phases list | enrollmentCount int64 | allocation string | interventionModel string | primaryPurpose class label | masking class label | healthyVolunteers bool | sex class label | oversightHasDmc bool | briefSummary string | detailedDescription string | conditions string | conditionsKeywords string | protocolPdfText string | numArms int64 | armDescriptions string | armGroupTypes list | numInterventions int64 | interventionTypes list | interventionDescriptions string | interventionNames string | numLocations int64 | locationDetails string | target int64 | nctid string |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
[
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 mo... | 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 treatm... | 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 inter... | intervention 1: Didanosine (ddI) intervention 2: Efavirenz (EFV) intervention 3: Emtricitabine (FTC) | 18 | San Diego | California | United States | -117.16472 | 32.71571
San Francisco | California | United States | -122.41942 | 37.77493
Aurora | Colorado | United States | -104.83192 | 39.72943
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Jacksonville | Florida | United States | -81.65565 | 3... | 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 ... | 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... | 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) A... | 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 | Portland | Oregon | United States | -122.67621 | 45.52345
Seattle | Washington | United States | -122.33207 | 47.60621 | 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 eff... | 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... | 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 gu... | 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 ... | 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 ... | 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 sto... | 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 rat... | 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 receiv... | [
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 d... | 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 fen... | 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 ... | 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 K... | 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 | Aurora | Colorado | United States | -104.83192 | 39.72943
Denver | Colorado | United States | -104.9847 | 39.73915
Baltimore | Maryland | United States | -76.61219 | 39.29038
Rochester | Minnesota | United States | -92.4699 | 44.02163
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
Nashville | Tennesse... | 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 ... | 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 h... | 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: \... | 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 go... | 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 | Santa Monica | California | United States | -118.49138 | 34.01949
Aurora | Colorado | United States | -104.83192 | 39.72943
Denver | Colorado | United States | -104.9847 | 39.73915
Chicago | Illinois | United States | -87.65005 | 41.85003
Baltimore | Maryland | United States | -76.61219 | 39.29038
Baltimore | Maryland ... | 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... | 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,... | 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 ra... | [
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 dail... | intervention 1: aldesleukin intervention 2: filgrastim intervention 3: therapeutic tumor infiltrating lymphocytes intervention 4: cyclophosphamide intervention 5: fludarabine phosphate intervention 6: radiation therapy | 2 | Bethesda | Maryland | United States | -77.10026 | 38.98067
Bethesda | Maryland | United States | -77.10026 | 38.98067 | 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 pop... | 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 p... | 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 wit... | [
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 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Tucson | Arizona | United States | -110.92648 | 32.22174
Los Angeles | California | United States | -118.24368 | 34.05223
Aurora | Colorado | United States | -104.83192 | 39.72943
Tampa | Florida | United States | -82.45843 | 27.94752
Chicago | Illinois | Unit... | 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 symptom... | 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 effectiv... | 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... | 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 pelvi... | 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 boos... | 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 doe... | 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 monte... | 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), a... | 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 diureti... | 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 ... | Cystic Fibrosis | cystic fibrosis Pseudomonas aeruginosa | null | 0 | null | null | 1 | [
0
] | intervention 1: None | intervention 1: AZLI 75 mg two times a day (BID)/ three times a day (TID) | 65 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Anchorage | Alaska | United States | -149.90028 | 61.21806
Phoenix | Arizona | United States | -112.07404 | 33.44838
Little Rock | Arkansas | United States | -92.28959 | 34.74648
La Jolla | California | United States | -117.2742 | 32.84727
Los Angeles | Califo... | 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 | 37.5833... | 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 | San Diego | California | United States | -117.16472 | 32.71571
San Francisco | California | United States | -122.41942 | 37.77493
Gainesville | Florida | United States | -82.32483 | 29.65163
Atlanta | Georgia | United States | -84.38798 | 33.749
Chicago | Illinois | United States | -87.65005 | 41.85003
Durham | North C... | 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... | \[Goal\] 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 intracra... | 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 | 37.65... | 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, multicente... | 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 t... | 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 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Chicago | Illinois | United States | -87.65005 | 41.85003
Detroit | Michigan | United States | -83.04575 | 42.33143
New York | New York | United States | -74.00597 | 40.71427
Chapel Hill | North Carolina | United States | -79.05584 | 35.9132
Winston-Salem | No... | 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 inc... | 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 dep... | 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 ... | [
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 m... | 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... | 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 ... | 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 incre... | 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 da... | 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... | 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 o... | 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 trial... | [
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 b... | 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 mult... | Depression, Bipolar | null | 1 | arm 1: Depakote ER up to 1500 mg/day | [
0
] | 1 | [
0
