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NCT ID: NCT05407675 Active, not recruiting - Clinical trials for Advanced Solid Tumors

A Study to Evaluate the Safety and Tolerability of BMS-986408 Alone and in Combination With Nivolumab or Nivolumab and Ipilimumab in Participants With Advanced Solid Tumors

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

The primary purpose of this study is to characterize the safety profile of BMS-986408 as monotherapy and in combination with nivolumab or nivolumab and ipilimumab to establish the maximum tolerated dose (MTD). The Recommended Phase 2 Dose (RP2D) that optimizes the pharmacokinetic/pharmacodynamic (PK/PD) relationship of BMS-986408 will also be determined.

NCT ID: NCT05407324 Active, not recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Dazucorilant in Patients With Amyotrophic Lateral Sclerosis

DAZALS
Start date: November 15, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of CORT113176 (dazucorilant) in patients with Amyotrophic Lateral Sclerosis (ALS).

NCT ID: NCT05405283 Active, not recruiting - COVID-19 Vaccines Clinical Trials

Randomized, Single-blinded, Multicenter Trial Comparing the Immune Response to a 2nd Booster Dose of COVID-19 mRNA Vaccine (Pfizer-BioNTech) or Sanofi /GSK B.1.351 Adjuvanted Vaccine in Adults

COVIBOOSTAnci1
Start date: June 8, 2022
Phase: Phase 3
Study type: Interventional

The effectiveness of COVID-19 vaccines in reducing the risk of severe COVID-19 is currently demonstrated. In France, since the beginning of the vaccination campaign, 54,266,859 people have received at least one injection (ie. 80.5% of the total population), 53,354,698 people now have a complete vaccination schedule (ie. 79.1% of the total population) and since the beginning of the booster campaign, 39,558,416 people have received a 1st booster dose. However, the data currently available on the persistence of immunity on the one hand, and the appearance of viral variants with reduced sensitivity to vaccine immunity on the other, suggest the need to administer booster doses at variable intervals depending on age and comorbidities. Real-life efficacy data from France and around the World confirm that people who have received a booster dose are better protected than those who have only received a primary vaccination schedule (HAS). In this context, the Ministry of Health, has pronounced on the possibility of administering a second booster dose for people aged 60 and over. Moreover, the recommendations for the Haute Autorité de Santé for the 2nd booster dose in general population should be available in June 2022. Three vaccines, mRNA BNT162b2 vaccine, Sanofi/GSK monovalent D614 and B.1.351 formulations were administered as 1st booster in the CoviBOOST trial. All three vaccines boosted antibodies and neutralizing response after a BNT162b2 initial course. Heterologous boosting with the Sanofi/GSK SARS-CoV-2 recombinant adjuvanted protein vaccine B.1.351 (Beta formulation) provided higher rates of neutralizing antibodies against variants, including Omicron BA.1, compared with the mRNA BNT162b2 vaccine. Due to the start of the study after the beginning of booster vaccination campaign in elderly, the enrollment of participants over 65 years of age was difficult so, only 8 subjects aged 60 years and over were enrolled. As vaccine immunogenicity is lower in older populations and is waning more rapidly, it is important to evaluate the adjuvanted vaccine in this population. The objective of this ancillary study is to compare, in participants aged of 60 years and older and previously vaccinated with 3 doses of mRNA vaccine (2 doses of Pfizer BioNTech) and a 3rd dose of Pfizer BioNTech or Moderna, the immunogenicity of a second booster dose of the B.1.351 strain recombinant protein- based subunit vaccine to BNT162b2 (mRNA Pfizer BioNTech Vaccine).These results will provide important information for booster vaccination recommendations in this age group.

NCT ID: NCT05405166 Active, not recruiting - Clinical trials for Plasma Cell Myeloma Recurrent

SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM

IRAKLIA
Start date: June 23, 2022
Phase: Phase 3
Study type: Interventional

This is a randomized, multicenter, Phase 3, open-label study evaluating subcutaneous (SC) vs intravenous (IV) administration of isatuximab in combination with pomalidomide and dexamethasone (Pd) in RRMM patients (study participants) who have received at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor (PI). Eligible participants will be randomized 1:1 into 1 of 2 study arms: Arm SC: Isatuximab SC + Pd Arm IV: Isatuximab IV + Pd Participants will be allowed to continue therapy until disease progression, unacceptable adverse events (AEs), participant request to discontinue therapy or any other reason, whichever comes first.

