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NCT ID: NCT02203032 Completed - Psoriasis Clinical Trials

A Study of Guselkumab in Participants With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab

NAVIGATE
Start date: October 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of guselkumab (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis (scaly skin rash) who had inadequate response to ustekinumab.

NCT ID: NCT02202967 Completed - Atrial Fibrillation Clinical Trials

Misoprostol for Small Bowel Ulcers and Obscure Bleeding Due to Aspirin or Nonsteroidal Antiinflammatory Drugs

MASTERS
Start date: January 7, 2016
Phase: Phase 3
Study type: Interventional

Anti-inflammatory tablets (non-steroidal anti-inflammatory drugs) continue to be used commonly worldwide to relieve pain caused by arthritis. Likewise, aspirin is used by many patients in order to prevent blood clots. Despite their desired benefits, these medicines can cause internal bleeding from the digestive system. The source of this bleeding can be obvious (overt), or obscure and thought to come from the small intestine. Obscure bleeding can show as anemia due to lack of iron in the blood. Small intestine ulcers are now easily diagnosed using an endoscope the size of a big pill (video capsule endoscopy). Small bowel ulcers are not related to stomach acid and therefore do not heal using remedies usually taken to stop acid formation. A different drug, misoprostol, consists of a chemical (prostaglandin) that is usually lacking in patients using aspirin or anti-inflammatory drugs. Misoprostol is licenced to heal stomach and duodenal ulcers in patients using these drugs. Our hypothesis is that misoprostol might be effective in healing small bowel ulcers as suggested by pilot studies; however, such works only included small numbers of patients, did not include control groups and both patients and investigators knew the nature of the tablets used. To test this hypothesis, we propose to compare misoprostol to a dummy tablet. The numbers of subjects to be studied have been calculated using established statistical methods

NCT ID: NCT02202356 Completed - Clinical trials for Respiratory Syncytial Virus Infections

A Study of ALS-008176 in Infants Hospitalized With RSV

Start date: July 23, 2014
Phase: Phase 1
Study type: Interventional

This study will assess the safety, tolerability, pharmacokinetics (PK) and anti-viral effect of single and multiple doses of ALS-008176 in infants hospitalized with respiratory syncytial virus (RSV)

NCT ID: NCT02202005 Completed - HIV-1 Clinical Trials

Multiple Dose BE Study With Nevirapine 400mg PR Tablets

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

The objective of this steady state pivotal study is to compare the rate and extent of absorption and to evaluate Bioequivalence of test drug compared to the approved reference product in HIV infected individuals

NCT ID: NCT02201953 Completed - Clinical trials for Hepatitis C Virus Infection

Comparison of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 24 Weeks in Adults With Chronic Genotype 3 HCV Infection

ASTRAL-3
Start date: July 2014
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to compare the efficacy of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks with that of sofosbuvir (SOF) + ribavirin (RBV) for 24 weeks and to evaluate the safety and tolerability of each treatment regimen in participants with chronic genotype 3 hepatitis C virus (HCV) infection.

NCT ID: NCT02201940 Completed - Clinical trials for Hepatitis C Virus Infection

Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic HCV Infection

ASTRAL-1
Start date: July 2014
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) for 12 weeks in adults with chronic genotype 1, 2, 4, 5, or 6 hepatitis C virus (HCV) infection.

NCT ID: NCT02201628 Completed - Child Clinical Trials

Correlation of Nasopharyngeal (NP) and Lower Oesophageal (LO) Temperatures in Ventilated Children

Start date: June 25, 2014
Phase: N/A
Study type: Interventional

Children lose heat under general anaesthesia, thus temperature is routinely monitored during anaesthesia for all but the shortest cases, and active warming can be used to prevent hypothermia and its resulting complications. Temperature can be measured at several sites dependent on the type of surgery and patient factors. Previously a temperature probe has been sited in the lower third of the oesophagus (swallowing tube) but it is difficult to accurately place this without an X-Ray. Consequently it is more common to use a temperature probe placed in the nasopharynx (where the nose and throat meet), when the child is anaesthetised. However the investigators do not know if the temperature in the nasopharynx correlates well with the real core temperature or not.This prospective, unblinded, agreement study will seek to find an agreement of 2 methods to measure temperature in children undergoing general anaesthesia with a breathing tube that has a leak.

NCT ID: NCT02201095 Completed - Clinical trials for Preoperative Hypothermia

Active Warming During Elective Caesearean Section

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

During anaesthesia for caesarean section it is common to lose heat and become hypothermic, (<36 degrees C). In order to try and avoid this all women are given warmed intravenous fluid and insulated from cold surfaces. There are also 2 types of machine available to actively warm women; 1. Forced Air Warming - that uses a disposable sheet the woman lies upon with lots of air pockets that have warm air blown into them continuously by a fan. 2. Conduction Warming Mattress - a thin mattress which covers the operating table and the woman lies on top. The padded mattress has strips of material that heat up when electricity passes through it, similar to a normal electric blanket. We plan to carry out a randomised controlled trial to compare these 2 methods with the current practice of no active warming. The hypothesis for this study is that active warming women during elective caesarean section prevents women's temperature from dropping and keeps them more comfortable than if active warming were not used.

NCT ID: NCT02200965 Completed - Diabetes Clinical Trials

Impact of Individualized Structured Information Provision to the Patients, on Diabetes Related Outcomes

WICKED
Start date: March 2013
Phase: N/A
Study type: Interventional

Health professionals usually lead in the management of long term conditions such as Diabetes. In a conventional professionally driven compliance model of care, patients may be placed in a secondary role. National audits show components of systematic diabetes care consistently fail despite several years of heavy expenditure in the service focused Diabetes Quality and Outcome Framework. To what extent is this due to the nature of that process which may not engage patients nor be focused on informed patient centred concerns? The aim of this research is to determine the effectiveness of a healthcare delivery approach in which patients, empowered with structured guidance and specific information about their diabetes, take decisions to get involved in their diabetes care as determined in hard measures of engagement and outcomes. The methodology will be by a whole population cluster randomised controlled study of an intervention the delivery of an individualised diabetes specific structured report, and we will look at its impact on measured key diabetes access and process outcomes. The contention is that the patients, guided in their understanding of empowerment and enablement, equipped with highly person specific risk stratified outcome based information, and informed regarding which actions they may accordingly take, will be enabled to make a significant and impactful contribution in improvement in their own care . This large scale project can deliver on that research question in a tested , efficient and cost effective manner.

NCT ID: NCT02200614 Completed - Clinical trials for Castration-Resistant

Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer

ARAMIS
Start date: September 12, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of BAY1841788 (ODM-201) in patients with non-metastatic castration-resistant prostate cancer.