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Virus Diseases clinical trials

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NCT ID: NCT05452187 Completed - Clinical trials for Inflammatory Bowel Diseases

Evaluation of the Safety and Effectiveness of Direct-acting Antiviral Drugs in the Treatment of Hepatitis C in Patients With Inflammatory Bowel Disease: National Multicenter Study

MIC project
Start date: March 12, 2021
Phase:
Study type: Observational

The prevalence of hepatitis C virus infection (HCV) in patients with inflammatory bowel disease (IBD) ranges from 1-6%. Direct-acting antivirals (DAAs), with cure rates >90%, represent a radical change from interferon-based therapies. The ECCO (European Crohn's and Colitis Organisation) guidelines (Kucharzik T, Ellul P, Greuter T, et al. ECCO Guidelines on the Prevention, Diagnosis, and Management of Infections in Inflammatory Bowel Disease. J Crohn's Colitis. 2021;15(6):879-913) warns about the risk of IBD reactivation due to the effect of DAAs, but HCV management in this situation is uncertain given the lack of evidence. The project is proposed as the largest retrospective multicenter descriptive study carried out to evaluate the use of DAAs for HCV eradication in patients with IBD. The Eneida database (Zabana Y, Panés J, Nos P, et al. The ENEIDA registry (Nationwide study on genetic and environmental determinants of inflammatory bowel disease) by GETECCU: Design, monitoring, and functions. Gastroenterol y Hepatol. 2020;43(9):551-8.) of the Spanish Working Group on Crohn's Disease and Ulcerative Colitis (GETECCU) is an adequate registry to identify patients with HCV infection. The serological status of the infection is frequently recorded in the ENEIDA database, and it is generally evaluated at the time of IBD diagnosis, before starting immunosuppressive treatment. The ENEIDA registry has the advantage over large population studies that researchers have access to relevant details of the clinical history, which can respond to the controversies raised. This multicenter retrospective descriptive study will provide useful information to be able to give evidence-based recommendations regarding treatment of HCV in patients with IBD.

NCT ID: NCT05422326 Completed - Clinical trials for Respiratory Tract Infections

A Study to Evaluate Safety and Immunogenicity of One or Two Booster Vaccinations With H5N6 Influenza Vaccine in Adults Primed With H5N1 Influenza Vaccine or Unprimed

Start date: July 18, 2022
Phase: Phase 2
Study type: Interventional

This is a Phase 2, randomized, multi-center study in approximately 300 adults who received 2 doses of aH5N1c or placebo in and completed the parent study V89_18 in the <65 years of age cohort. The study investigates whether two priming doses of MF59-adjuvanted H5N1 cell culture-derived vaccine (aH5N1c) followed by one or two booster vaccinations with a MF59-adjuvanted H5N6 cell culture derived vaccine (aH5N6c) 3 weeks apart elicit immune responses to the antigens used for priming (H5N1) and boosting (H5N6) after first and second heterologous booster vaccination. Eligible subjects, who received 2 doses of aH5N1c in the parent study V89_18 are randomized in a 1:1 ratio to receive either two aH5N6c vaccinations, 3 weeks apart (group 1) or an aH5N6c vaccination on Day 1 and saline placebo on Day 22 (group 2). Eligible subjects, who received placebo in the parent study will receive two aH5N6c vaccinations, 3 weeks apart (group 3). After the second vaccine administration, subjects are monitored for approximately 6 months for safety and antibody persistence. The total study duration will be approximately 7 months per subject.

NCT ID: NCT05414981 Completed - Chronic Hepatitis B Clinical Trials

A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-H3733 in Subjects With Chronic Hepatitis B Virus Infection

Start date: August 7, 2022
Phase: Phase 1
Study type: Interventional

This is a randomized, blinded, placebo-controlled, dose-ranging Phase 1b study of the safety, PK, and antiviral activity of ABI-H3733 in treatment-naïve or off-treatment chronic Hepatitis B virus (cHBV) subjects that are Hepatitis B e antigen (HBeAg) positive or negative. The study will enroll up to 5 sequential cohorts of 10 subjects each, for a total of up to 50 subjects, randomized 8:2 to receive ABI-H3733 or placebo.

