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NCT ID: NCT05831319 Recruiting - Clinical trials for Peripheral Arterial Disease

Evaluation of Standard of Care Practices, Procedural Outcomes and In-hospital Complications of Peripheral Endovascular Procedures

BIO-OSCAR SOC
Start date: May 29, 2023
Phase:
Study type: Observational

Significant advances in dedicated materials and techniques along with increased operator experience led to a significant increment in procedural success rate of peripheral endovascular interventions, exceeding 90% in expert hands with reported low procedural complication rates. However, there are still lack of data on procedural outcomes, in-hospital complications, and resource utilization on treatment of (complex) lesions in the femoral, popliteal and infrapopliteal artery in the real-world condition in Europe.

NCT ID: NCT05827016 Recruiting - Multiple Myeloma Clinical Trials

A Study to Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplant in Participants With Newly Diagnosed Multiple Myeloma

Start date: June 22, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the effectiveness of iberdomide maintenance to lenalidomide maintenance therapy after autologous stem cell transplantation (ASCT) in participants with newly diagnosed multiple myeloma (NDMM).

NCT ID: NCT05826600 Recruiting - Solid Tumor Clinical Trials

A Study of OMX-0407 in Patients With Previously Treated Solid Tumours That Can't be Removed Surgically

Start date: March 30, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The main purpose of this study is to determine the safety of different doses of OMX-0407. The study will also evaluate how the drug is distributed and exits the human body.

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: NCT05818410 Recruiting - Clinical trials for Lower Limb Amputation Below Knee (Injury)

Human-Prosthetic Interaction: Brain & Technology After Lower-Limb Loss

HumanIT
Start date: September 1, 2023
Phase: N/A
Study type: Interventional

This study evaluates brain neuroplasticity and functional performance in people with unilateral lower limb amputation.

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: NCT05815602 Recruiting - Clinical trials for IBS - Irritable Bowel Syndrome

Ebastine Versus Mebeverine in IBS Patients

Start date: March 30, 2023
Phase: Phase 3
Study type: Interventional

Multicenter randomized controlled clinical trial comparing ebastine and mebeverine as treatment of irritable bowel syndrome Trial rationale 1. To perform a randomized superiority trial comparing the clinical efficacy of ebastine and mebeverine 2. To evaluate the impact of treatment with ebastine compared to mebeverine on quality of life and quality-adjusted life years Primary objective To provide further evidence of the superiority of histamine 1 receptor antagonism as novel treatment for patients with non-constipated IBS, as compared to mebeverine, one of the spasmolytics currently used as first line treatment of IBS. Secondary objective(s) To provide evidence that the histamine 1 receptor antagonist ebastine is more effective in reducing abdominal pain compared to the commonly used antispasmodic mebeverine

NCT ID: NCT05815576 Recruiting - Clinical trials for Chronic Ankle Instability

Biomechanics and Intrinsic Foot Muscle Roles in Subjects With Chronic Ankle Instability

Start date: February 3, 2023
Phase: N/A
Study type: Interventional

The current study involves a prospective interventional study that primarily intends to compare foot joint loadings of participants with chronic ankle instability (CAI) with those of subjects who recovered after an ankle sprain (LAS copers) and healthy controls during running and more challenging tasks. This study further aims to explore the impact of foot muscle properties and fatigue on the same biomechanical outcomes. Therefore, the investigators will recruit 72 participants (24 per group) aged from 18 to 44 years. Each of them will come only once to the CMAL laboratory (UZ Leuven, Pellenberg).

NCT ID: NCT05814627 Recruiting - Clinical trials for Rheumatoid Arthritis

Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib Compared to Subcutaneous Adalimumab in Adult Participants With Moderate to Severe Rheumatoid Arthritis

SELECT- SWITCH
Start date: June 15, 2023
Phase: Phase 3
Study type: Interventional

Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. This study will assess how safe and effective upadacitinib is in treating RA when compared to adalimumab in adult participants with inadequate response or intolerance to one TNF-inhibitor who are on a stable dose of methotrexate (MTX). Adverse events and change in disease activity will be assessed. Upadacitinib is an approved drug for the treatment of RA. This study is double-blinded means that neither the participants nor the study doctors will know who will be given upadacitinib and who will be given adalimumab. Study doctors put the participants in 1 of the 2 groups, called treatment arms randomly, to receive either upadacitinib or adalimumab. There is 1 in 2 chance that participants will receive adalimumab. Each group consists of 2 periods. Approximately 480 participants diagnosed with RA will be enrolled in approximately 250 sites across the world. Participants will receive the oral upadacitinib once daily and matching adalimumab placebo every other week, or the subcutaneous adalimumab every other week and matching upadacitinib placebo once daily during Period 1. Eligible participants will continue to receive same study treatment in Period 2 as assigned in Period 1 and will be followed for 30 days and 70 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

NCT ID: NCT05811624 Recruiting - Clinical trials for Chronic Low-back Pain

Lifestyle Intervention in Overweight/Obese Chronic Low Back Pain (CLBP) Patients: an International Multi-center RCT

BO2WL
Start date: April 13, 2023
Phase: N/A
Study type: Interventional

Chronic low back pain (CLBP) is the most expensive cause of workrelated disability: it causes the highest number of years lived with disability. The most severe and debilitated CLBP patients often have comorbidities such as overweight and obesity. Despite the growing body of scientific literature pointing towards the close interaction between overweight/obesity and CLBP, few treatment programs for people with CLBP nowadays take overweight into account. Therefore this study will examine the added value of a behavioral weight reduction program (changes in diet, behavior and physical exercise) to current best evidence rehabilitation (pain neuroscience education plus cognition-targeted exercise therapy) for overweight or obese people with CLBP. An international, multicenter randomized controlled trial comparing a behavioral weight reduction program combined with pain neuroscience education and cognition-targeted exercise therapy versus pain neuroscience education and cognition-targeted exercise therapy alone, will be conducted. The primary outcome is pain and the primary endpoint was chosen at 12 months follow-up; secondary outcomes include health care use and daily functioning (see detailed description of outcomes for an overview of all secondary outcomes). If the promising results of the proof of concept study are corroborated, the new intervention will have a high socio-economic impact, including an annual health care cost reduction of €66 million in Switzerland, and €60 million in Flanders, and is expected to increase life expectancy in the long term.