There are about 36633 clinical studies being (or have been) conducted in France. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
Background: Sickle cell disease is the most common monogenic disease in the world caused by a mutation in the β-globin gene which creates abnormal hemoglobin called HbS. This polymer deforms the erythrocyte, making it more fragile and less flexible, thus leading to the occlusion of small blood vessels. This obstruction is the cause of painful vaso-occlusive crises and ischemia-reperfusion phenomena. Patients with sickle cell disease undergo major acute and chronic pain responsible for a significant deterioration in their quality of life and a significant consumption of analgesics, often daily, sometimes with the development of addictive behavior. Improved analgesic management was associated with improved disease prognosis. Several studies have shown the effectiveness of the osteopathic approach in the management of chronic pain. Our hypothesis is that the association with the standard treatment of osteopathy sessions could improve but also prevent the chronic pain frequent in patients with sickle cell disease. Objectives: Our main objective is to study the effectiveness of an osteopathic treatment in adult sickle cell patients with chronic pain on the reduction of the consumption of level I and II analgesics at 3 months (D90 +/- 15 days). Methods/Experimental design: This is a single-blind prospective randomized controlled monocentric study. The study population will be composed of 37 sickle cell patients aged over 18 years. The patients included will be allocated into two groups: one group will receive the osteopathic treatment and the 2nd group will receive the "placebo" treatment. Analgesic consumption will be assessed by weekly self- questionnaire. The evaluation of the pain will be carried out by the visual analogue scale (VAS). The degree of stress will be measured using the Perceived Stress Scale (PSS). Patients will receive an osteopathic treatment or a "placebo" treatment, one session every 4 weeks for 12 weeks with a total of 3 sessions per patient. The duration of each session is 45 minutes. Pain and stress assessments will be done before each session. A final evaluation will be carried out 3 months after the end of the osteopathic or "placebo" treatment. Data analysis will be performed using SPSS version 17.0 software. The significance threshold will be set at 0.05. This is the first protocol that aims to evaluate, with scientific rigor, the impact of the osteopathic approach in the management of pain in patients with sickle cell disease.
This study aims to provide a comprehensive understanding of sotorasib's mechanisms of action and resistance in NSCLC patients.
The aim of this first time in human proof of concept (FTiH-PoC) study is to evaluate safety and reactogenicity, to demonstrate efficacy and to explore immunogenicity of GlaxoSmithKline's (GSK) Neisseria gonorrhoeae generalized modules for membrane antigens (GMMA) (NgG) investigational vaccine compared to placebo (saline).
This study is intended to confirm the efficacy, safety, pharmacokinetic (PK) profile, and the durability of hepatitis B virus surface antigen (HBsAg) suppression observed with bepirovirsen for 24 weeks (with loading doses) as compared to the placebo arm. This study will have 4 stages: a) Double-blind treatment (bepirovirsen or placebo) for 24 weeks. b) Nucleos(t)ide analogue (NA) treatment for 24 weeks. c) NA cessation stage OR Continue NA for 24 weeks. d) Durability of response and follow up for further 24 weeks for participants who stopped NA treatment at Week 48. The arms will be stratified based on HBsAg level (HBsAg greater than or equal to [≥] 100 international unit per milliliter [IU/mL] to less than or equal [≤]1000 IU/mL or greater than [>] 1000 IU/mL to ≤3000 IU/mL) at screening. The total duration of the study, including screening (up to 60 days), the double-blind treatment stage (24 weeks), the On NA only stage (24 weeks), and the NA cessation and durability stages (48 weeks) is up to approximately 104 weeks at maximum for each participant.
This study is intended to confirm the efficacy, safety, pharmacokinetic (PK) profile, and the durability of hepatitis B virus surface antigen (HBsAg) suppression observed with bepirovirsen for 24 weeks (with loading doses) as compared to the placebo arm. This study will have 4 stages: a) Double-blind treatment (bepirovirsen or placebo) for 24 weeks. b) Nucleos(t)ide analogue (NA) treatment for 24 weeks. c) NA cessation stage OR Continue NA for 24 weeks. d) Durability of response and follow up for further 24 weeks for participants who stopped NA treatment at Week 48. The arms will be stratified based on HBsAg level (HBsAg greater than or equal to [≥] 100 international unit per milliliter [IU/mL] to less than or equal [≤]1000 IU/mL or greater than [>] 1000 IU/mL to ≤3000 IU/mL) at screening. The total duration of the study, including screening (up to 60 days), the double-blind treatment stage (24 weeks), the On NA only stage (24 weeks), and the NA cessation and durability stages (48 weeks) is up to approximately 104 weeks at maximum for each participant.
This is a Phase 2, randomized, double-blind, placebo-controlled 2 parallel-arm study to assess the effect on serum neurofilament light chain (sNfL), safety and tolerability of oral SAR443820 compared to placebo in male and female participants aged 18 to 60 years with relapsing-remitting multiple sclerosis (RRMS), secondary progressive multiple sclerosis (SPMS) (relapsing or non-relapsing), or primary progressive multiple sclerosis (PPMS) followed by an open-label long-term extension period. The total study duration is approximately 100 weeks and includes the following: 4-week screening period 48-week double-blind treatment period (Part A) 48-week open-label long-term extension period (Part B)
This is a multicentric, observational, retrospective and prospective study, aiming to estimate the risk of cancer occurrence in subjects carrying a PTEN mutation, based on the constitution of a national cohort.
This is a two-part, Phase IIa, multicenter, 12-week, open-label study. Up to 56 participants with deletion Angelman Syndrome (AS) aged 5-17 years (inclusive) will be enrolled in the study.
Overall, 100 Caucasian subjects participated in this 6-weeks lasting study, AC5+ was applied daily. All subjects had clinically confirmed mild to moderate alopecia and self-declared sensitive scalp. Instrumental assessments included Trans Epidermal Water Loss (TEWL), inflammation markers, clinical assessments included the severity of erythema, inflammation and greasiness. Subjective/Self assessments comprised the intensity of the scalp itch/pruritus and the evaluation of their head hair status (volume, abundance, strength). Same assessments were provided by the investigators.
The purpose of the study is to find out if iptacopan is effective and safe in adult patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who switch from their current standard of care treatment (eculizumab or ravulizumab) to study treatment, iptacopan/LNP023.