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NCT ID: NCT04797650 Completed - Alopecia Areata Clinical Trials

Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA2)

THRIVE-AA2
Start date: June 10, 2021
Phase: Phase 3
Study type: Interventional

This study evaluates the safety and effectiveness of an investigational study drug (called CTP-543) in adults (18 years and older) who have 50% or greater scalp hair loss.

NCT ID: NCT04797312 Recruiting - Anesthesia Clinical Trials

Comparison of an Opioid-Free Anesthesia Protocol Versus Standard Practices on Early and Late Post-operative Recovery

SOFA
Start date: July 12, 2021
Phase: Phase 3
Study type: Interventional

Opioid-Free Anesthesia (OFA) is an anesthesia protocol that does not use morphine, and is increasingly used routinely. Indeed, this protocol would theoretically allow a better post-operative analgesic control, a lower incidence of post-operative complications (e.g. post-operative nausea and vomiting). In the end, it would also allow a better overall post-operative recovery and a decrease in the incidence of chronic post-operative pain. Nevertheless, the literature is poor on this issue and no randomized controlled study has evaluated the effect of the use of this type of anesthesia protocol on postoperative recovery.

NCT ID: NCT04797143 Recruiting - Clinical trials for Drug Related Toxicity

Impact of a Multidisciplinary Consultation Program on Drug Adherence in First Oral Anticancer Treatment

IMPAM
Start date: March 11, 2021
Phase:
Study type: Observational

Oncology management has changed dramatically over the last decade with the approval and rapid adoption of newly targeted oral oncology medications. The movement to oral oncology medications has altered the balance of risks and adverse effects (AEs) in the treatment of cancer care. These treatments are associated with a different constellation of AEs and drug interactions. Patients receiving treatment with oral anticancer treatment (OAT) encounter several barriers to adherence, which may include limited access to specialty medications, severe adverse effects, complex medication regimens, and special handling precautions. Medication nonadherence not only reduces the efficacy of drug therapy but also has the potential to increase healthcare expenditures due to disease-related hospitalizations. The purpose of this study is to evaluate the drug adherence in cancer patients, using the medication possession ratio (MPR), before and after the implementation of a multidisciplinary consultation program (MCP), on initiation of OAT.

NCT ID: NCT04797117 Completed - Sepsis Clinical Trials

Analytical Validation of the abioSCOPE Device With a PSP Test: Point-of-Care Precision, Sample Type Comparison and Sample Stability

AB-PSP-005
Start date: April 29, 2021
Phase: N/A
Study type: Interventional

Abionic SA has developed a novel point-of-care (POC) platform, the abioSCOPE, and an in vitro diagnostic kit for the quantification of the pancreatic stone protein (PSP) to be analyzed specifically with the abioSCOPE® device. This test is intended to be used to aid in the early recognition of sepsis. The test is extremely easy to use and has a total turnaround time of approximately 8 minutes. This test uses only 30 microliters of K2/K3-EDTA anticoagulated whole blood or plasma. Results are quantitative (ng/ml). The product is for Investigational Use Only in the US and bears CE-marking. It is commercially available in selected European and non-European countries. The test has also been clinically validated in a multicentric, prospective, observational study performed (AB-PSP-001, clinicaltrials.gov identifier NCT03474809). The main goals of this study are to evaluate certain analytical performances components of this product in a point-of-care environment, in particular the precision, sample type comparability and specimen stability of the product. Such data will support regulatory filing of a US FDA 510(k) premarket notification file and of a European IVD Regulation technical file to continue product commercialization in 2022, when this novel regulation will be effective.

