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
[ 0 ]	78	RANDOMIZED	CROSSOVER	7BASIC_SCIENCE	2DOUBLE	false	0ALL	true	Attention deficit hyperactivity disorder (ADHD) is characterized by inattention, impulsivity, and hyperactivity that are frequently treated with stimulant medications such as Ritalin. Many people with ADHD smoke. The smoking prevalence rates are estimated to be 40% in adults with ADHD compared to 20% in the general pop...	null	ADHD	Nicotine ADHD Gender	null	1	arm 1: None	[ 0 ]	2	[ 0, 10 ]	intervention 1: 21 mg nicotine patches for smokers for 2 days 7 mg nicotine patches for nonsmokers for 2 days intervention 2: Placebo Patch	intervention 1: Nicotine intervention 2: Placebo	1	Irvine \| California \| United States \| -117.82311 \| 33.66946	52	NCT00573248	1COMPLETED	2009-12-01	2005-08-01	University of California, Irvine	7OTHER	false	false	false	null	0
[ 5 ]	11	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Mycophenolate sodium (Myfortic®) is a newly developed enteric-coated tablet version of mycophenolate mofetil (Cellcept®) which is currently used as therapy for the prevention of transplant rejection. Myfortic® was developed to improve the gastrointestinal tolerability of Cellcept®. The new enteric-coated, Myfortic® is ...	This is an open-labeled, prospective, non-randomized pilot-phase study of the enteric-coated, Myfortic® versus the non enteric-coated, Cellcept® in patients who are within 5 years of having undergone heart transplant surgery who are currently taking Cellcept®. After the initial screening, 20 patients who fulfill the in...	Gastrointestinal Symptoms Heart Transplantation	Heart Transplant gastrointestinal Cellcept Myfortic GI GI symptoms with Mycophenolate Mofetil post heart transplant	null	1	arm 1: 1440mg/day (720mg by mouth, twice a day) of enteric-coated Mycophenolate Sodium (Myfortic) for 6 months	[ 5 ]	1	[ 0 ]	intervention 1: 1440mg/day (720mg by mouth, twice a day)	intervention 1: Mycophenolate Sodium	1	Los Angeles \| California \| United States \| -118.24368 \| 34.05223	11	NCT00574197	1COMPLETED	2009-12-01	2006-06-01	Cedars-Sinai Medical Center	7OTHER	false	false	false	null	0
[ 1 ]	14	NON_RANDOMIZED	SINGLE_GROUP	null	1SINGLE	true	0ALL	true	This is a dose escalation study to determine the maximum tolerable dose of Parathyroid Hormone-related Protein, PTHrP, that can be given safely over one week. The investigators plan to infuse low doses of intravenous PTHrP to determine if it leads to a sustained and progressive suppression of bone formation as occurs i...	During this research the investigators administer PTHrP to healthy young volunteers in a controlled, continuous intravenous manner. As research subjects complete the week-long study without adverse effects, the dose of PThrP will be increased in later subjects. In the event of a significant adverse effect, immediate ac...	Osteoporosis Humoral Hypercalcemia of Malignancy Hyperparathyroidism	Endocrine System Diseases MusculoSkeletal System Diseases Hormones Malignancy Postmenopausal Women Bone metabolism	null	4	arm 1: PTHrP(1-36) at 2 picomoles/kg/hr for one week. arm 2: PTHrP(1-36) at 4 picomoles/kg/hr for one week. arm 3: PTHrP(1-36) at 5 picomoles/kg/hr for one week. arm 4: PTHrP(1-36) at 6 picomoles/kg/hr for one week.	[ 0, 0, 0, 0 ]	1	[ 0 ]	intervention 1: IND # 49,175	intervention 1: PTHrP (1-36)	1	Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062	14	NCT00580788	1COMPLETED	2009-12-01	2008-01-01	University of Pittsburgh	7OTHER	false	false	false	null	0
[ 5 ]	72	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The purpose of this study is to see whether memantine improves memory function in participants with bipolar disorder who have minimal symptoms. Secondary analyses will test the role of memantine in improving residual mood symptoms (depression and mania) in participants with bipolar disorder. We hypothesize that in par...	A large proportion of participants with bipolar disorder experience significant cognitive dysfunction, even when euthymic, after adequate treatment. The cognitive deficits in asymptomatic patients with bipolar disorder are very important for the participant's psychosocial function. In this population, cognitive deficit...	Bipolar Disorder	Bipolar disorder Cognitive dysfunction Memantine NMDA antagonist	null	2	arm 1: Placebo-matching memantine 5 mg tablet once per day for 1 week; dose increase if tolerated to placebo-matching memantine 5 mg twice a day, in the morning and the evening in Week 2; dose increase if tolerated to placebo-matching memantine 5 mg in the morning and placebo-matching memantine 10 mg in the evening in ...	[ 2, 0 ]	2	[ 0, 0 ]	intervention 1: Week 0: 5 mg memantine or placebo once a day (q.d.) Week 1: 5 mg memantine or placebo twice a day (b.i.d.) Week 2-3: 5 mg memantine or placebo once in the morning (q.a.m.)/10 mg once in the evening (q.p.m.) Week 4-12: 10mg Memantine or placebo b.i.d. intervention 2: Inactive comparator. Placebo-matching...	intervention 1: Memantine intervention 2: Placebo	3	Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	72	NCT00586066	1COMPLETED	2009-12-01	2005-11-01	Massachusetts General Hospital	7OTHER	false	false	false	null	0
[ 4 ]	95	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	To determine whether adding nebulized inhaled steroids to the standard care of acutely ill ED patients with refractory acute asthma helps improve forced expiratory volume at one second (FEV1) and decrease the need for hospitalization.	This is a randomized clinical trial studying the effect of nebulized budesonide (Pulmicort) in acutely ill adults presenting to the Emergency Department with severe asthma. Budesonide is an inhaled steroid FDA approved for the treatment of pediatric chronic asthma. ED entry criteria include hyporesponsiveness to nebuli...	Asthma	acute, emergency department	null	2	arm 1: Budesonide, 2mg, 4 doses, plus standard care arm 2: Placebo plus standard care	[ 0, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 2mg/dose by nebulizer, four doses over 3 hours intervention 2: 2.5mg/dose by nebulizer, 7 doses over 6 hours intervention 3: 2.5 mg, one dose intervention 4: 60mg PO	intervention 1: Budesonide intervention 2: albuterol intervention 3: Ipratropium bromide intervention 4: Prednisone	3	East Meadow \| New York \| United States \| -73.55902 \| 40.71399 Queens \| New York \| United States \| -73.83652 \| 40.68149 The Bronx \| New York \| United States \| -73.86641 \| 40.84985	95	NCT00588406	1COMPLETED	2009-12-01	2007-09-01	Northwell Health	7OTHER	false	false	false	null	0
[ 3 ]	18	RANDOMIZED	SINGLE_GROUP	0TREATMENT	3TRIPLE	false	0ALL	true	Babies having heart surgery often have problems after surgery with their blood pressure and getting enough blood to their bodies. To treat this they require medicines to keep their blood pressure high enough to get blood to their bodies. The side effects of these medicines include fast heart rates and increasing the am...	The study will be prospective. Patients who meet entry criteria will be randomized to receive corticosteroids versus placebo. Randomization will take into account biventricular versus univentricular repairs/palliations and whether the patients received intraoperative steroids. Patients will be compared with matched con...	Cardiac Output, Low	Congenital heart disease. Low cardiac output syndrome. Corticosteroids. Hydrocortisone. Blood pressure. Inotropes.	null	2	arm 1: Subjects in this arm will receive a 5 day tapering course of hydrocortisone. arm 2: Subjects in this arm will receive 5 days of placebo.	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Hydrocortisone taper (100mg/m2/day --\> 25mg/m2/day) over 5 days intravenously. intervention 2: Placebo for 5 days intravenously.	intervention 1: Hydrocortisone intervention 2: Placebo	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	18	NCT00590018	1COMPLETED	2009-12-01	2003-02-01	Baylor College of Medicine	7OTHER	false	false	false	null	0
[ 3 ]	61	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	Patients with surgically resectable T1N1M0 or T2-4N any M0 esophageal carcinoma will receive six weeks of induction chemotherapy with weekly irinotecan and cisplatin given weeks 1, 2, 4 and 5. Patients will then receive weekly irinotecan, cisplatin, and concurrent radiotherapy with chemotherapy given once weekly, weeks...	null	Esophageal Carcinoma	Esophageal Carcinoma Cisplatin Irinotecan Radiation Therapy 02-045	null	1	arm 1: External Beam Radiation Therapy, Cisplatin, Irinotecan	[ 0 ]	3	[ 0, 0, 4 ]	intervention 1: pts will receive weekly cisplatin 30mg/m2 after hydration on weeks 8,9,11 and 12 intervention 2: Irinotecan will be given 65 mg/m2 intervention 3: will be delivered with multiple (\>2) field techniques using mega-voltage radiation therapy. pts will receive 50.4 Gy and will be treated over a 6 week perio...	intervention 1: Cisplatin intervention 2: Irinotecan intervention 3: External Beam Radiation Therapy	1	New York \| New York \| United States \| -74.00597 \| 40.71427	55	NCT00590031	1COMPLETED	2009-12-01	2002-11-01	Memorial Sloan Kettering Cancer Center	7OTHER	false	false	false	null	0
[ 0 ]	13	NA	SINGLE_GROUP	0TREATMENT	0NONE	true	0ALL	null	This study is designed to evaluate anxious patients who are only partially responsive to typical SSRI or SNRI anti-anxiety medication therapy. Patients who are less than 50% anxiety-alleviated on their SSRI medication will be asked to join the study and be placed on Acamprosate as well. This type of add-on therapy is c...	Acamprosate is felt to restore the normal glutamate-GABA balance in the human brain. (Glutamate is a stimulating chemical in the brain, while GABA is an inhibitory chemical in the brain.) This GABA-glutamate balance is felt to play a role in the development of anxiety. Low GABA and high glutamate levels (similar to the...	Anxiety	Anxiety SSRI SNRI Acamprosate	null	1	arm 1: acamprosate tablets	[ 0 ]	1	[ 0 ]	intervention 1: acamprosate 333mg tab, 3 by mouth 3 times a day	intervention 1: Acamprosate	1	Syracuse \| New York \| United States \| -76.14742 \| 43.04812	13	NCT00591565	1COMPLETED	2009-12-01	2006-06-01	State University of New York - Upstate Medical University	7OTHER	false	false	false	null	0
[ 5 ]	17	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This will be an 8-week open-label trial, using daily doses of paliperidone (Invega) in the treatment of children and adolescents who meet DSM-IV criteria of Bipolar I, Bipolar II, or Bipolar Spectrum Disorder. Specific hypotheses are as follows: Hypothesis 1: Bipolar Disorder symptomatology in children and adolescents...	Invega (paliperidone), a second generation antipsychotic (SGA), is a psychotropic agent belonging to the chemical class of benzisoxazole derivatives. Invega is approved by the FDA for the treatment of schizophrenia in adults. Initial data suggest a promising role for Invega in the treatment of bipolar disorder with min...	Pediatric Bipolar Disorder	bipolar disorder children adolescents Invega	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: tablet, 3mgQAM - 6mgQAM, taken daily for 8 weeks	intervention 1: paliperidone	1	Cambridge \| Massachusetts \| United States \| -71.10561 \| 42.3751	15	NCT00592358	6TERMINATED	2009-12-01	2007-11-01	Massachusetts General Hospital	7OTHER	false	false	false	null	0
[ 4 ]	493	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study was to evaluate the safety and efficacy of peginesatide for the treatment of anemia in participants with chronic kidney disease, who are not on dialysis and not on erythropoiesis stimulating agent (ESA) treatment.	Anemia associated with chronic kidney disease is due to several factors, primarily the inability of the diseased kidneys to produce adequate amounts of endogenous erythropoietin. Ancillary factors include the shortened lifespan of red blood cells, iron and other nutritional deficiencies, infection, and inflammation. Th...	Chronic Renal Failure Chronic Kidney Disease Anemia	anemia chronic kidney disease CKD chronic renal failure CRF erythropoietin EPO erythropoiesis stimulating agent ESA Hematide™ hemoglobin Hb Hgb Omontys peginesatide red blood cell red blood cell production	null	3	arm 1: None arm 2: None arm 3: None	[ 0, 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL). intervention 2: Participants received peginesat...	intervention 1: peginesatide intervention 2: peginesatide intervention 3: Darbepoetin alfa	64	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Fayetteville \| Arkansas \| United States \| -94.15743 \| 36.06258 Fountain Valley \| California \| United States \| -117.95367 \| 33.70918 Fullerton \| California \| United States \| -117.92534 \| 33.87029 Granada Hills \| California \| United States \| -118.52314 \| 34.26472 ...	493	NCT00598442	1COMPLETED	2009-12-01	2007-11-01	Affymax	4INDUSTRY	false	false	false	null	-0
