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NCT ID: NCT01566721 Completed - Breast Neoplasms Clinical Trials

A Safety and Tolerability Study of Assisted and Self-Administered Subcutaneous (SC) Herceptin (Trastuzumab) as Adjuvant Therapy in Early Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer

SafeHER
Start date: May 17, 2012
Phase: Phase 3
Study type: Interventional

This multicenter, two-cohort, non-randomized, open-label study will evaluate the safety and tolerability of assisted and self-administered SC Herceptin as adjuvant therapy in participants with early HER2-positive breast cancer following tumor excision. Participants will receive Herceptin 600 milligrams (mg) SC every 3 weeks for 18 cycles, either by an assisted administration using a conventional syringe and needle/vial formulation (Cohort A) or with assisted and self-administration using a single-use injection device (SID) in selected participants (Cohort B).

NCT ID: NCT01550016 Completed - Dengue Fever Clinical Trials

International Research Consortium on Dengue Risk Assessment, Management, and Surveillance

IDAMS
Start date: October 2011
Phase: N/A
Study type: Observational

Improvements in diagnosis of dengue fever and prediction of which patients will get more severe disease are urgently needed to improve the treatment of patients with dengue. This is very important in places with many people who suffer from dengue but have limited health care resources. This study will enroll patients with fever which may be caused by dengue in 6 countries with high incidence of dengue over two continents (Brazil, Cambodia, El Salvador, Indonesia, Malaysia and Vietnam). All patients will be followed by a doctor with blood tests and exams until they recover. Symptoms and laboratory tests will be followed so that the cause of fever can be determined. For patients who have dengue, the investigators will look for symptoms and tests which indicate more serious disease. This study will help to determine how to identify patients with dengue fever based on symptoms and simple laboratory tests and those who will get more serious disease. It will also help to define a more standardized management of patients with dengue fever.

NCT ID: NCT01349998 Completed - Tinea Pedis Clinical Trials

Safety of a Topical Antifungal Treatment for Tinea Cruris, Tinea Pedis and Tinea Corporis

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

The purpose of this study is to examine the long-term safety of treating recurrent episodes of tinea pedis for 14 days for each recurrence and recurrent episodes of tinea corporis or tinea cruris for 7 days for each recurrence with Product 33525.

NCT ID: NCT01342315 Completed - Tinea Cruris Clinical Trials

Topical Antifungal Treatment for Tinea Cruris

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

To determine if a topical antifungal cream is safe and effective for the treatment of tinea cruris

NCT ID: NCT01279421 Completed - HIV Clinical Trials

High Risk Crack Use Settings and HIV in El Salvador

Encuentro
Start date: November 2010
Phase: N/A
Study type: Interventional

This project will first increase the accessibility and acceptability of rapid HIV testing in health clinics located in or near four low-income communities in San Salvador, El Salvador. The investigators will use crack users' social networks and small incentives, as recommended by the CDC, in collaboration with the Salvadoran Ministry of Public Health and Social Assistance (MSPAS) to encourage crack users to receive HIV testing. The second part of the intervention consists of training 8 Peer Leaders to recruit and lead a Peer Network Intervention among 400 crack users to change norms supporting HIV protective behaviors. The intervention will include monthly meetings open to crack using and non-crack using community residents to reinforce HIV risk reduction skills, and discussion of other topics related to HIV such as illicit drug use and interpersonal violence and community-wide HIV awareness events. Our hypothesis is that these two intervention features will singly, and in combination, reduce HIV risk behaviors among Salvadoran crack users.

NCT ID: NCT01043029 Completed - Clinical trials for Diabetes Mellitus Type 2

A Study of Aleglitazar in Type 2 Diabetes Patients With Moderate Renal Impairment

Start date: May 2010
Phase: Phase 2
Study type: Interventional

This multi-center, randomized, double-blind, active controlled, parallel-group study in type 2 diabetes patients with moderate renal impairment will evaluate the effect on renal function and the safety and tolerability of aleglitazar compared with pioglitazone. Patients will be randomized to receive either 150 mcg aleglitazar or 45 mg pioglitazone as daily oral doses. In addition, a diet and exercise plan will also be implemented during the anticipated time on study treatment of 52 weeks. The target sample size is 200-400 patients.

NCT ID: NCT00946218 Completed - Dengue Fever Clinical Trials

Diagnosis and Characterization of Dengue Fever in Children

Start date: July 2009
Phase: N/A
Study type: Observational

Dengue virus is an arbovirus transmitted by mosquitoes which causes significant morbidity and mortality among children in tropical regions, especially in resource limited countries. The objective of this protocol is to compare the sensitivity and specificity of clinical gestalt and two rapid antigen tests for dengue virus and to compare the gene expression of leukocytes in distinct dengue fever disease phenotypes module-based RNA microarray technology.

NCT ID: NCT00932802 Completed - Bronchitis, Chronic Clinical Trials

Greatest International Antiinfective Trial With Avelox

GIANT
Start date: February 2004
Phase: N/A
Study type: Observational

The observation period for each patient covered an initial treatment period with Avelox® plus optional 2 long-term follow-up periods (6 and 12 months).For each patient, the physician documented data at any initial visit (baseline) and at least one short-term follow-up visit (=initial treatment period).Optionally, long-term follow-ups (6 and 12 months) were documented, and a patient questionnaire was filled in.

NCT ID: NCT00751803 Completed - Migraine Disorders Clinical Trials

BI 44370 TA in Acute Migraine Attack

Start date: August 2008
Phase: Phase 2
Study type: Interventional

The objective of this trial is to assess the safety, tolerability, and efficacy of three doses of BI 44370 TA in the treatment of patients with an acute migraine attack and headache pain of moderate or severe intensity, compared to placebo and an active comparator.

NCT ID: NCT00625599 Completed - Osteoporosis Clinical Trials

Fractures in the Elderly Population of El Salvador at Hospital Zacamil: Exploring Knowledge, Causes, Risk Factors, and Outcomes

Start date: January 2008
Phase:
Study type: Observational

As the population's life expectancy increases, fractures among the elderly in El Salvador are also increasing. There is currently limited data specific to the incidence and cause of fractures in the elderly within developing countries, such as El Salvador. The problem of inadequate knowledge pertaining to bone health and osteoporosis among the elderly is contributing to this aging population's health issues. The purpose of this study is to investigate the incidence, prevalence, and risk factors effecting elderly patients admitted for fractures at the Hospital Zacamil in San Salvador, El Salvador. The study will also assess the current knowledge in two distinct populations on bone health and osteoporosis. The first population will be the patients over the age of 45 that present to Hospital Zacamil with acute fractures and are consulted by the department of orthopedics. The second population will consist of students at the Evangelical University over the age of 18 in non-medial track studies. All individuals will have to accept the invitation to participate in the study. In addition, educational materials will be developed on the prevention of fractures for medical professionals and for the elderly in El Salvador. The study objectives will determine incidence and prevalence of elderly fractures of patients over the age of 45 at Hospital Zacamil. Secondly, the study will look at demographic information, prevalent causes of fractures, treatment of the fractures, morbidity and mortality, and any complications that may arise in the fracture patients prior to their discharge from the hospital. Thirdly, the study will seek out the current level of knowledge on bone health, osteoporosis, and fracture prevention in the young, educated Salvadorians and patients over the age of 45 at Hospital Zacamil. Fourthly, the study will address the benefits of the information gained by use of educational materials with the patients and doctors of El Salvador. Hypothesis One: Fractures of the elderly at Hospital Zacamil are significantly associated with occurring at the hip, wrist, and vertebra in comparison to other fracture locations.