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NCT ID: NCT01643707 Completed - Clinical trials for Sinus Node Dysfunction

Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady)

IMPROVE Brady
Start date: July 2012
Phase:
Study type: Observational

Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady)

NCT ID: NCT01642004 Completed - Clinical trials for Squamous Cell Non-small Cell Lung Cancer

Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC) (CheckMate 017)

Start date: October 16, 2012
Phase: Phase 3
Study type: Interventional

The purpose of the study is to compare the overall survival of BMS-936558 as compared with Docetaxel in subjects with squamous cell non-small cell lung cancer (NSCLC), after failure of prior platinum-based chemotherapy.

NCT ID: NCT01641939 Terminated - Gastric Cancer Clinical Trials

A Study of Trastuzumab Emtansine Versus Taxane in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Gastric Cancer

Start date: September 3, 2012
Phase: Phase 2/Phase 3
Study type: Interventional

This multicenter, randomized, adaptive Phase II/III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) compared to standard taxane (docetaxel or paclitaxel) treatment in participants with human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer. At the start of the trial (stage 1), participants will be randomized with a ratio 2:2:1 to one of three treatment arms: Arm A: trastuzumab emtansine 3.6 milligram per kilogram (mg/kg) per intravenous injection (IV) every 3 weeks; Arm B: trastuzumab emtansine 2.4 mg/kg IV every week; Arm C: standard taxane therapy (docetaxel 75 milligram per meter square [mg/m^2] IV every 3 weeks or paclitaxel 80 mg/m^2 kg IV every week per investigator choice). At the end of the first stage of the study, the dose and schedule of trastuzumab emtansine that will be used in the second stage of the study will be selected by an Independent Data Monitoring Committee (IDMC). The regimen selection analysis will be made after approximately 100 participants across all three study arms have been treated for at least 12 weeks. Once a trastuzumab emtansine regimen has been selected, Stage I participants who were assigned to the treatment arm which was selected for Stage II of the study and participants who were in the standard taxane group will continue to receive their assigned treatment regimen. Stage I participants who were assigned to the regimen that was not selected for further evaluation will continue to receive their assigned regimen and will continue to be followed for efficacy and safety. In Stage II of the study, additional participants will be recruited and randomized with a ratio 2:1 to either the selected regimen of trastuzumab emtansine or to the standard taxane therapy. Participants will receive study treatment until disease progression, unacceptable toxicity, initiation of another cancer therapy or withdrawal.

NCT ID: NCT01641692 Completed - Asthma Clinical Trials

A 3-period Crossover Study With GSK573719 as Monotherapy in Adult Subjects With Asthma

Start date: May 2012
Phase: Phase 2
Study type: Interventional

This is a multi-national, randomized, double-blind, 3-period crossover, incomplete block design to evaluate 5 once-daily and 2 twice-daily doses of GSK573719 in combination with placebo. The study will explore the dose range of GSK573719 in asthmatic subjects who are currently using non-ICS controller medications. Subjects will participate in the study for up to a maximum of 14 weeks. At randomization subjects will be stratified by age to ensure adequate exposure to GSK573719 throughout the expected age range. The primary endpoint will be trough FEV1 obtained 24 hours after the last morning dose on Day 14 of each treatment sequence. A sub-group of subjects at selected sites (approximately 30% of the total population) will have additional serial assessments for spirometry, ECG and Holter, and pharmacokinetic sampling at the start and end of each treatment period. Safety assessments will include monitoring for adverse events, laboratory tests, asthma symptom assessments and twice daily PEF evaluation. Consenting subjects will have a blood sample taken for pharmacogenetic analysis.

NCT ID: NCT01641367 Completed - HIV-1 Infection Clinical Trials

A5288/MULTI-OCTAVE: Management Using Latest Technologies to Optimize Combination Therapy After Viral Failure

MULTI-OCTAVE
Start date: February 22, 2013
Phase: Phase 4
Study type: Interventional

The study was done to: - test a strategy of using a resistance test to choose anti-HIV drugs - see how well combinations of new anti-HIV drugs work to lower HIV infection - see if taking new anti-HIV drugs together is safe and tolerable - see if text messages improve people's anti-HIV drug-taking behavior (only at sites participating in the adherence study) - in people taking certain combinations of anti-HIV drugs with an anti-TB drug, compare how these drugs act in the body - to see how people do after they stop having frequent clinic visits as part of a research study

NCT ID: NCT01631214 Completed - Clinical trials for Postmenopausal Women With Osteoporosis

Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis

ARCH
Start date: May 4, 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if treatment is effective in preventing fractures in women with postmenopausal osteoporosis.

NCT ID: NCT01629667 Terminated - Clinical trials for Idiopathic Pulmonary Fibrosis

A Phase 2, Randomized Dose-ranging Study to Evaluate the Efficacy of Tralokinumab in Adults With Idiopathic Pulmonary Fibrosis

Start date: October 2012
Phase: Phase 2
Study type: Interventional

To study the safety and effectiveness of multiple-doses of tralokinumab on pulmonary function in adults with mild to moderate idiopathic pulmonary fibrosis (IPF). IPF is a chronic, progressive, irreversible, and usually fatal lung disease of unknown cause.

NCT ID: NCT01626664 Completed - Clinical trials for Adult T-cell Leukemia-Lymphoma

KW-0761 or Investigator's Choice in Subjects With Previously Treated Adult T-cell Leukemia-Lymphoma (ATL)

Start date: June 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to estimate the overall response rate of subjects with relapsed or refractory Adult T-cell Leukemia-Lymphoma (ATL).

NCT ID: NCT01625286 Completed - Clinical trials for Advanced or Metastatic Breast Cancer

Investigating Safety, Tolerability and Efficacy of AZD5363 When Combined With Paclitaxel in Breast Cancer Patients

BEECH
Start date: October 3, 2012
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to investigate the safety and efficacy of different doses and schedules of AZD5363, when in combination with paclitaxel, in treatment of patients with advanced or metastatic breast cancer. Also to investigate a selected dose and schedule of AZD5363 in combination with paclitaxel vs. paclitaxel in combination with placebo in treatment of patients with estrogen receptor-positive advanced or metastatic breast cancer, including a subgroup who have the phosphoinositide-3-kinase, catalytic, alpha polypeptide (PIK3CA) tumour mutation.

NCT ID: NCT01618669 Completed - Clinical trials for Coronary Artery Disease (CAD)

A Study to Assess Regadenoson Administration Following an Inadequate Exercise Stress Test as Compared to Regadenoson Alone for Myocardial Perfusion Imaging (MPI) Using Single Photon Emission Computed Tomography (SPECT)

EXERRT
Start date: June 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate that the strength of agreement between single photon emission computed tomography (SPECT) imaging with regadenoson following inadequate exercise stress testing and SPECT imaging with regadenoson alone is not inferior to the strength of agreement between two sequential regadenoson SPECT images without exercise.