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NCT ID: NCT05540327 Recruiting - Clinical trials for Systemic Lupus Erythematosus

The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)

Start date: September 16, 2022
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the long term safety and efficacy of orally administered M5049 in participants with subacute cutaneous lupus erythematosus (SCLE), discoid lupus erythematosus (DLE) and/or systemic lupus erythematosus (SLE) who have completed the 24 week treatment period of Willow study (MS200569_0003 [NCT05162586]).

NCT ID: NCT05537220 Recruiting - Clinical trials for Retinitis Pigmentosa

Oral N-acetylcysteine for Retinitis Pigmentosa

NAC Attack
Start date: October 11, 2023
Phase: Phase 3
Study type: Interventional

Retinitis pigmentosa (RP) is an inherited retinal degeneration caused by one of several mistakes in the genetic code. Such mistakes are called mutations. The mutations cause degeneration of rod photoreceptors which are responsible for vision in dim illumination resulting in night blindness. After rod photoreceptors are eliminated, gradual degeneration of cone photoreceptors occurs resulting in gradual constriction of side vision that eventually causes tunnel vision. Oxidative stress contributes to cone degeneration. N-acetylcysteine (NAC) reduces oxidative stress and in animal models of RP it slowed cone degeneration. In a phase I clinical trial in patients with RP, NAC taken by month for 6 months caused some small improvements in two different vision tests suggesting that long-term administration of NAC might slow cone degeneration in RP. NAC Attack is a clinical trial being conducted at many institutions in the US, Canada, Mexico, and Europe designed to determine if taking NAC for several years provides benefit in patients with RP.

NCT ID: NCT05536804 Recruiting - Obesity Clinical Trials

A Study of Tirzepatide (LY3298176) in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes

TREASURE-CKD
Start date: February 8, 2023
Phase: Phase 2
Study type: Interventional

We are doing this study to learn more about how tirzepatide may help fight chronic kidney disease in people with obesity with or without type 2 diabetes (T2D). The study will last about 56 weeks and include up to 12 visits.

NCT ID: NCT05535946 Recruiting - Ulcerative Colitis Clinical Trials

ABTECT - Maintenance

Start date: January 16, 2023
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized study to evaluate the long-term efficacy and safety of ABX464 50mg and 25mg administered once daily (QD) as maintenance therapy in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies [corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)] and/or advanced therapies [biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors]. This study is the maintenance phase of both previous induction studies ABX464-105 and ABX464-106. All eligible subjects who have completed either one of the induction studies above mentioned, will be given the opportunity to take part in the present ABX464-107 maintenance study and will be randomized to either a double blind, placebo-controlled part (Part #1) or allocated to ABX464 50mg or 25mg open label treatment arms (Part #2) depending on their clinical response at the end of induction. This study consists of a 44-week treatment phase and a 28-days follow-up period consisting in the End of Study (EOS) visit.

NCT ID: NCT05534984 Recruiting - Monkeypox Clinical Trials

Study of Tecovirimat for Human Monkeypox Virus

STOMP
Start date: September 12, 2022
Phase: Phase 3
Study type: Interventional

A5418 is a randomized, placebo-controlled, double-blind study to establish the efficacy of tecovirimat for the treatment of people with laboratory-confirmed or presumptive HMPXV disease.

NCT ID: NCT05534009 Recruiting - COVID-19 Clinical Trials

Health Care Workers Cohort Study in the EuCARE Project (EuCARE-HCW)

Start date: April 1, 2022
Phase:
Study type: Observational

The WP3 healthcare workers cohort in EuCARE is an observational multicentre study including collection of retrospective (historical) and prospective data and sample collection from health care workers with either a vaccination or a confirmed SARS-CoV-2 infection. Samples from HCW are sent to central laboratories for WP2 study were the impact of different variants in humoral and cellular immunity is to be analysed by biostatistical methods and with artificial intelligence in WP5. This analysis will focus on the impact on vaccine escape of viral variants / viral sequences as well as on any escape from any combination of natural and vaccine induced immunity. Eight countries will participate (Portugal, Italy, Germany, Lithuania, Georgia, Russia, Vietnam and Mexico).

