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NCT ID: NCT05541627 Active, not recruiting - Huntington Disease Clinical Trials

A Study to Evaluate AB-1001 Striatal Administration in Adults With Early Manifest Huntington's Disease

Start date: October 12, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

A Phase I/II Dose-Finding Study to Evaluate Striatal Administration of AB-1001 (previously BV-101) in Adults with Early Manifest Huntington's Disease

NCT ID: NCT05540288 Recruiting - Clinical trials for Behavioural Addiction

NAlmefene Versus Placebo in Addition to Treatment as Usual on Craving in Behavioural Addictions

NABAb
Start date: March 31, 2023
Phase: Phase 3
Study type: Interventional

Behavioural addictions (BAs) [gambling disorder (GD), food addiction (FA), sexual addiction (SA)] may lead to disastrous consequences. They are often associated with other addictive or psychiatric disorders, and high rates of suicide attempts. Epidemiological studies report prevalence reaching 2.7% for GD, 5% for SA, and up to 7.9% for FA. Many similarities have been highlighted between BAs, as well as with substance use disorders. One core clinical similarity between those disorders is craving (uncontrollable urge to engage in rewarding behaviours), which has been consistently associated with diminished control over the behaviour and relapse. At present, no pharmacological treatment has been approved for BAs, but several medications have been tested. Among them, two opioid receptor antagonists - naltrexone and nalmefene - appear the most promising. By decreasing dopamine neurotransmission in the reward circuitry, they reduce both excitement for rewarding behaviours and craving. Compared to naltrexone, nalmefene seems to have a better safety. To date, no study investigated the efficacy of nalmefene as a pan-addiction treatment for BAs. Two clinical trials have demonstrated its efficacy for the treatment of GD, but no clinical trial was conducted for FA and SA. The investigators hypothesise that nalmefene (36 mg/d), compared to a placebo, can have a therapeutic effect as an add-on to usual treatment for decreasing craving in several BAs.

NCT ID: NCT05540210 Completed - Device Clinical Trials

Analytical Validation of the abioSCOPE Device With the in Vitro Device (IVD) CAPSULE PSP Test: Comparison of PSP Values Measured With Venous Whole Blood and Those Measured With Arterial Whole Blood

AB-PSP-006
Start date: August 29, 2022
Phase: N/A
Study type: Interventional

Abionic society 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. The PSP is a host protein biomarker produced by the pancreas in response to a sepsis-related organ dysfunction and has shown a great potential in the early identification of septic patients 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 50 microliters of K2/K3-EDTA venous anticoagulated whole blood. 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 goal of this study is to evaluate the analytical performances components of this product in a point-of-care environment, in particular the sample type comparability between arterial and venous whole blood.

NCT ID: NCT05539937 Recruiting - Quality of Life Clinical Trials

Prospective Evaluation of the Quality of Life of Elderly Patients Undergoing Transfemoral Percutanous Aortic Valve Replacement (TAVI) for the Treatment of Severe Aortic Stenosis.

TAVI QdV
Start date: March 21, 2023
Phase:
Study type: Observational

In order to overcome the shortcomings of the assessment questionnaires currently available on the assessment of overall quality of life, the "Toronto Aortic Stenosis Quality of Life Questionnaire" (TASQ) was developed as a specific assessment tool for the impact of severe aortic stenosis in elderly patients, through 16 questions covering 5 domains: symptoms and physical limitations, emotional impact and expectations following TAVI, as well as social limitations incurred. A better knowledge and understanding of the clinical outcomes and quality of life of elderly patients with severe symptomatic aortic stenosis at 12 months of follow-up of a TAVI procedure would further optimize the clinical decision-making process and patient selection who will benefit the most from this intervention in the long term.

NCT ID: NCT05539573 Active, not recruiting - Aortic Stenosis Clinical Trials

PROVE ACURATE neo2™ - Post Market Safety and Performance Surveillance in Aortic Stenosis

PROVE
Start date: October 4, 2022
Phase:
Study type: Observational [Patient Registry]

Aortic valve sclerosis (aortic valve thickening and calcification without pressure gradient) is one of the most common valvular abnormalities in the Western world. Per year, about 1.8-1.9% of these patients develop aortic valve stenosis which will eventually be treated by TAVI (Transcatheter aortic valve implantation). The purpose of this study is to collect and monitor ongoing safety and performance clinical data of the ACURATE neo2™ aortic bioprosthesis and the ACURATE neo2™ transfemoral delivery system, hereafter referred to as the ACURATE neo2™ and transfemoral delivery system in the context of an observational investigator initiated trial (IIT).

