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	METADATA_wilson_lower_bound float32
[ 4 ]	672	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	1FEMALE	true	The purpose of the study is to compare the progression-free survival (PFS) of the combination of trabectedin + DOXIL with DOXIL monotherapy in patients with ovarian cancer.	This is a multicenter, open-label (all people know the identity of the intervention), randomized (study medication is assigned by chance), Phase 3 study comparing the combination of trabectedin + DOXIL with DOXIL monotherapy in patients with advanced ovarian cancer (who were previously treated and for whom first-line p...	Ovarian Cancer	Ovarian cancer Trabectedin Yondelis Advanced Relapsed Ovarian Cancer DOXIL CAELYX	null	2	arm 1: Combination arm - Trabectedin + DOXIL: DOXIL 30 mg/m2 intravenous (IV) infusion over 90 minutes + trabectedin 1.1 mg/m2 IV infusion over 3 hours every 3 weeks. patients will be premedicated with 20 mg dexamethasone or its equivalent IV infusion over 30 minutes prior to the DOXIL infusion. arm 2: Monotherapy arm ...	[ 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Type=exact number, unit=mg/m2, number=1.1, form=solution, route=IV. Trabectedin will be administered over 3 hours every 3 weeks. intervention 2: Type=exact number, unit=mg/m2, number=30, 50, form=solution, route=IV. DOXIL will be administered over 90 minutes every 4 weeks when administered alone (monoth...	intervention 1: Trabectedin intervention 2: DOXIL intervention 3: Dexamethasone	111	Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Newport Beach \| California \| United States \| -117.92895 \| 33.61891 Orange \| California \| United States \| -117.85311 \| 33.78779 Englewood \| Col...	663	NCT00113607	1COMPLETED	2010-11-01	2005-04-01	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	4INDUSTRY	false	false	false	null	0
[ 5 ]	115	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	This study will determine whether modafinil (Provigil®), a medication approved for the treatment of narcolepsy, is effective in reducing fatigue in adults with HIV/AIDS.	Fatigue is a common problem for many people with HIV/AIDS, interfering with daily activities and serving as a significant barrier to working among those whose health is otherwise stable or restored by antiretroviral (ARV) medication. Fatigue in HIV is associated with disability and diminished quality of life. It may be...	HIV Infections Fatigue	HIV AIDS Modafinil Depression	null	2	arm 1: Participants will take modafinil for 4 weeks. arm 2: Participants will take placebo for 4 weeks.	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 50 mg per day, increasing to 200 mg per day as clinically indicated intervention 2: 50 mg per day, increasing to 200 mg per day as clinically indicated	intervention 1: Modafinil intervention 2: Placebo	1	New York \| New York \| United States \| -74.00597 \| 40.71427	115	NCT00118378	1COMPLETED	2010-11-01	2004-12-01	New York State Psychiatric Institute	7OTHER	false	false	false	null	0
[ 4 ]	476	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	This study investigated the safety and efficacy of 400mg Versus 800mg imatinib in patients with newly diagnosed, previously untreated chronic myeloid leukemia in chronic phase (CML-CP) using molecular endpoints.	null	Leukemia, Myeloid, Chronic Phase	CML Philadelphia positive Bcr-abl imatinib mesylate Chronic myeloid leukemia (CML) in chronic phase	null	2	arm 1: Oral dose of 400mg Imatinib once daily. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol. arm 2: Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) ...	[ 0, 0 ]	1	[ 0 ]	intervention 1: Imatinib is packaged in bottles as 100mg and 400mg tablets	intervention 1: Imatinib mesylate	75	Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Berkeley \| California \| United States \| -122.27275 \| 37.87159 Berkeley \| California \| United States \| -122.27275 \| 37.87159 Campbell \| California \| United States \| -121.94996 \| 37.28717 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Denver \| Colo...	473	NCT00124748	6TERMINATED	2010-11-01	2005-06-01	Novartis Pharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 3 ]	344	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This is an open label, randomized, controlled, multicenter phase II study comparing 5-FU/FA + oxaliplatin (FOLFOX-4) + cetuximab versus 5-FU/FA + oxaliplatin as first-line treatment for epidermal growth factor receptor (EGFR)-expressing mCRC.	null	Neoplasm Metastasis Colorectal Cancer	FOLFOX-4 Cetuximab First-line mCRC EGFR positive metastatic CRC	null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 2, 0 ]	intervention 1: Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin folinic acid (FA) will be administered (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks)...	intervention 1: Cetuximab intervention 2: Oxaliplatin	78	Graz \| N/A \| Austria \| 15.45 \| 47.06667 Linz \| N/A \| Austria \| 14.28611 \| 48.30639 Salzburg \| N/A \| Austria \| 13.04399 \| 47.79941 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Zams \| N/A \| Austria \| 10.5897 \| 47.15844 Antwerp \| N/A \| Belgium \| 4.40026 \| 51.22047 Bonheiden \| N/A \| Belgium \| 4.54714 \| 51.02261 Bruges \| N/...	338	NCT00125034	1COMPLETED	2010-11-01	2005-07-01	Merck KGaA, Darmstadt, Germany	4INDUSTRY	false	false	false	null	0
[ 3 ]	33	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	false	RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sometimes when chemotherapy is given, it does not stop the growth of tumor cells. The tumor is said to be resistant to chemotherapy. Giving ...	OBJECTIVES: * Determine the response in patients with stage IVB, recurrent, or persistent cervical cancer treated with isotretinoin, interferon alpha-2b, and paclitaxel. OUTLINE: This is a multicenter study. Patients receive oral isotretinoin and interferon alpha-2b subcutaneously once daily on days 1-4 and paclitax...	Cervical Cancer	recurrent cervical cancer stage IVB cervical cancer	null	1	arm 1: * Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle * Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle * Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days	[ 0 ]	3	[ 2, 0, 0 ]	intervention 1: Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle intervention 2: Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle intervention 3: Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days	intervention 1: recombinant interferon alpha-2b intervention 2: isotretinoin intervention 3: paclitaxel	6	Hamilton \| New Jersey \| United States \| -74.08125 \| 40.20706 Morristown \| New Jersey \| United States \| -74.48154 \| 40.79677 New Brunswick \| New Jersey \| United States \| -74.45182 \| 40.48622 New Brunswick \| New Jersey \| United States \| -74.45182 \| 40.48622 Newark \| New Jersey \| United States \| -74.17237 \| 40.73566 Phila...	33	NCT00138151	6TERMINATED	2010-11-01	2001-03-01	University of Medicine and Dentistry of New Jersey	7OTHER	false	false	false	null	0
[ 4 ]	75	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	This study will determine the effectiveness of three different drug therapies in treating the symptoms of mania.	Mania is a serious condition characterized by extreme excitement, mental and physical hyperactivity, insomnia, and disconnected thoughts. Symptoms of mania are common in patients with schizophrenia or bipolar disorder. When associated with these conditions, mania reaches psychotic proportions and often includes halluci...	Bipolar Disorder Schizophrenia	Mania Manic-depressive Psychotic disorder	null	3	arm 1: Participants will receive divalproex ER at a therapeutic dose, plus placebo arm 2: Participants will receive divalproex ER at a therapeutic dose, plus quetiapine up to 800 mg arm 3: Participants will receive divalproex ER at a therapeutic dose, plus lithium at a therapeutic blood level	[ 2, 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks. intervention 2: Extended release lithium will be provided in 300 mg capsules. Participants will be dosed to a therapeutic blood level of lithium from ...	intervention 1: Divalproex-extended release (DVP-ER) intervention 2: Lithium intervention 3: Quetiapine	1	Palo Alto \| California \| United States \| -122.14302 \| 37.44188	75	NCT00183443	1COMPLETED	2010-11-01	2005-02-01	Palo Alto Veterans Institute for Research	7OTHER	false	false	false	null	0
[ 3 ]	76	RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	true	RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread...	This trial began as a 2-arm study with a docetaxel-alone arm. When bevacizumab became widely available, it was converted to a 1-arm open-label trial of docetaxel/bevacizumab. Patients enrolled in the docetaxel-alone arm were permitted to cross over to docetaxel/bevacizumab. Patients received bevacizumab 15 mg/kg and do...	Breast Cancer	stage IV breast cancer recurrent breast cancer	null	2	arm 1: docetaxel: 75 mg/m2 IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent. Bevacizumab: 15 mg/kg IV every 3 weeks. Subjects continue on study until disease progression, unacceptable toxicity, or withdrawal of patient consent. ...	[ 0, 1 ]	2	[ 2, 0 ]	intervention 1: Patients receive bevacizumab 15 mg/kg intravenously (I.V.) every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. intervention 2: docetaxel: 75 mg/m2 IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal o...	intervention 1: bevacizumab intervention 2: Docetaxel	1	Los Angeles \| California \| United States \| -118.24368 \| 34.05223	74	NCT00217672	1COMPLETED	2010-11-01	2005-05-01	Translational Oncology Research International	7OTHER	false	false	false	null	0
[ 3 ]	30	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide and gemtuzumab ozogamicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. PURPOSE: This phase II tr...	OBJECTIVES: Primary * Determine the efficacy of arsenic trioxide and gemtuzumab ozogamicin to achieve complete and partial remissions in patients with advanced myelodysplastic syndromes. Secondary * Determine the efficacy of this regimen, in terms of 50% decrease in Red Blood Cell (RBC) transfusion requirements and...	Leukemia Myelodysplastic Syndromes	refractory anemia with excess blasts in transformation refractory anemia with excess blasts chronic myelomonocytic leukemia secondary acute myeloid leukemia previously treated myelodysplastic syndromes secondary myelodysplastic syndromes de novo myelodysplastic syndromes	null	1	arm 1: Arsenic Trioxide 0.25 mg/kg D1-5 Week 1/Twice Weekly W2-12 + Gemtuzumab Ozogamicin 3 mg/m\^2 D8 for 1 or 2 Cycles of 12 Weeks each	[ 0 ]	2	[ 0, 0 ]	intervention 1: Arsenic trioxide will be administered at a dose of 0.25 mg/kg/day IV over 1-2 hours for 5 consecutive days during the first week. Subsequently, arsenic trioxide will be given at a dose of 0.25mg/kg/day twice a week for 11 additional weeks (weeks 2-12). intervention 2: Gemtuzumab ozogamicin consists of a...	intervention 1: arsenic trioxide intervention 2: gemtuzumab ozogamicin	1	Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995	30	NCT00274781	1COMPLETED	2010-11-01	2004-02-01	The Cleveland Clinic	7OTHER	false	false	false	null	0
[ 3 ]	32	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	1FEMALE	false	This research study involves the anti-cancer medication trastuzumab and the investigational drug vinflunine. The purpose of this trials is to see if trastuzumab and vinflunine used in combination or vinflunine alone is effective in the treatment of metastatic breast cancer	If the tumor is HER2neu positive, eligible patients will receive trastuzumab and vinflunine intravenously (IV) every 3 weeks. If the tumor is HER2neu negative, eligible patients will receive vinflunine intravenously (IV) every 3 weeks. Patients whose cancer does not grow or decreases in size may continue to receive t...	Breast Neoplasms Breast Cancer	Breast Neoplasms Breast Cancer Vinflunine Vinca Alkaloid Javlor	null	2	arm 1: Vinflunine 320 mg/m2 intravenously day 1 over 20 minutes, repeated every 21 days arm 2: Vinflunine 280 mg/m2 every 21 days with trastuzumab administered with a loading dose of 8 mg/kg, followed by 6 mg/kg IV on day 1 of each subsequent cycle, repeated every 21 days. If no grade 3/4 adverse events were encountere...	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Novel second generation vinca alkaloid intervention 2: Anti-HER2 monoclonal antibody	intervention 1: Vinflunine intervention 2: Trastuzumab	10	Anniston \| Alabama \| United States \| -85.83163 \| 33.65983 Fort Myers \| Florida \| United States \| -81.84059 \| 26.62168 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Lakeland \| Florida \| United States \| -81.9498 \| 28.03947 Gainesville \| Georgia \| United States \| -83.82407 \| 34.29788 Alexandria \| Louisiana...	32	NCT00284180	1COMPLETED	2010-11-01	2006-01-01	SCRI Development Innovations, LLC	7OTHER	false	false	false	null	0
[ 3 ]	30	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Thalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. Giving bortezomib together with thalidomide may kill more cancer cells. PURPOSE: This phase II trial is studying how we...	OBJECTIVES: * Determine the antitumor efficacy of bortezomib and thalidomide in patients with newly diagnosed stage II or III multiple myeloma. * Determine the incidence and severity of peripheral motor/sensory neuropathy in patients treated with this regimen. * Assess the ability to mobilize and collect stem cells in...	Multiple Myeloma	stage II multiple myeloma stage III multiple myeloma	null	1	arm 1: The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide.	[ 0 ]	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: bortezomib intervention 2: thalidomide	1	Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038	30	NCT00287872	1COMPLETED	2010-11-01	2004-09-01	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	7OTHER	false	false	false	null	0
[ 4 ]	3	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	2MALE	true	This study will help determine if CoQ10 and prednisone, alone and as a combination decrease the decline in cardiopulmonary and skeletal muscle function that occurs in the wheelchair confined phase of DMD. Participants who are enrolled in this study should not have taken any corticosteroids within the last six months. T...	Duchenne muscular dystrophy (DMD) is the most common form of muscular dystrophy affecting 1:3500 male births worldwide. Despite an increase in our understanding of the disorder since the discovery and characterization of the causative gene and its product dystrophin in 1987, current therapeutic management remains large...	Duchenne Muscular Dystrophy	Muscular dystrophy Duchenne CoQ10 prednisone	null	4	arm 1: CoenzymeQ10 taken once a day each morning by mouth. arm 2: Prednisone taken once a day each morning by mouth arm 3: CoenzymeQ10 and prednisone each taken once a day in the morning by mouth. arm 4: Enhanced standard of care.	[ 1, 1, 1, 4 ]	2	[ 0, 7 ]	intervention 1: Prednisone 0/75 mg/kg/day. intervention 2: serum levels of greater or equal to 2.5 micrograms/mL.	intervention 1: Prednisone intervention 2: Coenzyme Q10	1	Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062	3	NCT00308113	6TERMINATED	2010-11-01	2007-04-01	Cooperative International Neuromuscular Research Group	5NETWORK	false	false	false	null	0
[ 2, 3 ]	100	null	SEQUENTIAL	0TREATMENT	0NONE	false	2MALE	true	This phase I/II trial is studying the side effects and best dose of ixabepilone and mitoxantrone hydrochloride when given together with prednisone and to see how well they work in treating patients with metastatic prostate cancer that did not respond to hormone therapy and chemotherapy. Drugs used in chemotherapy, such...	PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose (MTD) and dose-limiting toxicities of the combination of ixabepilone, mitoxantrone hydrochloride, and prednisone in patients with hormone-refractory metastatic prostate cancer that progressed during or after taxane-based chemotherapy. (Phase I) II. Assess the...	Adenocarcinoma of the Prostate Recurrent Prostate Cancer Stage IV Prostate Cancer		null	1	arm 1: Patients receive mitoxantrone hydrochloride IV over 30 minutes and ixabepilone IV over 3 hours on day 1 and oral prednisone twice daily on days 1-21. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity.	[ 0 ]	3	[ 0, 0, 0 ]	intervention 1: Given IV intervention 2: Given IV intervention 3: Given orally	intervention 1: mitoxantrone hydrochloride intervention 2: ixabepilone intervention 3: prednisone	2	San Francisco \| California \| United States \| -122.41942 \| 37.77493 Madison \| Wisconsin \| United States \| -89.40123 \| 43.07305	88	NCT00331344	1COMPLETED	2010-11-01	2006-04-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0
