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https://www.readbyqxmd.com/read/29347996/the-apathy-in-dementia-methylphenidate-trial-2-admet-2-study-protocol-for-a-randomized-controlled-trial
#1
Roberta W Scherer, Lea Drye, Jacobo Mintzer, Krista Lanctôt, Paul Rosenberg, Nathan Herrmann, Prasad Padala, Olga Brawman-Mintzer, William Burke, Suzanne Craft, Alan J Lerner, Allan Levey, Anton Porsteinsson, Christopher H van Dyck
BACKGROUND: Alzheimer's disease (AD) is characterized not only by cognitive and functional decline, but also often by the presence of neuropsychiatric symptoms. Apathy, which can be defined as a lack of motivation, is one of the most prevalent neuropsychiatric symptoms in AD and typically leads to a worse quality of life and greater burden for caregivers. Treatment options for apathy in AD are limited, but studies have examined the use of the amphetamine, methylphenidate. The Apathy in Dementia Methylphenidate Trial (ADMET) found that treatment of apathy in AD with methylphenidate was associated with significant improvement in apathy in two of three outcome measures, some evidence of improvement in global cognition, and minimal adverse events...
January 18, 2018: Trials
https://www.readbyqxmd.com/read/29347991/the-benefits-and-tolerance-of-exercise-in-myasthenia-gravis-mgex-study-protocol-for-a-randomised-controlled-trial
#2
Simone Birnbaum, Jean-Yves Hogrel, Raphael Porcher, Pierre Portero, Bernard Clair, Bruno Eymard, Sophie Demeret, Guillaume Bassez, Marcela Gargiulo, Estelle Louët, Sonia Berrih-Aknin, Asmaa Jobic, Philippe Aegerter, Philippe Thoumie, Tarek Sharshar
BACKGROUND: Research exploring the effects of physical exercise in auto-immune myasthenia gravis (MG) is scarce. The few existing studies present methodological shortcomings limiting the conclusions and generalisability of results. It is hypothesised that exercise could have positive physical, psychological as well as immunomodulatory effects and may be a beneficial addition to current pharmacological management of this chronic disease. The aim of this study is to evaluate the benefits on perceived quality of life (QOL) and physical fitness of a home-based physical exercise program compared to usual care, for patients with stabilised, generalised auto-immune MG...
January 18, 2018: Trials
https://www.readbyqxmd.com/read/29347947/efficacy-of-pre-operative-quadriceps-strength-training-on-knee-extensor-strength-before-and-shortly-following-total-knee-arthroplasty-protocol-for-a-randomized-dose-response-trial-the-quadx-1-trial
#3
Rasmus Skov Husted, Anders Troelsen, Kristian Thorborg, Michael Skovdal Rathleff, Henrik Husted, Thomas Bandholm
BACKGROUND: Patients with knee osteoarthritis (OA) report knee pain, limitation in physical activities and low quality of life. The two primary treatments for knee OA are non-surgical treatment (e.g., exercise) and surgery (total knee arthroplasty (TKA)); however, national guidelines recommend non-surgical treatment to be tried prior to surgical procedures. Patients with knee OA are characterized by decreased muscle strength, particularly in the knee-extensor muscles. Correspondingly, decreased knee-extensor strength is found to be associated with an increased risk of development, progression and severity of knee OA symptoms...
January 18, 2018: Trials
https://www.readbyqxmd.com/read/29343303/comparison-of-modified-wet-suction-technique-and-dry-suction-technique-in-endoscopic-ultrasound-guided-fine-needle-aspiration-eus-fna-for-solid-lesions-study-protocol-for-a-randomized-controlled-trial
#4
Yun Wang, Qian Chen, Jinlin Wang, Xiaoli Wu, Yaqi Duan, Ping Yin, Qiaozhen Guo, Wei Hou, Bin Cheng
BACKGROUND: Several suction techniques have been developed recently to enhance tissue acquisition when sampling solid lesions using endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA). The aim of this study is to determine whether a new modified wet suction technique (MWST) compared with the conventional dry suction technique (DRST) shall present better outcomes with respect to diagnostic yield and specimen quality of solid lesions in the intra-abdomen and mediastinum. METHODS/DESIGN: This is a single-blind, randomized, controlled, superiority trial conducted at four large tertiary care centers in China...
January 17, 2018: Trials
https://www.readbyqxmd.com/read/29343283/the-classroom-communication-resource-ccr-intervention-to-change-peer-s-attitudes-towards-children-who-stutter-cws-study-protocol-for-a-randomised-controlled-trial
#5
Rizwana Mallick, Harsha Kathard, Lehana Thabane, Mershen Pillay
BACKGROUND: Children who stutter (CWS) are at a high-risk of being teased and bullied in primary school because of negative peer attitudes and perceptions towards stuttering. There is little evidence to determine if classroom-based interventions are effective in changing peer attitudes towards stuttering. The primary objective is to determine the effect of the Classroom Communication Resource (CCR) intervention versus usual practice, measured using the Stuttering Resource Outcomes Measure (SROM) 6-months post-intervention among grade 7 students...
