinical medicine.

  5. CLINICAL AND VIROLOGIC FOUNDATION FOR PATHOGENETIC THERAPY OF HUMAN HERPES VIRUS TYPE 6 INFECTION IN CHILDREN

    Directory of Open Access Journals (Sweden)

    N.A. Myukke

    2006-01-01

    Full Text Available Information about an infection caused by human herpes virus type 6, its' epidemiology, pathogenesis and clinical variants, is reviewed. Clinical cases, diagnosed at a time of study, are briefly reviewed.Key words: human herpes virus type 6, exanthema subitum (roseola infantum, fever of unknown origin, mononucleosis like syndrome, meningoencephalitis, children.

  6. Investigation of standing wave formation in a human skull for a clinical prototype of a large-aperture, transcranial MR-guided Focused Ultrasound (MRgFUS) phased array: An experimental and simulation study

    OpenAIRE

    Song, Junho; Pulkkinen, Aki; Huang, Yuexi; Hynynen, Kullervo

    2011-01-01

    Standing wave formation in an ex vivo human skull was investigated using a clinical prototype of a 30 cm diameter with 15 cm radius of curvature, low frequency (230 kHz), hemispherical transcranial Magnetic Resonance guided Focused Ultrasound (MRgFUS) phased-array. Experimental and simulation studies were conducted with changing aperture size and f-number configurations of the phased array, and qualitatively and quantitatively examined the acoustic pressure variation at the focus due to stand...

  7. Evaluation of effectiveness of hyaluronic acid in combination with bioresorbable membrane (poly lactic acid-poly glycolic acid) for the treatment of infrabony defects in humans: A clinical and radiographic study

    OpenAIRE

    Bhumika Sehdev; Manohar Laxmanrao Bhongade; Kiran Kumar Ganji

    2016-01-01

    Background: The combination of biomaterials, bone graft substitutes along with guided tissue regeneration (GTR) has been shown to be an effective modality of periodontal regenerative therapy for infrabony defects. Therefore, the present randomized controlled clinical study was undertaken to evaluate the effectiveness of hyaluronic acid (HA) in combination with bioresorbable membrane for the treatment of human infrabony defects. Materials and Methods: Twenty four infrabony defects in 20 system...

  8. Clinical impact of human breast milk metabolomics.

    Science.gov (United States)

    Cesare Marincola, Flaminia; Dessì, Angelica; Corbu, Sara; Reali, Alessandra; Fanos, Vassilios

    2015-12-01

    Metabolomics is a research field concerned with the analysis of metabolome, the complete set of metabolites in a given cell, tissue, or biological sample. Being able to provide a molecular snapshot of biological systems, metabolomics has emerged as a functional methodology in a wide range of research areas such as toxicology, pharmacology, food technology, nutrition, microbial biotechnology, systems biology, and plant biotechnology. In this review, we emphasize the applications of metabolomics in investigating the human breast milk (HBM) metabolome. HBM is the recommended source of nutrition for infants since it contains the optimal balance of nutrients for developing babies, and it provides a range of benefits for growth, immunity, and development. The molecular mechanisms beyond the inter- and intra-variability of HBM that make its composition unique are yet to be well-characterized. Although still in its infancy, the study of HBM metabolome has already proven itself to be of great value in providing insights into this biochemical variability in relation to mother phenotype, diet, disease, and lifestyle. The results of these investigations lay the foundation for further developments useful to identify normal and aberrant biochemical changes as well as to develop strategies to promote healthy infant feeding practices.

  9. Determination of Sodium Tanshinone IIA Sulfonate in human plasma by LC-MS/MS and its application to a clinical pharmacokinetic study.

    Science.gov (United States)

    Qin, WeiWei; Wang, Bin; Lu, XiaoPei; Liu, HaiMing; Wang, Li; Qi, WeiLin

    2016-03-20

    An assay based on protein precipitation and liquid chromatography-tandem mass spectrometry (LC-MS/MS) has been developed and validated for the quantitative analysis of Sodium Tanshinone IIA Sulfonate (STS) in human plasma. After the addition of dehydroepiandrosterone-D5-3-sulfate sodium salt (DHEAS-D5) as internal standard (IS) and formic acid, plasma samples were prepared by one-step protein precipitation with a mixture of acetonitrile and methanol. Isocratic mobile phase consisted of 0.4 mmol/L ammonium formate buffer (16 ppm formic acid)/acetonitrile (40/60, v/v) on a XSELECT™ HSS T3 column. Detection was performed on a triple-quadrupole mass spectrometer utilizing an electrospray ionization (ESI) interface operating in positive ion and selected reaction monitoring (SRM) mode with the precursor to product ion transitions m/z 373.3→357.1 for STS and m/z 373.0→97.8 for the IS. Calibration curves of STS in human plasma were linear (r=0.9957-0.9998) over the concentration range of 2-1000 ng/mL with acceptable accuracy and precision. The lower limit of quantification in human plasma was 2 ng/mL. The validated LC-MS/MS method has been successfully applied to a pharmacokinetic study of STS in Chinese healthy male volunteers.

  10. [Experimental and clinical studies on a sensitivity test of anticancer agents by 3H-thymidine autoradiography using a human malignant tumor transplanted to nude mice].

    Science.gov (United States)

    Nishimawari, K

    1986-02-01

    The 3H-thymidine uptake of human xenografts transplanted in nude mice and treated with various anticancer agents was studied by autoradiography and compared with the histological changes on the same specimen. One hundred and four human malignant tumors were transplanted into nude mice and treated with intraperitoneal administration of Mitomycin C (MMC) (3mg/kg), 5-Fluorouracil (5-FU) (25mg/kg X 3) and Cyclophosphamide (CPM) (80mg/kg), of which 97 cases were investigated. Autoradiographical evaluation was expressed as the inhibition rate of labeling index of the treated specimen in comparison with that of the control. Histological change was judged by Ohboshi and Shimosato's criteria. The rate of positive sensitivity was 65.5% in MMC, 34.9% in 5-FU and 51.8% in CPM by autoradiographical evaluation, while by histological evaluation 18.9%, 14.6% and 16.9%, respectively. From these results, it may be speculated that the autoradiographical evaluation of the tumor sensitivity against anticancer agents is more sensitive than the histological evaluation. As to MMC and CPM, statistically significant correlations were demonstrated between the results of this method and those of the experimental chemotherapy in accordance with the Battelle Columbus Laboratories Protocol using human malignant tumors serially transplanted into nude mice.

  11. CLINICAL STUDY OF ACUTE POISONING

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    Panduranga

    2014-09-01

    Full Text Available BACKGROUND AND OBJECTIVE: Acute poisoning is an important medical emergency. Studies of this nature will be useful tool in planning, early diagnosis and management of acute poisoning cases. The objective of the study are to study the clinical features, diagnosis and management, morbidity and mortality of various acute poisoning. METHODOLOGY: This study comprises of 350 patients of acute poisoning admitted to Chigateri General Hospital and Bapuji Hospital attached to J. J. M. Medical College, Davangere, between 1st March 2011 to 31st October 2011. REUSLTS: Out of 350 cases of acute poisoning studied, there were 268 males and 82 females. Males comprised 76.57%and females 23.42% of the total, in this series, Organophosphorous compounds were the commonest (30%, majority of the patients hailed from rural area 70%. Mortality is 10.57%.

  12. A community study of clinical traits and risk factors for human metapneumovirus and respiratory syncytial virus infection during the first year of life

    DEFF Research Database (Denmark)

    Linstow, Michael Ernst Von; Hogh, M.; Nordbo, S.A.;

    2008-01-01

    Human metapneumovirus (hMPV) and respiratory syncytial virus (RSV) are important respiratory pathogens with similar symptomatology. The aim of this prospective birth cohort study was to identify risk factors for an hMPV or RSV infection during the first year of life in unselected healthy children......% CI:0.09-0.85). Risk factors for RSV hospitalisation (n = 11) were: (1) older siblings (OR = 4.49; 95% CI: 1.08-18.73) and (2) smoking in the household (OR = 5.06; 95% CI: 1.36-18.76). Exclusive breastfeeding for the first 14 days of life protected against hospitalisation (OR = 0.21; 95% CI:0...

  13. CLINICAL STUDY OF ECTOPIC PREGNANCY

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    Swami

    2015-10-01

    Full Text Available An ectopic pregnancy is one in which fertilized ovum is implanted at the site other than normal uterine cavity.[1] Incidence of ectopic pregnancy is 1:160 deliveries.[2] Clinical presentation is variable from acute to chronic type. Due to its varied clinical presentation ectopic pregnancy poses great diagnostic difficulty both to obstetrician, physician and surgeons.[3] OBJECTIVE: To find out incidence in our study population and to evaluate symptomatically and clinical presentation in these patients. MATERIALS AND METHODS: Retrospective study of 34 ectopic pregnancies admitted and treated in Medical College hospital, Ujjain from 2010 to 2015 are included in the study. RESULTS: The incidence of ectopic pregnancy is more between the age group of 21-30years (73.52% and in Multigravida 64.71%. Infertility and previous tubal surgery are the high risk factors for tubal pregnancy. Pain in abdomen was present in all 34 cases, amenorrhea in 97.05% and bleeding per vagina in 76.47% cases. Syncopal attacks, vomiting were detected in 14.70% cases. Acute ectopic pregnancy was detected in 14.71% and chronic in 85.29% cases. 82.35% cases presented with adnexal mass, 79.41% with cervical motion tenderness, 50% with pallor, 32.35% with abdominal lump and tenderness and 11.76% with fullness in POD. CONCLUSION: Ectopic pregnancy is leading cause of maternal mortality in first trimester. In spite of advanced diagnostic techniques. It poses great diagnostic difficulties due to varied signs and symptoms. Previous tubal surgery pelvic inflammatory disease and infertility are the risk factors of tubal pregnancy.

  14. Large Field, High Resolution Full Field Optical Coherence Tomography: A Pre-clinical study of human breast tissue and cancer assessment

    CERN Document Server

    Assayag, Osnath; Sigal-Zafrani, Brigitte; Riben, Michael; Harms, Fabrice; Burcheri, Adriano; de Poly, Bertrand Le Conte; Boccara, Claude

    2012-01-01

    We present a benchmark pilot study in which high-resolution Full-Field Optical Coherence Tomography (FF-OCT) is used to image human breast tissue and is evaluated to assess its ability to aid the pathologist's management of intra-operative diagnoses. Our aim included evaluating the safety of FF-OCT on human tissue and determining the concordance between the images obtained with routinely prepared histopathological material. The compact device used for this study provides a 2 {\\mu}m-lateral and a 1 {\\mu}m-axial resolution, and is able to scan a 1.5cm^2 specimen in about 7 minutes. 75 breast specimens obtained from 22 patients have been imaged. Because the contrast in the images is generated by endogenous tissue components, no biological, contrast agents or specimen preparation is required. We characterized the major architectural features and tissue structures of benign breast tissue, including adipocytes, fibrous stroma, lobules and ducts. We subsequently characterized features resulting from their pathologic...

  15. Children and Clinical Studies: Why Clinical Studies Are Important

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  16. Ex vivo-expanded autologous bone marrow-derived mesenchymal stromal cells in human spinal cord injury/paraplegia: a pilot clinical study.

    Science.gov (United States)

    Pal, Rakhi; Venkataramana, Neelam K; Bansal, Abhilash; Balaraju, Sudheer; Jan, Majahar; Chandra, Ravi; Dixit, Ashish; Rauthan, Amit; Murgod, Uday; Totey, Satish

    2009-01-01

    Spinal cord injury (SCI) is a medically untreatable condition for which stem cells have created hope in the last few years. Earlier pre-clinical reports have shown that transplantation of bone marrow (BM) mesenchymal stromal cells (MSC) in SCI-simulated models can produce encouraging results. In a clinical pilot study, we investigated the growth kinetics of BM MSC from SCI patients, their safety and functional improvement post-transplantation. Thirty patients with clinically complete SCI at cervical or thoracic levels were recruited and divided into two groups based on the duration of injury. Patients with SCI were recruited into group 1 and patients with >6 months of post-SCI were included into group 2. Autologous BM was harvested from the iliac crest of SCI patients under local anesthesia and BM MSC were isolated and expanded ex vivo. BM MSC were tested for quality control, characterized for cell surface markers and transplanted back to the patient via lumbar puncture at a dose of 1 x 10(6) cells/kg body weight. At the time of writing, three patients had completed 3 years of follow-up post-BM MSC administration, 10 patients 2 years follow-up and 10 patients 1 year follow-up. Five patients have been lost to follow-up. None of the patients have reported any adverse events associated with BM MSC transplantation. The results indicate that our protocol is safe with no serious adverse events following transplantation in SCI patients. The number of patients recruited and the uncontrolled nature of the trial do not permit demonstration of the effectiveness of the treatment involved. However, the results encourage further trials with higher doses and different routes of administration in order to demonstrate the recovery/efficacy if any, in SCI patients.

  17. CLINICAL STUDY ON ACUTE PANCREATITIS

    Directory of Open Access Journals (Sweden)

    Suhaib Rehaman

    2015-07-01

    Full Text Available INTRODUCTION : Early diagnosis and severity evaluation on patients with acute pancreatitis are very important due to its potential morbidity and mortality. Given the wide spectrum of disease seen, the care of patients with pancreatitis must be highly individualized. Sev eral clinical, laboratory and radiologic factors and many scoring systems have been proposed for outcome prediction. AIMS AND OBJECTIVES: To study the symptomatology, clinical presentation and management in pancreatitis . To study the severity of acute panc reatitis according to Glasgow Scale . METHODS: Present study includes consecutive 38 patients hospitalized in CSI Holdsworth Memorial Hospital over the period of 2 years. All patients were thoroughly investigated and were stratified according to the Glasgow criteria. Data was collected on complications, investigations and interventions undertaken, outcome, duration of stay in hospital and ICU. STATISTICAL ANALYSIS USED: Descriptive, Chi square tests, Crosstabs (Contingency coefficient analysis . RESULTS : Mean age of presentation in our study was 43.1 years. There was a male predominance accounting for 68.4% compared to 31.6% females. Alcohol was the main etiological factor in about 50% of the patients. Sensitivity to S. amylase was about 100%. Accuracy of USG abdomen in diagnosing pancreatitis was about 88.5%. Ascitis was the commonest complication seen in 13.2%. Mean duration of hospital stay was 6.2 days. The patient were stratified according to Glasgow scoring system into mild (0 - 3 and severe (>3 panc reatitis. In our study 32 people were graded with mild pancreatitis, all improved and in 6 people who were graded with severe pancreatitis, 83.3 % improved and 2.6% expired because of complications. Test statistics showed Contingency coefficient 0.355 and P 0.019 (NS. CONCLUSION : Glasgow scoring system remains a valid predicting system for the outcome in patients with acute pancreatitis. It is simple easy to apply with

  18. Empyema thoracis: A clinical study

    Directory of Open Access Journals (Sweden)

    Acharya Preetam

    2007-01-01

    Full Text Available Background: Empyema thoracis is a disease that, despite centuries of study, still causes significant morbidity and mortality. Aim: The present study was undertaken to study the age-sex profile, symptomatology, microbiologic findings, etiology and the management and treatment outcome in a tertiary care hospital. Settings and Design: A prospective study of empyema thoracis was conducted on 40 consecutive patients with empyema thoracis admitted to the tuberculosis and chest diseases ward of a teaching hospital. Materials and Methods: The demographic data, clinical presentation, microbiological findings, etiology, the clinical course and management were recorded as per a planned pro forma and analyzed. Results: The peak age was in the range of 21-40 years, the male-to-female ratio was 3.4:1.0 and the left pleura was more commonly affected than the right pleura. Risk factors include pulmonary tuberculosis, chronic obstructive pulmonary diseases, smoking, diabetes mellitus and pneumonia. Etiology of empyema was tubercular in 65% cases and nontubercular in 35% cases. Gram-negative organisms were cultured in 11 cases (27.5%. Two patients received antibiotics with repeated thoracentesis only, intercostal chest tube drainage was required in 38 cases (95% and more aggressive surgery was performed on 2 patients. The average duration for which the chest tube was kept in the complete expansion cases was 22.3 days. Conclusion: It was concluded that all cases of simple empyema with thin pus and only those cases of simple empyema with thick pus where size of empyema is small should be managed by aspiration/s. Cases failed by the above method, all cases of simple empyema with thick pus and with moderate to large size of empyema and all cases of empyema with bronchopleural fistula should be managed by intercostal drainage tube connected to water seal. It was also observed that all cases of empyema complicated by bronchopleural fistula were difficult to manage and

  19. Children and Clinical Studies: Why Clinical Studies Are Important

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  20. Clinical significance of human alpha-fetoprotein

    Energy Technology Data Exchange (ETDEWEB)

    Yachnin, S.

    1978-01-01

    Deviations from the normal of alpha-fetoprotein (AFP) concentrations in fetal serum, amniotic fluid, maternal serum and adult human serum can be explained by understanding the normal physiology and the pathophysiology of AFP synthesis and metabolism. AFP is the prototype of oncofetal markers. Emphasis is given to the usefulness of elevated serum AFP levels in the diagnosis and management of primary hepatomas and tumors of germ cell origin. The ability to detect neural tube defects early in gestation by monitoring maternal serum and amniotic fluid AFP concentrations is discussed.

  1. CLINICAL STUDY OF ANORECTAL MALFORMATIONS

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    Umesh

    2015-01-01

    Full Text Available BACKGROUND: A norectal malformations are relatively encountered anomalies. Presentations may vary from mild to severe and bowel control is t he main concern. AIM: To study the modes of presentation , types of anomalies , associated anomalies , reliability of clinical signs and radiological investigations in the diagnosis and the prognosis and continence in the post - operative in relation to type of anomaly and associated anomaly (s. MATERIAL AND METHODS: 50 cases of anorectal malformations admit ted to Department of Paediatric Surgery , in Medical Coll ege and Research Institute , were included in the study. Data related to the objectives of the study were collected. RESULTS: Commonest mode of presentation was failure to pass meconium 50%. 59% of mal es had high anomalies , while 53% females had intermediate anomalies. The diagnosis of low anomaly was made clinically , while high and intermediate anomalies needed further investigations. Associated anomalies were noted in 46.6% of the cases. 71.42% of the se patients had either a high or intermediate ARM. All patients with high anomalies underwent a 3 stage procedure , while low anomalies underwent a single stage procedure followed by anal dilatations. Rectal mucosal prolapse (2 cases , wound infection (4 ca ses , stenosis (3 cases , retraction of neo anus (1 case was seen. All the patients with low anomalies had a good functional result post operatively , while 57% and 28% of patients with intermediate and high anomalies had good results. CONCLUSION : Anorectal malformations are common congenital anomalies. Males are more commonly affected (1.3:1. Low anomalies are the commonest lesions noted in both the sexes (36.67%. High anomalies are more frequent in males. Invertogram offer an accurate diagnosis for planning management in patients with anorectal malformations. Low anomalies have a better outcome following surgery. For intermediate and high anomalies a staged repair offers better results

  2. Human computer interaction issues in Clinical Trials Management Systems.

    Science.gov (United States)

    Starren, Justin B; Payne, Philip R O; Kaufman, David R

    2006-01-01

    Clinical trials increasingly rely upon web-based Clinical Trials Management Systems (CTMS). As with clinical care systems, Human Computer Interaction (HCI) issues can greatly affect the usefulness of such systems. Evaluation of the user interface of one web-based CTMS revealed a number of potential human-computer interaction problems, in particular, increased workflow complexity associated with a web application delivery model and potential usability problems resulting from the use of ambiguous icons. Because these design features are shared by a large fraction of current CTMS, the implications extend beyond this individual system.

  3. The role of human leukocyte antigen in susceptibility and clinical manifestations of sarcoidosis.

    Institute of Scientific and Technical Information of China (English)

    1997-01-01

    To investigate the association of human leukocyte antigen (HLA) with susceptibility and clinical manifestations of sarcoidosis, fifty-five patients with sarcoidosis were studied by using allele group specific polymerase chain reaction technique (PCR). Our data

  4. Planning a study abroad clinical experience.

    Science.gov (United States)

    Wright, Dolores J

    2010-05-01

    Not only is globalization expanding areas of human activity, it is also influencing the variety of educational offerings in universities. Therefore, globalization must be considered by nurse educators as they reevaluate ways of preparing nursing students to meet the health care needs of populations they currently serve and will care for in the future. Study abroad programs have been encouraged to be part of the college experience in the United States for more than 30 years; however, these programs have been relatively lacking in nursing education. Most of the study abroad programs described in the nursing literature are research-based or first-person accounts of an experience and provide little information about planning a study abroad program. This article describes a study abroad learning experience for senior nursing students and discusses the issues such as student selection, student safety, and available clinical experiences that need to be considered before undertaking such an endeavor.

  5. A clinical study of vitiligo

    Directory of Open Access Journals (Sweden)

    Martis Jacintha

    2002-01-01

    Full Text Available A clinical study of one hundred patients having vitiligo revealed the incidence among new patients to be 1.84%. The male/female ratio was 1:1.22. Family history of vitiligo was available in 8% of our patients. The different morphological pattern consisted of vitiligo vulgaris (39 cases, focal vitiligo (27 cases, acrofacial vitiligo (18 cases, lip - tip vitiligo (7 cases, lip vitiligo (5 cases, segmental vitiligo (3 cases and universal vitiligo (1 case. Associated diseases include atopic dermatitis (2 cases, Hansen s disease (2 cases, alopecia areata (1 case, halo naevus (1 case, chronic urticaria (1 case, lichen planus (1 case, diabetes mellitus (9 cases, hypertension (4 cases, hypothyroidism (2 cases, epilepsy (1 case and IHD (1 case.

  6. Large field, high resolution full-field optical coherence tomography: a pre-clinical study of human breast tissue and cancer assessment.

    Science.gov (United States)

    Assayag, Osnath; Antoine, Martine; Sigal-Zafrani, Brigitte; Riben, Michael; Harms, Fabrice; Burcheri, Adriano; Grieve, Kate; Dalimier, Eugénie; Le Conte de Poly, Bertrand; Boccara, Claude

    2014-10-01

    We present a benchmark pilot study in which high-resolution Full-Field Optical Coherence Tomography (FF-OCT) was used to image human breast tissue and is evaluated to assess its ability to aid the pathologist's management of intra-operative diagnoses. FF-OCT imaging safety was investigated and agreement between FF-OCT and routinely prepared histopathological images was evaluated. The compact setup used for this study provides 1 mm3 resolution and 200 mm imaging depth, and a 2.25 cm2 specimen is scanned in about 7 minutes. 75 breast specimens were imaged from 22 patients (21 women, 1 man) with a mean age of 58 (range: 25-83). Pathologists blind diagnosed normal/benign or malignant tissue based on FF-OCT images alone, diagnosis from histopathology followed for comparison. The contrast in the FF-OCT images is generated by intrinsic tissue scattering properties, meaning that no tissue staining or preparation is required. Major architectural features and tissue structures of benign breast tissue, including adipocytes, fibrous stroma, lobules and ducts were characterized. Subsequently, features resulting from pathological modification were characterized and a diagnosis decision tree was developed. Using FF-OCT images, two breast pathologists were able to distinguish normal/benign tissue from lesional with a sensitivity of 94% and 90%, and specificity of 75% and 79% respectively.

  7. Study of the stability of packaging and storage conditions of human mesenchymal stem cell for intra-arterial clinical application in patient with critical limb ischemia.

    Science.gov (United States)

    Gálvez-Martín, Patricia; Hmadcha, Abdelkrim; Soria, Bernat; Calpena-Campmany, Ana C; Clares-Naveros, Beatriz

    2014-04-01

    Critical limb ischemia (CLI) is associated with significant morbidity and mortality. In this study, we developed and characterized an intra-arterial cell suspension containing human mesenchymal stem cells (hMSCs) for the treatment of CLI. Equally, the stability of cells was studied in order to evaluate the optimal conditions of storage that guarantee the viability from cell processing to the administration phase. Effects of various factors, including excipients, storage temperature and time were evaluated to analyze the survival of hMSCs in the finished medicinal product. The viability of hMSCs in different packaging media was studied for 60 h at 4 °C. The best medium to maintain hMSCs viability was then selected to test storage conditions (4, 8, 25 and 37 °C; 60 h). The results showed that at 4 °C the viability was maintained above 80% for 48 h, at 8 °C decreased slightly, whereas at room temperature and 37 °C decreased drastically. Its biocompatibility was assessed by cell morphology and cell viability assays. During stability study, the stored cells did not show any change in their phenotypic or genotypic characteristics and physicochemical properties remained constant, the ability to differentiate into adipocytes and osteocytes and sterility requirements were also unaltered. Finally, our paper proposes a packing media composed of albumin 20%, glucose 5% and Ringer's lactate at a concentration of 1×10(6) cells/mL, which must be stored at 4 °C as the most suitable to maintain cell viability (>80%) and without altering their characteristics for more than 48 h.

  8. Physiopathology of human embryonic implantation: clinical incidences.

    Directory of Open Access Journals (Sweden)

    Pauline Demailly

    2010-01-01

    Full Text Available Embryo implantation consists of a series of events promoting the invasion of the endometrium and then the uterine arterial system by the extra-embryonic trophoblast. In order for this semi-heterologous implantation to succeed, the endometrium has to first undergo a number of structural and biochemical changes (decidualization. The decidua's various constituents subsequently play a role in the embryonic implantation. The third step is the transformation of the uterine vascular system and the growth of the placenta, which will provide the foetoplacental unit with nutrients. Several physiopathological aspects will be discussed: 1 the implantation window, regulated by maternal and embryonic hormonal secretions and thus influenced by any defects in the latter: dysharmonic luteal phase, 21-hydroxylase block, abnormal integrin expression, 2 the successive trophoblast invasions of uterine vessels which, when defective, lead to early embryo loss or late-onset vascular pathologies, as preeclampsia, 3 the pregnancy's immunological equilibrium, with a spontaneously tolerated semi-allogeneic implant, 4 the impact of pro-coagulant factors (thrombophilia on the pregnancy's progression, 5 the environment of the uterus, ranging from hydrosalpinx to uterine contractions. In summary, the least anatomical or physiological perturbation can interfere with human embryonic implantation - a very particular phenomenon and a true biological paradox.

  9. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... NHLBI Entire Site Health Topics News & Resources Intramural Research Public Health Topics Education & Awareness Resources Contact The ... Researchers Funding Training & Career Development Division of Intramural Research Research Resources Research Meeting Summaries Technology Transfer Clinical ...

  10. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Topics News & Resources Intramural Research Public Health Topics Education & Awareness Resources Contact The Health Information Center Health ... Systematic Evidence Reviews & Clinical Practice Guidelines Resources Continuing Education Researchers Funding Training & Career Development Division of Intramural ...

  11. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Topics News & Resources Intramural Research Public Health Topics Education & Awareness Resources Contact The Health Information Center Health ... Systematic Evidence Reviews & Clinical Practice Guidelines Resources Continuing Education Researchers Funding Training & Career Development Division of Intramural ...

  12. Impact of therapeutic drug monitoring of antiretroviral drugs in routine clinical management of patients infected with human immunodeficiency virus and related health care costs: a real-life study in a large cohort of patients

    Directory of Open Access Journals (Sweden)

    Perrone V

    2014-07-01

    Full Text Available Valentina Perrone,1 Dario Cattaneo,1 Sonia Radice,1 Diego Sangiorgi,2 Augusto B Federici,3 Maria Rita Gismondo,4 Massimo Medaglia,5 Valeria Micheli,4 Stefania Vimercati,5 Enza Pallone,6 Luca Degli Esposti,2 Emilio Clementi1,71Unit of Clinical Pharmacology, Department of Biomedical and Clinical Sciences, L Sacco University Hospital, University of Milan, Milan, 2CliCon Srl, Health, Economics and Outcomes Research, Ravenna, 3Hematology and Transfusion Medicine, Department of Clinical Sciences and Community Health, 4Clinical Microbiology Virology and Diagnosis of Bioemergency, 5Pharmaceutical Department, 6Quality Clinical Risk and Accreditation Unit, L Sacco University Hospital, Milan, 7Scientific Institute, IRCCS Eugenio Medea, Bosisio Parini, Lecco, ItalyBackground: Highly active antiretroviral therapy (HAART has reduced morbidity and mortality in patients infected with human immunodeficiency virus (HIV. Studies have documented high interindividual variability in the pharmacokinetics of antiretroviral drugs, which may impair the success of HAART if not managed properly. Therapeutic drug monitoring (TDM is a useful diagnostic tool that helps clinicians to optimize drug doses so that drug concentrations associated with the highest therapeutic efficacy are obtained with a reduced risk of concentration-dependent adverse effects. The aim of this study was to assess whether use of TDM improves clinical outcomes and cost of illness.Methods: A retrospective cohort study was conducted at L Sacco University Hospital in Milan, Italy, in HIV-infected patients aged ≥18 years with at least one prescription of antiretroviral drugs for which TDM was applied. The inclusion period was from January 2010 to December 2011, with a follow-up period of up to 12 months. Laboratory and administrative databases were analyzed and matched with each other.Results: The cohort consisted of 5,347 patients (3,861 males and 1,486 females of mean age 43.9±12.5 years. We found

  13. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... the general public. Last Updated: August 3, 2015 Resources Educational Website - English / Spanish ... FEAR ACT OIG CONTACT US National Institutes of Health Department of Health and Human Services USA.gov

  14. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... to fill an important gap in information and education for parents, clinicians, researchers, children, and the general public. Last Updated: August 3, 2015 ... US National Institutes of Health Department of Health and Human Services USA.gov

  15. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... in information and education for parents, clinicians, researchers, children, and the general public. Last Updated: August 3, 2015 Resources ... US National Institutes of Health Department of Health and Human Services USA.gov

  16. Clinical study of ectopic pregnancy.

    Science.gov (United States)

    Chhabra, S; Aher, K; Jaiswal, M

    1992-01-01

    Ectopic pregnancy remains a leading cause of maternal mortality and accounts for a sizeable proportion of infertility and ectopic recurrence. The possibility that a woman is experiencing an ectopic pregnancy must be considered when evaluating a woman, especially a sterilized woman, who has a possible pregnancy, amenorrhea, abdominal pain, or abnormal bleeding; studies have found that one in six pregnancies occurring after tubal sterilization are ectopic. The authors present a clinical study of 82 cases of ectopic pregnancy admitted to the department of Obstetrics and Gynecology of Mahatma Gandhi Institute of Medical Sciences, Sevagram. Cases of ectopic pregnancy represent 0.99% of total obstetric admissions, of whom 69.51% were diagnosed as such on admission. 40.24% of the women were older than 30 years, while 34.14% were elderly beyond third parity. 70.73% of the women presented before missing their second period. Patients presented with multiple complaints, but the most common was abdominal pain reported by 61.70%. 78.04% were admitted with an acute abdomen, but shock was present in only 7.14% of cases. The main surgical treatment modality was salpingectomy among 59.75%. There was no maternal mortality through postoperative morbidity in the form of paralytic ileus, although fever did occur in some women.

  17. A syphilis co-infection study in human papilloma virus patients attended in the sexually transmitted infection ambulatory clinic, Santa Casa de Misericórdia Hospital, Rio de Janeiro, Brazil

    Directory of Open Access Journals (Sweden)

    Lúcia Maria de Sena Souza

    Full Text Available Despite the prevalence of syphilis worldwide, little is known about its manifestations when associated with other Sexually Transmitted Infections (STI, specifically the Human Papilloma Virus (HPV. Current epidemiological studies show that there is a high incidence of both diseases in ambulatory clinics all over Brazil. This study aims to estimate the incidence of syphilis - HPV co-infections, among patients from the STI ambulatory clinic at the Santa Casa da Misericórdia Hospital, Rio de Janeiro, Brazil. Two-hundred and seven patients were seen in the clinic between March and December 2005, of which 113 (54.6% sought care for an HPV infection. Blood samples were taken from all patients to check syphilis serology using the flocculation and the non-treponemic test or VDRL (Venereal Disease Research Laboratory and the TPHA (Treponema Pallidum Hemagglutination Assay treponemic and confirmatory method. Of the 207 patients, 113 (54.6% consulted referring to HPV as their primary complaint, and of these, 18 (15.9% also presented with positive syphilis serology, demonstrating a high incidence of coinfection. The average age of the patients varied between 20 and 25 years, 203 (98.1% were male and 4 (1.9% were female. The predominance of the male sex in this sample confirms the profile usually treated in STI clinics across the country, and the age range is that of typically high sexually activity. Conclusion: The results demonstrated the need for a differentiated examination of all STD patients.

  18. The mental representation of the human gait in patients with severe knee osteoarthrosis: a clinical study to aid understanding of impairment and disability.

    Science.gov (United States)

    Jacksteit, Robert; Mau-Moeller, Anett; Behrens, Martin; Bader, Rainer; Mittelmeier, Wolfram; Skripitz, Ralf; Stöckel, Tino

    2017-07-01

    Objectives were (1) to explore differences in gait-specific long-term memory structures and gait performance between knee osteoarthrosis patients and healthy subjects and (2) to identify the extent to which the gait-specific mental representation is associated with gait performance. Cross-sectional study. In total, 18 knee osteoarthrosis patients and 18 control subjects. Spatio-temporal (gait speed, step length) and temporophasic (stance time, swing time, single support time, total double support time) gait parameters and gait variability were measured with an electronic walkway (OptoGait). The mental representation was assessed using the structural dimensional analysis of mental representations (SDA-M). (1) Patients showed significantly longer stance times ( P representation as compared with the healthy controls. (2) Correlation analyses revealed the mental representation of the human gait to be associated with actual gait performance in osteoarthrosis patients. Double support times were positively associated with the structural quality of the mental representation and step length variability was positively associated with the number of sequencing errors in the representation. The gait-specific mental representation and actual gait performance differ between patients with severe knee osteoarthrosis and healthy controls, and both are linked to one another. This finding suggests that musculoskeletal disorders can lead to changes in the mental representation of the gait, and as such the SDA-M could provide useful information to improve the rehabilitation following osteoarthrosis.

  19. SU-E-QI-21: Iodinated Contrast Agent Time Course In Human Brain Metastasis: A Study For Stereotactic Synchrotron Radiotherapy Clinical Trials

    Energy Technology Data Exchange (ETDEWEB)

    Obeid, L; Esteve, F; Adam, J [Grenoble Institut des Neurosciences, La Tronche, Isere (France); Tessier, A; Balosso, J [Centre Hospitalier Universitaire, La Tronche, Isere (France)

    2014-06-15

    Purpose: Synchrotron stereotactic radiotherapy (SSRT) is an innovative treatment combining the selective accumulation of heavy elements in tumors with stereotactic irradiations using monochromatic medium energy x-rays from a synchrotron source. Phase I/II clinical trials on brain metastasis are underway using venous infusion of iodinated contrast agents. The radiation dose enhancement depends on the amount of iodine in the tumor and its time course. In the present study, the reproducibility of iodine concentrations between the CT planning scan day (Day 0) and the treatment day (Day 10) was assessed in order to predict dose errors. Methods: For each of days 0 and 10, three patients received a biphasic intravenous injection of iodinated contrast agent (40 ml, 4 ml/s, followed by 160 ml, 0.5 ml/s) in order to ensure stable intra-tumoral amounts of iodine during the treatment. Two volumetric CT scans (before and after iodine injection) and a multi-slice dynamic CT of the brain were performed using conventional radiotherapy CT (Day 0) or quantitative synchrotron radiation CT (Day 10). A 3D rigid registration was processed between images. The absolute and relative differences of absolute iodine concentrations and their corresponding dose errors were evaluated in the GTV and PTV used for treatment planning. Results: The differences in iodine concentrations remained within the standard deviation limits. The 3D absolute differences followed a normal distribution centered at zero mg/ml with a variance (∼1 mg/ml) which is related to the image noise. Conclusion: The results suggest that dose errors depend only on the image noise. This study shows that stable amounts of iodine are achievable in brain metastasis for SSRT treatment in a 10 days interval.

  20. A clinical study of retinoblastoma

    Directory of Open Access Journals (Sweden)

    L Subha

    2015-01-01

    Full Text Available Aim: The aim was to analyze general incidence, age incidence, laterality, common mode of presentation, staging of the tumor, radiological evidence, histopathological confirmation, management and follow-up of cases, which were diagnosed as retinoblastoma. Design: Interventional case series study from April 1997 to March 2000. Materials and Methods: Detailed history regarding the symptoms such as white reflex, watering, pain, redness, protrusion of eyeball, squint, hyphema, and defective vision were obtained. Family history regarding consanguinity between parents, health of the siblings and other relatives were recorded. Ocular examination included vision, pupillary reaction, detailed fundus examination, ocular tension, and corneal diameter. Investigations included X-ray orbit and skull, computed tomography scan orbit and brain, B-scan orbit, serum and aqueous lactate dehydrogenase; enucleated eyes were subjected to holoprosencephaly (HPE. Enucleation, radiotherapy, cryotherapy and chemotherapy were modalities of treatment. The empty socket and the other apparently normal eye were examined carefully at each visit. Results: The incidence of retinoblastoma is less when compared to other diseases of the eye. There was no sex predilection. Most of the cases diagnosed were sporadic and unilateral. Age of onset is earlier for bilateral cases than unilateral cases. Consanguinity bears close relationship with bilateral involvement. Predominant clinical sign is white reflex in the pupillary area. Majority of cases presented in the second stage of the disease. Enucleation plays a greater role in the management of retinoblastoma. HPE should include several sections of the optic nerve to find out skip lesions.

  1. Effects of insulin-induced hypoglycaemia on lipolysis rate, lipid oxidation and adipose tissue signalling in human volunteers: a randomised clinical study.

    Science.gov (United States)

    Voss, Thomas S; Vendelbo, Mikkel H; Kampmann, Ulla; Pedersen, Steen B; Nielsen, Thomas S; Johannsen, Mogens; Svart, Mads V; Jessen, Niels; Møller, Niels

    2017-01-01

    (also known as PNPLA2) or CGI-58 (also known as ABHD5) mRNA levels. These findings suggest that NEFAs become a major fuel source during insulin-induced hypoglycaemia and that lipolysis may be an important component of the counter-regulatory response. These effects appear to be mediated by rapid stimulation of protein kinase A (PKA) and HSL, compatible with activation of the β-adrenergic catecholamine signalling pathway. ClinicalTrials.gov NCT01919788 FUNDING: : The study was funded by Aarhus University, the Novo Nordisk Foundation and the KETO Study Group/Danish Agency for Science Technology and Innovation (grant no. 0603-00479, to NM).

  2. Survivin and NAIP in Human Benign Prostatic Hyperplasia: Protective Role of the Association of Serenoa repens, Lycopene and Selenium from the Randomized Clinical Study

    Science.gov (United States)

    Morgia, Giuseppe; Micali, Antonio; Rinaldi, Mariagrazia; Irrera, Natasha; Marini, Herbert; Puzzolo, Domenico; Pisani, Antonina; Privitera, Salvatore; Russo, Giorgio I.; Cimino, Sebastiano; Ieni, Antonio; Trichilo, Vincenzo; Altavilla, Domenica; Squadrito, Francesco; Minutoli, Letteria

    2017-01-01

    Benign prostatic hyperplasia (BPH) treatment includes the apoptosis machinery modulation through the direct inhibition of caspase cascade. We previously demonstrated that Serenoa repens (Ser) with lycopene (Ly) and selenium (Se) reawakened apoptosis by reducing survivin and neuronal apoptosis inhibitory protein (NAIP) levels in rats. The aim of this study was to evaluate the effectiveness of Ser-Se-Ly association on survivin and NAIP expression in BPH patients. Ninety patients with lower urinary tract symptoms (LUTS) due to clinical BPH were included in this randomized, double-blind, placebo-controlled trial. Participants were randomly assigned to receive placebo (Group BPH + placebo, n = 45) or Ser-Se-Ly association (Group BPH + Ser-Se-Ly; n = 45) for 3 months. At time 0, all patients underwent prostatic biopsies. After 3 months of treatment, they underwent prostatic re-biopsy and specimens were collected for molecular, morphological, and immunohistochemical analysis. After 3 months, survivin and NAIP were significantly decreased, while caspase-3 was significantly increased in BPH patients treated with Ser-Se-Ly when compared with the other group. In BPH patients treated with Ser-Se-Ly for 3 months, the glandular epithelium was formed by a single layer of cuboidal cells. PSA showed high immunoexpression in all BPH patients and a focal positivity in Ser-Se-Ly treated patients after 3 months. Evident prostate specific membrane antigen (PSMA) immunoexpression was shown in all BPH patients, while no positivity was present after Ser-Se-Ly administration. Ser-Se-Ly proved to be effective in promoting apoptosis in BPH patients. PMID:28327526

  3. Survivin and NAIP in Human Benign Prostatic Hyperplasia: Protective Role of the Association of Serenoa repens, Lycopene and Selenium from the Randomized Clinical Study

    Directory of Open Access Journals (Sweden)

    Giuseppe Morgia

    2017-03-01

    Full Text Available Benign prostatic hyperplasia (BPH treatment includes the apoptosis machinery modulation through the direct inhibition of caspase cascade. We previously demonstrated that Serenoa repens (Ser with lycopene (Ly and selenium (Se reawakened apoptosis by reducing survivin and neuronal apoptosis inhibitory protein (NAIP levels in rats. The aim of this study was to evaluate the effectiveness of Ser-Se-Ly association on survivin and NAIP expression in BPH patients. Ninety patients with lower urinary tract symptoms (LUTS due to clinical BPH were included in this randomized, double-blind, placebo-controlled trial. Participants were randomly assigned to receive placebo (Group BPH + placebo, n = 45 or Ser-Se-Ly association (Group BPH + Ser-Se-Ly; n = 45 for 3 months. At time 0, all patients underwent prostatic biopsies. After 3 months of treatment, they underwent prostatic re-biopsy and specimens were collected for molecular, morphological, and immunohistochemical analysis. After 3 months, survivin and NAIP were significantly decreased, while caspase-3 was significantly increased in BPH patients treated with Ser-Se-Ly when compared with the other group. In BPH patients treated with Ser-Se-Ly for 3 months, the glandular epithelium was formed by a single layer of cuboidal cells. PSA showed high immunoexpression in all BPH patients and a focal positivity in Ser-Se-Ly treated patients after 3 months. Evident prostate specific membrane antigen (PSMA immunoexpression was shown in all BPH patients, while no positivity was present after Ser-Se-Ly administration. Ser-Se-Ly proved to be effective in promoting apoptosis in BPH patients.

  4. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... Paper Kingdom Video Game National Broadcast Film (Under Development) Posters and Postcards Facebook Page Twitter Facebook YouTube Google+ SITE INDEX ACCESSIBILITY PRIVACY STATEMENT FOIA NO FEAR ACT OIG CONTACT US National Institutes of Health Department of Health and Human Services USA.gov

  5. Simultaneous determination of diosmin and diosmetin in human plasma by ion trap liquid chromatography-atmospheric pressure chemical ionization tandem mass spectrometry: Application to a clinical pharmacokinetic study.

    Science.gov (United States)

    Campanero, Miguel Angel; Escolar, Manuel; Perez, Guiomar; Garcia-Quetglas, Emilio; Sadaba, Belen; Azanza, Jose Ramon

    2010-03-11

    Diosmetin (3',5,7-trihydroxy-4'-methoxyflavone) is the aglycone of the flavonoid glycoside diosmin (3',5,7-trihydroxy-4'-methoxyflavone-7-ramnoglucoside). Diosmin is hydrolyzed by enzymes of intestinal micro flora before absorption of its aglycone diosmetin. A specific, sensitive, precise, accurate and robust HPLC assay for the simultaneous determination of diosmin and diosmetin in human plasma was developed and validated. Plasma samples were incubated with beta-glucuronidase/sulphatase. The analytes were isolated by liquid-liquid extraction with tert-butyl methyl ether at pH 2, and separated on a C(18) reversed-phase column using a mixture of methanol/1% formic acid (58:42, v/v) at a flow rate of 0.5ml/min. APCI in the positive ion mode and multiple reaction monitoring (MRM) method was employed. The selected transitions for diosmin, diosmetin and the internal standard (7-ethoxycoumarin) at m/z were: 609.0-->463.0, 301.2-->286.1 and 191, respectively. A good linearity was found in the range of 0.25-500ng/ml (R(2)>0.992) for both compounds. The intra-batch assay precision (CV) for diosmin and diosmetin ranged from 1.5% to 11.2% and from 2.8% to 12.5%, respectively, and the inter-batch precision were from 5.2% to 11.5% and 8.5% to 9.8%, respectively. The accuracy was well within the acceptable range the accuracies (from -2.7% to 4.2% and -1.6% to 3.5% for diosmin and diosmetin, respectively). The mean recoveries of diosmin, diosmetin and the internal standard were 87.5%, 89.2% and 67.2%. Stability studies showed that diosmin and diosmetin were stable in different conditions. Finally, the method was successfully applied to the pharmacokinetic study of diosmin in healthy volunteers following a single oral administration (Daflon).

  6. Human bite of the hand: clinical and surgical approach

    OpenAIRE

    Simancas-Pereira Hernán; Fonseca-Caro John Fredy; Acevedo-Granados Camilo Andrés

    2012-01-01

    Introduction: human bites of the hand carries a risk of infection and functional and/oraesthetic complications, according to the mechanism of trauma, duration and specificfactors of the victim and the aggressor. The management of acute episodes isessential and must be an interdisciplinary care.Objective: to review human bites of the hand.Methodology: Thematic review which included the evaluation of clinical casereports published in the last fifteen years in English and Spanish, obtained by el...

  7. Human Motion Video Analysis in Clinical Practice (Review)

    OpenAIRE

    V.V. Borzikov; N.N. Rukina; O.V. Vorobyova; A.N. Kuznetsov; A. N. Belova

    2015-01-01

    The development of new rehabilitation approaches to neurological and traumatological patients requires understanding of normal and pathological movement patterns. Biomechanical analysis of video images is the most accurate method of investigation and quantitative assessment of human normal and pathological locomotion. The review of currently available methods and systems of optical human motion analysis used in clinical practice is presented here. Short historical background is provi...

  8. A clinical and radiological evaluation of the relative efficacy of demineralized freeze-dried bone allograft versus anorganic bovine bone xenograft in the treatment of human infrabony periodontal defects: A 6 months follow-up study

    Directory of Open Access Journals (Sweden)

    Vikram Blaggana

    2014-01-01

    Full Text Available Background: The ultimate goal of periodontal therapy entails regeneration of the periodontal tissues lost as a consequence of periodontitis. Predictable correction of vertical osseous defects has however posed as a constant therapeutic challenge. The aim of our present study is to evaluate the relative efficacy of demineralized freeze-dried bone allograft (DFDBA vs anorganic bovine bone xenograft (ABBX in the treatment of human infrabony periodontal defects. Materials and Methods: 15 patients with 30 bilaterally symmetrical defect sites in either of the arches, in the age group of 25-50 years were selected as part of split-mouth study design. Defect-A (right side was grafted with DFDBA while Defect-B (left side was grafted with ABBX. Various clinical and radiographic parameters viz. probing depth(PD, clinical attachment level(CAL and linear bone fill were recorded preoperatively, 12- & 24-weeks postoperatively. Results: Both defect-A & defect-B sites exhibited a highly significant reduction in probing depth, and gain in clinical attachment level and linear bone fill at 12-weeks & at the end of 24-weeks. Comparative evaluation between the study groups revealed a statistically non-significant reduction in probing depth (P<0.1 and mean gain in linear bone fill (P<0.1. However, there was a statistically significant gain in clinical attachment level (P <0.05 in Defect-A (CD=0.356 as compared to Defect-B (CD=0.346. Conclusions: Within the limits of this study, both the materials viz. ABBX and DFDBA are beneficial for the treatment of periodontal infrabony defects. Both the materials were found to be equally effective in all respects except the gain in attachment level, which was found to be more with DFDBA. Long-term studies are suggested to evaluate further the relative efficacy of the two grafts.

  9. Preclinical animal study and human clinical trial data of co-electrospun poly(L-lactide-co-caprolactone and fibrinogen mesh for anterior pelvic floor reconstruction

    Directory of Open Access Journals (Sweden)

    Wu XJ

    2016-02-01

    Full Text Available Xujun Wu,1,2,* Yuru Wang,3,* Cancan Zhu,2 Xiaowen Tong,3 Ming Yang,2 Li Yang,2 Zhang Liu,1,2 Weihong Huang,2 Feng Wu,2 Honghai Zong,2 Huaifang Li,3 Hongbing He2,41School of Materials Science and Engineering, Shanghai Jiao Tong University, 2Shanghai Pine & Power Biotech Co. Ltd., 3Department of Obstetrics and Gynecology, Shanghai Tongji Hospital, Tongji University, 4Section of Tissue Engineering, Institute of Peripheral Vascular Surgery, Fudan University, Shanghai, People’s Republic of China*These authors contributed equally to this workAbstract: Synthetic and biological materials are commonly used for pelvic floor reconstruction. In this study, host tissue response and biomechanical properties of mesh fabricated from co-electrospun poly(L-lactide-co-caprolactone (PLCL and fibrinogen (Fg were compared with those of polypropylene mesh (PPM in a canine abdominal defect model. Macroscopic, microscopic, histological, and biomechanical evaluations were performed over a 24-week period. The results showed that PLCL/Fg mesh had similar host tissue responses but better initial vascularization and graft site tissue organization than PPM. The efficacy of the PLCL/Fg mesh was further examined in human pelvic floor reconstruction. Operation time, intraoperative blood loss, and pelvic organ prolapse quantification during 6-month follow-up were compared for patients receiving PLCL/Fg mesh versus PPM. According to the pelvic organ prolapse quantification scores, the anterior vaginal wall 3 cm proximal to the hymen point (Aa point, most distal edge of the cervix or vaginal cuff scar point (C point, and posterior fornix point (D point showed significant improvement (P<0.01 at 1, 3, and 6 months for both groups compared with preoperatively. At 6 months, improvements at the Aa point in the PLCL/Fg group were significantly more (P<0.005 than the PPM group, indicating that, while both materials improve the patient symptoms, PLCL/Fg mesh resulted in more obvious

  10. Clinical studies of IGFBP-2 by radioimmunoassay

    DEFF Research Database (Denmark)

    Blum, W F; Horn, N; Kratzsch, J

    1993-01-01

    A specific radioimmunoassay for human IGFBP-2 was developed using a polyclonal antiserum directed against a partial sequence (hIGFBP-2(176-190)). The tracer was prepared by radioiodination of a [Tyr]o-hIGFBP-2(176-190) derivative. The assay was used to study IGFBP-2 levels in numerous clinical...... and experimental situations. There was little circadian fluctuations of serum level which showed a marked age-dependence with high levels at birth and senescence and low levels during puberty. Decreased IGFBP-2 levels were present in untreated insulin-dependent diabetes mellitus (IDDM), in acromegaly and during...... dexamethasone suppression test. GH deficiency, fasting, IGF-I administration to patients with GH receptor deficiency, hepatic failure and insulinomas caused a moderate increase of serum IGFBP-2. Markedly elevated levels were found in chronic renal failure, non-islet cell tumour induced hypoglycemia...

  11. Human primary aldosteronism: from clinical observations to in-vivo and ex-vivo studies on the pressor effects of Urotensin II

    OpenAIRE

    menegolo, mirko

    2013-01-01

    In a patient affected by primary aldosteronism we have identified the presence of a pheochromocytoma not secreting catecholamines. The analysis of the transcriptome in the pheochromocytoma revealed a high expression of Urotensin II (UII). UII is a somatostatin-like cyclic 11-aminoacid vasoconstrictor peptide, first identified in the teleost fish caudal-neuro-secretory system and then in humans, that has been demonstrated to be a potent vasoactive peptide involved in the physiology and path...

  12. Evaluation of effectiveness of hyaluronic acid in combination with bioresorbable membrane (poly lactic acid-poly glycolic acid for the treatment of infrabony defects in humans: A clinical and radiographic study

    Directory of Open Access Journals (Sweden)

    Bhumika Sehdev

    2016-01-01

    Full Text Available Background: The combination of biomaterials, bone graft substitutes along with guided tissue regeneration (GTR has been shown to be an effective modality of periodontal regenerative therapy for infrabony defects. Therefore, the present randomized controlled clinical study was undertaken to evaluate the effectiveness of hyaluronic acid (HA in combination with bioresorbable membrane for the treatment of human infrabony defects. Materials and Methods: Twenty four infrabony defects in 20 systemically healthy patients were randomly assigned to test (HA in combination with bioresorbable membrane and control (bioresorbable membrane alone treatment groups. Probing pocket depth (PPD, relative attachment level, and relative gingival margin level were measured with a computerized Florida disc probe at baseline and at 6 months follow-up. Radiographic measurements were also evaluated at baseline and at 6 months of postsurgery. Results: At 6 months, the mean reduction in PPD in test group and control group was 4.52 mm and 2.97 mm, respectively. Significantly higher clinical attachment level with a gain of 2.20 mm was found in the test group as compared to control group. In addition, statistically significant greater reduction of radiographic defect depth was observed in the test group. Conclusion: Regenerative approach using hyaloss in combination with GTR for the treatment of human infrabony defects resulted in a significant added benefit in terms of CAL gains, PPD reductions and radiographic defect fill, as well as LBG, compared to the GTR alone.