[ 0 ]	98	RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of the study is to help determine the appropriate dose of DepoDur for use in spinal surgery. The study will also assess the safety of this drug in this patient population.	Patients will be recruited from the general practices of Drs. Rechtine, Rubery, Molinari, and Zeidman. An epidural catheter will be placed under direct vision at the conclusion of surgery. The catheter will be advanced at least 4 cm to L1 level prior to injection. Two milliliters of air will be injected through the cat...	Lumbar Spine Surgery	Lumbar surgery Surgery L3-S1 DepoDur Post-operative pain Pain control Pain relief	null	2	arm 1: None arm 2: None	[ 0, 0 ]	1	[ 0 ]	intervention 1: An epidural catheter will be placed under direct vision at the conclusion of surgery. The catheter will be advanced at least 4cm to L1 level prior to injection. Two mililiters of air will be injected through the catheter to ensure patency. Aspiration will be done to ensure no intradural injections. Then...	intervention 1: DepoDur	1	Rochester \| New York \| United States \| -77.61556 \| 43.15478	98	NCT00335517	1COMPLETED	2010-11-01	2006-06-01	University of Rochester	7OTHER	false	false	false	null	0
[ 0 ]	18	NON_RANDOMIZED	PARALLEL	9OTHER	0NONE	true	0ALL	null	The purpose of this study is to learn more about why most patients with early stages of kidney disease have high blood pressure. We know the body produces natural substances that cause blood vessels to open wider to carry more blood when needed. An example is during exercise. Other natural substances cause blood vesse...	Enhanced adrenergic vascular reactivity may significantly contribute to hypertension and the excessive cardiovascular disease burden in patients with chronic kidney disease (CKD). Nitric oxide (NO), a modulator of neurovascular function, may be linked to adrenergic vascular responsiveness. The central HYPOTHESIS is tha...	Chronic Kidney Disease Hypertension	Blood Pressure Nitric Oxide L-NMMA Phenylephrine Vasoreactivity Blood Pressure	null	3	arm 1: None arm 2: None arm 3: None	[ 0, 1, 1 ]	1	[ 0 ]	intervention 1: None	intervention 1: Procedure: Regional phenylephrine arterial infusion	1	Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756	15	NCT00356265	6TERMINATED	2010-11-01	2006-07-01	University of Michigan	7OTHER	false	false	false	null	0
[ 3 ]	5	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Background: * Large granular lymphocyte (LGL) leukemia is a low-grade non-Hodgkin's lymphoma. * LGL is associated with low numbers of white blood cells (leading to recurring infections), red blood cells (causing anemia) and platelets (causing abnormal bleeding). * Cyclosporine (CSA) is an immunosuppressive drug that i...	Background: * LGL leukemia is a low grade non-Hodgkins Lymphoma characterized by tissue invasion of the marrow, spleen and liver * Recurrent infections due to chronic neutropenia and transfusion-dependent anemia are the principal causes for initiation of therapy * Approximately 50% of patients treated with cyclosporin...	Large Granular Lymphocytic Leukemia LGL Leukemia	Large Granular Lymphocyte (LGL) LGL Leukemia Cyclosporine Microarray Gene Expression Cyclosporin Large Granular Lymphocyte Leukemia LGL Leukemia	null	1	arm 1: Large Granular Lymphocyte Leukemia (LGL) is a low grade non-Hodgkins lymphoma characterized by tissue invasion of the marrow, spleen, and liver. Cyclosporine 5-10 mg/kg/day was administered as an oral preparation given every 12 hours. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml.	[ 0 ]	4	[ 0, 6, 6, 10 ]	intervention 1: An oral preparation given every 12 hours, 5-10 mg/kg/day in divided doses. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml. Levels will be checked twice weekly and once the patient has achieved steady state levels they shall be monitored once every 2 weeks. These therapeutic lev...	intervention 1: Cyclosporine intervention 2: Gene expression analysis intervention 3: Microarray analysis intervention 4: Laboratory biomarker analysis	1	Bethesda \| Maryland \| United States \| -77.10026 \| 38.98067	5	NCT00363779	6TERMINATED	2010-11-01	2006-06-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0
[ 5 ]	8,067	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	This study investigates if Celebrex has a lower incident of Gastrointestinal Events than other NSAIDS in subjects with osteoarthritis.	null	Osteoarthritis	GI events in patients with moderate GI risk treated with NSAIDS	null	2	arm 1: dosing as per USPI label arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: open-label intervention 2: dosing as per USPI label related to the chosen commercially marketed NSAID	intervention 1: Celecoxib intervention 2: Any commercially available NSAID with the indication for osteoarthritis	777	Abbeville \| Alabama \| United States \| -85.25049 \| 31.57184 Alexander City \| Alabama \| United States \| -85.95385 \| 32.94401 Bay Minette \| Alabama \| United States \| -87.77305 \| 30.88296 Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Birmingham \| Ala...	7,921	NCT00373685	1COMPLETED	2010-11-01	2006-10-01	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	4INDUSTRY	false	false	false	null	-0
[ 5 ]	250	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	true	0ALL	true	Low back pain (LBP) is the most frequent cause of sick leave and disability pension, and degenerative and osteoarthritic (OA) changes is a significant cause of pain and disability. Some indications exist for symptomatic and possible cartilage-structurmodifying effect on knee- and hip-osteoarthritis with glucosamine sul...	null	Low Back Pain	Chronic low back pain	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Oral intake of 1500 mg glucosamine sulfate(from Pharma Nord) daily for 6 months intervention 2: Oral intake of 3 placebo capsules (similiar looking to the glucosamine sulfate capsules)daily for 6 months	intervention 1: Glucosamine sulphate intervention 2: Placebo	1	Oslo \| Oslo County \| Norway \| 10.74609 \| 59.91273	250	NCT00404079	1COMPLETED	2010-11-01	2006-12-01	Ullevaal University Hospital	7OTHER	false	false	false	null	0
[ 3 ]	440	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	This study will determine whether acyclovir, a medicine used to treat herpes simplex virus 2 (HSV-2), can slow down the progression (worsening) of HIV disease in people with both HIV and HSV-2 infections. HSV-2 increases the amount of HIV virus in the blood of infected people and may make HIV progress faster. The study...	Interventions that slow HIV-1 disease progression among persons with CD4+ counts above 250 cells/microliter could postpone the need for antiretroviral therapy (ART) and prolong life-expectancy for HIV-infected persons. Herpes simplex virus type 2 (HSV-2) has been shown to up-regulate HIV-1 replication at the cellular l...	HIV Infections Herpes Genitalis	AIDS HIV Disease Progression Quality of Life HIV Viral Load Genital Ulcers HIV Treatment Naive	null	2	arm 1: None arm 2: None	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: 400mg twice daily for 24 months intervention 2: Placebo tablet twice daily for 24 months	intervention 1: Acyclovir intervention 2: Placebo	1	Kalisizo \| Rakai District \| Uganda \| 31.62139 \| -0.53639	440	NCT00405821	1COMPLETED	2010-11-01	2006-11-01	National Institute of Allergy and Infectious Diseases (NIAID)	0NIH	false	false	false	null	0
[ 4 ]	64	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The development of clots is a potentially deadly complication in many cancer patients. The current optimal treatment is unknown. Evidence supporting the effectiveness of the use of Inferior Vena Caval Filters is lacking. This study will compare the two standard of care treatment options: anticoagulation with or without...	The development of clots is a potentially deadly complication in many cancer patients. The current optimal treatment is unknown. Evidence supporting the effectiveness of the use of Inferior Vena Caval Filters is lacking. This study will compare the two standard of care treatment options: anticoagulation with or without...	Cancer Thromboembolism	Cancer thromboembolism	null	2	arm 1: Arixtra Alone arm 2: Arixtra + filter	[ 0, 1 ]	2	[ 0, 1 ]	intervention 1: Arixtra subq injection 5mg dose (dose also dependent upon size and age of pt) intervention 2: Arixtra as daily injections similar to arm I and placement of Inferior Vena Cava (IVC) filter.	intervention 1: Arixtra alone intervention 2: Arixtra + filter	1	Manhasset \| New York \| United States \| -73.69957 \| 40.79788	64	NCT00423683	6TERMINATED	2010-11-01	2007-01-01	Northwell Health	7OTHER	false	false	false	null	0
[ 3 ]	31	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The goal of this clinical research study is to learn if giving umbilical cord blood along with standard stem cells after high-dose chemotherapy will improve the response to a stem cell transplant. The safety of this treatment will also be studied.	Cord blood is a source of blood-forming cells that can be used for transplantation. Cord blood cells are taken from the umbilical cords of women who have given birth, and who have volunteered to donate their umbilical cord. Researchers hope that using cord blood before a stem cell transplant will help to reduce the ris...	Multiple Myeloma Leukemia Lymphoma	Multiple Myeloma Acute Myeloid Leukemia Myelodysplastic Syndrome Acute Lymphoblastic Leukemia Non-Hodgkin's Lymphoma Hodgkin's Lymphoma Chronic Lymphocytic Leukemia Cellular Therapy Umbilical Cord Blood Cells Cord Blood Transplantation Stem Cells Stem Cell Transplantation Allogeneic Hematopoietic Stem Cell Transplantat...	null	1	arm 1: Fludarabine 30 mg/m\^2 intravenous (IV) for 4 Days + Melphalan 140 mg/m\^2 IV for 1 Day + Rituximab 375 mg/m\^2 IV once weekly + Cord Blood Transplantation + Stem Cell Transplantation Infusion	[ 0 ]	5	[ 0, 0, 3, 0, 10 ]	intervention 1: 30 mg/m\^2 by vein for 4 Days (Day -10 through Day -7). intervention 2: 140 mg/m\^2 by vein for 1 Day (Day -7). intervention 3: 1 UCB Unit by vein on Day -5. intervention 4: 375 mg/m\^2 by vein once weekly (Days -7, -1, +7, +14) for 4 Weeks (if appropriate). intervention 5: Infusion of blood stem cells ...	intervention 1: Fludarabine intervention 2: Melphalan intervention 3: Umbilical Cord Blood intervention 4: Rituximab intervention 5: Peripheral Blood Stem Cell Infusion	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	30	NCT00427557	1COMPLETED	2010-11-01	2006-10-01	M.D. Anderson Cancer Center	7OTHER	false	false	false	null	0
[ 3 ]	168	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Primary Objectives: 1. To determine the efficacy of administering multiple doses of intravenous (i.v.) busulfan at a dose of 130 mg/m2, to yield a systemic plasma drug exposure represented by a daily area under the plasma concentration versus time curve (AUC) of approximately 5,000 mMol-min for 4 days, followed by i.v...	Busulfan and melphalan are both traditional alkylating agents that are designed to interfere with the production of cancer cells at the DNA (deoxyribonucleic acid) and RNA (ribonucleic acid) level. Before you can start treatment on this study, you will have what are called "screening tests". These tests will help the ...	Multiple Myeloma Lymphoma	Multiple Myeloma Hodgkin's Disease Non-Hodgkin's Lymphoma Leukemia Lymphoma Busulfan Melphalan Autologous bone marrow BMT Peripheral blood stem cell transplant PBSCT	null	1	arm 1: Busulfan 32 mg/m\^2 intravenous (IV) for 1 Day then 130 mg/m\^2 IV for 4 Days; and Melphalan 70 mg/m\^2 IV for 2 Days	[ 0 ]	2	[ 0, 0 ]	intervention 1: Test Dose = 32 mg/m\^2 IV for 1 Day; 130 mg/m\^2 IV for 4 Days intervention 2: 70 mg/m\^2 IV for 2 Days	intervention 1: Busulfan intervention 2: Melphalan	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	164	NCT00427765	1COMPLETED	2010-11-01	2004-12-01	M.D. Anderson Cancer Center	7OTHER	false	false	false	null	0
[ 4 ]	3,602	RANDOMIZED	FACTORIAL	0TREATMENT	1SINGLE	false	0ALL	true	The primary objectives of the trial are: 1. To establish the safety and efficacy of the use of bivalirudin (+ bail-out GP IIb/IIIa inhibitors) compared to the use of unfractionated heparin + GP IIb/IIIa inhibitors in patients with acute myocardial infarction undergoing a primary angioplasty strategy. 2. To establish t...	Prospective, 2 x 2 factorial single blind, randomized, multi-center trial of 3400 patients enrolled at up to 200 centers. Patients will be randomized 1:1 in the emergency room to a) anticoagulation with unfractionated heparin plus routine GP IIb/IIIa inhibition vs. b) bivalirudin and bail-out GP IIb/IIIa inhibition. Fo...	Myocardial Infarction	Myocardial Infarction Angioplasty Myocardial Ischemia Myocardial Reperfusion Stents Heart Disease	null	2	arm 1: To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angiopl...	[ 1, 1 ]	4	[ 0, 0, 1, 1 ]	intervention 1: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room). intervention 2: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room). intervention 3: Uncoated bare metal stent intervention 4: slow...	intervention 1: Bivalirudin intervention 2: Unfractionated heparin intervention 3: Bare metal stent intervention 4: Paclitaxel-eluting stent	1	Greensboro \| North Carolina \| United States \| -79.79198 \| 36.07264	6,608	NCT00433966	1COMPLETED	2010-11-01	2005-03-01	Cardiovascular Research Foundation, New York	7OTHER	false	false	false	null	0
[ 3 ]	39	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This phase II trial is studying how well dasatinib works in treating patients with stage III melanoma that cannot be removed by surgery or stage IV melanoma. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.	PRIMARY OBJECTIVES: I. Determine the objective response rate in patients with stage III unresectable or stage IV melanoma treated with dasatinib. II. Determine the progression-free survival of patients treated with this drug. SECONDARY OBJECTIVES: I. To assess the expression of targets of Dasatinib prior to treatme...	Recurrent Melanoma Stage IIIA Melanoma Stage IIIB Melanoma Stage IIIC Melanoma Stage IV Melanoma		null	1	arm 1: Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	[ 0 ]	1	[ 0 ]	intervention 1: None	intervention 1: dasatinib	2	New Haven \| Connecticut \| United States \| -72.92816 \| 41.30815 Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997	39	NCT00436605	1COMPLETED	2010-11-01	2006-12-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0
[ 3 ]	33	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	This study will evaluate the safety and effectiveness of a new drug called lenalidomide (Revlimid) for treating patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) who relapsed after their initial treatment. Patients 21 years of age and older with CLL or SLL who have previously receiv...	There is evidence that lenalidomide has single agent activity in chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL). Optimal dosing of lenalidomide in CLL has not been established yet. A pilot clinical trial in CLL studied single agent lenalidomide cycled every 4 weeks with 25 mg for three weeks on and...	Chronic Lymphocytic Leukemia (CLL) Small Lymphocytic Lymphoma	Monoclonal Antibody Therapy Biologic Response Modifier Therapy CLL SLL chemo-care (CC) 5013- Revlimid Chronic Lymphocytic Leukemia Small Lymphocytic Leukemia	null	1	arm 1: Lenalidomide regimen testing to determine efficacy for CLL/ SLL subjects	[ 0 ]	1	[ 0 ]	intervention 1: Lenalidomide (Revlimid) regimen testing to determine efficacy for SLL/ CLL subjects	intervention 1: Lenalidomide	1	Bethesda \| Maryland \| United States \| -77.10026 \| 38.98067	33	NCT00439231	1COMPLETED	2010-11-01	2007-02-01	Georg Aue, M.D.	0NIH	false	false	false	null	0