NCT ID: NCT04796727 Completed - Cardiac Arrest Clinical Trials

One Year Follow-up After Rescuscited Cardiac Arrest

ONYRCA
Start date: August 1, 2019
Phase:
Study type: Observational

While 80 % of all sudden cardiac death (SCD) result from coronary artery disease (CHD) approximatively 2/3 of SCD occur as a first manifestation of the CHD. VF (ventricular fibrillation) is the main cause of SCD in acute coronary syndrome (ACS), and the 2017 ESC Guidelines for the management of acute myocardial infarction, recommended direct admission to the catheterization laboratory in survivors of out of hospital cardiac arrest (OHCA) with criteria for STEMI on the post-resuscitation electrocardiogram (ECG) (Class I, grade B). However, During the past few years, the number of immediate coronary angiography (CA) for suspected ACS in patients presenting an OHCA increased, with a survival rate at discharge in this subgroup of patients better, about 60 to 80% (1). However, the survival rate remains poor in the global population of OHCA and some survivors patients may have neurological sequelles, related to global anoxia consequences or altered quality of life related to cardiac function impairement . While the survival rate at hospital discharge is well known, the investigators have few data on long term outcomes , particularly regarding cardiac and neurological states. Therefore the main objective of this study is to evaluate prospectively, in an observational study, the one-year prognosis of patients with rescuscited OHCA in whom a CA for suspected ACS was performed in the university hospital of Montpellier. Only patients alive at discharged are considered for the follow-up to eliminate the in-hospital mortality . The investigators aim to assess year neurological status using medical questionnaires at one year follow-up(primary end point). The investigators hypothesize that 10% of patients will discharged alive from hospital with severe neurological sequelae at 1 year.Secondary end point will evaluate cardiac status, quality of life and pronostic factors of adverse outcome.

NCT ID: NCT04796714 Recruiting - Stroke Clinical Trials

AntiPlatelet theraPy stratEgy followiNg Left Atrial appenDAGe closurE

APPENDAGE
Start date: October 3, 2022
Phase: Phase 4
Study type: Interventional

The APPENDAGE study is a phase 4 multicentre randomized opened clinical trial comparing 2 different antithrombotic strategies following left atrial appendage closure (LAAC) in patients with non valvular atrial fibrillation (AF). The primary objective of the study is to evaluate the efficacy of Aspirin versus Aspirin + Clopidogrel after LAAC by comparing the occurrence of ischemic lesions on cerebrovascular magnetic resonance imaging (MRI) studies.

NCT ID: NCT04796350 Recruiting - Osteoporosis Clinical Trials

RESTORE - Study of AGN1 LOEP to Prevent Secondary Hip Fractures

Start date: April 24, 2021
Phase: N/A
Study type: Interventional

A randomized controlled trial to evaluate AGN1 to prevent secondary hip fractures in osteoporotic women undergoing treatment of index hip fractures. Up to 2400 subjects will be randomized between a treatment group and a control group. Subjects will be followed for a minimum of 5 years after undergoing hip fracture repair surgery.

NCT ID: NCT04796337 Recruiting - Clinical trials for Pulmonary Arterial Hypertension

A Long-term Follow-up Study of Sotatercept for PAH Treatment (MK-7962-004/A011-12)

SOTERIA
Start date: May 12, 2021
Phase: Phase 3
Study type: Interventional

This study is being conducted to assess the long-term safety, tolerability, and efficacy of sotatercept (MK-7962, formerly called ACE-011) in participants with Pulmonary Arterial Hypertension (PAH). This open-label, long-term follow-up (LTFU) study is supported by data from the PULSAR study (Phase 2, NCT03496207) in which treatment with sotatercept resulted in hemodynamic and functional improvements in the study participants, including those receiving maximal PAH therapy with double/triple drug combinations and intravenous prostacyclin. The primary objective of this open-label, LTFU study is to evaluate the long-term safety and tolerability of sotatercept when added to background PAH therapy in adult participants with PAH who have completed prior sotatercept studies. The secondary objective is to evaluate continued efficacy in adult participants with PAH who have completed prior sotatercept studies.

NCT ID: NCT04796272 Terminated - Multiple Sclerosis Clinical Trials

Role of Individualized Versus Traditional Exercise in Combating Fatigue

REEN-SEP
Start date: April 2, 2021
Phase: N/A
Study type: Interventional

The objective of this project will be to characterise the benefits of an exercise programme adapted to each individual's abilities compared to a traditional exercise programme with the aim of reducing perceived fatigue and improving the quality of life of Patients with multiple sclerosis.

NCT ID: NCT04796194 Active, not recruiting - Advanced Melanoma Clinical Trials

Intratumoral Injection of LTX-315 in Combination With Pembrolizumab in Advanced Melanoma

ATLAS-IT-05
Start date: June 1, 2021
Phase: Phase 2
Study type: Interventional

ATLAS-IT-05 is an open-label, single-arm study in patients with advanced melanoma accessible for injections (cutaneous, subcutaneous, lymph node, or intramuscular tumors) and who have either exhausted treatment options or are not eligible for, suitable for, or willing to undergo such treatments.