sssohrab/ct-dosing-errors-benchmark · Datasets at Hugging Face

[ 2, 3 ]

43

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

Treatment of HIV-infected patients involves combining drugs from different classes of anti-HIV drugs. One preferred regimen for adults is 2 nucleoside reverse transcriptase inhibitors (NRTIs) and 1 protease inhibitor (PI). For children, this regimen may be too complicated or the drugs may be too difficult to take by mouth. The purpose of this study was to determine the long-term safety and effectiveness of daily didanosine (ddI), efavirenz (EFV), and emtricitabine (FTC) in pediatric patients who had taken few or no anti-HIV drugs.

Anti-HIV treatment options are limited for pediatric patients because combination therapies recommended for adults may not be appropriate for children or adolescents. Few PIs are available in formulations appropriate for pediatric patients, and complex dosing schedules and food requirements may be detrimental to treatment adherence. A once-daily regimen of the NRTIs ddI and FTC and the nonnucleoside reverse transcriptase inhibitor (NNRTI) EFV has been shown safe and well tolerated in adults. This Phase I/II open label study evaluated the long-term safety and efficacy of a ddI, FTC, and EFV regimen in pediatric patients. All study patients were either absolutely naive to antiretroviral therapy or had received less than or equal to 56 days perinatal prophylaxis or less than 7 days of cumulative antiretroviral therapy prior to study entry, and had a plasma screening plasma HIV-1 RNA levels \>= 5000 copies/mL. This study was written to characterize the disposition of FTC, determine the PK data for ddI-EC QD, comparing the bio-availability of the enteric coated formulation with ddI pediatric powder for oral solution, and to provide insight into the age related pharmacokinetics differences observed in this and other studies. HIV infected pediatric patients were stratified into three age Groups: Group 1: 90 days to \<3 years of age; Group 2: 3 years to 12 years of age (inclusive); and Group 3: 13 to 21 years of age (inclusive). The initial study doses for the triple drug regimen was FTC, 6 mk/kg up to a maximum of 200 mg once daily, for EFV, the dose for age Group 1 was determined in PACTG 382 and dose adjusted for body size, and the doses for age Groups 2 and 3 were defined in the dosing table of the protocol of up to a maximum of 600 mg once daily as a capsule or 720 mg as an oral solution; for ddI, 240 mg/m2 up to a maximum of 400 mg once daily. Comparison of age groups was not required as per the protocol. Patients were followed for a maximum of 192 weeks; all patients were to receive ddI, EFV, and FTC together once daily. Study visits occurred at study entry, Weeks 2,and 4, and every 4 weeks thereafter. Blood collection, medical history assessment, and a physical exam occurred at all visits; urine collection occurred at selected visits. Intensive pharmacokinetic (PK) studies was done at Weeks 2 and 12 to determine if dose adjustments were required for any of the drugs. If virologic failure was determined, PK studies was repeated 4 weeks after adjustments in therapy. Parents or guardians were asked to complete treatment adherence questionnaires at some visits. Some patients were also asked to participate in an additional PK study after Week 16 or week 96.

HIV Infections

Didanosine Drug Therapy, Combination Drug Administration Schedule Reverse Transcriptase Inhibitors Anti-HIV Agents Pharmacokinetics Deoxycytidine Efavirenz Treatment Naive

null

3

arm 1: Emtricitabine (FTC), Efavirenz (EFV) and Didanosine (ddI) together once daily arm 2: Emtricitabine (FTC), Efavirenz (EFV) and Didanosine (ddI) together once daily arm 3: Emtricitabine (FTC), Efavirenz (EFV) and Didanosine (ddI) together once daily

[ 0, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: Antiretroviral Didanosine (ddI) : 240 mg/m\^2 up to a maximum of 400 mg once daily intervention 2: Antiretroviral For Age Group 1 Efavirenz (EFV): dose adjusted for body size and for Age Groups 2 and 3 Efavirenz (EFV): up to a maximum of 600 mg once daily as a capsule ot 720 mg as an oral solution intervention 3: Antiretroviral Emtricitabine (FTC): 6 mg/Kg up to a maximum of 200 mg once daily

intervention 1: Didanosine (ddI) intervention 2: Efavirenz (EFV) intervention 3: Emtricitabine (FTC)

18

0

NCT00016718

[ 3 ]

17

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

This phase II trial studies how well reduced intensity donor peripheral blood stem cell (PBSC) transplant works in treating patients with de novo or secondary acute myeloid leukemia (AML) in remission. Giving low doses of chemotherapy, such as fludarabine phosphate, and total-body irradiation (TBI) before a donor PBSC transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening

PRIMARY OBJECTIVES: I. To determine if a one-year disease free survival of \>= 35% can be achieved among patients \>= 55 years old with de novo and secondary AML in first complete remission (CR1) who undergo nonmyeloablative hematopoietic stem cell transplant (HSCT) from human leukocyte antigen (HLA) identical related donors. II. To determine if a day +200 nonrelapse related mortality of \< 15% can be achieved among patients \>= 55 years old with de novo and secondary AML in CR1 who undergo nonmyeloablative HSCT from HLA identical related donors. OUTLINE: CONDITIONING REGIMEN: Patients receive fludarabine phosphate intravenously (IV) on days -4 to -2 and undergo TBI on day 0. TRANSPLANT: Patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine (CSP) orally (PO) twice daily (BID) on days -3 to 56 with taper to day 77. Patients also receive mycophenolate mofetil (MMF) PO BID on days 0-27. After completion of study treatment, patients are followed up on days 28, 56, and 84; months 6, 12, 18, and 24; and then yearly for 5 years.

Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome Adult Acute Megakaryoblastic Leukemia (M7) Adult Acute Minimally Differentiated Myeloid Leukemia (M0) Adult Acute Monoblastic Leukemia (M5a) Adult Acute Monocytic Leukemia (M5b) Adult Acute Myeloblastic Leukemia With Maturation (M2) Adult Acute Myeloblastic Leukemia Without Maturation (M1) Adult Acute Myeloid Leukemia in Remission Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Del(5q) Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) Adult Acute Myelomonocytic Leukemia (M4) Adult Erythroleukemia (M6a) Adult Pure Erythroid Leukemia (M6b) Secondary Acute Myeloid Leukemia

null

1

arm 1: CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANT: Patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients receive CSP PO BID on days -3 to 56 with taper to day 77. Patients also receive MMF PO BID on days 0-27.

[ 0 ]

6

[ 3, 0, 4, 0, 0, 3 ]

intervention 1: Undergo nonmyeloablative allogeneic PBSC transplant intervention 2: Given IV intervention 3: Undergo TBI intervention 4: Given PO intervention 5: Given PO intervention 6: Undergo nonmyeloablative allogeneic PBSC transplant

intervention 1: nonmyeloablative allogeneic hematopoietic stem cell transplantation intervention 2: fludarabine phosphate intervention 3: total-body irradiation intervention 4: cyclosporine intervention 5: mycophenolate mofetil intervention 6: peripheral blood stem cell transplantation

2

0

NCT00045435

[ 3 ]

31

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

RATIONALE: Biological therapies such as poly-ICLC use different ways to stimulate the immune system and stop tumor cells from growing. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining biological therapy with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining poly-ICLC with radiation therapy in treating patients who have newly diagnosed glioblastoma multiforme.

OBJECTIVES: * Determine the efficacy of poly ICLC and radiotherapy, in terms of total survival from date of diagnosis, in patients with newly diagnosed glioblastoma multiforme. * Determine the safety and toxicity profile of this regimen in these patients. * Determine the 12-month survival rate in patients treated with this regimen. * Assess progression-free survival at 6 months and median progression-free survival from date of diagnosis of patients treated with this regimen. * Assess response in patients treated with this regimen. * Assess changes in neurological status in patients treated with this regimen. OUTLINE: This is a multicenter study. Within 1-4 weeks after surgery, patients receive poly ICLC intramuscularly 3 times weekly (on days 1, 3, and 5). Treatment continues in the absence of disease progression or unacceptable toxicity. One week after the initiation of poly ICLC, patients undergo external beam radiotherapy once daily 5 days a week for 6 weeks. Patients are followed monthly for 1 year and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 2 years.

Brain and Central Nervous System Tumors

adult glioblastoma adult giant cell glioblastoma adult gliosarcoma

null

1

arm 1: Poly-ICLC 20ug/kg 3 times a week (Monday-Wednesday-Friday) starting one week before Radiation Therapy Intramuscular injection Drug Poly-ICLC

[ 0 ]

1

[ 0 ]

intervention 1: None

intervention 1: poly ICLC

1

San Francisco | California | United States | -122.41942 | 37.77493

0

NCT00052715

[ 3 ]

52

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

The goal of this study is to evaluate the effectiveness and safety of two antidepressants--nortriptyline and paroxetine, compared to placebo in patients with Parkinson's disease and depression.

Depression is the most common neuropsychiatric disorder found in patients with Parkinson's disease (PD). It causes immense personal suffering and is associated with increased disability and caregiver burden. Despite the adverse consequences of depression in patients with PD, there are virtually no empirical data to guide clinical treatment. This study will begin to answer some questions on the treatment of depression by testing a SSRI (selective serotonin reuptake inhibitor) antidepressant, paroxetine, a tricyclic antidepressant, nortriptyline, and placebo in a placebo-controlled trial. A total of 75 patients with PD will be randomized to each of the three arms in a balanced design.

Parkinson Disease Depression

Parkinson's disease Parkinson disease depression antidepressants nortriptyline paroxetine

null

3

arm 1: drug arm 2: drug arm 3: placebo

[ 0, 0, 2 ]

3

[ 0, 0, 10 ]

intervention 1: Paroxetine CR 12.5 - 25 mg q hs intervention 2: nortriptyline 25 - 75 mg q hs intervention 3: matching placebo

intervention 1: paroxetine intervention 2: Nortriptyline intervention 3: placebo

1

New Brunswick | New Jersey | United States | -74.45182 | 40.48622

0

NCT00062738

[ 3 ]

33

NA

SINGLE_GROUP

0TREATMENT

0NONE

true

0ALL

true

This phase II trial is studying how well giving 3-AP together with gemcitabine works in treating patients with unresectable or metastatic bile duct or gallbladder cancer. Drugs used in chemotherapy, such as 3-AP and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. 3-AP may help gemcitabine kill more cancer cells by making them more sensitive to the drug.

OBJECTIVES: I. To determine the objective response rates for the combination of triapine and gemcitabine in patients with primary tumors of the biliary ducts and gall bladder. II. To assess the toxicities and recovery from toxicities for patients with biliary duct and gall bladder tumors treated with the combination of triapine and gemcitabine. III. To determine the survival and progression free survival of patients with biliary and gall bladder tumors treated with the combination of triapine and gemcitabine. OUTLINE: This is a non-randomized, multicenter study. Patients are stratified according to bilirubin levels (normal vs abnormal). Patients receive 3-AP (Triapine) IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 1 additional course beyond CR. Patients are followed every 3 months for up to 2 years.

Stage II Gallbladder Cancer Stage IIIA Gallbladder Cancer Stage IIIB Gallbladder Cancer Stage IVA Gallbladder Cancer Stage IVB Gallbladder Cancer

null

1

arm 1: Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days

[ 0 ]

2

[ 0, 0 ]

intervention 1: Given IV intervention 2: Given IV

intervention 1: triapine intervention 2: gemcitabine

1

The Bronx | New York | United States | -73.86641 | 40.84985

0

NCT00075504

[ 3 ]

65

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

This phase II trial is studying how well giving cisplatin and etoposide together with bevacizumab works in treating patients with previously untreated extensive-stage small cell lung cancer. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or deliver tumor-killing substances to them. Giving chemotherapy with a monoclonal antibody may kill more tumor cells.

PRIMARY OBJECTIVES: I. To evaluate the combination of PE plus concurrent and sequential bevacizumab with respect to six month progression free survival in patients with previously untreated SCLC. II. To evaluate the combination of PE plus concurrent and sequential bevacizumab with respect to survival and response rate. III. To evaluate toxicity in patients with extensive small cell lung cancer, treated with the combination of PE plus concurrent and sequential bevacizumab who have received no prior systemic chemotherapy. SECONDARY OBJECTIVES: I. To determine if pre-treatment levels of plasma VEGF predict response to chemotherapy with Etoposide-Cisplatin plus concurrent + sequential bevacizumab. II. To determine if pre-treatment plasma VEGF is predictive of progression free survival and overall survival in advanced SCLC. III. To determine whether elevated plasma levels of endothelial cell-specific proteins (VCAM, E-selectin), reflective of chemotherapy or bevacizumab induced endothelial damage, are useful markers in assessing response to Etoposide/Cisplatin plus concurrent + sequential bevacizumab. IV. To determine whether pre- and post-treatment plasma levels of basic fibroblast growth factor (bFGF) is predictive of progression free survival and overall survival or predictive of response to therapy. OUTLINE: This is a multicenter study. Chemotherapy: Patients receive cisplatin IV over 30-60 minutes on day 1 and etoposide IV over 60 minutes on days 1-3. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Bevacizumab therapy: Beginning concurrently with chemotherapy, patients receive bevacizumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 17 courses (1 year) in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks for up to 3 years from study entry.

Extensive Stage Small Cell Lung Cancer

null

1

arm 1: Chemotherapy: Patients receive cisplatin IV over 30-60 minutes on day 1 and etoposide IV over 60 minutes on days 1-3. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Bevacizumab therapy: Beginning concurrently with chemotherapy, patients receive bevacizumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 17 courses (1 year) in the absence of disease progression or unacceptable toxicity.

[ 0 ]

4

[ 0, 0, 2, 10 ]

intervention 1: Given IV intervention 2: Given IV intervention 3: Given IV intervention 4: Correlative studies

intervention 1: cisplatin intervention 2: etoposide intervention 3: bevacizumab intervention 4: laboratory biomarker analysis

1

Boston | Massachusetts | United States | -71.05977 | 42.35843

0

NCT00079040

[ 3 ]

23

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

2MALE

null

This phase II trial is studying how well fenretinide works in treating patients with biochemically (rising PSA level) recurrent hormone-naïve (no previous hormone therapy) prostate cancer. Drugs used in chemotherapy, such as fenretinide, work in different ways to stop tumor cells from dividing so they stop growing or die

PRIMARY OBJECTIVES: I. To assess the PSA response in prostate cancer patients with only biochemical recurrence after local curative therapy who are then treated with fenretinide (4-HPR). II. To assess PSA doubling time as a measure of disease activity, time to PSA progression in prostate cancer patients receiving fenretinide. III. To evaluate the qualitative and quantitative toxicities of this agent in this patient population. IV. To evaluate pharmacokinetic studies on the bioavailability of 4-HPR in this patient population. OUTLINE: This is a multicenter study. Patients are stratified according to prior therapy (surgery vs radiotherapy and/or brachytherapy vs both), stage at diagnosis (organ confined vs extra-capsular extension vs lymph node positive), Gleason score at diagnosis (2-4 vs 5-6 vs 7-10), and prostate-specific antigen level at diagnosis (0-4 ng/mL vs 4.1-10 ng/mL vs \> 10 ng/mL). Patients receive oral fenretinide twice daily on days 1-7. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.

Adenocarcinoma of the Prostate Recurrent Prostate Cancer

null

1

arm 1: Patients receive oral fenretinide twice daily on days 1-7. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.

[ 0 ]

2

[ 0, 10 ]

intervention 1: Given orally intervention 2: Correlative studies

intervention 1: fenretinide intervention 2: laboratory biomarker analysis

1

Los Angeles | California | United States | -118.24368 | 34.05223

0

NCT00080899

[ 3 ]

152

RANDOMIZED

PARALLEL

1PREVENTION

3TRIPLE

false

0ALL

true

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Iloprost may be effective in preventing lung cancer. PURPOSE: This randomized phase II trial is studying how well iloprost works in preventing lung cancer in patients who are at high risk for this disease.

OBJECTIVES: Primary * Compare the reversal of premalignant histological changes in the bronchial epithelium of patients at high risk for lung cancer (defined by \> 20 pack years of smoking and sputum atypia) treated with iloprost vs placebo. * Determine whether this drug modulates Ki-67 proliferation index (Antigen Ki-67) in these patients. * Determine whether this drug affects prostaglandin metabolism in these patients. * Determine the toxicity profile of this drug in these patients. Secondary * Determine whether this drug modulates a panel of biomarkers, including MCM-2(Minichromosome maintenance protein: forms DNA helicase), EGFR (Epidermal growth factor receptor: cell surface receptor for the epidermal growth factor family of proteins. Mutations in EGFR expression or activity can result in cancer.) , HER2/neu (Human epidermal growth factor receptor 2 HER2 is a member of the EGFR family), RARβ (Retinoic Acic Receptor Beta is a nuclear transcription regulator and a member of the thyroid-steroid hormone receptor superfamily), p53, FHIT (Fragile histidine triad protein is an enzyme involved in purine metabolism and had been demonstrated to be a tumor suppressor), apoptotic index, and microvessel density, in these patients. * Determine the genes whose expression is altered by this drug in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to smoking status (current vs former) and participating center. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral iloprost twice daily. * Arm II: Patients receive oral placebo twice daily. In both arms, treatment continues for 6 months in the absence of unacceptable toxicity. Patients are followed at 1 month and then annually thereafter. PROJECTED ACCRUAL: A total of 152 patients (76 \[38 current smokers and 38 former smokers\] per treatment arm) will be accrued for this study within 2 years.

Lung Cancer Precancerous Condition

non-small cell lung cancer squamous lung dysplasia

null

2

arm 1: Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity. arm 2: Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.

[ 0, 2 ]

2

[ 0, 10 ]

intervention 1: Given orally intervention 2: Given orally

intervention 1: iloprost intervention 2: placebo

6

0

NCT00084409

[ 3 ]

9

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This study will examine whether the drug 17AAG (17-allylamino 17-demethoxygeldanamycin) can shrink kidney tumors in patients with Von Hippel-Lindau disease (VHL), a rare, inherited syndrome in which patients develop tumors in certain parts of the body. 17AAG contributes to the destruction of proteins in cells that may play in role in causing cancer and spurring tumor growth. The study will also look at the effect of 17AAG on other tumors patients may have that are caused by VHL, on the amount of blood vessels in the tumors, on the biologic activity of the tumor, and on cells circulating in the bloodstream, as well as the safety of the drug and its impact on the kidney tumor in patients whose tumor(s) is removed. Patients 18 years of age and older with von Hippel-Lindau disease who have at least one kidney tumor large enough to pose a risk of metastasis (spread of cancer to other parts of the body) may be eligible for this study. Candidates are screened with a medical history and physical examination, computed tomography (CT) scan, brain magnetic resonance imaging (MRI), see below), and blood and urine tests. Additional tests, including a 24-hour urine collection, ultrasound of the testicles in men, hearing test, eye exam, and MRI of the spine, may be done if recent test results are not available. Participants undergo the following tests and procedures: MRI: This test uses a strong magnetic field and radio waves to show structural and chemical changes in tissue. During the scan, the patient lies on a table in a narrow cylinder containing a magnetic field, wearing earplugs to muffle loud noises that occur with electrical switching of the magnetic fields. A catheter (plastic tube) is inserted into the patient's arm to administer a contrast dye that enhances the images. 17AAG treatment: Patients receive 17AAG infusions into a vein once a week for 3 weeks out of every 4, for 3 months. The infusions last up to 1 to 2 hours. Repeat testing: After 3 months, patients have repeat MRI scans to measure changes in tumor activity, blood flow, and number of blood vessels in the tumor since the pretreatment scans. They may have additional tests, including a CT scan, eye exam, and other tests to evaluate the effect of 17AAG on the tumors.

Background: Von Hippel-Lindau disease is a hereditary cancer syndrome in which affected individuals are at risk for developing tumors in a number of organs, including the brain, spine, adrenal glands, eyes and pancreas. The molecular hallmark of VHL is inactivation of the VHL gene which leads to accumulation of the hypoxia inducible factors (HIF); this, in turn results in overexpression of several genes including vascular endothelial growth factor (VEGF), glucose transporter 1 (GLUT-1), transforming growth factor alpha (TGF-α), platelet-derived growth factor (PDGF) and erythropoietin, which play an important role in tumorigenesis, tumor growth and metastasis. 17-allylamino-17-demethoxygeldanamycin (17AAG) is an inhibitor of the cellular chaperone heat shock protein 90 (Hsp90), and its interaction with Hsp90 leads to destabilization and degradation of several proteins, that depend on Hsp90 for their stability. The alpha subunit of HIF1 is one such Hsp90 client protein' and is susceptible to VHL independent, 17AAG-induced degradation. Objectives: To evaluate the efficacy of 17 AAG administered as a single agent in von Hippel Lindau patients with renal tumors. The primary endpoint of the trial is response of renal tumors following 3 cycles of therapy. To study the safety and tolerability of 17 AAG. To evaluate PD modulation of hsp90, and to explore the utility dynamic contrast enhanced MRI in evaluation of blood flow and metabolic changes in renal tumors before and during therapy Eligibility: Adults with clinical diagnosis of von Hippel Lindau disease Presence of one or more localized renal tumors for which surgical resection would be considered the standard approach Design: Patients will receive 17 AAG as an intravenous infusion at a dose of 300mg/m(2) on days 1, 8, and 15 of 28 day cycles. The study will follow a two-stage MinMax phase II design and will accrue a maximum of 26 patients.

Hippel-Lindau Disease Kidney Cancer

Kidney Cancer VHL 17 AAG Chemotherapy Von Hippel Lindau Disease Renal Tumor

null

1

arm 1: None

[ 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: 17 allylamino-17-demethoxygeldanamycin (17 AAG) given intravenously at a dose of 300 mg/m2 on days 1,8 and 15 of 28 day cycles. intervention 2: 18FDG PET performed at baseline and 12 weeks after treatment. At each timepoint participants can receive 250mCi 0-15 water and 15 mCi F18-FDG. intervention 3: \[15-0\] H20 performed at baseline and 12 weeks after treatment. At each time point participants can receive 250mCi 0-15 water and 15 mCi F18-FDG. The water scans were done as several intravenous injections for several scans but not over a total of 250 mCi. intervention 4: 17AAG is formulated with this diluent. Supplied in a 50 mL flint vial containing 48 mL of 2% egg phospholipids, and 5% dextrose in Water for Injection, USP. Patients with a history of serious allergic reactions to eggs should not receive this agent.

intervention 1: 17 allylamino-17-demethoxygeldanamycin intervention 2: 18 FDG (Fludeoxyglucose 18F) intervention 3: [15-O] H2O intervention 4: EPL diluent

1

Bethesda | Maryland | United States | -77.10026 | 38.98067

0

NCT00088374

[ 3 ]

60

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This is a Phase 2 study being conducted at multiple centers in the United States. Patients having thyroid cancer that has spread to other parts of the body (i.e., metastatic) are eligible to participate. Patients must have disease that was not controlled by previous treatment with radioactive iodine (131I) or not be good candidates for such treatment. The purpose of the study is to test whether the angiogenesis inhibitor AG-013736 is an effective treatment for metastatic thyroid cancer as shown by the number of patients in the study who experience significant and durable tumor shrinkage.

null

Thyroid Neoplasms

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: AG013736, tablets 5 mg BID daily until tumor progression or toxicity

intervention 1: AG013736

9

0

NCT00094055

[ 3 ]

34

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Biological therapies, such as cellular adoptive immunotherapy, work in different ways to stimulate the immune system and stop tumor cells from growing. Autologous stem cell transplant may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy. Interleukin-2 may stimulate a person's lymphocytes to kill tumor cells. Combining chemotherapy, radiation therapy, and biological therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cyclophosphamide and fludarabine together with radiation therapy followed by cellular adoptive immunotherapy, autologous stem cell transplant, and interleukin-2 works in treating patients with metastatic melanoma.

OBJECTIVES: Primary * Determine complete clinical tumor regression in patients with metastatic melanoma treated with a myeloablative lymphoid-depleting preparative regimen comprising cyclophosphamide, fludarabine, and total body irradiation followed by autologous tumor-reactive tumor-infiltrating lymphocyte infusion, autologous CD34+ stem cell transplantation, and low-dose or high-dose interleukin-2. * Evaluate the safety of this regimen in these patients. Secondary * Determine the survival of the infused lymphocytes by analyzing the sequence of the variable region of the T-cell receptor or flow cytometry in patients treated with this regimen. OUTLINE: * Autologous stem cell collection: Patients receive filgrastim (G-CSF) subcutaneously (SC) twice daily for 8 days. Beginning on day 5 of G-CSF, patients undergo apheresis daily for up to 3 days. Patients may receive 1 additional course of G-CSF and apheresis or use stem cells stored from a prior stem cell harvest in order to obtain an adequate number of cells. * Lymphocyte-depleting myeloablative preparative regimen: Patients receive cyclophosphamide intravenous (IV) over 1 hour on days -5 and -6 and fludarabine IV over 15-30 minutes on days -6 to -2. Patients also undergo total body irradiation on day -1. * Autologous lymphocyte infusion: Patients receive autologous tumor-reactive tumor-infiltrating lymphocytes IV over 20-30 minutes on day 0\* followed by G-CSF SC once daily until blood counts recover. * Autologous stem cell transplantation: Patients receive autologous CD34+ stem cells IV on day 2. * Interleukin therapy: Patients are assigned to 1 of 2 cohorts, depending on whether they have received prior high-dose interleukin-2 (IL-2). * Cohort 1 (patients who received prior high-dose IL-2): Beginning on day 0\*, patients receive high-dose IL-2 IV over 15 minutes 3 times daily for up to 5 days (maximum of 15 doses). * Cohort 3 (patients who have not received prior high-dose IL-2): Patients receive treatment as in cohort 1. NOTE: \*Day 0 is 1-4 days after the last dose of fludarabine. Patients are evaluated at 4-6 weeks. PROJECTED ACCRUAL: A total of 116 patients will be accrued for this study.

Melanoma (Skin)

stage IV melanoma recurrent melanoma

null

2

arm 1: Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator. Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient. arm 2: Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator. Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient.

[ 5, 5 ]

6

[ 2, 2, 2, 0, 0, 4 ]

intervention 1: high dose: 720,000 IU/kg intravenously over 15 minutes every 8 hours for up to 5 days (maximum 5 doses) or low dose: 250,000 IU/kg subcutaneously daily for 5 days, after a two day rest, 125,000 IU/kg subcutaneously daily for 5 days for five weeks (2 days rest per week) intervention 2: 10 mcg/kg/day daily subcutaneously until neutrophil count \>1x10\^9/1. intervention 3: Lymphocytes that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient. intervention 4: 60 mg/kg/day x 2 days intravenously over 1 hour intervention 5: 25 mg/m\^2/day intravenous piggyback daily over 15-20 minutes for 5 days intervention 6: Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.

intervention 1: aldesleukin intervention 2: filgrastim intervention 3: therapeutic tumor infiltrating lymphocytes intervention 4: cyclophosphamide intervention 5: fludarabine phosphate intervention 6: radiation therapy

2

0

NCT00096382

[ 3 ]

57

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

This phase II trial is studying how well lapatinib works in treating patients with locally advanced or metastatic biliary tract or liver cancer that cannot be removed by surgery. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PRIMARY OBJECTIVES: I. The goal of this study is to determine the objective response rate of GW572016 in patients with biliary cancer and hepatocellular cancer (HCC). SECONDARY OBJECTIVES: I. Determine the overall survival of patients entered onto study. II. Quantitative and qualitative toxicities of the patient population treated with GW572016. III. Determine the progression free survival of patients. IV. To perform molecular and pharmacogenomic correlative studies that will identify specific patient subsets that benefit from GW572016 therapy. OUTLINE: This is a multicenter study. Patients are stratified according to tumor site (biliary tree cancer \[includes ampullary, bile duct, and gall bladder cancer\] vs hepatocellular cancer). Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed for survival.

Adult Primary Hepatocellular Carcinoma Advanced Adult Primary Liver Cancer Localized Unresectable Adult Primary Liver Cancer Recurrent Adult Primary Liver Cancer Recurrent Extrahepatic Bile Duct Cancer Recurrent Gallbladder Cancer Unresectable Extrahepatic Bile Duct Cancer Unresectable Gallbladder Cancer

null

1

arm 1: Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

[ 0 ]

2

[ 0, 10 ]

intervention 1: Given PO intervention 2: Correlative studies

intervention 1: lapatinib ditosylate intervention 2: laboratory biomarker analysis

1

Sacramento | California | United States | -121.4944 | 38.58157

0

NCT00101036

[ 4 ]

270

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

true

The objectives of this study are to compare the anti-tumor activity as measured by Progression Free Survival (PFS) and tolerability of Sorafenib in combination with Paclitaxel and Carboplatin versus Paclitaxel and Carboplatin in combination with placebo in subjects with unresectable Stage III or Stage IV melanoma who progressed after receiving only one prior therapy containing Dacarbazine (DTIC) or Temozolomide (TMZ).

null

Melanoma

null

2

arm 1: Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die \[twice daily\]) on Study Days 2 to 19 + Paclitaxel (225 mg/m\^2 iv \[Intravenous\]) and Carboplatin (AUC \[area under the curve\] 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period. arm 2: Placebo, 2 tablets bid on Study Days 2-19 + Paclitaxel (225 mg/m\^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.

[ 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: Sorafenib, 400 mg po (per os), 2 tablets (200 mg each) bid Study Days 2-19 intervention 2: Paclitaxel (225 mg/m\^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1 intervention 3: Placebo, 2 tablets bid Study Days 2-19

intervention 1: Sorafenib (Nexavar, BAY43-9006) intervention 2: Carboplatin/Paclitaxel intervention 3: Placebo

66

0

NCT00111007

[ 2, 3 ]

13

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

The goal of this research study is to test the clinical effectiveness of a drug called infliximab (Remicade) in chronic beryllium disease (CBD). This drug may reduce tumor necrosis factor-alpha (TNF-a), which is associated with more severe disease and inflammation in the lung. Receiving infliximab may help with symptoms, and may improve clinical testing data normally ordered by your doctor, such as breathing tests. Baseline and follow-up testing will look for improvements in breathing tests (pulmonary function testing), exchange of oxygen in the lungs (exercise test), chest x ray, and lung inflammation.

Hypothesis: The central hypothesis of this study is that infliximab will prove to be efficacious in the treatment of chronic beryllium disease (CBD), and that it will do so by inhibiting beryllium specific T cell proliferation and cytokine production. Specific Aims: Specific Aim 1: To determine the clinical effectiveness of infliximab on chronic beryllium disease. The efficacy of infliximab will be measured by improvement in arterial gas exchange, or arterial alveolar oxygen gradient (A-ad02) at end exercise in subjects with CBD who remain symptomatic and with pulmonary impairment despite current treatment with prednisone and/or methotrexate. Secondary outcome measures will include change in airflow, lung volume, diffusing capacity (DLCO), profusion of small opacities on chest x-ray, dyspnea score, and quality of life questionnaires. Specific Aim 2: To determine the effect of infliximab on intermediate markers of biological function in CBD. In vitro studies will examine the effect of infliximab on blood and lung cells in culture, as measured by a decrease in beryllium (Be)-stimulated lymphocyte proliferation; a decrease in Be-stimulated cytokine production, including TNF-a, IFN-g, and IL-2; altered Be-stimulated apoptosis of macrophages or lymphocytes. Research Design and Methods: Since no information is available regarding the pharmacokinetics of infliximab in patients with CBD, the pharmacokinetic information available from the use of infliximab in other similar inflammatory conditions formed the basis for selecting the dose regimen for this protocol. Particularly, a 5mg/kg dose will be used for this study, based on the dose selection used in the sarcoidosis protocol C0168T48 presently underway in a multi-center trial (NJC IRB HS-1771). This is an investigator initiated, 40 week, randomized, double-blind, placebo controlled study to evaluate the efficacy of infliximab dosed at 5mg/kg, compared to placebo, in individuals with symptomatic CBD with pulmonary involvement despite prednisone and/or methotrexate treatment. Infliximab or placebo will be infused at weeks 0, 2, 6, 12, 18, and 24 including spirometry, lung volumes and DLCO. Approximately 20 participants will be enrolled in the study at National Jewish Medical and Research Center at a 3:1 drug: placebo rate. The primary endpoint of this study will be a change from baseline testing to week 28 testing in the A-adO2 at end exercise on a 6 minute walk. At baseline evaluation, subjects will undergo full pulmonary function testing, a blood draw for the beryllium lymphocyte proliferation test (BeLPT), 6 minute walk, chest x-ray, and quality of life and dyspnea questionnaires. Follow-up full pulmonary function testing, rest and end exercise A-ad02, pulse oximetry with total distance (workload) achieved on a 6 minute walk, and chest radiograph will be measured at week 12. Final outcome measurements (same as baseline testing), including bronchoscopy with BAL, will be repeated at week 28. A follow-up appointment will be scheduled at week 40 to assess patients' general health, as well as measure rest and end exercise A-ad02 and pulse oximetry with 6 minute walk, pulmonary function test, QOL/dyspnea scoring, and chest radiograph interstitial lung opacity profusion score. The effects of infliximab on the Be-stimulated immune response will be assessed by comparing the following markers before and after infliximab therapy: 1. BeLPT from blood and lavage cells (BAL); 2. Be-stimulated cytokine production from BAL cells including TNF-a, IFN-γ, and IL-2; 3. Cell-specific apoptosis. The assay will include an unstimulated control, 100 mM BeSO4, 100 mM Al2(SO4)3 metal-salt control, PHA - lymphocyte proliferation control, infliximab control, infliximab + BeSO4, infliximab + Al2(SO4)3. At days 4, 5, and 6 after Be exposure, the wells are pulsed with the DNA-specific precursor, 3H-TdR, incubated for four hours, harvested on glass fiber filters, and liquid scintillation methods are used for counting. Results are reported as a stimulation index, which is a ratio of the counts per minute of the treatment group to the counts per minute of the unstimulated group. To determine the effect of infliximab on cytokine production, CBD BAL and CBD PBMC will be stimulated with Be for 24 hours. ELISA will be used to determine TNF-α, IFN-γ, and IL-2 supernatant levels. After 24 hours of beryllium exposure, we will harvest supernatants and perform ELISA testing for TNF-α, IFN-γ, and IL-2. In order to determine if infliximab causes an increase in lymphocyte or macrophage apoptosis, CBD BAL cells will be cultured for 24 hours with Be. Cells will be double stained for CD4+ (Th1) and CD71+ macrophages versus intracellular activated caspase-3, caspase-8 and caspase-9. These in vitro studies will be used to assess the potential biologic function of infliximab on immune mediated diseases using a disease model with known antigen, CBD.