[ 3 ]	24	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	RATIONALE: Sunitinib 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. PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with locally recurrent or metastatic kidney cancer.	OBJECTIVES: Primary * Determine the efficacy of sunitinib malate in patients with locally recurrent or metastatic papillary renal cell carcinoma. OUTLINE: Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. A...	Kidney Cancer	recurrent renal cell cancer stage IV renal cell cancer	null	1	arm 1: The treatment will include Sunitinib malate 50 mg self-administered orally, once daily in the evening, without regard to meals, for 4 consecutive weeks (28 days) followed by 2 weeks (14 days) off, to comprise a complete cycle of 6 weeks.	[ 0 ]	1	[ 0 ]	intervention 1: None	intervention 1: sunitinib malate	1	New York \| New York \| United States \| -74.00597 \| 40.71427	23	NCT00459875	1COMPLETED	2010-11-01	2007-03-01	Memorial Sloan Kettering Cancer Center	7OTHER	false	false	false	null	0
[ 3 ]	153	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This single arm study will evaluate the relationship between the skin toxicity of Tarceva in combination with gemcitabine, and survival, in patients with advanced and/or metastatic pancreatic cancer. All patients will receive gemcitabine 100mg/m2 i.v. weekly; Tarceva will be administered 100mg po per day. The anticipat...	null	Pancreatic Cancer		null	2	arm 1: Participants with a rash graded less than (\<) 2 according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version (v.) 3.0 received erlotinib, 100 milligrams (mg), orally (PO), once per day until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment....	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: 100 mg, PO, once per day intervention 2: 1000 mg/m2, IV, on Days 1, 8 and 15 in 4-week cycles	intervention 1: Erlotinib intervention 2: Gemcitabine	29	Alcoy \| Alicante \| Spain \| -0.47432 \| 38.70545 Elche \| Alicante \| Spain \| -0.70107 \| 38.26218 Palma de Mallorca \| Balearic Islands \| Spain \| 2.65024 \| 39.56939 Barcelona \| Barcelona \| Spain \| 2.15899 \| 41.38879 Barcelona \| Barcelona \| Spain \| 2.15899 \| 41.38879 Barcelona \| Barcelona \| Spain \| 2.15899 \| 41.38879 Barcelo...	153	NCT00461708	1COMPLETED	2010-11-01	2007-05-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0
[ 4 ]	100	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The primary objective of this clinical trial is to evaluate safety of switching from fondaparinux to either unfractionated heparin or bivalirudin for patients experiencing acute coronary syndrome undergoing percutaneous coronary angioplasty.	This is a prospective open label, randomized, multi-center registry. One hundred patients who received fondaparinux within the 24 hours prior to presentation to the coronary catheterization lab and who are suitable for percutaneous coronary intervention. The patients will be randomized in a 1:1 fashion to either unfrac...	Acute Coronary Syndromes		null	2	arm 1: Patients are switched from fondaparinux to heparin, receiving a dose of 60 U/Kg IV during the PCI arm 2: Patients switched from fondaparinux to bivalirudin, received a bolus of 0.75 mg/kg IV followed by infusion of 1.75 mg/g per hour infusion during the PCI.	[ 1, 1 ]	1	[ 0 ]	intervention 1: None	intervention 1: Switching from Fondaparinux to Bivalirudin or Unfractionated Heparin	7	Bridgeport \| Connecticut \| United States \| -73.18945 \| 41.17923 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Stony Brook \| New York \| United States \| -73.14094 \| 40.92565 Chapel Hill \| North Carolina \| United States \| -79.05584 \| 35...	100	NCT00464087	1COMPLETED	2010-11-01	2007-06-01	Medstar Health Research Institute	7OTHER	false	false	false	null	0
[ 3 ]	53	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	RATIONALE: Sunitinib 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. PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with metastatic, locally advanced, or locally recurrent sarcomas.	OBJECTIVES: Primary * Determine the response rate (complete response and partial response) in patients with metastatic, locally advanced, or locally recurrent non-gastrointestinal stromal tumor sarcomas treated with sunitinib malate. Secondary * Determine the 16- and 24-week progression-free survival rate (complete...	Adult Malignant Fibrous Histiocytoma of Bone Desmoid Tumor Endometrial Cancer Ovarian Cancer Sarcoma Small Intestine Cancer	chondrosarcoma recurrent osteosarcoma localized adult malignant fibrous histiocytoma of bone metastatic adult malignant fibrous histiocytoma of bone recurrent adult malignant fibrous histiocytoma of bone recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor recurrent Kaposi sarcoma recurrent uterine sarcom...	null	3	arm 1: Vascular connective tissue neoplasms, leiomyosarcoma, dermatofibrosarcoma protuberans (DFSP), desmoid tumors. Sunitinib 37.5 mg daily continuously; one cycle is 28 days. Restaging: after every 2 cycles until after 6 cycles, when restaging will be decreased to once every 3 cycles. arm 2: High grade undifferentiat...	[ 0, 0, 0 ]	1	[ 0 ]	intervention 1: None	intervention 1: sunitinib malate	2	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 New York \| New York \| United States \| -74.00597 \| 40.71427	53	NCT00474994	1COMPLETED	2010-11-01	2007-04-01	Memorial Sloan Kettering Cancer Center	7OTHER	false	false	false	null	0
[ 3 ]	12	NON_RANDOMIZED	PARALLEL	7BASIC_SCIENCE	0NONE	false	2MALE	false	Silibinin has demonstrated anti-cancer activity in the laboratory for several different cancer types, including prostate cancer. Silibinin was originally obtained from milk thistle. Silybin-Phytosome, an oral form of silibinin, has been tested previously in prostate cancer patients to determine the safety of high-dose ...	Prostate cancer is the most common invasive malignancy and the second leading cause of cancer death in American males. In 2005, an estimated 230,000 men will be diagnosed and 30,000 will die from prostate cancer. The current estimated risk of developing prostate cancer is 1 in 6 men. Carcinogenesis and neoplastic progr...	Prostate Cancer	Prostate cancer	null	2	arm 1: Subjects in this group will take Silibin-Phytosome 13 grams daily, in three divided doses for 2-10 weeks. arm 2: Patients in this arm will not take any intervention.	[ 0, 4 ]	1	[ 0 ]	intervention 1: Subjects will take Silibin-Phytosome for 2-10 weeks. The dose of Silibin-Phytosome is 13 grams daily, in three divided doses. Patients will be asked to mix 1 level teaspoon and 1 heaping ¼ teaspoon of Silybin-Phytosome powder into 6 tablespoons of applesauce for each dose.	intervention 1: Silibin-Phytosome	1	Aurora \| Colorado \| United States \| -104.83192 \| 39.72943	12	NCT00487721	1COMPLETED	2010-11-01	2006-08-01	University of Colorado, Denver	7OTHER	false	false	false	null	0
[ 4 ]	458	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	Clinical trial of BAY43-9006 in patients with hepatocellular carcinoma.	null	Carcinoma, Hepatocellular	HCC Cancer Liver Cancer TACE	null	2	arm 1: Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity. arm 2: Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets...	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Multikinase Inhibitor; Sorafenib: 400mg bid of sorafenib intervention 2: Placebo: matching placebo	intervention 1: Sorafenib (Nexavar, BAY43-9006) intervention 2: Placebo	75	Nagoya \| Aichi-ken \| Japan \| 136.90641 \| 35.18147 Chiba \| Chiba \| Japan \| 140.11667 \| 35.6 Kashiwa \| Chiba \| Japan \| 139.97732 \| 35.86224 Matsuyama \| Ehime \| Japan \| 132.76574 \| 33.83916 Tōon \| Ehime \| Japan \| 132.89011 \| 33.79427 Fukui-shi \| Fukui \| Japan \| 136.22257 \| 36.06443 Fukuoka \| Fukuoka \| Japan \| 130.41667 \| ...	456	NCT00494299	1COMPLETED	2010-11-01	2006-04-01	Bayer	4INDUSTRY	false	false	false	null	0
[ 0 ]	69	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Primary Objectives: * To determine the effect of a single dose of Herceptin (trastuzumab) on the proliferation rate of Her-2/neu over-expressing ductal carcinoma in situ (DCIS) * To evaluate the effect of a single dose of Herceptin on the apoptotic index of Her-2/neu over-expressing DCIS	Herceptin (Trastuzumab) stops or slows the growth of certain breast cancer cells by blocking the chemical signals they need to grow. As part of your standard care for DCIS, you will have a complete routine physical exam, a mammogram of both breasts, and blood (about 2 tablespoons) will be drawn for routine tests. Some...	Ductal Carcinoma In Situ	Ductal Carcinoma In Situ Breast Cancer Herceptin Trastuzumab DCIS	null	1	arm 1: 8 mg/kg intravenously (IV) Over 90 Minutes	[ 0 ]	1	[ 0 ]	intervention 1: 8 mg/kg IV Over 90 Minutes	intervention 1: Herceptin (Trastuzumab)	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	69	NCT00496808	1COMPLETED	2010-11-01	2005-03-01	M.D. Anderson Cancer Center	7OTHER	false	false	false	null	0
[ 3 ]	23	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	false	The goal of this clinical research study is to find out if the combination of paclitaxel and carboplatin chemotherapy can shrink or slow the growth of mixed mullerian tumors (MMMT) of the uterus.	Before treatment starts, patients will have a complete check-up, blood tests, a chest x-ray, and a CT scan. Other scans or tests will be done as needed. Women able to have children must have a negative urine pregnancy test. A blood sample will be taken for routine testing once a week during treatment and a month after ...	Mixed Tumor, Mullerian	Uterine Neoplasms Endometrial Cancer Paclitaxel Taxol Carboplatin Paraplatin Malignant Mixed Mullerian Tumors MMMT Immunohistochemical markers	null	1	arm 1: Paclitaxel 175 mg/m\^2 intravenously (IV) over 3 hours and Carboplatin AUC 5 IV over 1 hour every 21 Days for 6 courses.	[ 0 ]	2	[ 0, 0 ]	intervention 1: AUC 5 By Vein Over 1 Hour Every 21 Days for 6 Courses intervention 2: 175 mg/m\^2 By Vein Over 3 Hours Every 21 Days for 6 Courses	intervention 1: Carboplatin intervention 2: Paclitaxel	4	Loma Linda \| California \| United States \| -117.26115 \| 34.04835 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Houston \| Texas \| United States \| -95.36327 \| 29.76328	23	NCT00502203	1COMPLETED	2010-11-01	2001-08-01	M.D. Anderson Cancer Center	7OTHER	false	false	false	null	0
[ 2, 3 ]	158	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this Phase 1/2 study is to evaluate the efficacy and safety of treatment with VELCADE, dexamethasone, and Revlimid® (VDR) as well as VELCADE, dexamethasone, cyclophosphamide, and Revlimid (VDCR) in patients with multiple myeloma who have received no prior treatment. This study will evaluate whether the a...	null	Multiple Myeloma	Treatment for patients with multiple myeloma who have received no prior treatment	null	4	arm 1: VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide) arm 2: VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide) arm 3: VELCADE (bortezomib), dexamethasone, cyclophosphamide arm 4: Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide	[ 0, 0, 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: bortezomib 1.3 mg/m\^2 given via IV on days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on days 1, 8, 15 and 22 of a 6-week cycle for 4 cycles (maintenance). intervention 2: dexamethasone 40 mg orally on days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop intervention 3: cyclophosphamid...	intervention 1: VELCADE (bortezomib) intervention 2: dexamethasone intervention 3: cyclophosphamide intervention 4: Revlimid (lenalidomide)	2	Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163	158	NCT00507442	1COMPLETED	2010-11-01	2007-08-01	Millennium Pharmaceuticals, Inc.	4INDUSTRY	false	false	false	null	0
[ 0 ]	90	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The investigators are conducting a study of asthma patients who use fluticasone with salmeterol (Advair) or any other combination of an inhaled corticosteroid (ICS) and a long acting beta agonist (LABA) to manage their asthma symptoms. Participants begin the study by continuing to use fluticasone with salmeterol or su...	Beta 2 (b2) agonists are the most common type of bronchodilator used to treat asthma. Beta 2 (b2) agonists are agents that bind to b2 receptors and cause muscle relaxation of the airways. There are different variants of the gene (genotypes) that influence how b2 agonists perform among the population. A recent study de...	Asthma	asthma beta agonist bronchodilator pulmonary genotype pharmacogenomics corticosteroid allergy immunology	null	4	arm 1: Asthma patients with the Arg/Arg genotype who are randomized to continue the combination therapy of a specific long-acting beta 2 agonist (salmeterol) and inhaled corticosteroid (fluticasone) in the form of Advair HFA. arm 2: Asthma patients with the Gly/Gly genotype who are randomized to continue the combinatio...	[ 1, 1, 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Fluticasone 45mcg, 115mcg, or 230mcg with salmeterol 21mcg, via HFA device, 2 puffs every 12 hrs, over 16 week study period. intervention 2: Fluticasone HFA alone at 44mcg, 110mcg or 220 mcg 2 puffs every 12 hrs, over 16 week study period. intervention 3: Primary as-needed rescue medication in all treat...	intervention 1: Fluticasone with salmeterol intervention 2: Fluticasone HFA intervention 3: Ipratropium HFA intervention 4: Albuterol HFA	3	Hackensack \| New Jersey \| United States \| -74.04347 \| 40.88593 New York \| New York \| United States \| -74.00597 \| 40.71427 New York \| New York \| United States \| -74.00597 \| 40.71427	61	NCT00521222	1COMPLETED	2010-11-01	2007-06-01	Columbia University	7OTHER	false	false	false	null	0
[ 3 ]	22	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Primary objective: * To determine the safety of adback T- or Natural Killer (NK) cells in patients with lymphoid malignancies receiving allogeneic stem cell transplantation with Campath-IH containing conditioning regimen. Secondary objective: * To determine the efficacy (disease-free-survival) of this strategy.	NK Cells, T-Cells, and the Study Drugs: NK and T-cells from a donor may decrease the risk of relapse (reappearance of disease) after stem cell transplantation. NK cells and T-cells are kinds of white blood cells. Both types of cells have the ability to fight infection and "kill" tumor cells in the body. NK cells are c...	Lymphoma Leukemia	Lymphoma Leukemia B-Cell Lymphoid Malignancies CLL Cll/Small Lymphocytic Lymphoma Follicular Lymphoma Mantle Cell Lymphoma Diffuse Large Cell Lymphoma Splenic Lymphoma MALT Lymphoplasmacytic Lymphoma Burkitt's Lymphoma ARA-C BCNU Campath-1H Cytoxan Etoposide Fludarabine Melphalan Rituximab Allogeneic Stem Cell Transpla...	null	1	arm 1: Possible Cell Adback - infusion NK cells or T-cells from donor given after blood stem cell transplantation for either Reduced intensity chemotherapy of campath, modified BEAM regimen of Campath-IH 15 mg intravenous (IV) Daily for 3 Days + BEAM Daily for 4 days (BCNU 300 mg/m\^2 IV, Etoposide 100 mg/m\^2 IV, Ara-...	[ 0 ]	13	[ 0, 0, 0, 0, 0, 0, 0, 0, 10, 4, 0, 0, 3 ]	intervention 1: 100 mg/m\^2 IV Daily Over 1 Hour for 4 Days intervention 2: 300 mg/m\^2 IV Over 1 Hour for 1 Day intervention 3: 15 mg IV Daily Over 30 Minutes for 3 Days intervention 4: 1000 mg/m\^2 IV Daily Over 1 Hour for 3 Days intervention 5: 100 mg/m\^2 IV Daily Over 3 Hours for 4 Days intervention 6: 30 mg/m\^2 ...	intervention 1: ARA-C intervention 2: BCNU intervention 3: Campath-1H intervention 4: Cyclophosphamide intervention 5: Etoposide intervention 6: Fludarabine intervention 7: Melphalan intervention 8: Rituximab intervention 9: Allogeneic Stem Cell Transplantation intervention 10: Total body radiation (TBI) intervention 1...	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	22	NCT00536978	1COMPLETED	2010-11-01	2007-09-01	M.D. Anderson Cancer Center	7OTHER	false	false	false	null	0