  13. The Human Thioredoxin System: Modifications and Clinical Applications

    Directory of Open Access Journals (Sweden)

    Seyed Isaac Hashemy

    2011-03-01

    Full Text Available The thioredoxin system, comprising thioredoxin (Trx, thioredoxin reductase (TrxR and NADPH, is one of the major cellular antioxidant systems, implicated in a large and growing number of biological functions. Trx acts as an oxidoreductase via a highly conserved dithiol/disulfide motif located in the active site (-Trp-Cys-Gly-Pro-Cys-Lys-. Different factors are involved in the regulation of Trx activity, including its expression level, localization, protein-protein interactions, post-translational modifications and some chemical inhibitors. Mammalian TrxRs are selenoproteins which have a –Cys-Val-Asn-Val-Gly-Cys- N-terminal active site, as well as a C-terminal selenium-containing active site. Besides two Cys-residues in the redox-regulatory domain of cytosolic Trx (Trx1, human Trx1 has three additional Cys-residues. Post-translational modifications of human Trx1 which are involved in the regulation of its activity can happen via modification of Cys-residues including thiol oxidation, glutathionylation and S-nitrosylation or via modification of other amino acid residues such as nitration of Tyr-49. Because of the numerous functions of the thioredoxin system, its inhibition (mainly happens via the targeting TrxR can result in major cellular consequences, which are potentially pro-oxidant in nature, leading to cell death via necrosis or apoptosis if overexpression of Trx and other antioxidative enzymes can not recuperate cell response. Considering this feature, several anticancer drugs have been used which can inhibit TrxR. Elevated levels of Trx and/or TrxR have been reported in many different human malignancies, positively correlated with aggressive tumor growth and poor prognosis. Moreover, anti-oxidative and anti-apoptotic effects of Trx are reasons to study its clinical application as a drug.

  14. Anaerococcus nagyae sp. nov., isolated from human clinical specimens

    NARCIS (Netherlands)

    Veloo, A C M; Vries , de E. D.; Jean-Pierre, H; van Winkelhoff, A J

    We describe a new Anaerococcus species isolated from human clinical specimens. Analyses of 16S rRNA gene sequences of three strains showed <98% similarity with its closest relative Anaerococcus octavius. Phylogenetically the isolated strains form a cluster and can be differentiated from other

  15. Anal human papillomavirus DNA in women at a colposcopy clinic.

    NARCIS (Netherlands)

    Hauwers, K.W.M. d'

    2012-01-01

    OBJECTIVES: To describe the type-specific prevalence of anal and cervical human papillomavirus (HPV) infections and the cytology in HIV-negative women without a history of cervical cancer, attending a colposcopy clinic. To examine if an HPV positive anal smear is related to anal pathology and

  16. Anal human papillomavirus DNA in women at a colposcopy clinic.

    NARCIS (Netherlands)

    Hauwers, K.W.M. d'

    2012-01-01

    OBJECTIVES: To describe the type-specific prevalence of anal and cervical human papillomavirus (HPV) infections and the cytology in HIV-negative women without a history of cervical cancer, attending a colposcopy clinic. To examine if an HPV positive anal smear is related to anal pathology and conseq

  17. Anaerococcus degenerii sp nov., isolated from human clinical specimens

    NARCIS (Netherlands)

    Veloo, A. C. M.; Elgersma, P. E.; van Winkelhoff, A. J.

    Four clinical isolates of gram-positive strict anaerobic cocci were isolated from four different human mixed anaerobic infections. The taxonomical status of the four strains could not be established using standard identification techniques. The biochemical features of the strains were established

  18. Therapeutic Role of Rifaximin in Inflammatory Bowel Disease: Clinical Implication of Human Pregnane X Receptor Activation

    OpenAIRE

    Cheng, Jie; Yatrik M. Shah; Ma, Xiaochao; Pang, Xiaoyan; Tanaka, Toshiya; Kodama, Tatsuhiko; Krausz, Kristopher W.; Gonzalez, Frank J.

    2010-01-01

    Human pregnane X receptor (PXR) has been implicated in the pathogenesis of inflammatory bowel disease (IBD). Rifaximin, a human PXR activator, is in clinical trials for treatment of IBD and has demonstrated efficacy in Crohn's disease and active ulcerative colitis. In the current study, the protective and therapeutic role of rifaximin in IBD and its respective mechanism were investigated. PXR-humanized (hPXR), wild-type, and Pxr-null mice were treated with rifaximin in the dextran sulfate sod...

  19. Hydrodynamic IL10 Gene Transfer in Human Colon: Results from an "EX VIVO" Study with Potential Clinical Application in Crohn's Disease.

    Science.gov (United States)

    Frasson, Matteo; Sendra, Luis; Miguel, Antonio; Herrero, Maria José; Montalvá, Eva; López-Andújar, Rafael; Martínez-Pastor, Juan; Martí-Bonmatí, Luis; Granero, Eduardo García; Aliño, Salvador

    2017-08-01

    The aim of this work is to evaluate the efficacy of hydrodynamic venous IL10 gene delivery to "ex vivo" human colon segments and to determine its potential interest in Crohn's disease treatment. Twenty human colon segments were obtained from surgical resections. Hydrodynamic transfection through the main vein of the pedicle with 50 mL of hIL10 plasmid (20 μg/mL) solution was performed on 13 of them. Tissue sections were cultured and DNA, RNA, and protein copies were determined after 1, 2, and 4 days. Data obtained were compared with 6 nontransfected specimens. Finally, 1 specimen was injected with gold nanoparticles, and their distribution was examined under electron microscope. IL10 DNA levels were higher in treated tissues than in controls (P < 0.001), decreasing along time. The amount of hIL10 RNA was significantly increased in treated tissues when compared with controls (P = 0.001). The indexes of protein IL10 translation in treated groups were much higher (P < 0.001) than the basal production. The protein expression was higher in transfected tissue (10-50-fold, with respect to control tissue); this difference being established during the first hours and maintained during, at least, 4 days. With electron microscopy, we hardly observed large (15 nm) gold nanoparticles within the tissue, always in the submucosa. However, multiple small (4 nm) nanoparticles were observed within the cytoplasm of enterocytes in mucosa. Hydrodynamic procedure efficiently delivers the IL10 gene to the human colon, achieving levels of tissue protein expression high enough to mediate pharmacological effects with interest in controlling immune response in patients with Crohn's disease.

  20. Determination of Retinol, α-Tocopherol, Lycopene, and β-Carotene in Human Plasma Using HPLC with UV-Vis Detection: Application to a Clinical Study

    Directory of Open Access Journals (Sweden)

    Roman Kand’ár

    2013-01-01

    Full Text Available A method is described here for the simultaneous determination of retinol, α-tocopherol, lycopene, and β-carotene in human plasma. The effectiveness of various protein precipitants and extraction solvents was tested. After adequate sample preparation, the samples were injected directly into the HPLC system. The separation was realized on an analytical reversed-phase column with a UV-Vis detection. The analytical performance of this method was satisfactory. The intraassay and interassay coefficients of variation were below 10%. The recoveries were as follows: 97.0% (CV 2.4% for retinol, 94.6% (CV 1.7% for α-tocopherol, 91.9% (CV 3.6% for lycopene, and 93.9% (CV 4.2% for β-carotene. The levels of selected fat-soluble vitamins in plasma of patients with cardiovascular disease were measured and discussed.

  1. Human cysticercosis: parasitology, pathology, clinical manifestations and available treatment.

    Science.gov (United States)

    Webbe, G

    1994-10-01

    Human cysticercosis is a global health problem and neurocysticercosis a serious clinical syndrome. The diagnosis of neurocysticercosis can now be made with a high degree of accuracy by scrutiny of clinical signs and symptoms in combination with X-ray, computed tomography or magnetic resonance imaging, serological tests and laboratory examinations. Differential clinical diagnosis with tumor, and vascular and inflammatory conditions, may however, prove difficult in nonendemic areas. The management of cysticercosis has been radically changed by the advent of effective chemotherapy. Both the heterocyclic pyrazinoisoquinoline compound, praziquantel and the benzimidazole carbamate, albendazole, have now been extensively tested and successfully used for treatments of neurocysticercosis, usually in combination with corticosteroids. The definition of appropriate criteria and guidelines for the use of chemotherapy, may however, require further research. Surgical interventions continue to play an important role in certain clinical presentations. Recent advances in immunological research hold realistic promise for the development of a vaccine against Taenia solium.

  2. Obesity induction in hamster that mimics the human clinical condition.

    Science.gov (United States)

    Jordania da Silva, Vivian; Dias, Sílvia Regina Costa; Maioli, Tatiani Uceli; Serafim, Luciana Ribeiro; Furtado, Luis Fernando Viana; Quintão Silva, Maria da Gloria; Faria, Ana Maria Caetano de; Rabelo, Élida Mara Leite

    2017-08-05

    Although obesity is well established in hamsters, studies using diets with high levels of simple carbohydrate associated with lipids are necessary to assess the impact of this type of food in the body. In this study a high sugar and butter diet (HSB) and high temperature were employed towards this end. Obesity was successfully induced at a temperature of 30.3°C to 30.9°C after 38 days feeding the animals an HSB diet. It was shown that although diet is important for the induction of obesity, temperature is also essential because at a temperature slightly below the one required, obesity was not induced, even when the animals were fed for a longer period (150 days).The obese clinical condition was accompanied by biochemical and hematological changes, as increased cholesterol and triglyceride levels and increased leukocyte numbers, similar to alterations observed in obese humans. Furthermore, it was demonstrated that increasing the intake of simple carbohydrates associated with lipids provided evidence of inflammation in obese animals.

  3. Optimizing high-performance liquid chromatography method with fluorescence detection for quantification of tamoxifen and two metabolites in human plasma: application to a clinical study.

    Science.gov (United States)

    Zhu, Yu-Bing; Zhang, Qian; Zou, Jian-Jun; Yu, Cui-Xia; Xiao, Da-Wei

    2008-01-22

    We set an improved high-performance liquid chromatography method with fluorescence detection HPLC-FLU assay with more sensitivity and precision for the quantification of tamoxifen and two metabolites: 4-hydroxytamoxifen and N-desmethyltamoxifen. The compounds and internal standard, mexiletine, were separated with an Agilent Extend C18 column set at 65 degrees C and a mobile phase of methanol-1% triethylamine aqueous solution (pH 11; 82:18, v/v). The detection system utilized offline ultraviolet irradiation to convert the analytes to their respective photocyclisation products, followed by fluorescence detection (lambda ex=260 nm and lambda em=375 nm). The limits of quantification for tamoxifen, N-desmethyltamoxifen and 4-hydroxytamoxifen in plasma were improved to 0.5, 0.5 and 0.1 ng/ml, respectively. And the retention times for tamoxifen, N-desmethyltamoxifen and 4-hydroxytamoxifen were minimized to 11, 10 and 3.9 min, respectively. A single stage liquid-liquid extraction method for determination of these triphenylethylene drugs in plasma was developed, with high extraction efficiency and rapid sample treatment for target compounds. The method has been validated for use in a clinical bioavailability research of tamoxifen.

  4. [Introduction of neuroethics: out of clinic, beyond academia in human brain research].

    Science.gov (United States)

    Fukushi, Tamami; Sakura, Osamu

    2008-11-01

    Higher cognitive function in human brain is one of well-developed fields of neuroscience research in the 21st century. Especially functional magnetic resonance imaging (fMRI) and near infrared recording system have brought so many non-clinical researchers whose background is such as cognitive psychology, economics, politics, pedagogy, and so on, to the human brain mapping study. Authors have introduced the ethical issues related to incidental findings during the fMRI recording for non-clinical purpose, which is a typical problem derived from such expanded human brain research under non clinical condition, that is, neuroethics. In the present article we would introduce neuroethical issues in contexts of "out of clinic" and "beyond academia".

  5. Stress and coping in patients with clinical manifestation of Human papillomavirus

    OpenAIRE

    Hrvoje Cvitanovic; Mirna Šitum; Jelena Meštrović-Štefekov; Liborija Lugović-Mihić

    2017-01-01

    Stressful life events in response to a psychosocial trigger have been reported to negatively affect the course of infections. This study was based on patients with clinical manifestations of human papillomavirus (HPV) infection and a control group of patients with psoriasis who were admitted over a period of one year to the Dermatology Department of Karlovac General Hospital. A total of 122 patients participated in the study, either with a confirmed diagnosis of clinical manifestations of HP...

  6. 精神病患者入院人性化干预的临床研究%Psychiatric patients admitted to intervene in human clinical study

    Institute of Scientific and Technical Information of China (English)

    闻俊修

    2009-01-01

    Objective:Discussion on the families of psychiatric patients admitted to hospital the first time, anxiety factors related to the method of nursing intervention.With a view to provide better security More user-friendly services.Methods:Application of self-rating anxiety scale of 200 cases of first-time hospitalization of mental patients in the clinical data were analyzed retrospectively.Evaluation of the results of self-control line.With the rating scale norm control.Results:1 year to assist the number of hospitalized patients admitted to the same period accounted for 12.2 percent of the total number of 20~40-year-old majority in patients with schizophrenia,vocational workers and cadres to a maximum.Conclusion:The main reason for intervention in the rationale of life lost violence,physical condition,as well as self-injury, suicide.Intervention to psychological induced mainly forced bound supplemented Carried out to help mental patients admitted to effectively eased the difficulties of the families of the mentally ill Is a measure conducive to social stability.%目的:探讨首次入院精神病患者家属焦虑情绪的相关因素及干预方法,以期为社会提供更安全、更人性化的服务.方法:应用焦虑自评量表对200例首次入院精神病患者的临床资料进行回顾性分析,测评结果行自身对照,与量表常模对照.结果:1年来协助入院例数占同期入院总数的12.2%,以20~40岁的精神分裂症患者居多,以工人和干部最多.结论:以心理诱导为主、强迫约束为辅协助精神病患者入院可有效地缓解精神病患者家属的困难,是一项有利于社会安定的措施.

  7. Anaerococcus nagyae sp. nov., isolated from human clinical specimens.

    Science.gov (United States)

    Veloo, A C M; de Vries, E D; Jean-Pierre, H; van Winkelhoff, A J

    2016-04-01

    We describe a new Anaerococcus species isolated from human clinical specimens. Analyses of 16S rRNA gene sequences of three strains showed octavius. Phylogenetically the isolated strains form a cluster and can be differentiated from other species of the genus Anaerococcus based on its phenotypic characteristics and its MALDI-TOF MS profile. We propose the name Anaerococcus nagyae, with A. nagyae DSM101193 (accession number KU043522) as the type strain. Copyright © 2015 Elsevier Ltd. All rights reserved.

  8. Clinical Characteristics and Genetic Variability of Human Rhinovirus in Mexico

    Directory of Open Access Journals (Sweden)

    Hilda Montero

    2012-01-01

    Full Text Available Human rhinovirus (HRV is a leading cause of acute respiratory infection (ARI in young children and infants worldwide and has a high impact on morbidity and mortality in this population. Initially, HRV was classified into two species: HRV-A and HRV-B. Recently, a species called HRV-C and possibly another species, HRV-D, were identified. In Mexico, there is little information about the role of HRV as a cause of ARI, and the presence and importance of species such as HRV-C are not known. The aim of this study was to determine the clinical characteristics and genetic variability of HRV in Mexican children. Genetic characterization was carried out by phylogenetic analysis of the 5′-nontranslated region (5′-NTR of the HRV genome. The results show that the newly identified HRV-C is circulating in Mexican children more frequently than HRV-B but not as frequently as HRV-A, which was the most frequent species. Most of the cases of the three species of HRV were in children under 2 years of age, and all species were associated with very mild and moderate ARI.

  9. Population and clinical genetics of human transposable elements in the (post) genomic era

    Science.gov (United States)

    Rishishwar, Lavanya; Wang, Lu; Clayton, Evan A.; Mariño-Ramírez, Leonardo; McDonald, John F.; Jordan, I. King

    2017-01-01

    ABSTRACT Recent technological developments—in genomics, bioinformatics and high-throughput experimental techniques—are providing opportunities to study ongoing human transposable element (TE) activity at an unprecedented level of detail. It is now possible to characterize genome-wide collections of TE insertion sites for multiple human individuals, within and between populations, and for a variety of tissue types. Comparison of TE insertion site profiles between individuals captures the germline activity of TEs and reveals insertion site variants that segregate as polymorphisms among human populations, whereas comparison among tissue types ascertains somatic TE activity that generates cellular heterogeneity. In this review, we provide an overview of these new technologies and explore their implications for population and clinical genetic studies of human TEs. We cover both recent published results on human TE insertion activity as well as the prospects for future TE studies related to human evolution and health.

  10. Clinical and laboratory features of human dirofilariasis in Russia

    Directory of Open Access Journals (Sweden)

    Larisa Ermakova

    2017-01-01

    Our data are consistent with the opinion of KI Skriabin about that human as «dual facultative host» for dirofiliaria. It is rare that parasite in human body is able to develop to the imago stage (according to our observations – 11.4%. The immune response to invasion by dirofiliaria in human is manifested as dense connective tissue which forms a capsule. According to our study the rare cases (22 of detection the sexual mature D. repens (10.4% were localized inside the capsule. Observations of patients with D. repens infection allowed concluding that human for this helminth is «a biological deadend».

  11. [The clinical use of cryopreserved human skin allografts for transplantation].

    Science.gov (United States)

    Martínez-Flores, Francisco; Chacón-Gómez, María; Madinaveitia-Villanueva, Juan Antonio; Barrera-Lopez, Araceli; Aguirre-Cruz, Lucinda; Querevalu-Murillo, Walter

    2015-01-01

    The biological recovery of human skin allografts is the gold standard for preservation in Skin Banks. However, there is no worldwide consensus about specific allocation criteria for preserved human skin allografts with living cells. A report is presented on the results of 5 years of experience of using human skin allografts in burned patient in the Skin and Tissue Bank at the "Instituto Nacional de Rehabilitacion" The human skin allografts were obtained from multi-organ donors. processed and preserved at -80 °C for 12 months. Allocation criteria were performed according to blood type match, clinical history, and burned body surface. Up to now, the Skin and Tissue Bank at 'Instituto Nacional de Rehabilitacion" has processed and recovered 125,000 cm(2) of human skin allografts. It has performed 34 surgical implants on 21 burned patients. The average of burn body surface was 59.2%. More than two-thirds (67.7%) of recipients of skin allografts were matched of the same to type blood of the donor, and 66.6% survived after 126 days hospital stay. It is proposed to consider recipient's blood group as allocation criteria to assign tissue; and use human skin allografts on patiens affected with burns over 30% of body surface (according the "rule of the 9"). Copyright © 2015 Academia Mexicana de Cirugía A.C. Published by Masson Doyma México S.A. All rights reserved.

  12. Pyridoxine hydrochloride attenuate and decrease the depressant effects of meclizine on human psychomotor performance: Randomized clinical trial, cross-over study.

    Directory of Open Access Journals (Sweden)

    Hayder M. Al-kuraishy

    2011-12-01

    Full Text Available The present study was conducted to assess and compare the cognitive and psychomotor effects of Pyridoxine HCl 50mg and meclizine 25mg or both in 30healthy adult volunteers in a single blind, randomized cross over study. Following single dose of each drug, the volunteers were subjected to perform a series of tests of cognitive and psychomotor performance at 2 hours post dose. The Leeds Battery Psychomotor Instrument test consisted of both subjective and objective tests which were further grouped into Instrumental tests which included Simple reaction time (SRT, Choice Reaction Time Task (CRT and Critical Flicker Fusion frequency threshold (CFFT. Meclizine at dose of 25mg was significantly different from placebo (p0.05. The dual and combined effects of pyridoxine HCl 50mg plus meclizine 25mg attenuate and remove the depressant effects that mediated via meclizine. These results allow the conclusion that pyridoxine at its recommended therapeutic dose of 50mg is needed to be mixed with meclizine or others antihistamine to eliminate psychomotor and cognitive impairment as usual adverse effect of meclizine

  13. A combination of various functional food ingredients as a weight management program: randomized, placebo-controlled, and double-blind human clinical studies

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    Harunobu Amagase

    2011-12-01

    Full Text Available ABSTRACT:Background: Lycium barbarum increased the postprandial energy expenditure (PPEE. Negative energy balance caused by the systematic procedure (TAIslim® System, including increasing metabolic rate through physical activity, use of Lycium barbarum-containing TAIslim (Product A, and decreasing caloric intake by consuming a chewable confection (TAIslim SKINNY=Product B, and a meal replacement shake (TAIslim SHAKE=Product C, would be successful for weight loss.Methods: We examined TAIslim System on anthropometrics, appetite in Study 1 and PPEE in Study 2, both in a randomized, placebo-controlled, double-blind manner. 1 A total of 67 participants were randomized into 2 groups (placebo or TAIslim System. Intake procedures were: Product A, 60 ml (20 kcal b.i.d. immediately before breakfast and lunch, Product B, 1 chew (20 kcal t.i.d. between meals and after dinner; Product C, 40.5 g (158 kcal as breakfast. A calorie-restricted diet with multi-vitamin supplementation and daily exercise was required. Anthropometric parameters were assessed at baseline, 4, 8, and 12 w. 2 Appetite was measured using a subjective visual analog scale during the initial 3-7 days of intake. 3 For PPEE evaluation, 12 participants consumed a single bout of TAIslim System products or placebo, and took part in 6 study sessions. EE was measured by an indirect calorimeter immediately before (baseline and at 1, 2, and 4 h post-intake of samples.Results: 1 Body weight was significantly reduced by 6.2±0.7%, compared to pre-intervention with TAIslim System (P<0.01. Waist circumference, total body fat, blood pressure, and fasting blood glucose levels were also significantly reduced by TAIslim System, in a range of 3.8-9.9%. TAIslim System was significantly more effective than the placebo (P<0.05. The placebo group showed -0.1-3.9% reduction from pre-intervention with no significant difference. 2 TAIslim Functional Foods in Health and Disease 2011, 1(12:555-573System also

  14. Review of clinical and laboratory features of human Brucellosis

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    Mantur B

    2007-01-01

    Full Text Available Infection with Brucella spp. continues to pose a human health risk globally despite strides in eradicating the disease from domestic animals. Brucellosis has been an emerging disease since the discovery of Brucella melitensis by Sir David Bruce in 1887. Although many countries have eradicated B. abortus from cattle, in some areas B. melitensis and B. suis have emerged as causes of this infection in cattle, leading to human infections. Currently B. melitensis remains the principal cause of human brucellosis worldwide including India. The recent isolation of distinct strains of Brucella from marine mammals as well as humans is an indicator of an emerging zoonotic disease. Brucellosis in endemic and non-endemic regions remains a diagnostic puzzle due to misleading non-specific manifestations and increasing unusual presentations. Fewer than 10% of human cases of brucellosis may be clinically recognized and treated or reported. Routine serological surveillance is not practiced even in Brucella - endemic countries and we suggest that this should be a part of laboratory testing coupled with a high index of clinical suspicion to improve the level of case detection. The screening of family members of index cases of acute brucellosis in an endemic area should be undertaken to pick up additional unrecognised cases. Rapid and reliable, sensitive and specific, easy to perform and automated detection systems for Brucella spp. are urgently needed to allow early diagnosis and adequate antibiotic therapy in time to decrease morbidity / mortality. The history of travel to endemic countries along with exposure to animals and exotic foods are usually critical to making the clinical diagnosis. Laboratory testing is indispensable for diagnosis. Therefore alertness of clinician and close collaboration with microbiologist are essential even in endemic areas to correctly diagnose and treat this protean human infection. Existing treatment options, largely based on

  15. THE TISSUE HYDRATION STATE IN UW-PRESERVED HUMAN DONOR LIVERS - A CLINICAL-STUDY OF THE RELATION BETWEEN PROTON MAGNETIC-RESONANCE RELAXATION-TIMES, DONOR CONDITION, PRESERVATION PROCEDURE, AND EARLY GRAFT FUNCTION

    NARCIS (Netherlands)

    WOLF, RFE; DENBUTTER, G; KAMMAN, RL; DEKETH, HP; SLUTTER, WJ; SLOOFF, MJH

    1994-01-01

    To determine the relation between tissue hydration state-as indicated by tissue proton magnetic resonance relaxation times-in UW-preserved human donor livers and viability parameters of the donor and early graft function, ''ex vivo'' magnetic resonance relaxometry was performed with a clinical MR im

  16. THE TISSUE HYDRATION STATE IN UW-PRESERVED HUMAN DONOR LIVERS - A CLINICAL-STUDY OF THE RELATION BETWEEN PROTON MAGNETIC-RESONANCE RELAXATION-TIMES, DONOR CONDITION, PRESERVATION PROCEDURE, AND EARLY GRAFT FUNCTION

    NARCIS (Netherlands)

    WOLF, RFE; DENBUTTER, G; KAMMAN, RL; DEKETH, HP; SLUTTER, WJ; SLOOFF, MJH

    1994-01-01

    To determine the relation between tissue hydration state-as indicated by tissue proton magnetic resonance relaxation times-in UW-preserved human donor livers and viability parameters of the donor and early graft function, ''ex vivo'' magnetic resonance relaxometry was performed with a clinical MR

  17. CLINICAL STUDY OF DUODENAL PERFORATION

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    Sambasiva Rao

    2016-04-01

    Full Text Available BACKGROUND The duodenal injury can pose a formidable challenge to the surgeon and failure to manage it properly may have devastating results. Over the centuries, there was little to offer the patient of acute abdomen beyond cupping, purgation and enemas, all of which did more harm than good. It was not until 1884 that Mikulicz made an attempt to repair a perforation. Recent statistics indicate roughly 10% of population develop gastric or duodenal ulcer in life time. Roughly 1-3% of population above the age of 20 years have some degree of peptic ulcer activity during any annual period. A detailed history with regards to the signs and symptoms of the patient, a meticulous examination, radiological and biochemical investigations help to arrive at a correct preoperative diagnosis. In this study, a sincere effort has been put to understand the demographic patterns, to understand the underlying aetiology and to understand the effectiveness of the standard methods of investigation and treatment in use today. METHODS This is a 24 months prospective study i.e., from September 2011 to September 2013 carried out at Dr. Pinnamaneni Siddhartha Institute of Medical Sciences & Research Foundation. The study included the patients presenting to Dr. Pinnamaneni Siddhartha Institute of Medical Sciences & Research Foundation to emergency ward with signs and symptoms of hollow viscus perforation. The sample size included 30 cases of duodenal perforation. RESULTS Duodenal ulcer perforation commonly occurs in the age group of 30-60 years, but it can occur in any age group. Majority of the patients were male. Smoking and alcohol consumption were risk factors in most cases (53.3% for the causation of duodenal ulcer perforation. Sudden onset of abdominal pain, situated at epigastrium and right hypochondrium was a constant symptom (100%. Vomiting, constipation and fever were not so common. CONCLUSION The emergency surgical management for perforated duodenal ulcer is by

  18. Phase 2 Clinical Trial of Intraoral Grafting of Human Tissue-Engineered Oral Mucosa

    Science.gov (United States)

    2013-10-01

    Engineered Oral Mucosa   PRINCIPAL INVESTIGATOR: Stephen E. Feinberg DDS, MS, PhD CONTRACTING ORGANIZATION: University of Michigan Ann Arbor MI 4810...September 29, 4. TITLE AND SUBTITLE Phase II Clinical Trial of Intraoral Grafting of Human Tissue-Engineered Oral Mucosa   5a. CONTRACT NUMBER...human EVPOME for soft tissue intraoral grafting procedures compared to the “gold standard” palatal oral mucosa (POM) graft. The study will determine

  19. How important are human immunodeficiency virus (HIV) clinical markers to the long-term formal employment among people living with HIV in developing countries? A study in South Africa.

    Science.gov (United States)

    Odek, W O; Glendinning, A; Charalambous, S

    2014-01-01

    To examine the relationship of Human Immunodeficiency Virus (HIV) clinical markers and socio-demographic characteristics with long-term formal employment among people living with HIV (PLHIV). 554 adults, 55% females, on HIV treatment for at least two years at two public hospitals in Johannesburg, South Africa. A retrospective cohort design, tracing changes in study participants' formal employment status since the first HIV-positive diagnosis. Data collection included historical medical records review and interviewer-administered questionnaires. 44% of all study participants (39% and 49% among males and females, respectively) were formally employed at the time of the study, primarily in low-skilled jobs in the private sector. The majority (83%) of males and 60% of females remained in formal employment since being diagnosed as HIV-positive. Female gender, education to grade 12 or higher, a smaller household size and being married were significantly associated with current formal employment. Formal employment was unrelated to HIV treatment indicators (CD4 count, viral load and duration since diagnosis). Of those in formal employment, 68 (28%) were aware of HIV policies at their workplaces, which was also positively associated with the duration in their current employment. PLHIV in developing country contexts can enter into and maintain formal employment, especially when treatment and workplace support are available. Thus, employer organisations should implement effective workplace HIV policies to enhance employment experiences of their workforce living with HIV. Care and support services for people on HIV treatment should also address their career development needs.

  20. [Clinical research III. The causality studies].

    Science.gov (United States)

    Talavera, Juan O; Wacher-Rodarte, Niels H; Rivas-Ruiz, Rodolfo

    2011-01-01

    The need to solve a clinical problem leads us to establish a starting point to address (risk, prognosis or treatment studies), all these cases seek to attribute causality. Clinical reasoning described in the book Clinical Epidemiology. The architecture of clinical research, offers a simple guide to understanding this phenomenon. And proposes three basic components: baseline, maneuver and outcome. In this model, different systematic errors (bias) are described, which may be favored by omitting characteristics of the three basic components. Thus, omissions in the baseline characteristics cause an improper assembly of the population and susceptibility bias, omissions in the application or evaluation of the maneuver provoke performance bias, and omissions in the assessment of out-come cause detection bias and transfer bias. Importantly, if this way of thinking facilitates understanding of the causal phenomenon, the appropriateness of the variables to be selected in the studies to which attribute or not causality, require additional arguments for evaluate clinical relevance.

  1. Human bartonellosis: seroepidemiological and clinical features with an emphasis on data from Brazil - A review

    Directory of Open Access Journals (Sweden)

    C Lamas

    2008-05-01

    Full Text Available Bartonellae are fastidious Gram-negative bacteria that are widespread in nature with several animal reservoirs (mainly cats, dogs, and rodents and insect vectors (mainly fleas, sandflies, and human lice. Thirteen species or subspecies of Bartonella have been recognized as agents causing human disease, including B. bacilliformis, B. quintana, B. vinsonii berkhoffii, B. henselae, B. elizabethae, B. grahamii, B. washoensis, B. koehlerae, B. rocha-limaea, and B. tamiae. The clinical spectrum of infection includes lymphadenopathy, fever of unknown origin, endocarditis, neurological and ophthalmological syndromes, Carrion's disease, and others. This review provides updated information on clinical manifestations and seroepidemiological studies with an emphasis on data available from Brazil.

  2. [Clinical research XXIV. From clinical judgment to ethics in research on humans].

    Science.gov (United States)

    Pérez-Rodríguez, Marcela; Palacios-Cruz, Lino; Rivas-Ruiz, Rodolfo; Talavera, Juan O

    2014-01-01

    Bioethics in research is an essential part of the structured review process of an article and it is based on three fundamental principles: respect for persons, beneficence and justice. In addition to not providing valid knowledge, a research with inadequate design, execution and statistical analysis is not ethical either, since these methodological deficiencies will produce information that will not be useful and, therefore, the risks that the participants were exposed to will have been in vain. Beyond scientific validity, there are other aspects that outline if an investigation is ethical, such as the clinical and social value of a study, a fair selection of participants, favorable risk-benefit balance, an independent review, the informed consent and respect for participants and potential participants. Throughout the article here presented, the documents that profile the behavior of investigators to protect the participants, such as the Declaration of Helsinki, the national regulations that rule us and the differences between research without risk, with minimal risk and with greater than minimal risk are discussed. That like in daily life, behavior in research involving human participants must be self-regulated, ie, people with knowledge of the existence of the law discover that the man is outside the realm of nature where work is done under the necessity of natural causality, and falls within the scope of the will; only if the man is free to decide their actions may be a law regulating their action.

  3. Acid etching of human enamel in clinical applications: a systematic review.

    Science.gov (United States)

    Zhu, Jia Jun; Tang, Alexander T H; Matinlinna, Jukka P; Hägg, Urban

    2014-08-01

    The laboratory-based enamel acid-etching doctrine with 30% to 50% phosphoric acid for 60 seconds to generate the maximum amount of Type 1 and/or Type 2 etch pattern has been established for more than 30 years. However, this recommendation may not be clinically relevant. The purpose of this systematic review was to compare clinically accepted protocols of enamel acid etching with the laboratory protocol. Studies were identified by searching 4 electronic databases: Medline, CINAHL Plus, Embase, and Cochrane Library. The final search was run on November 8, 2012. All clinical studies published in English that investigated enamel acid pretreatment methods on human permanent teeth were included. Additional publications were obtained from the reference lists of the included studies. The clinical evidence of all included studies was tabulated. Initially, 4543 publications were retrieved from the databases. A total of 4508 articles were excluded, including 2285 duplicates, 1805 publications according to exclusion criteria by their titles and abstracts, 368 laboratory articles, 49 reviews, and 1 pilot study. Only 1 study was added from reference lists of the included studies. Finally, 36 clinical publications were included. The included clinical studies provided different levels of clinical evidence on the efficacy of acid-etching protocols to enable successful enamel adhesion. Clinical protocols of enamel acid etching differ from the laboratory-generated doctrine, which may imply that maximization of the Type 1 and/or Type 2 etch pattern is not important in the clinical acid etching of human enamel. Copyright © 2014 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

  4. Pathogenesis, developmental consequences, and clinical correlations of human embryo fragmentation.

    Science.gov (United States)

    Fujimoto, Victor Y; Browne, Richard W; Bloom, Michael S; Sakkas, Denny; Alikani, Mina

    2011-03-15

    This narrative review summarizes the current state of knowledge about human embryo fragmentation during IVF. The clinical relevance of fragmentation is discussed and evidence supporting a central role for the oocyte in the pathogenesis of fragmentation is presented. A mechanism of fragmentation as aberrant cell division involving the cytoskeleton is described along with the novel concept of membrane instability in relation to follicular high-density lipoprotein metabolism and cholesterol transport. Copyright © 2011 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  5. Investigation of standing-wave formation in a human skull for a clinical prototype of a large-aperture, transcranial MR-guided focused ultrasound (MRgFUS) phased array: an experimental and simulation study.

    Science.gov (United States)

    Song, Junho; Pulkkinen, Aki; Huang, Yuexi; Hynynen, Kullervo

    2012-02-01

    Standing-wave formation in an ex vivo human skull was investigated using a clinical prototype of a 30-cm diameter with 15-cm radius of curvature, low-frequency (230 kHz), hemispherical transcranial magnetic resonance-guided focused ultrasound phased array. Experimental and simulation studies were conducted with changing aperture size and f -number configurations of the phased array and qualitatively and quantitatively examined the acoustic pressure variation at the focus due to standing waves. The results demonstrated that the nodes and antinodes of standing wave produced by the small-aperture array were clearly seen at approximately every 3 mm. The effect of the standing wave became more pronounced as the focus was moved closer to skull base. However, a sharp focus was seen for the full array, and there was no such standing-wave pattern in the acoustic plane or near the skull base. This study showed that the fluctuation pressure amplitude would be greatly reduced by using a large-scale, hemispherical phased array with a low f-number.

  6. Vasoprotective effects of human CD34+ cells: towards clinical applications

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    Lerman Amir

    2009-07-01

    Full Text Available Abstract Background The development of cell-based therapeutics for humans requires preclinical testing in animal models. The use of autologous animal products fails to address the efficacy of similar products derived from humans. We used a novel immunodeficient rat carotid injury model in order to determine whether human cells could improve vascular remodelling following acute injury. Methods Human CD34+ cells were separated from peripheral buffy coats using automatic magnetic cell separation. Carotid arterial injury was performed in male Sprague-Dawley nude rats using a 2F Fogarty balloon catheter. Freshly harvested CD34+ cells or saline alone was administered locally for 20 minutes by endoluminal instillation. Structural and functional analysis of the arteries was performed 28 days later. Results Morphometric analysis demonstrated that human CD34+ cell delivery was associated with a significant reduction in intimal formation 4 weeks following balloon injury as compared with saline (I/M ratio 0.79 ± 0.18, and 1.71 ± 0.18 for CD34, and saline-treated vessels, respectively P Conclusion Delivery of human CD34+ cells limits neointima formation and improves arterial reactivity after vascular injury. These studies advance the concept of cell delivery to effect vascular remodeling toward a potential human cellular product.

  7. A Study of Brucella Infection in Humans

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    Hasanjani Roushan Mohammad Reza

    2014-07-01

    Full Text Available Objective: Brucellosis is the most usual zoonotic disease around the world especially in the Middle East, Mediterranean and Indian sub-continent areas. This bacterium has ten species that Brucella melitensis among them recognized as the most important cause of human brucellosis. This infection transfer ways to human include of wounds, bacteria inhalation and consumption of septic dairy such as raw milk, cream and butter. Brucellosis as a systemic disease can involve more organs of patients that have symptoms such as fever, night sweating, and backache. This infection can be divided as acute, sub-acute and chronic forms according to the manner of clinical presentation. Materials and Methods: This research is a review study and conducted by reviewing of the literature, which is related to this issue and also visiting, PubMed, and other linked websites. Results: In human brucellosis domestic animals are the main natural reservoir of infection. Whenever incidence rate of this infection in domestic and wild animals is reduced on the other hand incidence rate in human also will reduce. Conclusion: Blood cultures, serological tests and molecular tests are common laboratory methods of this infection. Diminution of relapse and therapeutic failure rates are as most important aim, which is researcher’s regards.

  8. Comparison of the regenerative potential of an allograft used alone and that in conjunction with an immunosuppressive drug in the treatment of human periodontal infrabony defects: A clinical and radiological study

    Directory of Open Access Journals (Sweden)

    Dhawan Shivani

    2010-01-01

    Full Text Available Background: Experimentation confirmed the conclusion that bone allografts, like other tissue and organ allografts, are immunogenic. These immune responses cause resorption of allograft, thus lowering the bone formation capacity of the graft. An attempt has been made in this study to prevent immune reactions and achieve enhanced regeneration of allograft-demineralized freeze-dried bone matrix by incorporating it with an immunosuppressive drug Cyclosporine-A (CsA in the treatment of human periodontal infrabony defects. Materials and Methods: Fifteen patients showing clinical evidence of almost bilateral infrabony defects requiring bone grafting procedures were selected. In each patient, the infrabony defect of one side of the arch was designated as Group A (control site and the infrabony defect of the contralateral side of the same arch was designated as Group B (test site. Results: On comparative evaluation of the two groups (by Student t-test, the mean values of reduction in probing depth (P=0.81 NS and gain in clinical attachment level (P=1.00 NS of Group B were found to be greater than that of Group-A, but the differences were statistically non-significant. The mean linear bone fill (P=0.010 FNx08 of Group B was also detected to be higher than that of Group A, and the difference was found to be statistically significant. Conclusion: Increase in linear bone fill in Group B signifies the role of CsA in augmenting the regenerative potential of allograft by eliminating immune reactions.

  9. A longitudinal study of empathy in pre-clinical and clinical medical students and clinical supervisors.

    Science.gov (United States)

    Mahoney, Sarah; Sladek, Ruth M; Neild, Tim

    2016-10-18

    Although appropriate empathy in health professionals is essential, a loss of empathy can occur during medical education. The structure of clinical learning may be one factor that is implicated in a loss of empathy. This study examines student and doctor empathy, and possible associations between empathy and the structure of clinical learning. There were three groups of participants: medical students (n = 281), who completed a longitudinal survey consisting of the Jefferson Scale of Empathy and an open question about empathy at the beginning and end of the 2013 academic year; private doctors (medical practitioners) in South Australia (n = 78) who completed a survey consisting of the Jefferson Scale of Empathy and an open question about empathy at the end of the students' academic year; and doctors (medical practitioners) from public teaching hospitals (n = 72) in southern Adelaide, South Australia who completed a survey consisting of the Jefferson Scale of Empathy at the end of the students' academic year . Year one students' empathy scores at the end of the year (102.8 ± 17.7) were significantly lower than at the start of the year (112.3 ± 9.6) p empathy scores by year groups or across the two time points. Empathy scores were almost identical for private and hospital clinicians and higher than average scores for students. Free-text comments highlighted the importance students and doctors place on empathy. Students described issues that adversely affected their empathy, including specific incidents, systemic issues, and course structure, but also described some positive role models. Doctors' comments focused on the importance of empathy but qualified its meaning in the therapeutic setting. Medical students and practitioners alike ascribe importance to empathy in clinical practice, yet its developmental course remains poorly understood with possible decrement across the course of medical education. A more sophisticated understanding of empathy

  10. Digital communication to support clinical supervision: considering the human factors.

    Science.gov (United States)

    Mather, Carey; Marlow, Annette; Cummings, Elizabeth

    2013-01-01

    During the last three years the School of Nursing and Midwifery at the University of Tasmania has used a needs assessment survey to explore the needs of organizations and nursing professionals that facilitate and clinically supervise Bachelor of Nursing students in the workplace. Findings from the survey indicated that staff at healthcare organizations wanted a communication strategy that was easily accessible by clinicians who supervised students during work integrated learning placements. In particular they wanted to receive timely information related to the role and function of supervisors in practice. The development of the digital strategy to strengthen the development of a community of practice between the University, organizations, facilities and clinical supervisors was identified as the key method of improving communication. Blogging and micro blogging were selected as methods of choice for the implementation of the digital strategy because they were easy to set up, use and enable equity of access to geographically dispersed practitioners in urban and rural areas. Change champions were identified to disseminate information about the strategy within their workplaces. Although clinicians indicated electronic communication as their preferred method, there were a number of human factors at a systems and individual level identified to be challenges when communicating with clinical supervisors who were based off-campus. Information communication technology policies and embedded culture towards social presence were impediments to using this approach in some organizations. Additionally, it was found that it is necessary for this group of clinicians to be educated about using digital methods to undertake their role as clinical supervisors in their varied clinical practice environments.

  11. Clinical human brucellosis in Malaysia: a case report

    Directory of Open Access Journals (Sweden)

    Tyagita Hartady

    2014-04-01

    Full Text Available Clinical human brucellosis is quite rare in Malaysia although seroconverters are relatively more. This report describes a case of clinical human brucellosis in Malaysia. This case involved a 29-year-old research assistant in a veterinary microbiology laboratory. She complained of intermittent fever, anorexia, profuse sweating, malaise, headache, normotensive (110/60 mm Hg, muscle pain, and arthralgia for 3 d. Blood tests against dengue and malaria were negative thus she was prescribed vitamin C, paracetamol and cough syrup for common flu. The complaints, however, persisted on and off for the next 1 month. She eventually developed anemia and hypotension (90/50 mm Hg and started to show reduced body weight. Abdominal palpations revealed hepatomegaly and splenomegaly with pain. Thus, brucellosis was suspected before the Rose-Bengal plate test was performed, which revealed the presence of high level of antibody against Brucella. The same test was repeated after 14 d and the results confirmed the presence of high antibody level against Brucella. Following serum agglutination test, a diagnosis of brucellosis was made and she was eventually prescribed rifampicine p.o. once a day combined with doxycycline p.o. twice a day for 6 consecutive weeks before she made a full recovery.

  12. Inhibitory Interneurons of The Human Neocortex after Clinical Death

    Directory of Open Access Journals (Sweden)

    V. A. Akulinin

    2016-01-01

    Full Text Available Objective: to analyze the human neocortex interneurons (areas 4, 10, 17 and 21 by Brodmann after cardiac arrest (clinical death.Materials and methods. The main group included patients (n=7, men who survived 7—10 days and 70—90 days after cardiac arrest and later died due to heart failure. The control group (n=4, men included individuals after sudden fatal accidents. The morphometric and histological analysis of 420 neocortical fields (Nissl#staining,calbindin D28k, neuropeptide Y was performed using light and confocal microscopy.Results. We verified all main types of interneurons (Basket, Martinotti, and neurogliaform interneurons in neocortex based on the morphology of their bodies and dendritic processes in both groups. The number of calbindin- and NPY-positive neurons in the neocortex was similar in the control and in the postoperative period.However, calbindin- and NPY-immunopositive structure fields including neuronal cell bodies and their dendrites were significantly more represented in neocortex of patients from the main group. Maximum increase in common square in the relative areas of calbindin-immunopositive structures was observed 90 days after ischemia. The squares of NPY#immunopositive fields became larger seven days after resuscitation and remained increased on 90th day post-resuscitation.Conclusion. Our findings demonstrate an increase of calbindin and NPY expression in human neocortex after clinical death, which can be explained by a compensatory  eaction of undamaged inhibitory cortical interneurons directed to protectbrain from ischemia.

  13. Clinical-epidemiological study of leptospirosis in humans and reservoirs in Yucatán, México Estudio clínico-epidemiológico de leptospirosis en humanos y reservorios en Yucatán, México

    Directory of Open Access Journals (Sweden)

    Ignacio VADO-SOLÍS

    2002-12-01

    Full Text Available A leptospirosis clinical-epidemiological study was made in humans and reservoirs in the state of Yucatán, México. Interviews and serological analyses were made on 400 persons from an open population, 439 probable cases of leptospirosis and 1060 animal reservoirs (cows, pigs, dogs, rats and opossums. IgM Leptospira DipstickTM and Microscopic Agglutination Test (MAT was used to detect human antibodies to leptospiras and serovar respectively. Leptospirosis incidence in humans was 2.2/100,000 inhab. in 1998, 0.7/100,000 in 1999 and 0.9/100,000 in 2000. Overall seroprevalence was 14.2%, relatively unchanged from seroprevalences observed 20 years ago. Highest seropositivity was found in people over 56 years of age, predominating males over females. Predominant serovars in the open population were tarassovi, hardjo, pomona and panama. Leptospirosis cases were most frequent in rural areas, and the anicteric course predominated over the icteric. The panama, icterohaemorrhagiae and pomona serovars predominated in both anicteric and icteric courses. Dogs, pigs and rodents had the highest seropositivity among the reservoirs. Contact with rodents and natural water sources were significant factors (p £ 0.05. Human cases (74% occurred during the rainy season. It is concluded that leptospirosis is still a serious illness with important clinical and epidemiological implications in the state of Yucatán, Mexico.Un estudio clínico-epidemiológico de leptospirosis fue realizado en humanos y reservorios en el estado de Yucatán, México. Se entrevistaron y analizaron mediante serología 400 personas en población abierta, 439 pacientes sospechosos y 1060 reservorios (bovinos, cerdos, perros, roedores y zarigüeyas. En humanos para la detección de anticuerpos se utilizó IgM Dipstick LeptospiraTM y la prueba de aglutinación microscópica (MAT para detectar serovar. La incidencia en humanos fue de 2.2/100,000, 0.7/100,000 y 0.9/100,000 habitantes para los a

  14. Comparison of different culture conditions for human mesenchymal stromal cells for clinical stem cell therapy

    DEFF Research Database (Denmark)

    Haack-Sorensen, M.; Friis, T.; Bindslev, L.

    2008-01-01

    OBJECTIVE: Mesenchymal stromal cells (MSCs) from adult bone marrow (BM) are considered potential candidates for therapeutic neovascularization in cardiovascular disease. When implementing results from animal trials in clinical treatment, it is essential to isolate and expand the MSCs under...... used for MSC cultivation in animal studies simulating clinical stem cell therapy. MATERIAL AND METHODS: Human mononuclear cells (MNCs) were isolated from BM aspirates by density gradient centrifugation and cultivated in a GMP-accepted medium (EMEA medium) or in one of four other media. RESULTS: FACS...... conditions following good manufacturing practice (GMP). The aims of the study were first to establish culture conditions following GMP quality demands for human MSC expansion and differentiation for use in clinical trials, and second to compare these MSCs with MSCs derived from culture in four media commonly...

  15. Resistance to antivirals in human cytomegalovirus: mechanisms and clinical significance.

    Science.gov (United States)

    Pérez, J L

    1997-09-01

    Long term therapies needed for managing human cytomegalovirus (HCMV) infections in immunosupressed patients provided the background for the emergence of the resistance to antivirals active against HCMV. In addition, laboratory selected mutants have also been readily achieved. Both clinical and laboratory resistant strains share the same determinants of resistance. Ganciclovir resistance may be due to a few mutations in the HCMV UL97 gene and/or viral DNA pol gene, the former being responsible for about 70% of clinical resistant isolates. Among them, V464, V594, S595 and F595 are the most frequent mutations. Because of their less extensive clinical use, much less is known about resistance to foscarnet and cidofovir (formerly, HPMPC) but in both cases, it has been associated to mutations in the DNA pol. Ganciclovir resistant strains showing DNA pol mutations are cross-resistant to cidofovir and their corresponding IC50 are normally higher than those from strains harboring only mutations at the UL97 gene. To date, foscarnet resistance seems to be independent of both ganciclovir and cidofovir resistance.

  16. Liver Effects of Clinical Drugs Differentiated in Human Liver Slices

    Directory of Open Access Journals (Sweden)

    Alison E. M. Vickers

    2017-03-01

    Full Text Available Drugs with clinical adverse effects are compared in an ex vivo 3-dimensional multi-cellular human liver slice model. Functional markers of oxidative stress and mitochondrial function, glutathione GSH and ATP levels, were affected by acetaminophen (APAP, 1 mM, diclofenac (DCF, 1 mM and etomoxir (ETM, 100 μM. Drugs targeting mitochondria more than GSH were dantrolene (DTL, 10 μM and cyclosporin A (CSA, 10 μM, while GSH was affected more than ATP by methimazole (MMI, 500 μM, terbinafine (TBF, 100 μM, and carbamazepine (CBZ 100 μM. Oxidative stress genes were affected by TBF (18%, CBZ, APAP, and ETM (12%–11%, and mitochondrial genes were altered by CBZ, APAP, MMI, and ETM (8%–6%. Apoptosis genes were affected by DCF (14%, while apoptosis plus necrosis were altered by APAP and ETM (15%. Activation of oxidative stress, mitochondrial energy, heat shock, ER stress, apoptosis, necrosis, DNA damage, immune and inflammation genes ranked CSA (75%, ETM (66%, DCF, TBF, MMI (61%–60%, APAP, CBZ (57%–56%, and DTL (48%. Gene changes in fatty acid metabolism, cholestasis, immune and inflammation were affected by DTL (51%, CBZ and ETM (44%–43%, APAP and DCF (40%–38%, MMI, TBF and CSA (37%–35%. This model advances multiple dosing in a human ex vivo model, plus functional markers and gene profile markers of drug induced human liver side-effects.

  17. Liver Effects of Clinical Drugs Differentiated in Human Liver Slices.

    Science.gov (United States)

    Vickers, Alison E M; Ulyanov, Anatoly V; Fisher, Robyn L

    2017-03-07

    Drugs with clinical adverse effects are compared in an ex vivo 3-dimensional multi-cellular human liver slice model. Functional markers of oxidative stress and mitochondrial function, glutathione GSH and ATP levels, were affected by acetaminophen (APAP, 1 mM), diclofenac (DCF, 1 mM) and etomoxir (ETM, 100 μM). Drugs targeting mitochondria more than GSH were dantrolene (DTL, 10 μM) and cyclosporin A (CSA, 10 μM), while GSH was affected more than ATP by methimazole (MMI, 500 μM), terbinafine (TBF, 100 μM), and carbamazepine (CBZ 100 μM). Oxidative stress genes were affected by TBF (18%), CBZ, APAP, and ETM (12%-11%), and mitochondrial genes were altered by CBZ, APAP, MMI, and ETM (8%-6%). Apoptosis genes were affected by DCF (14%), while apoptosis plus necrosis were altered by APAP and ETM (15%). Activation of oxidative stress, mitochondrial energy, heat shock, ER stress, apoptosis, necrosis, DNA damage, immune and inflammation genes ranked CSA (75%), ETM (66%), DCF, TBF, MMI (61%-60%), APAP, CBZ (57%-56%), and DTL (48%). Gene changes in fatty acid metabolism, cholestasis, immune and inflammation were affected by DTL (51%), CBZ and ETM (44%-43%), APAP and DCF (40%-38%), MMI, TBF and CSA (37%-35%). This model advances multiple dosing in a human ex vivo model, plus functional markers and gene profile markers of drug induced human liver side-effects.

  18. Atlas of the clinical genetics of human dilated cardiomyopathy

    DEFF Research Database (Denmark)

    Haas, Jan; Frese, Karen S; Peil, Barbara;

    2015-01-01

    : This is to our knowledge, the first study that comprehensively investigated the genetics of DCM in a large-scale cohort and across a broad gene panel of the known DCM genes. Our results underline the high analytical quality and feasibility of Next-Generation Sequencing in clinical genetic diagnostics and provide...... a sound database of the genetic causes of DCM....

  19. PPB | What is a Clinical Study

    Science.gov (United States)

    The Pleuropulmonary blastoma (PPB) DICER1 Syndrome Study ‹an observational clinical research study‹is enrolling children with PPB and their families. In an observational study, investigators assess health outcomes in groups of participants according to a protocol or research plan.

  20. Clinical and Epidemiological Studies on Rickettsial Infections.

    Science.gov (United States)

    1980-06-01

    EPIDEMOLOGICAL STUDIES ON RICKETTSIAL INFECTI011-"- APPLICATION FOR RENEWAL FOR TEAR-7 (1979-1980) Pase 2 Repor Page 11 effective control of the infection were...34CLINICAL AND EPIDEMOLOGICAL STUDIES ON RICKETTSIAL INFECTIONS" ANINUAL REPORT. YFAR-7(1979-1980) Page 62 Report Page 31 OFFICE OF NAVAL RESEARCH

  1. Summary reports for key Hoodia clinical studies

    CSIR Research Space (South Africa)

    Maharaj, VJ

    2011-12-01

    Full Text Available The CSIR has acquired the reports to 14 clinical studies in which Hoodia has been assesses, using crude extracts and concentrated active ingredients formulated in a number of different ways. In many of the studies Hoodia was found to be generally...