NCT ID: NCT05539404 Terminated - Clinical trials for Acute Ischemic Stroke

Evaluate Endovascular Treatment of Large Ischemic Stroke With Substantial Penumbra.

FrameLP
Start date: November 2, 2022
Phase: N/A
Study type: Interventional

Large cerebral infarctions are frequent and associated with a poor outcome. Previous cohort studies results suggest that patients with an acute ischemic stroke with large core and substantial penumbra on perfusion imaging benefit from EVT while those with no salvageable ischemic tissue did not. The Investigator aim to demonstrate in a randomized controlled trials (RCT) that EVT (Endo Vascular Treatment) in addition to BMT (Best Medical Treatment) increases the rate of functional recovery (mRS 0-2) at 3 months in patients with a LVO-related AIS with a large core and substantial penumbra evolving for less than 24hrs

NCT ID: NCT05539391 Recruiting - Emergencies Clinical Trials

Optimisation Strategy for Emergency Tracheal Intubation

OSETIM
Start date: January 14, 2023
Phase: N/A
Study type: Interventional

This study has to objective to assess, in adults' patients needing tracheal intubation because of vital distress, the effect of a combined strategy to reduce intubation-related morbidity. This strategy will associate systematic use of rocuronium as paralyzing agent to facilitate tracheal intubation, bag face-mask ventilation before intubation and Gum Elastic Bougie (GEB) use.

NCT ID: NCT05539014 Recruiting - Clinical trials for Tuberculosis, Pulmonary

Tuberculosis Cohort Avicenne Hospital

COTB-AVC
Start date: January 18, 2023
Phase:
Study type: Observational [Patient Registry]

Tuberculosis represents the second highest death rate from an infectious disease in the world, just after COVID-19. The most affected department of France is Seine-Saint-Denis. Since 2005, this department with difficult socio-economic conditions has the highest incidence rate in metropolitan France, higher than that of Paris. In 2012, the reporting rate was 10 times higher among people born abroad compared to those born in France, with the highest rates found among people born in sub-Saharan Africa and Asia. It is proposed to constitute for the first time in France a cohort of patients with tuberculosis disease to better understand the characteristics of patients with unfavorable treatment outcomes and ultimately, to propose solutions to obtain better control of tuberculosis. This study would recruit all patients with tuberculosis disease for at least 4 years associated with 1 year of follow-up for a total duration of the study of at least 5 years.

NCT ID: NCT05538442 Completed - Sports Injury Clinical Trials

Trail Sciences Clecy: Markers of Performances

Start date: November 9, 2021
Phase: N/A
Study type: Interventional

The Scientific Trail Protocol of Clécy - Suisse Normande (TCS) is exploratory study including several specific protocols, on a real event of 156 km on hilly terrain (6000 m of difference in level), allowing to evaluate the constraints and immediate (6000 m of difference in altitude), allowing to evaluate the constraints and the immediate physiological adaptations under race conditions. The evaluations will be performed by collecting biological and neurobiological variables before, during and after the race (inflammation, hydro-electrolytic, cardiac, renal and muscular balance), physiological parameters whose thermoregulatory processes (core temperature, skin temperature, hydration), neuromuscular fatigue, cognitive performances (motivation, attention, emotion) and sleep changes (before, during and after the race).

NCT ID: NCT05538403 Recruiting - Fracture Clinical Trials

AI Performance for the Detection of Bone Fractures in Children

Start date: May 1, 2022
Phase:
Study type: Observational

The artificial intelligence (AI) software BoneView (GLEAMER Company, Paris, France) has been designed, tested and validated to detect and locate recent or semi-recent fractures on standard radiographs. The objective will be to assess the AI performance for the detection of bone fractures in children aged less than 2 years old in suspected child abuse setting. These patients benefit from a whole body radiography with a double blind reading by a "generalist" radiologist and a radiologist with expertise in child abuse. This readings will be compared with the AI results. Hypothesis is that AI is effective for child fractures detection and could be of help especially for radiologists who are not experts in child abuse.