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Clinical trial

Lyndon da Cruz, Kate Fynes, Odysseas Georgiadis, Julie Kerby, Yvonne H Luo, Ahmad Ahmado, Amanda Vernon, Julie T Daniels, Britta Nommiste, Shazeen M Hasan, Sakina B Gooljar, Amanda-Jayne F Carr, Anthony Vugler, Conor M Ramsden, Magda Bictash, Mike Fenster, Juliette Steer, Tricia Harbinson, Anna Wilbrey, Adnan Tufail, Gang Feng, Mark Whitlock, Anthony G Robson, Graham E Holder, Mandeep S Sagoo, Peter T Loudon, Paul Whiting, Peter J Coffey
Age-related macular degeneration (AMD) remains a major cause of blindness, with dysfunction and loss of retinal pigment epithelium (RPE) central to disease progression. We engineered an RPE patch comprising a fully differentiated, human embryonic stem cell (hESC)-derived RPE monolayer on a coated, synthetic basement membrane. We delivered the patch, using a purpose-designed microsurgical tool, into the subretinal space of one eye in each of two patients with severe exudative AMD. Primary endpoints were incidence and severity of adverse events and proportion of subjects with improved best-corrected visual acuity of 15 letters or more...
March 19, 2018: Nature Biotechnology
Xing Chen, Detlef Wolf, Juliane Siebourg-Polster, Christian Czech, Ulrike Bonati, Dirk Fischer, Omar Khwaja, Martin Strahm
Progressive and irreversible muscle atrophy characterizes Spinal Muscular Atrophy (SMA) and other similar muscle disorder diseases. Objective assessment of muscle functions is an essential and important, although challenging, prerequisite for successful clinical trials. Current clinical rating scales restrain the movement abnormalities to certain predefined coarse-grained individual items. The Kinect 3-D sensor has emerged as a low-cost and portable motion sensing technology used to capture and track people's movement in many medical and research fields...
February 12, 2018: Journal of Visualized Experiments: JoVE
Güldane Cengiz Seval, Pervin Topçuoğlu, Taner Demirer
Hematopoietic stem cell transplantation is an established treatment for patients with a wide range of malignant and nonmalignant conditions. Noninfectious pulmonary complications still remain a leading cause of morbidity and mortality in these patients. Treating hematopoietic stem cell transplantation recipients with noninfectious pulmonary complications is still challenging, and the current treatment armamentarium and strategies are not adequate for patients receiving hematopoietic stem cell transplantation...
March 15, 2018: Balkan Medical Journal
Hayley Treloar Padovano, Robert Miranda
OBJECTIVE: The present study used youth's in vivo reports of subjective responses to cannabis while smoking in their natural environments to identify real-world mechanisms of topiramate treatment for cannabis misuse. METHOD: Participants were 40 cannabis users (≥ twice weekly in past 30 days), ages 15-24 years (47.5% female), with at least one cannabis use episode during the final 3 weeks of a 6-week, randomized clinical trial. Youth reported subjective "high" while smoking, stimulation, sedation, stress, craving, and grams of marijuana used in the natural environment via wireless electronic devices...
March 2018: Journal of Studies on Alcohol and Drugs
Natasha A Lannin, Louise Ada, Coralie English, Julie Ratcliffe, Maria Crotty
Rationale Although clinical practice guidelines recommend that management of moderate to severe spasticity include the use of botulinum toxin-A in conjunction with therapy, there is currently no evidence to support the addition of therapy. Aims To determine the effect and cost-benefit of adding evidence-based movement training to botulinum toxin-A. Sample size estimate A total of 136 participants will be recruited in order to be able to detect a between-group difference of seven points on the Goal Attainment Scale T-score with 80% power at a two-tailed significance level of 0...
January 1, 2018: International Journal of Stroke: Official Journal of the International Stroke Society
Axel Pressler, Leonie Förschner, Jana Hummel, Bernhard Haller, Jeffrey W Christle, Martin Halle
Background Increased exercise capacity favourably influences clinical outcomes after transcatheter aortic valve implantation. In our SPORT:TAVI randomised pilot trial, eight weeks of endurance and resistance training (training group, TG) shortly after transcatheter aortic valve implantation resulted in significantly improved exercise capacity, muscular strength and quality of life compared to usual care (UC). However, the long-term clinical benefits of such an intervention are unknown. Design A randomised controlled trial...
January 1, 2018: European Journal of Preventive Cardiology
Yasin Yurt, Gül Şener, Yavuz Yakut
BACKGROUND: Foot orthoses are widely used in conservative treatment of painful flexible flatfoot however research is limited to choose the best option in orthotic treatment. AIM: We aimed to compare the effects of computer-aided design/computer-aided manufacturing (CAD-CAM) and conventional insole types in comparison with sham insole, on pain and health related quality of life in patients with painful flexible flatfoot. DESIGN: Randomized controlled trial...