[ 3 ]	6	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	Self-Injurious Behavior (SIB) is a dangerous and common symptom in Borderline Personality Disorder (BPD) patients. Approximately 70% of patients with BPD engage in SIB at some point, compared to 17.5% of patients with other personality disorders. While SIB may prompt unnecessary psychiatric hospitalizations, it may als...	Investigators have withdrawn study due to poor subject compliance. After 3 consecutive participants were either unable to complete all 6 weeks of the study or dropped out of the DBT program, a decision was reached to discontinue recruitment and study was terminated.	Borderline Personality Disorder Self-Injurious Behavior	Borderline Personality Disorder(BPD) Dialectical Behavioral Therapy (DBT) glutamate N-Acetylcysteine Borderline Personality Disorder with Self-Injurious Behavior	null	2	arm 1: Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose (3000 mg daily), in addition to the medication regimen they are on at enrollment arm 2: Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the...	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 3000 mg PO (1200 mg AM, 1800 mg PM), 6 weeks intervention 2: placebo, 2 capsules PO AM, 3 capsules PO PM, 6 weeks	intervention 1: N-Acetylcysteine intervention 2: placebo	1	New Haven \| Connecticut \| United States \| -72.92816 \| 41.30815	5	NCT00539188	6TERMINATED	2010-11-01	2007-09-01	Yale University	7OTHER	false	false	false	null	0
[ 4 ]	889	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva, compared with placebo, following platinum-based chemotherapy in patients with advanced, recurrent, or metastatic NSCLC who have not had disease progression or unacceptable toxicity during chemotherapy. Following 4 cycles of platinum-b...	null	Non-Small Cell Lung Cancer		null	2	arm 1: Participants received erlotinib, 150 milligrams (mg), orally (PO), daily from randomization until progressive disease (PD), death, or unacceptable toxicity. arm 2: Participants received a placebo, PO, daily, from randomization until PD, death, or unacceptable toxicity.	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 150mg po daily intervention 2: po daily	intervention 1: erlotinib [Tarceva] intervention 2: Placebo	133	St Leonards \| New South Wales \| Australia \| 151.19836 \| -33.82344 Waratah \| New South Wales \| Australia \| 151.72647 \| -32.90667 Brisbane \| Queensland \| Australia \| 153.02809 \| -27.46794 Adelaide \| South Australia \| Australia \| 138.59863 \| -34.92866 East Bentleigh \| Victoria \| Australia \| N/A \| N/A Fitzroy \| Victoria \| ...	878	NCT00556712	1COMPLETED	2010-11-01	2006-01-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0
[ 4 ]	546	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	The main objective of the study was to evaluate the effectiveness of aflibercept treatment by comparison to placebo in increasing the overall survival (OS) in participants with metastatic pancreatic cancer, treated with gemcitabine. The secondary objectives were to evaluate progression free survival, clinical benefit,...	The study included: * A screening visit of up to 21 days prior to randomization * Randomization at baseline * A Treatment period (initiated within 3 days of randomization), which included 28-day treatment cycles in both arms until predefined treatment discontinuation criteria were met * A follow-up visit 30 days after...	Pancreatic Neoplasm	metastatic pancreatic cancer angiogenesis inhibitor gemcitabine	null	2	arm 1: Participants with metastatic pancreatic cancer administered Placebo and 1000 mg/m\^2 Gemcitabine. arm 2: Participants with metastatic pancreatic cancer administered 4 mg/kg Aflibercept and 1000 mg/m\^2 Gemcitabine.	[ 2, 0 ]	3	[ 0, 0, 0 ]	intervention 1: 4 mg/kg was administered intravenously (IV) over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle. intervention 2: 4 mg/kg was administered intravenously (IV) over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle intervention 3: 1000 mg/m\^2 administered IV over 30 minute...	intervention 1: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) intervention 2: Placebo intervention 3: Gemcitabine	24	Bridgewater \| New Jersey \| United States \| -74.64815 \| 40.60079 Buenos Aires \| N/A \| Argentina \| -58.37723 \| -34.61315 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Diegem \| N/A \| Belgium \| 4.43354 \| 50.89727 Sofia \| N/A \| Bulgaria \| 23.32415 \| 42.69751 Laval \| N/A \| Canada \| -73.692 \| 45.56995 Santiago \| N/A \| Chile \| ...	541	NCT00574275	6TERMINATED	2010-11-01	2007-12-01	Sanofi	4INDUSTRY	false	false	false	null	0
[ 0 ]	23	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This study will evaluate the efficacy, safety, and tolerability of topical Vashe™ Wound Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist versus 5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 day...	null	Burns	Burn Burn wound management Burn graft	null	2	arm 1: Vashe Wound Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days. arm 2: 5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.	[ 0, 1 ]	2	[ 1, 0 ]	intervention 1: Antimicrobial irrigant intervention 2: Antimicrobial solution	intervention 1: Vashe intervention 2: Mafenide acetate	1	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838	19	NCT00586729	1COMPLETED	2010-11-01	2009-07-01	Valleywise Health	7OTHER	false	false	false	null	0
[ 4 ]	99	NON_RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	To investigate the safety and efficacy of long-term administration of aripiprazole by performing extended administration of the treatment administered in the preceding multicenter, double-blind, placebo-controlled, parallel group-comparison trial of aripiprazole in patients with bipolar disorder experiencing a manic or...	null	Bipolar I Disorder		null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: oral, 24mg(4 tablets)/day intervention 2: oral, 0mg(4tablets)/day	intervention 1: Aripiprazole intervention 2: placebo	12	Hong Kong \| N/A \| China \| 114.17469 \| 22.27832 Chubu Region \| N/A \| Japan \| N/A \| N/A Chugoku Region \| N/A \| Japan \| N/A \| N/A Hokkaido Region \| N/A \| Japan \| N/A \| N/A Hokuriku 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...	96	NCT00606177	1COMPLETED	2010-11-01	2008-01-01	Otsuka Pharmaceutical Co., Ltd.	4INDUSTRY	false	false	false	null	0
[ 4 ]	41	RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	To assess the safety and efficacy of long-term administration of aripiprazole in combination with mood stabilizer (lithium or valproate) in an unblinded manner in patients with Bipolar I Disorder experiencing a manic or mixed episode	null	Bipolar I Disorder		null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: oral, 24mg/day	intervention 1: Aripiprazole	5	Chugoku Region \| N/A \| Japan \| N/A \| N/A Hokuriku 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 Shikoku Region \| N/A \| Japan \| N/A \| N/A	41	NCT00606229	1COMPLETED	2010-11-01	2008-01-01	Otsuka Pharmaceutical Co., Ltd.	4INDUSTRY	false	false	false	null	0
[ 4 ]	258	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The primary objective of this trial is to evaluate the clinical efficacy and safety of aripiprazole in comparison to placebo in patients with Bipolar I Disorder experiencing a manic or mixed episode.	null	Bipolar I Disorder		null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: oral, 24mg/day intervention 2: oral, 0mg(4tablets)/day	intervention 1: Aripiprazole intervention 2: placebo	12	Hong Kong \| N/A \| China \| 114.17469 \| 22.27832 Chubu Region \| N/A \| Japan \| N/A \| N/A Chugoku Region \| N/A \| Japan \| N/A \| N/A Hokkaido Region \| N/A \| Japan \| N/A \| N/A Hokuriku 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...	248	NCT00606281	1COMPLETED	2010-11-01	2008-01-01	Otsuka Pharmaceutical Co., Ltd.	4INDUSTRY	false	false	false	null	0
[ 4 ]	59	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	To assess the safety and efficacy of long-term administration of aripiprazole by performing extended administration of aripiprazole in combination with mood stabilizer (lithium or valproate) in an unblinded manner to those patients who completed the preceding multicenter, double-blind, placebo-controlled, parallel grou...	null	Bipolar I Disorder		null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: oral, 24mg(4 tablets)/day	intervention 1: Aripiprazole	12	Hong Kong \| N/A \| China \| 114.17469 \| 22.27832 Chubu Region \| N/A \| Japan \| N/A \| N/A Chugoku Region \| N/A \| Japan \| N/A \| N/A Hokkaido Region \| N/A \| Japan \| N/A \| N/A Hokuriku 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...	56	NCT00606320	1COMPLETED	2010-11-01	2008-01-01	Otsuka Pharmaceutical Co., Ltd.	4INDUSTRY	false	false	false	null	0
[ 3 ]	63	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	RATIONALE: Drugs used in chemotherapy such as cyclophosphamide and dexamethasone work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving cycloph...	OBJECTIVES: Primary \* To evaluate the response rate (complete response \[CR\], near CR \[nCR\], and very good partial response) in patients with newly diagnosed multiple myeloma treated with bortezomib in combination with cyclophosphamide and dexamethasone . Secondary * Determine the overall response rate (partial...	Multiple Myeloma and Plasma Cell Neoplasm	stage II multiple myeloma stage III multiple myeloma	null	0	null	null	3	[ 0, 0, 0 ]	intervention 1: First 33 patients: 1.3 mg/m\^2 IV Days 1, 4, 8 \& 11 Remaining 30 patients: 1.5 mg/m\^2 IV Days 1, 8, 15 \& 22 intervention 2: 300mg/m\^2 PO days 1, 8, 15 \& 22 intervention 3: First 33 patients: 40 mg PO Days 1-4, 9-12, 17-20 Remaining 30 patients: 40 mg PO Days 1-4, 9-12, 17-20 for cycles 1-2; Days ...	intervention 1: bortezomib intervention 2: cyclophosphamide intervention 3: dexamethasone	2	Scottsdale \| Arizona \| United States \| -111.89903 \| 33.50921 Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643	63	NCT00609167	1COMPLETED	2010-11-01	2006-12-01	Mayo Clinic	7OTHER	false	false	false	null	0
[ 3 ]	2	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	RATIONALE: Rosiglitazone may help pituitary tumor cells become more like normal cells, and to grow and spread more slowly. PURPOSE: This phase II trial is studying how well rosiglitazone works in treating patients with newly diagnosed ACTH-secreting pituitary tumor (Cushing disease).	OBJECTIVES: Primary * To assess the effect of rosiglitazone on biochemical control in patients with newly diagnosed ACTH-secreting pituitary tumor (Cushing disease). Secondary * To assess the effect of this drug on corticotrophin (CRH)-stimulated pituitary tumor ACTH secretion. * To assess the overall safety and to...	Cushing's Disease	ACTH-producing pituitary tumor	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: None	intervention 1: rosiglitazone maleate	1	Los Angeles \| California \| United States \| -118.24368 \| 34.05223	2	NCT00612066	6TERMINATED	2010-11-01	2007-04-01	Jonsson Comprehensive Cancer Center	7OTHER	false	false	false	null	0
[ 3 ]	1	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	RATIONALE: Rosiglitazone may help pituitary adenoma cells become more like normal cells, and grow and spread more slowly. PURPOSE: This phase II trial is studying how well rosiglitazone works in treating patients with newly diagnosed or residual or recurrent pituitary adenoma.	OBJECTIVES: * To assess the effect of rosiglitazone maleate on the core biochemical parameter, 24-hour urinary free cortisol levels, in patients with recurrent or uncured pituitary-dependent Cushing disease. (Group 1) * To assess the effect of this drug on corticotropin-releasing hormone-stimulated pituitary tumor ACT...	Brain and Central Nervous System Tumors	recurrent pituitary tumor ACTH-producing pituitary tumor nonfunctioning pituitary tumor	null	2	arm 1: Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 6 months in the absence of disease progression or unacceptable toxicity. arm 2: Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once dail...	[ 0, 0 ]	1	[ 0 ]	intervention 1: Given orally	intervention 1: rosiglitazone maleate	1	Los Angeles \| California \| United States \| -118.24368 \| 34.05223	1	NCT00616642	6TERMINATED	2010-11-01	2006-10-01	Jonsson Comprehensive Cancer Center	7OTHER	false	false	false	null	0
[ 2, 3 ]	53	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This is an exploratory phase 1b/2, global, multicenter, single-arm, 2-part (phase 1b and 2) study of conatumumab in combination with panitumumab in patients with Metastatic Colorectal Cancer.	This is an exploratory phase 1b/2, global, multicenter, single-arm, 2-part (phase 1b and 2) study of conatumumab in combination with panitumumab in patients with Metastatic Colorectal Cancer. The objective for Part 1 is to identify a tolerable dose of conatumumab in combination with panitumumab based on the incidence ...	Colon Cancer Colorectal Cancer Rectal Cancer Metastatic Colorectal Cancer Oncology		null	1	arm 1: Participants received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.	[ 0 ]	2	[ 0, 0 ]	intervention 1: Administered by intravenous infusion intervention 2: Administered by intravenous infusion	intervention 1: Panitumumab intervention 2: Conatumumab	0	null	52	NCT00630786	1COMPLETED	2010-11-01	2008-01-01	Amgen	4INDUSTRY	false	false	false	null	0
[ 4 ]	318	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The purpose of this study is to examine the efficacy and safety of 26 weeks treatment with inhaled mannitol in subjects with cystic fibrosis. Previous studies have demonstrated improvements in lung function, mucociliary clearance, changes in physical properties of mucus, 24 hour sputum weight and quality of life. The r...	null	Cystic Fibrosis	cystic fibrosis mannitol mucoactive	null	2	arm 1: active treatment arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 400 mg BD for 26 + 26 weeks intervention 2: BD for 26 weeks followed by 26 weeks of inhaled mannitol in the open label phase	intervention 1: inhaled mannitol intervention 2: Placebo comparator	53	Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Hartford \| Connecticut \| United States \| -72.68509 \| 41.76371 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 Idaho City \| Idaho \| United...	305	NCT00630812	1COMPLETED	2010-11-01	2008-09-01	Syntara	4INDUSTRY	false	false	false	null	0
[ 3 ]	1	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	RATIONALE: Biological therapies, such as anti-thymocyte globulin, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing....	OBJECTIVES: Primary \* To evaluate the hematological response rate of anti-thymocyte globulin given in combination with melphalan in patients with relapsed multiple myeloma. Secondary * To assess the toxicity and tolerability of this combination in these patients. * To assess time to disease progression in patients...	Multiple Myeloma and Plasma Cell Neoplasm	refractory multiple myeloma stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma	null	1	arm 1: Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m\^2)	[ 0 ]	2	[ 2, 0 ]	intervention 1: 2.5 mg/kg intervention 2: 16 mg/m\^2	intervention 1: anti-thymocyte globulin intervention 2: melphalan	1	Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163	1	NCT00635024	6TERMINATED	2010-11-01	2008-05-01	Mayo Clinic	7OTHER	false	false	false	null	0
