A phase II, single-center, double-blind, randomized placebo-controlled trial to explore the efficacy and safety of intravenous melatonin in patients with COVID-19 admitted to the intensive care unit (MelCOVID study): a structured summary of a study protocol for a randomized controlled trial
AbstractObjectives• Primary objective: to evaluate the effect of intravenous melatonin (IVM) on mortality in adult patients admitted to the intensive care unit (ICU) with COVID-19.• Secondary objectives:◦ To evaluate the effect of IVM on ICU length of stay.◦ To evaluate the effect of IVM on the length of mechanical ventilation (MV).◦ To evaluate if the use of IVM is associated with an increase in the number of ventilator-free days.◦ To evaluate if the use of IVM is associated with a reduced number of failing organs as determined by the sequential organ failure assessment (SOFA) scale.◦ To evaluate if th...
Source: Trials - August 5, 2020 Category: Research Source Type: clinical trials

Tolerability and efficacy of vortioxetine versus SSRIs in elderly with major depression. Study protocol of the VESPA study: a pragmatic, multicentre, open-label, parallel-group, superiority, randomized trial
This study will fully adhere to the ICH E6 Guideline for Good Clinical Practice. Participants ’ data will be managed and safeguarded according to the European Data Protection Regulation 2016/679. An external Ethical Advisory Board will help guarantee high ethical standards.Trial registrationClinicaltrials.gov:NCT03779789, Registered on 19 December 2018. Submitted on 19 December. EudraCT number: 2018 –001444-66.Trial statusProtocol version 1.5; 09/06/2018. Recruitment started In February 2019 and it is ongoing. It is expected to end approximately on 30 September 2021. (Source: Trials)
Source: Trials - August 3, 2020 Category: Research Source Type: clinical trials

PROTECT Trial: A cluster-randomized study with hydroxychloroquine versus observational support for prevention or early-phase treatment of Coronavirus disease (COVID-19): A structured summary of a study protocol for a randomized controlled trial
This study is open label.Numbers to be randomized (sample size)For Group 1, a sample size of about 2000 SARS-CoV-2-exposed subjects such as household members and/or contacts of COVID-19 patients will take part in the study. Assuming around 1.5-2.0 asymptomatic household members and/or contacts for each COVID-19 patient, we expect to identify approximately 1000-1300 COVID-19 index cases to be randomized. An interim analysis on efficacy is planned using standard alpha-spending function.For Group 2, sufficient power for primary objective (negative swab within 14 days of randomization) will be reached given a sample size of 30...
Source: Trials - July 31, 2020 Category: Research Source Type: clinical trials

Containment Measures and Eating Disorders
Conditions:   Eating Disorders;   COVID 19 Intervention:   Sponsors:   University Hospital, Montpellier;   INSERM U1061 (Statistics) Completed (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - July 30, 2020 Category: Research Source Type: clinical trials

Manual therapy versus therapeutic exercise in non-specific chronic neck pain: a randomized controlled trial
ConclusionThere are no differences between groups in short and medium terms. Manual therapy achieves a faster reduction in pain perception than therapeutic exercise. Therapeutic exercise reduces disability faster than manual therapy. Clinical improvement could potentially be influenced by central processes.Trial registrationBrazilian Clinical Trial Registry, RBR-2vj7sw. Registered on 28 November 2018. (Source: Trials)
Source: Trials - July 28, 2020 Category: Research Source Type: clinical trials

Ursodeoxycholic acid for the prevention of symptomatic gallstone disease after bariatric surgery: statistical analysis plan for a randomised controlled trial (UPGRADE trial)
DiscussionThe UPGRADE trial will show if prophylactic use of UDCA reduces the incidence of symptomatic gallstone disease after bariatric surgery. Unforeseen deviations from the SAP at the time of analysis will be motivated and discussed.Trial registrationThe Netherlands Trial RegisterNL5954. Registered on 21 November 2016. (Source: Trials)
Source: Trials - July 23, 2020 Category: Research Source Type: clinical trials

