Split (3)

train · 29.5k rows

FEATURE_phases list	FEATURE_enrollmentCount int64	FEATURE_allocation string	FEATURE_interventionModel string	FEATURE_primaryPurpose class label	FEATURE_masking class label	FEATURE_healthyVolunteers bool	FEATURE_sex class label	FEATURE_oversightHasDmc bool	FEATURE_briefSummary string	FEATURE_detailedDescription string	FEATURE_conditions string	FEATURE_conditionsKeywords string	FEATURE_protocolPdfText string	FEATURE_numArms int64	FEATURE_armDescriptions string	FEATURE_armGroupTypes list	FEATURE_numInterventions int64	FEATURE_interventionTypes list	FEATURE_interventionDescriptions string	FEATURE_interventionNames string	FEATURE_numLocations int64	FEATURE_locationDetails string	LABEL_ct_level_ade_population int64	METADATA_nctId string	METADATA_overallStatus class label	METADATA_completionDate date32	METADATA_startDate date32	METADATA_leadSponsorName string	METADATA_leadSponsorClass class label	METADATA_hasProtocol bool	METADATA_hasSap bool	METADATA_hasIcf bool	METADATA_protocolPdfLinks string
[ 3 ]	27	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	RATIONALE: Current therapies for adults with anaplastic astrocytomas that have not responded to standard therapy provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of adults with anaplastic astrocytomas that have not re...	OBJECTIVES: * To determine the efficacy of Antineoplaston therapy in patients with anaplastic astrocytomas that have not responded to standard therapy, as measured by an objective response to therapy (complete response, partial response or stable disease). * To determine the safety and tolerance of Antineoplaston ther...	Anaplastic Astrocytoma	persistent anaplastic astrocytoma recurrent anaplastic astrocytoma adult anaplastic astrocytoma	null	1	arm 1: Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.	[ 0 ]	1	[ 0 ]	intervention 1: Adults with an anaplastic astrocytoma that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediat...	intervention 1: Antineoplaston therapy (Atengenal + Astugenal)	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	27	NCT00003470	1COMPLETED	2009-12-01	1996-03-01	Burzynski Research Institute	7OTHER	false	false	false	null
[ 4 ]	85	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	OBJECTIVES: I. To Evaluate the therapeutic efficacy of cholic acid during provision of compassionate treatment to patients with identified inborn errors of bile acid synthesis and metabolism II. To assess the safety and tolerability of cholic acid	Investigational Plan: A Phase III, open label, single arm, nonrandomized, non-comparative, compassionate treatment study of cholic acid in the treatment of defects of bile acid metabolism. The study was begun with a single study site at Cincinnati Children's Hospital Medical Center (CCHMC), but in 2005 was expanded s...	Infantile Refsum's Disease Zellweger Syndrome Adrenoleukodystrophy Peroxisomal Disorders Cholestasis		null	1	arm 1: None	[ 5 ]	1	[ 0 ]	intervention 1: 10-15 mg/kg body weight/day taken orally.	intervention 1: Cholic Acids	1	Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711	79	NCT00007020	1COMPLETED	2009-12-01	1992-01-01	Mirum Pharmaceuticals, Inc.	4INDUSTRY	false	false	false	null
[ 2, 3 ]	32	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of combining chemotherapy and monoclonal antibody therapy in ...	OBJECTIVES: * Determine the maximum tolerated dose of bismuth Bi 213 monoclonal antibody M195 following cytarabine in patients with advanced myeloid malignancies. * Determine the antileukemic effects of this treatment in this patient population. * Determine the toxicity of this treatment in this patient population. * ...	Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms	recurrent childhood acute myeloid leukemia recurrent adult acute myeloid leukemia accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia untreated adult acute myeloid leukemia untreated childhood acute myeloid leukemia and other myeloid malignancies refractory anemia with excess blast...	null	1	arm 1: Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing u...	[ 0 ]	3	[ 2, 0, 4 ]	intervention 1: None intervention 2: None intervention 3: None	intervention 1: filgrastim intervention 2: cytarabine intervention 3: bismuth Bi213 monoclonal antibody M195	1	New York \| New York \| United States \| -74.00597 \| 40.71427	32	NCT00014495	1COMPLETED	2009-12-01	2000-11-01	Memorial Sloan Kettering Cancer Center	7OTHER	false	false	false	null
[ 3 ]	60	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	This phase II trial studies the side effects and the best dose of alemtuzumab when given together with fludarabine phosphate and low-dose total body irradiation (TBI) and how well it works before donor stem cell transplant in treating patients with hematological malignancies. Giving chemotherapy and low-dose TBI before...	PRIMARY OBJECTIVES: I. To determine whether stable allogeneic engraftment from related and unrelated human leukocyte antigen (HLA)-mismatched stem cell donors can be safely established using a non-myeloablative conditioning regimen plus escalating doses of the anti-CD52 monoclonal antibody (mAb) Campath (alemtuzumab) ...	Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Del(5q) Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) Adult Nasal ...		null	1	arm 1: CONDITIONING REGIMEN: Patients receive alemtuzumab IV over 2 hours on days -8 to -5 and fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO...	[ 0 ]	7	[ 2, 0, 4, 3, 3, 0, 0 ]	intervention 1: Given IV intervention 2: Given IV intervention 3: Undergo TBI intervention 4: Undergo allogeneic HSCT intervention 5: Undergo allogeneic peripheral blood stem cell transplantation intervention 6: Given PO intervention 7: Given IV or PO	intervention 1: alemtuzumab intervention 2: fludarabine phosphate intervention 3: total-body irradiation intervention 4: allogeneic hematopoietic stem cell transplantation intervention 5: peripheral blood stem cell transplantation intervention 6: mycophenolate mofetil intervention 7: cyclosporine	7	Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Milwaukee \| Wisco...	60	NCT00040846	1COMPLETED	2009-12-01	2001-11-01	Fred Hutchinson Cancer Center	7OTHER	false	false	false	null
[ 4 ]	671	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether cisplatin combined with irinotecan is more effective than cisplatin combined with etoposide in treating extensive-st...	OBJECTIVES: * Compare the survival of patients with extensive stage small cell lung cancer treated with cisplatin and irinotecan vs cisplatin and etoposide. * Compare the objective response rate and progression-free survival of patients treated with these regimens. * Compare the toxic effects of these regimens in thes...	Lung Cancer	extensive stage small cell lung cancer	null	2	arm 1: None arm 2: None	[ 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Arm 1: 60 mg/m2 IV (over 30-60 min) on Day 1, Q 4 weeks x 4 Cycles Arm 2: 80 mg/m2 IV (over 30-60 min) on Day 1, Q 4 weeks x 4 Cycles intervention 2: 100 mg/m2 IV (over 30-60 min) on Days 1 , 2 \& 3. Q 3 weeks x 4 Cycles intervention 3: 60 mg/m2 IV (over 90 min)on Days 1, 8 \& 15. Q 4 weeks x 4 Cycles	intervention 1: cisplatin intervention 2: etoposide intervention 3: irinotecan hydrochloride	408	Anniston \| Alabama \| United States \| -85.83163 \| 33.65983 Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Opelika \| Alabama \| United States \| -85.37828 \| 32.64541 Anchorage \| Alaska \| United States \| -149.90028 \| 61.21806 Scottsdale \| Arizona \| United S...	648	NCT00045162	1COMPLETED	2009-12-01	2002-11-01	SWOG Cancer Research Network	5NETWORK	false	false	false	null
[ 3 ]	23	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have recurrent meningioma. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth	PRIMARY OBJECTIVE: I. Determine the efficacy of imatinib mesylate, in terms of 6-month progression-free survival, of patients with recurrent meningioma. SECONDARY OBJECTIVES I. Determine the response rate and overall survival of patients treated with this drug. II. Evaluate the safety profile of this drug in these p...	Adult Grade I Meningioma Adult Grade II Meningioma Adult Grade III Meningioma Adult Meningeal Hemangiopericytoma Adult Meningioma Recurrent Adult Brain Tumor		null	1	arm 1: Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Other: pharmacological study/ laboratory biomarker analysis	[ 0 ]	3	[ 0, 10, 10 ]	intervention 1: Given orally intervention 2: Correlative studies intervention 3: Correlative studies	intervention 1: imatinib mesylate intervention 2: laboratory biomarker analysis intervention 3: pharmacological study	7	Los Angeles \| California \| United States \| -118.24368 \| 34.05223 San Francisco \| California \| United States \| -122.41942 \| 37.77493 Bethesda \| Maryland \| United States \| -77.10026 \| 38.98067 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 New York \| New York \| United States \| -74.00597 \| 40.71427 Dallas \|...	22	NCT00045734	1COMPLETED	2009-12-01	2003-02-01	National Cancer Institute (NCI)	0NIH	false	false	false	null
[ 4 ]	221	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	The purpose of this study is: 1. To assess the efficacy of a lipid-lowering agent (atorvastatin) on the development of atherosclerosis that predisposes children with SLE to cardiovascular events in adulthood. 2. To assess the safety of intermediate-term (36 months) treatment of children and young adults with atorvasta...	Children and adolescents with SLE represent 15% of all SLE patients. Children with SLE suffer high morbidity that affects many organ systems, reduces their quality of life, and shortens their lifespan. As more children with SLE survive into adulthood, atherosclerotic cardiovascular disease has emerged as a major concer...	Lupus Erythematosus, Systemic	Pediatric lupus Atherosclerosis SLE HMG CoA reductase inhibitor	null	2	arm 1: Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes \[TLC\] diet, \[http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi\]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 m...	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months. intervention 2: Participants ...	intervention 1: Atorvastatin intervention 2: Placebo atorvastatin	1	Durham \| North Carolina \| United States \| -78.89862 \| 35.99403	221	NCT00065806	1COMPLETED	2009-12-01	2003-09-01	Laura Schanberg	7OTHER	false	false	false	null
[ 3 ]	48	RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is three-fold: 1) to examine the ability of the experimental drug tariquidar to improve chemotherapy results by blocking a protein (P-glycoprotein) on some cancer cells that acts to pump out cancer drugs; 2) examine how tariquidar interacts with the cancer drug docetaxel; and 3) evaluate the e...	Intrinsic and acquired drug resistance remain major obstacles in the treatment of cancer. Accumulating evidence indicates that in some malignancies P-glycoprotein (Pgp) can confer resistance, and that its reversal can improve therapeutic outcome. Clinical trials investigating Pgp antagonists have been hampered by the o...	Lung Neoplasms Ovarian Neoplasms Cervix Neoplasms Renal Neoplasms	Pharmacokinetics Pharmacodynamics Multidrug Resistance Reversal Molecular Target P-Glycoprotein Inhibition Lung Cancer Ovarian Cancer Cervical Cancer Renal Cancer	null	2	arm 1: Patients receive 40 mg/m\^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m\^2 docetaxel was administered every 21 days in combination with a single 150 mg dose. arm 2: Patients receive docetaxel intra...	[ 0, 0 ]	3	[ 0, 0, 10 ]	intervention 1: Patients receive docetaxel intravenous (IV) over 1 hour on days 1 and 8. intervention 2: Patients receive tariquidar intravenous (IV) over 30 minutes on days 8 and 22. intervention 3: Bolus injection of 29 mCi of 99mTc-sestamibi intravenously for each imaging study.	intervention 1: docetaxel intervention 2: tariquidar intervention 3: 99mTc-sestamibi imaging	1	Bethesda \| Maryland \| United States \| -77.10026 \| 38.98067	48	NCT00069160	1COMPLETED	2009-12-01	2003-09-01	National Cancer Institute (NCI)	0NIH	false	false	false	null
[ 4 ]	232	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	null	This research study was conducted to compare the safety and effectiveness of the investigational medication, LdT (Telbivudine) versus Lamivudine, a drug currently approved by the US, European and Asian Health Authorities for the treatment of Hepatitis B infection. The results for patients taking LdT will be compared to...	Multicenter, multinational, randomized, double-blind study designed to compare the safety and efficacy of telbivudine (600 mg/day) versus lamivudine (100 mg/day) for 104 weeks in adults with decompensated chronic hepatitis B and evidence of cirrhosis. Patients were pre-stratified by screening Child-Turcotte-Pugh score ...	Hepatitis Hepatitis B, Chronic Cirrhosis		null	2	arm 1: Participants received Telbivudine 600 mg and a matching lamivudine placebo orally once a day for up to 104 weeks. Participants were followed-up for 16 weeks post-treatment. arm 2: Lamivudine 100 mg and a Telbivudine matching placebo orally once a day for up to 104 weeks. Participants were followed-up for 16 week...	[ 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: 600mg/day oral tablet for 104 weeks intervention 2: 100mg/day oral tablet for 104 weeks intervention 3: Telbivudine matching placebo or lamivudine matching placebo tablet.	intervention 1: Telbivudine intervention 2: Lamivudine intervention 3: Placebo	28	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163 New York \| New Yor...	231	NCT00076336	1COMPLETED	2009-12-01	2003-12-01	Novartis Pharmaceuticals	4INDUSTRY	false	false	false	null
[ 3 ]	80	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	1FEMALE	true	Parathyroid hormone (PTH) increases bone formation and thereby improves bone density and bone strength in postmenopausal women with osteoporosis. However, prolonged PTH treatment increases bone formation less and less over time. This study will test whether increasing the daily dose of PTH sustains its ability to impro...	In women with postmenopausal osteoporosis, PTH increases bone mineral density more than anti-resorptive agents, and its use markedly reduces the incidence of new spine and non-spine fractures. Still, PTH is not a cure for osteoporosis in many patients because PTH-stimulated bone formation declines as PTH therapy contin...	Postmenopausal Osteoporosis Osteoporosis	Osteoporosis Parathyroid hormone Teriparatide Bone formation Bone resorption	null	2	arm 1: Participants will receive synthetic human parathyroid hormone fragment 1-34 (hPTH 1-34) once-daily in a constant dose of 30 mcg/day. arm 2: Participants will receive synthetic human parathyroid hormone fragment 1-34 (hPTH 1-34) once-daily in a dose that ascends at 6 month intervals (20-30-40 mcg/day).	[ 0, 0 ]	1	[ 0 ]	intervention 1: Either daily treatment with self-injected hPTH 1-34 or ascending dose treatment at 6-month intervals of hPTH 1-34	intervention 1: synthetic hPTH 1-34	1	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	80	NCT00086619	1COMPLETED	2009-12-01	2004-05-01	Massachusetts General Hospital	7OTHER	false	false	false	null
[ 3 ]	30	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating patients with HIV-related Kaposi's sarcoma.	OBJECTIVES: Primary * Determine clinical response in patients with HIV-related Kaposi's sarcoma treated with imatinib mesylate. Secondary * Determine the inhibition of platelet-derived growth factor receptors, as determined by immunohistochemistry, in patients treated with this drug. * Determine cytokine profiles b...	Sarcoma	AIDS-related Kaposi sarcoma recurrent Kaposi sarcoma	Prot_SAP_001.pdf: AMC # 042 (Version 7.0) 07/24/2007 NCI Version Date 07/24/07 i AMC AIDS ASSOCIATED MALIGNANCY CLINICAL TRIALS CONSORTIUM AMC PROTOCOL #042 A Phase II Trial of Imatinib Mesylate (GLEEVEC) in Patients with HIV Related Kaposi's Sarcoma A Multi-Center Trial of the AIDS Malignancy Con...	1	arm 1: Imatinib mesylate (Gleevec) taken 400 mg orally once a day for up to 6 months	[ 0 ]	1	[ 0 ]	intervention 1: 400 mg orally once a day for up to 6 months.	intervention 1: imatinib mesylate	15	La Jolla \| California \| United States \| -117.2742 \| 32.84727 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Palm Springs \| California \| United States \| -116.54529 \| 33.8303 San Francisco \| California \| United States \| -122.41942 \| 37.774...	30	NCT00090987	1COMPLETED	2009-12-01	2005-06-01	AIDS Malignancy Consortium	5NETWORK	true	true	false	https://cdn.clinicaltrials.gov/large-docs/87/NCT00090987/Prot_SAP_001.pdf
