Novavax and Serum Institute of India Announce World Health Organization Grants Emergency Use Listing for NVX-CoV2373 COVID-19 Vaccine
First EUL granted by WHO for a protein-based COVID-19 vaccine
EUL vaccine manufactured and marketed by SII as COVOVAX™
WHO EUL for Nuvaxovid™ currently under assessment; will be completed following European Medicines Agency (EMA)... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 17, 2021 Category: Pharmaceuticals Source Type: clinical trials
World Health Organization Strategic Advisory Group of Experts (SAGE) Interim Recommendation Supports Use of Johnson & Johnson COVID-19 Vaccine as a Booster
Growing body of evidence supports use of the Johnson& Johnson COVID-19 vaccine as both a mix-and-match and homologous booster, following primary vaccination regimen
NEW BRUNSWICK, N.J., December 9, 2021– Johnson& Johnson... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 9, 2021 Category: Pharmaceuticals Source Type: clinical trials
Effects of a periodized circuit training protocol delivered by telerehabilitation compared to face-to-face method for knee osteoarthritis: a protocol for a non-inferiority randomized controlled trial
This study presents a single-blinded protocol for a non-inferiority randomized controlled trial. One hundred participants diagnosed with knee OA (grades II and III Kellgren and Lawrence system), aged 40 years or more, and BMI< 30 kg/m2 will be randomly divided into two groups: telerehabilitation (TR) and face-to-face (FtF) circuit training. The FtF group will perform a 14-week periodized circuit training protocol supervised by a physical therapist, 3 times a week. The TR group will perform the same exercise protocol at home, at least 3 times a week. In addition, the TR group will be able to follow the execution an...
Source: Trials - December 6, 2021 Category: Research Source Type: clinical trials
A multi-centre, randomized, double-blind, placebo-controlled clinical trial of the efficacy and safety of chloroquine phosphate, hydroxychloroquine sulphate and lopinavir/ritonavir for the treatment of COVID-19 in Lagos State: study protocol for a randomized controlled trial
DiscussionThe current study is of strategic importance for Lagos State in potentially curbing the health, social and economic burden of COVID-19 disease. Should the current study demonstrate that either of the three intervention drugs is more efficacious than standard therapy alone, the State Ministry of Health will develop an evidence-based guideline for the management of COVID-19 in Lagos State. The findings will also be shared nationally and with other states which may lead to a standardized national guideline for the treatment of COVID-19 in Nigeria.Trial registrationPan African Clinical Trials RegisterPACTR20200480127...
Source: Trials - December 4, 2021 Category: Research Source Type: clinical trials
Impact of perinatal environmental health education intervention on exposure to endocrine disruptors during pregnancy —PREVED study: study protocol for a randomized controlled trial
DiscussionPREVED is a ground-breaking intervention research project dedicated to perinatal environmental health education that aims to identify pollutant sources in daily life and to offer accessible and realistic alternative solutions, by promoting the sharing of know-how and experience in a positive and non-alarmist approach.Trial registrationClinicalTrials.gov:NCT03233984 (current status: ongoing). Retrospectively registered on 31 July 2017 (https://clinicaltrials.gov/ct2/show/NCT03233984) because when the first participant was enrolled in this non-drug intervention,ClinicalTrials.gov was centered in therapeutic trials....
Source: Trials - December 4, 2021 Category: Research Source Type: clinical trials
Non-inferiority of low-dose compared to standard high-dose calcium supplementation in pregnancy: study protocol for two randomized, parallel group, non-inferiority trials in India and Tanzania
DiscussionThe trials will provide causal evidence on the non-inferiority of low-dose as compared to the standard high-dose supplementation in India and Tanzania. A single tablet, low-dose calcium supplementation regimen may improve individual-level adherence, reduce programmatic costs, and ultimately expand implementation of routine calcium supplementation in pregnancy in populations with low dietary calcium intake.Trial registrationClinicalTrials.gov identifier:NCT03350516; registered on 22 November 2018. Clinical Trials Registry —India identifier:CTRI/2018/02/012119; registered on 23 February 2018.Tanzania Medicines an...
Source: Trials - November 24, 2021 Category: Research Source Type: clinical trials
Safety and efficacy of intermittent presumptive treatment with sulfadoxine-pyrimethamine using rapid diagnostic test screening and treatment with dihydroartemisinin-piperaquine at the first antenatal care visit (IPTp-SP+): study protocol for a randomized controlled trial
DiscussionA hybrid approach to IPTp that combines screening and treatment with an artemisinin-based combination therapy at the first visit with standard IPTp-SP is hypothesized to confer added benefit over IPTp-SP alone in a high malaria transmission area with prevalent SP resistant parasites.Trial registrationPan African Clinical Trials Registry201905721140808. Registered retrospectively on 11 May 2019 (Source: Trials)
Source: Trials - November 20, 2021 Category: Research Source Type: clinical trials
Meeting report: South African Medical Research Council Standard of Care in Clinical Research in Low- And Middle-Income Settings Summit, November 2017
This report summarizes the presentations and discussions from the summit in order to highlight the importance of SoC in HIV prevention clinical trials. (Source: Trials)
Source: Trials - November 6, 2021 Category: Research Source Type: clinical trials
The 4MOTHERS trial of the impact of a mobile money-based intervention on maternal and neonatal health outcomes in Madagascar: study protocol of a cluster-randomized hybrid effectiveness-implementation trial
DiscussionA cluster-randomized, hybrid effectiveness-implementation design allows for a robust approach to determine whether the MMHW is a feasible and beneficial intervention in a resource-restricted public healthcare environment. We expect the results of our study to guide future initiatives and health policy decisions related to maternal and neonatal health and universal healthcare coverage through technology in Madagascar and other countries in sub-Saharan Africa.Trial registrationThis trial was registered on March 12, 2021: Deutsches Register Klinischer Studien (German Clinical Trials Register), identifier:DRKS0001492...
