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NCT ID: NCT01332019 Completed - Clinical trials for Relapsing Multiple Sclerosis

Long-Term Safety and Efficacy Study of Peginterferon Beta-1a

ATTAIN
Start date: April 2011
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the long-term safety and tolerability of peginterferon beta-1a (BIIB017) in participants originally treated in Study 105MS301 (NCT00906399) who continue peginterferon beta-1a treatment. The secondary objective of this study is to describe long-term multiple sclerosis (MS) outcomes in participants originally treated in Study 105MS301 (NCT00906399) who continue peginterferon beta-1a treatment.

NCT ID: NCT01327846 Completed - Atherosclerosis Clinical Trials

Cardiovascular Risk Reduction Study (Reduction in Recurrent Major CV Disease Events)

CANTOS
Start date: April 11, 2011
Phase: Phase 3
Study type: Interventional

Main Study (CACZ885M2301): The purpose of the pivotal phase of this trial was to test the hypothesis that canakinumab treatment of patients with myocardial infarction (MI) at least one month prior to study entry and elevated hsCRP could prevent recurrent cardiovascular events. The purpose of the extension phase of the main study is to collect additional long-term safety data on continued exposure to canakinumab in patients who participated in the pivotal phase. Sub-study 1 (CACZ885M2301S1): The purpose of this sub-study was to evaluate the effect of quarterly subcutaneous canakinumab treatment for 24 months comparted with placebo on the carotid plaque burden measured by integrated vascular MRI in patients enrolled in the CACZ885M2301 study (CANTOS). Sub-study 2 (CACZ885M2301S2): The purpose of this CANTOS sub-study was to determine whether, in patients with type 2 diabetes participating in the CANTOS main study, canakinumab compared to placebo, on top of standard of care could increase insulin secretion and insulin sensitivity.

NCT ID: NCT01326338 Completed - Diarrhea Clinical Trials

Nitazoxanide for the Treatment of Prolonged Diarrhea in Children

Start date: March 2005
Phase: Phase 3
Study type: Interventional

The purpose of this study was to determine the efficacy of nitazoxanide suspension compared to placebo in treating prolonged diarrhea in children.

NCT ID: NCT01318941 Completed - Clinical trials for Diabetic Macular Edema

Observe the Effectiveness and Safety of Ranibizumab in Real Life Setting

LUMINOUS
Start date: March 2011
Phase: N/A
Study type: Observational

This study will describe the long-term safety and effectiveness, treatment patterns,and patient reported quality of life associated with ranibizumab treatment in routine clinical practice for all approved indication included in the local product label.

NCT ID: NCT01316900 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

24-week Trial Comparing GSK573719/GW642444 With GW642444 and With Tiotropium in Chronic Obstructive Pulmonary Disease

Start date: March 1, 2011
Phase: Phase 3
Study type: Interventional

This is a Phase III multicenter, randomized, double-blind, double-dummy, parallel-group study to evaluate the efficacy and safety of two doses of GSK573719/GW642444 Inhalation Powder and GW642444 Inhalation Powder via a Novel Dry Powder Inhaler and tiotropium via HandiHaler when administered once-daily over a 24-week treatment period in subjects with chronic obstructive pulmonary disease (COPD). Subjects who meet eligibility criteria at Screening (Visit 1) will complete a 7 to10 day run-in period followed by a randomization visit (Visit 2) then a 24-week treatment period. There will be a total of 9 clinic study visits. A follow-up phone contact for adverse event assessment will be conducted approximately one week after the last study visit (Visit 9 or Early Withdrawal). The total duration of subject participation in the study will be approximately 26 weeks. The primary measure of efficacy is clinic visit trough (pre-bronchodilator and pre-dose) forced expiratory volume in one second (FEV1) on Treatment Day 169. Safety will be assessed by adverse events, 12-lead ECGs, vital signs, and clinical laboratory tests.

NCT ID: NCT01315353 Completed - HIV-1 Infection Clinical Trials

HPV Test-and-Treat-Strategy Versus Cytology-based Strategy for Prevention of CIN2+ in HIV-Infected Women

Start date: April 4, 2012
Phase: N/A
Study type: Interventional

Women sometimes develop cancer in an area called the cervix, which is the opening to the uterus, or womb. Women who have HIV are more likely to get this kind of cancer than women who do not have HIV. Nearly all of these cancers are caused by another virus, called human papilloma virus (or HPV). Other times, the cause of this cancer is not known. The investigators are looking for a better way to prevent cervical cancer. This study is comparing two different methods to prevent cancer of the cervix in women who have HIV. This study will also see if these methods are safe and tolerable in women who have HIV.

