Frontenay-rohan-rohan, France

Taekwondo for Axial Spondyloarthritis

This study is designed as a single-blind, parallel-group, exploratory pilot randomized controlled trial to evaluate the efficacy and safety of a 12-week Taekwondo training program in patients with ankylosing spondylitis and axial spondyloarthritis. 1) Total Taekwondo Intervention Period: 24 Weeks 1. Initial 12 weeks: Comparison between the Taekwondo training group and the control group in an RCT. 2. Post-RCT 12 weeks: The control group receives the same Taekwondo training, allowing for a pre- and post-intervention comparison. 2) Assessment Time Points 1. Baseline (Pre-Intervention): Within 2 weeks before the start of the 12-week Taekwondo training. 2. End of RCT (Post-Intervention): Within 1 week after completing the initial 12-week Taekwondo training. The primary effects of the intervention will be assessed through comparisons between the Taekwondo training group and the control group. 3. End of Control Group Intervention: Within 1 week after completing the 12-week Taekwondo training in the control group. Pre- and post-intervention comparisons will be conducted for the control group. 3) Group Composition 1. Taekwondo Training Group: Participates in a structured 12-week Taekwondo training program during the RCT period. 2. Control Group: Maintains usual daily activities for the initial 12 weeks, followed by participation in the same 12-week Taekwondo training program. 4) Blinding Procedure 1. Evaluator Blinding: The assessors conducting the outcome evaluations will remain blinded to the intervention status of participants to ensure unbiased assessments. All evaluations will be performed in a neutral setting. 2. Role of the Treating Physician: The treating physician will be responsible for managing participants' medication and medical history but will not be involved in any part of the patient evaluation process, including the assessment of the intervention's effects. 5) Randomization Method 1. Participants meeting the inclusion and exclusion criteria will undergo stratified randomization to ensure balanced distribution. 2. Stratification factors may include gender, age (below 40 years vs. 40 years and older), or disease severity (presence vs. absence of syndesmophytes on X-ray imaging). Final stratification factors will be determined based on the characteristics of enrolled participants. 3. Randomization will be performed by a designated research team member using Microsoft Excel's random function or other randomization software to allocate participants into the Taekwondo training group and the control group.

Initial Pilot Study to Evaluate the Safety and Temporary Symptom Improvement Efficacy of CKD-981

The aim of this pilot study is to evaluate the efficacy and safety of CKD-981 in patients with mild to moderate degenerative knee osteoarthritis who have been experiencing pain more than 8 weeks

Pivotal Trial of SAT-014 for Trauma and Stressor-Related Disorder Symptoms

Stress-related mental disorders, including Post-Traumatic Stress Disorder (PTSD) and Adjustment Disorder (AD), are caused by traumatic experiences or significant stressors. These conditions can lead to social dysfunction, decreased quality of life, and increased suicide risk if untreated. With high global prevalence and rising patient numbers, existing treatments such as psychotherapy and pharmacotherapy have limitations. Digital therapeutics (DTx) offer a more accessible, cost-effective solution with less external exposure. Based on studies showing the effectiveness of therapies like EMDR and MBCT, SAT-014, a cognitive therapy software, was developed. An exploratory clinical trial was conducted to assess its initial safety and efficacy for alleviating symptoms of PTSD and AD. This trial, involving 110 participants over 19 years old, aims to evaluate SAT-014's efficacy in comparison with conventional treatments and assess its safety. The primary efficacy endpoint is the change in PCL-5 score at Week 6 (Visit 7) compared to baseline, while secondary endpoints include changes in PCL-5, IES-R, BAI, PHQ-9, HAM-A, CGI, and SF-12 scores at various time points.

Evaluate the Efficacy and Safety of CMG190303 in Patients with Type 2 Diabetes and Dyslipidemia

A Phase 1b/2a, Study Evaluating the Safety, PK/PD and Efficacy of NS101 in Healthy Volunteers and SSNHL Patients

A Study of Jyseleca Tablet (Filgotinib Maleate) in Korean Participants

FFR Versus IVUS with Angiography-Derived FFR for Clinical Outcomes in Patients with Coronary Artery Disease

1. Hypothesis: The IVUS-guided stent implantation after angiography-derived FFR-based decision-making will show superiority in terms of a lower rate of patients-oriented composite outcomes (POCO) at 24 months after randomization compared with the FFR-guided PCI strategy in patients with coronary stenosis. 2. Research materials and indication for revascularization: 2.1 Experimental group: PCI will be performed if angiography-derived FFR ≤0.80 and will be deferred if angiography-derived FFR >0.80; If PCI is performed, PCI optimization using IVUS will be performed following the recommended criteria: ① Plaque burden at stent edge ≤55%; ② Minimal stent area ≥ 5.5 mm2, or minimal stent area ≥ distal reference lumen area. 2.2 Control group: PCI will be performed if FFR ≤0.80 and will be deferred if FFR >0.80; If PCI is performed, PCI optimization using FFR will be performed following the recommended criteria: ① Post-PCI FFR ≥ 0.88, or ② Post-PCI ΔFFR ([FFR at stent distal edge] - [FFR at stent proximal edge]) < 0.05. 3. Sample size: In the post-hoc analysis of the FLAVOUR I study applying QFR analysis, the 2-year POCO rate was 13.0% in the PCI group with FFR ≤0.80 and undergoing FFR-based PCI optimization and 7.1% in the PCI group with QFR ≤0.80 and undergoing IVUS-based PCI optimization. Meanwhile, the 2-year POCO rate was 5.8% and 6.5% in the deferral of PCI group with FFR >0.80 and QFR >0.80, respectively. Assuming a PCI rate of 70% in patients with coronary artery lesions with 50-90% stenosis that is the inclusion criteria for the current study, and considering event rates from historical studies evaluating FFR- and QFR-guided PCI strategies, the cumulative incidence rate of POCO at 24 months was estimated to be 13.0% in the control group (FFR group) and 9.0% in the experimental group (QFR-IVUS group). - Primary endpoint: POCO, defined as a composite of death from any cause, MI, or any revascularization at 24 months after randomization. - Design: superiority - Sampling ratio: experimental group : control group = 1:1 - Type I error (α): One-sided 2.5% - Accrual time: 24 months - Total time: 4 years (accrual 24 months + follow-up 24 months) - Assumption: POCO 13.0% vs. 9.0% in control or experimental group, respectively - Statistical power (1- β): 90% - Primary statistical method: Kaplan-Meier survival analysis with log-rank test - Estimated attrition rate: total 10% - Stratification in randomization: Presence of diabetes mellitus Based on the above assumption, we would need total 1,942 patients (971 patients in each group) with consideration of an attrition rate.

A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Crohn's Disease

The drug being tested in this study is TAK-279. TAK-279 is being tested to treat participants with moderately to severely active Crohn's disease. The study will look at the efficacy and safety of TAK-279. The study will enroll approximately 268 participants. During the Induction Period participants will be randomly assigned to one of the following treatment groups in a ratio of 1:1:1:1 to receive TAK-279 or placebo which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need): 1. TAK-279 Dose 1 2. TAK-279 Dose 2 3. TAK-279 Dose 3 4. Placebo This multi-center trial will be conducted globally. The overall study duration is approximately 60 weeks including a 4-week safety follow-up period.

Study of Tilpisertib Fosmecarbil in Participants With Moderately to Severely Active Ulcerative Colitis

Carvedilol in HF With Preserved EF