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NCT ID: NCT02329496 Completed - Aortic Stenosis Clinical Trials

REPRISE Next Generation Delivery System

NGDS
Start date: December 3, 2014
Phase: N/A
Study type: Interventional

To confirm the acute performance and safety of the Lotus™ Valve with the Next Generation Delivery System for transcatheter aortic valve replacement (TAVR) in symptomatic patients with severe calcific aortic stenosis who are considered high risk for surgical valve replacement.

NCT ID: NCT02328872 Active, not recruiting - Clinical trials for Cervical Intraepithelial Neoplasia

Compass - Randomised Controlled Trial of Primary HPV Testing for Cervical Screening in Australia

Compass
Start date: January 2015
Phase: N/A
Study type: Interventional

Compass is a randomised controlled trial of primary HPV testing for cervical cancer screening in Australia. A pilot study involving 5,000 women was carried out in 2013-2014. The trial will involve recruiting 76,300 women from primary health clinics. Women aged 25-69, attending for cervical screening or for routine follow-up will be invited to participate in the 2-arm trial. A liquid-based cytology (LBC) sample will be taken from consenting women and sent to VCS Pathology. Women will be randomised in a 1:2 parallel group allocation to LBC and HPV arms using randomisation with the minimisation procedure, with stratification by birth cohort according to whether offered HPV vaccination in Australia's national publicly-funded HPV vaccination program (date of birth >=July 1st 1980 and <1st July 1980). In the LBC (active control) arm, women will undergo 2.5 yearly image read cytology screening with reflex HPV triage testing for low grade cytology. In the HPV (intervention) arm women will undergo 5 yearly HPV screening with partial genotyping enabling separate identification of HPV16 and HPV18 and referral of this group for diagnostic evaluation, and secondary randomisation of "intermediate risk" women testing positive for oncogenic HPV (but not HPV 16 or 18) to either image read LBC screening or dual-stained (DS) cytology testing with p16/Ki67. The laboratory reports issued to practitioners will specify the recommended management for women, according to study arm and test results.Participating women will be flagged and clinical outcomes will be tracked via the Compass Register. Data linkage between the Compass Register and HPV vaccination records held on the Australian Immunisation Register will be performed in order to integrate vaccination and screening histories for trial participants. Participants will be actively followed for an anticipated 5 years from the time of recruitment and the primary outcome is based on the total cumulative detection of CIN3+ after exit testing at 5 years. The anticipated study completion date of March 2027 takes into consideration the final migration of participants to the National Cancer Screening Register and allows for two years to follow-up any intermediate risk results occurring in the last of the recruited trial participants.

NCT ID: NCT02326740 Terminated - Clinical trials for Pyoderma Gangrenosum

An Efficacy and Safety Study of Gevokizumab in Treating Active Ulcers of Pyoderma Gangrenosum

Start date: December 2014
Phase: Phase 3
Study type: Interventional

The study will evaluate the efficacy and safety of gevokizumab in treating active ulcers of pyoderma gangrenosum (PG).

NCT ID: NCT02325830 Completed - Heart Failure Clinical Trials

CARILLON Mitral Contour System® for Reducing Functional Mitral Regurgitation

REDUCE FMR
Start date: March 2015
Phase: N/A
Study type: Interventional

The objective of this prospective, multi-center, randomized, double-blind trial is to assess the safety and efficacy of the CARILLON Mitral Contour System in treating functional mitral regurgitation (FMR) associated with heart failure, compared to a randomized Control group which is medically managed according to heart failure guidelines.

NCT ID: NCT02325791 Completed - Clinical trials for Respiratory Syncytial Virus Infections

Study to Evaluate the Efficacy and Safety of Suptavumab (REGN2222) for the Prevention of Medically Attended RSV (Respiratory Syncytial Virus) Infection in Preterm Infants

Start date: July 21, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the efficacy, safety, pharmacokinetics (PK), and immunogenicity of suptavumab (REGN2222) in infants born no more than 35 weeks, 6 days gestational age who are no more than 6 months of age at the time of enrollment in their respective geographic location. In order to optimize the potential benefit in this vulnerable population, we conducted this study during the RSV season using dosing regimens that are expected to be effective.

NCT ID: NCT02324491 Terminated - Obesity Clinical Trials

An Efficacy and Safety Study of Beloranib in Obese Subjects With Type 2 Diabetes Mellitus

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

The purpose of this study is to evaluate efficacy and safety of ZGN-440 (beloranib) in obese adult subjects with type 2 diabetes mellitus.

NCT ID: NCT02324010 Completed - Diabetes Mellitus Clinical Trials

Effects of Sitagliptin on Gastric Emptying, Glycaemia and Blood Pressure in Type 2 Diabetes

Start date: July 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the acute effects of sitagliptin on postprandial glycemia, incretin hormones and blood pressure, and the relationship to gastric emptying, after a mashed potato meal in patients with type 2 diabetes.

NCT ID: NCT02323126 Terminated - Clinical trials for Non Small Cell Lung Cancer

Study of Efficacy and Safety of Nivolumab in Combination With EGF816 and of Nivolumab in Combination With INC280 in Patients With Previously Treated Non-small Cell Lung Cancer

Start date: February 9, 2015
Phase: Phase 2
Study type: Interventional

To determine the efficacy and safety of nivolumab in combination with EGF816 and of nivolumab in combination with INC280 in previously treated NSCLC patients

NCT ID: NCT02322840 Active, not recruiting - Clinical trials for Mitral Valve Insufficiency

Transcatheter Mitral Valve Replacement System (TMVR) Pilot Study and The Early Feasibility Study of the TMVR Transseptal System

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

PILOT: The study is pilot trial to evaluate the safety and performance of the Twelve TMVR System in very high risk mitral regurgitation patients. EFS: The study is an EFS trial to evaluate the safety and performance of the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System with Transfemoral Transseptal access in Patients with Severe, Symptomatic Mitral Regurgitation

NCT ID: NCT02322814 Terminated - Breast Cancer Clinical Trials

A Study of Cobimetinib Plus Paclitaxel, Cobimetinib Plus Atezolizumab Plus Paclitaxel, or Cobimetinib Plus Atezolizumab Plus Nab-Paclitaxel as Initial Treatment for Participants With Triple-Negative Breast Cancer That Has Spread

Start date: March 12, 2015
Phase: Phase 2
Study type: Interventional

This three-cohort, multi-stage, randomized, Phase II, multicenter trial will evaluate the safety and tolerability and estimate the efficacy of cobimetinib plus paclitaxel versus placebo plus paclitaxel in Cohort I, of cobimetinib plus atezolizumab plus paclitaxel in Cohort II, and of cobimetinib plus atezolizumab plus nab-paclitaxel in Cohort III in participants with metastatic or locally advanced, triple-negative adenocarcinoma of the breast who have not received prior systemic therapy for metastatic breast cancer (MBC). Participants may continue on study treatment until the development of progressive disease (PD) or the loss of clinical benefit, unacceptable toxicity, and/or consent withdrawal. The Cohort I target sample size is 12 participants for the safety run-in stage and approximately 90 participants in the expansion stage. Each of Cohorts II and III will consist of a safety run-in stage of approximately 15 participants followed by an expansion stage of approximately 15 participants.