[ 0 ]	453	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	The purpose of this study is to treat depression in patients who have undergone coronary artery bypass graft (CABG).	BACKGROUND: Cardiovascular disease morbidity and mortality is an important health issue. Depression has emerged as a risk factor for increased morbidity and mortality in patients with coronary heart disease. CABG is a surgical procedure that is specifically directed to improvement in quality of life for patients with ...	Cardiovascular Diseases Coronary Disease Heart Diseases Depression		null	3	arm 1: Telephone-based, nurse-delivered Collaborative Care program for depression; Involving: Psychoeducation; workbook for depression self-care; initiation or adjustment of antidepressant pharmacotherapy prescribed under their PCPs' direction; referral to mental health specialist arm 2: "Usual care" for depression; fe...	[ 0, 1, 4 ]	3	[ 5, 0, 10 ]	intervention 1: Counseling program intervention 2: Recommendations to patients' PCP for medication to treat depression intervention 3: Physicians' Usual care	intervention 1: Psychoeducation; Treatment recommendations intervention 2: Pharmacotherapy intervention 3: Usual Care	1	Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062	453	NCT00091962	1COMPLETED	2009-12-01	2003-08-01	University of Pittsburgh	7OTHER	false	false	false	null
[ 4 ]	508	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	The purpose of this study is to assess the safety and effectiveness of three different treatments for patients with Crohns disease who have not responded to previous treatment with a group of drugs commonly used to treat Crohn's Disease (5-ASA) and corticosteroids. Patients will receive either infliximab (a drug used t...	Crohns disease is characterized by inflammation (the changes that happen when tissues in the body are injured) and ulceration (open sores) of the intestines. Crohns disease is treated with medications that decrease inflammation, and reduce diarrhea, abdominal pain and other symptoms of Crohns disease. In addition, Croh...	Crohn Disease	Crohn's Disease infliximab azathioprine Remicade SONIC	null	3	arm 1: infliximab (IFX) infusion; azathioprine (AZA) caps AZA daily 2.5 mg/kg/day and IFX infusions 5 mg/kg at weeks 0, 2, 6, 14, and 22 arm 2: infliximab (IFX) placebo infusion; azathioprine (AZA) caps AZA daily 2.5 mg/kg/day and placebo IFX infusions at weeks 0, 2, 6, 14, and 22 arm 3: infliximab infusion; AZA placeb...	[ 0, 0, 0 ]	3	[ 2, 10, 0 ]	intervention 1: Infliximab 5 mg/kg at weeks 0, 2, 6, 14, and 22 and placebo AZA capsules intervention 2: AZA daily 2.5 mg/kg/day and IFX infusions 5 mg/kg at weeks 0, 2, 6, 14, and 22 intervention 3: AZA daily 2.5 mg/kg/day and placebo IFX infusions at weeks 0, 2, 6, 14, and 22	intervention 1: infliximab infusion; AZA placebo caps intervention 2: infliximab (IFX) infusion; azathioprine (AZA) caps intervention 3: infliximab (IFX) placebo infusion; azathioprine (AZA) caps	115	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Orange \| California \| United States \| -117.85311 \| 33.78779 Roseville \| California \| United States \| -121.28801 \| 38.75212 San Diego \| California \| United States \| -117.16472 \| 32.71571 San Luis Obispo ...	826	NCT00094458	1COMPLETED	2009-12-01	2005-03-01	Centocor Ortho Biotech Services, L.L.C.	4INDUSTRY	false	false	false	null
[ 4 ]	69	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This Phase 3, open-label, multicenter study is designed to compare the effects of exenatide and insulin glargine (Lantus® injection) on beta-cell function in patients with type 2 diabetes mellitus using metformin.	null	Type 2 Diabetes Mellitus	diabetes exenatide exendin-4 Amylin Lilly	null	2	arm 1: Exenatide and Metformin arm 2: Insulin Glargine and Metformin	[ 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: subcutaneous injection, titrated up to a maximum of 20mcg three times a day in order to meet defined blood glucose targets intervention 2: subcutaneous injection, once a day, titrated as necessary in order to meet defined blood glucose targets intervention 3: Patients usual dosage	intervention 1: exenatide intervention 2: Insulin glargine intervention 3: Metformin	3	Helsinki \| N/A \| Finland \| 24.93545 \| 60.16952 Amsterdam \| N/A \| Netherlands \| 4.88969 \| 52.37403 Gothenburg \| N/A \| Sweden \| 11.96679 \| 57.70716	69	NCT00097500	1COMPLETED	2009-12-01	2004-09-01	AstraZeneca	4INDUSTRY	false	false	false	null
[ 0 ]	25	RANDOMIZED	PARALLEL	null	0NONE	true	0ALL	false	The purpose of this study is to determine whether sampling nicotine replacement treatments (NRTs) is superior to learning about them by computer. Testing also covers preferences among the treatments. Subjects will be enrolled veterans who smoke. Hypothesis: Direct experience ("sampling") of NRTs will increase knowledg...	The study was designed to compare sampling of several nicotine replacement treatments (NRTs) in contrast to a computer learning control. The NRTs include: 2 dosages of nicotine gum, 2 dosages of nicotine lozenges and 2 dosages of oral nicotine inhalers. In the sampling group, each participant tries each of the 6 NRTs f...	Smoking	nicotine drug therapy Smoking Cessation	null	2	arm 1: Sampling = 3 minute testing of each of 6 NRTs (3 forms x 2 dosages) 2 mg and 4 mg nicotine gum; 2 mg and 4 mg nicotine lozenges; frequent and infrequent puffing on a nicotine inhaler (can yield 4 mg from 10 mg device). arm 2: Computer learning: learning about 6 NRTs (3 forms x 2 dosages) by computer only	[ 1, 3 ]	4	[ 0, 0, 0, 10 ]	intervention 1: None intervention 2: None intervention 3: can yield 4 mg from 10 mg device - infrequent and frequent puffing intervention 4: None	intervention 1: Nicotine gum - 2 mg and 4 mg intervention 2: Nicotine lozenges - 2 mg and 4 mg intervention 3: Nicotine inhaler (4 mg yield) - low and high "dosage" by frequency of puffing intervention 4: Computer learning	1	West Los Angeles \| California \| United States \| -118.43068 \| 34.0462	8	NCT00108342	6TERMINATED	2009-12-01	2007-10-01	US Department of Veterans Affairs	1FED	false	false	false	null
[ 4 ]	44	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The focus of this project is cardiovascular diabetic autonomic neuropathy (DAN). DAN affects the nerves that control heart rate and blood flow to the heart in people with diabetes. DAN may cause problems with the rhythm of the heartbeat or decrease blood flow to the heart. Three medications will be tested for their eff...	null	Diabetic Autonomic Neuropathy	Type 1 Diabetes Oxidative Stress Diabetic Complications Neuropathy	null	2	arm 1: Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally These drugs were given together as a combination and not as individual treatment. arm 2: Placebo administered twice daily.	[ 0, 2 ]	1	[ 0 ]	intervention 1: Comparison of triple antioxidant combination therapy vs placebo.	intervention 1: ORAL ANTIOXIDANT	1	Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756	44	NCT00116207	1COMPLETED	2009-12-01	2000-01-01	University of Michigan	7OTHER	false	false	false	null
[ 3 ]	10	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sorafenib before and after surgery may be an effective treatment for kidney cancer. This phase II trial is studying how well sorafenib works in treating patients who are un...	PRIMARY OBJECTIVES: I. Efficacy of BAY 43-9006 (sorafenib tosylate) by evaluating response rate. II. Toxicities of BAY 43-9006 in metastatic renal cell carcinoma (RCC). III. Intraoperative and peri/postoperative safety of BAY 43-9006. SECONDARY OBJECTIVES: I. Time to progression. II. Duration of response. II. Overal...	Clear Cell Renal Cell Carcinoma Recurrent Renal Cell Cancer Stage IV Renal Cell Cancer		null	3	arm 1: Patients undergo cytoreductive nephrectomy on day 1. Patients then receive oral sorafenib twice daily on days 15-84. In all groups, patients with stable or regressing disease continue to receive oral sorafenib twice daily for up to 1 year in the absence of disease progression or unacceptable toxicity. Some pati...	[ 0, 0, 0 ]	3	[ 3, 0, 10 ]	intervention 1: Undergo cytoreductive nephrectomy intervention 2: Given orally intervention 3: Correlative studies	intervention 1: therapeutic conventional surgery intervention 2: sorafenib tosylate intervention 3: laboratory biomarker analysis	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	10	NCT00126659	6TERMINATED	2009-12-01	2006-01-01	National Cancer Institute (NCI)	0NIH	false	false	false	null
[ 3 ]	2	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	true	RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by lowering the amount of estrogen the body makes. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Ot...	OBJECTIVES: Primary * Compare the overall objective response rate in postmenopausal women with estrogen receptor (ER)- and/or progesterone receptor (PR)-positive, HER2/neu-overexpressing stage IV breast cancer treated with first-line therapy comprising fulvestrant and/or trastuzumab (Herceptin®). Secondary * Compar...	Breast Cancer	stage IV breast cancer recurrent breast cancer	null	1	arm 1: see intervention description for details	[ 0 ]	2	[ 0, 2 ]	intervention 1: Administered IM at 500 mg on day 1 of cycle 1, followed by 500 mg on day 15 of cycle 1, then 500 mg on day 1 of each cycle thereafter. intervention 2: Given at 4 mg/kg IV on day 1 (cycle 1) then 2mg/kg IV weekly	intervention 1: Faslodex intervention 2: Herceptin	3	Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Redondo Beach \| California \| United States \| -118.38841 \| 33.84918 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412	2	NCT00138125	6TERMINATED	2009-12-01	2005-04-01	Translational Oncology Research International	7OTHER	false	false	false	null
[ 5 ]	41	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	1FEMALE	true	The aim of this pilot study is to determine the safety and efficacy of risperidone for the treatment of anorexia nervosa. Hypothesis 1: Subjects on risperidone will show a more significant decrease in body image distortion and Eating Disorder Inventory -2 scores than subjects on placebo. Hypothesis 2: Subjects on ris...	The lack of effective medications for the symptoms of anorexia nervosa (AN), combined with early promising findings in case reports (Risperidone and Olanzapine) and one open study of olanzapine have led to increased use of these medications for individuals with AN. This double-blind placebo controlled study of risperid...	Anorexia Nervosa	Anorexia Nervosa Risperidone Atypical Neuroleptics Dopamine Leptin Body Image Adolescents	null	2	arm 1: double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo. arm 2: Study is double blind, placebo controlled. This is the subject group on active medication	[ 2, 1 ]	2	[ 0, 0 ]	intervention 1: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks. intervention 2: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa.	intervention 1: Risperidone intervention 2: Placebo	1	Denver \| Colorado \| United States \| -104.9847 \| 39.73915	40	NCT00140426	1COMPLETED	2009-12-01	2004-08-01	University of Colorado, Denver	7OTHER	false	false	false	null
[ 5 ]	20	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	true	Our goal is to determine if a change in therapy to one containing Kaletra can improve the immune response in patients who have previously been immune partial responders or non-responders. We also are interested in knowing if this agent improves immune response by affecting cluster of differentiation 4 (CD4) + T cell de...	To our knowledge our study is the first study showing persistent apoptosis in a subgroup of patients with complete viral suppression in association with poor immune recovery. Immune alterations independent of active viral replication may be responsible. Recent data suggests that immune responses to antiretroviral thera...	HIV Infections	HIV HAART (Highly Active Anti-Retroviral Therapy) partial immune response no immune response Treatment Experienced	null	2	arm 1: Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone. arm 2: Patients in this study arm continued their current regimen.	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: Kaletra + Current Dual NRTI Backbone intervention 2: Current Regimen	1	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003	20	NCT00145795	1COMPLETED	2009-12-01	2004-04-01	University of Chicago	7OTHER	false	false	false	null
[ 0 ]	36	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	1FEMALE	false	The purpose of this study is to determine if a new test for osteoporosis can be useful in monitoring treatment. We are studying a new method for examining the quality of bone by an experimental method of computerized analysis of radiographic images (x-ray pictures) of the heel.	The study proposed in this application is a part of a larger project entitled "Clinical utility of radiographic texture analysis in diagnosing and treating osteoporosis". The overall goal of the larger project is to determine whether computerized texture analysis of digitized high-resolution images of trabecular bone (...	Osteoporosis Osteopenia	osteoporosis bone density women endocrine musculoskeletal metabolic	null	2	arm 1: All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 mg of Vitamin D with their evening meal. This group will also receive alendronate 70 mg once weekly, according to standard recommendations. arm 2: All subjects will receive 600 mg of elemental calcium (as calcium citrate) and 500 ...	[ 0, 1 ]	3	[ 0, 7, 7 ]	intervention 1: alendronate 70 mg once weekly intervention 2: 600 mg of calcium citrate intervention 3: 500 mg of Vitamin D consumed with the evening meal.	intervention 1: Alendronate intervention 2: Calcium Citrate intervention 3: Vitamin D	1	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003	36	NCT00145977	1COMPLETED	2009-12-01	2001-07-01	University of Chicago	7OTHER	false	false	false	null
[ 3 ]	24	NON_RANDOMIZED	SINGLE_GROUP	2DIAGNOSTIC	0NONE	false	0ALL	false	Using repeated arthroscopic biopsies of patients with rheumatoid arthritis, the researchers will assess changes in the immune response that occur as a result of treatment with rituximab.	Using repeated arthroscopic biopsies of patients with rheumatoid arthritis, the researchers will assess changes in the immune response that occur after treatment with rituximab.	Rheumatoid Arthritis	active disease despite concomitant methotrexate	null	1	arm 1: all patients get treatment	[ 0 ]	1	[ 0 ]	intervention 1: treatment with rituximab	intervention 1: rituximab	1	La Jolla \| California \| United States \| -117.2742 \| 32.84727	24	NCT00147966	1COMPLETED	2009-12-01	2008-06-01	University of California, San Diego	7OTHER	false	false	false	null
[ 3 ]	36	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to explore how this cancer is affected by a new medication, cetuximab. Cetuximab is directed towards a protein called EGFR (epidermal growth factor receptor), that is found in some types of cancer. Studies have shown that this drug can be beneficial in patients with colon cancer and has bee...	Sarcomas are mesenchymal malignancies that arise in the connective tissue throughout the body and afflict approximately 11,000 people in the United States yearly. Sarcomas are heterogeneous with well over 50 subtypes described. The peak incidence is subtype-specific with certain sarcomas seen in children and young adul...	Sarcoma	Unresectable/metastatic high grade soft tissue bony sarcoma	null	2	arm 1: The EGFR positive group will be conducted in a 2-stage minimax trial design to determine the rate of four-month progression free survival in this patient population treated with cetuximab arm 2: The EGFR negative group will help us explore the possibility of benefit of cetuximab in a patient whose tumor does not...	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: The initial dose of cetuximab is 400 mg/m2 intravenously administered over 120 minutes, followed by weekly infusions at 250 mg/m2 IV over 60 minutes. intervention 2: Cetuximab 400 mg/m2 over 120 min IV initial does followed by weekly Cetuximab 250 mg/m2 over 60 min	intervention 1: Cetuximab intervention 2: Cetuximab	1	Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756	36	NCT00148109	1COMPLETED	2009-12-01	2005-06-01	University of Michigan Rogel Cancer Center	7OTHER	false	false	false	null
