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NCT ID: NCT04958421 Terminated - Clinical trials for STEMI - ST Elevation Myocardial Infarction

A Study to Evaluate Safety and Feasibility of PiCSO Therapy in Patients With ST Elevation Inferior Wall Myocardial Infarction.

PiCSO-AMI-V
Start date: February 14, 2022
Phase: N/A
Study type: Interventional

The objective of this study is to assess safety and feasibility of Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) therapy in patients with extensive ST elevation inferior wall myocardial infarction presenting with TIMI 0 or 1 and symptom duration ≤ 12 hours undergoing percutaneous coronary intervention (PCI) compared to standard PCI.

NCT ID: NCT04944784 Terminated - Clinical trials for Amyotrophic Lateral Sclerosis

A Study to Evaluate the Efficacy and Safety of Reldesemtiv in Patients With Amyotrophic Lateral Sclerosis (ALS)

COURAGE-ALS
Start date: August 16, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the effect of reldesemtiv versus placebo on functional outcomes in ALS.

NCT ID: NCT04941222 Terminated - Clinical trials for Cognitive Impairment

Cost-utility Analysis of the Use of the Paro Robotic Seal by Elderly Patients With Moderate or Severe Cognitive Disorders in Institutions: a Randomised Study.

PEPINO
Start date: July 29, 2021
Phase: N/A
Study type: Interventional

Many residents from establishments for dependent elderly people (EHPAD) have memory disorders with behavioural problems such as agitation, aggression and anxiety, which make it difficult to assist them on a daily basis. Studies have proven the beneficial effect of the therapeutic seal robot PARO® in behavioural disorders. The present project aims to complement these data with a medico-economic study. At present, the only study of this type has been carried out in Australia, and is not transposable to France.

NCT ID: NCT04936451 Terminated - Breast Cancer Clinical Trials

Electrotherapy in the Management of Myofascial Syndrome

MODYMYO
Start date: January 5, 2022
Phase: N/A
Study type: Interventional

Myofascial syndrome is defined as "musculoskeletal pain characterized by local and referred pain perceived to be deep and constant, and by the presence of myofascial trigger points in any part of the body" Post-breast surgery myofascial syndrome affects up to 44.7% of operated women, mainly on the muscles of the greater shoulder girdle. The repercussions are significant, functional, somatic, psychological and socio-professional affecting the quality of life. The treatments offered may or may not be medicinal. Transcutaneous electrical nerve stimulation (TENS) is a therapy that uses low voltage electrical current to provide pain relief. A TENS unit consists of a battery-powered device that delivers electrical impulses through electrodes placed on the surface of your skin. The electrodes are placed at or near nerves where the pain is located or at trigger points.

NCT ID: NCT04934670 Terminated - Clinical trials for Steroid-Refractory Acute Graft Versus Host Disease

A Study to Compare T-Guard vs Ruxolitinib for Treatment of Steroid-Refractory Acute Graft-vs-Host Disease (BMT CTN 2002)

2002
Start date: June 16, 2022
Phase: Phase 3
Study type: Interventional

This is an open-label, randomized, Phase 3, multicenter trial, which has been designed to compare the efficacy and safety of T-Guard to ruxolitinib in patients with Grade III or IV Steroid-Refractory acute Graft-Versus-Host Disease (SR-aGVHD). The primary hypothesis is that T-Guard treatment will improve the Day 28 complete response (CR) rate in patients with Grades III and IV SR-aGVHD compared to ruxolitinib.

NCT ID: NCT04934046 Terminated - Parkinson Disease Clinical Trials

Evaluation of Dopaminergic Denervation by DaTSCAN Brain Scintigraphy Using a New Multipurpose CZT System

STARDAT
Start date: April 2, 2021
Phase: N/A
Study type: Interventional

DaTSCAN is an important tool in the diagnosis and clinical management of Parkinson's syndromes. New cadmium-zinc-telluride (CZT) systems allow time and/or dose reduction. This can be interesting in DaTSCAN acquisitions as those are long-lasting, often on difficult patients. This study will evaluate the diagnostic performances of a new 3D-ring CZT camera in DaTSCAN SPECT.

