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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: NCT03726112 Suspended - Balance Disorders Clinical Trials

Spoton Trial Evaluating the Efficacy on BAlance Disorder sYmptoms (STEADY)

STEADY
Start date: November 1, 2018
Phase: N/A
Study type: Interventional

A Randomized, Double Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of SpotOn specs for the Treatment of Chronic Dizziness & Imbalance.

NCT ID: NCT03725202 Active, not recruiting - Clinical trials for Giant Cell Arteritis (GCA)

A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis

SELECT-GCA
Start date: January 24, 2019
Phase: Phase 3
Study type: Interventional

This study consists of two periods. The objective of Period 1 is to evaluate the efficacy of upadacitinib in combination with a 26-week corticosteroid (CS) taper regimen compared to placebo in combination with a 52-week CS taper regimen, as measured by the proportion of participants in sustained remission at Week 52, and to assess the safety and tolerability of upadacitinib in participants with giant cell arteritis (GCA). The objective of period 2 is to evaluate the safety and efficacy of continuing versus withdrawing upadacitinib in maintaining remission in participants who achieved sustained remission in Period 1.

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.

NCT ID: NCT03724786 Enrolling by invitation - Pre-Eclampsia Clinical Trials

Management of Suspected Preeclampsia Based on 6-hour Versus 24-hour Urine Protein Collection

Start date: January 1, 2019
Phase: N/A
Study type: Interventional

In this trial - the investigators plan to study the efficacy of pregnancy management in cases of suspcted preeclampsia, based on a 6-hour urine collection for protein, as compared to the standard 24-hour collection. For participants hospitalized at the maternal fetal unit at our institution, one sample of urine collected over 6 hours will be analyzed, and a second one following an additional 18 hours. Participants will be blinded to the urine collection result used to manage their pregnancy (actual 24 hour collection versus calculated 24-hour collection), as will be their attending physicians. An external physician will compare the two urine collection results, and in case only one is pathological (>300 mg), will notify the research team and the attending physician.

NCT ID: NCT03724760 Completed - Mobility Limitation Clinical Trials

Pedometers for the Enhancement of Post Cesarean Mobility

Start date: December 3, 2018
Phase: N/A
Study type: Interventional

This is a randomized controlled trial, planned to study the effects of pedometers (digital step counters) on patient mobility following cesarean delivery. The investigators plan to randomize patients at high risk for thromboembolic events to participants with a personalized repeated feedback approach based on pedometer results, versus participants with no feedback to pedometer results.

NCT ID: NCT03723655 Active, not recruiting - Clinical trials for Hypertrophic Cardiomyopathy

A Long-Term Safety Extension Study of Mavacamten in Adults Who Have Completed MAVERICK-HCM or EXPLORER-HCM

Start date: October 5, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

Approximately 30 sites that enrolled participants in the MAVERICK-HCM (MYK-461-006) study in the United States (US) will initiate this study. Approximately 90 sites that enrolled participants in the EXPLORER-HCM (MYK-461-005) study in the US, Europe, and Israel will initiate this study. Note: Approximately 30 centers overlap between MAVERICK and EXPLORER.

NCT ID: NCT03720535 Recruiting - Heart Failure Clinical Trials

COMMUNITY STUDY- A Study to Collect Information Related to the Cordio System

Start date: February 11, 2019
Phase:
Study type: Observational

This is a multi-center, observational, non-interventional, prospective, Single-arm, open study for database establishment for R&D purposes. R&D data will be analyzed retrospectively in order to validate algorithm efficacy. The study will be conducted in the following settings: outpatinets clinics

NCT ID: NCT03720509 Recruiting - Clinical trials for Heart Failure,Congestive

A Study to Collect Information Related to the Cordio Medical System

Start date: August 17, 2015
Phase:
Study type: Observational

This is a multi-center observational non-interventional prospective study. A Single-arm, open, database establishment for R&D purposes when R&D data will be analyzed retrospectively for efficacy at the end of the study. The study will be conducted in the following settings: Hospital and at home.