[ 3 ]	93	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	Previous research has shown that disulfiram, a medication sometimes used for treating alcoholism, discourages cocaine use among cocaine addicts who are undergoing methadone treatment. By blocking the enzyme dopamine beta hydroxylase (DBH), disulfiram increases levels of dopamine and produces an unpleasant sense of hype...	Dopamine, a type of neurotransmitter, is the brain's "feel good" chemical. The amount of dopamine in the body may be an important factor in how cocaine addicts respond to treatment. Disulfiram, like cocaine, enhances dopamine activity. Upon taking disulfiram, subsequent intake of cocaine may elevate dopamine to excessi...	Cocaine Dependence Opioid Dependence	Opioid Dependence Substance Related Disorders	null	2	arm 1: Participants are randomly assigned to receive a daily dose of 250 mg of disulfiram for 12 weeks, while concurrently receiving methadone treatment. All participants will stop receiving study medication at week 14, at which point they will undergo a 4-week methadone detoxification period. arm 2: Participants are r...	[ 0, 1 ]	4	[ 0, 0, 5, 10 ]	intervention 1: Disulfiram 250 mg/day by mouth daily during study weeks 2-13. Disulfiram discontinued during study weeks 14-15. intervention 2: Initial dose 25 mg; increased by 5 mg at each subsequent daily dosing until 60 mg maintenace dose reached. intervention 3: 1-hour weekly, individual, manual-guided Cognitive Be...	intervention 1: Disulfiram intervention 2: Methadone intervention 3: CBT intervention 4: Lactose	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	74	NCT00149630	1COMPLETED	2009-12-01	2005-01-01	Baylor College of Medicine	7OTHER	false	false	false	null
[ 4 ]	50	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	We recruited 50 consenting adult subjects with DSM-IV TR diagnoses of bipolar disorder who were about to initiate or switch their current antipsychotic agent. Only 48 patients (23 in the risperidone LAI group and 25 in the oral AAP group) contributed data to the assessments. Patients were titrated and cross-tapered dur...	OBJECTIVE: To evaluate if a long acting injectable form of risperidone offers clinical advantages over comparison oral second generation antipsychotic agents following titration and stabilization in bipolar subjects. In keeping with current practice, it is expected the vast majority of patients will also be receiving ...	Bipolar I Disorder	Bipolar I Disorder Risperidone Consta - Long Acting Injection Oral second generation antipsychotic agents	null	2	arm 1: Oral Risperidone followed by Long acting Risperidone injections (Consta) arm 2: Oral second generation antipsychotic agents other than clozapine or risperidone (olanzapine, quetiapine, ziprasidone, aripiprazole)	[ 1, 1 ]	1	[ 0 ]	intervention 1: Injectable Risperidone (Consta) from 12.5 to 50 mg q 2 weeks Oral antipsychotic agents, olanzapine, quetiapine, ziprasidone, aripiprazole in doses approved in the US for bipolar disorder	intervention 1: Injectable Risperidone (Consta) or oral antipsychotic	4	Bridgeville \| Pennsylvania \| United States \| -80.11006 \| 40.35618 DuBois \| Pennsylvania \| United States \| -78.76003 \| 41.11923 McKeesport \| Pennsylvania \| United States \| -79.86422 \| 40.34785 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062	48	NCT00177164	1COMPLETED	2009-12-01	2003-11-01	University of Pittsburgh	7OTHER	false	false	false	null
[ 5 ]	390	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The PATCAR study has been designed to test the hypothesis that the strategy of pre-hospital use of a "clot busting" (thrombolytic) drug followed with emergent heart catheterization including stenting of the problematic coronary artery, will result in a lower mortality and reduced repeat heart attack rates. Early ident...	To demonstrate feasibility of the project in a pilot trial we plan to enroll up to 500 patients to pre-hospital thrombolysis/clot busting followed by emergent catheterization and stenting of the problematic or culprit artery. This will comprise an EMS system capable of performing pre-hospital ECGs followed by emergent...	Heart Disease Myocardial Infarction Acute Myocardial Infarction	Heart Disease Heart Attack Myocardial Infarction Thrombolytic Therapy Emergency Medicine	null	4	arm 1: Patients transported by participating EMS units and that were fibrinolytic eligible and treated with full dose, pre-hospital fibrinolysis with reteplase (treated in the ambulance with 10 units reteplase and randomized to a second 10-unit dose of reteplase). arm 2: Patients transported by participating EMS units ...	[ 0, 0, 1, 1 ]	4	[ 0, 0, 3, 3 ]	intervention 1: Thrombolytic-clot busting drug Retavase IV Bolus, 10 U followed by a second 10U dose intervention 2: Thrombolytic-clot busting drug Retavase IV Bolus in one 10U dose intervention 3: None intervention 4: None	intervention 1: Reteplase 10 Units (U) plus a second dose of reteplase 10 U intervention 2: Reteplase 10 U intervention 3: Urgent Percutaneous Coronary Intervention (PCI) intervention 4: Primary Percutaneous Coronary Intervention (PCI)	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	390	NCT00178620	1COMPLETED	2009-12-01	2003-09-01	The University of Texas Health Science Center, Houston	7OTHER	false	false	false	null
[ 2, 3 ]	33	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The purpose of the study is to determine the optimal safe and tolerable dose of gemcitabine in combination with once daily or twice daily dose of PTK/ZK in patients with unresectable pancreatic cancer. The Phase II part of this study planned to determine the antitumor activity of this regimen and its effectiveness of p...	null	Pancreatic Cancer		null	4	arm 1: Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily arm 2: Gemcitabine 850 mg/m2 + vatalanib 1250 mg arm 3: Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter arm 4: Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter	[ 0, 0, 0, 0 ]	2	[ 0, 0 ]	intervention 1: Vatalanib 250 mg PO Q12 hours x 7 days, 8th day forward 500 mg PO Q12 hours intervention 2: 850 mg/m2	intervention 1: Vatalanib intervention 2: Gemcitabine	1	Stanford \| California \| United States \| -122.16608 \| 37.42411	33	NCT00185588	1COMPLETED	2009-12-01	2004-10-01	George Albert Fisher	7OTHER	false	false	false	null
[ 3 ]	69	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This purpose of this study is to evaluate the role of gemcitabine and docetaxel, a well tolerated chemotherapy regimen in the treatment of advanced non-small cell lung cancer (NSCLC), in combination with a novel agent cetuximab.	Upon determination of eligibility all patients will receive: * Docetaxel + Gemcitabine + Cetuximab	Lung Cancer	Lung Cancer	null	1	arm 1: Newly-diagnosed unresectable stage III/IV NSCLC patients were treated with docetaxel-30mg/m2 IV; gemcitabine-1000mg/m2 IV days 1, 8; cetuximab-400mg/m2 IV day 1, then 250 mg/m2 IV weekly. Patients received up to 6 cycles (21-d).	[ 0 ]	3	[ 0, 0, 0 ]	intervention 1: 1000mg/m2 30min IV, Day 1 \& 8 intervention 2: 30mg/m2, 30min IV, day 1 \& 8 intervention 3: 100mg/m2 IV, Cycle 1 Day 1, 250mg/m2 IV day 8 \& 15, all subsequent cycles 250mg/m2 IV day 1, 8, \& 15	intervention 1: Gemcitabine intervention 2: Docetaxel intervention 3: Cetuximab	10	Anniston \| Alabama \| United States \| -85.83163 \| 33.65983 Jonesboro \| Arkansas \| United States \| -90.70428 \| 35.8423 Fort Myers \| Florida \| United States \| -81.84059 \| 26.62168 Gainesville \| Florida \| United States \| -82.32483 \| 29.65163 Gainesville \| Georgia \| United States \| -83.82407 \| 34.29788 Bowling Green \| Kentu...	69	NCT00193453	1COMPLETED	2009-12-01	2005-07-01	SCRI Development Innovations, LLC	7OTHER	false	false	false	null
[ 3 ]	72	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The purpose of this pilot study is to evaluate the potential effects of soy isoflavone supplements on cognitive function for men and women with Alzheimer's Disease (AD). Preliminary studies evaluating the effects of soy supplements on memory in cognitively healthy older adults have yielded promising results that are no...	null	Alzheimer's Disease		null	2	arm 1: 100mg/day soy isoflavones arm 2: 100mg/day matching placebo	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 100mg/day soy isoflavones intervention 2: 100mg/day matching placebo	intervention 1: Novasoy intervention 2: Placebo	1	Madison \| Wisconsin \| United States \| -89.40123 \| 43.07305	65	NCT00205179	1COMPLETED	2009-12-01	2005-01-01	University of Wisconsin, Madison	7OTHER	false	false	false	null
[ 5 ]	19	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	Recurrent respiratory papillomatosis (RRP) is the most common benign neoplasm of the larynx in the pediatric population. The impact of the disease on patients and families can be tremendous due to the need for frequent treatment. It would be highly beneficial to develop effective medical therapies as adjunctive measure...	The focus of the present study is to evaluate the usefulness of cidofovir injection in diminishing the frequency and magnitude of papilloma recurrences in adult and pediatric RRP patients. Briefly, patients will be randomized into either a treatment (cidofovir injection) or a placebo group. The following measures will ...	Recurrent Respiratory Papillomatosis		null	2	arm 1: Cidofovir (Vistide) is a commercially available agent approved by the FDA for the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS). The drug is not FDA approved for the treatment of RRP at this time. However, recent case reports have been encouraging with re...	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: With regard to cidofovir concentration, the FDA has allowed us to inject a concentration of 5 mg/ml into both children and adults. The injection will add less than 2 additional minutes to the surgery time and discharge time will not be affected. Because the volumes of cidofovir injected into the airway ...	intervention 1: Cidofovir intervention 2: Placebo	0	null	19	NCT00205374	1COMPLETED	2009-12-01	1999-11-01	University of Wisconsin, Madison	7OTHER	false	false	false	null
[ 3 ]	156	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	true	0ALL	true	The purpose of this study is to determine if dronabinol decreases the symptoms of marijuana addiction and withdrawal.	Marijuana addiction is associated with significant withdrawal symptoms, including anxiety, irritability, bodily discomfort, and insomnia. The purpose of this study is to determine the effectiveness of dronabinol in reducing withdrawal symptoms. During this twelve-week, double-blind, placebo-controlled study, study vis...	Marijuana Abuse	cannabis dependence dronabinol treatment	null	2	arm 1: Dronabinol: 20mg bid for a daily maximum dose of 40mg. arm 2: placebo	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: Dronabinol intervention 2: placebo	intervention 1: Dronabinol intervention 2: Placebo	1	New York \| New York \| United States \| -74.00597 \| 40.71427	156	NCT00217971	1COMPLETED	2009-12-01	2005-03-01	New York State Psychiatric Institute	7OTHER	false	false	false	null
[ 0 ]	166	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	1FEMALE	false	The primary objective of this project is to evaluate whether enhancing drug therapy with components of behavioral training, including pelvic floor muscle rehabilitation, results in better outcomes than drug therapy alone for urge incontinence in community-dwelling women.	Urinary incontinence in women is a major problem with significant medical, psychological, and social consequences. Previous research on urge incontinence, a common form of incontinence, has demonstrated that behavioral and drug interventions are effective, but do not cure most patients. Thus there is a need to improve ...	Urinary Incontinence	Behavior Therapy Behavioral Medicine Behavioral Research Behavioral Sciences Combined Modality Therapy Drug Therapy Overactive bladder Treatment Outcome Urge incontinence Urinary incontinence	null	2	arm 1: Oxybutynin chloride, extended-release, individually-titrated arm 2: Drug Therapy + Behavioral Training: Individually-titrated, extended-release oxybutynin chloride with management of side-effects. Behavioral training consists of teaching urge suppression strategies and pelvic floor muscle training.	[ 1, 0 ]	2	[ 0, 5 ]	intervention 1: Individually-titrated, extended-release oxybutynin chloride with management of side-effects. intervention 2: Behavioral training consists of teaching urge suppression strategies and pelvic floor muscle training.	intervention 1: Oxybutynin chloride, extended-release, individually-titrated intervention 2: Behavior Training	1	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066	64	NCT00223821	1COMPLETED	2009-12-01	2003-09-01	US Department of Veterans Affairs	1FED	false	false	false	null
[ 5 ]	209	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	2MALE	true	The purpose of this study is to determine whether testosterone replacement in older men with low testosterone levels will increase muscle strength, improve physical performance and overall sense of well being, and reduce fatigue.	The primary objective of this study is to determine whether testosterone replacement in older men, who have low testosterone levels and mild to moderate physical impairment, will increase their maximal voluntary muscle strength of major upper and lower extremity muscle groups. The second objective is to determine wheth...	Sarcopenia Hypogonadism Muscular Diseases	Andropause frailty hormone replacement therapy Aging	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day. intervention 2: Starting dose 15 g...	intervention 1: Topical testosterone gel 1% (active formulation) intervention 2: Topical gel (placebo formulation)	2	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	209	NCT00240981	6TERMINATED	2009-12-01	2005-01-01	Boston Medical Center	7OTHER	false	false	false	null
[ 0 ]	12	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Insulin resistance is known to be associated with mood disorders and cognitive difficulties. The purpose of this study is to treat depressed patients with rosiglitazone (also known as \[AKA\] Avandia), therefore improving glucose sensitivity, which in turn has the potential to affect mood and thinking. We, the research...	An association between insulin resistance (IR) and affective disorders has been postulated in a number of cross-sectional studies. Limited data exist on potential changes in IR associated with improvement in depressive symptoms and/or depression remission resolution - two studies reported decreased IR after successful ...	Depression Bipolar Disorder Insulin Resistance		null	1	arm 1: This group includes all 12 subjects who received rosiglitazone. Rosiglitazone was administered in addition to current antidepressant and/or mood-stabilizing medication at a dose of 4 mg/day for the first 4 weeks, with subsequent increase in dose to 9 mg/day for the remaining 8 weeks of the 12-week trial.	[ 0 ]	1	[ 0 ]	intervention 1: Rosiglitazone was administered at two different doses over the 12-week period.	intervention 1: rosiglitazone	1	Stanford \| California \| United States \| -122.16608 \| 37.42411	12	NCT00242619	1COMPLETED	2009-12-01	2007-07-01	Stanford University	7OTHER	false	false	false	null
[ 0 ]	22	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	true	1FEMALE	false	This research aims to explore the effectiveness of memantine (Namenda) in treating post-menopausal women between the ages of 50 and 65, who are at risk for cognitive decline. Memantine has already been shown to offer cognitive benefits to patients suffering from Alzheimer's disease, but it's potential for treating thos...	Memantine is a well-tolerated moderate-affinity, uncompetitive, voltage-dependent NMDA receptor antagonist that is shown to improve cognition and behavior in mild to moderate and moderate to severe Alzheimer's disease (AD). More recent, albeit limited, evidence also shows benefits of memantine treatment in a host of ot...	Dementia		null	2	arm 1: Subjects in this group did not carry the apolipoprotein E-epsilon 4 (apoE-e4) allele. During week 1 of the study, subjects were administered 5 mg of namenda once daily. During week 2 of the study, subjects were administered 5 mg of namenda in the morning and 5 mg in the evening (10 mg/day). During week 3 of the ...	[ 0, 0 ]	1	[ 0 ]	intervention 1: Namenda has already been shown to offer cognitive benefits to patients suffering from Alzheimer's disease, but it's potential for treating those at risk for cognitive decline without Alzheimer's disease or other dementia has yet to be evaluated. It is possible that memantine may offer neurocognitive ben...	intervention 1: Namenda	1	Stanford \| California \| United States \| -122.16608 \| 37.42411	22	NCT00242632	1COMPLETED	2009-12-01	2004-06-01	Stanford University	7OTHER	false	false	false	null
