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NCT ID: NCT05819398 Recruiting - Clinical trials for Hidradenitis Suppurativa

Lunsayil 1: A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa

Start date: April 10, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

This study is open to adults with moderate to severe hidradenitis suppurativa (HS). The purpose of this study is to find out whether a medicine called spesolimab helps people with HS. People who have previously taken specific medicines such as immunosuppressive biologics other than Tumor necrosis factor (TNF) inhibitors cannot take part. This study has 2 parts. In Part 1, participants are divided into 4 groups of almost equal size. 3 groups get different doses of spesolimab, 1 group gets placebo. All participants get injections into a vein or under the skin. Placebo injections look like spesolimab injections, but do not contain any medicine. Every participant has an equal chance of being in each group. In the beginning, participants get the study medicine every week and later every 2 weeks. After 4 months, participants in the placebo group switch to spesolimab treatment. In Part 2, participants are divided into 2 groups. One group gets a suitable dose of spesolimab that was found in Part 1 of the study. The other group gets placebo. After 4 months, participants in the placebo group switch to spesolimab treatment. Participants join only one of the two parts. They are in the study for about 1 year. During this time, they visit the study site in the beginning every week and later every 2 weeks. Some of the visits can be done at the participant's home instead of the study site. The doctors regularly check participants' HS symptoms. The results are compared between the groups to see whether spesolimab works. The doctors also regularly check participants' general health and take note of any unwanted effects.

NCT ID: NCT05819359 Recruiting - Parkinson's Disease Clinical Trials

Efficacy, Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of BIA 28-6156 in GBA-PD

ACTIVATE
Start date: March 31, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this randomized, double-blind, placebo-controlled study is to assess the efficacy of BIA 28-6156 over placebo in delaying clinical meaningful motor progression over 78 weeks in subjects with Parkinson's disease who have a pathogenic variant in the glucocerebrosidase 1 (GBA1) gene (GBA-PD).

NCT ID: NCT05818943 Recruiting - Clinical trials for GRIN-related Disorders

Evaluation of Radiprodil in Children With GRIN-related Disorder

Start date: March 7, 2023
Phase: Phase 1
Study type: Interventional

Study RAD-GRIN-101 is a phase 1B trial to assess safety, tolerability, PK, and potential efficacy of radiprodil for the treatment of GRIN-related disorder in children with a Gain-of-Function (GoF) genetic variant. The study is open-label, so all participants will be treated with radiprodil. Subjects' participation in the study is expected to last up to six months in Part A. After the end of part A, all participants who are still eligible can choose to continue to receive radiprodil as part of an open-label long-term treatment period (Part B).

NCT ID: NCT05818813 Recruiting - Hypertension Clinical Trials

The Long-term Safety and Effect of Renal Denervation

RDN flow
Start date: April 27, 2021
Phase:
Study type: Observational

The goal of this observational study is to learn about the effects of renal denervation in patients with resistant hypertension. The main question it aims to answer is: What are the long term effects of renal denervation on blood pressure and flow within the arteries? Participants will undergo an assessment of their blood pressure, echocardiogram and invasive measurements of blood pressure and flow in the aorta and renal arteries before undergoing the renal denervation procedure. 6 months later these assessments will be repeated.

NCT ID: NCT05818345 Terminated - Obesity Clinical Trials

Pricing Interventions Based on Energy Content in Restaurants

Start date: March 27, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to examine the impact of price decreases based on energy content in a full-service restaurant on immediate dietary consumption (in terms of kilocalories (kcals), sugar, fat, and salt intake) and dietary consumption the rest of the day following the intervention; and whether the intervention effects differ based on socioeconomic position (SEP). Participants will be asked to visit the restaurant twice. At visit 1, participants will receive a control study menu with the existing pricing structure of the restaurant. At visit 2, participants will receive the same study menu with the pricing intervention introduced. For comparative purposes a smaller subgroup of participants will receive the control menu at both visit 1 and 2 to allow the researchers to estimate whether any pre-post changes occur in the absence of a pricing intervention (and whether change differs by SEP).

