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NCT ID: NCT04350658 Active, not recruiting - Aortic Stenosis Clinical Trials

TAVR Without Predilatation

TAVIWOP
Start date: June 1, 2020
Phase:
Study type: Observational

The procedure is performed via transfemoral or transcaprotid access; Patients were confirmed to be eligible for TAVR by a multidisciplinary heart team including at least an interventional cardiologist, a cardiothoracic surgeon and an anesthetist. All TAVR implantation procedures were performed with the Edwards SAPIEN 3 THV or the MEDTRONIC CoreValve EVOLUT . For all patients, both vascular access and aortic valve were evaluated before the procedure by multislice computerized tomographic angiography (MSCT) of the entire aorta using vascular windows settings. The prosthesis and the vascular access were left to the discretion of the operating team. Transfemoral access was the first choice when possible. All TAVR procedures were performed in the same hybrid room (in Montpellier University Hospital), Most TAVR were performed under sedation or general anesthesia using mild low profile 14-16 French delivery systems and using percutaneous or surgical vascular access.

NCT ID: NCT04349046 Active, not recruiting - Clinical trials for Rheumatoid Arthritis

Exception Cementless Hip Stem

Exception
Start date: January 1, 2021
Phase:
Study type: Observational

This study is a multicenter, retrospective and prospective, non-controlled, non-randomized post market clinical follow-up study. The objectives of this study are to confirm the long-term safety, performance and clinical benefits the Exception Cementless femoral stem (standard and varized) when used in primary total hip arthroplasty.

NCT ID: NCT04348045 Active, not recruiting - Clinical trials for Metastatic Pancreatic Adenocarcinoma

Personalized Maintenance Therapy for m-PDAC Using Olaparib or Selumetinib + Durvalumab, Based on BRCAness and KRAS Status.

MAZEPPA
Start date: December 7, 2020
Phase: Phase 2
Study type: Interventional

MAZEPPA is open-label, phase II study to assess the efficacy of a genomic-driven maintenance therapy in terms of PFS in Pancreatic ductal adenocarcinoma (PDAC) patients with disease controlled after 4 months of mFOLFIRINOX chemotherapy as following: Patients with a BRCAness somatic profile: olaparib Arm A. Patients with no BRCAness profile and with KRAS mutation randomization between durvalumab plus selumetinib Arm B, versus FOLFIRI Arm C.

NCT ID: NCT04347070 Active, not recruiting - COVID-19 Clinical Trials

Implementation of Physiotherapy on COVID-19 Patients in ICU

PHYSIO-COVID
Start date: April 1, 2017
Phase:
Study type: Observational

Despite new charachersitics of COVID-19 patients, critical care implementation seems to be similar to those with Acute Respiratory Distress Syndrome (ARDS) in intensive care units (ICU). Regarding the initial gravity of these patients, sedation and neuromuscular blockers are usually administrated, increasing the risk to develope an ICU-acquired weakness which is directly correlated to morbi-mortality and a burden during recovery. Respiratory symptoms are mostly related to dyspnoea and non-productive cough, with only 33% of COVID-19 patient having a bronchial hypersecretion ; consequently, chest physiotherapy is only implemented in after case-by-case evaluation. This unprecedented situation requires to identify how physiotherapy is being implemented in COVID-19 patients in ICU. This retrospective, multicentric study aims to identify the charactheristics of physiotherapy (type and time spent) implemented in Argentina, Belgium, Chili, France, Italy and Spain

NCT ID: NCT04346238 Active, not recruiting - Friedreich Ataxia Clinical Trials

Characterization of the Interruptions of the GAA Expansion and Study of Their Influence on the Severity of Friedreich's Ataxia

INTREP-AF
Start date: March 1, 2020
Phase:
Study type: Observational

Friedreich's ataxia (FA) is the most frequent recessive genetic ataxia with an estimated prevalence of 1/50 000. The first symptoms appear around the age of 10 years with a progressive course and the need for an armchair 10- 15 years after the first symptoms. More rarely the disease can present with a late onset (after the age of 25) with a picture characterized by spastic paraparesis and slower progression ("LOFA" for "Late Onset Friedreich Ataxia" or VLOFA for "Very Late Appearance of Friedreich's ataxia "). AF is caused in 96% of cases by an expansion of GAAN triplets (N> 100 repeats) located in intron 1 of the FXN gene, present on the two alleles, and, in the rest of the cases, by an associated expansion a point mutation or a deletion in trans. During molecular diagnostics, it is not uncommon to find the presence of interruptions within the GAA expansion. This results in the absence and / or the shift of peak (s) within the chromatogram. To date, only the partial correlation between the size of the expansion and the age of onset of Friedreich's ataxia has been established. In particular, very atypical forms of AF with a late onset (after the age of 25) are in particular explained by the low number of repetitions in the expansion, typically between 100 and 500 repetitions. However, the presence of an interruption could stabilize the size of the expansion and, therefore, be mainly associated with expansions of small sizes and therefore with a late onset of the disease. The objective of this study is therefore to analyse and caracterize the presence and the type of interruptions of the GAA expansions in a group of patients with FA ; this data will be correlated with the age at onset of FA.