Berylliosis Beryllium Disease

Chronic Beryllium Disease Berylliosis Beryllium Disease CBD Infliximab

null

2

arm 1: infusion: 3:1 infliximab:placebo ratio administered at 0, 2, 6, 12, 18 and 24 weeks. arm 2: infusion: 3:1 infliximab:placebo ratio administered at 0, 2, 6, 12, 18 and 24 weeks.

[ 0, 2 ]

2

[ 0, 10 ]

intervention 1: anti-TNF intervention 2: Placebo infusion

intervention 1: Infliximab intervention 2: Placebo

1

Denver | Colorado | United States | -104.9847 | 39.73915

0

NCT00111917

[ 3 ]

25

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

true

0ALL

false

Preoperative chemoradiation leads to increased pelvic control and overall survival, but both distant and local disease control remain problematic in locally advanced rectal cancer patients. Enhancing the effect of chemotherapy and radiotherapy can increase tumor response as well as distant disease control. Patients who have complete response to therapy have increased sphincter preservation, and can possibly have more limited surgery (full thickness local excision). When combined with standard chemotherapy, bevacizumab \[RHUMAB VEGF, Avastin\] has been shown to improve response and median survival in patients with metastatic colorectal cancer in a recent randomized trial, has led to increased activity in preclinical studies with radiotherapy, and has been found to be very well tolerated with chemoradiation in a phase I trial conducted at the M.D. Anderson Cancer Center (MDACC) in patients with locally advanced pancreatic cancer. The hypothesis is that the addition of bevacizumab to standard chemoradiation will safely lead to increased tumor response in patients with locally advanced rectal cancer.

Avastin \[RHUMAB VEGF, Bevacizumab\] is a drug that has damaging effects on blood vessel growth in tumors. Before treatment starts, you will have a complete physical exam. About 2 tablespoons of blood will be drawn for routine tests and a urine test will be performed. Chest x-rays and CT scans of the abdomen and pelvis will be done. Women who are able to have children must have a negative blood pregnancy test. You will receive radiation therapy once a day for 5 days in a row (Monday-Friday) for 5 weeks and three days (a total of 28 treatments). You will take the chemotherapy drug capecitabine by mouth twice a day on each of the days that you receive radiation therapy. These pills will not be taken on Saturday and Sunday. You must not take cimetidine, and must be off of coumadin for at least one week and sorivudine and brivudine for at least four weeks before starting capecitabine and while taking capecitabine. You will receive the drug Avastin by vein once every 2 weeks for six weeks (a total of three doses). The infusion will at first last 90 minutes. If there are no allergic reactions, fevers or chills, it will be shortened to 60 minutes and then 30 minutes for later infusions. During the study, you will have physical exams, including weekly blood tests (about 2 teaspoons). The possible development of side effects will be closely monitored. All participants will have surgical removal of the rectal tumor 6-8 weeks after the completion of treatment as they would for the standard of care for their disease. No patients will have surgery before 6 weeks. After participation in this study is over, you will have follow-up evaluation as needed for standard of care. THIS IS AN INVESTIGATIONAL STUDY. Capecitabine is approved by the FDA, but Avastin has not yet been evaluated for approval. About 50 patients will take part in the study. All will be enrolled at the M. D. Anderson.

Rectal Cancer

Rectal Cancer Bevacizumab RHUMAB VEGF Avastin Capecitabine Neoadjuvant Concurrent Capecitabine Xeloda Radiation Radiotherapy Radiation Therapy XRT

null

1

arm 1: Capecitabine, Avastin (RHUMAB VEGF/Bevacizumab) And Radiotherapy

[ 0 ]

3

[ 0, 0, 4 ]

intervention 1: Starting Dose 5 mg/kg intravenously on day one of radiotherapy, given every 2 weeks +/- 2 days for a total of 3 doses. intervention 2: 900 mg/m\^2 by mouth twice a day during days of radiation for all five weeks of therapy. intervention 3: 45 Gy in 25 fractions to the pelvis followed by 5.4 Gy as a boost dose to the primary tumor with margin, for a total dose of 50.4 Gy over 28 treatment days.

intervention 1: Avastin (Bevacizumab, RHUMAB VEGF) intervention 2: Capecitabine intervention 3: Radiation Therapy

1

Houston | Texas | United States | -95.36327 | 29.76328

0

NCT00113230

[ 5 ]

102

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

true

0ALL

false

Some people with nasal allergy symptoms continue to have symptoms even after treatment with a nasal steroid spray. The purpose of this study is to see if these patients are helped by adding another medication (montelukast) to their treatment compared to placebo (a substance that looks like the active medication but does not contain the drug).

Clinicians frequently prescribe an oral H1 antihistamine for allergic rhinitis patients with residual symptoms after taking an intranasal steroid. Surprisingly, the only studies investigating this combination of drugs have failed to show added efficacy of the H1 receptor over the intranasal steroids alone. Adding montelukast, a leukotriene receptor antagonist, to an intranasal steroid has not been studied in a placebo controlled fashion. Wilson and colleagues, in an open study of patients with chronic rhinosinusitis, showed a benefit of adding montelukast. The investigators would like to recruit perennially allergic subjects and place them on fluticasone for 2 weeks. Those subjects with residual symptoms would then be randomized to receive either placebo or montelukast in addition to continuing the fluticasone for an additional 2 weeks. A positive study would support clinical practice and would serve as a preemptive strike against managed care plans that would not allow prescriptions for both drugs. Hypothesis: The addition of montelukast to treatment of a perennially allergic subject with an intranasal steroid is more effective at relieving symptoms than a placebo.

Rhinitis, Allergic, Perennial

perennial allergic rhinitis

null

2

arm 1: Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily) Placebo - 10 mg po daily for 2 weeks arm 2: Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily) Montelukast - 10 mg po daily for 2 weeks

[ 2, 1 ]

3

[ 0, 0, 0 ]

intervention 1: None intervention 2: None intervention 3: None

intervention 1: Placebo intervention 2: Montelukast intervention 3: Fluticasone propionate

1

Chicago | Illinois | United States | -87.65005 | 41.85003

0

NCT00119015

[ 3, 4 ]

45

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

This study is intended to assess the effects of once daily dosing of recombinant human insulin-like growth factor (rhIGF-1) in increasing height velocity.

Growth failure associated with primary IGF-1 deficiency (IGFD). Primary IGFD is a term that has been used to describe patients with intrinsic cellular defects in growth hormone (GH) action. In this protocol, primary IGFD is defined as short stature (\<-2 standard deviations \[SDs\] below the mean for age and gender), and abnormal serum IGF-1 (\<-2 SDs below the mean for age and gender). The trial is an open-label, concentration-controlled trial conducted at up to 20 centers throughout the United States.

Insulin-Like Growth Factor-1 Deficiency Growth Disorders

Primary IGF-1 Deficiency IGF-1

null

1

arm 1: Subjects received subcutaneous injection (SC) injections of rhIGF-1 once a day.

[ 0 ]

1

[ 0 ]

intervention 1: Once a day rhIGF-1 injections

intervention 1: rhIGF-1 (mecasermin) for a period of 86 weeks

1

Brisbane | California | United States | -122.39997 | 37.68077

0

NCT00125190

[ 0 ]

54

RANDOMIZED

CROSSOVER

0TREATMENT

1SINGLE

false

0ALL

false

The purpose of this study is to conduct a randomised trial to compare the insulin sensitivity, 24 hour blood pressure profile, and tolerability of nebivolol plus a thiazide-like diuretic versus atenolol plus a thiazide-like diuretic.

Retrospective studies of treated hypertensive cohorts have strongly implicated beta blocker therapy as increasing the risk of developing new-onset diabetes. This has led to the latest British Hypertension Society guidelines advising caution when using beta blockers particularly in combination with thiazide-like diuretics. However the National Institute of Clinical Excellence recommends beta-blocker + thiazide combinations as the treatment of choice in patients who are not at increased risk of developing diabetes. Nebivolol is a newer class of beta blocker. Some studies in diabetic hypertensive patients have suggested that nebivolol does not impair insulin sensitivity. The aim of this study is to compare the effect on insulin sensitivity of nebivolol versus atenolol, both in combination with a thiazide-like diuretic, in a group of non-diabetic hypertensive patients.

Hypertension

blood pressure insulin sensitivity beta blockers randomised double blind crossover trial

null

2

arm 1: atenolol 25mg daily arm 2: nebivolol 2.5mg daily

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Nebivolol 2.5mg daily intervention 2: Atenolol 25mg daily

intervention 1: Nebivolol intervention 2: Atenolol

1

Paddington | London | United Kingdom | -0.1763 | 51.51558

0

NCT00125853

[ 4 ]

274

NON_RANDOMIZED

null

0TREATMENT

0NONE

false

0ALL

true

The purpose of this study was to evaluate the safety and efficacy of multiple courses of AZLI in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).

People with CF often have lung infections that occur repeatedly or worsen over time. The lung infections are often caused by PA. Treatment with antibiotics is used to reduce the presence of the bacteria. The antibiotics may be given orally, intravenously, or inhaled as a mist. The purpose of this study was to evaluate whether AZLI, an investigational formulation of the antibiotic aztreonam, is safe in repeated courses in patients with CF and PA. A course of AZLI treatment in this study comprised 28 days, followed by a 28-day period off treatment. Participants could receive up to 9 courses of AZLI, with a total time on study of up to 18 months. Safety and efficacy results for the 18-month, 9-course period are reported, with efficacy results presented on a by-treatment course basis.

Cystic Fibrosis

cystic fibrosis Pseudomonas aeruginosa

null

0

null

1

[ 0 ]

intervention 1: None

intervention 1: AZLI 75 mg two times a day (BID)/ three times a day (TID)

65

0

NCT00128492

[ 4 ]

224

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

The purpose of this study is to confirm the efficacy of olanzapine in the treatment of manic or mixed symptoms associated with bipolar I disorder.

null

Bipolar Disorder

Manic or mixed episode associated with bipolar I disorder

null

3

arm 1: olanzapine: 5 to 20 mg per day for 6 weeks arm 2: haloperidol: 2.5 to 10 mg per day for 6 weeks arm 3: placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks

[ 0, 1, 2 ]

3

[ 0, 0, 0 ]

intervention 1: 5-20 mg, oral, once daily (evening), for 6 weeks intervention 2: 2.5-10 mg, oral, twice daily (morning and evening), for 6 weeks. intervention 3: placebo, oral tablets, twice daily (morning and evening), for 3 weeks

intervention 1: olanzapine intervention 2: haloperidol intervention 3: placebo

16

Aichi | N/A | Japan | 130.62158 | 32.51879 Akita | N/A | Japan | 140.11667 | 39.71667 Chiba | N/A | Japan | 140.11667 | 35.6 Fukuoka | N/A | Japan | 130.41667 | 33.6 Gunma | N/A | Japan | N/A | N/A Hokkaido | N/A | Japan | N/A | N/A Hyōgo | N/A | Japan | 144.43333 | 43.36667 Kanagawa | N/A | Japan | 139.91667 | 37.58333 Kumamoto | N/A | Japan | 130.69181 | 32.80589 Nagano | N/A | Japan | 138.18333 | 36.65 Okayama | N/A | Japan | 133.93333 | 34.65 Okinawa | N/A | Japan | 127.80139 | 26.33583 Osaka | N/A | Japan | 135.50107 | 34.69379 Saga | N/A | Japan | 130.3 | 33.23333 Saitama | N/A | Japan | 139.65657 | 35.90807 Tokyo | N/A | Japan | 139.69171 | 35.6895

0

NCT00129220

[ 5 ]

86

RANDOMIZED

PARALLEL

1PREVENTION

0NONE

false

0ALL

false

The purpose of this study is to determine the effect of sirolimus on the prevention of new non-melanoma skin cancer (NMSC) in kidney transplant recipients.

null

Skin Neoplasms Kidney Transplantation

Kidney Transplant Skin Cancer

null

2

arm 1: Conversion to a sirolimus-based regimen arm 2: Continuation of a CNI-based regimen

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: sirolimus intervention 2: cyclosporine or tacrolimus

23

0

NCT00129961

[ 5 ]

457

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

This study will recruit 480 acute stroke patients with symptomatic intracranial stenosis (M1 segment of Middle cerebral artery (MCA) or basilar artery). They will be randomly assigned into cilostazol group or clopidogrel group. Every patients will take 100mg of aspirin a day additionally. The primary outcome variable of this study is Progression rate of symptomatic intracranial stenosis on magnetic resonance angiogram (MRA).

\[Goal\] To Reveal the Effect and Safety of Cilostazol Compared with Clopidogrel on the Prevention of the Progression of Symptomatic Intracranial Arterial Stenosis. \[Trial Design\] Double-Blind, Active-Controlled, Randomized, Multicenter Trial \[Participants\] Acute ischemic stroke patients with symptomatic intracranial arterial stenosis \[Methods\] * Double-Blind, Active-Controlled, Randomized, Multicenter Trial * Investigational product (Double Dummy Method): Cilostazol 200mg (100mg twice per day) versus clopidogrel 75mg * Concomitant medication: Aspirin 100 (75-150) mg per day * Medication Duration: 7 months \[Outcome Variables\] Primary Outcome Variable: * Progression rate of symptomatic intracranial arterial stenosis Secondary outcome variables: * The occurrence of new MRI (magnetic resonance image) lesion on follow-up MRI * Stroke events * Overall cardiovascular events: stroke, acute coronary syndrome, vascular death * Ipsilateral ischemic stroke rate * Fatal or major bleeding complications

Cerebral Infarction Atherosclerosis

Infarction, Cerebral cilostazol stenosis atherosclerosis clopidogrel

null

2

arm 1: cilostazol 100mg bid plus placebo of clopidogrel arm 2: clopidogrel 75mg qd and matching placebo of cilostazol

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Clopidogrel 75mg once a day plus placebo of cilostazol twice a day intervention 2: Cilostazol 100mg twice a day plus placebo of clopidogrel once a day

intervention 1: clopidogrel intervention 2: Cilostazol

19

Hong Kong | N/A | Hong Kong | 114.17469 | 22.27832 Hong Kong | N/A | Hong Kong | 114.17469 | 22.27832 Manila | N/A | Philippines | 120.9822 | 14.6042 Manila | N/A | Philippines | 120.9822 | 14.6042 Seoul | Gwangjin-gu Hwayang-dong | South Korea | 126.9784 | 37.566 Goyang-si | Gyeonggi-do | South Korea | 126.835 | 37.65639 Goyang | Kyoungki-do | South Korea | 127.19731 | 36.21689 Anyang | Kyunggi | South Korea | 127.1464 | 36.9577 Seoul | Seoul | South Korea | 126.9784 | 37.566 Inchon | N/A | South Korea | 126.6251 | 35.55479 Seongnam | N/A | South Korea | 127.39683 | 35.54127 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Bangkok | N/A | Thailand | 100.50144 | 13.75398 Bangkok | N/A | Thailand | 100.50144 | 13.75398

0

NCT00130039

[ 4 ]

10,154

RANDOMIZED

PARALLEL

1PREVENTION

3TRIPLE

true

1FEMALE

true

Preeclampsia is one of the most common complications of pregnancy and is characterized by high blood pressure and protein in the urine. This can cause problems in the second half of pregnancy for both the mother and fetus. This study of preeclampsia consists of two parts: 1) a randomized, placebo controlled, multicenter clinical trial of 10,000 low-risk nulliparous women between 9 and 16 weeks gestation and 2) an observational, cohort study of 4,000 patients between 9 and 12 weeks gestation who are also enrolled in the trial. Subjects in both parts will receive either 1000 mg of vitamin C and 400 IU of vitamin E or matching placebo daily. The purpose of the randomized, clinical trial is to find out if high doses of vitamin C and E will reduce the risk of preeclampsia and other problems associated with the disease. The study will also evaluate the safety of antioxidant therapy for mother and infant. Patients will be seen monthly to receive their supply of study drug, to have weight and blood pressure recorded, to have urine protein measured, and to assess any side effects. At two visits, blood and urine will be collected. The observational, cohort study will prospectively measure potential biochemical and biophysical markers that might predict preeclampsia. These patients will have additional procedures including uterine artery Doppler and blood drawn for a complete blood count (CBC).

A Randomized, Clinical Trial of Antioxidants to Prevent Preeclampsia: Preeclampsia is the leading cause of maternal morbidity, as well as perinatal morbidity and mortality. Once the diagnosis has been established, therapy other than delivery has not been successful except to prolong pregnancy minimally (at some risk to mother and infant). Prevention efforts to reduce or eliminate preeclampsia are directed at the pathophysiology of the disorder prior to clinically evident preeclampsia and before irreversible changes have occurred. This double-masked, placebo-controlled trial of 10,000 subjects is designed to evaluate the effects of antioxidant therapy in preventing serious complications associated with pregnancy-related hypertension in low risk, nulliparous women who begin treatment at 9-16 weeks gestation. The hypothesis being tested is that antioxidant therapy initiated prior to 16 weeks gestation will reduce the frequency of serious maternal and infant complications associated with pregnancy-related hypertension. After randomization, subjects will receive either 1000 mg of vitamin C and 400 IU of vitamin E or matching placebo daily. They will be seen for monthly pill counts and to assess side effects, weight, blood pressure, and urine for protein. Blood and urine are collected at 24 and 32 weeks' gestation. An Observational Cohort Study to Predict Preeclampsia: A prospective, cohort study has been designed to complement the randomized, controlled, trial (RCT) and will test various biochemical and biophysical markers for ability to predict preeclampsia in 4,000 of the women who are enrolled in the RCT and are between 9 and 12 weeks gestation. These subjects will have additional procedures including a CBC and uterine artery Doppler.

Preeclampsia

Antioxidants Preeclampsia Pregnancy Hypertension

null

2

arm 1: 1000mg of Vitamin C and 400IU of Vitamin E per capsule, twice daily between randomization (at 9 to 16 weeks) up to delivery. arm 2: Placebo capsules consisting of Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell, twice daily between randomization (at 9 to 16 weks) up to delivery.

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Vitamin C (1000 mg) and Vitamin E (400 IU) per capsule, two capsules daily between randomization (at 9 - 16 weeks gestation) up to delivery. intervention 2: Placebo two capsules daily between randomization (at 9 - 16 weeks gestation) up to delivery.

intervention 1: Dietary Supplement/Vitamins intervention 2: Placebo for Vitamin C and Vitamin E

16

0

NCT00135707

[ 3 ]

86

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

true

Lofexidine is an experimental medication that may be beneficial in reducing opiate withdrawal symptoms, such as sleep difficulty, anxiety, and tension. The purpose of this study is to determine whether lofexidine in combination with naltrexone can improve an individual's ability to cope with stress and subsequently increase the chances of remaining abstinent from opiates.

Naltrexone is a medication currently used to treat opiate dependence. Naltrexone blocks the euphoric effects of opiates. However, naltrexone treatment suffers from high rates of drop-out and relapse. One possible explanation for this is that opiate addicts continue to experience stress in early recovery from opiate dependence. Lofexidine is an experimental medication currently used in the United Kingdom for opiate detoxification and to treat opiate withdrawal symptoms, including sleep difficulty, muscle pain, anxiety, and tension. The purpose of this study is to examine whether lofexidine in combination with naltrexone can improve an individual's ability to cope with stress. The study will examine whether this, in turn, increases the likelihood that an individual remains abstinent from opiates and maintains recovery for a longer time period. Participants in this 12-week, double-blind, placebo-controlled trial will be randomly assigned to receive either lofexidine or placebo while currently receiving standard naltrexone outpatient treatment. Lofexidine will be initiated at twice daily doses of 0.4 mg and increased to 0.8 mg by the end of Week 1. The doses will be increased to 1.2 mg by the end of Week 2, and maintained at this level for Weeks 3 through 12. During Week 12, lofexidine discontinuation will be tapered over 4 days. Hour-long study visits will occur 3 times each week to assess vital signs, medication side effects, and withdrawal symptoms. Blood, alcohol, and urine tests will be performed as well as a psychiatric evaluation. Administration of naltrexone will also occur 3 times each week. Follow-up visits will occur at Months 1 and 3 after discontinuation of lofexidine.

Opioid-Related Disorders

Opioid dependence

null

2

arm 1: Lofexidine: Study medication Participants will receive daily lofexidine and the dosing will be initiated at 0.4 mg bid and increased to 0.8mg in week 1 and 1.0 and 1.2 mg bid in week 2, and maintained at 1.2mg bid for weeks 3 to 12. They are then tapered down to 0 over the course of four days in week 12. While the target dose will be 2.4 mg daily, if any subject shows reduced tolerability at this or a lower dose, the dose will be adjusted to the maximum tolerated dose for that subject. arm 2: Placebo pill. Participants will receive daily placebo and will follow the same scheduled delivery as those in the intervention for 12 weeks.

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Participants will receive lofexidine. The dosing will be initiation at 0.4 mg bid and increased to 0.8mg in week 1 and 1.0 and 1.2 mg bid in week 2, and maintained at 1.2mg bid for weeks 3 to 12. They are then tapered down to 0 over the course of four days in week 12. While the target dose will be 2.4 mg daily, if any subject shows reduced tolerability at this or a lower dose, the dose will be adjusted to the maximum tolerated dose for that subject. intervention 2: Lofexidine Placebo

intervention 1: Lofexidine intervention 2: Placebo

1

New Haven | Connecticut | United States | -72.92816 | 41.30815

0

NCT00142909

[ 5 ]

3,031

RANDOMIZED

PARALLEL

2DIAGNOSTIC

0NONE

false

0ALL

true

The KYOTO HEART Study is to assess the add-on effect of valsartan, an Angiotensin-Receptor Blocker, on top of the conventional treatment in high risk patients in Japan with hypertension in terms of the morbidity and mortality.

Although many reports show that ACE inhibitors and angiotensin II receptor blockers (ARB) are superior for prevention of cardiovascular events, previous data are not enough for the patients who have more than one risk factor and for anti-atherosclerotic effects of ARB. In Japan, there were only a few large-scale trials for cardiovascular disease prevention, and it has not been clarified whether the evidence in Western countries could be unqualifiedly applied to Japanese patients as a long-range strategy. The KYOTO HEART Study is to assess the add-on effect of valsartan, an Angiotensin-Receptor Blocker, on top of the conventional treatment in high risk patients with hypertension in terms of the morbidity and mortality.

Hypertension Ischemic Heart Disease Congestive Heart Failure Stroke

High risk hypertension Ischemic heart disease Angiotensin receptor blockers Cardiovascular mortality- morbidity KYOTO HEART Study

null

2

arm 1: 'Non-ARB' was defined as Conventional anti-hypertensive treatment except for ARB and ACEIs arm 2: Valsartan add-on treatment

[ 1, 0 ]

2

[ 0, 0 ]

intervention 1: Valsartan add-on arm: valsartan 40-160 mg per day, and an additional antihypertensive drugs other than ARB and ACEI are administered if necessary. intervention 2: 'Non-ARB' was defined conventional anti-hypertensive treatment except for ACEIs and ARBs

intervention 1: Valsartan intervention 2: Non-ARB

1

Kyoto | Kyoto | Japan | 135.75385 | 35.02107

0

NCT00149227

[ 3 ]

361

NON_RANDOMIZED

null

1PREVENTION

0NONE

false

0ALL

null

To determine the long term safety and efficacy of BIBR 1048 in patients with chronic atrial fibrilla tion, with or without concomitant chronic treatment with acetylsalicylic acid (ASA).

null

Atrial Fibrillation Stroke

null

4

arm 1: dosage used at study start arm 2: dosage used at study start arm 3: dosage used at study start arm 4: dosage used at study start

[ 0, 0, 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: dosage used at study start intervention 2: dosage used at study start intervention 3: dosage used at study start intervention 4: dosage used at study start

intervention 1: dabigatran etexilate intervention 2: dabigatran etexilate intervention 3: dabigatran etexilate intervention 4: dabigatran etexilate

50

La Mesa | California | United States | -117.02308 | 32.76783 Pensacola | Florida | United States | -87.21691 | 30.42131 Port Charlotte | Florida | United States | -82.09064 | 26.97617 St. Petersburg | Florida | United States | -82.67927 | 27.77086 Baltimore | Maryland | United States | -76.61219 | 39.29038 Westminster | Maryland | United States | -76.99581 | 39.57538 Pittsfield | Massachusetts | United States | -73.24538 | 42.45008 Troy | Michigan | United States | -83.14993 | 42.60559 Hawthorne | New York | United States | -73.79597 | 41.10732 New Hyde Park | New York | United States | -73.68791 | 40.7351 North Durham | North Carolina | United States | N/A | N/A Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 Aalborg | N/A | Denmark | 9.9187 | 57.048 Aarhus C | N/A | Denmark | 10.21231 | 56.16558 Brædstrup | N/A | Denmark | 9.61129 | 55.97153 Elsinore | N/A | Denmark | 12.6136 | 56.03606 Esbjerg | N/A | Denmark | 8.45187 | 55.47028 Frederikssund | N/A | Denmark | 12.06896 | 55.83956 Herlev | N/A | Denmark | 12.43998 | 55.72366 Holbæk | N/A | Denmark | 11.71279 | 55.7175 Hvidovre | N/A | Denmark | 12.47708 | 55.64297 Køge | N/A | Denmark | 12.18214 | 55.45802 Odense | N/A | Denmark | 10.38831 | 55.39594 Roskilde | N/A | Denmark | 12.08035 | 55.64152 Svendborg | N/A | Denmark | 10.60677 | 55.05982 Amstelveen | N/A | Netherlands | 4.86389 | 52.30083 Amsterdam | N/A | Netherlands | 4.88969 | 52.37403 Amsterdam | N/A | Netherlands | 4.88969 | 52.37403 Apeldoorn | N/A | Netherlands | 5.96944 | 52.21 Assen | N/A | Netherlands | 6.5625 | 52.99667 Den Helder | N/A | Netherlands | 4.75933 | 52.95988 Ede | N/A | Netherlands | 5.65833 | 52.03333 Hengelo | N/A | Netherlands | 6.79306 | 52.26583 Hoorn | N/A | Netherlands | 5.05972 | 52.6425 Rotterdam | N/A | Netherlands | 4.47917 | 51.9225 Sittard | N/A | Netherlands | 5.86944 | 50.99833 Tilburg | N/A | Netherlands | 5.0913 | 51.55551 Veldhoven | N/A | Netherlands | 5.40278 | 51.41833 Eskilstuna | N/A | Sweden | 16.5077 | 59.36661 Falun | N/A | Sweden | 15.62597 | 60.60357 Jönköping | N/A | Sweden | 14.15618 | 57.78145 Kalmar | N/A | Sweden | 16.36163 | 56.66157 Malmo | N/A | Sweden | 13.00073 | 55.60587 Norrköping | N/A | Sweden | 16.1826 | 58.59419 Örebro | N/A | Sweden | 15.2066 | 59.27412 Stockholm | N/A | Sweden | 18.06871 | 59.32938 Stockholm | N/A | Sweden | 18.06871 | 59.32938 Umeaa | N/A | Sweden | N/A | N/A Uppsala | N/A | Sweden | 17.63889 | 59.85882 Västerås | N/A | Sweden | 16.55276 | 59.61617

0

NCT00157248

[ 5 ]

40

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

true

0ALL

true

Men and women who have suffered sexual and/or physical abuse before the age of 12 are at increased risk for anxiety and mood disorders, other serious psychiatric disorders, and likely medical illnesses. What is not known is whether adult survivors of childhood adversity experience heightened negative emotions and increased physical responses due to altered norepinephrine or serotonin systems in their brains and bodies. The investigators expect to see that survivors of childhood adversity experience heightened negative emotions and increased physical responses to stress.

null

Major Depressive Disorder

platelet function childhood abuse depression antidepressants immune function stress response

null

2

arm 1: None arm 2: None

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: 10 mg of Escitalopram, and titrated up to 20 mg of Escitalopram after day 22 of intervention intervention 2: 25 mg of Desipramine for day 1-3, 50 mg of Desipramine for day 4-7, 75 mg of Desipramine for day 8-14, 100 mg of Desipramine for day 15-21. Titrated between 125 mg to 200 mg of Desipramine for day 22-56 of intervention

intervention 1: Escitalopram intervention 2: Desipramine

1

Atlanta | Georgia | United States | -84.38798 | 33.749

0

NCT00166114

[ 3 ]

239

RANDOMIZED

CROSSOVER

1PREVENTION

1SINGLE

true

0ALL

true

The primary goal of the study is to assess the residual effects of heavy drinking on academic performance. The investigators will also explore whether these effects differ by family history of alcohol abuse and hangover symptoms, as well as compare males and females with respect to these effects. The primary hypothesis is that intoxication (0.10 g% blood alcohol concentration \[BAC\]) with an alcoholic beverage impairs next-day academic performance, as measured by scores on quizzes, standardized academic achievement tests, and standardized neurobehavioral assessments. The secondary hypothesis is that family-history-positive individuals will show a greater performance decrement the day after heavy drinking than family-history-negative individuals.

The primary goal of the study is to assess the effect of heavy drinking on next day academic performance. A placebo-controlled 2-period crossover design will be used to compare the effects of dosing status on academic performance, with participants serving as their own controls. Participants are dosed on two separate occasions, once with non-alcoholic beverage and the other time with alcoholic beverage sufficient to raise blood alcohol to 0.10 g%. The morning after dosing, participants' academic performance is measured using a standardized achievement test (Graduate Record Exam). Participants' cognition is tested using the the Psychomotor Vigilance Test (PVT). Data on participants' demographics, family history of drinking problems and alcohol use. We are also collecting information on hangover symptoms and sleep quality the morning after dosing, in addition to participants' self ratings of academic performance. The procedure is conducted twice with one week in between, switching the individuals' dosing status, presenting a different, but comparable lecture and reading, and administering a different quiz based on the new lecture and reading and a different, but comparable standardized achievement exam. This design is intended to test the hypothesis that intoxication (0.10 g% BAC) with alcoholic beverage impairs next-day academic performance. Participation involves a total of five sessions over a two week period. Participants are undergraduates who volunteer and meet inclusion criteria. Prior to enrollment, volunteers are screened to ensure they meet initial eligibility criteria. Eligible volunteers receive written instructions regarding participation and are scheduled for the study sessions. Participants report to the study site on the first session for an additional screening by the study physician and go through the informed consent process. Eligible participants report back the next week for their first dosing night where they receive several drinks (alcohol or placebo) sufficient to raise their Breath Alcohol Level (BrAC) to 0.10 g%; the amount of beverage administered is based on their body weight. Those receiving placebo receive the same total quantity of beverage as those receiving alcohol. Both alcohol-dosed and placebo-dosed participants are breath-tested after they have completed their required dose. Participants sleep at the study site and are monitored overnight. The next morning they are awakened and are escorted to the exam room for the performance trials. They return the next week for the second dosing night/dosing morning, and receive either alcohol or placebo, depending on what was administered the previous week, and take different but comparable performance tests.

