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NCT ID: NCT05070663 Active, not recruiting - Asthma Clinical Trials

A Study in Male and Female Adolescent Participants With Severe Uncontrolled Asthma Starting Treatment With Dupilumab Injection (Dupixent®)

PEDIASTHMA
Start date: November 4, 2021
Phase:
Study type: Observational [Patient Registry]

Primary objective: - Describe the characteristics of enrolled severe asthma patients Secondary objectives: - Assess the control of asthma under dupilumab (Dupixent®) treatment until 1 year - Assess the clinical objectives of the asthma care - Assess comorbidities associated with Type 2 inflammation - Assess safety during the year of treatment

NCT ID: NCT05070364 Active, not recruiting - Clinical trials for Hepatitis Delta Virus

Phase 3 Study to Evaluate the Efficacy and Safety of Peginterferon Lambda for 48 Weeks in Patients With Chronic HDV

LIMT-2
Start date: December 21, 2021
Phase: Phase 3
Study type: Interventional

The Phase 3 LIMT-2 study will evaluate the safety and efficacy of Peginterferon Lambda treatment for 48 weeks with 24 weeks follow-up compared to no treatment for 12 weeks in patients chronically infected with HDV. The primary analysis will compare the proportion of patients with HDV RNA < LLOQ at the 24-week post-treatment visit in the Peginterferon Lambda treatment group vs the proportion of patients with HDV RNA < LLOQ at the Week 12 visit in the no-treatment comparator group.

NCT ID: NCT05068128 Active, not recruiting - Dementia Clinical Trials

Combined Flow and Pressure Study of Craniospinal Dynamic

REVERT
Start date: September 1, 2021
Phase:
Study type: Observational

Normal pressure hydrocephalus (NPH) can cause a type of dementia. However, this type of dementia is the only one that is reversible. To treat this dementia it is necessary to evacuate the accumulation of CSF from the brain to another body cavity using a device called a shunt. But the implantation of this shunt is only effective when the cause of the pathology is an alteration of the normal circulation of the CSF. To diagnose these patients, morphological MRI and lumbar puncture are standard approaches used but remain perfectible in diagnostic terms. The main objective is to build a new model of the interaction of intracranial pressures and fluids in order to obtain a new parameter allowing to obtain information on the cerebral biomechanics.

NCT ID: NCT05067127 Active, not recruiting - C3 Glomerulopathy Clinical Trials

Phase III Study Assessing the Efficacy and Safety of Pegcetacoplan in Patients With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis

VALIANT
Start date: November 12, 2021
Phase: Phase 3
Study type: Interventional

This is a Phase 3 study to assess the efficacy and safety of twice-weekly subcutaneous (SC) doses of pegcetacoplan compared to placebo in patients with C3 glomerulopathy (C3G) or immune-complex membranoproliferative glomerulonephritis (IC-MPGN) on the basis of a reduction in proteinuria.

NCT ID: NCT05064462 Active, not recruiting - Virus Clinical Trials

TTV Viral Load in Heart Transplant Recipients

TTVCoeur
Start date: March 3, 2022
Phase:
Study type: Observational

This prospective, multicenter, non-interventional trial aims to study the association between TTV viral load and the occurrence of rejection or infection during the first year after transplantation. The TTV viral loads, taken once a month during the first year after the transplant, will be measured at the end of the study.

NCT ID: NCT05064358 Active, not recruiting - Multiple Myeloma Clinical Trials

Study to Investigate Alternative Dosing Regimens of Belantamab Mafodotin in Participants With Relapsed or Refractory Multiple Myeloma

DREAMM 14
Start date: March 3, 2022
Phase: Phase 2
Study type: Interventional

This study aims to evaluate alternative dosing regimens of single-agent belantamab mafodotin in participants with relapsed or refractory multiple myeloma (RRMM) to determine if an improved overall benefit/risk profile can be achieved by modifying the belantamab mafodotin dose, schedule, or both.

