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random clinical trial

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
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
J S Gomes, A P Trevizol, D V Ducos, A Gadelha, B B Ortiz, A O Fonseca, H T Akiba, C C Azevedo, L S P Guimaraes, P Shiozawa, Q Cordeiro, A Lacerda, A M Dias
Background: The lack of efficacy of pharmacological treatments for cognitive and negative symptoms in schizophrenia highlights the need for new interventions. We investigated the effects of tDCS on working memory and negative symptoms in patients with schizophrenia. Method: Double-blinded, randomized, sham-controlled clinical trial, investigating the effects of 10 sessions of tDCS in schizophrenia subjects. Stimulation used 2 mA, for 20 min, with electrodes of 25 cm2 wrapped in cotton material soaked in saline solution...
June 2018: Schizophrenia Research. Cognition
Kenji Yamada, Hideaki Shiraishi, Eishin Oki, Mika Ishige, Toshiyuki Fukao, Yusuke Hamada, Norio Sakai, Fumihiro Ochi, Asami Watanabe, Sanae Kawakami, Kazuyo Kuzume, Kenji Watanabe, Koji Sameshima, Kiyotaka Nakamagoe, Akira Tamaoka, Naoko Asahina, Saki Yokoshiki, Takashi Miyakoshi, Kota Ono, Koji Oba, Toshiyuki Isoe, Hiroshi Hayashi, Seiji Yamaguchi, Norihiro Sato
Introduction: Fatty acid oxidation disorders (FAODs) are rare diseases caused by defects in mitochondrial fatty acid oxidation (FAO) enzymes. While the efficacy of bezafibrate, a peroxisome proliferator-activated receptor agonist, on the in vitro FAO capacity has been reported, the in vivo efficacy remains controversial. Therefore, we conducted a clinical trial of bezafibrate in Japanese patients with FAODs. Materials and methods: This trial was an open-label, non-randomized, and multicenter study of bezafibrate treatment in 6 patients with very long-chain acyl-CoA dehydrogenase (VLCAD) deficiency and 2 patients with carnitine palmitoyltransferase-II (CPT-2) deficiency (median age, 8...
June 2018: Molecular Genetics and Metabolism Reports
Katherine Smith, Jeffrey P Fleming, Bernard Gros
Heart failure (HF) is one of the most prevalent chronic diseases in the United States (U.S.), with an estimated prevalence of five million patients in the U.S. and an annual healthcare cost of greater than 30 billion dollars. Readmission rates for HF patients are astronomically high, with up to 25% of hospitalized patients with HF requiring readmission within 30 days of discharge. The Hospital Readmissions Reduction Program (HRRP) of the Patient Protection and Affordable Care Act aims to address these concerns by financially penalizing institutions with unacceptably high risk-adjusted 30-day readmission rates for HF patients...
January 15, 2018: Curēus
Karim Yahia Jaffer, Tiffany Chang, Brigitte Vanle, Jonathan Dang, Alexander J Steiner, Natalie Loera, Marina Abdelmesseh, Itai Danovitch, Waguih William Ishak
OBJECTIVE: While trazodone is approved for the treatment of depression, the off-label use of this medication for insomnia has surpassed its usage as an antidepressant. In this systematic review, we examined the evidence for the efficacy and safety of trazodone for insomnia. METHODS: A literature search was conducted using MEDLINE/PubMed databases from the past 33 years (1983-2016) and the keywords insomnia, trazodone, sedative, treatment, and hypnotics. The results were restricted to English language and human subjects...
July 2017: Innovations in Clinical Neuroscience
François Jacques, Adrian Schembri, Avi Nativ, Chantal Paquette, Pawel Kalinowski
Background: Both prolonged-release fampridine (PRF) and enabling active motor training (EAMT) are beneficial in multiple sclerosis (MS) patients. Their combined effect is, however, understudied. Objective: The objective of this paper is to determine if PRF augments the beneficial effect of EAMT in MS patients as opposed to placebo. Method: This is a pilot, randomized, placebo-controlled, double-blind 14-week study. Participants were randomly assigned to receive PRF 10 mg BID ( n  = 21) or placebo ( n  = 20)...
January 2018: Multiple Sclerosis Journal—Experimental, Translational and Clinical
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