[ 3 ]	4	NON_RANDOMIZED	SINGLE_GROUP	4SUPPORTIVE_CARE	0NONE	false	0ALL	true	RATIONALE: Deferasirox may be effective in treating iron overload caused by blood transfusions in patients who have undergone donor stem cell transplant. PURPOSE: This phase II trial is studying the side effects and how well deferasirox works in treating patients with iron overload after donor stem cell transplant.	OBJECTIVES: Primary * To evaluate the safety of deferasirox given over 6 months in reducing liver iron concentration in patients with transfusional iron overload after undergoing allogeneic hematopoietic stem cell transplantation. Secondary * To evaluate the efficacy of deferasirox in reducing liver iron overload i...	Breast Cancer Iron Overload Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Neuroblastoma Ovarian Cancer	iron overload	null	1	arm 1: Includes patients that were treated with deferasirox for 6 months.	[ 0 ]	1	[ 0 ]	intervention 1: 20 mg/kg once daily orally for 6 months	intervention 1: deferasirox	1	Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997	3	NCT00602446	6TERMINATED	2009-12-01	2007-08-01	Masonic Cancer Center, University of Minnesota	7OTHER	false	false	false	null	0
[ 3 ]	5	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	false	The purpose of this study is to determine whether Cisplatin when given with radiation therapy prior to surgery is effective in improving response to treatment in breast cancer patients. Tumor, blood and bone marrow samples will be collected in this study and will also help researchers determine if cisplatin is able to ...	After Diagnosis: Clinical Stage IIB, III Breast Cancer, Triple Negative Week 0: Port-A-Cath placement Tumor biopsy (Core and FNA) Blood collection Bone marrow aspiration Sentinel Lymph node biopsy, if axillary US negative Week 1: Chemo \& Radiation Day 1: Radiation Therapy, Cisplatin 75mg/m\^2 (cycle 1) Days 2-5: Rad...	Breast Cancer	Breast Cancer Locally Advanced Neoadjuvant	null	1	arm 1: Cisplatin 75 mg/m\^2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10 Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks. Surgery (recommended...	[ 0 ]	3	[ 0, 4, 3 ]	intervention 1: None intervention 2: None intervention 3: (RECOMMENDED BUT NOT REQUIRED)	intervention 1: Cisplatin intervention 2: Radiation Therapy intervention 3: Mastectomy	1	St Louis \| Missouri \| United States \| -90.19789 \| 38.62727	5	NCT00603408	6TERMINATED	2009-12-01	2007-12-01	Washington University School of Medicine	7OTHER	false	false	false	null	0
[ 4 ]	92	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Examine the efficacy, safety and pharmacokinetics of gabapentin as adjunctive therapy in Japanese pediatric patients with partial seizures	null	Epilepsies, Partial		null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Orally administered gabapentin	intervention 1: gabapentin	26	Obu-shi,Morioka-machi \| Aichi-ken \| Japan \| N/A \| N/A Jonan-ku \| Fukuoka \| Japan \| N/A \| N/A Sapporo \| Hokkaido \| Japan \| 141.35 \| 43.06667 Kobe \| Hyōgo \| Japan \| 135.183 \| 34.6913 Suma-Ku, Kobe \| Hyōgo \| Japan \| 135.183 \| 34.6913 Kanazawa \| Ishikawa-ken \| Japan \| 136.61667 \| 36.6 Zentsuuji \| Kagawa-ken \| Japan \| N/A \|...	89	NCT00603473	1COMPLETED	2009-12-01	2008-01-01	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	4INDUSTRY	false	false	false	null	0
[ 4 ]	226	NA	SINGLE_GROUP	2DIAGNOSTIC	0NONE	false	0ALL	false	This is a multicenter Phase III study to demonstrate the diagnostic utility of 124I-cG250 PET/CT pre-surgical imaging in patients with operable renal masses.	A preoperative 124I-cG250 PET scan may distinguish between clear cell and non-clear cell renal carcinoma in patients with renal masses. Studies of imaging characteristics of 124I by a variety of PET cameras, quantification of tumor uptake of 124I-labeled antibody and correlation with biopsy measurement of tumor and nor...	Renal Cell Carcinoma Kidney Cancer	Renal Mass Clear Cell Renal Cell Carcinoma Cancer of Kidney Kidney Cancer Neoplasms cG250 antibody, monoclonal Iodine 124 Positron-Emission Tomography Kidney Renal Cancer Renal Neoplasms	null	1	arm 1: Single arm study, comparing 124I cG250 PET/CT and CT. Each patient underwent a PET/CT and CT scan days (+/-2days) after receipt of 124I cG250.	[ 5 ]	2	[ 0, 3 ]	intervention 1: i.v. and PET/CT scan 4+/-2 days after administration intervention 2: contrast enhanced CT scan	intervention 1: 124-Iodine-cG250 (124I-cG250) intervention 2: CT	14	Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Stanford \| California \| United States \| -122.16608 \| 37.42411 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Burlington \| Massachusetts \| United States \| -71.19561 \| 42.50482 Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756 Las Vegas \| ...	226	NCT00606632	1COMPLETED	2009-12-01	2008-03-01	Heidelberg Pharma AG	4INDUSTRY	false	false	false	null	-0
[ 3 ]	187	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of the study is to evaluate the efficacy of retigabine vs. placebo in reducing pain associated with post-herpetic neuralgia.	This is a Phase 2a proof of concept study evaluating the safety/efficacy of retigabine vs. placebo in patients with post-herpetic neuralgia. After screening, patients will enter a maximum 6 week titration period followed by a 4 week maintenance period and a 3 week taper phase.	Postherpetic Neuralgia	Postherpetic Neuralgia, PHN, Shingles,	null	2	arm 1: Retigabine arm 2: Placebo	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 150mg/day up to 900mg/day intervention 2: daily	intervention 1: Retigabine intervention 2: Placebo	45	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Mesa \| Arizona \| United States \| -111.82264 \| 33.42227 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Garden Grove \| California \| United States \| -117.94145 \| 33.77391 La Jolla \| Californi...	187	NCT00612105	1COMPLETED	2009-12-01	2007-10-01	Bausch Health Americas, Inc.	4INDUSTRY	false	false	false	null	0
[ 4 ]	280	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	1FEMALE	false	The purpose of this study is to determine whether Diclectin® (doxylamine succinate USP 10 mg and pyridoxine HCl 10 mg) is more effective at controlling the nausea and vomiting of pregnancy than a placebo.	Nausea and vomiting of pregnancy (NVP), also known as "morning sickness," is a common condition that affects a large percentage of pregnant women. The symptoms can range from mild nausea to severe nausea and vomiting for which a woman may need to be hospitalized. Nausea and vomiting of pregnancy can affect a woman's qu...	Nausea and Vomiting of Pregnancy	Nausea Vomiting Pregnancy Hyperemesis gravidarum Pregnancy complications	null	2	arm 1: Diclectin® (doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg) delayed release tablet arm 2: Placebo tablets identical in size, shape, taste, and color to the experimental treatment (Diclectin®)	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: up to 4 tablets daily, titrated according to the protocol intervention 2: 2 to 4 tablets daily titrated according to the protocol	intervention 1: doxylamine succinate 10 mg/pyridoxine hydrochloride 10 mg intervention 2: Placebo	7	Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Bethesda \| Maryland \| United States \| -77.10026 \| 38.98067 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 Galveston \| Texas \| United States \| -94....	261	NCT00614445	1COMPLETED	2009-12-01	2008-01-01	Duchesnay Inc.	4INDUSTRY	false	false	false	null	0
[ 3 ]	5	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Selenomethionine may slow the growth of tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving...	OBJECTIVES: Primary * To determine the complete pathological response rate of the combination of capecitabine, oxaliplatin, selenomethionine, and radiotherapy in patients with stage II or III rectal adenocarcinoma. * To determine the T-downstaging rate with this regimen in patients with stage II or III rectal adenoca...	Colorectal Cancer	adenocarcinoma of the rectum stage II rectal cancer stage III rectal cancer	null	1	arm 1: Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends	[ 0 ]	9	[ 7, 0, 0, 10, 10, 3, 3, 3, 4 ]	intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None intervention 8: None intervention 9: None	intervention 1: selenomethionine intervention 2: capecitabine intervention 3: oxaliplatin intervention 4: laboratory biomarker analysis intervention 5: pharmacological study intervention 6: adjuvant therapy intervention 7: neoadjuvant therapy intervention 8: therapeutic conventional surgery intervention 9: radiation th...	1	Buffalo \| New York \| United States \| -78.87837 \| 42.88645	5	NCT00625183	6TERMINATED	2009-12-01	2008-03-01	Roswell Park Cancer Institute	7OTHER	false	false	false	null	0
[ 5 ]	5	RANDOMIZED	CROSSOVER	6HEALTH_SERVICES_RESEARCH	0NONE	false	0ALL	false	Tacrolimus (Prograf) belongs to a class of medications known as the calcineurin inhibitors. It is a maintenance drug that is used to prevent rejection in kidney, liver, and heart transplant recipients. Calcineurin inhibitors display high pharmacokinetic (the body's effects on a drug) variability and necessitate use of ...	Tacrolimus (Prograf) belongs to a class of medications known as the calcineurin inhibitors. It is a maintenance drug that is used to prevent rejection in kidney, liver, and heart transplant recipients. Calcineurin inhibitors display high pharmacokinetic (the body's effects on a drug) variability and necessitate use of ...	Kidney Failure, Chronic	Kidney Transplantation Tacrolimus (Prograf) Pharmacokinetics Sublingual administration Drug interactions (Cytochrome P450 and p-glycoprotein)	null	2	arm 1: Administer sublingual tacrolimus 2 mg every 12 hours (subject weight \< 90 kg) or 3 mg every 12 hours (subject weight \> 90kg) (study day 1 - 3). Tacrolimus capsules will be opened and the contents placed under the participants tongue. Oral tacrolimus at same dose every 12 hours (study day 6 - 8). Tacrolimus cap...	[ 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Study day 1 (9a): Initiate sublingual (SL) tacrolimus and clotrimazole troche x 5 doses; Study day 3 (9a): Collection of pharmacokinetic parameters around the 5th SL tacrolimus dose; Study day 3 (9p): Start washout period, no drug administration (tacrolimus, clotrimazole); Study day 5 (9p): End washout ...	intervention 1: Tacrolimus (Arm B) intervention 2: Clotrimazole Troche intervention 3: Tacrolimus (Arm A) intervention 4: Nystatin Suspension	1	New York \| New York \| United States \| -74.00597 \| 40.71427	5	NCT00629122	1COMPLETED	2009-12-01	2008-02-01	Weill Medical College of Cornell University	7OTHER	false	false	false	null	0
[ 0 ]	44	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose is to examine the safety and efficacy of 16wks of pioglitazone (Actos; 30mg/d) with and without aerobic and strength exercise training for reducing glucose intolerance and central adiposity in HIV-infected people. We anticipate that pioglitazone + exercise training will improve glucose metabolism and insuli...	Our prior research has examined the pathogenesis and potential treatments for metabolic complications in people living with HIV. We have adopted the "lipotoxicity" hypothesis for Metabolic Syndrome X to explain the pathogenesis of impaired glucose tolerance (IGT) and fat redistribution in HIV: increased lipolysis and m...	HIV Infections Type 2 Diabetes Obesity HIV AIDS Cardiovascular Disease Lipodystrophy	PPAR-gamma agonist glucose metabolism inflammation adipose tissue distribution cardiac function vascular function mass spectrometry Treatment Experienced	null	2	arm 1: Pioglitazone (Actos; 30mg/day) for 16 weeks. arm 2: Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.	[ 0, 1 ]	2	[ 0, 5 ]	intervention 1: Oral 30mg/day for 16 weeks intervention 2: Supervised aerobic and resistance exercise training (1.5hrs/day x 3 days/wk) for 16 weeks	intervention 1: Pioglitazone intervention 2: Exercise training	1	St Louis \| Missouri \| United States \| -90.19789 \| 38.62727	39	NCT00639457	1COMPLETED	2009-12-01	2005-01-01	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	0NIH	false	false	false	null	0
