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NCT ID: NCT01672892 Completed - Cervical Cancer Clinical Trials

Standard Versus Intensity-Modulated Pelvic Radiation Therapy in Treating Patients With Endometrial or Cervical Cancer

Start date: November 2012
Phase: Phase 3
Study type: Interventional

RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. PURPOSE: This randomized phase III trial is studying two different methods of radiation and their side effects and comparing how well they work in treating endometrial and cervical cancer after surgery.

NCT ID: NCT01667601 Completed - Schizophrenia Clinical Trials

Mindfulness-based Illness Management Program for Schizophrenia

MBPP
Start date: August 2010
Phase: N/A
Study type: Interventional

Only a few intervention studies have also focused on changing patients' negative thoughts and feelings towards the illness and their relationship to the suffering caused by those thoughts, which is evidenced to empower psychosocial functioning and control of distressing thoughts in severe depression and psychotic disorders by using the Mindfulness-Based Stress Reduction program. This controlled trial is designed to test the effects of a mindfulness-based Illness management program (MBPP) for Chinese patients with schizophrenia on their symptom severity, illness insight and psychosocial functioning.

NCT ID: NCT01663402 Completed - Clinical trials for Atherosclerotic Cardiovascular Disease

ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab

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

Primary Objective: To compare the effect of alirocumab with placebo on the occurrence of cardiovascular (CV) events (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, unstable angina (UA) requiring hospitalization) in participants who experienced an acute coronary syndrome (ACS) event 4 to 52 weeks prior to randomization and were treated with evidence-based medical and dietary management of dyslipidemia. Secondary Objectives: - To evaluate the effect of alirocumab on secondary endpoints (any CHD event , major CHD event, any CV event, composite of all cause mortality/non-fatal MI/non-fatal ischemic stroke, CHD deaths, CV deaths, all cause mortality). - To evaluate the safety and tolerability of alirocumab. - To evaluate the effect of alirocumab on lipid parameters.

NCT ID: NCT01662869 Completed - Gastric Cancer Clinical Trials

A Study of Onartuzumab in Combination With mFOLFOX6 in Participants With Metastatic HER2-Negative and MET-Positive Gastroesophageal Cancer

Start date: November 2012
Phase: Phase 3
Study type: Interventional

This randomized, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with 5-fluorouracil, folinic Acid, and oxaliplatin (mFOLFOX6) in participants with metastatic human epidermal growth receptor (HER) 2-negative and MET-positive adenocarcinoma of the stomach or gastroesophageal junction. Participants will be randomized in a 1:1 ratio to receive either onartuzumab or placebo in combination with mFOLFOX6. Participants may continue to receive onartuzumab or placebo until disease progression, unacceptable toxicity, participant or physician decision to discontinue treatment.

NCT ID: NCT01661270 Completed - Clinical trials for Colorectal Cancer Metastatic

A Study of Aflibercept Versus Placebo With FOLFIRI in Patients With Metastatic Colorectal Cancer Previously Treated With an Oxaliplatin Chemotherapy

AFLAME
Start date: July 2012
Phase: Phase 3
Study type: Interventional

Primary Objective: To evaluate the improvement in progression-free survival of aflibercept versus placebo in participants with metastatic colorectal cancer treated with FOLFIRI as second-line treatment for metastatic disease. Secondary Objectives: To compare the overall survival in the 2 treatment arms. To compare the overall response rate in the 2 treatment arms. To assess the safety profile of the 2 treatment arms. To assess immunogenicity of IV aflibercept in selected centers.

NCT ID: NCT01660451 Completed - Clinical trials for Lymphoma, Non-Hodgkin

Open-label, Uncontrolled Phase II Trial of Intravenous PI3K Inhibitor BAY80-6946 in Patients With Relapsed, Indolent or Aggressive Non-Hodgkin's Lymphomas

Start date: November 19, 2012
Phase: Phase 2
Study type: Interventional

The objective of the study (part A) is to evaluate the efficacy and safety of BAY80-6946 in patients with indolent or aggressive Non-Hodgkin's Lymphoma, who have progressed after standard therapy. 30 patients will be enrolled to both indolent and aggressive disease group. The objective of the study part B (CHRONOS-1) is to evaluate the efficacy and safety of BAY80-6946 in patients with relapsed/refractory follicular lymphoma. 120 patients will be enrolled in the part B of the study. Further objectives are to evaluate the pharmacokinetics and biomarkers. Quality of life will be a further objective of part B of the study. In a cohort of 20 patients (enrolled both in part A and B) an ECG substudy will be performed to assess the potential for cardiac toxicity and QT/QTc interval prolongation of BAY80-6946. After an up to 28-day screening period, eligible patients will start treatment with BAY80-6946 at a dose of 0.8 mg/kg (Part A) and at a dose of 60 mg (Part B). Treatment will be continued until disease has progressed or until another criterion is met for withdrawal from study. An end-of-treatment visit will be performed within 7 days after discontinuation of study treatment. Thirty to 35 days after last study drug administration, a safety followup visit will be performed for the collection of adverse events (AEs) and concomitant medication data. Patients will be contacted quarterly to determine overall survival status up to 4 years after last patient completed treatment. Patients who discontinue study drug for reasons other than disease progression will enter the Active Assessment Follow-up period. The end of study notification to Health Authorities will be based on the completion of the collection of survival data. The efficacy is measured by the decrease in tumor size. Tumor assessments will be done at Screening, every 8 weeks during Year 1, every 12 weeks during Year 2, and every 6 months during Year 3. Blood samples will be collected for pharmacokinetic analysis. Archival tumor tissue and blood samples will be collected for biomarker analysis (mandatory) and for central pathology review (part B), fresh biopsy tissue will also be collected if available.

NCT ID: NCT01657162 Completed - Clinical trials for Postmenopausal Osteoporosis

Twenty-Four Month Extension Study of BA058-05-003 (Abaloparatide) in Participants With Osteoporosis

ACTIVExtend
Start date: November 20, 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to provide 24 months of standard of care data on participants previously enrolled in Study BA058-05-003 (NCT02653417).

NCT ID: NCT01652508 Completed - Smoking Cessation Clinical Trials

Acceptance and Commitment Therapy for Smoking Cessation in the Primary Care Setting

ACT
Start date: July 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the feasibility and potential efficacy of Acceptance and Commitment Therapy (ACT) in enhancing smoking cessation among attendees in primary healthcare settings.

NCT ID: NCT01648114 Completed - Pregnancy Clinical Trials

A Randomized Controlled Trial of an Antenatal Intervention to Increase Exclusive Breastfeeding

ABFS
Start date: August 2012
Phase: N/A
Study type: Interventional

The investigators will conduct an educational intervention for pregnant women who are planning to breastfeed to promote exclusive breastfeeding and to increase the duration of breastfeeding.

NCT ID: NCT01645930 Completed - Multiple Myeloma Clinical Trials

Phase 1 Pharmacokinetic Study of Oral Ixazomib Plus Lenalidomide and Dexamethasone in Adult Asian Participants With Relapsed and/or Refractory Multiple Myeloma

Start date: December 17, 2012
Phase: Phase 1
Study type: Interventional

The purpose of this Phase 1 study is to characterize the pharmacokinetic (PK) and tolerability of oral ixazomib (MLN9708) when administered in combination with lenalidomide and dexamethasone in adult Asian participants with relapsed and/or refractory multiple myeloma.