A comparison of different community models of antiretroviral therapy delivery with the standard of care among stable HIV+ patients: rationale and design of a non-inferiority cluster randomized trial, nested in the HPTN 071 (PopART) study
DiscussionThis trial was designed to provide rigorous randomized evidence of safety and efficacy of non-facility-based delivery of ART for stable PLHIV in high-burden resource-limited settings. This trial will inform policy regarding best practices and what is needed to strengthen scale-up of differentiated models of ART delivery in resource-limited settings.Trial registrationClinicalTrials.govNCT03025165. Registered on 19 January 2017 (Source: Trials)
Source: Trials - January 12, 2021 Category: Research Source Type: clinical trials

COvid-19 and high-dose VITamin D supplementation TRIAL in high-risk older patients (COVIT-TRIAL): study protocol for a randomized controlled trial
DiscussionCOVIT-TRIAL is to our knowledge the first randomized controlled trial testing the effect of vitamin D supplementation on the prognosis of COVID-19 in high-risk older patients. High-dose vitamin D supplementation may be an effective, well-tolerated, and easily and immediately accessible treatment for COVID-19, the incidence of which increases dramatically and for which there are currently no scientifically validated treatments.Trial registrationClinicalTrials.govNCT04344041. Registered on 14 April 2020Trial statusRecruiting. Recruitment is expected to be completed in April 2021. (Source: Trials)
Source: Trials - December 28, 2020 Category: Research Source Type: clinical trials

Effect of “motivational interviewing” and “information, motivation, and behavioral skills” counseling interventions on choosing the mode of delivery in pregnant women: a study protocol for a randomized controlled trial
DiscussionThe interventions of this protocol have been programmed to reduce unnecessary Cesarean sections. Findings may contribute to a rise in normal vaginal delivery, and the effective intervention may be extended for use in national Cesarean section plans.Trial registrationIran Randomized Clinical Trial CenterIRCT20151208025431N7. Registered on December 07, 2018. (Source: Trials)
Source: Trials - November 25, 2020 Category: Research Source Type: clinical trials

Study of PRRT in Metastatic, World Health Organization (WHO) Grade 1 or 2, SSTR Positive, GEP-NET Who Are Candidates for Cytoreductive Surgery
Condition:   Gastroenteropancreatic Neuroendocrine Tumor Interventions:   Drug: Lutathera;   Drug: Gallium 68 Dotatate;   Procedure: Computed Tomography (CT);   Procedure: Magnetic Resonance Imaging (MRI);   Procedure: PET/CT Sponsors:   Stanford University;   Advanced Accelerator Applications Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - October 30, 2020 Category: Research Source Type: clinical trials

Russian Application of Sputnik V Vaccine for WHO Vaccine Prequalification Among the First Applications Submitted
Moscow, October 27, 2020 – The Russian Direct Investment Fund, (RDIF, Russia's sovereign wealth fund), has submitted applications to the World Health Organization (WHO) for accelerated registration (Emergency Use Listing, EUL) and... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - October 27, 2020 Category: Pharmaceuticals Source Type: clinical trials

An investigation into the beneficial effects of high-dose interferon beta 1-a, compared to low-dose interferon beta 1-a (the base therapeutic regimen) in moderate to severe COVID-19: A structured summary of a study protocol for a randomized controlled l trial
This study will be undertaken at the Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences.Intervention and ComparatorCOVID- 19 confirmed patients (using the RT-PCR test or CT scan) will be randomly assigned to one of two groups. The intervention group (Arms1) will be treated with lopinavir / ritonavir (Kaletra) + high dose Interferon- β 1a (Recigen) and the control group will be treated with lopinavir / ritonavir (Kaletra) + low dose Interferon-β 1a (Recigen) (the base therapeutic regimen). Both groups will receive standard care consisting of the necessary oxygen support, non-invasive, or invasi...
Source: Trials - October 26, 2020 Category: Research Source Type: clinical trials

Convalescent plasma transfusion therapy in severe COVID-19 patients- a safety, efficacy and dose response study: A structured summary of a study protocol of a phase II randomized controlled trial
AbstractObjectivesGeneral: To assess the safety, efficacy and dose response of convalescent plasma (CP) transfusion in severe COVID-19 patientsSpecific:a. To identify the appropriate effective dose of CP therapy in severe patientsb. To identify the efficacy of the therapy with their end point based on clinical improvement within seven days of treatment or until discharge whichever is later and in-hospital mortalityc. To assess the clinical improvement after CP transfusion in severe COVID-19 patientsd. To assess the laboratory improvement after CP transfusion in severe COVID-19 patientsTrial DesignThis is a multicentre, mul...
Source: Trials - October 26, 2020 Category: Research Source Type: clinical trials

Gilead Sciences Statement on the Solidarity Trial
October 15, 2020 -- We are aware that initial data from the World Health Organization’s (WHO) SOLIDARITY Trial has been made public prior to publication in a peer-reviewed journal. The emerging data appear inconsistent with more robust... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - October 15, 2020 Category: Pharmaceuticals Source Type: clinical trials

