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NCT00839436
Background: * Idiopathic CD4 lymphocytopenia (ICL) is a condition in which patients have low levels of T cells, a type of white blood cell that helps fight infection. Animal studies have shown that an experimental drug Interleukin 7 (IL-7), which is named CYT107, can increase the number and function of T cells. CYT107, however, has not been used in people with ICL. Objectives: * To determine the safety of CYT107 in people with ICL. * To determine whether CYT107 will increase the number and function of T cells in people with ICL. Eligibility: * Patients 18 years of age and older diagnosed with ICL and who are at risk of becoming sick because of this condition are eligible for this study. In addition, patients must not be pregnant, or have other illnesses that would cause low CD4 T cell counts, such as human immunodeficiency virus (HIV) or human T-lymphotrophic virus (HTLV) infection. Design: * The initial screening visit will include the following examinations and tests: * A complete physical exam and medical history * Blood analysis, including CD4 T cell count; complete blood count and additional blood tests to determine clotting ability and blood composition; thyroid, liver, kidney, and pancreatic function tests; HIV and HTLV tests; and tests for anti-IL-7 antibodies that block normal IL-7 activity * Routine urine test * Urine or blood pregnancy test for women * Chest X-ray * Electrocardiogram * Spleen ultrasound. * The baseline visit will include blood tests to determine levels of each of the major types of antibodies, a test of genetic background, and more detailed CD4 and protein analysis. In addition, leukapheresis (a procedure to collect large numbers of immune cells without red blood cells) will be done. Participants will also have the option of having colon and lymph node biopsies. * The schedule will be as follows: * Weeks 1, 2, and 3 (Cycle 1): Three weekly IL-7 dosing visits. * Weeks 5, 8, and 12: Follow-up visits. * Weeks 24, 25, and 26 (Cycle 2): Three more weekly IL-7 dosing visits. * Weeks 28, 31, and 35: Follow-up visits. * Week 48: End of study visit. * Tests conducted before getting IL-7 will be repeated during the IL-7 cycles and follow-up visits to compare with earlier values. Optional colon and lymph node biopsies done at baseline will be repeated 1 6 weeks prior to Cycle 2 and 1 6 weeks prior to Week 48.
NCT00437073
This study is for patients with ErbB2 overexpressing breast cancer that has spread to the brain and is still progressing there even after radiation treatment using WBRT (whole brain radiotherapy) or SRS (stereotactic radiosurgery) to the brain. The study will determine how safe and effective lapatinib is when given in combination with capecitabine to treat patients with ErbB2 overexpressing breast cancer that has spread to the brain. Lapatinib is an oral drug that will be taken every day. Tests for safety and efficacy will be performed regularly during the course of the study.
NCT02575157
Bisphosphonates (BP) are widely used in the prevention and treatment of osteoporosis in postmenopausal women and older men. Recently, there has been concern about the risk of adverse events after several years of using these agents. This has resulted in a publication from the Food and Drug Administration that suggested that, for many individuals, a holiday from bisphosphonates might be considered after 4-5 years of continuous use. In that publication there was little, if any, guidance on how clinicians should proceed after the holiday is initiated.
NCT00103142
RATIONALE: Vaccines made from a gene-modified virus and a person's white blood cells may make the body build an effective immune response to kill tumor cells. Biological therapies, such as Granulocyte-macrophage colony-stimulating factor (GM-CSF), may stimulate the immune system in different ways and stop tumor cells from growing. Combining different types of biological therapies may kill more tumor cells. PURPOSE: This randomized phase II trial is studying giving vaccine therapy together with dendritic cells to see how well it works compared to giving vaccine therapy together with GM-CSF in treating patients with liver or lung metastases from colorectal cancer removed by surgery.
NCT01494259
This double-blind, randomized, controlled clinical trial comparing patient-reported pain and pain medication/narcotic use between patients randomized to treatment (bupivacaine) or placebo (saline) delivered via pain pump to the mastectomy site. Candidates will have chosen to have a mastectomy on one side immediately followed with tissue expander placement breast reconstruction. Patients will be randomized 1:1 to bupivacaine- (treatment) or saline-(placebo) filled percutaneously-placed pain pumps; neither the participants nor the study staff will know participants' treatment. Data on patient-perceived pain and pain medication use will be collected before surgery, during surgery, and after surgery on Days 1, 2, 3, 7, and 90, and at Years 2 and 4 by phone. The investigators hypothesize that patients randomized to the treatment (bupivacaine) group will have significantly lower pain scores and use less pain medicine than patients who receive placebo during the first 90 days following their surgery. The Year 2 and Year 4 follow-ups are included as tertiary endpoints to capture differences in chronic pain, and patients will be asked to complete the same questionnaires as at the Day 90 follow up.
