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NCT ID: NCT01655433 Terminated - Hypothermia Clinical Trials

Evaluation of Ultrafast Hypothermia Before Reperfusion in STEMI Patients

VELOCITY
Start date: November 2012
Phase: Phase 2
Study type: Interventional

This study will look at the safety of treating patients with heart attack with mild hypothermia induced using a system of automated peritoneal lavage. The hypothesis is that the Velomedix Automated Peritoneal Lavage System can treat patients with heart attack safely and with adequate performance.

NCT ID: NCT01654562 Terminated - Choroideremia Clinical Trials

The Short-term Effects of Simvastatin on the Vision of Males Affected by Choroideremia

Start date: December 2012
Phase: Phase 1/Phase 2
Study type: Interventional

Primary objective: To examine the short-term effects of of simvastatin on the vision on males with choroideremia, evaluated by full-field scotopic threshold testing. The investigators hypothesize that they will see a reversible decrease in the dark-adapted vision in participants taking simvastatin.

NCT ID: NCT01652911 Terminated - Type I Diabetes Clinical Trials

A Phase I/II Study of the Safety and Efficacy of Sernova's Cell PouchTM for Therapeutic Islet Transplantation

Start date: June 2012
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open-label, single arm, non-randomized safety and efficacy study, where participants with Type-1 diabetes will receive the Sernova Cell Pouch™ implanted in the subcutaneous site, two to approximately twelve weeks prior to transplantation of islets into the Cell Pouch™. The primary objective of this study is to assess the safety of the Sernova Cell Pouch™ in adult participants with Type-1 diabetes receiving islet transplantation for the first time. Secondary objectives are the following: 1. To determine the proportion of subjects implanted with the Cell Pouch™ and transplanted with islets into the Cell Pouch™ who achieve and maintain insulin independence after islet transplantation. 2. To obtain preliminary data on the efficacy of the Cell Pouch™ to maintain adequate immunological protection against both allo- and autoimmunity of islet transplant recipients. 3. To determine through retrospective analysis comparative metabolic function and engraftment efficiency using patients undergoing standard intraportal islet transplantation under the current alemtuzumab standard of care protocol.

NCT ID: NCT01651273 Terminated - Clinical trials for Hypercholesterolemia

A Safety Study of BMS-852927 in Subjects With Hypercholesterolemia

Start date: November 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety of BMS-852927 after 28 days of dosing in patients with high cholesterol.

NCT ID: NCT01650805 Terminated - Clinical trials for Chronic Myeloid Leukemia

Ponatinib in Newly Diagnosed Chronic Myeloid Leukemia (CML) (EPIC)

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

The purpose of this study is to compare the efficacy of ponatinib and imatinib in patients with newly diagnosed chronic myeloid leukemia (CML) in the chronic phase.

NCT ID: NCT01650740 Terminated - Clinical trials for Major Depressive Disorder

Study of Placebo Without Deception Versus Standard Antidepressant for Major Depressive Disorder

Start date: August 2012
Phase: N/A
Study type: Interventional

In recent years, there has been growing evidence that antidepressants are only marginally effective compared to placebo for mild to moderate depression. In other words, although many people improve when they take antidepressant medications, almost as many get better with placebo pills. One possible solution to this problem would be to give patients a trail of a placebo prior to giving them an antidepressant, however there are ethical issues with doing this deceptively. New evidence from other placebo-responsive disorders such as irritable bowel syndrome shows that people may benefit from placebos even if they know they are taking them. This study aims to determine whether giving placebos without deception to people with major depressive disorder followed by the option to switch to an antidepressant is an effective strategy. There will be 3 groups of subjects. The first group is a standard treatment arm and will receive duloxetine, an antidepressant. The second will be given a placebo with the option to switch to duloxetine if they do not improve. The third group will receive supportive clinical visits the option to switch to duloxetine if they do not improve. This design will allow us to determine whether a sequenced treatment of a placebo without deception and then the option to switch to an antidepressant is a viable strategy. It will also help us to determine to what degree the benefit comes from the ritual of receiving and taking the placebo tablet versus the benefit of visits with a doctor alone. The primary hypothesis is that there will be a less than 5% difference between response rates after 12 weeks in the sequenced placebo-then-antidepressant treatment group (both subjects who have remained on placebo as well as those who have switched to the antidepressant will be considered as one group) compared to the immediate antidepressant therapy group.

NCT ID: NCT01648959 Terminated - Clinical trials for Complex Partial Seizures

Intra Cranial EEG Activity During Dexmedetomidine Sedation

Start date: July 2012
Phase:
Study type: Observational

Various parts of the brain are sensitive to various anesthetics.We like to study the effect of dexmedetomidine on the different parts of the brain in patients who are coming for DBS electrode removal under sedation.

NCT ID: NCT01648218 Terminated - Clinical trials for Post-Transplant Glucocorticoid Induced Diabetes

Insulin Therapy for Post-transplant Glucocorticoid Induced Hyperglycemia

PTHG
Start date: August 2012
Phase: Phase 4
Study type: Interventional

No consensus guidelines exist for management of post-transplant glucocorticoid induced hyperglycemia, but most published reviews recommend insulin as first line therapy. A variety of insulin regimens have been proposed, including mealtime short-acting regular or analog insulin, once daily neutral protamine hagedorn (NPH) insulin, pre-mixed insulin, or basal insulin alone such as glargine or detemir. However, no randomized trial has ever examined different insulin regimens to determine which most effectively controls post-transplant steroid-induced hyperglycemia. Consequently, the proposed study intends to examine three commonly used insulin regimens used for managing post-transplant once-daily glucocorticoid-induced hyperglycemia to determine which is most effective: - Group 1: Intermediate-acting (NPH) insulin at breakfast - Group 2: Short-acting insulin (regular or aspart) before meals - Group 3: Insulin glargine at breakfast Question/Hypothesis: Among three commonly used insulin regimens, which is most effective for managing post-transplant once-daily glucocorticoid-induced hyperglycemia?

NCT ID: NCT01647789 Terminated - Prostatic Neoplasms Clinical Trials

A Study of Oral CFG920 in Patients With Castration Resistant Prostate Cancer

Start date: December 4, 2012
Phase: Phase 1
Study type: Interventional

This study was supposed to have assessed the safety and preliminary antitumor activity of CFG920, a new CYP17 inhibitor in castration resistant prostate cancer patients who are abiraterone naive or abiraterone resistant. The study was terminated after Phase I (dose escalation phase) and Phase II part of the study was not initiated. Novartis voluntarily terminated this study and hence stopped further enrollment of patients into this study. As the decision to terminate the study was not due to any safety issues, the patients enrolled in the study by the time of this decision were allowed to continue with treatment per the protocol.

NCT ID: NCT01647334 Terminated - Clinical trials for Non Small Cell Lung Cancer

Shrinking Target Adaptive Radiotherapy for Locally Advanced Non-Small Cell Lung Cancer

Start date: January 2013
Phase: N/A
Study type: Interventional

This study aims to use a type of radiation (adaptive radiotherapy) to deliver curative-intent treatment to patients with non-small cell lung cancer, whose tumors would otherwise be too large for standard curative treatment. The study will use adaptive radiotherapy to achieve these goals. Adaptive radiotherapy is a process whereby treatment plans are modified during the course of treatment due to patient and tumor variations (ie. weight loss or tumor shrinkage). This may allow for dose escalation, while limiting the side effects.