  2. Isolation, cryopreservation and culture of human amnion epithelial cells for clinical applications.

    Science.gov (United States)

    Murphy, Sean V; Kidyoor, Amritha; Reid, Tanya; Atala, Anthony; Wallace, Euan M; Lim, Rebecca

    2014-12-21

    Human amnion epithelial cells (hAECs) derived from term or pre-term amnion membranes have attracted attention from researchers and clinicians as a potential source of cells for regenerative medicine. The reason for this interest is evidence that these cells have highly multipotent differentiation ability, low immunogenicity, and anti-inflammatory functions. These properties have prompted researchers to investigate the potential of hAECs to be used to treat a variety of diseases and disorders in pre-clinical animal studies with much success. hAECs have found widespread application for the treatment of a range of diseases and disorders. Potential clinical applications of hAECs include the treatment of stroke, multiple sclerosis, liver disease, diabetes and chronic and acute lung diseases. Progressing from pre-clinical animal studies into clinical trials requires a higher standard of quality control and safety for cell therapy products. For safety and quality control considerations, it is preferred that cell isolation protocols use animal product-free reagents. We have developed protocols to allow researchers to isolate, cryopreserve and culture hAECs using animal product-free reagents. The advantage of this method is that these cells can be isolated, characterized, cryopreserved and cultured without the risk of delivering potentially harmful animal pathogens to humans, while maintaining suitable cell yields, viabilities and growth potential. For researchers moving from pre-clinical animal studies to clinical trials, these methodologies will greatly accelerate regulatory approval, decrease risks and improve the quality of their therapeutic cell population.

  3. Characterization of clinical and environmental Mycobacterium avium spp. isolates and their interaction with human macrophages.

    Directory of Open Access Journals (Sweden)

    Evelyn Guirado

    Full Text Available Members of the Mycobacterium avium complex (MAC are naturally occurring bacteria in the environment. A link has been suggested between M. avium strains in drinking water and clinical isolates from infected individuals. There is a need to develop new screening methodologies that can identify specific virulence properties of M. avium isolates found in water that predict a level of risk to exposed individuals. In this work we have characterized 15 clinical and environmental M. avium spp. isolates provided by the US Environmental Protection Agency (EPA to improve our understanding of the key processes involved in the binding, uptake and survival of these isolates in primary human macrophages. M. avium serovar 8 was predominant among the isolates studied. Different amounts and exposure of mannose-capped lipoarabinomannan (ManLAM and glycopeptidolipids (GPLs, both major mycobacterial virulence factors, were found among the isolates studied. Reference clinical isolate 104 serovar 1 and clinical isolates 11 and 14 serovar 8 showed an increased association with macrophages. Serum opsonization increased the cell association and survival at 2 h post infection for all isolates. However, only the clinical isolates 104 and 3 among those tested showed an increased growth in primary human macrophages. The other isolates varied in their survival in these cells. Thus we conclude that the amounts of cell envelope ManLAM and GPL, as well as GPL serovar specificity are not the only important bacterial factors for dictating the early interactions of M. avium with human macrophages.

  4. Human studies of cannabinoids and medicinal cannabis.

    Science.gov (United States)

    Robson, P

    2005-01-01

    Cannabis has been known as a medicine for several thousand years across many cultures. It reached a position of prominence within Western medicine in the nineteenth century but became mired in disrepute and legal controls early in the twentieth century. Despite unremitting world-wide suppression, recreational cannabis exploded into popular culture in the 1960s and has remained easily obtainable on the black market in most countries ever since. This ready availability has allowed many thousands of patients to rediscover the apparent power of the drug to alleviate symptoms of some of the most cruel and refractory diseases known to humankind. Pioneering clinical research in the last quarter of the twentieth century has given some support to these anecdotal reports, but the methodological challenges to human research involving a pariah drug are formidable. Studies have tended to be small, imperfectly controlled, and have often incorporated unsatisfactory synthetic cannabinoid analogues or smoked herbal material of uncertain composition and irregular bioavailability. As a result, the scientific evaluation of medicinal cannabis in humans is still in its infancy. New possibilities in human research have been opened up by the discovery of the endocannabinoid system, a rapidly expanding knowledge of cannabinoid pharmacology, and a more sympathetic political environment in several countries. More and more scientists and clinicians are becoming interested in exploring the potential of cannabis-based medicines. Future targets will extend beyond symptom relief into disease modification, and already cannabinoids seem to offer particular promise in the treatment of certain inflammatory and neurodegenerative conditions. This chapter will begin with an outline of the development and current status of legal controls pertaining to cannabis, following which the existing human research will be reviewed. Some key safety issues will then be considered, and the chapter will conclude with

  5. Supporting human interaction and human resources coordination in distributed clinical guidelines.

    Science.gov (United States)

    Bottrighi, Alessio; Torchio, Mauro; Montani, Stefania; Molino, Gianpaolo; Terenziani, Paolo

    2010-01-01

    Clinical guidelines (GL) play an important role in medical practice: the one of optimizing the quality of patient care on the basis of the best and most recent evidence based medicine. In order to achieve this goal, the interaction between different actors, who cooperate in the execution of the same GL, is a crucial issue. As a matter of fact, in many cases (e.g. in chronic disease treatment) the GL execution requires that patient treatment is not performed/completed in the hospital, but is continued in different contexts (e.g. at home, or in the general practitioner's ambulatory), under the responsibility of different actors. In this situation, the correct interaction and communication between the actors themselves is critical for the quality of care, and human resources coordination is a key issue to be addressed by the managers of the involved healthcare service. In this paper we describe how computerized GL management can be extended in order to support such needs, and we illustrate our approach by means of a practical case study.

  6. Does awareness of status and risks of human immunodeficiency virus impact risky transmission behavior among infected adolescents? A case study of clients Attending an Antiretroviral Therapy (ART clinic in Kano, Kano State, Nigeria

    Directory of Open Access Journals (Sweden)

    Umar Muhammad Lawan

    2016-01-01

    Full Text Available Background: Human immunodeficiency virus (HIV-positive adolescents by virtue of their position are prone to dangerous behaviors including risk-taking for HIV transmission. Objective: To determine the awareness of HIV status and risk factors for HIV transmission among HIV-positive adolescents, and how these impact their behavior. Materials and Methods: A case study approach was used to study a random sample of 400 HIV-positive adolescent children attending an antiretroviral (ART clinic in Kano, Kano State, Nigeria. Data were analyzed using Statistical Package for the Social Sciences (SPSS 16.0 computer statistical software. Result: The mean age of the adolescents was 14.9 ± 3.15 years. The majority were females (54.8% from a polygamous family (57.5%. About two-thirds or 251 (62.8% patients knew their HIV status. The age of 14 years and above (z = 11.36, P = 0.0001 and having at least secondary school level of education (z = 2.78, P = 0.005 were significantly associated with awareness of HIV status on binary logistic regression. Up to 311 (77.8% patients had good awareness of the risks of HIV transmission. Awareness of risk of HIV transmission was associated with awareness of HIV status (X 2 = 166.2, P = 0.0001. There was a significant variation in the behaviors between those who were aware of their HIV status and those who were not. Paradoxically, the percentage differences in risk-taking were remarkably high in all the variables examined, and were all in the direction of the adolescents who had good knowledge of the risk factors for HIV transmission. Conclusion and Recommendation: Health ministries, development partners working in this field, and behavioral change communication experts should develop formidable strategies for addressing this menace. There is also a dire need for further research in this area.

  7. [Clinical use of recombinant human thrombopoietin. Status and perspectives].

    Science.gov (United States)

    Hansen, P B; Hasselbalch, H C

    2001-05-07

    Thrombopoietin (TPO) is primarily produced by hepatocytes and regulates the production and differentiation of megakaryocytes and platelets in the bone marrow. The endogenous TPO level is increased when the megakaryocyte count is low, and high in aplastic anaemia and after myeloablative chemotherapy. TPO is cloned and manufactured by a recombinant technique for clinical use. Treatment with recombinant human TPO (rhTPO) after intensive chemotherapy may reduce the need for platelet transfusions. Administration of granulocyte colony-stimulating factor in combination with rhTPO has enhanced the mobilisation and harvest product of haematopoietic stem cells. Whether rhTPO is effective in the treatment of the myelodysplastic syndrome, aplastic anaemia, and other conditions with bone marrow insufficiency (including AIDS) is not yet known. In liver cirrhosis, the endogenous TPO level rapidly increases after liver transplantation. Accordingly, substitution of rhTPO may be indicated in advanced liver failure complicated by thrombocytopenia and bleeding.

  8. Hepcidin modulation in human diseases: From research to clinic

    Institute of Scientific and Technical Information of China (English)

    Alberto Piperno; Raffaella Mariani; Paola Trombini; Domenico Girelli

    2009-01-01

    By modulating hepcidin production, an organism controls intestinal iron absorption, iron uptake and mobilization from stores to meet body iron need. In recent years there has been important advancement in our knowledge of hepcidin regulation that also has implications for understanding the physiopathology of some human disorders. Since the discovery of hepcidin and the demonstration of its pivotal role in iron homeostasis, there has been a substantial interest in developing a reliable assay of the hormone in biological fluids. Measurement of hepcidin in biological fluids can improve our understanding of iron diseases and be a useful tool for diagnosis and clinical management of these disorders. We reviewed the literature and our own research on hepcidin to give an updated status of the situation in this rapidly evolving field.

  9. [Recent knowledge on the linkage of strain specific genotypes with clinical manifestations of human citomegalovirus disease].

    Science.gov (United States)

    Pignatelli, Sara

    2011-01-01

    Human citomegalovirus (CMV) is a beta-herpesvirus able to establish lifelong persistent infections which usually remain asymptomatic. However, severe diseases may develop in immunocompromised subjects (e.g., AIDS patients and transplant recipients) and if acquired in utero. Circulating CMV clinical strains display genetic polymorphisms in multiple genes, which may be implicated in CMV-induced immunopathogenesis, as well as strain-specific tissue-tropism, viral spread in the host cells and virulence, finally determining the wide spectrum of clinical manifestations of CMV disease. Current literature report a number of studies regarding the main CMV polymorphic genes (UL55-gB, UL144, UL73-gN, UL74-gO), their diagnostic and therapeutic impact, their potential clinical relevance as prognostic markers. This paper aims to critically analyse the results of these studies and evaluate the linkage of strain-specific genotypes with clinical manifestations of CMV disease and their perspective implications.

  10. Marketing and clinical trials: a case study.

    Science.gov (United States)

    Francis, David; Roberts, Ian; Elbourne, Diana R; Shakur, Haleema; Knight, Rosemary C; Garcia, Jo; Snowdon, Claire; Entwistle, Vikki A; McDonald, Alison M; Grant, Adrian M; Campbell, Marion K

    2007-11-20

    Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, of 12 factors that may affect the success of the marketing and sales activities associated with clinical trials. The case study demonstrates that trials need various categories of people to buy in - hence, to be successful, trialists must embrace marketing strategies to some extent. The performance of future clinical trials could be enhanced if trialists routinely considered these factors.

  11. Clinical evidence for Japanese population based on prospective studies--linking clinical trials and clinical practice.

    Science.gov (United States)

    Ogawa, Hisao; Kojima, Sunao

    2009-10-01

    "Evidence-based medicine (EBM)" implies effective and high quality practice for patients based on well-grounded medical science. The success of clinical trials in Japan is essential to build original evidence specific for Japanese patients. Based on this concept, we have performed several large-scale clinical trials to provide EBM, including the Japanese Antiplatelets Myocardial Infarction Study [JAMIS; clinical improvement in acute myocardial infarction (AMI) patients with antiplatelet therapy], the Japanese beta-Blockers and Calcium Antagonists Myocardial Infarction (JBCMI; comparison of the effects of beta-blockers and calcium antagonists on cardiovascular events in post-AMI patients), a multicenter study for aggressive lipid-lowering strategy by HMG-CoA reductase inhibitors in patients with AMI (MUSASHI; effects of statin therapy on cardiovascular events in patients with AMI), and the Japanese Primary Prevention of Atherosclerosis with Aspirin for Diabetes (JPAD trial; efficacy of low-dose aspirin therapy for primary prevention of atherosclerotic events in type 2 diabetic patients). The results of these prospective studies were directly linked with clinical practice. We have acquired the know-how of large-scale clinical trials; an important point is to have passion for "buildup evidence specific for the Japanese" and to recruit subjects for enrollment after explaining the significance of "clinical trials for the Japanese".

  12. Human tolerogenic DC-10: perspectives for clinical applications

    Directory of Open Access Journals (Sweden)

    Amodio Giada

    2012-09-01

    Full Text Available Abstract Dendritic cells (DCs are critically involved in inducing either immunity or tolerance. During the last decades efforts have been devoted to the development of ad hoc methods to manipulate DCs in vitro to enhance or stabilize their tolerogenic properties. Addition of IL-10 during monocyte-derived DC differentiation allows the induction of DC-10, a subset of human tolerogenic DCs characterized by high IL-10/IL-12 ratio and co-expression of high levels of the tolerogenic molecules HLA-G and immunoglobulin-like transcript 4. DC-10 are potent inducers of adaptive type 1 regulatory T cells, well known to promote and maintain peripheral tolerance. In this review we provide an in-depth comparison of the phenotype and mechanisms of suppression mediated by DC-10 and other known regulatory antigen-presenting cells currently under clinical development. We discuss the clinical therapeutic application of DC-10 as inducers of type 1 regulatory T cells for tailoring regulatory T-cell-based cell therapy, and the use of DC-10 as adoptive cell therapy for promoting and restoring tolerance in T-cell-mediated diseases.

  13. Pathogen inactivation of human serum facilitates its clinical use for islet cell culture and subsequent transplantation.

    Science.gov (United States)

    Ståhle, Magnus U; Brandhorst, Daniel; Korsgren, Olle; Knutson, Folke

    2011-01-01

    Serum is regarded as an essential supplement to promote survival and growth of cells during culture. However, the potential risk of transmitting diseases disqualifies the use of serum for clinical cell therapy in most countries. Hence, most clinical cell therapy programs have replaced human serum with human serum albumin, which can result in inferior quality of released cell products. Photochemical treatment of different blood products utilizing Intercept® technology has been shown to inactivate a broad variety of pathogens of RNA and DNA origin. The present study assesses the feasibility of using pathogen-inactivated, blood group-compatible serum for use in human pancreatic islet culture. Isolated human islets were cultured at 37°C for 3-4 days in CMRL 1066 supplemented with 10% of either pathogen-inactivated or nontreated human serum. Islet quality assessment included glucose-stimulated insulin release (perifusion), ADP/ATP ratio, cytokine expression, and posttransplant function in diabetic nude mice. No differences were found between islets cultured in pathogen-inactivated or control serum regarding stimulated insulin release, intracellular insulin content, and ADP/ATP ratio. Whether media was supplemented with treated or nontreated serum, islet expression of IL-6, IL-8, MCP-1, or tissue factor was not affected. The final diabetes-reversal rate of mice receiving islets cultured in pathogen-inactivated or nontreated serum was 78% and 87%, respectively (NS). As reported here, pathogen-inactivated human serum does not affect viability or functional integrity of cultured human islets. The implementation of this technology for RNA- and DNA-based pathogen inactivation should enable reintroduction of human serum for clinical cell therapy.

  14. RETINAL VEIN OCCLUSIONS - A CLINICAL STUDY

    Directory of Open Access Journals (Sweden)

    Ramadevi

    2015-11-01

    Full Text Available Retinal vein occlusion is the most common retinal occlusive disorder encountered by opthalmologists and is usually associated with a variable amount of visual loss.The study was conducted over a period of 22 months, we performed a combined analysis of risk factors, clinical presentation, management and complication of these 51 patients

  15. Spirulina in Clinical Practice: Evidence-Based Human Applications

    OpenAIRE

    Karkos, P. D.; Leong, S. C.; C. D. Karkos; Sivaji, N.; Assimakopoulos, D. A.

    2011-01-01

    Spirulina or Arthrospira is a blue-green alga that became famous after it was successfully used by NASA as a dietary supplement for astronauts on space missions. It has the ability to modulate immune functions and exhibits anti-inflammatory properties by inhibiting the release of histamine by mast cells. Multiple studies investigating the efficacy and the potential clinical applications of Spirulina in treating several diseases have been performed and a few randomized controlled trials and sy...

  16. Good clinical practices in phase I studies.

    Science.gov (United States)

    Decousus, H; Perpoint, B; Mismetti, P; Ollagnier, M; Queneau, P

    1990-01-01

    In France, official guidelines for good clinical practices in clinical trials were issued in 1987. In December 1988, a law was passed that fixed the requirements for carrying out experiments in healthy subjects. It will be completed by official guidelines for the structures in which experiments on healthy subjects (and patients as well, when the investigation would not benefit the health of the patients) may be conducted. Hence a battery of recent legal instructions precisely state what good clinical practices are in the setting of phase I studies. Of particular importance are: subject recruitment and selection methods and procedures; specific competence of the investigator, in particular to interpret the pre-trial data; necessary and sufficient facilities to guarantee the subjects' safety; careful quality control to check all laboratory procedures; necessity of written standard operating procedures.

  17. Animal models that best reproduce the clinical manifestations of human intoxication with organophosphorus compounds.

    Science.gov (United States)

    Pereira, Edna F R; Aracava, Yasco; DeTolla, Louis J; Beecham, E Jeffrey; Basinger, G William; Wakayama, Edgar J; Albuquerque, Edson X

    2014-08-01

    The translational capacity of data generated in preclinical toxicological studies is contingent upon several factors, including the appropriateness of the animal model. The primary objectives of this article are: 1) to analyze the natural history of acute and delayed signs and symptoms that develop following an acute exposure of humans to organophosphorus (OP) compounds, with an emphasis on nerve agents; 2) to identify animal models of the clinical manifestations of human exposure to OPs; and 3) to review the mechanisms that contribute to the immediate and delayed OP neurotoxicity. As discussed in this study, clinical manifestations of an acute exposure of humans to OP compounds can be faithfully reproduced in rodents and nonhuman primates. These manifestations include an acute cholinergic crisis in addition to signs of neurotoxicity that develop long after the OP exposure, particularly chronic neurologic deficits consisting of anxiety-related behavior and cognitive deficits, structural brain damage, and increased slow electroencephalographic frequencies. Because guinea pigs and nonhuman primates, like humans, have low levels of circulating carboxylesterases-the enzymes that metabolize and inactivate OP compounds-they stand out as appropriate animal models for studies of OP intoxication. These are critical points for the development of safe and effective therapeutic interventions against OP poisoning because approval of such therapies by the Food and Drug Administration is likely to rely on the Animal Efficacy Rule, which allows exclusive use of animal data as evidence of the effectiveness of a drug against pathologic conditions that cannot be ethically or feasibly tested in humans.

  18. Left ventricular noncompaction: Clinical-echocardiographic study

    Directory of Open Access Journals (Sweden)

    Nikolić Aleksandra

    2012-01-01

    Full Text Available Background/Aim. Left ventricular noncompaction (LVNC is a disorder in endomyocardial morphogenesis, seen either isolated (in the absence of other cardiac anomalies or in association with congenital heart disease and some neuromuscular diseases. Intrauterine arrest of the compaction of myocardial fibers is postulated to be the reason of LVNC. Recognition of this condition is extremely important due to its high mortality and morbidity that lead to progressive heart failure, ventricular arrhythmias and thromboembolic events. The aim of this study was to determine the prevalence and clinical presentation of LVNC among consecutive outpatients according to clinical and echocardiographyic findings. Methode. A total of 3,854 consecutive patients examined at the Institute for Cardiovascular Diseases within a period January 2006 - January 2007 were included in the study. All the patients underwent echocardiographic examination using the same equipment (Vivid 7, GE Medical System. Echocardiographic parameters and clinical presentation in patients with echocardiographic criteria for LVNC were analyzed. Results. Analyzing 3,854 consecutive outpatients, using two-dimensional Color Doppler echocardiography from January 2006 to January 2007, 12 patients met the criteria for LVNC. Seven of them were male. The mean age at diagnosis was 45 ± 15 years. Analyzing clinical manifestation of LVNC it was found that seven patients had signs of heart failure, six had arrhythmias with no embolic events. Conclusion. Our results suggest that the real prevalence of LVNC may be higher than expected. New studies have to be done to solve this problem.

  19. Human genetics after the bomb: Archives, clinics, proving grounds and board rooms.

    Science.gov (United States)

    Lindee, Susan

    2016-02-01

    In this paper I track the history of post-1945 human genetics and genomics emphasizing the importance of ideas about risk to the scientific study and medical management of human heredity. Drawing on my own scholarship as it is refracted through important new work by other scholars both junior and senior, I explore how radiation risk and then later disease risk mattered to the development of genetics and genomics, particularly in the United States. In this context I excavate one of the central ironies of post-war human genetics: while studies of DNA as the origin and cause of diseases have been lavishly supported by public institutions and private investment around the world, the day-to-day labor of intensive clinical innovation has played a far more important role in the actual human experience of genetic disease and genetic risk for affected families. This has implications for the archival record, where clinical interactions are less readily accessible to historians. This paper then suggests that modern genomics grew out of radiation risk; that it was and remains a risk assessment science; that it is temporally embedded as a form of both prediction and historical reconstruction; and that it has become a big business focused more on risk and prediction (which can be readily marketed) than on effective clinical intervention.

  20. Developing clinical skills in paediatric dysphagia management using human patient simulation (HPS).

    Science.gov (United States)

    Ward, Elizabeth C; Hill, Anne E; Nund, Rebecca L; Rumbach, Anna F; Walker-Smith, Katie; Wright, Sarah E; Kelly, Kris; Dodrill, Pamela

    2015-06-01

    The use of simulated learning environments to develop clinical skills is gaining momentum in speech-language pathology training programs. The aim of the current study was to examine the benefits of adding Human Patient Simulation (HPS) into the university curriculum in the area of paediatric dysphagia. University students enrolled in a mandatory dysphagia course (n = 29) completed two, 2-hour HPS scenarios: (a) performing a clinical feeding assessment with a medically complex infant; and (b) conducting a clinical swallow examination (CSE) with a child with a tracheostomy. Scenarios covered technical and non-technical skills in paediatric dysphagia management. Surveys relating to students' perceived knowledge, skills, confidence and levels of anxiety were conducted: (a) pre-lectures; (b) post-lectures, but pre-HPS; and (c) post-HPS. A fourth survey was completed following clinical placements with real clients. Results demonstrate significant additive value in knowledge, skills and confidence obtained through HPS. Anxiety about working clinically reduced following HPS. Students rated simulation as very useful in preparing for clinical practice. Post-clinic, students indicated that HPS was an important component in their preparation to work as a clinician. This trial supports the benefits of incorporating HPS as part of clinical preparation for paediatric dysphagia management.

  1. Clinical experience with recombinant human thrombopoietin in chemotherapy-induced thrombocytopenia.

    Science.gov (United States)

    Vadhan-Raj, S

    2000-04-01

    Since the identification and cloning of c-Mpl ligand, two forms of recombinant human thrombopoietin have undergone clinical development. Both the full-length molecule, known as rhTPO, and the truncated version of the molecule, known as pegylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF), have been evaluated in phase I/II clinical trials in cancer patients receiving myelosuppressive chemotherapy. Early clinical trials with PEG-rHuMGDF in cancer patients demonstrated its clinical safety and platelet-stimulating activity. However, the development of neutralizing antibodies and clinically significant thrombocytopenia in some patients and normal donors who received PEG-rHuMGDF have led to discontinuation of clinical trials with this molecule in the United States. Clinical experience with rhTPO so far indicates that this full-length glycosylated molecule is remarkably well tolerated and has a favorable safety profile. In these studies, rhTPO exhibited dose-dependent increases in circulating platelet counts and bone marrow megakaryocytes before chemotherapy. In addition, there was an increase in the frequency and proliferation of bone marrow progenitor cells and mobilization of progenitors into the peripheral blood. Early results also showed that rhTPO can attenuate chemotherapy-induced severe thrombocytopenia and reduce the need for platelet transfusions. However, in this setting, the optimal schedule of rhTPO administration may depend on the length of the regimen and anticipated timing of the platelet nadir. These initial results indicate that rhTPO is a safe and potentially useful agent in the prevention and management of chemotherapy-induced thrombocytopenia. Results of larger randomized clinical trials will determine the therapeutic potential of this novel growth factor in various clinical settings.

  2. Spirulina in clinical practice: evidence-based human applications.

    Science.gov (United States)

    Karkos, P D; Leong, S C; Karkos, C D; Sivaji, N; Assimakopoulos, D A

    2011-01-01

    Spirulina or Arthrospira is a blue-green alga that became famous after it was successfully used by NASA as a dietary supplement for astronauts on space missions. It has the ability to modulate immune functions and exhibits anti-inflammatory properties by inhibiting the release of histamine by mast cells. Multiple studies investigating the efficacy and the potential clinical applications of Spirulina in treating several diseases have been performed and a few randomized controlled trials and systematic reviews suggest that this alga may improve several symptoms and may even have an anticancer, antiviral and antiallergic effects. Current and potential clinical applications, issues of safety, indications, side-effects and levels of evidence are addressed in this review. Areas of ongoing and future research are also discussed.

  3. Spirulina in Clinical Practice: Evidence-Based Human Applications

    Directory of Open Access Journals (Sweden)

    P. D. Karkos

    2011-01-01

    Full Text Available Spirulina or Arthrospira is a blue-green alga that became famous after it was successfully used by NASA as a dietary supplement for astronauts on space missions. It has the ability to modulate immune functions and exhibits anti-inflammatory properties by inhibiting the release of histamine by mast cells. Multiple studies investigating the efficacy and the potential clinical applications of Spirulina in treating several diseases have been performed and a few randomized controlled trials and systematic reviews suggest that this alga may improve several symptoms and may even have an anticancer, antiviral and antiallergic effects. Current and potential clinical applications, issues of safety, indications, side-effects and levels of evidence are addressed in this review. Areas of ongoing and future research are also discussed.

  4. Comparative clinical and radiographic evaluation of mineralized cancellous bone allograft (puros®) and autogenous bone in the treatment of human periodontal intraosseous defects: 6-months follow-up study

    Science.gov (United States)

    Reddy, B. Ravinder; Sudhakar, J.; Rajesh, Nichenametla; Sandeep, V.; Reddy, Y. Muralidhar; Gnana Sagar, W. R.

    2016-01-01

    Aims: Several materials have been introduced as bone grafts, i.e., autografts, allograft, xenografts, and alloplastic grafts, and studies have shown them to produce greater clinical bone defect fill than open flap debridement alone. The aim of this clinical and radiological 6-month study was to compare and evaluate the clinical outcome of deep intraosseous defects following reconstructive surgery with the use of mineralized cancellous bone allograft (Puros®) or autogenous bone. Materials and Methods: Ten patients with 12 sites exhibiting signs of moderate generalized chronic periodontitis were enrolled in the study. The investigations were confined to two and three-walled intra bony defects with a preoperative probing depth of ≥5 mm. Six of these defects were treated with Puros® (group A) the remaining six were treated with autogenous bone graft (group B). Allocation to the two groups was randomized. The clinical parameters, plaque index (PI), gingival index (GI), probing pocket depth (PPD), clinical attachment level (CAL), and bone fill, were recorded at different time intervals at the baseline, 1 month, 3 months, and 6 months. Intraoral radiographs were taken using standardized paralleling cone technique at baseline, 1, 3, and 6 months. Statistical analysis was done by using the one-way analysis of variance (ANOVA) followed by Tukey highly significant difference. Results: Both groups resulted in decrease in probing depth (group A, 3.0 mm; group B, 2.83 mm) and gain in clinical attachment level (group A, 3.33 mm; group B, 3.0 mm) over a period of 6 months, which was statistically insignificant. Conclusion: Within the limitations of the present study, it can be concluded that both mineralized cancellous bone allograft (Puros®) or autogenous bone result in significant clinical improvements. PMID:28217545

  5. Isolation and clinical sample typing of human leptospirosis cases in Argentina.

    Science.gov (United States)

    Chiani, Yosena; Jacob, Paulina; Varni, Vanina; Landolt, Noelia; Schmeling, María Fernanda; Pujato, Nazarena; Caimi, Karina; Vanasco, Bibiana

    2016-01-01

    Leptospira typing is carried out using isolated strains. Because of difficulties in obtaining them, direct identification of infective Leptospira in clinical samples is a high priority. Multilocus sequence typing (MLST) proved highly discriminatory for seven pathogenic species of Leptospira, allowing isolate characterization and robust assignment to species, in addition to phylogenetic evidence for the relatedness between species. In this study we characterized Leptospira strains circulating in Argentina, using typing methods applied to human clinical samples and isolates. Phylogenetic studies based on 16S ribosomal RNA gene sequences enabled typing of 8 isolates (6 Leptospira interrogans, one Leptospira wolffii and one Leptospira broomii) and 58 out of 85 (68.2%) clinical samples (55 L. interrogans, 2 Leptospira meyeri, and one Leptospira kirschneri). MLST results for the L. interrogans isolates indicated that five were probably Canicola serogroup (ST37) and one was probably Icterohaemorrhagiae serogroup (ST17). Eleven clinical samples (21.6%), provided MLST interpretable data: five were probably Pyrogenes serogroup (ST13), four Sejroe (ST20), one Autumnalis (ST22) and one Canicola (ST37). To the best of our knowledge this study is the first report of the use of an MLST typing scheme with seven loci to identify Leptospira directly from clinical samples in Argentina. The use of clinical samples presents the advantage of the possibility of knowing the infecting strain without resorting to isolates. This study also allowed, for the first time, the characterization of isolates of intermediate pathogenicity species (L. wolffii and L. broomii) from symptomatic patients.

  6. Orbitofrontal sulcal and gyrus pattern in human: an anatomical study

    OpenAIRE

    Thiago Pereira Rodrigues; Mariana Athaniel Silva Rodrigues; Daniel de Araújo Paz; Marcos Devanir Silva da Costa; Ricardo Silva Centeno; Feres Eduardo Chaddad Neto; Sergio Cavalheiro

    2015-01-01

    The anatomical characterization of the orbitofrontal cortex in human is limited in literature instead of many functional and clinical studies involving it. Objective Anatomically define the orbitofrontal region aiming to possible neurosurgical treatments and unify the scientific nomenclature as well. Method We analyze eighty four human hemispheres using a surgical microscope. Then we chose four hemispheres and dissect them according to Klinger’ technique. Results We found five main sulc...

  7. Can clinical tests help monitor human papillomavirus vaccine impact?

    Science.gov (United States)

    Meites, Elissa; Lin, Carol; Unger, Elizabeth R; Steinau, Martin; Patel, Sonya; Markowitz, Lauri E; Hariri, Susan

    2013-09-01

    As immunization programs for human papillomavirus (HPV) are implemented more widely around the world, interest is increasing in measuring their impact. One early measurable impact of HPV vaccine is on the prevalence of specific HPV types in a population. In low-resource settings, a potentially attractive strategy would be to monitor HPV prevalence using clinical cervical cancer screening test results to triage specimens for HPV typing. We assessed this approach in a nationally representative population of U.S. females aged 14-59 years. Using self-collected cervico-vaginal swab specimens from 4,150 women participating in the National Health and Nutrition Examination Survey during 2003-2006, we evaluated type-specific HPV prevalence detected by the Roche linear array (LA) research test on all specimens, compared with type-specific HPV prevalence detected by LA conducted only on specimens positive by the digene hybrid capture 2 (HC-2) clinical test. We calculated weighted prevalence estimates and their 95% confidence intervals (CIs), and examined relative type-specific HPV prevalence according to the two testing approaches. The population prevalence of oncogenic HPV vaccine types 16/18 was 6.2% (CI:5.4-7.1) by LA if all specimens were tested, and 2.4% (CI:1.9-3.0) if restricted to positive HC-2. Relative prevalence of individual HPV types was similar for both approaches. Compared with typing all specimens, a triage approach would require testing fewer specimens, but a greater reduction in HPV prevalence or a larger group of specimens would be needed to detect vaccine impact. Further investigation is warranted to inform type-specific HPV monitoring approaches around the world.

  8. Reversal of dental fluorosis: A clinical study.

    Science.gov (United States)

    Mehta, Dhaval N; Shah, Jigna

    2013-01-01

    This study was conducted to evaluate the clinical reversal of dental fluorosis with various combinations of calcium, vitamin D3, and ascorbic acid, along with changes in levels of certain biochemical parameters concerned with dental fluorosis. The role of fluoride level of drinking water in the etiology of dental fluorosis and the prevalence of dental fluorosis in both dentitions and teeth were also assessed. A total number of 50 patients with clinical features of dental fluorosis without trauma and any adverse habits were selected. Of these, in 30 co-operative patients, estimation of water fluoride level and pretreatment and post-treatment serum and urine fluoride levels were done with ion selective electrode method. The selected 30 patients were divided into three groups, that is, group A, group B, and group C, and were given various combinations of medications like calcium with vitamin D3 supplements, ascorbic acid with vitamin D3 supplements, and chlorhexidine mouthwash (placebo) for three months, respectively. These 30 patients were assessed for any change in the clinical grading of dental fluorosis. No change in clinical grading of dental fluorosis was noted. Considerable reduction in serum and urine fluoride levels was noted in both group A and group B patients. Dental fluorosis was noted in permanent teeth more commonly than deciduous teeth, and permanent maxillary central incisors had the highest prevalence rate. This study comprises only 30 patients with three months of follow-up. So, this sample of patients and duration of follow-up period are conclusive to observe changes in biochemical parameters but not sufficient to observe changes in clinical grading.

  9. Nail disorders in children, a clinical study

    Directory of Open Access Journals (Sweden)

    Ayşe Akbaş

    2016-04-01

    Full Text Available Introduction: Aims of the study to investigate the frequency and the nature ofnail disorders in children significant clinical data is available. Nail disorders although common in children in some parts of our country. This study was carried out to document the clinical and demographic pattern of nail disorders in a dermatology outpatient clinic of a pediatric hospital in Ankara, Turkey. Material and Methods: All consecutive patients a total of 3000 children from age 0-16 were admitted to dermatology outpatient clinic of Ankara Pediatric Hematology and Oncology Education and Research Hospital during January 2011 to December 2011 were studied and retrospectively evaluated for age, gender, drug use, diseases, systemic or genetic disorders and demographic features. Diagnostic evaluation results were noted and patients were categorized for demographic features and diagnosis. Results: These 133 patients (M: F 58:75, %44 vs 56, respectively were under 16 years of age and have 17 different dermatological disorders related with nail symptoms. Fifty three of (39,8% these patient were under 2 years of age, 31 (23.3% were between 3-5 years, 30 (22.5% were between 6-11 years old, 19 of 133 (14%, 2 were between 11-16 years of age. Through all of ages and independent of gender the most etiologies of nail disorders were, onychomadesis, paronychia, onycholysis, onychomycosis and systemic nail presentation of systemic dermatosis. Conclusion: Nail disorders are different in children than in adults. In our study, the first 5 years of age was found in 53% of nail disorders. Nail disorders are uncommon but may be seen as a part of a systemic disease and may be associated with cosmetic and psychologic problem.

  10. Clinical and histopathological study of palmoplantar keratoderma

    Directory of Open Access Journals (Sweden)

    Mahajan P

    1994-01-01

    Full Text Available Study of palmo-plantar keratoderma in eighty-two cases showed that twenty different diseases, both hereditary and acquired were responsible for palmoplantar keratoderma. Maximum number of cases were of hereditary variety of palmoplantar keratoderma (Unna-Thost syndrome (28.05%. Whereas psoriasis was the leading cause among the acquired conditions (17.07%. Two histopathological types of Unna-Thost syndrome and their correlation with clinical features are reported.

  11. Drug Insight: the role of leptin in human physiology and pathophysiology--emerging clinical applications.

    Science.gov (United States)

    Brennan, Aoife M; Mantzoros, Christos S

    2006-06-01

    Leptin is an adipocyte-secreted hormone with a key role in energy homeostasis. Studies in animal models, in humans with congenital complete leptin deficiency, and observational and interventional studies in humans with relative leptin deficiency (lower than normal leptin levels) have all indicated that leptin regulates multiple physiological functions, primarily in states of energy deficiency. This information led to proof-of-concept clinical trials involving leptin administration to individuals with relative or complete leptin deficiency. These conditions include congenital complete leptin deficiency, due to mutations in the leptin gene, and states of relative leptin deficiency including lipoatrophy and some forms of hypothalamic amenorrhea. Leptin, in replacement doses, normalizes neuroendocrine, metabolic and immune function in patients with these conditions, but further clinical studies are required to determine its long-term efficacy and safety. Management of leptin-deficient states with replacement doses of leptin holds promise as a therapeutic option. In addition, elucidation of the mechanisms underlying leptin resistance, which characterizes hyperleptinemic states such as human obesity and diabetes, might provide novel therapeutic targets for these prevalent clinical problems.

  12. Clinical and Statistical Study on Canine Impaction

    Directory of Open Access Journals (Sweden)

    Adina-Simona Coșarcă

    2013-08-01

    Full Text Available Aim: The aim of this study was to perform a clinical and statistical research on permanent impacted canine patients among those with dental impaction referred to and treated at the Oral and Maxillo-Facial Surgery Clinic of Tîrgu Mureș, over a four years period (2009-2012. Materials and methods: The study included 858 patients having dental impaction, and upon clinical records, different parameters, like frequency, gender, age, quadrant involvement, patient residence, associated complications, referring specialist and type of treatment, related to canine impaction, were assessed. Results: The study revealed: about 10% frequency of canine impaction among dental impactions; more frequent in women, in the first quadrant (tooth 13; most cases diagnosed between the age of 10-19 years; patients under 20 were referred by an orthodontist, those over 20 by a dentist; surgical exposure was more often performed than odontectomy. Conclusions: Canine impaction is the second-most frequent dental impaction in dental arch after third molars; it occurs especially in women. Due to its important role, canine recovery within dental arch is a goal to be achieved, whenever possible. Therefore, diagnose and treatment of canine impaction requires an interdisciplinary approach (surgical and orthodontic

  13. Clinical features of human intestinal capillariasis in Taiwan

    Institute of Scientific and Technical Information of China (English)

    Ming-Jong Bair; Kao-Pin Hwang; Tsang-En Wang; Tai-Cherng Liou; Shee-Chan Lin; Chin-Roa Kao; Tao-Yeuan Wang; Kwok-Kuen Pang

    2004-01-01

    Human intestinal capillariasis is a rare parasitosis that was first recognized in the Philippines in the 1960 s. Parasitosis is a life threatening disease and has been reported from Thailand, Japan, South of Taiwan (Kaoh-Siung), Korea,Tran, Egypt, Italy and Spain. Its clinical symptoms are characterized by chronic diarrhea, abdominal pain,borborygmus, marked weight loss, protein and electrolyte loss and cachexia. Capillariasis may be fatal if early treatment is not given. We reported 14 cases living in rural areas of Taiwan. Three cases had histories of travelling to Thailand. They might have been infected in Thailand while stayed there. Two cases had the diet of raw freshwater fish before. Three cases received emergency laparotomy due to peritonitis and two cases were found of enteritis cystica profunda. According to the route of transmission,freshwater and brackish-water fish may act as the intermediate host of the parasite. The most simple and convenient method of diagnosing capillariasis is stool examination. Two cases were diagnosed by histology.Mebendazole or albendezole 200 mg orally twice a day for 20-30 d is the treatment of choice. All the patients were cured, and relapses were not observed within 12 mo.

  14. Photodynamic therapy of port wine stain: preliminary clinical studies

    Science.gov (United States)

    Nelson, J. Stuart

    1993-07-01

    The broad, long term objective of this work is the development of Photodynamic Therapy (PDT) for application in the clinical management of patients with port wine stain (PWS). PDT involves the use of an exogenous drug which is concentrated in a targeted tissue. When irradiated at wavelengths specifically absorbed by the drug, selective destruction of the targeted tissue, without the production of heat, occurs. The results of this preliminary study demonstrate in human PWS patients that a photosensitizer, such as PHOTOFRINR, activated by red light at the appropriate therapeutic wavelength, can cause destruction of subsurface blood vessels in the skin with a high degree of specificity, and further study appears warranted.

  15. Prospect of Human Pluripotent Stem Cell-Derived Neural Crest Stem Cells in Clinical Application

    Directory of Open Access Journals (Sweden)

    Qian Zhu

    2016-01-01

    Full Text Available Neural crest stem cells (NCSCs represent a transient and multipotent cell population that contributes to numerous anatomical structures such as peripheral nervous system, teeth, and cornea. NCSC maldevelopment is related to various human diseases including pigmentation abnormalities, disorders affecting autonomic nervous system, and malformations of teeth, eyes, and hearts. As human pluripotent stem cells including human embryonic stem cells (hESCs and human induced pluripotent stem cells (hiPSCs can serve as an unlimited cell source to generate NCSCs, hESC/hiPSC-derived NCSCs can be a valuable tool to study the underlying mechanisms of NCSC-associated diseases, which paves the way for future therapies for these abnormalities. In addition, hESC/hiPSC-derived NCSCs with the capability of differentiating to various cell types are highly promising for clinical organ repair and regeneration. In this review, we first discuss NCSC generation methods from human pluripotent stem cells and differentiation mechanism of NCSCs. Then we focus on the clinical application potential of hESC/hiPSC-derived NCSCs on peripheral nerve injuries, corneal blindness, tooth regeneration, pathological melanogenesis, Hirschsprung disease, and cardiac repair and regeneration.

  16. Prospect of Human Pluripotent Stem Cell-Derived Neural Crest Stem Cells in Clinical Application

    Science.gov (United States)

    Zhu, Qian; Lu, Qiqi; Gao, Rong

    2016-01-01

    Neural crest stem cells (NCSCs) represent a transient and multipotent cell population that contributes to numerous anatomical structures such as peripheral nervous system, teeth, and cornea. NCSC maldevelopment is related to various human diseases including pigmentation abnormalities, disorders affecting autonomic nervous system, and malformations of teeth, eyes, and hearts. As human pluripotent stem cells including human embryonic stem cells (hESCs) and human induced pluripotent stem cells (hiPSCs) can serve as an unlimited cell source to generate NCSCs, hESC/hiPSC-derived NCSCs can be a valuable tool to study the underlying mechanisms of NCSC-associated diseases, which paves the way for future therapies for these abnormalities. In addition, hESC/hiPSC-derived NCSCs with the capability of differentiating to various cell types are highly promising for clinical organ repair and regeneration. In this review, we first discuss NCSC generation methods from human pluripotent stem cells and differentiation mechanism of NCSCs. Then we focus on the clinical application potential of hESC/hiPSC-derived NCSCs on peripheral nerve injuries, corneal blindness, tooth regeneration, pathological melanogenesis, Hirschsprung disease, and cardiac repair and regeneration. PMID:28090209

  17. Clinical, biochemical & cytomorphologic study on Hashimoto's thyroiditis

    Science.gov (United States)

    Thomas, Tina; Sreedharan, Suja; Khadilkar, Urmila N.; Deviprasad, D; Kamath, M. Panduranga; Bhojwani, Kiran M.; Alva, Arathi

    2014-01-01

    Background & objectives: Despite, the extensive salt iodization programmes implemented in India, the prevalence of goiter has not reduced much in our country. The most frequent cause of hypothyroidism and goiter in iodine sufficient areas is Hashimoto's thyroiditis (HT). This study records the clinical presentation, biochemical status, ultrasonographic picture and cytological appearance of this disease in a coastal endemic zone for goiter. Methods: Case records of patients with cytological diagnosis of HT were studied in detail, with reference to their symptoms, presence of goiter, thyroid function status, antibody levels and ultrasound picture. Detailed cytological study was conducted in selected patients. Results: A total of 144 patients with cytological proven HT/lymphocytic thyroiditis were studied. Ninety per cent of the patients were females and most of them presented within five years of onset of symptoms. Sixty eight per cent patients had diffuse goiter, 69 per cent were clinically euthyroid and 46 per cent were biochemically mildly hypothyroid. Antibody levels were elevated in 92.3 per cent cases. In majority of patients the sonographic picture showed heterogeneous echotexture with increased vascularity. Cytological changes were characteristic. Interpretation & conclusions: Our study showed predominance of females in the study population in 21-40 yr age group with diffuse goiter. We suggest that in an endemic zone for goiter, all women of the child bearing age should be screened for HT. PMID:25758571

  18. Participating in Clinical Trials

    Science.gov (United States)

    ... this page please turn Javascript on. Participating in Clinical Trials About Clinical Trials A Research Study With Human Subjects A clinical ... to treat or cure a disease. Phases of Clinical Trials Clinical trials of drugs are usually described based ...

  19. Clinical uses of melatonin: evaluation of human trials.

    Science.gov (United States)

    Sánchez-Barceló, E J; Mediavilla, M D; Tan, D X; Reiter, R J

    2010-01-01

    During the last 20 years, numerous clinical trials have examined the therapeutic usefulness of melatonin in different fields of medicine. The objective of this article is to review, in depth, the science regarding clinical trials performed to date. The efficacy of melatonin has been assessed as a treatment of ocular diseases, blood diseases, gastrointestinal tract diseases, cardiovascular diseases, diabetes, rheumatoid arthritis, fibromyalgia, chronic fatigue syndrome, infectious diseases, neurological diseases, sleep disturbances, aging and depression. Melatonin has been also used as a complementary treatment in anaesthesia, hemodialysis, in vitro fertilization and neonatal care. The conclusion of the current review is that the use of melatonin as an adjuvant therapy seems to be well funded for macular degeneration, glaucoma, protection of the gastric mucosa, irritable bowel syndrome, arterial hypertension, diabetes, side effects of chemotherapy and radiation in cancer patients or hemodialysis in patients with renal insufficiency and, especially, for sleep disorders of circadian etiology (jet lag, delayed sleep phase syndrome, sleep deterioration associated with aging, etc.) as well as in those related with neurological degenerative diseases (Alzheimer, etc.,) or Smith-Magenis syndrome. The utility of melatonin in anesthetic procedures has been also confirmed. More clinical studies are required to clarify whether, as the preliminary data suggest, melatonin is useful for treatment of fibromyalgia, chronic fatigue syndrome, infectious diseases, neoplasias or neonatal care. Preliminary data regarding the utility of melatonin in the treatment of ulcerative colitis, Crohn's disease, rheumatoid arthritis are either ambiguous or negative. Although in a few cases melatonin seems to aggravate some conditions, the vast majority of studies document the very low toxicity of melatonin over a wide range of doses.

  20. Clinical relevance of infections with zoonotic and human oral species of Campylobacter.

    Science.gov (United States)

    Lee, Soomin; Lee, Jeeyeon; Ha, Jimyeong; Choi, Yukyung; Kim, Sejeong; Lee, Heeyoung; Yoon, Yohan; Choi, Kyoung-Hee

    2016-07-01

    Genus Campylobacter has been recognized as a causative bacterial agent of animal and human diseases. Human Campylobacter infections have caused more concern. Campylobacters can be classified into two groups in terms of their original host: zoonotic and human oral species. The major zoonotic species are Campylobacter jejuni and Campylobacter coli, which mostly reside in the intestines of avian species and are transmitted to humans via consumption of contaminated poultry products, thus causing human gastroenteritis and other diseases as sequelae. The other campylobacters, human oral species, include C. concisus, C. showae, C. gracilis, C. ureolyticus, C. curvus, and C. rectus. These species are isolated from the oral cavity, natural colonization site, but have potential clinical relevance in the periodontal region to varying extent. Two species, C. jejuni and C. coli, are believed to be mainly associated with intestinal diseases, but recent studies suggested that oral Campylobacter species also play a significant role in intestinal diseases. This review offers an outline of the two Campylobacter groups (zoonotic and human oral), their virulence traits, and the associated illnesses including gastroenteritis.

  1. Clinical study on osteoradionecrosis of the jaws

    Energy Technology Data Exchange (ETDEWEB)

    Okano, Atsuo; Kato, Joji

    1988-07-01

    In the present study osteoradionecrosis which had developed after radiotherapy for malignant tumor was studied clinically and therapeutically and the following results were obtained. 1. The subjects were 28 patients with squamous cell carcinoma and 2 patients with adenoid cystic carcinoma aged 38 to 72. The ratio of male: female was 3.3 : 1. The time of manifestation was 1 month-14 years after irradiation. The main symptoms were pain and exposed bone mainly in the region of mandibular molar tooth. 2. Osteoradionecrosis was observed in 10 cases supposed to be induced by tooth extraction but also in 5 edentulous cases. 3. When the osteoradionecrosis cases were classified into limited area type and wide range type on the basis of clinical findings. X-ray of the jaws showed the presence of bone resorption and induration together in many wide range type cases. 4. Scintigram of bone showed widespread accumulation of radiation even in clinically limited area type, and the picture of some loss of bone and the intensity of the accumulation were considered to be extremely useful as an index in making therapeutical plans and decisions on the prognosis of tumor of the jaws. 5. As the method of treatment, sequestrectomy was performed in 14 of 19 cases of the limited area type and 4 of 11 cases of the wide range type and excision of the jaws in 4 cases. 6. Hyperbaric oxygen therapy was carried out in 3 cases and had good effect. (J.P.N.).

  2. CLINICAL STATISTICAL STUDIES ON HEMATURIA IN OUTPATIENTS

    OpenAIRE

    青木, 正治; 熊本, 悦明

    1982-01-01

    Clinical statistical studies on hematuria were performed in outpatients who were seen at our Department, during the 7-year period from 1974 through 1980. Of the 11,574 outpatients studied, the total number of outpatients with hematuria 1,705; macroscopic hematuria was found in 446 cases (3.9%) and microscopic hematuria was in 1,259 cases (10.9%). The most frequent cause of macroscopic hematuria was malignant urinary tumors and that of microscopic hematuria was urinary tract infections. Macros...

  3. Clinical Study on Ocular Trauma in Children

    Institute of Scientific and Technical Information of China (English)

    Zicai Huang; Hongni Li; Yixia Huang; Zhongxia Zhou

    2002-01-01

    Purpose: To investigate the clinical characteristics of ocular trauma in children and put forward the major treatment and prevention of ocular trauma in children.Methods: To analyze the clinical data by 77 eyes in 77 cases of ocular trauma in children from April 1999 to February 2002. Results: The male and female were in the ratio of 2.21: 1. Right eye ocular traumas were more than left ones. Ocular penetrating trauma was 83.12% and blunt trauma 12.99%. 41 cases (53.25%) were injured by themselves while 33 cases by others. 90.91% patients came from the countryside.Conclusion: The rate of blindness of children with ocular trauma could be reduced by prompt treatment. The study indicated that ocular trauma preventive publicity should be faced in the countryside in order to improve the understanding of the severity of ocular trauma and treat it as a social problem.

  4. Robust diffusion imaging framework for clinical studies

    CERN Document Server

    Maximov, Ivan I; Neuner, Irene; Shah, N Jon

    2015-01-01

    Clinical diffusion imaging requires short acquisition times and good image quality to permit its use in various medical applications. In turn, these demands require the development of a robust and efficient post-processing framework in order to guarantee useful and reliable results. However, multiple artefacts abound in in vivo measurements; from either subject such as cardiac pulsation, bulk head motion, respiratory motion and involuntary tics and tremor, or imaging hardware related problems, such as table vibrations, etc. These artefacts can severely degrade the resulting images and render diffusion analysis difficult or impossible. In order to overcome these problems, we developed a robust and efficient framework enabling the use of initially corrupted images from a clinical study. At the heart of this framework is an improved least trimmed squares diffusion tensor estimation algorithm that works well with severely degraded datasets with low signal-to-noise ratio. This approach has been compared with other...

  5. Cryogenic Thermophysical Studies for Clinical Medicine

    Institute of Scientific and Technical Information of China (English)

    华泽钊

    2002-01-01

    Cryogenic technology has been widely used in clinical medicine and in pharmaceutics, so thermophysical studies are extremely important to solve problems during freezing and thawing. This paper reports some recent research in clinical medicine, including cryo-injury, cryosurgery, and cryopreservation of some important cells and tissues. Microscopic images of the freezing process with a cryomicroscope system show that the dendritic ice growth is affected by the solution concentration, the cooling rate, and the number of embryos. An enthalpy method is used for the freeze-thaw analysis of the cryosurgery with a program developed to predict the temperature profile and the interface motion, which compares well with experimental results. A very rapid cooling technique is developed by quenching the samples into subcooled liquid nitrogen for vitrification of cells and tissues. An analytical method developed to prevent the fracture of arteries during freezing has been verified by the electronic microscopic investigation.

  6. [Draft of Guidelines for Human Body Dissection for Clinical Anatomy Education and Research and commentary].

    Science.gov (United States)

    Shichinohe, Toshiaki; Kondo, Satoshi; Ide, Chizuka; Higuchi, Norio; Aiso, Sadakazu; Sakai, Tatsuo; Matsumura, George; Yoshida, Kazunari; Kobayashi, Eiji; Tatsumi, Haruyuki; Yaginuma, Hiroyuki; Hishikawa, Shuji; Sugimoto, Maki; Izawa, Yoshimitsu; Imanishi, Nobuaki

    2011-07-01

    This article analyses the Draft of Guidelines for Human Body Dissection for Clinical Anatomy Education and Research drawn by the Study Group for Future Training Systems of Surgical Skills and Procedures established by the Fiscal Year 2010 research program of the Ministry of Health, Labor and Welfare. The purpose of the Draft of Guidelines is: First, to lay out the required basic guidelines for human cadaver usage to allow medical and dental faculty to conduct clinical education and research in accordance with existing regulations. Second, the guidelines are expected to give physicians a regulatory framework to carry out cadaver training in accordance with the current legal framework. This article explains the Draft of Guidelines in detail, outlines the future of cadaver training, and describes issues which must still be solved.

  7. [Draft of guidelines for human body dissection for clinical anatomy education and research and commentary].

    Science.gov (United States)

    Shichinohe, Toshiaki; Kondo, Satoshi; Ide, Chizuka; Higuchi, Norio; Aiso, Sadakazu; Sakai, Tatsuo; Matsumura, George; Yoshida, Kazunari; Kobayashi, Eiji; Tatsumi, Haruyuki; Yaginuma, Hiroyuki; Hishikawa, Shuji; Sugimoto, Maki; Izawa, Yoshimitsu; Imanishi, Nobuaki

    2011-06-01

    This article analyses the Draft of Guidelines for Human Body Dissection for Clinical Anatomy Education and Research drawn by the Study Group for Future Training Systems of Surgical Skills and Procedures established by the Fiscal Year 2010 research program of the Ministry of Health, Labor and Welfare. The purpose of the Draft of Guidelines is: First, to lay out the required basic guidelines for human cadaver usage to allow medical and dental faculty to conduct clinical education and research in accordance with existing regulations. Second, the guidelines are expected to give physicians a regulatory framework to carry out cadaver training in accordance with the current legal framework. This article explains the Draft of Guidelines in detail, outlines the future of cadaver training, and describes issues which must still be solved.