[ 3 ]	55	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	RATIONALE: Some cancers need growth factors which are made by the body's white blood cells to keep growing.Anakinra may interfere with the growth factor and stop multiple myeloma from growing. Dexamethasone may stop cancer cells from growing. Giving anakinra together with dexamethasone may be an effective treatment for...	OBJECTIVES: Primary \* Determine the response rate in patients with smoldering or indolent multiple myeloma treated with anakinra. Secondary * Determine the toxicity of anakinra alone or in combination with dexamethasone in these patients. * Evaluate the response rate in patients treated with anakinra in combinatio...	Multiple Myeloma and Plasma Cell Neoplasm	stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma	null	1	arm 1: Anakinra was given alone for 6 months at which time response was assessed. If participants achieved a minor response or better they continued on Anakinra alone until disease progression. If participants achieved stable disease, they added low dose Dexamethasone to Anakinra until progression. If at any time a ...	[ 0 ]	2	[ 2, 0 ]	intervention 1: 100mg daily subcutaneously administered intervention 2: Low dose - 20 mg/week High dose - 40mg days 1-4, 9-12, 17-20 every 28 days ODD cycles OR 40 mg days 1-4 every 28 days EVEN cycles. (Starting dose was determined by treating physician)	intervention 1: Anakinra (IL-1Ra) intervention 2: Dexamethasone acetate	1	Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163	54	NCT00635154	1COMPLETED	2010-11-01	2002-12-01	Mayo Clinic	7OTHER	false	false	false	null	0
[ 3 ]	44	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	This phase II trial is studying how well giving vorinostat together with bortezomib works in treating patients with progressive, recurrent glioblastoma multiforme. Vorinostat and bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vorinostat together with bortezo...	PRIMARY OBJECTIVES: I. To determine the clinical efficacy of vorinostat (SAHA) and bortezomib, in terms of progression-free survival (PFS) at 6 months, in patients with progressive, recurrent glioblastoma multiforme. SECONDARY OBJECTIVES: I. To determine the clinical efficacy of this regimen, in terms of overall sur...	Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Recurrent Adult Brain Tumor		null	2	arm 1: Patients receive oral vorinostat (SAHA) once daily on days 1-14 and bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. arm 2: Patients receive oral SAHA once daily for 2 days prior to surgery and then on the day of surgery. Patients...	[ 0, 0 ]	3	[ 0, 3, 0 ]	intervention 1: Given orally intervention 2: Patient undergoes surgery intervention 3: Given IV	intervention 1: vorinostat intervention 2: therapeutic conventional surgery intervention 3: bortezomib	214	Scottsdale \| Arizona \| United States \| -111.89903 \| 33.50921 Aurora \| Colorado \| United States \| -104.83192 \| 39.72943 Boulder \| Colorado \| United States \| -105.27055 \| 40.01499 Colorado Springs \| Colorado \| United States \| -104.82136 \| 38.83388 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Denver \| Colorado...	44	NCT00641706	1COMPLETED	2010-11-01	2008-07-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0
[ 3 ]	130	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	This study will assess the effect of RO4607381, compared to placebo, on atherosclerotic plaque in patients with coronary heart disease (CHD) including patients with other CHD risk factors. After a pre-randomisation period during which positron emission tomography computed tomography (PET/CT) and MRI will be conducted, ...	null	Coronary Heart Disease		null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 600mg po daily for 24 months intervention 2: po daily for 24 months	intervention 1: Dalcetrapib (RO4607381) intervention 2: Placebo	12	Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Royal Oak \| Michigan \| United States \| -83.14465 \| 42.48948 Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997 Kansas City \| Missouri \| United States \| -94.57857 \| 39.09973 New York \| New York \| United States \| -74.00597 \| 40.71427 Statesville \| ...	130	NCT00655473	1COMPLETED	2010-11-01	2008-03-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0
[ 3 ]	15	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	RATIONALE: Radioactive drugs, such as iodine I 131 metaiodobenzylguanidine (MIBG), may carry radiation directly to tumor cells and not harm normal cells. A bone marrow or peripheral stem cell transplant using stem cells from the patient may be able to replace blood-forming cells that were destroyed by I 131 MIBG. PURP...	OBJECTIVES: Primary * To establish the maximum tolerated dose of iodine I 131 metaiodobenzylguanidine (\^131I-MIBG) in patients with relapsed/refractory high-risk neuroblastoma. Secondary * To describe toxicity following treatment with \^131I-MIBG in patients with relapsed/refractory high-risk neuroblastoma. * To e...	Neuroblastoma	recurrent neuroblastoma	null	1	arm 1: Eligible patients received a diagnostic imaging dose of Ultratrace™ Iobenguane I 131 (1-5 mCi) within 7 days of study enrollment, followed by three dosimetry scans over 3-6 days. If the imaging dose demonstrated normal biodistribution and tumor uptake, then the patient received a therapeutic dose within 7-28 day...	[ 0 ]	2	[ 0, 0 ]	intervention 1: 0.1 mCi/kg \[3.7 MBq/kg\] (minimum dose 1mCi \[37MBq\] but not to exceed 5 mCi \[185 MBq\]) of UltratraceTM Iobenguane I 131 given 7 -28 days before therapeutic dose administration on day 0. Thyroid protection will be administered per institutional protocol for I-131-MIBG however, thyroid blocking must ...	intervention 1: UltratraceTM Iobenguane I 131 Imaging intervention 2: UltratraceTM Iobenguane I 131 Therapy	8	Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Palo Alto \| California \| United States \| -122.14302 \| 37.44188 San Francisco \| California \| United States \| -122.41942 \| 37.77493 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756 Cincinn...	15	NCT00659984	1COMPLETED	2010-11-01	2008-06-01	Molecular Insight Pharmaceuticals, Inc.	4INDUSTRY	false	false	false	null	0
[ 4 ]	124	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This single-arm study will assess the efficacy and safety of monthly administration of intravenous methoxy polyethylene glycol-epoetin beta (CERA/Mircera) for the maintenance of hemoglobin (Hb) levels in participants on dialysis with chronic renal anemia in routine clinical practice in Hungary. Participants currently r...	null	Anemia		null	1	arm 1: Participants with chronic renal anemia previously treated with ESA therapy will receive intravenous Mircera, also known as continuous erythropoietin receptor activator (CERA), every 4 weeks for a total of 52 weeks in this single-arm study. The first dose will be determined by the dose of ESA received prior to ad...	[ 0 ]	1	[ 0 ]	intervention 1: Participants will receive intravenous CERA/Mircera every month, with starting dose based on previous ESA therapy. Treatment will continue for 52 weeks.	intervention 1: Methoxy polyethylene glycol-epoetin beta	10	Baja \| N/A \| Hungary \| 18.95307 \| 46.18299 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Debrecen \| N/A \| Hungary \| 21.62444 \| 47.53167 Esztergom \| N/A \| Hungary \| 18.74148 \| 47.7928 Keszthely \| N/A \| Hungary \| 17.24317 \| 46.76812 Miskolc \| N/A \| Hungary \| 20.77806 \| 48.10306 Salgótarján \| N/A \| Hungary \| 19.80303 \| 4...	114	NCT00660023	1COMPLETED	2010-11-01	2008-08-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0
[ 5 ]	344	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This study is designed to look at how best to start and then gradually intensify (as needed) the insulin lispro premix regimen in type 2 diabetes patients who consume a light breakfast.	null	Diabetes Mellitus, Type 2		null	2	arm 1: Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs) arm 2: Premixed Insulin Lispro (mid-mixture or low-mixture) 1,2 or 3 injections plus OAMs	[ 1, 0 ]	2	[ 0, 0 ]	intervention 1: patient glucose-level dependent, injection, as needed per patient glucose level, 48 weeks intervention 2: patient glucose level dependent, injection, as needed per patient glucose level, 48 weeks	intervention 1: Insulin Glargine intervention 2: Insulin Lispro Premix (mid-mixture and low-mixture)	27	Smiths Falls \| Ontario \| Canada \| -76.02333 \| 44.90452 Alexandria \| N/A \| Egypt \| 29.91582 \| 31.20176 Bāb al Lūq \| N/A \| Egypt \| 31.23997 \| 30.04458 Cairo \| N/A \| Egypt \| 31.24967 \| 30.06263 Heliopolis \| N/A \| Egypt \| 31.37924 \| 30.10882 Ahmedabad \| N/A \| India \| 72.58727 \| 23.02579 Hyderabaad \| N/A \| India \| N/A \| N/A...	342	NCT00664534	1COMPLETED	2010-11-01	2008-04-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0
[ 0 ]	7	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The goal of this clinical research study is to learn if giving certain combinations of chemotherapy drugs before and after surgery, mostly in the outpatient clinic instead of in the hospital, can result in fewer hospital stays during treatment for osteosarcoma. The drugs and schedules will vary depending on the status ...	The Study Drugs: The standard treatment combination used to treat patients with osteosarcoma is doxorubicin, cisplatin, and methotrexate with or without ifosfamide. When this treatment combination is given in the hospital, it can require around 18-22 hospital stays. Somewhat recently, chemotherapy for osteosarcoma has...	Osteosarcoma	Doxorubicin AD Hydroxydaunomycin hydrochloride Cisplatin Paraplatin® Methotrexate Ifosfamide Osteosarcoma Sargramostim Leukine™ Leucovorin Gemcitabine Gemzar Gemcitabine Hydrochloride GM-CSF Questionnaire Survey	null	2	arm 1: Pre-Surgery, Regimen 1: Doxorubicin intravenous (IV) 90 mg daily, Cisplatin 60 mg/m\^2/day for 2 days, Methotrexate 12 gm/m\^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Surgery; Post-Surgery, Regimen 1: Methotrexate 12 gm/m\^2, Doxorubicin IV 90 mg, Cisplatin 60 mg/ m\^2 twice daily, Leucovor...	[ 0, 0 ]	11	[ 0, 0, 0, 0, 0, 0, 5, 0, 0, 3, 0 ]	intervention 1: Pre-Surgery, Regimen 1: IV Over 15 Minutes on Day 1 of Weeks 1 and 6; Post-Surgery, Regimen 1: IV on Day 1 of Weeks 16, 21, and 26; Pre-Surgery, Regimen 2: IV over 15 Minutes on Day 1 of Weeks 1, 4, and 7. Dose 90 mg/m\^2. intervention 2: Pre-Surgery, Regimen 1: IV Over 48 Hours, on Days 1 and 2 of Week...	intervention 1: Doxorubicin intervention 2: Cisplatin intervention 3: Methotrexate intervention 4: Leucovorin intervention 5: Dexrazoxane intervention 6: Ifosfamide intervention 7: Questionnaire intervention 8: Gemcitabine intervention 9: Sargramostim intervention 10: Surgery intervention 11: Mesna	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	7	NCT00673179	6TERMINATED	2010-11-01	2008-05-01	M.D. Anderson Cancer Center	7OTHER	false	false	false	null	0
[ 4 ]	250	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	This is a Phase 3 multi-center trial designed to evaluate the clinical efficacy and safety of VIVITROL® (Medisorb® naltrexone 380 mg) versus placebo when administered to adults upon discharge from inpatient treatment for opioid dependence. The study was conducted in 2 parts, Part A and Part B. The clinical portion of ...	Part A was a double-blind, randomized, placebo-controlled assessment of the efficacy and safety of 24 weeks of monthly treatment with VIVITROL compared to placebo in opioid-dependent adults. Subjects who completed Part A could choose to continue to Part B, which was an open-label extension to assess longer-term safety...	Opiate Dependence	Addiction Opiate dependence Inpatient detoxification opioid dependence heroin dependence	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Administered via intramuscular (IM) injection once every 4 weeks for 24 weeks during Part A, followed by once every 4 weeks for 52 weeks in Part B. intervention 2: Administered via IM injection once every 4 weeks for 24 weeks during Part A, followed by VIVITROL® 380 mg via IM injection once every 4 week...	intervention 1: VIVITROL® 380 mg intervention 2: Placebo	1	Moscow \| N/A \| Russia \| 37.61556 \| 55.75222	250	NCT00678418	1COMPLETED	2010-11-01	2008-06-01	Alkermes, Inc.	4INDUSTRY	false	false	false	null	0
[ 4 ]	27	NON_RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	false	0ALL	true	1. To investigate the effect of insulin glargine (Lantus™) vs NPH insulin regarding glycemic control during the early AM (dawn phenomenon) in individuals with type 1 diabetes. 2. To measure hormones implicated in the pathogenesis of the dawn phenomenon in individuals with type 1 diabetes.	Title: COMPARISON of LANTUS and NPH INSULIN IN THE DAWN PHENOMENON I. Background and Significance Diabetes mellitus affects greater than 6% of the population, with type 2 more prevalent than type 1. For individuals with type 1 diabetes, the challenge has been to replicate insulin secretion of the healthy pancreas to ...	Type 1 Diabetes Dawn Phenomenon	glucose cortisol growth hormone glucagon insulin	null	2	arm 1: Long acting insulin, glargine, that subject currently used as an outpatient. SC injections. Dose given at 22:00 is based on past week blood glucose data during evening overnight hours and AM glucose. 20.2 +/- 11.7 units glargine (mean +/- SD). Glargine (Lantus): Sanolfi Aventis Hourly blood glucose from 22:00 ...	[ 1, 1 ]	1	[ 0 ]	intervention 1: Described in Arm Description	intervention 1: Lantus (glargine)	1	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	30	NCT00694122	1COMPLETED	2010-11-01	2005-06-01	Massachusetts General Hospital	7OTHER	false	false	false	null	0
[ 5 ]	21	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	This study is being conducted to find a way to predict how individual schizophrenic patients will respond if they are treated with different types of antipsychotic drugs. This could help doctors prescribe the medication that will work best for each individual.	The primary objective of the proposed research project is to identify a practical method of predicting differential antipsychotic drug treatment response in patients with schizophrenia. In particular, we will examine differential response to two antipsychotic drugs, aripiprazole and risperidone, that have contrasting p...	Schizophrenia	Schizophrenia Antipsychotic drug treatment response Risperidone Aripiprazole Fallypride Positron emission tomography Magnetic Resonance Imaging Dopamine D2 Receptors	null	3	arm 1: Screening and Baseline Procedures followed by Referral to Community Care. Baseline Procedures may be repeated at a later time if appropriate. arm 2: Screening and Baseline Procedures followed by 16 weeks of treatment with aripiprazole, followed by repeat of baseline procedures and referral to community care. arm...	[ 4, 1, 1 ]	2	[ 0, 0 ]	intervention 1: Target dose = 15mg by mouth per day for 16 weeks. The dosage will be titrated in accordance with the treating physician's clinical judgment, generally reaching full dosage within one week of initiation. The dosage may be increased as clinically indicated, by the treating physician. Any deviation from th...	intervention 1: Aripiprazole intervention 2: Risperidone	1	Kettering \| Ohio \| United States \| -84.16883 \| 39.6895	21	NCT00712270	6TERMINATED	2010-11-01	2005-04-01	Kettering Health Network	7OTHER	false	false	false	null	0
[ 5 ]	29	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to determine whether the combination of Myfortic and sirolimus is effective at preventing rejection while preserving kidney function in stable kidney transplant recipients.	One-year graft survival after renal transplantation dramatically improved with the addition of calcineurin inhibitors (tacrolimus or cyclosporine) to maintenance immunosuppression regimens. Much of this improvement in early graft survival has been attributed to the efficacy of the calcineurin inhibitors in preventing e...	Renal Transplantation	Kidney transplantation Sirolimus Immunosuppression Tacrolimus	null	1	arm 1: All subjects who enroll in this study will be converted from their calcineurin inhibitor to sirolimus. There is no comparotor arm	[ 5 ]	1	[ 0 ]	intervention 1: Oral tablet(s) taken daily for 6 months; dose will be based on serum trough levels.	intervention 1: sirolimus	1	San Francisco \| California \| United States \| -122.41942 \| 37.77493	13	NCT00713284	1COMPLETED	2010-11-01	2007-05-01	California Pacific Medical Center Research Institute	7OTHER	false	false	false	null	0
