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NCT ID: NCT04026087 Completed - Clinical trials for Antibody-mediated Rejection

Subclass of Donor-specific Antibody as a Risk Factor of Antibody Mediated Rejection in Renal Transplantation

COR-HUM
Start date: July 18, 2019
Phase:
Study type: Observational

Antibody-mediated rejection is now recognized as the first cause of long-term kidney transplant loss. This type of rejection is mediated by the presence of graft-specific antibodies, usually directed against HLA (Human Leukocyte Antigens), called DSA (Donor Specific Antibody). De novo DSA (ie, post-transplantation) is detected in approximately 20% of transplant recipients in the first five years, and is a major risk factor for antibody mediated rejection and graft loss. All anti-HLA antibodies therefore do not have the same pathogenicity. Some teams have shown that the detection of IgG3 anti-HLA by cytometry is associated with a higher risk of humoral rejection but these results have not been confirmed by others. One of the limitations of the cytometry by Luminex technique is that it only informs the detection of each subclass but does not allow analysis of the distribution of the different subclasses of a DSA. A method has been developed for the relative detection and quantification of different subclasses of the DSA using the mass spectrometry technique and will be tested during this study. This new quantification method therefore opens up the prospect of studying whether, not only the presence but especially the distribution of IgG subclasses, in particular IgG3, could constitute a reliable and robust marker of humoral rejection.

NCT ID: NCT04026035 Completed - Clinical trials for Septicemia in Hemodialysis

PCR Technic Evaluation in the Microbial Diagnostic of Septicemia in Hemodialysis Patients With Catheter.

PCRDial
Start date: August 1, 2019
Phase:
Study type: Observational

The aims of this study are to evaluate the PCR on whole blood approach to determine rapidly both the susceptibility and the identification of Staphylococcus responsible of septicemia in patients under hemodialysis with catheter. The results obtained with this novel experimental approach will be compared to those obtained on the same clinical samples by the routine diagnostic laboratory.

NCT ID: NCT04025411 Completed - Stroke Clinical Trials

Effectiveness of Computerized Device New of Visual Motor Simulation Versus Mirror Therapy in Hemiplegic Patients.

SI-VIM
Start date: October 28, 2019
Phase: N/A
Study type: Interventional

Mirror Therapy (TM) has been shown to be effective in motor rehabilitation of the hemiplegic upper limb, but its implementation in current clinical practice has several difficulties, both from the patient and physiotherapist point of view. A new computerized Mirror Therapy (TM) device (Intensive Visual Simulation 3 (IVS3), Dessintey) which aims to solve the TM compliance problems and make it more efficient have been developed.

NCT ID: NCT04025138 Completed - Clinical trials for Ultra-marathon Runners

Fatigability Compared Men and Women Induced According to the Distance Traveled on an Ultra-marathon in the Mountains

UTMB_2019
Start date: July 2, 2019
Phase: N/A
Study type: Interventional

Acute physiological consequences of ultra-marathon running are still unknown, particularly in women. Some studies have suggested that the proportion of fatigue attributable to peripheral and central mechanisms varies between males and females; however, results are contradictory. The results from the investigators of the present experiment in two studies conducted in 2009 and 2012 showed that: - A large part of fatigue induced by a mountain ultra-marathon could be attributed to central fatigue in males and that, - Females exhibited less peripheral fatigue in the plantar flexors than males did after a 110-km ultra-trail-running race. According to the literature, there seems to be a plateau in fatigue after 12-15 hours of running.

NCT ID: NCT04024930 Completed - Clinical trials for EUS Guided Biliary Drainage

Endoscopic Ultrasound Guided Choledocoduodenostomy With the Lumen Apposing Metal Stent [Axios® Stent]

Start date: September 1, 2017
Phase:
Study type: Observational

Endoscopic Ultrasound (EUS) guided biliary drainage is indicated in case of impossibility or failure of classic biliary drainage by endoscopic retrograde cholangio-pancreatography (ERCP). Recently the investigators reported a good efficiency of EUS guided choledocoduodenostomy using the HOT-AXIOS device (Electrocautery enhanced lumen apposing metal stent) in a retrospective multicentric study. Utilization of the recommended technique (direct punction with the HOT AXIOS using a pure cut current + using a 6 mm Stent) was the only predicting factor of clinical success. The investigators reevaluate this procedure one year after in the same centers.

