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NCT ID: NCT05436028 Recruiting - Clinical trials for Tricuspid Regurgitation

A Study to Evaluate the Safety and Performance of LuX-Valve Plus System for Tricuspid Replacement

Start date: May 23, 2023
Phase: N/A
Study type: Interventional

This is a prospective, single-arm, multi-center trial to evaluate the LuX-Valve Plus system for treating symptomatic severe or greater TR in patients who are deemed high risk for tricuspid surgery. Treatment with the LuX-Valve Plus system may enable patients with tricuspid regurgitation to have a complete tricuspid valve replacement with a minimally invasive approach. A total of 93 subjects will be enrolled at up to 20 institutions worldwide. No single institution will be allowed to register more than 25% of total subjects. There is no minimum number of subjects to be registered at any site. Up to an additional 42 roll-in subjects, up to 3 per site, may be enrolled by operators without prior experience with the LuX-Valve Plus system to gain hands-on experience. The data of roll-in subjects will not count towards the overall enrollment cap. Safety and effectiveness results of roll-in subjects will be reported separately. All subjects will be evaluated at baseline, discharge, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years post-procedure

NCT ID: NCT05435976 Recruiting - Dental Surgery Clinical Trials

Evaluation of a Non-cross-linked Porcine Acellular Dermal Matrix Used in Dental Surgery

Start date: September 12, 2022
Phase:
Study type: Observational

The general objective of the study is to confirm the medium/long-term safety and clinical performance of the CELLIS Dental membrane used in dental surgery and to identify emerging risks in comparison to clinical data related to other treatment modalities. The present study will be a prospective multicentric non-randomized and noncontrolled trial involving 50 patients followed for 24 months. The study will be conducted in France in 4 investigational centres.

NCT ID: NCT05435794 Recruiting - OSA Clinical Trials

Long-term Benefits of CPAP or MAD Treatment on the Sleep of OSAS Patients

REMAP
Start date: July 15, 2022
Phase:
Study type: Observational

The REMAP study aims to follow a cohort of 400 patients in around ten sleep centers in France and to collect clinical routine data. The objectives of this study are to investigate the effects of one-year management of OSA by CPAP or MAD on sleep architecture defined by objective macro and micro sleep architecture parameters using a sleep test device. sleep connected at home, to assess the quality of sleep and the quality of life reported by patients. The study will also allow us to define predictive factors for improving sleep quality during OSA treatment.

NCT ID: NCT05435690 Not yet recruiting - Gonarthrosis Clinical Trials

Evaluation of a New Navigation System in Computer-assisted Total Knee Arthroplasty

NaviKnee
Start date: September 1, 2022
Phase: N/A
Study type: Interventional

Evaluation of a new navigation system in computer-assisted total knee arthroplasty.

NCT ID: NCT05435040 Completed - Clinical trials for Proprioceptive Disorders

Evaluation of Proprioceptive Abilities While Wearing an Elastic Orthosis in Patients With Proprioceptive Knee Deficits

CAPROG
Start date: October 19, 2022
Phase: N/A
Study type: Interventional

The objective of the study is to compare, with or without wearing an elastic proprioceptive knee brace, the functional proprioceptive capacity of the knee in patients suffering from proprioceptive deficit.

NCT ID: NCT05434858 Recruiting - Hyperuricemia Clinical Trials

Imagery as Biomarker of Gout

TIGER
Start date: September 9, 2022
Phase: N/A
Study type: Interventional

The objective of this study is to determine whether MSU crystal deposits visualized on ultrasound and/or DECT are associated with the development of symptomatic gout (according to ACR 2015 / EULAR criteria) over 5 years in hyperuricemic individuals.