] | intervention 1: Depakote ER | 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 corticostero... | Secondary outcomes include urinary cortisol-creatinine rations, symptom severity scores and peak flow rates. | Asthma | 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 | Bellevue | Pennsylvania | United States | -80.05172 | 40.49396
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062 | 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/oxalipl... | 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 p... | Esophagus Cancer | 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 ... | [
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... | intervention 1: Oxaliplatin intervention 2: Docetaxel intervention 3: Capecitabine intervention 4: Radiation therapy | 7 | Beverly Hills | California | United States | -118.40036 | 34.07362
Jacksonville | Florida | United States | -81.65565 | 30.33218
Atlanta | Georgia | United States | -84.38798 | 33.749
Gainesville | Georgia | United States | -83.82407 | 34.29788
Marietta | Georgia | United States | -84.54993 | 33.9526
Louisville | Kentu... | 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... | Breast Cancer | 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 patien... | [
0
] | 2 | [
0,
0
] | intervention 1: Imatinib intervention 2: Docetaxel | intervention 1: Imatinib intervention 2: Docetaxel | 6 | Gainesville | Georgia | United States | -83.82407 | 34.29788
Louisville | Kentucky | United States | -85.75941 | 38.25424
Baton Rouge | Louisiana | United States | -91.18747 | 30.44332
Omaha | Nebraska | United States | -95.94043 | 41.25626
Cincinnati | Ohio | United States | -84.51439 | 39.12711
Nashville | Tennessee ... | 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 ... | 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 | 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 | Jacksonville | Florida | United States | -81.65565 | 30.33218
Terre Haute | Indiana | United States | -87.41391 | 39.4667
Bowling Green | Kentucky | United States | -86.4436 | 36.99032
Louisville | Kentucky | United States | -85.75941 | 38.25424
Baton Rouge | Louisiana | United States | -91.18747 | 30.44332
Cincinnati ... | 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 motiv... | 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 impossibl... | 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 stres... | 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, on... | 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.
Seco... | 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 myelogen... | 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 aprepit... | 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 millio... | 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 table... | 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 st... | 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,... | 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 inha... | 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 ... | 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 ranibiz... | 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 mo... | [
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 speci... | 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... | 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 fo... | [
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 | Tucson | Arizona | United States | -110.92648 | 32.22174
Los Angeles | California | United States | -118.24368 | 34.05223
Boston | Massachusetts | United States | -71.05977 | 42.35843
Las Vegas | Nevada | United States | -115.13722 | 36.17497
New York | New York | United States | -74.00597 | 40.71427
New York | New Yor... | 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 thems... | 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 | New Haven | Connecticut | United States | -72.92816 | 41.30815
Glen Oaks | New York | United States | -73.71152 | 40.74705
Orangeburg | New York | United States | -73.94958 | 41.04649 | 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 | 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 asse... | 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 o... | [
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 capsul... | 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 gett... | 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 d... | Scleroderma, Systemic | 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 | Hot Springs | Arkansas | United States | -93.05518 | 34.5037
La Verne | California | United States | -117.76784 | 34.10084
Norwich | Connecticut | United States | -72.07591 | 41.52426
Augusta | Georgia | United States | -81.97484 | 33.47097
Coeur d'Alene | Idaho | United States | -116.78047 | 47.67768
Billings | Montan... | 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 biom... | 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. Secondar... | 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 pso... | 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 increas... | 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 subcuta... | [
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... | 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... | 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 associati... | 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... | 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 | Minneapolis | Minnesota | United States | -93.26384 | 44.97997
Upland | Pennsylvania | United States | -75.38269 | 39.85261 | 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 | ... | 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 ho... | 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 multic... | 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 ... | 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 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 ... | 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 ... | 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 ... | 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 ... | [
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 beginn... | intervention 1: Bevacizumab intervention 2: Pemetrexed intervention 3: Radiotherapy intervention 4: Folic Acid intervention 5: vitamin B12 intervention 6: carboplatin | 7 | Gainesville | Florida | United States | -82.32483 | 29.65163
Lakeland | Florida | United States | -81.9498 | 28.03947
Marietta | Georgia | United States | -84.54993 | 33.9526
Louisville | Kentucky | United States | -85.75941 | 38.25424
Cincinnati | Ohio | United States | -84.51439 | 39.12711
Chattanooga | Tennessee | U... | 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 funct... | "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 rec... | 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 screen... | 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 | Scottsdale | Arizona | United States | -111.89903 | 33.50921
Sacramento | California | United States | -121.4944 | 38.58157
San Diego | California | United States | -117.16472 | 32.71571
Santa Ana | California | United States | -117.86783 | 33.74557
Santa Rosa | California | United States | -122.71443 | 38.44047
Clearw... | 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... | 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 t... | [
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 tak... | 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 t... | 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)... | 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 I... | 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 p... | 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 |... | 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... | 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 cessatio... | [
