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NCT ID: NCT02702713 Terminated - Metabolic Syndrome Clinical Trials

Pivotal Assessment of the Effects of Bioactive on Health and Wellbeing. From Human Genome to Food Industry

PATHWAY-27
Start date: February 2016
Phase: N/A
Study type: Interventional

This is a multi-centre, randomised, double-blind, placebo-controlled, parallel-arm dietary intervention study. In total, 800 men and women at risk for Metabolic Syndrome (MS) will be recruited. Subjects will be eligible to the study if they present with two to four of the MS diagnostic criteria, at least one of them being: - fasting triglycerides ≥150 mg/dL but ≤400 mg/dL OR - HDL-cholesterol ≤50 mg/mL in women, ≤ 40mg/mL in men (with fasting triglycerides ≥110 mg/dL). Each of the four recruiting centres will recruit 200 volunteers. Participants will be randomly assigned to one of four groups to receive either: - Dairy BEF + egg placebo + bakery placebo - Egg BEF + dairy placebo + bakery placebo - Bakery BEF + dairy placebo + egg placebo - Dairy, egg and bakery placebo Participants will be required to consume all three of the allocated products each day for 12 weeks. Eligible volunteers will be included and randomly allocated to one of the four groups. At baseline, 6 weeks and 12 weeks after inclusion, each participant will visit the recruiting centre for clinical and biochemical investigations. At 3 weeks and 9 weeks participants will complete questionnaires relating to their satisfaction with the food products, compliance to consumption of the study food products, and any gastrointestinal side effects or health-related adverse events that have occurred in the previous 3 weeks. At each recruiting centre 40 participants will be required to take part in additional activities, these are: stool sample collection, adipose tissue aspiration, body composition analysis by dual energy x-ray absorptiometry (DEXA) and assessment of physical activity.

NCT ID: NCT02701634 Terminated - Clinical trials for Chronic Graft Versus Host Disease

Efficacy and Tolerability of Entospletinib in Combination With Systemic Corticosteroids as First-Line Therapy in Adults With Chronic Graft Versus Host Disease (cGVHD)

Start date: May 27, 2016
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the effect of entospletinib (ENTO) on the best overall response rate in adults with chronic graft versus host disease (cGVHD) who are currently receiving systemic corticosteroids as part of first-line therapy for cGVHD.

NCT ID: NCT02699385 Terminated - Gastroenteritis Clinical Trials

A Study to Evaluate the Safety and Efficacy of Domperidone in Pediatric Participants With Nausea and Vomiting Due to Acute Gastroenteritis

Start date: December 7, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate that domperidone suspension plus oral rehydration therapy (ORT) is more effective than placebo plus ORT at reducing the symptoms of vomiting associated with acute gastroenteritis (AG) within the first 48 hours of treatment administration in pediatric participants with AG and mild-to-moderate dehydration.

NCT ID: NCT02697851 Terminated - HIV Clinical Trials

Pharmacokinetic Effect of Evotaz/Microgynon Co-administration

Start date: July 2016
Phase: Phase 1
Study type: Interventional

This study will investigate the pharmacokinetic of evotaz (atazanavir/cobicistat) and microgynon (ethinylestradiol/levonorgestrel ) when administered alone and together. There will be two study arms, who will take the medications in different orders: GROUP 1: Microgynon 30® for 21 days, Followed by Microgynon 30® for 21 days plus Evotaz® for 14 days, Followed by Evotaz® for 14 days GROUP 2: Evotaz® for 14 days followed by 7 days wash-out, Followed by Microgynon 30® for 21 days plus Evotaz® for 14 days, Followed by Microgynon 30® for 14 days (participants may chose to complete a 21 day pack). The total duration of the study is 57 days (+screening and follow up visits) and patients will have 3 intensive pharmacokinetic days on days 14, 35 and 56.

NCT ID: NCT02690350 Terminated - Clinical trials for Advanced Solid Tumors

An Open Study Assessing the Safety and Tolerability of U3-1784

Start date: February 29, 2016
Phase: Phase 1
Study type: Interventional

The main objectives of the trial are: - To evaluate the safety and tolerability of U3-1784 in patients with advanced solid tumours - To determine the maximum tolerated dose (MTD) and or establish the safety and tolerability of the maximum administered dose (MAD) of U3-1784

NCT ID: NCT02688413 Terminated - Stroke Clinical Trials

Study Evaluating the MindMotionPRO for Early Post-stroke Upper-limb Rehabilitation

MOVE-Rehab
Start date: August 2016
Phase: N/A
Study type: Interventional

Randomised controlled multi-centered study using MindMotionPRO, an immersive virtual reality based system for upper limb motor rehabilitation in early post-stroke patients. The study aims to evaluate the ability of MindMotionPRO technology to increase the rehabilitation dose. Effectiveness will be evaluated by validated rehabilitation performance scales. Cost-effectiveness will be assessed by the resource utilization.