[ 4 ]	2,500	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	To determine the effectiveness of four different strength combinations of three approved anti-hypertension therapies (olmesartan medoxomil, amlodipine, and hydrochlorothiazide) for lowering blood pressure.	null	Hypertension		null	4	arm 1: olmesartan medoxomil 40mg and amlodipine 10mg arm 2: olmesartan medoxomil 40mg and hydrochlorothiazide 25mg arm 3: amlodipine 10mg and hydrochlorothiazide 25mg arm 4: olmesartan medoxomil 40mg, amlodipine 10mg, and hydrochlorothiazide 25mg	[ 0, 1, 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: 40mg olmesartan medoxomil intervention 2: Amlodipine 10mg intervention 3: Hydrochlorothiazide 25mg	intervention 1: Olmesartan medoxomil intervention 2: Amlodipine intervention 3: Hydrochlorothiazide	232	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Columbiana \| Alabama \| United States \| -86.60721 \| 33.17817 Gulf Shores \| Alabama \| United States \| -87.70082 \| 30.24604 Hoover \| Alabama \| United States \| -86.81138 \| 33.40539 Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 Mobile \| Alabama \| Unite...	2,302	NCT00649389	1COMPLETED	2009-12-01	2008-05-01	Daiichi Sankyo	4INDUSTRY	false	false	false	null	0
[ 3, 4 ]	66	RANDOMIZED	PARALLEL	9OTHER	0NONE	true	0ALL	true	This study will examine changes in brain dopamine transporter activity before and after antidepressant therapy.	Depression is a serious psychiatric disorder that affects about 10% of the adult population in the United States in a given year. Common symptoms of depression include a persistent down mood and disinterest in previously enjoyed activities, often causing strain on work, social, and family life. A person's depression ca...	Depression	Dopamine Transporter Biomarker SPECT Brain Imaging Antidepressant Therapy	null	3	arm 1: Healthy participants will undergo TRODAT-1 SPECT imaging. arm 2: Participants with depression will undergo TRODAT-1 SPECT imaging and treatment with s-citalopram. arm 3: Participants with depression will undergo TRODAT-1 SPECT imaging and treatment with cognitive behavioral therapy.	[ 1, 0, 1 ]	3	[ 0, 5, 3 ]	intervention 1: Participants will take 10 to 30 mg of s-citalopram daily for 12 weeks. intervention 2: Participants will attend twice weekly CBT sessions for 2 weeks and then once weekly sessions for 10 weeks. Sessions will focus on modifying thoughts and behaviors that may contribute to depression. intervention 3: Par...	intervention 1: S-citalopram intervention 2: Cognitive behavioral therapy (CBT) intervention 3: TRODAT-1 single photon emission computed tomographic (SPECT) imaging	1	Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	0	NCT00655057	1COMPLETED	2009-12-01	2005-10-01	University of Pennsylvania	7OTHER	false	false	false	null	0
[ 4 ]	71	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to compare the efficacy of Alogliptin, once daily (QD), taken by itself and with pioglitazone on postprandial lipid measures in type 2 diabetes.	SYR-322 (alogliptin) is a selective, orally available inhibitor of dipeptidyl peptidase IV being developed as a treatment for type 2 diabetes mellitus. Dipeptidyl peptidase IV is the primary enzyme involved in the in vivo degradation of at least 2 peptide hormones released in response to nutrient ingestion, namely gluc...	Diabetes Mellitus	Glucose Metabolism Disorder Dysmetabolic Syndrome Type II Diabetes Diabetes Mellitus Lipoatrophic; Dyslipidemia Drug Therapy	null	3	arm 1: None arm 2: None arm 3: None	[ 2, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks. intervention 2: Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks. intervention 3: Alogliptin placebo-matchin...	intervention 1: Alogliptin and Pioglitazone intervention 2: Alogliptin intervention 3: Placebo	2	Amsterdam \| N/A \| Netherlands \| 4.88969 \| 52.37403 Gothenburg \| N/A \| Sweden \| 11.96679 \| 57.70716	71	NCT00655863	1COMPLETED	2009-12-01	2007-07-01	Takeda	4INDUSTRY	false	false	false	null	0
[ 4 ]	123	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	This study will evaluate the safety and efficacy of two dose levels of pimavanserin (ACP-103) compared to placebo in patients with Parkinson's disease psychosis.	null	Parkinson's Disease Psychosis		null	3	arm 1: pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks arm 2: Placebo tablet, once daily by mouth, 6 weeks arm 3: pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks	[ 0, 2, 0 ]	3	[ 0, 0, 0 ]	intervention 1: 10 mg, tablet, once daily by mouth, for six weeks intervention 2: 20 mg, tablet, once daily by mouth, for six weeks intervention 3: Placebo, tablet, once daily by mouth, for six weeks	intervention 1: Pimavanserin tartrate (ACP-103) intervention 2: Pimavanserin tartrate (ACP-103) intervention 3: Pimavanserin tartrate (ACP-103)	50	La Habra \| California \| United States \| -117.94617 \| 33.93196 Laguna Hills \| California \| United States \| -117.71283 \| 33.61252 Reseda \| California \| United States \| -118.53647 \| 34.20112 Ventura \| California \| United States \| -119.29317 \| 34.27834 Englewood \| Colorado \| United States \| -104.98776 \| 39.64777 Farmington...	121	NCT00658567	1COMPLETED	2009-12-01	2008-03-01	ACADIA Pharmaceuticals Inc.	4INDUSTRY	false	false	false	null	0
[ 5 ]	98	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	Assess the efficacy and safety of alefacept with nbUVB compared to alefacept alone in chronic plaque psoriasis subjects. Combination therapy may improve the clinical response to psoriatic subjects as both modalities have an effect on T cells	null	Plaque Psoriasis	plaque psoriasis alefacept Amevive narrow band ultraviolet B phototherapy	null	2	arm 1: 15 mg alefacept intramuscularly (IM) once weekly for 12 weeks arm 2: 15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks	[ 1, 0 ]	2	[ 0, 3 ]	intervention 1: IM intervention 2: UVB Phototherapy	intervention 1: alefacept intervention 2: Narrow Band UVB Phototherapy	12	Calgary \| Alberta \| Canada \| -114.08529 \| 51.05011 Surrey \| British Columbia \| Canada \| -122.82509 \| 49.10635 Vancouver \| British Columbia \| Canada \| -123.11934 \| 49.24966 St. John's \| Newfoundland and Labrador \| Canada \| -52.70931 \| 47.56494 London \| Ontario \| Canada \| -81.23304 \| 42.98339 Markham \| Ontario \| Canada \|...	98	NCT00658606	1COMPLETED	2009-12-01	2007-10-01	Astellas Pharma Inc	4INDUSTRY	false	false	false	null	0
[ 5 ]	45	RANDOMIZED	PARALLEL	null	0NONE	false	0ALL	false	The study objective was to assess the effect of single and multiple doses of aliskiren on renal plasma flow, glomerular filtration rate and to compare the effects of single and multiple doses of aliskiren versus captopril or irbesartan on renal blood flow, glomerular filtration rate, and retinal blood flow in patients ...	null	Type 2 Diabetes Mellitus	Type 2 diabetes mellitus renal disease hypertension renal blood flow retinal blood flow aliskiren irbesartan captopril	null	2	arm 1: On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days. arm 2: On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets oral...	[ 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Aliskiren 300 mg tablets intervention 2: Irbesartan 300 mg tablets intervention 3: Captopril 25 mg tablet	intervention 1: Aliskiren intervention 2: Irbesartan intervention 3: Captopril	1	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	88	NCT00660309	1COMPLETED	2009-12-01	2008-04-01	Novartis	4INDUSTRY	false	false	false	null	0
[ 3 ]	54	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	The purpose of this Phase II study is to determine if AZD4877, an experimental drug that is a novel anti-mitotic agent (Eg5 or Kinesin Spindle Protein inhibitor that interferes with tumor cell division leading to tumor growth), can reduce tumor sizes in patients with bladder cancer	null	Bladder Cancer Transitional Cell Bladder Cancer Urethra Cancer Ureter Cancer Renal Pelvis Cancer	Anti-mitotic Eg5 Inhibitor Kinesin Spindle Protein Inhibitor Urothelial Cancer Bladder Cancer Renal Pelvis Cancer Urethra Cancer Ureter Cancer Recurrent Advanced Stage IV	null	1	arm 1: Single agent AZD4877	[ 0 ]	1	[ 0 ]	intervention 1: Intravenous (IV)25mg/weekly	intervention 1: AZD4877	36	Palo Alto \| California \| United States \| -122.14302 \| 37.44188 San Bernardino \| California \| United States \| -117.28977 \| 34.10834 Southington \| Connecticut \| United States \| -72.8776 \| 41.59649 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Marietta \| Geor...	41	NCT00661609	1COMPLETED	2009-12-01	2008-05-01	AstraZeneca	4INDUSTRY	false	false	false	null	0
[ 3 ]	32	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	Primary objective: To determine the 6-month progression free survival of patients with recurrent glioblastoma multiforme (GBM) treated with Erlotinib plus Sirolimus. Secondary objectives: To further define the safety and tolerability of Erlotinib plus Sirolimus when administered to patients with recurrent GBM; and t...	The primary objective of this study will be to determine the 6-month progression free survival of patients with recurrent GBM treated with Erlotinib plus Sirolimus. This is an exploratory, single-arm, phase II study designed to assess the anti-tumor activity of a combinatorial regimen consisting of Erlotinib plus Siro...	Glioblastoma Gliosarcoma	GBM Brain tumor Erlotinib Sirolimus Glioblastoma multiforme Glioblastoma Gliosarcoma3 Tarceva Rapamune	null	1	arm 1: Erlotinib \& sirolimus on a daily dosing schedule on a 28-day cycle. Dosing was 150 mg of erlotinib and 5mg of sirolimus for patients not on concurrent Cytochrome P450, family 3 (CY3PA)-inducing anti-epileptics (EIAEDS) and 400 mg of erlotinib and 10 mg of sirolimus for patients on concurrent EIAEDS.	[ 0 ]	1	[ 0 ]	intervention 1: Erlotinib \& sirolimus on a daily dosing schedule on a 28-day cycle. Dosing was 150 mg of oral erlotinib and 5mg of oral sirolimus for patients not on concurrent CY3PA-inducing anti-epileptics (EIAEDS) and 400 mg of oral erlotinib and 10 mg of oral sirolimus for patients on concurrent EIAEDS.	intervention 1: Erlotinib + sirolimus	1	Durham \| North Carolina \| United States \| -78.89862 \| 35.99403	32	NCT00672243	1COMPLETED	2009-12-01	2007-04-01	Duke University	7OTHER	false	false	false	null	0
[ 2, 3 ]	6	RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The primary objectives of the study are to evaluate the safety profile and the anti-tumor activity of 2 dose levels of natalizumab in participants with relapsed or refractory multiple myeloma. Secondary objectives are to assess the pharmacokinetic (PK) profile of natalizumab in this study population and to assess perip...	Despite no protocol-defined study stopping criteria being met, the sponsor decided to terminate enrollment after the phase 1 portion was complete and to not move into the phase 2 portion of the study. This decision was made due to difficulty enrolling participants and was not due to any safety concerns.	Multiple Myeloma	Relapsed or refractory Multiple Myeloma	null	2	arm 1: Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months. arm 2: Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.	[ 0, 0 ]	1	[ 0 ]	intervention 1: None	intervention 1: BG00002 (natalizumab)	2	Scottsdale \| Arizona \| United States \| -111.89903 \| 33.50921 Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163	6	NCT00675428	6TERMINATED	2009-12-01	2008-09-01	Biogen	4INDUSTRY	false	false	false	null	0
[ 4 ]	361	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, used in a 2-step dose titration regimen in monotherapy, over a period of 12 weeks of treatment. The primary objective is to assess the effects of lixisenatide, in comparison to placebo, on glycemic cont...	This is a double-blind, randomized, placebo-controlled, 4-arm, unbalanced design, parallel group study with a two-step titration regimen or a one-step titration regimen. The study is double-blind with regard to active and placebo treatments; however neither the study drug volume nor the titration regimens (that is, two...	Diabetes Mellitus, Type 2	hyperglycemia, GLP-1	null	4	arm 1: 2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 12. arm 2: 1-step initiation regimen of volume matching placebo: 10 mcg QD for 2 weeks, then 20 mcg QD up to Week 12. arm 3: 2-step initiation regimen o...	[ 2, 2, 0, 0 ]	3	[ 0, 0, 1 ]	intervention 1: Self administered by subcutaneous injections once daily within the hour preceding breakfast. intervention 2: Self administered by subcutaneous injections once daily within the hour preceding breakfast. intervention 3: None	intervention 1: Lixisenatide (AVE0010) intervention 2: Placebo intervention 3: Pen auto-injector	12	Bridgewater \| New Jersey \| United States \| -74.64815 \| 40.60079 Diegem \| N/A \| Belgium \| 4.43354 \| 50.89727 Mumbai \| N/A \| India \| 72.88261 \| 19.07283 Netanya \| N/A \| Israel \| 34.85992 \| 32.33291 Tokyo \| N/A \| Japan \| 139.69171 \| 35.6895 Mexico \| N/A \| Mexico \| -98.43784 \| 18.88011 Warsaw \| N/A \| Poland \| 21.01178 \| 52...	722	NCT00688701	1COMPLETED	2009-12-01	2008-05-01	Sanofi	4INDUSTRY	false	false	false	null	0