  8. Studies of human vision recognition: some improvements

    Science.gov (United States)

    Wu, Bo-Wen; Fang, Yi-Chin; Chang, Lin-Song

    2010-01-01

    This paper proposes a new method to improve human recognition by artificial intelligence, specifically of images without the interference of high frequencies. The human eye is the most delicate optical system. Notwithstanding the dramatic progression of its structure and functions through a long evolution, the capability of visual recognition is not yet close to perfection. This paper is a study, based on the limitations of recognition by the human eye, of image recognition through the application of artificial intelligence. Those aspects which have been explored focus on human eye modeling, including aberration analysis, creative models of the human eye, human vision recognition characteristics and various mathematical models for verification. By using images consisting of four black and white bands and modulation transfer function (MTF) curve evaluation recognition capability on all the studied models, the optimum model most compatible with the physiology of the human eye is found.

  9. [Depression and dementia: perspectives from clinical studies].

    Science.gov (United States)

    Nozaki, Shoko; Yoshimura, Kimio; Mimura, Masaru

    2012-12-01

    In this review, we present an overview of clinical studies that addressed the relationship between depression and dementia or cognitive decline. Cross-sectional studies and meta-analyses have repeatedly shown an association between late-life depression (LLD) and dementia, particularly Alzheimer's disease (AD) and vascular dementia; however, the findings of cohort studies have been inconsistent. Furthermore, studies on the association between depression with a younger age of onset and dementia have yielded inconsistent results. Regarding cognitive decline associated with LLD, several studies have reported an association between LLD and mild cognitive impairment, suggesting that depression itself can cause persistent cognitive impairment. Other studies have compared the cognitive profile between LLD and depression with a younger age of onset, but their results have been inconclusive, especially regarding the association between memory impairment and the age of onset of depression. LLD is associated with vascular change and white matter degeneration of the brain, as shown by magnetic resonance imaging (MRI). Recently, several studies reported an association between gray matter change and LLD. Studies currently in progress employ functional brain imaging methods such as single-photon emission computed tomography, functional MRI, and positron emission tomography. Clinically, it is important to understand how subtypes of depression can be defined in terms of risk of developing dementia, and to devise effective treatments. One paper explored the possibility of detecting depression associated with AD by measuring the blood Aβ40/Aβ42 levels, and other studies have suggested that symptoms of apathy and loss of interest are associated with conversion of depression to AD. Unfortunately, current antidepressants may have limited efficacy on depression with dementia; therefore, further investigation for devising methods of predicting conversion of depression to dementia and

  10. Clinical significance of vasculogenic mimicry in human gliomas.

    Science.gov (United States)

    Liu, Xiao-mei; Zhang, Qing-ping; Mu, Yong-gao; Zhang, Xiang-hen; Sai, Ke; Pang, Jesse Chung-Sean; Ng, Ho-Keung; Chen, Zhong-ping

    2011-11-01

    Vasculogenic mimicry (VM) is known as non-endothelial tumor cell-lined microvascular channels in aggressive tumors. We have previously found the presence of VM in high-grade gliomas. In this study, we aimed to identify VM patterns in gliomas and to explore their clinical significance. Tumor samples as well as their detailed clinical/prognostic data were collected from 101 patients. Vasculogenic mimicry in the glioma samples was determined by dual staining for endothelial marker CD34 and periodic acid-Schiff (PAS). Tumor samples were also immunohistochemically stained for Ki-67, VEGF, COX-2 and MMP-9. The association between VM and the clinical characteristics of the patients were analyzed. A Kaplan-Meier survival analysis and log-rank tests were performed to compare survival times of the patients. Vasculogenic mimicry was present in 13 out of 101 samples. The higher grade gliomas had a higher incidence of VM than that of lower grade gliomas (P = 0.006). Vasculogenic mimicry channels were associated with the expression of COX-2 and MMP-9 (P age and preoperative epilepsy of the patients, or expression of Ki-67 and VEGF. However, patients with VM-positive gliomas survived a shorter period of time than those with VM negative gliomas (P = 0.027). Interestingly, in high-grade gliomas, the level of microvascular density was lower in VM positive tumors than those VM negative tumors (P = 0.039). Our results suggest that VM channels in gliomas correlate with increasing malignancy and higher aggressiveness, and may provide a complementation to the tumor's blood supply, especially in less vascularized regions, which may aid in the identification of glioma patients with a poorer prognosis.

  11. Clinical Application of Human Mesenchymal Stromal Cells for Bone Tissue Engineering

    Directory of Open Access Journals (Sweden)

    Anindita Chatterjea

    2010-01-01

    Full Text Available The gold standard in the repair of bony defects is autologous bone grafting, even though it has drawbacks in terms of availability and morbidity at the harvesting site. Bone-tissue engineering, in which osteogenic cells and scaffolds are combined, is considered as a potential bone graft substitute strategy. Proof-of-principle for bone tissue engineering using mesenchymal stromal cells (MSCs has been demonstrated in various animal models. In addition, 7 human clinical studies have so far been conducted. Because the experimental design and evaluation parameters of the studies are rather heterogeneous, it is difficult to draw conclusive evidence on the performance of one approach over the other. However, it seems that bone apposition by the grafted MSCs in these studies is observed but not sufficient to bridge large bone defects. In this paper, we discuss the published human clinical studies performed so far for bone-tissue regeneration, using culture-expanded, nongenetically modified MSCs from various sources and extract from it points of consideration for future clinical studies.

  12. The spectrum of genital human papillomavirus infection among men attending a Swedish sexually-transmitted infections clinic: human papillomavirus typing and clinical presentation of histopathologically benign lesions.

    Science.gov (United States)

    Wikström, Arne; Vassilaki, Ismini; Hedblad, Mari-Anne; Syrjänen, Stina

    2013-03-27

    There have been a number of Swedish studies on human papillomavirus (HPV) typing in men, most of which have used less sensitive HPV-typing techniques. The present study included male patients with genital HPV-induced lesions planned for surgery. Samples were prepared for histopathology and PCR. HPV was detected in 233/253 (92%) and HPV 6 or 11 in 89% of the HPV-positive lesions. There were statistically significant differences regarding morphology (p=0.002), location (p=0.000001) and colour (p=0.005) of the lesions for low- vs. mixed or high-risk HPV types. For example, acuminate lesions were mostly found among men with low-risk HPV types, whereas macular lesions were over-represented among them with mixed or high-risk types. The HPV type distribution is similar to that in earlier studies, but we also found correlations with some clinical parameters.

  13. The impact of early human data on clinical development: there is time to win.

    Science.gov (United States)

    Swart, Piet; Lozac'h, Frederic; Simon, Marjorie; van Duijn, Esther; Vaes, Wouter H J

    2016-06-01

    Modern accelerator mass spectrometry (AMS) methods enable the routine application of this technology in drug development. By the administration of a (14)C-labelled microdose or microtrace, pharmacokinetic (PK) data, such as mass balance, metabolite profiling, and absolute bioavailability (AB) data, can be generated easier, faster, and at lower costs. Here, we emphasize the advances and impact of this technology for pharmaceutical companies. The availability of accurate intravenous (iv) PK and human absorption, distribution, metabolism, and excretion (ADME) information, even before or during Phase I trials, can improve the clinical development plan. Moreover, applying the microtrace approach during early clinical development might impact the number of clinical pharmacology and preclinical safety pharmacology studies required, and shorten the overall drug discovery program.

  14. Clinical Study on Treatment of Infantile Rotaviral

    Institute of Scientific and Technical Information of China (English)

    魏连波; 李智军; 陈宝田; 栾图; 高云飞; 李吉来; 孙升云

    2001-01-01

    Objective: To observe the clinical effect of guava leaf (GL) in treating infantile rotaviral enteritis.Methods: Sixty-two patients of rotaviral enteritis were randomly divided into the treated group treated with GL and the control group treated with Gegen Qinlian Decoction. The time for ceasing diarrhea, content of Na+ in blood, content of Na+ and glucose in stool, and the rate of negative conversion of human rotavirus antigen (HRVA) were observed.Results: The 3-day recovery rate in the treated group (87.1%) was significantly higher than that in the control group (58.1%, P<0.05). The time of ceasing diarrhea in the treated group (25.1±9.5 hrs) was significantly shorter than that in the control group (38.7±15.2 hrs, P<0.01). Moreover, content of Na+ and glucose in stool were reduced obviously in the treated group but not in the control group; and negative conversion rate of HRVA in the former group also got better than that in the latter group (87.1% vs 58.1%, P<0.05). Consequently, the effect of GL was superior to that of the control significantly.Conclusion: GL has good curative effect on infantile rotaviral enteritis.

  15. A clinical and investigational study of donovanosis

    Directory of Open Access Journals (Sweden)

    Veeranna S

    2003-03-01

    Full Text Available A clinical and investigational study of 25 cases of Donovanosis was undertaken. The incidence was found to be 1.53% of all STD cases and 2.9% of GUD. M:F ratio was 2.12:1. Incidence was more in unmarried people. Fleshy exuberant type was seen in 88% of cases. Two patients (8% had extragenital ulcers. Donovan bodies were found in 88%. Pseudo elephantiasis was seen in 8 patients. Biopsy was done in 8 cases and showed ocanthosis, plasma cell infiltration and pseudo epitheliomatous hyperplasia. One patient developed squamous cell carcinoma of vulva.

  16. Non-clinical studies in the process of new drug development - Part II: Good laboratory practice, metabolism, pharmacokinetics, safety and dose translation to clinical studies.

    Science.gov (United States)

    Andrade, E L; Bento, A F; Cavalli, J; Oliveira, S K; Schwanke, R C; Siqueira, J M; Freitas, C S; Marcon, R; Calixto, J B

    2016-12-12

    The process of drug development involves non-clinical and clinical studies. Non-clinical studies are conducted using different protocols including animal studies, which mostly follow the Good Laboratory Practice (GLP) regulations. During the early pre-clinical development process, also known as Go/No-Go decision, a drug candidate needs to pass through several steps, such as determination of drug availability (studies on pharmacokinetics), absorption, distribution, metabolism and elimination (ADME) and preliminary studies that aim to investigate the candidate safety including genotoxicity, mutagenicity, safety pharmacology and general toxicology. These preliminary studies generally do not need to comply with GLP regulations. These studies aim at investigating the drug safety to obtain the first information about its tolerability in different systems that are relevant for further decisions. There are, however, other studies that should be performed according to GLP standards and are mandatory for the safe exposure to humans, such as repeated dose toxicity, genotoxicity and safety pharmacology. These studies must be conducted before the Investigational New Drug (IND) application. The package of non-clinical studies should cover all information needed for the safe transposition of drugs from animals to humans, generally based on the non-observed adverse effect level (NOAEL) obtained from general toxicity studies. After IND approval, other GLP experiments for the evaluation of chronic toxicity, reproductive and developmental toxicity, carcinogenicity and genotoxicity, are carried out during the clinical phase of development. However, the necessity of performing such studies depends on the new drug clinical application purpose.

  17. Non-clinical studies in the process of new drug development - Part II: Good laboratory practice, metabolism, pharmacokinetics, safety and dose translation to clinical studies

    Directory of Open Access Journals (Sweden)

    E.L. Andrade

    Full Text Available The process of drug development involves non-clinical and clinical studies. Non-clinical studies are conducted using different protocols including animal studies, which mostly follow the Good Laboratory Practice (GLP regulations. During the early pre-clinical development process, also known as Go/No-Go decision, a drug candidate needs to pass through several steps, such as determination of drug availability (studies on pharmacokinetics, absorption, distribution, metabolism and elimination (ADME and preliminary studies that aim to investigate the candidate safety including genotoxicity, mutagenicity, safety pharmacology and general toxicology. These preliminary studies generally do not need to comply with GLP regulations. These studies aim at investigating the drug safety to obtain the first information about its tolerability in different systems that are relevant for further decisions. There are, however, other studies that should be performed according to GLP standards and are mandatory for the safe exposure to humans, such as repeated dose toxicity, genotoxicity and safety pharmacology. These studies must be conducted before the Investigational New Drug (IND application. The package of non-clinical studies should cover all information needed for the safe transposition of drugs from animals to humans, generally based on the non-observed adverse effect level (NOAEL obtained from general toxicity studies. After IND approval, other GLP experiments for the evaluation of chronic toxicity, reproductive and developmental toxicity, carcinogenicity and genotoxicity, are carried out during the clinical phase of development. However, the necessity of performing such studies depends on the new drug clinical application purpose.

  18. Clinical Symptoms of Human Rotavirus Infection Observed in Children in Sokoto, Nigeria

    Directory of Open Access Journals (Sweden)

    B. R. Alkali

    2015-01-01

    Full Text Available Rotavirus has been identified among the most important causes of infantile diarrhoea, especially in developing countries. The present study was undertaken to determine the occurrence and clinical symptoms of human rotavirus disease among children presenting with varying degree of diarrhoea in selected urban hospitals in Sokoto metropolis, Nigeria. Diarrhoea samples were collected from 200 diarrheic children younger than 5 years of age and tested using a commercially available DAKO Rotavirus ELISA kit which detects the presence of human group A rotaviruses. A questionnaire, based on WHO generic protocol, was completed for each child to generate the primary data. Of the total number of samples collected, 51 were found to be positive for human group A rotavirus indicating 25.5% prevalence of the disease in Sokoto state. The symptoms associated with the disease were analyzed and discussed.

  19. Evaluating the first-in-human clinical trial of a human embryonic stem cell-based therapy.

    Science.gov (United States)

    Chapman, Audrey R; Scala, Courtney C

    2012-09-01

    Phase I clinical trials generally raise greater ethical and human protection challenges than later stage clinical trials, suggesting a need to proceed cautiously. This is particularly the case for Phase I trials with a novel therapy being tested in humans for the first time, usually termed first-in-human (FIH) trials. In January 2009, the Food and Drug Administration approved the Investigational New Drug application of Geron Corporation, a small California-based biopharmaceutical company, to initiate a clinical trial to assess GRNOPC1, a human embryonic stem cell-derived candidate therapy for severe spinal cord injuries. This article evaluates the ethical and human subject protection issues raised by the Geron FIH trial. It identifies problems with the approval process and with the conduct of the trial, and then recommends ways to improve review of future proposed trials with novel and high-risk therapies.

  20. Angular cheilitis: a clinical and microbial study.

    Science.gov (United States)

    Ohman, S C; Dahlén, G; Möller, A; Ohman, A

    1986-04-01

    The purpose of this prospective study was to re-examine the relative importance of various factors in the pathogenesis of angular cheilitis. Sixty-four patients with cheilitis were examined clinically and microbiologically. In addition, a subsample of 23 patients was examined for serum iron and transferrin. The clinical appearance of the lip lesions fell into 4 categories. A ground rhagad at the corner of the mouth involving adjacent skin, was the most frequent type among dentate patients, whereas among denture wearers a deep lesion following the labial marginal sulcus was frequently observed. Dentate patients and denture wearers with cheilitis often had atopic constitution or cutaneous diseases. Pathogenic microorganisms were cultured from the lesions in all 64 patients; Staphylococcus aureus in 40 patients and Candida albicans in 45. The results of this study indicate a correlation between angular cheilitis and pathogenic microorganisms. Furthermore, among dentate patients, a correlation exists between cutaneous discomfort and angular cheilitis. Other etiological factors suggested for this disorder were found to be of subordinate importance.

  1. Evidence-based review of clinical studies on pulpotomy.

    Science.gov (United States)

    2009-08-01

    Although pulpotomy procedures have a long history of clinical application, comparatively few dental clinical trials have evaluated this treatment approach. In this section, we provide an analysis of recent clinical studies evaluating pulpotomy procedures in dental patients.

  2. Genetic studies in chronic kidney disease: interpretation and clinical applicability.

    Science.gov (United States)

    Witasp, Anna; Nordfors, Louise; Carrero, Juan Jesus; Luttropp, Karin; Lindholm, Bengt; Schalling, Martin; Stenvinkel, Peter

    2012-01-01

    The tools of modern molecular biology are evolving rapidly, resulting in vastly more efficient approaches to illuminating human genetic variations and their effects on common multifactorial disorders such as chronic kidney disease (CKD). Indeed, candidate gene association studies and genome-wide association studies (GWASs) have generated novel genetic variants in previously unrecognized biological pathways, highlighting disease mechanisms with a potential role in CKD etiology, morbidity and mortality. Nephrologists now need to find ways to make use of these advancements and meet the increasingly stringent requirements for valid study design, data handling and interpretation of genetic studies. Adding to our prior article in this journal, which introduced the basics of genotype-phenotype association studies in CKD, this second article focuses on how to ascertain robust and reproducible findings by applying adequate methodological and statistical approaches to genotype-phenotype studies in CKD populations. Moreover, this review will briefly discuss genotype-based risk prediction, pharmacotherapy, drug target identification and individualized treatment solutions, specifically highlighting potentially important findings in CKD patients. This increased knowledge will hopefully facilitate the exciting transition from conventional clinical medicine to gene-based medicine. However, before this can be accomplished, unsolved issues regarding the complex human genetic architecture as well technical and clinically oriented obstacles will have to be overcome. Additionally, new policies and standardized risk evaluations for genetic testing in the clinical setting will have to be established to guarantee that CKD patients are provided with high-quality genotype-guided counseling that will help to improve their poor outcomes.

  3. Korean Clinic Based Outcome Measure Studies

    Directory of Open Access Journals (Sweden)

    Jongbae Park

    2003-02-01

    Full Text Available Background: Evidence based medicine has become main tools for medical practice. However, conducting a highly ranked in the evidence hierarchy pyramid is not easy or feasible at all times and places. There remains a room for descriptive clinical outcome measure studies with admitting the limit of the intepretation. Aims: Presents three Korean clinic based outcome measure studies with a view to encouraging Korean clinicians to conduct similar studies. Methods: Three studies are presented briefly here including 1 Quality of Life of liver cancer patients after 8 Constitutional acupuncture; 2 Developing a Korean version of Measuring yourself Medical Outcome profile (MYMOP; and 3 Survey on 5 Shu points: a pilot In the first study, we have included 4 primary or secondary liver cancer patients collecting their diagnostic X-ray film and clinical data f개m their hospital, and asked them to fill in the European Organization Research and Treatment of Cancer, Quality of Life Questionnaire before the commencement of the treatment. The acupuncture treatment is set up format but not disclosed yet. The translation and developing a Korean version of outcome measures that is Korean clinician friendly has been sought for MYMOP is one of the most appropriate one. The permission was granted, the translation into Korean was done, then back translated into English only based on the Korean translation by the researcher who is bilingual in both languages. The back translation was compared by the original developer of MYMOP and confirmed usable. In order to test the existence of acupoints and meridians through popular forms of Korean acupuncture regimes, we aim at collecting opinions from 101 Korean clinicians that have used those forms. The questions asked include most effective symptoms, 5 Shu points, points those are least likely to use due to either adverse events or the lack of effectiveness, theoretical reasons for the above proposals, proposing outcome measures

  4. A CLINICAL STUDY ON BLUNT INJURY ABDOMEN

    Directory of Open Access Journals (Sweden)

    G. Kishore Babu

    2016-10-01

    Full Text Available BACKGROUND Abdominal trauma continues to account for a large number of trauma-related injuries and deaths. Motor vehicle accidents and urban violence, respectively, are the leading causes of blunt and penetrating trauma to this area of the body. Unnecessary deaths and complications can be minimized by improved resuscitation, evaluation and treatment. The new techniques and diagnostic tools available are important in the management of abdominal trauma. These improved methods, however, still depend on experience and clinical judgment for application and determination of the best care for the injured patient. The aim of the study is to 1. Analyse the incidence, clinical characteristics, diagnosis, indications for laparotomy, therapeutic methods and morbidity & mortality rates. 2. To study nature of blunt abdominal trauma. 3. To assess patient for surgical intervention and to avoid negative laparotomy. 4. To assess morbidity rate in different organs injury. 5. To evaluate modalities of treatment, complications and prognosis. MATERIALS AND METHODS This study is a prospective study on 97 patients with Blunt injuries to the abdomen admitted in S.V.R.R.G.G. Hospital, Tirupati during October 2013-15. Inclusion Criteria Patients > 13 years, with Blunt injury to abdomen either by RTA, fall, object contact, assault giving written informed consent. Exclusion Criteria Patients <13 yrs. Blunt injuries due to blasts, patients with severe cardiothoracic and head injuries who are hemodynamically unstable. CONCLUSION Blunt Trauma to abdomen is on rise due to excessive use of motor vehicles. It poses a therapeutic and diagnostic dilemma for the attending surgeon due to wide range of clinical manifestations ranging from no early physical findings to progression to shock. So, the Trauma surgeon should rely on his physical findings in association with use of modalities like x-ray abdomen, USG abdomen and abdominal paracentesis. Hollow viscus perforations are

  5. The clinical studies to developing BV Partner

    Directory of Open Access Journals (Sweden)

    Kwon Gi-Rok

    2001-12-01

    Full Text Available Objective: This study was performed to examine the Herbal Acupuncture decrease the side effect of Bee Venom. Methods: We treated Bee Venom and various Herbal Acupuncture mixed Bee Venom using double blind test to 70th health youth, and checked pain, edema size, CBC, Serum biochemistry and Thermography. Results:1. Herbal Acupuncture made by Morus bombycis Koidzumi showed good results to decrease the side effect of Bee Venom than any other Herbal Acupuncture. 2. We examined CBC, ESR and Serum biochemistry before and after treated. Special change was not showed. 3. We observed the pain and edema after treated Bee Venom and Morus bombycis Koidzumi Herbal Acupuncture mixed Bee Venom. We knew that Morus bombycis Koidzumi Herbal Acupuncture was decrease the pain and edema due to Bee Venom. 4. According to these clinical studies, Morus bombycis Koidzumi Herbal Acupuncture has a possibility to be a good partner of Bee Venom.

  6. Clinical studies on mercury poisoning in cattle

    Energy Technology Data Exchange (ETDEWEB)

    Sonoda, M.; Nakamura, R.; Too, K.; Matsuhashi, A.; Ishimoto, H.; Sasaki, R.; Ishida, K.; Takahashi, M.

    1956-01-01

    A sporadic outbreak of an unknown disease occurred among dairy cattle, from early February to late May 1955, in Japan. The characteristic symptoms of this disease were dyspnea and depilation; out of 29 cases, 8 died while 2 were slaughtered. Clinical studies have disclosed that the symptoms were similar to those found in cases of mercury poisoning as described by others. So the animals' feed was suspected of being the cause of the sickness. It was confirmed that the incident was due to poisoning resulting from ingestion of linseed meal treated with a mercurial fungicide. From the results of the testing anamnesis, it was found that 171 cattle were fed with the meal and 29 cases were affected. In veiw of the wide use of mercurial preparations for treating seed grains against fungi infection, a further experimental study was made on the effects of the feed and fungicide upon calves.

  7. Recommendations from a global cross-company data sharing initiative on the incorporation of recovery phase animals in safety assessment studies to support first-in-human clinical trials.

    Science.gov (United States)

    Sewell, Fiona; Chapman, Kathryn; Baldrick, Paul; Brewster, David; Broadmeadow, Alan; Brown, Paul; Burns-Naas, Leigh Ann; Clarke, Janet; Constan, Alex; Couch, Jessica; Czupalla, Oliver; Danks, Andy; DeGeorge, Joseph; de Haan, Lolke; Hettinger, Klaudia; Hill, Marilyn; Festag, Matthias; Jacobs, Abby; Jacobson-Kram, David; Kopytek, Stephan; Lorenz, Helga; Moesgaard, Sophia Gry; Moore, Emma; Pasanen, Markku; Perry, Rick; Ragan, Ian; Robinson, Sally; Schmitt, Petra M; Short, Brian; Lima, Beatriz Silva; Smith, Diane; Sparrow, Sue; van Bekkum, Yvette; Jones, David

    2014-10-01

    An international expert group which includes 30 organisations (pharmaceutical companies, contract research organisations, academic institutions and regulatory bodies) has shared data on the use of recovery animals in the assessment of pharmaceutical safety for early development. These data have been used as an evidence-base to make recommendations on the inclusion of recovery animals in toxicology studies to achieve scientific objectives, while reducing animal use. Recovery animals are used in pharmaceutical development to provide information on the potential for a toxic effect to translate into long-term human risk. They are included on toxicology studies to assess whether effects observed during dosing persist or reverse once treatment ends. The group devised a questionnaire to collect information on the use of recovery animals in general regulatory toxicology studies to support first-in-human studies. Questions focused on study design, the rationale behind inclusion or exclusion and the impact this had on internal and regulatory decisions. Data on 137 compounds (including 53 biologicals and 78 small molecules) from 259 studies showed wide variation in where, when and why recovery animals were included. An analysis of individual study and programme design shows that there are opportunities to reduce the use of recovery animals without impacting drug development.

  8. A CLINICAL STUDY ON SLIDING INGUINAL HERNIAS

    Directory of Open Access Journals (Sweden)

    Sobha Rani

    2015-09-01

    Full Text Available INTRODUCTION: A sliding hernia is a type of hernia in which posterior wall of the sac is not only formed by the parietal peritoneum, but also by sigmoid colon with its mesentery on its left side; caecum on right side and often with portion of bladder in both sides. During surgery care is taken not t o separate the content from the sac as the posterior wall of the sac is formed by the sliding component itself and attempts to dissect it from wall results in vascular injury to the structure and end in ischemic insult of the sliding component. Thus slidin g hernia is important for the special surgical technique and care during intraoperative period which decreases the morbidity. AIMS AND OBJECTIVE S : To study the incidence of sliding hernia in S.V.R.R.G. General Hospital Tirupati . To know the presentation, o rgan involved in the sliding, post - operative complications in the management of sliding hernias. METHODOLOGY : STUDY DESIGN: Prospective Clinical Study , STUDY AREA: Sri Venka teswara Medical College Tirupat i . SOURCE OF DATA: This study is an observational study in which 600 patients with hernia were studied and 40 patients with sliding component during intra operative period were studied in a period of 12 months. S AMPLE SIZE: 40 patients fulfilling the inclusion criteria . METHOD OF COLLECTION OF DATA: Detai led history taking , Complete clinical examination , Appropriate Investigations Blood & Urine Examination, USG , Surgery is performed & Operative findings were recorded. INCLUSION CRITERIA: Patients more than 13 years, with inguinal hernia giving written inform ed consent. EXCLUSION C RITERIA: Patients less than 13 yrs. Patients with comorbid conditions like heart diseases, liver and renal diseases. SOFTWARE: Statistical software mainly SPSS 11.0 and Systat 8.00 was used for the analysis of the data and Microsoft word and excel have been used to generate graphs tables etc. CONCLUSION: In the observational study done on 40 ca ses of

  9. Human brain diffusion tensor imaging at submillimeter isotropic resolution on a 3Tesla clinical MRI scanner.

    Science.gov (United States)

    Chang, Hing-Chiu; Sundman, Mark; Petit, Laurent; Guhaniyogi, Shayan; Chu, Mei-Lan; Petty, Christopher; Song, Allen W; Chen, Nan-kuei

    2015-09-01

    The advantages of high-resolution diffusion tensor imaging (DTI) have been demonstrated in a recent post-mortem human brain study (Miller et al., NeuroImage 2011;57(1):167-181), showing that white matter fiber tracts can be much more accurately detected in data at a submillimeter isotropic resolution. To our knowledge, in vivo human brain DTI at a submillimeter isotropic resolution has not been routinely achieved yet because of the difficulty in simultaneously achieving high resolution and high signal-to-noise ratio (SNR) in DTI scans. Here we report a 3D multi-slab interleaved EPI acquisition integrated with multiplexed sensitivity encoded (MUSE) reconstruction, to achieve high-quality, high-SNR and submillimeter isotropic resolution (0.85×0.85×0.85mm(3)) in vivo human brain DTI on a 3Tesla clinical MRI scanner. In agreement with the previously reported post-mortem human brain DTI study, our in vivo data show that the structural connectivity networks of human brains can be mapped more accurately and completely with high-resolution DTI as compared with conventional DTI (e.g., 2×2×2mm(3)).

  10. A validated enantioselective LC-MS/MS assay for quantification of a major chiral metabolite of an achiral 11-β-hydroxysteroid-dehydrogenase 1 inhibitor in human plasma: Application to a clinical pharmacokinetic study.

    Science.gov (United States)

    Furlong, Michael T; Ji, Qin C; Iacono, Lisa; Dang, Oanh; Noren, Marzena; Bruce, John; Aubry, Anne-Françoise; Arnold, Mark E

    2016-06-01

    BMS-823778 is a potent 11-β-hydroxysteroid-dehydrogenase 1 (11βHSD-1) inhibitor and a potential therapeutic agent for type 2 diabetes mellitus (T2DM). A high performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay was developed and validated to enable reliable separation and quantification of both enantiomers of a chiral hydroxy metabolite (BMT-094817) in human plasma. Following liquid-liquid extraction in a 96-well plate format, chromatographic separation of the metabolite enantiomers was achieved by isocratic elution on a Chiralpak IA-3 column. Chromatographic conditions were optimized to ensure separation of both metabolite enantiomers. Metabolite enantiomers and stable isotope-labeled (SIL) internal standards were detected by positive ion electrospray tandem mass spectrometry. The LC-MS/MS assay was validated over a concentration range of 0.200-200ng/mL. Intra- and inter-assay precision values for replicate quality control samples were less than 9.9% for both enantiomers during the assay validation. Mean quality control accuracy values were within ±7.3%. Assay recoveries were high (>75%) and consistent across the assay range. The metabolite enantiomers were stable in human blood for 2h on ice. The analytes were also stable in human plasma for 25h at room temperature, 34days at -20°C and -70°C, and following five freeze-thaw cycles. No interconversion of the metabolite enantiomers was detected under any bioanalytical stress conditions, from blood collection/processing through extracted sample storage. The validated assay was successfully applied to the quantification of both metabolite enantiomers in human plasma in support of a human pharmacokinetic study.

  11. Omega-3 fatty acids (ῳ-3 fatty acids) in epilepsy: animal models and human clinical trials.

    Science.gov (United States)

    DeGiorgio, Christopher M; Taha, Ameer Y

    2016-10-01

    There is growing interest in alternative and nutritional therapies for drug resistant epilepsy. ῳ-3 fatty acids such as fish or krill oil are widely available supplements used to lower triglycerides and enhance cardiovascular health. ῳ-3 fatty acids have been studied extensively in animal models of epilepsy. Yet, evidence from randomized controlled clinical trials in epilepsy is at an early stage. This report focuses on the key ῳ-3 fatty acids DHA and EPA, their incorporation into the lipid bilayer, modulation of ion channels, and mechanisms of action in reducing excitability within the central nervous system. This paper presents pre-clinical evidence from mouse, rat, and canine models, and reports the efficacy of n-3 fatty acids in randomized controlled clinical trials. An English language search of PubMed and Google scholar for the years 1981-2016 was performed for animal studies and human randomized controlled clinical trials. Expert commentary: Basic science and animal models provide a cogent rationale and substantial evidence for a role of ῳ-3 fatty acids in reducing seizures. Results in humans are limited. Recent Phase II RCT evidence suggests that low to moderate dose of ῳ-3 fatty acids reduce seizures; however, larger multicenter randomized trials are needed to confirm or refute the evidence. The safety, health effects, low cost and ease of use make ῳ-3 fatty acids an intriguing alternative therapy for drug resistant epilepsy. Though safety of profile is excellent, the human data is not yet sufficient to support efficacy in drug resistant epilepsy at this time.

  12. Therapeutic role of rifaximin in inflammatory bowel disease: clinical implication of human pregnane X receptor activation.

    Science.gov (United States)

    Cheng, Jie; Shah, Yatrik M; Ma, Xiaochao; Pang, Xiaoyan; Tanaka, Toshiya; Kodama, Tatsuhiko; Krausz, Kristopher W; Gonzalez, Frank J

    2010-10-01

    Human pregnane X receptor (PXR) has been implicated in the pathogenesis of inflammatory bowel disease (IBD). Rifaximin, a human PXR activator, is in clinical trials for treatment of IBD and has demonstrated efficacy in Crohn's disease and active ulcerative colitis. In the current study, the protective and therapeutic role of rifaximin in IBD and its respective mechanism were investigated. PXR-humanized (hPXR), wild-type, and Pxr-null mice were treated with rifaximin in the dextran sulfate sodium (DSS)-induced and trinitrobenzene sulfonic acid (TNBS)-induced IBD models to determine the protective function of human PXR activation in IBD. The therapeutic role of rifaximin was further evaluated in DSS-treated hPXR and Pxr-null mice. Results demonstrated that preadministration of rifaximin ameliorated the clinical hallmarks of colitis in DSS- and TNBS-treated hPXR mice as determined by body weight loss and assessment of diarrhea, rectal bleeding, colon length, and histology. In addition, higher survival rates and recovery from colitis symptoms were observed in hPXR mice, but not in Pxr-null mice, when rifaximin was administered after the onset of symptoms. Nuclear factor κB (NF-κB) target genes were markedly down-regulated in hPXR mice by rifaximin treatment. In vitro NF-κB reporter assays demonstrated inhibition of NF-κB activity after rifaximin treatment in colon-derived cell lines expressing hPXR. These findings demonstrated the preventive and therapeutic role of rifaximin on IBD through human PXR-mediated inhibition of the NF-κB signaling cascade, thus suggesting that human PXR may be an effective target for the treatment of IBD.

  13. [Purine metabolism in ankylosing spondylitis: clinical study].

    Science.gov (United States)

    Jiménez Balderas, F J; Robles, E J; Juan, L; Badui, E; Arellano, H; Espinosa Said, L; Mintz Spiro, G

    1989-01-01

    We undertook a prospective study of 23 male patients with Ankylosing Spondylitis (AS) (New York Criteria), 18 HLA-B27 positive and 5 HLA-B27 negative, five of them had hyperuricemia. The following data of evolution were taken into consideration: age at onset of disease, time course of the disease, presence of urolithiasis, heart disease, flares of uveitis. Clinical activity and degree of disability were evaluated every one to 3 months; on each visit, every patient had determinations of serum and urinary uric acid levels, serum and phosphorus, erythrocyte sedimentation rate (ESR), serum protein electrophoresis, as well as X-ray films of the vertebral spine and pelvis. Three groups of patients were detected, all of them with equal age at onset, duration of disease, frequency of B27, peripheral arthritis, and leukocytosis. One group had hyperuricemia (5 of 23 patients, 80% of them HLA-B27 positive) and a lesser degree of clinical activity of the disease (p less than .001, a higher frequency of uveitis (40%, lower levels of serum gammaglobulins (p less than 0.05) and ESR (p less than 0.05), a lesser degree of ankylosis of the spine, and a better functional prognosis than the other groups. Another group (8 of 23 patients, 75% of them were HLA-B27 positive) had normouricemia and hyperuricosuria, and showed a higher frequency of fever (50%), an abnormal urinalysis, and urolithiasis (25%).

  14. Controlled outcome studies of child clinical hypnosis.

    Science.gov (United States)

    Adinolfi, Barbara; Gava, Nicoletta

    2013-09-01

    Background Hypnosis is defined as "as an interaction in which the hypnotist uses suggested scenarios ("suggestions") to encourage a person's focus of attention to shift towards inner experiences". Aim of the work The focus of this review is to summarize the findings of controlled outcome studies investigating the potential of clinical hypnosis in pediatric populations. We will examine the following themes: anesthesia, acute and chronic pain, chemotherapy-related distress, along with other specific medical issues. Results Hypnosis is an effective method to reduce pain and anxiety before, during and after the administration of anesthetics, during local dental treatments, invasive medical procedures and in burn children. Hypnosis can be successfully used to manage recurrent headaches, abdominal pain, irritable bowel syndrome and chemotherapy-related distress. Hypnosis has an important role in managing symptoms and improving the quality of life of children suffering from asthma and cystic fibrosis and in facilitating the treatment of insomnia in school-age children. Finally, hypnosis can be effectively used for the treatment of some habitual disorders such as nocturnal enuresis and dermatologic conditions, including atopic dermatitis and chronic eczema Conclusions Clinical hypnosis seems to be a useful, cheap and side-effects free tool to manage fear, pain and several kinds of stressful experiences in pediatric populations. Children who receive self-hypnosis trainings achieve significantly greater improvements in their physical health, quality of life, and self-esteem.

  15. Evidence Based Studies in Clinical Transfusion Medicine

    NARCIS (Netherlands)

    A.J.G. Jansen (Gerard)

    2007-01-01

    textabstractAfter the introduction of blood component therapy in the 1960s, more and more attention is given to clinical transfusion medicine. Although blood transfusion is an important treatment in different clinical settings, there are still lack of much randomized clinical trials. Nowadays bloo

  16. Evidence Based Studies in Clinical Transfusion Medicine

    NARCIS (Netherlands)

    A.J.G. Jansen (Gerard)

    2007-01-01

    textabstractAfter the introduction of blood component therapy in the 1960s, more and more attention is given to clinical transfusion medicine. Although blood transfusion is an important treatment in different clinical settings, there are still lack of much randomized clinical trials. Nowadays

  17. [Lymphocytic duodenosis: etiological study and clinical presentations].

    Science.gov (United States)

    Santolaria, Santos; Dominguez, Manuel; Alcedo, Javier; Abascal, Manuel; García-Prats, M Dolores; Marigil, Miguel; Vera, Jesus; Ferrer, Margarita; Montoro, Miguel

    2013-11-01

    Lymphocytic duodenosis (LD) is a characteristic lesion in the initial phases of celiac disease (CD) but can be associated with many other entities. The aim of this study was to evaluate the prevalence of distinct causes of LD and possible differences in clinical presentation according to etiology. A retrospective study was performed that included 194 patients diagnosed with LD (more than 25 intraepithelial lymphocytes per 100 epithelial cells). A preestablished strategy to evaluate the cause of the disease was followed that included celiac serology (antitransglutaminase antibodies), HLA-DQ2/DQ8 genotypes, diagnosis of Helicobacter pylori and small intestinal bacterial overgrowth (SIBO). Diagnosis of CD was established on the basis of clinical and histological response to a gluten-free diet in patients with positive serology or compatible findings on HLA-DQ2 (at least one of the alleles) or -DQ8 (both alleles) study. The most frequent cause of LD was CD (39%), followed by SBBO (22%), H.pylori (14%), CD and SIBO (12%), and other causes (13%). Most of the patients (83%) had a compatible HLA-DQ2 or -DQ8 genotype. In these patients, the most frequent diagnosis was CD (46%), while in the absence of HLA-DQ2/DQ8, the most frequent diagnoses were SIBO (44%) and H. pylori (22%). CD was the most frequent diagnosis in patients referred for dyspepsia, diarrhea and anemia, while H. pylori was the most frequent diagnosis in patients with abdominal pain. The most common causes of LD in our environment are CD, followed by SIBO and H. pylori infection. Copyright © 2013 Elsevier España, S.L. and AEEH y AEG. All rights reserved.

  18. Human tibial torsion - Morphometric assessment and clinical relevance

    Directory of Open Access Journals (Sweden)

    Swati Gandhi

    2014-02-01

    Full Text Available Background: Tibial torsion is an important anatomical parameter in clinical practice and displays variability among individuals. These variations are extremely significant in view of alignment guides such as those related to rotational landmarks of tibia in total knee arthroplasty. Further, precise knowledge and information pertaining to angle of tibial torsion also helps in correction of traumatic malunion or congenital maltorsion of tibia. Methods: The present study was carried out to determine the angle of tibial torsion in 100 adult dry tibia bones in the Department of Anatomy, Government Medical College, Amritsar. The study group comprised 50 males and 50 females with equal number of right- and left-sided bones. The measurements were meticulously recorded and the data were subjected to statistical analysis. The results were analyzed and discussed in the light of existing literature. Results: On the right side, it was found to be 29.84° ± 4.86°° (range = 22.00° -38.00° in males and 28.92° ± 5.10°° (range = 15.00°-38.00° in females. On the left side, it was found to be 28.00° ± 4.94°° (range = 20.00°-40.00°° in males and 28.12° ± 4.28°° (range = 20.00°-37.00°° in females. Conclusion: The present study is an endeavor to provide baseline data with reference to the angle of tibial torsion in the Indian population. The results of the study assume special importance in view of the technical advancements in reconstructive surgical procedures in orthopedic practice.

  19. Study on Angiogenesis Factor of Human Osteosarcoma

    Institute of Scientific and Technical Information of China (English)

    2000-01-01

    Angiogenesis factor of human osteosarcoma was partially purified and its biological features were studied. The active peptide with 8000 to 10 000 u molecular weight in the conditioned medium obtained from the cultivation of human osteosarcoma cells were partially purified by ultrafiltration, chromatography and dialysis. The angiogenic effects of the fractions were assessed by proliferation assay of human umbilical vein and pig aorta thoracic endothelial cells. The results showed that the chromatography fractions of 4 to 6 could significantly promote the proliferation of the endothelial cells. It was suggested that the human osteosarcoma cells could synthesize and secrete angiogenesis factor with a molecular weight of 8000 to 10 000 u.

  20. A Guide to Studying Human Hair Follicle Cycling In Vivo.

    Science.gov (United States)

    Oh, Ji Won; Kloepper, Jennifer; Langan, Ewan A; Kim, Yongsoo; Yeo, Joongyeub; Kim, Min Ji; Hsi, Tsai-Ching; Rose, Christian; Yoon, Ghil Suk; Lee, Seok-Jong; Seykora, John; Kim, Jung Chul; Sung, Young Kwan; Kim, Moonkyu; Paus, Ralf; Plikus, Maksim V

    2016-01-01

    Hair follicles (HFs) undergo lifelong cyclical transformations, progressing through stages of rapid growth (anagen), regression (catagen), and relative "quiescence" (telogen). Given that HF cycling abnormalities underlie many human hair growth disorders, the accurate classification of individual cycle stages within skin biopsies is clinically important and essential for hair research. For preclinical human hair research purposes, human scalp skin can be xenografted onto immunocompromised mice to study human HF cycling and manipulate long-lasting anagen in vivo. Although available for mice, a comprehensive guide on how to recognize different human hair cycle stages in vivo is lacking. In this article, we present such a guide, which uses objective, well-defined, and reproducible criteria, and integrates simple morphological indicators with advanced, (immuno)-histochemical markers. This guide also characterizes human HF cycling in xenografts and highlights the utility of this model for in vivo hair research. Detailed schematic drawings and representative micrographs provide examples of how best to identify human HF stages, even in suboptimally sectioned tissue, and practical recommendations are given for designing human-on-mouse hair cycle experiments. Thus, this guide seeks to offer a benchmark for human hair cycle stage classification, for both hair research experts and newcomers to the field.

  1. Are Social Studies Teachers Teaching Secular Humanism?

    Science.gov (United States)

    Farmer, Rod

    1980-01-01

    Discusses the controversy over teaching what religious fundamentalists and social conservatives consider secular humanism. Suggests that modern social studies does not support secular humanism even though they share epistemological and ethical assumptions (the use of the scientific method, intelligent reasoning). Provides suggestions for teachers…

  2. Hypothesis of human penile anatomy, erection hemodynamics and their clinical applications

    Institute of Scientific and Technical Information of China (English)

    Geng-Long Hsu

    2006-01-01

    Aim: To summarize recent advances in human penile anatomy, hemodynamics and their clinical applications. Methods:Using dissecting, light, scanning and transmission electron microscopy the fibroskeleton structure, penile venous vasculature,the relationship of the architecture between the skeletal and smooth muscles, and erection hemodynamics were studied on human cadaveric penises and clinical patients over a period of 10 years. Results: The tunica albuginea of the corpora cavernosa is a bi-layered structure with inner circular and outer longitudinal collagen bundles. Although there is no bone in the human glans, a strong equivalent distal ligament acts as a trunk of the glans penis. A guaranteed method of local anesthesia for penile surgeries and a tunical surgery was developed accordingly. On the venous vasculature it is elucidated that a deep dorsal vein, a couple of cavernosal veins and two pairs of para-arterial veins are located between the Buck's fascia and the tunica albuginea. Furthermore, a hemodynamic study suggests that a fully rigid erection may depend upon the drainage veins as well, rather than just the intracavernosal smooth muscle. It is believed that penile venous surgery deserves another look, and that it may be meaningful if thoroughly and carefully performed. Accordingly, a penile venous surgery was developed. Conclusion: Using this new insight into penile anatomy and physiology, exact penile curvature correction, refined penile implants and promising penile venous surgery, as well as a venous patch, for treating Peyronie's deformity might be performed under pure local anesthesia on an outpatient basis.

  3. Characterization of black raspberry functional food products for cancer prevention human clinical trials.

    Science.gov (United States)

    Gu, Junnan; Ahn-Jarvis, Jennifer H; Riedl, Kenneth M; Schwartz, Steven J; Clinton, Steven K; Vodovotz, Yael

    2014-05-07

    Our team is designing and fully characterizing black raspberry (BRB) food products suitable for long-term cancer prevention studies. The processing, scale-up, and storage effects on the consistency, quality, bioactive stability, and sensory acceptability of two BRB delivery systems of various matrices are presented. BRB dosage, pH, water activity, and texture were consistent in the scale-up production. Confections retained >90% of anthocyanins and ellagitannin after processing. Nectars had >69% of anthocyanins and >66% of ellagitannin retention, which varied with BRB dosage due to the processing difference. Texture remained unchanged during storage. BRB products consumed in a prostate cancer clinical trial were well accepted in sensory tests. Thus, this study demonstrates that two different BRB foods can be formulated to meet quality standards with a consistent bioactive pattern and successfully scaled up for a large human clinical trial focusing on cancer risk and other health outcomes.

  4. Comparative wound healing--are the small animal veterinarian's clinical patients an improved translational model for human wound healing research?

    Science.gov (United States)

    Volk, Susan W; Bohling, Mark W

    2013-01-01

    Despite intensive research efforts into understanding the pathophysiology of both chronic wounds and scar formation, and the development of wound care strategies to target both healing extremes, problematic wounds in human health care remain a formidable challenge. Although valuable fundamental information regarding the pathophysiology of problematic wounds can be gained from in vitro investigations and in vivo studies performed in laboratory animal models, the lack of concordance with human pathophysiology has been cited as a major impediment to translational research in human wound care. Therefore, the identification of superior clinical models for both chronic wounds and scarring disorders should be a high priority for scientists who work in the field of human wound healing research. To be successful, translational wound healing research should function as an intellectual ecosystem in which information flows from basic science researchers using in vitro and in vivo models to clinicians and back again from the clinical investigators to the basic scientists. Integral to the efficiency of this process is the incorporation of models which can accurately predict clinical success. The aim of this review is to describe the potential advantages and limitations of using clinical companion animals (primarily dogs and cats) as translational models for cutaneous wound healing research by describing comparative aspects of wound healing in these species, common acute and chronic cutaneous wounds in clinical canine and feline patients, and the infrastructure that currently exists in veterinary medicine which may facilitate translational studies and simultaneously benefit both veterinary and human wound care patients.

  5. A CLINICAL STUDY OF OCULAR TRAUMA

    Directory of Open Access Journals (Sweden)

    Bharat Kumar

    2015-12-01

    Full Text Available AIM This study is designed to enumerate various causes of ocular trauma, clinical spectrum of presentation and to evaluate the visual outcome after appropriate management. MATERIALS AND METHODS A prospective study was conducted on total of 136 patients from the places in and around Kakinada, East Godavari District of Andhra Pradesh, India. A detailed work up of all patients including slit lamp biomicroscopy, direct, indirect ophthalmoscopy and ultra sonography B scan was done. RESULTS Observations from the study were analyzed, discussed and compared with the existing studies in the literature. Mean age group of patients belong to young adults between 20-30 years (57.9%, males (81% affected more than females. Illiterates, Agricultural labourers, Industrial workers affected more. Road Traffic Accidents (25.73%, industrial injuries (22.05% and agricultural hazards (19.11% being the major cause of unilateral eye injury. Closed globe injuries (80.88% more common than Open globe injuries (19.12. CONCLUTIONS Ophthalmic injuries due to innumerable causes results in various types of ocular trauma, leading to untold misery, visual impairment and economic burden to the family, society and country as a whole. Health education regarding use of preventive measures, seeking early treatment and appropriate rehabilitation are very much recommended to reduce the burden of morbidity due to ocular trauma.

  6. Mesiodens: a clinical and radiographic study.

    Science.gov (United States)

    Kim, Su-Gwan; Lee, Sang-Ho

    2003-01-01

    The term 'mesiodens' refers to a supernumerary tooth present in the midline of the maxilla between the two central incisors. This study seeks to investigate the characteristics of mesiodens among children in Korea. The study population consisted of 40 children whose ages ranged from 4 to-26-years. The characteristics of mesiodens were obtained from radiographs and clinical examination results, and were confirmed by surgical intervention. Results showed that males were affected approximately 4 times as frequendy as females. Twenty-five percent of the patients had more than 1 supernumerary tooth. About 66% of the mesiodens were conical in shape and about 52% of the mesiodens were in the upward position. The age and sex distribution, number of mesiodens per patient, shape, direction, size, and effect on permanent maxillary incisors are also presented in this study. The incidence of mesiodens has been estimated at 0.15% to 1% of the population. It occurs more frequently in boys than in girls, with the ratio being approximately 2:1. In this study, a male:female ratio of 4:1 for the prevalence for mesiodens was found. Ten (25%) out of the 40 patients had 2 mesiodens.

  7. Phase I clinical and pharmacokinetic study of LY 195448.

    Science.gov (United States)

    Cassidy, J; Lewis, C; Adams, L; Setanoians, A; Bayssas, M; Boder, G G; Rankin, E M; Kaye, S B

    1989-01-01

    LY 195448 is a phenethanolamine that has shown anti-tumour activity in a range of murine tumour models, although its mechanism of action is unknown. Pre-clinical studies have indicated the absence of "standard" side effects such as myelosuppression and gastrointestinal toxicity. The present phase I trial was carried out in nine patients at doses ranging up to 133 mg/m2. The major toxicities up to that dose were mild, reversible hypotension, tachycardia and tremor. No haematological or biochemical toxicity was observed. Murine pharmacokinetics were assessed at a dose level that was effective in experimental tumours and compared with human pharmacokinetic parameters derived from this study. The results indicated the clinical possibility of reaching peak drug levels associated with experimental activity. However, no responses were seen at the doses used. This study was terminated prior to its completion due to an unexplained loss of activity against murine tumours since September 1987. No significant loss of the in vitro anti-mitotic activity originally reported by Boder et al. [3] was observed. Possible reasons for the apparent loss of in vivo activity have been intensively investigated, but no cause has been determined. Therefore, clinical trials with LY 195448 have been discontinued.

  8. Human biomonitoring pilot study DEMOCOPHES in Germany

    DEFF Research Database (Denmark)

    Schwedler, Gerda; Seiwert, Margarete; Fiddicke, Ulrike

    2017-01-01

    on a European Scale) and DEMOCOPHES (Demonstration of a study to Coordinate and Perform Human Biomonitoring on a European Scale) were formed, comprising 35 partners from 27 European countries. In COPHES a research scheme and guidelines were developed to exemplarily measure in a pilot study mercury in hair......Human biomonitoring (HBM) is an effective tool to assess human exposure to environmental pollutants, but comparable HBM data in Europe are lacking. In order to expedite harmonization of HBM studies on a European scale, the twin projects COPHES (Consortium to Perform Human Biomonitoring......, cadmium, cotinine and several phthalate metabolites in urine of 6–11 year old children and their mothers in an urban and a rural region. Seventeen European countries simultaneously conducted this cross-sectional DEMOCOPHES feasibility study. The German study population was taken in the city of Bochum...

  9. Clinical implications of microRNAs in human glioblastoma

    Directory of Open Access Journals (Sweden)

    Masahiro eMizoguchi

    2013-02-01

    Full Text Available Glioblastoma (GBM is one of the most common and dismal brain tumors in adults. Further elucidation of the molecular pathogenesis of GBM is mandatory to improve the overall survival of patients. A novel small non-coding RNA molecule, microRNA (miRNA, appears to represent one of the most attractive target molecules contributing to the pathogenesis of various types of tumors. Recent global analyses have revealed that several miRNAs are clinically implicated in GBM, with some reports indicating the association of miRNA dysregulation with acquired temozolomide (TMZ resistance. More recent studies have revealed that miRNAs could play a role in cancer stem cell (CSC properties, contributing to treatment resistance. In addition, greater impact might be expected from miRNA-targeted therapies based on tumor-derived exosomes that contain numerous functional miRNAs, which could be transferred between tumor cells and surrounding structures. Tumor-derived miRNAs are now considered to be a novel molecular mechanism promoting the progression of GBM. Establishment of miRNA-targeted therapies based on miRNA dysregulation of CSCs could provide effective therapeutic strategies for TMZ-resistant GBM. Recent progress has revealed that miRNAs are not only putative biological markers for diagnosis, but also one of the most promising targets for GBM treatment. Herein, we summarize the translational aspects of miRNAs in the diagnosis and treatment of GBM.

