Clinical Trials Database

Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Sarcoma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of high-dose combination chemotherapy and peripheral stem cell transplantation in treating patients who have advanced or...

Pamidronate to Treat Osteogenesis Imperfecta in Children

This study will evaluate the effect of pamidronate-a drug that decreases bone resorption (breakdown)-on osteogenesis imperfecta. This is a genetic disorder of collagen, the major protein in bone. The abnormal collagen causes weak bones, and children with severe osteogenesis imperfecta sustain many fractures throughout their lives. They also have growth deficiency, curvature of the spine, crumbling teeth, hearing loss, easy bruising and heart and lung problems. The study wil...

Immune Response to Hepatitis C Virus

This study will identify and characterize immune factors involved in hepatitis C infection and elimination of the virus. Individual responses to hepatitis C infection vary; some people are able to eliminate the virus, whereas others remain chronically infected. This study may identify factors important in preventing infection that may be of help in developing a vaccine or more effective treatments. People over 18 years old who have been exposed to hepatitis C virus may parti...

Positron Emission Tomography (PET) to Study Brain Signaling

This study uses positron emission tomography (PET) to examine brain function and signaling involving phospholipids, and to see how signaling is related to blood flow. Much of the brain is composed of fatty molecules called phospholipids. These molecules are involved in the way brain cells signal each other to direct brain function. Brain disease may change phospholipids and disturb brain structure and signaling. Studies of brain phospholipid composition and metabolism may help...

Imiquimod Cream in Treating Patients With Basal Cell Skin Cancer

RATIONALE: Biological therapies, such as imiquimod cream, work in different ways to stimulate the immune system and stop tumor cells from growing. PURPOSE: This randomized phase I trial is studying how well imiquimod cream works in treating patients with basal cell skin cancer.

A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-181)(COMPLETED)

The purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following dental surgery.

Effects of Exenatide and Insulin Glargine in Subjects With Type 2 Diabetes

This Phase 3, open-label, multicenter study is designed to compare the effects of exenatide and insulin glargine (Lantus® injection) on beta-cell function in patients with type 2 diabetes mellitus using metformin.

Open-label Follow up Trial to Evaluate Long-term Safety and Efficacy of Brivaracetam in Subjects Aged 16 Years or Older Suffering From Epilepsy.

This trial, evaluating the long-term safety and tolerability of brivaracetam will provide subjects suffering from epilepsy, who may have benefited from brivaracetam as adjunctive treatment, the opportunity to receive open label brivaracetam treatment.

Vorinostat and Gemcitabine in Treating Patients With Metastatic or Unresectable Solid Tumors

This phase I trial is studying the side effects and best dose of vorinostat and gemcitabine in treating patients with metastatic or unresectable solid tumors. Drugs used in chemotherapy, such as vorinostat and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to th...

Body Heat Content and Dissipation in Obese and Normal Weight Adults

This study will investigate how different parts of the body lose body heat and will measure the heat released by specific areas such as the limbs and abdomen. Animal studies suggest that dissipation of body heat may affect energy expenditure, and therefore, body weight. This study will explore the relationship between obesity and heat in humans. Healthy people 18 years of age and older who are of normal weight or who are obese and who are not taking medications for obesity-rel...

Vaccine Therapy in Treating Patients Who Are Being Considered For a Solid Organ Transplant and Are at Risk For Post-Transplant Lymphoproliferative Disorder

RATIONALE: Vaccines made from a person's white blood cells may help the body build an effective immune response. PURPOSE: This phase I trial is studying the side effects of vaccine therapy in treating patients who are being considered for solid organ transplant who are at risk for post-transplant lymphoproliferative disorder.

Study of Markers of Cosmic Radiation Exposure and Effect Among Flight Crews

Ionizing radiation efficiently induces chromosomal aberrations (CA) and several studies of CA have now been conducted among small groups of flight crews. However, most of the studies only evaluated the unstable aberrations that reflect recent exposures, but not long-term cumulative cosmic radiation exposure. Chromosome painting by fluorescence in situ hybridization (FISH) is a widely used and established cytogenetic method for detecting stable aberrations such as translocatio...

A Type 2 Diabetes Study of the Longer-Term Glycemic Effect of AVANDAMET vs. Metformin

This study will evaluate the longer-term glycemic effect of two medicines approved for initial treatment of type 2 diabetes. The study consists of a 2 week screening period (2 study visits), followed by an 80 week double-blind treatment period (11 study visits). Also, a sub-study was included to look at changes in bone mineral density (BMD) at the lumbar spine.

Dutasteride in Treating Patients With Recurrent Prostate Cancer That Did Not Respond to Androgen-Deprivation Therapy

RATIONALE: Dutasteride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well dutasteride works in treating patients with recurrent prostate cancer that did not respond to androgen-deprivation therapy.

