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NCT ID: NCT01603199 Completed - Clinical trials for Primary Biliary Cirrhosis

High-protein High-fiber Diet in Patients With Primary Biliary Cirrhosis

Start date: September 2011
Phase: N/A
Study type: Interventional

Primary biliary cirrhosis is a chronic cholestatic autoimmune liver disease with a progressive course that can lead to liver cirrhosis. There are few studies on dietary management in primary biliary cirrhosis and most of them have focused on micronutrients specifically vitamin D intake to prevent osteoporosis, and lipid control to prevent hyperlipidemia, but few recommendations have been made regarding a complete dietary approach. Fiber has been proven to increase the excretion of nitrogen products and consequently reduce its blood levels, and an adequate protein intake (1- 1.5 g per kg) has shown to decrease endogenous catabolism in cirrhotic patients. The purpose of this study is to evaluate the impact of a high-protein, high-fiber diet in the nutritional status of patients with primary biliary cirrhosis.

NCT ID: NCT01602770 Completed - Contraception Clinical Trials

Qlaira Post-authorization Safety Study Related to Most Common Adverse Events in Mexican Women Who Wish to Avoid Pregnancy

Start date: February 6, 2015
Phase:
Study type: Observational

Qlaira is a combined oral contraceptive (COC) containing dienogest/estradiol valerate being the first oral contraceptive delivering estradiol. It has been recently approved in Mexico. To evaluate the clinical profile of this drug combination under routine medical condition, a post-authorization safety study required by Mexican Health Authorities will be conducted in Mexican women. The study will be performed as a descriptive study, no hypothesis will be tested. The cohort consists of 300 new users (first-ever users or switchers) of Qlaira under routine medical conditions. Subjects should provide all necessary information on health-related events or changes in health status during Qlaira use. Primary variable will be the incidence of Adverse Events (AE) at any time point, whether or not related to Qlaira during at least 2 years of observation. In order to comply with the criteria of a non-interventional study, women only will be informed about the study, asked to participate and included in the study after Qlaira has been prescribed. Study patients follow-up will be done in accordance with common clinical practice as described at Mexican Official Guidelines for prescription of Family Planning Methods (NOM 005-SSA2-1993).

NCT ID: NCT01602380 Active, not recruiting - Clinical trials for Hormone Receptor Positive Breast Cancer

A Global Study to Compare the Effects of Fulvestrant and Arimidex in a Subset of Patients With Breast Cancer.

FALCON
Start date: October 17, 2012
Phase: Phase 3
Study type: Interventional

The purpose of the study is to compare how treatment with Fulvestrant (FASLODEX) or Anastrozole (ARIMIDEX) effects disease progression for women with locally advanced or metastatic breast cancer who have not had prior hormonal treatment.

NCT ID: NCT01602224 Completed - Multiple Myeloma Clinical Trials

A Study of Tabalumab (LY2127399) in Participants With Previously Treated Multiple Myeloma (MM)

Start date: July 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate an investigational drug called tabalumab in participants with Multiple Myeloma (MM) who have tried at least one other therapy in the past. Tabalumab will be given in combination with standard doses of two other drugs that are often used to treat MM. Study doctors will collect information about the effectiveness and side effects of this therapy.

NCT ID: NCT01600963 Withdrawn - Clinical trials for Multi-drug Resistant Tuberculosis

A Study to Evaluate the Efficacy and Safety of TMC207 in Patients With Pulmonary Infection With Multi-drug Resistant Mycobacterium Tuberculosis

Start date: March 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to provide safety and efficacy data for TMC207 and to demonstrate that TMC207 added to a background regimen (BR) is superior to treatment with the BR plus placebo.

NCT ID: NCT01599923 Completed - Clinical trials for Scorpion Sting Envenomation

Open Label Study of Alacramyn® in Pediatric Patients With Scorpion Sting Envenomation

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

There is no FDA approved therapy for the treatment of scorpion envenomation in the United States. Centruroides scorpion envenomation produces a pattern of neurotoxicity with a spectrum of severity ranging from trivial to life threatening. Patients stung by Centruroides scorpions develop a clinical syndrome which may require sedation with benzodiazepines and observation for 6 to 28 hours of intensive care monitoring. A safe therapy is necessary to halt the progression of symptoms early in the clinical course while avoiding the clinical deterioration that can occur en route to a tertiary facility. Alacramyn® is anticipated to be safer and more effective than the present standard of care in the United States, midazolam, and faster-acting thus eliminating the need to transport most rural patients and reducing hospitalization time.

NCT ID: NCT01599806 Completed - Clinical trials for Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis

Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)

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

The purpose of this study is to evaluate the effects of Ceftazidime Avibactam compared to Doripenem for treating hospitalized patients with complicated urinary tract infections, including acute pyelonephritis

NCT ID: NCT01595438 Completed - Clinical trials for Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis

Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)

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

The purpose of this study is to evaluate the effects of Ceftazidime Avibactam compared to Doripenem for treating hospitalized patients with complicated urinary tract infections, including acute pyelonephritis

NCT ID: NCT01591993 Completed - Clinical trials for Skin Irritancy Tests

Determination of Sensitive Skin and Its Biophysical Response in a Latin-American Population

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

Sensitive skin syndrome is a frequent self-diagnosed entity that has not been previously described in a Latin-american population. One hypothesis to its development is an alteration of the barrier function of the skin. The aim of the study is to describe the frequency of sensitive skin in a mexican population detected through the lactic acid test, and to explore its response through biophysical measures (colorimetry, transepidermal water loss (TEWL) and capacitance). The prevalence of this syndrome in studied populations is approximately 50%. Considering racial skin differences, the investigators would expect at least a 20% prevalence. For this purpose, the investigators would need a minimum of 243 healthy volunteers, 18 years or older, with previous informed consent, to whom the lactic acid test will be performed. The investigators will record any unpleasant sensation graded in a Visual Analog Scale (VAS) of 10 points, colorimetry, TEWL and capacitance before the test and at 3, 5, 8 and 10 minutes after the lactic acid test.

NCT ID: NCT01590459 Completed - Clinical trials for Rheumatoid Arthritis

24-week Study With Open Label Extension of VX-509, an Oral JAK3 Inhibitor, in Subjects Taking Methotrexate

Start date: April 2012
Phase: Phase 2
Study type: Interventional

This study is designed to evaluate the safety and efficacy of VX-509, an oral JAK3 inhibitor, for treatment of subjects with active RA who have had an inadequate response to Methotrexate.