[ 4 ]	244	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	This study aims to assess the efficacy of peginterferon α-2b, compared to a control arm not receiving any maintenance treatment, in adult subjects with multiple myeloma who have responded to a prior induction therapy. Peginterferon α-2b will be given once weekly as an injection until disease progression or relapse, or ...	null	Multiple Myeloma		null	2	arm 1: Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years. arm 2: Participants will be observed and will receive no treatment.	[ 0, 4 ]	1	[ 0 ]	intervention 1: Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.	intervention 1: Peginterferon	0	null	244	NCT00732641	1COMPLETED	2010-11-01	2000-12-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0
[ 3 ]	11	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	false	The goal of this clinical research study is to learn if Tarceva® (erlotinib hydrochloride) can help control triple receptor-negative breast cancer. The safety of this drug will also be studied. Objectives: To assess the clinical efficacy, biologic effects and safety of the EGFR inhibitor erlotinib in the treatment of...	The Study Drug: Erlotinib hydrochloride is designed to block the activity of a protein found on the surface of many tumor cells that may control tumor growth and survival. This may stop tumors from growing. Screening Tests: Before you can start treatment on this study, you will have "screening tests." These tests wi...	Breast Cancer	Breast cancer Carcinoma of the breast Stage IV Triple receptor-negative Triple receptor-negative breast cancer Metastatic triple receptor-negative breast cancer Epidermal growth factor receptor EGFR EGFR-overexpressing GFR inhibitor erlotinib Erlotinib hydrochloride Erlotinib Tarceva OSI-774	null	1	arm 1: Tarceva oral 150 mg daily.	[ 0 ]	1	[ 0 ]	intervention 1: Tarceva (erlotinib hydrochloride) given alone, at 150 mg by mouth daily.	intervention 1: Tarceva	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	3	NCT00739063	6TERMINATED	2010-11-01	2008-07-01	M.D. Anderson Cancer Center	7OTHER	false	false	false	null	0
[ 3 ]	104	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	1FEMALE	null	The study was a Phase II, randomized, placebo-controlled, double-blind, multicenter clinical trial of vismodegib (GDC-0449) in patients with ovarian cancer in a second or third complete remission. Patients were randomized in a 1:1 ratio to either vismodegib or placebo. Randomization was stratified based on whether thei...	null	Ovarian Cancer	Systemic Hedgehog Hedgehog Pathway Inhibitor	null	2	arm 1: Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study. arm 2: Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawa...	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Vismodegib 150 mg was provided in hard gelatin capsules. intervention 2: Placebo to vismodegib consisted of the excipients for vismodegib without the active molecule in hard gelatin capsules matching the active drug product in color and size.	intervention 1: Vismodegib 150 mg intervention 2: Placebo to vismodegib	0	null	104	NCT00739661	1COMPLETED	2010-11-01	2008-12-01	Genentech, Inc.	4INDUSTRY	false	false	false	null	0
[ 3 ]	66	RANDOMIZED	CROSSOVER	0TREATMENT	3TRIPLE	false	0ALL	true	1. Assess the efficacy of varenicline, relative to placebo, on a performance based measure of cognition in patients with mild to moderate Alzheimer's disease 2. Evaluate the effects of varenicline on clinically relevant measures including attention and executive function, behavior, and clinician rated global change. 3....	null	Alzheimer's Disease	Efficacy Safety Pharmacokinetics Alzheimer's disease	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 0.5 mg once daily for 1 week followed by 0.5 mg twice daily for 1 week followed by 1 mg twice daily for 4 weeks intervention 2: Placebo once daily for 1 week followed by placebo twice daily for 5 weeks.	intervention 1: Varenicline intervention 2: Placebo	8	Seongnam \| Gyunggido \| South Korea \| 127.39683 \| 35.54127 Busan \| N/A \| South Korea \| 129.03004 \| 35.10168 Daegu \| N/A \| South Korea \| 128.59111 \| 35.87028 Incheon \| N/A \| South Korea \| 126.70515 \| 37.45646 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Seoul \| N/A \| South K...	119	NCT00744978	1COMPLETED	2010-11-01	2009-07-01	Pfizer	4INDUSTRY	false	false	false	null	0
[ 2, 3 ]	37	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	false	The primary objective of the study was to explore whether mefloquine can delay or stop progression of progressive multifocal leukoencephalopathy (PML) as measured by JC virus (human polyomavirus or JCV) deoxyribonucleic acid (DNA) levels in cerebrospinal fluid (CSF). The secondary objective of the study was to explore ...	null	Progressive Multifocal Leukoencephalopathy	PML Human Polyomavirus JC HIV Central Nervous System Disease Mefloquine JC Virus	null	2	arm 1: All participants received local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital. Participants in this treatment arm had the option of adding 250 mg mefloquine by mouth at Week 4 (Day 2...	[ 4, 0 ]	1	[ 0 ]	intervention 1: 250 mg orally each day for 3 days and then weekly up to 6 months.	intervention 1: mefloquine	12	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 New York \| New York \| United States \| -74.00597 \| 40.71427 São Paulo \| N/A \| Braz...	47	NCT00746941	6TERMINATED	2010-11-01	2009-01-01	Biogen	4INDUSTRY	false	false	false	null	0
[ 3 ]	20	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This is a Phase II open-label exploratory trial of BIBW 2992 administered to patients with tumors of various histologies found to possess EGFR and/or HER2 gene amplification, or EGFR activating mutations.	null	Neoplasms		null	1	arm 1: BIBW 2992 (Afatinib) for patients FISH positive for/or harboring EGFR or HER2 Mutation	[ 0 ]	1	[ 0 ]	intervention 1: BIBW 2992 (Afatininb) for patients FISH positive for/or harboring EGFR or HER2 Mutation	intervention 1: BIBW 2992 (Afatinib)	15	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 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 Albany \| New Yo...	20	NCT00748709	6TERMINATED	2010-11-01	2008-10-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0
[ 3 ]	422	NA	SINGLE_GROUP	2DIAGNOSTIC	0NONE	false	0ALL	false	The aim of this study is to evaluate the efficacy, safety of a single dose of BAY 94-9172 (ZK 6013443) as an investigational medicinal product (IMP) in detecting cerebral protein-plaque (amyloid beta) with positron emission tomography (PET). IMP binds to amyloidal beta protein accumulating in brain tissue already from ...	null	Alzheimer Disease Amyloid Beta-Protein	Alzheimer Disease Amyloid beta-Protein	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Healthy volunteers and patients with probable Alzheimer's disease receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions	intervention 1: Florbetaben (BAY94-9172)	23	Sun City \| Arizona \| United States \| -112.27182 \| 33.59754 Stanford \| California \| United States \| -122.16608 \| 37.42411 New Haven \| Connecticut \| United States \| -72.92816 \| 41.30815 New York \| New York \| United States \| -74.00597 \| 40.71427 New York \| New York \| United States \| -74.00597 \| 40.71427 The Bronx \| New Yo...	422	NCT00750282	1COMPLETED	2010-11-01	2008-08-01	Life Molecular Imaging SA	4INDUSTRY	false	false	false	null	-0
[ 3 ]	4	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	This research is being done to find out if adding a drug called Avastin to an already approved regimen used for soft-tissue sarcoma, Doxorubicin, will improve overall survival, and slow disease progression. The study will also evaluate the overall safety of combining these drugs. It is not known if combining these drug...	The rationale for this trial is to improve the efficacy of prototypical anti-sarcoma chemotherapeutic regimen Doxorubicin when combined with Avastin®. Soft tissue sarcomas are highly vascular tumors and are therefore ideally suited to trials combining angiogenic inhibitors with chemotherapy. Several studies have reveal...	Sarcoma Soft Tissue Sarcoma	STS	null	1	arm 1: Patients will be treated with Avastin 15 mg/kg IV infusion plus doxorubicin 60 mg/M2 (body surface area) IV 6-hour infusion on Day 1 of each 21-day treatment cycle. Dose reductions/modifications will be applied as indicated by toxicities and/or patient tolerance.	[ 0 ]	2	[ 0, 0 ]	intervention 1: Combination of Avastin and doxorubicin. If initial 90 +/- 15 minute infusion of Avastin is tolerated without fever and chills, the 2nd dose may be infused over 60 +/- 10 minutes. If well tolerated, all subsequent infusions may be delivered over 30 +/- 10 minutes. intervention 2: The Day 1 6- hour contin...	intervention 1: Avastin intervention 2: Doxorubicin	1	Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038	4	NCT00755261	6TERMINATED	2010-11-01	2008-09-01	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	7OTHER	false	false	false	null	0
[ 4 ]	239	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	This study is designed to primarily assess the efficacy and safety of duloxetine 60-120 mg once daily (QD) compared with placebo on the reduction of pain severity in participants with central neuropathic pain due to Multiple Sclerosis.	Study is a multicenter, randomized, double-blind, parallel, placebo-controlled, 20-week trial with 4 study periods. Participants who screen successfully (Study Period I) will be randomized in a 1:1 fashion to duloxetine 60 mg QD or placebo. Starting with Study Period II, participants will be treated in a double-blind m...	Multiple Sclerosis	Central Neuropathic Pain Multiple Sclerosis	null	2	arm 1: None arm 2: None	[ 2, 0 ]	2	[ 0, 0 ]	intervention 1: Participants received 30 mg duloxetine (po, QD) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period. If the participant completes the double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, ...	intervention 1: Duloxetine Hydrochloride (HCI) intervention 2: Placebo	22	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Aurora \| Colorado \| United States \| -104.83192 \| 39.72943 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Bradenton \| Florida \| United S...	448	NCT00755807	1COMPLETED	2010-11-01	2008-10-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0
[ 4 ]	274	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study was to assess the comparative safety and effectiveness of aztreonam for inhalation solution versus tobramycin inhalation solution in adult and pediatric patients with cystic fibrosis (CF) and pulmonary Pseudomonas aeruginosa (PA) infection.	Number of Subjects Planned: Approximately 240 randomized patients Target Population: CF patients \>= 6 years of age with stable pulmonary disease, who at study entry had a recent positive sputum culture for PA and had been previously treated with aerosolized antibiotics without demonstration of drug intolerance. The ...	Cystic Fibrosis	aztreonam lysine tobramycin inhalation solution tobramycin nebuliser solution cystic fibrosis pseudomonas aeruginosa lung infection CFQ-R inhaled antibiotic	null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Aztreonam for inhalation solution (75 mg) was administered 3 times a day (TID) for 28 days for each treatment cycle via the PARI eFlow electronic nebulizer. intervention 2: Tobramycin inhalation solution (300 mg) was administered 2 times a day (BID) for 28 days for each treatment cycle via the PARI LC P...	intervention 1: Aztreonam for Inhalation Solution (AZLI) intervention 2: Tobramycin Inhalation Solution (TIS)	92	Anchorage \| Alaska \| United States \| -149.90028 \| 61.21806 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Tuscon \| Arizona \| United States \| N/A \| N/A Orange \| California \| United States \| -117.85311 \| 33.78779 Aurora \| Colorado \| United States \| -104.83192 \| 39.72943 Denver \| Colorado \| United States \| -104...	268	NCT00757237	1COMPLETED	2010-11-01	2008-08-01	Gilead Sciences	4INDUSTRY	false	false	false	null	0
[ 5 ]	17	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to determine whether continuous intravenous ketorolac infusion reduces pain in patients who are having percutaneous nephrolithotomy for kidney stone disease.	null	Renal Calculus Kidney Stones	Percutaneous Nephrolithotomy Kidney stones	null	2	arm 1: 90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery. arm 2: 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery. intervention 2: 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.	intervention 1: Ketorolac intervention 2: Placebo	1	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838	17	NCT00765128	1COMPLETED	2010-11-01	2008-10-01	Mayo Clinic	7OTHER	false	false	false	null	0
[ 5 ]	111	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to determine whether continuous intravenous ketorolac infusion reduces pain in patients who are having laparoscopic surgery to donate a kidney.	null	Nephrectomy Laparoscopic Donor Nephrectomy	laparoscopic donor nephrectomy	null	2	arm 1: 90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery. arm 2: 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery. intervention 2: 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.	intervention 1: Ketorolac intervention 2: Placebo	1	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838	111	NCT00765232	1COMPLETED	2010-11-01	2008-10-01	Mayo Clinic	7OTHER	false	false	false	null	0
[ 4 ]	366	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	Evaluation of the safety and efficacy of Oxcarbazepine XR as adjunctive treatment for adults with partial onset seizures	Multicenter, double-blind, randomized, placebo-controlled, three-arm. parallel-group study of the efficacy and safety of extended-release oxcarbazepine in the treatment of adults with refractory partial onset epilepsy.	Epilepsies, Partial	Partial onset epilepsy Partial onset seizures	null	3	arm 1: Placebo - four identical tablets taken orally once daily arm 2: 2400mg OXC XR taken orally once daily as four identical tablets arm 3: 1200mg OXC XR taken orally once daily as four identical tablets	[ 2, 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Non-active tablet identical to study drug tablets intervention 2: tablets containing 600mg OXC XR, identical to non-active tablets intervention 3: two active tablets and two non-active tablets, all identical	intervention 1: Placebo intervention 2: 2400mg SPN-804 intervention 3: 1200mg SPN-804	71	Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 Northport \| Alabama \| United States \| -87.57723 \| 33.22901 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Riverside \| California \| ...	366	NCT00772603	1COMPLETED	2010-11-01	2008-11-01	Supernus Pharmaceuticals, Inc.	4INDUSTRY	false	false	false	null	0
[ 3 ]	29	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	A published phase 2 study reported that lonafarnib was administered as a single agent via continuous or intermittent oral dosing to 76 women with advanced breast cancer who were previously treated with chemotherapy and/or with endocrine therapy. Objective response rates of approximately 10% were observed. This study wi...	OUTLINE: This is a multi-center study Patients will be treated with lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion. 1 Cycle = 21 days of lonafarnib (plus the time required to recover from toxicity if encountered). EC...	Metastatic Breast Cancer		null	1	arm 1: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.	[ 0 ]	1	[ 0 ]	intervention 1: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.	intervention 1: Lonafarnib	6	Galesburg \| Illinois \| United States \| -90.37124 \| 40.94782 Bloomington \| Indiana \| United States \| -86.52639 \| 39.16533 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Lafayette \| Indiana \| United States \| -86.87529 \| 40.4167 Lafayette \| Indiana \| United States \| -86.87529 \| 40.4167 Cleveland \| Ohio \| Un...	29	NCT00773474	6TERMINATED	2010-11-01	2008-10-01	George Sledge	7OTHER	false	false	false	null	0
