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NCT ID: NCT04746703 Recruiting - Bariatric Surgery Clinical Trials

New Imaging Tools to Explore Impact of Bariatric Surgery on Pancreatic Lesions: PACHIBA- Bariatric Surg

PACHIBA
Start date: February 10, 2021
Phase: N/A
Study type: Interventional

The investigators propose an exploratory study aiming at assessing the impact of surgical bariatric treatment on the improvement of pancreatic lesions detected by MRI. Pancreatic MRI will be performed in severe-obese patients with a planned bariatric surgery, before and 6 months after bariatric surgery. To assess the impact of bariatric surgery on pancreatic Magnetic Resonance Imaging (MRI) parameters in severe-obese patients

NCT ID: NCT04746625 Recruiting - Hydrocephalus Clinical Trials

Safety and Performance of the Polaris® 24 Adjustable Valve System in Hydrocephalus Patients' Treatment

SAPPHYRE
Start date: June 4, 2021
Phase:
Study type: Observational [Patient Registry]

The SAPPHYRE study is an ambispective (retrospective and prospective) PMCF study with the objective to evaluate the safety and performance of the Polaris® 24 adjustable valve system in the treatment of 126 patients with hydrocephalus.

NCT ID: NCT04746560 Terminated - Clinical trials for Cardiopulmonary Bypass

TEG 6s® for Perioperative Monitoring of Platelet Function During Cardiopulmonary Bypass for Cardiac Surgery

TEG-PM
Start date: April 21, 2021
Phase:
Study type: Observational

Excessive bleeding is common during cardiopulmonary bypass (CPB) for cardiac surgery. This may result from the systemic activation of the coagulation pathway and the acquired platelet dysfunction during the procedure. This study aims to compare the diagnostic performances of the TEG®6S device and its Platelet mapping® cartridge to those of the "gold standard" tests (light transmittance aggregometry and Multiplate®) for platelet function monitoring in patients undergoing CPB for cardiac surgery.

NCT ID: NCT04746534 Recruiting - Mesenteric Ischemia Clinical Trials

Cohort SURVI : Intestinal Ischemia and Vascular Diseases

Survibase
Start date: November 27, 2020
Phase:
Study type: Observational

The first Intestinal Vascular Emergency Unit (SURVI), with the institutional support of AP-HP, opened on 4 January 2016, within the Paris-Nord Val de Seine University Hospital Group. This intensive care is dedicated to the management of mesenteric ischemias (acute mesenteric ischemias, chronic mesenteric ischemias) and Intestinal Vascular Diseases Without Ischemia. The organisation of this type of dedicated centre, combining advances in resuscitation, interventional radiology and knowledge of intestinal vascular diseases, has led to a radical change in the prognosis for acute mesenteric ischaemia with a survival rate of over 80% and an intestinal resection rate of less than 40%. Acute mesenteric ischaemia (AMI) is characterised by the combination of digestive distress and vascular insufficiency: occlusive (thrombosis, embolism, arterial, venous) or non-occlusive (low flow or vasospasm). The vital prognosis is catastrophic in the absence of treatment (the mortality rate of an intestinal infarction is almost 100% without treatment), and the functional and anatomical after-effects are major for the survivors. Many intestinal vascular diseases have been identified as providing acute and chronic mesenteric ischaemia. The nosological framework of these diseases is broad, ranging from constitutional diseases of the vessels (collagenosis, arcuate ligament syndrome) to acquired diseases of a thrombophilic, cardiac, degenerative, autoimmune, iatrogenic, traumatic nature... The rarity of these diseases (with the exception of atherosclerotic disease, the incidence of which is increasing with the ageing of the population) makes their level of knowledge insufficient. The natural history of vascular diseases without ischaemia (rate of acute and chronic mesenteric ischaemia, mortality rate, resection rate...) is currently not described. The construction of a longitudinal observational cohort is necessary for the prevalence of ischaemic complications and predictive factors.