Alcoholic Intoxication Neurobehavioral Manifestations

Alcohol abuse Alcoholic beverages (beer) Residual effects Psychomotor performance Psychomotor vigilance test Neurobehavioral Evaluation System Family history of alcohol use Alcoholic Consumption Unhealthy alcohol use Alcohol

null

2

arm 1: Participants report for their first dosing night where they receive several alcohol drinks. After a wash out period of 1 week they then return and receive several placebo drinks. Participants sleep at the study site, are monitored overnight, and the next morning are awakened and escorted to the performance trials. arm 2: Participants report for their first night where they receive several placebo drinks. After a wash out period of 1 week they then return and receive several alcohol drinks. Participants sleep at the study site, are monitored overnight, and the next morning are awakened and escorted to the performance trials.

[ 0, 0 ]

2

[ 0, 10 ]

intervention 1: Participants report for their first dosing night where they receive several alcohol/beer drinks sufficient to raise their BrAC to 0.10 g%. Participants are breath-tested after completing their required dose. Participants return in a week for the 2nd session and receive placebo drinks. Participants are breath-tested after completing their placebo drinks. intervention 2: Participants report for their first night where they receive several placebo drinks. Participants are breath-tested after completing their placebo drinks. Participants return in a week for the 2nd session and receive alcohol drinks sufficient to raise their BrAC to 0.10 g%. Participants are breath-tested after completing their required dose.

intervention 1: Alcohol intervention 2: Placebo

1

Boston | Massachusetts | United States | -71.05977 | 42.35843

0

NCT00183170

[ 5 ]

28

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to examine the safety and efficacy of Depakote ER in bipolar depression and to evaluate metabolic and GABA changes with Depakote ER administration using PET and MRI/MRS brain imaging techniques.

Mood disorders are important public health problems. Bipolar disorder is a major psychiatric disorder characterized by mood cycles alternating between mania and depression and affects approximately 1% of the population. Most patients are treated beginning in the early twenties and then embark on a course marked by multiple recurrences, hospitalizations, and encounters with legal authorities. These disorders inflict substantial morbidity which yields important deficits in occupational and interpersonal function. The risk of suicide in mood disorders may be as high as 10%. Although the outlook for recovery from acute manic or depressive episodes is generally excellent, the long-term prognosis of the disorder varies tremendously across the patient population. The introduction of lithium, anticonvulsants and atypical antipsychotics significantly changes the outlook for bipolar disorder, with some individuals on chronic treatment attaining complete remission and indefinite prophylaxis against mood episodes. However, such optimum outcomes may be limited to as few as one-third to one-half of all treated patients. The remaining experiences various combinations of breakthrough mood episodes, including chronic mood instability, persistent depression, and rapid cycling. Very little research has been conducted with bipolar disorder, and no medications have an FDA indication to treat bipolar depression. Previous studies suggest that Depakote is promising in the treatment of mixed and depressed episodes of bipolar disorder. This study utilizes the extended release formulation of divalproex sodium, with demonstrated increased tolerability. We propose investigating safety, tolerability and efficacy of Depakote ER monotherapy in Bipolar I, II or NOS depression, and monitoring associated changes in brain GABA levels. In addition, we intend to evaluate and assess the differences between brain metabolic rate and GABA levels in bipolar disorder patients and healthy volunteers.

Depression, Bipolar

null

1

arm 1: Depakote ER up to 1500 mg/day

[ 0 ]

1

[ 0 ]

intervention 1: Depakote ER

1

Stanford | California | United States | -122.16608 | 37.42411

0

NCT00186186

[ 5 ]

61

RANDOMIZED

PARALLEL

1PREVENTION

0NONE

false

0ALL

null

Subjects aged 1-8 years who have been discharged from the emergency department/outpatient care facility with a diagnosis of asthma/bronchospasm/wheezing after usual standard care will be enrolled into this open-label, randomized, parallel-group study to compare the efficacy of nebulized budesonide and oral corticosteroids in preventing asthma exacerbation relapse rates during the 21-day follow-up period.

Secondary outcomes include urinary cortisol-creatinine rations, symptom severity scores and peak flow rates.

Asthma

null

2

arm 1: Subject is treated with nebulized budesonide 0.5 BID for 3 weeks arm 2: Subject is treated with usual care as provided by the doctor. Usual care normally consists of treatment with albuterol with or without an oral steroid.

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: Subject is treated with nebulized budesonide 0.5 BID for 3 weeks intervention 2: Subject is treated with usual care as prescribed by the doctor (normally albuterol with or without oral steroid)

intervention 1: Nebulized Budesonide intervention 2: Usual care (albuterol with or without oral steroid)

2

0

NCT00189436

[ 2, 3 ]

59

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

In this phase I/II trial, we will evaluate a novel combination of chemotherapy, used concurrently with radiation therapy, in the preoperative therapy of locoregional carcinoma of the esophagus and gastroesophageal junction. In the brief phase I portion of this trial, we will determine whether 2 drugs (docetaxel/oxaliplatin) or 3 drugs (docetaxel/oxaliplatin/capecitabine) can be used concurrently with radiation therapy. If the 3-drug regimen is tolerated, the phase II portion will proceed with this regimen. If the 3-drug combination is considered too toxic, the phase II study will proceed with docetaxel/oxaliplatin in combination with radiation therapy.

Upon determination of eligibility, patients will be receive: Oxaliplatin + Docetaxel + Capecitabine + Radiation therapy If the three-drug chemotherapy regimen, with radiation therapy, is tolerable, this regimen will be taken forward into the phase II portion of the trial. If the three-drug regimen is too toxic, the phase II portion will proceed with the two-drug regimen Oxaliplatin + Docetaxel + Radiation therapy

Esophagus Cancer

null

2

arm 1: Oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions). Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved. arm 2: Oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Capecitabine was administered 1000 mg/m2 orally twice daily on days 1 to 7, 15 to 21, and 29 to 35. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions). Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved.

[ 0, 0 ]

4

[ 0, 0, 0, 4 ]

intervention 1: 40 mg/m2 IV over 2 hours on days 1, 8, 15, 22, and 29 in both treatment cohorts intervention 2: 20 mg/m2 IV over 30 minutes was administered on days 1, 8, 15, 22, and 29 in both cohorts intervention 3: In Cohort 2, capecitabine was administered 1000 mg/m2 orally twice daily on days 1 to 7, 15 to 21, and 29 to 35. intervention 4: In both cohorts, radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).

intervention 1: Oxaliplatin intervention 2: Docetaxel intervention 3: Capecitabine intervention 4: Radiation therapy

7

0

NCT00193128

[ 3 ]

37

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This trial evaluates the novel combination of docetaxel with imatinib as first or second line therapy in advanced breast cancer with the aim of achieving higher effectiveness and potentially reducing side effects.

All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily

Breast Cancer

null

1

arm 1: All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily.

[ 0 ]

2

[ 0, 0 ]

intervention 1: Imatinib intervention 2: Docetaxel

6

0

NCT00193180

[ 3 ]

48

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

In this phase II trial, we will evaluate the feasibility and efficacy of the oxaliplatin/capecitabine combination in patients who have had one previous chemotherapy regimen for the treatment of carcinoma of unknown primary site. Patients who are relapsed after a previous response to treatment will be eligible, as well as those who were refractory to first-line therapy.

All patients received treatment with oxaliplatin 130mg/m2, given intravenously on day 1 of each 21 day cycle. Capecitabine 1000mg/m2 PO BID was administered on days 1-14 of each cycle.

Neoplasms, Unknown Primary

null

1

arm 1: All patients received treatment with oxaliplatin 130mg/m2, given intravenously on day 1 of each 21 day cycle. Capecitabine 1000mg/m2 by mouth twice daily was administered on days 1-14 of each cycle.

[ 0 ]

2

[ 0, 0 ]

intervention 1: 130 mg/m2 IV day 1 of 21 day cycle intervention 2: 1000 mg/m2 by mouth twice daily on days 1-14 of each 21 day cycle

intervention 1: Oxaliplatin intervention 2: Capecitabine

10

0

NCT00193609

[ 4 ]

37

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this long-term study is to determine whether Zinc Acetate is effective and safe in the treatment of Wilson's disease among Japanese.

Wilson disease is an autosomal recessive disorder with copper metabolism. In Japan, the standard treatment is the use of copper chelating agents, such as D-penicillamine and trientine. In this study, we investigate efficacy on zinc acetate in Japanese patients with Wilson disease.

Wilson's Disease

null

1

arm 1: zinc acetate

[ 0 ]

1

[ 0 ]

intervention 1: zinc acetate

intervention 1: NPC-02

0

null

0

NCT00212355

[ 3 ]

332

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

true

0ALL

true

Smokeless tobacco (ST), which includes both chewing tobacco and snuff, has health risks associated with its use. While treatment programs that focus on stopping tobacco use may be effective, past research has shown that interventions that specifically focus on reducing tobacco use may be equally effective and may motivate individuals to eventually quit using tobacco. This study will compare the effectiveness of a ST reduction treatment program versus a usual tobacco cessation treatment program (immediate cessation) for reducing tobacco use in ST users.

Individuals who use ST are at increased risk for cancer or dying from cardiovascular disease. Other long-term effects include tooth abrasion, gum recession, and loss of bone in the jaw. Many individuals who use ST recognize the health risks associated with ST, but either do not want to quit or feel that it is impossible to quit. For these individuals, tobacco reduction may be an important transitional goal, either prior to quitting or as a treatment endpoint. By participating in a tobacco reduction program, these individuals may be motivated to eventually stop using tobacco altogether. The purpose of this study is to compare a ST reduction treatment program versus a standard tobacco cessation treatment program (immediate cessation) for reducing tobacco use in ST users. This study will enroll regular users of ST. Participants will be randomly assigned to either a tobacco reduction program or to usual care, a standard tobacco cessation program during the first telephone contact. At the first clinic visit, participants assigned to the tobacco Reduction Group will replace their usual brand of ST with one of two options: an ST brand with less nicotine or nicotine lozenge. Participants will be encouraged to reduce their nicotine intake by at least 50% the first two weeks and encouraged to further reduce their nicotine intake in the following 4 weeks. Participants assigned to the Usual Care Group will be advised to quit and will be asked to set a quit date within two weeks. Telephone counseling, ideas on methods for sustaining cessation, and a self-help manual will also be provided along with a 2 week supply of nicotine patches. Study visits will occur at 2, 4, 8, 12, 26, and 32 (for reduction group) weeks. Outcome assessments will include vital signs, physiological measures related to tobacco use, levels of nicotine reduction, tobacco use status, and measures of motivation and self-efficacy to quit.

Tobacco Use Disorder

Nicotine Dependence Tobacco Dependence

null

2

arm 1: Usual care for cessation with immediate quit date scheduled and two weeks of nicotine patch supplied. arm 2: Reduction in nicotine exposure for 6 weeks prior to quit date using medicinal nicotine lozenge or reduced nicotine smokeless tobacco.

[ 1, 0 ]

2

[ 0, 10 ]

intervention 1: Nicotine replacement therapy intervention 2: Subject selects preferred method for reduction.

intervention 1: Usual Care Group intervention 2: Reduction Group

1

Minneapolis | Minnesota | United States | -93.26384 | 44.97997

0

NCT00218296

[ 0 ]

8

RANDOMIZED

CROSSOVER

0TREATMENT

4QUADRUPLE

false

0ALL

false

This double-blind placebo controlled crossover pilot trial will test the hypothesis that prazosin, an alpha-1 adrenergic receptor antagonist, reduces craving for their drug of choice in cocaine-dependent and alcohol-dependent veterans. Both the study medication period and the placebo period are each 4 weeks in duration.

1. Objective of the project: To evaluate the efficacy of prazosin on the reduction of craving in alcohol and cocaine dependent individuals. The investigators hypothesize that prazosin will be more effective than placebo in the reduction of craving that is stimulated by exposure to visual cues or to intolerance to stress in individuals dependent on cocaine and in individuals dependent on alcohol. Specifically, the investigators hypothesize that in this laboratory study: * Subjects in the prazosin condition will report a reduction in craving induced in the laboratory by exposure to visual cues compared to subjects in the placebo condition. * Subjects in the prazosin condition will show less reaction of the noradrenergic system when craving is induced in the laboratory by exposure to visual cues compared to subjects in the placebo condition. * Subjects will be less likely to relapse to their drug of choice while they are in the prazosin condition compared to when they are in the placebo condition. Most individuals who are able to achieve sobriety in chemical dependency treatment eventually relapse. Until the investigators can prevent the cravings for drugs, which usually precedes relapse, it is unlikely that the investigators will have more effective treatment for drug addiction. Our final hypothesis is that the alpha-1, adrenergic antagonist, prazosin, will prove to be an effective pharmacological agent for treatment of drug dependency. 2. Research plan study design: The proposed study will be a double-blind, placebo-controlled, crossover study of prazosin in subjects who are either dependent on alcohol or on cocaine, and who have been able to achieve one month of sobriety while in intensive outpatient treatment. The double-blind, crossover protocol will last 8 weeks and will include 32 subjects; 16 of whom are alcohol-dependent, and 16 of whom are cocaine-dependent. The focus of this first study will be on subjective and physiological measures of craving that will be induced in a controlled setting by exposure to visual cues. 3. Methodology Setting: This study will occur in room 6A-107 in Building 1 at the Veterans Administration Puget Sound Health Care System in Seattle. This is a soundproof room specifically designed and constructed for studies of this type. Participants: 16 alcohol-dependent adults and 16 cocaine-dependent adults presenting for chemical dependency treatment at the VA Puget Sound Health Care System (VAPSHCS) Addiction Treatment Center. Study Procedures: Once potential subjects have provided their consent to participate in the study, they will undergo a 2 hour baseline assessment that consists of some pencil and paper questionnaires, providing a medical and psychiatric history, and a physical exam. They will provide blood for some basic screening labs to insure they are healthy enough to proceed with the study, and have their baseline vital signs measured. Veterans who are screened for the study will then be enrolled once their lab results and the screening process have determined that they do not meet any medical exclusion criteria. At that point, participants will be randomized to either the study medication or placebo. During the course of the study, participants continue with their outpatient chemical dependency treatment through the Addiction Treatment Center at the VA Puget Sound. During the eight weeks of the study, participants will have weekly orthostatic vital sign and adverse events monitoring by the study nurse or physician. All serious or unexpected adverse events will be reported to the FDA and UW Human Subjects Committee in accordance with requirements. Participants will also provide self-reports of drug or alcohol use and urine drug analysis specimens at these weekly visits. At the end of week 4, each participant will be tested in a 1 hour craving session in room 6A-107 at VA Puget Sound. Subjects will have their heart rate and skin conductance response continuously measured, and have their blood pressure measured every 5 minutes. They will be shown 5 1-minute films, 3 of which are designed to be neutral and 2 of which are designed to provoke craving for their drug of choice. They will be asked to complete a subjective scale of craving prior to each video and after the last video. Participants will not be permitted to leave the craving lab after the last film, until they feel that they have subjectively returned to a level of normal physiological arousal and are no longer experiencing any craving. 4. Findings: No findings to date.

Alcoholism Cocaine Dependence

Alcoholism Cocaine Dependence Prazosin Substance use disorders

null

2

arm 1: Placebo no active medication arm 2: Prazosin flexible dose titration up to 12 mg per day.

[ 5, 1 ]

2

[ 0, 0 ]

intervention 1: FDA approved medication for hypertension intervention 2: None

intervention 1: Prazosin intervention 2: placebo

1

Seattle | Washington | United States | -122.33207 | 47.60621

0

NCT00240227

[ 0 ]

40

RANDOMIZED

PARALLEL

4SUPPORTIVE_CARE

4QUADRUPLE

false

0ALL

true

RATIONALE: Antiemetic drugs, such as aprepitant, ondansetron, and dexamethasone, may help lessen or prevent nausea and vomiting in patients undergoing a stem cell transplant. PURPOSE: This randomized clinical trial is studying aprepitant, ondansetron, and dexamethasone to see how well they work compared to placebo, ondansetron, and dexamethasone in preventing nausea and vomiting in patients who are undergoing a stem cell transplant.

OBJECTIVES: Primary * Compare the efficacy of standard antiemetic therapy comprising ondansetron and dexamethasone combined with either aprepitant or placebo in controlling nausea and vomiting, as determined by the number of retch/emesis-free days, in patients undergoing hematopoietic stem cell transplantation. Secondary * Determine the safety of aprepitant in these patients. * Compare nausea, appetite, taste changes, nutritional intake, and mucositis in patients treated with these regimens. * Determine the pharmacokinetics of cyclophosphamide, carboxyethylphosphoramide mustard, hydroxycyclophylamide, and aprepitant in these patients. OUTLINE: This is a randomized, placebo-controlled, single-blind, pilot study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Beginning on the first day of conditioning chemotherapy, patients receive oral aprepitant once daily and standard antiemetic therapy comprising oral or IV ondansetron and oral dexamethasone. * Arm II: Patients receive oral placebo once daily and standard antiemetic therapy as in arm I. In both arms, treatment continues until day 4 after stem cell transplant in the absence of unacceptable toxicity. After completion of study therapy, patients are followed until day 18. PROJECTED ACCRUAL: A total of 40 patients (20 per treatment arm) will be accrued for this study.

Cancer

nausea and vomiting adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) accelerated phase chronic myelogenous leukemia adult acute lymphoblastic leukemia in remission adult acute myeloid leukemia in remission atypical chronic myeloid leukemia blastic phase chronic myelogenous leukemia chronic eosinophilic leukemia chronic idiopathic myelofibrosis chronic myelomonocytic leukemia chronic neutrophilic leukemia chronic phase chronic myelogenous leukemia de novo myelodysplastic syndromes disseminated neuroblastoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue myelodysplastic/myeloproliferative disease, unclassifiable nodal marginal zone B-cell lymphoma noncontiguous stage II adult Burkitt lymphoma noncontiguous stage II adult diffuse large cell lymphoma noncontiguous stage II adult diffuse mixed cell lymphoma noncontiguous stage II adult diffuse small cleaved cell lymphoma noncontiguous stage II adult immunoblastic large cell lymphoma noncontiguous stage II adult lymphoblastic lymphoma noncontiguous stage II grade 1 follicular lymphoma noncontiguous stage II grade 2 follicular lymphoma noncontiguous stage II grade 3 follicular lymphoma noncontiguous stage II mantle cell lymphoma noncontiguous stage II marginal zone lymphoma noncontiguous stage II small lymphocytic lymphoma poor prognosis metastatic gestational trophoblastic tumor previously treated myelodysplastic syndromes recurrent adult acute lymphoblastic leukemia recurrent adult acute myeloid leukemia recurrent adult Burkitt lymphoma recurrent adult Hodgkin lymphoma recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent mantle cell lymphoma recurrent marginal zone lymphoma recurrent mycosis fungoides/Sezary syndrome recurrent neuroblastoma recurrent ovarian epithelial cancer recurrent ovarian germ cell tumor recurrent small lymphocytic lymphoma recurrent malignant testicular germ cell tumor refractory chronic lymphocytic leukemia refractory hairy cell leukemia refractory multiple myeloma relapsing chronic myelogenous leukemia secondary acute myeloid leukemia secondary myelodysplastic syndromes splenic marginal zone lymphoma stage I multiple myeloma stage II multiple myeloma stage II ovarian epithelial cancer stage III adult Burkitt lymphoma stage III adult Hodgkin lymphoma stage III adult diffuse large cell lymphoma stage III adult diffuse mixed cell lymphoma stage III adult diffuse small cleaved cell lymphoma stage III adult immunoblastic large cell lymphoma stage III adult lymphoblastic lymphoma stage III chronic lymphocytic leukemia stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage III grade 3 follicular lymphoma stage III mantle cell lymphoma stage III marginal zone lymphoma stage III multiple myeloma stage III ovarian epithelial cancer stage III small lymphocytic lymphoma stage III malignant testicular germ cell tumor stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer stage IV adult Burkitt lymphoma stage IV adult Hodgkin lymphoma stage IV adult diffuse large cell lymphoma stage IV adult diffuse mixed cell lymphoma stage IV adult diffuse small cleaved cell lymphoma stage IV adult immunoblastic large cell lymphoma stage IV adult lymphoblastic lymphoma stage IV breast cancer stage IV chronic lymphocytic leukemia stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma stage IV mantle cell lymphoma stage IV marginal zone lymphoma stage IV ovarian epithelial cancer stage IV small lymphocytic lymphoma unspecified adult solid tumor, protocol specific

null

2

arm 1: None arm 2: Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant

[ 1, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant intervention 2: For Cyclophosphamide Total Body Irradiation(CyTBI) patients: Dexamethasone study drug 1 capsule PO daily, 1 hour prior to chemotherapy with aprepitant on total body irradiation(TBI) and cyclophosphamide chemotherapy days; For Busulfan Cyclophosphamide(BuCy) patients: Dexamethasone 1 capsule orally once daily, discontinue after last dose of chemotherapy. intervention 3: For CyTBI patients: Ondansetron 8 mg orally evert 12 hours, begin 1 hour prior to first TBI dose and discontinue after last dose; then Ondansetron 8 mg IV every 12 hours X 4 doses, begin 30 minutes prior to first cyclophosphamide chemotherapy; For BuCy patients: Ondansetron 8 mg orally every 6 hours, begin 1 hour prior to first busulfan dose and discontinue after last busulfan dose is given. then: Ondansetron 8 mg IV Q 12 hours X 4 doses, begin 30 minutes prior to first cyclophosphamide chemotherapy intervention 4: Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant

intervention 1: aprepitant intervention 2: dexamethasone intervention 3: ondansetron intervention 4: placebo

1

Portland | Oregon | United States | -122.67621 | 45.52345

0

NCT00248547

[ 0 ]

812

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to determine the effectiveness of several anti-HIV treatment strategies in resource-poor South African communities. The strategies being studied are using specially trained doctors or nurses to administer HIV care.

The introduction of antiretroviral therapy (ART) for the treatment of HIV has dramatically improved morbidity and mortality for HIV infected people in the developed world. However, research data on the efficacy of ART regimens in developing countries, such as South Africa, are limited. There are an estimated 4.7 million HIV infected individuals in the South African population of about 40 million inhabitants. The greatest social impact may be achieved by treating an entire household affected by HIV to ensure maximum adherence to prescribed ART regimens and to minimize the sharing of antiretroviral drugs. This study will evaluate the effectiveness of ART given by an HIV-trained doctor compared to ART given by an HIV-trained primary health care nurse. Participants failing first-line therapy will receive a second-line regimen based on what medications are available at the clinic, with approval by the clinical safety team. Participants in this study will be recruited from resource-poor communities outside Johannesburg and Cape Town, South Africa. This study will last 5 years. HIV infected people and other HIV infected members of their household 16 years of age and older will be enrolled. Study participants will receive first-line ART consisting of efavirenz (EFV) once daily, lamivudine (3TC) twice daily, and stavudine (d4T) twice daily. Women of childbearing potential who are unwilling to use acceptable forms of contraception and who have CD4 counts less than 250 cells/mm3 will receive 3TC twice daily; nevirapine (NVP) daily for 2 weeks, then twice daily; and d4T twice daily. Women who are pregnant at baseline, who become pregnant on study treatment, or who are unwilling to use acceptable methods of contraception and have CD4 counts of 250 cells/mm3 or more, or children who were previously exposed to NVP will receive 3TC twice daily, lopinavir/ritonavir (LPV/r) twice daily, and d4T twice daily. Participants will be randomly assigned to one of two arms. Arm 1 will receive ART under the monitoring care of an HIV-trained medical doctor, while Arm 2 will receive ART under the monitoring care of an HIV-trained primary health care nurse with training in HIV diagnosis and treatment. Participants who fail their first-line regimen will receive a second-line regimen but will remain in their treatment arms. Study visits will occur at study entry; Weeks 2, 4, 8, and 12; and every 12 weeks thereafter. A physical exam, measurement of height and weight, tuberculosis (TB) and hepatitis B infection screening, blood collection, pill counts, and compliance/adherence and resource utilization counseling will occur at most visits. Participants will also be asked to complete quality of life and household cost questionnaires at selected visits. Study visits for participants who fail first-line treatment will occur at treatment failure, between Days 15 and 30, Week 4 post-treatment failure, every 4 weeks until Week 48 post-treatment failure, and every 12 weeks thereafter. A targeted physical exam, measurement of height and weight, TB infection screening, blood collection, pill counts, and compliance/adherence and resource utilization counseling will occur at most visits. Participants will also be asked to complete quality of life and household cost questionnaires at selected visits.

HIV Infections

Treatment Naive

null

2

arm 1: Study-specified Antiretroviral regimen under care of HIV-trained medical doctor arm 2: Study-specified Antiretroviral regimen under care of HIV-trained primary care nurse

[ 1, 1 ]

7

[ 5, 5, 0, 0, 0, 0, 0 ]

intervention 1: Participants will receive care from an HIV-trained medical doctor intervention 2: Participants will receive care from an HIV-trained primary care nurse intervention 3: 600 mg tablet taken orally daily intervention 4: 150 mg tablet taken orally daily intervention 5: 400 mg lopinavir/100mg ritonavir tablet taken orally twice daily intervention 6: 200 mg tablet taken orally for 14 days before taking a 200 mg tablet orally twice daily intervention 7: Tablet taken orally daily. Dosage depends on weight.

intervention 1: Monitoring by an HIV-trained medical doctor intervention 2: Monitoring by an HIV-trained primary care nurse intervention 3: Efavirenz intervention 4: Lamivudine intervention 5: Lopinavir/Ritonavir intervention 6: Nevirapine intervention 7: Stavudine

0

null

0

NCT00255840

[ 4 ]

139

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to evaluate the long-term safety and effectiveness of EN3267 in treating breakthrough pain episodes in opioid cancer patients who are using stable doses of opioid medication.

This was a Phase 3 non-randomized, open-label, multicentre study designed to evaluate the long-term safety of EN3267 in the treatment of BTcP in opioid-tolerant cancer patients. The study was conducted in 2 parts: 1. A Titration Period during which patients had up to 2 weeks to determine a single, effective dose of study medication (EN3267) for adequate treatment of BTcP, and 2. A maintenance Period of up to 12 months in which episodes of BTcP were treated with study medication.

Pain Cancer

EN3267 Breakthrough Pain Safety Study Fentanyl Tablets

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: EN3267 will be available in 100, 200, 300, 400, 600 (two 300 ug tablets), and 800 ug (two 400 ug tablets) doses

intervention 1: EN3267

1

Winston-Salem | North Carolina | United States | -80.24422 | 36.09986

0

NCT00263575

[ 5 ]

70

RANDOMIZED

PARALLEL

1PREVENTION

4QUADRUPLE

true

0ALL

true

The purpose of the study is to test higher versus lower doses of aspirin on markers of atherosclerosis in patients at risk of a first heart attack.

Aspirin reduces risks of heart attacks, strokes, and deaths from cardiovascular causes in patients who have survived a prior event as well as during an acute heart attack. Aspirin also prevents a first heart attack. Low dose aspirin is sufficient to achieve complete inhibition of platelet aggregability, or stickiness, and this is the mechanism whereby aspirin prevents formation of blood clots. Our research is designed to explore whether higher doses of aspirin provide additional benefits on markers of atherosclerosis.

Cardiovascular Diseases Metabolic Syndrome X Atherosclerosis

Primary prevention Cardiovascular diseases Aspirin Metabolic Syndrome X Atherosclerosis

null

5

arm 1: 81 mg Aspirin arm 2: 162 mg Aspirin arm 3: 325 mg Aspirin arm 4: 650 mg Aspirin arm 5: 1300 mg Aspirin

[ 1, 1, 1, 1, 1 ]

1

[ 0 ]

intervention 1: Dosage

intervention 1: Aspirin

1

Towson | Maryland | United States | -76.60191 | 39.4015

0

NCT00272311

[ 5 ]

13

NA

SINGLE_GROUP

2DIAGNOSTIC

0NONE

true

0ALL

null

The researcher proposes to assess levels of sputum inflammatory markers (eosinophils, eosinophil cationic protein (ECP), neutrophils IL-8) before and while on anti-IgE therapy in a pediatric population of moderate to severe asthmatics who have ongoing persistent asthma symptoms despite on moderate to high doses of inhaled corticosteroids (ICS). Associations will be assessed between the types of sputum inflammatory markers and the patient's atopic status and level of asthma control as indicated by the following measures: 1. pulmonary function test (PFT) 2. asthma symptoms based on the Asthma Control Test (ACT)

Objectives: Primary: Describe inflammatory cell types in study patients and compare changes in inflammatory cell patterns before and during anti-IgE therapy. Secondary:Describe patterns of sputum eosinophilia and neutrophilia in relation to asthma symptom improvement based on ACT and PFT Hypotheses: Differences in inflammatory response after the addition of anti-IgE therapy can be described in neutrophilic, eosinophilic and neutrophilic/eosinophilic asthmatics. Neutrophilic asthmatics patients will fail to respond when placed on anti-IgE while eosinophilic asthmatics will respond well. Sputum inflammatory markers are sensitive markers of inflammation and can predict response to new asthma treatment modalities such as anti-IgE therapy.

ALLERGIC ASTHMA

null

1

arm 1: One arm:active drug

[ 0 ]

1

[ 0 ]

intervention 1: Xolair dosing is based on body weight and baseline serum total IgE concentration(0.016 x kg body weight x IgE levels), with a maximum dose per 4 weeks of 750mg.Depending on their weight and IgE levels, patients get their Xolair shots every 2 or every 4 weeks.

intervention 1: ANTI-IGE THERAPY (XOLAIR)

0

null

0

NCT00283504

[ 2, 3 ]

88

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

Open-label Multicenter, Phase I/II Study comprising three phases (single dose, multiple dose and extension phase), Assessing the Safety and Efficacy of Ranibizumab (RFB002) in Japanese Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD).

The safety and tolerability of single intravitreal injections of ranibizumab was evaluated in patients enrolled in the single dose phase (Group A). Patients who successfully completed the single dose phase (i.e. did not experience a grade-3 targeted adverse event) could enter the multiple dose phase and receive ranibizumab injections for an additional 11 months. Simultaneously, the multiple dose phase was initiated in two parallel dose groups of additional patients (Group B), who received ranibizumab injections for 12 months. After patients in Group A and Group B had completed the multiple dose phase, all patients who provided written consent and were considered eligible based on the inclusion and exclusion criteria of the extension phase had the opportunity to continue on study treatment with the individualized flexible treatment regimen guided by monthly acuity scores and other ophthalmic examinations until approval of ranibizumab in Japan.

Subfoveal Choroidal Neovascularization(CNV) Secondary to Age-related Macular Degeneration (AMD)

Subfoveal CNV, AMD, ranibizumab

null

4

arm 1: In the single dose phase, all patients randomized in Group A received a single intravitreal injection of 0.3 mg of ranibizumab into the study eye. Those patients who successfully completed this phase entered the multiple dose phase, where they received an intravitreal injection of 0.3 mg of ranibizumab once a month for an additional 11 months. Subsequently patients enrolling in the extension phase received an intravitreal injection of 0.3 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.70 years. arm 2: In the single dose phase, all patients randomized in Group A received a single intravitreal injection of 0.5 mg of ranibizumab into the study eye. Those patients who successfully completed this phase entered the multiple dose phase, where they received an intravitreal injection of 0.5 mg of ranibizumab once a month for an additional 11 months. Subsequently Group A patients enrolling in the extension phase received an intravitreal injection of 0.5 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.93 years. arm 3: Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study. Group B patients who enrolled in the extension phase received an intravitreal injection of 0.3 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.45 years. arm 4: Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study. Group B patients who enrolled in the extension phase received an intravitreal injection of 0.5 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.36 years.