January 17, 2018: Trials
https://www.readbyqxmd.com/read/29343280/pregabalin-versus-placebo-in-targeting-pro-nociceptive-mechanisms-to-prevent-chronic-pain-after-whiplash-injury-in-at-risk-individuals-a-feasibility-study-for-a-randomised-controlled-trial
#6
J Nikles, G Keijzers, G Mitchell, S Schug, R Ware, S A McLean, L Connelly, S Gibson, S F Farrell, M Sterling
BACKGROUND: Whiplash-associated disorders (WAD) are an enormous and costly burden to Australian society. Up to 50% of people who experience a whiplash injury will never fully recover. Whiplash is resistant to treatment and no early management approach has yet been shown to prevent chronic pain. The early presence of central sensitization is associated with poor recovery. Pregabalin's effects on central sensitization indicate the potential to prevent or modulate these processes after whiplash injury and to improve health outcomes, but this has not been investigated...
January 17, 2018: Trials
https://www.readbyqxmd.com/read/29338759/correction-to-avoidable-waste-related-to-inadequate-methods-and-incomplete-reporting-of-interventions-a-systematic-review-of-randomized-trials-performed-in-sub-saharan-africa
#7
Lee Aymar Ndounga Diakou, Francine Ntoumi, Philippe Ravaud, Isabelle Boutron
In the original publication [1] the last sentence in the last paragraph under 'Perspectives and implications' in the Discussions section needs to be removed. The correct version can be found in this Erratum.
January 16, 2018: Trials
https://www.readbyqxmd.com/read/29335018/danggwijagyaksan-for-climacteric-syndrome-in-peri-and-postmenopausal-women-with-a-blood-deficiency-dominant-pattern-study-protocol-for-a-randomized-double-blind-placebo-controlled-pilot-trial
#8
Mikyung Kim, Ae-Ran Kim, Hyo-Ju Park, Ojin Kwon, Joo-Hee Kim, Eun-Ji Park, Seon-Eun Baek, Jeong-Eun Yoo, Jun-Hwan Lee
BACKGROUND: This study aims to explore the safety, efficacy, and feasibility of Danggwijagyaksan (DJS) for alleviating climacteric syndrome in peri- and postmenopausal women with a blood-deficiency dominant pattern. METHODS/DESIGN: This is a randomized, double-blind, placebo-controlled pilot clinical trial. A total of 34 women with climacteric syndrome who have signed informed consent forms will be registered in this study. Placebo or DJS will be randomly assigned to the participants in an equal proportion...
January 15, 2018: Trials
https://www.readbyqxmd.com/read/29335017/effect-of-laparoscopy-by-single-port-endoscopic-access-in-benign-adnexal-surgery-study-protocol-for-a-randomized-controlled-trial
#9
Andy Schmitt, Patrice Crochet, Karine Baumstark, Claire Tourette, Sabine Poizac, Audrey Pivano, Léon Boubli, Ludovic Cravello, Aubert Agostini
BACKGROUND: Laparoscopic surgery has become the preferred surgical approach due to a reduction in postoperative pain, better recovery, shorter hospitalization, and improved esthetic outcomes. Laparoscopic surgery with single-port laparoscopy (SPL) is a laparoscopic surgery technique that is based on making a single parietal incision using a single trocar specifically designed to allow introduction of several instruments. The level of evidence regarding the advantages of SPL in terms of postoperative pain has remained low despite several randomized studies...
January 15, 2018: Trials
https://www.readbyqxmd.com/read/29335013/fit-for-function-study-protocol-for-a-randomized-controlled-trial
#10
Julie Richardson, Ada Tang, Gordon Guyatt, Lehana Thabane, Feng Xie, Demetrios Sahlas, Robert Hart, Rebecca Fleck, Genevieve Hladysh, Louise Macrae
BACKGROUND: The current state of evidence suggests that community-based exercise programs are beneficial in improving impairment, function, and health status, and are greatly needed for persons with stroke. However, limitations of these studies include risk of bias, feasibility, and cost issues. METHODS/DESIGN: This single-blinded, randomized controlled trial (RCT) of 216 participants with stroke will compare the effectiveness of a 12-week YMCA community-based wellness program (FIT for FUNCTION) specifically designed for community-dwelling persons with stroke to persons who receive a standard YMCA membership...