[ 3 ]	41	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	true	RATIONALE: Drugs used in chemotherapy, such as carboplatin and docetaxel, 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. Radiation therapy uses high-energy x-rays to ...	OBJECTIVES: Primary * Determine the time to progression in patients with stage III or IV or recurrent endometrial cancer treated with induction chemotherapy comprising carboplatin and docetaxel followed by radiotherapy and consolidation chemotherapy comprising carboplatin and docetaxel. Secondary * Determine the to...	Endometrial Cancer	recurrent endometrial carcinoma stage III endometrial carcinoma stage IV endometrial carcinoma	null	1	arm 1: Patients with advanced or current endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (Weekly, 5 days/week over 6-7 weeks, tailored 4500 cGy) and followed by 3 courses of consolidation docetaxel (75 mg/m\^2 on Day 1 of each course) /carboplatin (Dose = Area-under-the-curve 6 on...	[ 0 ]	3	[ 0, 0, 4 ]	intervention 1: Dose = Area-under-the-curve 6 on Day 1 every 3 weeks for 3 cycles. intervention 2: 75 mg/m\^2 on Day 1 of each course intervention 3: Weekly, 5 days/week over 6-7 weeks (tailored 4500 cGy)	intervention 1: carboplatin intervention 2: docetaxel intervention 3: radiation therapy	2	Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997 Saint Louis Park \| Minnesota \| United States \| -93.34801 \| 44.9483	41	NCT00258362	1COMPLETED	2009-12-01	2005-07-01	Masonic Cancer Center, University of Minnesota	7OTHER	false	false	false	null
[ 3, 4 ]	278	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	2MALE	false	The purpose of this extension study was to collect long-term safety and tolerability information to support a marketing authorisation application for a three-month dosage regimen of degarelix.	The data include data from the participants who participated in both the main study FE200486 CS15 (NCT00113753) and the extension study FE200486 CS15A.	Prostate Cancer	Prostate Cancer Androgen ablation therapy	null	3	arm 1: Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL). a...	[ 0, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Participants who completed the main study initially continued with the same dose in the FE200486 CS15A extension study. A protocol amendment changed the dosage to 360 mg (60 mg/mL) or 480 mg (60 mg/mL). Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given...	intervention 1: Degarelix intervention 2: Degarelix intervention 3: Degarelix	23	Leuven \| N/A \| Belgium \| 4.70093 \| 50.87959 Helsinki \| N/A \| Finland \| 24.93545 \| 60.16952 Joensuu \| N/A \| Finland \| 29.76316 \| 62.60118 Oulu \| N/A \| Finland \| 25.46816 \| 65.01236 Tampere \| N/A \| Finland \| 23.78712 \| 61.49911 Nice \| N/A \| France \| 7.26608 \| 43.70313 Aachen \| N/A \| Germany \| 6.08342 \| 50.77664 Novi Sad ...	278	NCT00268892	1COMPLETED	2009-12-01	2006-01-01	Ferring Pharmaceuticals	4INDUSTRY	false	false	false	null
[ 0 ]	55	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	The majority of patients with moderate to severe chronic kidney disease (CKD) (stages 3 and 4) develop secondary hyperparathyroidism (2°HPT), but the optimal therapy to control hyperparathyroidism in this group is unknown. The National Kidney Foundation presented guidelines in 2003 recommending vitamin D supplementatio...	Patients with CKD stage 3 were randomly allocated (by blinded group allocation) to either cholecalciferol (4000 U per day for one month then 2000 IU daily thereafter) or doxercalciferol (2.5 mcg po daily. Assessments for blood endpoints (primary end point PTH; secondary calcium, phosphorus) were done monthly. Other ass...	Renal Osteodystrophy	kidney, parathyroid hormone, vitamin d	null	2	arm 1: doxercalciferol 1 mcg capsule orally daily for 3 months. This is a form of vitamin D that does not require activation by enzymes in the liver and kidney. arm 2: cholecalciferol 4000 IU capsule orally daily for one month, then 2000 IU capsule daily orally for 2 months. this form of vitamin D requires activation b...	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: form of vitamin D that is already in active form. intervention 2: from of vitamin D that requires cells in the body to make active	intervention 1: doxercalciferol intervention 2: Cholecalciferol	1	Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838	47	NCT00285467	1COMPLETED	2009-12-01	2006-01-01	Indiana University School of Medicine	7OTHER	false	false	false	null
[ 4 ]	855	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	This is a phase III randomized study designed to evaluate the efficacy of mitomycin, doxifluridine, and cisplatin compared to mitomycin and doxifluridine.	Stomach cancer is the most common cancer in Korea and one of the major health problems worldwide. The most effective treatment for gastric cancer is curative surgical resection of primary tumor. However, a substantial number of patients eventually die of recurrences after curative resection. A number of randomized tria...	Stomach Cancer	Stomach cancer Adjuvant chemotherapy Mitomycin Cisplatin Doxifluridine	null	2	arm 1: Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28-day 84) arm 2: Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168)	[ 1, 0 ]	2	[ 0, 0 ]	intervention 1: Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168) intervention 2: Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28-day 84)	intervention 1: Mitomycin, doxifluridine and cisplatin intervention 2: Mitomycin and doxifluridine	1	Seoul \| N/A \| South Korea \| 126.9784 \| 37.566	847	NCT00296335	1COMPLETED	2009-12-01	2002-02-01	Asan Medical Center	7OTHER	false	false	false	null
[ 5 ]	150	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This was a study to compare less intense immunosuppression with a more traditional approach. The hypothesis was that less immunosuppression will provide similar protection against rejection than typical 2-3 drug therapy.	This was a prospective, randomized, controlled (open-label) trial of 2 different strategies of immunosuppression in de novo post-heart transplant patients. The hypothesis was that immunosuppression with tacrolimus and mycophenolate mofetil, coupled with rapid steroid weaning would provide similar anti-rejection efficac...	Immunosuppression	immunosuppression steroid withdrawal rejection coronary disease cytomegalovirus infection	null	2	arm 1: Tacrolimus alone arm 2: tacrolimus with mycophenolate mofetil	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: tacrolimus intervention 2: MMF	intervention 1: Tacrolimus intervention 2: combination therapy	2	Newark \| New Jersey \| United States \| -74.17237 \| 40.73566 New York \| New York \| United States \| -74.00597 \| 40.71427	150	NCT00299221	1COMPLETED	2009-12-01	2004-04-01	Newark Beth Israel Medical Center	7OTHER	false	false	false	null
[ 3 ]	57	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	2MALE	true	This study will determine if the drug dutasteride can improve weakness, mobility, functioning, nerve function, and quality of life in patients with spinal and bulbar muscular atrophy (SBMA). Patients with this inherited disease have an abnormal androgen receptor protein. The male hormones testosterone and dihydrotestos...	Background: Spinal and bulbar muscular atrophy (SBMA) or Kennedy's disease is a slowly progressive, X-linked motor neuron disease for which there is currently no treatment. It is caused by a mutation in the androgen receptor that results in a polyglutamine repeat expansion. Recent animal studies have demonstrated that...	Kennedy's Disease Spinal and Bulbar Muscular Atrophy	Motor Neuron Androgen Receptor Polyglutamine X-Linked Ligand Dependency Spinal and Bulbar Muscular Atrophy SBMA Kennedy Disease	null	2	arm 1: Dutasteride 0.5 mg/day arm 2: Matched placebo	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: Dutasteride 0.5 mg/day intervention 2: Matched placebo	intervention 1: Dutasteride intervention 2: Placebo	1	Bethesda \| Maryland \| United States \| -77.10026 \| 38.98067	50	NCT00303446	1COMPLETED	2009-12-01	2006-03-01	National Institute of Neurological Disorders and Stroke (NINDS)	0NIH	false	false	false	null
[ 5 ]	77	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This study will evaluate the effectiveness of ziprasidone treatment versus treatment with a standard atypical antipsychotic drug in improving insulin sensitivity and reducing excess abdominal fat storage in people with schizophrenia who are at risk for diabetes.	People with schizophrenia often lead more sedentary lifestyles than people without the disease, and they are frequently treated with antipsychotic medications that cause weight gain. Combined, these factors produce an increased risk for metabolic syndrome, which can lead to heart disease and type 2 diabetes. Characteri...	Schizophrenia Metabolic Syndrome X Insulin Resistance	Ziprasidone Olanzapine Risperidone Schizoaffective Disorder Insulin Sensitivity Visceral Adiposity Metabolic Syndrome	null	2	arm 1: Participants on risperidone or olanzapine who will remain on risperidone or olanzapine and do not switch to ziprasidone arm 2: Participants who enter on risperidone or olanzapine and switch to ziprasidone	[ 1, 0 ]	2	[ 0, 0 ]	intervention 1: Participants who are switched to ziprasidone will take a max daily dose of 200 mg, flexibly dosed based on symptoms and adverse effects. intervention 2: Participants will remain taking the same medications of risperidone or olanzapine as they were before study entry.	intervention 1: Switch intervention 2: Control	1	San Diego \| California \| United States \| -117.16472 \| 32.71571	55	NCT00338949	1COMPLETED	2009-12-01	2006-06-01	Veterans Medical Research Foundation	7OTHER	false	false	false	null
[ 3 ]	75	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This study is being conducted to characterize the safety/tolerability of pazopanib and lapatinib when administered in combination with enzyme-inducing anticonvulsants in patients with recurrent Grade III or IV malignant gliomas.	This study is being conducted to characterize the safety/tolerability of pazopanib and lapatinib when administered in combination with enzyme-inducing anticonvulsants in patients with recurrent Grade III or IV malignant gliomas.	Glioma	relapsed lapatinib Pazopanib glioblastoma	null	1	arm 1: Pazopanib and Lapatinib in combination. Subjects remain on treatment until disease progression or withdrawal from study.	[ 0 ]	2	[ 0, 0 ]	intervention 1: Pazopanib is a novel compound being developed for the treatment of various cancers. intervention 2: Lapatinib is a novel compound being developed for the treatment of various cancers.	intervention 1: pazopanib intervention 2: lapatinib	0	null	75	NCT00350727	1COMPLETED	2009-12-01	2006-12-01	GlaxoSmithKline	4INDUSTRY	false	false	false	null
[ 2, 3 ]	6	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	true	The purpose of this study is to determine the safety of the anti-CD20 antibody rituximab in treating patients with Primary Biliary Cirrhosis (PBC). Rituximab is a laboratory-made antibody currently used to treat some kinds of lymphoma. Rituximab may also help people with PBC, a disease of the immune system. However, th...	This is a pilot, open-label, study on 10 female patients with AMA-positive PBC to determine the effects of two infusions of rituximab on response of memory B cells to bacterial motifs, on biochemical function, and histological features. We will enroll 10 consecutive AMA-positive patients with the diagnosis of PBC based...	Primary Biliary Cirrhosis	Primary Biliary Cirrhosis	null	1	arm 1: rituximab 1000 mg IV on days 1 and 15, given over 5 - 6 hours	[ 0 ]	1	[ 0 ]	intervention 1: rituximab 1000 mg IV day 1 and 15, given over 5 - 6 hours	intervention 1: rituximab	1	Sacramento \| California \| United States \| -121.4944 \| 38.58157	6	NCT00364819	1COMPLETED	2009-12-01	2007-01-01	University of California, Davis	7OTHER	false	false	false	null
[ 5 ]	45	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	To assess the effectiveness of Lunesta on cancer patients who have received chemotherapy and who require patient controlled analgesia (PCA), specifically to assess whether Lunesta will: * improve sleep thereby decreasing need for opiates via PCA * improve sleep thereby decreasing pain by self report * improve sleep th...	Pain and fatigue are the most common symptom complaints of cancer patients. Although dramatic improvements have come about in recognizing and treating cancer related pain, less progress has been made in treating fatigue. Interventions to improve sleep may offer benefit in terms of pain and fatigue. One of the less com...	Sleep Initiation and Maintenance Disorders	pain fatigue sleep bone marrow transplant cancer	null	2	arm 1: active drug arm 2: placebo	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: eszopiclone 2 to 3 mg po at bedtime intervention 2: placebo 2 to 3 mg po at bedtime	intervention 1: Eszopiclone intervention 2: Placebo	1	La Jolla \| California \| United States \| -117.2742 \| 32.84727	45	NCT00365261	1COMPLETED	2009-12-01	2006-09-01	University of California, San Diego	7OTHER	false	false	false	null
[ 5 ]	134	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	The purpose of this study is to determine whether Sertraline, compared to placebo, is effective in the treatment of alcohol dependence as a function of the subtype of alcoholic patient being treated. This involved administering sertraline (to a maximum of 200 mg/day) or an inactive placebo for a 14-week treatment perio...	In an effort to broaden the options for pharmacotherapy of alcoholism, this study will examine the effects of sertraline, a selective serotonin reuptake inhibitor (SSRI), for the treatment of alcohol dependence. The study is based on evidence that, although SSRI therapy is not appropriate for all alcoholics, there exis...	Alcoholism	Alcohol Drinking Alcohol Dependence Sertraline Pharmacotherapy Alcoholism Subtypes Early- versus Late-Onset Alcoholism	null	2	arm 1: Oral sertraline, cognitive-behavioral counseling to maintain abstinence from alcohol arm 2: Placebo, cognitive-behavioral counseling to maintain abstinence from alcohol	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Sertraline (to a maximum of 200 mg/day) for 14-week treatment period intervention 2: Placebo for 14-week treatment period	intervention 1: Sertraline intervention 2: Placebo	1	Farmington \| Connecticut \| United States \| -72.83204 \| 41.71982	134	NCT00368550	1COMPLETED	2009-12-01	2004-02-01	UConn Health	7OTHER	false	false	false	null
[ 3 ]	66	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This study will evaluate the safety, tolerability and efficacy of SU011248 in patients with non-small cell lung cancer with brain metastases.	null	Non-Small Cell Lung Cancer	brain metastases Sunitinib Phase 2	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Sunitinib 37.5 mg daily by oral capsule in a continuous regimen until progression or unacceptable toxicity	intervention 1: Sunitinib	27	Norwalk \| Connecticut \| United States \| -73.4079 \| 41.1176 Cocoa Beach \| Florida \| United States \| -80.60922 \| 28.32055 Merritt Island \| Florida \| United States \| -80.69 \| 28.359 Titusville \| Florida \| United States \| -80.80755 \| 28.61222 City of Saint Peters \| Missouri \| United States \| -90.62651 \| 38.80033 Creve Coeu...	64	NCT00372775	1COMPLETED	2009-12-01	2007-03-01	Pfizer	4INDUSTRY	false	false	false	null
