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NCT ID: NCT04786964 Terminated - Clinical trials for Metastatic Non-squamous Non Small Cell Lung Cancer

Study of Pemetrexed+Platinum Chemotherapy With or Without Cosibelimab (CK-301) in First Line Metastatic Non-squamous Non-Small Cell Lung Cancer

CONTERNO
Start date: December 8, 2021
Phase: Phase 3
Study type: Interventional

This is an efficacy and safety study of cosibelimab (CK-301) combined with pemetrexed/platinum chemotherapy versus pemetrexed/platinum chemotherapy alone in participants with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have not previously received systemic therapy for advanced disease. Participants will be randomly assigned in a 2:1 ratio to receive cosibelimab combined with pemetrexed/platinum (Investigators choice of cisplatin or carboplatin), OR pemetrexed/platinum (Investigators choice of cisplatin or carboplatin). The primary hypothesis is that cosibelimab in combination with pemetrexed/platinum chemotherapy prolongs Overall Survival (OS) compared to pemetrexed/platinum chemotherapy alone.

NCT ID: NCT04786873 Active, not recruiting - Clinical trials for Growth Hormone Deficiency

A Research Study of How Well Macimorelin Works to Find Out if Children Have a Lack of Growth Hormone and How Safe it is

DETECT
Start date: November 16, 2021
Phase: Phase 3
Study type: Interventional

This research study will find out if a new growth hormone stimulation test is safe and works as well as other tests to diagnose growth hormone deficiency (GHD) in children. The stimulation test will use a new growth hormone stimulating substance called macimorelin. By now, only adults in the USA can get this new stimulation test. The results of this study are expected to help children and teenagers with suspected GHD to get the macimorelin stimulation test. The macimorelin test will be compared to a clonidine and an arginine test. Both are known standard stimulation tests. Altogether two macimorelin tests are planned to be performed in the study, to show how repeatable macimorelin tests results are (under a set of similar conditions).

NCT ID: NCT04779242 Active, not recruiting - Clinical trials for Community-acquired Pneumonia

Omadacycline vs. Moxifloxacin for the Treatment of Community-Acquired Bacterial Pneumonia

Start date: February 25, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of omadacycline as compared to moxifloxacin in the treatment of adults with community-acquired bacterial pneumonia.

NCT ID: NCT04777851 Recruiting - Clinical trials for Carcinoma, Hepatocellular

Regorafenib-pembrolizumab vs. TACE/TARE in Intermediate Stage HCC Beyond Up-to-7

REPLACE
Start date: October 11, 2023
Phase: Phase 3
Study type: Interventional

REPLACE is a phase III, multicenter, randomized, open-label trial to evaluate the efficacy and safety of regorafenib and pembrolizumab (Rego-Pembro) versus transarterial chemoembolization (TACE) or transarterial radioembolization (TARE) for the first-line treatment of hepatocellular carcinoma (HCC or liver cancer). Approximately 496 patients in around 80 clinical sites worldwide will be randomized to receive either: - Investigational arm: Regorafenib in combination with pembrolizumab - Control arm: Transarterial chemoembolization (TACE) or transarterial radioembolization (TARE) In both arms, patients will receive trial treatment until progressive disease, unacceptable toxicity, deterioration of patient's condition that warrants permanent trial treatment discontinuation or other treatment discontinuation criteria is met. After trial treatment discontinuation, subsequent treatment will be administered according to the Investigator's clinical judgment.

NCT ID: NCT04775264 Completed - Atrial Fibrillation Clinical Trials

Safety and Feasibility of Atrial Deganglionation as Adjunctive Therapy for AF

Neural-AF
Start date: May 17, 2021
Phase: N/A
Study type: Interventional

A prospective, single arm, multi-center exploratory study of safety and feasibility in the treatment of patients undergoing cardiothoracic surgery.

NCT ID: NCT04772742 Completed - Migraine Clinical Trials

Eptinezumab in Adults With Migraine and Medication Overuse Headache

Sunlight
Start date: February 17, 2021
Phase: Phase 3
Study type: Interventional

This study evaluates the efficacy of eptinezumab to prevent migraine and headache in patients with the combined diagnosis of migraine and medication overuse headache

NCT ID: NCT04761627 Completed - Psoriasis Clinical Trials

A Study to Investigate Interchangeability of ABP 654 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis

Start date: March 24, 2021
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate pharmacokinetic similarity, efficacy, safety and immunogenicity of multiple switches between ustekinumab and ABP 654 compared with continued use of ustekinumab in participants with moderate to severe plaque psoriasis.

NCT ID: NCT04758598 Completed - Open Angle Glaucoma Clinical Trials

The Effects of DSLT and SLT on the Corneal Endothelium: A GLAUrious Trial Sub-Study

Start date: March 1, 2021
Phase: N/A
Study type: Interventional

The objective of this study is to compare the long-term (6 months) effects of Direct Selective Laser Trabeculoplasty (DSLT) treatment and SLT (Selective Laser Trabeculoplasty) treatment on corneal endothelial cell counts and corneal thickness.

NCT ID: NCT04751487 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD) (AERIFY-2)

Start date: February 12, 2021
Phase: Phase 3
Study type: Interventional

Primary Objective: Primary population (former smokers cohort): - Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPD Secondary Objectives: Primary population (former smokers cohort): - Evaluate the efficacy of itepekimab compared with placebo on pulmonary function in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on occurrence of acute exacerbation of COPD (AECOPD) in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on severe AECOPD in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on corticosteroid-treated AECOPD in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on respiratory symptoms in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on Forced Expiratory Volume in 1 second (FEV1) slope in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on health-related quality of life (HRQoL) as assessed by St. George's Respiratory Questionnaire (SGRQ) in former smokers with moderate-to-severe COPD - Evaluate the safety and tolerability of itepekimab in former smokers with moderate-to-severe COPD - Evaluate the pharmacokinetic (PK) profile of itepekimab in former smokers with moderate-to-severe COPD - Evaluate immunogenicity to itepekimab in former smokers with moderate-to-severe COPD Secondary population (current smokers cohort) - Estimate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate or severe COPD exacerbations in current smokers with moderate-to-severe COPD - Estimate the efficacy of itepekimab compared with placebo on pulmonary function in current smokers with moderate-to-severe COPD - Estimate the safety and tolerability of itepekimab in current smokers with moderate-to-severe COPD - Estimate the PK profile of itepekimab in current smokers with moderate to severe COPD - Estimate immunogenicity to itepekimab in current smokers with moderate-to-severe COPD

NCT ID: NCT04745832 Terminated - Clinical trials for Non Hodgkin Lymphoma

Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL)

Start date: August 13, 2021
Phase: Phase 3
Study type: Interventional

This is a Phase 3 study of the PI3Kδ inhibitor Zandelisib (ME-401) in combination with rituximab, in comparison to standard immunochemotherapy (Rituximab-Bendamustine or Rituximab-CHOP) in subjects with relapsed or refractory FL and MZL.