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NCT ID: NCT05536687 Terminated - Healthy Clinical Trials

VALIDITY AND RELIABILITY OF THE 6-MINUTES WALKING TEST EVALUATED BY FEETME® INSOLES

ValiFeet6
Start date: October 1, 2021
Phase: N/A
Study type: Interventional

Currently, the guidelines for performing the 6MWT established by the American Thoracic Society and the European Respiratory Society (ATS/ERS) recommend the use of an indoor or outdoor corridor with a 30 m flat surface (6MWT30) for patients with respiratory diseases, which is also a recommendation for healthy adults. However, not all hospitals, nursing homes or clinics have a corridor of sufficient length to properly perform the 6MWT. A simple way to make the test available to more health care professionals would be to reduce the length of the hallway. In times when access to the hospital is difficult, the ability to assess functional abilities at a distance becomes essential. Today, this is becoming possible with tools such as connected watches, accelerometers, connected shoes and insoles. They give access to a quantitative analysis of walking without necessarily requiring large spaces, specialized personnel or even being in a hospital environment. The FeetMe® Evaluation device consists of connected insoles as well as a mobile application allowing the evaluation of standard clinical walking tests. This device allows a better understanding of patients' walking and is transposable in real life. The objective of the present study is to demonstrate the validity and reliability of the measurement of the distance walked during a 6-minute test with connected insoles in standard conditions (6MW30), degraded conditions (6MW10) in a clinic and at home in a healthy population divided into age subgroups. In addition, this study will investigate whether there is a relationship between 6 minutes of uncontrolled walking from real-life walking data and a standard 6-minute test.

NCT ID: NCT05493293 Terminated - Focal Onset Seizure Clinical Trials

Extension Study to Evaluate the Safety and Tolerability of NBI-921352 When Used With Anti-seizure Medications in Adults With Focal Onset Seizures

Start date: November 9, 2022
Phase: Phase 2
Study type: Interventional

This Phase 2, prospective, interventional, active extension study was designed to evaluate the long-term safety and tolerability of NBI-921352 as adjunctive therapy in adult participants with focal onset seizures who completed 11 weeks of treatment in randomized, double-blind, placebo-controlled Study NBI-921352-FOS2021. Eligible participants may enroll directly following the completion of the Week 11 study visit of Study NBI-921352-FOS2021 or after a gap following completion of that study.

NCT ID: NCT05479058 Terminated - Ulcerative Colitis Clinical Trials

A Study Evaluating the Effect of Filgotinib Dose De-escalation in Participants With Ulcerative Colitis (UC) in Remission

CAPYBARA
Start date: July 26, 2022
Phase: Phase 3
Study type: Interventional

Participants who are in clinical remission on 200 mg filgotinib once daily (q.d.) for at least 2 consecutive quarterly visits in the ongoing SELECTION-LTE study (GS-US-418-3899, NCT02914535), are planned to be rolled over and randomized in this study. The primary objective of this study is to evaluate the efficacy of filgotinib in participants in stable clinical remission on 200 mg filgotinib q.d. for whom the dose was decreased to 100 mg q.d. compared to participants remaining on 200 mg q.d.

NCT ID: NCT05471206 Terminated - Healthy Clinical Trials

Evaluation of Gastrointestinal pH and Motility After the Consumption of Milk

ROVER
Start date: November 24, 2022
Phase: N/A
Study type: Interventional

This pilot study is designed as a monocentric, open label, interventional, parallel arms, controlled clinical trial. The aim of the study is to assess the gastrointestinal pH and motility after the consumption of milk. The clinical study is categorized as an interventional research involving the human person with low risks and constraints (RIPH 2) and which does not assess a health product. The milk and medical device used in this clinical study are both authorized and already commercialized in France.

NCT ID: NCT05448677 Terminated - Clinical trials for Hepatocellular Carcinoma

Ezurpimtrostat Autophagy Inhibitor in Association With Atezolizumab-Bevacizumab in First Line Treatment of Unresectable Hepatocellular Carcinoma

ABE-LIVER
Start date: December 15, 2022
Phase: Phase 2
Study type: Interventional

The study will assess the efficacy of Ezurpimtrostat in association with standard of care (Atezolizumab-Bevacizumab), compared to standard of care alone, as first line treatment in patients with unresectable hepatocellular carcinoma.The study drug which is tested is the Ezurpimtrostat in association with Atezolizumab-Bevacizumab to allow a better tumor response as well as better survival outcomes with an acceptable safety.

NCT ID: NCT05429762 Terminated - Neoplasm Clinical Trials

Effect of Tusamitamab Ravtansine on QTc Interval in Participants With Metastatic Solid Tumors

TusaRav-QT
Start date: October 3, 2022
Phase: Phase 1
Study type: Interventional

This is a Phase1, single-arm study for treatment. This is a prospective multicenter, multinational, open-label study to assess the effect of tusamitamab ravtansine on the QT interval in participants with metastatic colorectal cancer (CRC), nonsquamous non small cell lung cancer (NSQ NSCLC), or gastric/ gastroesophageal junction (GEJ) adenocarcinoma for which in the judgement of the Investigator, no standard alternative therapy is available.