March 16, 2018: European Journal of Physical and Rehabilitation Medicine
Irina Tammenmaa-Aho, Rosie Asher, Karla Soares-Weiser, Hanna Bergman
BACKGROUND: Tardive dyskinesia (TD) remains a troublesome adverse effect of conventional antipsychotic (neuroleptic) medication. It has been proposed that TD could have a component of central cholinergic deficiency. Cholinergic drugs have been used to treat TD. OBJECTIVES: To determine the effects of cholinergic drugs (arecoline, choline, deanol, lecithin, meclofenoxate, physostigmine, RS 86, tacrine, metoxytacrine, galantamine, ipidacrine, donepezil, rivastigmine, eptastigmine, metrifonate, xanomeline, cevimeline) for treating antipsychotic-induced TD in people with schizophrenia or other chronic mental illness...
March 19, 2018: Cochrane Database of Systematic Reviews
Daniele Pastori, José Miguel Rivera-Caravaca, María Asunción Esteve-Pastor, Vanessa Roldán, Francisco Marín, Pasquale Pignatelli, Francesco Violi, Gregory Y H Lip
BACKGROUND: Two risk scores have been developed to predict composite outcomes in atrial fibrillation (AF): the 2MACE and TIMI-AF scores. The aim of this study was to compare the predictive ability of these scores in 2 separate warfarin-treated cohorts (one 'real world', one clinical trial) of AF patients.Methods and Results:The 2MACE and TIMI-AF scores were calculated in the 'real-world' ATHERO-AF cohort (n=907), and in the randomized controlled AMADEUS trial (n=2,265). Endpoints were major adverse cardiovascular events (MACEs), net clinical outcomes (NCO) and a combination of them, namely "clinically relevant events" (CREs)...
March 16, 2018: Circulation Journal: Official Journal of the Japanese Circulation Society
Steffen Moritz, Karla Spirandelli, Insa Happach, Despina Lion, Fabrice Berna
OBJECTIVES: There is mixed evidence regarding whether patients with obsessive-compulsive disorder (OCD) display substantial neurocognitive deficits. Several studies implicate poor motivation, comorbid disorders, or distraction due to obsessive thoughts as potential causes of secondary malperformance. The present study examined the impact of stereotype threat (i.e., confrontation with a negative stereotype may impair performance) on neuropsychological functioning in individuals with OCD...
March 19, 2018: Journal of the International Neuropsychological Society: JINS
Emily A Kringle, Lauren Terhorst, Meryl A Butters, Elizabeth R Skidmore
OBJECTIVES: The purpose of this exploratory study was to identify clinical predictors that could distinguish clients' level of engagement in inpatient rehabilitation following stroke. METHODS: This is a secondary analysis of pooled data from three randomized controlled trials that examined the effects of a behavioral intervention. The sample (n=208) consisted of clients with stroke who had cognitive deficits (Quick-EXIT≥3) and were admitted to inpatient rehabilitation facilities associated with a university medical center...
March 19, 2018: Journal of the International Neuropsychological Society: JINS
Veeru Kasivisvanathan, Antti S Rannikko, Marcelo Borghi, Valeria Panebianco, Lance A Mynderse, Markku H Vaarala, Alberto Briganti, Lars Budäus, Giles Hellawell, Richard G Hindley, Monique J Roobol, Scott Eggener, Maneesh Ghei, Arnauld Villers, Franck Bladou, Geert M Villeirs, Jaspal Virdi, Silvan Boxler, Grégoire Robert, Paras B Singh, Wulphert Venderink, Boris A Hadaschik, Alain Ruffion, Jim C Hu, Daniel Margolis, Sébastien Crouzet, Laurence Klotz, Samir S Taneja, Peter Pinto, Inderbir Gill, Clare Allen, Francesco Giganti, Alex Freeman, Stephen Morris, Shonit Punwani, Norman R Williams, Chris Brew-Graves, Jonathan Deeks, Yemisi Takwoingi, Mark Emberton, Caroline M Moore
Background Multiparametric magnetic resonance imaging (MRI), with or without targeted biopsy, is an alternative to standard transrectal ultrasonography-guided biopsy for prostate-cancer detection in men with a raised prostate-specific antigen level who have not undergone biopsy. However, comparative evidence is limited. Methods In a multicenter, randomized, noninferiority trial, we assigned men with a clinical suspicion of prostate cancer who had not undergone biopsy previously to undergo MRI, with or without targeted biopsy, or standard transrectal ultrasonography-guided biopsy...
March 18, 2018: New England Journal of Medicine
James D Neaton, Birgit Grund, Deborah Wentworth
BACKGROUND: Data monitoring committees for randomized clinical trials have the responsibility of safeguarding interests of trial participants. To do so, the data monitoring committee must receive reports on safety and efficacy to assess risk/benefit and on trial conduct to ensure that the study can achieve its goals. This article outlines the key components of reports to the data monitoring committee and the important role of the unblinded statistician in preparing those reports. METHODS: Most data monitoring committee meetings include open and closed sessions...