[ 0, 0, 0, 0 ]

1

[ 0 ]

intervention 1: Ranibizumab was administered by intravitreal injection in the study eye. Intravitreal injection was performed by the investigator following slitlamp examination.

intervention 1: Ranibizumab

1

Tokyo | N/A | Japan | 139.69171 | 35.6895

0

NCT00284089

[ 5 ]

36

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

The purpose of this study is to assess the ability of Ultrafiltration to influence the rate of hemodynamic improvement, as measured by the decline in the pulmonary artery occlusion pressure, in patients with NYHA class III/IV Heart Failure.

This study will be preformed in a specialized heart failure unit at the Cleveland Clinic Foundation (CCF) and will include both the UF-treated group and a control group receiving usual and customary care. Patients will be stratified according to renal function at the time of admission. Therapies will be guided by specific hemodynamic criteria routinely used at the study institution.

Heart Failure CHF

Heart Failure Congestive Heart Failure CHF

null

2

arm 1: Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure. arm 2: Patients treated with conventional diuretic therapy upon hospital admission for treatment of decompensated heart failure.

[ 1, 1 ]

2

[ 0, 1 ]

intervention 1: Use of conventional diuretic therapy upon hospital admission for treatment of decompensated heart failure. intervention 2: Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.

intervention 1: IV loop diuretic intervention 2: NxStage System One

1

Cleveland | Ohio | United States | -81.69541 | 41.4995

0

NCT00288587

[ 3 ]

130

RANDOMIZED

PARALLEL

1PREVENTION

2DOUBLE

false

0ALL

true

The purpose of this study is to learn whether apixaban is well-tolerated and acceptable as anticoagulant therapy, when administered to patients with advanced or metastatic cancer and at increased risk for venous thromboembolic events. Demonstration of a favorable benefit:risk profile could lead to significant reduction in this serious and sometimes fatal complication of ongoing cancer and its treatment.

null

Thrombosis Cancer Pulmonary Embolism

anticoagulant

null

6

arm 1: Participants received placebo tablets once daily arm 2: Participants received apixaban as tablet, 5 mg, once daily arm 3: Participants received apixaban as tablet, 10 mg, once daily arm 4: Participants received apixaban as tablet, 20 mg, once daily arm 5: Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily. arm 6: Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.

[ 2, 2, 1, 1, 2, 1 ]

2

[ 0, 0 ]

intervention 1: Oral tablets administered once daily in 5-, 10-, or 20-mg dose intervention 2: Oral tablets administered once daily

intervention 1: Apixaban intervention 2: Placebo

14

0

NCT00320255

[ 3 ]

55

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

This study will determine whether increasing D-serine within the body will improve negative symptoms and cognitive impairments in people with schizophrenia.

Schizophrenia is a life-long brain disorder affecting approximately 1 percent of Americans each year. Schizophrenia can be extremely disabling, causing people to hear voices, experience paranoia or hallucinations, believe that others are controlling their thoughts, and even fail at maintaining a job or caring for themselves. Current medications help to relieve most of these symptoms, but not all. Some people with schizophrenia still suffer from negative symptoms, such as difficulty with talking, expressing emotions, and motivation; they may also suffer from cognitive impairments, such as decreased concentration and memory loss. D-serine, an amino acid found within the body, activates brain cell receptors that appear to play a role in learning and memory. This study will determine whether adding a D-serine solution to a stable antipsychotic medication regimen will decrease negative symptoms in people with schizophrenia. Participants in this open-label study will remain on their regular medication regimen for at least 2 weeks. During this time and before starting treatment, participants will be interviewed about their emotional problems, marital status, education, family background, employment history, and any drug or alcohol problems. Participants will also undergo a physical exam, an electrocardiogram (EKG), vital sign measurements, psychological tests, cognitive tasks, and an electroencephalogram (EEG). Participants will then begin 4 weeks of treatment with D-serine. In addition to participants' regular medication regimen, they will drink a D-serine powder mixed with water twice daily. Every 2 weeks, participants will undergo a physical exam and an interview about any changes in symptoms or emotional problems that they may be experiencing. Blood and urine samples will be taken throughout the study. After 4 weeks, participants will undergo an EKG, EEG, and the same psychological tests and cognitive tasks completed prior to treatment. A follow-up visit will occur 2 weeks post-treatment to monitor any changes in negative symptoms.

Schizophrenia

Negative symptoms NMDA Glutamate Glycine

null

3

arm 1: D-serine 30 mg/kg arm 2: D-serine 60 mg/kg arm 3: D-serine 120 mg/kg

[ 0, 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: D-serine at following dose levels: 30 mg/kg, 60 mg/kg, and 120 mg/kg. PK/PD studies done at day 1. Medication will be administered as powder dissolved in liquid given in two divided doses daily for 4 weeks. intervention 2: None intervention 3: None intervention 4: None

intervention 1: D-serine intervention 2: D-serine intervention 3: D-serine intervention 4: D-serine

3

0

NCT00322023

[ 5 ]

114

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

1FEMALE

null

The purpose of this study is to describe the joint symptoms and structural joint changes under anastrozole as adjuvant treatment in postmenopausal women with early breast cancer.

null

Early Breast Cancer

breast cancer treatment joint disorders

null

0

null

1

[ 0 ]

intervention 1: 1mg/Day oral

intervention 1: Anastrozole

5

Bordeaux | N/A | France | -0.5805 | 44.84044 Caen | N/A | France | -0.35912 | 49.18585 Lyon | N/A | France | 4.84671 | 45.74846 Paris | N/A | France | 2.3488 | 48.85341 Poitiers | N/A | France | 0.34348 | 46.58261

0

NCT00323479

[ 5 ]

34

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

The aim of this exploratory study is to evaluate the rejection rate in patients treated with cyclosporine (CsA) preceding oral administration of cyclosporine micro emulsion in de novo liver recipients. The blood levels of CsA and CsA micro emulsion will be monitored by C-2h monitoring. In addition, this study will assess the safety of this treatment regimen.

null

Liver Transplantation

Liver transplantation, Cyclosporine

null

1

arm 1: Period 1: Cyclosporine (Sandimmun® i.v.) intravenous given 2 times daily as an infusion over four hours staring at a dose of 2 X 200 mg/day for 7 days followed by Period 2: Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.

[ 0 ]

2

[ 0, 0 ]

intervention 1: Cyclosporine (Sandimmun® i.v.) intravenous given 2 times daily as an infusion over four hours staring at a dose of 2 X 200 mg/day for 7 days. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels. intervention 2: Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.

intervention 1: Cyclosporine (Sandimmun® i.v.) intervention 2: Cyclosporine (Sandimmun® Optoral)

1

Various Cities | N/A | Germany | N/A | N/A

0

NCT00332462

[ 0 ]

7

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

Researchers from the Division of Pulmonary and Critical Care Medicine at University of California, San Francisco (UCSF) are conducting a study to evaluate whether mycophenolate mofetil (an immunosuppressive medication, trade named CellCept) is safe and effective for preventing the lung damage from scleroderma from getting worse.

The proposed study is designed to evaluate the safety and efficacy of mycophenolate mofetil (CellCept) for the treatment of symptomatic pulmonary alveolitis due to systemic sclerosis (SSc). This study utilizes a prospective, open-label, experimental design. Primary Hypothesis: The alveolitis in patients with SSc, as defined by decreased forced vital capacity (FVC), bronchoalveolar lavage (BAL), and High Resolution Chest Tomography (HRCT) is responsive to 1 year of daily mycophenolate mofetil therapy. Secondary Hypothesis: Quality of life, six-minute walk and single-breath diffusing capacity for carbon monoxide (DLCO) improve in patients with SSc mediated alveolitis after therapy with mycophenolate mofetil. This response to therapy is associated with a change in the inflammatory cytokine profile present in BAL fluid.

Scleroderma, Systemic

null

1

arm 1: Mycophenolate Mofetil

[ 0 ]

1

[ 0 ]

intervention 1: None

intervention 1: Mycophenolate mofetil

1

San Francisco | California | United States | -122.41942 | 37.77493

0

NCT00333437

[ 5 ]

16

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

1FEMALE

false

This study is being conducted to evaluate the effectiveness of ramelteon 8mgs in the treatment of insomnia in patients that have completed their first chemotherapy treatment for breast cancer.

Phase IV, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy of ramelteon 8mgs in the treatment of insomnia in patients with breast cancer.

Chronic Insomnia

chronic insomnia

null

2

arm 1: Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period. arm 2: Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.

[ 2, 1 ]

2

[ 0, 0 ]

intervention 1: Placebo taken 30 minutes before bedtime days 1-28 of treatment period intervention 2: 8 mgs daily for days 1-28 of treatment period

intervention 1: Placebo intervention 2: Ramelteon

10

0

NCT00337272

[ 5 ]

97

RANDOMIZED

PARALLEL

1PREVENTION

4QUADRUPLE

false

0ALL

false

This study is designed as a prospective, randomized, placebo-controlled, double-blind analysis of atorvastatin 80 mg versus placebo administered on average 4 hours prior to percutaneous coronary intervention \[PCI\] (at least 2 hours) in patients presenting with unstable angina. Only patients with negative cardiac biomarkers, measured on 2 separate occasions a few hours apart will be eligible for inclusion. Furthermore, patients already on high-dose statin therapy; patients taking any statin within 24 hours prior to the PCI; and patients with contraindications to statins will be excluded from the study. The primary endpoint is a quantitative troponin level at 18-24 hours after PCI. At an enrollment of a total of 150 patients (75 per group), the study is powered to detect a 30% difference in troponin level. Secondary endpoints include elevation of creatine kinase (CK) and CK-MB above the upper limit of normal, change in C-reactive protein (CRP) levels from baseline and thrombolysis in myocardial infarction (TIMI) myocardial perfusion grade. All patients will be started on statin therapy the day after the procedure, as deemed appropriate by their treating physicians.

STUDY OBJECTIVES: 1. The primary endpoint of the study is to evaluate the effects of a single high dose of atorvastatin versus placebo on peri-procedural myonecrosis, as measured by troponin T (TnT), during percutaneous coronary intervention (PCI) in patients presenting with acute coronary syndromes (ACS). 2. Secondary endpoints include the measurements of other biomarkers of myocyte injury (CK, CK-MB) and inflammation (CRP). 3. Other secondary endpoints include the relative angiographic efficacy of atorvastatin versus placebo on the post PCI growth of tissue level perfusion circumference and the post PCI growth of tissue level perfusion brightness using digital subtraction angiography. METHODS: I. Selection and Number of Patients The study subjects are to be selected from those patients presenting to the BIDMC for cardiac catheterization. Eligible patients will be identified in the cardiac catheterization holding area prior to their procedure. After obtaining informed consent, patients will be randomized to a single dose of atorvastatin or placebo, which will be administered in the holding area about 4 hours prior to the procedure. There will be a total of 150 subjects enrolled in the study. There are a total of 2500 PCIs performed at the BIDMC per year, a third of which are for ACS. We anticipate that 30-40% of patients with ACS will be eligible for study participation. II. Informed Consent Informed consent will be obtained from all individuals prior to enrolment in the study according to local Internal Review Board guidelines. III. Pretreatment Data Collection Baseline clinical data will be recorded at enrolment and will include: Subject's age, sex, weight and height, diabetes, hypertension, smoking status, hypercholesterolemia (including cholesterol levels if available), the presence of coronary or peripheral artery disease and prior history of PCI or coronary artery bypass surgery. Further, all current medications will be recorded. A detailed angina history will be collected from the patient and the medical record looking for evidence of unstable angina as defined by Braunwald. IV. Medications A. Study Medication Patients will be randomly assigned to atorvastatin 80 mg po or placebo in a double-blind fashion. The study medication will be administered immediately after informed consent is obtained and the patient is randomized to a treatment group in the cardiac catheterization holding area. Given the typical waiting time between first presentation in the holding area and PCI in a non-emergent case, it is estimated that the study medication will be administered 4 hours prior to the procedure (minimal time of 2 hours). All patients will receive a single dose of study medication prior to the procedure. After the completion of the procedure, all statin therapy will be withheld until the next day. Eligible patients can then receive statin therapy according to the treating physicians' preferences. All potential adverse reactions to the study medication will be recorded. B. Concomitant Therapy Aspirin (325 mg/day) will be administered prior to intervention and during follow-up. Clopidogrel (300 mg or 600 mg bolus followed by 75 mg/day) will be administered post-stent deployment. It is expected that the majority of patients will receive a glycoprotein IIb/IIIa inhibitor during the procedure and for 18 hours thereafter. V. Procedures A. Laboratory Tests At baseline, levels of troponin, CK and CK-MB will be obtained at the time of presentation and immediately prior to PCI. Patients with any of these serum markers above the upper limit of normal will be excluded from the study. Post-procedural enzymes will be obtained 6-8 hours after the procedure and the next morning (18-24 hours after the procedure). Patients with elevated enzymes may undergo further sampling to determine the peak enzyme rise. The peak troponin level obtained from any post-procedural blood draw will be used as the primary endpoint. Furthermore, baseline CRP levels will be obtained prior to PCI and on the next day. B. Digital Subtraction Angiography To quantitate the kinetics of dye entry into the myocardium, digital subtraction angiography can be used. Digital subtraction angiography will be performed at end diastole by aligning cineframe images before dye filled the myocardium with the frame in which dye first reached its peak brightness. The spine, ribs, diaphragm and the epicardial artery are then subtracted. A representative region of the myocardium is sampled that is free of overlap by epicardial arterial branches to determine the increase in the gray scale brightness of the myocardium. The circumference of the myocardial blush is measured using a handheld planimeter (Fowler, Inc). The frame count ÷ number of frames per second is used to measure the time elapsed during angiography to quantitate the rate of rise in the growth (cm/sec) and brightness (gray/sec) of myocardial blush. Blush will also be assessed visually using the TIMI myocardial perfusion grade.

Coronary Disease

Acute coronary syndrome Percutaneous coronary intervention Peri-procedure myocardial infarction

null

3

arm 1: 80 mg atorvastatin on average of 2-4 hours pre angio/PCI for ACS arm 2: placebo on average of 2-4 hours pre angio/PCI for ACS arm 3: Patients signed consent if willing to participate. Patients will continue onto randomization if appropriate per inc/exc (i.e. stent placement) otherwise screen fail

[ 1, 2, 4 ]

3

[ 0, 0, 10 ]

intervention 1: placebo pre-PCI for ACS intervention 2: atorvastatin 80 mg pre-angio/PCI intervention 3: Patients signed consent to be screened for eligibility for randomization to placebo vs. study drug (atorvastatin)

intervention 1: Placebo Oral Tablet intervention 2: Atorvastatin 80mg intervention 3: Screening

1

Boston | Massachusetts | United States | -71.05977 | 42.35843

0

NCT00344019

[ 3 ]

10

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

true

This study will examine the effect of the drug Raptiva (efalizumab) in patients with Sjögren's syndrome (SS), an autoimmune disease affecting the glands producing saliva \& tears. The cause of SS is not known, but inflammation plays an important role. Raptiva is approved by the Food and Drug Administration to treat psoriasis, an inflammatory skin disease. Patients 18 years of age \& older with SS may be eligible for this study. Candidates are screened with a history \& physical examination, chest x-ray, and oral \& eye examinations. Participants are randomly assigned to receive either Raptiva or placebo (an inactive substance that looks like Raptiva) for the first 3 months of the study. For the next 3 months, all participants receive Raptiva. Both Raptiva \& placebo are injected under the skin once a week. Evaluation during treatment \& for 2 months after treatment as follows: Full comprehensive evaluations (beginning of the study, at weeks 13 \& 25 and 2 months after treatment ends): * Physical examination \& blood draw. * Saliva collection done in two ways: 1) suctions cups connected to collection tubes are placed over the salivary gland ducts in the mouth and under the tongue; and 2) a sour-tasting liquid is applied to the top \& sides of the tongue at 30-second intervals to stimulate saliva production. * Eye exam for tear gland function. * Questionnaires about mouth \& eye dryness, energy level and overall well-being. * Lip biopsy (screening \& week 13 visits only). A few minor salivary glands are removed for examination under a microscope. The lower lip is numbed, a small cut is made on the inside of the lip, and several glands are removed. The cut is closed with a few stitches that are removed after 5 to 7 days. * Magnetic resonance imaging of the parotid glands (salivary glands near the ear) at weeks 1, 13 and 25. The patient lies on a stretcher that is moved into the scanner (a metal cylinder containing a strong magnetic field). The head is held in place during the scan. The study lasts about 90 minutes. * Short evaluations at weeks 3, 5, 9, 15, 17, 21 and 1 month after treatment ends. * Medical history \& physical examination, blood draw, evaluation for changes in symptoms and side effects, review of current medications at weeks 3, 9, 15 and 21. * Laboratory tests, evaluation for changes in symptoms and side effects, review of current medications, saliva collection without the sour liquid and short evaluation of tear production at weeks 5 and 17. * Blood tests at week 29

The LFA-1/ICAM-1 interaction is important in migration of lymphocytes to inflammatory sites, T-lymphocyte activation, antigen presentation, and maintaining the integrity of the immunologic synapse. In both murine and human Sjogren's Syndrome, increased expression of LFA-1 was found on activated lymphocytes, and increased expression of ICAM-1 was present on the activated endothelial cells in the diseased salivary and lacrimal glands. In animal models, blockade of the LFA-1/ICAM-1 interaction resulted in reduction of glandular inflammation. Raptiva (efalizumab) is a recombinant humanized monoclonal antibody that binds to human CD11a, the alpha-subunit of Leukocyte Function Antigen-1 (LFA-1) and inhibits the LFA-1/ICAM-1 interaction. Raptiva is an FDA-approved medication for treatment of mild-to-moderate psoriasis. In this pilot, proof of concept, randomized, double-blind, placebo-controlled study, up to 25 patients with Sjogren's syndrome may be enrolled. In the first, double-blind phase of the study, patients will be randomized and treated with weekly subcutaneous (SC) injections of either Raptiva (1mg/kg) or placebo for 12 weeks. In the second open label phase, all patients will be treated with weekly SC injections of Raptiva (1mg/kg) for another 12 weeks and then followed for an additional 8 weeks. Safety will be evaluated using standard clinical and laboratory parameters. To assess the potential effect of Raptiva on Sjogren's syndrome, minor salivary gland biopsy, oral and ocular evaluations, and measurements of surrogate markers of inflammation will be compared between the Raptiva and placebo treated groups before and after the treatment. Patients who either do not tolerate the drug or have worsening in their disease activity will be withdrawn from the protocol. If Raptiva is well tolerated in this study and the treatment is associated with improvement in clinical parameters of Sjogren's Syndrome, further large studies of efficacy are planned.

Sjogren's Syndrome

Adhesion Molecule Interventional Study Immunomodulation Autoimmunity Sjogren Syndrome SS

null

2

arm 1: At the beginning of the first (week 1) and second (week 13) phases, all patients will receive reduced dose of the study medication determined at 0.7 mg/kg/week. During all the subsequent administrations, all patients will receive full dose of the study medication determined at 1 mg/kg/week. arm 2: Weekly subcutaneous injection of a placebo (formulated to match the commercial vial of Raptiva in appearance and content except for the active ingredient) for the first 12 weeks of the study.

[ 0, 2 ]

1

[ 0 ]

intervention 1: During the first phase of the study, subjects are randomized in a double blind fashion to receive weekly subcutaneous injections of efalizumab (Raptiva) or placebo (weeks 0-12). The second 12 weeks long phase is open label with all subjects receiving weekly subcutaneous injections of efalizumab.

intervention 1: Raptiva

1

Bethesda | Maryland | United States | -77.10026 | 38.98067

0

NCT00344448

[ 0 ]

25

RANDOMIZED

PARALLEL

1PREVENTION

4QUADRUPLE

false

0ALL

false

People with asthma may have asthma worsening when they have an upper respiratory infection due to a virus or a common cold. Leukotrienes are increased in nasal secretions from children with Respiratory Syncytial Virus (RSV) and lung washings during times of acute lung inflammation. Experimental virus exposure in adults is also associated with increases in nasal leukotrienes. The degree to which leukotrienes play a role in asthma worsening is unknown.There is information linking leukotrienes to viral infections, allergic inflammation, and asthma exacerbation.This information supports the hypothesis that virus-induced leukotrienes contribute to the severity of respiratory infections and in susceptible individuals, lead to lower airway obstruction and exacerbations of asthma. We propose to use montelukast in an experimental viral challenge model to explore this hypothesis.

Viral infections are important causes of wheezing illnesses throughout childhood and in adults with asthma. There has been progress in identifying mechanisms and risk factors for severe respiratory symptoms, and in particular, wheezing. Given this close relationship, it would be attractive to apply antiviral strategies to the prevention and treatment of asthma, and both RV and RSV are obvious targets. Unfortunately, attempts at developing an RSV vaccine have so far been unsuccessful, and vaccination to prevent RV infection does not seem to be feasible due to the large number of serotypes. Antiviral medications have been tested in clinical trials, however one problem with this approach is that once the clinical signs and symptoms appear, viral replication is well underway. The other potential therapeutic approach for respiratory viral infections would be to selectively inhibit pro-inflammatory immune responses induced by the virus. The beneficial effects of systemic glucocorticoids indicate that this approach is valid; the challenge will be to develop treatments with greater efficacy and a reduced potential for adverse effects. The large body of information linking cysteinyl leukotrienes to viral infections, allergic inflammation, and asthma exacerbations, strongly supports the hypothesis that virus-induced leukotrienes contribute to the severity of respiratory infections and in susceptible individuals, lead to lower airway obstruction and exacerbations of asthma. We propose to use montelukast in an experimental viral challenge model to explore this hypothesis.

Asthma

asthma leukotrienes rhinovirus

null

2

arm 1: montelukast (10 mg everyday) arm 2: Placebo comparator

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: 10 mg everyday intervention 2: like placebo

intervention 1: montelukast intervention 2: placebo

1

Madison | Wisconsin | United States | -89.40123 | 43.07305

0

NCT00359073

[ 5 ]

108

NA

SINGLE_GROUP

5SCREENING

0NONE

true

0ALL

false

The purpose of the study is to test whether atorvastatin (also known as Lipitor) has anti-inflammatory effects in people with no known heart disease or high cholesterol. We also are investigating whether or not genetic differences between people plays a role in the drug response.

All subjects received 16 weeks of Atorvastatin after a two week run in. Key dependent variables were the 16 week value minus the baseline value (post run-in). Last observation carried forward was used for missing values. The key comparisons are for two groups OATP1B1 reduced carriers and on-carriers and their association with Cytokines and Lipids. Secondarily, we were interested in changes over the 16 weeks for the pooled sample, irrespective of genetics.

Inflammation

null

1

arm 1: 80mg of atorvastatin given once daily for 16 weeks

[ 5 ]

1

[ 0 ]

intervention 1: atorvastatin 80mg tablets given by mouth once daily for 16 weeks with follow-up visits every 4 weeks

intervention 1: Atorvastatin

1

Gainesville | Florida | United States | -82.32483 | 29.65163

0

NCT00361283

[ 3 ]

44

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

1FEMALE

true

RATIONALE: Fondaparinux may help prevent blood clots from forming in patients who are undergoing surgery for gynecologic cancer. PURPOSE: This phase II trial is studying how well fondaparinux works in preventing blood clots in patients undergoing surgery for gynecologic cancer.

OBJECTIVES: Primary * Evaluate the efficacy of prolonged (4 weeks) fondaparinux sodium administration in venous thromboembolism prophylaxis in patients undergoing gynecologic oncology surgery. Secondary * Evaluate the safety of this regimen in these patients (4 weeks). * Determine the feasibility of this regimen in these patients (4 weeks). OUTLINE: This is an open-label study. Beginning after surgery, patients receive fondaparinux sodium subcutaneously once daily on days 1-28 in the absence of disease progression or unacceptable toxicity. Patients undergo duplex ultrasonography of the lower extremities between day 28-35.

Cervical Cancer Endometrial Cancer Fallopian Tube Cancer Ovarian Cancer Sarcoma Thromboembolism Vaginal Cancer Vulvar Cancer

thromboembolism cervical cancer endometrial cancer ovarian epithelial cancer ovarian germ cell tumor borderline ovarian surface epithelial-stromal tumor ovarian sarcoma ovarian stromal cancer uterine sarcoma vaginal cancer vulvar cancer fallopian tube cancer

null

1

arm 1: Patients treated with at least one dose of Fondaparinux (2.5 mg subcutaneous, Days 1-28 by mouth).

[ 0 ]

1

[ 0 ]

intervention 1: Fondaparinux, 2.5 mg subcutaneous, Days 1-28 by mouth.

intervention 1: fondaparinux sodium

2

0

NCT00381888

[ 4 ]

3,991

null

PARALLEL

0TREATMENT

null

false

0ALL

null

The objective of the study is to evaluate the long-term (one year) efficacy and safety of tiotropium delivered by the Respimat inhaler in patients with COPD. Specifically, the study will examine the effect of treatment on COPD exacerbations.

null

Pulmonary Disease, Chronic Obstructive

null

2

arm 1: Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded) arm 2: Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)

[ 5, 5 ]

2

[ 1, 0 ]

