Protocol for a randomised controlled trial to investigate the effects of vitamin K2 on recovery from muscle-damaging resistance exercise in young and older adults —the TAKEOVER study
DiscussionEthical approval has been granted by the College of Medical Veterinary and Life Sciences Ethical Committee at the University of Glasgow (Project No 200190189) and recruitment is ongoing. Study findings will be disseminated through a presentation at scientific conferences and in scientific journals.Trial registrationClinicialTrials.gov NCT04676958. Prospectively registered on 21 December 2020. (Source: Trials)
Source: Trials - December 20, 2022 Category: Research Source Type: clinical trials

Eisai Presents Full Results of Lecanemab Phase 3 Confirmatory Clarity Ad Study for Early Alzheimer ’s Disease At Clinical Trials On Alzheimer’s Disease (Ctad) Conference
TOKYO and CAMBRIDGE, November 29, 2022 -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, " Eisai " ) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, " Biogen " ) announced today... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - November 29, 2022 Category: Pharmaceuticals Source Type: clinical trials

Effect of intraoperative goal-directed fluid therapy on the postoperative brain edema in patients undergoing high-grade glioma resections: a study protocol of randomized control trial
AbstractIntroductionBrain edema is the most frequent postoperative complication after brain tumor resection, especially in patients with high-grade glioma. However, the effect of SVV-based goal-directed fluid therapy (GDFT) on postoperative brain edema and the prognosis remain unclear.Methods and analysisThis is a prospective, randomized, double-blinded, parallel-controlled trial aiming to observe whether stroke volume variation (SVV)-based GDFT could improve the postoperative brain edema in patients undergoing supratentorial high-grade gliomas compared with traditional fluid therapy. The patient will be given 3 ml/kg hydr...
Source: Trials - November 19, 2022 Category: Research Source Type: clinical trials

Kangyi Qiangshen Gong exercise prescription for pulmonary function and quality of life in patients recovered from COVID-19: a study protocol for a randomized controlled trial
DiscussionThis trial will serve high-quality evidence of the value of KQG for treating discharged patients with COVID-19 in rehabilitation period.Trial registrationChinese Clinical Trial Registry ChiCTR2200059504. Registered on 03 May 2022.DisseminationThe results will be published in peer-reviewed journals and disseminated through the study ’s website, and conferences. (Source: Trials)
Source: Trials - October 14, 2022 Category: Research Source Type: clinical trials

Development of a core outcome set for hypertensive intracerebral hemorrhage in clinical trials of traditional Chinese medicine: a study protocol
ConclusionBy doing this, we can increase the reporting consistency and reduce the reporting bias in the outcome, which leads to the reuse of research data in meta-analysis and the making of informed healthcare decisions.Ethics and disseminationThe entire project has received approval from the Ethics Committee of Xiyuan Hospital, China Academy of Chinese Medical Sciences. The final COS will be published and reported at the national and international conferences.Trial registrationThis study is registered with the Core Outcome Measures in Effectiveness Trials database as study1475. Registered on December 2019. (Source: Trials)
Source: Trials - October 12, 2022 Category: Research Source Type: clinical trials

Internet-based cognitive therapy for women with antenatal depressive symptoms during the COVID-19 pandemic: protocol for a multi-center randomized controlled trial across China
The objective of this trial is to evaluate the short-term and long-term effects of iCBT on reducing depressive symptoms among pregnant women during the COVID-19 pandemic with the overall goal of preventing depression recurrence in the first 12 months postpartum.MethodsA multi-site randomized controlled trial will be conducted where 300 pregnant women early in their third trimester will be screened for depression symptoms using the Edinburgh Postnatal Depression Scale (EPDS) during a routine obstetrical visit. Eligible and consenting women with a score greater than 9 will be randomly allocated (1:1) to either intervention g...
Source: Trials - September 21, 2022 Category: Research Source Type: clinical trials

The iHealth-T2D study: a cluster randomised trial for the prevention of type 2 diabetes amongst South Asians with central obesity and prediabetes —a statistical analysis plan
DiscussionThe iHealth-T2D trial will provide evidence of whether an intensive family-based lifestyle modification programme for South Asians who are at high risk for T2D is effective in the prevention of T2D. The data from the trial will be analysed according to this pre-specified SAP.Ethics and disseminationThe trial was approved by the international review board of each participating study site. Study findings will be disseminated through peer-reviewed publications and in conference presentations.Trial registrationEudraCT2016 –001,350-18. Registered on 14 April 2016. ClinicalTrials.govNCT02949739. Registered on 31 Octo...
Source: Trials - September 6, 2022 Category: Research Source Type: clinical trials

Protocol for the development of a core domain set for individuals with ankle osteoarthritis
ConclusionThis protocol describes the methods that will be used to develop a core domain set of health-related aspects for ankle OA. Importantly, it will include both healthcare professional and patient involvement. This is a prerequisite step to developing a core outcome set for ankle OA that should be reported in all clinical trials for ankle OA. The findings will be widely disseminated across peer-refereed publication(s) and national and international conferences, as well as via relevant professional societies, patient support group organisations, and social media platforms.Project registrationThis project is registered...
Source: Trials - September 5, 2022 Category: Research Source Type: clinical trials

Effects of Different Telerehabilitation Methods on Pain, Functional Limitation, Muscle Strength, Balance, and Quality of Life in Patients With Knee Osteoarthritis.
Condition:   Osteoarthritis, Knee Interventions:   Other: Exercise Therapy via video conference;   Other: Exercise Therapy via mobile application Sponsor:   Marmara University Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - August 24, 2022 Category: Research Source Type: clinical trials