[ 5 ]	659	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	The hypothesis is that varenicline will be effective (compared with placebo) for smoking cessation when subjects are allowed to set their own quit date within the first 5 weeks of treatment.	null	Smoking Cessation	smoking cessation smoking treatment patient self-selected quit date	null	2	arm 1: None arm 2: None	[ 2, 0 ]	2	[ 0, 0 ]	intervention 1: placebo tablet taken orally twice daily for 12 weeks intervention 2: varenicline tablets, 1 mg taken orally twice daily for 12 weeks	intervention 1: placebo intervention 2: varenicline	33	Litchfield Park \| Arizona \| United States \| -112.35794 \| 33.49337 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Santa Ana \| California \| United States \| -117.86783 \| 33.74557 Overland Park \| Kansas \| United States \| -94.67079 \| 38.98223 Lexington \| Kentucky \| United States \| -84.47772 \| 37.98869 Milf...	651	NCT00691483	1COMPLETED	2009-12-01	2008-09-01	Pfizer	4INDUSTRY	false	false	false	null	0
[ 5 ]	59	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	2MALE	true	Type 2 Diabetes Mellitus (T2DM) represents a model of endothelial dysfunction, where chronic nitric oxide deprivation, hyperglycaemia and hyperinsulinemia and fibrogenic mediators lead to cardiovascular remodelling associated with diabetic cardiomyopathy and in consequence to secondary complications of diabetes. Specif...	Type 2 Diabetes Mellitus (T2DM) represents a model of endothelial dysfunction at central and peripheral levels, where chronic nitric oxide deprivation, due to hyperglycaemia, leads to a loss of vascular endothelium-relaxant function and ischaemia-reperfusion ventricular damage. Since haemodynamic and oxidative stress c...	Diabetes Mellitus, Type 2 Endothelial Dysfunction	Type 2 diabetes mellitus Endothelial dysfunction Sildenafil	null	2	arm 1: Sildenafil 100 mg arm 2: Placebo 100 mg	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: 100 mg daily (3 capsules/day) intervention 2: Placebo 100 mg (3 capsules/day)	intervention 1: Sildenafil intervention 2: Placebo	1	Rome \| N/A \| Italy \| 12.51133 \| 41.89193	59	NCT00692237	1COMPLETED	2009-12-01	2008-01-01	University of Roma La Sapienza	7OTHER	false	false	false	null	0
[ 4 ]	192	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	The purpose of this study is to examine the safety of two doses of MAP0010 in asthmatic children, 12 months to 8 years of age, over a 40-week period.	null	Asthma	asthmatic children	null	2	arm 1: 0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks arm 2: 0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: 0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks intervention 2: 0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks	intervention 1: 0.135mg MAP0010 intervention 2: 0.25mg MAP0010	0	null	192	NCT00697697	6TERMINATED	2009-12-01	2008-04-01	Allergan	4INDUSTRY	false	false	false	null	0
[ 2 ]	80	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This study will look for the highest tolerated dose of dalotuzumab (MK-0646) given as weekly, every other week. or a every three week infusion. The hypothesis of this study is that administration of dalotuzumab as a one- to two-hour weekly, every other week, or every three week infusion in participants with advanced c...	Trial Duration of Treatment: Participants can be treated for up to two years if their disease has not progressed and they are not having unmanageable side effects.	Solid Tumor Multiple Myeloma		null	11	arm 1: Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) intravenous (IV) infusion 1 time every 1 week (Q1W). arm 2: Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W. arm 3: Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W. arm 4: Participants received dalotuzumab 10 mg/k...	[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]	1	[ 0 ]	intervention 1: IV infusion	intervention 1: Dalotuzumab	0	null	80	NCT00701103	1COMPLETED	2009-12-01	2006-01-12	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0
[ 3 ]	107	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to evaluate the long-term safety of paricalcitol injection. Subjects will administer clinical supplies 3 times a week, 40 weeks at dialysis session in dose-titration manner, following 12 weeks of treatment in the dose-response study, M10-309 (NCT00667576).	The first 12-week period in this study was a dose-response study reported as Study M10-309 (NCT00667576). Only subjects who completed 12 weeks in NCT00667576 were enrolled into this study (M10-312). Baseline in this study was the same as Baseline in NCT00667576. The duration of treatment in Study M10-312 was 40 weeks (...	Secondary Hyperparathyroidism Hemodialysis	Secondary hyperparathyroidism Hemodialysis paricalcitol	null	4	arm 1: Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2...	[ 0, 0, 0, 0 ]	1	[ 0 ]	intervention 1: Intravenous (IV) paricalcitol, 3 times weekly, immediately before completion of hemodialysis.	intervention 1: Paricalcitol	12	Aichi \| N/A \| Japan \| 130.62158 \| 32.51879 Chiba \| N/A \| Japan \| 140.11667 \| 35.6 Fukuoka \| N/A \| Japan \| 130.41667 \| 33.6 Hokkaido \| N/A \| Japan \| N/A \| N/A Ibaraki \| N/A \| Japan \| 135.56828 \| 34.81641 Kanagawa \| N/A \| Japan \| 139.91667 \| 37.58333 Kumamoto \| N/A \| Japan \| 130.69181 \| 32.80589 Nagano \| N/A \| Japan \| 13...	106	NCT00701805	1COMPLETED	2009-12-01	2008-07-01	Abbott	4INDUSTRY	false	false	false	null	0
[ 2 ]	83	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The purpose of this study is to evaluate the utility of 18Fluorine Fluorodeoxyglucose Positron Emission Tomography (18FDG-PET) as a tool to quantify atherosclerotic plaque.	null	Atherosclerotic Vascular Disease		null	2	arm 1: 10 mg atorvastatin + placebo arm 2: 80 mg atorvastatin + placebo	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: Participants will be asked to self-administer one atorvastatin 10 mg or 80 mg tablet at approximately the same time each day. intervention 2: Participants will be asked to self-administer one tablet of placebo to atorvastatin 10 mg or 80 mg at approximately the same time each day.	intervention 1: atorvastatin intervention 2: placebo	0	null	83	NCT00703261	1COMPLETED	2009-12-01	2008-08-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0
[ 3 ]	1	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to establish single-dose tolerability of inhaled treprostinil sodium in idiopathic pulmonary fibrosis (IPF) patients with pulmonary hypertension, and to explore the acute hemodynamic effects over a range of tolerable doses. The safety and pharmacodynamic information obtained from this study...	This is Phase 2, multi-center, open-label, four-cohort study in subjects with pulmonary hypertension (PH) associated with idiopathic pulmonary fibrosis (IPF). Each cohort of four subjects will receive a single dose of inhaled treprostinil sodium. Cohorts will be enrolled sequentially, starting with the lowest dose of 1...	Idiopathic Pulmonary Fibrosis Pulmonary Hypertension	fibrosis, pulmonary hypertension, pulmonary exercise, aerobic	null	0	null	null	1	[ 0 ]	intervention 1: Administration of inhaled treprostinil sodium 0.6 mg/ml in 3mL ampoules Duration of Treatment: single dose Dose: * Cohort 1: dosed at 3 breaths (18 mcg) * Cohort 2: dosed at 6 breaths (36 mcg) * Cohort 3: dosed at 9 breaths (54 mcg) * Cohort 4: dosed at 12 breaths (72 mcg) The decision to advance to ...	intervention 1: Treprostinil sodium for inhalation	6	La Jolla \| California \| United States \| -117.2742 \| 32.84727 Sacramento \| California \| United States \| -121.4944 \| 38.58157 Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Falls Church \| Virgin...	1	NCT00703339	6TERMINATED	2009-12-01	2008-06-01	Lung Biotechnology PBC	4INDUSTRY	false	false	false	null	0
[ 3 ]	33	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	There are few therapies suitable for the treatment of psoriasis on the face and skin folds. As these areas are sensitive, irritation and other adverse reactions are more common than elsewhere on the body. The purpose of the study is to monitor the effect of once daily treatment for up to 8 weeks of an ointment containi...	null	Psoriasis Vulgaris		null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Once daily application	intervention 1: Calcipotriol plus hydrocortisone (LEO 80190)	11	Hot Springs \| Arkansas \| United States \| -93.05518 \| 34.5037 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Ormond Beach \| Florida \| United States \| -81.05589 \| 29.28581 Troy \| Michigan \| United States \| -83.14993 \| 42.60559 East Windsor \| New Jersey \| United States \| -74.54043 \| 40.268 Norfolk \| Virgini...	33	NCT00704262	1COMPLETED	2009-12-01	2008-05-01	LEO Pharma	4INDUSTRY	false	false	false	null	0
[ 4 ]	156	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery	null	Cataract	Cataract extraction intraocular lens implantation	null	2	arm 1: Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily arm 2: Placebo, dosed 1 drop daily	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: sterile ophthalmic solution intervention 2: sterile ophthalmic solution	intervention 1: Bromfenac intervention 2: Placebo	1	Irvine \| California \| United States \| -117.82311 \| 33.66946	146	NCT00704418	1COMPLETED	2009-12-01	2008-06-01	Bausch & Lomb Incorporated	4INDUSTRY	false	false	false	null	0
[ 0 ]	9	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to determine the short term safety and effectiveness of lubiprostone when used for constipation in adults with cystic fibrosis.	Cystic fibrosis (CF) affects about 30,000 people in the United States. It is caused by an absent or dysfunctional protein called CF transmembrane conductance regulator (CFTR) which functions as a chloride channel. Lubiprostone is a medication indicated for constipation that activates type 2 chloride channels (ClC-2) an...	Constipation Cystic Fibrosis	constipation cystic fibrosis lubiprostone Constipation in adults with cystic fibrosis	null	0	null	null	1	[ 0 ]	intervention 1: lubiprostone 24 microgram capsule taken twice daily for 4 weeks	intervention 1: lubiprostone	1	Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648	7	NCT00706004	1COMPLETED	2009-12-01	2008-07-01	University of Arkansas	7OTHER	false	false	false	null	0
[ 0 ]	7	RANDOMIZED	PARALLEL	9OTHER	2DOUBLE	true	0ALL	false	The purpose of this study is to test the ways that a drug called varenicline helps smokers to quit smoking. Varenicline is also called Chantix® and is approved by the United States Food and Drug Administration (FDA) to help people quit smoking. We will test how varenicline works by having you quit smoking and complete ...	The purpose of this study is to understand the therapeutic mechanisms of varenicline, a novel nicotinic analogue, through focused measures of potential psychological and physiological mediators. Varenicline is an FDA-approved pharmacotherapy for smoking cessation that is believed to provide relief from craving and with...	Nicotine Dependence	Tobacco nicotine smoking varenicline human laboratory study stress tolerance startle response cognitive assessment progressive ratio	null	2	arm 1: Placebo Varenicline arm 2: Varenicline	[ 2, 1 ]	2	[ 0, 0 ]	intervention 1: Days 1 - 3 (0.5 mg tablet, q.d.), Days 4 - 7 (0.5 mg tablet, b.i.d.), and Day 8 - 21 (1 mg tablet, b.i.d.). intervention 2: Days 1 - 3 (0.5 mg tablet, q.d.), Days 4 - 7 (0.5 mg tablet, b.i.d.), and Day 8 - 21 (1 mg tablet, b.i.d.).	intervention 1: Placebo intervention 2: Varenicline	1	Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997	7	NCT00709696	1COMPLETED	2009-12-01	2008-04-01	University of Minnesota	7OTHER	false	false	false	null	0