[ 4 ]	156	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The purpose of this clinical research study is to learn whether Saxagliptin can improve the body's ability to make its own insulin and lower blood sugar in people with type 2 diabetes	All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects who have an elevated blood sugar that requires additional medicatio...	Type 2 Diabetes		null	2	arm 1: Metformin 500-1500 mg (open-label, as needed for rescue in LT) arm 2: Metformin 500-1500 mg (open-label, as needed for rescue in LT)	[ 0, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Tablet, Oral, 5 mg, Once daily, (up to 12 weeks ST, up to 104 weeks LT) intervention 2: Tablet, Oral, 0 mg, Once daily (up to 12 weeks ST) intervention 3: Tablet, Oral, 500 mg titrated to 1000 mg, Once daily (up to 104 weeks LT, starting at Week 12) intervention 4: Tablets, Oral, 500-1500 mg, as needed ...	intervention 1: Saxagliptin intervention 2: Placebo intervention 3: Metformin (blinded) intervention 4: Metformin (open-label)	3	San Diego \| California \| United States \| -117.16472 \| 32.71571 Baton Rouge \| Louisiana \| United States \| -91.18747 \| 30.44332 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412	36	NCT00374907	1COMPLETED	2009-12-01	2006-09-01	AstraZeneca	4INDUSTRY	false	false	false	null
[ 3 ]	48	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	null	The primary purpose of the study is to evaluate the long term efficacy of sodium oxybate (Xyrem®) and zolpidem tartrate (Ambien®) in treating chronic insomnia. We will compare the efficacy of sodium oxybate with zolpidem tartrate (Ambien®), and compare the efficacy of each of these two medications with placebos.	Primary aim: 1\. To assess the long term efficacy of sodium oxybate and zolpidem tartrate in reducing insomnia and improving sleep quality as assessed by a range of self-reported measures. Questionnaires and Rating Scales: Subjects completed the following questionnaires and scales: Insomnia Severity Index, Epworth Sl...	Sleep Initiation and Maintenance Disorders		null	3	arm 1: Eligible subjects randomized to this arm received placebo as gelatin capsule and a liquid capsule to fully maintain the blind. arm 2: Eligible subjects randomized to this arm received zolpidem as gelatin capsule and a placebo liquid capsule to fully maintain the blind. arm 3: Eligible subjects randomized to this...	[ 2, 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: None intervention 2: None intervention 3: None	intervention 1: zolpidem tartrate intervention 2: sodium oxybate intervention 3: Matching Placebos	1	Stanford \| California \| United States \| -122.16608 \| 37.42411	49	NCT00383643	1COMPLETED	2009-12-01	2006-05-01	Stanford University	7OTHER	false	false	false	null
[ 3 ]	35	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	To determine the anti-tumour activity and biological effects of cediranib (AZD2171) at a dose of 45mg, primarily in Gastrointestinal Stromal Tumour (GIST) patients who are resistant to imatinib mesylate (current standard therapy) and also in patients with metastatic Soft Tissue Sarcoma (STS) resistant to standard thera...	null	Gastrointestinal Stromal Tumors Soft Tissue Sarcomas	cancer tumour advanced cancer Metastatic Gastro-Intestinal Stromal Tumours gastro-intestinal cancer RECENTIN	null	0	null	null	1	[ 0 ]	intervention 1: 45 mg oral tablet once daily dose	intervention 1: AZD2171	2	Manchester \| N/A \| United Kingdom \| -2.23743 \| 53.48095 Sutton \| N/A \| United Kingdom \| -0.2 \| 51.35	34	NCT00385203	1COMPLETED	2009-12-01	2006-09-01	AstraZeneca	4INDUSTRY	false	false	false	null
[ 3 ]	17	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to look at how well the combination of two chemotherapy drugs, pemetrexed (Alimta) and gemcitabine (Gemzar) work to treat your cancer.	This research study is being done because we have not yet been able to find the best treatment for recurrent or advanced head and neck cancer (SCCHN). Pemetrexed and gemcitabine have helped fight against SCCHN when each was given by itself. This study is different from others because it tests these two drugs together, ...	Head and Neck Cancer	advanced head neck cancer	Prot_SAP_000.pdf: Page 1 of 60 Amendment 1 01/09/2007 Fox Chase Cancer Center Extramural Research Program Protocol Phase II Study of Pemetrexed and Gemcitabine in Patients with Advanced Head and Neck Cancer (SCCHN) PEMETREXED (LY231514) Eli Lilly and Company Prin...	1	arm 1: pemetrexed 500mg/m2 and gemcitabine 1500mg/m2 given on day 1 and day 15 of each 28 day cycle	[ 0 ]	2	[ 0, 0 ]	intervention 1: pemetrexed 500mg/m2 given on day 1 and day 15 of each 28 day cycle intervention 2: gemcitabine 1500mg/m2 given on day 1 and day 15 of each 28 day cycle	intervention 1: pemetrexed intervention 2: gemcitabine	1	Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	17	NCT00394147	6TERMINATED	2009-12-01	2006-10-01	Fox Chase Cancer Center	7OTHER	true	true	false	https://cdn.clinicaltrials.gov/large-docs/47/NCT00394147/Prot_SAP_000.pdf
[ 3 ]	100	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This study evaluates the safety, efficacy, and pharmacokinetics (PK) of plerixafor given in addition to granulocyte-colony stimulating factor (G-CSF) for collection of peripheral blood stem cells (PBSCs) for autologous transplantation in patients who would benefit from an autologous stem cell transplant but have failed...	This is a Phase 2, multicenter, prospective, open-label study. Once 70 patients have enrolled, subsequent patients enrolled should have a diagnosis of lymphoma. Patients who would benefit from an autologous stem cell transplant, who have failed previous collections or collection attempts with a mobilization regimen of ...	Autologous Stem Cell Transplantation	Multiple Myeloma Non-Hodgkin's Lymphoma autologous transplantation AMD3100 stem cell mobilization plerixafor	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Participants underwent mobilization with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days, administered by subcutaneous injection (SC) injection each morning. On the evening of Day 4, participants received a dose of plerixafor 240 µg/kg, administered by SC injection. On Day 5, parti...	intervention 1: G-CSF plus plerixafor	8	Duarte \| California \| United States \| -117.97729 \| 34.13945 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Jackson \| Mississippi \| United States \| -90.18481 \| 32.29876 Kansas City \| Missouri \| United States \| -94.57857 \| 39.09973 Hackensack \| New Jersey \| U...	100	NCT00396331	1COMPLETED	2009-12-01	2005-10-01	Genzyme, a Sanofi Company	4INDUSTRY	false	false	false	null
[ 2, 3 ]	72	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	There will be 2 phases in this study. Patients will either be enrolled to the first phase or to the second phase, depending upon when they enroll into the study. The first phase of this study is done to evaluate the safety of enzastaurin in patients. This is done by gradually increasing the dose of the drug in small g...	null	Glioblastoma Glioblastoma Multiforme Gliosarcoma		null	1	arm 1: The Phase 1 consisted of the dose escalation of enzastaurin in 2 cohorts of up to 6 patients to assess maximum tolerated dose (MTD). Cohort 1 = radiotherapy/enzastaurin 250 mg per day/temozolomide 75 mg/m\^2 therapy. The 6 initial cohort patients were clinically evaluated for dose-limiting toxicities (DLT). If n...	[ 0 ]	3	[ 0, 0, 4 ]	intervention 1: Phase 1 - 250 mg Cohort 1 with one dose escalation allowed to 500 mg for Cohort 2, oral, daily, 6 weeks then twelve 28 day cycles Phase 2 - Phase 1 established dose, oral, daily, 6 weeks then twelve 28 day cycles intervention 2: 75 milligrams per meter squared (mg/m\^2), oral, daily, 6 weeks then 200 m...	intervention 1: enzastaurin intervention 2: temozolomide intervention 3: radiation therapy	1	San Francisco \| California \| United States \| -122.41942 \| 37.77493	72	NCT00402116	1COMPLETED	2009-12-01	2006-09-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null
[ 5 ]	129	NA	SINGLE_GROUP	9OTHER	0NONE	false	0ALL	null	Evaluation of efficacy of topical preoperative antibiotics in patients undergoing intravitreous injections.	null	Intravitreous Injections		null	1	arm 1: topical gatifloxacin 4 times per day	[ 0 ]	1	[ 0 ]	intervention 1: None	intervention 1: gatifloxacin	1	Stanford \| California \| United States \| -122.16608 \| 37.42411	129	NCT00410891	1COMPLETED	2009-12-01	2008-07-01	Stanford University	7OTHER	false	false	false	null
[ 2, 3 ]	25	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The aim of this research project is to determine the amount of capecitabine (Xeloda) which can be given safely with PHY906 (investigational drug) on a novel schedule. It is also the aim of this research project to determine what the effects, good and/or bad, are of combining capecitabine (Xeloda) with PHY906 (investiga...	null	Pancreatic Cancer	Pancreatic	null	1	arm 1: PHY906 800mg, orally, twice a day for days 1-4 and capecitabine 1500mg/m\^2 days 1-7 of a 14-day cycle	[ 0 ]	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: Capecitabine intervention 2: PHY906	1	New Haven \| Connecticut \| United States \| -72.92816 \| 41.30815	25	NCT00411762	1COMPLETED	2009-12-01	2006-12-01	Yale University	7OTHER	false	false	false	null
[ 4 ]	94	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	This two-arm study will compare the efficacy and safety of erlotinib (Tarceva) versus placebo in participants with resected head and neck squamous cell cancer who are receiving concurrent chemoradiotherapy or radiotherapy alone. Participants will be randomized to receive either erlotinib 150 milligrams (mg) orally (PO)...	null	Head and Neck Cancer		null	2	arm 1: Participants treated with surgical resection and chemoradiotherapy or radiotherapy alone will receive erlotinib tablets as 150 mg PO daily for 1 year until disease progression or intolerable toxicity. arm 2: Participants treated with surgical resection and chemoradiotherapy or radiotherapy alone will receive pla...	[ 0, 2 ]	3	[ 0, 0, 10 ]	intervention 1: Participants will receive placebo tablets (matched to erlotinib) once daily. intervention 2: Erlotinib will be given as 150 mg PO once daily. intervention 3: Additional clinical management including surgical resection and chemoradiotherapy or radiotherapy alone will be at the discretion of the Investiga...	intervention 1: Placebo intervention 2: Erlotinib intervention 3: Standard of care	31	Alcorcón \| N/A \| Spain \| -3.82487 \| 40.34582 Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879 Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879 Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879 Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879 Burgos \| N/A \| Spain \| -3.70184 \| 42.34106 Córdoba \| N/A \| Spain \| -4.77275 \| 37.89155 Donostia...	94	NCT00412217	6TERMINATED	2009-12-01	2006-11-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null
[ 2 ]	24	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	This study will evaluate the use of a blood thinner, fondaparinux, which is approved for use in adults (not in children) in a children aged 1-18 years. Subject with a blood clot (thrombosis) or heparin-induced thrombocytopenia who need to be on a blood thinner will be eligible to participate. Subjects will receive a on...	This clinical trial will assess the pharmacokinetics and safety of the novel anticoagulant, fondaparinux sodium (Arixtra) in pediatric patients with thromboembolism. Currently available anticoagulants have significant limitations especially as it applies to the pediatric population. Thus novel agents with improved phar...	Thrombosis Heparin-induced Thrombocytopenia	fondaparinux thrombosis heparin-induced thrombocytopenia pediatrics	null	0	null	null	1	[ 0 ]	intervention 1: Fondaparinux 0.1 mg/kg (up to 7.5 mg max initial dose) once daily for up to 21 days.	intervention 1: Fondaparinux	4	Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Orange \| California \| United States \| -117.85311 \| 33.78779 Columbus \| Ohio \| United States \| -82.99879 \| 39.96118 Houston \| Texas \| United States \| -95.36327 \| 29.76328	24	NCT00412464	1COMPLETED	2009-12-01	2006-09-01	Children's Hospital Los Angeles	7OTHER	false	false	false	null
[ 5 ]	60	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	false	0ALL	null	For people with HIV who are currently taking specific medications (including Sustiva (efavirenz)) and have no detectable viral load, this study tracks how patients do if they take their medications for five days of the week compared with seven days of the week.	The purpose of this study is to evaluate virologic control of a weekly schedule of 5 days of treatment followed by two days off treatment versus continuous treatment with the same regimen. This is a larger study based on the results of our successful pilot study using the same protocol. The 48 week, phase IV trial addr...	HIV Infections	HIV/AIDS efavirenz tenofovir emtricitabine FOTO treatment interruption Atripla Truvada Treatment Experienced	null	2	arm 1: Subjects randomized to the control arm will remain on daily dosing of the pre-study regimen of 600mg efavirenz and 1 coformulated tablet of 300mg tenofovir df + 200 mg emtricitabine by mouth daily, or the equivalent coformulated single tablet of 600mg efavirenz + 300mg tenofovir df + 200 mg emtricitabine by mout...	[ 5, 0 ]	1	[ 0 ]	intervention 1: Intermittent dosing treatment is the maintenance of the "5/2" schedule, where the regimen, 300 mg tenofovir td, 600 mg efavirenz, 200 mg emtricitabine is dosed for 5 consecutive days - typically Monday through Friday - followed by two days off of medication, 300 mg tenofovir td, 600 mg efavirenz, 200 mg...	intervention 1: Intermitent Dosing	7	Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 Vero Beach \| Florida \| United States \| -80.39727 \| 2...	60	NCT00414635	1COMPLETED	2009-12-01	2006-08-01	Community Research Initiative of New England	7OTHER	false	false	false	null
[ 4 ]	52	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	This study assessed the effect of pancrelipase delayed release capsules on fat and nitrogen absorption in subjects with PEI due to Chronic Pancreatitis and Pancreatectomy. There was a run-in with a 5-day of single-blind placebo treatment, followed by a 7-day Double-blind period and a 6-month Open-Label Follow-up.	null	Chronic Pancreatitis Pancreatectomy Pancreatic Exocrine Insufficiency	Chronic Pancreatitis Pancreatectomy Pancreatic Exocrine Insufficiency	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 24,000 unit capsule intervention 2: Placebo	intervention 1: Pancrelipase delayed release capsule intervention 2: Placebo Comparator	30	Scottsdale \| Arizona \| United States \| -111.89903 \| 33.50921 Bristol \| Connecticut \| United States \| -72.94927 \| 41.67176 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Maywood \| Illinois \| United St...	103	NCT00414908	1COMPLETED	2009-12-01	2007-10-01	Solvay Pharmaceuticals	4INDUSTRY	false	false	false	null
[ 3 ]	9	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This phase II trial is studying how well giving bortezomib together with carboplatin works in treating patients with metastatic pancreatic cancer. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin, work in different ways...	PRIMARY OBJECTIVES: I. To evaluate overall survival (OS) at 6 months with the combination of bortezomib and carboplatin in patients who previously received 1 prior regimen for metastatic pancreatic cancer. SECONDARY OBJECTIVES: I. To evaluate the objective tumor response rate, the duration of response, time to tumor...	Acinar Cell Adenocarcinoma of the Pancreas Duct Cell Adenocarcinoma of the Pancreas Stage IV Pancreatic Cancer		null	1	arm 1: Patients receive bortezomib IV on days 1, 4, 8, and 11 and carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.	[ 0 ]	3	[ 0, 0, 10 ]	intervention 1: Given IV intervention 2: Given IV intervention 3: Correlative studies	intervention 1: bortezomib intervention 2: carboplatin intervention 3: laboratory biomarker analysis	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	9	NCT00416793	6TERMINATED	2009-12-01	2006-12-01	National Cancer Institute (NCI)	0NIH	false	false	false	null
[ 3 ]	54	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	AMB-220-E is an international, multicenter, open-label study examining the long-term safety of ambrisentan (BSF 208075) in subjects who have previously completed Myogen study NCT00046319, "A Phase II, Randomized, Double-Blind, Dose-Controlled, Dose-Ranging, Multicenter Study of BSF 208075 Evaluating Exercise Capacity i...	null	Pulmonary Hypertension		null	0	null	null	1	[ 0 ]	intervention 1: 1, 2.5, 5, and 10 mg ambrisentan given orally once daily	intervention 1: ambrisentan	0	null	54	NCT00424021	1COMPLETED	2009-12-01	2003-04-01	Gilead Sciences	4INDUSTRY	false	false	false	null