intervention 1: None intervention 2: None

intervention 1: Respimat intervention 2: Tiotropium

334

Birmingham | Alabama | United States | -86.80249 | 33.52066 Birmingham | Alabama | United States | -86.80249 | 33.52066 Mobile | Alabama | United States | -88.04305 | 30.69436 Berkeley | California | United States | -122.27275 | 37.87159 Huntington Park | California | United States | -118.22507 | 33.98168 Long Beach | California | United States | -118.18923 | 33.76696 Long Beach | California | United States | -118.18923 | 33.76696 Los Angeles | California | United States | -118.24368 | 34.05223 Los Angeles | California | United States | -118.24368 | 34.05223 Rancho Mirage | California | United States | -116.41279 | 33.73974 San Diego | California | United States | -117.16472 | 32.71571 Boulder | Colorado | United States | -105.27055 | 40.01499 Norwalk | Connecticut | United States | -73.4079 | 41.1176 Brandon | Florida | United States | -82.28592 | 27.9378 Clearwater | Florida | United States | -82.8001 | 27.96585 Miami Beach | Florida | United States | -80.13005 | 25.79065 West Palm Beach | Florida | United States | -80.05337 | 26.71534 Winter Park | Florida | United States | -81.33924 | 28.6 Calhoun | Georgia | United States | -84.95105 | 34.50259 Normal | Illinois | United States | -88.99063 | 40.5142 Dubuque | Iowa | United States | -90.66457 | 42.50056 Wichita | Kansas | United States | -97.33754 | 37.69224 Shreveport | Louisiana | United States | -93.75018 | 32.52515 Biddeford | Maine | United States | -70.45338 | 43.49258 Columbia | Maryland | United States | -76.83942 | 39.24038 Rockville | Maryland | United States | -77.15276 | 39.084 Detroit | Michigan | United States | -83.04575 | 42.33143 Minneapolis | Minnesota | United States | -93.26384 | 44.97997 Chesterfield | Missouri | United States | -90.57707 | 38.66311 St Louis | Missouri | United States | -90.19789 | 38.62727 Omaha | Nebraska | United States | -95.94043 | 41.25626 Albuquerque | New Mexico | United States | -106.65114 | 35.08449 Mineola | New York | United States | -73.64068 | 40.74927 Rochester | New York | United States | -77.61556 | 43.15478 Syracuse | New York | United States | -76.14742 | 43.04812 Chapel Hill | North Carolina | United States | -79.05584 | 35.9132 Charlotte | North Carolina | United States | -80.84313 | 35.22709 Elizabeth City | North Carolina | United States | -76.25105 | 36.2946 Raleigh | North Carolina | United States | -78.63861 | 35.7721 Winston-Salem | North Carolina | United States | -80.24422 | 36.09986 Cincinnati | Ohio | United States | -84.51439 | 39.12711 Cincinnati | Ohio | United States | -84.51439 | 39.12711 Cincinnati | Ohio | United States | -84.51439 | 39.12711 Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756 Eugene | Oregon | United States | -123.08675 | 44.05207 Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 Swathmore | Pennsylvania | United States | N/A | N/A Dallas | Texas | United States | -96.80667 | 32.78306 Dallas | Texas | United States | -96.80667 | 32.78306 Fort Worth | Texas | United States | -97.32085 | 32.72541 Killeen | Texas | United States | -97.7278 | 31.11712 New Braunfels | Texas | United States | -98.12445 | 29.703 San Antonio | Texas | United States | -98.49363 | 29.42412 Danville | Virginia | United States | -79.39502 | 36.58597 Lynchburg | Virginia | United States | -79.14225 | 37.41375 Richmond | Virginia | United States | -77.46026 | 37.55376 Tacoma | Washington | United States | -122.44429 | 47.25288 Glebe | New South Wales | Australia | 151.18426 | -33.87884 Cairns | Queensland | Australia | 145.76613 | -16.92366 Redcliffe | Queensland | Australia | 153.10648 | -27.22649 Port Lincoln | South Australia | Australia | 135.87442 | -34.72625 Toorak Gardens | South Australia | Australia | 138.63639 | -34.93478 Woodville | South Australia | Australia | 138.54291 | -34.877 Box Hill | Victoria | Australia | 145.12545 | -37.81887 Geelong | Victoria | Australia | 144.36069 | -38.14711 Malvern | Victoria | Australia | 145.02811 | -37.86259 Nedlands | Western Australia | Australia | 115.8073 | -31.98184 Florianópolis | N/A | Brazil | -48.54917 | -27.59667 Goiânia | N/A | Brazil | -49.25389 | -16.67861 Recife | N/A | Brazil | -34.88111 | -8.05389 São Paulo - SP | N/A | Brazil | N/A | N/A São Paulo - SP | N/A | Brazil | N/A | N/A Vitória | N/A | Brazil | -40.33778 | -20.31944 Calgary | Alberta | Canada | -114.08529 | 51.05011 Calgary | Alberta | Canada | -114.08529 | 51.05011 Edmonton | Alberta | Canada | -113.46871 | 53.55014 Edmonton | Alberta | Canada | -113.46871 | 53.55014 Wetaskiwin | Alberta | Canada | -113.36869 | 52.96683 Chilliwack | British Columbia | Canada | -121.95257 | 49.16638 Vancouver | British Columbia | Canada | -123.11934 | 49.24966 Saint John | New Brunswick | Canada | -66.05616 | 45.27076 St. John's | Newfoundland and Labrador | Canada | -52.70931 | 47.56494 Grimsby | Ontario | Canada | -79.56631 | 43.20011 London | Ontario | Canada | -81.23304 | 42.98339 Niagara Falls | Ontario | Canada | -79.06627 | 43.10012 Ottawa | Ontario | Canada | -75.69812 | 45.41117 Sarnia | Ontario | Canada | -82.40407 | 42.97866 Sarnia | Ontario | Canada | -82.40407 | 42.97866 Scarborough Village | Ontario | Canada | -79.22124 | 43.73899 La Malbaie | Quebec | Canada | -70.15268 | 47.654 Saskatoon | Saskatchewan | Canada | -106.66892 | 52.13238 Saskatoon | Saskatchewan | Canada | -106.66892 | 52.13238 Beijing | N/A | China | 116.39723 | 39.9075 Beijing | N/A | China | 116.39723 | 39.9075 Beijing | N/A | China | 116.39723 | 39.9075 Chengdu, Sichuan Province | N/A | China | 104.06667 | 30.66667 Chongqing | N/A | China | 106.55771 | 29.56026 Guangzhou | N/A | China | 113.25 | 23.11667 Shanghai | N/A | China | 121.45806 | 31.22222 Shanghai | N/A | China | 121.45806 | 31.22222 Shanghai | N/A | China | 121.45806 | 31.22222 Shenyang | N/A | China | 123.43278 | 41.79222 Shenyang | N/A | China | 123.43278 | 41.79222 Wuhan | N/A | China | 114.26667 | 30.58333 Aarhus C | N/A | Denmark | 10.21231 | 56.16558 Horsens | N/A | Denmark | 9.85034 | 55.86066 Hvidovre | N/A | Denmark | 12.47708 | 55.64297 København NV | N/A | Denmark | 12.52343 | 55.71258 Odense C | N/A | Denmark | 10.39538 | 55.40841 Silkeborg | N/A | Denmark | 9.54508 | 56.1697 Helsinki | N/A | Finland | 24.93545 | 60.16952 Jyväskylä | N/A | Finland | 25.72088 | 62.24147 Lahti | N/A | Finland | 25.66151 | 60.98267 Tampere | N/A | Finland | 23.78712 | 61.49911 Castelnau-le-Lez | N/A | France | 3.90137 | 43.63605 Castelnau-le-Lez | N/A | France | 3.90137 | 43.63605 Chamalières | N/A | France | 3.06703 | 45.77364 Clermont-Ferrand | N/A | France | 3.08682 | 45.77969 Denain | N/A | France | 3.3943 | 50.3293 Grasse | N/A | France | 6.92537 | 43.65783 Marseille | N/A | France | 5.38107 | 43.29695 Metz | N/A | France | 6.17269 | 49.11911 Metz | N/A | France | 6.17269 | 49.11911 Montigny-lès-Metz | N/A | France | 6.15271 | 49.0956 Montigny-lès-Metz | N/A | France | 6.15271 | 49.0956 Nantes | N/A | France | -1.55336 | 47.21725 Nice | N/A | France | 7.26608 | 43.70313 Nice | N/A | France | 7.26608 | 43.70313 Nîmes | N/A | France | 4.35788 | 43.83665 Nîmes | N/A | France | 4.35788 | 43.83665 Nîmes | N/A | France | 4.35788 | 43.83665 Ollioules | N/A | France | 5.84766 | 43.1399 Ollioules | N/A | France | 5.84766 | 43.1399 Reims | N/A | France | 4.02853 | 49.26526 Reims | N/A | France | 4.02853 | 49.26526 Saint-Gaudens | N/A | France | 0.72318 | 43.10813 Saint-Gaudens | N/A | France | 0.72318 | 43.10813 Saint-Laurent-du-Var | N/A | France | 7.19 | 43.67323 Six Four Les Plages | N/A | France | N/A | N/A Toulon | N/A | France | 5.92836 | 43.12442 Toulouse | N/A | France | 1.44367 | 43.60426 Toulouse | N/A | France | 1.44367 | 43.60426 Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.52437 Bonn | N/A | Germany | 7.09549 | 50.73438 Bruchsal | N/A | Germany | 8.59804 | 49.12426 Frankfurt am Main | N/A | Germany | 8.68417 | 50.11552 Gelnhausen | N/A | Germany | 9.18742 | 50.20164 Gütersloh | N/A | Germany | 8.37853 | 51.90693 Hanover | N/A | Germany | 9.73322 | 52.37052 Kassel | N/A | Germany | 9.5 | 51.31667 Minden | N/A | Germany | 8.91455 | 52.28953 München | N/A | Germany | 13.31243 | 51.60698 Weinheim | N/A | Germany | 8.66697 | 49.54887 Weyhe | N/A | Germany | 8.66667 | 52.96667 Wiesloch | N/A | Germany | 8.69846 | 49.29504 Witten | N/A | Germany | 7.35258 | 51.44362 Athens | N/A | Greece | 23.72784 | 37.98376 Athens | N/A | Greece | 23.72784 | 37.98376 Athens | N/A | Greece | 23.72784 | 37.98376 Athens | N/A | Greece | 23.72784 | 37.98376 Athens | N/A | Greece | 23.72784 | 37.98376 Corinth | N/A | Greece | 22.9513 | 37.94007 Heraklion-Crete | N/A | Greece | N/A | N/A Kalamaria | N/A | Greece | 22.95028 | 40.5825 Kavala | N/A | Greece | 24.40687 | 40.93959 Komotini | N/A | Greece | 25.40535 | 41.11917 Nafplion | N/A | Greece | 22.80691 | 37.56863 Serres | N/A | Greece | 23.54757 | 41.08499 Thebes | N/A | Greece | 23.31889 | 38.325 Thessaloniki | N/A | Greece | 22.93086 | 40.64361 Thessaloniki | N/A | Greece | 22.93086 | 40.64361 Hong Kong | N/A | Hong Kong | 114.17469 | 22.27832 Kowloon | N/A | Hong Kong | 114.18333 | 22.31667 Budapest | N/A | Hungary | 19.04045 | 47.49835 Debrecen | N/A | Hungary | 21.62444 | 47.53167 Deszk | N/A | Hungary | 20.24322 | 46.21802 Érd | N/A | Hungary | 18.91361 | 47.39489 Mosonmagyaróvár | N/A | Hungary | 17.26994 | 47.86789 Sopron | N/A | Hungary | 16.59049 | 47.68501 Andhra Pradesh | N/A | India | N/A | N/A Andhra Pradesh | N/A | India | N/A | N/A Bangalore | N/A | India | 77.59369 | 12.97194 Bangalore | N/A | India | 77.59369 | 12.97194 Calicut,Kerala | N/A | India | 92.73333 | 11.6 Chennai | N/A | India | 80.27847 | 13.08784 Chennai | N/A | India | 80.27847 | 13.08784 Coimbatore | N/A | India | 76.96612 | 11.00555 Gujarat | N/A | India | N/A | N/A indore,MP | N/A | India | 75.8333 | 22.71792 Maharashtra | N/A | India | N/A | N/A Mumbai | N/A | India | 72.88261 | 19.07283 Mumbai | N/A | India | 72.88261 | 19.07283 New Delhi | N/A | India | 77.2148 | 28.62137 Punjab | N/A | India | N/A | N/A Tamil Nadu | N/A | India | N/A | N/A Uttar Pradesh | N/A | India | N/A | N/A Mullingar | N/A | Ireland | -7.3385 | 53.52466 Bussolengo (vr) | N/A | Italy | 10.85371 | 45.46903 Ferrara | N/A | Italy | 11.62057 | 44.83804 Genova | N/A | Italy | 11.87211 | 45.21604 Genova | N/A | Italy | 11.87211 | 45.21604 Milan | N/A | Italy | 12.59836 | 42.78235 Modena | N/A | Italy | 10.92539 | 44.64783 Orbassano (to) | N/A | Italy | 7.53813 | 45.00547 Pisa | N/A | Italy | 10.4036 | 43.70853 Pordenone | N/A | Italy | 12.66051 | 45.95689 Prato (fi) | N/A | Italy | 11.09699 | 43.8805 Roma | N/A | Italy | 11.10642 | 44.99364 Trieste | N/A | Italy | 13.77678 | 45.64953 Kaunas | N/A | Lithuania | 23.90961 | 54.90272 Kaunas | N/A | Lithuania | 23.90961 | 54.90272 Vilnius | N/A | Lithuania | 25.2798 | 54.68916 George Town | N/A | Malaysia | 100.33543 | 5.41123 Johor Bahru | N/A | Malaysia | 103.7578 | 1.4655 Kelantan Darul Naim | N/A | Malaysia | N/A | N/A Kuala Lumpur | N/A | Malaysia | 101.68653 | 3.1412 Kuala Lumpur | N/A | Malaysia | 101.68653 | 3.1412 Kuala Selangor | N/A | Malaysia | 101.25 | 3.35 Kuching, Sarawak | N/A | Malaysia | 110.33333 | 1.55 Chihuahua City | N/A | Mexico | -106.08889 | 28.63528 Col. Seccion XVI | N/A | Mexico | N/A | N/A Cuernavaca, Mor. México | N/A | Mexico | -99.23075 | 18.9261 Guadalajara | N/A | Mexico | -103.34749 | 20.67738 Guadalajara Jal. | N/A | Mexico | N/A | N/A Hermosillo, Sonora | N/A | Mexico | N/A | N/A Huixquilucan Edo.Mex. | N/A | Mexico | N/A | N/A Merida Yuc. | N/A | Mexico | N/A | N/A Mexicali Baja California Norte | N/A | Mexico | N/A | N/A Mérida Yucatán | N/A | Mexico | N/A | N/A Monterrey, Nuevo León | N/A | Mexico | N/A | N/A Monterrey, Nuevo León | N/A | Mexico | N/A | N/A San Luis Potosí City | N/A | Mexico | -100.97135 | 22.15234 Zapopan, Jal. | N/A | Mexico | N/A | N/A Amsterdam | N/A | Netherlands | 4.88969 | 52.37403 Drachten | N/A | Netherlands | 6.0989 | 53.11254 Groningen | N/A | Netherlands | 6.56667 | 53.21917 Hoofddorp | N/A | Netherlands | 4.68889 | 52.3025 Leeuwarden | N/A | Netherlands | 5.80859 | 53.20139 Roosendaal | N/A | Netherlands | 4.46528 | 51.53083 Sneek | N/A | Netherlands | 5.6589 | 53.03297 Utrecht | N/A | Netherlands | 5.12222 | 52.09083 Voorburg | N/A | Netherlands | 4.35972 | 52.07417 Weerselo | N/A | Netherlands | 6.85694 | 52.35167 Winschoten | N/A | Netherlands | 7.03472 | 53.14417 Ålesund | N/A | Norway | 6.15492 | 62.47225 Sandvika | N/A | Norway | 13.59125 | 64.46377 Trondheim | N/A | Norway | 10.39506 | 63.43049 Amadora | N/A | Portugal | -9.23083 | 38.75382 Lisbon | N/A | Portugal | -9.1498 | 38.72509 Lisbon | N/A | Portugal | -9.1498 | 38.72509 Porto | N/A | Portugal | -8.61099 | 41.14961 Viana do Castelo | N/A | Portugal | -8.83287 | 41.69323 Singapore | N/A | Singapore | 103.85007 | 1.28967 Singapore | N/A | Singapore | 103.85007 | 1.28967 Singapore | N/A | Singapore | 103.85007 | 1.28967 Bratislava | N/A | Slovakia | 17.10674 | 48.14816 Nové Zámky | N/A | Slovakia | 18.16195 | 47.98544 Bellville | N/A | South Africa | 18.62847 | -33.90022 Cape Town | N/A | South Africa | 18.42322 | -33.92584 Cape Town | N/A | South Africa | 18.42322 | -33.92584 Cape Town | N/A | South Africa | 18.42322 | -33.92584 Centurion | N/A | South Africa | 28.18577 | -25.85891 Durban | N/A | South Africa | 31.0292 | -29.8579 Pretoria | N/A | South Africa | 28.18783 | -25.74486 Somerset West | N/A | South Africa | 18.82113 | -34.08401 Anyang | N/A | South Korea | 127.1464 | 36.9577 Daegu | N/A | South Korea | 128.59111 | 35.87028 Daejoen | N/A | South Korea | N/A | N/A Incheon | N/A | South Korea | 126.70515 | 37.45646 Jeonbuk | N/A | South Korea | N/A | N/A Kwangju | N/A | South Korea | 127.1279 | 36.9122 Pusan | N/A | South Korea | 128.3681 | 36.3809 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Cáceres | N/A | Spain | -6.37224 | 39.47649 Madrid | N/A | Spain | -3.70256 | 40.4165 Madrid | N/A | Spain | -3.70256 | 40.4165 Terrassa (Barcelona) | N/A | Spain | 2.01667 | 41.56667 Valencia | N/A | Spain | -0.37966 | 39.47391 Boden | N/A | Sweden | 21.68864 | 65.82518 Höllviken | N/A | Sweden | 12.9558 | 55.40982 Linköping | N/A | Sweden | 15.62157 | 58.41086 Stockholm | N/A | Sweden | 18.06871 | 59.32938 Sundsvall | N/A | Sweden | 17.3063 | 62.39129 Lugano | N/A | Switzerland | 8.96004 | 46.01008 Montana | N/A | Switzerland | 7.48839 | 46.31338 Zurich | N/A | Switzerland | 8.55 | 47.36667 Kaohsiung City | N/A | Taiwan | 120.31333 | 22.61626 Tainan City | N/A | Taiwan | 120.21333 | 22.99083 Taipei | N/A | Taiwan | 121.52639 | 25.05306 Taipei | N/A | Taiwan | 121.52639 | 25.05306 Taipei | N/A | Taiwan | 121.52639 | 25.05306 Taipei | N/A | Taiwan | 121.52639 | 25.05306 Taipei | N/A | Taiwan | 121.52639 | 25.05306 Taipei | N/A | Taiwan | 121.52639 | 25.05306 Taoyuan District | N/A | Taiwan | 121.3187 | 24.9896 Ankara | N/A | Turkey (Türkiye) | 32.85427 | 39.91987 Ankara | N/A | Turkey (Türkiye) | 32.85427 | 39.91987 Bursa | N/A | Turkey (Türkiye) | 29.06013 | 40.19559 Edirne | N/A | Turkey (Türkiye) | 26.55597 | 41.67719 Istanbul | N/A | Turkey (Türkiye) | 28.94966 | 41.01384 Istanbul | N/A | Turkey (Türkiye) | 28.94966 | 41.01384 Izmir | N/A | Turkey (Türkiye) | 27.13838 | 38.41273 Kayseri | N/A | Turkey (Türkiye) | 35.48528 | 38.73222 Konya | N/A | Turkey (Türkiye) | 32.48464 | 37.87135 Samsun | N/A | Turkey (Türkiye) | 36.3361 | 41.27976 Aston Clinton, Aylesbury | N/A | United Kingdom | N/A | N/A Carmarthen | N/A | United Kingdom | -4.30535 | 51.85552 Chertsey | N/A | United Kingdom | -0.50782 | 51.38812 Chesterfield | N/A | United Kingdom | -1.41667 | 53.25 Darlington | N/A | United Kingdom | -1.55039 | 54.52429 East Horsley | N/A | United Kingdom | -0.43207 | 51.27358 Fowey | N/A | United Kingdom | -4.6386 | 50.33634 Frome | N/A | United Kingdom | -2.32211 | 51.22834 Greenisland | N/A | United Kingdom | -5.87479 | 54.70081 Heywood | N/A | United Kingdom | -2.21941 | 53.59245 Isleworth | N/A | United Kingdom | -0.34246 | 51.47518 Kirkby in Ashfield | N/A | United Kingdom | -1.24379 | 53.09982 Mortimer | N/A | United Kingdom | -1.06299 | 51.37692 Nottingham | N/A | United Kingdom | -1.15047 | 52.9536 Penzance | N/A | United Kingdom | -5.53715 | 50.11861 Plymouth | N/A | United Kingdom | -4.14305 | 50.37153 Saint Just, Penzance | N/A | United Kingdom | N/A | N/A Sheffield | N/A | United Kingdom | -1.4659 | 53.38297 Sneinton, Nottingham | N/A | United Kingdom | N/A | N/A St Austell | N/A | United Kingdom | -4.77442 | 50.3425 Sunderland | N/A | United Kingdom | -1.38222 | 54.90465 Wellingborough | N/A | United Kingdom | -0.69446 | 52.30273 Westbury on Trym | N/A | United Kingdom | -2.62045 | 51.49239 Windsor | N/A | United Kingdom | -0.6 | 51.48333 Woking | N/A | United Kingdom | -0.55893 | 51.31903

0

NCT00387088

[ 3 ]

80

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

RATIONALE: Drugs used in chemotherapy, such as irinotecan and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving irinotecan together with carboplatin works in treating patients with metastatic or recurrent small cell lung cancer.

OBJECTIVES: * Determine the response rates in patients with metastatic or recurrent small cell lung cancer treated with irinotecan hydrochloride and carboplatin. * Determine the median survival of patients treated with this regimen. * Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy (yes vs no) and disease stage (metastatic vs relapsed). Patients receive irinotecan hydrochloride IV over 90 minutes and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Lung Cancer

extensive stage small cell lung cancer limited stage small cell lung cancer recurrent small cell lung cancer

null

2

arm 1: Irinotecan 200 mg/m2, every 21 days (intravenous) + Carboplatin AUC = 5 mg/ml x min (intravenous), every 21 days for 6 cycles arm 2: Irinotecan 150 mg/m2 (intravenous), every 21 days + Carboplatin AUC = 5 mg/ml x min (intravenous, every 21 days for 6 cycles

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Patients receive carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. intervention 2: Patients receive irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

intervention 1: carboplatin intervention 2: irinotecan

1

Sacramento | California | United States | -121.4944 | 38.58157

0

NCT00387660

[ 5 ]

252

RANDOMIZED

PARALLEL

0TREATMENT

1SINGLE

false

0ALL

false

The purpose is to study if HF treatment guided by NTproBNP in addition to clinical symptoms and signs is more effective than treatment guided by clinical symptoms and signs alone in patients with HF and left ventricular systolic dysfunction

null

Heart Failure Ventricular Dysfunction, Left

Heart Failure Ventricular Dysfunction NTproBNP

null

2

arm 1: Treatment guided by clinical symptoms and signs + NTproBNP arm 2: Treatment guided by clinical symptoms and signs

[ 5, 5 ]

16

[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 3, 3 ]

intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None intervention 8: None intervention 9: None intervention 10: None intervention 11: None intervention 12: None intervention 13: None intervention 14: None intervention 15: None intervention 16: None

intervention 1: Captopril intervention 2: Enalapril intervention 3: Lisinopril intervention 4: Ramipril intervention 5: Trandolapril intervention 6: Bisoprolol intervention 7: Carvedilol intervention 8: Metoprolol succinate intervention 9: Candesartan intervention 10: Valsartan intervention 11: Eplerenone intervention 12: Spironolactone intervention 13: Diuretics intervention 14: HF treatment according to Swedish guidelines intervention 15: Blood samples intervention 16: The Kansas City Cardiomyopathy Questionnaire (KCCQ)

39

Alvesta | N/A | Sweden | 14.55559 | 56.89935 Arvika | N/A | Sweden | 12.58518 | 59.65528 Bjuv | N/A | Sweden | 12.91914 | 56.08372 Borensberg | N/A | Sweden | 15.28333 | 58.56667 Bromma | N/A | Sweden | 17.94 | 59.34 Dalby | N/A | Sweden | 13.34976 | 55.66655 Eskilstuna | N/A | Sweden | 16.5077 | 59.36661 Gagnef | N/A | Sweden | 15.07745 | 60.59856 Gothenburg | N/A | Sweden | 11.96679 | 57.70716 Hisings Kärra | N/A | Sweden | 11.99716 | 57.79145 Huddinge | N/A | Sweden | 17.98192 | 59.23705 Huskvarna | N/A | Sweden | 14.30214 | 57.78596 Jönköping | N/A | Sweden | 14.15618 | 57.78145 Kalmar | N/A | Sweden | 16.36163 | 56.66157 Kungälv | N/A | Sweden | 11.98054 | 57.87096 Lerum | N/A | Sweden | 12.26904 | 57.77051 Lessebo | N/A | Sweden | 15.26969 | 56.75185 Lidköping | N/A | Sweden | 13.15765 | 58.50517 Lilla Edet | N/A | Sweden | 12.13333 | 58.13333 Linköping | N/A | Sweden | 15.62157 | 58.41086 Ludvika | N/A | Sweden | 15.18776 | 60.14959 Lyckeby | N/A | Sweden | 15.65 | 56.2 Malmo | N/A | Sweden | 13.00073 | 55.60587 Moheda | N/A | Sweden | 14.56667 | 57.0 Motala | N/A | Sweden | 15.03649 | 58.53706 Örebro | N/A | Sweden | 15.2066 | 59.27412 Östersund | N/A | Sweden | 14.63566 | 63.1792 Skanör | N/A | Sweden | 12.85 | 55.41667 Söderåkra | N/A | Sweden | 16.06667 | 56.45 Stenungsund | N/A | Sweden | 11.8181 | 58.07046 Stocksund | N/A | Sweden | 18.06667 | 59.38333 Timrå | N/A | Sweden | 17.32613 | 62.48654 Uddevalla | N/A | Sweden | 11.9424 | 58.34784 Ulricehamn | N/A | Sweden | 13.41422 | 57.79159 Umeå | N/A | Sweden | 20.25972 | 63.82842 Uppsala | N/A | Sweden | 17.63889 | 59.85882 Vaxjo | N/A | Sweden | 14.80906 | 56.87767 Västerås | N/A | Sweden | 16.55276 | 59.61617 Västervik | N/A | Sweden | 16.63733 | 57.7584

0

NCT00391846

[ 3 ]

5

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to see if this combination of chemotherapy plus radiation therapy and immunotherapy (with bevacizumab) expands treatment options for patients with non-small cell lung cancer.

The patients on this study will receive treatment in 3 stages of therapy. The first stage is Induction Therapy. This therapy is 7 weeks long. Patients will receive bevacizumab followed by pemetrexed followed by carboplatin all by vein once a week in weeks 1 and 4. During Induction patients will also receive radiation therapy daily, Monday through Friday, for 7 weeks (weeks 1-7). This is followed by 2 weeks of rest. During this rest period patients will have scans done to see how their disease has responded to treatment. The next stage of treatment is Consolidation Therapy. This stage is 10 weeks long. Patients will receive bevacizumab followed by pemetrexed followed by carboplatin all by vein once a week in weeks 10, 13 and 16. This is followed by 3 weeks rest. During week 19 patients will have scans to see how their disease has responded to treatment. The last stage of treatment is Maintenance Therapy. Patients will receive bevacizumab alone by vein every 3 weeks. Treatment will be given every three weeks for up to 9 treatments. (week 45)

Lung Cancer

null

1

arm 1: Induction treatment included: carboplatin AUC=5, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously weeks 1 and 4. Radiation was administered concurrently at a dose of 1.8 Gy/d weeks 1 to 7 to a total of 61.2 Gy per institutional guidelines. Consolidative therapy, following an 8-week break from chemoradiotherapy, included carboplatin AUC=6, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously on week 16, repeated weeks 19 and 22. Folic acid (350 to 1,000 ug or equivalent) supplementation was administered orally beginning 1 to 2 weeks before the first dose of pemetrexed and continued daily until the patient discontinued study therapy. Vitamin B12(1,000ug) was administered by intramuscular injection 1 to 2 weeks before the first dose of study therapy and repeated every 9 weeks until the patient discontinued therapy.

[ 0 ]

6

[ 0, 0, 3, 10, 10, 0 ]

intervention 1: 15mg/kg week 1, 4, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, 46, and 49. intervention 2: 500mg/m2 week 1, 4, 16, 19 and 22. intervention 3: 1.8 Gy single daily fractions(Monday-Friday), to total dose 61.2 Gy (7 weeks) intervention 4: 350 to 1,000 ug or equivalent supplementation administered orally beginning 1 to 2 weeks before the first dose of pemetrexed and continued daily until the patient discontinues study therapy. intervention 5: 1,000ug administered by intramuscular injection 1 to 2 weeks before the first dose of study therapy and repeated every 9 weeks until the patient discontinues therapy. intervention 6: AUC=5 administered intravenously weeks 1 and 4.

intervention 1: Bevacizumab intervention 2: Pemetrexed intervention 3: Radiotherapy intervention 4: Folic Acid intervention 5: vitamin B12 intervention 6: carboplatin

7

0

NCT00402883

[ 3 ]

54

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

Primary Total Knee joint replacement surgery is highly successful surgery for relieving pain and improving function in patients with disabling arthritis. Unfortunately, like all biomedical devices, prosthesis failure is a complication of knee replacement surgery that leads to disabling pain, stiffness and loss of function. Approximately 1% of the knee replacements fail every year leading to a 20% failure rate over 20 years. The common causes of failure of prosthetic joint are infection, loosening, trauma or wear of the prosthesis. Currently, a revision surgery is the best option for long term pain relief (analgesics or other pain medications are options but are of limited benefit). Surgery may not be feasible in patients due to advancing age, other medical conditions and surgical/technical difficulties or patient's choice. In addition, the results from revision surgery are not as good as the initial knee joint surgery. Therefore, there is a great need for a novel, targeted therapy that provides an option to patients who are unfit, unable, or unwilling to undergo surgery. In the investigators' recent pilot study, a single injection of Botulinum toxin A (Botox) in painful natural knee, ankle and shoulder joints of patients with various types of arthritis led to significant and durable improvement in pain and function and was safe to use. The investigators propose this 6-month study to compare pain relief, improvement of function and safety of an injection of Botulinum toxin compared to placebo in patients with a painful prosthetic knee joint. Both patients and investigators will be blinded to the treatment assignment to a patient until the study is completed. The investigators will assess the amount and duration of pain relief, improvement in function and short term safety of Botulinum toxin using standard validated measures. Patients will be evaluated at baseline, 2 weeks, 1-, 2-, 3-, 4- and 6-months after a single injection of either placebo or BoNT/A in the hip or knee prosthesis. The six-month follow-up is to assess the duration of meaningful pain relief. If successful, this will offer a new treatment option for patients with a chronically painful knee prosthetic joint, provide more insight into the origin and cause of pain in prosthetic joints and direct future investigations in new directions.

"This 6-month randomized, placebo-controlled, double blind trial will compare a single intra-articular (IA) injection of 100 units of Botulinum Toxin A (BoNT/A) to placebo for improvement in pain, function and quality of life (QOL), and safety in patients with painful total knee arthroplasty (TKA). Patients will be recruited at the Minneapolis VA Medical Center. Patients will be eligible if they are over age 18, have TKA, have pain ≥6/10 on 0-10 numeric rating scale (NRS) and are not candidates for revision surgery. The primary outcome is: (1) proportion with clinically meaningful change in pain severity (on 0-10 scale) 2 months after IA injection. The choice of 2-month for primary end-point is based on previous observations from open-label case series in painful TKA. Secondary outcomes will be assessed at each efficacy follow-up (FU) visit. The duration of the trial is 6-months to capture the duration of pain relief. Based on other trials of Botulinum toxin, we expect the peak effect between 2-8 weeks and expect the effect to wear off between 2-4 months. Therefore, for all analyses except duration of pain relief, the efficacy time-points (2 wk, 4 wk, 2 month) and possibly 3- or 4-month (depending on duration of pain relief) will be used. Secondary outcomes include: (1) clinically meaningful pain relief (≥2-point or ≥30% decrease) in pain severity (0-10 scale); (2) change in pain severity at 2 months and at all efficacy time-points; (3) percent with Minimal Clinically Important Improvement on Western Ontario MacMaster Arthritis Index (WOMAC) pain and function sub-scales at 2 months and at all efficacy time-points; (4) amount and duration of pain relief; (5) patient and physician global assessment of response at 2 months and at all efficacy time-points; (6) QOL assessed by WOMAC and Short-form 36 (SF-36) scores at 2 months and at all efficacy time-points; (7) change in function by Timed Stands Test (TST) and Timed-up-and-go (TUG) tests at 2 months and at all efficacy time-points; (8) change in dose of analgesics during the study. We will determine time to onset of and duration of pain relief and time to improvement in function. Safety will be assessed by structured interview form for adverse effects, sensory and manual muscle strength testing, and index joint examination for swelling, erythema and tenderness. At visit #1, after informed consent and screening for inclusion/exclusion criteria, patients will undergo: index joint X-ray, laboratory tests; history, physical examination, index joint pain history, comorbidity and medication history; patient pain assessments, WOMAC and SF-36; and blinded index joint, neurological examination, TST and TUG tests. 50 patients will be randomized to receive either IA BoNT/A 100 units or sterile saline in the index joint. FU phone interviews at 2 and 4-weeks will include pain assessments, WOMAC, patients' global assessment and adverse effects. Interim visits at 2, 3 and 4-months will be identical to visit #1, but will also include patients' and physicians' global assessment and there will be no joint injection. End of study visit at 6 months will be identical to interim visits with the addition of index joint X-ray and laboratory tests. Main analyses will include patients with unilateral TKAs. Sensitivity analyses will be done by including patients with bilateral knees, accounting for correlatedness of observations. Multiple analysis of variance, mixed model regression analyses and/or generalized estimating equations will be used for analysis of continuous and categorical outcomes respectively. Chi-square tests will be used to compare frequency of adverse events. Analysis will be intention-to-treat.

Knee Pain

Painful Knee Arthroplasty Botulinum Toxin A Randomized Controlled Trial Pain and Function

null

2

arm 1: Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit arm 2: Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit intervention 2: Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit

intervention 1: Botulinum toxin A intervention 2: Normal Saline

1

Minneapolis | Minnesota | United States | -93.26384 | 44.97997

0

NCT00403273

[ 3 ]

190

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

true

The purpose of this study is to evaluate whether sapropterin dihydrochloride is safe and effective in the treatment of intermittent claudication (IC) caused by peripheral arterial disease (PAD).

This was a Phase 2, multicenter, multinational, prospective, randomized, double-blind, placebo-controlled, parallel study designed to assess the efficacy and safety of sapropterin dihydrochloride in subjects with intermittent claudication (IC) caused by peripheral arterial disease (PAD). Subjects who met initial screening criteria were monitored criteria and that dosages of permitted concomitant medications were stable.

Intermittent Claudication

Intermittent Claudication IC Symptomatic Peripheral Arterial Disease Peripheral Arterial Disease PAD 6R-BH4 BH4 sapropterin dihydrochloride endothelial dysfunction Nitric Oxide NO

null

2

arm 1: Subjects receive 400 mg oral sapropterin dihydrochloride twice daily for 24 weeks. arm 2: Subjects receive matching oral Placebo twice daily for 24 weeks.

[ 0, 2 ]

2

[ 10, 0 ]

intervention 1: Subjects receive matching oral Placebo twice daily for 24 weeks. intervention 2: Subjects receive 400 mg oral sapropterin dihydrochloride twice daily for 24 weeks.

intervention 1: Placebo intervention 2: Sapropterin Dihydrochloride

20

0

NCT00403494

[ 5 ]

181

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

A three-arm, randomized, double-blind, placebo-controlled, Phase 4, multicenter study to compare the efficacy and safety of atomoxetine versus placebo in children and adolescents aged 6 through 17 years with attention-deficit/hyperactivity disorder (ADHD) and comorbid oppositional defiant disorder (ODD) who are treated as outpatients in Germany. After an initial 3- to 28-day screening and washout phase, participants will be assigned to double-blind treatment with atomoxetine or placebo. A 2 week up-titration period will be succeeded by a 7 week treatment period at the target dose. The primary efficacy measure will be the Swanson, Nolan and Pelham Rating Scale Revised (SNAP-IV) ODD subscale score.

null

Attention Deficit Hyperactivity Disorder Oppositional Defiant Disorder

null

3

arm 1: 0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks arm 2: 0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks arm 3: matching placebo daily dose taken orally

[ 0, 0, 2 ]

2

[ 0, 0 ]

intervention 1: Dosage form for the atomoxetine fast and slow titration arms consists of 2.5 mg, 10 mg, 20 mg, 25 mg, and 40 mg capsules. Double-blind treatment will consist of 3 capsules taken once per day for approximately 9 weeks. intervention 2: Double-blind treatment will consist of 3 matching placebo capsules taken once per day by mouth for approximately 9 weeks.

intervention 1: Atomoxetine intervention 2: Placebo

6

Berlin | N/A | Germany | 13.41053 | 52.52437 Düsseldorf | N/A | Germany | 6.77616 | 51.22172 Fulda | N/A | Germany | 9.67518 | 50.55162 Hamburg | N/A | Germany | 9.99302 | 53.55073 Heppenheim an der Bergstrasse | N/A | Germany | 8.63206 | 49.64145 München | N/A | Germany | 13.31243 | 51.60698

0

NCT00406354

[ 3 ]

3

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

Primary Objective: To determine if amifostine in combination with IMRT can mitigate the decrease in production of saliva by the submandibular and sublingual salivary glands in patients with HNSCC. Secondary Objectives: 1. To establish a parotid gland dose volume histogram (DVH) versus measured flow relationship in this patient population: * When the mean dose is \< 24-26 Gy (shift recovery time to left) * When the mean dose is \> 24-26 Gy (DVH shift) 2. To observe mucositis in the following lower dose RT areas: * Upper lip * Lower lip * Right cheek * Left cheek * Right ventral and lateral tongue * Left ventral and lateral tongue * Floor of the mouth * Soft palate * Hard palate. 3. To observe the incidence and patterns of occipital scalp epilation; 4. To observe the incidence of dysphagia using the List Performance Status Scale (LPSS); and 5. To further evaluate the safety profile of amifostine in this patient population.

