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NCT ID: NCT04490915 Active, not recruiting - Clinical trials for Congenital Adrenal Hyperplasia

Global Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal Hyperplasia

CAHtalyst
Start date: November 16, 2020
Phase: Phase 3
Study type: Interventional

This is a Phase 3 study to evaluate the efficacy, safety, and tolerability of crinecerfont versus placebo administered for 24 weeks in approximately 165 adult participants with classic CAH due to 21-hydroxylase deficiency. The study consists of a 6-month randomized, double-blind, placebo-controlled period, followed by 1 year of open-label treatment with crinecerfont. Subsequently, participants may elect to participate in the open-label extension (OLE) period. The duration of participation in the study is approximately 20 months for the core study and will be a variable amount of time per subject for the OLE (estimated to be approximately 3 years).

NCT ID: NCT04488133 Active, not recruiting - Clinical trials for Muscular Atrophy, Spinal

A Study of Nusinersen Among Participants With Spinal Muscular Atrophy Who Received Onasemnogene Abeparvovec

RESPOND
Start date: January 4, 2021
Phase: Phase 4
Study type: Interventional

The primary objective of this study is to evaluate the clinical outcomes following treatment with nusinersen in participants with spinal muscular atrophy (SMA) who previously received onasemnogene abeparvovec. The secondary objectives of this study are to evaluate the safety and tolerability; clinical outcomes and pharmacodynamics (PD) of nusinersen treatment in participants with SMA who previously received onasemnogene abeparvovec.

NCT ID: NCT04487080 Active, not recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

MARIPOSA
Start date: September 30, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy of the amivantamab and lazertinib combination, compared with osimertinib, in participants with epidermal growth factor receptor (EGFR) mutation (Exon 19 deletions [Exon 19del] or Exon 21 L858R substitution) positive, locally advanced or metastatic non-small cell lung cancer (NSCLC).

NCT ID: NCT04487067 Active, not recruiting - Clinical trials for Carcinoma, Hepatocellular

A Study of Atezolizumab (Tecentriq) in Combination With Bevacizumab to Investigate Safety and Efficacy in Patients With Unresectable Hepatocellular Carcinoma Not Previously Treated With Systemic Therapy-Amethista

AMETHISTA
Start date: August 25, 2020
Phase: Phase 3
Study type: Interventional

This is a Phase IIIb, one arm, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab + bevacizumab in patients with unresectable HCC who have received no prior systemic treatment.

NCT ID: NCT04486274 Active, not recruiting - Clinical trials for Endoscopic Ultrasonography With Tissue Acquisition

Macroscopic on Site Evaluation (MOLSE) vs Standard Specimen Acquisition of Solid Lesions During EUS-FNB

MOSE
Start date: July 17, 2020
Phase: N/A
Study type: Interventional

Endoscopic ultrasonography (EUS) with tissue acquisition (TA) is nowadays a well-established technique for the sampling of solid lesions pancreatic and non-pancreatic lesions. Actually the standard methods to obtain sampling in gastrointestinal (GI) and non-GI solid masses is the fine needle aspiration (FNA) performed by endoscopic ultrasonography (EUS). Its sensitivity, specificity and diagnostic accuracy for malignant cytology are actually reported of 85-95%, 95%-98% and 78-95% respectively. These data could be affected by the presence of cytopathologist in endoscopy room during the tissue sampling. The rapid on-site evaluation (ROSE) has been advocated to significantly increase EUS-FNA accuracy. To overcome this problem fine needle biopsy (FNB) for TA to obtain histological specimens was proposed. These needles allow as the acquisition of an histological specimen than the cytological one with FNA needles. Recently, the need to obtain a histological, instead of a cytological, specimen during EUS has become more urgent and necessary due to innovative oncological treatment options. An acquired histological specimen could avoid the need of a cytopathologist in the endoscopic room, diminishing costs, procedures time, number of passes and reducing the additional costs of a possible repeated EUS-FNA, in case of an inconclusive diagnosis. With the advent of FNB, the macroscopic on-site evaluation (MOSE) of the specimen by the endosonographer was proposed, resulting in a comparable alternative to ROSE.

NCT ID: NCT04485533 Active, not recruiting - Dry Eye Syndromes Clinical Trials

Clinical Investigation to Assess the Efficacy and the Safety of VisuXL® Gel Administered in Patients Affected by Moderate DED

Start date: July 6, 2020
Phase: N/A
Study type: Interventional

This is a post-market, european multicenter study. This is a randomized, cross-over, double blind study with competitive enrolment, aimed to enroll a total of 90 patients with a diagnosis of moderate dry eye disease (DED).

NCT ID: NCT04484142 Active, not recruiting - Clinical trials for Non-small Cell Lung Cancer

Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations (TROPION-Lung05)

Start date: March 30, 2021
Phase: Phase 2
Study type: Interventional

This is a study of the efficacy, pharmacokinetics, and safety of DS-1062a in participants with advanced or metastatic non-small cell lung cancer (NSCLC) with known actionable genomic alterations.

NCT ID: NCT04483739 Active, not recruiting - Multiple Myeloma Clinical Trials

Isa-KRd vs KRd in Newly Diagnosed Multiple Myeloma Patients Eligible for Autologous Stem Cell Transplantation (IsKia TRIAL)

IsKia
Start date: September 25, 2020
Phase: Phase 3
Study type: Interventional

This protocol is a phase III study designed to compare the efficacy and the safety of Isa-KRd induction, transplant, Isa-KRd post ASCT consolidation and Isa-KRd light consolidation vs KRd induction, transplant, KRd post ASCT consolidation and KRd light consolidation After confirmation of eligibility criteria patients will be randomized to one of the 2 treatment groups in a 1:1 randomization ratio.

NCT ID: NCT04483089 Active, not recruiting - Clinical trials for Tricuspid Valve Regurgitation

An Observational Real-world Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip™ Device (bRIGHT)

bRIGHT
Start date: August 27, 2020
Phase:
Study type: Observational

The bRIGHT EU PAS study is an observational real-world study evaluating severe tricuspid regurgitation patients treated with the Abbott TriClip™ device (bRIGHT EU Post-Approval Study).

NCT ID: NCT04475939 Active, not recruiting - Clinical trials for Lung Cancer, Non-Small Cell

Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants With Advanced/Metastatic Non-small Cell Lung Cancer

ZEAL-1L
Start date: October 26, 2020
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized, double-blind, placebo-controlled study of niraparib plus pembrolizumab versus placebo plus pembrolizumab as maintenance therapy in participants with advanced or metastatic non-small cell lung cancer (NSCLC) who have achieved stable disease (SD), partial response (PR), or complete response (CR) following completion of standard of care first-line platinum-based induction chemotherapy with pembrolizumab. The primary hypotheses are: participants with confirmed diagnosis of NSCLC could benefit from niraparib plus pembrolizumab versus placebo plus pembrolizumab with respect to Progression-free survival (PFS) and Overall survival (OS).