Brain Peripheral Benzodiazepine Receptors in Patients With Multiple Sclerosis

This study will use positron emission tomography (PET) to measure a brain protein called peripheral benzodiazepine receptor (PBR) in patients with multiple sclerosis. PBR is created during the inflammation process, and brain inflammation is a key feature of multiple sclerosis (MS). PBR usually affects one type of brain cell, but it can also cause damage to surrounding areas of the brain in patients with MS. PET studies of PBRs and brain inflammation may help elucidate the role...

Anxiety Self-Management for ICU Patients Receiving Mechanical Ventilation

The purpose of this study is to test whether patients who are receiving mechanical ventilation in the ICU who listened to preferred, relaxing music whenever they desire for as long as they desire will have less anxiety, receive fewer medications, stay in the ICU for a shorter time, and experience less stress than patients who do not listen to music.

Treatment for Growth Failure in Patients With X-Linked Severe Combined Immunodeficiency: Phase 2 Study of Insulin-Like Growth Factor-1

This study will evaluate the safety and effectiveness of insulin-like growth factor-1 (IGF-1) to treat patients with X-linked severe combined immunodeficiency (XSCID). Those who have XSCID lack white blood cells that protect their bodies from invasion by all types of germs. IGF-1 is the main hormone responsible for the body's growth and metabolism. As a medication, IGF-1 is Increlex[(Trademark)] (mecasermin), Patients ages 2 to 20 who have not yet begun puberty, have a diagnos...

Collection of Samples and Data for the National Marrow Donor Program Repository

This protocol will collect blood samples and medical information from patients who have had a bone marrow transplant using cells from an unrelated donor identified through the National Marrow Donor Program (NMDP). The NMDP has two programs in which patients can participate: the Research Database Program and the Research Sample Repository. Patients who have received a bone marrow transplant at the NIH or other institution from an unrelated donor affiliated with the NMDP may be...

Evaluation of M118 in Percutaneous Coronary Intervention (EMINENCE)

The primary objective is to evaluate the safety and feasibility of using M118 as an anticoagulant in the target population of subjects with stable coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI). The secondary objectives are to evaluate the effect of M118 on procedural indices including procedure success, abrupt closure, post-procedure TIMI flow, and catheter thrombus. Substudy Primary Objective The primary objective of the substudy is to cha...

Biomarkers in Phototherapy of Barrett's Esophagus

This study is being done to find out if Photodynamic Therapy (treatment with a red light and a drug called photofrin) or Radiofrequency ablation works the same for patients who have biomarkers (abnormalities in molecules of cells that may or may not help predict cancer) present in their Barrett's esophagus as for patients who do not have biomarkers.

Quality of Life and Pain Outcomes Following Video-Assisted Thoracic Surgery (VATS) Anatomic Lung Resection Versus Thoracotomy and Anatomic Lung Resection

The purpose of this study is to see if different types of surgery for lung cancer have different effects on quality of life and pain. What we learn from this study may help us find new ways to improve the quality of life of lung cancer patients who have surgery.

Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis

The primary objective is to demonstrate that early intervention with Teriflunomide in patients presenting with their first clinical episode consistent with MS prevents or delays conversion to clinically definite Multiple Sclerosis [MS]. The secondary objectives are: - to demonstrate that Teriflunomide prevents or delays conversion to MS based on the revised McDonald Criteria and delays disability progression, - to evaluate the long-term safety of Teriflunom...

Initial Local Anesthetic Dose With Continuous Interscalene Analgesia

Objective: To determine a minimally effective initial local anesthetic bolus required to provide satisfactory analgesia using continuous brachial plexus infusion following arthroscopic shoulder surgery using a double-blind, randomized, study comparing 3 initial doses.

Oral Versus Intravenous Rehydration for Prevention of Dehydration in Premature Babies, During the First Days of Life.

This prospective randomised study comparing administration of a hypo-osmolar oral hydration solution with the classical hydration via IV (intravenous) infusion in premature infants of more than 32 weeks GA (gestational age) aims to determine whether administration of a hypo-osmolar oral hydration solution is as efficient as intravenous infusion.

Pilot Trial to Assess Effect of CNI Conversion of Efalizumab on T Reg Cells

The purpose of this pilot trial is to determine whether a conversion from calcineurin inhibitors (CNI) and mycophenolate mofetil (MMF) to a regimen consisting of efalizumab and sirolimus is associated with an increase in T regulatory cells, white cells that control the immune system and can prevent autoimmune diseases like arthritis or rejection of foreign organs,and does not result in an increase in acute rejection.