January 15, 2018: Trials
https://www.readbyqxmd.com/read/29334992/the-efficacy-of-a-multimodal-physical-activity-intervention-with-supervised-exercises-health-coaching-and-an-activity-monitor-on-physical-activity-levels-of-patients-with-chronic-nonspecific-low-back-pain-physical-activity-for-back-pain-payback-trial-study
#11
Crystian B Oliveira, Márcia R Franco, Chris G Maher, Anne Tiedemann, Fernanda G Silva, Tatiana M Damato, Michael K Nicholas, Diego G D Christofaro, Rafael Z Pinto
BACKGROUND: Physical activity plays an important role in the management of chronic low back pain (LBP). Engaging in an active lifestyle is associated with a better prognosis. Nevertheless, there is evidence to suggest that patients with chronic LBP are less likely to meet recommended physical activity levels. Furthermore, while exercise therapy has been endorsed by recent clinical practice guidelines, evidence from systematic reviews suggests that its effect on pain and disability are at best moderate and not sustained over time...
January 15, 2018: Trials
https://www.readbyqxmd.com/read/29329559/simplification-of-medications-prescribed-to-long-term-care-residents-simpler-study-protocol-for-a-cluster-randomised-controlled-trial
#12
Janet K Sluggett, Esa Y H Chen, Jenni Ilomäki, Megan Corlis, Sarah N Hilmer, Jan Van Emden, Choon Ean Ooi, Kim-Huong Nguyen, Tracy Comans, Michelle Hogan, Tessa Caporale, Susan Edwards, Lyntara Quirke, Allan Patching, J Simon Bell
BACKGROUND: Complex medication regimens are highly prevalent in residential aged care facilities (RACFs). Strategies to reduce unnecessary complexity may be valuable because complex medication regimens can be burdensome for residents and are costly in terms of nursing time. The aim of this study is to investigate application of a structured process to simplify medication administration in RACFs. METHODS: SImplification of Medications Prescribed to Long-tErm care Residents (SIMPLER) is a non-blinded, matched-pair, cluster randomised controlled trial of a single multidisciplinary intervention to simplify medication regimens...
January 12, 2018: Trials
https://www.readbyqxmd.com/read/29329555/exercise-during-and-after-neoadjuvant-rectal-cancer-treatment-the-exert-trial-study-protocol-for-a-randomized-controlled-trial
#13
Andria R Morielli, Nawaid Usmani, Normand G Boulé, Diane Severin, Keith Tankel, Tirath Nijjar, Kurian Joseph, Alysa Fairchild, Kerry S Courneya
BACKGROUND: Standard treatment for locally advanced rectal cancer includes 5-6 weeks of neoadjuvant chemoradiotherapy (NACRT) followed by total mesorectal excision 6-8 weeks later. NACRT improves local disease control and surgical outcomes but also causes side effects including fatigue, diarrhea, hand-foot syndrome, and physical deconditioning that may impede quality of life (QoL), treatment completion, treatment response, and long-term prognosis. Interventions to improve treatment outcomes and manage side effects that are safe, tolerable and low-cost are highly desirable...
January 12, 2018: Trials
https://www.readbyqxmd.com/read/29329551/efficacy-and-safety-of-combined-treatment-of-miniscalpel-acupuncture-and-non-steroidal-anti-inflammatory-drugs-an-assessor-blinded-randomized-controlled-pilot-study
#14
Seungah Jun, Jung Hee Lee, Han Mi Gong, Yeon-Joong Chung, Ju-Ran Kim, Chung A Park, Seong Hun Choi, Geon-Mok Lee, Hyun-Jong Lee, Jae Soo Kim
BACKGROUND: Chronic neck pain is a common musculoskeletal disease during the lifespan of an individual. With an increase in dependence on computer technology, the prevalence of chronic neck pain is expected to rise and this can lead to socioeconomic problems. We have designed the current pilot study to evaluate the efficacy and safety of miniscalpel acupuncture treatment combined with non-steroidal anti-inflammatory drugs (NSAIDs) in patients with chronic neck pain. METHODS: This seven-week clinical trial has been designed as an assessor-blinded, randomized controlled trial with three parallel arms...
January 12, 2018: Trials
https://www.readbyqxmd.com/read/29325598/influence-of-peer-review-on-the-reporting-of-primary-outcome-s-and-statistical-analyses-of-randomised-trials
#15
Sally Hopewell, Claudia M Witt, Klaus Linde, Katja Icke, Olubusola Adedire, Shona Kirtley, Douglas G Altman
BACKGROUND: Selective reporting of outcomes in clinical trials is a serious problem. We aimed to investigate the influence of the peer review process within biomedical journals on reporting of primary outcome(s) and statistical analyses within reports of randomised trials. METHODS: Each month, PubMed (May 2014 to April 2015) was searched to identify primary reports of randomised trials published in six high-impact general and 12 high-impact specialty journals. The corresponding author of each trial was invited to complete an online survey asking authors about changes made to their manuscript as part of the peer review process...