Double-Blind, Randomized, Placebo-Controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of treating Healthcare Professionals with the Adsorbed COVID-19 (Inactivated) Vaccine Manufactured by Sinovac – PROFISCOV: A structured summary of a study protocol for a randomised controlled trial
AbstractObjectivesTo evaluate the efficacy of two doses of the adsorbed vaccine COVID-19 (inactivated) produced by Sinovac in symptomatic individuals, with virological confirmation of COVID-19, two weeks after the completion of the two-dose vaccination regimen, aged 18 years or older who work as health professionals providing care to patients with possible or confirmed COVID-19.To describe the occurrence of adverse reactions associated with the administration of each of two doses of the adsorbed vaccine COVID-19 (inactivated) produced by Sinovac up to one week after vaccination in Adults (18-59 years of age) and Elderly (6...
Source: Trials - October 15, 2020 Category: Research Source Type: clinical trials

An International Randomized Trial of Additional Treatments for COVID-19 in Hospitalized Patients Who Are All Receiving the Local Standard of Care - WHO-SOLIDARITY-GERMANY
Conditions:   SARS-CoV-2 Infection;   COVID-19;   Moderate and Severe COVID-19 Interventions:   Other: Standard of Care (SoC);   Drug: Remdesivir Sponsors:   Professor Dr. Bernd Mühlbauer;   Dept. of Statistics and Medical Biometry, University of Bremen;   INSERM (Institut national de la santé et de la recherche médicale), Paris, France;   World Health Organization (WHO), R&D Blueprint, Geneva, Switzerland Active, not recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - October 5, 2020 Category: Research Source Type: clinical trials

Personalised health education against health damage of COVID-19 epidemic in the elderly Hungarian population (PROACTIVE-19): protocol of an adaptive randomised controlled clinical trial
DiscussionThese interventions may boost the body ’s cardiovascular and pulmonary reserve capacities, leading to improved resistance against the damage caused by COVID-19. Consequently, lifestyle changes can reduce the incidence of life-threatening conditions and attenuate the detrimental effects of the pandemic seriously affecting the older popu lation.Trial registrationThe study has been approved by the Scientific and Research Ethics Committee of the Hungarian Medical Research Council (IV/2428- 2 /2020/EKU) and has been registered at clinicaltrials.gov (NCT04321928) on 25 March 2020. (Source: Trials)
Source: Trials - September 28, 2020 Category: Research Source Type: clinical trials

Serial MR Imaging and MR Spectroscopic Imaging for the Characterization of Lower Grade Glioma
Conditions:   Recurrent World Health Organization (WHO) Grade II Glioma;   Recurrent WHO Grade III Glioma;   WHO Grade II Glioma;   WHO Grade III Glioma Interventions:   Drug: Hyperpolarized Carbon C 13 Pyruvate;   Procedure: Magnetic Resonance Imaging;   Procedure: Magnetic Resonance Spectroscopic Imaging Sponsors:   Susan Chang;   GE Healthcare;   Sigma-Aldrich;   Phillips-Medisize Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - September 7, 2020 Category: Research Source Type: clinical trials

The VOICE-COVID-19, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Study World Health Organization (WHO)
Condition:   Covid19 Intervention:   Device: Alexa Amazon Sponsors:   McGill University Health Centre/Research Institute of the McGill University Health Centre;   Amazon Web Services (AWS) Canada Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - August 11, 2020 Category: Research Source Type: clinical trials

Comprehensive Analysis of the Program:Salud Escolar
Condition:   Obesity Intervention:   Behavioral: World Health Organization Health Promoting Schools Sponsors:   Instituto Nacional de Salud Publica, Mexico;   UNICEF;   Ministry of Education, Mexico;   Ministry of Health, Mexico Suspended (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - August 11, 2020 Category: Research Source Type: clinical trials

The VOICE-COVID-19, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Study World Health Organization (WHO)
Condition:   Covid19 Intervention:   Device: Alexa Amazon Sponsors:   McGill University Health Centre/Research Institute of the McGill University Health Centre;   Amazon Web Services (AWS) Canada Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - August 11, 2020 Category: Research Source Type: clinical trials

Comprehensive Analysis of the Program:Salud Escolar
Condition:   Obesity Intervention:   Behavioral: World Health Organization Health Promoting Schools Sponsors:   Instituto Nacional de Salud Publica, Mexico;   UNICEF;   Ministry of Education, Mexico;   Ministry of Health, Mexico Suspended (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - August 11, 2020 Category: Research Source Type: clinical trials

The VOICE-COVID-19, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Study World Health Organization (WHO)
Condition:   Covid19 Intervention:   Device: Alexa Amazon Sponsors:   McGill University Health Centre/Research Institute of the McGill University Health Centre;   Amazon Web Services (AWS) Canada Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - August 11, 2020 Category: Research Source Type: clinical trials

Comprehensive Analysis of the Program:Salud Escolar
Condition:   Obesity Intervention:   Behavioral: World Health Organization Health Promoting Schools Sponsors:   Instituto Nacional de Salud Publica, Mexico;   UNICEF;   Ministry of Education, Mexico;   Ministry of Health, Mexico Suspended (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - August 11, 2020 Category: Research Source Type: clinical trials