Amifostine is designed to protect the cells in normal tissues against the toxicities of chemotherapy and radiation therapy. Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. Blood (about 2 tablespoons) will be drawn for routine blood tests. Your complete medical history will be recorded. You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate), weight, and height. You will have a dental exam. You will complete a questionnaire that asks questions about dry mouth. In addition, you will be asked questions about your diet and eating habits. This should take no longer than 10 minutes. Also, saliva will be collected by a simple, in-office oral test that measures saliva flow rate over a 5 minute period. Women who are able to have children must have a negative blood (about 1-2 teaspoons) pregnancy test. If you are found to be eligible to take part in this study, you will receive IMRT Monday -Friday over a 6-7 week period. In addition, 2-3 hours before IMRT, you will also take pre-medications by mouth to prevent potential nausea and skin reactions (anti-nausea \& antihistamine), including drinking water.You will receive daily IMRT therapy, excluding weekends and holidays. The radiation dose is designed to conform to the 3-dimensional shape of the tumor by controlling the intensity of the radiation beam to focus a higher radiation dose on the tumor (and not the surrounding normal tissue). Thirty (30) to 60 minutes before every IMRT treatment, you will receive study drug in two injections beneath the skin. IMRT will take about 30 minutes to complete. Every day that you are receiving IMRT (Monday-Friday), you will be asked about any drugs you are taking and any side effects you are experiencing. Your vital signs will be recorded. Every week (Weeks 2-7), you will have a complete oral and physical exam. You will complete the questionnaire that asks questions about dry mouth. You will be asked questions about your ability to perform daily activities (performance status evaluation). Your weight will also be measured. You will be asked to complete the symptom survey (the M.D. Anderson Symptom Inventory) that will ask you to rate your symptoms and how much the symptoms interfere in your daily activities. On the last day you receive IMRT or amifostine (whichever is last), you will have a complete oral exam and you will complete the questionnaire about dry mouth. Six (6) weeks after the end of therapy, you will have an end-of-therapy visit. At this visit, you will have a complete physical and oral exam with a saliva collection. You will complete the questionnaire about dry mouth. Your weight will be measured, and you will have a performance status evaluation. Blood (about (2) tablespoons) will be drawn for routine blood tests. You will be asked about any drugs you are taking and any side effects you are experiencing. In addition, you will be asked questions about your diet and eating habits. You will be asked to complete the symptom survey (the M.D. Anderson Symptom Inventory) that will ask you to rate your symptoms and how much the symptoms interfere in your daily activities every week for 2 months after the end of radiation therapy. After this point, you will be asked to complete the symptom survey every month for 1 year. You will have follow-up visits 4, 7, 10, and 12 months after the end of therapy. At these visits, you will have a complete oral exam and saliva collection. You will complete the dry mouth questionnaire. Your weight will be measured, and you will have a performance status evaluation and you will be asked questions about your diet and eating habits. THIS IS AN INVESTIGATIONAL STUDY. Amifostine is FDA approved and commercially available. Amifostine is FDA approved to be given through a needle in your vein but not FDA approved to be given through a needle under the skin. Up to 20 patients will take part in this study. All patients will be enrolled at M. D. Anderson.

Head and Neck Cancer

Head and Neck Cancer HNSCC Submandibular and Sublingual Salivary Sparing Amifostine Ethyol Radiation Therapy

null

1

arm 1: Intensity-Modulated Radiation Therapy (IMRT) 2.0 to 2.2 Gy delivered in 30 fractions + Amifostine 500 mg, 2 divided doses subcutaneously 30-60 minutes prior to IMRT.

[ 0 ]

2

[ 0, 3 ]

intervention 1: 500 mg in two divided doses subcutaneously given 30-60 minutes prior to IMRT. intervention 2: 2.0 to 2.2 Gy delivered in 30 fractions

intervention 1: Amifostine intervention 2: Intensity- Modulated Radiation Therapy

1

Houston | Texas | United States | -95.36327 | 29.76328

0

NCT00409331

[ 5 ]

7

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

true

0ALL

true

The PDT/Lucentis trial will be a Phase IV comparative trial comparing the use of combination therapy with ITV ranibizumab and verteporfin PDT to ITV ranibizumab alone in patients with exudative AMD.

The PDT/Lucentis trial will be a Phase IV comparative trial comparing the use of combination therapy with ITV ranibizumab and verteporfin PDT to ITV ranibizumab alone in patients with exudative AMD. Patients will be randomized to one of three groups. All patients will receive three consecutive monthly treatments with ITV ranibizumab. Patients randomized to group I will receive only ITV ranibizumab. Patients randomized to group II will also receive one treatment with reduced fluence (20% fluence) verteporfin PDT at day 0. Patients randomized to group III will also receive one treatment with reduced fluence (40% fluence) vPDT. All patients will also be evaluated for possible retreatment with ranibizumab according to established criteria. Thirty patients (ten per group) will be recruited from one U.S. sites in a 6-month period. Randomization will occur at the time of entry into the study. Follow-up will continue until month 12 (from day 0) in all subjects.

Age-Related Macular Degeneration

LUV Lucentis Visudyne PDT AMD ARMD Age Related Macular Degeneration

null

3

arm 1: drug - intravitreal ranibizumab arm 2: 40% fluence photodynamic therapy-PDT therapy with 0.5mg ranibizumab arm 3: 20% fluence photodynamic therapy-PDT therapy with 0.5mg ranibizumab

[ 1, 0, 0 ]

2

[ 0, 0 ]

intervention 1: as needed, one intravitreal injection of 0.50mg ranibizumab intervention 2: as needed, one intravitreal injection of 0.50mg ranibizumab

intervention 1: Ranibizumab (Lucentis) intervention 2: 0.5mg ranibizumab

1

Houston | Texas | United States | -95.36327 | 29.76328

0

NCT00423189

[ 4 ]

74

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

null

The purpose of this study is to evaluate the safety and efficacy of three doses of valsartan (0.25, 1.0, and 4.0 mg/kg) on mean sitting systolic blood pressure (MSSBP) and mean sitting diastolic blood pressure (MSDBP) in 6 months - 5 year old children with hypertension (sitting systolic blood pressure \[SSBP\] ≥ 95th percentile ).

null

Hypertension

Children pediatrics High Blood Pressure Hypertension Valsartan

null

3

arm 1: None arm 2: None arm 3: None

[ 0, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: once daily intervention 2: once daily intervention 3: once daily

intervention 1: Valsartan 0.25 mg/kg intervention 2: Valsartan 1.0 mg/kg intervention 3: Valsartan 4.0 mg/kg

11

USA | New Jersey | United States | N/A | N/A Belgium | N/A | Belgium | N/A | N/A Brazil | N/A | Brazil | N/A | N/A Paris | N/A | France | 2.3488 | 48.85341 Hungary | N/A | Hungary | N/A | N/A India | N/A | India | 75.36261 | 23.01533 Italy | N/A | Italy | N/A | N/A Poland | N/A | Poland | N/A | N/A South Africa | N/A | South Africa | 18.357 | -31.3096 Sweden | N/A | Sweden | N/A | N/A Turkey | N/A | Turkey (Türkiye) | N/A | N/A

0

NCT00435162

[ 5 ]

15

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to determine whether duloxetine is effective in the treatment of panic disorder.

Panic Disorder is relatively common, with a lifetime prevalence of 3.5 % (Kessler, et al 1994) and characterized by a typically chronic course (Marzol \& Pollack, 2000). Affected individuals tend to be high utilizers of general health care services, frequently receiving extensive and unrevealing medical work-ups (Katon, 1997); while the panic disorder itself often goes unrecognized (Sartorious, et al 1993). Panic disorder has a significant negative impact on work, family, and social life (Rubin, et al 2000), and is associated with increased rates of negative life events and diminished overall quality of life (Cramer, et al 2005). Research indicates that the quality of life and well-being of patients with panic disorder is similarly or more impaired than that of patients with serious medical illnesses, such as type II diabetes (Rubin, et al 2000). Treatment of panic disorder is focused on the reduction of panic attacks, avoidance behavior, and anticipatory anxiety, as well as the resolution of comorbid conditions. The overarching goal of panic disorder treatment is reduction in symptoms to allow improvement in overall quality of life (Pollack, 2005). Duloxetine is a serotonin-norepinephrine reuptake inhibitor (SNRI) that has greater initial noradrenergic effects than venlafaxine (Goldstein, et al 2004). Recent data from a placebo controlled fixed dose study, suggested that venlafaxine at 225 mg/d (a dose at which noradrenergic effects are likely to be relevant), was more efficacious on a number of measures of panic disorder than the SSRI, paroxetine (Pollack, et al 2003). This data, combined with our clinical experience with duloxetine to date, support the assertion that duloxetine is likely to prove an effective agent for panic disorder. Thus, we propose to perform the first systematic examination of the efficacy of duloxetine for panic disorder in a study in which 15 patients with panic disorder will receive duloxetine flexibly dosed from 30 to 120 mg/d in open treatment for 8 weeks. Information learned in this study will help guide treatment selection for panic disorder by providing initial open efficacy data for duloxetine in panic disorder.

Panic Disorder

Panic Disorder Anxiety Disorder Duloxetine

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: Treatment will be initiated at 30mg/day in the first week (week 0), and then increased to 60mg/day at week 1, with the option to increase to 90mg at week 4, and 120mg at week 6.

intervention 1: Duloxetine

1

Boston | Massachusetts | United States | -71.05977 | 42.35843

0

NCT00438971

[ 3 ]

246

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

true

0ALL

true

The purpose of this study is designed to examine the effects of Selegiline Transdermal System and behavioral intervention in smoking cessation as compared to behavioral intervention alone.

null

Nicotine Dependence

null

2

arm 1: Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -4 week Screening/Baseline Phase. During treatment, subjects received Selegiline Transdermal System, 6mg -20cm(2) patch, one time per day for 9 weeks Subjects were provided with on-site, individual smoking cessation counseling sessions 1x per week for 9 weeks arm 2: Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -4 week Screening/Baseline Phase. During treatment, subjects received matched placebo 20cm(2) patch transdermal patch one time per day for 9 weeks Subjects were provided with on-site, individual smoking cessation counseling sessions 1x per week for 9 weeks

[ 1, 2 ]

3

[ 0, 0, 5 ]

intervention 1: Selegiline cm(2) via transdermal system intervention 2: Matching placebo via transdermal system intervention 3: Subjects were provided with on-site, individual smoking cessation counseling sessions 1x per week for 9 weeks

intervention 1: Selegiline Transdermal Patch intervention 2: Placebo intervention 3: Smoking Cessation Counseling

4

0

NCT00439413

[ 3 ]

6

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

Determine the time to progression for the combination of erlotinib and bevacizumab in patients with previously treated metastatic cancer of the esophagus or gastroesophageal junction

We postulate that the addition of bevacizumab may increase the efficacy of erlotinib in patients with metastatic esophageal cancer, without adding significant toxicity. The non-overlapping toxicity profiles may allow the administration of the maximum tolerated doses for both agents without additive toxicities with the goal of demonstrating synergistic clinical activity. This combination has been previously tested in two studies for other malignancies with good tolerance and encouraging results.

Esophageal Neoplasms Esophageal Diseases

Esophagus Esophagogastric Junction Avastin Bevacizumab Erlotinib

null

1

arm 1: Patients will be treated with erlotinib 150 mg oral daily and Avastin 15 mg/kg intravenously each cycle of therapy (each cycle is 21 days or every 3 weeks). The first infusion of Avastin will be administered over 90 minutes. If tolerated, the second infusion will be given over 60 minutes and in 30 minutes for the subsequent treatments. Treatment will be administered until disease progression or intolerable side effects.

[ 0 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: Erlotinib intervention 2: Avastin

1

St Louis | Missouri | United States | -90.19789 | 38.62727

0

NCT00442507

[ 3 ]

14

RANDOMIZED

SINGLE_GROUP

0TREATMENT

2DOUBLE

true

1FEMALE

false

* Study Hypothesis: Use of 5% topical lidocaine ointment will result in improved ability to have sexual intercourse and decreased pain scores in women with vestibulitis when compared to placebo. * This is a study to assess if topical lidocaine will improve symptoms in women with vulvar vestibulitis. It compares use of nightly 5% topical lidocaine ointment to placebo ointment. The duration of the study is 8 weeks. 28 women will be in each arm for a total of 56 women in the study.

* After consent is obtained patients will undergo the following treatment plan: randomization to treatment with 5% lidocaine ointment or placebo for vestibulitis. There will be 56 women total (28 in each arm).The placebo used will be hydrophilic petrolatum. Randomization will be performed using computer generated permuted blocks. A standard history and physical exam incorporating assessment of skin allodynia (testing with q-tip swab) on the vestibule and pressure measurements of the pelvic floor muscles (how much tenderness there is on perineal muscles with palpation) will be performed. Baseline questionnaires that will evaluate sexual frequency, sexual function survey (Female sexual function index), the modified Gracely pain scale of intercourse related pain, and psychometric evaluation including evaluation of anxiety, somatization (State-Trait Anxiety Inventory and Brief Symptom Inventory). Depression can also be evaluated with the Brief Symptom Inventory. Lastly, overall quality of health can be assessed with the SF-12. There is a baseline, 2 week and 6 week visit. Women will abstain from intercourse during these 6 weeks. Women will have a physical exam evaluation of the vestibule at each visit. They will then be able to have intercourse and will repeat surveys of sexual frequency, function, pain scale of intercourse related pain and the SF-12 at 8 weeks. * Aim 1: To assess if lidocaine ointment produces a superior treatment response to placebo. * Hypothesis 1: Use of topical lidocaine, compared with placebo, will result in improved sexual function and self-reported pain scores. This is to be measured as the ability to have successful intercourse. Secondarily, sexual function, quality of life and scores for intercourse related pain will be evaluated. * Aim 2: To assess if there are predictors of response to treatment such as demographics, duration of disease, primary or secondary vulvar vestibulitis, or psychometric assessments (anxiety and somatization). * Hypothesis 2: There are predictors of response to treatment of vulvar vestibulitis based upon patient characteristics, characteristics of the disease and psychometric assessments.

Vulvar Vestibulitis

vulvar vestibulitis vestibulitis

null

2

arm 1: 5% topical lidocaine cream. arm 2: None

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Lidocaine 5% in hydrophilic petrolatum, dime-sized amount, applied nightly. intervention 2: hydrophilic petrolatum, dime-sized amount, applied nightly.

intervention 1: 5% topical lidocaine ointment intervention 2: Placebo cream

1

Chapel Hill | North Carolina | United States | -79.05584 | 35.9132

0

NCT00450242

[ 3 ]

22

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

2MALE

false

The purpose of this research study is to determine if the combination of mitoxantrone, prednisone and sorafenib will improve the time to progression of advanced stage metastatic hormone-refractory prostate cancer.

The primary objective of this study is to test the hypothesis that the combination of Mitoxantrone, Prednisone and Sorafenib in taxane-refractory patients with metastatic hormone refractory prostate cancer (mHRPC) will result in an improvement of the median time to progression (TTP). Since the median (i.e 50% of patients) TTP for Mitoxantrone/Prednisone is 3 months, our hypothesis is that 70% will have not progressed at 3 months with this investigational combination. Progression will be assessed by radiologic imaging criteria. The early stopping point is 21 subjects. If 10 or fewer subjects with tumor favorable response are observed when 21 subjects are accrued then the null hypothesis is accepted and the trial is terminated. If 16 or more subjects with tumor favorable response are observed when 21 subjects are accrued then the alternative hypothesis is accepted and the trial is terminated. The probability of early stopping under the null is 0.51, and under the alternative is 0.39. If the trial progresses until 42 subjects are evaluated and 24 or more subjects with favorable response are observed then the null hypothesis is rejected. This design minimizes the average sample number under the null, which is 31.2.

Metastatic Prostate Cancer

Prostate Cancer

null

0

null

3

[ 0, 0, 0 ]

intervention 1: Once six patients are accrued at dose level 1, the maximum tolerated dose (MTD) will be assessed by following them through one cycle of treatment. If 2/6 patients experience dose limiting toxicity (DLT) at the 400 mg twice a day (bid) level then the MTD will be defined as 400 mg daily (QD). Additional patients will be enrolled at the MTD for the phase II portion. Dose Level -2, Mitoxantrone 9mg/m2 Dose Level -1 Mitoxantrone 12mg/m2 Dose Level 1 Mitoxantrone 12mg/m2 intervention 2: Once six patients are accrued at dose level 1, the maximum tolerated dose (MTD) will be assessed by following them through one cycle of treatment. If 2/6 patients experience dose limiting toxicity (DLT) at the 400 mg twice a day (bid) level then the MTD will be defined as 400 mg daily (QD). Additional patients will be enrolled at the MTD for the phase II portion. Dose Level -2, Prednisone 5mg bid Dose Level -1 Prednisone 5mg bid Dose Level 1 Prednisone 5mg bid intervention 3: Once six patients are accrued at dose level 1, the maximum tolerated dose (MTD) will be assessed by following them through one cycle of treatment. If 2/6 patients experience dose limiting toxicity (DLT) at the 400 mg twice a day (bid) level then the MTD will be defined as 400 mg daily (QD). Additional patients will be enrolled at the MTD for the phase II portion. Dose Level -2, Sorafenib 400 mg QD Dose Level -1 Sorafenib 400 mg QD Dose Level 1 Sorafenib 400 mg bid

intervention 1: Mitoxantrone intervention 2: Prednisone intervention 3: Sorafenib

10

0

NCT00452387

[ 4 ]

1,029

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

This study will evaluate the efficacy, safety and tolerability of topical 10% terbinafine hydrogen chloride applied daily versus 5% amorolfine nail lacquer applied twice a week in patients with mild to moderate toenail onychomycosis, for a total treatment duration of 48 weeks.

null

Onychomycosis

Toenail fungus Onychomycosis Nail fungus Toenail fungal infection Tinea unguium Dermatophytes Foot dermatoses

null

2

arm 1: 10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry. arm 2: 5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: 10 % terbinafine hydrogen chloride (HCL) intervention 2: 5 % amorolfine nail lacquer

intervention 1: terbinafine hydrogen chloride intervention 2: amorolfine nail lacquer

10

Various Cities | N/A | Finland | N/A | N/A Various Cities | N/A | France | N/A | N/A Various Cities | N/A | Germany | N/A | N/A Various Cities | N/A | Hungary | N/A | N/A Various Cities | N/A | Iceland | N/A | N/A Various Cities | N/A | Norway | N/A | N/A Various Cities | N/A | Poland | N/A | N/A Various Cities | N/A | Russia | N/A | N/A Various Cities | N/A | Spain | N/A | N/A Various Cities | N/A | Turkey (Türkiye) | N/A | N/A

0

NCT00459537

[ 4 ]

400

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

This study will evaluate the efficacy and safety of Brivaracetam to support the submission file in the indication of adjunctive treatment in adolescents and adults with partial onset seizures.

null

Epilepsy

Epilepsy Brivaracetam Partial Onset Seizures, Adolescents & Adults

null

4

arm 1: Matching Placebo tablets administered twice a day. Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 12-week Treatment Period. arm 2: Brivaracetam 5 mg/day, 2.5 mg administered twice a day. Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 5 mg /day in a double-blinded way for the 12-week Treatment Period. arm 3: Brivaracetam 20 mg/day, 10 mg administered twice a day. Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 20 mg /day in a double-blinded way for the 12-week Treatment Period. arm 4: Brivaracetam 50 mg/day, 25 mg administered twice a day. Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 50 mg /day, in a double-blinded way for the 12-week Treatment Period.

[ 2, 0, 0, 0 ]

4

[ 10, 0, 0, 0 ]

intervention 1: * Active Substance: Placebo * Pharmaceutical Form: Film-coated tablet * Concentration: 2.5 mg, 10 mg and 25 mg * Route of Administration: Oral use intervention 2: * Active Substance: Brivaracetam * Pharmaceutical Form: Film-coated tablet * Concentration: 2.5 mg * Route of Administration: Oral use intervention 3: * Active Substance: Brivaracetam * Pharmaceutical Form: Film-coated tablet * Concentration: 10 mg * Route of Administration: Oral use intervention 4: * Active Substance: Brivaracetam * Pharmaceutical Form: Film-coated tablet * Concentration: 25 mg * Route of Administration: Oral use

intervention 1: Placebo intervention 2: Brivaracetam 2.5 mg intervention 3: Brivaracetam 10 mg intervention 4: Brivaracetam 25 mg

69

0

NCT00464269

[ 4 ]

1,271

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

1FEMALE

true

This study is designed to evaluate the endometrial safety of a testosterone patch as treatment for low libido in naturally postmenopausal women.

Naturally postmenopausal women with hypoactive sexual desire disorder (HSDD) will be randomized into a 52-week, multicenter, double-blind (DB), parallel-group, placebo-controlled study. Patients will be stratified based on whether they use concomitant estrogen/progestin therapy and then randomized in a 4:1 ration to receive either testosterone transdermal system (300 mcg/day) or placebo. Patients using estrogen/progestin at the start of the study should maintain this therapy throughout the study; patients not using estrogen/progestin at the start of the study should not initiate estrogen/progestin therapy throughout the study. Endometrial biopsies and transvaginal ultrasounds will be collected/performed at screening and study exit for all patients. Safety will be assessed by adverse events, reports of vaginal bleeding, lipids, serum chemistry, and hematology. Physical exams, pap smears, and mammograms will be monitored.

Hypoactive Sexual Desire Disorder

Natural Menopause

null

2

arm 1: 28 cm² Placebo patch arm 2: Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks

[ 2, 0 ]

2

[ 0, 0 ]

intervention 1: Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks intervention 2: placebo patch, changed twice a week for 52 weeks

intervention 1: Testosterone Transdermal System intervention 2: Placebo patch

115

0

NCT00467259

[ 3 ]

6

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

This is a Phase II, open-label clinical trial examining the role of Panhematin® in patients with MDS. The objective of this study is to evaluate the safety and efficacy of Panhematin® (hematin for injection) in the treatment of adult patients (≥ 18 years of age) with low-risk MDS. The study will be conducted on an outpatient basis and will consist of the following: * A Screening Period (within 28 days of the Day 1) * Screening bone marrow aspiration and biopsy up to 60 days prior to receiving study medication * An 8-week Treatment Period (Days 1 through 4 of Week 1, and weekly visits during Weeks 2 through 8); partial and complete responders in any of the three cell lines may continue treatment for an additional 4 weeks * A 6-month Post treatment Follow-up Period (monthly clinic visits during Weeks 12 40)

The myelodysplastic syndromes (MDS), a diverse group of hematopoietic stem cell (HSC) disorders, are characterized by ineffective hematopoiesis that manifest clinically as anemia, neutropenia, and/or thrombocytopenia. MDS is most frequently observed in the elderly population (median age between 60 and 70 years) and has a male predominance. The incidence of MDS varies from 2.1 to 12.6 cases per 100,000 people per year, with an estimated prevalence of up to 55,000 patients in the United States \[Catenacci, 2005; Williamson, 1994; Aul, 1998; Aul, 2001\]. Patients with MDS most frequently present with symptoms of fatigue, pallor, exertional dyspnea, infection, bleeding or bruising \[Catenacci, 2005\]. MDS can be divided into 2 major subtypes: indolent (or early) MDS, in which pro-apoptotic forces predominate, and aggressive (or advanced) MDS, in which pro-proliferative factors are more common. The only curative therapy for MDS is allogeneic transplantation \[Catenacci, 2005; Thompson, 2005\]. Curative treatments are restricted to younger, healthier individuals with histocompatible-matched donors or those able to undergo intensive chemotherapeutic regimens \[Catenacci, 2005\]. Recently, the FDA approved 3 agents for the treatment of this disease, Vidaza, Dacogen, and revlimid. The latter is approved for a subset of patients with MDS with del 5q abnormality, the former two are more applicable to higher risk disease. Rhu-EPO is currently available to patients with low risk MDS however, if they fail, their options are limited to the agents mentioned above, all of which have significant myelotoxic effects. Effective and less myelosuppressive treatments for low-risk MDS are needed. We are proposing a novel approach for the treatment of patients with low-risk MDS using heme supplementation with Panhematin® (hemin for injection). Panhematin® is an iron-containing metalloporphyrin, indicated for the amelioration of recurrent attacks of acute intermittent porphyria; it acts to limit the hepatic and/or marrow synthesis of porphyrin, presumably, as a result of the inhibition of aminolevulinic acid synthetase (the enzyme which limits the rate of porphyrin/heme biosynthetic pathway) \[Panhematin® Product Prescribing Information\]. There are pre-clinical and clinical data to suggest that heme supplementation with Panhematin® (hematin for injection) has potential as a treatment option for patients with MDS. Preliminary data indicate hemin administration has the potential to stimulate progenitor cell growth, stimulate globin synthesis, and elevate overall hemoglobin levels. Panhematin® has been proven to be well tolerated when used therapeutically in patients with acute intermittent porphyria, and it is anticipated to be well tolerated in this patient population. For this study, selected patients will have low or intermediate 1 risk disease by IPSS, and the standard of care for MDS (supportive therapies) will be administered as needed. Measurement of serum porphyrin levels and Hgb F will be done at baseline and at week 8.

Myelodysplastic Syndrome

myelodysplastic MDS Panhematin Hemin

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: None

intervention 1: Panhematin

1

Chicago | Illinois | United States | -87.65005 | 41.85003

0

NCT00467610

[ 5 ]

62

RANDOMIZED

CROSSOVER

0TREATMENT

1SINGLE

false

0ALL

false

The purpose of this pilot study is to compare Adderall ® and Adderall XR ® in terms of their effectiveness and side effects for the treatment of ADHD in adults.

This will be a randomized, cross-over study in which adults with ADHD will receive three weeks of treatment with Adderall (IR) (15, 30, or 45 mg TID) and three weeks of treatment of Adderall XR (XR) (15, 30, or 45 mg QD) for evaluation of dosing adherence and treatment efficacy. The order of the two conditions (TID-QD or QD-TID) will be counterbalanced across subjects, with a washout period in between treatment periods. Participants will be required to come to the site for 9 visits over approximately an 8-week period. The study will consist of the following four phases: * Phase 1 * Screening Visit (Visit 1) * Treatment "A" Baseline Visit (Visit 2) * Phase 2 o Treatment Period "A" - participants will take either Adderall or Adderall XR for 3 weeks (Visits 3-5) * Phase 3 * 7-Day Washout Period - participants will be off Treatment "A" medication * Treatment "B" Baseline visit (Visit 6) * Phase 4 o Treatment Period "B" - participants will take either Adderall or Adderall XR for 3 weeks (Visits 7-9) Eligible participants will be randomized in a 1:1 ratio to one of two schedules of treatment, Adderall IR followed by Adderall XR, or Adderall XR followed by Adderall IR. Within both schedules, each treatment will consist of a 3-week dose optimization titration evaluation period with a washout week prior to switching to the second respective treatment. The maximum total daily dose will be 45mg, with 15mg TID for IR or 45mg QD for XR. Throughout the medication treatment periods, participants will visit the clinic weekly for evaluations of efficacy, tolerance, and adherence. Medical evaluations will also be conducted at each treatment visit, including assessment of weight, blood pressure, and pulse. Efficacy and adherence data will collected by separate research staff, so that the rater evaluating efficacy will be blinded to the adherence results. The clinician evaluating efficacy will also be blinded to the participants' treatment assignment.

Attention Deficit Hyperactivity Disorder

null

2

arm 1: This group was treated with Adderall extended release, either during phase 2 of the trial, or during phase 3 (this subset received Adderall immediate release during phase 2 and then underwent a washout period). This was a counterbalanced crossover study, with a washout period in between treatment periods. Participants were randomized in a 1:1 ratio to one of two schedules Adderall IR followed by Adderall XR, or Adderall XR followed by Adderall IR. arm 2: This group was treated with Adderall immediate release, either during phase 2 of the trial, or during phase 3 (this subset received Adderall extended release during phase 2 and then underwent a washout period). This was a counterbalanced crossover study, with a washout period in between treatment periods. Participants were randomized in a 1:1 ratio to one of two schedules Adderall IR followed by Adderall XR, or Adderall XR followed by Adderall IR.

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Adderall Immediate release (IR) was provided as treatment for three weeks (at 15, 30 or 45 mg TID). The medication was optimized for titration. intervention 2: Adderall Extended Release (XR) was provided as treatment for three weeks at (15, 30, or 45 mg QD). The medication was optimized for titration.

intervention 1: Adderall ® Immediate Release intervention 2: Adderall XR ®

1

New York | New York | United States | -74.00597 | 40.71427

0

NCT00468143

[ 3 ]

71

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

true

0ALL

true

Modafinil is a non-amphetamine type stimulant that acts as a wakefulness-promoting drug, and is approved for managing symptoms of narcolepsy (i.e., daytime somnolence). Its precise mechanism of action in promoting wakefulness remains unclear. This trial is a placebo-controlled double-blind trial of modafinil, on a platform of contingency management (CM) and individual cognitive-behavioral (CBT) counseling, for the treatment of methamphetamine dependence. Participants in this study will complete a 2-week baseline screening period during which they will provide urine samples and complete physical and psychological assessments to establish their eligibility for the study. In addition, participants will be asked to provide a blood or saliva specimen for genetic testing in order to identify genetic variations that influence response to methamphetamine and to treatment with modafinil. Upon successful completion of screening, participants will be randomly assigned to receive either modafinil (400mg qd) or placebo during the 12 weeks of the study. Neither the participants nor study staff will know who is receiving active medication or placebo. Regardless of medication condition, all participants will receive CM and weekly individual CBT counseling sessions to help them stop using methamphetamine and prevent relapse. They will attend the clinical research site (either at the UCLA Hollywood Clinic, or the Rancho Cucamonga site) three times per week, providing urine samples at each visit, completing data measures, and receiving individual CBT counseling on one visit each week. At the end of the 12-week study, the medication or placebo will be discontinued. Participants will return to the research site approximately 30 days following medication discontinuation for a brief health check to assess any possible lingering side effects and complete brief data measures.

This application proposes a placebo-controlled double-blind trial of modafinil, on a platform of contingency management (CM) and individual cognitive-behavioral counseling (CBT once weekly individual session), for the treatment of methamphetamine dependence. Modafinil is a medication warranting evaluation as a treatment for MA dependence. It has a half-life of approximately 15 hours and reaches steady state in 2-4 days (Package insert) and will likely require once daily dosing, which reduces problems with medication adherence. Modafinil has potent psychiatric and behavioral effects that include brightening mood (Menza et al., 2000; Ninan et al., 2004), improving cognition (Turner et al., 2004a, b; 2003), improving impulse control (Turner et al., 2003; Turner et al., 2004a), and countering fatigue (Beusterien et al., 1999, Stahl et al., 2003). These effects neatly counterbalance effects produced by MA withdrawal (Newton et al., 2004) and may have particular value in ameliorating the negative reinforcing properties of MA, i.e., when MA is used to immediately relieve depressed mood due to recent abstinence (Peck et al., 2005b). CM is a behavioral intervention that effectively helps substance abusers to initiate abstinence, particularly from cocaine (Higgins et al., 1993; Higgins et al., 2000; Higgins et al., 1991) and from methamphetamine (Roll \& Shoptaw, in press; Shoptaw et al., 2005). As well, CM has been shown to reduce substance abuse and optimize the effects of medications in reducing substance abuse (Carroll, 2004; Shoptaw et al., 2002). The objective of this study is to determine whether modafinil reduces methamphetamine use and concomitant physical and psychological symptoms more effectively than placebo when administered in conjunction with CM and CBT. The purpose of this project is to evaluate whether methamphetamine abusers seeking outpatient treatment demonstrate significantly significant reductions of methamphetamine when randomly assigned to receive modafinil (400mg qd) in combination with CM and weekly CBT compared their peers randomly assigned to receive placebo in combination with CM and weekly CBT. Research Hypotheses: 1. Participants receiving active experimental drug (modafinil 400mg) will demonstrate statistically significant reductions in methamphetamine use over participants receiving placebo. Methamphetamine use outcomes will be measured using urine samples and analyzed with the following indices: Treatment Effectiveness Score, the Joint Probability Index, self-report of methamphetamine use verified by urine drug screening, and the longest uninterrupted period of methamphetamine abstinence. Primary analyses will be conducted using modeling approaches (Generalized Estimation Equations, Markov Chain Transition Models) depending upon the structure of the dataset. Self-report of methamphetamine use will be analyzed using the Addiction Severity Index drug composite scale and Substance Use Inventory (SUI). 2. Participants receiving active experimental drug will remain in treatment for significantly longer periods compared to participants receiving placebo. Retention will be measured by the number of days in the protocol and analyzed using survival analysis. a. Specifically, participants with mild cognitive dysfunction (as measured as \<=1 SD below the published mean for the MicroCog assessments) receiving modafinil (400mg) will demonstrate significantly greater overall retention, and attendance to CBT sessions than those participants with cognitive function measured at greater than 1 SD below the mean for the MicroCog assessments who are receiving placebo. 3. Participants receiving active experimental drug (modafinil 400mg) will demonstrate statistically significant reductions in reported methamphetamine craving over participants receiving placebo. Craving outcomes will be measured using a visual analogue scale. 4. Participants receiving active experimental drug (modafinil 400mg) will demonstrate statistically significant reductions in withdrawal symptoms and somatic complaints compared to participants receiving placebo. These outcomes will be measured using the BSI, the Beck Depression Inventory-II, and the Quality of Well-Being scale. Exploratory analyses will also be conducted to identify potential genetic variants associated with treatment response to modafinil for MA dependence. Candidate genes implicated by previous research as being involved in the pathogenesis of MA dependence and/or the molecular mechanism of modafinil (for example, genes for neurotransmitter receptors and transporters, including dopamine, norepinephrine, GABA, and glutamate, as well as genes for enzymes involved in the metabolism of these neurotransmitter, such as catechol-O-methyltransferase and monoamine oxidase A) will be sequenced in order to determine the frequency of known single nucleotide polymorphisms (SNPs), as well as potentially identify novel SNPs, in these genes among MA dependent participants. Initial analyses will focus on genes involved in the dopaminergic pathway, given the importance of dopamine in the neurobiology of MA dependence, but additional genes may also be assessed. SNPs associated with response to modafinil will be identified in order to generate hypotheses for future pharmacogenomic studies.