NCT ID: NCT05434481 Active, not recruiting - Clinical trials for Aortic Aneurysm and Dissection

MITAORTA - Role of Mitochondrial Dynamic in Aneurysm and Dissection of Ascending Thoracic Aorta

MITAORTA
Start date: September 7, 2022
Phase: N/A
Study type: Interventional

The main objective is to compare the mitochondrial dynamic between patients operated for aneurysm of ascending aorta or type A aortic dissection (AAD) or control group

NCT ID: NCT05434338 Recruiting - Clinical trials for High Grade Intraepithelial

Papillomavirus Post-THErapeutique

PAPOTHE
Start date: December 23, 2022
Phase: N/A
Study type: Interventional

In recent years, studies have multiplied to demonstrate the value of performing an HPV test compared to a cervical smear test (CSP) in cervical cancer screening but also in the follow-up of surgical removal of high-grade intraepithelial lesions (HGILs). Thus, since June 2019, the High Health Authority recommends performing HPV genome testing by PCR for primary cervical cancer screening. Since September 2019, the National Cancer Institute recommends an HPV test in the follow-up of HGILs 6 months after conization. However, this delay was determined thanks to the previous recommendations which advocated a cervical smear test 6 months after conization. Thus, the kinetics of HPV clearance in the immediate postoperative period and in the 6 months following surgical excision remain unknown to this day. A better knowledge of the clearance of HPV postoperatively would allow to adapt and simplify the follow-up of the patients and to personalize it according to the type of HPV.

NCT ID: NCT05433441 Recruiting - Parkinson Disease Clinical Trials

Evaluation of the Effectiveness of the Parkinson Specialized Teams Intervention

ES-Park
Start date: December 6, 2022
Phase: N/A
Study type: Interventional

A pilot experiment interventional study is proposed in order to set up multidisciplinary team for Parkinson's patients at home. The aim of this study is to evaluate the effectiveness of this specialized Parkinson's team (ESPark) intervention a on the quality of life of patients with moderate to severe Parkinson's disease

NCT ID: NCT05433168 Recruiting - Spondyloarthritis Clinical Trials

Study Evaluating the Effectiveness of Shiatsu on Fatigue in Patients With Axial Spondyloarthritis

SFASPA
Start date: September 20, 2022
Phase: N/A
Study type: Interventional

Spondyloarthritis is a potentially serious disease with reduced life expectancy. Even if the clinical presentation is eminently variable from one patient to another, the most frequently encountered manifestations such as inflammatory spinal pain, peripheral arthritis or even extra-articular involvement of the disease all represent disabling symptoms, origin of pain, temporary or in some cases permanent functional incapacity, but also general repercussions on daily life (asthenia, reactive depressive syndrome, etc.) which require a multidisciplinary approach, involving several medical, paramedical and other stakeholders, The objective of treatment is to improve quality of life, to control symptoms and inflammation, to prevent structural damage, particularly in peripheral damage, to preserve or restore functional capacities, autonomy and social participation of patients with spondyloarthritis. In France, the main professional reference for shiatsu is the Syndicat des Professionnels de Shiatsu, which proposes the following definition to define shiatsu: Shiatsu (finger pressure in Japanese) is an energetic manual discipline addressing the individual as a whole. Shiatsu is part of personal assistance. He receives himself, dressed in soft clothes. Shiatsu is a discipline of well-being and prevention for better health. Its objective is to correct both the energy flow (ki, blood, lymph, etc.) and the body structure (muscles, tendons, etc.) by applying rhythmic pressure to the whole body, most often with the inches. It is for everyone and at all ages. Its principle of action is to restore the free flow of Ki (qi, Energy) in the body. Shiatsu is a set of pressures performed mainly with the thumbs and the palms of the hands on different areas of the body, often taking up the points of the acupuncture meridians. Shiatsu pressures can be (Ishizuka 1993; Kagotani 1984; Okamoto 2016): - mobile in a given place and lasting 3 to 5 seconds: a phase of increasing pressure followed by a short holding time then release, - static: same phases but with a hold time of up to approximately 1 minute or even longer. To date, there is no treatment specifically targeting fatigue in axSpA. Indeed, the underlying mechanisms of fatigue in SpA remain poorly understood, and could for example involve pro-inflammatory cytokines and the inflammatory process, and/or psychological distress. The effectiveness of non-pharmacological interventions and in particular the care provided by shiatsu practitioners have not been the subject of studies evaluating, according to the criteria of evidence-based medicine, the benefit of this practice, particularly in the context of treatment of spondyloarthritis.