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 | College Park | Maryland | United States | -76.93692 | 38.98067
New Brunswick | New Jersey | United States | -74.45182 | 40.48622
Cincinnati | Ohio | United States | -84.51439 | 39.12711
Milwaukee | Wisconsin | United States | -87.90647 | 43.0389 | 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 ... | 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 th... | [
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 ... | * 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 permu... | 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 patien... | Metastatic Prostate Cancer | Prostate Cancer | null | 0 | null | 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 p... | intervention 1: Mitoxantrone intervention 2: Prednisone intervention 3: Sorafenib | 10 | La Verne | California | United States | -117.76784 | 34.10084
Atlanta | Georgia | United States | -84.38798 | 33.749
Macon | Georgia | United States | -83.6324 | 32.84069
Marietta | Georgia | United States | -84.54993 | 33.9526
Billings | Montana | United States | -108.50069 | 45.78329
Columbus | Ohio | United States |... | 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 affect... | [
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 |... | 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 Brivarace... | [
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 interv... | intervention 1: Placebo intervention 2: Brivaracetam 2.5 mg intervention 3: Brivaracetam 10 mg intervention 4: Brivaracetam 25 mg | 69 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | United States | -110.92648 | 32.22174
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Fresno | California | United States | -119.77237 | 36.74773
Los Angeles | California | United States | -118.24368 | 34.05223
Newport Beach | Ca... | 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 re... | 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 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Birmingham | Alabama | United States | -86.80249 | 33.52066
Mobile | Alabama | United States | -88.04305 | 30.69436
Montgomery | Alabama | United States | -86.29997 | 32.36681
Chandler | Arizona | United States | -111.84125 | 33.30616
Peoria | Arizona | United... | 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 out... | 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... | 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 ... | 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. Partic... | [
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 plat... | 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 treatmen... | 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... | 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 diagnosi... | 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 joint... | 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. Blocki... | 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 | Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Baltimore | Maryland | United States | -76.61219 | 39.29038 | 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 bl... | 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,... | 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 /... | [
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 addi... | 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 | 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... | 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 continuou... | 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 a... | 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... | 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... | [
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 G... | 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. 4... | [
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 ... | [
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 | Maebashi | Gunma | Japan | 139.08333 | 36.4
Kobe | Hyōgo | Japan | 135.183 | 34.6913
Nishinomiya | Hyōgo | Japan | 135.33199 | 34.71562
Yokohama | Kanagawa | Japan | 139.65 | 35.43333
Kyoto | Kyoto | Japan | 135.75385 | 35.02107
Sendai | Miyagi | Japan | 140.86667 | 38.26667
Osaka | Osaka | Japan | 135.50107 | 34.69379... | 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 | Downey | California | United States | -118.13257 | 33.94001
RajajiNagar | Bangalore | India | 77.54906 | 12.98474 | 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, s... | 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 | Mexico City | Mexico City | Mexico | -99.12766 | 19.42847
Tlalpan | Mexico City | Mexico | -99.16206 | 19.29513 | 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 wi... | 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 hospi... | 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 ... | [
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 ass... | null | Pulmonary Disease, Chronic Obstructive | null | 0 | null | 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... | 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 cance... | 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 progres... | 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 | Tucson | Arizona | United States | -110.92648 | 32.22174
Beverly Hills | California | United States | -118.40036 | 34.07362
Greenbrae | California | United States | -122.5247 | 37.94854
Long Beach | California | United States | -118.18923 | 33.76696
Stanford | California | United States | -122.16608 | 37.42411
Fort Col... | 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 evalua... | 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) Respo... | 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 | Fort Myers | Florida | United States | -81.84059 | 26.62168
Jacksonville | Florida | United States | -81.65565 | 30.33218
Orlando | Florida | United States | -81.37924 | 28.53834
Gainesville | Georgia | United States | -83.82407 | 34.29788
Louisville | Kentucky | United States | -85.75941 | 38.25424
Cincinnati | Ohio |... | 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 pai... | 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 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 ... | 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 admi... | [
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 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Huntsville | Alabama | United States | -86.58594 | 34.7304
Phoenix | Arizona | United States | -112.07404 | 33.44838
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Anaheim | California | United States | -117.9145 | 33.83529
La Jolla | California... | 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 pharmacokineti... | 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 ... | 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 administer... | intervention 1: ketamine hydrochloride | 2 | Palo Alto | California | United States | -122.14302 | 37.44188
Denver | Colorado | United States | -104.9847 | 39.73915 | 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
Stoc... | 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 | Kowloon | N/A | Hong Kong | 114.18333 | 22.31667
Shatin | N/A | Hong Kong | 114.18333 | 22.38333
Nagoya | Aichi-ken | Japan | 136.90641 | 35.18147
Chuo-ku, Chiba-shi | Chiba | Japan | 140.11667 | 35.6
Eiheiji-cyo,yoshida-gun, | Fukui | Japan | N/A | N/A
Fukuoka | Fukuoka | Japan | 130.41667 | 33.6
Koga-shi | Fukuoka | ... | 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 t... | [
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 | -74.7813... | 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 fina... | 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 fina... | 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 |
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