NCT ID: NCT04344730 Active, not recruiting - COVID-19 Clinical Trials

Dexamethasone and Oxygen Support Strategies in ICU Patients With Covid-19 Pneumonia

COVIDICUS
Start date: April 10, 2020
Phase: N/A
Study type: Interventional

The main manifestation of COVID-19 is acute hypoxemic respiratory failure (AHRF). In patients with AHRF, the need for invasive mechanical ventilation is associated with high mortality. Two hypotheses will be tested in this study. The first hypothesis is the benefit of corticosteroid therapy on severe COVID-19 infection admitted in ICU in terms of survival. The second hypothesis is that, in the subset of patients free of mechanical ventilation at admission, either Continuous Positive Airway Pressure (CPAP) or High-Flow Nasal Oxygen (HFNO) allows to reduce intubation rate safely during COVID-19 related acute hypoxemic respiratory failure.

NCT ID: NCT04343820 Active, not recruiting - Clinical trials for Breast Cancer Female

Delayed Breast Reconstruction by Prepectoral Implant After Lipo-preparation (RM2prepec)

RM2prepec
Start date: December 24, 2019
Phase:
Study type: Observational

Breast implants associated with the installation of a complementary matrix (of dermal or synthetic origin), showed satisfactory results in term of post-operative follow-up but also aesthetic outcomes. The objective of the subcutaneous positioning of this implant, is to reduce the muscular pain related to the stretching of the muscular muscle, the deformations related to the muscular contraction with an animation of the prothesis, but also the risk of hull when associated with a matrix. It also pursues the objective, of obtaining a better aesthetic result, by systematically coupling at least one lipo-modelling session. For a long time, patients with a history of mastectomy and radiotherapy benefited from secondary breast flap reconstruction, in order to reduce the risk of complications and achieve a satisfying aesthetic outcome. But the lipo-filling technique allowed to reconsider the management of these patients. The benefits of fat tissue transplants are know to improve tissue trophicity (flexibility, thickness, vascularization). The objective of this study, is to evaluate the feasibility of secondary breast reconstructions by prepectoral positioned implant after lipo-preparation of the wall.

NCT ID: NCT04341701 Active, not recruiting - Asthma Copd Clinical Trials

Phenotype Identification Based on Multimodal MRI Analysis of Patients With Bronchial Obstructive Diseases

PIMABOD
Start date: August 5, 2021
Phase: N/A
Study type: Interventional

The hypothesis is that pulmonary and cardiac proton MRI allows phenotyping of patients with bronchial obstruction by cluster analysis based on quantitative multimodal imaging of bronchi, pulmonary vessels, pulmonary parenchyma, right and left ventricular function, myocardial fibrosis and pulmonary arterial pressure. Such imaging will also offer the advantage of being non-irradiating and without contrast products, which will ultimately allow CT to be replaced by MRI in the follow-up of bronchial obstructive patients, thus avoiding the risks associated with repeated exposure to ionizing radiation.

NCT ID: NCT04341142 Active, not recruiting - Clinical trials for CoV2 Positive Caregivers

Assessment of Serological Techniques for Screening Patients Regarding COVID-19-COVID-SER

COVID-SER
Start date: April 10, 2020
Phase: N/A
Study type: Interventional

Covid-SER is a prospective multi-center study for the evaluation of diagnostic performance of available serological tests

NCT ID: NCT04338399 Active, not recruiting - Clinical trials for Head and Neck Cancer

The BURAN Study of Buparlisib in Patients With Recurrent or Metastatic HNSCC

BURAN
Start date: December 12, 2020
Phase: Phase 3
Study type: Interventional

The BURAN study is a randomized, open-label phase III study to assess the treatment effect of once-daily buparlisib in combination with weekly paclitaxel compared to weekly paclitaxel alone in patients with refractory, recurrent, or metastatic head and neck squamous cell carcinoma (HNSCC) that have progressed after prior anti PD 1/anti PD L1 monotherapy; prior anti PD 1/anti PD L1 therapy in combination with platinum-based therapy; or after sequential treatment of anti PD 1/anti PD L1 therapy, either prior to or post, platinum-based therapy.