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NCT ID: NCT03740919 Completed - Clinical trials for Type 1 Diabetes Mellitus

A Study Comparing LY900014 to Insulin Lispro (Humalog) in Children and Adolescents With Type 1 Diabetes

PRONTO-Peds
Start date: April 7, 2019
Phase: Phase 3
Study type: Interventional

The reason for this study is to compare the study drug LY900014 to insulin lispro (Humalog) in children and adolescents with type 1 diabetes (T1D).

NCT ID: NCT03739996 Completed - HIV Infections Clinical Trials

Long-Acting Cabotegravir Plus VRC-HIVMAB075-00-AB (VRC07-523LS) for Viral Suppression in Adults Living With HIV-1

Start date: December 31, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and antiviral activity of long-acting cabotegravir (CAB LA) plus the broadly neutralizing monoclonal antibody,VRC-HIVMAB075-00-AB (VRC07-523LS), in adults living with HIV-1 with suppressed plasma viremia.

NCT ID: NCT03739203 Completed - Clinical trials for Major Depressive Disorder

The Objective of This Study is to Evaluate the Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD) Who Have Had an Inadequate Response to Antidepressants Alone

Start date: November 10, 2018
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the efficacy, safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with MDD who have had an inadequate response to antidepressants alone.

NCT ID: NCT03736785 Completed - Clinical trials for Type 2 Diabetes Mellitus

A Study of LY3209590 in Participants With Type 2 Diabetes Mellitus

Start date: November 15, 2018
Phase: Phase 2
Study type: Interventional

The reason for this study is to see if the study drug LY3209590 is safe and effective in participants with type 2 diabetes that have already been treated with basal insulin.

NCT ID: NCT03733730 Completed - Presbyopia Clinical Trials

Post Approval Study of the AcrySof® IQ ReSTOR® Toric IOLs

Start date: November 27, 2018
Phase: N/A
Study type: Interventional

This is a prospective, multicenter, post-approval active surveillance study. The purpose of this study is to report the rate of post-surgical intraocular inflammation (based upon a specified case definition) reported within a 180-day post-surgical period following attempted implantation of an ACRYSOF IQ RESTOR Toric or ACRYSOF IQ RESTOR IOL in the US.

NCT ID: NCT03732534 Terminated - Tourette Syndrome Clinical Trials

Rollover Study for Continuing NBI-98854 Administration in Pediatric Subjects With Tourette Syndrome

Start date: October 17, 2018
Phase: Phase 2
Study type: Interventional

This is an open-label, rollover study to collect long-term safety, tolerability, and investigator- and participant-reported pharmacodynamic (PD) data after chronic administration of NBI-98854 in pediatric participants with Tourette Syndrome (TS), as well as to provide open-label access to NBI-98854 for the treatment of TS for pediatric participants who have taken part in a Phase 2 NBI-98854 study.

NCT ID: NCT03730662 Completed - Clinical trials for Type 2 Diabetes Mellitus

A Study of Tirzepatide (LY3298176) Once a Week Versus Insulin Glargine Once a Day in Participants With Type 2 Diabetes and Increased Cardiovascular Risk

SURPASS-4
Start date: November 20, 2018
Phase: Phase 3
Study type: Interventional

The purpose of the trial is to assess the efficacy and safety of tirzepatide taken once a week to insulin glargine taken once daily in participants with type 2 diabetes and increased cardiovascular risk. The study will last about 108 weeks and may include up to 30 visits.

NCT ID: NCT03728309 Completed - Clinical trials for Skin Smoothness of the Cheeks

JUVÉDERM® VOLITE™ XC for Cheek Skin Smoothness

Start date: November 9, 2018
Phase: N/A
Study type: Interventional

This is a pivotal study to collect safety and effectiveness data on JUVÉDERM VOLITE™ XC for improvement in skin smoothness of the cheeks in order to support FDA product approval.

NCT ID: NCT03725059 Active, not recruiting - Breast Cancer Clinical Trials

Study of Pembrolizumab (MK-3475) Versus Placebo in Combination With Neoadjuvant Chemotherapy & Adjuvant Endocrine Therapy in the Treatment of Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (MK-3475-756/KEYNOTE-756)

Start date: December 27, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in the treatment of adults who have high-risk early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer. The primary study hypotheses are: 1) pembrolizumab is superior to placebo, both in combination with the protocol-specified neoadjuvant anticancer therapy, as assessed by pathological Complete Response (pCR) rate defined by the local pathologist, and 2) pembrolizumab is superior to placebo (both in combination with the protocol-specified neoadjuvant and adjuvant anticancer therapies) as assessed by Event-Free Survival (EFS) as determined by the investigator. The study is considered to have met its primary objective if pembrolizumab is superior to placebo with respect to either pCR (ypT0/Tis ypN0) or EFS.

NCT ID: NCT03725007 Active, not recruiting - Clinical trials for Juvenile Idiopathic Arthritis (JIA)

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects With Polyarticular Course Juvenile Idiopathic Arthritis

SELECT-YOUTH
Start date: June 24, 2019
Phase: Phase 1
Study type: Interventional

This is a study to evaluate pharmacokinetics, safety and tolerability of upadacitinib in pediatric participants with polyarticular course juvenile idiopathic arthritis. This study consists of three parts: Part 1 is multiple-cohort study that consists of two sequential multiple dose groups. Participants benefiting from the study drug with no ongoing adverse events of special interest or serious adverse events will have option to enroll in Part 2. Part 2 is open-label, long term extension study to evaluate safety and tolerability. Part 3 is an additional safety cohort to evaluate long-term safety and tolerability.