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NCT ID: NCT02305290 Recruiting - Adenoma, Villous Clinical Trials

Upper GI Outcomes Following EMR

UGI-EMR
Start date: August 2014
Phase:
Study type: Observational

The purpose of this study is to evaluate the long-term outcomes of Endoscopic Resection (ER) of superficial lesions of the Upper Gastrointestinal Tract(UGIT)

NCT ID: NCT02304484 Completed - Clinical trials for Hypercholesterolemia

Open-label Extension (OLE) Study to Assess Safety and Efficacy of Evolocumab

Start date: November 24, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study was to characterize the safety and tolerability of long-term administration of evolocumab in adults with known coronary artery disease and hypercholesterolemia.

NCT ID: NCT02303834 Terminated - Hypertension Clinical Trials

CPAP in Preeclampsia

Start date: February 2015
Phase: N/A
Study type: Interventional

Study design: Single blinded randomised control trial Planned sample size: 30 (women randomized 2:1 to receive either CPAP or no CPAP) Objectives: Primary objective: Assess the effects of nasal CPAP on sleep physiology, 24 blood pressures and fetal movements in pregnant women (24-37 weeks gestation) with preeclampsia. Secondary objective: Assess baseline sleep physiology, blood pressure control and fetal well-being in pregnant women (24-37 weeks gestation) with preeclampsia by completing sleep studies, 24 hour blood pressure monitors, CO2 monitors, and nocturnal fetal movement and HR monitors. Study Procedure: Participants will be recruited from the antenatal ward or high-risk antenatal clinic. Following informed consent participants will be randomly assigned to receive either CPAP or no CPAP for one night, following an initial baseline overnight sleep study. Baseline- Night 1 1. Sleep study with fetal movement and HR monitor 2. 24 hour BP monitor 3. CO2 monitor Intervention- Night 2 (Nasal CPAP device or no CPAP) 1. Sleep study with fetal movement and HR monitor 2. 24 hour BP monitor 3. CO2 monitor Post-partum questionnaire A brief questionnaire to be completed within the first 6 weeks post-partum related to the participant's personal health, their child's birth details and health.

NCT ID: NCT02303821 Active, not recruiting - Clinical trials for Acute Lymphoblastic Leukemia (ALL)

Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia

Start date: February 16, 2015
Phase: Phase 1
Study type: Interventional

The purpose of Phase 1b of this study is to: - Asses the safety, tolerability and activity of carfilzomib, alone and in combination with induction chemotherapy, in children with relapsed or refractory acute lymphoblastic leukemia (ALL). - Determine the maximum tolerated dose (MTD) and to recommend a phase 2 dose of carfilzomib in combination with induction chemotherapy. The purpose of Phase 2 of this study is to compare the rate of complete remission (CR) of carfilzomib in combination with vincristine, dexamethasone, PEG asparaginase, daunorubicin (VXLD) at the end of induction therapy to an appropriate external control.

NCT ID: NCT02303366 Completed - Breast Neoplasms Clinical Trials

Pilot Study of Stereotactic Ablation for Oligometastatic Breast Neoplasia in Combination With the Anti-PD-1 Antibody MK-3475

BOSTON II
Start date: September 2015
Phase: Phase 1
Study type: Interventional

This is a prospective, observational pilot study that will describe the safety profile and biological effects of combining stereotactic ablative body radiosurgery (SABR) treatment (20Gy/1#) and a PD-1 antibody, MK-3475. 15 patients with oligometastatic breast cancer with at least one lesion considered safe for SABR radiotherapy, will be treated with SABR for their oligometatastic disease in addition to 6 months of MK-3475 treatment (1 cycle every 3 weeks, a total of 8 cycles). This investigator driven pilot study will examine the safety and biological effects of combining MK-3475 (Pembrolizumab) an antibody targeted against the anti-programmed cell death 1 (PD-1) T cell checkpoint, with SABR therapy for oligometastatic disease. We hypothesise that the safety profile of this combination, will be clinically acceptable and well tolerated for patients, and that we will observe evidence of systemic immune activation.

NCT ID: NCT02302872 Active, not recruiting - Clinical trials for Mitral Valve Regurgitation

Treatment of Heart Failure and Associated Functional Mitral Valve Regurgitation

MAVERIC
Start date: October 2013
Phase: N/A
Study type: Interventional

The objective of the study is to evaluate the safety and performance of the ARTO System in patients with mitral valve regurgitation (MR) associated with congestive heart failure (CHF).

NCT ID: NCT02302807 Completed - Bladder Cancer Clinical Trials

A Study of Atezolizumab Compared With Chemotherapy in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer [IMvigor211]

Start date: January 13, 2015
Phase: Phase 3
Study type: Interventional

This is a Phase III, global, multicenter, open-label, two-arm, randomized, controlled study designed to evaluate the efficacy and safety of atezolizumab compared with chemotherapy in participants with locally advanced or metastatic urothelial bladder cancer (UBC) who have progressed during or following a platinum-containing regimen. The anticipated time on study treatment is based on continued clinical benefit, i.e., until disease progression or unacceptable toxicity. The target sample size is 931 participants.

NCT ID: NCT02301234 Completed - Pain Clinical Trials

Study of Safety, Efficacy of Fulranumab Adjunctive Use in OA of Hip or Knee, PAI3007

Start date: March 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate the efficacy, safety, and tolerability of fulranumab as adjunctive therapy compared with placebo in participants with signs and symptoms of osteoarthritis of the hip or knee that are not adequately controlled by current pain therapy.

NCT ID: NCT02300831 Completed - NSCLC Clinical Trials

LUMINIST: LUng Cancer Molecular Insights Non Interventional Study

LUMINIST
Start date: December 1, 2014
Phase: N/A
Study type: Observational

The recent development of therapies targeting specific biomarkers mutations is changing the standards of care and prognosis of patients with advanced NSCLC, but very few data are currently available on those emerging biomarkers. In addition, the correlation of biomarkers with patients' clinical outcomes in a standard of care setting is poorly understood. This study aims to address that need.

NCT ID: NCT02300103 Completed - Clinical trials for Hepatitis C Virus Infection

Efficacy And Safety Of Sofosbuvir/Velpatasvir Fixed Dose Combination With Ribavirin in Chronic HCV Infected Adults Who Participated in a Prior Gilead Sponsored HCV Treatment Study

Start date: December 1, 2014
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) with ribavirin (RBV) for 24 weeks in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead sponsored study and did not achieve sustained virologic response (SVR).