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NCT ID: NCT02223871 Completed - Healthy Subjects Clinical Trials

Effect of ACT-451840 Against Early Plasmodium Falciparum Blood Stage Infection in Healthy Subjects

Start date: June 2014
Phase: Phase 1
Study type: Interventional

This was a single-center study using induced blood stage malaria infection to characterize the activity of ACT-451840 against early Plasmodium falciparum blood stage infection

NCT ID: NCT02223624 Completed - Clinical trials for Chronic Heart Failure

Effect of an Eccentric Exercise Program on Quality of Life and Function in People With Chronic Heart Failure.

Start date: August 2014
Phase: N/A
Study type: Interventional

Many studies have shown that exercise training is beneficial for patients with chronic heart failure (CHF). Heart Foundation guidelines strongly recommend regular physical activity and referral to a specifically designed rehabilitation program for all patients with CHF who are medically stable. Such programs usually comprise aerobic exercises such as walking, and light weightlifting with care to avoid heavy straining due to stress that this may place on the heart. Eccentric contractions are those in which the muscle lengthens as it contracts. Exercise involving eccentric contractions is known to increase muscle strength and this type of exercise also requires less oxygen. This is because it requires less power to resist lowering a weight than it does to lift a weight. Initial evidence suggests that this form of exercise has favourable outcomes in the frail elderly and those with chronic disease. This study aims to determine if eccentric exercise can be applied to patients with heart failure to increase their physical function while using less energy so that exercise is more tolerable for patients who complain of significant breathlessness and fatigue. This study also aims to determine if eccentric exercise is a safe alternative exercise option for patients at risk of negative events. The investigators propose to run a randomised controlled trial. Eccentric exercise will be delivered to a group of heart failure patients referred to the existing heart failure rehabilitation program at the Northern Hospital. The program will consist of eight weeks of twice weekly exercise of one hour's duration comprising eccentric exercise combined with walking and light weight training. This will be compared to a group of patients participating in the current exercise program consisting of light weightlifting and aerobic exercises for the same length and duration of exercise and also to a third group of patients who will be wait listed for 8 weeks. Following the completion of the eight week waiting period, these patients will be offered the option of joining the standard exercise program. The investigators expect that the eccentric exercise group will have improved walking capacity and quality of life compared with the traditional program and the wait-list control group. It is also possible that there is no difference between the eccentric and traditional program in terms of functional outcomes but that the participants report that eccentric exercise is easier.

NCT ID: NCT02222493 Completed - Clinical trials for Rheumatoid Arthritis

A Study of PF-06438179 (Infliximab-Pfizer) and Infliximab in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (REFLECTIONS B537-02).

Start date: August 26, 2014
Phase: Phase 3
Study type: Interventional

The study will assess the efficacy and safety of PF-06438179 and infliximab in combination with methotrexate in subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate.

NCT ID: NCT02222207 Completed - Clinical trials for Macular Degeneration

Regorafenib Eye Drops: Investigation of Efficacy and Safety in Neovascular Age Related Macular Degeneration

DREAM
Start date: October 2014
Phase: Phase 2
Study type: Interventional

Part A (Phase IIa): Primary objectives: The study part A is designed to investigate whether the use of regorafenib eye drops can help patients with neovascular (wet) Age-Related Macular Degeneration (wAMD) to see better after 4 weeks and 12 weeks after inclusion into this study. Secondary objectives: The study will also evaluate the safety and tolerability of the regorafenib eye drops. Part B (Phase IIb): Primary objectives: The study part B is designed to investigate: - how often the regorafenib eye drops need to be given per day - whether the use of regorafenib eye drops can help patients with neovascular (wet) Age-Related Macular Degeneration (wAMD) to see better after 4 weeks and 12 weeks after inclusion into this study. Secondary objectives: The study will also evaluate how the different dosings of regorafenib eye drops affect patients vision, the safety and the tolerability.