[ 3 ]	13	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cancer or abnormal cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and h...	OBJECTIVES: Primary * To estimate the probability of survival at 1 year in patients with advanced hematological malignancies or other diseases treated with non-myeloablative unrelated donor umbilical cord blood transplantation. Secondary * Six month non-relapse mortality. * Chimerism at days 7, 14, 21, 28, 56, and ...	Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases	chronic myelogenous leukemia acute lymphoblastic leukemia acute myeloid leukemia atypical chronic myeloid leukemia chronic myelomonocytic leukemia anaplastic large cell lymphoma splenic marginal zone lymphoma nodal marginal zone B-cell lymphoma recurrent adult Hodgkin lymphoma recurrent adult diffuse large cell lymphom...	null	2	arm 1: Subjects with hematological malignancies with prior autologous transplant, \>2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months. Refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. arm 2: Subject...	[ 0, 0 ]	7	[ 2, 0, 0, 0, 0, 3, 4 ]	intervention 1: 30mg/Kg Days -6 to -4 intervention 2: 50 mg/Kg Day -6 intervention 3: Patients will receive cyclosporine A (CSA) therapy beginning on Day -3 maintaining a trough level between 250 and 500 ng/mL. For adults the initial dose will be 2.5 mg/kg IV over 1 hour every 12 hours. For children \< 40 kg the initia...	intervention 1: anti-thymocyte globulin intervention 2: cyclophosphamide intervention 3: cyclosporine intervention 4: fludarabine phosphate intervention 5: mycophenolate mofetil intervention 6: umbilical cord blood transplantation intervention 7: total body irradiation	1	Seattle \| Washington \| United States \| -122.33207 \| 47.60621	13	NCT00719849	6TERMINATED	2009-12-01	2005-11-01	Fred Hutchinson Cancer Center	7OTHER	false	false	false	null	0
[ 5 ]	35	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	The study is 12-week randomized placebo controlled trial compared to topiramate to treat patients with posttraumatic stress disorder, according to DSM-IV criteria. Patients will receive topiramate or placebo, the dose will start with 25 mg/day and every week 25mg will be increment according to patients tolerance to si...	Seventy-two (72) patients will be randomly allocated, in a stratified manner, according to sex and comorbidity with depression, into two (2) groups: topiramate and routine clinical follow-up, and a group that would receive placebo pills and routine clinical follow-up. The patients will be submitted to evaluations by tr...	Posttraumatic Stress Disorder	PTSD, posttraumatic stress disorder, randomization, placebo, controlled	null	2	arm 1: patients receiving the active drug: topiramate arm 2: patients received pills content placebo, that were identical to the pills content active drug	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: patients will receive the active drug. The starting dose was 25 mg/day, with weekly increments of 25 mg/day, according to clinical status. The maximum dose considered was 200 mg/day intervention 2: initial dose 25 mg day, increments of 25 mg each 2 weeks. Up to 100 mg/day Those with no intolerance and n...	intervention 1: Topiramate intervention 2: placebo control group	1	São Paulo \| São Paulo \| Brazil \| -46.63611 \| -23.5475	35	NCT00725920	1COMPLETED	2009-12-01	2007-01-01	Federal University of São Paulo	7OTHER	false	false	false	null	0
[ 4 ]	258	RANDOMIZED	PARALLEL	1PREVENTION	4QUADRUPLE	true	0ALL	false	Children who are undergoing surgery need intravenous fluids to prevent dehydration and maintain their electrolyte balance. The current standard of care in these children is to use a fluid which is low in sodium (hypotonic fluid). The safety of this practice has never been tested. There is ongoing concern from the medic...	Research Question: In general pediatric surgical patients, do isotonic PMS compared to hypotonic PMS, result in a lower risk of acute hospital acquired plasma sodium derangements, occurring at any time during the study intervention? Primary efficacy objective -To determine the impact of postoperative administration of...	Hyponatremia Hypernatremia	Parenteral Fluids Isotonic Hypotonic Pediatric Fluid overload	null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Intravenous Fluid Isotonic Parenteral Fluid intervention 2: Intravenous Fluid Hypotonic Parenteral Fluid	intervention 1: 0.9% NaCl intervention 2: 0.45%NaCl	1	Hamilton \| Ontario \| Canada \| -79.84963 \| 43.25011	258	NCT00734214	1COMPLETED	2009-12-01	2008-03-01	Hamilton Health Sciences Corporation	7OTHER	false	false	false	null	0
[ 5 ]	204	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	null	Efficacy and safety evaluation of Combigan with timolol when each is used as adjunctive therapy to Xalatan in subjects with glaucoma or ocular hypertension.	null	Glaucoma Ocular Hypertension		null	2	arm 1: Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%) adjunctive to Xalatan® (latanoprost 0.005%) arm 2: Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)	[ 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: 1 drop of fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% taken approximately 12 hours apart, up to 2 times a day. intervention 2: 1 drop of timolol maleate 0.5% taken approximately 12 hours apart, up to 2 times a day. intervention 3: 1 drop of latanoprost 0.005% once nightly.	intervention 1: Fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% intervention 2: timolol maleate 0.5% intervention 3: latanoprost 0.005%	2	Newark \| New Jersey \| United States \| -74.17237 \| 40.73566 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884	204	NCT00735449	1COMPLETED	2009-12-01	2008-07-01	Allergan	4INDUSTRY	false	false	false	null	0
[ 5 ]	36	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	true	0ALL	true	Insulin resistance has been implicated as the central pathogenetic feature of cardiovascular risk factor cluster that includes hypertension, impaired glucose tolerance, diabetes, dyslipidemia, and hemostatic disorders. Recent evidence suggests that increased levels of free fatty acids (FFA) in obese subjects is a leadi...	The FFA-induced hypertension constitutes a useful model with which to examine disease mechanisms and test new therapeutic interventions to correct the different disorders associated with insulin resistance and metabolic syndrome. The effect of FFA on insulin action is well established (4-6); however, the pressor effect...	Type 2 Diabetes Hypertension	diabetes, hypertension, free-fatty acids	null	2	arm 1: Obese, normotensive African-Americans with diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours, then normal saline 0.9% at 40 ml/hr intravenously for 48 hours, and then randomized to rosiglitazone for six weeks followed by Intralipid 20% at 40ml/hr intravenously for 48 hours arm 2: Obese, norm...	[ 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Diabetic subjects will be receive rosiglitazone for 6 weeks intervention 2: Normal saline 0.9% intravenous infusion at 40ml/hr for 48 hours intervention 3: Intralipid 20% at 40ml/hr intravenously for 48 hours	intervention 1: Rosiglitazone intervention 2: Normal saline 0.9% intervention 3: Intralipid 20%	1	Atlanta \| Georgia \| United States \| -84.38798 \| 33.749	32	NCT00738023	1COMPLETED	2009-12-01	2004-03-01	Emory University	7OTHER	false	false	false	null	0
[ 3 ]	120	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	Functional constipation (FC) is a common complaint in clinical practice, but treatment for this condition in conventional medicine is suboptimal. Complementary and alternative medicines, especially Chinese herbal medicine (CHM) are used frequently by patients, however, there is little research evidence about these comm...	Constipation is a common gastrointestinal complaint in clinical practice, which affects in estimated 12%-19% of American, 14% of Asian, and up to 27% of the population depending on demographic factor, sampling, and definition. With the unsatisfactory response to current symptomatic treatments, many patients seek help f...	Functional Gastrointestinal Disorders Constipation	Functional Constipation Chinese Herbal Medicine MaZiRenWan Hemp Seed Pill Traditional Chinese Medicine Herbal Medicine	null	2	arm 1: MZRW granule, 7.5g/sachet arm 2: Placebo granule, 7.5g/sachet	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: MZRW granule dissolved in 150ml hot water (oral), 7.5g/sachet, twice daily intervention 2: Placebo granule dissolved in 150ml hot water (oral), 7.5g/sachet, twice daily	intervention 1: MaZiRenWan (MZRW) intervention 2: Placebo	1	Hong Kong \| N/A \| China \| 114.17469 \| 22.27832	120	NCT00741936	1COMPLETED	2009-12-01	2008-07-01	Hong Kong Baptist University	7OTHER	false	false	false	null	0
[ 0 ]	3	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	Parkinson's disease (PD) is the second most common neurodegenerative disorder of the elderly that affects a million patients in US. Sleep dysfunction impacts up to 90% of PD patients. PD patients experience a variety of sleep disorders including parasomnias, specifically REM behavior disorder (RBD) that can precede the...	See above.	REM Behavior Disorder Parkinsonism	Parkinson's disease Multiple Systems Atrophy Lewy Body Dementia	null	2	arm 1: Ramelteon (TAK-375) 8mg tablets arm 2: Placebo 8 mg tablets	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Subjects take 1 8mg tablet 30 minutes before bedtime everyday for 8 weeks. intervention 2: Placebo 8 mg tablets	intervention 1: Rozerem intervention 2: Placebo	1	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003	3	NCT00745030	6TERMINATED	2009-12-01	2008-06-01	Northwestern University	7OTHER	false	false	false	null	0
[ 2, 3 ]	45	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The primary objectives of this study are to evaluate the safety and efficacy of VI-0521 compared to placebo in the treatment of obese adults with obstructive sleep apnea (OSA) and to assess the relative contributions of weight loss on parameters of OSA in these subjects.	null	Sleep Apnea	Sleep apnea; obesity	null	2	arm 1: 15 mg Phentermine and 92 mg Topiramate arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 15 mg Phentermine and 92 mg Topiramate intervention 2: placebo	intervention 1: VI-0521 intervention 2: placebo	1	Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424	45	NCT00745251	1COMPLETED	2009-12-01	2008-08-01	VIVUS LLC	4INDUSTRY	false	false	false	null	0
[ 5 ]	162	RANDOMIZED	PARALLEL	1PREVENTION	3TRIPLE	false	0ALL	false	The investigators evaluated the effect of pre-biopsy treatment with 1-deamino-8-D-arginine (DDAVP) on the incidence of post-biopsy bleeding complications. This is a IV phase single centre, double blind, randomized controlled study in patients, with acute and chronic nephropathy, undergoing ultrasound-guided percutaneou...	Renal biopsy is an essential procedure in the diagnosis of primary and secondary renal diseases. The technique has significantly improved over the past two decades because of the introduction of ultrasonography and automated-gun biopsy devices; however an accurate clinical, chemistry and renal ultrasound evaluation bef...	Kidney Failure	Vasopressin bleeding biopsy ultrasonography	null	2	arm 1: patients treated with 1 ml of s.c. saline solution arm 2: treated with DDAVP (0.3 mcg/Kg s.c.) 1 hour before renal biopsy	[ 2, 0 ]	2	[ 0, 0 ]	intervention 1: 0.3 mcg/kg subcutaneous intervention 2: saline solution 1 ml subcutaneous	intervention 1: DDAVP intervention 2: saline solution	1	Bari \| Bari \| Italy \| 16.86982 \| 41.12066	162	NCT00748072	1COMPLETED	2009-12-01	2008-08-01	University of Bari	7OTHER	false	false	false	null	0
[ 4 ]	707	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	true	0ALL	false	A research study to compare the safety and effectiveness of an investigational medication called NAFT-500 to placebo, when used in subjects with tinea pedis (athlete's foot).	To evaluate the efficacy and safety of NAFT-500 compared to placebo in the treatment of subjects with potassium hydroxide (KOH) and culture positive symptomatic tinea pedis.	Tinea Pedis Athlete's Foot	Tinea Pedis Athlete's foot	null	4	arm 1: Naftin 2% cream applied daily for 2 weeks arm 2: Placebo cream applied daily for two weeks arm 3: Active comparator applied daily for 4 weeks arm 4: placebo cream applied daily for 4 weeks	[ 0, 2, 1, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: topical cream 1 application every day up to 4 weeks weeks intervention 2: placebo cream 1 application every day for up to 4 weeks intervention 3: topical allylamine cream applied once a day for up to 4 weeks intervention 4: topical placebo cream applied once a day for up to 4 weeks	intervention 1: NAFT-500 intervention 2: Placebo 2-weeks intervention 3: Naftin 1% intervention 4: Placebo 4-weeks	17	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 San Francisco \| California \| United States \| -122.41942 \| 37.77493 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Miramar \| Florida \| United States \| -80.23227 \| 25.98731 Buffalo Grove \| ...	707	NCT00750139	1COMPLETED	2009-12-01	2008-08-01	Merz North America, Inc.	4INDUSTRY	false	false	false	null	0