  10. Comparative evaluation of the efficacy of synthetic nanocrystalline hydroxyapatite bone graft (Ostim® and synthetic microcrystalline hydroxyapatite bone graft (Osteogen® in the treatment of human periodontal intrabony defects: A clinical and denta scan study

    Directory of Open Access Journals (Sweden)

    Monika Kamboj

    2016-01-01

    Full Text Available Background: To evaluate the relative efficacy of synthetic nanocrystalline hydroxyapatite (HA (Ostim® and microcrystalline HA (Osteogen® bone grafts in the treatment of human periodontal intrabony defects clinically and radiographically through denta scan. Materials and Methods: Ten chronic periodontitis patients with bilateral intrabony periodontal defects of ≥2 mm radiographic defect depth below 55 years of age were selected randomly and treated with synthetic nanocrystalline HA (Ostim® or synthetic microcrystalline HA (Osteogen® bone graft. Clinical parameters including probing depth (PD and clinical attachment level (CAL were measured preoperatively and postoperatively at 3 and 6 months for each of the defects using an occlusal acrylic stent. Radiographic parameters were measured with the help of denta scan preoperatively and postoperatively at 6 months. Results: At 6 months following therapy, the Osteogen® group showed a reduction in mean PD from 11.10 ± 1.663 to 8.50 ± 0.850 mm and a change in mean CAL from 6.30 ± 1.160 to 3.40 ± 0.516 mm, whereas in the Ostim® group, the mean PD decreased from 11.20 ± 0.919 to 8.30 ± 0.823 mm and mean CAL decreased from 6.10 ± 0.738 to 3.30 ± 0.483 mm. At 6 months following therapy, denta scan showed a reduction in mean intrabony defect depth in the Osteogen® group from 2.54 ± 0.786 to 1.01 ± 0.448 mm, whereas in the Ostim® group, it was 2.71 ± 0.650 mm to 1.12 ± 0.563 mm. Conclusion: It was concluded that both the HA bone grafts produced statistically significant reduction in pocket depth, in the depth of osseous lesion, and a statistically significant gain in attachment level, irrespective of their physico-chemical properties.

  11. Development and validation of a sensitive liquid chromatographic-tandem mass spectrometric method for the simultaneous analysis of granisetron and 7-hydroxy granisetron in human plasma and urine samples: application in a clinical pharmacokinetic study in pregnant subject.

    Science.gov (United States)

    Zhao, Yang; Chen, Hui-Jun; Caritis, Steve; Venkataramanan, Raman

    2016-02-01

    A liquid chromatography-tandem mass spectrometric method for the quantification of granisetron and its major metabolite, 7-hydroxy granisetron in human plasma and urine samples was developed and validated. Respective stable isotopically labeled granisetron and 7-hydroxy granisetron were used as internal standards (IS). Chromatography was performed using an Xselect HSS T3 analytical column with a mobile phase of 20% acetonitrile in water (containing 0.2 mM ammonium formate and 0.14% formic acid, pH 4) delivered in an isocratic mode. Tandem mass spectrometry operating in positive electrospray ionization mode with multiple reaction monitoring was used for quantification. The standard curves were linear in the concentration ranges of 0.5-100 ng/mL for granisetron and 0.1-100 ng/mL for 7-hydroxy granisetron in human plasma samples, and 2-2000 ng/mL for granisetron and 2-1000 ng/mL for 7-hydroxy granisetron in human urine samples, respectively. The accuracies were >85% and the precision as determined by the coefficient of variations was validated method was successfully applied to a pharmacokinetic study after intravenous administration of 1 mg granisetron to a pregnant subject.

  12. 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.

  13. A CLINICAL STUDY ON ILEAL PERFORATION

    Directory of Open Access Journals (Sweden)

    Kishore Babu

    2016-03-01

    Full Text Available INTRODUCTION Ileal perforation is a common problem seen in tropical countries, the commonest cause being typhoid fever. In western countries the causes are malignancy, trauma and mechanical aetiology, in the order of frequency.1,2,3 Over the years a definite changing trend has been observed in ileal perforations both in terms of causes, treatment and prognosis. Better antibiotics, aggressive surgery and the elimination of conservative treatment, better preoperative and postoperative care have all significantly contributed to the improvement in patient outcome.4,5 But still cases of ileal perforation cause a significant morbidity and mortality that persists despite the significant changes in health care over the years. AIMS AND OBJECTIVES To study the aetiology, presentation, management outcome and the factors influencing prognosis and outcome in ileal perforations. MATERIAL & METHODS Study Setting S. V. Medical College, Department of General Surgery, Tirupati. Study Period Patients attending S. V. Medical College, Department of General Surgery with perforation during the period from November 2012 to October 2015. Inclusion Criteria Patients between age group of more than 14 years presenting with pain abdomen and who are diagnosed to have ileal perforation in the intra operative period are selected. Exclusion Criteria Patients with peritonitis due to other causes like gastric, duodenum or large bowel perforation are excluded. Study Method The present study is a prospective study done on 28 patients of ileal perforation due to typhoid complication, nonspecific and traumatic perforations. History, clinical examination, investigations, operative findings, post-operative complications were recorded. In patients with non-traumatic perforations Widal test was done. CONCLUSION Typhoid fever and traumatic aetiology are the most common cause of Ileal perforation, followed by TB. Patients are more of male gender and are in reproductive age group. Widal

  14. Safety and pharmacokinetics of hyperimmune anti-human immunodeficiency virus (HIV) immunoglobulin administered to HIV-infected pregnant women and their newborns. Pediatric AIDS Clinical Trials Group Protocol 185 Pharmacokinetic Study Group.

    Science.gov (United States)

    Lambert, J S; Mofenson, L M; Fletcher, C V; Moye, J; Stiehm, E R; Meyer, W A; Nemo, G J; Mathieson, B J; Hirsch, G; Sapan, C V; Cummins, L M; Jimenez, E; O'Neill, E; Kovacs, A; Stek, A

    1997-02-01

    The pharmacokinetics and safety of hyperimmune anti-human immunodeficiency virus (HIV) intravenous immunoglobulin (HIVIG) were evaluated in the first 28 maternal-infant pairs enrolled in a randomized, intravenous immunoglobulin (IVIG)-controlled trial of HIVIG maternal-infant HIV transmission prophylaxis. Using 200 mg/kg, mean half-life and volume of distribution (Vd) in women were 15 days and 72 mL/kg, respectively, after one and 32 days and 154 mL/kg after three monthly infusions, with stable 4 mL/kg/day clearance. Transplacental passage occurred. Newborn single-dose half-life, Vd, and clearance were 30 days, 143 mL/kg, and 4 mL/kg/day, respectively. HIVIG rapidly cleared maternal serum immune complex-dissociated p24 antigen, and plasma HIV-1 RNA levels were stable. Mild to moderate adverse clinical effects occurred in 2 of 103 maternal and 2 of 25 infant infusions. No adverse hematologic, blood chemistry, or immunologic effects were seen. HIVIG is well-tolerated in HIV-infected pregnant women and their newborns, clears antigenemia, crosses the placenta, and exhibits pharmacokinetics similar to those of other immunoglobulin preparations.

  15. Parastomal hernias -- clinical study of therapeutic strategies.

    Science.gov (United States)

    Târcoveanu, E; Vasilescu, A; Cotea, E; Vlad, N; Palaghia, M; Dănilă, N; Variu, M

    2014-01-01

    Parastomal hernias are parietal defects adjacent to the stomasite, after ileostomy and colostomy. Their incidence is variable and they are generally underestimated. Between 2001 and 2010 at the First Surgical Clinic Iasi, we treated 861 incisional hernias, of which there were 31 parastomal hernias in 26 patients (3%), 5 of which were recurrent parastomal hernias. Parastomal hernias have been explored clinically, through imaging and intraoperatively.Because our experience and literature review have demonstrated that a mesh repair is a safe procedure in the treatment of parastomal hernia, in 2010 we initiated a prospective randomized trial on the use of prophylactic polypropylene mesh at the time of stoma formation to reduce the risk of parastomal hernia. We enrolled in the study 20 patients with mesh implanted at the primary operation and 22 patients without mesh. The inclusion criteria were: patients with low rectal cancer, stage II-III, irradiated, obese, with a history of hernias, patients who do physical work. Most parastomal hernias were asymptomatic; only six cases with parastomal hernias required emergency surgical treatment. We performed local tissue repair in 16 cases (4 cases with recurrent parastomal hernia, stoma relocation in one case), sublay mesh repair in 15 cases (one case with recurrent parastomal hernia; stoma relocation in 5 cases). Postoperative morbidity registered included 4 wound infections (one case after mesh repair which required surgical reintervention) and stoma necrosis in one case with strangulation parastomal hernia with severe postoperative evolution and death. After local tissue repair recurrences were seen in 6 cases, after mesh repair we registered recurrence only in one case and no relapse after the relocation of the stoma. The patients with prophylactic mesh at the time of stoma formation to reduce the risk of parastomal hernia were followed for a median of 20 months(range 12 to 28 months) by clinical examination and ultrasound

  16. Community Engagement in Observational Human Exposure Studies

    Science.gov (United States)

    Although observational human exposure studies do not deliberately expose participants to chemicals or environmental conditions, merely involving people as research participants and conducting research inside homes raises ethical issues. Community engagement offers a promising st...

  17. Statistical Issues in TBI Clinical Studies

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    Paul eRapp

    2013-11-01

    Full Text Available The identification and longitudinal assessment of traumatic brain injury presents several challenges. Because these injuries can have subtle effects, efforts to find quantitative physiological measures that can be used to characterize traumatic brain injury are receiving increased attention. The results of this research must be considered with care. Six reasons for cautious assessment are outlined in this paper. None of the issues raised here are new. They are standard elements in the technical literature that describes the mathematical analysis of clinical data. The purpose of this paper is to draw attention to these issues because they need to be considered when clinicians evaluate the usefulness of this research. In some instances these points are demonstrated by simulation studies of diagnostic processes. We take as an additional objective the explicit presentation of the mathematical methods used to reach these conclusions. This material is in the appendices. The following points are made:1. A statistically significant separation of a clinical population from a control population does not ensure a successful diagnostic procedure.2. Adding more variables to a diagnostic discrimination can, in some instances, actually reduce classification accuracy.3. A high sensitivity and specificity in a TBI versus control population classification does not ensure diagnostic successes when the method is applied in a more general neuropsychiatric population. 4. Evaluation of treatment effectiveness must recognize that high variability is a pronounced characteristic of an injured central nervous system and that results can be confounded by either disease progression or spontaneous recovery. A large pre-treatment versus post-treatment effect size does not, of itself, establish a successful treatment.5. A procedure for discriminating between treatment responders and nonresponders requires, minimally, a two phase investigation. This procedure must include a

  18. Study on Virtual Human Skeleton System

    Institute of Scientific and Technical Information of China (English)

    郭巧; 李亦

    2004-01-01

    A solution of virtual human skeleton system is proposed. Some issues on integration of anatomical geometry, biodynamics and computer animation are studied. The detailed skeleton system model that incorporates the biodynamic and geometric characteristics of a human skeleton system allows some performance studies in greater detail than that performed before. It may provide an effective and convenient way to analyze and evaluate the movement performance of a human body when the personalized anatomical data are used in the models. An example shows that the proposed solution is effective for the stated problems.

  19. Clinical description of human bocavirus viremia in children with LRTI, Eastern Province, Saudi Arabia

    Directory of Open Access Journals (Sweden)

    Dalal K Bubshait

    2015-01-01

    Full Text Available Human bocavirus (HBoV is a major etiology of lower respiratory tract infection (LRTI in young children. We tested 149 patients admitted to King Fahd Hospital of the University with diagnosis of LRTI. Viremia caused by the different studied viruses was detected in 31.5% of the total cases by Real-time Polymerase chain reaction. We report five patients who were positive for HBoV in serum samples. Clinical presentation ranged from mild to severe disease as one of them required admission to intensive care unit. Wheezing was a striking feature in most of our patients, but fever was not a consistent finding.

  20. Molecular identification of nocardia isolates from clinical samples and an overview of human nocardiosis in Brazil.

    Directory of Open Access Journals (Sweden)

    Paulo Victor Pereira Baio

    Full Text Available BACKGROUND: Nocardia sp. causes a variety of clinical presentations. The incidence of nocardiosis varies geographically according to several factors, such as the prevalence of HIV infections, transplants, neoplastic and rheumatic diseases, as well as climate, socio-economic conditions and laboratory procedures for Nocardia detection and identification. In Brazil the paucity of clinical reports of Nocardia infections suggests that this genus may be underestimated as a cause of human diseases and/or either neglected or misidentified in laboratory specimens. Accurate identification of Nocardia species has become increasingly important for clinical and epidemiological investigations. In this study, seven clinical Nocardia isolates were identified by multilocus sequence analysis (MLSA and their antimicrobial susceptibility was also determined. Most Nocardia isolates were associated to pulmonary disease. METHODOLOGY/PRINCIPAL FINDINGS: The majority of Brazilian human isolates in cases reported in literature were identified as Nocardia sp. Molecular characterization was used for species identification of Nocardia nova, Nocardia cyriacigeorgica, Nocardia asiatica and Nocardia exalbida/gamkensis. Data indicated that molecular analysis provided a different Nocardia speciation than the initial biochemical identification for most Brazilian isolates. All Nocardia isolates showed susceptibility to trimethoprim-sulfamethoxazole, the antimicrobial of choice in the treatment nocardiosis. N. nova isolated from different clinical specimens from one patient showed identical antimicrobial susceptibility patterns and two distinct clones. CONCLUSIONS/SIGNIFICANCE: Although Brazil is the world's fifth-largest country in terms of land mass and population, pulmonary, extrapulmonary and systemic forms of nocardiosis were reported in only 6 of the 26 Brazilian states from 1970 to 2013. A least 33.8% of these 46 cases of nocardiosis proved fatal. Interestingly, coinfection

  1. Human factors in resuscitation: Lessons learned from simulator studies

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    Hunziker S

    2010-01-01

    Full Text Available Medical algorithms, technical skills, and repeated training are the classical cornerstones for successful cardiopulmonary resuscitation (CPR. Increasing evidence suggests that human factors, including team interaction, communication, and leadership, also influence the performance of CPR. Guidelines, however, do not yet include these human factors, partly because of the difficulties of their measurement in real-life cardiac arrest. Recently, clinical studies of cardiac arrest scenarios with high-fidelity video-assisted simulations have provided opportunities to better delineate the influence of human factors on resuscitation team performance. This review focuses on evidence from simulator studies that focus on human factors and their influence on the performance of resuscitation teams. Similar to studies in real patients, simulated cardiac arrest scenarios revealed many unnecessary interruptions of CPR as well as significant delays in defibrillation. These studies also showed that human factors play a major role in these shortcomings and that the medical performance depends on the quality of leadership and team-structuring. Moreover, simulated video-taped medical emergencies revealed that a substantial part of information transfer during communication is erroneous. Understanding the impact of human factors on the performance of a complex medical intervention like resuscitation requires detailed, second-by-second, analysis of factors involving the patient, resuscitative equipment such as the defibrillator, and all team members. Thus, high-fidelity simulator studies provide an important research method in this challenging field.

  2. CLINICAL STUDY OF EARLY BREAST CARCINOMA

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    Kiran Kumar

    2016-01-01

    Full Text Available Carcinoma of the breast is one of the commonest cancers occurring in female and accounts for 1/3rd of all the malignant diseases occurring in them. It is mainly a disease of the developed countries and accounts for 1,00,000 deaths annually. Breast carcinoma is classified as Early breast cancer, Locally advanced breast cancer and Metastatic breast cancer. By definition early stage breast cancer constitutes breast tumors of clinical stages I, IIa and T2N1M0. Early breast cancer is the one diagnosed by mammography. Women when approaches at this stage, they can go for breast conservation surgery. Not all women are candidates for this approach, and some require mastectomy as part of their treatment. AIM To observe the incidence of early breast carcinoma with particular reference to the time taken by the patients to seek medical advice after the symptoms have developed i.e. the average time taken by the patients to seek medical advice, their appropriate management and prognosis. MATERIALS AND METHODS This prospective study was conducted over a period of 2 years from Oct-2012 to Oct-2014 in 30 female patients aged between 25-65 years who were presented with lump in breast of size ≤5cms with or without pain, with or without lymph nodes to the outpatient department. All the patients were thoroughly asked about history, examined clinically, investigated, staged and managed by surgery either Breast Conservation Surgery or Modified Radical Mastectomy. Postoperative complications were recorded and followed up regularly. RESULTS The incidence of early breast cancer in this study was 0.98% with peak age incidence between 40-60 years and duration of symptoms <6 months in 18 patients. Breast Conservation Surgery + axillary dissection + Radiotherapy was done in 23%. Prognosis was good in these patients with no local recurrence and death. CONCLUSION The prognosis of early stage breast carcinoma patients in this study was good. To have long term tumor free and

  3. Bioavailability studies and the clinical pharmacologist: correlation of drug distribution with clinical effects.

    Science.gov (United States)

    Ogilvie, R I

    1975-06-01

    Bioavailability studies can be interpreted only when clinical information is available which correlates drug distribution with both efficacious and toxic clinical effects. The clinical pharmacologist should be instrumental in the development of safe and effective drug therapy by the systematic application of well designed clinical trials, the clear definition of therapeutically desirable clinical responses, and the development and application of improved techniques of measuring these effects.

  4. Kinematic Measures during a Clinical Diagnostic Technique for Human Neck Disorder: Inter- and Intraexaminer Comparisons

    Directory of Open Access Journals (Sweden)

    Joseph Vorro

    2013-01-01

    Full Text Available Diagnoses of human musculoskeletal dysfunction of the cervical spine are indicated by palpable clues of a patient’s structural compliance/noncompliance as this body segment responds to diagnostic motion demands applied by a clinician. This process includes assessments of motion range, motion performance, and changes in tissue responses. However, biomechanical quantification of these diagnostic actions and their reproducible components is lacking. As a result, this study sought to use objective kinematic measures to capture aspects of the diagnostic process to compare inter- and intraexaminer motion behaviors when performing a specific clinical diagnostic protocol. Pain-free volunteers and a group determined to be symptomatic based on a psychometric pain score were examined by two clinicians while three-dimensional kinematic data were collected. Intraexaminer diagnostic motion ranges of cervical lateral flexion and secondary rotations were consistent for each examiner and for each subject group. However, interexaminer comparisons for motion range, secondary rotations, and average velocities yielded consistently larger measures for one examiner for both subject groups (P<0.05. This research demonstrates that fundamental aspects of the clinical diagnostic process for human neck disorders can be identified and measured using kinematic parameters. Further, these objective data have the potential to be linked to clinical decision making.

  5. Transcription pattern of UL131A-128 mRNA in clinical strains of human cytomegalovirus

    Indian Academy of Sciences (India)

    Zhengrong Sun; Gaowei Ren; Yanping Ma; Ning Wang; Yaohua Ji; Ying Qi; Mali Li; Rong He; Qiang Ruan

    2010-09-01

    Human cytomegalovirus (HCMV) mRNA was obtained from human embryonic lung fibroblast cells infected by HCMV clinical strains from urine samples of infants at different kinetic periods. The cDNA of UL131A-128 mRNAs was amplified using reverse transcription-polymerase chain reaction (RT-PCR) and analysed by sequencing. Mean while, clones containing UL131A-128 transcripts in an HCMV cDNA library of a clinical strain were selected and sequenced. It was demonstrated that UL131A-128 mRNA was expressed with immediately early, early and late kinetics. Sequences obtained by RT-PCR showed that the UL131A gene consisted of two exons and the coding region of the UL130 gene was not interrupted by any intron in the region as reported earlier. However, the transcript of the UL128 gene showed two patterns: one pattern consisted of three exons as reported earlier; the other contained the three exons and also the first intron. Moreover, the above characteristics of UL131A-128 spliced transcripts were confirmed by the sequences of clones selected from the HCMV cDNA library. Our results demonstrated that the UL131A, UL130 and UL128 genes were transcribed with the 3′-coterminal, although the initiation points of their mRNA may be different. The variation in the transcripts found in our study indicated the complex nature of transcription of UL131A-128 genes in clinical strains of HCMV.

  6. Clinical regressions and broad immune activation following combination therapy targeting human NKT cells in myeloma.

    Science.gov (United States)

    Richter, Joshua; Neparidze, Natalia; Zhang, Lin; Nair, Shiny; Monesmith, Tamara; Sundaram, Ranjini; Miesowicz, Fred; Dhodapkar, Kavita M; Dhodapkar, Madhav V

    2013-01-17

    Natural killer T (iNKT) cells can help mediate immune surveillance against tumors in mice. Prior studies targeting human iNKT cells were limited to therapy of advanced cancer and led to only modest activation of innate immunity. Clinical myeloma is preceded by an asymptomatic precursor phase. Lenalidomide was shown to mediate antigen-specific costimulation of human iNKT cells. We treated 6 patients with asymptomatic myeloma with 3 cycles of combination of α-galactosylceramide-loaded monocyte-derived dendritic cells and low-dose lenalidomide. Therapy was well tolerated and led to reduction in tumor-associated monoclonal immunoglobulin in 3 of 4 patients with measurable disease. Combination therapy led to activation-induced decline in measurable iNKT cells and activation of NK cells with an increase in NKG2D and CD56 expression. Treatment also led to activation of monocytes with an increase in CD16 expression. Each cycle of therapy was associated with induction of eosinophilia as well as an increase in serum soluble IL2 receptor. Clinical responses correlated with pre-existing or treatment-induced antitumor T-cell immunity. These data demonstrate synergistic activation of several innate immune cells by this combination and the capacity to mediate tumor regression. Combination therapies targeting iNKT cells may be of benefit toward prevention of cancer in humans.

  7. Translating dosages from animal models to human clinical trials--revisiting body surface area scaling.

    Science.gov (United States)

    Blanchard, Otis L; Smoliga, James M

    2015-05-01

    Body surface area (BSA) scaling has been used for prescribing individualized dosages of various drugs and has also been recommended by the U.S. Food and Drug Administration as one method for using data from animal model species to establish safe starting dosages for first-in-human clinical trials. Although BSA conversion equations have been used in certain clinical applications for decades, recent recommendations to use BSA to derive interspecies equivalents for therapeutic dosages of drug and natural products are inappropriate. A thorough review of the literature reveals that BSA conversions are based on antiquated science and have little justification in current translational medicine compared to more advanced allometric and physiologically based pharmacokinetic modeling. Misunderstood and misinterpreted use of BSA conversions may have disastrous consequences, including underdosing leading to abandonment of potentially efficacious investigational drugs, and unexpected deadly adverse events. We aim to demonstrate that recent recommendations for BSA are not appropriate for animal-to-human dosage conversions and use pharmacokinetic data from resveratrol studies to demonstrate how confusion between the "human equivalent dose" and "pharmacologically active dose" can lead to inappropriate dose recommendations. To optimize drug development, future recommendations for interspecies scaling must be scientifically justified using physiologic, pharmacokinetic, and toxicology data rather than simple BSA conversion.

  8. Using human simulation to prepare physical therapy students for acute care clinical practice.

    Science.gov (United States)

    Silberman, Nicki J; Panzarella, Karen J; Melzer, Barbara A

    2013-01-01

    The acute care setting requires a unique skill set for all health care providers, including Doctor of Physical Therapy (DPT) students. This study explores high-fidelity human simulation (HFHS) training in a DPT education program to achieve learning objectives specific to preparation of DPT students for acute care clinical practice. Twenty-three DPT students participated in a HFHS acute care experience, provided feedback about the learning experience, and completed a survey regarding preparedness for clinical practice. Student feedback was interpreted to gain content validity of the learning experience, and descriptive statistics were used to analyze survey results. In this pilot study, students identified four learning objectives met during the simulation experience: interprofessional communication, preparation of the treatment environment, patient safety, and discharge planning. Following the experience, 91.5% of the students reported more confidence in interprofessional communication, and 67% were more knowledgeable in discharge disposition. All students agreed that simulations should be part of the curriculum, and 95.2% reported simulation valuable in preparation for clinical practice. As a result of HFHS training in the DPT program, students' educational objectives were met, and simulation was deemed valuable in integrating prior learning and providing an enhanced understanding of the acute care setting. The findings support continued investigation of the effectiveness of simulation to prepare DPT students for acute care clinical practice.

  9. Redesign of a computerized clinical reminder for colorectal cancer screening: a human-computer interaction evaluation

    Directory of Open Access Journals (Sweden)

    Saleem Jason J

    2011-11-01

    Full Text Available Abstract Background Based on barriers to the use of computerized clinical decision support (CDS learned in an earlier field study, we prototyped design enhancements to the Veterans Health Administration's (VHA's colorectal cancer (CRC screening clinical reminder to compare against the VHA's current CRC reminder. Methods In a controlled simulation experiment, 12 primary care providers (PCPs used prototypes of the current and redesigned CRC screening reminder in a within-subject comparison. Quantitative measurements were based on a usability survey, workload assessment instrument, and workflow integration survey. We also collected qualitative data on both designs. Results Design enhancements to the VHA's existing CRC screening clinical reminder positively impacted aspects of usability and workflow integration but not workload. The qualitative analysis revealed broad support across participants for the design enhancements with specific suggestions for improving the reminder further. Conclusions This study demonstrates the value of a human-computer interaction evaluation in informing the redesign of information tools to foster uptake, integration into workflow, and use in clinical practice.

  10. Periodontal conditions in vegetarians: a clinical study.

    Science.gov (United States)

    Staufenbiel, I; Weinspach, K; Förster, G; Geurtsen, W; Günay, H

    2013-08-01

    Investigations about possible correlations between vegetarian diet and periodontal conditions are rare and characterized by small case numbers. The aim of this clinical study was to investigate the influence of a vegetarian diet on periodontal parameters with an appropriate sample size. A total of 200 patients, 100 vegetarians and 100 non-vegetarians, were included in the study. All patients were examined including a full mouth assessment of the periodontal and dental conditions. In addition, a questionnaire was handed out to ask for patients' oral hygiene habits and level of education. For statistical analysis the Mann-Whitney Test (χ(2) for analysis of the questionnaire) was applied (level of significance: Pvegetarians versus 41.72 years non-vegetarians). Vegetarians had significantly lower probing pocket depths (P=0.039), bleeding on probing (P=0.001), periodontal screening index (P=0.012), a better hygiene index (Pvegetarians. Furthermore, vegetarians had a higher level of education (PVegetarians revealed better periodontal conditions (less inflammation signs, less periodontal damage and a better dental home care). However, it should be considered that vegetarians are not only avoiding meat in their nutrition but are also characterized by an overall healthier life style.

  11. CLINICAL STUDY OF HEART DISEASE COMPLICATING PREGNANCY

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    Richa

    2014-07-01

    Full Text Available Introduction-Heart disease complicating pregnancy is considered as a high risk situation. Increased cardiac demands during the course of pregnancy potentially increase morbidity and mortality in women with underlying heart disease. AIM: To determine maternal and fetal outcome in women with heart disease complicating pregnancy, To emphasize on proper protocol for managing pregnancy complicated by heart disease, To correlate the time of booking & NYHA grading with maternal & fetal outcome. Risk of adverse outcome is more in rural population as compared to its urban counterpart. METHOD: A prospective clinical study of 25 cases of pregnancy complicated by heart disease, reporting to tertiary care hospital for delivery, was carried out to find out the incidence and maternal and fetal outcome. RESULTS: The incidence of heart disease in pregnancy in the present study was 0.6%. Most of the women (91% belonged to low socioeconomic class in the rural population. Rheumatic heart lesions constituted 77% of the cases. Mitral stenosis was the commonest lesion in 40% of cases. Ten (40% women delivered spontaneously vaginally at term. Cesarean section was performed in 14 cases (56%. There were 5 maternal deaths. There were no perinatal deaths. CONCLUSION: Early diagnosis of heart disease, regular antenatal check-up, institutional delivery, limiting family size can reduce the maternal and perinatal mortality and morbidity associated with heart disease

  12. CLINICAL STUDY OF FISTULA IN ANO

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    Sushma Ramteke

    2017-02-01

    Full Text Available BACKGROUND Fistula in ano is one of the common problem faced in today’s world. Fistula in ano is track lined by granulation tissue that connect deeply in the anal canal or rectum and superficially on the skin around the anus. It usually results from cryptoglandular infection causing abscess, which burst spontaneously or was drained inadequately. The study is conducted to find most common aetiological factor and to evaluate various surgical technique and their outcome. The aim of the study is to- 1. Study the incidence of various aetiologies of fistula in ano. 2. Study the clinical presentation of fistula in ano. 3. Evaluate different modalities of surgical approach and their outcome. MATERIALS AND METHODS This prospective study was conducted at Late Lakhiram Agrawal Memorial Government Medical College, Raigarh, during the study period of July 2015 to July 2016. All the 50 cases were included in this study who were above 15 year of age diagnosed with fistula in ano on the basis of clinical examination who underwent surgical procedure. RESULTS In present study of 50 cases, 60% of cases were in the age group of 31-50 years. Male:female ratio was 9:1. 80% of cases belong to low socioeconomic status. The most common mode of presentation was discharging sinus in 96% of cases. 70% of patient had past history of burst abscess or surgical drainage of abscess. 90% of cases have single external opening. 80% of cases had posterior external opening. Most of the fistula are of low anal type, which was 92% and rest of the patient had an internal opening situated above the anorectal ring. The most common surgical approach done was fistulectomy. Only fistulectomy was done in 80% of patients. Fistulectomy with sphincterectomy was done in two patients. These two patients had associated anal fissure. Fistulectomy with seton placement was done in two patients of high level of fistula type. Fistulotomy was done in four patients (8%, these were of low fistula type

  13. A CLINICAL STUDY ON GASTRIC OUTLET OBSTRUCTION

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    Latchu

    2015-11-01

    Full Text Available INTRODUCTION Gastric outlet obstruction (GOO is obstruction in the first part of duodenum secondary to cicatrised duodenal ulcer or proximally where the diagnosis of carcinoma is most probable. GOO can be a diagnostic and treatment dilemma. Once a mechanical obstruction is confirmed, differentiate between benign and malignant processes. Cicatrized duodenal ulcer was the most common cause of GOO. But with increased awareness, change in the dietary habits and availability of H2 receptor blockers and Proton Pump Inhibitors and H pylori kits all have resulted in decreased incidence of patients requiring surgery and also the complications like pyloric stenosis have reduced. At the same time the incidence of antral carcinoma of stomach producing GOO has comparatively increased, which may be due to increased early diagnosis of the condition with the help of flexible fibro optic endoscope. AIMS & OBJECTIVES To study and identify the cause of cases of GOO with respect to benign peptic ulcer and malignancy of stomach. MATERIALS AND METHODS An observational study comparing of 30 cases of GOO. An elaborate study of the cases with regard to history, clinical features, routine and special investigation, pre operative treatment, operative findings, post operative management and complications in the post operative period is done. Apart from routine surgical profile special investigations like serum electrolytes, barium meal study, Upper GI Endoscopy and ultrasound abdomen and pelvis will be carried. For peptic ulcer disease truncal vagotomy with posterior gastrojejunostomy was done and for carcinoma partial gastrectomy with Billroth II reconstruction or anterior GJ or palliative resection with anterior GJ were done. INCLUSION CRITERIA 1. Peptic ulcer disease 2. Carcinoma pyloric antrum, 3. Benign neoplasm of stomach. EXCLUSION CRITERIA 1. Carcinoma stomach with liver metastasis, ascites, peritoneal implantation, 2. Gastro duodenal tuberculosis. ETHICAL ISSUES

  14. Characterizing human lung tissue microbiota and its relationship to epidemiological and clinical features.

    Science.gov (United States)

    Yu, Guoqin; Gail, Mitchell H; Consonni, Dario; Carugno, Michele; Humphrys, Michael; Pesatori, Angela C; Caporaso, Neil E; Goedert, James J; Ravel, Jacques; Landi, Maria Teresa

    2016-07-28

    The human lung tissue microbiota remains largely uncharacterized, although a number of studies based on airway samples suggest the existence of a viable human lung microbiota. Here we characterized the taxonomic and derived functional profiles of lung microbiota in 165 non-malignant lung tissue samples from cancer patients. We show that the lung microbiota is distinct from the microbial communities in oral, nasal, stool, skin, and vagina, with Proteobacteria as the dominant phylum (60 %). Microbiota taxonomic alpha diversity increases with environmental exposures, such as air particulates, residence in low to high population density areas, and pack-years of tobacco smoking and decreases in subjects with history of chronic bronchitis. Genus Thermus is more abundant in tissue from advanced stage (IIIB, IV) patients, while Legionella is higher in patients who develop metastases. Moreover, the non-malignant lung tissues have higher microbiota alpha diversity than the paired tumors. Our results provide insights into the human lung microbiota composition and function and their link to human lifestyle and clinical outcomes. Studies among subjects without lung cancer are needed to confirm our findings.

  15. Dynamic changes in gene expression during human early embryo development: from fundamental aspects to clinical applications.

    Science.gov (United States)

    Assou, Said; Boumela, Imène; Haouzi, Delphine; Anahory, Tal; Dechaud, Hervé; De Vos, John; Hamamah, Samir

    2011-01-01

    The first week of human embryonic development comprises a series of events that change highly specialized germ cells into undifferentiated human embryonic stem cells (hESCs) that display an extraordinarily broad developmental potential. The understanding of these events is crucial to the improvement of the success rate of in vitro fertilization. With the emergence of new technologies such as Omics, the gene expression profiling of human oocytes, embryos and hESCs has been performed and generated a flood of data related to the molecular signature of early embryo development. In order to understand the complex genetic network that controls the first week of embryo development, we performed a systematic review and study of this issue. We performed a literature search using PubMed and EMBASE to identify all relevant studies published as original articles in English up to March 2010 (n = 165). We also analyzed the transcriptome of human oocytes, embryos and hESCs. Distinct sets of genes were revealed by comparing the expression profiles of oocytes, embryos on Day 3 and hESCs, which are associated with totipotency, pluripotency and reprogramming properties, respectively. Known components of two signaling pathways (WNT and transforming growth factor-β) were linked to oocyte maturation and early embryonic development. Omics analysis provides tools for understanding the molecular mechanisms and signaling pathways controlling early embryonic development. Furthermore, we discuss the clinical relevance of using a non-invasive molecular approach to embryo selection for the single-embryo transfer program.

  16. Uncertainty sources in radiopharmaceuticals clinical studies; Fontes de incertezas em estudos clinicos com radiofarmacos

    Energy Technology Data Exchange (ETDEWEB)

    Degenhardt, Aemilie Louize; Oliveira, Silvia Maria Velasques de, E-mail: silvia@cnen.gov.br, E-mail: amilie@bolsista.ird.gov.br [Instituto de Radioprotecao e Dosimetria, (IRD/CNEN-RJ), Rio de Janeiro, RJ (Brazil)

    2014-07-01

    The radiopharmaceuticals should be approved for consumption by evaluating their quality, safety and efficacy. Clinical studies are designed to verify the pharmacodynamics, pharmacological and clinical effects in humans and are required for assuring safety and efficacy. The Bayesian analysis has been used for clinical studies effectiveness evaluation. This work aims to identify uncertainties associated with the process of production of the radionuclide and radiopharmaceutical labelling as well as the radiopharmaceutical administration and scintigraphy images acquisition and processing. For the development of clinical studies in the country, the metrological chain shall assure the traceability of the surveys performed in all phases. (author)

  17. Osteometric study of human femur

    Directory of Open Access Journals (Sweden)

    Khaleel N.

    2014-02-01

    Full Text Available Skeleton is playing important role in various like Medicine, Forensic sciences, Anthropology etc. Estimation of sex, age, race, stature by skeleton and the presence of disease is discovered by Krogman and Iscan (1986. Sex is determined after death by skeletal remains of that individual by some forensic anthropologists with the help of pelvis, skull and long bones. The study was undertaken in 50 femurs for measuring epicondylar breadth, Neck shaft angle, transverse and vertical diameter of head. The results were the average meanepicondylar breadth was 75.6 ± 6.06mm, mean right epicondylar breadth was 73.96 ± 4.99mm and left it was 76.35 ± 7.0mm. The average mean neck shaft angle was 125.3 ± 6.50mm, mean right neck shaft angle was 124.44 ± 5.7mm and left it was 126.3 ± 7.33mm. The average mean transverse diameter of head was 37.86 ± 3.06mm, mean right transverse diameter of head was 37.74 ± 3.05mm and left it was 38.00 ± 3.13mm. The average mean vertical diameter of head was 42.24 ± 3.53mm, mean right vertical diameter of head was 41.63 ± 3.09mm and left it was 42.96 ± 3.92mm, Neck shaft angle ranges from a minimum of 106° to maximum 135° with a mean value of 125.3°. The knowledge of osteometric values is helpful to anthropological and forensic practice. [Int J Res Med Sci 2014; 2(1.000: 104-107

  18. Characterization of a 2016 Clinical Isolate of Zika Virus in Non-human Primates

    Directory of Open Access Journals (Sweden)

    Xiao-Feng Li

    2016-10-01

    Full Text Available Animal models are critical to understand disease and to develop countermeasures for the ongoing epidemics of Zika virus (ZIKV. Here we report a non-human primate model using a 2016 contemporary clinical isolate of ZIKV. Upon subcutaneous inoculation, rhesus macaques developed fever and viremia, with robust excretion of ZIKV RNA in urine, saliva, and lacrimal fluid. Necropsy of two infected animals revealed that systematic infections involving central nervous system and visceral organs were established at the acute phrase. ZIKV initially targeted the intestinal tracts, spleen, and parotid glands, and retained in spleen and lymph nodes till 10 days post infection. ZIKV-specific immune responses were readily induced in all inoculated animals. The non-human primate model described here provides a valuable platform to study ZIKV pathogenesis and to evaluate vaccine and therapeutics.

  19. Concise review: animal substance-free human embryonic stem cells aiming at clinical applications.

    Science.gov (United States)

    Hovatta, Outi; Rodin, Sergey; Antonsson, Liselotte; Tryggvason, Karl

    2014-11-01

    Human embryonic stem cells have been considered the gold standard as a cell source for regenerative medicine since they were first cultured in 1998. They are pluripotent and can form principally all the cells types in the body. They are obtained from supernumerary human in vitro fertilization embryos that cannot be used for infertility treatment. Following studies on factors regulating pluripotency and differentiation, we now have techniques to establish and effectively expand these cells in animal substance-free conditions, even from single cells biopsied from eight-cell stage embryos in chemically defined feeder-free cultures. The genetic stability and absence of tumorigenic mutations can be determined. There are satisfactory animal tests for functionality and safety. The first clinical trials are ongoing for two indications: age-related macular degeneration and spinal cord injury. ©AlphaMed Press.

  20. Characterization of a 2016 Clinical Isolate of Zika Virus in Non-human Primates.

    Science.gov (United States)

    Li, Xiao-Feng; Dong, Hao-Long; Huang, Xing-Yao; Qiu, Ye-Feng; Wang, Hong-Jiang; Deng, Yong-Qiang; Zhang, Na-Na; Ye, Qing; Zhao, Hui; Liu, Zhong-Yu; Fan, Hang; An, Xiao-Ping; Sun, Shi-Hui; Gao, Bo; Fa, Yun-Zhi; Tong, Yi-Gang; Zhang, Fu-Chun; Gao, George F; Cao, Wu-Chun; Shi, Pei-Yong; Qin, Cheng-Feng

    2016-10-01

    Animal models are critical to understand disease and to develop countermeasures for the ongoing epidemics of Zika virus (ZIKV). Here we report a non-human primate model using a 2016 contemporary clinical isolate of ZIKV. Upon subcutaneous inoculation, rhesus macaques developed fever and viremia, with robust excretion of ZIKV RNA in urine, saliva, and lacrimal fluid. Necropsy of two infected animals revealed that systematic infections involving central nervous system and visceral organs were established at the acute phrase. ZIKV initially targeted the intestinal tracts, spleen, and parotid glands, and retained in spleen and lymph nodes till 10days post infection. ZIKV-specific immune responses were readily induced in all inoculated animals. The non-human primate model described here provides a valuable platform to study ZIKV pathogenesis and to evaluate vaccine and therapeutics.

  1. FETAL ECHOCARDIOGRAPHY: A STUDY OF CLINICAL OUTCOME

    Directory of Open Access Journals (Sweden)

    Rajanish

    2014-01-01

    Full Text Available BACKGROUND : S tructural abnormalities of the heart and great vessels are fairly common congenital lab normalities with the incidenceof8 in 1000 live births. With the advent of real time scanners fetal cardia can atomy can be analyze d echocardiographically. The earlier diagnosis will make an impact on clinical management of fetus with congenital heart disease. It helps intimely triage and optimal management of specific congenital heart disease either structural , functional orarrhythmia . OBJECTIVES : This study was conducted to note the spectrum of congenital heart diseases detected on fetal echo in pregnant mothers referred with high risk for CHD sand to assess the outcome of prenatally detected congenital heart diseases. MATERIAL S AND METHODS : T he study is aprospective descriptive study conducted in a tertiary care pediatric hospital in Mumbai over period of one year . P regnant mothers were referred for fetal echo , where pregnancy was considered as high risk for CHDs due to maternal , fetalfactorsorabnormallevel 1 scan.Fetal echowas performed by a trained pediatric cardiologistat 18 to 20 week of gestation using HP sonos 2000 echocardiographicmachinewith3/3.5 Hz transducer. Cardiac lesionsandoutcome of pregnancy was noted by postnatal follow - up of patients. RESULTS : A total of 170 patients underwent fetal echo , 13 patients have not delivered and 48 were lost to follow - up. Fetal echo was normal in 130(76.4% and abnormalities were detected in 40(23.5%.Structural anomalies were seen in 24(14.1% , arrhythmia in 5(2.9% and functional abnormalities in 11(6.4%.On outcome analysis84 (77.1% arealive , IUD /terminationof pregnancyoccurred in 18(16.5% , neonatal death in 6 (5.5% , infant death in 1 (0.9%. CONCLUSIONS : All ranges of CHDs can be diagnosed by fetal echocardiography . O utcome of prenatally detected complex congenital heart disease is poor ; nonetheless earlier detection provides a n opportunity for early interventions and

  2. CLINICAL STUDY AND MANAGEMENT OF CHOLEDOCHOLITHIASIS

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    Suresh

    2014-10-01

    Full Text Available BACKGROUND AND OBJECTIVES: Choledocholithiasis complicates the working and management of cholelithiasis necessitating additional diagnostic procedures, increasing morbidity and mortality. CBD stone generally remain asymptomatic but when symptoms start appearing, cause a lot of suffering. There are various treatment modalities available presently. The objective of our study was to study the incidence, various modes of clinical presentations and different modalities of treatment in common bile duct stones. MATERIALS AND METHODS: 35 Patients were prospectively studied from July 2012 to June 2014 as in-patients in Victoria Hospital. RESULTS: CBD stones occurred predominantly in elderly females and presented from subclinical jaundice to complications in the form of biliary pancreatitis and cholangitis. USG abdomen with LFT was able to diagnose majority of the CBD stones preoperatively. Per operative cholangiogram was used selectively in case USG was inconclusive, ERCP was used in patients presenting with severe obstructive jaundice, pancreatitis, cholangitis, minimal CBD ductal dilation. Open exploration was the main focus with a wide variety of procedures performed according to specific indications. CONCLUSION: CBD was more common in elderly female patients probably due to neglected gall bladder stones. CBD stones can occur from occult asymptomatic stones only with altered LFT to symptomatic presentation in the form of cholangitis, pancreatitis. USG abdomen was inexpensive and easily available imaging modality to diagnose CBD stones with per operative cholangiogram being needed in minority of the cases. While ERCP was good in treating complications of CBD stones and early stages of the disease; the more advanced stage of the disease with gross CBD ductal dilation and multiple stones open CBD exploration were more productive.

  3. Comparing the Effectiveness of a Clinical Registry and a Clinical Data Warehouse for Supporting Clinical Trial Recruitment: A Case Study

    Science.gov (United States)

    Weng, Chunhua; Bigger, J Thomas; Busacca, Linda; Wilcox, Adam; Getaneh, Asqual

    2010-01-01

    This paper reports a case study comparing the relative efficiency of using a Diabetes Registry or a Clinical Data Warehouse to recruit participants for a diabetes clinical trial, TECOS. The Clinical Data Warehouse generated higher positive predictive accuracy (31% vs. 6.6%) and higher participant recruitment than the Registry (30 vs. 14 participants) in a shorter time period (59 vs. 74 working days). We identify important factors that increase clinical trial recruitment efficiency and lower cost. PMID:21347102

  4. Comparing the effectiveness of a clinical registry and a clinical data warehouse for supporting clinical trial recruitment: a case study.

    Science.gov (United States)

    Weng, Chunhua; Bigger, J Thomas; Busacca, Linda; Wilcox, Adam; Getaneh, Asqual

    2010-11-13

    This paper reports a case study comparing the relative efficiency of using a Diabetes Registry or a Clinical Data Warehouse to recruit participants for a diabetes clinical trial, TECOS. The Clinical Data Warehouse generated higher positive predictive accuracy (31% vs. 6.6%) and higher participant recruitment than the Registry (30 vs. 14 participants) in a shorter time period (59 vs. 74 working days). We identify important factors that increase clinical trial recruitment efficiency and lower cost.

  5. Epidemiology and clinical presentation of the four human parainfluenza virus types

    Directory of Open Access Journals (Sweden)

    Liu Wen-Kuan

    2013-01-01

    Full Text Available Abstract Background Human parainfluenza viruses (HPIVs are important causes of upper respiratory tract illness (URTI and lower respiratory tract illness (LRTI. To analyse epidemiologic and clinical characteristics of the four types of human parainfluenza viruses (HPIVs, patients with acute respiratory tract illness (ARTI were studied in Guangzhou, southern China. Methods Throat swabs (n=4755 were collected and tested from children and adults with ARTI over a 26-month period, and 4447 of 4755 (93.5% patients’ clinical presentations were recorded for further analysis. Results Of 4755 patients tested, 178 (3.7% were positive for HPIV. Ninety-nine (2.1% samples were positive for HPIV-3, 58 (1.2% for HPIV-1, 19 (0.4% for HPIV-2 and 8 (0.2% for HPIV-4. 160/178 (88.9% HPIV-positive samples were from paediatric patients younger than 5 years old, but no infant under one month of age was HPIV positive. Seasonal peaks of HPIV-3 and HPIV-1 occurred as autumn turned to winter and summer turned to autumn. HPIV-2 and HPIV-4 were detected less frequently, and their frequency of isolation increased when the frequency of HPIV-3 and HPIV-1 declined. HPIV infection led to a wide spectrum of symptoms, and more “hoarseness” (p=0.015, “abnormal pulmonary breathing sound” (p Conclusions HPIV infection led to a wide spectrum of symptoms, and similar clinical manifestations were found in the patients with four different types of HPIVs. The study suggested pathogenic activity of HPIV in gastrointestinal illness. The clinical presentation of HPIV infection may differ by patient age.

  6. Primary pontine hemorrhage. A clinical study

    Energy Technology Data Exchange (ETDEWEB)

    Saito, Jun; Kagimoto, Hiroshi; Maeda, Masanobu; Soda, Takao [Shimane Prefectural Central Hospital, Izumo (Japan)

    2002-07-01

    We studied the relationship between outcome and clinical symptoms or CT findings of 34 cases with primary pontine hemorrhage diagnosed by CT scan from April 1994 to March 1999. This series comprised 19 males and 15 females ranging in age from 45 to 89 years with a mean of 67.1 years. According to their outcome at discharge, the cases were divided into 6 groups. Sixteen cases died within 2 weeks after onset (group AD), 4 cases died with complication in the chronic phase (group D), 3 cases were severely disabled to bed-ridden state (group C), 2 cases recovered to a daily life with wheelchair (group B), 4 cases recovered to a daily life with partial assistance (group A), and 5 cases showed a full recovery (group J). The factors significantly correlated with bed outcome are as follows: young age, consciousness disturbance, respiratory disturbance, tachycardia over 90 beats per minute, hyperthermia over 39 deg C, abnormal pupils, loss of oculocephalic reflex, tetraplegia, decerebrate rigidity, bilateral extension or over 30 mm transverse diameter of the hematoma. (author)

  7. Air pollution and asthma: clinical studies with sulfuric acid aerosols

    Energy Technology Data Exchange (ETDEWEB)

    Utell, M.J.; Frampton, M.W.; Morrow, P.E. (University of Rochester School of Medicine and Dentistry, NY (United States))

    1991-11-01

    Until recently, acid deposition has been widely considered a serious ecological problem but not a threat to human health. The controlled clinical study is an important approach in linking acidic aerosol inhalation with respiratory effects. Asthmatic patients represent a subpopulation most responsive to sulfuric acid aerosols. In a series of studies with asthmatic volunteers, several factors have been identified that may modulate the intensity of the bronchoconstrictor response to inhaled acidic aerosols. We found (1) enhancement of the bronchoconstrictor response during exercise, (2) the more acidic aerosols provoke the greatest changes in lung function, and (3) mitigation of airway responses during sulfuric acid aerosol inhalation caused by high respiratory ammonia concentrations. Additional factors influencing responsiveness await identification.

  8. A STUDY ON THORACIC VERTEBRAL SYNOSTOSIS & ITS CLINICAL IMPORTANCE

    Directory of Open Access Journals (Sweden)

    Md. Khaleel

    2015-01-01

    Full Text Available Vertebral anomalies are of interest not only to anatomist, but also to orthopedician, neurologist & neurosurgeons. Various vertebral anomalies of anatomic interest have been reported namely; occipitalisation, sacralisation, lumbarisation, absence of posterior elements of vertebral arch & vertebral s ynostosis. The fusion of vertebral column is rare anomalies usually congenital in origin. The fusion of thoracic vertebrae can present many clinical sign including congenital scoliosis. A study on 594 dry adult human vertebrae of unknown age & sex collected from the department of anatomy and phase I students of KBNIMS, Kalaburagi, Karnataka. The study was done over a period of 6 months (July to December 2014 during routine osteology classes for 1 year MBBS, we found the fusion of typical thoracic vertebrae between T 3 & T 4 . The cause could be failure of re - segmentation of somitomeres or acquired.

  9. Pathobiology of human cerebrovascular malformations: basic mechanisms and clinical relevance.

    Science.gov (United States)

    Gault, Judith; Sarin, Hemant; Awadallah, Nabil A; Shenkar, Robert; Awad, Issam A

    2004-07-01

    Cerebrovascular malformations affect more than 3% of the population, exposing them to a lifetime risk of hemorrhagic stroke, seizures, and focal neurological deficits. Cerebral cavernous malformations (CCMs) exhibit an immature vessel wall, a brittle hemorrhagic tendency, and epileptogenesis, whereas arteriovenous malformations (AVMs) lack capillary beds and manifest apoplectic bleeding under high-flow conditions. There are also more benign venous anomalies, capillary malformations, and lesions with mixed and transitional features. Advances have been made toward understanding the natural history, radiological and pathological correlates, and clinical management. Yet, mechanisms of lesion genesis and clinical manifestations remain largely unknown, and the clinical behavior in individual patients is highly unpredictable. Lesion pathogenesis likely involves abnormal assembly or maintenance of blood vessels, resulting in dysmorphic vessel phenotypes. Familial CCM disease is in part caused by mutations in a cytoskeletal-related protein that is likely integral to interendothelial cell connectivity and maturation of the vascular wall. Rare familial forms of AVM disease have been correlated with two different transforming growth factor-beta receptor components, possibly causing disturbance in signaling during vascular assembly. Relevance of these mechanisms to the more common and otherwise identical sporadic CCM and AVM lesions is being explored. In this report, basic mechanisms of vasculogenesis and angiogenesis and how they possibly relate to the common cerebrovascular malformation lesions are reviewed. Novel concepts are discussed related to the cellular, molecular, and genetic substrates in CCM and AVM as well as to how this knowledge can be applied to predict, explain, and possibly modify clinical disease manifestations.

  10. Human Rights and the Regulation of Transnational Clinical Trials

    NARCIS (Netherlands)

    Pierik, R.

    2015-01-01

    One of the more worrying trends in globalization today is the growing practice of western companies relocating clinical trials to impoverished countries. This paper starts by providing a comprehensive description of the practice and its current regulatory oversight. It argues that this regulatory

  11. CLINICAL STUDY OF FISTULA IN ANO

    Directory of Open Access Journals (Sweden)

    Raj

    2015-10-01

    Full Text Available Fistula in Ano is a benign treatable lesion of the rectum and the anal canal. Cryptoglandular infection accounts for about 90% of these cases. Majority of the infections are Acute and a minority contributed by chronic low grade infection hence pointing to varying etiologies. The pathogenesis has been attributed to the bursting open of an acute or inadequately treated Anorectal abscess into the peri anal skin. Diagnosis of the condition can be made easily with a good source of light, a proctoscope and a meticulous digital examination. Establishing a cure in this condition is difficult owing to two reasons. Firstly, the site of the infection makes the patient reluctant to subject themselves to examination. Secondly, a significant percent of these diseases persist or recur when appropriate surgery is not done or when the post op care is inadequate. Mostly it affects the young and the middle age group thus affecting productive man hours and quality of life. MATERIALS AND METHODS: All cases of clinically diagnosed Fistulae-in-ano above the age of 12 years, admitted in various surgical units in K.R. Hospital (attached to Government Medical College, Mysore during the study period December 1, 2008 to May 31, 2010. REUSLTS: Age Incidence, Sex Incidence, Socio Economic Status, Modes of Presentation, No. of External Openings, Situation of External Openings, Level of Fistulae, Type of surgical treatment, Associated with Fissure in Ano, Postoperative complication and Results were studied. CONCLUSION: Commonest age of presentation in our series is 30-40 years – 40%. Males are more commonly affected. Ratio Male: Female::3:1, Disease is more commonly seen in people with lower socio economic status group. 80% High socio economic class 20%. Discharging sinus is the commonest mode of presentation 72% and pain 72% and 84% pass history of perianal abscess was the presenting symptoms.

  12. Nail alterations during pregnancy: a clinical study.

    Science.gov (United States)

    Erpolat, Seval; Eser, Ayla; Kaygusuz, Ikbal; Balci, Hatice; Kosus, Aydin; Kosus, Nermin

    2016-10-01

    During pregnancy, cutaneous and appendageal alterations manifest and may cause concern in the subject. The nails may be affected by pregnancy. This study investigated the frequency and nature of nail changes occurring during pregnancy in 312 healthy, 18-40-year-old pregnant women in gestation weeks 16-40. After a routine obstetric examination at the obstetrics and gynecology clinic at the study institution, all subjects submitted to an examination of all fingernails and toenails. Only nail alterations that had developed during pregnancy were recorded. Any nail changes that had occurred before the start of gestation were not considered. Data were presented as percentages. The Shapiro-Wilk and chi-squared tests were used to make categorical comparisons. A P-value of nail pathologies were detected in 116 (37.2%) of the 312 subjects. The most commonly found nail change was leukonychia (24.4%). Ingrown toenail (9.0%) and onychoschizia (9.0%) represented the second most common nail changes. Rapid nail growth and subungual hyperkeratosis were observed in 6.7% and 4.2%, respectively, of subjects. When the alterations were evaluated according to gestational age, the most common nail pathology was leukonychia at both 14-28 weeks (16.3%) and 29-42 weeks (27.4%) of pregnancy. Leukonychia, onychoschizia, onycholysis, and brittle nail pathologies were frequently observed at 29-42 weeks of pregnancy (P = 0.047). A large proportion of nail changes that occur during pregnancy are benign and do not require treatment. However, these changes may cause significant cosmetic stress in women.

