Clinical trials: FRENCH STUDY
Melanoma
Post-ATU Study of Nivolumab
Nivolumab obtained European Marketing authorization in June 2015. Before this date, a Temporary Authorization for Use (ATU) Program in France for nivolumab was set up between September 2014 and August 2015.
- Trial name
- Post-ATU (NCT03325257)
- Testing
- Routine care
- Where
- 17 sites in France
- Volunteers
- 350 people
- Sponsor
- Nantes University Hospital
Parkinson Disease
French Parkinson's Disease Cohort - NS-PARK
The aim of NS-PARK cohort are to describe the natural history of Parkinson's disease (PD), and to propose patients stratification models based on PD pathophysiological mechanisms.
- Trial name
- NS-PARK (NCT04888364)
- Where
- France
- Volunteers
- 30,000 people, healthy volunteers welcome
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
Coronary Disease
Bile Acids and Gut Microbiota as Potent Coronary Atheroma Risk Factors: a Prospective Study in Human
The purpose of this study is to describe the composition of bile acids and the gut microbiota comparing two populations: patients with coronary atheroma and the healthy subjects.
- Trial name
- MABAC (NCT02375893)
- Testing
- No intervention, Healthy subject
- Where
- France
- Volunteers
- 80 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Coronary Artery Calcification, HIV Infections
French CAC-HIV Cohort Study
Clinical study: Methods: observational transversal two-arm cohort study including adults living with HIV (PLHIV) and HIV negative subjects (HIV-) at intermediate cardiovascular risk.
- Trial name
- CAC-HIV (NCT05563116)
- Testing
- Computed tomography coronary artery calcium (CAC) score (part of routine workup)
- Volunteers
- 689 people
- Sponsor
- Franck Boccara
Asthma
Nation-wide Health Resource Consumption and Costs Associated With Mepolizumab
Currently, no study has addressed real-life data describing changes in health resource consumption and related costs attributable to mepolizumab treatment.
- Trial name
- Resala (NCT04550780)
- Testing
- Mepolizumab
- Where
- France
- Volunteers
- 7,938 people
- Sponsor
- University Hospital, Montpellier
Pulmonary Arterial Hypertension
A Pulmonary Arterial Hypertension Study With Macitentan to Validate the PAH-SYMPACT™ in France, Italy and Spain
Prospective, multi-center, open-label, single-arm, Phase 3b psychometric validation study. Primary objectives: To evaluate the psychometric characteristics of reliability and construct validity of the French, Italian and Spanish…
- Trial name
- ORCHESTRA (NCT02081690)
- Testing
- Macitentan
- Where
- 39 sites in France, Italy and 1 more
- Volunteers
- 160 people
- Sponsor
- Actelion
Chronic Kidney Disease Requiring Chronic Dialysis, Hemodialysis, Home
Body Composition Monitor Among Daily Home Dialysis With Low Flow Dialysate
The fluid overload measured by the Body Composition Monitor (BCM Fresenius Medical Care) is a new independent risk factor of mortality.
- Conditions
- Chronic Kidney Disease Requiring Chronic Dialysis, Hemodialysis, Home, Electric Impedance
- Trial name
- VOLODIA (NCT03994133)
- Testing
- Measurement of the hydration state by bio-impedance spectroscopy
- Where
- France
- Volunteers
- 85 people
- Sponsor
- University Hospital, Caen
Multicenter Clinical Study
Prediction of Recruitment Potential of Participating Centers in Clinical Trials by Standardized Translation of Selection Criteria and Queries From DRG Database
This retrospective study aims to assess, on a large number of clinical trials (CT), the usefulness of converting CT eligibility criteria into standardized queries performed on commonly available data, i.e.
- Trial name
- Pred-Inclus (NCT03019068)
- Where
- France
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Urinary Incontinence, Stress, Urinary Incontinence, Urge
French Study to Evaluate the Impact of a Cognitive Therapy on Urinary Incontinent Women of All Age's Perineal Settings.
This trial is a pathophysiological study evaluating the impact of a cognitive therapy on the perineal neuromuscular mechanisms in women patients with urinary incontinence.
- Trial name
- NCT03797365
- Testing
- Classical rehabilitation, Cognitive associated rehabilitation
- Volunteers
- 40 people
- Sponsor
- Pierre and Marie Curie University
Inborn Errors of Metabolism
Retrospective Study of Adult Patients With Inborn Errors of Metabolism in Switzerland
This is a retrospective study aimed at establishing a database of the current health of adult patients with IEM in the French-speaking part of Switzerland. .