NCT ID: NCT04746404 Completed - Clinical trials for Borderline Personality Disorder

Application of a Positive Psychology Program for the Development of Emotional Skills in Prison

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

Studies show that emotional competence plays a significant role in psychological and physical health, and that programs aimed at their development are effective. Can a positive psychology program aimed at the development of emotional competence be implemented as part of care in lieu of deprivation of liberty? The investigators hypothesize the interest and possibility of implementing an emotional skills development program in the specific context of custodial care. The main expected outcome of this study is the identification of necessary adaptations of the emotional skills development program of Kotsou, I. et al (2011) for its implementation in remand homes.

NCT ID: NCT04746313 Recruiting - Scleroderma Clinical Trials

Prevalence of Hyperprolactinemia in Systemic Scleroderma

SCLERO-PRL
Start date: March 1, 2021
Phase:
Study type: Observational

Systemic sclerosis is an autoimmune and inflammatory disease characterized primarily by fibrosis and vascular involvement. We know that the immune system is disrupted in systemic sclerosis, but there are probably other mechanisms to explain the disease, including deregulation of certain proteins such as prolactin

NCT ID: NCT04746287 Completed - Healthy Volunteers Clinical Trials

Evaluation of the Safety and Tolerability of CKD-510 in Healthy Subjects

Start date: January 14, 2020
Phase: Phase 1
Study type: Interventional

This is a first-in-human study of CKD-510 in single-ascending dose and multiple-ascending dose in healthy subjects. This trial is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics of food effects of CKD-510.

NCT ID: NCT04746053 Completed - Clinical trials for Genital Diseases, Female

Ovarian Function and Gynecological Profile of Patients Carrying a Pathogenic Variant of the HNF1B Gene (GYN-HNF1)

GYN-HNF1
Start date: April 12, 2021
Phase: N/A
Study type: Interventional

The main objective of this study is to study the ovarian function of patients with hepatocyte nuclear factor-1beta (HNF1B) abnormality, followed in the reference centers of Toulouse and Paris University Hospitals. The secondary objectives are to know the gynecological profile of these patients. A dosage of anti-mullerian hormone (AMH) will be added to the usual balance, whatever the phase of the cycle and a pelvic ultrasound will be performed by the same operator by center. Patients will be received in a dedicated consultation to complete a questionnaire on gynecological and obstetric history, as well as their personal and family history. There will be no gynecological examination during this consultation.

NCT ID: NCT04745871 Recruiting - Prostate Cancer Clinical Trials

Diagnostic Performance of PSMA PET/CT for Pre-operative Lymph Node Assessment in Intermediate and High-risk Non-metastasic Prostate Cancer (PREOP-PSMA ).

PREOP-PSMA
Start date: May 20, 2021
Phase: N/A
Study type: Interventional

In France, prostate cancer is the most common cancer in men over 50 years of age (nearly 50,000 new cases per year) and is the second most common cause of cancer death in men (approximately 9,000 deaths per year). Although mortality has been declining since the end of the 1990s (about 7%/year), about 30 to 35% of them will have a biological recurrence. Accurate assessment of local, regional and distant spread of the disease is therefore needed to design optimal personalised care for each patient, either curative or palliative. Currently, in France, recommended disease assessment includes bone scintigraphy and Abdomino-Pelvic Magnetic Resonance Imaging. However, conventional imaging has limited performance with regard to lymph node extension. Node dissection is the best way to assess node status. Currently, no imaging exam allows this level of accuracy. Recently, molecular imaging has emerged as a promising tool to improve the initial extensional assessment of prostate cancer. Prostate-specific membrane antigen (PSMA) is a transmembrane glycoprotein, specific to the prostate, which is over-expressed on the surface of prostate cancer cells. Recent studies of PSMA PET/CT as part of the initial extension assessment of prostate cancer report superior diagnostic performance in terms of sensitivity and specificity compared to conventional tests, as well as an impact of PSMA PET/CT on patient management.

NCT ID: NCT04745832 Terminated - Clinical trials for Non Hodgkin Lymphoma

Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL)

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

This is a Phase 3 study of the PI3Kδ inhibitor Zandelisib (ME-401) in combination with rituximab, in comparison to standard immunochemotherapy (Rituximab-Bendamustine or Rituximab-CHOP) in subjects with relapsed or refractory FL and MZL.