NCT ID: NCT05533554 Completed - Clinical trials for Alcohol; Harmful Use

Brief Intervention Based on the Theory of Planned Behavior to Reduce Alcohol Consumption in University Students

Start date: September 23, 2022
Phase: N/A
Study type: Interventional

Brief behavioral intervention designed from the guidelines of the Theory of Planned Action (TAP) of Ajzen (1991). It has the general objective of reducing the intention and hazardous and harmful consumption of alcohol in young university students in the first year of their undergraduate degree. The following specific objectives are considered: (a) Impact on the personal and descriptive norm by modifying the perception of the actual use of alcohol and its level of acceptance among the population of university students. (b) Modify attitudes towards consumption by reducing the value attributed to the expectations associated with risky alcohol consumption. (c) Increase perceived behavioral control and self-efficacy to avoid alcohol consumption behavior by: establishing a goal, consumption planning, and increase assertive communication.(d) Reduce the negative consequences of the use of alcohol in different situations of young people through pleasant healthy activities. e) Increase the intention to seek help for alcohol-related problems.The intervention will be developed through 3 phases. The first phase corresponds to the pre-intervention evaluation, the second phase concerns the two intervention sessions and the third phase is the post-intervention evaluation. Hypothesis: The mean alcohol consumption will be lower in young adults with hazardous and harmful alcohol consumption in the experimental group who received a brief online intervention compared to the control group.

NCT ID: NCT05533073 Completed - Healthy Clinical Trials

Comparative Bioavailability Study Between Etoricoxib and Tramadol, Administered Individually or in Combination

Start date: August 3, 2020
Phase: Phase 1
Study type: Interventional

Study carried out in the Clinical and Analytical Unit of the Department of Pharmacology and Toxicology of the Faculty of Medicine of the Autonomous University of Nuevo León, with the objective of comparing the bioavailability (Cmax, AUC) of an oral formulation containing Etoricoxib 90 mg / Tramadol 50 mg in combination with that of two oral formulations, Etoricoxib 90 mg or Tramadol 50 mg, administered as a single dose, in healthy subjects under fasting conditions.

NCT ID: NCT05531773 Recruiting - COVID-19 Clinical Trials

Post COVID-19 Condition

Start date: July 1, 2022
Phase:
Study type: Observational

The EuCARE-POSTCOVID study is an observational multicentre study enrolling COVID-19 patients recovered from the acute phase of disease to investigate the prevalence and possible predictors of post COVID-19 condition. The study will retrospectively analyze data already collected at the post COVID-19 outpatients services of the participating centers; furthermore, a prospective cohort study will be performed.

NCT ID: NCT05531565 Recruiting - Clinical trials for Subacute Cutaneous Lupus Erythematosus

A Study to Assess the Efficacy and Safety of BIIB059 (Litifilimab) in Participants With Active Subacute Cutaneous Lupus Erythematosus (SCLE) and/or Chronic Cutaneous Lupus Erythematosus (CCLE) With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy

AMETHYST
Start date: September 13, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objectives of the study are to evaluate the efficacy of BIIB059 (litifilimab) compared with placebo in reducing skin disease activity measured by the Cutaneous Lupus Activity of Physician's Global Assessment-Revised (CLA-IGA-R) score [Parts A and B (US)] and the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score [Part B (ROW)] in participants with active SCLE and/or CCLE with or without systemic manifestations and refractory and/or intolerant to antimalarials. The secondary objectives of the study are to evaluate the efficacy of BIIB059 in reducing SCLE and/or CCLE disease activity by CLA-IGA-R, CLASI-A; to evaluate additional efficacy parameters of BIIB059 in reducing SCLE and/or CCLE disease activity; safety; tolerability; and immunogenicity of BIIB059 [Parts A and B].