- Trial name
- NCT03534752
- Where
- Switzerland
- Volunteers
- 220 people
- Sponsor
- University of Lausanne
Patient With Dyslipidemia
Assessment of Compliance With European and French Guidelines for the Management of Dyslipidaemias
Cardiovascular disease (CVD) due to atherosclerosis of the arterial vessel wall and to thrombosis is the foremost cause of premature mortality and of disability-adjusted life years in Europe, and is also increasingly common in…
- Trial name
- OBDYSLIP (NCT03449784)
- Testing
- Detection of patients with dyslipidemia
- Where
- France
- Volunteers
- 977 people
- Sponsor
- University Hospital, Montpellier
Juvenile Systemic Sclerosis
Juvenile Systemic Sclerosis, a Retrospective Epidemiological Study on a French Cohort
Scleroderma is an inflammatory attack of the vessels leading to localized or multisystemic sclerosis. It is a rare autoimmune pathology in pediatrics.
- Trial name
- JSSc (NCT06019234)
- Where
- France
- Volunteers
- 30 people
- Sponsor
- University Hospital, Strasbourg, France
Mental Health Disorder
CoCo-20: a Longitudinal Follow-up Study of the French Paediatric Population During and After the Coronavirus Pandemic COVID-19
In the context of a viral outbreak and of widespread quarantine measures, a significant increase in psychological disorders, such as stress or fear behaviours, had previously been observed.
- Trial name
- CoCo-20 (NCT04498416)
- Testing
- Quantitative and qualitative assessments of mental health
- Where
- France
- Volunteers
- 70 people
- Sponsor
- Fondation Lenval
Chronic Pain Syndrome
Post-reimbursement Study to Follow Spinal Neurostimulator Devices for Pain Therapy (French SCS Registry)
Observational study to evaluate the long term efficacy of Spinal Cord Stimulation (SCS) over 2 years following SCS implant. This study is requested by French Health Authorities for reimbursement renewal, to maintain reimbursement…
- Trial name
- SME (NCT01778426)
- Where
- France
- Volunteers
- 414 people
- Sponsor
- MedtronicNeuro
Septic Shock
Fluid Resuscitation for Suspected Sepsis in Paediatric Emergency Departments
With 25.2 million children affected and 3.4 million deaths in 2017, paediatric sepsis is the leading cause of under-five mortality worldwide and has recently been described as "significant global health threat" by the World…
- Trial name
- FRESSPED (NCT05066464)
- Testing
- Fluid Resuscitation
- Where
- France
- Volunteers
- 60 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
RSV Infection
Prevention Strategy for Respiratory Syncytial Virus (RSV) Infections in Infants in France
Bronchiolitis is a viral lower respiratory tract infection, caused in 50 to 80% of cases by the respiratory syncytial virus (RSV).
- Trial name
- SPIRAV (NCT06881953)
- Testing
- Questionnaire
- Where
- France
- Volunteers
- 400 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Cerebrovascular Accident, Thrombolysis
Prospective Study of Cerebrovascular Accidents (CVA) in 3 French Cities (Besançon, Cayenne and Tours)
The objective of this study is to specify the typology of CVA in French Guiana by prospectively comparing consecutive strokes observed at each of the three study sites (Cayenne, Tours, Besançon)
- Trial name
- AVCBCT (NCT04925869)
- Testing
- Observational study
- Where
- French Guiana
- Volunteers
- 300 people
- Sponsor
- Centre Hospitalier de Cayenne
Childhood Solid Tumor
French Childhood Cancer Survivor Study
The FCCSS is a multicentric national large-scale collaborative population-based study of children treated for a solid tumor before 2000 in France and before the age of 19 years.
- Trial name
- FCCSS (NCT01620372)
- Where
- 36 sites in France
- Volunteers
- 18,000 people
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
PROM, Cochlear Hearing Loss
A Study Evaluating the French Version of the CIQoL-35 Quality of Life Questionnaire in Adult Cochlear Implant Use.
The Cochlear Implant - Quality of Life (CIQoL) PROM is a quality-of-life assessment questionnaire for adults with cochlear implants.
- Conditions
- PROM, Cochlear Hearing Loss, Hearing Loss, Quality of Life
- Trial name
- CIQoL (NCT05709431)
- Testing
- Questionnaire CIQoL-35
- Where
- France
- Volunteers
- 50 people
- Sponsor
- Oticon Medical
Chronic Heart Failure, Central Sleep Apnea
French Cohort Study of Chronic Heart Failure Patients With Central Sleep Apnoea Eligible for Adaptive Servo-Ventilation (PaceWave, AutoSet CS)
The purpose of FACE study is to provide in routine practice complementary long-term data on the mortality and morbidity of Chronic Heart Failure (CHF) patients with Central Sleep Apnea eligible for Adaptative Servo-Ventilation…
- Trial name
- FACE (NCT01831128)
- Testing
- ASV Treatment
- Where
- 18 sites in France
- Volunteers
- 509 people
- Sponsor
- ResMed