Methamphetamine Dependence

Methamphetamine Modafinil Medication Contingency Management Crystal meth Los Angeles Addiction Meth

null

2

arm 1: Modafinil 400mg oral dose taken daily for 12 weeks arm 2: Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: 400mg pills taken orally daily for 12 wks. intervention 2: 400mg pills taken orally daily for 12 wks

intervention 1: Modafinil intervention 2: Placebo

1

Hollywood | California | United States | -118.32674 | 34.09834

0

NCT00469508

[ 3 ]

104

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

To investigate the dose response for changes from baseline in body weight as a primary endpoint and to investigate improvement in ascites, abdominal circumference, lower-limb edema, and pleural effusion as secondary endpoints in seven-day repeated oral administration of OPC-41061 at 7.5, 15, and 30 mg/day or placebo in cirrhosis patients with ascites despite taking conventional diuretics.

null

Cirrhosis

OPC-41061 Tolvaptan ascites Cirrhosis

null

4

arm 1: None arm 2: None arm 3: None arm 4: None

[ 2, 0, 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: 7.5mg, 1 tablet a day intervention 2: placebo, 1 tablet a day intervention 3: 15mg, 1 tablet a day intervention 4: 30mg, 1 tablet a day

intervention 1: OPC-41061 7.5mg intervention 2: OPC-41061 placebo intervention 3: OPC-41061 15mg intervention 4: OPC-41601 30mg

7

Chubu Region | N/A | Japan | N/A | N/A Chugoku Region | N/A | Japan | N/A | N/A Hokkaido Region | N/A | Japan | N/A | N/A Kanto Region | N/A | Japan | N/A | N/A Kinki Region | N/A | Japan | N/A | N/A Kyusyu Region | N/A | Japan | N/A | N/A Tohoku Region | N/A | Japan | N/A | N/A

0

NCT00479336

[ 0 ]

151

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

Lumbar zygapophysial (facet) joint pain is a common cause of low back pain. Radiofrequency (RF) denervation is an effective and low risk treatment of chronic low back pain of suspected facet joint etiology. Blocks of the medial branches innervating the joints are commonly used to localize the pain and make the diagnosis of facet joint pain. There is currently no standard number of diagnostic blocks: zero, one, and two blocks have all been utilized. Considering the high false positive and false negative rates of these blocks, the cost: benefit ratio has been questioned. No study to date has examined the practice of diagnostic medial branch blocks before RF denervation. The purpose of this study is to determine the optimal number of blocks before radiofrequency denervation. Three groups of patients will be studied. In group I, patients will undergo RF denervation based on history and physical exam alone. In group II, patients will undergo RF denervation based on a positive response to a single diagnostic block with local anesthetic. In group III, patients will undergo RF treatment only after a positive screening block and a positive confirmatory block.

Lumbar zygapophysial (facet) joints are recognized as one of the most common causes of chronic low back pain with an estimated prevalence among patients with LBP ranging from 15% to 40%. Radiofrequency (RF) denervation of facet joints has been utilized as an effective treatment of chronic pain attributed to these joints. Blocks of the medial branches innervating the joints are commonly used to localize the pain and make a diagnosis of lumbar zygapophysial (l-z) joint pain. However, considering the high false-positive rates of these blocks (25-40%), the false-negative rates (8-10%), and the number of blocks necessary to make the diagnosis before treatment, the cost-effectiveness of performing these blocks and the benefit of exposing these patients to additional risks is under question. The risks of RF denervation are so low (equivalent to performing the diagnostic block), some have questioned whether or not any diagnostic facet blocks should be performed before RF lesioning. The purpose of the study is to determine the optimal number of diagnostic blocks that should be performed before radiofrequency denervation in patients with chronic lower back pain with suspected facet joint etiology. In this prospective randomized study, we will recruit 150 patients with suspected chronic (l-z) joint pain without neurological symptoms to undergo one of three treatment modalities. In group I, 50 patients will undergo RF denervation based on history and physical exam alone (what we advocate in a recent review article). In group II, 50 patients will receive a single diagnostic block with 0.5% bupivacaine. Those that obtain greater than 50% pain reduction will undergo RF denervation. In group III, 50 patients will receive a block with either 2% lidocaine or 0.5% bupivacaine. Those patients that obtain greater than 50% pain relief with the first block receive a second block with the other local anesthetic. Patients that obtain greater than 50% pain relief with the second block then undergo RF. Patients in any group that obtain less than 50% pain relief with any block exit the study.

Low Back Pain

Low back pain of suspected lumbar zygapophysial etiology

null

3

arm 1: Radiofrequency lumbar facet joint denervation only if positive response to 2 diagnostic facet blocks. arm 2: Radiofrequency lumbar facet joint denervation if positive response to single facet joint block. arm 3: Radiofrequency lumbar facet denervation without a diagnostic facet block.

[ 0, 0, 0 ]

7

[ 3, 0, 0, 3, 3, 3, 3 ]

intervention 1: Radiofrequency of medial branches that innervate the lumbar facet joints intervention 2: Diagnostic medial branch block with 0.5% bupivacaine. Blocking the nerves that innervate the facet joints with a long-acting local anesthetic. intervention 3: Diagnostic medial branch block with 2% lidocaine. Blocking the nerves that innervate the facet joints with a short-acting local anesthetic. intervention 4: Radiofrequency lumbar facet denervation without a diagnostic block intervention 5: Radiofrequency lumbar facet denervation only if positive response to 2 diagnostic blocks. intervention 6: Lumbar facet radiofrequency denervation if positive response to a single diagnostic facet block intervention 7: Radiofrequency lumbar facet denervation without a diagnostic facet block.

intervention 1: Radiofrequency denervation of medial branches intervention 2: 0.5% bupivacaine intervention 3: 2% lidocaine intervention 4: Radiofrequency denervation intervention 5: Radiofrequency denervation intervention 6: Radiofrequency denervation intervention 7: Radiofrequency denervation

2

0

NCT00484159

[ 0 ]

56

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

Surgery induces a stress effect on the body partially through a catabolic energy state. In turn, glucose levels may rise to levels which have been associated with major morbidity (Golden, 1999) and mortality (Ouattara, 2005). An increasing body of evidence suggests that intensive insulin therapy for tight control of blood glucose levels in certain surgical and critical care patient populations may improve mortality and selected morbidity outcomes when compared to those patients receiving conventional insulin therapy and blood glucose management. More specifically, poor intra-operative blood glucose control is associated with worse outcome after cardiac surgery. Intensive insulin therapy with tight blood glucose control in surgical patients while in the ICU may reduce morbidity and mortality. Such outcome improvements would clearly provide benefits to patients, providers and payers. To date, there is scant research examining whether intensive insulin therapy for tight control of blood glucose in the perioperative period can alter outcomes for the non cardiac surgery population. The purpose of this study is to determine whether intensive insulin therapy for tight control of blood glucose in the perioperative period in non cardiac major surgery patients is associated with altered morbidity and mortality rates.

Intensive insulin therapy to control blood glucose levels reduces morbidity and mortality in intensive care unit patients and in cardiac surgical patients but its role in patients undergoing non-emergent non-cardiac surgery is unknown. Benefits of glucose control may result from prevention of immune system dysfunction, reduction in systemic inflammation, and protection of endothelium and mitochondrial structure and function, all of which are known to be altered by high stress states such as that induced by surgical procedures. In a prospective, randomized, controlled study of adult patients admitted to our operating suite for non-emergent non-cardiac surgery, we propose to correlate in-hospital morbidity and mortality with blood glucose levels of patients who are expected to have moderate to high levels of physiologic stress as a result of their pre-existing medical conditions or as a result of the proposed surgical procedure. Specifically, patients who are deemed to be American Society of Anesthesiologists Risk Classification 1-3 or higher, or patients undergoing intermediate and high risk procedures shall be considered to have moderate to high physiologic stress. Determination of intermediate / high risk procedures shall be according to the American College of Cardiology / American Heart Association 2002 Guidelines for Perioperative Cardiovascular Evaluation for Noncardiac Surgery as outlined in Table 1. Table 1. Cardiac Event Risk Stratification for Noncardiac Surgical Procedures High (Reported cardiac risk often \>5%) * Emergent major operations, particularly in the elderly * Aortic and other major vascular surgery * Peripheral vascular surgery * Anticipated prolonged surgical procedures associated with large fluid shifts and/or blood loss Combined incidence of cardiac death and nonfatal myocardial infarction. Further preoperative cardiac testing is not generally required. Intermediate (Reported cardiac risk generally \<5%) * Intraperitoneal and intrathoracic surgery * Carotid endarterectomy surgery * Head and neck surgery * Orthopedic surgery * Prostate surgery Low (Reported cardiac risk generally \<1%): * Endoscopic procedures * Superficial procedures * Cataract surgery * Breast surgery Prior to entering the operating suite for surgery, patients will be randomly assigned to receive either intensive insulin treatment or conventional insulin treatment. Treatment assignment will be performed using sealed envelopes, and patients stratified according to Table 2. TABLE 2. Baseline Characteristics of Patients. Variable Intention to Treat Group P Value Male sex (%) Age (Years) Type of Surgery * Intracranial (%) * Head \& Neck (%) * Thoracic (%) * Vascular (%) * Gastrointestinal (%) * Urologic (%) * Orthopedic (%) * Gynecologic (%) * Myocutaneous (%) History of Cancer (%) History of Organ Failure before Surgery (%) Organ Failure After Surgery (%) History of Diabetes (%) * Treated with insulin * Treated with oral diabetic agent, diet or both Inclusion criteria: * Patients scheduled for non emergent surgery under either general or regional anesthesia deemed to have moderate to high physiologic stress * Male and female subjects over the age of 18 with or without a diagnosis of diabetes mellitus * Patients must be able to provide informed consent Exclusion criteria: * Cognitively impaired * Non-English or Spanish speaking with no relative present who is fluent in reading and comprehending English or Spanish. * Female patients of child bearing age who have a positive pregnancy test on admission. In all patients, whole blood hemoglobin A1C and glucose levels will be drawn prior to induction of anesthesia. Additional whole blood glucose levels will be drawn at the time of induction of anesthesia, at skin incision, hourly throughout the operation, at emergence from anesthesia, every hour up to three hours after the completion of surgery, and then once per day until the patient is discharged from the hospital. In the intensive treatment group, continuous insulin infusion (50 IU of Novolin R \[Novo Nordisk\]) in 50mL of 0.9% saline via infusion pump will be started when the blood glucose level exceeds 110 mg/dL and will be adjusted to maintain the blood glucose level between 80 and 110 mg/dL. Adjustments will be made according to the University Hospital's ICU Adult Insulin Infusion Protocol. When the blood glucose level falls below 80 mg/dL, the insulin infusion will be tapered and discontinued. For patients going to the ICU after surgery, insulin infusions will be continued according to the University Hospital's ICU Adult Insulin Infusion Protocol under the direction of the ICU staff. For patients not being to the ICU after surgery, insulin infusions will be tapered to off after the final hourly blood glucose determination at three hours after the completion of surgery. The University Hospital's Blood Glucose Management Order Set for Medical and Surgical Patients will then be adopted for continued glucose management. In the conventional treatment group, continuous insulin infusion will be started when the blood glucose level exceeds 200 mg/dL and will be adjusted to maintain the blood glucose level between 180 and 200 mg/dL. Adjustments will be made according to a modified ICU Adult Insulin Infusion Protocol. When the blood glucose level falls below 180mg/dL, the insulin infusion will be tapered and discontinued. For patients transferred to an ICU after surgery, insulin infusions will be continued according to the University Hospital's ICU Adult Insulin Infusion Protocol under the direction of the ICU staff. For patients not being transferred to an ICU after surgery, insulin infusions will be tapered to off after the final hourly blood glucose determination at three hours after the completion of surgery. The University Hospital's Blood Glucose Management Order Set for Medical and Surgical Patients will then be adopted for continued glucose management. How will the study be analyzed? At baseline, data on demographic and clinical characteristics of the patients (see Table 1) will be obtained. Blood will be systematically sampled and whole blood glucose levels determined as described above. All blood glucose values will be tabulated from baseline through end of study. A research associate blinded to the treatment groups will determine morbidity and mortality by reviewing the patient's medical record upon discharge from the hospital and recording the occurrence of morbidity and mortality by the following criteria: 1. Post-operative surgical wound infection - a clinical condition requiring antibiotic treatment beyond the UH Surgical Infection Prevention (SIP) protocol and / or subsequent wound drainage / debridement 2. Systemic infection - presence of bacteremia or prolonged (i.e. greater than 10 days) use of antibiotics 3. Myocardial Injury - postoperative EKG changes that reveal new Q waves or S-T segment elevations greater than 1mm in any lead(s) or serum troponin levels that exceed…. 4. Malignant arrhythmia - asystole, ventricular tachycardia or fibrillation requiring cardiopulmonary resuscitation, antiarrhythmia therapy, or defibrillator implantation 5. Respiratory Injury - mechanical ventilation for more than 48 hours, reintubation, or planned tracheostomy 6. Neurological Injury - focal brain injury with permanent functional deficit, irreversible encephalopathy 7. Renal Injury - a level of serum creatinine twice that present on admission to the hospital or acute renal failure requiring dialysis 8. Hepatic Injury - bilirubin level of \>3mg per deciliter 9. Venous Thromboembolism - deposition of thrombus in peripheral or central veins as determined by Doppler ultrasonography, angiography or computed tomography.

Hyperglycemia

glycemic control, diabetes, obesity, comorbidities

null

2

arm 1: In the intensive treatment group, continuous insulin infusion (50 IU of Novolin R \[Novo Nordisk\]) in 50ml of 0.9% saline via infusion pump will be started when the blood glucose level exceeds 110 mg / dL on two consecutive samples and will be adjusted to maintain the blood glucose level between 80 and 110 mg / dL. If the glucose level falls below 80 mg / dL, the insulin infusion will be tapered and discontinued. arm 2: In this group if the subject's blood glucose level should exceed 200 mg/dL the subject will be treated with a continuous insulin infusion to maintain blood glucose levels between 180-200mg/dL

[ 0, 1 ]

2

[ 3, 0 ]

intervention 1: intravenous insulin titrated every 30 minutes to serum glycemic level of 80-100mg/dl intervention 2: Novo regular insulin administered when glucose level exceeded 200 mg/dl and titrated to maintain level between 180-200 mg/dl

intervention 1: intensive glycemic control intervention 2: conventional glycemic control

1

Newark | New Jersey | United States | -74.17237 | 40.73566

0

NCT00487162

[ 5 ]

24

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This is a study of patients with high blood pressure who are already treated with an angiotensin converting enzyme inhibitor or receptor blocker and have achieved good or fair blood pressure control. The hypothesis is that addition of the beta-adrenergic receptor blocker, sustained-release metoprolol, will provide additional blockade of the sympathetic nervous system, thereby further improving left ventricular filling and blood pressure control.

Patients were to receive sympathetic cardiac innervation testing with I-123 MIBG at baseline and again after receiving a titrate dose of beta-blocker. Data were to be assesses by repeated measures testing.

Hypertension

hypertension sympathetic nervous system

null

1

arm 1: Subjects will undergo I-123 MIBG testing before and after sustained-release beta-adrenergic blockade.

[ 0 ]

1

[ 0 ]

intervention 1: Once daily, oral, 12.5 mg to 200 mg, dose titrated to reduce heart rate by 20% or to less than 65 beats per minute.

intervention 1: Metoprolol Succinate

0

null

0

NCT00491387

[ 3 ]

64

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

1FEMALE

false

To assess the efficacy of ZD6474 in combination with docetaxel in the treatment of ABC using the progression event count methodology

null

Advanced Breast Cancer

Zactima

null

2

arm 1: Docetaxel + placebo vandetanib arm 2: Vandetanib + Docetaxel

[ 2, 0 ]

2

[ 0, 0 ]

intervention 1: once daily oral dose intervention 2: intravenous infusion

intervention 1: Vandetanib (ZD6474) intervention 2: Docetaxel

12

Budapest | N/A | Hungary | 19.04045 | 47.49835 Pécs | N/A | Hungary | 18.23083 | 46.0725 Bloemfontein | N/A | South Africa | 26.214 | -29.12107 Cape Town | N/A | South Africa | 18.42322 | -33.92584 Observatory | N/A | South Africa | 18.46787 | -33.93613 Barakaldo | N/A | Spain | -2.98813 | 43.29639 Lleida | N/A | Spain | 0.62218 | 41.61674 Zaragoza | N/A | Spain | -0.87734 | 41.65606 Umeå | N/A | Sweden | 20.25972 | 63.82842 Uppsala | N/A | Sweden | 17.63889 | 59.85882 Västerås | N/A | Sweden | 16.55276 | 59.61617 Taipei | N/A | Taiwan | 121.52639 | 25.05306

0

NCT00494481

[ 5 ]

51

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

Primary Objectives: 1. To determine whether aerosolized ribavirin is effective when given at an intermittent dose over 3 hours every 8 hours for therapy of RSV upper respiratory tract infection (URI) and whether it can prevent progression to pneumonia. 2. To determine the effect of this regimen on persistence of viral shedding.

Ribavirin is the drug that is normally given to treat upper respiratory infections caused by RSV. The drug is only effective when inhaled as an aerosol. This treatment requires the patient to be in a tent and inhale the medication. The usual method for administering this drug has been to inhale the medication continuously over 18 hours. In this study, the same total dose of the medication will be used, however, treatment will be for 3 hours every 8 hours. As part of your standard care, before treatment you will have blood drawn (around 2 teaspoons) for routine blood tests. You will have a washing from your throat and nose collected. For this procedure, around 1 teaspoon of saline will be sprayed into each nostril and you will blow your nose into a cup. You will have a swab of the nose and throat. You will also have a chest x-ray to check on the status of the disease. Women who are able to have children must have a negative blood or urine pregnancy test. Before treatment, you will be randomly assigned (as in the toss of a coin) to one of two groups. Participants in one group will receive treatment with ribavirin over 3 hours every 8 hours. Participants in the other group will receive treatment using the standard treatment schedule, ribavirin over 18 hours every 24 hours. For both groups, the drug will be administered as an aerosol using a face mask. This will require you to be in a tent while you are receiving therapy. Treatment will last between 5 and 10 days. This will require hospitalization. In addition to ribavirin treatment, you will also receive Xopenex inhalation therapy every 6 - 8 hours. Xopenex is a drug designed to make breathing easier. We may need to use another breathing treatment, albuterol inhalation therapy for one time if needed, directly after receiving ribavirin to make breathing easier. Every 2-4 days during treatment you will have blood collected (around 2 teaspoons) for routine tests. On Days 3 and 7 of treatment (+/- 2 days), you will have a repeat throat and nose washings/swabs. The washings and swabs will then be repeated once a week for 2 weeks, or until 2 consecutive cultures are negative, if that occurs sooner. If your doctor feels it is necessary, you may have a repeat chest x-ray. If at any time you develop signs of pneumonia, you will be removed from the study and will be treated with the standard schedule of ribavirin by continuous inhalation and/or other therapy for 18 hours a day. Also, if you develop any intolerable side effects, you will be taken off the study and your doctor will discuss other treatment options with you. This is an investigational study. Ribavirin is FDA approved and is commercially available. However, the method of administration of ribavirin is investigational. Up to 50 patients will participate in this study. All will be enrolled at M. D. Anderson.

Hematological Malignancies

Hematological Malignancies Respiratory Infection Respiratory Syncytial Virus RSV Ribavirin Virazole

null

2

arm 1: Aerosolized Ribavirin 6 grams over 18 hours every 24 hours arm 2: Aerosolized Ribavirin 2 grams over 3 hours every 8 hours

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Arm 1 = 6 Grams Over 18 hours Every 24 Hours intervention 2: Arm 2 = 2 Grams Over 3 Hours Every 8 Hours.

intervention 1: Ribavirin intervention 2: Ribavirin

1

Houston | Texas | United States | -95.36327 | 29.76328

0

NCT00500578

[ 3 ]

59

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

1FEMALE

false

Primary Objectives: 1. Determine response rate, time to progression, and toxicity of a schedule of carboplatin by IV (intravenous) infusion, GM-CSF and rIFN-g by SC (subcutaneous injection) in patients with potentially platinum-sensitive recurrent Müllerian carcinomas. 2. Determine whether this treatment schedule is associated with: 1. increased levels of monocytes (\>2-fold and absolute numbers 1000 cells/ml,) and of LN-DR+ DC (CD11c+ and CD123+ subsets) 2. induction of priming and activation of MO/MA (monocytes/ macrophages), and maturation of DC (dendritic cells). 3. Determine the toxicity profile of consolidation treatment with IP (intraperitoneal) injections of rIFN-g added to carboplatin (IV) and GM-CSF (SC) for 4 doses/course. 4. Determine the effects of carboplatin plus GM-CSF and rIFN-g on quality of life in patients with platinum-sensitive Müllerian carcinomas. 5. To begin an exploration of cell surface proteins on purified activated peripheral blood and ascites monocyte/macrophages both before and after treatment with GM-CSFand rIFN-g.

Carboplatin is a chemotherapy drug that is used for the treatment of ovarian cancer. GM-CSF is a protein that is used to increase the production of white blood cells. rIFN-g is a protein that stimulates cells of the immune system. Participants will need to have pre-study blood work (about 4 teaspoons) as part of their evaluation for study entry. In addition, a chest x-ray and CT scan of the abdomen and pelvis will need to be done before any treatments. Participants in this study will receive a frequently used dose of carboplatin by vein over 1 hour every 28 days. In addition, GM-CSF will be given for 7 days and rIFN-g will be given for 2 days before and after chemotherapy. Both drugs will be given as injections under the skin. They will be repeated with each chemotherapy course that participants receive. GM-CSF and rIFN-g are being used to try to stimulate the immune system in the belief that this adds to the effectiveness of the chemotherapy on the tumor. During each course of chemotherapy treatment, blood samples will be taken in order to evaluate the blood count response to GM-CSF. Participants will need to remain in the Houston area beginning with the first injection of GM-CSF and for up to 9 days following the carboplatin infusion for the first course. QOL forms will be completed at 5 separate time points during the first course of chemotherapy. Later courses will only have 2 time points for completion of the QOL forms. The completion of these forms will help researchers to evaluate the effects of the carboplatin and the 2 proteins on participants and their quality of life. Participants will receive 3 courses of treatment (each course will include 1 treatment with carboplatin followed by 2 separate treatment cycles with GM-CSF and rIFN-g) and then be evaluated for tumor response. If the tumor is responding, 3 additional courses will be given. If after 6 courses of treatment, the tumor has completely responded and there is no evidence of the disease, then up to 4 additional courses can be given for completion of therapy. If the tumor is still responding after 6 courses but has not completely gone away, then additional courses can be given as long as the tumor is responding before completion therapy can be considered. Completion therapy will include carboplatin given every 28 days by vein along with injections of GM-CSF under the skin before and after the chemotherapy. Injections of rIFN-g will be given directly into the abdomen through an abdominal catheter if possible. If this is not possible, then the rIFN-g will be given as injections under the skin. Participants may choose not to receive the rIFN-g through a catheter during the completion phase and can continue to receive it under the skin with the chemotherapy. A maximum of 4 additional courses can be given during this phase of the study. Participants whose disease gets worse will be taken off the study. Participants who have intolerable side effect from the study drugs will also be taken off the study treatment. Participants will have follow up CT scans after every 3 courses of treatment. Following completion of all treatments, participants will need to return to M. D. Anderson every 3 months for follow-up exams. This will include a physical exam, blood work, and a CT scan. This is an investigational study. A total of 65 patients will take part in this study.

Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer

Müllerian Carcinomas Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer Epithelial Ovarian Peritoneal Fallopian Tube Chemoimmunotherapy Platinum Sensitive Müllerian Carboplatin Paraplatin GM-CSF Sargramostim Interferon Gamma Quality of Life QOL

null

1

arm 1: GM-CSF Starting dose of 400 mg injected under the skin once a day for 7 days prior to and following each course of chemotherapy + rIFN-g (Interferon Gamma) 0.1 mg injected under the skin for 2 days before and after chemotherapy (Day 5 and Day 7 of each 7-day GM-CSF cycle) + Paraplatin (Carboplatin) AUC of 5 by 1 hour IV infusion every 28 days

[ 0 ]

3

[ 0, 0, 0 ]

intervention 1: AUC of 5 by 1 hour IV infusion every 28 days. intervention 2: Starting dose of 400 mg injected under the skin once a day for 7 days prior to and following each course of chemotherapy. intervention 3: 0.1 mg injected under the skin for 2 days before and after chemotherapy (Day 5 and Day 7 of each 7-day GM-CSF cycle).

intervention 1: Carboplatin intervention 2: GM-CSF (Sargramostim) intervention 3: Interferon Gamma

1

Houston | Texas | United States | -95.36327 | 29.76328

0

NCT00501644

[ 0 ]

28

RANDOMIZED

CROSSOVER

7BASIC_SCIENCE

2DOUBLE

false

0ALL

false

The purpose of this study is to evaluate the cardiovascular and lipid effects of two doses of an omega-3 fatty acid concentrate in a group of people who normally are not treated for high lipids.

null

Hypertriglyceridemia

triglycerides hypertriglyceridemia omega-3 n-3 eicosapentaenoic acid EPA docosahexaenoic acid DHA flow mediated dilation fish Moderate hypertriglyceridemia

null

6

arm 1: 4 g/day Dose Prescription Omega-3 acid ethyl esters (P-OM3)capsules(4) for first intervention (8 weeks), followed by 1g/day P-OM3 capsules(4) for 2nd intervention (8 weeks), followed by Placebo corn oil capsules, 4/day, for the 3rd intervention (8 weeks). arm 2: 1g capsules for 8-wks, followed by 6-wk washout. 4g capsules for 8 wks,followed by 6-wk washout. Placebo capsules for 8-wks. arm 3: Corn Oil placebo capsules for 8-wks, followed by 6-wk washout. 4g P-OM3 capsules for 8-wks, followed by 6-wk washout. 1g P-OM3 for 8-wks. arm 4: 4g capsules for 8-wks, followed by 6-wk washout. Placebo capsules for 8-wks, followed by 6-wk washout. 1g capsules for 8 wks. arm 5: 1g capsules for 8-wks, followed by 6-wk washout. Placebo capsules for 8-wks, followed by 6-wk washout. 4g capsules for 8 wks. arm 6: Corn oil placebo capsules for 8-wks, followed by 6-wk washout.1g capsules for 8-wks, followed by 6-wk washout. 4g capsules for 8 wks.

[ 0, 0, 0, 0, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: 4/day of 4g P-OM3 capsules for 8 weeks intervention 2: 4/day of 1g P-OM3 capsules for 8 weeks intervention 3: 4 capsules per day of corn oil placebo for 8 weeks

intervention 1: 4/day of 4g P-OM3 capsules intervention 2: 4/day of 1g P-OM3 capsules intervention 3: Corn Oil Placebo, 4 capsules/day for 8 weeks

1

University Park | Pennsylvania | United States | -77.85639 | 40.80201

0

NCT00504309

[ 3, 4 ]

249

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

1FEMALE

false

The purpose of this study is to investigate efficacy of drospirenone for dysmenorrhea.

null

Dysmenorrhea

Dysmenorrhea Dysmenorrheal score Drospirenone DRSP Ethinylestradiol

null

4

arm 1: 1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle arm 2: 1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle arm 3: 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle arm 4: 1 tablet per day placebo for 28 days in each 28-day cycle

[ 0, 0, 0, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Drospirenone 1mg/EE 20µg (ß-CDC) intervention 2: Drospirenone 3 mg/EE 20µg (ß-CDC) intervention 3: Drospirenone 2 mg/EE 20µg (ß-CDC) intervention 4: Placebo

intervention 1: SH T04740B intervention 2: SH T00186DF intervention 3: SH T04740F intervention 4: Placebo

12

0

NCT00511797

[ 4 ]

859

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

The study will determine the safety and efficacy of gatifloxacin eye drops in patients with bacterial conjunctivitis

null

Bacterial Conjunctivitis

null

2

arm 1: Gatifloxacin 0.5% Eye Drops arm 2: Placebo Eye Drops

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Day 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily intervention 2: Day 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily

intervention 1: Gatifloxacin 0.5% eye drops intervention 2: placebo eye drops

2

0

NCT00518089

[ 3 ]

7

NA

SINGLE_GROUP

9OTHER

0NONE

false

0ALL

false

The purpose of this study is to determine whether the addition of Pyridostigmine to Highly Active Antiretroviral Therapy (HAART) increases the number of CD4+ T-cells in discordant patients in which viral load diminishes, but T-cell levels remain low after the initiation of treatment.

In HIV-1 infected patients, HAART suppresses viral replication, reflected by a reduced viral load, and a recovery in the frequency of CD4+ T-cells. The latter is associated with a reduced risk for developing opportunistic infectious diseases, and death. T-cell recovery, however, is highly variable within individuals, suggesting that virological eradication is but one factor of it. A phenomenon known as Immune Discordance has been well known. It reflects a subpopulation -as high as 30% of patients- in whom there is an adequate suppression of viral replication, but CD4+ cell levels rise modestly (below safety levels). In this setting, patients remain susceptible to develop opportunistic infections, have disease progression, and die. Various mechanisms have been proposed, but one common factor is enhanced CD4+-cell activation, leading to cell dysfunction and apoptosis. It is known that an inflammatory response is able to activate the anti-inflammatory cholinergic pathway, in which acetylcholine (ACh) is released and in turn activates nicotinic receptors in macrophages. The result is a diminished synthesis of inflammatory cytokines such as TNF-α, and IL-1. We have recently shown in an ex-vivo, proof-of-concept study carried in HIV-infected subjects in early phases of the infection (not requiring specific treatment) that Pyridostigmine diminishes CD4+-cell activation and an increase in the subpopulation of regulatory T-cells (T-reg). Pyridostigmine, an ACh-esterase inhibitor, has been shown to be safe in other populations, including healthy Gulf War military personnel, and patients with Myasthenia Gravis. Its hypothetical effect is by reducing the degrading rate of the naturally occurring ACh (released by the vagus nerve) by the enzyme ACh-esterase. This in turn enhances its coupling to nicotinic receptors in macrophages that, according to our previous study (unpublished data), improves the T-cell milieu, diminishes T-cell activation (a well known trigger for apoptosis), and enhances T-reg proliferation. The purpose of this study is to determine whether the addition of Pyridostigmine to Highly Active Antiretroviral Therapy (HAART) increases the number of CD4+ T-cells in discordant patients in which viral load diminishes, but T-cell levels remain low after the initiation of treatment.

HIV Infections

AIDS Immunological non-responders Neuroimmune modulation Pyridostigmine Treatment Experienced

null

1

arm 1: Patients will be taking oral Pyridostigmine 30mg tid, as well as their usual antiretroviral treatment

[ 0 ]

1

[ 0 ]

intervention 1: Patients will take 30mg tid PO for 12 weeks

intervention 1: Pyridostigmine tablets

2

0

NCT00518154

[ 4 ]

20

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

To investigate the pharmacokinetics, pharmacodynamics (urine volume and fluid intake), efficacy(body weight, pulmonary congestion and other congestions including cardiothoracic ratio) and safety of 7-day repeated oral administration of OPC-41061 at 7.5 mg or 15 mg in congestive heart failure (cardiac edema) patients with extracellular volume expansion despite the use of a diuretic.

null

Cardiac Edema

Vasopressin antagonist Cardiac Edema Diuretics

null

2

arm 1: OPC-41061 arm 2: placebo

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Subjects will be orally administered OPC-41061 7.5 mg or 15 mg once daily after breakfast for seven days. intervention 2: Subjects will be orally administered placebo once daily after breakfast for seven days.

intervention 1: OPC-41061(Tolvaptan) intervention 2: Placebo

2

Kanto Region | N/A | Japan | N/A | N/A Kyushu Region | N/A | Japan | N/A | N/A

0

NCT00525265

[ 3 ]

100

RANDOMIZED

PARALLEL

4SUPPORTIVE_CARE

3TRIPLE

false

0ALL

true

This study compares the efficacy of the Synera patch with Eutectic Mixture of Local Anesthetics (EMLA) as a topical anesthetic for venipuncture in pediatric patients.