NCT ID: NCT04024709 Completed - Gastroparesis Clinical Trials

Long-term Results of Per-oral Pyloromyotomy for Refractory Gastroparesis

Start date: January 1, 2017
Phase:
Study type: Observational

This is a large multicenter retrospective French cohort conducted in seven French centers that had performed at least five G-POEM procedures at the end of 2017. All patients treated by G-POEM for refractory gastroparesis since April 30, 2014 (first case of GPOEM in France) in these seven centers were included in this study and followed until April 2019. The data were collected retrospectively regarding medical and technical data, and then prospectively for the following data, which were included in a database for each center and combined for analysis. Gastric Cardinal Symptoms Index (GCSI) was used to evaluate symptoms and their severity. It applies a Likert scale ranging from 0 to 5 (5 being the highest score) for three subscales: satiety (mean of four items), nausea/vomiting (mean of three items), and bloating (mean of two items). The total GCSI score was the mean of the three subscales. A GCSI score ≥ 2.6 is considered moderate gastroparesis and ≥ 3 is considered severe. Gastric emptying scintigraphy (GES) was used to confirm delayed gastric emptying, since it is considered the gold standard according to the American Society of Neurogastroenterology. Patients consume a radiolabeled meal, receive imaging at specific time-points to determine gastric retention. The exam is pathological when retention is > 90% after 1 hour, > 60% after 2 hours (H2), > 30% after 3 hours (H3), and > 10% after 4 hours (H4). All but one center performed the GES according to the US guidelines: that center performed a 3-hour GES with a local validation of a threshold of 30% retention at H3 to define delayed gastric emptying. A %H4 retention > 30% was defined as severe delayed gastric emptying.

NCT ID: NCT04024683 Completed - Thoracic Surgery Clinical Trials

The Effect of the Ultrasound-guided Serratus Anterior Plane Block in Combinaison With Thoracic Paravertebral cathéter Versus Thoracic Paravertebral Cather for Perioperative Analgesia in Thoracic Surgery

Start date: March 1, 2018
Phase:
Study type: Observational

Introduction The paravertebral catheter has been shown to be effective in controlling postoperative pain, but has never been associated with the deep dentate block in thoracic surgery. The objective of this study was to compare the efficacy of single-dose deep dentate block-level postoperative pain control in combination with a continuous perfusion paravertebral catheter versus continuous perfusion paravertebral catheter alone in controlled thoracic surgery. Materials and methods We retrospectively included 159 ASA I-III major patients who underwent scheduled thoracic surgery in the operating theater of Dijon University Hospital, between March and November 2018. All patients benefited from the same anesthetic protocol routinely used in controlled thoracic surgery. They were included in two groups: deep serrate deep group (GS) with a deep serrated deep serrate block immediately after orotracheal intubation with 0.2% Ropivacaine at 0.75 mg / kg and paravertebral catheter placed by the surgeon and put in charge at the fall of the surgical drapes versus control group (GC) benefiting from a paravertebral catheter alone. The primary endpoint was 24-hour morphine equivalent consumption. The criteria for secondary judgments were intraoperative remifentanil consumption, VAS at 0h, 24h and 48h, morphine consumption at 0h, 48h and the profile of the various complications. The morphine equivalent was calculated according to an equivalence table with reference to Oxycodone per os. Quantitative data are presented in median and standard deviation and were compared by Student's t-test or Wilcoxon test.

NCT ID: NCT04024228 Completed - Healthy Volunteers Clinical Trials

Study to Assess the Immune Response and the Safety Profile of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Europeans Adults 60 Years of Age and Older

Start date: October 28, 2019
Phase: Phase 3
Study type: Interventional

Primary Objective: To demonstrate that high-dose quadrivalent influenza vaccine (QIV-HD) induces an immune response that is superior to the responses induced by standard-dose quadrivalent influenza vaccine (QIV-SD) for all 4 virus strains 28 days post-vaccination in participants 60 to 64 years of age and in participants 65 years of age and older. Secondary Objective: - Immunogenicity: To further describe the immune response induced by QIV-HD and QIV-SD in all participants by age group, in pooled age groups, and by vaccine group (QIV-HD; QIV-SD). - Safety: To describe the safety profile of all participants by age group, in pooled age groups, and by vaccine group (QIV-HD; QIV-SD).

NCT ID: NCT04024176 Completed - Arthropathy Clinical Trials

Gait Analysis in Moderate Hemophiliac Patients (AQM-Hemophile)

Start date: November 29, 2019
Phase: N/A
Study type: Interventional

The management of moderate hemophilia is less codified than those of severe patients; because these patients are theoretically less likely to bleed and therefore less likely to develop arthropathies. Nowaways, the question arises as to the appropriateness of this "symptomatic" management for the prevention of the occurrence of hemophilic arthropathies. Indeed, a significant number of moderate hemophiliacs seems to develop severe arthropathies that cause significant disability. However, because of the very small proportion of these patients in the total number of hemophiliacs, data are lacking on the impact of arthropathies on this population. The investigators therefore propose to include moderate hemophiliac patients in the study to carry out an evaluation of gait, using a gait analysis to determine the consequences of arthropathies, even sub-clinical ones, according to the duration of the disease's progression. In an associated way, the analysis of different clinical (joint assessment; quality of life score;...), radiological (radiographic; ultrasound (synovial thickness)), biological (level of associated factors ; other associated marker), in order to provide a complete picture of the articular situation in these patients with moderate haemophilia.

NCT ID: NCT04024150 Completed - Anti-integrases Clinical Trials

Pregnancy, Anti-integrase and Lymphocyte Repertoire of the Newborn

RAGIIF
Start date: December 4, 2019
Phase:
Study type: Observational

The objective of the study is to evaluate at birth, the diversity of the T repertoire of newborns exposed in utero to anti-integrases in comparison with a control group of children exposed to other antiretroviral drugs.