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NCT ID: NCT03445871 Completed - Clinical trials for Rheumatoid Arthritis

Association Between Methotrexate Erythrocyte Polyglutamate Concentration and Clinical Response in Rheumatoid Arthritis Patients Treated With Subcutaneous Injectable Methotrexate

POLYGLU
Start date: July 2, 2018
Phase: Phase 4
Study type: Interventional

Methotrexate (MTX) is the first-line treatment of rheumatoid arthritis (RA). In case of MTX failure, it is discussed to start a Biologic Disease-modifying Antirheumatic Drug (bDMARDs) according to the latest European recommendations of the EULAR. Before to add a Biologic Disease-modifying Antirheumatic Drug (bDMARDs), an objective estimation of MTX impregnation could be carried out by MTX polyglutamates (MTX-PG). In rheumatoid arthritis patients with active disease estimated by DAS28 (Disease activity Score 28)> 3.2 insufficiently controlled by MTX subcutaneously and patients in remission obtained with a DAS 28 <2.6 with methotrexate prescribed since more than 6 months at stable dose for at least 3 months, a concentration of MTX-PG will be achieved.

NCT ID: NCT03445832 Completed - Clinical trials for Neuromuscular Diseases

Pulmonary Function and Neuromuscular Disease

PREMDEN
Start date: January 8, 2018
Phase:
Study type: Observational

This study aims to describe the evolution of pulmonary function in 3 neuromuscular diseases : Duchenne muscular dystrophy, Werdnig-Hoffinann disease, congenital myopathy, monitored in Besançon university hospital.

NCT ID: NCT03445065 Completed - Diabetes Mellitus Clinical Trials

A French Study to Evaluate the Usefulness of an Implantable Continuous Glucose Monitoring (CGM) Sensor to Improve Glycemic Control in Participants With Diabetes Mellitus

Start date: February 28, 2018
Phase: N/A
Study type: Interventional

This study will be conducted in France and will evaluate the usefulness of using a long-term subcutaneously inserted continuous glucose monitoring (CGM) sensor (the Eversense XL CGM System) to improve glycemic control in patients with either Type 1 or Type 2 diabetes mellitus under insulin therapy. Participants will be enrolled into one of two cohorts (Cohorts 1 and 2). Cohort 1 will be focused on participants with Type 1 or Type 2 diabetes with hemoglobin A1C (HbA1c) >8%. Cohort 2 will be focused on participants with Type 1 diabetes spending more than 1.5 hours per day with mean glucose <70 mg/dL, including excursions below 54 mg/dL, for at least 28 days. Within each cohort, participants will be randomized in a 2:1 ratio to one of two groups: the Enabled and Control groups, respectively. The Enabled group will be trained to use the CGM system, whereas the Control group will continue with their usual glucose monitoring system (self-monitoring of blood glucose [SMBG] or flash glucose monitoring [FGM]).

NCT ID: NCT03444909 Completed - Pregnancy Related Clinical Trials

Collection of Information by Tocography External

CIPTEx
Start date: December 11, 2018
Phase: N/A
Study type: Interventional

The purpose of this trial is to create a comparative database, with data obtained with a new monitoring device of pregnant women,Toconaute, and two standard : a clinical cardiotocograph,and an electrophysiological signal medical device. It will allow to optimize the development of this new device. The use of the Toconaute and/or the electrophysiological medical device will succeed to the usual monitoring of pregnant women with a cardiotocograph. It will not change their medical care. The trial will include up to 35 pregnant women between 24 and 41 weeks of amenorrhea that requires discontinuous monitoring. It will last about 12 months, with an estimated inclusion period of 11 month.