NCT ID: NCT05429645 Terminated - Cardiac Anomaly Clinical Trials

Cardiac Resynchronization Under Electroanatomical Guidance After Failure of Primary Implantation

CRT3D
Start date: July 28, 2022
Phase: N/A
Study type: Interventional

The purpose of the study is to assess the feasibility of cardiac resynchronization under electroanatomic guidance in the event of primary implantation failure due to catheterization failure or instability in the coronary sinus ostium

NCT ID: NCT05419986 Terminated - Opioid Use Disorder Clinical Trials

Epigenetic Biomarker for Opioid Use Disorder

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

Study rationale Opioid use disorder (OUD) is a chronic and severe condition, defined by problematic opioid use, which results from interactions among sociological factors, psychiatric symptoms and life experiences, altogether determining OUD severity. Recently, behavioral epigenetics has emerged as a possible strategy to help identify molecular mechanisms that may explain how these various interactions result in dysregulations affecting gene expression, brain function, and, ultimately, emotional regulation. Here the investigators propose a pilot study as a first step towards a larger multidisciplinary project whose goal will be to characterize simultaneously major psychiatric and social factors in individuals with OUD, across a wide range of disease severity. In the present pilot study, the investigators propose to first characterize technical feasibility of the molecular investigations proposed in these 2 projects. OUD severity The severity of OUD is well defined in the DSM-5 (2013), with 3 categories, from mild to severe, on the basis of the number of dimensional criteria met by patients (among 11 criteria). These criteria relate to the following main aspects: tolerance, the need to increase the amount of drugs to avoid withdrawal; psychic and physic withdrawal in case of substance discontinuation; social and interpersonal consequences of drug use; biological and psychic consequences of use; and craving, the irrepressible need to consume1. Here, the investigators postulate that molecular adaptations detected in the blood of OUD patients may represent biomarkers of this severity. Epigenetic blood biomarkers A main limitation for conducting peripheral blood biomarker investigations in active opioid abusers comes from the fact that phlebotomies are reputedly difficult & potentially iatrogenic in these subjects, as they associate with external cues and trigger internal states that are closely related to drug consumption. To overcome this difficulty, we propose to test the hypothesis that sufficient DNA amounts can be recovered from fingerstick blood drops (corresponding to capillary blood, similar to sugar testing) to generate robust and reliable DNA methylation measures in the full human epigenome. In other words, the investigators assume that DNA methylation can be measured using capillary blood. Objectives The investigators will first investigate in healthy volunteers whether the method consisting in collecting and analyzing small DNA amounts from capillary blood (fingerstick blood drops) retrieves DNA methylation measures for a number of CG dinucleotide sites (where DNA methylation occurs in the mammalian genome) that is comparable to that classically observed using veinous blood (phlebotomy). Second, the investigators will test the feasibility of measuring DNA methylation using capillary blood samples collected from patients with OUD. To this purpose, the investigators propose to collect veinous and capillary blood samples from healthy volunteers, and capillary blood from opioid users.

NCT ID: NCT05418673 Terminated - Parkinson Disease Clinical Trials

A Study to Assess if BIIB122 Tablets Are Safe and Can Slow Worsening of Early-Stage Parkinson's Disease in Participants With Specific LRRK2 Genetic Variants Between the Ages of 30 and 80 Using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale

LIGHTHOUSE
Start date: August 26, 2022
Phase: Phase 3
Study type: Interventional

In this study, researchers will learn more about a study drug called BIIB122 in participants with early-stage Parkinson's disease (PD). The study will focus on participants with a specific genetic variant in their LRRK2 gene. The main question researchers are trying to answer is if taking BIIB122 slows the worsening of PD more than placebo in the early stages of PD. To help answer this question, researchers will use a questionnaire called the Movement Disorder Society-Unified Parkinson's Disease Rating Scale, also known as the MDS-UPDRS. - The MDS-UPDRS measures impairment and disability in people living with PD. It was created in the 1980s and is one of the most used rating scales for PD symptoms. - The MDS-UPDRS has 4 parts, and a higher score means more severe PD symptoms. - Part I assesses non-motor experiences of daily living, including but not limited to memory loss, problems sleeping, pain, depression, and anxiety. - Part II measures motor experiences of daily living. - Part III is the results of a motor symptoms exam by a medical professional. - Part IV records PD complications caused by motor symptoms. Researchers will also learn more about the safety of BIIB122. A description of how the study will be done is given below. - Participants will take BIIB122 or a placebo as tablets by mouth. A placebo looks like the study drug but contains no real medicine. - Participants will be in the study for 103 weeks to 187 weeks. This includes the screening and follow-up periods. - Participants will take BIIB122 or placebo 1 time a day for 96 to 180 weeks. - Participants can continue to take certain medications for PD. Participants must be on the same dose of medication for at least 90 days before the study begins. - Participants will visit the clinic less often as the study continues, ranging every 4 weeks to every 24 weeks.

NCT ID: NCT05417581 Terminated - Clinical trials for Bariatric Surgery Candidate

Mitochondrial Oxygraphy on Subcutaneous and Peri-visceral Adipose Tissue: Influence of Body Composition

OxMiTiAd
Start date: April 14, 2021
Phase: N/A
Study type: Interventional

The objective of this study is to adapt the oxygraphy technique on human adipocytes and to characterize respiration measurements according to patients' body mass index and white adipose tissue localization (subcutaneous vs visceral).