[ 3 ]	4	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Phase II Study of Maintenance Tarceva (Erlotinib) in patients with locally advanced Head and Neck Cancer after treatment with curative intent	null	Head and Neck Cancer	squamous cell cancer of head and neck SCCHN	null	1	arm 1: None	[ 5 ]	1	[ 0 ]	intervention 1: 150 mg per day orally until disease progression occurs, up to a maximum of 12 months	intervention 1: Erlotinib	1	Danville \| Pennsylvania \| United States \| -76.61273 \| 40.96342	0	NCT00750555	6TERMINATED	2009-12-01	2008-09-01	Geisinger Clinic	7OTHER	false	false	false	null	0
[ 4 ]	161	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	true	0ALL	false	A multi-center, randomized, parallel group, comparative, active controlled, safety assessor blinded trial in adult subjects comparing rocuronium plus sugammadex versus succinylcholine alone in subjects undergoing short surgical procedures in out-patient surgicenters. The primary objective was to evaluate changes in pla...	null	Neuromuscular Blockade		null	2	arm 1: Rocuronium - Sugammadex 4.0 mg/kg arm 2: Succinylcholine 1.0 mg/kg	[ 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: A single bolus intubation dose of 0.6 mg/kg rocuronium will be administered following induction of anesthesia and if required, single bolus dose(s) of 0.15 mg/kg rocuronium will be administered to maintain the neuromuscular block. intervention 2: At the end of the surgical procedure at a target depth of...	intervention 1: rocuronium intervention 2: sugammadex intervention 3: succinylcholine	0	null	146	NCT00751179	1COMPLETED	2009-12-01	2008-11-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0
[ 3 ]	102	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to determine the efficacy and safety of Peginesatide Injection for the maintenance of anemia in patients with chronic renal failure who are on hemodialysis or do not require dialysis and who were previously treated with Darbepoetin Alfa.	Anemia, resulting primarily from insufficient production of erythropoietin to support erythropoiesis, is a common consequence of chronic renal failure. Both North America and Europe have established clinical practice guidelines for the treatment and hemoglobin targets in chronic renal failure/chronic kidney disease pat...	Anemia	Anemia Drug Therapy Hemodialysis Kidney Failure	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL fr...	intervention 1: Peginesatide	10	Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Sacramento \| California \| United States \| -121.4944 \| 38.58157 San Diego \| California \| United States \| -117.16472 \| 32.71571 Middlebury \| Connecticut \| United States \| -73.12761 \| 41.52787 Lauderdale Lakes \| Florida \| United States \| -80.20838 \| 26.16647...	101	NCT00752609	1COMPLETED	2009-12-01	2008-09-01	Takeda	4INDUSTRY	false	false	false	null	0
[ 0 ]	28	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	true	0ALL	true	Obesity is common in African American (AA) patients with newly diagnosed diabetes who present with diabetic ketoacidosis (DKA). Despite the presentation with severe symptoms of insulinopenia and ketoacidosis, clinical and immunogenetic observations indicate that most obese AA patients with DKA have type 2 diabetes. In ...	Obese AA patients with a history of DKA who later experience near-normoglycemia remission represent an ideal population in which to define the sequence of events that lead to b-cell dysfunction in type 2 diabetes. The researchers hypothesize that obese AA with DKA will prove particularly susceptible to beta-cells dysfu...	Diabetes Mellitus, Type 2	Hyperglycemia	null	3	arm 1: Obese African Americans with type 2 diabetes with history of diabetic ketoacidosis (DKA) receiving Intralipid 20% and a glucose infusion. arm 2: Obese African American with type 2 diabetes with hyperglycemia without ketosis receiving Intralipid 20% and a glucose infusion. arm 3: Obese African Americans without d...	[ 1, 1, 1 ]	2	[ 0, 0 ]	intervention 1: Participants receive a 48-hour infusion with Intralipid at 40 milliliters per hour (mL/hr). intervention 2: Participants receive a glucose infusion consisting of 10% dextrose infused intravenously at a rate of 200 mg/m\^2/min for 20 hours.	intervention 1: Intralipid 20% intervention 2: Glucose infusion	1	Atlanta \| Georgia \| United States \| -84.38798 \| 33.749	28	NCT00753142	1COMPLETED	2009-12-01	2004-03-01	Emory University	7OTHER	false	false	false	null	0
[ 0 ]	20	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	1FEMALE	false	The purpose of this study is to make available an agent,Mesna, which can assist the surgeon during the procedure of capsulectomy.	Mesna is a FDA approved drug for the treatment of respiratory diseases and is used a protective agent against drugs in oncology patients. It has also been used in Gynecologic surgery and ENT. Mesna is a drug that breaks down adhesions between tissue layers.	Implant Capsular Contracture	capsular contracture capsulectomy mesna Capsular contracture after breast implant placement	null	2	arm 1: Standard treatment arm 2: Standard surgical procedure with Mesna	[ 4, 0 ]	1	[ 0 ]	intervention 1: B. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed	intervention 1: Mesna	0	null	20	NCT00758667	6TERMINATED	2009-12-01	2005-01-01	Vanderbilt University	7OTHER	false	false	false	null	0
[ 0 ]	19	NA	SINGLE_GROUP	7BASIC_SCIENCE	1SINGLE	false	0ALL	true	This study will determine whether or not saphenous vein \[arterial\] bypass grafts in the leg relax in response to increases in blood flow.	Subjects who have undergone saphenous vein \[arterial\] bypass grafts from the femoral to above-knee popliteal artery will undergo ultrasound imaging at rest, and again after 5 minutes of blood pressure cuff occlusion of the calf. (at 1 minute and 15 minutes) Subjects will then be given sub-lingual nitroglycerin, and r...	Peripheral Arterial Disease	saphenous vein bypass grafts flow-mediated vasodilation	null	1	arm 1: ultrasound imaging of saphenous vein bypass graft following an ischemic stimulus, administration of sublingual nitroglycerin and intravenous administration of L-NMMA.	[ 0 ]	1	[ 0 ]	intervention 1: L-NMMA was infused at a dose of 1 mg/kg over 10 minutes to competitively inhibit the production of nitric oxide. Ultrasound imaging of the saphenous vein \[arterial\] bypass at baseline, and following an ischemic stimulus, administration of sublingual nitroglycerin, and intravenous administration of L-N...	intervention 1: L-N^G monomethyl arginine (L-NMMA)	1	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	19	NCT00759707	1COMPLETED	2009-12-01	2006-04-01	Brigham and Women's Hospital	7OTHER	false	false	false	null	0
[ 5 ]	148	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	Randomized (1:1 ratio) study of subcutaneous (SC) versus intravenous (IV) fluid rehydration in mildly to moderately dehydrated pediatric patients.	This is a prospective, randomized (1:1 ratio), open-label, parallel group, multicenter, multi-national, study of SC versus IV fluid rehydration in mildly to moderately dehydrated pediatric patients treated in the Emergency Department (ED), inpatient pediatric unit, and/or outpatient urgent care facility. It is expected...	Dehydration	pediatric hylenex subcutaneous infusion hyaluronidase rHuPH20 recombinant human hyaluronidase	null	2	arm 1: Isotonic fluid rehydration by SC administration with hylenex (150 Units in 1 mL) arm 2: Isotonic fluid rehydration by IV	[ 1, 1 ]	1	[ 0 ]	intervention 1: 150 Units in 1 mL	intervention 1: recombinant human hyaluronidase	25	Hartford \| Connecticut \| United States \| -72.68509 \| 41.76371 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Dalton \| Georgia \| United States \| -...	148	NCT00773175	1COMPLETED	2009-12-01	2008-10-01	Halozyme Therapeutics	4INDUSTRY	false	false	false	null	0
[ 5 ]	342	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of the study is to determine the efficacy and safety of the combination of ADVAIR DISKUS® 250/50mcg (FLUTICASONE PROPIONATE/SALMETEROL COMBINATION PRODUCT) plus SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) compared to SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) in patients with COPD. SPIRIVA® and HA...	null	Pulmonary Disease, Chronic Obstructive	Spirometry COPD	null	2	arm 1: Fluticasone Propionate/Salmeterol Combination Product 250/50mcg BID Plus Tiotropium Bromide 18 mcg QD arm 2: Tiotropium Bromide 18mcg QD plus Placebo DISKUS BID	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Long-acting muscarinic antagonist intervention 2: Inhaled corticosteroid plus long-acting bronchodilator	intervention 1: Tiotropium Bromide intervention 2: Fluticasone Propionate/Salmeterol	35	Riverside \| California \| United States \| -117.39616 \| 33.95335 Fort Collins \| Colorado \| United States \| -105.08442 \| 40.58526 Clearwater \| Florida \| United States \| -82.8001 \| 27.96585 DeLand \| Florida \| United States \| -81.30312 \| 29.02832 Naranja \| Florida \| United States \| -80.42283 \| 25.51816 Coeur d'Alene \| Idaho...	342	NCT00784550	1COMPLETED	2009-12-01	2008-12-01	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0
[ 3 ]	76	NA	SINGLE_GROUP	0TREATMENT	1SINGLE	false	0ALL	false	The purpose of this study is to assess the potential effects of trabectedin on the QT/QTc interval duration measured by electrocardiograms (ECGs) in participants with advanced solid tumor malignancies when administered at a therapeutic dose.	This is a single-blind (where the participant does not know the treatment he receives), multicenter (study conducted at multiple sites), placebo-controlled (an inactive substance that is compared with the study medication to test whether the study medication has a real effect in clinical study), sequential design (it i...	Solid Tumor	Solid tumor Advanced solid tumor Malignant tumors Sarcoma Breast tumor Ovarian tumor QT interval Trabectedin Yondelis Ecteinascidin 743 ET743	null	1	arm 1: 3-hour placebo intravenous infusion on Day 1 and trabectedin 1.3 mg/m2 3-hour intravenous infusion on Day 2 (single-blind). Patients may continue treatment with trabectedin until clinical benefit or drug is commercially available (open-label).	[ 0 ]	2	[ 0, 0 ]	intervention 1: Trabectedin will be administered as 1.3 mg/m2 3-hour intravenous infusion on Day 2. intervention 2: Participants will receive 3-hour placebo intravenous infusion on Day 1.	intervention 1: Trabectedin intervention 2: Placebo	17	Miami \| Florida \| United States \| -80.19366 \| 25.77427 Charlotte \| North Carolina \| United States \| -80.84313 \| 35.22709 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Tacoma \| Washington \| United States \| -122.44429 \| 47.25288 Brussels \| N/A \| Belgium \| 4.34878 \| 50.85045 Edegem \| N/A \| Belgium \| 4...	75	NCT00786838	1COMPLETED	2009-12-01	2008-10-01	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	4INDUSTRY	false	false	false	null	0
[ 5 ]	16	RANDOMIZED	PARALLEL	1PREVENTION	0NONE	false	0ALL	false	Compare Clinical Success and Costs in two Arms	Demonstrate clinical and economic utility between the study Arms.	Suspected Heparin-Induced Thrombocytopenia	Suspected Heparin Induced Thrombocytopenia (HIT)	null	2	arm 1: Patients with suspected HIT without thrombosis syndrome (HIT/TS), randomized to SC Desirudin arm 2: Patients randomized to IV Argatroban®	[ 0, 1 ]	1	[ 0 ]	intervention 1: Desirudin 15mg SC Argatroban® IV dosing per Package Insert	intervention 1: Desirudin or Argatroban®	24	Aurora \| Colorado \| United States \| -104.83192 \| 39.72943 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Honolulu \| Hawaii...	16	NCT00787332	6TERMINATED	2009-12-01	2008-09-01	Canyon Pharmaceuticals, Inc.	4INDUSTRY	false	false	false	null	0
[ 3 ]	33	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	This pilot study is being conducted as a prelude to a randomized trial to compare levodopa/carbidopa plus patching versus patching alone. The purpose of the pilot study is to demonstrate recruitment potential, to provide prospective data on the tolerability of levodopa as a treatment for amblyopia, to provide limited d...	Amblyopia is the most common cause of monocular visual impairment in both children and young and middle-aged adults. Both patching and atropine are accepted treatment modalities for the management of moderate amblyopia in children. Despite best efforts with conventional amblyopia treatment, many older children and teen...	Amblyopia	Amblyopia Patching Levodopa	null	2	arm 1: Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid (3 to 1 formulation) combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam 9 weeks after starting medication. arm 2: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid (approximately 4.5 to 1 form...	[ 1, 1 ]	3	[ 0, 1, 0 ]	intervention 1: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid (approximately 4.5 to 1 formulation) intervention 2: 2 hours daily patching intervention 3: Oral levodopa 0.51mg/kg tid with carbidopa 0.17 mg/kg tid (3 to 1 formulation)	intervention 1: levodopa/carbidopa intervention 2: patching intervention 3: levodopa/carbidopa	1	Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038	33	NCT00789672	1COMPLETED	2009-12-01	2009-01-01	Jaeb Center for Health Research	7OTHER	false	false	false	null	0