NCT ID: NCT05064059 Active, not recruiting - Colorectal Cancer Clinical Trials

A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Standard of Care in Subjects With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (MK-4280A-007)

Start date: November 10, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of coformulated favezelimab/pembrolizumab (MK-4280A) in participants with metastatic colorectal cancer. The study will also compare MK-4280A with the standard of care treatment of regorafenib and TAS-102 (trifluridine and tipiracil). The primary study hypothesis is that coformulated favezelimab/pembrolizumab (MK-4280A) is superior to standard of care with respect to overall survival.

NCT ID: NCT05063786 Active, not recruiting - Clinical trials for Advanced Breast Cancer

Trastuzumab + Alpelisib +/- Fulvestrant vs Trastuzumab + CT in Patients With PIK3CA Mutated Previously Treated HER2+ Advanced BrEasT Cancer (ALPHABET)

ALPHABET
Start date: September 14, 2021
Phase: Phase 3
Study type: Interventional

Randomized phase III trial of trastuzumab + Alpelisib +/- fulvestrant versus trastuzumab + chemotherapy in patients with PIK3CA mutated previously treated HER2+ Advanced Breast cancer.

NCT ID: NCT05063097 Active, not recruiting - Clinical trials for Substance-Related Disorders

Addiction in Intensive Cardiac Care Units

ADDICT-CCU
Start date: April 6, 2021
Phase:
Study type: Observational

Background: Illicit drug use is a growing issue in Europe and leading cause of acute cardiac events in patients admitted to intensive cardiac care units. Indeed, cardiovascular complications are one of the main causes of death due to illicit drug use. However, its prevalence in patients hospitalized in intensive cardiac care units is unknown. Objectives: This large multicenter prospective study will assess the prevalence of illicit drug use in consecutive patients hospitalized in intensive cardiac care units by urine drug assay. Eligibility: - Patient over 18 years old admitted to intensive Cardiac Care Unit (CCU) for any reason. - Without hospitalization for a planned interventional procedure. - Without hospitalization for more than 24 hours at any hospital facility before admission to the CCU. Design: - Multicentre cohort study with a prospective enrolment of all consecutive patients admitted to the CCU to assess the prevalence of illicit drug use in 40 centers throughout France. - Participants will be screened with a physical exam, medical history and addiction survey. - Participants will be screened for drug use by urine drug assay (NarcoCheck®, Kappa City Biotech SAS, Montluçon, France) and for tobacco by standardized exhaled carbon monoxide (CO) measurement with a CO-Check Pro device (Bedfont Scientific Ltd, Kent, UK). - Participants will be followed at 6 months of follow-up to assess the occurrence of cardiovascular events.

NCT ID: NCT05061420 Active, not recruiting - Clinical trials for Squamous Cell Carcinoma of Head and Neck

A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With HNSCC (Master Protocol) (Pegathor Head and Neck 204)

Start date: October 8, 2021
Phase: Phase 2
Study type: Interventional

The is a phase 2 multi-cohort, non-randomized, open-label, multi-center study assessing the clinical benefit of SAR444245 combined with other anticancer therapies for the treatment of participants aged 18 years and older with HNSCC. This study is structured as a master protocol for the investigation of SAR444245 with other anticancer therapies. Substudy 1-Cohort A1 aims to establish proof-of-concept that SAR444245 combined with the anti-PD1 antibody pembrolizumab, will result in a significant increase in the observed number of objective responses in trial participants with HNSCC who are treatment-naïve for recurrent and/or metastatic (R/M) disease. Substudy 4-Cohort B1 aims to establish proof-of-concept that SAR444245 combined with the anti-PD1 antibody pembrolizumab, will result in a significant increase in the observed number of objective responses in trial participants with HNSCC who have received treatment with PD1/PD-L1 and platinum-based regimen. Substudy 5-Cohort B2 aims to establish proof-of-concept that SAR444245 combined with cetuximab will result in a significant increase in the observed number of objective responses in trial participants with HNSCC previously treated with platinum-based regimen & cetuximab-naive after failure of no more than 2 regimens for recurrent and/or metastatic (R/M) disease.