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NCT ID: NCT02300987 Completed - Teratoma Clinical Trials

A Randomized, Blinded, Placebo-controlled, Phase II Trial of LEE011 in Patients With Relapsed, Refractory, Incurable Teratoma With Recent Progression

Start date: February 26, 2015
Phase: Phase 2
Study type: Interventional

This was a multi-center, randomized, double blind (investigator and subject), placebo controlled Phase II study to determine the efficacy and safety of treatment with ribociclib versus placebo in subjects with progressive relapsed, refractory incurable teratoma. Eligible subjects were randomized in a 2:1 ratio to ribociclib or placebo. After discontinuation of study treatment, patients were followed up for safety, disease progression and overall survival.

NCT ID: NCT02300831 Completed - NSCLC Clinical Trials

LUMINIST: LUng Cancer Molecular Insights Non Interventional Study

LUMINIST
Start date: December 1, 2014
Phase: N/A
Study type: Observational

The recent development of therapies targeting specific biomarkers mutations is changing the standards of care and prognosis of patients with advanced NSCLC, but very few data are currently available on those emerging biomarkers. In addition, the correlation of biomarkers with patients' clinical outcomes in a standard of care setting is poorly understood. This study aims to address that need.

NCT ID: NCT02300779 Completed - Diabetes Mellitus Clinical Trials

Diet for Colonoscopy Preparation in Diabetic Patients

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

This trial will compare the efficacy of to 2 different sets of dietary recommendations to be followed before colon cleansing for colonoscopy in diabetic patients.

NCT ID: NCT02300623 Completed - HIV Clinical Trials

Intermittent ART in Primary HIV Infection

PHI-IL2
Start date: March 2000
Phase: Phase 4
Study type: Interventional

Interventions during primary HIV infection (PHI) can modify the immune control and the clinical evolution during the chronic phase. Although several studies suggest the benefit of antiretroviral treatment (ART) during PHI, indication of ART is still not universally recommended. The investigators randomized patients with PHI, with a favourable immunological profile and well controlled on ART, to undergone structured treatment interruptions alone or with low doses of IL-2, stopping ART thereafter. The endpoints were immune control of HIV replication and time to resume ART. Immunological profile, specific CD4 and CD8 responses and clinical data were analysed for both groups up to 48 weeks, and during a long follow-up, up to nine years since final ART stop.

NCT ID: NCT02299713 Completed - Clinical trials for Osteoarthritis, Knee

Electro-Acupuncture Treatment in Patients With Osteoarthritis Of The Knee (EATOAK)

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

The purpose of this study is to assess the efficacy of electroacupuncture (EA) on pain control, perception of pain, plasma cortisol and beta-endorphins levels, patient-perceived quality of life and use of pain medications, in people with chronic knee pain.

NCT ID: NCT02299505 Completed - Clinical trials for Non-Small Cell Lung Cancer

Pharmacokinetic and Safety Study of Lower Doses of Ceritinib Taken With a Low-fat Meal Versus 750 mg of Ceritinib in the Fasted State in Adult Patients With (ALK-positive) Metastatic Non-small Cell Lung Cancer (NSCLC)

Start date: April 9, 2015
Phase: Phase 1
Study type: Interventional

A Phase I study to assess the systemic exposure, effiacy, and safety of 450 mg ceritinib taken with a low-fat meal and 600 mg ceritinib taken with a low-fat meal as compared with that of 750 mg ceritinib taken in the fasted state in adult patients with ALK rearranged (ALK-positive) metastatic non-small cell lung cancer (NSCLC)

NCT ID: NCT02299375 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Safety and Efficacy Study of Losmapimod (GW856553) in Frequently Exacerbating Participants With Chronic Obstructive Pulmonary Disease (COPD)

Start date: December 9, 2014
Phase: Phase 2
Study type: Interventional

This is a randomised, double-blind, parallel-group, multi-centre study evaluating 15 milligram (mg) twice daily/ Bi-daily (BID) of losmapimod versus placebo, in addition to standard of care (SoC). The primary objective of this study is to explore the therapeutic potential of losmapimod as a treatment to reduce the rate of exacerbations in the subset of participants with moderate-to-severe COPD who are at high risk of exacerbation, having experienced two or more moderate/severe exacerbations in the preceding 12 months, and who have <=2% of blood eosinophils at screening. As secondary objectives safety, effects on lung function, quality of life, pharmacokinetic (PK), biomarkers of both disease and inflammation shall be evaluated. The duration of the treatment period is variable but will be at least 26 weeks and up to a maximum of 52 weeks, with the end of study date being established once the final participant has been randomized. The purpose of the variable dosing regimen is to enable participants to remain in the study for a longer duration, as it is anticipated that this will increase the likelihood of observing exacerbation events without increasing the overall study duration. It will also enable safety data on dosing periods beyond 6 months to be generated. Approximately 200 participants in a 1:1 ratio between losmapimod and placebo will be randomized to the study. Sample size re-estimation will be performed during the course of the study to potentially increase the sample size up to a maximum of 600 participants.

NCT ID: NCT02299362 Completed - Clinical trials for Thoracic Insufficiency Syndrome

The Treatment of Progressive Early Onset Spinal Deformities: A Multi-Center Outcome Study

GSSG
Start date: October 2008
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to examine the treatment, both surgical and non-surgical, of patients with any form of early onset scoliosis. Such treatment may include the use of growth friendly devices that are surgically or magnetically lengthened; or the use of serial body casting or bracing, or observation. Outcomes examined will be what can be seen physically on the patient and on x-ray, as well as parent perception of how the treatment effects their child with the use of a health-related quality of life (HRQOL) questionnaire.

NCT ID: NCT02298478 Completed - Flying Phobia Clinical Trials

Efficacy of an Internet-based Treatment for Flying Phobia: NO-FEAR Airlines

Start date: September 1, 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the efficacy of a computer-aided self-help treatment for flying phobia with or without support by the therapist, compared to a waiting list control group. Secondary objectives: a) to explore two ways of delivering NO-FEAR Airlines, with or without therapist guidance and b) to study the patients' acceptability through expectations, preferences and satisfaction towards the online program. In this work, we present the study design. The principal hypothesis is that the two intervention groups will improve significantly compared to the waiting list control group.

NCT ID: NCT02297945 Completed - Cushing's Syndrome Clinical Trials

Effects of Metyrapone in Patients With Endogenous Cushing's Syndrome

PROMPT
Start date: April 2015
Phase: Phase 3
Study type: Interventional

The purpose of this prospective, international phase III/IV study is to assess the efficacy and safety of metyrapone in patients with endogenous Cushing's syndrome during up to 36 weeks of treatment. The ability of metyrapone (250 mg capsules) to normalize urinary free cortisol (UFC) levels will be assessed during up to 36 weeks (9 months) of treatment.