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NCT ID: NCT02345070 Completed - Clinical trials for Idiopathic Pulmonary Fibrosis

Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis

ESTAIR
Start date: May 1, 2015
Phase: Phase 2
Study type: Interventional

Primary Objective: To evaluate, in comparison with placebo, the efficacy of 2 dose levels/regimens of SAR156597 administered subcutaneously during 52 weeks on lung function of participants with Idiopathic Pulmonary Fibrosis (IPF). Secondary Objectives: To evaluate the efficacy of 2 dose levels/regimens of SAR156597 compared to placebo on IPF disease progression. To evaluate the safety of 2 dose levels/regimens of SAR156597 compared to placebo in participants with IPF.

NCT ID: NCT02343406 Completed - Glioblastoma Clinical Trials

Adult Study: ABT-414 Alone or ABT-414 Plus Temozolomide vs. Lomustine or Temozolomide for Recurrent Glioblastoma Pediatric Study: Evaluation of ABT-414 in Children With High Grade Gliomas

INTELLANCE-2
Start date: February 17, 2015
Phase: Phase 2
Study type: Interventional

This study was conducted to evaluate the efficacy and safety of depatuxizumab mafodotin (ABT-414) alone or with temozolomide versus temozolomide or lomustine alone in adult participants with recurrent glioblastoma. The study also included a substudy to evaluate safety, tolerability and pharmacokinetics of ABT-414 in a pediatric population.

NCT ID: NCT02342002 Terminated - Pregnancy Clinical Trials

Mifepristone and Misoprostol Versus Misoprostol Alone for Missed Abortion: A Randomized-controlled Trial

Start date: January 2015
Phase: Phase 4
Study type: Interventional

The purpose of the proposed study is to compare - in a randomized, placebo-controlled, double-blinded trial - a combination of mifepristone and misoprostol to misoprostol used alone for missed abortion.

NCT ID: NCT02340221 Terminated - Breast Cancer Clinical Trials

A Study of Taselisib + Fulvestrant Versus Placebo + Fulvestrant in Participants With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy

SANDPIPER
Start date: April 9, 2015
Phase: Phase 3
Study type: Interventional

This international, multicenter, randomized, double-blinded, placebo-controlled study is designed to compare the efficacy and safety of taselisib + fulvestrant with that of placebo + fulvestrant in postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative, oncogene that encodes for phosphatidylinositol-4,5-bisphosphate 3-kinase (PIK3CA)-mutant, unresectable, locally advanced or metastatic breast cancer after recurrence or progression during or after an aromatase inhibitor (AI) therapy. There will be a 2:1 randomization to the taselisib arm versus the placebo arm. Enrollment will be enriched for participants with PIK3CA mutant tumors via central testing. The anticipated duration of the study is approximately 3.5 years.

NCT ID: NCT02337933 Completed - Clinical trials for Metabolic Syndrome X

Effect of Ursolic Acid Administration on Insulin Sensitivity and Metabolic Syndrome

Start date: September 2014
Phase: Phase 2
Study type: Interventional

The metabolic syndrome is characterized by the presence of overweight/obesity, insulin resistance, hyperglycemia, dyslipidaemia and hypertension and an inflammatory state, which together increase the risk of developing cardiovascular disease (CVD) or diabetes mellitus type 2 (DM2). It is also characterized by a decreased insulin sensitivity, namely, lower ability of insulin to metabolize glucose, key in the physiopathogeny of disease process. In the search for a pharmacological agent that can attend more components of the metabolic syndrome and above all improve insulin sensitivity to effectively prevent the development of CVD and DM2, ursolic acid is a promising compound. Ursolic acid is a pentacyclic carboxylic acid present in medicinal herbs, parts of some fruits like apple peel, and plants such as rosemary. There is scientific evidence of important benefits of ursolic acid level in vitro and in vivo on insulin, metabolism of lipids and glucose, as well as on the body weight and metabolic parameters. However, the results are not clear and the mechanisms are not fully elucidate. The aim of this study is to evaluate the effect of ursolic acid on the insulin sensitivity and metabolic syndrome.