  13. Clinical studies on inferior right hepatic veins

    Institute of Scientific and Technical Information of China (English)

    Xue Xing; Hong Li; Wei-Guo Liu

    2007-01-01

    BACKGROUND:Many small veins are called accessory, short hepatic veins in addition to the right, middle and left hepatic veins. The size of these veins varied from a pinhole to 1 cm; the size of inferior right hepatic veins (IRHVs) is thicker than that of short hepatic veins or more than 1 cm occasionally. Adults have a higher incidence rate of the IRHV. DATA SOURCES:A literature search of the PubMed database was conducted and research articles were reviewed. RESULTS:The size of IRHVs is related to the size of the right hepatic vein, i.e. the larger the diameter of the right hepatic vein, the smaller the diameter of the IRHVs, and vice versa. The IRHVs are divided into superior, medial and inferior groups, separately named the superior, medial and inferior right hepatic veins according to the position of the IRHV entering the inferior vena cava. The superior right hepatic vein mainly drains the superior part of segmentⅦ, and the medial right hepatic vein drains the middle part of segmentⅦ. A thicker IRHV mainly drains segmentⅥ and the inferior part of segmentⅦ and a thinner IRHV drains the inferior part of segmentⅤ. CONCLUSIONS:The clinical signiifcance of these studies on IRHVs is varied: (1) Hepatic caudate lobe resection could be introduced after study on the veins of that lobe. (2) It is very important to identify the draining region of the IRHV for guiding hepatic segmentectomy. The postero-inferior area of the right lobe can be preserved along with the hypertrophic IRHV even if the entire main right hepatic vein is resected during segmentectomy ofⅦ andⅧwith right hepatic vein resection for patients with primary liver cancer. (3) The ligation of the major hepatic vein for the treatment of juxtahepatic vein injury is recommended because of severe hemorrhagic shock and dififculty in

  14. HUMAN HAND STUDY FOR ROBOTIC EXOSKELETON DELVELOPMENT

    Directory of Open Access Journals (Sweden)

    BIROUAS Flaviu Ionut

    2016-11-01

    Full Text Available This paper will be presenting research with application in the rehabilitation of hand motor functions by the aid of robotics. The focus will be on the dimensional parameters of the biological human hand from which the robotic system will be developed. The term used for such measurements is known as anthropometrics. The anthropometric parameters studied and presented in this paper are mainly related to the angular limitations of the finger joints of the human hand.

  15. Human mesenchymal stromal cells : biological characterization and clinical application

    NARCIS (Netherlands)

    Bernardo, Maria Ester

    2010-01-01

    This thesis focuses on the characterization of the biological and functional properties of human mesenchymal stromal cells (MSCs), isolated from different tissue sources. The differentiation capacity of MSCs from fetal and adult tissues has been tested and compared. Umbilical cord blood (UCB) has be

  16. Translation of the human genome into clinical allergy, part 2

    Directory of Open Access Journals (Sweden)

    Hirohisa Saito

    2004-01-01

    Full Text Available After completion of sequencing of the human genome, you will no longer be able to discover a new gene and may not be able to find a new molecule in the human body. Instead, you may find many new molecule networks. It will be possible to select information obtained from animal models just where orthologous genes are functioning similarly. Mouse disease models will not be used any longer where key orthologous genes are working differently than in humans. Analysis of cell type-selective transcripts from database searches is now available to minimize the efforts required for drug discovery. As such, it will soon be possible to use computational modeling to analyze integrative biological function and to test hypotheses without performing any in vivo or in vitro experimentation. However, before establishing a system simulating the human body, which consists of a variety of organs, which further consist of various types of cells, which then consist of various types of proteins, which consist of 20 types of amino acids, there are many steps that need to be understood.

  17. A Clinical Study of Recombinant Human Brain Natriuretic Peptide on Patients with Acute Decompensated Heart Failure%重组人脑利钠肽治疗急性心力衰竭的疗效观察

    Institute of Scientific and Technical Information of China (English)

    周秀金; 卢竟前

    2013-01-01

    Objective:To observe the clinic efficacy and safety of used recombinant human brain natriuretie peptide (rh-BNP)on patients with acute decompensated heart failure.Methods:48 patients who suffered from acute decompensated heart failure patients were divided into rh-BNP group(n=22)and control group(n=26).The rh-BNP group received rh-BNP made by China and traditional heart failure treatment; the control group was treated with traditional heart failure treatment.The changes of the clinical efficacy, left ventricular ejection fraction (LVEF)and brain natriuretie peptide test parameters were observed. Results:After 7 days treatment, clinical efficacy improvements were more significant in rh-BNP group compared control group (81.7% vs 61.6,P<0.05).LVEF were improved in rh-BNP group compared with control group((51±6)%vs(46±5)%,P<0.01).and BNP level were decreased obviously in rh-BNP group than control group((498±209)pg/ml vs(642±318)pg/ml,P<0.01),and there had positive relation in BNP decrease and LVEF increased(P<0.05).Conclusion:The use of rh-BNP is efficient and safe for acute decompensated heart failure patient.And BNP test can provide a dog marker for diagnosis and prognostic.%目的:探讨在监测血清脑钠肽水平下,短期使用注射用重组人脑利钠肽治疗急性心力衰竭或慢性心力衰竭急性发作的临床效果。方法:48例急性心力衰竭患者根据是否使用注射用重组人脑利钠肽分为常规组和注射用重组人脑利钠肽组,对比两组治疗的临床效果和超声心动图情况,并监测BNP水平。结果:治疗7 d后,注射用重组人脑利钠肽组临床有效率明显好于常规组(81.7%vs61.6%,P<0.05),左室射血分数明显高于常规组(51±6)%vs(46±5)%,(P<0.01),且血清脑钠肽水平明显降低(498±209)pg/mL vs(642±318)pg/mL,(P<0.01),血清脑钠肽下降水平和左室射血分数提高水平差异有统计学意义(P<0.05),有

  18. Teaching clinical reasoning and problem-solving skills using human patient simulation

    National Research Council Canada - National Science Library

    Vyas, Deepti; Ottis, Erica J; Caligiuri, Frank J

    2011-01-01

    This paper discusses using human patient simulation (HPS) to expose students to complex dynamic patient cases that require clinical judgment, problem-solving skills, and teamwork skills for success...

  19. Clinical, radiographic, and histopathologic evaluation of Nd:YAG laser pulpotomy on human primary teeth.

    Science.gov (United States)

    Odabaş, Mesut Enes; Bodur, Haluk; Bariş, Emre; Demir, Cem

    2007-04-01

    The purpose of this study was to compare clinical, radiographic, and histopathologic effects of Nd:YAG laser pulpotomy to formocresol pulpotomy on human primary teeth. Patients with at least two vital primary molar teeth that required pulpotomy, because of pulpal exposure to caries, were selected for this study. After hemorrhage control, complete hemostasis into the canal orifice was achieved by exposure to Nd:YAG laser (1064 nm) and an He-Ne laser (the aiming beam of the Nd:YAG laser) in noncontact mode at 2 W, 20 Hz, 100 mJ, or was achieved by applying 1:5 dilution of formocresol. Forty-two teeth in two groups were to be followed up clinically and radiographic at 1, 3, 6, 9, and 12 months. Eighteen teeth planned for serial extractions were selected for histopathologic study. The teeth were extracted at 7 and 60 days. The teeth in the laser group had a clinical success rate of 85.71% and a radiographic success rate 71.42% at 12 months. The teeth in the formocresol group had a clinical and radiographic success rate of 90.47% at 12 months. There were no statistically significant differences between laser and formocresol group with regard to both clinical and radiographic success rates. There was a statistically significant difference between 7- and 60-day laser groups with regard to inflammatory cell response criteria. Dentin bridge was absent in all samples. No stained bacteria were observed in any of these samples. In conclusion, Nd:YAG laser may be considered as an alternative to formocresol for pulpotomies in primary teeth.

  20. Clinical characteristics of human infection with a novel avian-origin influenza A(H10N8) virus

    Institute of Scientific and Technical Information of China (English)

    Zhang Wei; Wan Jianguo; Qian Kejian; Liu Xiaoqing; Xiao Zuke; Sun Jian; Zeng Zhenguo

    2014-01-01

    Background Novel influenza A viruses of avian-origin may be the precursors of pandemic strains.This descriptive study aims to introduce a novel avian-origin influenza A (H10N8) virus which can infect humans and cause severe diseases.Methods Collecting clinical data of three cases of human infection with a novel reassortment avian influenza A (H10N8)virus in Nanchang,Jiangxi Province,China.Results Three cases of human infection with a new reassortment avian influenza A(H10N8) virus were described,of which two were fatal cases,and one was severe case.These cases presented with severe pneumonia that progressed to acute respiratory distress syndrome (ARDS) and intractable respiratory failure.Conclusion This novel reassortment avian influenza A (H10N8) virus in China resulted in fatal human infections,and should be added to concerns in clinical practice.

  1. What is a clinical decision analysis study?

    Directory of Open Access Journals (Sweden)

    Aleem Ilyas

    2008-01-01

    Full Text Available Decision making in clinical practice often involves the need to make complex and intricate decisions with important long-term consequences. Decision analysis is a tool that allows users to apply evidence-based medicine to make informed and objective clinical decisions when faced with complex situations. A Decision Tree, together with literature-derived probabilities and defined outcome values, is used to model a given problem and help determine the best course of action. Sensitivity analysis allows an exploration of important variables on final clinical outcomes. A decision-maker can thereafter establish a preferred method of treatment and explore variables which influence the final outcome. The present paper is intended to give an overview of decision analysis and its application in clinical decision making.

  2. Validation and implementation of a liquid chromatography/tandem mass spectrometry assay to quantitate dimethyl benzoylphenylurea (BPU) and its five metabolites in human plasma and urine for clinical pharmacology studies.

    Science.gov (United States)

    Rudek, Michelle A; Zhao, Ming; He, Ping; Zabelina, Yelena; Jin, Runyan; Messersmith, Wells A; Wolff, Antonio C; Baker, Sharyn D

    2005-12-15

    A method has been developed for the quantitation of N-[4-(5-bromo-2-pyrimidinyloxy)-3-methylphenyl]-N'-(2-dimethylamino-benzoyl)urea (BPU) and its metabolites in human plasma and urine. BPU and metabolites were separated on a C18 column with acetonitrile-water mobile phase containing 0.1% formic acid using isocratic flow for 5 min. The analytes were monitored by tandem mass spectrometry. Calibration curves were generated over the range of 2.5-500 ng/mL for BPU, mmBPU, and aminoBPU in plasma; and 0.1-20, 0.1-20, 0.5-100, 10-2000, 1-200, and 3-600 ng/mL for BPU, mmBPU, aminoBPU, G280, G308, and G322 in urine, respectively. The method has been successfully applied to study the pharmacokinetics of BPU.

  3. Hematopoietic differentiation from human ESCs as a model for developmental studies and future clinical translations. Invited review following the FEBS Anniversary Prize received on 5 July 2009 at the 34th FEBS Congress in Prague.

    Science.gov (United States)

    Moreno-Gimeno, Inmaculada; Ledran, Maria H; Lako, Majlinda

    2010-12-01

    Human embryonic stem cells (hESCs) and induced pluripotent stem cells are excellent models for the study of embryonic hematopoiesis in vitro, aiding the design of new differentiation models that may be applicable to cell-replacement therapies. Adult and fetal hematopoietic stem cells are currently being used in biomedical applications; however, the latest advances in regenerative medicine and stem cell biology suggest that hESC-derived hematopoietic stem cells are an outstanding tool for enhancing immunotherapy and treatments for blood disorders and cancer, for example. In this review, we compare various methods used for inducing in vitro hematopoietic differentiation from hESCs, based on co-culture with stromal cells or formation of embryoid bodies, and analyse their ability to give rise to hematopoietic precursors, with emphasis on their engraftment potential as a measure of their functionality in vivo.

  4. Genetics in endocrinology: genetic variation in deiodinases: a systematic review of potential clinical effects in humans.

    Science.gov (United States)

    Verloop, Herman; Dekkers, Olaf M; Peeters, Robin P; Schoones, Jan W; Smit, Johannes W A

    2014-09-01

    Iodothyronine deiodinases represent a family of selenoproteins involved in peripheral and local homeostasis of thyroid hormone action. Deiodinases are expressed in multiple organs and thyroid hormone affects numerous biological systems, thus genetic variation in deiodinases may affect multiple clinical endpoints. Interest in clinical effects of genetic variation in deiodinases has clearly increased. We aimed to provide an overview for the role of deiodinase polymorphisms in human physiology and morbidity. In this systematic review, studies evaluating the relationship between deiodinase polymorphisms and clinical parameters in humans were eligible. No restrictions on publication date were imposed. The following databases were searched up to August 2013: Pubmed, EMBASE (OVID-version), Web of Science, COCHRANE Library, CINAHL (EbscoHOST-version), Academic Search Premier (EbscoHOST-version), and ScienceDirect. Deiodinase physiology at molecular and tissue level is described, and finally the role of these polymorphisms in pathophysiological conditions is reviewed. Deiodinase type 1 (D1) polymorphisms particularly show moderate-to-strong relationships with thyroid hormone parameters, IGF1 production, and risk for depression. D2 variants correlate with thyroid hormone levels, insulin resistance, bipolar mood disorder, psychological well-being, mental retardation, hypertension, and risk for osteoarthritis. D3 polymorphisms showed no relationship with inter-individual variation in serum thyroid hormone parameters. One D3 polymorphism was associated with risk for osteoarthritis. Genetic deiodinase profiles only explain a small proportion of inter-individual variations in serum thyroid hormone levels. Evidence suggests a role of genetic deiodinase variants in certain pathophysiological conditions. The value for determination of deiodinase polymorphism in clinical practice needs further investigation. © 2014 European Society of Endocrinology.

  5. A CLINICAL STUDY OF STROKE IN YOUNG

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    Kumbha Thulasi Ram

    2015-02-01

    Full Text Available NTRIDUCTION : Stroke is one of the important causes of morbidity and mortality all over the world. Incidence of stroke steadily increases with age. Experts are concerned of the emerging stroke epidemic in India. Stroke affecting the young has potentially devastating consequence son the individual and his family. Certain risk factors are unique to the young. I t needs more studies for identification and modification of risk factors. The study aims to evaluate clinical features, risk factors, etiology and mortality of stroke in young patients. METHODS : 74 young patients satisfying the inclusion criteria were included in this study. A detailed history was taken from young stroke patients, systemic examination and required investigations were done. Data was collected in standardized proforma and analysed. RESULTS: Stroke in young accounts for 7.95% of stroke cases of all age groups. The mean age of the patients was 34.66 ± 7.48 years. Among 74 patients, 47(63.51% were male and 27(36.49% were female. Seizures, decreased consciousness, speech involvement and motor deficit were observed in 33.78%, 44.59%, 22.97% and 100% of cases respectively. 82.43% patients had ischemic and 17.57% patients had hemorrhagic stroke. Among ischemic stroke, large artery atherosclerosis was 16.21%, tuberculous meningoencephalitis with vasculitis was 16.21%, lacunar stroke was 10.81%, CVT was 10.81% and cardio embolic stroke was 6.76%. Smoking (59.45%, alcoholism (58.10%, hypertension (43.24%, coronary artery disease (8.10%, diabetes mellitus (10.81%, elevated total cholesterol (25.67%, elevated low density lipo proteins (22.97%, elevated triglycerides (27.02% and low HDL (22.97% were important risk factors. Carotid doppler was abnormal in 9.45% of patients. 6.76% patients had mitral stenosis in echocardiogram. Low protein C and protein S were found in 1.35% of patients. Eight (10.81% patients died during the hospital stay. INTERPRETATION AND CONCLUSIONS: The major risk

  6. Corneal stromal dystrophies: a clinical pathologic study

    Directory of Open Access Journals (Sweden)

    Elvira Barbosa Abreu

    2012-12-01

    Full Text Available INTRODUCTION: Corneal dystrophy is defined as bilateral and symmetric primary corneal disease, without previous associated ocular inflammation. Corneal dystrophies are classified according to the involved corneal layer in superficial, stromal, and posterior dystrophy. Incidence of each dystrophy varies according to the geographic region studied. PURPOSE: To evaluate the prevalence of stromal corneal dystrophies among corneal buttons specimens obtained by penetrating keratoplasty (PK in an ocular pathology laboratory and to correlate the diagnosis with patient age and gender. METHODS: Corneal button cases of penetrating keratoplasty from January-1996 to May-2009 were retrieved from the archives of The Henry C. Witelson Ophthalmic Pathology Laboratory and Registry, Montreal, Canada. The cases with histopathological diagnosis of stromal corneal dystrophies were stained with special stains (Peroxid acid Schiff, Masson trichrome, Congo red analyzed under polarized light, and alcian blue for classification and correlated with epidemiological information (age at time of PK and gender from patients' file. RESULTS: 1,300 corneal buttons cases with clinical diagnose of corneal dystrophy were retrieved. Stromal corneal dystrophy was found in 40 (3.1% cases. Lattice corneal dystrophy was the most prevalent with 26 cases (65%. Nineteen were female (73.07% and the PK was performed at average age of 59.3 years old. Combined corneal dystrophy was found in 8 (20% cases, 5 (62.5% of them were female and the average age of the penetrating keratoplasty was 54.8 years old. Granular corneal dystrophy was represented by 5 (12.5% cases, and 2 (40% of them were female. Penetrating keratoplasty was performed at average age of 39.5 years old in granular corneal dystrophy cases. Macular corneal dystrophy was present in only 1 (2.5% case, in a 36 years old female. CONCLUSION: Systematic histopathological approach and evaluation, including special stains in all stromal

  7. Ano-Genital Warts and HIV Status– A Clinical Study

    Science.gov (United States)

    Sharma, Shimpa; Gulbake, Arvind

    2017-01-01

    Introduction Ano-Genital Warts (AGW) like other Sexually Transmitted Diseases (STD) is associated with Human Immunodeficiency Virus (HIV) infection. This study of AGW was done in HIV positive and HIV negative patients. Aim To study the risk factors and clinical presentations of ano-genital warts in HIV positive and negative patients. Materials and Methods A comparative, cross-sectional, descriptive study of 25 HIV positive and 25 HIV negative (n=50) AGW patients between 15-60 years of both sex was conducted in Dr. D. Y. Patil Hospital and Research Centre from July 2014 to July 2016. Results Significant association of HIV positivity (phomosexuality (p0.05). No patient presented with changes of malignancy. Four were adolescents below 19 years. Two patients had atypical presentations of giant condylomata i.e., Buschke-Lowenstein Tumour (BLT). Conclusion HIV positivity was significantly associated with the risk factors of age below 30 years, homo sexuality and multiple sexual partners. Anal warts were significantly common in HIV positive patients. Four adolescents with AGW underline the need for high risk behaviour counselling. No patient had malignant ano-genital warts. Follow up of these patients with Human Papilloma Virus (HPV) sub-typing is necessary. PMID:28274028

  8. Genetic and biomarker studies of human longevity

    NARCIS (Netherlands)

    Deelen, Joris

    2014-01-01

    The aim of this thesis was to identify novel lifespan regulating loci that influence human longevity and population mortality. To this end, we performed two genome-wide association studies, one of long-lived individuals from the family-based Leiden Longevity Study (LLS) and an extended one of long-l

  9. EVA Health and Human Performance Benchmarking Study

    Science.gov (United States)

    Abercromby, A. F.; Norcross, J.; Jarvis, S. L.

    2016-01-01

    Multiple HRP Risks and Gaps require detailed characterization of human health and performance during exploration extravehicular activity (EVA) tasks; however, a rigorous and comprehensive methodology for characterizing and comparing the health and human performance implications of current and future EVA spacesuit designs does not exist. This study will identify and implement functional tasks and metrics, both objective and subjective, that are relevant to health and human performance, such as metabolic expenditure, suit fit, discomfort, suited postural stability, cognitive performance, and potentially biochemical responses for humans working inside different EVA suits doing functional tasks under the appropriate simulated reduced gravity environments. This study will provide health and human performance benchmark data for humans working in current EVA suits (EMU, Mark III, and Z2) as well as shirtsleeves using a standard set of tasks and metrics with quantified reliability. Results and methodologies developed during this test will provide benchmark data against which future EVA suits, and different suit configurations (eg, varied pressure, mass, CG) may be reliably compared in subsequent tests. Results will also inform fitness for duty standards as well as design requirements and operations concepts for future EVA suits and other exploration systems.

  10. Translation of Human-Induced Pluripotent Stem Cells: From Clinical Trial in a Dish to Precision Medicine.

    Science.gov (United States)

    Sayed, Nazish; Liu, Chun; Wu, Joseph C

    2016-05-10

    The prospect of changing the plasticity of terminally differentiated cells toward pluripotency has completely altered the outlook for biomedical research. Human-induced pluripotent stem cells (iPSCs) provide a new source of therapeutic cells free from the ethical issues or immune barriers of human embryonic stem cells. iPSCs also confer considerable advantages over conventional methods of studying human diseases. Since its advent, iPSC technology has expanded with 3 major applications: disease modeling, regenerative therapy, and drug discovery. Here we discuss, in a comprehensive manner, the recent advances in iPSC technology in relation to basic, clinical, and population health.

  11. [Changing surgical therapy because of clinical studies?].

    Science.gov (United States)

    Schwenk, W; Haase, O; Müller, J M

    2002-04-01

    The randomised controlled clinical trial (RCT) is a powerful instrument to evaluate different therapeutic regimens. In a survey among 115 physicians visiting the 25th annual meeting of the Surgical Society of Berlin and Brandenburg, the RCT was judged to be very important when changes of therapeutic strategies are discussed. 90 % of all participants claimed to use data from RCTs in the clinical routine and 89 % would participate in such a trial. In official (e. g. discussions during coffee breaks at scientific meetings) or non-medical (e. g. non-scientific press or media) sources of information were assessed as irrelevant for decisions regarding therapeutic strategies. However, in contrast to this view laparoscopic cholecystectomy was introduced into clinical practice rapidly because patients informed by external (non-medical) sources preferred to be operated on with the "modern" technique. Clinical trials with a high level of evidence had no relevant influence on the rapid distribution of laparoscopic cholecystectomy. Controversial discussions concerning the extent of lymphadenectomy with gastric resection for carcinoma demonstrate that the value of excellent clinical RCTs is low if their results challenge a stable paradigma of the surgical scientific society. To allow a rational judgement, new surgical technologies should undergo a scientific gradual evaluation in agreement with the principles of evidence based medicine.

  12. Using Clinical Gait Case Studies to Enhance Learning in Biomechanics

    Science.gov (United States)

    Chester, Victoria

    2011-01-01

    Clinical case studies facilitate the development of clinical reasoning strategies through knowledge and integration of the basic sciences. Case studies have been shown to be more effective in developing problem-solving abilities than the traditional lecture format. To enhance the learning experiences of students in biomechanics, clinical case…

  13. Teaching clinical reasoning and problem-solving skills using human patient simulation.

    Science.gov (United States)

    Vyas, Deepti; Ottis, Erica J; Caligiuri, Frank J

    2011-11-10

    This paper discusses using human patient simulation (HPS) to expose students to complex dynamic patient cases that require clinical judgment, problem-solving skills, and teamwork skills for success. An example of an HPS exercise used to teach multifaceted clinical concepts in a therapeutics course also is provided.

  14. [Clinical studies of pediatric malabsorption syndromes].

    Science.gov (United States)

    Hosoyamada, Takashi

    2006-11-01

    Multiple cases with various types of pediatric malabsorption syndromes were evaluated. The clinical manifestations, laboratory findings, pathophysiology, and histopathological descriptions of each patient were analyzed in an effort to clear the pathogenesis of the malabsorption syndromes and the treatments were undertaken. The cases studied, included one patient with cystic fibrosis, two with lactose intolerance with lactosuria (Durand type), one with primary intestinal lymphangiectasia, two with familial hypobetalipoproteinemia, one with Hartnup disease, one with congenital chroride diarrhea, one with acrodermatitis enteropathica, one with intestinal nodular lymphoid hyperplasia (NLH), five with intractable diarrhea of early infancy and four with glycogenosis type Ia. Each case description and outcome is described below: 1. A 15-year-old Japanese boy with cystic fibrosis presented with severe symptoms, including pancreatic insufficiency, bronchiectasis, pneumothorax and hemoptysis. His prognosis was poor. Analysis of the CFTR genes of this patient revealed a homozygous large deletion from intron 16 to 17b. 2. In the sibling case of Durand type lactose intolerance, the subjects'disaccaridase activity of the small bowel, including lactase, were within normal limits. The results of per oral and per intraduodenal lactose tolerance tests confirmed lactosuria in both. These observations suggested, not only an abnormal gastric condition, but also duodenal and intestinal mucosal abnormal permeability of lactose. 3. In the case of primary intestinal lymphangiectasia, the subject had a lymphedematous right arm and hand, a grossly coarsened mucosal pattern of the upper gastrointestinal tract (identified via radiologic examination) and the presence of lymphangiectasia (confirmed via duodenal mucosal biopsy). The major laboratory findings were hypoalbuminemia, decreased immunoglobulin levels and lymphopenia resulting from loss of lymph fluid and protein into the gastro

  15. Evaluation of the regenerative potential of 25% doxycycline-loaded biodegradable membrane vs biodegradable membrane alone in the treatment of human periodontal infrabony defects: A clinical and radiological study

    Directory of Open Access Journals (Sweden)

    Chaturvedi Rashi

    2008-01-01

    Full Text Available Background: Microbial colonization of the barrier membranes used for guided tissue regeneration is inevitable and can lead to delayed healing. Aims: Antimicrobial coating of the membrane with 25% doxycycline paste has been attempted to prevent infection and achieve enhanced regeneration in periodontal infrabony defects. Materials and Methods: Twenty-four patients with 2-walled or 3-walled infrabony defects were selected and randomly divided into two equal groups. Infrabony defects of group A were treated with a biodegradable membrane coated with 25% doxycycline while those of group B were treated with membrane alone. Clinical assessment of probing depth and attachment level and radiographic evaluation of the defect depth was done preoperatively and at 12 and 24 weeks postoperatively. Statistical Analysis: The relative efficacy of the two treatment modalities were evaluated using the paired Student′s t- test and the comparative evaluation between the two groups was done using the independent Student′s t -test. Results: Both the groups exhibited a highly significant reduction in probing depth and gain in clinical attachment level and linear bone fill at the end of 24 weeks. Comparative evaluation between the two study groups revealed a significant reduction in probing depth ( P = 0.016 FNx01 and linear bone fill ( P = 0.02 FNx01 in group A as compared to group B. Mean gain in attachment level was greater for group A than for group B but the difference was statistically nonsignificant ( P = 0.065 NS . Conclusions: The results suggest that doxycycline is beneficial in reducing membrane-associated infection and can potentiate regeneration through host modulation.

  16. Establishing a multicenter longitudinal clinical cohort Study in ...

    African Journals Online (AJOL)

    ... clinical cohort Study in Ethiopia: Advanced Clinical Monitoring of Antiretroviral Treatment Project. ... Ethiopian Journal of Health Sciences ... Using similar recruitment procedures, a total of 120 children were enrolled in each of retrospective ...

  17. A CLINICAL AND MICROBIAL STUDY OF OTOMYCOSIS: AN ORIGINAL STUDY

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    Prakash

    2015-09-01

    Full Text Available Otomycosis or “Otitis externa myotica” refers to a fungal or yeast infection of the external auditory meatus. Fungi can be isolated in up to 40 percent of all cases of external otitis, especially “Aspergillus niger and Candida albicans”. It has a worldwide distribution with higher prev alence in the hot, humid and dusty climate of the tropical and subtropical regions and sometimes in association with immunosuppression and poor hygienic conditions. The purpose of this study is to analyse the etiology, clinical manifestations, microbial pa ttern of otomycosis and treatment.

  18. Ten years' clinical experience with biosimilar human growth hormone: a review of efficacy data.

    Science.gov (United States)

    López-Siguero, Juan Pedro; Pfäffle, Roland; Chanson, Philippe; Szalecki, Mieczyslaw; Höbel, Nadja; Zabransky, Markus

    2017-01-01

    In 2006, the European Medicines Agency (EMA) approved Omnitrope(®) as a biosimilar recombinant human growth hormone (rhGH), on the basis of comparable quality, safety, and efficacy to the reference medicine (Genotropin(®), Pfizer). Data continue to be collected on the long-term efficacy of biosimilar rhGH from several on-going postapproval studies. Particular topics of interest include efficacy in indications granted on the basis of extrapolation, and whether efficacy of growth hormone treatment is affected when patients are changed to biosimilar rhGH from other rhGH products. Data from clinical development studies and 10 years of postapproval experience affirm the clinical efficacy and effectiveness of biosimilar rhGH across all approved indications. In addition, the decade of experience with biosimilar rhGH since it was approved in Europe confirms the scientific validity of the biosimilar pathway and the approval process. Concerns about clinical effect in extrapolated indications, and also about the impact of changing from other rhGH preparations, have been alleviated. Biosimilar rhGH is an effective treatment option for children who require therapy with rhGH.

  19. A comprehensive clinical review of recombinant human bone morphogenetic protein-2 (INFUSE® Bone Graft)

    Science.gov (United States)

    Peckham, Steven M.; Badura, Jeffrey M.

    2007-01-01

    The combination of recombinant human bone morphogenetic protein-2 (rhBMP-2) on an absorbable collagen sponge (ACS) carrier has been shown to induce bone formation in a number of preclinical and clinical investigations. In 2002, rhBMP-2/ACS at a 1.5-mg/cc concentration (INFUSE® Bone Graft, Medtronic Spinal and Biologics, Memphis, TN) was FDA-approved as an autograft replacement for certain interbody spinal fusion procedures. In 2004, INFUSE® Bone Graft was approved for open tibial fractures with an intermedullary (IM) nail fixation. Most recently, in March 2007, INFUSE® Bone Graft was approved as an alternative to autogenous bone grafts for sinus augmentations, and for localised alveolar ridge augmentations for defects associated with extraction sockets. The culmination of extensive preclinical and clinical research and three FDA approvals makes rhBMP-2 one of the most studied, published and significant advances in orthopaedics. This review article summarises a number of clinical findings of rhBMP-2/ACS, including the FDA-approved investigational device exemption (IDE) studies used in gaining the aforementioned approvals. PMID:17639384

  20. DNA damage in human skin fibroblasts exposed to UVA light used in clinical PUVA treatment

    Energy Technology Data Exchange (ETDEWEB)

    Bredberg, A.

    1981-06-01

    Human skin fibroblasts were irradiated with a clinically used UVA light source. The doses (1.1 and 3 J/cm2) were similar to those reaching the dermis during clinical PUVA treatment of psoriasis. DNA strand breaks, as determined by alkaline elution, were formed in a dose-dependent way and disappeared within 1 hr of postincubation at 37 degrees C. These findings have clinical implications since UVA-induced DNA damage may be accompanied by mutagenic and tumor promoting effects.

  1. Human Permanent Ectoparasites; Recent Advances on Biology and Clinical Significance of Demodex Mites: Narrative Review Article

    Directory of Open Access Journals (Sweden)

    Dorota LITWIN

    2017-02-01

    Full Text Available Background: Demodex is a genus of mites living predominantly in mammalian pilosebaceous units. They are commonly detected in the skin of face, with increasing numbers in inflammatory lesions. Causation between Demodex mites and inflammatory diseases, such as rosacea, blepharitis, perioral and seborrhoeic dermatitis or chalazion, is controversially discussed. Clinical observations indicate a primary form of human Demodex infection. The aim of this review was to highlight the biological aspects of Demodex infestation and point out directions for the future research.Methods: We conducted a broad review based on the electronic database sources such as MEDLINE, PubMed and Scopus with regard to the characteristics of the Demodex species, methods of examination and worldwide epidemiology, molecular studies and its role in the complex human ecosystem.Results: Demodex mites are organisms with a worldwide importance as they act in indicating several dermatoses, under certain conditions. However, correlations between Demodex and other parasites or microorganisms occupying one host, as well as interactions between these arachnids and its symbiotic bacteria should be considered. There are few methods of human mites' examination depending on purpose of the study. Nevertheless, paying attention must be needed as polymorphism of Demodex species has been reported.Conclusion: Overall, the present review will focus on different aspects of Demodex mites’ biology and significance of these arachnids in human’s health.

  2. Experimental infection of human volunteers with Haemophilus ducreyi: fifteen years of clinical data and experience.

    Science.gov (United States)

    Janowicz, Diane M; Ofner, Susan; Katz, Barry P; Spinola, Stanley M

    2009-06-01

    Haemophilus ducreyi causes chancroid, which facilitates transmission of human immunodeficiency virus type 1. To better understand the biology of H. ducreyi, we developed a human inoculation model. In the present article, we describe clinical outcomes for 267 volunteers who were infected with H. ducreyi. There was a relationship between papule formation and estimated delivered dose. The outcome (either pustule formation or resolution) of infected sites for a given subject was not independent; the most important determinants of pustule formation were sex and host effects. When 41 subjects were infected a second time, their outcomes segregated toward their initial outcome, confirming the host effect. Subjects with pustules developed local symptoms that required withdrawal from the study after a mean of 8.6 days. There were 191 volunteers who had tissue biopsy performed, 173 of whom were available for follow-up analysis; 28 (16.2%) of these developed hypertrophic scars, but the model was otherwise safe. Mutant-parent trials confirmed key features in H. ducreyi pathogenesis, and the model has provided an opportunity to study differential human susceptibility to a bacterial infection.

  3. Relatedness of Mycobacterium avium subspecies hominissuis clinical isolates of human and porcine origins assessed by MLVA.

    Science.gov (United States)

    Leão, Célia; Canto, Ana; Machado, Diana; Sanches, Ilda Santos; Couto, Isabel; Viveiros, Miguel; Inácio, João; Botelho, Ana

    2014-09-17

    Mycobacterium avium subsp. hominissuis (MAH) is an important opportunistic pathogen, infecting humans and animals, notably pigs. Several methods have been used to characterize MAH strains. RFLP and PFGE typing techniques have been used as standard methods but are technically demanding. In contrast, the analysis of VNTR loci is a simpler, affordable and highly reliable PCR-based technique, allowing a numerical and reproductive digitalization of typing data. In this study, the analysis of Mycobacterium avium tandem repeats (MATRs) loci was adapted to evaluate the genetic diversity of epidemiological unrelated MAH clinical strains of human (n=28) and porcine (n=69) origins, collected from diverse geographical regions across mainland Portugal. These MAH isolates were found to be genetically diverse and genotypes are randomly distributed across the country. Some of the human strains shared identical VNTR profiles with porcine isolates. Our study shows that the VNTR genotyping using selected MATR loci is a useful analysis technique for assessing the genetic diversity of MAH isolates from Portugal. This typing method could be successfully applied in other countries toward the implementation of a worldwide open-access database of MATR-VNTR profiles of MAH isolates, allowing a better assessment of the global epidemiology traits of this important pathogenic species.

  4. REFRACTORY EPILEPSY TREATMENT WITH HUMAN NEURAL STEM CELLS : A PILOT CLINICAL STUDY%神经干细胞治疗难治性癫痫临床研究

    Institute of Scientific and Technical Information of China (English)

    邱英; 邢智伟; 曹冉华; 苏乌云; 云升

    2012-01-01

    目的:本临床研究旨在观察人类神经干细胞治疗脑外伤后难治性癫痫的有效性,安全性和可行性.方法:临床研究对象为两例有脑外伤史的男性难治性癫痫病人(年龄14,43岁),静脉输注Nestin表面标志阳性的人类神经干细胞后对其癫痫发作次数及程度,智力行为及不良反应观察随访1a.结果:治疗2mo后病人癫痫发作完全控制,记忆力及行为也显著改善,脑电图异常波形消失,观察1a无复发,也未发现任何副作用.结论:本研究显示人类神经干细胞治疗外伤后所致的难治性癫痫有效、安全、可行性强.%Refractory epilepsy mainly occurs in symptomatic epileptic patients. The sufferers are usually with learning difficulties, impaired mental abilities and other neurological symptoms due to recurrent and long-lasting seizures,and have poor therapeutic responses to antiepileptic drugs. Human neural stem cells as a source of new therapy becomes attempting as they can self-renew and also integrate into brain tissue and/ develop into different types of neurons. The main objective of this pilot study is to investigate the efficacy, safety and feasibility of the new therapy. Two refractory epileptic patients with trauma history were enrolled in the study. Human neural stem cells were derived from a seven-week therapeutic aborted foetus brain and expanded in tissue culture and confirmed expressing strong nestin marker. Two months after intravenous injection of the stem cells, both patients were completely free from seizures; their memory and behaviour were also improved remarkably. They were still seizure free and there was no obvious side effect observed over one year observation. The study indicates that observed neural stem cell therapy can be a new choice for refractory epilepsy as it is effective, safe and easy to administrate.

  5. Technologies for Clinical Diagnosis Using Expired Human Breath Analysis

    Directory of Open Access Journals (Sweden)

    Thalakkotur Lazar Mathew

    2015-02-01

    Full Text Available This review elucidates the technologies in the field of exhaled breath analysis. Exhaled breath gas analysis offers an inexpensive, noninvasive and rapid method for detecting a large number of compounds under various conditions for health and disease states. There are various techniques to analyze some exhaled breath gases, including spectrometry, gas chromatography and spectroscopy. This review places emphasis on some of the critical biomarkers present in exhaled human breath, and its related effects. Additionally, various medical monitoring techniques used for breath analysis have been discussed. It also includes the current scenario of breath analysis with nanotechnology-oriented techniques

  6. [Consensus statement of the National AIDS Plan Secretariat, Spanish Society of Emergency Medicine and AIDS Study Group of the Spanish Society of Infectious Diseases and Clinical Microbiology on Emergency and Human Immunodeficiency Virus Infection].

    Science.gov (United States)

    2013-01-01

    Supporting non-HIV specialist professionals in the treatment of patients with urgent diseases resulting from HIV infection. These recommendations have been agreed by an expert panel from the National AIDS Plan Secretariat, the Spanish Society of Emergency Medicine, and the AIDS Study Group. A review has been made of the safety and efficacy results of clinical trials and cohort studies published in biomedical journals (PubMed and Embase) or presented at conferences. The strength of each recommendation (A, B, C) and the level of supporting evidence (I, II, III) are based on a modification of the criteria of the Infectious Diseases Society of America. The data to be collected from the emergency medical history in order to recognize the patient at risk of HIV infection were specified. It stressed the basic knowledge of ART principles and its importance in terms of decline in morbidity and mortality of HIV+ patients and referring to the HIV specialist for follow-up, where appropriate, including drug interactions. Management of different emergency situations that may occur in patients with HIV infection is also mentioned. The non-HIV specialist professional, will find the necessary tools to approach HIV patients with an emergency disease. Copyright © 2012 Elsevier España, S.L. All rights reserved.

  7. Clinical manifestations of human papillomavirus infection in nongenital sites.

    Science.gov (United States)

    Melton, J L; Rasmussen, J E

    1991-04-01

    Our knowledge of warts dates thousands of years. Most warts represent no more than a transient infection in the hands and feet of children and adults. With the relatively recent medical advances permitting the prolonged survival of immunocompromised hosts, however, HPV-induced lesions have become an important problem. In these patients, lesions represent a recurring, intractable infection that predisposes the patient to the development of skin cancer. Such problems have been appreciated for some time in patients with EV. Newer laboratory techniques have led to an increasing number of clinical entities linked with an HPV cause in the nonimmunosuppressed host. Although evidence incriminating HPV as a causative factor for genital cancers of the cervix and the skin continues to mount, such evidence for nongenital Bowen's disease, certain squamous cell carcinomas of the skin, keratoacanthomas, and other tumors of the skin also has begun to grow. It is to be hoped that continued advances in molecular biologic techniques will further delineate the relationship between HPV and these conditions, lead to an HPV classification scheme that is more utilitarian from a clinical point of view, and ultimately lead to improved treatment.

  8. Culturing and expansion of "clinical grade" precursors cells from the fetal human central nervous system.

    Science.gov (United States)

    Gelati, Maurizio; Profico, Daniela; Projetti-Pensi, Massimo; Muzi, Gianmarco; Sgaravizzi, Giada; Vescovi, Angelo Luigi

    2013-01-01

    NSCs have been demonstrated to be very useful in grafts into the mammalian central nervous system to investigate the exploitation of NSC for the therapy of neurodegenerative disorders in animal models of neurodegenerative diseases. To push cell therapy in CNS on stage of clinical application, it is necessary to establish a continuous and standardized, clinical grade (i.e., produced following the good manufacturing practice guidelines) human neural stem cell lines. In this chapter, we illustrate some of the protocols routinely used into our GMP cell bank for the production of "clinical grade" human neural stem cell lines.

  9. Analysis of Safety from a Human Clinical Trial with Pterostilbene

    Directory of Open Access Journals (Sweden)

    Daniel M. Riche

    2013-01-01

    Full Text Available Objectives. The purpose of this trial was to evaluate the safety of long-term pterostilbene administration in humans. Methodology. The trial was a prospective, randomized, double-blind placebo-controlled intervention trial enrolling patients with hypercholesterolemia (defined as a baseline total cholesterol ≥200 mg/dL and/or baseline low-density lipoprotein cholesterol ≥100 mg/dL. Eighty subjects were divided equally into one of four groups: (1 pterostilbene 125 mg twice daily, (2 pterostilbene 50 mg twice daily, (3 pterostilbene 50 mg + grape extract (GE 100 mg twice daily, and (4 matching placebo twice daily for 6–8 weeks. Safety markers included biochemical and subjective measures. Linear mixed models were used to estimate primary safety measure treatment effects. Results. The majority of patients completed the trial (91.3%. The average age was 54 years. The majority of patients were females (71% and Caucasians (70%. There were no adverse drug reactions (ADRs on hepatic, renal, or glucose markers based on biochemical analysis. There were no statistically significant self-reported or major ADRs. Conclusion. Pterostilbene is generally safe for use in humans up to 250 mg/day.

  10. Analysis of safety from a human clinical trial with pterostilbene.

    Science.gov (United States)

    Riche, Daniel M; McEwen, Corey L; Riche, Krista D; Sherman, Justin J; Wofford, Marion R; Deschamp, David; Griswold, Michael

    2013-01-01

    Objectives. The purpose of this trial was to evaluate the safety of long-term pterostilbene administration in humans. Methodology. The trial was a prospective, randomized, double-blind placebo-controlled intervention trial enrolling patients with hypercholesterolemia (defined as a baseline total cholesterol ≥200 mg/dL and/or baseline low-density lipoprotein cholesterol ≥100 mg/dL). Eighty subjects were divided equally into one of four groups: (1) pterostilbene 125 mg twice daily, (2) pterostilbene 50 mg twice daily, (3) pterostilbene 50 mg + grape extract (GE) 100 mg twice daily, and (4) matching placebo twice daily for 6-8 weeks. Safety markers included biochemical and subjective measures. Linear mixed models were used to estimate primary safety measure treatment effects. Results. The majority of patients completed the trial (91.3%). The average age was 54 years. The majority of patients were females (71%) and Caucasians (70%). There were no adverse drug reactions (ADRs) on hepatic, renal, or glucose markers based on biochemical analysis. There were no statistically significant self-reported or major ADRs. Conclusion. Pterostilbene is generally safe for use in humans up to 250 mg/day.

  11. Clinically relevant known and candidate genes for obesity and their overlap with human infertility and reproduction.

    Science.gov (United States)

    Butler, Merlin G; McGuire, Austen; Manzardo, Ann M

    2015-04-01

    Obesity is a growing public health concern now reaching epidemic status worldwide for children and adults due to multiple problems impacting on energy intake and expenditure with influences on human reproduction and infertility. A positive family history and genetic factors are known to play a role in obesity by influencing eating behavior, weight and level of physical activity and also contributing to human reproduction and infertility. Recent advances in genetic technology have led to discoveries of new susceptibility genes for obesity and causation of infertility. The goal of our study was to provide an update of clinically relevant candidate and known genes for obesity and infertility using high resolution chromosome ideograms with gene symbols and tabular form. We used computer-based internet websites including PubMed to search for combinations of key words such as obesity, body mass index, infertility, reproduction, azoospermia, endometriosis, diminished ovarian reserve, estrogen along with genetics, gene mutations or variants to identify evidence for development of a master list of recognized obesity genes in humans and those involved with infertility and reproduction. Gene symbols for known and candidate genes for obesity were plotted on high resolution chromosome ideograms at the 850 band level. Both infertility and obesity genes were listed separately in alphabetical order in tabular form and those highlighted when involved with both conditions. By searching the medical literature and computer generated websites for key words, we found documented evidence for 370 genes playing a role in obesity and 153 genes for human reproduction or infertility. The obesity genes primarily affected common pathways in lipid metabolism, deposition or transport, eating behavior and food selection, physical activity or energy expenditure. Twenty-one of the obesity genes were also associated with human infertility and reproduction. Gene symbols were plotted on high resolution

  12. Adenocarcinoma in situ and associated human papillomavirus type distribution observed in two clinical trials of a quadrivalent human papillomavirus vaccine

    DEFF Research Database (Denmark)

    Ault, Kevin A; Joura, Elmar A; Kjaer, Susanne K;

    2011-01-01

    The primary objective of this report is to describe the detection of adenocarcinoma in situ (AIS) and associated human papillomavirus (HPV) type distribution that was observed in the context of two phase 3 clinical trials of a quadrivalent HPV6/11/16/18 vaccine. In this intention-to-treat analysis...

  13. HIGH VARIABILITY OF HUMAN CYTOMEGALOVIRUS UL150 OPEN READING FRAME IN LOW-PASSAGED CLINICAL ISOLATES

    Institute of Scientific and Technical Information of China (English)

    2006-01-01

    Objective To investigate the polymorphism of human cytomegalovirus (HCMV) UL150 open reading frame(ORF) in low-passaged clinical isolates, and to study the relationship between the polymorphism and different pathogenesis of congenital HCMV infection.Methods PCR was performed to amplify the entire HCMV UL150 ORF region of 29 clinical isolates, which hadbeen proven containing detectable HCMV-DNA using fluorescence quantitative PCR. PCR amplifcation products weresequenced directly, and the data were analyzed.Results Totally 25 among 29 isolates were amplified, and 18 isolates were sequenced successfully. HCMVUL150 ORF sequences derived from congenitally infected infants were high variability. The UL150 ORF in all 18 clinical isolates shifted backward by 8 nucleotides leading to frame-shift, and contained a single nucleotide deletion at nucleotide position 226 compared with that of Toledo strain. The nucleotide diversity was 0. 1% to 6. 8% and the amino acid diversity was 0. 2% to 19. 2% related to Toledo strain. However, the nucleotide diversity was 0. 1% to 6.4% and amino acid diversity was 0. 2% to 8.3% by compared with Merlin strain. Compared with Toledo, 4 new cysteine residues and 13 additional posttranslational modification sites were observed in UL150 putative proteins of clinical isolates. Moreover, the UL150 putative protein contained an additional transmembrane helix at position of 4-17 amino acid related to Toledo.Conclusion HCMV UL150 ORF and deduced amino acid sequences of clinical strains are hypervariability. No obvious linkage between the polymorphism and different pathogenesis of congenital HCMV infection is found.

  14. Evaluation of the detection of Mycobacterium tuberculosis with metabolic activity in culture-negative human clinical samples.

    Science.gov (United States)

    Cubero, N; Esteban, J; Palenque, E; Rosell, A; Garcia, M J

    2013-03-01

    Mycobacterium tuberculosis is assumed to remain in a quiescent state during latent infection, being unable to grow in culture. The aim of this study was to evaluate the detection of viable but non-cultivable bacilli with metabolic activity in human clinical samples using a procedure that is independent of the immunological status of the patient. The study was performed on 66 human clinical samples, from patients subjected to routine diagnosis to rule out a mycobacterial infection. Specimens from pulmonary and extra-pulmonary origins were verified to contain human DNA before testing for M. tuberculosis DNA, rRNA and transient RNA by real-time quantitative PCR. Clinical records of 55 patients were also reviewed. We were able to detect viable but non-cultivable bacilli with a metabolic activity in both pulmonary and extra-pulmonary samples. Mycobacterium tuberculosis RNA was detected in the majority of culture-positive samples whereas it was detected in one-third of culture-negative samples, 20% of them showed metabolic activity. Amplifications of the ftsZ gene and particularly of the main promoter of the ribosomal operon rrnA, namely PCL1, seem to be good targets to detect active bacilli putatively involved in latent infection. Moreover, this last target would provide information on the basal metabolic activity of the bacilli detected. © 2012 The Authors. Clinical Microbiology and Infection © 2012 European Society of Clinical Microbiology and Infectious Diseases.

  15. Cryptogenic Polyneuropathy : Clinical, Environmental, And Genetic Studies

    OpenAIRE

    Lindh, Jonas

    2011-01-01

    Objectives: The purpose of this medical thesis was to describe the clinical and neurophysiological features and to evaluate the health related quality of life (HR-QoL) in patients with cryptogenic polyneuropathy. We also wanted to investigate different occupational, and leisure time exposures as determinants for cryptogenic polyneuropathy, and to analyze whether polymorphisms for the null alleles of Glutathione S-Transferase Mu-1 (GSTM1), and Theta-1 (GSTT1), and a low activity genetic variat...

  16. [Organizational ethics: a study in ophthalmologic clinics].

    Science.gov (United States)

    Sanches, Maria Aparecida; Scarpi, Marinho Jorge

    2005-01-01

    Research on the field of organizational ethics to investigate to which extent ophthalmologic clinics, inserted in the competitive atmosphere, in the condition of organizations in search of survival, subordinate ethics to competitiveness in the managerial praxis, that is, in the administrative sphere. Kohlberg is taken as theoretical reference, approaching the theme of ethical subordination to competitiveness. The instrument to evaluate moral behaviors of organizations, elaborated by Licht, is applied. The quantitative method is used, adopting analytic instruments, such as Q of Yule and non parametric tests, when dealing with the data of 41 ophthalmologic clinics. The results of the research seem to indicate that administrators of ophthalmologic clinics of greater performance subordinate ethical principles to competitiveness, seeking to assure the survival of the company and, when confronted with the instrument to evaluate their moral behavior, proposed by Kohlberg, have a significantly smaller presence in the postconventional stage than administrators of ophthalmologic clinics with a smaller performance. One may affirm, according to non parametric tests, at the level of significance of 0.05, that the levels of moral development of the two groups differ significantly. The obtained results are according to the literature, especially concerning the "paradox of the ethical subordination and competitiveness". They also suggest that the warrant of the survival of the company tends to reduce the perception of the groups in power regarding the problems that happen in the community, and that a reduction of the ethical values subordinated to competition occurs, and such reduction provokes growing feelings of economical disputes in the social sphere.

  17. Celiac Patients: A Randomized, Controlled Clinical Study

    Directory of Open Access Journals (Sweden)

    Giuseppe Mazzarella

    2012-01-01

    Full Text Available A lifelong gluten-free diet (GFD is mandatory for celiac disease (CD but has poor compliance, justifying novel strategies. We found that wheat flour transamidation inhibited IFN-γ secretion by intestinal T cells from CD patients. Herein, the primary endpoint was to evaluate the ability of transamidated gluten to maintain GFD CD patients in clinical remission. Secondary endpoints were efficacy in prevention of the inflammatory response and safety at the kidney level, where reaction products are metabolized. In a randomized single blinded, controlled 90-day trial, 47 GFD CD patients received 3.7 g/day of gluten from nontransamidated (12 or transamidated (35 flour. On day 15, 75% and 37% of patients in the control and experimental groups, respectively, showed clinical relapse (=0.04 whereas intestinal permeability was mainly altered in the control group (50% versus 20%, =0.06. On day 90, 0 controls and 14 patients in the experimental group completed the challenge with no variation of antitransglutaminase IgA (=0.63, Marsh-Oberhuber grading (=0.08, or intestinal IFN-γ mRNA (>0.05. Creatinine clearance did not vary after 90 days of treatment (=0.46. In conclusion, transamidated gluten reduced the number of clinical relapses in challenged patients with no changes of baseline values for serological/mucosal CD markers and an unaltered kidney function.

  18. Clinically failed eggs as a source of normal human embryo stem cells.

    Science.gov (United States)

    De Sousa, Paul A; Gardner, John; Sneddon, Sharon; Pells, Steve; Tye, Britt Jorgensen; Dand, Pawlina; Collins, Daniel M; Stewart, Karen; Shaw, Lisa; Przyborski, Stefan; Cooke, Michael; McLaughlin, K John; Kimber, Susan J; Lieberman, Brian A; Wilmut, Ian; Brison, Daniel R

    2009-05-01

    The promise of human embryo stem cells (hESCs) for regenerative medicine is offset by the ethical and practical challenges involved in sourcing eggs and embryos for this objective. In this study we sought to isolate an hESC line from clinically failed eggs, the usage of which would not conflict with donor interests to conceive. A total of 8 blastocysts were allocated for hESC derivation from a pool of 579 eggs whose fertilization had been clinically assessed to have occurred abnormally (i.e., three pronuclei) or failed (i.e., no pronuclei) following in vitro insemination or intracytoplasmic sperm injection (ICSI). The latter were subjected to a recovery intervention consisting of either reinsemination by ICSI or parthenogenetic stimulation. One hESC line (RCM1) was obtained from a failed-to-fertilize inseminated egg recovered by parthenogenetic activation. Standard in vitro and in vivo characterization revealed this line to possess all of the properties attributed to a normal euploid hESC line. Whole-genome single-nucleotide polymorphism analysis further revealed that the line was biparental, indicating that sperm penetration had occurred, although parthenogenetic stimulation was required for activation. Our results demonstrate the viability of an alternative strategy to generate normal hESC lines from clinically failed eggs, thereby further minimizing the potential to conflict with donor reproductive interest to conceive.