NCT ID: NCT02221960 Completed - Clinical trials for Recurrent or Metastatic Solid Tumors

A Phase 1 Study to Evaluate MEDI6383 Alone and in Combination With MEDI4736 in Adult Subjects With Select Advanced Solid Tumors

Start date: September 15, 2014
Phase: Phase 1
Study type: Interventional

To evaluate MEDI6383 when given alone or together with MEDI4736 in adult subjects with recurrent or metastatic solid tumors.

NCT ID: NCT02219880 Completed - Clinical trials for Generalized Anxiety Disorder

Kava for the Treatment of Generalised Anxiety Disorder: A Double-Blind Randomised Placebo-Controlled Trial

KGAD
Start date: October 13, 2015
Phase: Phase 4
Study type: Interventional

The use of Kava in Generalised Anxiety Disorder: an 18-week double-blind, randomised, placebo-controlled study.

NCT ID: NCT02219724 Completed - Neoplasms Clinical Trials

A Study to Assess Safety and Pharmacokinetics of MOXR0916 in Participants With Locally Advanced or Metastatic Solid Tumors

Start date: August 12, 2014
Phase: Phase 1
Study type: Interventional

This is a first-in-human, Phase 1, open-label, multicenter, dose-escalation study designed to evaluate the safety, tolerability, and pharmacokinetics of MOXR0916 administered intravenously in participants with locally advanced or metastatic solid tumors that have progressed after all available standard therapy or for which standard therapy has proven to be ineffective or intolerable, or is considered inappropriate. This study will consist of a screening period, an initial treatment period, a re-treatment period (for participants who discontinue MOXR0916 after demonstration of prolonged clinical benefit), and a post-treatment follow-up period. Participants will be enrolled in two stages: a dose-escalation stage and an expansion stage. The planned duration of the study is approximately 3 years.

NCT ID: NCT02219490 Completed - Clinical trials for Chronic Hepatitis C Virus (HCV) Infection Genotype 1

A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

TOPAZ-I
Start date: October 30, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the effect of treatment with ABT-450 co-formulated with ritonavir and ABT-267 (ABT-450/r/ABT-267) and ABT-333; 3-DAA regimen, with or without ribavirin (RBV) in adults with chronic hepatitis C virus genotype 1 (HCV GT1) infection.

NCT ID: NCT02218723 Completed - Asthma Clinical Trials

Pharmacokinetic Profile of Four Formulations of Fluticasone Furoate (FF) Using Unit Dose Dry Powder Inhaler (UD-DPI) Compared With FF ELLIPTA® Presentation

Start date: October 28, 2014
Phase: Phase 1
Study type: Interventional

This is an open-label, five- period, cross-over, randomized, single dose, single centre study in healthy subjects. This is the second clinical study for the UD-DPI. This study will ascertain whether the Pharmacokinetics (PK) systemic exposure [in terms of area under the plasma concentration-time curve (AUC) and maximum observed plasma concentration (Cmax)] of FF delivered via the UD-DPI is comparable to the systemic exposure of FF delivered via the ELLIPTA Dry Powder Inhaler (DPI). For this reason four treatment doses consisting of three dose strengths and 2 percentage blends will be assessed when delivered via the UD-DPI. This study is designed to compare the pharmacokinetic profile of various doses and blends of FF administered via UD-DPI and relative to FF administered via ELLIPTA DPI. Subjects will be screened 28 days prior to study initiation. During each treatment period, subjects will be at study site from evening prior to dosing until completion of the 48 hour post-dose PK sample collection on Day 3. Minimum 7 days washout will be between treatments after completion of all five treatments and the follow-up visit will be conducted 7-14 days post last dose. Duration of study is 13 weeks. ELLIPTA is a registered trademark of the GSK group of companies.

NCT ID: NCT02217475 Completed - Clinical trials for Nonalcoholic Steatohepatitis

Efficacy and Safety Study of Cenicriviroc for the Treatment of Nonalcoholic Steatohepatitis (NASH) in Adult Participants With Liver Fibrosis

CENTAUR
Start date: September 18, 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether cenicriviroc is effective and safe in the treatment of nonalcoholic steatohepatitis (NASH) in adult participants with liver fibrosis.