Better Outcomes for Older people with Spinal Trouble (BOOST) trial: statistical analysis plan for a randomised controlled trial of a combined physical and psychological intervention for older adults with neurogenic claudication
This study has been registered in the International Standard Randomised Controlled Trial Number registry, reference numberISRCTN12698674. Registered on 10 November 2015. (Source: Trials)
Source: Trials - July 21, 2020 Category: Research Source Type: clinical trials

Virtual Anatomical Reconstruction of Mandibular Bone Defects Using a Statistical Shape Model
Conditions:   Mandibular Diseases;   SSM Intervention:   Other: CT-scan evaluation and segmentation Sponsor:   CADskills Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - July 17, 2020 Category: Research Source Type: clinical trials

Safety and efficacy of belimumab after B cell depletion therapy in systemic LUPUS erythematosus (BEAT-LUPUS) trial: statistical analysis plan
This article describes the statistical analysis plan for this trial as an update to the published protocol. It is written prior to the end of patient follow-up, while the outcome of the trial is still unknown.Design and methodsBEAT-LUPUS is a randomised, double-blind, phase II trial of 52  weeks of belimumab versus placebo, initiated 4–8 weeks after rituximab treatment. The primary outcome is anti-dsDNA antibodies at 52 weeks post randomisation. Secondary outcomes include lupus flares and damage, adverse events, doses of concomitant medications, quality of life, and clinical biomarkers. We descri...
Source: Trials - July 16, 2020 Category: Research Source Type: clinical trials

Functional Follow-up After Endoscopic Calcaneoplasty for Haglund's Deformity
Condition:   Haglund's Deformity Intervention:   Other: Classification statistics Sponsor:   Peking University Third Hospital Completed (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - July 15, 2020 Category: Research Source Type: clinical trials

A Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly (CROSSFIRE): a statistical analyses plan
AbstractBackgroundWe are performing a combined randomised and observational study comparing internal fixation to non-surgical management for common wrist fractures in older patients. This paper describes the statistical analysis plan.Methods/designA Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly (CROSSFIRE) is a randomised controlled trial comparing two types of usual care for treating wrist fractures in older patients, surgical fixation using volar locking plates and non-surgical treatment using closed reduction and plaster immobilisation. The primary aim of this c...
Source: Trials - July 15, 2020 Category: Research Source Type: clinical trials

The Australasian COVID-19 Trial (ASCOT) to assess clinical outcomes in hospitalised patients with SARS-CoV-2 infection (COVID-19) treated with lopinavir/ritonavir and/or hydroxychloroquine compared to standard of care: A structured summary of a study protocol for a randomised controlled trial
AbstractObjectivesTo determine if lopinavir/ritonavir +/- hydroxychloroquine will reduce the proportion of participants who survive without requiring ventilatory support, 15 days after enrolment, in adult participants with non-critically ill SARS-CoV-2 infection.Trial designASCOT is an investigator-initiated, multi-centre, open-label, randomised controlled trial. Participants will have been hospitalised with confirmed COVID-19, and will be randomised 1:1:1:1 to receive lopinavir /ritonavir, hydroxychloroquine, both or neither drug in addition to standard of care management.ParticipantsParticipants will be recruited from>...
Source: Trials - July 14, 2020 Category: Research Source Type: clinical trials

Effects of high-protein diet combined with exercise to counteract frailty in pre-frail and frail community-dwelling older adults: study protocol for a three-arm randomized controlled trial
DiscussionThe finding of this study may add to the knowledge about the beneficial effects of high-protein diet from dairy products combined with power training to counteract frailty in community-dwelling older adults. This may ultimately have an impact on the ability to live well and independent for longer.Trial registrationClinicalTrials.govNCT03842579. Registered on 15 February 2019, version 1 (Source: Trials)
Source: Trials - July 11, 2020 Category: Research Source Type: clinical trials