NCT ID: NCT02687191 Terminated - Clinical trials for Intracerebral Hemorrhage

Safety and Tolerability of PF-05230907 in Intracerebral Hemorrhage

Start date: November 2016
Phase: Phase 1
Study type: Interventional

This study employs a modified continual reassessment method (mCRM) design to estimate the maximum tolerated dose (MTD) of PF-05230907, defined as a target toxicity rate of 15% based on treatment emergent thromboembolic and/or ischemic events (TIEs). The mCRM design utilizes Bayesian methodology to continuously learn the dose-toxicity relationship, which is characterized by a parametric model. Subjects with a diagnosis of ICH (determined by computed tomography) will be enrolled in cohorts of 3. The total length of time planned for study participation is approximately 3 months; 6.0 hours for screening, a single dose administration with a 4-day minimum hospital confinement period and follow-up visits through Day 91. Severity of adverse events (AEs) and serious adverse events (SAEs) will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. All subjects who receive PF-05230907 are evaluable for TIEs. The determination of MTD using mCRM modeling will be based on TIEs which occur through 7 days post-dose (Day 8).

NCT ID: NCT02686281 Terminated - Healthy Clinical Trials

Safety and Pharmacokinetics Study of a New Drug for Type 2 Diabetes

Start date: September 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the toxicity, tolerability and safety of single ascending doses of GMC-252-L-Lysine Salt in healthy male subjects.

NCT ID: NCT02683941 Terminated - Clinical trials for Neuroendocrine Tumors in Lung

Efficacy and Safety of Lanreotide Autogel/ Depot 120 mg vs. Placebo in Subjects With Lung Neuroendocrine Tumours

SPINET
Start date: March 6, 2017
Phase: Phase 3
Study type: Interventional

This is a Phase 3, prospective, multi-center, randomized, double-blind, study evaluating the efficacy and safety of LAN plus BSC versus placebo plus BSC for the treatment of well-differentiated, metastatic and/or unresectable, typical or atypical bronchopulmonary NETs. This study contains two phases: the Double-Blind (DB) Phase, and the Open Label (OL) Phase. The DB Phase includes: Screening, Baseline and Treatment period. The OL Phase will consist of two periods: Treatment Period and Follow-Up Period. The primary objective will be to describe the antitumour efficacy of Lanreotide Autogel/Depot 120 mg (LAN) plus Best Supportive Care (BSC) every 28 days, in terms of progression-free survival (PFS), measured by central review using Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 criteria, every 12 weeks, in subjects randomized to LAN with unresectable and/or metastatic well differentiated, typical or atypical bronchopulmonary neuroendocrine tumours. Recent updates of National Cancer Institute Cancer Network (NCCN) & European Neuroendocrine Tumor Society (ENETS) guidelines recommend SSA in first line for the treatment of locoregional unresectable or metastatic bronchopulmonary NETs as an option beyond 'observation' leading to slow and difficult recruitment in SPINET study. Consequently, it was decided to prematurely stop the recruitment in the SPINET study and to transition all subjects still treated in the double-blind phase to the open label (OL) treatment and follow-up phases following respective country approvals of Amendment #5. The new aim of this Phase 3, multicenter, prospective, randomized placebo-controlled clinical study is to describe the antitumor efficacy and safety of Lanreotide Autogel/Depot 120 mg (LAN) plus Best Supportive Care (BSC) in subjects with well-differentiated, metastatic and/or unresectable, typical or atypical, bronchopulmonary NETs.

NCT ID: NCT02682420 Terminated - Clinical trials for Chronic Kidney Disease

everlinQ endoAVF Post Market Study

Start date: September 20, 2016
Phase: N/A
Study type: Interventional

Prospective, multi-center study to evaluate the everlinQ endoAVF System when used to create an endovascular arteriovenous fistula (endoAVF) for patients who require vascular access for hemodialysis.