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NCT ID: NCT05262023 Active, not recruiting - Clinical trials for Frontotemporal Dementia

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants and Participants With Frontotemporal Dementia (FTD-GRN)

Start date: February 1, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1/2, multicenter, randomized, placebo-controlled, double-blind study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of DNL593 in two parts followed by an optional open-label extension (OLE) period. Part A will evaluate the safety, tolerability, PK, and PD of single doses of DNL593 in healthy male and healthy female participants of nonchildbearing potential. Part B will evaluate the safety, tolerability, PK, and PD of multiple doses of DNL593 in participants with frontotemporal dementia (FTD) over 25 weeks. Part B will be followed by Part C, an optional 18-month OLE period available for all participants who complete Part B.

NCT ID: NCT05261828 Recruiting - Clinical trials for Non Specific Low Back Pain

Efficacy of a Short Multidisciplinary Education and Rehabilitation Program for Patients With Subacute and Chronic Low Back Pain (LBP) (LOMBAFAST)

LOMBAFAST
Start date: February 14, 2023
Phase: N/A
Study type: Interventional

The main purpose of this study is to assess the clinical efficiency of an intervention including a short multidisciplinary program of education and rehabilitation and a personalized follow-up, in patients with subacute and chronic low back pain and no severe disability. The secondary objectives are: - to assess the capacity of the program to modify and reduce the risk factors for evolution of patients towards a severe disability, - to estimate the cost-utility ratio of the intervention.

NCT ID: NCT05261399 Recruiting - Carcinoma Clinical Trials

Savolitinib Plus Osimertinib Versus Platinum-based Doublet Chemotherapy in Participants With Non-Small Cell Lung Cancer Who Have Progressed on Osimertinib Treatment

SAFFRON
Start date: August 3, 2022
Phase: Phase 3
Study type: Interventional

Clinical study to investigate the efficacy and safety of savolitinib in combination with osimertinib versus platinum-based doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed on treatment with Osimertinib.

NCT ID: NCT05261204 Active, not recruiting - Prosthesis Survival Clinical Trials

Transcatheter Aortic Valve Implantation Versus Standard Surgical Aortic Valve Operation

TAVISAR
Start date: May 19, 2022
Phase:
Study type: Observational

The mechanical intervention is treating aortic valve stenosis (AVS) which may be performed using the standard open surgical approach for aortic valve replacement (AVR) or transcatheter aortic valve implantation (TAVI). The key question of this study is to establish the difference in all-cause and cause-specific (cardiac vs noncardiac) mortality, all hospitalizations for heart failure within 24 months of follow-up, left ventricular reverse remodeling after adjustment for death, as assessed by means of the left ventricular end-diastolic volume (LVEDV), in patients who received the TAVI vs the standard surgical procedure for AVS.

NCT ID: NCT05261074 Recruiting - Clinical trials for Foreign Body Ingestion

Foreign Body Ingestion During COVID-19 Lockdown

COCE
Start date: October 20, 2021
Phase:
Study type: Observational

Ingestion of foreign bodies (FB) is one of the most observed domestic accidents and a frequent reason for consultation in pediatric emergency departments (PED). In the United States, nearly 100,000 ingestions of FB have been recorded by the National Poison Data System (NPDS), which represented the 4th cause of intoxication in 2015. Ingestion of FB involves very different mechanisms in children and adult patients. Unlike adults, 98% of FB ingestions in children are accidental and involve common objects found at home environment. Ingested FBs are of many types and vary depending on the object composition of the child's environment and supervision. The lockdown for COVID-19 pandemic highly modified children environment and parent supervision. Children remained at home and parents lived at home for teleworking. In this study, the modifications of children environment that could affect epidemiology of FB ingestion will be evaluated. This is a retrospective study with a sample of around > 100 children of Louis Mourier hospital from January 1 to December 31, 2019 and from March 1 to May 31, 2020. The total duration of the study is planned for 10 months. Primary outcomes: • To determine the role of COVID-19 pandemic linked containment on the prevalence of FB ingestions in children. Secondary outcomes: - Describe the epidemiological-clinical, radiological, therapeutic and evolutionary characteristics of the FB consultant's ingestions in the emergency department - Determine the frequency of endoscopy or surgery - Determine the factors favoring the use of endoscopic extraction From March 16 to May 10, 2020.

