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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.

NCT ID: NCT01307241 Active, not recruiting - Clinical trials for Acute Myeloblastic Leukemia

RFC and MTHFR SNPs & hENT1- dCK Expression as Prognostic Factors in ALL & hENT1- dCK Expression as Prognostic Factors in AML

Start date: December 2010
Phase: N/A
Study type: Observational

Results of actual treatment in ALL are not optimal. New prognostic factors, which may determine clinical & molecular response are required. Hyper-CVAD is an internationally accepted schema for such patients. The objective of this pilot study is to evaluate polymorphisms regarding RFC (reduced folate carrier) and MTHFR enzyme, which may affect the function of these proteins, and therefore the intracellular bioavailability of methotrexate. Also, the expression levels of hENT1 and dCK will be evaluated, since such genes codify for citarabine intracellular transport and activation, respectively. Clinical characteristics will be tabulated and analyzed for responders & non-responders patients. Uni- & multivariate analysis will be done to evaluate factors influencing on response and survival.

NCT ID: NCT01306214 Completed - Obesity Clinical Trials

Safety and Efficacy of BI 10773 as add-on to Insulin Regimen in Patients With Type 2 Diabetes Mellitus

Start date: February 2011
Phase: Phase 3
Study type: Interventional

This trial will evaluate use of BI 10773 as add-on to insulin regimen alone or with metformin in patients with typr 2 diabetes. Both lowering glucose and HbA1c and reducing the use of insulin in this population would provide significant new information for the BI 10773 use and would offer a potential new therapeutic option in this population.

NCT ID: NCT01305746 Completed - Clinical trials for Systemic Lupus Erythematosus

A Trial for Subjects With Systemic Lupus Erythematosus Who Have Completed Protocol AN-SLE3321

Start date: April 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the long-term safety of A-623 in subjects with SLE.

NCT ID: NCT01304888 Completed - Malnutrition Clinical Trials

Evaluating the Impact of the Food Support Program (Programa de Apoyo Alimentaria)

Start date: October 2003
Phase: N/A
Study type: Interventional

The Programa de Apoyo Alimentaria (PAL) started in 2003 and is targeted to communities in Mexico that do not receive benefits from other federal food aid programs, have less than 2,500 inhabitants and a high level of marginalization. Marginalization is a term used in Mexico for the multidimensional assessment of poverty in a community. When the program started in 2003 it provided beneficiary households either a cash transfer of 150 Mexican pesos (equivalent to approximately 14 USD at the time) per month or a monthly food basket with a cost to the program of 150 pesos. The size of the cash transfer and the amount of food was the same for all households, i.e. no adjustments for family size or composition were made. The basket contained a number of staple and basic food products and powdered whole milk (Liconsa), which is fortified with Zn, Fe, Vitamin C, and folate (Table 1). The composition of the food basket conformed to the Mexican norm for food aid programs (NOM-169-SSA1-1998), which states that food transfers need to provide at least 20% of the recommended daily energy and protein requirements. Beneficiary households were required to attend nutrition and health education sessions and had to participate in program related logistic activities in order to receive the benefits. These program conditionalities, however, were not strictly enforced. A community randomized controlled intervention trial was used to evaluate the impact of the intervention. A random sample of 208 rural communities was drawn from the pool of eligible communities in 8 of the poorest states in the South/Eastern region of Mexico (Chiapas, Guerrero, Oaxaca, Quintana Roo, Tabasco, Campeche, Yucatan and Veracruz). Within each community a random sample of 33 households was selected. The baseline survey was conducted from October 2003 to April 2004. After baseline data collection, the 208 selected communities (6,687 households) randomly assigned to one of four study groups: food basket without education (52 communities, 1657 households), food basket with education (52 communities, 1680 households), cash transfer with education (53 communities, 1687 communities) or control (51 communities, 1663 households). Treatment allocation was carried out by the Ministry of Social Development.

NCT ID: NCT01304836 Completed - Clinical trials for Kidney Transplantation

A Study Looking at Diabetes in Kidney Transplant Recipients Receiving Immunosuppressive Regimen With or Without Steroids

ADVANCE
Start date: January 22, 2011
Phase: Phase 4
Study type: Interventional

The purpose of this study is to focus on potential differences in the occurrence of new-onset Diabetes Mellitus (a glucose metabolism disorder) when two different regimens of immunosuppressive treatment are compared.

NCT ID: NCT01302067 Completed - Overactive Bladder Clinical Trials

A 12 Week Study to Confirm the Effectiveness of 8mg of Fesoterodine Compared to 4mg of Fesoterodine

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

This study is designed to confirm if 8mg of fesoterodine is more effective in reducing overactive bladder symptoms than 4mg of fesoterodine. In addition the study is designed to assess if the higher dose reduces the overall effect of overactive bladder on the subject's daily life more than the lower dose. The study also assesses the side effects and safety of the two doses.

NCT ID: NCT01302054 Completed - Clinical trials for Urinary Bladder, Overactive

A Clinical Study in Patients With Overactive Bladder With Leakage of Urine, to Find Out if the Medicine, Fesoterodine, Works in Those Patients Who Did Not Have Enough Response to the Medicine, Tolterodine.

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

Patients with overactive bladder are often treated with tolterodine, a medication that helps relax the bladder, helping symptoms of urinary incontinence and urinary frequency. Sometimes patients do not have a satisfactory response, and may benefit from trying an alternative oral medicine. Fesoterodine is related to tolterodine by producing the same active substance that acts on the bladder, but potentially at higher and more effective levels. So, a patient who has a poor response to tolterodine may still obtain a good response to fesoterodine. This study will help find out if this is what happens.

NCT ID: NCT01299272 Completed - Clinical trials for Major Depressive Disorder

A Study in Prevention of Re-emergence of Depression Symptoms

Start date: May 2011
Phase: Phase 3
Study type: Interventional

The primary objective of this study was to assess the maintenance of efficacy of LY2216684 compared with placebo as adjunctive therapy to selective serotonin reuptake inhibitors (SSRIs) as measured by the time-to-symptom reemergence among participants with major depressive disorder (MDD) who met randomization criteria with adjunctive LY2216684 during the stabilization period. This trial consists of two distinct periods: an open-label treatment period, which consists of two parts, 8 weeks acute open-label with movement to 12 weeks open-label stabilization if participants are in remission at end of 8 weeks (open-label for 20 weeks total) followed by a randomized, double-blind, placebo-controlled period for 24 weeks.

NCT ID: NCT01298882 Completed - Obesity Clinical Trials

Diacerein on Insulin Secretion in Diabetes

Start date: n/a
Phase: Phase 2
Study type: Interventional

Aim. To assess the effect of interleukin 1β (IL-1β) and tumor necrosis factor α (TNFα) inhibition with diacerein administration on insulin secretion and metabolic control of drug-naïve patients with type 2 diabetes mellitus (T2DM) and overweight or obesity. Hypothesis. Diacerein administration improves insulin secretion and metabolic control of drug-naïve patients with type 2 diabetes mellitus (T2DM) and overweight or obesity. Materials and methods. Design: Randomized, double-blind, placebo-controlled clinical trial. Population: 40 drug-naïve adult patients with T2DM and overweight or obesity. Measurements: A metabolic profile including IL-1β, TNFα, interleukin 6, and fasting insulin levels, as well as, hyperglycemic-hyperinsulinemic clamp technique; to assess the phases of insulin secretion and insulin sensitivity. Intervention for 2 mo: diacerein (50 mg once daily) for the first 15 days and twice daily for 45 additional days or placebo. Statistical analyses: Wilcoxon signed rank and Mann-Whitney U test.