[ 4 ]	34	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	Globally, children who acquire HIV-1 increasingly do so in the context of maternal antiretroviral prophylaxis. It is important to determine whether maternal antiretroviral prophylaxis should alter infant treatment regimens. Nevirapine (NVP) is commonly used for PMTCT and is also a commonly used first-line drug for trea...	Hypotheses 1. Infants older than 6 months who do not have detectable nevirapine resistance on genotypic testing will respond equivalently to a nevirapine-sparing or a nevirapine-containing HAART regimen, despite previous single-dose nevirapine exposure. 2. Genotypic drug resistance levels may predict response to thera...	HIV Infections	HIV-1 Pediatric nevirapine HAART Resistance Treatment Naive	null	2	arm 1: Infants randomized to this arm will receive nevirapine-containing HAART regimen arm 2: Infants randomized to this arm will receive nevirapine-sparing HAART	[ 0, 1 ]	7	[ 0, 0, 0, 0, 0, 0, 0 ]	intervention 1: First line regimen intervention 2: First line regimen intervention 3: First line regimen intervention 4: First line regimen For children who have anaemia(Hb of\<8g/dl), AZT will be substituted for d4T. intervention 5: Second line regimen intervention 6: Second line regimen - Among children randomized to...	intervention 1: AZT/3TC/NVP (zidovudine/lamivudine/nevirapine) intervention 2: d4T/3TC/NVP (stavudine/lamivudine/nevirapine) intervention 3: AZT/3TC/ABC (zidovudine/lamivudine/abacavir) intervention 4: d4T/3TC/ABC (stavudine/lamivudine/abacavir) intervention 5: ddI/ABC/LPV/r (didanosine/abacavir/lopinavir-ritonavir) in...	1	Nairobi \| N/A \| Kenya \| 36.81667 \| -1.28333	34	NCT00427297	6TERMINATED	2009-12-01	2007-09-01	University of Washington	7OTHER	false	false	false	null
[ 4 ]	22	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The primary purpose of this study is to determine how efficacy of quetiapine (seroquel XR) in improving the sleep in recovering alcohol dependent subjects.	Sober alcohol dependent subjects frequently complain of difficulty falling asleep as well as staying asleep which may eventually lead to relapse. Novel antipsychotic medications such as quetiapine have shown some efficacy in treating alcoholism and have also shown some benefit in improving insomnia. The primary aim of...	Alcoholism Sleep Initiation and Maintenance Disorders	Alcoholism Insomnia Quetiapine Seroquel	null	2	arm 1: Quetiapine XR arm 2: Placebo	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Quetiapine is a second generation antipsychotic medication, which has also recently shown to be associated with properties of mood stabilization in bipolar disorder. intervention 2: Inactive or inert pill which will be used as a comparator.	intervention 1: Quetiapine XR intervention 2: Placebo.	1	Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	20	NCT00434876	1COMPLETED	2009-12-01	2007-08-01	Subhajit Chakravorty	1FED	false	false	false	null
[ 3 ]	6	NON_RANDOMIZED	CROSSOVER	0TREATMENT	1SINGLE	false	0ALL	null	The purpose of this study is to evaluate the dietary supplement Siliphos, which comes from milk thistle, to determine whether it is safe and well-tolerated in adults who have non-alcoholic steatohepatitis (NASH). An additional aim of this study is to determine whether Siliphos may be beneficial in treatment of NASH as ...	Non-alcoholic fatty liver disease (NAFLD) encompasses a spectrum of liver conditions characterized by fat accumulation in the liver. Non-alcoholic steatohepatitis (NASH) is one form of NAFLD that may progress to cirrhosis in some people. Currently, there are no medications that are approved for the treatment of NASH. M...	Fatty Liver	Clinical Trials Pilot Projects Milk Thistle Liver Function Tests	null	2	arm 1: Received study medication first followed by placebo arm 2: Received placebo first followed by study medicaiton	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: 1 pill 3 times daily x 6 weeks intervention 2: 1 pill 3 times daily x 6 weeks	intervention 1: IdB 1016 (Siliphos) intervention 2: Matched placebo	1	San Diego \| California \| United States \| -117.16472 \| 32.71571	12	NCT00443079	1COMPLETED	2009-12-01	2007-03-01	Heather Patton	7OTHER	false	false	false	null
[ 5 ]	38	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of the study is to determine if tissue changes are predictor of clinical response to therapy. The hypothesis is that the patients who have laryngeal signs and symptoms related to acid reflux, will have ultrastructural changes on a laryngeal biopsy which are predictors of response to therapy.	Gastroesophageal reflux disease (GERD) has been implicated, in part, as the cause of various laryngeal signs and symptoms (1-7). This is often termed reflux laryngitis, ear, nose, and throat (ENT) reflux, or laryngopharyngeal reflux (LPR). GERD was first described to be a causative agent in developing contact ulcers of...	Larynx Disease Gastroesophageal Reflux		null	1	arm 1: Patients who have documented GERD as evidenced by erosive esophagitis or those patients who have newly diagnosed laryngopharyngeal reflux as diagnosed by endoscopy.	[ 0 ]	2	[ 0, 3 ]	intervention 1: 30 mg bid for 3 months intervention 2: repeat egd with biopsy after Prevacid 30 mg bid for 3 months	intervention 1: Prevacid intervention 2: Esophageal and Laryngeal Biopsies	1	Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589	19	NCT00444145	1COMPLETED	2009-12-01	2007-03-01	Vanderbilt University Medical Center	7OTHER	false	false	false	null
[ 4 ]	667	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	2MALE	false	Benign Prostatic Hypertrophy (BPH) is a common and bothersome condition of aging men. It is characterized by an enlargement of the prostate occurring in human male over the age of 50 which increases in prevalence with age, and among those aged 50 to 80, about 40% report moderate or severe urinary symptoms of prostatism...	The objectives of the study are to develop a safe and tolerable intermittent dosage regimen of cetrorelix pamoate that provides prolonged improvement in BPH-related signs and symptoms. Patients will enter a 4-week run-in no-treatment observation period to confirm severity and stability of voiding symptoms based on the...	Benign Prostatic Hypertrophy	Cetrorelix	null	3	arm 1: Treatment course 1: Cetrorelix 78 mg + 78 mg * Week 0: 52 mg CET (2 injections) * Week 2: 26 mg CET (1 injection) Treatment course 2: * Week 26: 52 mg CET (2 injections) * Week 28: 26 mg CET(1 injection) 4 days with treatment, Day 1 of each indicated week, 6 injections in total per patient. arm 2: Treatmen...	[ 0, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: None intervention 2: None intervention 3: None	intervention 1: Cetrorelix 78 mg + 78 mg intervention 2: Cetrorelix 78 mg + 52 mg intervention 3: Placebo	68	Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 Fort Smith \| Arkansas \| United States \| -94.39855 \| 35.38592 Laguna Hills \| California \| United States \| -117.71283 \| 33.61252 Newport Beach \| California \| United States \| -117.92895 \| 33.61891 San Diego \| California \| United States \| -117.16472 \| 32.71571 Tarz...	667	NCT00449150	6TERMINATED	2009-12-01	2007-03-01	AEterna Zentaris	4INDUSTRY	false	false	false	null
[ 3 ]	134	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	2MALE	true	This is a double-blind randomized phase II trial to determine whether two different doses of BoNT/A injection into the prostate gland demonstrate sufficient improvement in the management of lower urinary symptoms due to BPH to warrant more extensive research. Subjects will receive either a 100U or 300U dose. Participat...	null	Benign Prostatic Hyperplasia	benign prostatic hyperplasia BPH botulinum toxin BoNT/A	null	2	arm 1: 100 units botulinum toxin type A (BoNT/A) arm 2: 300 units botulinum toxin type A (BoNT/A)	[ 1, 1 ]	1	[ 0 ]	intervention 1: 100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designe...	intervention 1: botulinum toxin type A (BoNT/A)	7	Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163 New York \| New York \| United States \| -74.00597 \| 40.71427 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Houston \| Texas \| United States ...	134	NCT00451191	1COMPLETED	2009-12-01	2006-10-01	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	0NIH	false	false	false	null
[ 2, 3 ]	27	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	true	BZL 101 is an aqueous extract from herba Scutellaria Barbata D. Don of the Lamiaceae family. Preclinical studies suggest that this herb has antitumor activity for breast cancer and preliminary clinical data suggest that it is tolerable in patients with metastatic breast cancer. The overall goals of this Phase I/II tria...	null	Metastatic Breast Cancer	Breast Cancer Bionovo BZL101 Chinese Herbs	null	0	null	null	1	[ 0 ]	intervention 1: Freeze dried powder mixed with liquid. Administered as a daily dose. Dosage to be determined in Phase 1 portion.	intervention 1: BZL101	0	null	27	NCT00454532	1COMPLETED	2009-12-01	2007-03-01	Bionovo	4INDUSTRY	false	false	false	null
[ 0 ]	357	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	Metabolic syndrome consists of a group of co-occuring conditions that increase an individual's risk of developing heart disease, stroke, and diabetes. The purpose of this study is to evaluate the long-term effectiveness of chloroquine, a protein-activation medication, at reducing the progression of atherosclerosis in p...	Metabolic syndrome is one of the most common disorders in industrialized countries. It consists of abnormal serum lipids, glucose intolerance, elevated blood pressure, and central obesity in the setting of insulin resistance. The syndrome substantially increases the risk of developing diabetes and vascular disease, but...	Metabolic Syndrome X Overweight Hypertension Dyslipidemias Prediabetic State	Metabolic Syndrome Atherosclerosis	null	2	arm 1: Participants will receive 80 mg of chloroquine on a daily basis. arm 2: Participants will receive a placebo comparator tablet on a daily basis.	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: One tablet of 80 mg of chloroquine on a daily basis for 12 months followed by 12 months off drug with 1 visit at month 24 intervention 2: Chloroquine Placebo tablet daily for 12 months followed by 12 months off drug with 1 visit at month 24	intervention 1: Chloroquine intervention 2: Placebo Comparator	1	St Louis \| Missouri \| United States \| -90.19789 \| 38.62727	116	NCT00455403	1COMPLETED	2009-12-01	2006-04-01	Washington University School of Medicine	7OTHER	false	false	false	null
[ 2 ]	76	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Patients received oral AC220 daily for 14 days to study the side effects, tolerability and best dose for treating relapsed or refractory acute myeloid leukemia, regardless of FLT3 status.	This is a multi-center clinical study conducted in the USA and two international sites. This open-label, dose escalation study was designed to characterize the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of orally administered AC220 as a single agent given daily for 14 days. Cohorts of 3 patie...	Acute Myeloid Leukemia Leukemia Myelodysplastic Syndrome AML MDS	RTK kinase inhibitor tyrosine acute FLT3 AC220 pharmacokinetic pharmacokinetics PK pharmacodynamic pharmacodynamics mutations PD receptor class III relapsed refractory t(8;21) q22;q22 AML1/ETO t(16;16 p13;q22 CBFbeta/MYH11 inv(16) p13q22 11q23 dysplasia myeloid myelomonocytic monoblastic monocytic erythroid erythroleuk...	null	1	arm 1: Determine safety, tolerability and pharmacokinetic (PK) parameters of AC220	[ 0 ]	1	[ 0 ]	intervention 1: Powder in bottle formulation supplied as 50mg or 350 mg in glass, crimped serum vials. Requires reconstitution by a pharmacist, and must be stored securely and protected from light.	intervention 1: AC220	5	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626 Houston \| Texas \| United States \| -95.36327 \| 29.76328 T'Bilisi \| N/A \| Georgia \| N/A \| N/A T'bilisi \| N/A \| Georgia \| N/A \| N/A	76	NCT00462761	1COMPLETED	2009-12-01	2007-01-01	Daiichi Sankyo	4INDUSTRY	false	false	false	null
[ 0 ]	1,102	RANDOMIZED	PARALLEL	1PREVENTION	0NONE	true	0ALL	false	The purpose of this study is to compare the effectiveness of two strategies of post-exposure prophylaxis (PEP) in healthcare workers (HCWs) who have been vaccinated with acellular pertussis vaccine and have been exposed to pertussis Secondary Objectives include a comparison of the costs of each PEP strategy and an asse...	Pertussis, caused by the bacterium Bordetella pertussis, is an acute respiratory tract infection transmitted to susceptible persons through aerosolized respiratory droplets and direct contact with respiratory secretions. Classic pertussis disease is characterized by three phases of illness: the catarrhal phase where pe...	Pertussis	Pertussis Healthcare worker Post-exposure prophylaxis Vaccination Pertussis in healthcare workers following occupational exposure to pertussis	null	2	arm 1: Subjects who did receive PEP following pertussis exposure arm 2: Subjects who did not receive PEP following pertussis exposure	[ 1, 4 ]	2	[ 0, 0 ]	intervention 1: Azithromycin 1000mg po x 1, then 500mg po Q day for 4 days; TMP-SMX DS one BID for 14 days intervention 2: TMP-SMX DS po BID for 14 days	intervention 1: Antibiotic PEP intervention 2: Antibiotic PEP	1	Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589	86	NCT00469274	1COMPLETED	2009-12-01	2007-05-01	Vanderbilt University	7OTHER	false	false	false	null
[ 3 ]	9	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	true	RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome 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...	OBJECTIVES: Primary * Estimate the response rate in patients with recurrent or stage III or IV primary endometrial carcinoma treated with doxorubicin hydrochloride liposome and carboplatin. Secondary * Determine progression-free survival of patients treated with this regimen. * Determine overall survival of patient...	Endometrial Cancer	recurrent endometrial carcinoma stage III endometrial carcinoma stage IV endometrial carcinoma	null	1	arm 1: Patients receive doxorubicin hydrochloride liposome IV over 1 hour on day 1 and carboplatin IV over 30 minutes on day 1	[ 0 ]	2	[ 0, 0 ]	intervention 1: IV intervention 2: IV	intervention 1: carboplatin intervention 2: pegylated liposomal doxorubicin hydrochloride	1	Buffalo \| New York \| United States \| -78.87837 \| 42.88645	9	NCT00470067	6TERMINATED	2009-12-01	2007-02-01	Roswell Park Cancer Institute	7OTHER	false	false	false	null
[ 5 ]	25	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This research study is designed to determine if replacing your current antipsychotic and/or mood stabilizer with ziprasidone (Geodon) will impact weight. This research is being conducted because Geodon has a documented effect on mood. Additionally, we believe Geodon to be an effective medication for overweight or obese...	null	Bipolar Disorder		null	1	arm 1: Ziprasidone/Geodon up to 320 mg per day	[ 0 ]	1	[ 0 ]	intervention 1: Ziprasidone/Geodon	intervention 1: Ziprasidone/Geodon	1	Stanford \| California \| United States \| -122.16608 \| 37.42411	25	NCT00472641	1COMPLETED	2009-12-01	2007-01-01	Stanford University	7OTHER	false	false	false	null
[ 0 ]	96	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	true	0ALL	false	The pathogenesis of post-malaria anaemia is multifactorial. Iron supplementation remains the mainstay of management of moderate and severe anaemia; however the management of mild anaemia (Hb 80-110g/l) is problematic as population supplementation studies of children in malaria endemic areas demonstrate adverse effects ...	Pathogenesis of Malaria Anaemia Although the pathogenesis of malaria anaemia is not completely understood (1), mechanisms that have been proposed include immune and non-immune-mediated hemolysis of parasitized and non-parasitized red blood cells, bone marrow dysfunction and iron delocalisation (2-4). Plasmodium falcip...	Malaria Anaemia	malaria anaemia chloroquine iron delocalisation macrophages	null	2	arm 1: Subjects initially treated with Co-arthemeter, and then continued on weekly chloroquine till day 90 arm 2: Subjects initially treated with Co-arthemeter, and then continued on weekly placebo till day 90	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: This is an orange syrup in a 60ml amber coloured glass bottle containing 50mg of chloroquine base per 5mls as the chloroquine phosphate. The syrup was manufactured by Medreich Sterilab Ltd, Avalahalli, Bangalore, India. Chloroquine: weekly treatment of 7.5mg/kg for 90 days intervention 2: The placebo is...	intervention 1: Chloroquine intervention 2: Placebo	0	null	96	NCT00473837	1COMPLETED	2009-12-01	2007-07-01	Medical Research Council Unit, The Gambia	7OTHER	false	false	false	null
