Long-term Interventional Follow-up Study of Children With Prader-Willi Syndrome Included in the OTBB3 Clinical Trial
This study is a prospective, multicentre, interventional cohort study in children with Prader-Willi Syndrome (PWS) over 4 years (no treatment administered). The duration of the preceding OTTB3 study is 26 weeks. An untreated cohort of children with PWS will be included at an age of 2 years and followed up until an age of 4 years.
Regarding the untreated cohort, children with PWS born in France an
Study InterventionsFollow-up study of the treated cohort, Follow-up study of the untreated cohortPrimary EndpointsConfirmation of the long term safety profile (1); Confirmation of the long term safety profile (2)Study Period2021-09-07 → 2025-04-01 Evolution Of Growth Rate In Children With Growth Retardation Due to Glucocorticosteroid Therapy And Treated By Genotonorm
To estimate the evolution of height and growth rate over 5 years of growth hormone (GH) treatment To estimate the prognostic factors of growth rate with GH treatment To confirm the good clinical and biological safety of GH treatment in such children
Study InterventionsSomatropinPrimary EndpointsChange From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36: Full Analysis Population; Change From Baseline in Height Standard Deviation Score (SD) for Chronological Age (CA) at Month 36: Per Protocol (PP) PopulationStudy Period2005-01 → 2014-12 Effects of Exercise Training on Systemic Inflammation an Muscle Repair According to the Obstructive Chronic Pulmonary Disease (COPD) Phenotype
AIM: To identify those mechanisms involved in the systemic and muscular response to exercise treatment, in two different Obstructive Chronic Pulmonary Disease (COPD) phenotypes (emphysema and non-emphysema). The investigators will evaluate the effect of exercise training, on exercise outcomes, peripheral muscle strength measures, dyspnea and quality of life indices, and markers of systemic inflamm
Study InterventionsCombined Training (endurance and strength exercises)Primary EndpointsChange from baseline in TNF-alpha and its receptors, muscle isoforms of IGF-1 and its receptor in samples of quadriceps muscle satellite cells at 3 moths.Study Period2011-01 → 2012-12 Hormonal Status, Performance and Health in Elite Female Athlete
The repercussions of the hormonal status of high-level sportswomen on their performance and health as well as on the Athlete's Biological Passport (ABP) have been little studied and remain poorly known. The investigators therefore propose to contribute to the improvement of current knowledge by determining, thanks to the implementation of a multidisciplinary monitoring, with the use of various tes
Study InterventionsMultidisciplinary monitoring of healthy womenPrimary EndpointsChange from baseline weight; Change from baseline fat and lean massStudy Period2021-09-15 → 2025-05-31 A Study of Soticlestat as an Add-on Therapy in Children and Adults With Dravet Syndrome or Lennox-Gastaut Syndrome
The main aim of the study is to learn if soticlestat, when given as an add-on therapy, reduces the number of seizures in children and adults with Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS).
Participants will receive their standard anti-seizure therapy, plus tablets of soticlestat. There will be scheduled visits and follow-up phone calls throughout the study.
Study InterventionsSoticlestatPrimary EndpointsNumber of Participants With At Least One Treatment Emergent Adverse Event (TEAE); Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) ScoreStudy Period2022-03-04 → 2025-09-24 Investigating Efficacy and Safety of Once-weekly NNC0195-0092 Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency
This trial is conducted globally. The aim of the trial is to investigate efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency.
The main trial period will consist of 26 weeks of treatment, followed by a 26 week extension period.
Study Interventionssomapacitan, Norditropin® FlexPro® penPrimary EndpointsHeight Velocity (HV) (cm/Year) During the First 26 Weeks of Treatment, Measured as Standing Height With Stadiometer; Cohort II and Cohort III - Adverse Events Rate, Including Injection Site Reactions in Children With GHD.Study Period2016-03-31 → 2024-09-26 Changes in Breast Density and Blood Hormone Levels in Postmenopausal Women Receiving Anastrozole or Exemestane for Breast Cancer
RATIONALE: Studying changes in breast density and blood hormone levels in women receiving anastrozole or exemestane for breast cancer may help doctors learn more about the long-term effects of treatment and may help the study of breast cancer in the future.
PURPOSE: This clinical trial is studying changes in breast density and blood hormone levels in postmenopausal women receiving anastrozole or
Study Interventionspolymorphism analysis, high performance liquid chromatography, laboratory biomarker analysisPrimary EndpointsChanges in percent breast density in response to 1 year of aromatase inhibitor therapy; Changes in dense area in response to 1 year of aromatase inhibitor therapyStudy Period2007-09 → 2009-12 Predictive Elements of Trauma and Its After-effects: Importance of the Quality of Neurobiological Response to Stress
The neurobiological response to stress is an adaptive response allowing us to cope with the multiple aggressions of daily life. This response orchestrates the body's systemic reaction. The intensity of response to stress can modify the body's functioning, which implies a variety of fields where biomarkers may be isolated: immunity, psychology, neurophysiology, integrative physiology. When stress i
Study InterventionsBlood collection, Saliva collection, Electrocardiography (ECG)Primary EndpointsOccurrence of depression; Occurrence of "psychosomatic death"Study Period2020-11-04 → 2023-05 A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day (REAL4)
The study compares 2 medicines for children who do not have enough hormone to grow: somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already prescribe). Researchers will test to see how well somapacitan works. The study will also test if somapacitan is safe. Participants will either get somapacitan or Norditropin® - which treatment particip
Study InterventionsSomapacitan, Norditropin®Primary EndpointsHeight Velocity: In-trial Observation Period; Height Velocity: On-treatment Observation PeriodStudy Period2019-05-20 → 2025-09-30 A Study to Evaluate Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Participants With Childhood Epilepsy
The purpose of the study is to evaluate the efficacy of perampanel as measured by the 50 percent (%) responder rate during the maintenance period of the core study for seizure frequency in participants with pediatric epileptic syndrome (Cohort 1) and partial-onset seizures (POS) (Cohort 2).
Study InterventionsPerampanel Oral Suspension, Perampanel TabletPrimary EndpointsProportion of 50% Responders For All Seizures During the Maintenance Period of Core StudyStudy Period2019-05-31 → 2027-12-23