[ 3 ]	165	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	In this study the impact of Oleogel-S-10 versus placebo on actinic keratoses over a treatment period of 3 months will be tested. Additionally, once and twice daily applications are tested.	Oleogel-S-10 has shown efficacy and was well tolerated in two previous clinical trials. In the second open label phase II trial the efficacy of Oleogel-S-10 alone was similar compared to a more invasive treatment with cryotherapy. Response rates of 85% with a clear-ance of more than 75 % of the lesions of the patients ...	Actinic Keratoses	Actinic Keratoses	null	4	arm 1: Oleogel-S10 100 mg/g ointment for three months once a day (54 patients) arm 2: Oleogel-S10 100 mg/g ointment for three months twice a day (54 patients) arm 3: Placebo (petroleum jelly) for three months once a day (27 patients) arm 4: Placebo (petroleum jelly) for three months twice a day (27 patients)	[ 0, 0, 2, 2 ]	2	[ 0, 0 ]	intervention 1: topical use once or twice daily intervention 2: topical use once or twice daily	intervention 1: Oleogel-S10 100 mg/g intervention 2: Placebo (petroleum jelly)	6	Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Freiburg im Breisgau \| N/A \| Germany \| 7.85222 \| 47.9959 Tübingen \| N/A \| Germany \| 9.05222 \| 48.52266 Wuppertal \| N/A \| Germany \| 7.14816 \| 51.25627 Athens \| N/A \| Greece \| 23.72784 \| 37.98376 Heraklion \| N/A \| Greece \| 25.14341 \| 35.32787	165	NCT00786994	1COMPLETED	2010-11-01	2008-10-01	Birken AG	4INDUSTRY	false	false	false	null	-0
[ 4 ]	142	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to evaluate the safety and efficacy of fentanyl one-day transdermal patch (JNS020QD, patch containing a drug that is put on the skin so the drug will enter the body through the skin) in participants with chronic (lasting a long time) pain.	This is an open-label (all people know the identity of the intervention), multi-center (conducted in more than one center) and non-comparative study of fentanyl one-day transdermal patch. The study consists of 4 periods: Screening period (3-14 days), Treatment period 1 (4 weeks), Treatment period 2 (48 weeks), Tapering...	Chronic Pain	Chronic pain Fentanyl Patch	null	1	arm 1: Fentanyl transdermal patch will be applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose will be increased as per Investigators' discretion in both treatment periods and the...	[ 0 ]	1	[ 0 ]	intervention 1: Fentanyl transdermal patch will be applied daily starting at a dose of 12.5 mcg/hr, and up to 52 weeks. Dose will be increased as per Investigator's discretion.	intervention 1: Fentanyl	23	Amagasaki \| N/A \| Japan \| 135.41667 \| 34.71667 Chūō \| N/A \| Japan \| 139.77544 \| 35.67004 Fukuoka \| N/A \| Japan \| 130.41667 \| 33.6 Hiroshima \| N/A \| Japan \| 132.45 \| 34.4 Izumo \| N/A \| Japan \| 132.76667 \| 35.36667 Kanazawa \| N/A \| Japan \| 136.61667 \| 36.6 Kawasaki \| N/A \| Japan \| 139.71722 \| 35.52056 Kitakyushu \| N/A \| ...	142	NCT00788372	1COMPLETED	2010-11-01	2008-11-01	Janssen Pharmaceutical K.K.	4INDUSTRY	false	false	false	null	0
[ 0 ]	24	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	1FEMALE	false	The purpose of this clinical trial is to find out how effective low dose oral naltrexone is on reducing body weight when compared to placebo in women with schizophrenia and schizoaffective disorder.	null	Obesity Schizophrenia Schizoaffective Disorder	obesity schizophrenia schizoaffective disorder weight loss	null	2	arm 1: None arm 2: None	[ 1, 2 ]	2	[ 0, 10 ]	intervention 1: Naltrexone 25mg caplets taken orally once a day for 8 weeks intervention 2: Placebo caplet (inactive substance) taken orally once a day for 8 weeks	intervention 1: Naltrexone 25mg intervention 2: Placebo	1	New Haven \| Connecticut \| United States \| -72.92816 \| 41.30815	21	NCT00793780	1COMPLETED	2010-11-01	2008-12-01	Yale University	7OTHER	false	false	false	null	0
[ 4 ]	30	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	Systane Ultra is at least as efficacious and safe as Refresh Tears in Asian people with Dry Eyes	Comparison of efficacy of Systane Ultra and Refresh Tears	Xerophthalmia Blepharitis		null	2	arm 1: Used four times a day topically to each eye arm 2: Used four times a day topically to each eye	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Four times a day intervention 2: Four times a day	intervention 1: Systane Ultra eyedrops intervention 2: Refresh eye drops	1	Singapore \| N/A \| Singapore \| 103.85007 \| 1.28967	30	NCT00796926	1COMPLETED	2010-11-01	2009-07-01	Louis Tong	2OTHER_GOV	false	false	false	null	0
[ 0 ]	218	RANDOMIZED	FACTORIAL	0TREATMENT	3TRIPLE	false	0ALL	false	This study will test the hypothesis that adding dexamethasone significantly prolongs the duration of ropivacaine and bupivacaine analgesia, and that the magnitude of the effect differs among the two local anaesthetics.. Participants will be patients undergoing shoulder surgery with an interscalene nerve block.	This is a double-blinded randomized study of four groups of patients undergoing shoulder surgery using interscalene nerve blocks. Participants will be randomized into one of four groups: * Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline (placebo) for interscalene block; * Bupivacaine: 30 ml 0.5% bupivacaine ...	Anesthesia, Local Shoulder Surgery	ropivacaine bupivacaine glucocorticoid	null	4	arm 1: Group 1 Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline for interscalene block arm 2: Group 2 Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline arm 3: Group 3 Ropivacaine and dexamethasone: 30 ml 0.5% ropivacaine mixed with dexamethasone 8 mg (2 ml) arm 4: Group 4 Bupivacaine and steroid: 30 ml...	[ 2, 2, 1, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 2 ml 0.9% saline (placebo) intervention 2: dexamethasone 8 mg (2 ml) intervention 3: 30 ml 0.5% ropivacaine intervention 4: 30 ml 0.5% bupivacaine	intervention 1: saline intervention 2: Dexamethasone intervention 3: ropivacaine intervention 4: Bupivacaine	1	Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995	218	NCT00801138	6TERMINATED	2010-11-01	2008-11-01	The Cleveland Clinic	7OTHER	false	false	false	null	0
[ 3 ]	16	RANDOMIZED	CROSSOVER	0TREATMENT	3TRIPLE	false	0ALL	true	Pediatric patients with chronic liver disease may have Minimal Hepatic Encephalopathy(MHE)which can cause changes in behavior,intelligence and neurological function.By utilizing cognitive and developmental testing we will determine if patients have MHE. If so, we will trial 3 months of blinded placebo or Lactulose trea...	In addition ,serum ammonia levels will be obtained at beginning of study,post-washout and at end of study to evaluate Lactulose effect on serum ammonia.	Minimal Hepatic Encephalopathy	encephalopathy pediatric liver disease pediatric cirrhosis serum ammonia levels	null	2	arm 1: 3 months of Lactulose therapy based on pt. weight arm 2: 1.5 ml/kg day po of sugar water placebo for three months	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: 1.5cc/kg/day po for three months intervention 2: 1.5 ml sugar water/kg day for three months	intervention 1: Lactulose intervention 2: placebo	1	Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838	21	NCT00811434	6TERMINATED	2010-11-01	2009-01-01	Indiana University	7OTHER	false	false	false	null	0
[ 4 ]	598	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of the study is to evaluate the efficacy, safety and tolerability of nalmefene in the treatment of alcohol dependence.	Alcohol dependence is a maladaptive pattern of alcohol use, leading to clinically significant impairment or distress, as manifested by at least three of a number of criteria such as tolerance, withdrawal symptoms, frequent use of alcohol in larger amounts or over longer periods than was intended, and others. Excessive ...	Alcohol Dependence	Alcohol-Related Disorders Alcoholism Mental Disorders Central Nervous System Agents	null	2	arm 1: None arm 2: None	[ 2, 0 ]	2	[ 0, 0 ]	intervention 1: as-needed use, tablets, orally, 6 months intervention 2: 18.06 mg, as-needed use, tablets, orally, 6 months. 18.06 mg nalmefene equals 20 mg nalmefene hydrochloride.	intervention 1: Placebo intervention 2: Nalmefene	39	Linz \| N/A \| Austria \| 14.28611 \| 48.30639 Salzburg \| N/A \| Austria \| 13.04399 \| 47.79941 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Helsinki \| N/A \| Finland \| 24.93545 \| 60.16952 Helsinki \| N/A \| Finland \| 24.93545 \| 60.16952 Järvenpää \| N/A \| Finland \| 25.08992 \| 60.4736...	598	NCT00811720	1COMPLETED	2010-11-01	2008-12-01	H. Lundbeck A/S	4INDUSTRY	false	false	false	null	0
[ 3 ]	36	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The objectives of this study are to assess the safety, tolerability and local tolerance, and to investigate the plasma levels and terminal elimination half life of MCI-186, and to review the routine clinical and neurological assessments data of MCI-186 in subjects with acute ischemic stroke.	null	Acute Ischemic Stroke (AIS)		null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Cohort 1: Edaravone: circa 1000 mg / 72-hour infusion Cohort 2: Edaravone: circa 2000 mg / 72-hour infusion intervention 2: Cohort1:circa 1000mg / 72-hour infusion matching placebo Cohort2:circa 2000mg / 72-hour infusion matching placebo	intervention 1: MCI-186 intervention 2: Placebo	3	Helsinki \| N/A \| Finland \| 24.93545 \| 60.16952 Rotterdam \| N/A \| Netherlands \| 4.47917 \| 51.9225 Newcastle \| N/A \| United Kingdom \| -5.88979 \| 54.21804	36	NCT00821821	1COMPLETED	2010-11-01	2009-02-01	Mitsubishi Tanabe Pharma Corporation	4INDUSTRY	false	false	false	null	0
[ 3 ]	8	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to determine how safe and effective allantoin 3% cream (Alwextin) is in improving the healing of recurrent skin lesions and reducing overall blistering in people with epidermolysis bullosa (EB). Allantoin 3% cream is applied topically to the entire body once daily.	Potential subjects came to the for a screening visit. Eligible subjects had baseline assessments performed and were provided study medication, allantoin 3% cream. Subjects were instructed to apply the study medication to the entire body once daily and to keep daily record of study medication use. Subjects returned ever...	Epidermolysis Bullosa	Epidermolysis bullosa	null	1	arm 1: 8 subjects enrolled in this single study arm. All 8 subjects completed the study.	[ 0 ]	1	[ 0 ]	intervention 1: Alwextin cream contains active ingredient, allantoin 3%. Use 1 application daily for 3 month duration.	intervention 1: Alwextin cream	1	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003	8	NCT00825565	1COMPLETED	2010-11-01	2009-02-01	Northwestern University	7OTHER	false	false	false	null	0
[ 2 ]	10	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	This study is an open label 6 month study. All subjects will be treated with Polyphenon E (400 mg EGCG twice a day) for six months. The main outcome of this pilot phase will be safety. Secondary outcomes are the change in NAA levels over 6 months as measured by MR-spectroscopy. NAA levels are a marker of neuronal funct...	Additional clinical data include changes in EDSS, MS functional composite and cognitive testing.	Multiple Sclerosis	Multiple sclerosis safety open label Polyphenon E EGCG NAA N-acetyl-aspartate MRI	null	1	arm 1: Standarized green tea extract containing 50% EGCG	[ 0 ]	1	[ 0 ]	intervention 1: Polyphenon E capsules containing 200 mg of Epigallocachin-galleate. Two capsules twice a day.	intervention 1: Polyphenon E	1	New Orleans \| Louisiana \| United States \| -90.07507 \| 29.95465	10	NCT00836719	1COMPLETED	2010-11-01	2009-02-01	Louisiana State University Health Sciences Center in New Orleans	7OTHER	false	false	false	null	0
[ 2, 3 ]	59	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	true	2MALE	false	The purpose of this investigational study is to determine how much male hormone, testosterone, is necessary to maintain sperm production in the testis. This knowledge will be used to help in the development of a safe male hormonal contraception.	Three study drugs will be used in this study: Testim (testosterone gel), Human Chorionic Gonadotropin (hCG) and acyline. Testosterone is a naturally occurring hormone in men. When given to normal men, testosterone gel will temporarily lower the amount of testosterone in the testes and lower sperm counts. hCG is a femal...	Healthy Males	hCG testosterone Acyline Intratesticular hormone	null	5	arm 1: Acyline 300 ug/kg subcutaneous (SQ) injections on Day 1 plus subcutaneous placebo hCG injection (inj) every other day (5 doses) for 10 days arm 2: Acyline 300 ug/kg (SQ) inj(s) on Day 1 plus subcutaneous 15 IU hCG injection (inj) every other day (5 doses) for 10 days arm 3: Acyline 300 ug/kg subcutaneous (SQ) in...	[ 0, 0, 0, 0, 0 ]	6	[ 0, 10, 0, 0, 0, 0 ]	intervention 1: 300 ug/kg subcutaneous injections on Day 1. intervention 2: placebo hCG intervention 3: 15 IU subcutaneous injection every other day for 10 days (5 doses) intervention 4: 60 IU subcutaneous injection intervention 5: 125 IU subcutaneous injection intervention 6: 75 mg testosterone gel applied transdermal...	intervention 1: Acyline intervention 2: placebo hCG (no active ingredient) intervention 3: hCG (human chorionic gonadotropin) intervention 4: hCG (human chorionic gonadotropin) intervention 5: hCG (human chorionic gonadotropin) intervention 6: Testosterone gel	1	Seattle \| Washington \| United States \| -122.33207 \| 47.60621	31	NCT00839319	1COMPLETED	2010-11-01	2009-03-01	University of Washington	7OTHER	false	false	false	null	0
[ 3 ]	17	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Investigation into the long-term safety and efficacy of OPC-41061 in repeated oral administrations at doses of 15 mg twice daily in patients with ADPKD who completed the preceding dose-finding study (156-04-001).	Investigation into the long-term safety and efficacy of OPC-41061 in repeated oral administrations at doses of 15 mg twice daily in patients with ADPKD who completed the preceding dose-finding study (156-04-001).	Autosomal Dominant Polycystic Kidney Disease	ADPKD Tolvaptan	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years.	intervention 1: OPC-41061	1	Kanto Region \| N/A \| Japan \| N/A \| N/A	17	NCT00841568	1COMPLETED	2010-11-01	2006-04-01	Otsuka Pharmaceutical Co., Ltd.	4INDUSTRY	false	false	false	null	0
[ 2, 3 ]	29	RANDOMIZED	CROSSOVER	0TREATMENT	4QUADRUPLE	false	0ALL	false	Background: * Essential tremor (ET) is a neurological disorder characterized by uncontrollable shaking. Several medications are used to treat ET; however, they are often only partly effective and can have side effects. * Research studies have shown that octanol, a food additive similar to alcohol, can improve tremor i...	OBJECTIVE: We propose a study to examine the safety and efficacy of octanoic acid in essential tremor (ET). STUDY POPULATION: We will study 19 adult subjects with ethanol-responsive ET. DESIGN: Octanoic acid will be tested in a double-blind, randomized, placebo-controlled, cross-over design in 19 patients with ess...	Essential Tremor	Essential Tremor Octanol Octanoic Acid Ethanol Accelerometry	null	2	arm 1: None arm 2: None	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: 4mg/kg intervention 2: identical capsules	intervention 1: Octanoic Acid intervention 2: Placebo	1	Bethesda \| Maryland \| United States \| -77.10026 \| 38.98067	56	NCT00848172	1COMPLETED	2010-11-01	2009-02-01	National Institute of Neurological Disorders and Stroke (NINDS)	0NIH	false	false	false	null	0
[ 0 ]	1	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The purpose of the study is to compare the effects of nebivolol and metoprolol on 24-hour ambulatory blood pressure characteristics and basal metabolic rates in patients with hypertension.	null	Hypertension	Hypertension Beta-blockers Ambulatory blood pressure Basal metabolic rate Quality of life	null	1	arm 1: metoprolol 25-200mg at a stable daily dose for 4 weeks, then change to nebivolol at a comparable stable dose (5-20 mg) for 4 -5 weeks.	[ 0 ]	2	[ 0, 0 ]	intervention 1: Metoprolol tablets 25-200 mg daily times four weeks. Nebivolol daily for 4-5 weeks intervention 2: 5 - 20 mg daily, at a stable dose for 4 to 5 weeks	intervention 1: Metoprolol intervention 2: Nebivolol	1	Jackson \| Mississippi \| United States \| -90.18481 \| 32.29876	1	NCT00849810	6TERMINATED	2010-11-01	2009-01-01	University of Mississippi Medical Center	7OTHER	false	false	false	null	0