[ 3 ]	10	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	2MALE	true	The purpose of this study is to determine if treatment with fulvestrant leads to a slowing of tumor progression in patients who have developed androgen-independent (AIPC) or hormone-refractory prostate cancer (HRPC) and who have a rising serum prostate specific antigen (PSA).	The purpose of this study is to determine if treatment with fulvestrant leads to a slowing of tumor progression in patients who have developed androgen-independent (AIPC) or hormone-refractory prostate cancer (HRPC) and who have a rising serum prostate specific antigen (PSA). In vitro studies have shown that fulvestran...	Prostatic Neoplasms Prostate Cancer		null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Fulvestrant 250 mg IM on Days 1 and 14 in the first month, thereafter 250 mg monthly	intervention 1: Fulvestrant	1	Stanford \| California \| United States \| -122.16608 \| 37.42411	10	NCT00476645	1COMPLETED	2009-12-01	2006-09-01	Stanford University	7OTHER	false	false	false	null
[ 3 ]	1	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	1FEMALE	true	In this study we plan to study the combination of ZD6474, a dual inhibitor of EGFR and VEGFR-2 with anastrozole in the neoadjuvant setting for patients with Stage I-III breast cancer. The aim is to overcome mechanisms of resistance and simultaneously block multiple critical signaling pathways known to stimulate breast ...	The use of adjuvant chemotherapy and endocrine therapy has had a significant impact on breast cancer survival. However, not all patients will benefit from each of these therapies. Increasing data suggests that patients with hormone receptor-positive breast cancer derive marginal benefit from the addition of adjuvant ch...	Breast Cancer		null	2	arm 1: Vandetanib and Anastrozole as neoadjuvant therapy arm 2: Anastrozole as neoadjuvant therapy	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 300 mg daily intervention 2: 1 mg daily	intervention 1: Vandetanib intervention 2: Anastrozole	1	Stanford \| California \| United States \| -122.16608 \| 37.42411	1	NCT00481845	6TERMINATED	2009-12-01	2008-01-01	Stanford University	7OTHER	false	false	false	null
[ 5 ]	123	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	Ropinirole Hydrochloride (ROP) was granted approval for the treatment of Parkinson's Disease (PD) on 20 October 2006. ROP is expected to be used for a long term in clinical practice. However, no long-term clinical data with ROP administered three times daily are currently available from Japanese patients, and the clin...	null	Parkinson Disease Parkinson's Disease	Ropinirole hydrochloride L-dopa Parkinson's Disease Dopamine agonist	null	1	arm 1: None	[ 0 ]	2	[ 0, 0 ]	intervention 1: Ropinirole Hydrochloride monotherapy group (ROP): Patients will receive ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose will start at 0.75 mg/day and will be increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Mainten...	intervention 1: ROP intervention 2: ROP+L-Dopa	22	Chiba \| N/A \| Japan \| 140.11667 \| 35.6 Fukuoka \| N/A \| Japan \| 130.41667 \| 33.6 Fukuoka \| N/A \| Japan \| 130.41667 \| 33.6 Fukuoka \| N/A \| Japan \| 130.41667 \| 33.6 Hyōgo \| N/A \| Japan \| 144.43333 \| 43.36667 Ibaraki \| N/A \| Japan \| 135.56828 \| 34.81641 Kanagawa \| N/A \| Japan \| 139.91667 \| 37.58333 Kanagawa \| N/A \| Japan \|...	123	NCT00485069	1COMPLETED	2009-12-01	2007-06-01	GlaxoSmithKline	4INDUSTRY	false	false	false	null
[ 4 ]	392	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	This was a Phase III, multicenter, randomized, double-masked, sham injection-controlled study of the efficacy and safety of intravitreal ranibizumab compared with sham injections in patients with macular edema secondary to central retinal vein occlusion (CRVO); 392 patients with CRVO were enrolled at 95 investigational...	null	Macular Edema Retinal Vein Occlusion	CRVO RVO Lucentis Edema	null	3	arm 1: None arm 2: None arm 3: None	[ 3, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections. intervention 2: Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections. intervention 3: Ranib...	intervention 1: Sham injection intervention 2: Ranibizumab injection 0.3 mg intervention 3: Ranibizumab injection 0.5 mg	0	null	390	NCT00485836	1COMPLETED	2009-12-01	2007-07-01	Genentech, Inc.	4INDUSTRY	false	false	false	null
[ 2, 3 ]	7	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	Uveitis is an inflammation (swelling and irritation) inside the eye, affecting the uvea. The uvea is the layer of the eye between the sclera and the retina and provides most of the blood supply to the retina. Uveitis is an important cause of visual loss. There are 30,000 new cases of legal blindness each year due to u...	Uveitis, an inflammation that affects the uvea (iris, ciliary body and choroid), is an important cause of visual loss. There are 30,000 new cases of legal blindness each year due to uveitis in the U.S. Sight-threatening complications associated with uveitis include macular edema, which may persist even when inflammatio...	Uveitis Cytoid Macular Edema	uveitis cytoid macular edema steroid Lucentis	null	1	arm 1: 0.5 mg of ranibizumab by intravitreal injection at baseline and at monthly intervals for the following two months for a total of 3 injections. Afterwards, PRN injections for 9 months.	[ 0 ]	1	[ 0 ]	intervention 1: 0.5 mg of ranibizumab by intravitreal injection at baseline and at monthly intervals for the following two months for a total of 3 injections. Afterwards, PRN injections for 9 months.	intervention 1: Ranibizumab	1	San Francisco \| California \| United States \| -122.41942 \| 37.77493	7	NCT00498355	1COMPLETED	2009-12-01	2007-07-01	University of California, San Francisco	7OTHER	false	false	false	null
[ 5 ]	24	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	2MALE	false	There is increasing evidence of the linkage of type 2 diabetes with low testosterone levels in men.	Testosterone treatment has shown beneficial effects on blood sugar control and obesity in pilot studies in men with type 2 diabetes. Beneficial effects have also been seen on angina- a disease related to atherosclerosis (narrowing of the arterial blood vessels). Peripheral vascular disease is also caused by atheroscler...	Hypogonadism Peripheral Vascular Disease Type 2 Diabetes	Testosterone Hypogonadism Diabetes PVD RCT	null	2	arm 1: Testosterone 200 mg intramuscular every 2 weeks arm 2: Saline	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Sustanon- 200mg- Intramuscular testosterone every 2 weeks intervention 2: Saline injection every two weeks	intervention 1: Testosterone intervention 2: saline	1	Barnsley \| South Yorkshire \| United Kingdom \| -1.48333 \| 53.55	24	NCT00504712	1COMPLETED	2009-12-01	2006-02-01	Barnsley Hospital	7OTHER	false	false	false	null
[ 4 ]	67	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	The primary objective of this study is to determine whether low-dose cytarabine in combination with arsenic trioxide is more effective than low-dose cytarabine alone in achieving complete remission in elderly patients (≥60 years of age) with acute myeloid leukemia.	null	Acute Myeloid Leukemia	acute myeloid leukemia, cytarabine, arsenic trioxide.	null	2	arm 1: Cycle 1 cytarabine 10 mg/m\^2 was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2 A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease. Patients...	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: Arsenic trioxide will be administered intravenously (iv) at a dose of 0.25 mg/kg. intervention 2: Cytarabine will be administered at a dose of 10 mg/m\^2 subcutaneously (sc) twice a day (bid).	intervention 1: Arsenic trioxide intervention 2: Low-dose cytarabine alone	12	Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Buffalo \| New York \| United States \| -78.87837 \| 42.88645 New York \| N...	66	NCT00513305	6TERMINATED	2009-12-01	2007-10-01	Cephalon	4INDUSTRY	false	false	false	null
[ 3 ]	19	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	true	This study has the purpose to demonstrate clinical efficacy of the investigational new drug ertumaxomab in patients with human epidermal growth factor receptor-2 (HER-2/neu) overexpressing (3+ or 2+ with a positive Fluorescence In Situ Hybridization (FISH) test result) metastatic breast cancer progressing after trastuz...	This study is an open-label, non-randomized, uncontrolled, two-stage phase II study evaluating the efficacy and safety of ertumaxomab. Ertumaxomab will be administered three times at 7 day intervals by constant rate 3 hour intravenous (i.v.) infusions according to the following dose schedule: 10 µg (day 0); 100 µg (day...	Metastatic Breast Cancer Advanced Breast Cancer	Breast Cancer investigational drug drug therapy Antineoplastic Protocols Immunotherapy Metastatic breast cancer Advanced breast cancer Stage IV breast cancer Her-2/neu expressing breast cancer Her-2/neu Trastuzumab refractory	null	0	null	null	1	[ 0 ]	intervention 1: Ertumaxomab will be intravenously administered to see if it can increase the patient's objective response rate.	intervention 1: ertumaxomab	5	Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997 Lebanon \| New Hampshire \| United States \| -72.25176 \| 43.64229 New York \| New York \| United States \| -74.00597 \| 40.71427 Ottawa \| Ontario \| Canada \| -75.69812 \| 45.41117 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884	19	NCT00522457	6TERMINATED	2009-12-01	2008-01-01	Neovii Biotech	4INDUSTRY	false	false	false	null
[ 5 ]	180	RANDOMIZED	PARALLEL	4SUPPORTIVE_CARE	0NONE	false	1FEMALE	true	The purpose of this study is to determine whether spinal anesthesia combined with intrathecal morphine in abdominal hysterectomy on benign gynecological indications gives better outcome concerning duration of hospital stay and postoperative patient comfort than general anesthesia.	null	Hysterectomy (MeSH nr: E04.950.300.399)	Hospitalization Postoperative care Quality of Life Health economy Anesthesia. Spinal Anesthesia, General	null	2	arm 1: Spinal anesthesia combined with intrathecal morphine. Spinal anesthesia applied in intervertebral space L3/L4 or L2/L3 with hyperbaric bupivacaine 20 mg and morphine 0.2 mg intrathecally. Sedation with propofol. arm 2: General anesthesia. General anesthesia induced with propofol, fentanyl and rocuronium, and mai...	[ 1, 1 ]	7	[ 0, 0, 0, 0, 0, 0, 0 ]	intervention 1: 5 mg/mL, 4 mL intrathecally as a single dos intervention 2: 0.4 mg/mL; 0.5 mL intrathecally as a single dosage intervention 3: 2-5 mg/kg body weight/hours IV (intravenously) for sedation during the surgery intervention 4: Induction of anesthesia with 1-2 mg/kg body weight IV (intravenously). After intub...	intervention 1: Bupivacain intervention 2: Morphine intervention 3: Propofol intervention 4: Propofol intervention 5: Fentanyl intervention 6: Rocuronbromid intervention 7: Morphine	5	Eksjö \| N/A \| Sweden \| 14.97205 \| 57.66643 Jönköping \| N/A \| Sweden \| 14.15618 \| 57.78145 Linköping \| N/A \| Sweden \| 15.62157 \| 58.41086 Norrköping \| N/A \| Sweden \| 16.1826 \| 58.59419 Värnamo \| N/A \| Sweden \| 14.04001 \| 57.18604	180	NCT00527332	1COMPLETED	2009-12-01	2007-03-01	Preben Kjolhede	7OTHER	false	false	false	null
[ 2 ]	7	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	2MALE	false	The objective of this study is to evaluate the safety and efficacy of intraprostatic injection of Botox for the treatment of men diagnosed with chronic nonbacterial prostatitis/chronic pelvic pain syndrome (CP/CPPS).	This is a prospective open label study examining the efficacy and safety of intraprostatic Botox . Men with a clinical diagnosis of chronic nonbacterial prostatitis/CPPS will be treated with intraprostatic Botox™ and followed for 12 weeks (primary efficacy analyses), and 24 weeks (long term follow-up) for responders. ...	Prostatitis Chronic Pain Syndrome	prostatitis Botox	null	1	arm 1: 300 IU botox	[ 0 ]	1	[ 0 ]	intervention 1: 300 units	intervention 1: Botox	1	Kingston \| Ontario \| Canada \| -76.48098 \| 44.22976	7	NCT00529386	6TERMINATED	2009-12-01	2006-01-01	Queen's University	7OTHER	false	false	false	null
[ 4 ]	16	RANDOMIZED	SINGLE_GROUP	0TREATMENT	1SINGLE	false	0ALL	true	Both malnutrition and inflammation are associated with death in dialysis patients and also with cardiovascular disease. The researchers are testing the idea that inflammation causes malnutrition by using a drug to suppress inflammation in hemodialysis patients to find out whether that will increase blood tests that are...	4.1 Pre-assignment measurements will include: 1. Patient is eligible for enrollment. 2. Complete physical examination. 3. Blood draw at initiation of hemodialysis session 4. Instruction on birth control methods required. 5. Subjects who are non-compliant with regard to medication compliance range or birth control requ...	Hypoalbuminemia	Inflammation albumin	null	2	arm 1: 1. 12 End stage renal disease (ESRD) patients on hemodialysis for at least 3 months 2. Serum C reactive protein level of ≥ 0.8 mg/dl 3. Serum albumin \< 3.8 g/dl (BCG) 4. Patients will receive 100mg Thalidomide for a period of 4 weeks; if somnolence tolerated, dosage is increased to 200mg nightly for a period of...	[ 1, 2 ]	2	[ 0, 10 ]	intervention 1: Thalidomide by mouth at night for a total of 24 weeks intervention 2: Placebo by mouth at night for a total of 24 weeks	intervention 1: Thalidomide intervention 2: Sugar pill	1	New York \| New York \| United States \| -74.00597 \| 40.71427	4	NCT00529633	6TERMINATED	2009-12-01	2007-09-01	George A. Kaysen, M.D.	7OTHER	false	false	false	null
[ 5 ]	23	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to determine the tissue kinetics of ertapenem in colonic tissue from three hours up to six hours (25% of dosing interval) after administration of ertapenem.	The purpose of this study is to determine the tissue kinetics of ertapenem in colorectal tissue from three hours up to six hours (25% of dosing interval) after administration of ertapenem before an elective surgical intervention (open or laparoscopic surgery) at the colon/rectum. Subjects are patients. Hospitalized pat...	Diverticulosis, Colonic Rectal Neoplasms Colonic Neoplasms		null	1	arm 1: Administration of 1 gram ertapenem I.V.	[ 0 ]	1	[ 0 ]	intervention 1: powder for infusion, 1 gram I.V., single dose over 30 min.	intervention 1: Ertapenem	1	Ulm \| N/A \| Germany \| 9.99155 \| 48.39841	20	NCT00535652	1COMPLETED	2009-12-01	2007-09-01	University of Ulm	7OTHER	false	false	false	null
[ 3, 4 ]	180	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	To investigate superiority of SPM 962 over placebo in early Parkinson's disease patients in a multi-center, placebo-controlled, double-blind study following once-daily multiple transdermal doses of SPM 962 within a range of 4.5 to 36.0 mg (12-week dose titration/maintenance period)	null	Early Parkinson's Disease	SPM 962 rotigotine Parkinson's disease monotherapy	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: transdermal application, 1 time per day intervention 2: transdermal application, 1 time per day	intervention 1: SPM 962 intervention 2: placebo	6	Chubu 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 Kyushu Region \| N/A \| Japan \| N/A \| N/A Tohoku Region \| N/A \| Japan \| N/A \| N/A	180	NCT00537485	1COMPLETED	2009-12-01	2007-09-01	Otsuka Pharmaceutical Co., Ltd.	4INDUSTRY	false	false	false	null