NCT ID: NCT05261061 Not yet recruiting - COVID-19 Clinical Trials

Prognosis of Geriatric Patients 1 Year After Hospitalization for COVID-19

PROVID-Ger
Start date: July 2022
Phase:
Study type: Observational

Old patients hospitalized in Acute Geriatric Units are characterize by advanced age, frailty, high number of comorbidities, cognitive impairment and loss of functional autonomy. Although, intra-hospital mortality in geriatric population (out of COVID) is low (6%) the long-term prognosis is often worse (30 to 60% of loss of autonomy and 30% of one-year mortality among hospital survivors). For geriatric patients with COVID19, intra-hospital mortality is higher than in younger Covid patients (1), but also higher than in geriatric patients outside the Covid context (30 vs 6% (2, 3)). Our hypothesis is that geriatric patients surviving hospitalization for COVID-19 have a worse vital and functional prognosis at 12 months than geriatric patients surviving hospitalization for another medical reason.

NCT ID: NCT05260866 Completed - Clinical trials for Mental Disorder, Child

Impact of the COVID-19 Pandemic on Mental Health Service Utilization in Children and Adolescents

MENTALPED
Start date: July 1, 2021
Phase:
Study type: Observational

Mental health consequences of the COVID-19 pandemic may be vast and may potentially overwhelm the mental health system in a long-lasting manner. Evaluating the effects of the COVID-19 pandemic on mental health in vulnerable groups such as children and adolescents has become an immediate priority. The aim of this study is to evaluate the impact of COVID-19 pandemic on use of mental health resources namely 1) prescriptions of psychotropic medications and 2) mental health-related outpatient visits, hospitalizations and emergency department visits in children and adolescents in France. Secondary aim is to evaluate the impact of the pandemic on episodes of fatal and non-fatal self-harm episodes in the same population. This will be a population-based cohort study using data from healthcare claims, administrative medical and outpatient drug dispensation databases in France between January 1, 2016 and June 1, 2021. Findings will inform on the risk of upcoming outbreaks of mental disorders that can result in significant morbidity and mortality and guide timely targeted actions to improve mental health outcomes and wellbeing in the youngest.

NCT ID: NCT05260528 Recruiting - Clinical trials for Acute Myeloid Leukemia

CPX-351 vs Intensive Chemotherapy in Patients With de Novo Intermediate or Adverse Risk AML Stratified by Genomics

ALFA2101
Start date: May 3, 2023
Phase: Phase 2
Study type: Interventional

The trial is a randomized, open-label phase II study comparing CPX-351 vs conventional intensivechemotherapy in patients with newly diagnosed de novo AML and intermediate- or adverse-risk genetics (according to 2017 ELN criteria)

NCT ID: NCT05260021 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 2

A Study to Evaluate Tirzepatide (LY3298176) in Pediatric and Adolescent Participants With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin or Basal Insulin or Both

SURPASS-PEDS
Start date: April 13, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to learn more about the safety and efficacy of tirzepatide compared to placebo in children or teenagers with type 2 diabetes taking metformin, or basal insulin, or both. The overall study will last about 60 weeks with up to 14 clinic visits and 6 phone visits. Clinic visits will include blood sample collection, physical exam and questionnaire.

NCT ID: NCT05259917 Completed - Clinical trials for Hereditary Angioedema

A Phase III, Crossover Trial Evaluating the Efficacy and Safety of KVD900 for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE)

Start date: February 23, 2022
Phase: Phase 3
Study type: Interventional

This study is a randomized, double-blind, placebo-controlled, phase III, three-way crossover clinical trial evaluating the efficacy and safety of KVD900, in the treatment of hereditary angioedema attacks in adolescent and adult Patients