[ 4 ]	76	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	false	Azithromycin had a potent in vitro activities and broad spectrum from typical and atypical bacteria to anaerobes. Azithromycin intravenous formulation demonstrated high efficacy and eradication rate in the western clinical trials. Development of azithromycin intravenous formulation would bring the clinical benefit to p...	null	Pelvic Inflammatory Disease		null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: The patients will receive 500 mg intravenous azithromycin QD for 1 to 2 days. The period of administration of intravenous dosing is judged by investigators according to patient status. Following intravenous administration, the patients will be received the 250 mg oral azithromycin (tablet formulation) Q...	intervention 1: Azithromycin	31	Aichi-gun \| Aichi-ken \| Japan \| N/A \| N/A Ichinomiya \| Aichi-ken \| Japan \| 136.8 \| 35.3 Nagoya-city Naka-ku \| Aichi-ken \| Japan \| N/A \| N/A Tanba-gun Fusou-chou \| Aichi-ken \| Japan \| N/A \| N/A Hirosaki \| Aomori \| Japan \| 140.4725 \| 40.59306 Niihama \| Ehime \| Japan \| 133.30522 \| 33.96047 Kasuga \| Fukuoka \| Japan \| 130.4...	76	NCT00871494	1COMPLETED	2010-11-01	2009-05-01	Pfizer	4INDUSTRY	false	false	false	null	0
[ 3, 4 ]	27	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	Thalassemia is an inherited blood disorder that can result in mild to severe anemia. Many people with thalassemia also have pulmonary hypertension, which is high blood pressure in the arteries in the lungs. This study will evaluate the safety and effectiveness of the medication sildenafil at reducing blood pressure in ...	Thalassemia is an inherited blood disorder in which the body makes an abnormal form of hemoglobin-the protein in red blood cells that carries oxygen. A potential complication of thalassemia is pulmonary hypertension, which is a condition characterized by abnormally high blood pressure in the arteries of the lungs. Peop...	Thalassemia Hypertension, Pulmonary	Pulmonary Hypertension	null	2	arm 1: Participants with thalassemia who have pulmonary hypertension will receive sildenafil for 12 weeks. arm 2: Participants with thalassemia who do not have pulmonary hypertension will be part of a control group and will only be undergoing screening/baseline assessments.	[ 1, 4 ]	1	[ 0 ]	intervention 1: Participants will receive sildenafil for 12 weeks with the following therapy: 50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg	intervention 1: Sildenafil	1	Oakland \| California \| United States \| -122.2708 \| 37.80437	14	NCT00872170	1COMPLETED	2010-11-01	2009-03-01	Carelon Research	7OTHER	false	false	false	null	0
[ 3 ]	7	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	RATIONALE: 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. Drugs used in chemotherapy, such as ifosfamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing....	OBJECTIVES: Primary * Assess the safety, toxicity, and efficacy of neoadjuvant sorafenib tosylate and ifosfamide in patients with resectable high-grade soft tissue or bone sarcoma. Secondary * Assess the long-term efficacy or impact of therapy in these patients, in terms of the duration of local recurrence-free sur...	Sarcoma	localized osteosarcoma stage II adult soft tissue sarcoma stage III adult soft tissue sarcoma	null	1	arm 1: \* Neoadjuvant therapy: Patients receive oral sorafenib tosylate twice daily on days 1-14 in course 1. Patients then receive oral sorafenib tosylate twice daily on days 1-28 and ifosfamide IV continuously on days 1-7 in courses 2 and 3. Treatment repeats every 14-28 days\* for 3 courses. NOTE: \*Course 1 is 14 ...	[ 0 ]	2	[ 0, 0 ]	intervention 1: Patients with sarcoma who have resectable disease will be treated with neoadjuvant sorafenib and ifosfamide. PET/CT will be used to assess the metabolic and radiographic response to therapy. intervention 2: Patients with sarcoma who have resectable disease will be treated with neoadjuvant ifosfamide and...	intervention 1: sorafenib intervention 2: Ifosfamide	1	Los Angeles \| California \| United States \| -118.24368 \| 34.05223	7	NCT00880542	6TERMINATED	2010-11-01	2008-08-01	Jonsson Comprehensive Cancer Center	7OTHER	false	false	false	null	0
[ 4 ]	381	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	This study examines the efficacy of three doses of IPX066 as compared to placebo in Parkinson's disease.	A randomized, double-blind, placebo-controlled, fixed-dose, parallel-arm study of three doses of IPX066 versus placebo. Total of 427 subjects were screened and 381 were randomized and received one of the four treatment groups (1) placebo (N=92), (2) IPX066 145 mg LD (N=87) (3) IPX066 245 mg LD (N=104) (4) IPX066 390 m...	Parkinson's Disease	Parkinson's disease	null	4	arm 1: One Placebo capsule was given TID for the first 21 days. Two placebo capsules were given TID on days 22 till end of study (week 30). arm 2: One IPX066 95 mg LD was given TID on days 1-3. One IPX066 145 mg LD was given TID on days 4-21. One IPX066 145 mg LD and one placebo capsule were given TID on days 22 till e...	[ 2, 0, 0, 0 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: Placebo intervention 2: IPX066 capsule containing 95 mg LD/23.75 mg CD intervention 3: IPX066 capsule containing 145 mg LD/36.25 mg CD intervention 4: IPX066 capsule containing 195 mg LD/48.75 mg CD intervention 5: IPX066 capsule containing 245 mg LD/61.25 mg CD	intervention 1: Placebo intervention 2: IPX066 95 mg LD intervention 3: IPX066 145 mg LD intervention 4: IPX066 195 mg LD intervention 5: IPX066 245 mg LD	60	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Garden Grove \| California \| United States \| -117.94145 \| 33.77391 La Jolla \| California \| United States \| -117.2742 \| 32.84727 La Jolla \| California \| United States \| -117.2742 \| 32.84727 Sunnyvale \| Ca...	381	NCT00880620	1COMPLETED	2010-11-01	2009-04-01	Impax Laboratories, LLC	4INDUSTRY	false	false	false	null	0
[ 3, 4 ]	556	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	null	This was a four month dose ranging study followed by a 24 to 48 month extension at the selected dose to characterize the safety and efficacy of the injectable IL-1B (interleukin 1, beta) antagonist canakinumab in the treatment of patients with Type 2 diabetes mellitus (T2DM) already treated on maximum dose metformin.	null	Diabetes Mellitus, Type 2	type 2 diabetes canakinumab	null	5	arm 1: In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose \>2...	[ 0, 0, 0, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Canakinumab lyophilized cake (25 mg and 150 mg in individual 6 mL glass vials ) was reconstituted and then used to dilute the 25mg or 150mg solutions to make 5mg, 15mg and 50mg injections. intervention 2: Before randomization, in drug naïve patients at a dose of 1000 mg with the evening meal or 500 mg b...	intervention 1: Canakinumab intervention 2: Metformin intervention 3: Placebo	106	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 La Jolla \| California \| United States \| -117.2742 \| 32.84727 Los Gatos \| California \| United States \| -121.97468 \| 37.22661 Santa Monica \| California \| United States \| -118.49138 \| 34.01949 Tustin \| California \| United States \| -117.82617 \| 33.74585 Atlanta \| Ge...	551	NCT00900146	6TERMINATED	2010-11-01	2009-04-01	Novartis	4INDUSTRY	false	false	false	null	0
[ 3 ]	459	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	This will be a multicenter, randomized, double-blind, placebo-controlled study designed to assess the tolerability, safety, and efficacy of OPC-34712 (0.25 to 6.0 mg) for the treatment of adult subjects hospitalized with an acute relapse of schizophrenia. Aripiprazole (10 to 20 mg) is included as a positive control to ...	null	Schizophrenia	Schizophrenia Relapsed	null	6	arm 1: OPC-34712 0.25 mg arm arm 2: OPC-34712 low-dose arm arm 3: OPC-34712 mid-dose arm arm 4: OPC-34712 high-dose arm arm 5: None arm 6: Aripiprazole arm	[ 0, 0, 0, 0, 2, 1 ]	3	[ 0, 0, 0 ]	intervention 1: oral, once daily intervention 2: Placebo intervention 3: oral, once daily	intervention 1: OPC-34712 intervention 2: Placebo intervention 3: Aripiprazole	73	Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Escondido \| California \| United States \| -117.08642 \| 33.11921 Garden Grove \| California \| United States \| -117.94145 \| 33.77391 Long Beach \| California \| United States \| -118.18923 \| 33.76696 Oceanside \| California \| United States \| -117.37948 \| 33.19587 Pa...	459	NCT00905307	1COMPLETED	2010-11-01	2009-07-01	Otsuka Pharmaceutical Development & Commercialization, Inc.	4INDUSTRY	false	false	false	null	0
[ 4 ]	626	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	The primary objective of the double-blind phase of the study is to compare the effects of two doses of oxybutynin gel to placebo gel. The objective of the open-label extension is to evaluate the extended safety and skin-irritation profile of topically administered oxybutynin gel. The hypothesis is that topically admin...	null	Urge Urinary Incontinence Urinary Frequency		null	3	arm 1: None arm 2: None arm 3: None	[ 0, 0, 2 ]	2	[ 0, 0 ]	intervention 1: Oxybutynin Gel. Transdermal gel was applied once-daily (in the morning) during 12 weeks of treatment. Evaluation: reduction of incontinent episodes (baseline vs 12 weeks); comparison 56 resp. 84 mg vs placebo intervention 2: Placebo Gel Oxybutynin Gel. Transdermal gel was applied once-daily (in the mor...	intervention 1: Oxybutynin intervention 2: Placebo	55	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Laguna Hills \| California \| United States \| -117.71283 \| 33.61252 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 San Diego \| California \| United States \| -117.16472 \| 32.71571 San ...	626	NCT00909181	1COMPLETED	2010-11-01	2009-03-01	Antares Pharma Inc.	4INDUSTRY	false	false	false	null	0
[ 4 ]	507	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	true	1FEMALE	false	To investigate the potential benefits of a new oral contraceptive (SH T00658ID) on alleviating complaints of dysmenorrhea associated with oral contraceptive use.	null	Primary Dysmenorrhea	Primary Dysmenorrhea Oral Contraception	null	2	arm 1: Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles arm 2: Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles	[ 0, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Daily oral administration of one tablet SH T00658ID for 28 days per cycle in the respective treatment period; no tablet-free interval intervention 2: Daily oral administration of one tablet for 28 days per cycle in the respective treatment period; no tablet-free interval intervention 3: Daily oral admin...	intervention 1: Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027) intervention 2: Ethinyl estradiol, Levonorgestrel (Miranova) intervention 3: Placebo Match to SH T00658ID intervention 4: Placebo Match to SH D593B	41	Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 San Diego \| California \| United States \| -117.16472 \| 32.71571 Hialeah \| Florida \| United States \| -80.27811 \| 25.8576 Leesburg \| Florida \| United States \| -81.87786 \| 28.81082 Sandy Springs \| Georgia \| United States \| -84.37854 \| 33.92427 Idaho Falls \| Idaho \| U...	464	NCT00909857	1COMPLETED	2010-11-01	2009-04-01	Bayer	4INDUSTRY	false	false	false	null	0
[ 0 ]	306	RANDOMIZED	PARALLEL	9OTHER	0NONE	true	0ALL	false	The purpose of this study is to compare the efficacy of 15-day versus 10-day doxycycline treatment in patients with erythema migrans.	null	Erythema Chronicum Migrans	erythema migrans Lyme borreliosis doxycycline treatment outcome subjective symptoms	null	3	arm 1: None arm 2: None arm 3: None	[ 1, 1, 2 ]	3	[ 0, 0, 0 ]	intervention 1: doxycycline 100 mg bid, 10 days intervention 2: doxycycline 100 mg bid, 15 days intervention 3: control subjects without a history of Lyme borreliosis	intervention 1: doxycycline intervention 2: doxycycline intervention 3: placebo	1	Ljubljana \| N/A \| Slovenia \| 14.50513 \| 46.05108	225	NCT00910715	1COMPLETED	2010-11-01	2009-06-01	University Medical Centre Ljubljana	7OTHER	false	false	false	null	-0
[ 3 ]	154	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	This study will investigate how well adalimumab works in people with hidradenitis suppurativa (HS) in the short and long term.	This Phase 2 randomized, double-blind, placebo-controlled multicenter study consists of 2 treatment periods: a 16-week double-blind, placebo-controlled period (Period 1: Weeks 0 through the end of Week 15) followed by a 36-week open-label period (Period 2: Weeks 16 through 52). Participants are randomized in a 1:1:1 ra...	Hidradenitis Suppurativa	Hidradenitis Suppurativa Adalimumab Nodule Abscess Fistula Physicians Global Assessment Hurley Stage Sartorius Scale	null	3	arm 1: Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15. arm 2: Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15. arm 3: Matching placebo for adalim...	[ 0, 0, 2 ]	2	[ 2, 0 ]	intervention 1: Subcutaneous injection using prefilled syringe containing adalimumab 40 mg in 0.8 milliliters intervention 2: Subcutaneous injection using prefilled syringe containing 0.8 milliliters	intervention 1: adalimumab intervention 2: Placebo	26	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Bakerfield \| California \| United States \| N/A \| N/A Los Angeles \| California \| United States \| -118.24368 \| 34.05223 San Diego \| California \| United States \| -117.16472 \| 32.71571 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Atlanta \| Georgia \| Unite...	154	NCT00918255	1COMPLETED	2010-11-01	2009-04-01	Abbott	4INDUSTRY	false	false	false	null	-0
[ 4 ]	72	NA	SINGLE_GROUP	1PREVENTION	0NONE	true	1FEMALE	false	A prospective, open-label, single arm, multicenter study to evaluate efficacy, safety and acceptability of pericoital oral contraception with levonorgestrel	This is a prospective, open-label, single arm, multicenter study to evaluate efficacy, safety and acceptability of pericoital oral contraception with levonorgestrel (LNG). The objectives of the study as stated in the study protocol are as follows: * To evaluate the efficacy of the study regimen among women who have se...	Healthy	Contraception	null	1	arm 1: 0.75 mg of levonorgestrel within 24 hours of sex	[ 0 ]	1	[ 0 ]	intervention 1: oral contraceptive pills	intervention 1: levonorgestrel	4	Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Campinas \| Campinas \| Brazil \| -47.06083 \| -22.90556	72	NCT00922233	1COMPLETED	2010-11-01	2010-01-01	FHI 360	7OTHER	false	false	false	null	0
[ 3 ]	51	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	1FEMALE	true	A Phase II, multicenter, double-blind, randomized, placebo-controlled, dose-ranging, study to assess the efficacy and safety of the 100, 200, 400, 800, 1200 and 1600 mcg Misoprostol Vaginal Priming Insert (MVPI) for Women Requiring Cervical Priming prior to an in-office hysteroscopy procedure. Each subject will be rand...	Prior to the hysteroscopy procedure, study staff will record the type of procedure that will be conducted and the desired cervical dilatation. The study drug will be removed in the office and then a vaginal examination will be performed for signs of irritation or trauma. The diameter of the internal os will then be ass...	Cervical Priming	Hysteroscopy Cervical priming Cervical dilatation Misoprostol Endoscopy, uterine	null	2	arm 1: One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. The initial dose is 400 mcg and dose will be adjusted between 100 - 1600 mcg after each study cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB). arm 2: One vaginal...	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: One vaginal insert containing 100, 200, 400, 800, 1200, 1600 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure. An adaptive design will be used to determine whether to escalate or reduce the dose, starting with MVPI 400 mcg. in...	intervention 1: misoprostol intervention 2: placebo	2	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986	51	NCT00925938	1COMPLETED	2010-11-01	2010-01-01	Ferring Pharmaceuticals	4INDUSTRY	false	false	false	null	0

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