NCT ID: NCT05404685 Active, not recruiting - Clinical trials for Kidney Tumors Treated With Minimally Invasive Surgery

Partial Nephrectomy in Low Pressure

P-NeLoP
Start date: October 4, 2022
Phase: N/A
Study type: Interventional

The main objective is to prospectively assess the impact of low insufflation pressure using AirSeal system (7mm Hg) during RAPN on post-operative patient pain (main location and intensity), 24 hours after surgery. The study will be conducted among 15 centers of the French research network on kidney cancer UroCCR.

NCT ID: NCT05403450 Active, not recruiting - Clinical trials for Relapsed/Refractory Peripheral T-cell Lymphoma

A Study of Tolinapant in Combination With Oral Decitabine/Cedazuridine and Oral Decitabine/Cedazuridine Alone in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma (R/R PTCL)

Start date: June 23, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The primary purpose of the study is to assess safety, and to identify the recommended phase 2 dose (RP2D) of tolinapant in combination with oral decitabine/cedazuridine in Phase 1 and to assess preliminary efficacy as determined by overall response rate (ORR) in Phase 2.

NCT ID: NCT05402371 Active, not recruiting - NAFLD Clinical Trials

A Study to Evaluate the Efficacy and Safety of Rencofilstat in Subjects With NASH and Advanced Liver Fibrosis

ASCEND
Start date: October 15, 2022
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, parallel-dosing, multi-center study to evaluate the efficacy and safety of Rencofilstat as evidenced by histopathological improvements in fibrosis in adult NASH subjects with F2 or F3 fibrosis (NASH CRN system). Antifibrotic biomarker activity will be evaluated on an exploratory basis.

NCT ID: NCT05397470 Active, not recruiting - Clinical trials for Facioscapulohumeral Muscular Dystrophy (FSHD)

Efficacy and Safety of Losmapimod in Treating Participants With Facioscapulohumeral Muscular Dystrophy (FSHD) (REACH)

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

This is a study to evaluate the safety and efficacy of losmapimod in treating participants with Facioscapulohumeral Muscular Dystrophy (FSHD). Participants diagnosed with Facioscapulohumeral muscular dystrophy type 1 (FSHD1) or Facioscapulohumeral muscular dystrophy type 2 (FSHD2) will participate in Part A (Placebo-controlled treatment period) and will be randomized in a 1:1 ratio to receive losmapimod 15 milligrams (mg) or placebo orally twice daily (BID). Upon completion of Part A, participants will have the option to rollover into Part B (open-label extension) to evaluate the long-term safety, tolerability, and efficacy of losmapimod and will receive losmapimod 15 mg orally BID.

NCT ID: NCT05395897 Active, not recruiting - Psychotropic Drugs Clinical Trials

ORiginal meThodology for Assessing the Impact of the Coronavirus Health Crisis on Psychotropic Drug Use

TORNADO
Start date: January 1, 2023
Phase:
Study type: Observational

The health crisis linked to the coronavirus has had a significant impact on the mental health. The question of the repercussion of this crisis on the consumption of psychotropic drugs is crucial. It is all the more true in France, which was already among the countries with the highest consumption of psychotropic drugs before the crisis. Indeed, an increase in the number of reimbursements for anxiolytic, hypnotic and antidepressant drugs has been highlighted in the context of the health crisis, using data from the health insurance database. To enhance the understanding about the impacts of the health crisis on the use of psychotropic drugs, it is essential to characterize the evolution of the use at the individual level. The main objective is to assess the impact of the coronavirus-related health crisis on the consumption of psychotropic drugs by studying the trajectories of reimbursements. The secondary objective of the project is to evaluate the evolution of problematic consumption of psychotropic drugs in the context of the health crisis.

NCT ID: NCT05395299 Active, not recruiting - Clinical trials for Prostatic Hyperplasia, Benign

Prostatic Arterial Embolization With SQUID (Ethylene Vinyl Alcohol Copolymer )

SQUID
Start date: November 22, 2022
Phase: N/A
Study type: Interventional

The aim of this pilot study is to analyze the feasibility of prostatic embolization for the treatment of symptomatic benign prostatic hypertrophy with a non adhesive liquid embolic agent (Squid)