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NCT ID: NCT01923168 Completed - Breast Cancer Clinical Trials

Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women

Start date: March 11, 2014
Phase: Phase 2
Study type: Interventional

The purpose of the study was to determine whether treatment with a PI3K inhibitor plus letrozole led to an increase in pathologic clinical response and Objective Response Rate compared to treatment with placebo plus letrozole in patients with Breast cancer.

NCT ID: NCT01922310 Completed - Clinical trials for Tissue and Organ Procurement

Communication Regarding Organ and Tissue Donation in Intensive Care

COMFORT
Start date: May 1, 2013
Phase: N/A
Study type: Interventional

The overarching aim of this study is to examine the process of organ donation decision-making and to determine whether changes in requesting practices change rates of consent for donation, and other family-based outcomes.

NCT ID: NCT01921205 Completed - Epilepsy Clinical Trials

Study to Investigate Lacosamide as Add-on Therapy in Subjects ≥4 Years to <17 Years of Age With Partial Onset Seizures

Start date: August 29, 2013
Phase: Phase 3
Study type: Interventional

Study to evaluate the efficacy of Lacosamide (LCM) administered in addition to 1 to ≤3 other Anti-Epileptic Drugs in subjects with epilepsy ≥4 years to <17 years of age who currently have uncontrolled partial onset seizures.

NCT ID: NCT01920711 Completed - Clinical trials for Heart Failure With Preserved Ejection Fraction

Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction

PARAGON-HF
Start date: July 18, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the effect of LCZ696 compared to valsartan in the reduction of cardiovascular death and heart failure(HF) hospitalizations in patients with HF with preserved ejection fraction.

NCT ID: NCT01913613 Completed - Heart Failure Clinical Trials

REDUCE LAP-HF TRIAL

REDUCE LAP-HF
Start date: September 2013
Phase: N/A
Study type: Interventional

The objective of this clinical study is to evaluate the safety and performance of the IASD System II in the treatment of heart failure patients with elevated left atrial pressure, who remain symptomatic despite appropriate medical management.

NCT ID: NCT01912456 Completed - Clinical trials for Hereditary Angioedema Types I and II

A Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema

Start date: January 2014
Phase: Phase 3
Study type: Interventional

The aim of this study is to assess the efficacy of C1-esterase inhibitor in preventing hereditary angioedema attacks when it is administered under the skin of subjects with hereditary angioedema. The safety of C1-esterase inhibitor will also be assessed. Each subject will enter a run-in period of up to 8-weeks. Subjects who complete the run-in period and who are eligible will then enter the treatment phase which comprises two sequential treatment periods. In the treatment phase, subjects will be randomized to one of four arms consisting of treatment with low- or higher-volume C1-esterase inhibitor in one treatment period and treatment with low- or higher-volume placebo in the other treatment period. The study will measure the number of hereditary angioedema attacks that subjects experience while receiving each treatment.

NCT ID: NCT01911767 Completed - Multiple Sclerosis Clinical Trials

Biogen Multiple Sclerosis Pregnancy Exposure Registry

Start date: October 30, 2013
Phase:
Study type: Observational [Patient Registry]

The primary objective of the study is to prospectively evaluate pregnancy outcomes in women with multiple sclerosis who were exposed to a Registry-specified Biogen Multiple Sclerosis product during the eligibility window for that product. The Registry-specified Biogen MS products being studied are dimethyl fumarate, and Pegylated human interferon beta-1a. The secondary objective of the study is to prospectively evaluate pregnancy outcomes in women with MS who were unexposed to disease-modifying therapies (DMTs).

NCT ID: NCT01910740 Completed - Clinical trials for Frail Older People Undergoing Inpatient Rehabilitation

Mobility in Older People

MOVE
Start date: January 2014
Phase: N/A
Study type: Interventional

The main aim of this study is to investigate whether increasing the amount of physical activity in frail older people during hospital based rehabilitation is associated with better mobility outcomes compared to usual care. A second aim is to investigate whether this physical activity intervention is associated with improvements in health related quality of life. Finally we plan to investigate whether increasing the amount of physical activity during rehabilitation is cost effective, measured from a health system perspective, compared with usual care. Older people receiving inpatient rehabilitation will be randomly assigned to an intervention group, who will receive extra physical activity on weekdays and weekends or a control group, who will receive additional activities based on social interaction. The activity sessions will be individualized to the particular participant. Both groups of people will be assessed at baseline, discharge from hospital and at 6 months following discharge. The intervention group will be provided with one or two extra sessions on weekdays and two extra sessions on weekends for the duration of their rehabilitation stay. To account for the extra physiotherapy time that the intervention group receives, the people in the control group will spend the same amount of time performing other activities, such as cards, board games or reading, whilst seated. To ensure the safety of the participants in this study, each physical activity session will be supervised by either a physiotherapist or allied health assistant. Hypothesis 1: The primary hypothesis is that, compared with usual care, increasing the amount of physical activity in frail older people during rehabilitation will lead to more optimal mobility at discharge, as measured by gait speed. Secondary hypotheses are that, compared with usual care, increasing the amount of physical activity during rehabilitation will: Hypothesis 2: lead to significantly greater improvements in mobility and function both at discharge and six months following discharge. Hypothesis 3: lead to better quality of life six months following hospital discharge, measured using the EuroQol Health (EQ5D) Questionnaire and the EuroQol-Visual Analogue Scale (EQ-VAS). Hypothesis 4: be cost effective compared to usual care

NCT ID: NCT01909804 Completed - Hepatitis C Clinical Trials

Safety and Efficacy of Sofosbuvir Plus Velpatasvir With or Without Ribavirin in Treatment-experienced Subjects With Chronic HCV Infection

Start date: June 2013
Phase: Phase 2
Study type: Interventional

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV) in treatment-naive adults with chronic genotype (GT) 1 or 3 hepatitis C virus (HCV) infection.

NCT ID: NCT01908829 Completed - Urologic Diseases Clinical Trials

A Trial Comparing Combination Treatment (Solifenacin Plus Mirabegron) With One Treatment Alone (Solifenacin)

BESIDE
Start date: July 10, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study was to see if adding a new type of medication recently approved to treat overactive bladder (mirabegron) to an antimuscarinic treatment (solifenacin) would be more effective in controlling incontinence than when using the antimuscarinic treatment alone.