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NCT ID: NCT02340234 Completed - Atopic Dermatitis Clinical Trials

A Study of Lebrikizumab in Participants With Persistent Moderate to Severe Atopic Dermatitis

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

This randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of lebrikizumab administered subcutaneously (SC) in adult participants with persistent moderate to severe atopic dermatitis (AD) who are inadequately controlled by topical corticosteroids (TCS). The study includes a screening visit, a 2-week run-in period, a 12-week blinded treatment period, and an 8-week safety follow-up period. Following screening visit, eligible participants will enter in run-in period (Days − 14 to − 1) during which a protocol-specified topical therapy regimen will be initiated. At the end of the run-in period, participants who have: 1) demonstrated compliance with the protocol-specified TCS regimen, and 2) who continue to fulfill the eligibility criteria will be randomized.

NCT ID: NCT02340104 Completed - Healthy Volunteers Clinical Trials

A Study to Measure Baricitinib (LY3009104) Absorption in Healthy Participants

Start date: January 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to compare how much baricitinib (study drug) gets into the blood stream when it is given as a single dose (in tablet form) and as an intravenous infusion (injection given directly into a vein via a small needle). Each participant in the study will make four visits to the investigator site over the course of about 6 weeks.

NCT ID: NCT02340039 Completed - Clinical trials for Postprandial Hyperglycemia

Effects of Fruit Extracts on Glycaemia: The GLU-FRU Study

GLU-FRU
Start date: January 2015
Phase: N/A
Study type: Interventional

Raised blood glucose levels can lead to adverse modifications to functional proteins within the body and eventually lead to the development of type 2 diabetes. Fruit polyphenols may help to control glycaemia following a carbohydrate meal or beverage. The aim of this study is to investigate the effects of blackcurrant (BC) and apple (A) extracts on postprandial glycaemia, insulinaemia and plasma gastric inhibitory polypeptide concentrations following a mixed carbohydrate test meal.

NCT ID: NCT02338843 Completed - Sepsis Clinical Trials

A Phase 3 Study of LJPC-501 in Patients With Catecholamine-Resistant Hypotension

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

This is a Phase 3, double-blind, randomized study of LJPC-501 (angiotensin II) in adult patients diagnosed with catecholamine-resistant hypotension (CRH) conducted in multiple centers globally.

NCT ID: NCT02338622 Completed - Advanced Cancer Clinical Trials

Trial of Olaparib in Combination With AZD5363 (ComPAKT)

ComPAKT
Start date: March 31, 2014
Phase: Phase 1
Study type: Interventional

This is a phase I trial of the combination of the PARP inhibitor olaparib and AKT inhibitor AZD5363. There are two parts to this study. Part A: dose escalation, and Part B: dose expansion. Part A will investigate the combination of 300 mg bd of olaparib with intrapatient ascending doses of AZD5363 administered for either 4-days-on, 3-days-off, and 2-days-on, 5-days-off. Once the Maximum Tolerated Dose (MTD) is reached for both arms (or under the advice from the Safety Review Committee (SRC) one of the schedules will be discontinued), the schedule with the optimum safety and PK/PD profile will be taken forward to a dose expansion phase (Part B). Part B will evaluate the optimized dose/schedule identified in Part A of the study in patients with (1) BRCA1/2 mutant cancers (with previous disease progression on PARP inhibitor monotherapy), or (2) advanced sporadic tumours (e.g. TNBC, CRPC, HGSOC and tumours with somatic mutations or other aberrations known to result in a hyperactivated PI3K-AKT pathway).

NCT ID: NCT02338154 Completed - Aortic Stenosis Clinical Trials

EDWARDS INTUITY Valve System FOUNDATION Study

FOUNDATION
Start date: July 2012
Phase:
Study type: Observational

The purpose of this active post-market surveillance study is to confirm the safety and effectiveness of the EDWARDS INTUITY Valve System in the study population. The objective is to evaluate cardiac performance characteristics and adverse events rates associated with the EDWARDS INTUITY Valve in patients undergoing AVR. The AVR surgical approach is either full or partial sternotomy or a right anterior thoracotomy.

NCT ID: NCT02337907 Completed - Alzheimer Disease Clinical Trials

BI 409306 in Patients With Cognitive Impairment Due to Alzheimer's Disease.

Start date: January 21, 2015
Phase: Phase 2
Study type: Interventional

The study is designed to compare the effects of BI 409306 compared to placebo in patients with cognitive impairment due to Alzheimer's Disease

NCT ID: NCT02337543 Completed - Clinical trials for Osteoarthritis, Knee

NEO6860, a TRPV1 Antagonist, First in Human Study

Start date: January 2015
Phase: Phase 1
Study type: Interventional

This study is a double blind, placebo controlled, ascending single and multiple oral dose study conducted in two parts, aimed at determining the safety and tolerability of single and multiple oral doses of NEO6860 in healthy subjects. Key secondary objectives are: assessment of the pharmacokinetic profile, effect of food and gender. The analgesic effect of NEO6860 will be investigated using experimental capsaicin-evoked pain methods. Part A will comprise an ascending single dose, with 6 dose levels. Part B will comprise an ascending multiple dose, with 2 dose levels.

NCT ID: NCT02337114 Completed - Clinical trials for Brain Injuries, Traumatic

Recovery Enhancement From Traumatic Brain Injury Using Acceptance and Commitment Therapy - a Pilot Study.

REACT
Start date: January 2015
Phase: Phase 0
Study type: Interventional

Is Acceptance and Commitment Therapy (ACT) feasible and acceptable for adults with severe Traumatic Brain Injury (sTBI) in inpatient services? sTBI is associated with depression, anxiety and low self awareness. A key factor in recovery is adjustment to the effects of injury. Psychological intervention may facilitate this change; however what works is unclear. ACT seeks to improve psychological flexibility; the ability to be present with difficult thoughts and emotions, rather than fighting them, and to accept ourselves as we are, not what we believe we should be. Current research is limited, but what is published suggests it may be useful for this group. Due to the limited research this pilot study aims to conduct preliminary analysis on the acceptability and feasibility of ACT for people with sTBI whilst also examining the suitability of the study protocol in order to make recommendations for future studies. Clients and staff from three Brain Injury Rehabilitation Trust (BIRT) centres will be recruited, one of which will serve as the intervention centre. Clients in the intervention group will be asked to complete questionnaires a week before and after participation in the 6 week ACT programme. Clients in the comparison group will be asked to complete questionnaires a week before and after receiving 6 weeks of treatment as usual (TAU). The treatment group will also receive TAU. All participants will be invited to participate in a focus group at the end of this 8 week period to discuss their involvement in the study. Staff will be asked to complete a parallel version of one of the client questionnaires within a similar timeframe. In addition staff at the intervention centre will be invited to attend a focus group and complete an additional questionnaire after the eight week period.

NCT ID: NCT02336698 Completed - Pain Clinical Trials

Study of Efficacy, Safety of Fulranumab Monotherapy for OA of Hip or Knee, PAI3002

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

The purpose of this study is to demonstrate the efficacy, safety, and tolerability of fulranumab as Monotherapy 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.