NCT ID: NCT02330341 Completed - Glucose Intolerance Clinical Trials

Effect of Artemisia Dracunculus on Glucose Intolerance, Insulin Sensitivity and Insulin Secretion

Start date: December 2014
Phase: N/A
Study type: Interventional

The term prediabetes has been used to encompass the first alterations on glucose metabolism such as impaired fasting glucose and glucose intolerance, and its early detection and treatment could prevent the appearance of diabetes mellitus type 2, a high prevalence disease worldwide. Artemisia dracunculus, also known as estragon, has been used in Ayurvedic medicine for the treatment of diabetes. Different in vitro and in vivo studies have shown that Artemisia dracunculus increases insulin signaling and improves insulin sensitivity. The aim of this study is evaluate the effect of Artemisia dracunculus on glucose intolerance, insulin sensitivity and insulin secretion.

NCT ID: NCT02328222 Completed - Clinical trials for END STAGE RENAL DISEASE

ESTEROID WITHDRAWAL STUDY, SAFETY AND EFFICACY IN RENAL TRANPLANTATION

ESWMEX001
Start date: June 2010
Phase: Phase 4
Study type: Interventional

BACKGROUND: Non-steroid maintenance immunosuppression after transplantation can improve long-term lipid and hemodynamic profiles without severe acute rejection (AR) events that alter graft function or survival. Our objective was to evaluate the effects of early steroid withdrawal (ESW) on the frequency and severity of AR using an immunosuppressive scheme consisting of mycophenolate (MMF) and tacrolimus (TAC) in combination with an induction treatment with basiliximab. METHODS: A randomized clinical trial was performed on first renal transplant recipients. In the ESW group, patients were selected for corticosteroid treatment withdrawal on the fifth day post-transplantation. In the Control group, patients continued steroid treatment.

NCT ID: NCT02328144 Completed - Hemorrhoids Clinical Trials

Effectiveness of Metronidazole in Pain Control Posthemorrhoidectomy

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

Hemorrhoidal disease occurs in 50% of people over 40 years old and is the most common cause of anorectal surgery. One of the complications of hemorrhoidectomy is pain, which is a difficult symptom to appreciate and assess, by its frequent and large variations in sensitivity in each patient. Many studies have been done to reduce patient postoperative pain, but there is no ideal method. The application of both oral and topical metronidazole has shown to decrease pain following hemorrhoidectomy, but its use is not standardized. The investigators evaluated the effect of oral administration of metronidazole versus homologated placebo in pain control after hemorrhoidectomy

NCT ID: NCT02326857 Completed - Breast Cancer Clinical Trials

Molecular Profiling of Stage II and III Breast Cancer in Latin American Women Receiving Standard-of-Care Treatment

Start date: December 23, 2014
Phase:
Study type: Observational

Background: - Researchers want to learn more about breast cancer in Latin American women. They also want to learn how and why women respond differently to standard treatment. Tissue and blood samples from women with breast cancer are needed to study this disease in order to find new ways to prevent, diagnose, and treat it. Objective: - To learn more about the biology and genetics of breast cancer in Latin American women. Eligibility: - Latin American women age 18 and older of all ethnic backgrounds who have clinical stage II or III breast cancer. They must still be active and able to self-care. Design: - Participants are only agreeing to have extra tissue or blood samples collected. They are also letting tissue left over from surgery be used for research. No procedures outside of standard care will be done. - Participants may have a medical history, physical exam, and blood tests. They may have a pregnancy test. They may have an ultrasound, mammogram, and other scans. They may have an intravenous needle placed in an arm vein. - Participants may have a core biopsy. For this, a needle is inserted into the breast. A piece of tissue is extracted. - Participants who have chemotherapy may have blood taken after treatment/before surgery. Tissue may also be collected. - Participants will complete a questionnaire. It will ask about their social and economic background. It will ask about their family history of cancer. It will also ask about access to diagnosis and treatment of breast cancer. - Participants may be followed for up to 5 years.

NCT ID: NCT02322762 Completed - Clinical trials for Type 2 Diabetes Mellitus

DISCOVERing Treatment Reality of Type 2 Diabetes in Real World Settings

DISCOVER
Start date: December 30, 2014
Phase:
Study type: Observational

DISCOVER is a Non Interventional Study study to describe the disease management patterns and clinical evolution over three years in type 2 diabetes mellitus patients initiating a second line anti-diabetic treatment.