  19. Liver fibrosis in human immunodeficiency virus/hepatitis C virus coinfection: Diagnostic methods and clinical impact

    Institute of Scientific and Technical Information of China (English)

    Caterina; Sagnelli; Salvatore; Martini; Mariantonietta; Pisaturo; Giuseppe; Pasquale; Margherita; Macera; Rosa; Zampino; Nicola; Coppola; Evangelista; Sagnelli

    2015-01-01

    Several non-invasive surrogate methods have recently challenged the main role of liver biopsy in assessing liver fibrosis in hepatitis C virus(HCV)-monoinfected and human immunodeficiency virus(HIV)/HCV-coinfected patients, applied to avoid the well-known side effects of liver puncture. Serological tests involve the determination of biochemical markers of synthesis or degradation of fibrosis, tests not readily available in clinical practice, or combinations of routine tests used in chronic hepatitis and HIV/HCV coinfection. Several radiologic techniques have also been proposed, some of which commonly used in clinical practice. The studies performed to compare the prognostic value of noninvasive surrogate methods with that of the degree of liver fibrosis assessed on liver tissue have not as yet provided conclusive results. Each surrogate technique has shown some limitations, including the risk of over- or under-estimating the extent of liver fibrosis. The current knowledge on liver fibrosis in HIV/HCVcoinfected patients will be summarized in this review article, which is addressed in particular to physicians involved in this setting in their clinical practice.

  20. Human imprinting anomalies in fetal and childhood growth disorders: clinical implications and molecular mechanisms.

    Science.gov (United States)

    Azzi, Salah; Brioude, Fréderic; Le Bouc, Yves; Netchine, Irène

    2014-01-01

    Genomic imprinting is among the most important epigenetic mechanisms whereby expression of a subset of genes is restricted to a single parental allele. Loss of imprinting (LOI) through hypo or hyper methylation is involved in various human syndromes. These LOI occur early during development and usually impair growth. Some imprinting syndromes are the consequences of genetic anomalies, such as uniparental disomies (UPD) or copy number variations (deletion or duplications) involving the imprinted domains; others are due to LOI at the imprinting control regions (ICR) regulating each domain. Imprinting disorders are phenotypically heterogeneous, although some share various common clinical features such that diagnosis may be difficult. Multilocus imprinting defects associated with several syndromes have been increasingly reported in recent years, although there are no obvious clinical differences between monolocus and multilocus LOI patients. Subsequently, some rare mutations of transacting factors have been identified in patients with multilocus imprinting defects but they do not explain the majority of the cases; this therefore implies that other factors are involved. By contrast, no mutation of a transacting factor has yet been identified in monolocus LOI. The effect of the environment on the regulation of imprinting is clearly illustrated by studies of assisted reproductive technology (ART). The regulation of imprinting is complex and involves a huge range of genetic and environmental factors; the identification of these factors will undoubtedly help to elucidate the regulation of imprinting and contribute to the understanding of imprinting disorders. This would be beneficial for diagnostics, clinical follow up and the development of treatment guidelines.

  1. Human rhinovirus infections in hospitalized children: clinical, epidemiological and virological features.

    Science.gov (United States)

    Tran, D N; Trinh, Q D; Pham, N T K; Pham, T M H; Ha, M T; Nguyen, T Q N; Okitsu, S; Shimizu, H; Hayakawa, S; Mizuguchi, M; Ushijima, H

    2016-01-01

    Molecular epidemiology and clinical impact of human rhinovirus (HRV) are not well documented in tropical regions. This study compared the clinical characteristics of HRV to other common viral infections and investigated the molecular epidemiology of HRV in hospitalized children with acute respiratory infections (ARIs) in Vietnam. From April 2010 to May 2011, 1082 nasopharyngeal swabs were screened for respiratory viruses by PCR. VP4/VP2 sequences of HRV were further characterized. HRV was the most commonly detected virus (30%), in which 70% were diagnosed as either pneumonia or bronchiolitis. Children with single HRV infections presented with significantly higher rate of hypoxia than those infected with respiratory syncytial virus or parainfluenza virus (PIV)-3 (12·4% vs. 3·8% and 0%, respectively, P < 0·05), higher rate of chest retraction than PIV-1 (57·3% vs. 34·5%, P = 0·028), higher rate of wheezing than influenza A (63·2% vs. 42·3%, P = 0·038). HRV-C did not differ to HRV-A clinically. The genetic diversity and changes of types over time were observed and may explain the year-round circulation of HRV. One novel HRV-A type was discovered which circulated locally for several years. In conclusion, HRV showed high genetic diversity and was associated with significant morbidity and severe ARIs in hospitalized children.

  2. Advanced studies on human gene ZNF322

    Institute of Scientific and Technical Information of China (English)

    LI Yongqing; WANG Yuequn; YUAN Wuzhou; DENG Yun; ZHU Chuanbing; WU Xiushan

    2007-01-01

    The human novel gene of ZNF322 is cloned from human fetal eDNA library using the primers on the basis of the ZNF322 sequence analyzed with computer.The gene is located on Chromosome 6p22.1,and encodes a protein consisting of 402 amino acid residues and containing nine tandem C2H2-type zinc-finger motifs.Northern blot result shows that the gene is expressed in all examined adult tissues.Subcellular location study indicates that ZNF322-EGFP fusion protein is distributed in the nucleus and cytoplasm.Reporter gene assays show that ZNF322 is a potential transcriptional activator.

  3. CLINICAL AND INVESTIGATIONAL STUDY OF DIABETIC KETOACIDOSIS

    Directory of Open Access Journals (Sweden)

    Narasimham

    2015-06-01

    Full Text Available BACKGROUND AND OBJECTIVES: To compare the clinical features and biochemical profile in DKA. To assess the response in the patients with standard treatment of DKA. Clinical descriptions of polyuric states resembling diabetes mellitus have been described in the Ebers papyrus of Egypt in 15th century BC . 1,2 A yurvedic literature from the times of Charaka and Sushrutha, the ancient Indian physicians identified two forms of “MadhuMeha” ( H oneyed Urine in 400 BC . 3 John Rolo of England in 1797 was one of 1st who coined the term diabetes mellitus. William Prout of E ngland described diabetic coma during 1810 – 20. In 1886, Dreschfeld8 described DKA and HHNS (Hyper osmolar Hyperglycemic Non - ketotic Syndrome. In 1922 Banting , Best, Collip and Macleod isolated and clinically used insulin and later won Nobel prize for that memorable invention. SETTING: Inpatients of king George Hospital attached to Andhra Medical College, Visakhapatnam . METHODS: Diagnosis of diabetic ketoacidosis was made according to the inclusion criteria. Hyperglycemia >250 mg/dl, acidosis with blood pH <7.3, serum bicarbonate <15 mEq/l, urine positive for ketones. RESULTS: Of the 100 patients admitted for diabetic ketoacidosis; 84 had type 2 diabetes (84% and 16(16% were type I diabetes. Average age at the time of presentation was 42.9±12.9 years. Th e commonest precipitating factor was infection (56% followed by other factors (28% and irregular treatment (16%. The most common clinical features at the time of presentation were vomiting, abdominal pain, acidotic breathing and dehydration. The values for RBS, HCO3, and pH were 355.3±69.1, 14.9±3.4 and 7.2±0.1 respectively. INTERPRETATION AND CONCLUSION: Most common precipitating factors are infection and omission of insulin or irregular treatment. Most common clinical features at the time of presentati on are vomiting, abdominal pain, dehydration, acidotic breathing and tachycardia. Mortality rate in diabetic

  4. Safety and immunogenicity of recombinant human thrombin: a pooled analysis of results from 10 clinical trials.

    Science.gov (United States)

    Singla, Neil K; Foster, Kevin N; Alexander, W Allan; Pribble, John P

    2012-11-01

    To evaluate the safety and immunogenicity of recombinant human thrombin (rThrombin), an active topical stand-alone hemostatic agent. Analysis of pooled data from 10 rThrombin clinical trials. A total of 644 adult and pediatric patients treated with rThrombin; 609 patients were included in the immunogenicity analysis. In all studies, rThrombin was applied during a single surgical procedure (day 1); the procedures consisted of spinal procedures, major hepatic resection, peripheral arterial bypass, arteriovenous graft formation for hemodialysis access, and synchronous burn wound excision and skin grafting. A dosage of 1000 IU/ml of rThrombin was administered for more than 99% of patients. Adverse events and clinical laboratory values were monitored through day 29. Blood samples were obtained for immunogenicity analyses before the procedure and on day 29. Adverse events were mild or moderate in severity for the majority of patients; no patients discontinued from an rThrombin study due to adverse events. The most commonly reported adverse events in the 644 patients were incision site pain (305 patients [47.4%]), procedural pain (215 patients [33.4%]), and nausea (170 patients [26.4%]). Five patients (0.8%) died during the studies; all deaths were considered unrelated to rThrombin treatment. Antibodies to the rThrombin product developed in 5 (0.8%, 95% confidence interval 0.4-2.8%) of 609 patients by day 29, approximately 1 month after treatment; these antibodies did not neutralize the activity of native human thrombin. The development of antibodies did not appear to differ substantively by type of surgical procedure, amount of rThrombin administered, or patient age. Recombinant human thrombin was well tolerated, and adverse events were consistent with those reported in the postoperative setting in the surgical populations studied. Approximately 1 month after treatment, less than 1% of the patients had developed antibodies to the rThrombin product, and these

  5. Towards a clinical use of human embryonic stem cell-derived cardiac progenitors: a translational experience.

    Science.gov (United States)

    Menasché, Philippe; Vanneaux, Valérie; Fabreguettes, Jean-Roch; Bel, Alain; Tosca, Lucie; Garcia, Sylvie; Bellamy, Valérie; Farouz, Yohan; Pouly, Julia; Damour, Odile; Périer, Marie-Cécile; Desnos, Michel; Hagège, Albert; Agbulut, Onnik; Bruneval, Patrick; Tachdjian, Gérard; Trouvin, Jean-Hugues; Larghero, Jérôme

    2015-03-21

    There is now compelling evidence that cells committed to a cardiac lineage are most effective for improving the function of infarcted hearts. This has been confirmed by our pre-clinical studies entailing transplantation of human embryonic stem cell (hESC)-derived cardiac progenitors in rat and non-human primate models of myocardial infarction. These data have paved the way for a translational programme aimed at a phase I clinical trial. The main steps of this programme have included (i) the expansion of a clone of pluripotent hESC to generate a master cell bank under good manufacturing practice conditions (GMP); (ii) a growth factor-induced cardiac specification; (iii) the purification of committed cells by immunomagnetic sorting to yield a stage-specific embryonic antigen (SSEA)-1-positive cell population strongly expressing the early cardiac transcription factor Isl-1; (iv) the incorporation of these cells into a fibrin scaffold; (v) a safety assessment focused on the loss of teratoma-forming cells by in vitro (transcriptomics) and in vivo (cell injections in immunodeficient mice) measurements; (vi) an extensive cytogenetic and viral testing; and (vii) the characterization of the final cell product and its release criteria. The data collected throughout this process have led to approval by the French regulatory authorities for a first-in-man clinical trial of transplantation of these SSEA-1(+) progenitors in patients with severely impaired cardiac function. Although several facets of this manufacturing process still need to be improved, these data may yet provide a useful platform for the production of hESC-derived cardiac progenitor cells under safe and cost-effective GMP conditions. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.

  6. Genotypic characterisation and cluster analysis of Campylobacter jejuni isolates from domestic pets, human clinical cases and retail food

    Directory of Open Access Journals (Sweden)

    Acke Els

    2011-03-01

    Full Text Available Abstract The genetic similarity of Campylobacter jejuni isolates from pets, compared to human clinical cases and retail food isolates collected in Ireland over 2001-2006 was investigated by cluster analysis of pulsed-field gel electrophoresis (PFGE fingerprinting profiles. Comparison of the PFGE profiles of 60 pet isolates and 109 human isolates revealed that seven (4.1% profiles were grouped in clusters including at least one human and one pet C. jejuni isolate. In total six (1.6% of 60 pet and 310 food profiles were in clusters with at least one food and one pet C. jejuni isolate. The detection of only a small number of genetically indistinguishable isolates by PFGE profile cluster analysis from pets and from humans with enteritis in this study suggests that pets are unlikely to be an important reservoir for human campylobacteriosis in Ireland. However, genetically indistinguishable isolates were detected and C. jejuni from pets may circulate and may contribute to clinical infections in humans. In addition, contaminated food fed to pets may be a potential source of Campylobacter infection in pets, which may subsequently pose a risk to humans.

  7. Clinical trials of a matrix metalloproteinase inhibitor in human periodontal disease. SDD Clinical Research Team.

    Science.gov (United States)

    Ashley, R A

    1999-06-30

    After demonstration by Golub et al. of the ability of the tetracyclines to inhibit elevated collagenolytic activity in animal models of periodontal diseases, a clinical development program was initiated to demonstrate the potential of a subantimicrobial dose of doxycycline (SDD) to augment and maintain the improvements in clinical parameters of adult periodontitis (AP) afforded by conventional nonsurgical periodontal therapy. Clinical trials were carried out in which a number of different SDD dosing regimens and placebo were compared in patients administered a variety of adjunctive nonsurgical therapies. Measured parameters included levels of collagenase activity in gingival crevicular fluid (GCF) and gingival specimens, clinical attachment levels (cALv), probing pocket depths (PD), bleeding on probing (BOP), and subtraction radiographic measurements of alveolar bone height. When used as an adjunct to either scaling and root planing or supragingival scaling and dental prophylaxis, SDD was shown to reduce collagenase levels in both GCF and gingival biopsies, to augment and maintain cALv gains and PD reductions, to reduce BOP, and to prevent loss of alveolar bone height. These clinical responses arose in the absence of any significant effects on the subgingival microflora and without evidence of an increase in the incidence or severity of adverse reactions relative to the control groups. It is proposed that one of the mechanisms of action of SDD is as an inhibitor of pathologically elevated MMPs, including neutrophil and bone cell collagenases (MMP-8 and MMP-13), which are associated with the host response in chronic AP, and that SDD provides a novel systemic approach to the management of AP.

  8. Comparison of the Effect of Two Human Milk Fortifiers on Clinical Outcomes in Premature Infants

    Directory of Open Access Journals (Sweden)

    Melissa Thoene

    2014-01-01

    Full Text Available The use of human milk fortifiers (HMF helps to meet the high nutritional requirements of the human milk-fed premature infant. Previously available powdered products have not met the protein requirements of the preterm infant population and many neonatologists add powder protein modulars to help meet protein needs. The use of powdered products is discouraged in neonatal intensive care units (NICU due to concern for invasive infection. The use of a commercially available acidified liquid product with higher protein content was implemented to address these two concerns. During the course of this implementation, poor growth and clinically significant acidosis of infants on Acidified Liquid HMF (ALHMF was observed. The purpose of this study was to quantify those observations by comparing infant outcomes between groups receiving the ALHMF vs. infants receiving powdered HMF (PHMF. A retrospective chart review compared outcomes of human milk-fed premature infants <2000 g receiving the ALHMF (n = 23 and the PHMF (n = 46. Infant growth, enteral feeding tolerance and provision, and incidence of necrotizing enterocolitis (NEC, metabolic acidosis, and diaper dermatitis were compared between the two groups. No infants were excluded from this study based on acuity. Use of ALHMF resulted in a higher incidence of metabolic acidosis (p = 0.002. Growth while on HMF as measured in both g/kg/day (10.59 vs. 15.37, p < 0.0001 and in g/day (23.66 vs. 31.27, p = 0.0001 was slower in the ALHMF group, on increased mean cal/kg/day (128.7 vs. 117.3, p = 0.13 with nearly twice as many infants on the ALHMF requiring increased fortification of enteral feedings beyond 24 cal/ounce to promote adequate growth (48% vs. 26%, p = 0.10. Although we were not powered to study NEC as a primary outcome, NEC was significantly increased in the ALHMF group. (13% vs. 0%, p = 0.03. Use of a LHMF in an unrestricted NICU population resulted in an increase in clinical complications within a high

  9. New graduate nurses' clinical competence, clinical stress, and intention to leave: a longitudinal study in Taiwan.

    Science.gov (United States)

    Cheng, Ching-Yu; Tsai, Hsiu-Min; Chang, Chia-Hao; Liou, Shwu-Ru

    2014-01-01

    This longitudinal research study aimed to develop a pregraduation clinical training program for nursing students before graduation and evaluate its effect on students' self-perceived clinical competence, clinical stress, and intention to leave current job. A sample of 198 students returned the questionnaires before and after the program. They were followed up at 3, 6, and 12 months after graduation. Results showed that posttest clinical competence was significantly higher than pretest competence, positively related to clinical competence at 3 and 12 months, and negatively related to clinical stress at 3 months. The clinical competence at 3 months was positively related to clinical competence at 6 and 12 months, and clinical competence at 6 months was related to intention to leave at 12 months. Intention to leave at 6 months was positively related to intention to leave at 3 and 12 months. Clinical stress at 3 months was positively related to clinical stress at 6 and 12 months, but not related to intention to leave at any time points. The training program improved students' clinical competence. The stressful time that was correlated with new graduate nurses' intention to leave their job was between the sixth and twelfth months after employment.

  10. CLINICAL OBSERVATION ON VERTICAL TRANSMISSION OF HUMAN PAPILLOMAVIRUS

    Institute of Scientific and Technical Information of China (English)

    徐倏燊; 刘兰青; 吕绳敏; 任舒月

    1998-01-01

    Objective. To observe the possibility of maternal-fetal vertical transmission of human papillomavirus (HPV)via amniotic fluid. Subjects and methods. Specimens of cervical secretions from 30 pregnant women were obtained during the third trimester before rupture of membrane, and specimens of pharyngeal secretsions of their neonates weee obtained 12-48 h after birth. Amniotic fluids were collected in 13 pregnant women during cesarean section. The presence of HPV types 6,11,16,18,31,33,35,38 deoxyribonucleic acid were detected by consensus polymerase chain reaction. Remits. HPV deoxyribonucleic acid was found in 18 cervical secretions, 14 pharyngeal secretions and in 8 amniotic fluids, the positive rate was 53. 3%, 46.7%, 23. 1% respectively. The pharyngeal secretion was also HPV positive in one of the three neonates from the amnlotic fluid positive mothers. Conclusion. The results indic.am that HPV can be transmitted in utezo through amniotic fluid and cesarean section can not protect the neonates against vertical transmission completely.

  11. 上海市人类精子库捐精现状及临床应用回顾性分析%Retrospective study of sperm donation and its clinical use of Shanghai Human Sperm Bank

    Institute of Scientific and Technical Information of China (English)

    平萍; 曹小蓉; 闫峰; 徐迪萍; 关志刚; 刘勇; 胡洪亮; 李铮

    2011-01-01

    Objective Explore the current condition of sperm donation and outcome of its cinical use, so to provide suggestion for policy making. Methods The retrospective research was based on the data of donors from January 2003 to December 2010. The investigated items included: the intention about sperm donation; the factors of drop-out; the reasons of midway withdraw of qualified donors; parameters of cryostored samples pre- and post-frosing, assistant reproductive techniques(ART) cycle number, pregnant rate and birth rate. Results 12 858 sperm donors were screened and 2 083 donors (16.2%) were recruited. Main reasons of drop out were unqualified semen parameters and positive results in sexual transmitted disease tests. There were 6.9 % qualified donors breaking off the program because of frustration by unqualified semen parameters, intention of free medical examination or job transfer. There were 31 056 vials of donors' semen cryopreserved. In 7 341 AID cycles, the clinical pregnant rate was 20.13%, live-births 723. In 1 521IVF cycles, clinical pregnant rate was 38.66%, live-births 410. Conclusion The human semen banking in the China had developed into a regulary stage after the implementation of ' Rules and Guidelines'. The quality of donor sperm cryopreserved had increased. All the measures play an important roles in the goal that everyone enjoies reproductive health for all of the people in our country.%目的 探讨上海市人类精子库捐精现状与临床应用,为中国精子捐献制度的完善提供理论依据.方法 对上海市人类精子库自2003年3月至2010年12月间所有初次捐精者与合格捐精者的信息回顾性分析,研究内容包括:(1)捐精者筛查不合格原因;(2)合格捐精者脱失率及原因;(3)捐精动机;(4)精液标本冷冻前后参数;(5)捐献者精子用于辅助生殖治疗的结果.结果 1.研究期间,共有12 858名志愿者接受捐精筛查,只有2 083名(16.2%)入选.落选的主要原因为:(1)

  12. [Limitations and pitfalls of clinical studies in oncology].

    Science.gov (United States)

    Cerny, Thomas

    2008-01-01

    Nowadays results of clinical studies in oncology are often first found and commented in the news media because of their high relevance to the pharmaceutical market. The limits and pitfalls of clinical studies are manifold and not always appreciated even by specialists as well as journalists and politicians. The planning of a study is a most crucial phase, and most deficits are due to inappropriate design and conduct of a study. Adequate and skilful interpretation of a study is often hampered by many known but mostly overlooked variable pitfalls. Today there is an overrepresentation of pharmaceutically sponsored studies and a painful lack of well-designed academic studies with really meaningful endpoints for patient care. This paper touches several important aspects of today's shortcomings of clinical studies in oncology and highlights the importance of strengthening the academic clinical research. Evidence-based medicine needs to be more clinically relevant, and therefore we need well-designed, and critically interpreted studies in the future.

  13. Enhanced expression of resistin-like molecule beta in human colon cancer and its clinical significance.

    Science.gov (United States)

    Zheng, Li-Duan; Tong, Qiang-Song; Weng, Mi-Xia; He, Jun; Lv, Qing; Pu, Jia-Rui; Jiang, Guo-Song; Cai, Jia-Bin; Liu, Yuan; Hou, Xiao-Hua

    2009-02-01

    Previous studies have indicated that resistin-like molecule beta (RELM beta), an intestinal goblet cell-specific protein, is markedly increased in the intestinal tumors of min mice and over-expressed in a human colon cancer cell line. We hypothesized that RELM beta might be enhanced in human colon cancer. The aim of this study was to examine the clinical importance of RELM beta expression in colon cancer patients and to correlate its expression with various clinicopathological parameters, upstream regulatory molecule expression, tumor proliferative capacity, and patients' survival. Of the 80 colon cancer patients studied, 65 (81.25%) tested positive for RELM beta, mainly in the cytoplasm of colon mucosa. Contrasting sharply with the strongly RELM beta-positive tumors, normal colon mucous membrane was negative or weakly positive. RELM beta positivity in colon cancer was correlated with histological grade of differentiation and lymph node metastasis, but not with age, gender, tumor location and size, tumor infiltration, Dukes' stage, liver metastasis, and venous invasion. RELM beta expression was significantly correlated with the expression of transcription factor CDX-2 (P 0.05). The mean postoperative survival time (2.76 years) of RELM beta-positive patients was significantly longer than that (1.26 years) of RELM beta-negative patients (P = 0.032). These findings support evidence of the enhanced RELM beta expression in colon cancer patients and suggest that further investigation is warranted to explore the role of RELM beta in colon cancer.

  14. Role of antibiotics in generalized aggressive periodontitis: A review of clinical trials in humans

    Science.gov (United States)

    Ahuja, Annapurna; Baiju, C. S.; Ahuja, Vipin

    2012-01-01

    Background: It is well-recognized fact that periodontal diseases are caused by multifactorial etiologies, in which microorganisms play an important role. An essential component of therapy is to eliminate or manage these pathogens. This has been traditionally accomplished through mechanical means by scaling and root planning which is ineffective in some of the aggressive periodontal diseases. These aggressive diseases involve particular groups of microorganisms which are not eliminated by mechanical means; and they require anti-infective therapy, which includes local and systemic antimicrobials. This approach of therapy is of interest to periodontist due to the aforementioned shortcomings of conventional methods. Materials and Methods: A manual and electronic search was made for human studies up to March 2011 that presented clinical and microbiological data for the efficacy of a systemic antibiotics in generalized aggressive periodontitis along with scaling and root planning. A systematic approach was followed by two independent reviewers and included eligibility criteria for study inclusion, quality assessment, and determination of outcome measures, data extraction, data synthesis, and drawing of conclusion. Results: Only three randomized controlled human trials qualified, and they concluded that both scaling and root planing (SRP) mono-therapy and SRP with antibiotics proves beneficial in improving clinical and microbiological parameters in aggressive periodontitis. Better results were seen in SRP with antibiotic groups as compared with SRP alone. Conclusion: Because of the insufficient quantity and heterogenecity of studies, no adequate evidence could be gathered to use the beneficial effects of these antibiotics along with SRP in aggressive periodontitis compared with SRP alone. PMID:23162322

  15. Human REM sleep: influence on feeding behaviour, with clinical implications.

    Science.gov (United States)

    Horne, James A

    2015-08-01

    Rapid eye movement (REM) sleep shares many underlying mechanisms with wakefulness, to a much greater extent than does non-REM, especially those relating to feeding behaviours, appetite, curiosity, exploratory (locomotor) activities, as well as aspects of emotions, particularly 'fear extinction'. REM is most evident in infancy, thereafter declining in what seems to be a dispensable manner that largely reciprocates increasing wakefulness. However, human adults retain more REM than do other mammals, where for us it is most abundant during our usual final REM period (fREMP) of the night, nearing wakefulness. The case is made that our REM is unusual, and that (i) fREMP retains this 'dispensability', acting as a proxy for wakefulness, able to be forfeited (without REM rebound) and substituted by physical activity (locomotion) when pressures of wakefulness increase; (ii) REM's atonia (inhibited motor output) may be a proxy for this locomotion; (iii) our nocturnal sleep typically develops into a physiological fast, especially during fREMP, which is also an appetite suppressant; (iv) REM may have 'anti-obesity' properties, and that the loss of fREMP may well enhance appetite and contribute to weight gain ('overeating') in habitually short sleepers; (v) as we also select foods for their hedonic (emotional) values, REM may be integral to developing food preferences and dislikes; and (vii) REM seems to have wider influences in regulating energy balance in terms of exercise 'substitution' and energy (body heat) retention. Avenues for further research are proposed, linking REM with feeding behaviours, including eating disorders, and effects of REM-suppressant medications.

  16. Eph/ephrin profiling in human breast cancer reveals significant associations between expression level and clinical outcome.

    Directory of Open Access Journals (Sweden)

    Dana M Brantley-Sieders

    Full Text Available Pre-clinical studies provide compelling evidence that Eph family receptor tyrosine kinases (RTKs and ligands promote cancer growth, neovascularization, invasion, and metastasis. Tumor suppressive roles have also been reported for the receptors, however, creating a potential barrier for clinical application. Determining how these observations relate to clinical outcome is a crucial step for translating the biological and mechanistic data into new molecularly targeted therapies. We investigated eph and ephrin expression in human breast cancer relative to endpoints of overall and/or recurrence-free survival in large microarray datasets. We also investigated protein expression in commercial human breast tissue microarrays (TMA and Stage I prognostic TMAs linked to recurrence outcome data. We found significant correlations between ephA2, ephA4, ephA7, ephB4, and ephB6 and overall and/or recurrence-free survival in large microarray datasets. Protein expression in TMAs supported these trends. While observed no correlation between ephrin ligand expression and clinical outcome in microarray datasets, ephrin-A1 and EphA2 protein co-expression was significantly associated with recurrence in Stage I prognostic breast cancer TMAs. Our data suggest that several Eph family members are clinically relevant and tractable targets for intervention in human breast cancer. Moreover, profiling Eph receptor expression patterns in the context of relevant ligands and in the context of stage may be valuable in terms of diagnostics and treatment.

  17. A prospective clinical study of polycarboxylate cement in periapical surgery

    National Research Council Canada - National Science Library

    Peñarrocha-Diago, M-A; Ortega-Sánchez, B; García-Mira, B; Maestre-Ferrín, L; Peñarrocha-Oltra, D; Gay-Escoda, C

    .... A prospective clinical study was made of 25 patients subjected to periapical surgery with ultrasound and magnifying loupes, in which polycarboxylate cement was used as retrograde filling material...

  18. Declaration of the 2nd Meeting of the Committee on Clinical Application of Human Organ Transplantation of China and National Summit of Clinical Application and Management of Human Organ Transplantation

    Institute of Scientific and Technical Information of China (English)

    2007-01-01

    @@ We, medical practitioners of human organ transplantation, met in the 2nd Meeting of the People's Republic of China Ministry of Health Committee on Clinical Application of Human Organ Transplantation and National Summit of Clinical Application and Management of Human Organ Transplantation in Guangzhou, Guangdong Province, People's Republic of China, on 13 and 14 November 2006.

  19. Development and validation of a high-performance liquid chromatography-tandem mass spectrometry method for the simultaneous determination of irinotecan and its main metabolites in human plasma and its application in a clinical pharmacokinetic study.

    Directory of Open Access Journals (Sweden)

    Elena Marangon

    Full Text Available Irinotecan is currently used in several cancer regimens mainly in colorectal cancer (CRC. This drug has a narrow therapeutic range and treatment can lead to side effects, mainly neutropenia and diarrhea, frequently requiring discontinuing or lowering the drug dose. A wide inter-individual variability in irinotecan pharmacokinetic parameters and pharmacodynamics has been reported and associated to patients' genetic background. In particular, a polymorphism in the UGT1A1 gene (UGT1A1*28 has been linked to an impaired detoxification of SN-38 (irinotecan active metabolite to SN-38 glucuronide (SN-38G leading to increased toxicities. Therefore, therapeutic drug monitoring of irinotecan, SN-38 and SN-38G is recommended to personalize therapy. In order to quantify simultaneously irinotecan and its main metabolites in patients' plasma, we developed and validated a new, sensitive and specific HPLC-MS/MS method applicable to all irinotecan dosages used in clinic. This method required a small plasma volume, addition of camptothecin as internal standard and simple protein precipitation. Chromatographic separation was done on a Gemini C18 column (3 μM, 100 mm x 2.0 mm using 0.1% acetic acid/bidistilled water and 0.1% acetic acid/acetonitrile as mobile phases. The mass spectrometer worked with electrospray ionization in positive ion mode and selected reaction monitoring. The standard curves were linear (R2 ≥0.9962 over the concentration ranges (10-10000 ng/mL for irinotecan, 1-500 ng/mL for SN-38 and SN-38G and 1-5000 ng/mL for APC and had good back-calculated accuracy and precision. The intra- and inter-day precision and accuracy, determined on three quality control levels for all the analytes, were always <12.3% and between 89.4% and 113.0%, respectively. Moreover, we evaluated this bioanalytical method by re-analysis of incurred samples as an additional measure of assay reproducibility. This method was successfully applied to a pharmacokinetic study in

  20. Clinical comparison of human and canine atopic dermatitis using human diagnostic criteria (Japanese Dermatological Association, 2009): proposal of provisional diagnostic criteria for canine atopic dermatitis.

    Science.gov (United States)

    Terada, Yuri; Nagata, Masahiko; Murayama, Nobuo; Nanko, Hiroko; Furue, Masutaka

    2011-08-01

    Atopic dermatitis (AD) is a common skin disease encountered in both humans and dogs. Canine AD can be used in the analysis of naturally occurring AD; however, details of clinical comparison have been lacking. The purpose of this study is to compare those clinical features using the human diagnostic criteria (Japanese Dermatological Association, 2009). Fifty-one dogs with canine AD were evaluated by the human criteria. Prior to this study, canine AD was basically diagnosed by the fulfillment of two authentic canine AD criteria and a positive reaction against Dermatophagoides farinae in serum immunoglobulin E levels and/or in intradermal tests. Among the human AD criteria items, behavior corresponding to pruritus was observed in all 51 dogs. Skin lesions corresponding to eczematous dermatitis were seen in 50 dogs, and symmetrical distribution of skin lesions was noted in all 51 dogs. A chronic or chronically relapsing course was observed in 50 dogs. Based on these results, the concordance rate for the criteria was 96% (49/51). Differential diagnoses of AD were also investigated in the same manner. The concordance rate for the criteria was 0% (0/69) in scabies, 2% (1/50) in pyoderma, 0% (0/50) in demodicosis, 0% (0/9) in cutaneous lymphoma, 0% (0/2) in ichthyosis, 25% (2/7) in flea allergy, 48% (24/50) in seborrheic dermatitis and 75% (3/4) in food allergy. Canine AD is thus indicated as a valuable counterpart to human AD in clinical aspects. In addition, the human AD criteria could be applicable, with some modification, as provisional diagnostic criteria for canine AD.

  1. Advances in understanding of mammalian penile evolution, human penile anatomy and human erection physiology: clinical implications for physicians and surgeons.

    Science.gov (United States)

    Hsieh, Cheng-Hsing; Liu, Shih-Ping; Hsu, Geng-Long; Chen, Heng-Shuen; Molodysky, Eugen; Chen, Ying-Hui; Yu, Hong-Jeng

    2012-07-01

    Recent studies substantiate a model of the tunica albuginea of the corpora cavernosa as a bi-layered structure with a 360° complete inner circular layer and a 300° incomplete outer longitudinal coat spanning from the bulbospongiosus and ischiocavernosus proximally and extending continuously into the distal ligament within the glans penis. The anatomical location and histology of the distal ligament invites convincing parallels with the quadrupedal os penis and therefore constitutes potential evidence of the evolutionary process. In the corpora cavernosa, a chamber design is responsible for facilitating rigid erections. For investigating its venous factors exclusively, hemodynamic studies have been performed on both fresh and defrosted human male cadavers. In each case, a rigid erection was unequivocally attainable following venous removal. This clearly has significant ramifications in relation to penile venous surgery and its role in treating impotent patients. One deep dorsal vein, 2 cavernosal veins and 2 pairs of para-arterial veins (as opposed to 1 single vein) are situated between Buck's fascia and the tunica albuginea. These newfound insights into penile tunical, venous anatomy and erection physiology were inspired by and, in turn, enhance clinical applications routinely encountered by physicians and surgeons, such as penile morphological reconstruction, penile implantation and penile venous surgery.

  2. Clinical and microbiological impact of human bocavirus on children with acute otitis media.

    Science.gov (United States)

    Beder, Levent Bekir; Hotomi, Muneki; Ogami, Masashi; Yamauchi, Kazuma; Shimada, Jun; Billal, Dewan Sakhawat; Ishiguro, Nobuhisa; Yamanaka, Noboru

    2009-11-01

    Human Bocavirus (HBoV) as a newly discovered parvovirus has been commonly detected in respiratory tract infections. However, its role in acute otitis media (AOM) has not been well studied. We examined HBoV in Japanese children with AOM and evaluated the virus prevalence together with clinical manifestations and bacterial findings. Overall, 222 nasopharyngeal swabs and 176 middle ear fluids (MEF) samples were collected from 222 children with AOM (median age, 19 months) between May 2006 and April 2007. HBoV detection was performed by PCR and bacterial isolation by standard culture methods. HBoV was found in the nasopharyngeal aspirates of 14 children (6.3%) and in the MEF of six children (2.7%). When HBoV detection results were evaluated with clinical characteristics of children, resolution time of AOM was significantly longer (p=0.04), and rate of fever symptom was also higher in HBoV-positive group (p=0.04). Furthermore, we found positive correlation between detection of HBoV and Streptococcus pneumoniae in the MEF (p=0.004). Nevertheless, nasopharyngeal proportion of S. pneumoniae was similar between virus positive and negative groups. Furthermore, S. pneumoniae was detected as a single pathogen in all MEF of HBoV-positive cases but one, while it presents mixed with other pathogenic bacteria in nasopharynx. In conclusion, HBoV may worsen the clinical symptoms and prolong the clinical outcome of AOM in pediatric population. Finally, HBoV may prime the secondary bacterial infection in the middle ear in favor of S. pneumoniae.

  3. Prevalence of human papillomavirus infection in a clinic sample of transsexuals in Italy.

    Science.gov (United States)

    Loverro, Giuseppe; Di Naro, Edoardo; Caringella, Anna Maria; De Robertis, Anna Lisa; Loconsole, Daniela; Chironna, Maria

    2016-02-01

    Detectable human papillomavirus (HPV) DNA is the most common sexually transmitted infection. Reports on the prevalence of detectable HPV DNA among transsexuals (not sex workers) are scarce. The objective of the study was to determine the prevalence of detectable HPV DNA in a clinic sample of transsexuals and to assess the relationship between detectable HPV DNA and cytological outcomes. Clinical samples (oral, anal, vaginal, cervicovaginal and penile scraped cells) from 35 transsexuals (surgically treated and surgically untreated) who attended the outpatient Clinic of Gender Identity Dysphoria of the Department of Obstetrics and Gynecology of Policlinico Hospital (Bari, Italy) were collected for cytological analysis and HPV DNA detection and typing. All enrolled subjects answered an anonymous structured questionnaire about their sexual habits. Serological status for other sexually transmitted diseases (hepatitis B virus (HBV), hepatitis C virus (HCV), HIV and syphilis) was also evaluated. HPV DNA was detected in 14 of 35 patients (40.0%). The prevalence of detectable HPV DNA was 38.2% (13/34) in tested anal samples, 9.1% (2/22) in vaginal samples and 8.3% (1/12) in penile samples. Oncogenic HPV genotypes have been detected in 93% of HPV-positive transsexuals. More than one-third (35.7%) of HPV-positive transsexuals were infected with at least one of the four vaccine-preventable genotypes, 6, 11, 16 and 18. The high rate of detectable HPV DNA by oncogenic types suggests that periodic cytological screening and clinical evaluation may be necessary since transsexuals are at high risk of anogenital cancer. Also promoting HPV vaccination in younger subjects may be advisable. 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/

  4. Combination With Low-dose Dextromethorphan Improves the Effect of Amlodipine Monotherapy in Clinical Hypertension: A First-in-human, Concept-proven, Prospective, Dose-escalation, Multicenter Study.

    Science.gov (United States)

    Yin, Wei-Hsian; Chen, Pei; Yeh, Hung-I; Wang, Kuo-Yang; Hung, Yi-Jen; Tseng, Wei-Kung; Wen, Ming-Shien; Wu, Tao-Cheng; Wu, Chau-Chung; Cheng, Shu-Meng; Chen, Jaw-Wen

    2016-03-01

    The combination of low rather than high dose of dextromethorphan (DXM) with amlodipine (AM) could improve blood pressure (BP) reduction in hypertensive animals. The study aimed to evaluate the feasibility of different doses of DXM combined with standard AM treatment in clinical hypertension.This was a prospective, 14-week, dose-escalation, multicenter study. After 2-week run-in period with AM 5 mg/day, hypertensive patients who got the BP goal of 140/90 mmHg kept receiving AM monotherapy for another 12 weeks. The nonresponders, while kept on AM 5 mg/day, received additional DXM treatment for 3 sequential dose-titrated periods with initially 2.5 mg/day, followed by 7.5 mg/day, and finally 30 mg/day. Each period was for 4 weeks. The patients at BP goal after each treatment period were defined as the responders and kept on the same combination till the end of the study. The responder rate of each treatment period was recorded. The changes of BP and serum antioxidant/endothelial markers between week 14 and week 2 were evaluated.Of the 103 patients initially enrolled, 89 entered the treatment period. In the 78 patients completing the study, 31 (40%) at BP goal after 2-week AM run-in kept on AM monotherapy (DXM0). The addition of 2.5 (DXM2.5) and 7.5 mg/day (DXM7.5) of DXM enabled BP goal achievement in 22 (47%) nonresponders to AM monotherapy including 16 (29%) with DXM2.5 and 6 (18%) with DXM7.5. Only 4 patients (16%) reached BP goal with the combination of DXM 30 mg/day (DXM30). Overall, 73% of the 78 patients reached BP goal at the end of the 14-week study. Mean systolic BP was reduced by 7.9% ± 7.0% with DXM2.5 (P < 0.001) and by 5.4% ± 2.4% with DXM7.5 (P = 0.003) respectively at week 14 from that at week 2, which was unchanged in either DXM0 or DXM30 group. Besides, the effects of combination treatment were particularly significant in the patients with impaired endothelial function suggested by reduced serum NOx level at baseline

  5. CLINICAL STUDY OF POSTOPERATIVE WOUND INFECTION

    OpenAIRE

    Sudheer Darbha; Giddaluru Srihari

    2016-01-01

    BACKGROUND The aim of the study is to study the most common organisms encountered and their sensitivity and resistance to antibiotics in postoperative wound infection and to study relation of emergency and elective surgery to postoperative wound infection and to study efficacy of different modes of preoperative preparation on postoperative wound infection and to study distribution of postoperative wound infection among different surgeries based on bacterial contamination such a...

  6. Oral mucocele: A clinical and histopathological study

    Science.gov (United States)

    More, Chandramani B; Bhavsar, Khushbu; Varma, Saurabh; Tailor, Mansi

    2014-01-01

    Background: Oral mucocele is the most common benign minor (accessory) salivary gland lesion, caused due to mechanical trauma to the excretory duct of the gland. Clinically they are characterized by single or multiple, soft, fluctuant nodule, ranging from the normal color of the oral mucosa to deep blue. It affects at any age and is equally present in both sexes with highest incidence in second decade of life. They are classified as extravasation or retention type. Objectives: To analyze the data between 2010 and 2011 of, clinically and histopathologically diagnosed 58 oral mucoceles for age, gender, type, site, color, cause, symptoms and dimension. Results: Oral mucoceles were highly prevalent in the age group of 15-24 years, were seen in 51.72% of males and 48.28% of females, with a ratio of 1.07:1. The extravasation type (84.48%) was more common than the retention type (15.52%). The most common affected site was lower lip (36.20%) followed by ventral surface of the tongue (25.86%). The lowest frequency was observed in floor of mouth, upper lip and palate. The maximum numbers of mucoceles were asymptomatic (58.62%), and the color of the overlying mucosa had color of adjacent normal mucosa (48.28%). It was also observed that most of the mucoceles had diameter ranging from 5 to 14 mm. The causative factors of the lesion were lip biting (22.41%), trauma (5.18%) and numerous lesions (72.41%). Conclusion: Oral Mucoceles are frequently seen in an oral medicine service, mainly affecting young people and lower lip, measuring around 5 to 14 mm and the extravasation type being the most common. PMID:25364184

  7. Prospective Clinical Study of Precision Oncology in Solid Tumors.

    Science.gov (United States)

    Sohal, Davendra P S; Rini, Brian I; Khorana, Alok A; Dreicer, Robert; Abraham, Jame; Procop, Gary W; Saunthararajah, Yogen; Pennell, Nathan A; Stevenson, James P; Pelley, Robert; Estfan, Bassam; Shepard, Dale; Funchain, Pauline; Elson, Paul; Adelstein, David J; Bolwell, Brian J

    2016-03-01

    Systematic studies evaluating clinical benefit of tumor genomic profiling are lacking. We conducted a prospective study in 250 patients with select solid tumors at the Cleveland Clinic. Eligibility required histopathologic diagnosis, age of 18 years or older, Eastern Cooperative Oncology Group performance status 0-2, and written informed consent. Tumors were sequenced using FoundationOne (Cambridge, MA). Results were reviewed at the Cleveland Clinic Genomics Tumor Board. Outcomes included feasibility and clinical impact. Colorectal (25%), breast (18%), lung (13%), and pancreatobiliary (13%) cancers were the most common diagnoses. Median time from consent to result was 25 days (range = 3-140). Of 223 evaluable samples, 49% (n = 109) of patients were recommended a specific therapy, but only 11% (n = 24) received such therapy: 12 on clinical trials, nine off-label, three on-label. Lack of clinical trial access (n = 49) and clinical deterioration (n = 29) were the most common reasons for nonrecommendation/nonreceipt of genomics-driven therapy.

  8. A clinical and radiological study of peroneal tendon pathology.

    Science.gov (United States)

    Giza, Eric; Mak, Walter; Wong, Stephanie E; Roper, Glade; Campanelli, Valentina; Hunter, John C

    2013-12-01

    The proportion of patients with clinical findings referable to peroneal pathology and magnetic resonance imaging (MRI)-diagnosed peroneal tendon pathology is unknown. Previous studies have correlated surgical findings with clinical data and preoperative MRI, but there are no published studies that reference clinical examination findings to imaging findings. To determine the relationship between peroneal tendon pathology as diagnosed by MRI and clinical findings of peroneal tendon pathology. Fifty-six patients who had both MRI evidence of peroneal tendon pathology and an associated clinical examination of the ankle were evaluated over a 3-year period at a tertiary care institution. Clinical examination criteria included lateral ankle tenderness, dislocation/snapping, and lateral ankle pain. A board-certified, fellowship-trained musculoskeletal radiologist confirmed the presence of MRI findings consistent with peroneal tendon pathology. Of the 56 patients with positive findings on MRI, 27 patients had an associated positive clinical exam and 29 patients had a negative clinical exam. The positive predictive value of MRI for peroneal tendon tears with positive clinical findings was 48% (95% confidence interval = 35% to 61%). Patients with MRI findings of peroneal tendon pathology should undergo careful clinical examination, as the positive predictive value of MRI for peroneal tendon pathology with actual clinical findings is low. This study demonstrates that peroneal tendon tears are often incidental findings on MRI.

  9. Stress and Coping in Patients with Clinical Manifestations of Human Papillomavirus.

    Science.gov (United States)

    Cvitanović, Hrvoje; Šitum, Mirna; Meštrović-Štefekov, Jelena; Lugović-Mihić, Liborija

    2017-04-01

    Stressful life events in response to a psychosocial trigger have been reported to negatively affect the course of infections. This study was based on patients with clinical manifestations of human papillomavirus (HPV) infection and a control group of patients with psoriasis who were admitted over a period of one year to the Dermatology Department of Karlovac General Hospital. A total of 122 patients participated in the study, either with a confirmed diagnosis of clinical manifestations of HPV infection (n=66) or in a psoriasis control group (n=56). The aim of this study was to determine which coping strategies are used in patients with clinical manifestations of HPV infection. We used the Recent Life Changes Questionnaire and Brief COPE test for stress evaluation. There were no statically significant differences between adaptive and maladaptive coping strategies comparing patients with HPV and a control group. The difference in specific coping strategies between HPV and control groups showed that self-blame and planning strategies were statistically significantly more common in the HPV group. Patients with HPV with genital warts used maladaptive coping statistically significantly more than patients with non-genital localization of HPV. Patients with HPV who had a higher score of life stress events used maladaptive coping statistically significantly more than patients with a lower life stress events score. The results point to the need for patients with HPV with genital localization and high numbers of stress events to learn how to cope with stress, enabling them to take action and change their ways of coping. There is also a need to integrate psychological intervention into standard care protocols of dermatologic diseases.

  10. Comparison of Hemagglutination and Hemolytic Activity of Various Bacterial Clinical Isolates Against Different Human Blood Groups

    Science.gov (United States)

    HRV, Rajkumar; Devaki, Ramakrishna

    2016-01-01

    Among the various pathogenic determinants shown by microorganisms hemagglutination and hemolysin production assume greater significance in terms of laboratory identification. This study evaluated the hemagglutination and hemolytic activity of various bacterial isolates against different blood groups. One hundred and fifty bacterial strains, isolated from clinical specimens like urine, pus, blood, and other body fluids were tested for their hemagglutinating and hemolytic activity against human A, B, AB, and O group red blood cells. Among the 150 isolates 81 were Escherichia coli, 18 were Klebsiella pneumoniae, 19 were Pseudomonas aeruginosa, 10 were Pseudomonas spp, six were Proteus mirabilis, and the rest 16 were Staphylococcus aureus. Nearly 85% of the isolates agglutinated A group cells followed by B and AB group (59.3% and 60.6% respectively). Least number of isolates agglutinated O group cells (38.0%). When the hemolytic activity was tested, out of these 150 isolates 79 (52.6%) hemolyzed A group cells, 61 (40.6%) hemolyzed AB group cells, 46 (30.6%) hemolyzed B group cells, and 57 (38.6%) isolates hemolyzed O group cells. Forty-six percent of the isolates exhibited both hemagglutinating and hemolytic property against A group cells, followed by B and AB group cells (28.6% and 21.3% respectively). Least number of isolates i.e., 32 (21.3%) showed both the properties against O group cells. The isolates showed wide variation in their hemagglutination and hemolytic properties against different combinations of human blood group cells. The study highlights the importance of selection of the type of cells especially when human RBCs are used for studying the hemagglutination and hemolytic activity of bacterial isolates because these two properties are considered as characteristic of pathogenic strains. PMID:27014523

  11. Dynamic cerebral autoregulation to induced blood pressure changes in human experimental and clinical sepsis.

    Science.gov (United States)

    Berg, Ronan M G; Plovsing, Ronni R; Bailey, Damian M; Holstein-Rathlou, Niels-Henrik; Møller, Kirsten

    2016-11-01

    Previous studies have demonstrated that dynamic cerebral autoregulation to spontaneous fluctuations in blood pressure is enhanced following lipopolysaccharide (LPS) infusion, a human experimental model of early sepsis, whereas by contrast it is impaired in patients with severe sepsis or septic shock. In this study, we hypothesized that this pattern of response would be identical during induced changes in blood pressure. Dynamic cerebral autoregulation was assessed in nine healthy volunteers and six septic patients. The healthy volunteers underwent a 4-h intravenous infusion of LPS (total dose: 2 ng kg(-1) ). Mean arterial blood pressure (MAP, arterial transducer) and middle cerebral artery blood flow velocity (MCAv, transcranial Doppler ultrasound) were recorded continuously during thigh-cuff deflation-induced changes in MAP for the determination of a modified rate of regulation (RoR). This was performed before and after LPS infusion in healthy volunteers, and within 72 h following clinical diagnosis of sepsis in patients. In healthy volunteers, thigh-cuff deflation caused a MAP reduction of 16 (13-20) % at baseline and 18 (16-20) % after LPS, while the MAP reduction was 12 (11-13) % in patients (Psepsis, they remain inconclusive with regard to more advanced stages of disease, because thigh-cuff deflation failed to induce sufficient MAP reductions in patients. © 2015 Scandinavian Society of Clinical Physiology and Nuclear Medicine. Published by John Wiley & Sons Ltd.

  12. Expression, regulation and clinical relevance of the ATPase inhibitory factor 1 in human cancers

    Science.gov (United States)

    Sánchez-Aragó, M; Formentini, L; Martínez-Reyes, I; García-Bermudez, J; Santacatterina, F; Sánchez-Cenizo, L; Willers, I M; Aldea, M; Nájera, L; Juarránz, Á; López, E C; Clofent, J; Navarro, C; Espinosa, E; Cuezva, J M

    2013-01-01

    Recent findings in colon cancer cells indicate that inhibition of the mitochondrial H+-adenosine triphosphate (ATP) synthase by the ATPase inhibitory factor 1 (IF1) promotes aerobic glycolysis and a reactive oxygen species (ROS)-mediated signal that enhances proliferation and cell survival. Herein, we have studied the expression, biological relevance, mechanism of regulation and potential clinical impact of IF1 in some prevalent human carcinomas. We show that IF1 is highly overexpressed in most (>90%) of the colon (n=64), lung (n=30), breast (n=129) and ovarian (n=10) carcinomas studied as assessed by different approaches in independent cohorts of cancer patients. The expression of IF1 in the corresponding normal tissues is negligible. By contrast, the endometrium, stomach and kidney show high expression of IF1 in the normal tissue revealing subtle differences by carcinogenesis. The overexpression of IF1 also promotes the activation of aerobic glycolysis and a concurrent ROS signal in mitochondria of the lung, breast and ovarian cancer cells mimicking the activity of oligomycin. IF1-mediated ROS signaling activates cell-type specific adaptive responses aimed at preventing death in these cell lines. Remarkably, regulation of IF1 expression in the colon, lung, breast and ovarian carcinomas is exerted at post-transcriptional levels. We demonstrate that IF1 is a short-lived protein (t1/2 ∼100 min) strongly implicating translation and/or protein stabilization as main drivers of metabolic reprogramming and cell survival in these human cancers. Analysis of tumor expression of IF1 in cohorts of breast and colon cancer patients revealed its relevance as a predictive marker for clinical outcome, emphasizing the high potential of IF1 as therapeutic target. PMID:23608753

  13. Clinical and genetic features of human prion diseases in Catalonia: 1993-2002.

    Science.gov (United States)

    Sanchez-Valle, R; Nos, C; Yagüe, J; Graus, F; Domínguez, A; Saiz, A

    2004-10-01

    We describe the clinical and genetic characteristics of the 85 definite or probable human prion diseases cases died between January 1993 and December 2002 in Catalonia (an autonomous community of Spain, 6 million population). Seventy-three (86%) cases were sporadic Creutzfeld-Jakob diseases (sCJD) (49 definite, 24 probable), with a median age at onset of 66 years. The clinical presentation was dementia in 29 cases, ataxia in 14 and visual symptoms in five. The median survival was 3 months. The 14-3-3 assay was positive in 93% cases, 62% presented periodic sharp wave complexes (PSWC) in EEG but only 18% the typical signs on MRI. Forty-eight sCJD were studied for codon 129 PRNP polymorphism: 69% were methionine/methionine (M/M), 14.5% valine/valine (V/V) and 16.5% M/V. Six out of seven V/V cases did not present PSWC and in two survival was longer than 20 months. Eleven cases (13%) were genetic: five familial fatal insomnia and six familial CJD (fCJD). Up to four (67%) fCJD lacked family history of disease, two presented seizures early at onset and one neurosensorial deafness. The only iatrogenic case was related to a dura mater graft. No case of variant CJD was registered. The study confirms in our population the consistent pattern reported worldwide on human prion diseases. Atypical features were seen more frequently in sporadic 129 V/V CJD and fCJD cases.