NCT ID: NCT01314937 Completed - Malnutrition Clinical Trials

The Effect of a Deworming Intervention to Improve Early Childhood Growth and Development in Resource-poor Areas

Start date: September 2011
Phase: Phase 4
Study type: Interventional

Worldwide, over 2 billion people suffer from worm infections in developing countries. These infections are especially damaging to the health of children, resulting in both short-term and lifelong disability. Older children with worm infections are more likely to be stunted, underweight, vulnerable to other illnesses and perform poorly in school compared to non-infected children. Large-scale deworming programs in school-age children are therefore recommended by the World Health Organization (WHO). WHO also recommends deworming of preschool-age children (as of 12 months of age) in these areas; however, the benefits of deworming, especially in the 12-24 month age group, have been inadequately studied. This knowledge is urgently needed as studies show that all children have a similar potential for healthy growth and development, provided that appropriate nutrition and health interventions are given in the critical window of opportunity before the age of two. Therefore, the investigators are proposing to undertake a randomized controlled trial to determine the effect of deworming program for improving growth and development in children between 12 and 24 months of age. Our results will provide solid rigorous evidence on if, when, and how often, deworming should be integrated into routine child health care packages provided by Ministries of Health in the 130 countries in the world where worm infections are endemic.

NCT ID: NCT01308580 Completed - Prostate Cancer Clinical Trials

Cabazitaxel at 20 mg/m² Compared to 25 mg/m² With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer

PROSELICA
Start date: April 2011
Phase: Phase 3
Study type: Interventional

Primary Objective: - To demonstrate the non inferiority in term of overall survival (OS) of cabazitaxel 20 mg/m² (Arm A) versus cabazitaxel 25 mg/m² (Arm B) in combination with prednisone in patients with metastatic castration resistant prostate cancer (MCRPC) previously treated with a docetaxel-containing regimen. Secondary Objectives: - To evaluate safety in the 2 treatment arms and to assess if cabazitaxel 20 mg/m² is better tolerated than cabazitaxel 25 mg/m². - To compare efficacy of cabazitaxel at 20 mg/m² and 25 mg/m² for: - Progression Free Survival (PFS) defined as the first occurrence of any of the following events: tumor progression per Response Evaluation Criteria In Solid Tumors (RECIST), PSA progression, pain progression or death due to any cause - Prostate-Specific Antigen (PSA)-Progression - Pain progression - Tumor response in patients with measurable disease (RECIST 1.1). - PSA response - Pain response in patients with stable pain at baseline. - To compare Health-related Quality of Life (HRQL) - To assess the pharmacokinetics and pharmacogenomics of cabazitaxel

NCT ID: NCT01308567 Completed - Prostate Cancer Clinical Trials

Cabazitaxel Versus Docetaxel Both With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer

FIRSTANA
Start date: May 5, 2011
Phase: Phase 3
Study type: Interventional

Primary Objective: - To demonstrate the superiority of cabazitaxel plus prednisone at 25 mg/m^2 (Arm A) or 20 mg/m^2 (Arm B) versus docetaxel plus prednisone (Arm C) in term of overall survival (OS) in participants with metastatic castration resistant prostate cancer (mCRPC) and not previously treated with chemotherapy. Secondary Objectives: - To evaluate safety in the 3 treatment arms. - To compare efficacy of cabazitaxel at 20 mg/m^2 and 25 mg/m^2 to docetaxel for: - Progression Free Survival (PFS) (RECIST 1.1) - Tumor progression free survival (RECIST 1.1) - Tumor response in participants with measurable disease (RECIST 1.1), - PSA response - PSA-Progression free survival (PSA-PFS). - Pain response in participants with stable pain at baseline - Pain progression free survival - Time to occurrence of any skeletal related events (SRE) - To compare Health-Related Quality of Life (HRQL). - To assess the pharmacokinetics and pharmacogenomics of cabazitaxel.

NCT ID: NCT01307397 Completed - Malignant Melanoma Clinical Trials

A Study of Vemurafenib in Participants With Metastatic Melanoma

Start date: March 1, 2011
Phase: Phase 3
Study type: Interventional

This multi-center study evaluates the safety and efficacy of vemurafenib in participants with BRAF V600 mutation-positive, surgically incurable, and unresectable Stage IIIC or IV (American Joint Committee on Cancer [AJCC]) metastatic melanoma.