NCT ID: NCT03444597 Completed - Clinical trials for Venous or Mixed Leg Ulcers

Post-Market Clinical-Follow-Up Study of Suprasorb® C Collagen Wound Dressing

Suprasorb®C
Start date: January 24, 2018
Phase:
Study type: Observational

Post-Market Clinical-Follow-Up Study of Suprasorb® C collagen wound dressing

NCT ID: NCT03444051 Completed - Pancreatic Tumor Clinical Trials

Comparison of Two Endoscopic Biopsic Needles for Pancreatic Tumors

Mousquetaires
Start date: March 1, 2017
Phase: N/A
Study type: Observational

This observational study compared quality of histological sampling of pancreatic EUS-FNB with the 20-gauge Procore® and 22-gauge Acquire® needles. In total, 68 patients were recruited. Histological diagnosis was achieved and a histological core biopsy was obtained in 82% of patients (28/34) in the 20-gauge Procore® group and 97% of patients (33/34) in the 22-gauge Acquire® group (P=0.1). Core biopsy specimens obtained were significantly longer with the 22-gauge Acquire® needle with a mean cumulative length of tissue core biopsies per needle pass of 4,33±3,46mm vs. 7,9±4,35mm for the 20-gauge Procore® (P<0,01). Reproducibility of this simple histological criterion was validated in intra and inter-observer.

NCT ID: NCT03443869 Completed - CMV Disease Clinical Trials

Letermovir Versus Valganciclovir to Prevent Human Cytomegalovirus Disease in Kidney Transplant Recipients (MK-8228-002)

Start date: May 3, 2018
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of letermovir (LET) versus valganciclovir (VGCV) in preventing CMV disease in adult kidney transplant recipients. The primary hypotheses are that LET is non-inferior to VGCV; and if non-inferiority is demonstrated, that LET is superior to VGCV, in preventing CMV disease through 52 weeks post-transplant.

NCT ID: NCT03443609 Completed - Clinical trials for Prostate Cancer Recurrent

Study of 68Ga-HBED-PSMA PET/CT and Conventional Imaging in Occult Biological Relapse Prostate Cancer

PSMA REBIOLOC
Start date: March 31, 2017
Phase: N/A
Study type: Interventional

68Ga-HBED-CC-PSMA is a radiopharmaceutical allowing a new imaging modality for the detection of prostate cancer recurrences, used in recent years in clinical studies by some teams mainly in Europe (1-6 ). The aim of this study is to study the diagnostic performance of 68Ga-HBED-PSMA PET / CT in occult recurrent carcinoma (PCa) by prospectively comparing it to the standard techniques used in this indication: optimized bone scintigraphy with double TEMP / CT systematic and abdominopelvic MRI. The therapeutic impact and tolerance of this examination will also be evaluated. The expected results are a demonstration of the superiority of 68Ga-HBED-PSMA PET compared to the standard assessment, with a potential impact on the therapeutic management of patients

NCT ID: NCT03442010 Completed - Adverse Drug Event Clinical Trials

Adverse Drug Events at Emergency Department

ADEsED
Start date: November 1, 2011
Phase:
Study type: Observational

Emergency departments (EDs) are a crucial element of the health care systems at interface between hospital and communities. The goals of the ED are to make an initial diagnosis and deliver urgent and critical care 24 hour per day and 365 days a year. Also, many Adverse Drug Events (ADEs) are not identified by emergency physicians. ADEs are injuries resulting from a drug related medical intervention. Their detection, documentation and reporting are essential for adequate medical care and knowledge of risk/benefit profiles of medication throughout their lifecycle. However, a number of studies indicate that in clinical practice the under-reporting of ADEs is a pervasive and widespread problem. The main reasons for under-reporting were difficulty in determining the cause of the ADE, lack of time, poor integration of ADE-reporting systems and uncertainty about reporting procedures. Successful treatment of ADEs depends on the ability of physicians to attribute ADEs to a medication. Some studies have reported that pharmacists but also student pharmacists were one of the best health care providers to establish medication history. Consequently, the aims of our study were to assess prevalence and characteristics of ADEs identified in an emergency department and to identify factors associated with ADEs in ED patients. This prospective observational study is conducted at the ED of a tertiary care hospital (University hospital of Montpellier). This department supports 80 000 patients every years. Patient were not included if they were less than 18 years old, present acute psychological disturbance or they did not agree to participate at this study. For each patient included, a pharmaceutical team conducted: medication reconciliation process to establish medication history and a structured interviews to determine self-reported adherence and self-medication. ADEs were attributed to a medication by the treating senior emergency physician: directly during patient consultation or after being alerted by the pharmaceutical team.

NCT ID: NCT03441243 Completed - Parturition Clinical Trials

Evaluation of the Psychological Consequences of Complicated Childbirth

ESPT Obst
Start date: May 23, 2018
Phase:
Study type: Observational

Prospective, non-interventional, monocentric, case-control study