Efficacy of chloroquine versus lopinavir/ritonavir in mild/general COVID-19 infection: a prospective, open-label, multicenter, randomized controlled clinical study
DiscussionThis experiment should reveal the efficacy and safety of using chloroquine versus lopinavir/ritonavir for patients with mild/general COVID-19 infection. If the new treatment including chloroquine shows a higher rate of throat-swab SARS-CoV-2 real-time fluorescent reverse transcription polymerase chain reaction (RT-PCR) negativity and is safe, it could be tested as a future COVID-19 treatment.Trial registrationChinese Clinical Trial Registry, ID:ChiCTR2000029741. Registered on 11 February 2020. (Source: Trials)
Source: Trials - July 8, 2020 Category: Research Source Type: clinical trials

Tennis Elbow Patients Undergoing Closed Therapy Can Easily Cause Tendon Tear
Conditions:   Tennis Elbow;   MRI;   Hyperlipidemia Intervention:   Other: classification statistics Sponsor:   Peking University Third Hospital Completed (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - July 7, 2020 Category: Research Source Type: clinical trials

The curative effects of shortwave diathermy on treating Novel coronavirus (COVID-19) pneumonia: A structured summary of a study protocol for a randomised controlled trial
This study will be conducted in Tongji Hospital, Caidian, Wuhan, People ’s Republic of China.Intervention and comparatorThe experimental group will be given the nationally recommended standard medical treatment + ultra-short-wave diathermy treatment. Ultra-short-wave therapy treatment will be performed through application of ultra-short-wave therapy machine electrodes on the anterior and posterior parts of the trunk for 10 minutes, twice a day for 12 consecutive days. The comparator will be the control, not receiving ultra-short-wave therapy, and will be given only the nationally recommended standard medical treatmen...
Source: Trials - July 3, 2020 Category: Research Source Type: clinical trials

ChemoPROphyLaxIs with hydroxychloroquine For covId-19 infeCtious disease (PROLIFIC) to prevent covid-19 infection in frontline healthcare workers: A structured summary of a study protocol for a randomised controlled trial
AbstractObjectivesPrimary objectiveTo determine whether chemoprophylaxis with hydroxychloroquine versus placebo increases time to contracting coronavirus disease 2019 (COVID-19) in frontline healthcare workers.Secondary objectivesTo determine whether chemoprophylaxis with daily versus weekly dosing of hydroxychloroquine increases time to contracting COVID-19 disease in frontline healthcare workers.To compare the number of COVID-19 cases between each trial arm on the basis of positive tests (as per current clinical testing methods and/or serology)To compare the percentage of COVID-19 positive individuals with current testin...
Source: Trials - July 2, 2020 Category: Research Source Type: clinical trials

Single dose versus 24  h antibiotic prophylaxis in reduction mammaplasty: study protocol for a randomized controlled trial
This study will test the hypothesis that maintaining the use of antibiotics for 24  h does not reduce infection rates compared to the use of a single preoperative dose.Trial registrationClinicaltrials.govNCT04079686. Registered on September 6, 2019. (Source: Trials)
Source: Trials - July 2, 2020 Category: Research Source Type: clinical trials

Antibody Detection in COVID-19 Cured Patients (SARS-CoV-2-CZ-Immunity)
Conditions:   COVID;   SARS-CoV-2 Interventions:   Diagnostic Test: Quantitative analysis of anti-SARS-CoV-2-antibodies;   Diagnostic Test: SARS-CoV-2 diagnostic rapid test Sponsors:   Institute of Health Information and Statistics of the Czech Republic;   Ministry of Health, Czech Republic;   Faculty of Medicine, Masaryk University;   Institute for Clinical and Experimental Medicine;   Brno University Hospital;   St. Anne's University Hospital Brno, Czech Republic;   Ma...
Source: ClinicalTrials.gov - July 1, 2020 Category: Research Source Type: clinical trials

Analysis of the Mass Skiers' Injury in a Large Ski Resort in Chongli, China
Condition:   Skiing Injury Intervention:   Other: Classification statistics Sponsor:   Peking University Third Hospital Completed (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - July 1, 2020 Category: Research Source Type: clinical trials