March 1, 2018: Clinical Trials: Journal of the Society for Clinical Trials
Sabine Landau, Richard Emsley, Graham Dunn
BACKGROUND: Random allocation avoids confounding bias when estimating the average treatment effect. For continuous outcomes measured at post-treatment as well as prior to randomisation (baseline), analyses based on (A) post-treatment outcome alone, (B) change scores over the treatment phase or (C) conditioning on baseline values (analysis of covariance) provide unbiased estimators of the average treatment effect. The decision to include baseline values of the clinical outcome in the analysis is based on precision arguments, with analysis of covariance known to be most precise...
March 1, 2018: Clinical Trials: Journal of the Society for Clinical Trials
Xiao-Meng Zhang, Yong-Nan Jin, Bing Zhang, Ning Li
Rheumatoid arthritis (RA) has the characteristics of long course of disease and difficulty in treatment. The conventional therapy may easily induce adverse drug reactions or events (ADR/ADE) due to the long-time medication. Thus, it should be given special attentions to treatment benefit and medication risk of RA patients. Aconitum, a kind of toxic traditional Chinese herbs, is an important complement therapy for RA, with some controversy in clinical application. Coming straight to the practical problem of combined use of traditional Chinese medicines (TCM) and Western medicines (WM), this study conducted quantitative assessment on the benefits and risks of Aconitum using combined with WM or not, which was carried out by the method of multi-criteria decision analysis model...
January 2018: Zhongguo Zhong Yao za Zhi, Zhongguo Zhongyao Zazhi, China Journal of Chinese Materia Medica
Xiao-Meng Zhang, Bing Zhang, Fan Li, Zhi-Ping Tian
To analyze the efficacy and safety of the combination therapy of Aconitum and Western medicine in the treatment of rheumatoid arthritis (RA) by Meta-analysis, and provide evidence for its clinic application for RA. The random clinical trials (RCTs) regarding the combination therapy for treating RA were retrieved in the database of China National Knowledge Infrastructure database, China Science and Technology Journal database, WanFang, Chinese Biomedical Medical Database, PubMed, and Cochrane Library up to July 2017...
January 2018: Zhongguo Zhong Yao za Zhi, Zhongguo Zhongyao Zazhi, China Journal of Chinese Materia Medica
Jun-Hua Zhang, You-Ping Li, Bo-Li Zhang
The introduction and popularization of evidence-based medicine has opened up a new research field of clinical efficacy evaluation of traditional Chinese medicine(TCM), produced new research ideas and methods, and promoted the progress of clinical research of TCM. After about 20 years assiduous study and earnest practice, the evidence based evaluation method and technique, which conforms to the characteristics of TCM theory and practice, has been developing continuously. Evidence-based Chinese medicine (EBCM) has gradually formed and become an important branch of evidence-based medicine...
January 2018: Zhongguo Zhong Yao za Zhi, Zhongguo Zhongyao Zazhi, China Journal of Chinese Materia Medica
Xiao Jie Wang, Kun Miao, Yan Luo, Rui Li, Tao Shou, Ping Wang, Xin Li
PURPOSE: To evaluate the clinical efficacy and safety of endostar combined with cisplatin/pemetrexed (CP) chemotherapy for elderly patients with advanced malignant pleural effusion (MPE) of lung adenocarcinoma. METHODS: A total of 128 lung adenocarcinoma patients with MPE were randomly divided into two groups. Patients in the treatment group were treated with pemetrexed 500 mg/m2 , i.v., d 1, cisplatin intracavitary administration with a total dose of 75 mg/m2 , d 2, 5 and 8, and endostar intracavitary administration 45 mg, d 1, 4 and 7...
January 2018: Journal of B.U.ON.: Official Journal of the Balkan Union of Oncology
Karla Soares-Weiser, John Rathbone, Yusuke Ogawa, Kiyomi Shinohara, Hanna Bergman
BACKGROUND: Antipsychotic (neuroleptic) medication is used extensively to treat people with chronic mental illnesses. Its use, however, is associated with adverse effects, including movement disorders such as tardive dyskinesia (TD) - a problem often seen as repetitive involuntary movements around the mouth and face. This review, one in a series examining the treatment of TD, covers miscellaneous treatments not covered elsewhere. OBJECTIVES: To determine whether drugs, hormone-, dietary-, or herb-supplements not covered in other Cochrane reviews on TD treatments, surgical interventions, electroconvulsive therapy, and mind-body therapies were effective and safe for people with antipsychotic-induced TD...
March 19, 2018: Cochrane Database of Systematic Reviews
Toshirou Nishida
There are some disparities between the clinical practice and profiles of cancer in Asia and those in Europe & North America. In Asia, surgical oncologists still have a major role in the multidisciplinary therapy of gastrointestinal stromal tumor (GIST), whereas medical oncologists hold this status in the West. Although the incidence of clinical GIST is considered similar between the two areas, small gastric GISTs are more frequently treated by surgery in East Asia compared with Europe & North America...
2018: Translational Gastroenterology and Hepatology
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