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NCT ID: NCT01666704 Withdrawn - Clinical trials for Atherosclerotic Cardiovascular Disease

Proof of Concept Study of BMS-823778 to Assess the Effects on Atherosclerosis

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

The purpose of the study is to assess the effect of BMS-823778 on reducing atherosclerotic plaque inflammation

NCT ID: NCT01757327 Withdrawn - Breast Neoplasms Clinical Trials

LDE225 in Treating Patients With Stage II-III Estrogen Receptor- and HER2-Negative Breast Cancer

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

This randomized phase II trial studies the effects of erismodegib (LDE225) on disseminated tumor cells (DTCs) in patients with stage III-III estrogen receptor (ER)-negative and human epidermal growth factor receptor 2 (HER2)-negative breast cancer. The presence of DTCs after completing treatment for breast cancer may be linked to recurrence of the disease. LDE225 may eliminate DTCs in bone marrow and reduce the risk of recurrence.

NCT ID: NCT01784081 Withdrawn - Pancreas Cancer Clinical Trials

Integrating Palliative Care and Modern Palliative Care Tools Into the Care of Patients With Pancreas Cancer

iPC3
Start date: April 2014
Phase: N/A
Study type: Observational

The main purpose of this study is to evaluate the acceptance by patients with metastatic pancreas cancer of integrating palliative care with usual cancer treatment. Palliative care intervention will involve use of pancreas cancer-specific decision aides (iPC3)about prognosis, treatment choices, and advance care planning for patients facing a treatment decision as well as symptom assessments. We hypothesize that palliative care consultations with iPC3 will be accepted, symptoms can be diminished, information can be received in a way that improves choices, and that the quality of care can be improved.

NCT ID: NCT01810731 Withdrawn - HIV Clinical Trials

Safety and Immunogenicity Study of Influenza Vaccines in HIV-infected and HIV-uninfected Pregnant Women in Western Kenya

Start date: April 2014
Phase: Phase 2/Phase 3
Study type: Interventional

In 2012, the WHO Strategic Advisory Group of Experts (SAGE) concluded that pregnant women are the most important risk group for season influenza vaccination based upon "compelling evidence of substantial risk of severe disease in this group and evidence that seasonal influenza vaccine is safe and effective in preventing disease in pregnant women as well as their young infants, in whom disease burden is also high". Recent data from Kenya, similarly suggest rates of influenza-associated hospitalizations in children under age 1 to be as high, or higher, than those observed in the United States. However, TIV may have reduced immunogenicity in HIV-infected adults, and HIV infection has been shown to reduce placental transfer of both tetanus and measles antibodies. Therefore, we propose to conduct a double-blind randomized controlled trial of influenza vaccines stratified by HIV status in up to 720 pregnant women in their second and third trimesters and their infants residing in health and demographic surveillance sites (HDSS) in Nyanza Province, Western Kenya. We propose to assess the safety, immunogenicity, and efficacy of standard dose QIV and double dose QIV in HIV-infected and HIV-uninfected pregnant women. Findings will inform maternal influenza vaccination policies in Kenya and other African countries.

NCT ID: NCT01825239 Withdrawn - Cardiomyopathy Clinical Trials

Virtual LV Lead Navigation in Patients With Ischemic Cardiomyopathy

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

Presently, the left ventricular lead is placed in a similar position for all patients. It is not known whether placing this lead in different positions in the heart will make the heart pump better. In this study, the investigator will collect measurements of the heart's electrical activity during an Electrophysiology Study (EP study or EPS). The hope is that these measurements will provide the know how to develop an individualized left ventricular lead placement "prescription" for patients referred for left ventricular lead pacing.

NCT ID: NCT01837927 Withdrawn - Clinical trials for Pulmonary Disease, Chronic Obstructive

Efficacy of NVA237 (50 μg o.d) Using Tiotropium (5μg μg o.d) as Active Control in COPD Patients.

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

This study will assess the Efficacy of NVA237 (50 μg o.d) using tiotropium (5μg μg o.d) as active control in COPD patients.

NCT ID: NCT01865188 Withdrawn - Hypertension Clinical Trials

Study of the Efficacy and Safety of LCZ696 Alone and in Combination With Amlodipine in Patients With Hypertension

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

To evaluate the blood pressure lowering effect and safety of LCZ696 when given alone and in combination with amlodipine in patients with essential hypertension.

NCT ID: NCT01868685 Withdrawn - Clinical trials for Mechanical Ventilation

Study of Muscle Effects of BYM338 in Mechanically Ventilated Patients

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

The purpose of this study is to evaluate the effect of BYM338 on muscle mass and function in Group III failure to wean patients, as compared to placebo controls.

NCT ID: NCT01904786 Withdrawn - Clinical trials for Newborn Hypoxic Ischemic Encephalopathy

Melatonin Treatment for Newborn Infants With Moderate to Severe Hypoxic Ischemic Encephalopathy

Start date: April 2014
Phase: Phase 1
Study type: Interventional

During the birth process certain conditions can cause oxygen delivery and/or blood flow to the baby's brain to become interrupted. This can cause permanent brain damage. Brain damage occurs in two phases. The first occurs at the time of injury when brain cells in the affected area 'die'. There is nothing that can be done about this. The second phase of injury occurs over the next few days. This second phase is caused by inflammation and release of toxic chemicals from the injured site. Cooling the baby to a temperature of 92.5° F, for 3 days has been shown to reduce the second phase of injury and bran death. All babies will receive the benefit of cooling. Although cooling helps it does not completely stop the second phase of injury. Melatonin is a naturally occurring hormone that is produced by the brain, and helps regulate the sleep-wake cycle. It has the potential to stop the second phase of brain injury by inhibiting inflammation and release of toxic chemicals. The reason for this research is to find out if melatonin can or cannot improve the outcome of babies with this kind of brain damage. Every baby enrolled in the study has a 50:50 chance of getting melatonin. A total of six doses of medicine will be given. The baby's brain function will be assessed by an EEG, brain oxygen monitoring, and a neurologic examination at 18 months of life. All of these are routinely used as part of standard care for patients with this kind of problem. The only difference is that half the babies enrolled in the study will get the drug called melatonin and the other half will receive placebo. The dose of melatonin being used in the study is higher than the amount normally produced by the body. No side-effects of this dose have been reported in other research studies using melatonin in newborn and premature babies.

NCT ID: NCT01953536 Withdrawn - Breast Neoplasms Clinical Trials

Safety and Efficacy Study of Vintafolide and Vintafolide Plus Paclitaxel Compared to Paclitaxel Alone in Participants With Triple Negative Breast Cancer (TNBC) (MK-8109-004)

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

The purpose of this study is to assess the efficacy and safety of vintafolide alone compared to vintafolide plus paclitaxel and paclitaxel alone in participants with with 100% positive folate receptor (FR) triple negative breast cancer (TNBC). The primary hypothesis of this study is the vintafolide alone and/or vintafolide + paclitaxel will improve progression free survival (PFS) in participants with FR (100%) TNBC compared to paclitaxel alone.