Source: Trials - October 21, 2021 Category: Research Source Type: clinical trials
Measuring the effects of a personalized music intervention on agitated behaviors among nursing home residents with dementia: design features for cluster-randomized adaptive trial
DiscussionThis adaptive trial allows investigators to estimate the impact of a popular non-pharmaceutical intervention (personalized music) on residents ’ behaviors, under pragmatic, real-world conditions testing two implementation strategies. This design has the potential to reduce the research timeline by improving the likelihood of powered results, increasingly enrolling residents most likely to benefit from intervention, sequentially assessing the effectiveness of implementation strategies in the same trial, and creating a statistical model to reduce the future need for onsite data collection. The design may also inc...
Source: Trials - October 7, 2021 Category: Research Source Type: clinical trials
Single-dose HPV vaccination efficacy among adolescent girls and young women in Kenya (the KEN SHE Study): study protocol for a randomized controlled trial
This study will evaluate single-dose HPV vaccine efficacy in Africa and has the potential to guide public health policy and increase HPV vaccine coverage. The secondary aims will assess generalizability of the trial results by evaluating immunobridging from younger ages, durability of the immune response, and the long-term health benefits and cost of single-dose HPV vaccine delivery.Trial registrationClinicalTrials.govNCT03675256. Registered on September 18, 2018 (Source: Trials)
Source: Trials - September 27, 2021 Category: Research Source Type: clinical trials
Employing a mobile health decision aid to improve decision-making for patients with advanced prostate cancer and their decision partners/proxies: the CHAMPION randomized controlled trial study design
DiscussionThe CHAMPION intervention is designed to leverage dynamic resources, such as CPN teams, mHealth technology, and theory-based information, to support decision-making for advanced prostate cancer patients and their decision partners. This intervention is intended to engage decision partners in addition to patients and represents a novel, sustainable, and scalable way to build on individual and community strengths. Patients from minority populations, in particular, may face unique challenges during clinical communication. CHAMPION emphasizes the inclusion of decision partners and CPNs as facilitators to help address...
Source: Trials - September 16, 2021 Category: Research Source Type: clinical trials
The future is now: our experience starting a remote clinical trial during the beginning of the COVID-19 pandemic
ConclusionsFlexibility in design, a multidisciplinary research team, prompt cooperation among research, funding, ethics review groups, and finding innovative study approaches enabled this work. Concerns were balancing study recruitment against unduly influencing individuals anxious for protection from the pandemic and exclusion of groups based on lack of Internet access and technology. An issue to address going forward is establishing research cooperation across community health systems before emergencies develop.Trial registrationClinicalTrials.govNCT04652648. Registered on December 3, 2020. (Source: Trials)
Source: Trials - September 7, 2021 Category: Research Source Type: clinical trials
Efficacy and safety of intramuscular administration of allogeneic adipose tissue derived and expanded mesenchymal stromal cells in diabetic patients with critical limb ischemia with no possibility of revascularization: study protocol for a randomized controlled double-blind phase II clinical trial (The NOMA Trial)
DiscussionChronic lower limb ischemia has limited therapeutic options and constitutes a public health problem in both developed and underdeveloped countries. Given that the current treatment is not established in daily clinical practice, it is essential to provide evidence-based data that allow taking a step forward in its clinical development. Also, the multidisciplinary coordination exercise needed to develop this clinical trial protocol will undoubtfully be useful to conduct academic clinical trials in the field of cell therapy in the near future.Trial registrationClinicalTrials.govNCT04466007. Registered on January 07,...
Source: Trials - September 6, 2021 Category: Research Source Type: clinical trials
Effects of a Brazilian cardioprotective diet and nuts on cardiometabolic parameters after myocardial infarction: study protocol for a randomized controlled clinical trial
The objective of this trial is to evaluate the effects of the Brazilian Cardioprotective Diet (DIetaCArdioprotetoraBrasileira, DICA Br) based on consumption of inexpensive locally accessible foods supplemented or not with mixed nuts on cardiometabolic features in patients with previous myocardial infarction (MI).MethodsDICA-NUTS study is a national, multicenter, randomized 16-week follow-up clinical trial. Patients over 40 years old with diagnosis of previous MI in the last 2 to 6 months will be recruited (n = 388). A standardized questionnaire will be applied to data collection and blood samples will be obtained. Pat...
Source: Trials - September 1, 2021 Category: Research Source Type: clinical trials