[ 3 ]	82	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	true	0ALL	true	This study will examine whether administration of oral Vitamin D3 given over 21 days will change the antimicrobial peptide expression in the skin or saliva of subjects with Atopic Dermatitis (AD). This study will help researchers determine if the lack of the expression of antimicrobial peptides in individuals with AD p...	Atopic Dermatitis (AD) is a chronic inflammatory skin disorder in which the skin becomes extremely itchy and is susceptible to recurrent skin infections. AD is thought to occur from a combination of immunological, genetic, and environmental factors. Individuals with AD are at risk for developing a severe and widely dis...	Atopic Dermatitis Psoriasis	Vitamin D3 Atopic Dermatitis Antimicrobial Peptide Expression	null	2	arm 1: Subjects received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 international units \[IU\] arm 2: Subjects received a 21-day course of oral vitamin D3-placebo	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Administration of oral vitamin D3 at 4000IU intervention 2: Administration of oral Vitamin D3 placebo	intervention 1: Vitamin D3 intervention 2: Placebo	3	San Diego \| California \| United States \| -117.16472 \| 32.71571 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Portland \| Oregon \| United States \| -122.67621 \| 45.52345	82	NCT00789880	1COMPLETED	2009-12-01	2008-12-01	National Institute of Allergy and Infectious Diseases (NIAID)	0NIH	false	false	false	null	0
[ 5 ]	532	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of the study is to evaluate the blood pressure lowering effect and safety of aliskiren in combination with Hydrochlorothiazide (HCTZ) compared to aliskiren monotherapy when given to metabolic syndrome patients with stage 2 systolic hypertension (mean sitting systolic blood pressure \[msSBP\] ≥ 160 mm Hg and...	null	Hypertension	Hypertension Metabolic Syndrome aliskiren hydrochlorothiazide systolic blood pressure diastolic blood pressure stage 2	null	2	arm 1: Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form. arm 2: Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once dail...	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Aliskiren 150 mg or 300 mg taken once daily in oral form intervention 2: Hydrochlorothiazide 12.5 mg or 25 mg taken once daily in oral form.	intervention 1: Aliskiren intervention 2: Hydrochlorothiazide	1	East Hanover \| New Jersey \| United States \| -74.36487 \| 40.8201	532	NCT00797316	1COMPLETED	2009-12-01	2008-11-01	Novartis	4INDUSTRY	false	false	false	null	0
[ 3 ]	56	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The study will evaluate the safety and efficacy of the intravitreal dexamethasone implant in the study eye of vitrectomized subjects with diabetic macular edema. Subjects will be followed for 26 weeks.	null	Diabetic Macular Edema Vitrectomy		null	1	arm 1: 700 µg dexamethasone implant in the study eye at Day 1	[ 0 ]	1	[ 0 ]	intervention 1: 700 µg Dexamethasone Posterior Segment Drug Delivery System Applicator System at Day 1 in the study eye.	intervention 1: Dexamethasone	2	Charlotte \| North Carolina \| United States \| -80.84313 \| 35.22709 Sydney \| New South Wales \| Australia \| 151.20732 \| -33.86785	55	NCT00799227	1COMPLETED	2009-12-01	2009-01-01	Allergan	4INDUSTRY	false	false	false	null	0
[ 5 ]	15	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	false	A 10 week evaluation, crossover design study including a 3 week washout period between treatments, to determine the effects of Combigan® (fixed combination brimonidine tartrate 0.2%/timolol maleate 0.5%) and Cosopt® (fixed combination dorzolamide hydrochloride-timolol maleate ophthalmic solutions) on ocular blood flow ...	null	Glaucoma		null	2	arm 1: Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks. arm 2: Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution)...	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: 1 drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks intervention 2: 1 drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks	intervention 1: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution intervention 2: fixed combination of dorzolamide hydrochloride timolol maleate ophthalmic solution	1	Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838	30	NCT00811850	1COMPLETED	2009-12-01	2008-12-01	Allergan	4INDUSTRY	false	false	false	null	0
[ 3 ]	374	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	1FEMALE	true	The purpose of this study is to assess the efficacy and safety of the 100, 150 and 200 mcg Misoprostol Vaginal Insert (MVI 100, MVI 150 and MVI 200) for women requiring cervical ripening and induction of labor.	null	Cervical Ripening Induction of Labor	Misoprostol vaginal insert Induction of labor Cervical ripening Rate of cesarean section	null	3	arm 1: MVI 100 mcg vaginal insert arm 2: MVI 150 mcg vaginal insert arm 3: MVI 200 mcg vaginal insert	[ 0, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the st...	intervention 1: MVI 100 intervention 2: MVI 150 intervention 3: MVI 200	11	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Long Beach \| California \| United States \| -118.18923 \| 33.76696 Orange \| California \| United States \| -117.85311 \| 33.78779 Albuquerque \| New Mexico \| United States \| -106.65114 \| 35.08449 Durham \| North C...	374	NCT00828711	1COMPLETED	2009-12-01	2009-04-01	Ferring Pharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 2 ]	60	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	true	1FEMALE	false	To assess the effect of fesoterodine 8 mg as compared to solifenacin 10 mg on colonic transit.	null	Healthy	Healthy; Fesoterodine; Solifenacin	null	3	arm 1: Tablets arm 2: Tablets arm 3: Tablets	[ 0, 2, 1 ]	3	[ 0, 0, 0 ]	intervention 1: 8 mg OD for 14 days intervention 2: OD for 14 days intervention 3: 10 mg OD for 14 days	intervention 1: fesoterodine fumarate intervention 2: placebo intervention 3: solifenacin	1	Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163	59	NCT00832650	6TERMINATED	2009-12-01	2009-04-01	Pfizer	4INDUSTRY	false	false	false	null	0
[ 0 ]	10	RANDOMIZED	PARALLEL	6HEALTH_SERVICES_RESEARCH	0NONE	false	0ALL	false	The investigators hypothesize that subcutaneous pramlintide as an adjunct to mealtime insulin immediately prior to meals can significantly reduce post-prandial glucose concentrations compared with mealtime insulin alone in children with type 1 diabetes. This is a 36 day, randomized, two-arm, open-label study with a tr...	Participants aged 13-17 years who have been diagnosed with type 1 diabetes for more than 1 year will be invited to participate.Other inclusion factors are: * HbA1c level between 7.5 and 10% inclusive * Currently using carbohydrate to insulin ratio * Acceptable form of birth control Exclusion factors: * Oral hypergly...	Type 1 Diabetes	type 1 diabetes adolescents post prandial glucose	null	2	arm 1: Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin arm 2: Usual bolus insulin dose at each meal	[ 0, 4 ]	1	[ 0 ]	intervention 1: subcutaneous injection (15 mcg initial dose)prior to meals	intervention 1: pramlintide	1	Aurora \| Colorado \| United States \| -104.83192 \| 39.72943	0	NCT00842075	1COMPLETED	2009-12-01	2006-12-01	University of Colorado, Denver	7OTHER	false	false	false	null	0
[ 3 ]	11	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	true	2MALE	true	The purpose of this study is to test how the body absorbs and processes new forms of oral testosterone. Information gained during the study may help develop better forms of testosterone therapy in the future.	We will be using three drugs: The first, acyline, temporarily turns off the body's production of testosterone for about two weeks. Subjects will receive acyline as shots three times over a six-week drug administration period. During the time when the body's production of testosterone is turned off, we will give testost...	Healthy Males Male Contraceptive	5α-reductase androgen dihydrotestosterone (DHT) drug delivery oestradiol	null	3	arm 1: Acyline 300mcg/kg subcutaneous on days 1, 15 and 29 + Testosterone Undecanoate (TU)200mg twice daily, orally for 7 days + placebo finasteride twice daily, orally for 7 days during one of the three intervention periods (First Intervention, Second Intervention or Third Intervention) arm 2: Acyline 300mcg/kg subcut...	[ 2, 0, 0 ]	5	[ 0, 10, 0, 0, 10 ]	intervention 1: Acyline 300mcg/kg subcutaneous (days 1, 15 \& 29) + testosterone undecanoate 200 mg, twice daily orally + finasteride placebo intervention 2: Washout of 7 days between each of the 3 treatment arms intervention 3: Acyline 300mcg/kg subcutaneous + testosterone undecanoate 200 mg, twice daily orally + fina...	intervention 1: First Intervention (7 days) intervention 2: First Washout (7 days) intervention 3: Second Intervention (7 days) intervention 4: Third Intervention (7 days) intervention 5: Second wash-out period	1	Seattle \| Washington \| United States \| -122.33207 \| 47.60621	33	NCT00842751	1COMPLETED	2009-12-01	2009-07-01	University of Washington	7OTHER	false	false	false	null	0
[ 4 ]	318	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	2MALE	false	The purpose of this study is to evaluate the safety and efficacy of tadalafil when given to men who are currently taking a medication called an alpha blocker for the treatment of benign prostatic hyperplasia (BPH) symptoms (such as urinary frequency, urgency, and a feeling that the bladder is not completely emptied aft...	null	Benign Prostatic Hyperplasia	Prostate BPH Benign Prostatic Hyperplasia BPH-LUTS LUTS Phosphodiesterase Inhibitors tadalafil alpha blockers	null	2	arm 1: None arm 2: None	[ 2, 0 ]	2	[ 0, 0 ]	intervention 1: 5 mg taken by mouth once daily for 12 weeks intervention 2: By mouth once daily for 12 weeks	intervention 1: Tadalafil intervention 2: Placebo	31	Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 Anchorage \| Alaska \| United States \| -149.90028 \| 61.21806 Anaheim \| California \| United States \| -117.9145 \| 33.83529 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Paramount \| California \| United States \| -118.15979 \| 33.88946 San Diego \| Ca...	318	NCT00848081	1COMPLETED	2009-12-01	2009-03-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0
[ 2, 3 ]	73	RANDOMIZED	SINGLE_GROUP	0TREATMENT	4QUADRUPLE	false	0ALL	true	Purpose: The purpose of the study is to assess the safety and effectiveness of minocycline, an antibiotic, in the treatment of Human immunodeficiency virus (HIV)-associated cognitive impairment in Uganda. Study Design: Treatment, 24-week Randomized, Placebo-Controlled, Double-Blind Phase with Optional 24-week Open Lab...	null	HIV-associated Cognitive Impairment HIV Infections	Human immunodeficiency virus (HIV) HIV associated cognitive impairment HIV dementia Uganda Acquired immune deficiency syndrome (AIDS) Treatment Naive	null	2	arm 1: Minocycline 100 mg orally every 12 hours arm 2: Placebo minocycline capsules every 12 hours	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: 100 mg capsule every 12 hours by mouth intervention 2: 1 capsule every 12 hours by mouth	intervention 1: minocycline intervention 2: minocycline placebo capsule	1	Kampala \| N/A \| Uganda \| 32.58219 \| 0.31628	73	NCT00855062	6TERMINATED	2009-12-01	2008-04-01	Johns Hopkins University	7OTHER	false	false	false	null	0