NCT01280123
This is a multi-center, double-blind, placebo controlled clinical trial of two dosages of oral pioglitazone (15 milligram(mg) and 45 milligram (mg)) for safety, tolerability, and futility. Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day for at least 8 weeks but no more than 8 months, will be randomized to one of two dosages of oral pioglitazone (15 mg and 45 mg) or matching placebo. The study will measure disease progression by the change in total Unified Parkinson's Disease Rating Scale (UPDRS) score between the baseline visit and 44 weeks.
NCT00373191
RATIONALE: Collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. PURPOSE: This laboratory study is looking at the effects of surgery, radiation therapy, chemotherapy, and hormone therapy on biomarkers in women with stage I, stage II, stage III breast cancer, or ductal carcinoma in situ that can be removed by surgery.
NCT01727713
The goal of the current trial is to determine safety of Once-daily aripiprazole in reducing Total Tic Severity in children and adolescents with Tourette's Disorder.
NCT01262456
The purpose of this trial was to confirm/establish long-term safety and efficacy of desmopressin orally disintegrating tablets at dose levels of 50 μg and 75 μg and to further evaluate the safety of an efficacious higher dose level of 100 μg in males with nocturia.
NCT01007292
The purpose of this study is to evaluate response rate, survival, safety and tolerability of YM155 given in combination with rituximab in subjects with Non-Hodgkin's Lymphoma.
NCT01150357
This double-blind 8 week study will evaluate dose response, efficacy (blood pressure lowering effect) and safety of aliskiren in children 6 - 17 years old with hypertension at low, mid and high weight-based doses. The low dose ranges from 6.25 mg to 25 mg of aliskiren, the mid dose ranges from 37.5 mg to 150 mg of aliskiren and the high dose ranges from 150 mg to 600 mg of aliskiren. This study is being conducted to support monotherapy registration of aliskiren for the treatment of hypertension in children 6-17 years of age.
NCT00022074
RATIONALE: Gabapentin may be effective for the control of hot flashes. It is not yet known if gabapentin is effective in treating hot flashes. PURPOSE: Randomized clinical trial to study the effectiveness of gabapentin in controlling hot flashes in women who have breast cancer.
NCT00020657
RATIONALE: Antiemetic drugs may help to reduce or prevent nausea and vomiting in patients being treated with chemotherapy. PURPOSE: This randomized phase III trial is comparing how well different antiemetic drugs work in preventing delayed nausea after chemotherapy in patients who have cancer.
NCT01922089
The purpose of this study is to assess the safety and tolerability of initiating LCZ696 in heart failure patients with reduced ejection fraction (HF-rEF) using conservative (reaching target dose over 6 weeks) and condensed (reaching target dose over 3 weeks) up-titration regimens.
NCT02212106
This is a study to assess the safety of a bioCSL split virion, inactivated Trivalent Influenza Virus vaccine containing the 2014/2015 Northern Hemisphere strains of vaccine in children aged 5 years to less than 9 years. Comparison will be made to a licensed Quadrivalent Influenza Virus vaccine that complies with the FDA recommendations for the 2014/2015 influenza season in the US.
NCT00031837
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Anticoagulants such as dalteparin may help prevent blood clots in patients being treated with gemcitabine for unresectable or metastatic pancreatic cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine with or without dalteparin in treating patients who have unresectable or metastatic pancreatic cancer.
NCT02025647
Innerview can address some of the challenges of integrating mental health and primary care by accurately and reliably collecting mental health evidence and activities directly from patients, and then organizing and automating that evidence and activity into reports for providers and care teams that support diagnosis, treatment planning and monitoring of the mental health issues within a practice population.
NCT00428168
This is a randomized, double-blind, placebo-controlled, multicenter, multinational study. Approximately 78 subjects (39 per treatment group) will be randomized into this 16 week study. A screening visit will be used to determine subject suitability for inclusion in the trial. Within 7 days of the screening visit, subjects who meet all inclusion criteria and none of the exclusion criteria will be randomly assigned to 1 of the following 2 treatment groups: * Olanzapine OD plus betahistine 24 mg BID (48 mg/day total), * Olanzapine OD plus matching placebo BID. Double-blind treatment will continue for 16 weeks. During this period, olanzapine dosage will be determined according to the discretion of the treating physician. In addition, 5 study visits (at 2, 4, 8, 12, and 16 weeks) will take place. Study medication (betahistine or matching placebo) will be administered BID (in the morning and together with olanzapine in the evening). The primary statistical hypothesis to be tested is that the mean change from Baseline to Week 16 will be different between the treatment and placebo groups
NCT00983957
The purpose of this study is to assess the effect of BMS-790052 on the pharmacokinetics of Ortho Tri-Cyclen® in healthy female subjects.
NCT01872078
To assess the effects of AZD4901 when given in multiple doses to females with Polycystic Ovary Syndrome