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NCT ID: NCT01960504 Active, not recruiting - Clinical trials for Coronary Artery Disease

First in Man Study of the DREAMS 2nd Generation Drug Eluting Absorbable Metal Scaffold (BIOSOLVE-II)

BIOSOLVE-II
Start date: October 2013
Phase: N/A
Study type: Interventional

BIOSOLVE-II is a prospective, international, multicenter, First in Man study. The purpose of this study is to assess the safety and clinical performance of the drug eluting absorbable metal scaffold (DREAMS 2nd Generation).

NCT ID: NCT01959308 Recruiting - Clinical trials for Focus : To Study the Differences in Patient Compliance to Immunosuppressive Treatments and Patient Preference.

Adherence to Immunosuppressive Therapy Liver Transplant Recipients

AIM
Start date: June 2013
Phase: N/A
Study type: Observational

Immunosuppressive therapy is fundamental in post-liver transplant patients to prevent and reduce the incidence of acute cellular rejection. Non-compliance to treatment leading to graft rejection is a well-recognized event. This study aims to study the differences in patient compliance to immunosuppressive treatments and patient preference.

NCT ID: NCT01958892 Completed - Clinical trials for Benign Prostatic Hyperplasia

To Compare Outcomes After Transurethral Enucleation of Prostate Versus Transurethral Resection of Prostate

Start date: n/a
Phase: N/A
Study type: Observational

The purpose of the study is to assess whether transurethral enucleation of prostate gives better or equivalent outcomes compared to the gold standard of transurethral resection of the prostate

NCT ID: NCT01958021 Completed - Clinical trials for Advanced, Metastatic Breast Cancer

Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer.(MONALEESA-2)

MONALEESA-2
Start date: December 17, 2013
Phase: Phase 3
Study type: Interventional

This is a multi-center, randomized, double-blinded, placebo controlled trial.

NCT ID: NCT01953913 Completed - Clinical trials for Carcinoma, Non-Small-Cell Lung

Afatinib (BIBW 2992) in Advanced Non-Small Cell Lung Cancer Patients With EGFR Mutation

Start date: September 30, 2013
Phase: Phase 3
Study type: Interventional

Primary objective of the trial is to evaluate the safety of afatinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR (Epidermal growth factor receptor) mutation(s) and have never been treated with an EGFR-TKI (tyrosine kinase inhibitor). Secondary objective is to assess the time to symptomatic progression (as judged by investigator).

NCT ID: NCT01953003 Completed - Clinical trials for Malignant Neoplasm of Breast

Phase III Study of Vinflunine Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer

Start date: September 2013
Phase: Phase 3
Study type: Interventional

Options for the treatment of patients who have progressed after an anthracycline and a taxane are limited. Capecitabine currently has a role in this setting, yet as many as 80% of patients do not respond to this treatment and those who respond eventually develop clinical resistance. The antitumour activity of vinflunine has been demonstrated in patients with breast cancer after exposure to anthracycline and to taxane. Vinflunine plus capecitabine has been shown to be a feasible combination for patients previously treated with an anthracycline and a taxane. Each drug in combination can be administered at efficacious doses. This population has few therapeutic options with established clinical benefit. The development of a new regimen and potential new standard of care for this group is important. - Primary objective: • to compare in patients with advanced breast cancer pretreated with anthracycline and taxane the efficacy of the combination of vinflunine and capecitabine with capecitabine alone, in terms of progression-free survival. - Secondary objectives: - to evaluate the response rate, the time to response and the duration of response in both arms - to compare the disease control rate between arms - to evaluate the duration of disease control in both arms - to evaluate the overall survival in both arms - to evaluate safety Methodology This multicentre, open-label, randomised, Phase III study will enrol a total of 334 patients with advanced breast cancer who have previously been treated with an anthracycline and a taxane. Patients will be randomised in a 1:1 ratio to receive VFL plus capecitabine (Arm A) or capecitabine alone (Arm B).

NCT ID: NCT01951638 Completed - Heart Failure Clinical Trials

Phase IIb Safety and Efficacy Study of Four Dose Regimens of BAY1021189 in Patients With Heart Failure and Preserved Ejection Fraction Suffering From Worsening Chronic Heart Failure (SOCRATES-PRESERVED)

Start date: November 6, 2013
Phase: Phase 2
Study type: Interventional

Objective of the study is to find the optimal dose of the once daily oral soluble guanylate cyclase stimulator (sGC) BAY1021189 for Phase III that can be given in addition to standard diuretic and comorbidity treatment for heart failure with preserved ejection fraction (HFpEF)

NCT ID: NCT01951625 Completed - Heart Failure Clinical Trials

Phase IIb Safety and Efficacy Study of Four Dose Regimens of BAY1021189 in Patients With Heart Failure With Reduced Ejection Fraction Suffering From Worsening Chronic Heart Failure (SOCRATES-REDUCED)

Start date: November 29, 2013
Phase: Phase 2
Study type: Interventional

Objective of the study is to find the optimal dose of the once daily oral soluble guanylate cyclase stimulator (sGC) BAY1021189 for Phase III that can be given in addition to standard therapy for heart failure with reduced ejection fraction (HFrEF).

NCT ID: NCT01950819 Completed - Hemodialysis Clinical Trials

Advancing Renal TRANSplant eFficacy and Safety Outcomes With an eveRolimus-based regiMen (TRANSFORM)

TRANSFORM
Start date: December 3, 2013
Phase: Phase 4
Study type: Interventional

This is a 2-year, randomized, multicenter, open-label, 2-arm study evaluating the graft function of everolimus and reduced CNI versus MPA and standard CNI in adult de novo renal transplant recipients.

NCT ID: NCT01950676 Completed - Diabetes Mellitus Clinical Trials

Feasibility of Using a Smart Phone Application for Self-titration of Insulin on Glycemic Control in Patients With T2DM

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

The primary aim of this study is to investigate the feasibility of using a patient-centered smart phone application for insulin self-titration on glycemic control. Over a 18-month period, suboptimally controlled type 2 diabetes mellitus (T2DM) on oral antidiabetic agents, thus requiring insulin treatment patients, will be recruited from the Singapore General Hospital (SGH). Patients randomized to the intervention group will be instructed to self-adjust their insulin dose using a smart phone application designed to guide self-titration; patients randomized to the control group will receive the usual clinical care. The primary outcome measure is change in glycated hemoglobin level (HbA1c), 6 months post-enrollment. The investigators hypothesize that using a smart phone application for insulin self-titration is effective in improving glycemic control in T2DM patients compared with usual care.