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NCT ID: NCT04885361 Recruiting - Clinical trials for Coronavirus Disease (COVID-19)

To Evaluate the Safety, and Immunogenicity of Vaccine Candidate Against COVID-19, in Healthy Adults

COVEPIT 3
Start date: May 26, 2021
Phase: Phase 1
Study type: Interventional

The proposed study is a phase 1 study which will evaluate the safety, reactogenicity and immunogenicity of two doses regimen of CoVepiT vaccine (OSE-13E) in the population of n=48 healthy volunteers 18 to 45 (inclusive) years old, vaccinated or not by authorized COVID-19 vaccine. Study will be open label and will be randomized 1:1 in two parallel study arms receiving either one single dose or two doses separated by 21 days. First 4 subjects will serve as sentinel cohort and 7 days reactogenicity data of these subjects will be reviewed by the independent safety monitoring committee (SMC) before proceeding to the vaccination of remaining volunteers. The progress of the study will be overviewed by a safety monitoring committee (SMC). The CoVepiT vaccine is a peptide-based vaccine aiming to induce CD8+T-cell-mediated immune response against 11 different proteins of SARS-CoV-2 virus.

NCT ID: NCT04883905 Recruiting - Clinical trials for Acute Hepatic Porphyria

ELEVATE, a Registry of Patients With Acute Hepatic Porphyria (AHP)

ELEVATE
Start date: April 26, 2021
Phase:
Study type: Observational

This global patient registry is being conducted to characterize the natural history and real-world clinical management of patients with AHP, and to further characterize the real-world safety and effectiveness of givosiran and other approved AHP therapies.

NCT ID: NCT04883840 Recruiting - Ulcerative Colitis Clinical Trials

Drug Repurposing - Statins as Microbiota Modulating Agents in Ulcerative Colitis

ReMiDy
Start date: October 22, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

- Evaluation of the microbiota modulation away from inflammation associated microbiota profile Bacteroides2 (Bact2) - Evaluation of the microbiota modulation potential of statins in Bact2- enterotyped, healthy volunteers and ulcerative colitis patients. - Evaluation of the effect of microbiota modulation on disease activity in ulcerative colitis patients. - Evaluation of reduced inflammatory parameters of participants involved in trial

NCT ID: NCT04882904 Recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Continuous Measurement of Activity in Patients With Muscle Pathology and in Control Subjects. ActiSLA Part.

Start date: September 25, 2020
Phase: N/A
Study type: Interventional

ActiSLA is a monocentric academic study. Patients with amyotrophic lateral sclerosis may be included on a voluntary basis. The investigators plan to include a group of approximately 20 patients with ALS. The investigators have planned to assess patient every three months for a year. On each visit, participants will undergo a clinical examination with MRC sum score and Ashworth scores. They will perform few tests ( 6-minutes walk test (6MWT), dynamometric measure, electromyography, Edinburgh Cognitive and Behavioural ALS Screen ) and will answer to some questionaires (dysphagia handicap scale, ALS-SFR-r). After each visit, participants will wear Actimyo for one month daily.

NCT ID: NCT04882007 Recruiting - Ulcerative Colitis Clinical Trials

Study of OSE-127 vs Placebo in Patients With Moderate to Severe Active Ulcerative Colitis

CoTikiS
Start date: October 2, 2020
Phase: Phase 2
Study type: Interventional

This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study in patients with moderate to severe active ulcerative colitis.

NCT ID: NCT04879329 Recruiting - Clinical trials for Urothelial Carcinoma

A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2

Start date: May 3, 2022
Phase: Phase 2
Study type: Interventional

This study is being done to see if a drug called disitamab vedotin, alone or with pembrolizumab, works to treat HER2 expressing urothelial cancer. It will also test how safe the drug is for participants. Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic). It will also study what side effects happen when participants get the drug. A side effect is anything a drug does to your body besides treating the disease.

NCT ID: NCT04877288 Recruiting - Clinical trials for Renal Allograft Recipients

A Study to Evaluate the Benefits and Risks of Conversion of Existing Adolescent Kidney Transplant Recipients Aged 12 to <18 Years to a Belatacept-based Immunosuppressive Regimen as Compared to Continuation of a Calcineurin Inhibitor-based Regimen, and Their Adherence to Immunosuppressive Medications

Start date: July 21, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the benefits and risks of conversion of existing adolescent kidney allograft recipients aged 12 to less than 18 years of age to a belatacept-based immunosuppressive regimen as compared to continuation of a calcineurin inhibitor-based regimen and their adherence to immunosuppressive medications.

NCT ID: NCT04874961 Recruiting - Clinical trials for Hypertension, Systolic

Olive Polyphenols in Cardiovascular Prevention

Start date: May 20, 2021
Phase: Phase 4
Study type: Interventional

The aim of this study is to evaluate whether the use of a commercially available standardized olive extract (Tensiofytol®) in individuals with elevated blood pressure 1. Leads to a clinically relevant reduction of blood pressure on the short term, 2. Leads to a clinically relevant reduction of cholesterol levels, especially LDL, 3. Leads to a change in oxidative stress biomarkers. Participants will be stratified by sex before randomization to one of the three treatments for 8 weeks: - Tensiofytol: 100 mg oleuropein and 20 mg hydroxytyrosol per day - Placebo All treatments have an identical shape and color and should be used in the same way (oral intake; 3 capsules/day during dinner). No dietary instructions are given and participants are asked not to change their dietary habits, nor to start other therapies (medication, supplements, slimming diets, extra physical activity, etc.) during their study period. Standardized questionnaires are used to obtain information on demographics, dietary habits and side effects. At baseline and after 8 weeks, 27 ml blood is drawn for various biological analyses, and blood pressure, BMI and waist circumference are measured.

NCT ID: NCT04873661 Recruiting - Pain Clinical Trials

Cognitive Trance, Hypnosis and Meditation in Oncology

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

Patients with cancer often suffer from a symptom cluster, including pain, fatigue, sleep difficulties, emotional distress and cognitive impairments. In oncology settings, there is a growing interest in "mind-body" intervention, to relieve them in a non-pharmacological way. Hypnosis and meditation are two modified state of consciousness shown to positively this symptom cluster. Cognitive trance is also a modified state of consciousness, but is induced by body movements and/or vocalizations. Subjective reports of experts in cognitive trance showed a modification of self, emotion regulation, pain perception, attention and concentration. However, we still need to develop studies to better characterise this particular state of consciousness and its clinical applications. Our randomized-controlled trial aims at comparing both interventions in terms of (1) benefits on cancer patients' quality of life (pain, fatigue, sleep, distress, cognitive impairments), (2) phenomenological/subjective experiences and neurophysiological correlates, and (3) mechanisms involved in patients' responsiveness, based on the biopsychosocial model of hypnosis.

NCT ID: NCT04873362 Recruiting - Breast Cancer Clinical Trials

A Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy

Astefania
Start date: May 4, 2021
Phase: Phase 3
Study type: Interventional

This is a Phase III, two-arm, randomized, double-blind placebo-controlled study in participants with HER2-positive primary breast cancer who have received preoperative chemotherapy and HER2-directed therapy, including trastuzumab followed by surgery, with a finding of residual invasive disease in the breast and/or axillary lymph nodes. As of June 4, 2024, this study is no longer accepting any newly screened participants.