  14. Epigenetics and human disease: translating basic biology into clinical applications

    OpenAIRE

    Rodenhiser, David; Mann, Mellissa

    2006-01-01

    Epigenetics refers to the study of heritable changes in gene expression that occur without a change in DNA sequence. Research has shown that epigenetic mechanisms provide an "extra" layer of transcriptional control that regulates how genes are expressed. These mechanisms are critical components in the normal development and growth of cells. Epigenetic abnormalities have been found to be causative factors in cancer, genetic disorders and pediatric syndromes as well as contributing factors in a...

  15. Methodological Aspects in Studies Based on Clinical Routine Data.

    Science.gov (United States)

    Kennes, Lieven Nils

    2017-09-12

    Randomized controlled clinical trials are regarded as the gold standard for comparing different clinical interventions, but generally their conduct is operationally cumbersome, time-consuming, and expensive. Studies and investigations based on clinical routine data on the contrary utilize existing data acquired under real-life conditions and are increasingly popular among practitioners. In this paper, methodological aspects of studies based on clinical routine data are discussed. Important limitations and considerations as well as unique strengths of these types of studies are indicated and exemplarily demonstrated in a recent real-case study based on clinical routine data. In addition two simulation studies reveal the impact of bias in studies based on clinical routine data on the type I error rate and false decision rate in favor of the inferior intervention. It is concluded that correctly analyzing clinical routine data yields a valuable addition to clinical research; however, as a result of a lack of statistical foundation, internal validity, and comparability, generalizing results and inferring properties derived from clinical routine data to all patients of interest has to be considered with extreme caution. Grünenthal GmbH.

  16. The survey of clinical human experimentation research in ethical review of postgraduates students.

    Science.gov (United States)

    Xu, Yifan; Zhu, Zheng; Wang, Liyu

    2012-06-01

    An anonymous questionnaire was used to investigate the status quo of ethics review of human subject experiments among postgraduate students in clinical practice with the main conclusions as follows: Human subject experiments make up a large ratio of clinical research; the construction of an ethics review has been initially formulated, but there exists a gap in ethics awareness between advisors and the postgraduates with the desperate need to receive ethics review. It is necessary to realize the importance of informed consent and to strengthen the strict supervision of placebo application.

  17. Use of the human patient simulator to teach clinical judgment skills in a baccalaureate nursing program.

    Science.gov (United States)

    Rhodes, Mattie L; Curran, Cynthia

    2005-01-01

    Nurse educators are finding it increasingly more challenging to prepare undergraduate students for the ever-changing and more acute clinical environment. As an answer to this dilemma, the human patient simulator can provide students with the opportunity to enhance knowledge, to facilitate skill acquisition, to decrease anxiety, and to promote clinical judgment in a safe environment. These experiences assist the novice nursing student to progress to the advanced beginner stage of practice. This article describes how faculty used the human patient simulator in creating a case scenario that enhanced critical thinking in senior nursing students.

  18. Oral mucocele: A clinical and histopathological study

    Directory of Open Access Journals (Sweden)

    Chandramani B More

    2014-01-01

    Objectives: To analyze the data between 2010 and 2011 of, clinically and histopathologically diagnosed 58 oral mucoceles for age, gender, type, site, color, cause, symptoms and dimension. Results: Oral mucoceles were highly prevalent in the age group of 15-24 years, were seen in 51.72% of males and 48.28% of females, with a ratio of 1.07:1. The extravasation type (84.48% was more common than the retention type (15.52%. The most common affected site was lower lip (36.20% followed by ventral surface of the tongue (25.86%. The lowest frequency was observed in floor of mouth, upper lip and palate. The maximum numbers of mucoceles were asymptomatic (58.62%, and the color of the overlying mucosa had color of adjacent normal mucosa (48.28%. It was also observed that most of the mucoceles had diameter ranging from 5 to 14 mm. The causative factors of the lesion were lip biting (22.41%, trauma (5.18% and numerous lesions (72.41%. Conclusion: Oral Mucoceles are frequently seen in an oral medicine service, mainly affecting young people and lower lip, measuring around 5 to 14 mm and the extravasation type being the most common.

  19. [Surgical clinical studies and their practical realization].

    Science.gov (United States)

    Uhl, W; Wente, M N; Büchler, M W

    2000-06-01

    The employment of the optimal therapeutic option according to the best current knowledge is called evidence-based medicine (EBM). Moreover, considering the cost explosion in public health systems, EBM should contribute towards economical and targeted use of the restricted resources and towards quality assurance in medicine. Obviously, this is applicable to the operative specialties and can be termed as evidence-based surgery. Surgeons have to do their "homework" about this subject and to perform randomized controlled trials (the gold standard with the greatest evidence) on a large scale, in order to come up to this expectation in future. Evidence-based therapy is essential for the preservation and especially for the further development and evolution of high-quality surgery with, at the same time, quality assurance in the new millenium. This article presents the definition of EBM and its implication in the operative fields. Fundamental principles for the practical conduct of clinical randomized controlled trials are defined and the specific problems in surgery are discussed.

  20. Corticosteroid myopathy: a clinical and pathological study.

    Science.gov (United States)

    Khaleeli, A A; Edwards, R H; Gohil, K; McPhail, G; Rennie, M J; Round, J; Ross, E J

    1983-02-01

    In six patients with Cushing's syndrome and three with steroid myopathy, the clinical, functional, biochemical and structural characteristics of myopathy are described. Proximal muscle weakness occurred in all the patients, preferentially affected the lower limbs and was accompanied by muscle wasting in all but one patient. Force measurements confirmed quadriceps weakness in every patient. Vastus lateralis muscle biopsies showed light microscopic abnormalities in two of three patients with steroid myopathy and one of five patients with Cushing's syndrome. Type II fibre atrophy was the commonest abnormality. Reduced type II mean fibre areas occurred in all the patients with steroid myopathy and were common in Cushing's syndrome patients. Type I mean fibre areas were also reduced in two of the former group and one of the latter group and two further patients in this group had areas at the lower end of the normal range. Abnormalities in electron microscopy, mitochondrial function tests and chemical content of skeletal muscle were frequent and are described and discussed. A plasma creatine kinase activity (CK) at the lower end of the normal range, a myopathic electromyogram (EMG) and a raised 24-h urinary 3-methylhistidine/creatinine ratio on a creatine free diet were other characteristic findings in both groups of patients.

  1. First-in-human clinical trials of imaging devices: an example from optical imaging.

    Science.gov (United States)

    Gibbs-Strauss, Summer L; Rosenberg, Mireille; Clough, Barbara L; Troyan, Susan L; Frangioni, John V

    2009-01-01

    Clinical translation of scientific discoveries is often the long-term goal of academic medical research. However, this goal is not always realized due to the complicated path between bench research and clinical use. In this review, we outline the fundamental steps required for first-in-human testing of a new imaging device, and use the FLARE() (Fluorescence-Assisted Resection and Exploration) near-infrared fluorescence optical imaging platform as an example.

  2. Clinical characteristics and lung function in older children vertically infected with Human Immunodeficiency Virus in Malawi

    OpenAIRE

    Mwalukomo, Thandie; Rylance, Sarah; Webb, Emily; Anderson, Suzanne; O'Hare, Bernadette Ann-Marie; van Oosterhout, Joep J; Ferrand, Rashida A.; Corbett, Elizabeth L; Rylance, Jamie

    2015-01-01

    T. M. was funded by the Commonwealth scholarship, with research costs from a grant fom Helse Nord Northern Norway Regional Health Authority. E. L. C., R. A. F., and J. R. are supported by Wellcome Trust Fellowships (Senior Fellowship in Clinical Sciences WT091769, Career Development Fellowship WT095878 and Clinical PhD Fellowship 086756/B/08/Z, respectively). Background Antiretroviral therapy (ART) has led to increased survival of children with vertically acquired human immunodeficiency vi...

  3. A systematic review of the clinical presentation, treatment and relapse characteristics of human Plasmodium ovale malaria.

    Science.gov (United States)

    Groger, Mirjam; Fischer, Hannah S; Veletzky, Luzia; Lalremruata, Albert; Ramharter, Michael

    2017-03-11

    Despite increased efforts to control and ultimately eradicate human malaria, Plasmodium ovale malaria is for the most part outside the focus of research or public health programmes. Importantly, the understanding of P. ovale-nowadays regarded as the two distinct species P. ovale wallikeri and P. ovale curtisi-largely stems from case reports and case series lacking study designs providing high quality evidence. Consecutively, there is a lack of systematic evaluation of the clinical presentation, appropriate treatment and relapse characteristics of P. ovale malaria. The aim of this systematic review is to provide a systematic appraisal of the current evidence for severe manifestations, relapse characteristics and treatment options for human P. ovale malaria. This systematic review was performed according to the PRISMA guidelines and registered in the international prospective register for systematic reviews (PROSPERO 2016:CRD42016039214). P. ovale mono-infection was a strict inclusion criterion. Of 3454 articles identified by the literature search, 33 articles published between 1922 and 2015 met the inclusion criteria. These articles did not include randomized controlled trials. Five prospective uncontrolled clinical trials were performed on a total of 58 participants. P. ovale was sensitive to all tested drugs within the follow-up periods and on interpretable in vitro assays. Since its first description in 1922, only 18 relapsing cases of P. ovale with a total of 28 relapse events were identified in the scientific literature. There was however no molecular evidence for a causal relationship between dormant liver stages and subsequent relapses. A total of 22 severe cases of P. ovale malaria were published out of which five were fatal. Additionally, two cases of congenital P. ovale malaria were reported. Current knowledge of P. ovale malaria is based on small trials with minor impact, case reports and clinical observations. This systematic review highlights that P

  4. The Effect of Learning Styles, Critical Thinking Disposition, and Critical Thinking on Clinical Judgment in Senior Baccalaureate Nursing Students during Human Patient Simulation

    Science.gov (United States)

    McCormick, Kiyan

    2014-01-01

    Simulated learning experiences using high-fidelity human patient simulators (HPS) are increasingly being integrated into baccalaureate nursing programs. Thus, the purpose of this study was to examine relationships among learning style, critical thinking disposition, critical thinking, and clinical judgment during high-fidelity human patient…

  5. Real-time monitoring for human clinical trials

    Energy Technology Data Exchange (ETDEWEB)

    Harker, Y.D. [Idaho National Engineering Lab., Idaho Falls, ID (United States)

    1995-11-01

    On August 3-4, 1994, an INEL team made measurements related to a real-time monitoring system for use on the epithermal beam facility at the BMRR. BNL has installed two fission chambers in front of the beam collimator, which are to monitor the beam coming from the reactor. These two monitors are located with one just above the 16-cm dia. front aperture and the other is just below. The fission chambers contain depleted uranium, but because of the small amount of U-235 present, they respond to thermal and near thermal neutrons rather than fast neutrons. This feature combined with their relatively small size (0.6 cm dia x 4 cm long) makes them very good monitors in the BMRR epithermal neutron beam. The INEL team worked with H.B. Lui (BNL) in performing initial tests of these monitors and established the settings to achieve stable operation. The main purpose of the measurement studies was to establish a basis for a monitoring method that tracks the dose the patient is receiving rather than the neutron fluence being delivered down the beam line.

  6. Genotyping of Cryptosporidium isolates from human clinical cases in Poland.

    Science.gov (United States)

    Bajer, Anna; Bednarska, Małgorzata; Cacciò, Simone M; Wolska-Kuśnierz, Beata; Heropolitanska-Pliszka, Edyta; Bernatowska, Ewa; Wielopolska, Małgorzata; Paziewska, Anna; Welc-faleciak, Renata; Siński, Edward

    2008-06-01

    Cryptosporidium spp. infection is usually self-limited in immunocompetent hosts but can be severe and life threatening in children and in immunocompromised individuals including those with primary or acquired immunodeficiencies. One hundred and three faecal samples were collected from 35 hospitalised patients with different symptoms and tested for the presence of the parasite. Cryptosporidium oocysts were found in four of 35 patients (11.4%) using Ziehl-Neelsen staining of faecal smears and immunofluorescence assay, whereas 12 (34.3%) samples tested positive by nested polymerase chain reaction assay. Cryptosporidium DNA was detected in one bile sample but not in a liver tissue biopsy sample collected from a patient who suffered from sclerosing cholangitis. Sequence analysis of oocyst wall protein and beta-tubulin gene fragments revealed three different parasite species (Cryptosporidium hominis, Cryptosporidium meleagridis and Cryptosporidium parvum) in children with primary immunodeficiencies, whereas only C. parvum was found in immunocompetent individuals and in those with secondary immunodeficiencies. This study has revealed a high prevalence of Cryptosporidium infection in hospitalised patients in Poland and confirmed that molecular techniques enable a more sensitive detection of the parasite.

  7. Clinical Study of Tuina for Stiff Neck

    Institute of Scientific and Technical Information of China (English)

    吴耀持; 张峻峰; 汪崇淼; 王健雄; 张沈煜

    2009-01-01

    Objective: To observe the clinical effect of Tuina for stiffneck. Methods: All of 216 cases with stiff neck were randomly allocated into a tuina group (110 cases) and a control group (106 cases). The patients in the tuina group were treated with "Three Parts, Four Points,Five Manipulation" tuina therapy, while those in the control group were treated with pucturing Wailaogong (Ex-UE 8), Houxi (SI 3), Jianjing (GB 21) and Ashi points in the affected side,Once a day, and 3 times constitute one treatment course. The effect was observed after 2-course treatments. Result: The effective rate in the tuina group and the control group was 93.64% and 83.02%, respectively, and there was statistical difference between the two groups (P < 0.05).Conclusion: The tuina therapy of "Three Parts, Four Points, Five Manipulations" is better than simple acupuncture therapy in treating stiff neck.%目的:观察推拿治疗落枕的临床疗效.方法:将216例落枕患者随机分为推拿组110例和对照组106例,推拿组用"三部四穴五法"推拿法治疗,对照组针刺患侧外劳宫、后溪、肩井和阿是穴.每日1次,3次为1个疗程;治疗2个疗程后观察疗效. 结果:推拿组有效率为93.64%,对照组为83.02%,两者比较有统计学意义(P<0.05)结论:"三部四穴五法"推拿法治疗落枕明显优于单纯针刺疗法.

  8. Towards achieving semantic interoperability of clinical study data with FHIR.

    Science.gov (United States)

    Leroux, Hugo; Metke-Jimenez, Alejandro; Lawley, Michael J

    2017-09-19

    Observational clinical studies play a pivotal role in advancing medical knowledge and patient healthcare. To lessen the prohibitive costs of conducting these studies and support evidence-based medicine, results emanating from these studies need to be shared and compared to one another. Current approaches for clinical study management have limitations that prohibit the effective sharing of clinical research data. The objective of this paper is to present a proposal for a clinical study architecture to not only facilitate the communication of clinical study data but also its context so that the data that is being communicated can be unambiguously understood at the receiving end. Our approach is two-fold. First we outline our methodology to map clinical data from Clinical Data Interchange Standards Consortium Operational Data Model (ODM) to the Fast Healthcare Interoperable Resource (FHIR) and outline the strengths and weaknesses of this approach. Next, we propose two FHIR-based models, to capture the metadata and data from the clinical study, that not only facilitate the syntactic but also semantic interoperability of clinical study data. This work shows that our proposed FHIR resources provide a good fit to semantically enrich the ODM data. By exploiting the rich information model in FHIR, we can organise clinical data in a manner that preserves its organisation but captures its context. Our implementations demonstrate that FHIR can natively manage clinical data. Furthermore, by providing links at several levels, it improves the traversal and querying of the data. The intended benefits of this approach is more efficient and effective data exchange that ultimately will allow clinicians to switch their focus back to decision-making and evidence-based medicines.

  9. Clinical Study of Recombinant Human atrial Natriuretic Peptide in Treatment of Acute Heart Failure%重组人心钠肽治疗急性心力衰竭的临床研究

    Institute of Scientific and Technical Information of China (English)

    贺宇峰

    2015-01-01

    目的:探讨重组人心钠肽治疗急性心力衰竭疗效。方法:对自2011年5月~2013年2月我院收治的急性心力衰竭患者应用重组人心钠肽治疗,于用药前后监测患者的血流动力学参数。结果:66例患者59例症状缓解,显效27例,有效32例,无效7例,有效率89.39%。结论:重组人心钠肽是治疗急性心力衰竭疗效可靠的药物,安全性高。%Objective:To investigate the recombinant human atrial natriuretic peptide in treatment of acute heart failure efficacy .Meth-ods:the application of recombinant human atrial natriuretic peptide in patients with acute heart failure treatment since 2011 May to 2013 February in our hospital , in hemodynamic parameters monitoring of patients before and after treatment .Results:of the 66 patients, 59 ca-ses of remission, 27 cases markedly effective, effective 32 cases, invalid 7 cases, efficiency of 89.39%.Conclusion:recombinant human atrial natriuretic peptide drugs and reliable effect in the treatment of acute heart failure , high safety.

  10. CLINICAL STUDY OF ACUTE POISONING: A RETROSPECTIVE STUDY

    Directory of Open Access Journals (Sweden)

    Praveen

    2014-11-01

    Full Text Available : OBJECTIVES: To determine the common agents, clinical features and outcomes of acute poisoning. MATERIALS AND METHODS: A retrospective study of patients of acute poisoning of more than 14 years age admitted through emergency with a history of intentional, self-inflicted and suicidal poisoning in SRMS-IMS from Jan 2010 to Dec 2012. RESULTS: A total of 58 cases were included with a common age of affection 16 to 25 years and male to female ratio 1.63: 1. Poisoning cases occur throughout the year with maximum prevalence in May and minimum in June. Organophosphorus was the most common poison followed by aluminium phosphide. Vomiting was the most common symptoms followed by altered sensorium. 70.68% patients were discharged, 20.68% expired and 8.62% left against medical advice. Aluminium phosphide was the most common toxin consumed by dead patients. CONCLUSION: Acute poisoning is commonly affecting young population and is caused by variety of toxin. High mortality is associated with aluminum phosphide.

  11. CLINICAL AND EPIDEMIOLOGICAL STUDIES ON VASECTOMY

    Institute of Scientific and Technical Information of China (English)

    TANGGuang-Hua

    1989-01-01

    In order to ascertain whether vasectomy presented any increased risk of diseases or long-term sequelae, we conducted from 1981 to 82 a large scale cross sectional prevalence study on coronary heart disease, hypertension and other diseases following

  12. Alopecia areata and autoimmunity: A clinical study

    Directory of Open Access Journals (Sweden)

    Thomas Emy

    2008-01-01

    Full Text Available Alopecia areata (AA frequently occur in association with other autoimmune diseases such as thyroid disorders, anemias and other skin disorders with autoimmune etiology. Despite numerous studies related to individual disease associations in alopecia areata, there is paucity of literature regarding comprehensive studies on concomitant cutaneous and systemic diseases. The present study has been designed to determine if there is a significant association between alopecia areata and other autoimmune diseases. This study covers 71 patients with the diagnosis of alopecia areata as the case group and 71 patients with no evidence of alopecia areata as the control group. Among the cutaneous diseases associated with AA, atopic dermatitis (AD showed maximum frequency with an O/E ratio of 2.5, which indicates that it is two to three times more common in patients with alopecia areata. In our study, thyroid disorders showed the highest frequency with on O/E ratio of 3.2 and a P value of 0.01, which is statistically highly significant. Among the thyroid disorders, hypothyroidism was the most frequent association (14.1% in our study. Since systemic involvement is not infrequent in patients with alopecia areata, it is imperative to screen these patients for associated disorders, particularly atopy, thyroid diseases, anemias and other autoimmune disorders, especially if alopecia areata is chronic, recurrent and extensive.

  13. Study of the trial subjects’ protection aspects in Phase I clinical trials and bioequivalence studies

    Directory of Open Access Journals (Sweden)

    K. O. Zupanets

    2016-03-01

    Full Text Available Protection of rights, health and well-being of persons who are taking the drug during the trial (trial subjects is one of the basic principles of clinical trials (CT management. Aim. In order to study key aspects of volunteer protection, determine factors that influence these indicators and estimate the importance of ensuring their proper implementation on the clinical site (CS three survey of 135 trial subjects were carried out to evaluate the importance of assessing the impact of factors such as the procedure of signing the informed consent (IC at the CS and testing procedures for HIV / AIDS, hepatitis and others. Assessment of the quality of life of trial subjects as indirect indicator of the quality of clinical trials that ensures the proper protection of their life was the subject of the third survey. Methods and results. The general model of the relationship between the key aspects of the trial subjects protection and the factors which are providing them during the clinical trials of drugs management was substantiated, which included the main aspects of the trial subjects’ protection, protective factors and basic CT management procedures, the impact of the above factors on the possibility of providing protection aspects depends on their implementation quality. It was found that trial subjects’ protection improvement can be achieved during the IC signing process. It is necessary to ensure a higher level of volunteers understanding of the terms that could be used in the IC form. Regarding the procedure of compulsory testing for HIV/AIDS in the course of screening, we can conclude that the majority of the trial subjects believe that this procedure is an additional factor in their health protection and do not consider it as an excessive psychological pressure on them. Conclusion. Assessing the quality of life during the bioequivalence study at the CS makes possible to reach a conclusion on general well-being and satisfaction with those

  14. Extraction of the human cerebral ventricular system from MRI: inclusion of anatomical knowledge and clinical perspective

    Science.gov (United States)

    Aziz, Aamer; Hu, Qingmao; Nowinski, Wieslaw L.

    2004-04-01

    The human cerebral ventricular system is a complex structure that is essential for the well being and changes in which reflect disease. It is clinically imperative that the ventricular system be studied in details. For this reason computer assisted algorithms are essential to be developed. We have developed a novel (patent pending) and robust anatomical knowledge-driven algorithm for automatic extraction of the cerebral ventricular system from MRI. The algorithm is not only unique in its image processing aspect but also incorporates knowledge of neuroanatomy, radiological properties, and variability of the ventricular system. The ventricular system is divided into six 3D regions based on the anatomy and its variability. Within each ventricular region a 2D region of interest (ROI) is defined and is then further subdivided into sub-regions. Various strict conditions that detect and prevent leakage into the extra-ventricular space are specified for each sub-region based on anatomical knowledge. Each ROI is processed to calculate its local statistics, local intensity ranges of cerebrospinal fluid and grey and white matters, set a seed point within the ROI, grow region directionally in 3D, check anti-leakage conditions and correct growing if leakage occurs and connects all unconnected regions grown by relaxing growing conditions. The algorithm was tested qualitatively and quantitatively on normal and pathological MRI cases and worked well. In this paper we discuss in more detail inclusion of anatomical knowledge in the algorithm and usefulness of our approach from clinical perspective.

  15. Antibiofilm Activity of the Brown Alga Halidrys siliquosa against Clinically Relevant Human Pathogens

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    Alessandro Busetti

    2015-06-01

    Full Text Available The marine brown alga Halidrys siliquosa is known to produce compounds with antifouling activity against several marine bacteria. The aim of this study was to evaluate the antimicrobial and antibiofilm activity of organic extracts obtained from the marine brown alga H. siliquosa against a focused panel of clinically relevant human pathogens commonly associated with biofilm-related infections. The partially fractionated methanolic extract obtained from H. siliquosa collected along the shores of Co. Donegal; Ireland; displayed antimicrobial activity against bacteria of the genus Staphylococcus; Streptococcus; Enterococcus; Pseudomonas; Stenotrophomonas; and Chromobacterium with MIC and MBC values ranging from 0.0391 to 5 mg/mL. Biofilms of S. aureus MRSA were found to be susceptible to the algal methanolic extract with MBEC values ranging from 1.25 mg/mL to 5 mg/mL respectively. Confocal laser scanning microscopy using LIVE/DEAD staining confirmed the antimicrobial nature of the antibiofilm activity observed using the MBEC assay. A bioassay-guided fractionation method was developed yielding 10 active fractions from which to perform purification and structural elucidation of clinically-relevant antibiofilm compounds.

  16. Epidemiology, clinical manifestations, and outcomes of Streptococcus suis infection in humans.

    Science.gov (United States)

    Huong, Vu Thi Lan; Ha, Ngo; Huy, Nguyen Tien; Horby, Peter; Nghia, Ho Dang Trung; Thiem, Vu Dinh; Zhu, Xiaotong; Hoa, Ngo Thi; Hien, Tran Tinh; Zamora, Javier; Schultsz, Constance; Wertheim, Heiman Frank Louis; Hirayama, Kenji

    2014-07-01

    Streptococcus suis, a bacterium that affects pigs, is a neglected pathogen that causes systemic disease in humans. We conducted a systematic review and meta-analysis to summarize global estimates of the epidemiology, clinical characteristics, and outcomes of this zoonosis. We searched main literature databases for all studies through December 2012 using the search term "streptococcus suis." The prevalence of S. suis infection is highest in Asia; the primary risk factors are occupational exposure and eating of contaminated food. The pooled proportions of case-patients with pig-related occupations and history of eating high-risk food were 38.1% and 37.3%, respectively. The main clinical syndrome was meningitis (pooled rate 68.0%), followed by sepsis, arthritis, endocarditis, and endophthalmitis. The pooled case-fatality rate was 12.8%. Sequelae included hearing loss (39.1%) and vestibular dysfunction (22.7%). Our analysis identified gaps in the literature, particularly in assessing risk factors and sequelae of this infection.

  17. Airways, vasculature, and interstitial tissue: anatomically informed computational modeling of human lungs for virtual clinical trials

    Science.gov (United States)

    Abadi, Ehsan; Sturgeon, Gregory M.; Agasthya, Greeshma; Harrawood, Brian; Hoeschen, Christoph; Kapadia, Anuj; Segars, W. P.; Samei, Ehsan

    2017-03-01

    This study aimed to model virtual human lung phantoms including both non-parenchymal and parenchymal structures. Initial branches of the non-parenchymal structures (airways, arteries, and veins) were segmented from anatomical data in each lobe separately. A volume-filling branching algorithm was utilized to grow the higher generations of the airways and vessels to the level of terminal branches. The diameters of the airways and vessels were estimated using established relationships between flow rates and diameters. The parenchyma was modeled based on secondary pulmonary lobule units. Polyhedral shapes with variable sizes were modeled, and the borders were assigned to interlobular septa. A heterogeneous background was added inside these units using a non-parametric texture synthesis algorithm which was informed by a high-resolution CT lung specimen dataset. A voxelized based CT simulator was developed to create synthetic helical CT images of the phantom with different pitch values. Results showed the progressive degradation in depiction of lung details with increased pitch. Overall, the enhanced lung models combined with the XCAT phantoms prove to provide a powerful toolset to perform virtual clinical trials in the context of thoracic imaging. Such trials, not practical using clinical datasets or simplistic phantoms, can quantitatively evaluate and optimize advanced imaging techniques towards patient-based care.

  18. Twenty years of human immunodeficiency virus care at the Mayo Clinic: Past, present and future

    Science.gov (United States)

    Cummins, Nathan W; Badley, Andrew D; Kasten, Mary J; Sampath, Rahul; Temesgen, Zelalem; Whitaker, Jennifer A; Wilson, John W; Yao, Joseph D; Zeuli, John; Rizza, Stacey A

    2016-01-01

    The Mayo human immunodeficiency virus (HIV) Clinic has been providing patient centered care for persons living with HIV in Minnesota and beyond for the past 20 years. Through multidisciplinary engagement, vital clinical outcomes such as retention in care, initiation of antiretroviral therapy and virologic suppression are maximized. In this commentary, we describe the history of the Mayo HIV Clinic and its best practices, providing a “Mayo Model” of HIV care that exceeds national outcomes and may be applicable in other settings. PMID:27175350

  19. Orbitofrontal sulcal and gyrus pattern in human: an anatomical study

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    Thiago Pereira Rodrigues

    2015-05-01

    Full Text Available The anatomical characterization of the orbitofrontal cortex in human is limited in literature instead of many functional and clinical studies involving it. Objective Anatomically define the orbitofrontal region aiming to possible neurosurgical treatments and unify the scientific nomenclature as well. Method We analyze eighty four human hemispheres using a surgical microscope. Then we chose four hemispheres and dissect them according to Klinger’ technique. Results We found five main sulcus: olfatory sulcus, orbital medial sulcus, orbital lateral sulcus, orbital transverse sulcus and orbital intermediate sulcus. These sulcus, excluding the intermediate sulcus, delimit five gyrus: rectus gurys, orbital medial gyrus, orbital anterior gyrus, orbital lateral gyrus and orbital posterior gyrus. The main sulcal configuration can be divided on four more frequently patterns. Conclusion Orbitofrontal cortex is associated with many psychiatric disorders. Better anatomical and functional characterization of the orbitofrontal cortex and its connections will improve our knowledge about these diseases.

  20. Liver Afferents Contribute to Water Drinking-Induced Sympathetic Activation in Human Subjects: A Clinical Trial

    Science.gov (United States)

    May, Marcus; Gueler, Faikah; Barg-Hock, Hannelore; Heiringhoff, Karl-Heinz; Engeli, Stefan; Heusser, Karsten; Diedrich, André; Brandt, André; Strassburg, Christian P.; Tank, Jens; Sweep, Fred C. G. J.; Jordan, Jens

    2011-01-01

    Water drinking acutely increases sympathetic activity in human subjects. In animals, the response appears to be mediated through transient receptor potential channel TRPV4 activation on osmosensitive hepatic spinal afferents, described as osmopressor response. We hypothesized that hepatic denervation attenuates water drinking-induced sympathetic activation. We studied 20 liver transplant recipients (44±2.6 years, 1.2±0.1 years post transplant) as model of hepatic denervation and 20 kidney transplant recipients (43±2.6 years, 0.8±0.1 years post transplant) as immunosuppressive drug matched control group. Before and after 500 ml water ingestion, we obtained venous blood samples for catecholamine analysis. We also monitored brachial and finger blood pressure, ECG, and thoracic bioimpedance. Plasma norepinephrine concentration had changed by 0.01±0.07 nmol/l in liver and by 0.21±0.07 nmol/l in kidney transplant recipients (pwater drinking. While blood pressure and systemic vascular resistance increased in both groups, the responses tended to be attenuated in liver transplant recipients. Our findings support the idea that osmosensitive hepatic afferents are involved in water drinking-induced sympathetic activation in human subjects. Trial Registration ClinicalTrials.gov NCT01237431 PMID:22016786

  1. Liver afferents contribute to water drinking-induced sympathetic activation in human subjects: a clinical trial.

    Directory of Open Access Journals (Sweden)

    Marcus May

    Full Text Available UNLABELLED: Water drinking acutely increases sympathetic activity in human subjects. In animals, the response appears to be mediated through transient receptor potential channel TRPV4 activation on osmosensitive hepatic spinal afferents, described as osmopressor response. We hypothesized that hepatic denervation attenuates water drinking-induced sympathetic activation. We studied 20 liver transplant recipients (44±2.6 years, 1.2±0.1 years post transplant as model of hepatic denervation and 20 kidney transplant recipients (43±2.6 years, 0.8±0.1 years post transplant as immunosuppressive drug matched control group. Before and after 500 ml water ingestion, we obtained venous blood samples for catecholamine analysis. We also monitored brachial and finger blood pressure, ECG, and thoracic bioimpedance. Plasma norepinephrine concentration had changed by 0.01±0.07 nmol/l in liver and by 0.21±0.07 nmol/l in kidney transplant recipients (p<0.05 between groups after 30-40 minutes of water drinking. While blood pressure and systemic vascular resistance increased in both groups, the responses tended to be attenuated in liver transplant recipients. Our findings support the idea that osmosensitive hepatic afferents are involved in water drinking-induced sympathetic activation in human subjects. TRIAL REGISTRATION: ClinicalTrials.gov NCT01237431.

  2. Competence of novice nurses: role of clinical work during studying.

    Science.gov (United States)

    Manoochehri, H; Imani, E; Atashzadeh-Shoorideh, F; Alavi-Majd, A

    2015-01-01

    Aim: Clinical competence is to carry out the tasks with excellent results in a different of adjustments. According to various studies, one of the factors influencing clinical competence is work experience. This experience affects the integrity of students' learning experience and their practical skills. Many nursing students practice clinical work during their full-time studying. The aim of this qualitative research was to clarify the role of clinical work during studying in novice nurses' clinical competence. Methods: This qualitative content analysis performed with the conventional approach. All teaching hospitals of Hormozgan University of Medical Sciences selected as the research environment. To collect data, deep and semi-structured interviews, presence in the scene and manuscripts used. To provide feedback for the next release and the capacity of the data, interviews were transcribed verbatim immediately. Results: 45 newly-graduated nurses and head nurses between 23 and 40 with 1 to 18 years of experience participated in the study. After coding all interviews, 1250 original codes were derived. The themes extracted included: task rearing, personality rearing, knowledge rearing, and profession rearing roles of clinical work during studying. Conclusion: Working during studying can affect performance, personality, knowledge, and professional perspectives of novice nurses. Given the differences that may exist in clinical competencies of novice nurses with and without clinical work experience, it is important to pay more attention to this issue and emphasize on their learning in this period.

  3. Preclinical safety studies on autologous cultured human skin fibroblast transplantation.

    Science.gov (United States)

    Zeng, Wei; Zhang, Shuying; Liu, Dai; Chai, Mi; Wang, Jiaqi; Zhao, Yuming

    2014-01-01

    Recently, FDA approved the clinical use of autologous fibroblasts (LAVIV™) for the improvement of nasolabial fold wrinkles in adults. The use of autologous fibroblasts for the augmentation of dermal and subcutaneous defects represents a potentially exciting natural alternative to the use of other filler materials for its long-term corrective ability and absence of allergic adverse effects proved by clinical application. However, compared to the clinical evidence, preclinical studies are far from enough. In this study, human skin-derived fibroblasts were cultured and expanded for both in vitro and in vivo observations. In vitro, the subcultured fibroblasts were divided into two groups. One set of cells underwent cell cycle and karyotype analysis at passages 5 and 10. The second group of cells was cocultured in medium with different concentrations of human skin extract D for the measurement of collagen concentration and cell count. In vivo, the subcultured fibroblasts were injected into nude mice subcutaneously. Biopsies were taken for morphology observation and specific collagen staining at 1, 2, and 3 months after injection. The results in vitro showed no significant differences in cell cycle distribution between passages 5 and 10. Cell proliferation and secretion were inhibited as the concentration of extract D increased. In vivo, the fibroblasts were remarkably denser on the experimental side with no dysplastic cells. Mitotic cells were easily observed at the end of the first month but were rare at the end of the third month. Type III collagen was detected at the end of the first month, while collagen type I was positive at the end of the second month. The content of both collagens increased as time passed. The above results indicated that the use of the autologous fibroblasts was safe, providing a basic support for clinical use of fibroblasts.

  4. Towards Data Value-Level Metadata for Clinical Studies.

    Science.gov (United States)

    Zozus, Meredith Nahm; Bonner, Joseph

    2017-01-01

    While several standards for metadata describing clinical studies exist, comprehensive metadata to support traceability of data from clinical studies has not been articulated. We examine uses of metadata in clinical studies. We examine and enumerate seven sources of data value-level metadata in clinical studies inclusive of research designs across the spectrum of the National Institutes of Health definition of clinical research. The sources of metadata inform categorization in terms of metadata describing the origin of a data value, the definition of a data value, and operations to which the data value was subjected. The latter is further categorized into information about changes to a data value, movement of a data value, retrieval of a data value, and data quality checks, constraints or assessments to which the data value was subjected. The implications of tracking and managing data value-level metadata are explored.

  5. Incisional Hernia: An Experimental and Clinical Study

    NARCIS (Netherlands)

    M. van 't Riet (Martijne)

    2004-01-01

    markdownabstract__Abstract__ Incisional hernia is one of the most common long-term complications of abdominal surgery. In prospective studies with sufficient follow-up, incidences of incisional hernia after laparotomy up to 20% are reported. Incisional hernia can be defined as an internal abdominal

  6. Melanocytic nevi in children: A clinical study

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    Senthilkumar M

    2006-01-01

    Full Text Available BACKGROUND: Melanocytic nevi show different presentations in children which have not much studied in India. PURPOSES: To document the incidence and pattern of melanocytic nevi in children. METHODS: A total of 4,256 paediatric cases attending the dermatology OPD, JIPMER during the study period from August 2002 to August 2004 were screened for melanocytic nevi. FINDINGS: Out of these, 41 (0.96% cases were found to have melanocytic nevi. The mean age of these cases was 1.4 years (range of 3 days to 14 years. Fourteen (34.1% of them were males and 27 (65.9% were females with male to female ratio of 1:1.9. Majority of these cases (32 cases, 78% were in the age group of 0-1 year. Thirty-seven (90.2% cases had single lesion and 4 (9.8% cases had multiple lesions. The size of the nevi varied from 1.5 cm to 20 cm in 40 (97.6% cases and more than 20 cm in 1 (2.4% case. The most common site of involvement was the back (32 cases, 78% followed by head and neck (6 cases, 14.6%. Out of the total of 41 cases, 30 (73.2% were Mongolian spots, 8 (19.5% were congenital melanocytic nevi, one case (2.4% each had giant congenital melanocytic nevus, nevus spilus and nevus of Ota. Four cases had other associated cutaneous disorders. These included ashleaf macules in 2 cases, epidermolysis bullosa simplex in 1 case and a solitary case had both cafι-au-lait macule and mixed hemangioma. The systemic associations included seizures (suspected neurocutaneous melanosis in a solitary case of congenital melanocytic nevi. CONCLUSIONS: The spectrum of melanocytic nevi seen in children in this study partially differs from this of abroad studies. LIMITATION: Unicentre hospital-based study which cannot be generalized.

  7. Zebrafish Fins as a Model System for Skeletal Human Studies

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    Manuel Marí-Beffa

    2007-01-01

    Full Text Available Recent studies on the morphogenesis of the fins of Danio rerio (zebrafish during development and regeneration suggest that a number of inductive signals involved in the process are similar to some of those that affect bone and cartilage differentiation in mammals and humans. Akimenko et al. (2002 has shown that bone morphogenetic protein-2b (BMP2b is involved in the induction of dermal bone differentiation during fin regeneration. Many other groups have also shown that molecules from the transforming growth factor-beta superfamily (TGFβ, including BMP2, are effective in promoting chondrogenesis and osteogenesis in vivo in higher vertebrates, including humans. In the present study, we review the state of the art of this topic by a comparative analysis of skeletal tissue development, regeneration and renewal processes in tetrapods, and fin regeneration in fishes. A general conclusion of this study states that lepidotrichia is a special skeletal tissue different to cartilage, bone, enamel, or dentine in fishes, according to its extracellular matrix (ECM composition. However, the empirical analysis of inducing signals of skeletal tissues in fishes and tetrapods suggests that lepidotrichia is different to any responding features with main skeletal tissues. A number of new inductive molecules are arising from fin development and regeneration studies that might establish an empirical basis for further molecular approaches to mammal skeletal tissues differentiation. Despite the tissue dissimilarity, this empirical evidence might finally lead to clinical applications to skeletal disorders in humans.

  8. Clinical Manifestations of Cytomegalovirus-Associated Posterior Uveitis and Panuveitis in Patients Without Human Immunodeficiency Virus Infection

    NARCIS (Netherlands)

    Pathanapitoon, Kessara; Tesavibul, Nattaporn; Choopong, Pitipol; Boonsopon, Sutasinee; Kongyai, Natedao; Ausayakhun, Somsanguan; Kunavisarut, Paradee; Rothova, Aniki

    2013-01-01

    Importance: Little attention has been paid to clinical features of cytomegalovirus (CMV) infections in individuals without human immunodeficiency virus (HIV). Objective: To describe the clinical manifestations and comorbidities of patients without HIV infection who have CMV-associated posterior uvei

  9. The Human Bitumen Study: executive summary.

    Science.gov (United States)

    Raulf-Heimsoth, Monika; Pesch, Beate; Rühl, Reinhold; Brüning, Thomas

    2011-06-01

    Bitumen has attracted attention from the scientific community and regulating agencies. The debate on health effects of exposure to vapours and aerosols of bitumen during the hot application of bitumen ranges from respiratory and neurological effects to carcinogenicity. In 2000, the German Hazardous Substances Committee (AGS), in collaboration with the German Bitumen Forum, initiated the examination of a group of mastic asphalt workers and a same number of construction workers without exposure bitumen using a cross-shift design. The study was then extended to the Human Bitumen Study, and the recruitment was finished in 2008 after examination of 500 workers on 80 construction sites. Three hundred and twenty workers exposed to vapours and aerosols of bitumen at high processing temperatures and 118 workers at outdoor construction sites were included. In the Human Bitumen Study external exposure to vapours and aerosols of bitumen, internal exposure to PAH by analysing urinary 1-hydroxypyrene, the sum of hydroxyphenanthrenes and the sum of 1- and 2-hydroxynaphthalenes, irritative effects in the upper and lower airways and genotoxic effects in blood cells were investigated. The study turned out to be one of the largest investigations of workers exposed to vapours and aerosols of bitumen under current exposure conditions. The present paper summarizes its background and main topics.

  10. The research subject advocate at minority Clinical Research Centers: an added resource for protection of human subjects.

    Science.gov (United States)

    Easa, David; Norris, Keith; Hammatt, Zoë; Kim, Kari; Hernandez, Esther; Kato, Kambrie; Balaraman, Venkataraman; Ho, Tammy; Shomaker, Samuel

    2005-01-01

    In early 2001, the National Institutes of Health (NIH) created the research subject advocate (RSA) position as an additional resource for human subjects protection at NIH-funded Clinical Research Centers (CRCs) to enhance the protection of human participants in clinical research studies. We describe the RSA position in the context of clinical research, with a particular emphasis on the role of the RSA in two of the five CRCs funded by the NIH Research Centers in Minority Institutions (RCMI) program. Through participation in protocol development, informed consent procedures, study implementation and follow-up with adverse events, the RSA works closely with research investigators and their staff to protect study participants. The RSA also conducts workshops, training and education sessions, and consultation with investigators to foster enhanced communication and adherence to ethical standards and safety regulations. Although we cannot yet provide substantive evidence of positive outcomes, this article illuminates the value of the RSA position in ensuring that safety of research participants is accorded the highest priority at CRCs. On the basis of initial results, we conclude that the RSA is an effective mechanism for achieving the NIH goal of maintaining the utmost scrutiny of protocols involving human subjects.

  11. Clinical audit of COPD in outpatient respiratory clinics in Spain: the EPOCONSUL study

    Science.gov (United States)

    Calle Rubio, Myriam; Alcázar Navarrete, Bernardino; Soriano, Joan B; Soler-Cataluña, Juan J; Rodríguez González-Moro, José Miguel; Fuentes Ferrer, Manuel E; López-Campos, José Luis

    2017-01-01

    Background Chronic obstructive pulmonary disease (COPD) outpatients account for a large burden of usual care by respirologists. EPOCONSUL is the first national clinical audit conducted in Spain on the medical care for COPD patients delivered in outpatient respiratory clinics. We aimed to evaluate the clinical interventions and the degree of adherence to recommendations in outpatients of current COPD clinical practice guidelines. Methodology This is an observational study with prospective recruitment (May 2014–May 2015) of patients with a COPD diagnosis as seen in outpatient respiratory clinics. The information collected was historical in nature as for the clinical data of the last and previous consultations, and the information concerning hospital resources was concurrent. Results A total of 17,893 clinical records of COPD patients in outpatient respiratory clinics from 59 Spanish hospitals were evaluated. Of the 5,726 patients selected, 4,508 (78.7%) were eligible. Overall, 12.1% of COPD patients did not fulfill a diagnostic spirometry criteria. Considerable variability existed in the available resources and work organization of the hospitals, although the majority were university hospitals with respiratory inpatient units. There was insufficient implementation of clinical guidelines in preventive and educational matters. In contrast, quantitative evaluation of dyspnea grade (81.9%) and exacerbation history (70.9%) were more frequently performed. Only 12.4% had COPD severity calculated according to the Body mass index, airflow Obstruction, Dyspnoea and Exercise capacity (BODE) index. Phenotype characteristics according to Spanish National Guideline for COPD were determined in 46.3% of the audited patients, and the risk evaluation according to Global initiative for chronic Obstructive Lung Disease was estimated only in 21.9%. Conclusion The EPOCONSUL study reports the current situation of medical care for COPD patients in outpatient clinics in Spain, revealing

  12. Clinical Features, Presence of Human Herpesvirus-8 and Treatment Results in Classic Kaposi Sarcoma

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    Özlem Su

    2008-12-01

    Full Text Available Background and Design: Classic Kaposi sarcoma (KS occurs predominantly among the elderly, with Jews, Italians and Greeks. Classic KS has been seen relatively frequently in Turkey. Our aim was to evaluate the demographic, clinical features of Kaposi sarcoma and etiopathological role of human herpesvirus-8 (HHV-8. Treatment results of 18 classic Kaposi’s sarcoma were also concluded.Material and Method: Eighteen cases of classic Kaposi sarcoma diagnosed as clinically and histopathologically between January 2001 and August 2008 in our dermatology department were taken to this study. Demographic, clinical features and treatment results were reviewed retrospectively in all patients. HHV-8 was investigated in the lesional skin of 7 patients.Results: A male/female ratio of 2/1 was found. Mean age at diagnosis was 67.2 (37-94 years. Bilaterally lower extremities were involved in 15 patients (83.3%, the trunk was involved in 3 patients (16.6%. Plaques and nodules were the common type of lesions (66.6% and 55.5%. Nine patients had no symptoms (50%. Edema was the most common symptom (38.8%. A second primary malignancy was found in 2 patients (11.1%. HHV-8 was detected in 6 of the 7 patients(85.7%. Majority of the patients were treated with interferon alfa (subcutaneously and cryotherapy as a monotherapy or a combination therapy. Imiquimod was the second agent in combined treatment (27.7%. Conclusion: We suggest that interferon alfa and imiquimod can be used as first line therapy agents with their antiviral and immunmodulatuar features in the treatment of KKS. (Turkderm 2008; 42: 122-6

  13. The clinical characteristics and outcomes of patients with human granulocytic anaplasmosis in China.

    Science.gov (United States)

    Li, Huiyu; Zhou, Yan; Wang, Wenjie; Guo, Dongmei; Huang, Shiang; Jie, Shenghua

    2011-12-01

    The incidence of human granulocytic anaplasmosis (HGA), a tick-borne disease caused by the obligate intracellular bacterium Anaplasma phagocytophilum, has increased across the world. However, information on HGA is lacking in China. The purpose of this study was to investigate the clinical features and outcomes of HGA patients in China. A total of 83 patients with HGA from the provinces of Hubei and Henan in China, who were admitted to Union Hospital between March 2009 and September 2010, were included in this study. We investigated the epidemiology, clinical features, laboratory markers, and therapeutic effects in these patients. We also analyzed life-threatening complications such as systemic inflammatory response syndrome (SIRS)/multiple organ dysfunction syndrome (MODS) following HGA and assessed the risk factors for a poor clinical outcome. In our study, an HGA outbreak peak was observed for the months May to August. The highest age-specific incidence occurred among the group of patients aged 50-59 years. With regard to patient occupation and pathological origin, we found that 73 of the 83 patients with HGA had a peasant occupation. With respect to symptoms, 45 patients had no complications and 38 patients diagnosed with HGA met SIRS criteria, of whom 25 rapidly developed MODS. The mortality for the entire cohort was 26.5%. The factors predictive of patients developing MODS and an adverse outcome were advanced age, disturbance of consciousness, highly elevated lactate dehydrogenase, creatinine, and aspartate aminotransferase levels, and the presence of SIRS. Moreover, MODS was found to be an independent predictor of death. In China, HGA patients had severe clinical symptoms and high rates of complications and mortality. These findings may provide useful information so that physicians will be on the alert for severe complications after a diagnosis of HGA; they will also be useful for optimizing supportive care for HGA-related critical illness. Prompt treatment

  14. CLINICAL STUDY OF PENETRATING INJURIES OF ABDOMEN

    OpenAIRE

    Raghu; Santhosh Babu; Devender

    2016-01-01

    Penetrating trauma forms an important component of surgical emergencies. The importance of this category becomes further apparent when one realises that most of such trauma victims are essentially healthy people and in the prime of their life. Over the past century, great advances were made in the management of such wounds. The operative management replaced the expectant therapy and reduced mortality rates. So this study is being done to evaluate the various indications for early ...

  15. Clinical study of patient with Ankylosing Spondylitis

    OpenAIRE

    Lee Jae-Min; Hong Kwon-eui

    2006-01-01

    Object : This study is designed in order to evaluate oriental medical treatment of ankylosing spondylitis. Methods : The authors observed patient by ROM & VAS for operated acupuncture treatment, herbal medicine treatment and physiotherapy Conclusion : 1. Ankylosing spondylitis patient of this case is caused by taiyang channel warm-heat evi. 2. Ankylosing spondylitis patient by taiyang channel warm-heat evi is evaluated by acupuncture treatment. ; SP3, S36, LIll, LI4, S40. 3. A...

  16. Clinical study of histologically proven conjunctival cysts

    Science.gov (United States)

    Thatte, Shreya; Jain, Jagriti; Kinger, Mallika; Palod, Sapan; Wadhva, Jatin; Vishnoi, Avijit

    2014-01-01

    Purpose This is a clinco-histopathological study of different varieties of conjunctival cysts where modification of surgical technique was done as per requirement for intact removal of cysts to minimise recurrence rate. Materials and methods Retrospective study of 40 cases of conjunctival cysts. A thorough ocular examination and basic haematological work up was done for all patients. B-scan USG and MRI was done wherever required to see the posterior extent. All patients underwent surgical excision of cyst followed by histo-pathological examination. Results The various types of conjunctival cysts found in our study were primary inclusion cyst 12 (30%), secondary inclusion cyst 6 (15%), pterygium with cysts 15 (37.5%), parasitic cyst 4 (10%), lymphatic cyst 2 (5%), and orbital cyst with rudimentary eye 1 (2.5%). The common symptoms noted were progressive increase in size of cyst (39.45%), cosmetic disfigurement (26.23%), foreign body sensations (27.86%), proptosis (1.6%), ocular motility restrictions (3.2%) and decreased visual acuity (1.6%). The patients were followed till one year after surgical excision for any recurrence and complications and no recurrence was seen. Conclusion Careful and intact removal of conjunctival cyst is important to prevent recurrence. Minor modifications in surgical technique according to the size, site and nature of cyst help in intact removal and prevent recurrence. PMID:25892928

  17. CLINICAL STUDY OF LABOUR IN TWIN PREGNANCY

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    Amudha

    2015-07-01

    Full Text Available OBJECTIVES: The objective of the present study is to analyse the incidence of preterm labour, intrapartum complications, incidence of operative delivery both vaginal and cesarean and indications for such interventions. METHODOLOGY: A total of 150 cases of twin pregnancy were analyzed between the period of September 2012 to February 2014. These cases were stud ied with respect to period of gestation at the onset of labour, fetal presentations at the onset of labour, route and mode of delivery, indications in cases of cesarean delivery, intrapartum complications and delivery interval between twins. OBSERVATIONS A ND RESULTS: In the present study there was increased incidence of preterm labour (52.6%, fetal malpresentations (43.3%, operative vaginal delivery (29.5%, cesarean delivery (17.3%. CONCLUSION: In this study it is observed that above mentioned labour ev ents and complications double up in the event of a twin pregnancy. Regular antenatal visits, planned delivery and anticipation and identification of complications will help for better pregnancy outcome.

  18. Clinical study of nail changes in vitiligo.

    Science.gov (United States)

    Anbar, Tag; Hay, Rania Abdel; Abdel-Rahman, Amal T; Moftah, Noha H; Al-Khayyat, Mohamed A

    2013-03-01

    Both vitiligo and alopecia areata (AA) are associated together, associated with other autoimmune diseases, and autoimmunity is one of the important theories in their etiology. Nail changes are a known association with AA, thus we hypothesized that nail changes can be found in vitiligo patients. On revising the literature, only two types of nail changes were described in association with vitiligo. Our aim was to study the frequency and types of nail changes among vitiligo patients in comparison with normal healthy volunteers. This multi-centric study was carried on 91 patients with vitiligo, as well as 91 normal healthy control subjects who were age- and sex-matched. Nails were examined for changes in nail plates as regards striations, texture, curvature, dystrophy, and pigmentation. The presence or absence of the thumb lunula was also reported. Nail changes were observed in 62 patients (68.1%) and 46 (50.5%) control subjects with a statistically significant difference (P = 0.016). Longitudinal ridging and absent lunula were significantly higher in patients than in the controls (P = 0.001 and 0.037, respectively). Other reported nail abnormalities in the current study included punctate leukonychia, pitting, flag sign, and Terry's nails. Awareness of this association will widen the clinician's perspective to carefully examine the nail changes in vitiligo patients and conversely examine patients with nail changes for vitiligo.

  19. Clinical and molecular characterisation of human syndromes with congenital patellar malformations

    NARCIS (Netherlands)

    Bongers, M.H.F.

    2006-01-01

    In this thesis the results are described of clinical and molecular investigation of human syndromes with congenital patellar malformations as a hallmark feature, with emphasis on nail patella syndrome, small patella syndrome, isolated patellar aplasia or hypoplasia, and Meier-Gorlin syndrome. The el

  20. Clinical and molecular characterisation of human syndromes with congenital patellar malformations

    NARCIS (Netherlands)

    Bongers, M.H.F.

    2006-01-01

    In this thesis the results are described of clinical and molecular investigation of human syndromes with congenital patellar malformations as a hallmark feature, with emphasis on nail patella syndrome, small patella syndrome, isolated patellar aplasia or hypoplasia, and Meier-Gorlin syndrome. The

  1. Relation between clinical mature and immature lymphocyte cells in human peripheral blood and their spatial label free scattering patterns

    Science.gov (United States)

    Zhang, Lu; Zhao, Xin; Zhang, Zhenxi; Zhao, Hong; Chen, Wei; Yuan, Li

    2016-07-01

    A single living cell's light scattering pattern (LSP) in the horizontal plane, which has been denoted as the cell's "2D fingerprint," may provide a powerful label-free detection tool in clinical applications. We have recently studied the LSP in spatial scattering planes, denoted as the cell's "3D fingerprint," for mature and immature lymphocyte cells in human peripheral blood. The effects of membrane size, morphology, and the existence of