NCT ID: NCT04927247 Terminated - Sickle Cell Disease Clinical Trials

A Study of a Single Dose of Inclacumab to Reduce Re-admission in Participants With Sickle Cell Disease and Recurrent Vaso-occlusive Crises

Start date: December 13, 2021
Phase: Phase 3
Study type: Interventional

This Phase 3 study will assess the safety and efficacy of a single dose of inclacumab, a P-selectin inhibitor, for a vaso-occlusive crisis (VOC) after an index VOC in participants with sickle cell disease (SCD). Participants will be randomized to receive either inclacumab or placebo.

NCT ID: NCT04925388 Terminated - Clinical trials for Postoperative Peritonitis

Impact of Rapid Molecular Diagnostic Method on Antibiotics Exposure Duration in ICU Patients With Postoperative Peritonitis

DIRECTABDO
Start date: December 30, 2022
Phase: N/A
Study type: Interventional

Hospitals, and more specifically Intensive Care Units (ICU), face the challenging issue of emergence and rapid spread of multi-drug resistant bacteria (MDR). In some cases, the therapeutic choice is extremely limited. Prevention and adequacy of antibiotic therapy (AB) are the key responses applied toward these threats. A delayed adequate AB is a known factor of poor prognosis. Intra-abdominal infections (IAI) are frequent, polymicrobial and life threatening diseases. Source control and adequate AB are instrumental issues in this setting. Despite technical advances, susceptibility testing of the microorganisms collected from peritoneal samples is not usually available before day two or three after surgery. In this time lapse, empiric AB might be inadequate (not targeting all the pathogens, which leads to a prolonged duration of AB and potential increased morbidity/mortality risk) or too broad (with the two issues of ecology with an increased risk of selection of MDR bacteria and additional costs). In a pilot study evaluating the potential benefit of a direct culture of peritoneal samples from resuscitation patients treated for peritonitis, we observed that conventional treatment made it possible to obtain microbiological results within a median of 3 [extremes 2-7] days whereas a direct microbiological technique by E-test gave results in 1 [1-2] days (p <0.0001). With this technique close to conventional microbiological, a change in antibiotic therapy could have been achieved within an average of 1 [1-2] days versus 4 [1-11] days with conventional management (p = 0, 0006). The development of modern molecular techniques suggests that a large margin of improvement for the rendering and the precision of the results is possible.

NCT ID: NCT04913675 Terminated - Covid19 Clinical Trials

Intramuscular and Intravenous VIR-7831 (Sotrovimab) for Mild/Moderate COVID-19.

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

The COMET-TAIL main study evaluated efficacy, safety, and tolerability of IM sotrovimab versus IV sotrovimab in high-risk patients for the treatment of mild/moderate COVID-19. In the safety substudy, the aim was to evaluate the safety and tolerability of sotrovimab across a single ascending dose level and over different infusion times when given for the treatment of mild/moderate COVID-19 to participants at high risk of disease progression Main study was completed successfully. The safety sub-study was discontinued early in the context of evolving variants with increased fold changes in the in vitro half maximal inhibitory concentration (IC50) and uncertainty in the clinical relevance of these changes.

NCT ID: NCT04906577 Terminated - Premature Birth Clinical Trials

Effects of the Odour of the Very Preterm Infant on Maternal Psychobiology

PREMOLF
Start date: September 12, 2021
Phase: N/A
Study type: Interventional

At birth, the study of interactions, particularly sensory interactions between a mother and her child, allows us to better understand the process of attachment. The sensory signals within the mother-infant dyad will lead to behavioural and metabolic adaptations in both individuals. Currently, the conditions of reception of a very premature newborn in the neonatal intensive care unit of the CHU of Nice lead to a separation between mother and child, with a reduction in sensory interactions. The immediate and long-term consequences of this "sensory rupture" are widely documented in the child, but little studied in the mother. The hypothesis at the origin of this work is that olfactory stimulations emanating from the newborn would allow a perceptive continuity between the newborn and his mother. In the pathological situation of the birth of a premature child, these stimulations would lead to neurobiological and behavioural modifications in the mother and would play a role in the attachment process.