January 11, 2018: Trials
https://www.readbyqxmd.com/read/29325595/mortality-impact-of-an-increased-blood-glucose-cut-off-level-for-hypoglycaemia-treatment-in-severely-sick-children-in-malawi-sugarfact-trial-study-protocol-for-a-randomised-controlled-trial
#16
Tim Baker, Queen Dube, Josephine Langton, Helena Hildenwall
BACKGROUND: Mortality in children remains high in sub-Saharan African hospitals. While antimalarial drugs, antibiotics and other definitive treatments are well understood, the role of emergency care with supportive therapies, such as maintaining normal glucose and electrolyte balances, has been given limited attention. Hypoglycaemia is common in children admitted to hospital in low-income settings. The current definition of hypoglycaemia is a blood glucose level < 2.5 mmol/L in a well-nourished child...
January 11, 2018: Trials
https://www.readbyqxmd.com/read/29325594/treatment-of-persistent-allergic-rhinitis-via-acupuncture-at-the-sphenopalatine-acupoint-a-randomized-controlled-trial
#17
Jiaoping Mi, Xinye Chen, Xiaoyan Lin, Jianling Guo, Hongtao Chen, Liao Wei, Haiyu Hong
BACKGROUND: Allergic rhinitis is a common respiratory disease. Acupuncture is used to treat it in traditional Chinese medicine, and generally, the L120, ST2 and ST36 acupoints are selected in clinical practice. We report a new method of acupuncture at the sphenopalatine acupoint (SPA) for treatment of persistent allergic rhinitis (PAR). The effect of this treatment was investigated using two different needling depths. The efficacy of this treatment was associated with accurate stimulation of the sphenopalatine ganglion (SPG)...
January 11, 2018: Trials
https://www.readbyqxmd.com/read/29325593/evaluating-the-long-term-impact-of-the-fostering-changes-training-programme-for-foster-carers-in-wales-the-confidence-in-care-trial-study-protocol-for-a-randomised-controlled-trial
#18
Gwenllian Moody, Lucy Brookes-Howell, Rebecca Cannings-John, Sue Channon, Elinor Coulman, Mandy Lau, Alyson Rees, Jonathan Scourfield, Jeremy Segrott, Michael Robling
BACKGROUND: The Fostering Changes programme was developed by the Adoption and Fostering National Team at the Maudsley Hospital, South London, in conjunction with King's College London. It is a 12-week group-based training programme for foster and kin carers, which aims to build positive relationships between carers and children, encourage positive child behaviour and set appropriate limits, through a practical skills-based approach. The programme also aims to improve foster carers' understanding of the causes of children's social and emotional difficulties and their confidence in applying this knowledge in various situations...
January 11, 2018: Trials
https://www.readbyqxmd.com/read/29325585/clinical-research-ethics-review-process-in-lebanon-efficiency-and-functions-of-research-ethics-committees-results-from-a-descriptive-questionnaire-based-study
#19
David Atallah, Malak Moubarak, Nadine El Kassis, Sara Abboud
BACKGROUND: Clinical trials conducted in Lebanon are increasing. However, little is known about the performance of research ethics committees (RECs) in charge of reviewing the research protocols. This study aimed to assess the level of adherence to the ethics surrounding the conduct of clinical trials and perceptions of team members regarding roles of the RECs during the conduct of clinical trials in Lebanon. The research question was: Are RECs adherent to the ethics surrounding the conduct of clinical trials (chapters II and IV in 'Standards and Operational Guidance for Ethics Review of Health-related Research with Human Participants' in Lebanon?' METHODS: This was a quantitative and descriptive questionnaire-based study conducted among RECs of university hospitals in Lebanon...
January 11, 2018: Trials
https://www.readbyqxmd.com/read/29325583/an-integrated-delivery-of-care-approach-to-improve-patient-reported-physical-function-and-mental-wellbeing-after-orthopedic-trauma-study-protocol-for-a-randomized-controlled-trial
#20
Laura Zdziarski-Horodyski, MaryBeth Horodyski, Kalia K Sadasivan, Jennifer Hagen, Terrie Vasilopoulos, Matthew Patrick, Robert Guenther, Heather K Vincent
BACKGROUND: Orthopedic trauma injury impacts nearly 2.8 million people each year. Despite surgical improvements and excellent survivorship rates, many patients experience poor quality of life (QOL) outcomes years later. Psychological distress commonly occurs after injury. Distressed patients more frequently experience rehospitalizations, pain medication dependence, and low QOL. This study was developed to test whether an integrative care approach (IntCare; ten-step program of emotional support, education, customized resources, and medical care) was superior to usual care (UsCare)...
January 11, 2018: Trials
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