[ 4 ]	3,472	RANDOMIZED	FACTORIAL	1PREVENTION	2DOUBLE	false	0ALL	true	Diabetic retinopathy (DR) is an eye disease that can occur in people with diabetes and can cause poor vision or blindness. The Action to Control Cardiovascular Risk in Diabetes (ACCORD) study is examining the effect of various treatments on cardiovascular disease in people with diabetes. This current study will examine...	DR is the most common diabetic eye disease and is the leading cause of blindness in adults in the United States. It is caused by damage to the blood vessels of the retina, which is the light-sensitive outer layer of the eye. Retinal blood vessels are often affected by the high blood sugar levels associated with diabete...	Diabetic Retinopathy	Type 2 Diabetes Mellitus Cardiovascular Diseases	null	6	arm 1: A strategy of intensive glycemia treatment to HbA1c less than 6% arm 2: A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9% arm 3: A strategy of BP treatment for SBP less than 120 mm Hg arm 4: A strategy of BP treatment for SBP less than 140 mm Hg arm 5: Blinded fenofibrate + simvastatin 20-40 mg/d arm 6:...	[ 0, 1, 0, 1, 0, 2 ]	7	[ 0, 0, 0, 0, 0, 0, 0 ]	intervention 1: Multiple drugs including insulins and oral hypoglycemia agents for HbA1c less than 6% intervention 2: A strategy of glycemia drugs for HbA1c 7% - 7.9% intervention 3: A strategy of multiple BP agents to reduce SBP less than 120 mm Hg intervention 4: A strategy of BP drugs for SBP less than 140 mm Hg int...	intervention 1: Hypoglycemic Agents intervention 2: Standard glycemia control intervention 3: Intensive BP treatment intervention 4: Standard BP control intervention 5: Fenofibrate intervention 6: Simvastatin intervention 7: Placebo	7	Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997 New York \| New York \| United States \| -74.00597 \| 40.71427 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Memphis \| Tennessee \| United States \| -90.04898 \| 35.14953 Seattle \| Wash...	0	NCT00542178	1COMPLETED	2009-12-01	2003-10-01	National Heart, Lung, and Blood Institute (NHLBI)	0NIH	false	false	false	null
[ 2, 3 ]	32	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	Phase 1b, safety, pharmacokinetic, and efficacy, multicenter, dose-escalating Study of Imprime PGG™ Injection dosed in combination with Cetuximab and concomitant irinotecan therapy. Enrolled patients will have a confirmed diagnosis of recurrent or progressive colorectal carcinoma following treatment with a 5-fluorourac...	null	Recurrent Colorectal Carcinoma Progressive Colorectal Carcinoma	Colorectal Carcinoma Recurrent Progressive Cetuximab Irinotecan 5-Fluorouracil	null	6	arm 1: Treatment Arm 1 2.0 mg/kg Imprime PGG administered weekly with combination therapy of cetuximab and irinotecan. arm 2: Treatment Arm 1 4.0 mg/kg Imprime PGG administered weekly with combination therapy of cetuximab and irinotecan. arm 3: Treatment Arm 1 6.0 mg/kg Imprime PGG administered weekly with combination ...	[ 0, 0, 0, 0, 0, 0 ]	5	[ 2, 2, 2, 0, 2 ]	intervention 1: Infusion of 2mg/kg on Day 1 of each week for 6 weeks (one cycle) Number of Cycles: until progression or unacceptable toxicity develops. intervention 2: Infusion of 4mg/kg on Day 1 of each week for 6 weeks (one cycle). Number of Cycles: until progression or unacceptable toxicity develops. intervention 3:...	intervention 1: Imprime PGG 2 mg/kg intervention 2: Imprime PGG 4 mg/kg intervention 3: Cetuximab intervention 4: Irinotecan intervention 5: Imprime PGG 6mg/kg	2	Makati City \| N/A \| Philippines \| 121.03269 \| 14.55027 Manila \| N/A \| Philippines \| 120.9822 \| 14.6042	32	NCT00545545	1COMPLETED	2009-12-01	2007-10-01	HiberCell, Inc.	4INDUSTRY	false	false	false	null
[ 0 ]	16	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	This study is being done to see if reflux of stomach fluid might be a cause of chronic fluid in the ears. Our hypothesis is that treatment with an anti-reflux medication (lansoprazole) will increase the rate of resolution of chronic middle ear fluid in children.	This study is being done to see if reflux of stomach fluid might be a cause of fluid in the ears. Earlier studies have found pepsin or pepsinogen, a component of stomach fluid, in the middle ear fluid of many children with chronic middle ear fluid. Anti-reflux medicines called proton pump inhibitors (PPI) reduce the ac...	Otitis Media With Effusion	otitis media with effusion gastroesophageal reflux ear infection proton pump inhibitor	null	2	arm 1: Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months arm 2: Placebo SoluTab once daily for 2 months	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Prevacid SoluTab 15 mg daily by mouth for 2 months (patients weighing 10-30 kg),or Prevacid SoluTab 30 mg daily by mouth for 2 months (patients weighing \>30 kg) is the experimental arm. Placebo Solutabs will be given in the same dosage, frequency, and duration for the placebo arm. intervention 2: Place...	intervention 1: lansoprazole intervention 2: placebo	1	St Louis \| Missouri \| United States \| -90.19789 \| 38.62727	16	NCT00546117	1COMPLETED	2009-12-01	2007-10-01	Washington University School of Medicine	7OTHER	false	false	false	null
[ 4 ]	80	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	This 2 arm study will evaluate the efficacy of intravenous Mircera treatment for the correction of anemia in patients with chronic kidney disease who are on dialysis. Patients will be randomized to receive either Mircera 0.6 micrograms/kg i.v. every 2 weeks, or epoetin 3 times per week i.v. according to approved treatm...	null	Anemia		null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 0.6 micrograms/kg every 2 weeks intervention 2: As prescribed, iv, 3 times weekly	intervention 1: methoxy polyethylene glycol-epoetin beta [RO0503821, Mircera] intervention 2: Epoetin	7	Gyeonggi-do \| N/A \| South Korea \| 126.76917 \| 37.58944 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Sungnam \| N/A \| South Korea \| N/A \|...	131	NCT00546481	1COMPLETED	2009-12-01	2007-11-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null
[ 4 ]	402	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	This is a multicenter, double-blind, double-dummy, randomized, active-controlled study that will include an 8-day treatment period followed by a 1-week follow-up period in patients experiencing symptoms of an acute exacerbation of gouty arthritis.	null	Arthritis, Gouty		null	4	arm 1: None arm 2: None arm 3: None arm 4: None	[ 1, 0, 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: indomethacin 50 mg three times a day (TID) for 8 days. intervention 2: An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg two times a day (BID) for 7 days. intervention 3: An initial dose of celecoxib 400 m...	intervention 1: Indomethacin intervention 2: Celecoxib intervention 3: Celecoxib intervention 4: Celecoxib	81	Glendale \| Arizona \| United States \| -112.18599 \| 33.53865 Mesa \| Arizona \| United States \| -111.82264 \| 33.42227 Paradise Valley \| Arizona \| United States \| -111.94265 \| 33.53115 Peoria \| Arizona \| United States \| -112.23738 \| 33.5806 Roseville \| California \| United States \| -121.28801 \| 38.75212 San Diego \| Californi...	400	NCT00549549	1COMPLETED	2009-12-01	2008-02-01	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	4INDUSTRY	false	false	false	null
[ 4 ]	172	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The primary objective of the study was to evaluate the efficacy of Alfuzosin in comparison to Placebo on the detrusor Leak Point Pressure (LPP) in children and adolescents 2-16 years of age with elevated detrusor LPP of neuropathic etiology and detrusor LPP ≥ 40 cm H2O. Secondary objectives were: * To investigate the...	Patients who met the study entry criteria were randomized (2:1:2:1) to one of the 4 dosage groups (Alfuzosin 0.1 mg/kg/day, matching placebo 0.1 mg/kg/day, Alfuzosin 0.2 mg/mg/kg, matching placebo 0.2 mg/kg/day). Patients received their treatment using either solution or tablet formulation depending on age as follows:...	Neurogenic Urinary Bladder	child bladder neuropathic alpha blockers	null	3	arm 1: Matching placebo 0.1 mg/kg/day or 0.2 mg/kg/day arm 2: None arm 3: None	[ 2, 0, 0 ]	2	[ 0, 0 ]	intervention 1: Form: solution or tablet according to age Route: oral Dose: daily dose adjusted to body weight intervention 2: Form: matching solution or matching tablet according to age Route: oral Dose: daily dose adjusted to body weight	intervention 1: Alfuzosin intervention 2: Placebo	18	Bridgewater \| New Jersey \| United States \| -74.64815 \| 40.60079 Sofia \| N/A \| Bulgaria \| 23.32415 \| 42.69751 Laval \| N/A \| Canada \| -73.692 \| 45.56995 Tallinn \| N/A \| Estonia \| 24.75353 \| 59.43696 Paris \| N/A \| France \| 2.3488 \| 48.85341 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Mumbai \| N/A \| India \| 72.88261 \| 19....	169	NCT00549939	1COMPLETED	2009-12-01	2007-10-01	Sanofi	4INDUSTRY	false	false	false	null
[ 3 ]	26	NON_RANDOMIZED	SINGLE_GROUP	1PREVENTION	0NONE	false	0ALL	false	This study is designed to collect additional pharmacokinetic and safety data of voriconazole in immunocompromised adolescents receiving intravenous and oral voriconazole. This will help establish voriconazole dosing recommendations for adolescents.	null	Pharmacokinetics	pharmacokinetics and safety data of voriconazole in immunocompromised adolescents	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Voriconazole will be used for prophylaxis purpose. 6 mg/kg IV q12h on the first day (Day 1) and 4 mg/kg IV q12h for at least 5.5 days. The IV treatment is no more than 20 days. Then switch to 300 mg oral tablets q12h for at least 6.5 days. The total treatment duration is no more than 30 days.	intervention 1: Voriconazole	9	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 New Orleans \| Louisiana \| United States \| -90.07507 \| 29.95465 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Nashville \| Tennessee \|...	48	NCT00556998	1COMPLETED	2009-12-01	2008-06-01	Pfizer	4INDUSTRY	false	false	false	null
[ 4 ]	339	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This study will compare insulin lispro protamine suspension (ILPS) and insulin glargine in combination with the patient's oral diabetes medications and exenatide, for their ability to control blood sugar in patients with type 2 diabetes.	null	Diabetes Mellitus, Type 2		null	2	arm 1: Insulin Lispro Protamine Suspension (ILPS) arm 2: Insulin Glargine	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: Administered subcutaneously once a day at bedtime intervention 2: Administered subcutaneously once a day at bedtime	intervention 1: Insulin Lispro Protamine Suspension intervention 2: Insulin Glargine	52	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Concord \| California \| United States \| -122.03107 \| 37.97798 Escondido \| California \| United States \| -117.08642 \| 33.11921 Fresno \| California \| United States \| -119.77237 \| 36.74773 Modesto \| California \| United States \| -120.99688 \| 37.6391 Orange \| Californi...	337	NCT00560417	1COMPLETED	2009-12-01	2007-11-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null
[ 3 ]	242	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	Study is to investigate the use of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scale in a cervical dystonia population treated with botulinum toxin type A, and placebo.	null	Cervical Dystonia		null	4	arm 1: Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments. arm 2: Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments. arm 3: Intramuscular injections of the assigned study medi...	[ 1, 1, 5, 5 ]	3	[ 2, 2, 0 ]	intervention 1: Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments. intervention 2: Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments. intervention 3: Intramuscular injections...	intervention 1: botulinum toxin type A intervention 2: botulinum toxin type A Formulation 2 intervention 3: Normal Saline	16	Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Halifax \| Nova Scotia \| Canada \| -63.57688 \| 44.64269 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Mumbai \| N/A \| India \| 72.88261 \| 19.07283 Manila \| N/A \| P...	241	NCT00564681	1COMPLETED	2009-12-01	2007-12-01	Allergan	4INDUSTRY	false	false	false	null
[ 2, 3 ]	22	RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	There is strong scientific rationale for exploring the role of sorafenib with capecitabine and cisplatin (XP) in AGC. XP is a new standard of care in AGC and sorafenib is a novel signal transduction inhibitor that prevents tumor cell proliferation and angiogenesis through blockade of the Raf/MEK/ERK pathway at the leve...	null	Advanced Gastric Cancer	Gastric cancer capecitabine cisplatin sorafenib phase I phase II	null	2	arm 1: XP+sorafenib arm 2: XP	[ 0, 2 ]	1	[ 0 ]	intervention 1: Capecitabine ( ) mg/m2 bid D1-D15 Cisplatin 80 mg/m2 D1 Sorafenib ( ) mg bid PO daily every 3 weeks	intervention 1: Capecitabine, Cisplatin, Sorafenib	1	Seoul \| N/A \| South Korea \| 126.9784 \| 37.566	21	NCT00565370	1COMPLETED	2009-12-01	2007-11-01	Asan Medical Center	7OTHER	false	false	false	null
[ 0 ]	5	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	We aim to study the efficacy of intravenous ceftriaxone in a four-week, inpatient, placebo-controlled, double-blind study, as an augmentation therapy in patients with bipolar disorder, currently depressed, who have failed to respond to conventional treatments.	null	Bipolar Depression	Ceftriaxone Acute Antidepressant Effects Glutamatergic System Double-Blind Mood Disorders Bipolar Disorder Depression Affective Disorders	null	2	arm 1: None arm 2: None	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks. intervention 2: Saline solution will be administered IV via midline, 7 days a week for 4 weeks.	intervention 1: ceftriaxone intervention 2: Saline solution	1	New Haven \| Connecticut \| United States \| -72.92816 \| 41.30815	5	NCT00566111	6TERMINATED	2009-12-01	2007-09-01	Yale University	7OTHER	false	false	false	null
[ 3 ]	20	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	1FEMALE	true	1. To evaluate the impact of ranolazine extended-release tablets in women with subendocardial ischemia due to microvascular endothelial dysfunction on myocardial ischemia (Cardiac Magnetic Resonance (CMR) extent, severity. 2. To evaluate the impact of ranolazine extended-release tablets in women with subendocardial isc...	Interested women will be considered for the study if they meet inclusion and exclusion criteria including review of baseline CMR, ECG and blood work (liver and kidney function). The baseline CMR must be completed within 12 months previous to enrollment. Eligible women with angina and CMR subendocardial perfusion abnor...	Myocardial Ischemia	Ranolazine Myocardial ischemia Double blinded Placebo controlled	null	2	arm 1: Participants first received study drug Ranexa, 500mg, orally twice daily for 2 weeks, assuming tolerance, followed by 1000mg orally twice daily for an additional 2 weeks. If the participant is unable to increase dose secondary to side effects, she will remain on 500mg twice daily for the second 2-week interval. ...	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: 500mg, orally twice daily for 2 weeks, assuming tolerance, followed by 1000mg orally twice daily for an additional 2 weeks. If the participant is unable to increase dose secondary to side effects, she will remain on 500mg twice daily for the second 2-week interval. intervention 2: Placebo, 500mg, orally...	intervention 1: Ranolazine intervention 2: Placebo	1	Los Angeles \| California \| United States \| -118.24368 \| 34.05223	40	NCT00570089	1COMPLETED	2009-12-01	2007-04-01	Cedars-Sinai Medical Center	7OTHER	false	false	false	null
[ 3 ]	155	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	The purpose of this study is to investigate the activity of MORAb-009 when added to a standard regimen of gemcitabine in patients with previously untreated unresectable stage 3 or 4 pancreatic cancer.	null	Pancreatic Cancer		null	2	arm 1: MORAb-009 plus gemcitabine ('MORAb-009'): MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxic...	[ 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Monoclonal antibody administered once weekly by intravenous injection. intervention 2: As per package insert. intervention 3: Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed...	intervention 1: MORAb-009 intervention 2: Placebo intervention 3: Gemcitabine	45	La Jolla \| California \| United States \| -117.2742 \| 32.84727 San Diego \| California \| United States \| -117.16472 \| 32.71571 San Diego \| California \| United States \| -117.16472 \| 32.71571 Vallejo \| California \| United States \| -122.25664 \| 38.10409 Southington \| Connecticut \| United States \| -72.8776 \| 41.59649 Torringt...	148	NCT00570713	1COMPLETED	2009-12-01	2007-12-01	Morphotek	4INDUSTRY	false	false	false	null

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