NCT ID: NCT05818150 Recruiting - Knee Osteoarthritis Clinical Trials

GAE Using Embosphere Microspheres vs Corticosteroid Injections for Treatment of Symptomatic Knee OA

MOTION
Start date: January 16, 2024
Phase: N/A
Study type: Interventional

This multicenter, prospective, interventional trial is designed to assess the outcome of subjects with symptomatic knee osteoarthritis (OA) that are randomized to treatment with either genicular artery embolization (GAE) using Embosphere Microspheres or steroid injection over a period of 24 months.

NCT ID: NCT05818124 Active, not recruiting - Influenza Infection Clinical Trials

Efficacy and Safety of Molnupiravir in Healthy Participants Inoculated With Experimental Influenza Virus (MK-4482-019)

Start date: August 21, 2023
Phase: Phase 1
Study type: Interventional

This is a phase 2a double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of molnupiravir (MK-4482) in healthy participants inoculated with experimental influenza virus. The primary hypotheses are that MK-4482 initiated 12 hours following intranasal inoculation of the influenza challenge virus reduces the peak viral load compared to placebo and that MK-4482 initiated 2 days following intranasal inoculation of the influenza challenge virus reduces the viral load area under the curve (AUC) compared to placebo.

NCT ID: NCT05817942 Recruiting - Ulcerative Colitis Clinical Trials

Prospective Observational Study of Effectiveness and Safety of Filgotinib in Participants With Ulcerative Colitis (UC)

GALOCEAN
Start date: June 12, 2023
Phase:
Study type: Observational

To describe the effectiveness, treatment patterns, quality of life, and safety of participants with moderately or severely active UC treated with filgotinib in a real-world setting.

NCT ID: NCT05817812 Active, not recruiting - Clinical trials for Hemophilia A, Severe

A Study Evaluating Physical Activity and Joint Health in Severe Haemophilia A Patients ≥12 Years Treated Once Weekly With Efanesoctocog Alfa

FREEDOM
Start date: July 31, 2023
Phase: Phase 3
Study type: Interventional

FREEDOM is a multicentre, open-label, single-arm, phase 3b study in Europe that aims to enrol approximately 90 previously treated severe haemophilia A patients aged ≥12 years, currently on prophylaxis. After a run-in period of 30-45 days, patients will receive efanesoctocog alfa prophylaxis, 50 IU/kg once-weekly for 24 months (additional preventive dose not permitted). An activity tracker and an electronic patient diary will be used to collect data on physical activity, bleeds, factor dosing, pain, and injuries from screening throughout the study. The primary objective is to describe changes in physical activities over 24 months on efanesoctocog alfa prophylaxis, with a primary endpoint of change from baseline in International Physical Activity Questionnaire (IPAQ) at month 24. Secondary objectives include relationship between physical activity and other variables (bleeds, joint status, pain, injuries, and quality of life); changes in joint status as assessed by HEAD-US, HJHS and MRI; occurrence of bleeds, injuries, pain. Safety and tolerability of efanesoctocog alfa will also be evaluated.

NCT ID: NCT05817461 Completed - Clinical trials for Cardiovascular Diseases

An ADME Study of [14C]AZD0780 in Healthy Male Subjects

Start date: April 19, 2023
Phase: Phase 1
Study type: Interventional

The Sponsor is developing a new test medicine, AZD0780, with the aim to lower low-density lipoprotein cholesterol (LDL-C, fatty deposits) levels and cardiovascular (heart disease) risk, when given on top of standard care. This two-part healthy volunteer study will try to identify how the test medicine is taken up, broken down and removed from the body. To help investigate this, the test medicine is radiolabelled, which means that the test medicine has a radioactive component (carbon-14; also referred as 14C) which helps us to track where the test medicine is in the body. The safety and tolerability of the test medicine will also be studied. This study will take place at one non-NHS site, enrolling up to 8 male volunteers aged between 30 and 55 years.