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NCT ID: NCT05710718 Enrolling by invitation - Nocturnal Enuresis Clinical Trials

PureWick™ France and U.S. At-Home Pilot Study

Start date: October 31, 2023
Phase: N/A
Study type: Interventional

In this prospective, post-market, multi-site, open-label, crossover trial, women with urinary incontinence requiring the use of diapers (changes complets (French term)) at night will be 1:1 randomized to a treatment sequence using two devices (PureWick™ System and Hollister® Female Urinary Pouch External Collection Device) and followed for approximately 10 weeks through 2 treatment phases. The primary objectives are to evaluate safety (skin injury) and efficacy (capture rate). Safety will be assessed using the Draize Scale and efficacy will be measured based on daily urine capture rate.

NCT ID: NCT05686668 Enrolling by invitation - Clinical trials for Major Depressive Disorder

Evolution of the Sensory Profile in Depression

DEPSENS
Start date: January 10, 2022
Phase:
Study type: Observational

The perception of the environment through the study of sensory awareness is important to understand the adaptive or symptomatological behaviors (e.g., withdrawal, increased activity level, stimulation seeking, etc.). Sensory processing disorders, such as hypersensitivities or hyposensitivities, have been described in people with depression using the Adolescent Adult Sensory Profile scale. In a recent study, similar results consistent with extreme sensory profiles (hypersensitivity, hyposensitivity, sensation avoidance) in adults with a major depressive disorder were observed. The evolution over time of the sensory profile in people with a depressive disorder is not known. It is currently unknown whether these extreme sensory processing profiles are stable over time or whether they may evolve with the depressive symptomatology to normalize with clinical improvement. This knowledge could have an important impact both on the symptomatological expression of the disorder, its recognition, and also on the management of the patient. The investigators aim to study the evolution over time of the sensory profile of depressed subjects hospitalized using the ASSP. The behavioral responses of individuals with sensory processing disorder may be related to the coping strategies of these individuals with their living environment. In a second step, the investigators will study the second step the sensory profile of subjects with depression according to their coping strategies, their living environment and their clinical characteristics (anxiety (anxiety, psychomotor slowing, self-esteem, anhedonia).

NCT ID: NCT05626751 Enrolling by invitation - Clinical trials for Diffuse Cutaneous Systemic Sclerosis

An Open-label Extension Trial of HZNP-HZN-825-301 in Adult Participants With Diffuse Cutaneous Systemic Sclerosis (Diffuse Cutaneous SSc)

Start date: November 4, 2022
Phase: Phase 2
Study type: Interventional

Primary Objectives: 1. The primary efficacy objective is to assess the efficacy of 52 weeks of open-label treatment with HZN-825 in participants with diffuse cutaneous systemic sclerosis, as measured by change from both baselines in forced vital capacity percent (FVC %) predicted. 2. The primary safety objective is to examine the safety and tolerability of 52 weeks of open-label treatment with HZN-825, inclusive of, but not limited to, adverse events (AEs), serious AEs (SAEs) and the adverse event of special interest (AESI), from Day 1 to 4 weeks after last dose.

NCT ID: NCT05619783 Enrolling by invitation - Clinical trials for Amyotrophic Lateral Sclerosis

Extension Study Evaluating The Safety And Tolerability of AMX0035

Start date: December 29, 2022
Phase: Phase 3
Study type: Interventional

The primary objective is to evaluate the safety and tolerability of AMX0035 over 108 weeks of open label treatment for participants previously enrolled in Study A35-004 (PHOENIX).

NCT ID: NCT05604170 Enrolling by invitation - Clinical trials for Tuberous Sclerosis Complex

Open-label Study of Adjunctive GNX Treatment in Children and Adults With TSC-related Epilepsy

Start date: May 16, 2022
Phase: Phase 3
Study type: Interventional

This is a Phase 3, global, open-label extension (OLE) study of adjunctive GNX treatment in children and adults with TSC who previously participated in either Study 1042-TSC-3001 or Study 1042-TSC-2001

NCT ID: NCT05595252 Enrolling by invitation - Clinical trials for Cervical Intraepithelial Neoplasia

Retrospective Study on the Evolution of CIN 1 to 3 in Per and Postpartum in Nancy From 2014 to 2022

Start date: January 1, 2014
Phase:
Study type: Observational

In France, the screening rate for cervical cancer remains too low. Screening is simple and non-invasive. Pregnant patients are most of the time young and are part of the target population for screening, and for many women, it is the first encounter with a gynecologist. The cervical smear is therefore an important step of the first consultation during pregnancy In the case of pathological results, colposcopies with biopsies are performed, frequently finding CIN 1 to 3. (cervical intraepithelial neoplasia) These CIN lesions evolve slowly and most of the time, treatment can be withheld until the end of the pregnancy. Several studies suggest a higher regression rate in pregnant patients. Our study will evaluate the rate of regression, progression or persistence of these lesions in per and post partum patients in Nancy, between 2014 and 2022. To obtain our results, we will compare the results of per and post partum biopsies in each patient. In a second step, we will study the risk factors of aggravation or on the contrary the protective factors, allowing a faster regression of the lesions

NCT ID: NCT05589675 Enrolling by invitation - Colorectal Cancer Clinical Trials

Evaluation of a New Invitation Procedure to the French Organized Colorectal Cancer Screening Program

KITCOLO22
Start date: April 1, 2023
Phase: N/A
Study type: Interventional

This is a randomized controlled trial comparing the effect on participation rates to colorectal cancer screening between an intervention arm (invitation letter to the screening program including a FIT test with or without prior notification) and a control arm with the standard of care (invitation letter to visit the GP who will deliver the FIT test).

NCT ID: NCT05543252 Enrolling by invitation - Parkinson's Disease Clinical Trials

An Extension Study to Evaluate the Long-Term Efficacy, Safety and Tolerability of Minzasolmin (UCB0599) in Study Participants With Parkinson's Disease

Start date: August 29, 2022
Phase: Phase 2
Study type: Interventional

The purpose of the study is to estimate the pharmacodynamic effects of minzasolmin (UCB0599) on brain pathophysiology in Early-start versus Delayed-start participants originally diagnosed with new onset Parkinson's disease.

NCT ID: NCT05515536 Enrolling by invitation - Friedreich Ataxia Clinical Trials

A Study to Assess the Safety and Efficacy of Vatiquinone in Participants With Friedreich Ataxia

Start date: December 8, 2022
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to assess the long-term safety of vatiquinone in participants with Friedreich ataxia (FA) previously exposed to vatiquinone.

NCT ID: NCT05481827 Enrolling by invitation - Clinical trials for Age Related Macular Degeneration (AMD)

ORACLE: A Long-term Follow-up Study to Evaluate the Safety of GT005 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration Treated in a Gyroscope-sponsored Antecedent Study

ORACLE
Start date: July 12, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the long-term safety of GT005 in participants with Geographic Atrophy (GA) secondary to AMD who have been treated in an antecedent study.