Venipunctures are common and necessary components of pediatric health care. Unfortunately, many children have "needle phobia" and even a simple procedure, such as a venipuncture, can cause significant stress and anxiety to the patient and the parents involved. Studies have shown that needles are the worst part of hospital/healthcare related visits for children. The Synera patch uses a controlled heating system to transcutaneously deliver a lidocaine/tetracaine mixture for analgesic effect. No published studies compare the efficacy of the Synera patch with other topical anesthetics in children. The objective of this study is to compare the efficacy of the Synera patch applied for 20 minutes with the efficacy of EMLA Cream applied for 60 minutes in reducing pain associated with venipunctures in children. Patients, 4-12 years old children requiring venipunctures in clinics, were randomized to receive Synera for 20 minutes or EMLA for 60 minutes. A blinded observer recorded pain scores using a numerical rating scale (NRS). Child and parent assessed pain with the Wong-Baker FACES Scale and the NRS, respectively. The primary outcome was the number of subjects reporting "no pain". Secondary outcomes were parent and observer measures of the child's pain and the presence of skin reactions.

Pain Needle Phobia

EMLA venipuncture children Synera patch pediatric Lidocaine/prilocaine

null

2

arm 1: Participants will have a dose of EMLA Cream applied to the venipuncture site 1 hour before the procedure. Dosage based on age and weight: 4-6 years old and heavier than 10kg will receive 10g of EMLA; 7-12 years old and more than 20kg will receive 20g of EMLA. arm 2: Participants will have a Synera Patch applied to the venipuncture site 20 minutes prior to the procedure.

[ 1, 1 ]

2

[ 0, 8 ]

intervention 1: 60 minutes x1 intervention 2: 20 minutes x1

intervention 1: EMLA Cream intervention 2: Synera Patch

1

The Bronx | New York | United States | -73.86641 | 40.84985

0

NCT00530803

[ 5 ]

344

null

CROSSOVER

0TREATMENT

null

false

0ALL

null

The primary objective of this study is to demonstrate that treatment with a free combination of tiotropium and salmeterol provides superior improvement in static lung volumes and exercise tolerance compared to a fixed combination of fluticasone and salmeterol in patients with COPD. The secondary objective includes assessment of safety.

null

Pulmonary Disease, Chronic Obstructive

null

0

null

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: Tiotropium plus Salmeterol intervention 2: Fluticasone/Salmeterol

42

Gänserndorf | N/A | Austria | 16.72016 | 48.33925 Hallein | N/A | Austria | 13.1 | 47.68333 Leoben | N/A | Austria | 15.09144 | 47.3765 Linz | N/A | Austria | 14.28611 | 48.30639 Neumarkt am Wallersee | N/A | Austria | 13.23333 | 47.95 Salzburg | N/A | Austria | 13.04399 | 47.79941 Vancouver | British Columbia | Canada | -123.11934 | 49.24966 Halifax | Nova Scotia | Canada | -63.57688 | 44.64269 Hamilton | Ontario | Canada | -79.84963 | 43.25011 Kingston | Ontario | Canada | -76.48098 | 44.22976 Ottawa | Ontario | Canada | -75.69812 | 45.41117 Toronto | Ontario | Canada | -79.39864 | 43.70643 Montreal | Quebec | Canada | -73.58781 | 45.50884 Québec | Quebec | Canada | -71.21454 | 46.81228 Saskatoon | Saskatchewan | Canada | -106.66892 | 52.13238 Beuvry | N/A | France | 2.68541 | 50.51674 Beuvry | N/A | France | 2.68541 | 50.51674 Créteil | N/A | France | 2.46569 | 48.79266 Grenoble | N/A | France | 5.71479 | 45.17869 Saint-Priest-en-Jarez | N/A | France | 4.37678 | 45.4739 Strasbourg | N/A | France | 7.74553 | 48.58392 Strasbourg | N/A | France | 7.74553 | 48.58392 Toulouse | N/A | France | 1.44367 | 43.60426 Toulouse | N/A | France | 1.44367 | 43.60426 Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.52437 Cologne | N/A | Germany | 6.95 | 50.93333 Donaustauf | N/A | Germany | 12.20459 | 49.03258 Großhansdorf | N/A | Germany | 10.28333 | 53.66667 Kiel | N/A | Germany | 10.13489 | 54.32133 Catania | N/A | Italy | 15.07041 | 37.49223 Gaiato Pavullo (mo) | N/A | Italy | N/A | N/A Milan | N/A | Italy | 12.59836 | 42.78235 Pisa | N/A | Italy | 10.4036 | 43.70853 Roma | N/A | Italy | 11.10642 | 44.99364 Roma | N/A | Italy | 11.10642 | 44.99364 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Jönköping | N/A | Sweden | 14.15618 | 57.78145 Lund | N/A | Sweden | 13.19321 | 55.70584 Uppsala | N/A | Sweden | 17.63889 | 59.85882

0

NCT00530842

[ 5 ]

161

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This trial is conducted in Europe. This is a clinical trial investigating the effectiveness and the safety of using biphasic insulin aspart 30 both for initiation and intensification of insulin treatment in type 2 diabetes.

null

Diabetes Diabetes Mellitus, Type 2

null

1

arm 1: Biphasic insulin aspart 30 administered once daily for 16 weeks. If HbA1c is higher than 7.0 % after 16 weeks of treatment, dose is increased to twice daily for another 16 weeks. If HbA1c is higher than 7.0 % after 32 weeks of treatment, dose is increased to three times daily until week 48 (end of trial).

[ 0 ]

1

[ 0 ]

intervention 1: Treat-to-target dose titration scheme (dose individually adjusted), injected s.c. (under the skin)

intervention 1: biphasic insulin aspart

1

Istanbul | N/A | Turkey (Türkiye) | 28.94966 | 41.01384

0

NCT00537277

[ 3 ]

5

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

RATIONALE: Drugs used in chemotherapy, such as PR-104, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well PR-104 works in treating patients with previously untreated or relapsed small cell lung cancer (SCLC).

OBJECTIVES: Primary * Estimate the response rate of PR-104 in patients with treatment-naive or sensitive-relapse small cell lung cancer. * Evaluate safety of this drug in these patients. Secondary * Evaluate survival of these patients. * Evaluate progression-free survival of these patients. * Evaluate time to progression in these patients. * Assess the pharmacokinetics (PK) of PR-104 and its alcohol metabolite. * Estimate the rate of hypoxia using 18F-fluoromisonidazole (FMISO) positron emission topography (PET) imaging. * Collect plasma samples for assessment of potential biomarkers of tumor hypoxia. OUTLINE: This is a multicenter study. Patients are stratified according to disease type (treatment-naive vs sensitive-relapse). Patients receive PR-104 intravenously (IV) over 1 hour on day 1. Treatment repeats every 21 days for up to 4 courses (for treatment-naive patients) or in the absence of disease progression or unacceptable toxicity (for sensitive-relapse patients). PK studies are performed during course 1 and after course 3. Blood is collected at baseline, during course 1, and at study completion for biomarker studies of tumor hypoxia (plasma proteins). Patients also undergo FMISO PET and fludeoxyglucose F18 (FDG) PET scans at baseline and after the second course of study therapy.

Lung Cancer

extensive stage small cell lung cancer limited stage small cell lung cancer recurrent small cell lung cancer

null

1

arm 1: PR104 will be administered once every 21 days by IV

[ 0 ]

2

[ 0, 10 ]

intervention 1: administered at a dose of 1100 mg/m\^2 by intravenous infusion over 1 hour and repeated every three weeks intervention 2: administered intravenously prior to PET scan

intervention 1: PR104 intervention 2: F-18-fluoromisonidazole

18

0

NCT00544674

[ 3 ]

41

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

2MALE

false

Currently, there are no established 2nd-line or salvage chemotherapy regimens for patients with HRPC, many of whom retain an excellent performance status. The antitumor characteristics and toxicity profile of vinflunine make it an ideal agent to be investigated in this setting. In this Phase II trial, we plan to evaluate the efficacy, toxicity, and feasibility of administering IV vinflunine at a dose of 320 mg/m2 q3w as salvage chemotherapy in patients with HRPC. The patients will be evaluated for response, survival, and toxicity. If significant antitumor activity is demonstrated, further evaluation of this agent either alone or combination regimens and at earlier stages of disease will be indicated.

This is a non-randomized (single-arm), open-label, multi-center, single-agent, Phase II study of vinflunine as second- or third-line treatment of subjects with HRPC. The primary objective of the study is to evaluate the efficacy of vinflunine in the salvage treatment, as measured by Protein-Specific Antigen (PSA) Response Rate endpoint. The primary objective of this study is as follows: To evaluate the efficacy (as measured by the PSA response rate) of IV vinflunine administered q3w in HRPC patients who have progressed after one or two previous chemotherapy regimens. Secondary Objectives The secondary objectives of this study are as follows: * To evaluate the efficacy of IV vinflunine administered q3w in HRPC patients who have previously received chemotherapy (one or two regimens), as measured by: * Time to PSA progression * Overall survival * Palliative response in patients with an Analgesic Score (AS) ≥10 and stable baseline pain * Health-Related Quality of Life * To assess the efficacy (as measured by the PSA response rate) of IV vinflunine in HRPC patients based on their response to prior chemotherapy * Chemotherapy responsive - previous response to most recent chemotherapy regimen lasting \>2 months after completion. * Chemotherapy refractory - failure to respond to, or progression during or within three months of completing last chemotherapy. * To assess the response rate to IV vinflunine in the subset of patients with measurable disease, as measured by traditional Response Evaluation Criteria in Solid Tumors (RECIST) criteria (Therasse et al. 2000). * To evaluate the safety of IV vinflunine administered every three weeks in HRPC patients who have previously received chemotherapy.

Prostate Cancer

Prostate Cancer Hormone Refractory Vinflunine Salvage Chemotherapy

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: Vinflunine 320 mg/m2 will be administered as a 20 minute IV infusion q3w. Patients will be evaluated for toxicity after each cycle of therapy. Response to vinflunine will be assessed every 6 weeks (every 2 cycles) of treatment. A maximum of 6 cycles of therapy are planned.

intervention 1: Vinflunine

12

0

NCT00545766

[ 4 ]

459

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

This study will test an experimental drug called OROS® hydromorphone hydrochloride (HCl) (NMED-1077), a once daily opioid analgesic that can relieve pain. A large number of clinical studies have been conducted to test this drug. OROS hydromorphone HCl is currently approved in both the US and Europe to treat chronic pain. The purpose of this study is to compare OROS hydromorphone to placebo to see if it is safe and efficacious.

null

Chronic Low Back Pain

Back Pain Chronic Low Back Pain Chronic Back Pain Pain Chronic Pain

null

2

arm 1: OROS hydromorphone tablets administered orally once daily in total daily doses of 12, 16, 24, 32, 40, 48, or 64 mg arm 2: Matching placebo tablets orally once daily (number and dosage of tablets to match the number and dosage of the stable dose of OROS hydromorphone obtained in the Conversion and Titration phase).

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: hydromorphone 12, 16, 24, 32, 40, 48, or 64 mg tablets intervention 2: Placebo

intervention 1: OROS hydromorphone intervention 2: Placebo

0

null

0

NCT00549042

[ 3 ]

51

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

true

CRx-102 is a synergistic combination drug candidate containing the cardiovascular drug dipyridamole and a very low dose of the glucocorticoid prednisolone. CRx-102 is believed to work through a novel mechanism of action in which dipyridamole selectively amplifies the anti-inflammatory and immunomodulatory activities of the glucocorticoid without replicating the dose-dependent adverse effects. CRx-102 has been associated with clinical benefit in proof of concept studies in subjects with hand Osteoarthritis (OA) and Rheumatoid Arthritis (RA). In this trial, CRx-102 will be given to subjects with active RA as an add-on therapy to existing stable doses of Disease Modifying Anti-Rheumatic Drugs (DMARDs) including methotrexate (MTX), sulfasalazine, hydroxychloroquine, leflunomide or azathioprine. MTX in combination with other DMARDs (e.g., sulfasalazine or hydroxychloroquine) will be permitted to reflect the current standard of care practices within rheumatology.

The study was discontinued before the enrollment objective was met. Preliminary review of the efficacy dataset revealed that the efficacy dataset was not robust enough to support an extensive formal efficacy analysis as described in the SAP. Therefore, only the CRP values over time and the percent change in C-reactive protein (CRP) values in the As-Treated population were calculated.

Rheumatoid Arthritis

CombinatoRx CRx-102 Rheumatoid Arthritis Prednisolone Dipyridamole ACR20

null

5

arm 1: CRx-102 dose 1 total daily dose during treatment period (days 14-98) 2.7 mg prednisolone plus 180 mg dipyridamole administered as 1.8 mg prednisolone plus 90 mg dipyridamole at 8 AM and 0.9 mg prednisolone plus 90 mg dipyridamole at 1 PM titration dose (days 0-13) 2.7 mg prednisolone plus 90 mg dipyridamole administered as 1.8 mg prednisolone plus 45 mg dipyridamole at 8 AM and 0.9 mg prednisolone plus 45 mg dipyridamole at 1 PM arm 2: CRx-102 Dose 2 total daily dose during treatment period (days 14-98) 2.7 mg prednisolone plus 360 mg dipyridamole administered as 1.8 mg prednisolone plus 180 mg dipyridamole at 8 AM and 0.9 mg prednisolone plus 180 mg dipyridamole at 1 PM titration dose 1 (days 0-6) 2.7 mg prednisolone plus 90 mg dipyridamole administered as 1.8 mg prednisolone plus 45 mg dipyridamole at 8 AM and 0.9 mg prednisolone plus 45 mg dipyridamole at 1 PM titration dose 2 (days 7-13) 2.7 mg prednisolone plus 180 mg dipyridamole administered as 1.8 mg prednisolone plus 90 mg dipyridamole at 8 AM and 0.9 mg prednisolone plus 90 mg dipyridamole at 1 PM arm 3: treatment dose ( days 0-98) total daily dose of 2.7 mg prednisolone administered as 1.8 mg prednisolone at 8 AM and 0.9 mg prednisolone at 1 PM arm 4: total daily dose during treatment period (days 14-98) 360 mg dipyridamole administered as 180 mg dipyridamole at 8 AM and and 180 mg dipyridamole at 1 PM titration dose 1 (days 0-6) 90 mg dipyridamole administered 45 mg dipyridamole at 8 AM and 45 mg dipyridamole at 1 PM titration dose 2 (days 7-13) 180 mg dipyridamole administered as 90 mg dipyridamole at 8 AM and 90 mg dipyridamole at 1 PM arm 5: placebo administered twice per day at 8 AM and 1 PM

[ 0, 0, 1, 1, 2 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: prednisolone 2.7 mg plus dipyridamole 180 mg intervention 2: prednisolone (2.7 mg) intervention 3: dipyridamole 360 mg intervention 4: placebo intervention 5: Prednisolone 2.7 mg plus Dipyridamole 360 mg

intervention 1: CRx-102 (2.7/180) intervention 2: prednisolone intervention 3: dipyridamole intervention 4: placebo intervention 5: CRx-102 (2.7/360)

48

0

NCT00551707

[ 0 ]

21

NA

SINGLE_GROUP

7BASIC_SCIENCE

0NONE

false

0ALL

false

Dosing of medications is based on the plasma level achieved with a given dose and how long the medicine remains in the body. This study is called pharmacokinetics-that is, what the body does to the medication. Ketamine is an intravenous medication used for anesthesia and sedation in children. However the pharmacokinetics of Ketamine has not been systematically studied. We propose to study the pharmacokinetics of ketamine in different age groups of children ranging from infants to teenagers.

This is an open label study that will be conducted in infants and children presenting for procedures (eg., surgery or cardiac catheterization) at Stanford and Lucile Packard Children's hospital in California and at The Children's Hospital in Denver, CO. Patients with abnormal kidney or liver functions will be excluded from the study as the dysfunction in these organs affects the clearance of medications from the body and affects dosing. Preterm neonates will also be excluded. All patients will be premedicated and anesthetised at the discretion of the anesthesia faculty providing clinical care for the child. Once the patient's procedure is underway, a 0.5 cc blood sample will be drawn from an intravenous line. This is the preload blood sample (T0). Following this a 2mg/kg intravenous bolus of Ketamine will be administered over 5 minutes (this is the usual dose and manner in which ketamine is administered). Five minutes after the bolus, timed blood samples will be drawn at the following intervals: 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360 and 720 minutes after bolus. (Total 14 blood samples; total blood required is 7 mls for the entire study). When the procedure is completed the anesthesiologist will awaken the patient as per their usual practice. Blood samples that still need drawing will be done in the post-anesthesia recovery room or intensive care or ward-any location where the patient is likely to remain after the surgery.

The Pk of IV Ketamine in Children With Heart Disease

anesthesia children ketamine pharmacokinetics

null

1

arm 1: Then a 2 mg/kg IV bolus of Ketamine hydrochloride will be given as part of general anesthesia for procedure

[ 5 ]

1

[ 0 ]

intervention 1: Open label pharmacokinetic study to be conducted in infants and children presenting for medical procedures (eg., surgery or cardiac catheterization). After the start of the procedure, a 0.5 cc preload blood sample (T0) will be drawn from an IV line. Then a 2 mg/kg IV bolus of Ketamine will be administered over 5 minutes. Timed 0.5 ml blood samples will be drawn at the following intervals: 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360 and 720 minutes after bolus.

intervention 1: ketamine hydrochloride

2

0

NCT00553839

[ 5 ]

10

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

To establish the effects of genotropin replacement on cognitive function in patients with severe growth hormone deficiency after traumatic brain injury.

The study was terminated on 15-Dec-2008 due to an inability to recruit the protocol specified patient population. The study has not been terminated due to any safety concerns.

Brain Injuries Growth Hormone Deficiency

traumatic brain Injury, cognitive function

null

2

arm 1: None arm 2: None

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Subcutaneous injection, starting dose 0.2mg/day for males and 0.3mg/day for female with dose titration at 0.1mg to 0.2 mg increments in accordance to IGF-1 results for a total duration of 36 weeks. intervention 2: Subcutaneous injection, with dummy dose titration for a total duration of 36 weeks.

intervention 1: Genotropin intervention 2: Placebo

9

Créteil | N/A | France | 2.46569 | 48.79266 Paris | N/A | France | 2.3488 | 48.85341 Ferrara | N/A | Italy | 11.62057 | 44.83804 Roma | N/A | Italy | 11.10642 | 44.99364 Rotterdam | N/A | Netherlands | 4.47917 | 51.9225 Seville | Sevilla | Spain | -5.97317 | 37.38283 Gothenburg | N/A | Sweden | 11.96679 | 57.70716 Stockholm | N/A | Sweden | 18.06871 | 59.32938 Salford | Manchester | United Kingdom | -2.29042 | 53.48771

0

NCT00555009

[ 3 ]

951

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

To evaluate the efficacy and safety of fesoterodine in comparison to placebo for overactive bladder.

null

Overactive Bladder

null

3

arm 1: None arm 2: None arm 3: None

[ 0, 2, 0 ]

3

[ 0, 0, 0 ]

intervention 1: 8mg tablets OD for 12 weeks intervention 2: Corresponding placebo tablets OD for 12 weeks intervention 3: 4mg tablets OD for 12 weeks

intervention 1: fesoterodine fumarate intervention 2: Placebo intervention 3: fesoterodine fumarate

65

0

NCT00561951

[ 4 ]

1,002

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

null

This study evaluated the safety and efficacy of 26 weeks treatment with indacaterol, placebo or salmeterol in patients with chronic obstructive pulmonary disease.

null

Chronic Obstructive Pulmonary Disease (COPD)

Chronic obstructive pulmonary disease, indacaterol, salmeterol, placebo controlled

null

3

arm 1: Indacaterol 150 μg once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study. arm 2: Placebo to Indacaterol once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study. arm 3: Salmeterol 50 μg twice daily delivered via a proprietary dry powder inhaler in the morning and in the evening. Placebo to Indacaterol daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.

[ 0, 2, 1 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Indacaterol 150 μg once daily (o.d) inhaled intervention 2: Salmeterol 50 μg twice daily (b.i.d) delivered via a proprietary dry powder inhaler intervention 3: Placebo to Indacaterol inhaled via SDDPI. intervention 4: Placebo to salmeterol delivered via a proprietary dry powder inhaler

intervention 1: Indacaterol 150 μg intervention 2: Salmeterol 50 μg intervention 3: Placebo to Indacaterol intervention 4: Placebo to Salmeterol

128

Edmonton | N/A | Canada | -113.46871 | 53.55014 Edmonton | N/A | Canada | -113.46871 | 53.55014 London | N/A | Canada | -81.23304 | 42.98339 Mirabel | N/A | Canada | -74.08251 | 45.65008 Montreal | N/A | Canada | -73.58781 | 45.50884 Toronto | N/A | Canada | -79.39864 | 43.70643 Barranquilla | N/A | Colombia | -74.78132 | 10.96854 Bogota D.C. | N/A | Colombia | N/A | N/A Medellín | N/A | Colombia | -75.57151 | 6.245 Cvikov | N/A | Czechia | 14.63298 | 50.77668 Lovosice | N/A | Czechia | 14.05103 | 50.51504 Novy Jocin | N/A | Czechia | N/A | N/A Pardubice | N/A | Czechia | 15.77659 | 50.04075 Prague | N/A | Czechia | 14.42076 | 50.08804 Žatec | N/A | Czechia | 13.54577 | 50.32717 Aalborg | N/A | Denmark | 9.9187 | 57.048 Aarhus | N/A | Denmark | 10.21076 | 56.15674 Copenhagen | N/A | Denmark | 12.56553 | 55.67594 Copenhagen | N/A | Denmark | 12.56553 | 55.67594 Frederikssund | N/A | Denmark | 12.06896 | 55.83956 Hellerup | N/A | Denmark | 12.57093 | 55.73204 Hvidovre | N/A | Denmark | 12.47708 | 55.64297 Odense | N/A | Denmark | 10.38831 | 55.39594 Roslev | N/A | Denmark | 8.98638 | 56.70387 Silkeborg | N/A | Denmark | 9.54508 | 56.1697 Søborg | N/A | Denmark | 12.31803 | 56.08481 Vaerloese | N/A | Denmark | N/A | N/A Hus | N/A | Finland | N/A | N/A Jyväskylä | N/A | Finland | 25.72088 | 62.24147 Lahti | N/A | Finland | 25.66151 | 60.98267 Oulu | N/A | Finland | 25.46816 | 65.01236 Tampere | N/A | Finland | 23.78712 | 61.49911 Turku | N/A | Finland | 22.26869 | 60.45148 Ambroise | N/A | France | N/A | N/A Beuvry | N/A | France | 2.68541 | 50.51674 Férolles-Attilly | N/A | France | 2.63088 | 48.73184 Nice | N/A | France | 7.26608 | 43.70313 Bad Segeberg | N/A | Germany | 10.30745 | 53.93775 Berlin | N/A | Germany | 13.41053 | 52.52437 Bielefeld | N/A | Germany | 8.53333 | 52.03333 Bochum | N/A | Germany | 7.21648 | 51.48165 Bonn | N/A | Germany | 7.09549 | 50.73438 Brühl | N/A | Germany | 6.90499 | 50.82928 Cologne | N/A | Germany | 6.95 | 50.93333 Cottbus | N/A | Germany | 14.32888 | 51.75769 Dortmund | N/A | Germany | 7.466 | 51.51494 Düren | N/A | Germany | 6.49299 | 50.80434 Eggenfelden | N/A | Germany | 12.75752 | 48.40509 Eschwege | N/A | Germany | 10.05329 | 51.18386 Forchheim | N/A | Germany | 11.05877 | 49.71754 Freudenberg | N/A | Germany | 7.87415 | 50.89741 Fürth | N/A | Germany | 10.98856 | 49.47593 Gelsenkirchen | N/A | Germany | 7.09654 | 51.50508 Gummersbach | N/A | Germany | 7.56473 | 51.02608 Hagen | N/A | Germany | 7.47168 | 51.36081 Hanover | N/A | Germany | 9.73322 | 52.37052 Kassel | N/A | Germany | 9.5 | 51.31667 Kempten | N/A | Germany | 7.93702 | 49.96729 Landsberg am Lech | N/A | Germany | 10.88282 | 48.04819 Langenfeld | N/A | Germany | 6.94831 | 51.10821 Leipzig | N/A | Germany | 12.37129 | 51.33962 Mainz | N/A | Germany | 8.2791 | 49.98419 Munich | N/A | Germany | 11.57549 | 48.13743 München | N/A | Germany | 13.31243 | 51.60698 Neuss | N/A | Germany | 6.68504 | 51.19807 Nuremberg | N/A | Germany | 11.07752 | 49.45421 Oschersleben | N/A | Germany | 11.22898 | 52.03039 Ruhmannsfelden | N/A | Germany | 12.98347 | 48.98327 Sinsheim | N/A | Germany | 8.87867 | 49.2529 Solingen | N/A | Germany | 7.0845 | 51.17343 Steinfort-borghorst | N/A | Germany | N/A | N/A Vilshofen | N/A | Germany | 13.19222 | 48.62695 Wallerfing | N/A | Germany | 12.88035 | 48.68416 Witten | N/A | Germany | 7.35258 | 51.44362 Budapest | N/A | Hungary | 19.04045 | 47.49835 Debrechen | N/A | Hungary | N/A | N/A Deszk | N/A | Hungary | 20.24322 | 46.21802 Mosonmagyaróvár | N/A | Hungary | 17.26994 | 47.86789 Székesfehérvár | N/A | Hungary | 18.41034 | 47.18995 Reykhavik | N/A | Iceland | N/A | N/A Chennai | N/A | India | 80.27847 | 13.08784 Coimbatore | N/A | India | 76.96612 | 11.00555 Goa | N/A | India | 72.72583 | 24.60243 Hyderabad | N/A | India | 78.45636 | 17.38405 Jaipur | N/A | India | 75.78781 | 26.91962 Kerala | N/A | India | N/A | N/A Mangalore | N/A | India | 74.85603 | 12.91723 Mumbai | N/A | India | 72.88261 | 19.07283 Vellore | N/A | India | 79.13255 | 12.9184 Ancona | N/A | Italy | 13.5103 | 43.60717 Arenzano | N/A | Italy | 8.68315 | 44.40521 Ascoli Piceno | N/A | Italy | 13.57395 | 42.85351 Brescia | N/A | Italy | 10.21472 | 45.53558 Cagliari | N/A | Italy | 9.11917 | 39.23054 Chieti | N/A | Italy | 14.16494 | 42.34827 Ferrara | N/A | Italy | 11.62057 | 44.83804 Milan | N/A | Italy | 9.18951 | 45.46427 Milan | N/A | Italy | 12.59836 | 42.78235 Orbassano | N/A | Italy | 7.53813 | 45.00547 Palermo | N/A | Italy | 13.3636 | 38.1166 Reggio Emilia | N/A | Italy | 10.63125 | 44.69825 Rome | N/A | Italy | 12.51133 | 41.89193 Sexten | N/A | Italy | 12.34962 | 46.70216 Siena | N/A | Italy | 11.33064 | 43.31822 Terni | N/A | Italy | 12.64329 | 42.56335 Callao | N/A | Peru | -77.13452 | -12.05162 Miraflores | N/A | Peru | -77.03274 | -12.11331 San Borja | N/A | Peru | -77.01107 | -12.09841 San Isidro | N/A | Peru | -77.04258 | -12.09655 San Martín de Porres | N/A | Peru | -74.56901 | -8.39936 Surco | N/A | Peru | -76.44002 | -11.88401 Kazan' | N/A | Russia | 49.12214 | 55.78874 Moscow | N/A | Russia | 37.61556 | 55.75222 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Samara | N/A | Russia | 50.15 | 53.20007 Yaroslavl | N/A | Russia | 39.87368 | 57.62987 Yekaterinburg | N/A | Russia | 60.6122 | 56.8519 Bardejov | N/A | Slovakia | 21.27271 | 49.29175 Bratislava | N/A | Slovakia | 17.10674 | 48.14816 Košice | N/A | Slovakia | 21.25808 | 48.71395 Kovice | N/A | Slovakia | N/A | N/A Spišská Nová Ves | N/A | Slovakia | 20.56153 | 48.94464 Changhua | N/A | Taiwan | 120.5512 | 24.0692 Kaohsiung City | N/A | Taiwan | 120.31333 | 22.61626 Kaohusing | N/A | Taiwan | N/A | N/A Lin-ko | N/A | Taiwan | N/A | N/A Taichung | N/A | Taiwan | 120.6839 | 24.1469 Taipei | N/A | Taiwan | 121.52639 | 25.05306

0

NCT00567996

[ 4 ]

360

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

The purpose of this study is to examine the safety and efficacy of two doses of MAP0010 versus placebo in asthmatic infants and children, 12 months to 8 years of age, over a 12-week treatment period.

null

Asthma

asthmatic children

null

3

arm 1: 0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks arm 2: Placebo delivered by nebulization twice daily for 12 weeks arm 3: 0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks

[ 0, 2, 0 ]

3

[ 0, 0, 0 ]

intervention 1: 0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks intervention 2: 0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks intervention 3: Placebo delivered by nebulization twice daily for 12 weeks

intervention 1: 0.135mg MAP0010 intervention 2: 0.25mg MAP0010 intervention 3: Placebo

0

null

0

NCT00569192

[ 3 ]

30

RANDOMIZED

CROSSOVER

0TREATMENT

0NONE

false

0ALL

null

The original protocol was a randomized, open-label, 3-way cross-over study with 9 scheduled visits. The visits comprised an initial screening visit, 3 treatment visits for the meal challenge followed by a 2-6-week blood-loss recovery period, an interim safety visit, 3 sequential visits for the glucose clamp, and a final close-out visit. Protocol Amendment 1 was a randomized, open-label, 2-way cross-over study with 7 visits for each completed subject. The visits comprise an initial screening visit, 2 treatment visits for the meal challenge followed by a 2-6-week blood-loss recovery period, an interim safety visit, 2 sequential visits for the glucose clamp, and a final close-out visit. For both the original protocol and Protocol Amendment 1, subjects were hospitalized in the clinical unit for all procedures.

The original protocol was a randomized, open-label, 3-way cross-over study with 9 scheduled visits. The visits comprised an initial screening visit, 3 treatment visits for the meal challenge followed by a 2-6-week blood-loss recovery period, an interim safety visit, 3 sequential visits for the glucose clamp, and a final close-out visit. After review of the meal challenge data from the Original Protocol design, it became apparent that the TI Inhalation Powder, insulin lispro, and Exubera doses were not well matched, and resulted in significantly higher insulin exposure following insulin lispro than the two inhaled treatments. All meal challenge visits were completed for the 18 subjects enrolled. However, the glucose clamp visits were discontinued since it was discovered that a direct comparison between the treatments was not possible. The protocol was amended (Amendment 1) to ensure that the insulin exposures between TI Inhalation Powder and insulin lispro were more suited (increased the TI Inhalation Powder doses and decreased the insulin lispro dose). An Exubera arm was not included in Amendment 1 due to the market removal of this product. Protocol Amendment 1 was a randomized, open-label, 2-way cross-over study with 7 visits for each completed subject. The visits comprise an initial screening visit, 2 treatment visits for the meal challenge followed by a 2-6-week blood-loss recovery period, an interim safety visit, 2 sequential visits for the glucose clamp, and a final close-out visit. For both the original protocol and Protocol Amendment 1, subjects were hospitalized in the clinical unit for all procedures.

Diabetes Mellitus, Type 2

Inhaled Insulin

null

1

arm 1: Technosphere Insulin

[ 0 ]

1

[ 0 ]

intervention 1: Inhalation 15U/30U

intervention 1: Technosphere Insulin

1

Neuss | GER | Germany | 6.68504 | 51.19807

0

NCT00570687