NCT ID: NCT05412173 Completed - COVID-19 Clinical Trials

Pharmacokinetics and Bioequivalence of Molnupiravir, 200 mg Capsules and Lagevrio, 200 mg Capsules in Healthy Volunteers

Start date: April 22, 2022
Phase: N/A
Study type: Interventional

The study aimed for: 1. Comparative evaluation of the safety of the drug Molnupiravir, capsules, 200 mg (JSC "Valenta Pharm", Russia), and Lagevrio, capsules, 200 mg (Merck Sharp & Dohme (UK) Limited, UK), based on the analysis of adverse events (AEs); 2. Comparative assessment of pharmacokinetic parameters and bioequivalence of the drug Molnupiravir, capsules, 200 mg (Valenta Pharm JSC, Russia), and Lagevrio, capsules, 200 mg (Merck Sharp & Dohme (UK) Limited, UK), in healthy volunteers in fasted conditions.

NCT ID: NCT05385445 Completed - Dementia Clinical Trials

Electronic Medical Records to Increase Adherence to the Choosing Wisely Recommendations

Start date: January 1, 2016
Phase: N/A
Study type: Interventional

Audit and Feedback (A&F), a strategy aimed at promoting modified practice through performance feedback, is a method to change provider behaviour and reduce unnecessary medical services. This study aims to assess the use of A&F to change: 1. antibiotic prescribing for viral infections 2. antipsychotic prescribing to patients with dementia 3. routine measure of vitamin D in low risk adults 4. annual screening blood tests (without direct indication by the risk profile of the patient)

NCT ID: NCT05381454 Completed - COVID-19 Clinical Trials

An Open Label Study in Adults to Test the Efficacy of Mitoquinone/Mitoquinol Mesylate to Prevent Severe Viral Illness

Start date: April 28, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

Open label clinical trial of persons (adults) that will determine the safety and efficacy of the diet supplement oral mitoquinone/mitoquinol mesylate (Mito-MES) to prevent the development and progression of severe viral infections like COVID-19 after high-risk exposure to a person with possible respiratory viral infection such as SARS-CoV-2 infection in persons who will receive Mito-MES compared to persons who will not receive Mito-MES (controls).

NCT ID: NCT05374668 Completed - Post-COVID-19 Clinical Trials

The Effects of Video-based Yoga Interventions for Patients With Post-corona Virus Disease

Yoga
Start date: March 22, 2021
Phase: N/A
Study type: Interventional

Aimed to understand if yoga exercises are superior to posture exercises as an alternative exercise therapy for relieving musculoskeletal pain, improving functional status, and improving quality of life during the post- corona virus disease (COVID-19) period?

NCT ID: NCT05364268 Completed - Clinical trials for SARS-CoV-2 Infection

Evaluation of the AudibleHealth Dx AI/ML-Based Dx SaMD Using FCV-SDS in the Diagnosis of COVID-19 Illness: Clinical Validation

Start date: May 4, 2022
Phase:
Study type: Observational

The AudibleHealth Dx is a diagnostic software as a medical device (Dx SaMD) consisting of an ensemble of software subroutines that interacts with a proprietary database of Signal Data Signatures (SDS), using Artificial Intelligence/Machine Learning (AI/ML) to analyze forced cough vocalization signal data signatures (FCV-SDS) for diagnostic purposes. This study will evaluate the performance of the AudibleHealth Dx in comparison to a standard of care Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) test for the diagnosis of COVID-19. A secondary purpose of the study will be usability testing of the device for participants and providers.

NCT ID: NCT05321433 Completed - COVID-19 Clinical Trials

Tobacco Use and the Risk of COVID-19 and Adverse Outcomes

Start date: April 1, 2022
Phase:
Study type: Observational [Patient Registry]

This is an observational study of pooled population-based samples in three Nordic countries. Country-specific data has already been analysed in previous studies in Sweden, Finland, and Norway. The primary objective is to examine the association between tobacco use, the risk of SARS-CoV-2 infection, and adverse Outcomes using pooled population-based samples.

NCT ID: NCT05307991 Completed - HIV Infections Clinical Trials

Integrating Enhanced HIV PrEP Into a STI Clinic in Lilongwe

Start date: March 9, 2022
Phase:
Study type: Observational

This is a prospective cohort study evaluating acceptability, feasibility, and effectiveness of integrating HIV pre-exposure prophylaxis (PrEP) into a sexually transmitted infection (STI) clinic alongside assisted partner notification and etiologic STI testing in Lilongwe, Malawi.