[ 0 ]	12	NA	SINGLE_GROUP	0TREATMENT	0NONE	true	0ALL	false	The main purpose of this protocol is to study the effect of an HIV medication known as Raltegravir on Buprenorphine in people who have been receiving the same dose of Buprenorphine for at least 3 weeks before study entry. This will be determined by giving Raltegravir along with Buprenorphine and by measuring the amount...	A large number of people who are infected with HIV have acquired it through injection drug use. Some of these people are currently being treated with Buprenorphine for their addiction and with medications for HIV infection. Raltegravir is a medication that was approved by the Food and Drug Administration (FDA) for the ...	HIV Infection HIV Infections	HIV Pharmacokinetics Pharmacodynamics Buprenorphine Raltegravir HIV seronegativity Interaction	null	1	arm 1: Buprenorphine and Raltegravir co-administration	[ 0 ]	1	[ 0 ]	intervention 1: 400 mg of raltegravir orally twice daily together with normally prescribed stable dose of buprenorphine for a minimum of 4 days and up to 14 days.	intervention 1: Raltegravir	1	New Haven \| Connecticut \| United States \| -72.92816 \| 41.30815	12	NCT00858962	1COMPLETED	2009-12-01	2009-03-01	Yale University	7OTHER	false	false	false	null	0
[ 4 ]	858	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The primary objective of this trial is to demonstrate that following eight weeks of treatment the FDC of telmisartan 80 mg plus amlodipine 10 mg (T80/A10) is superior as first line therapy in reducing mean seated trough cuff Systolic Blood Pressure \[SBP\] compared to the monotherapies of telmisartan 80 mg (T80) and am...	null	Hypertension		null	3	arm 1: telmisartan and amlodipine used in combination vs amlodipine or telmisartan arm 2: telmisartan and amlodipine used in combination vs amlodipine or telmisartan arm 3: telmisartan and amlodipine used in combination vs amlodipine or telmisartan	[ 0, 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: amlodipine 5mg for the first 2w then force titration to Amlodipine 10mg for remaining 6 w intervention 2: telmisartan 80mg for the 8w, no titration required intervention 3: telmisartan 80 and amlodipine 5mg for the first 2 weeks, then force titrated to telmisartan 80mg and amlodipine 10mg for the remain...	intervention 1: amlodipine intervention 2: telmisartan intervention 3: telmisartan and amlodipine	137	Buena Park \| California \| United States \| -117.99812 \| 33.86751 Long Beach \| California \| United States \| -118.18923 \| 33.76696 Long Beach \| California \| United States \| -118.18923 \| 33.76696 Roseville \| California \| United States \| -121.28801 \| 38.75212 Tustin \| California \| United States \| -117.82617 \| 33.74585 Westl...	858	NCT00860262	1COMPLETED	2009-12-01	2009-03-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0
[ 5 ]	511	RANDOMIZED	PARALLEL	2DIAGNOSTIC	2DOUBLE	false	0ALL	false	This study is intended to assess the safety and tolerance of regadenoson in subjects with renal impairment.	null	Kidney Diseases Coronary Artery Disease	regadenoson chronic kidney disease stage III chronic kidney disease stage IV renal impairment coronary artery disease	null	2	arm 1: Matching intravenous (IV) bolus injection arm 2: 0.4 mg/5 mL intravenous bolus injection	[ 2, 0 ]	2	[ 0, 0 ]	intervention 1: IV intervention 2: IV	intervention 1: Regadenoson intervention 2: Placebo	41	Anniston \| Alabama \| United States \| -85.83163 \| 33.65983 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Bell Gardens \| California \| United States \| -118.15146 \| 33.96529 Fullerton \| California \| United States \| -117.92534 \| 33.87029 Garden Grove \| California \| United States \| -117.94145 \| 33.77391 Los A...	504	NCT00863707	1COMPLETED	2009-12-01	2009-04-01	Astellas Pharma Inc	4INDUSTRY	false	false	false	null	0
[ 3 ]	93	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	The primary objective of the study was to evaluate the safety and tolerability of VX-809 in participants with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene.	This was a Phase 2, randomized, double-blind, placebo-controlled, multiple-dose study of orally-administered VX-809 in participants with CF who are homozygous for the specific CFTR mutation known as ∆F508 or F508del. Enrollment was planned for 90 participants at approximately 20 centers. Participants were planned to be...	Cystic Fibrosis	∆F508 F508del Cystic Fibrosis Transmembrane Conductance Regulator CFTR Pancreatic diseases Lung diseases Genetic disease, inborn Infant, newborn, diseases	null	5	arm 1: Placebo matched to VX-809 capsule orally once daily for 28 days. arm 2: VX-809, 25 milligram (mg) capsule orally once daily for 28 days. arm 3: VX-809, 50 mg capsule orally once daily for 28 days. arm 4: VX-809, 100 mg capsule orally once daily for 28 days. arm 5: VX-809, 200 mg capsule orally once daily for 28 ...	[ 2, 0, 0, 0, 0 ]	2	[ 0, 0 ]	intervention 1: Capsules intervention 2: Placebo matched to VX-809 capsules.	intervention 1: VX-809 intervention 2: Placebo	25	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Palo Alto \| California \| United States \| -122.14302 \| 37.44188 San Diego \| California \| United States \| -117.16472 \| 32.71571 Aurora \| Colorado \| United States \| -104.83192 \| 39.72943 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Chicago \| Illinois \| ...	89	NCT00865904	1COMPLETED	2009-12-01	2009-03-01	Vertex Pharmaceuticals Incorporated	4INDUSTRY	false	false	false	null	0
[ 3 ]	49	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. PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with metastatic kidney cancer that has not responded to sunitinib or bevacizumab...	OBJECTIVES: Primary * To determine the tumor burden reduction rate in patients with sunitinib malate- or bevacizumab-refractory, metastatic clear cell renal cell carcinoma treated with sorafenib tosylate. Secondary * To determine the safety of sorafenib tosylate in these patients. * To record the duration of tumor ...	Kidney Cancer	clear cell renal cell carcinoma recurrent renal cell cancer stage IV renal cell cancer	null	1	arm 1: Chemotherapy single agent systemic. Sorafenib given up to 600mg orally every 12 hours for up to 10 months (40 weeks).	[ 0 ]	1	[ 0 ]	intervention 1: Sorafenib (BAY 43-9006) is an oral multi-kinase inhibitor targeting both tumor cells and the tumor vasculature. Patients with metastatic RCC meeting eligibility criteria will receive 400 mg BID of sorafenib in a single-arm phase II study. Treatment will be administered on an outpatient basis.	intervention 1: sorafenib tosylate	2	Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Dallas \| Texas \| United States \| -96.80667 \| 32.78306	47	NCT00866320	1COMPLETED	2009-12-01	2006-02-01	Case Comprehensive Cancer Center	7OTHER	false	false	false	null	0
[ 3 ]	120	RANDOMIZED	PARALLEL	1PREVENTION	4QUADRUPLE	false	0ALL	false	The purpose of this study was to assess the effects of patiromer on serum potassium participants with heart failure. This study also assessed the safety and tolerability of patiromer in participants with heart failure.	This was a double-blind, randomized, placebo-controlled, parallel-group, multiple-dose study in congestive heart failure participants. Depending on the outcome from the initial cohort of 100 participants (Part 1), a second cohort of 170 participants could have been enrolled (Part 2). Based on the results of Part 1 of t...	Hyperkalemia Heart Failure	HF Heart failure hyperkalemia chronic kidney disease prevention of hyperkalemia in heart failure participants	null	2	arm 1: None arm 2: None	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: Active investigational drug intervention 2: placebo	intervention 1: patiromer intervention 2: placebo	33	Miami \| Florida \| United States \| -80.19366 \| 25.77427 Port Charlotte \| Florida \| United States \| -82.09064 \| 26.97617 Peoria \| Illinois \| United States \| -89.58899 \| 40.69365 Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997 Buffalo \| New York \| United States \| -78.87837 \| 42.88645 Northport \| New York \| ...	105	NCT00868439	1COMPLETED	2009-12-01	2009-04-01	Relypsa, Inc.	4INDUSTRY	false	false	false	null	0
[ 5 ]	132	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to evaluate the participants with toenail onychomycosis (fungal infection of the nail) confirmed positive by potassium hydroxide (KOH) and bacterial identification test after administration of itraconazole (ICZ) capsule, to identify the change in Scoring Clinical Index for Onychomycosis (SC...	This is an open-label (all people know the identity of the intervention), multicenter (when more than one hospital or medical school team work on a medical research study) study of ICZ in participants with onychomycosis. The present study consists of 2 periods: Screening period (up to Week minus 2) and Treatment period...	Onychomycosis, Toe	Onychomycosis, Toe Itraconazole Sporanox	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Itraconazole (ICZ) capsule will be administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle will consist of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment will be 49 weeks.	intervention 1: Itraconazole	0	null	130	NCT00871728	1COMPLETED	2009-12-01	2007-01-01	Janssen Korea, Ltd., Korea	4INDUSTRY	false	false	false	null	0
[ 5 ]	81	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	The primary objective of this study is to evaluate the safety and efficacy of clobetasol propionate spray versus vehicle spray for the management of moderate to severe plaque psoriasis of the scalp.	null	Scalp Psoriasis		null	2	arm 1: None arm 2: None	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: Apply enough product to cover affected areas topically twice daily at least 8 hours apart intervention 2: Apply enough product to cover affected areas topically twice daily at least 8 hours apart	intervention 1: clobetasol propionate spray 0.05% intervention 2: Vehicle spray	4	Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Evansville \| Indiana \| United States \| -87.55585 \| 37.97476 New York \| New York \| United States \| -74.00597 \| 40.71427 Seattle \| Washington \| United States \| -122.33207 \| 47.60621	81	NCT00881868	1COMPLETED	2009-12-01	2009-04-01	Galderma R&D	4INDUSTRY	false	false	false	null	0
[ 3 ]	110	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	A study to determine if using Retin-A Micro 0.04% as facial acne treatment in patients ages 9 to 11 is safe and efficacious.	Approximately 100 female and male subjects, aged from 9 to 11 years of age, will be enrolled in this randomized, double blind, multi-center study. Following satisfaction of entry criteria and screening procedures, subjects will receive either RETIN-A MICRO 0.04% or a color matched gel vehicle for once daily use during...	Acne Vulgaris	acne irritation objective sensory methods	null	2	arm 1: Retin-A Micro 0.04% facial acne treatment used once daily arm 2: Color matched facial gel vehicle control used once daily	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Retin-A Micro 0.04% facial acne treatment used once daily intervention 2: Color-matched facial gel vehicle control used once daily	intervention 1: Retin-A Micro 0.04% facial acne treatment intervention 2: Vehicle control	12	Encino \| California \| United States \| -118.50119 \| 34.15917 San Diego \| California \| United States \| -117.16472 \| 32.71571 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424 Somerset \| New Jersey \|...	110	NCT00907335	1COMPLETED	2009-12-01	2009-02-01	Bausch Health Americas, Inc.	4INDUSTRY	false	false	false	null	0
[ 5 ]	114	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	The investigators hypothesize that Arixtra patients will be less likely to experience wound infection than patients who have received low-molecular weight heparin, coumadin or aspirin with mechanical compression.	null	Total Knee Replacement		null	1	arm 1: Effect of Arixtra on would drainage and length of stay for the patients with hip and knee replacement	[ 0 ]	1	[ 0 ]	intervention 1: 2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days.	intervention 1: Fondaparinux Sodium (Arixtra)	1	Sacramento \| California \| United States \| -121.4944 \| 38.58157	114	NCT00909064	1COMPLETED	2009-12-01	2009-06-01	Paul Di Cesare,MD	7OTHER	false	false	false	null	0
[ 0 ]	50	RANDOMIZED	PARALLEL	7BASIC_SCIENCE	4QUADRUPLE	true	0ALL	false	Do functional brain changes occur during Venlafaxine ER (extended release) versus Fluoxetine treatment and do changes in selective structures, such as the amygdala, predict treatment response?	This is a single site, controlled, double-blind study of outpatients. There are two arms: 1. Forty participants who have a current Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revised (DSM-IV-TR) diagnosis of Major Depression will be recruited. These subjects will be randomized to receive o...	Major Depressive Disorder	Major Depressive Disorder	null	3	arm 1: Currently depressed subjects; Randomized medication treatment with Venlafaxine extended release tablets (Venlafaxine ERT). Dosage 75-300mg/day for up to 6 months. arm 2: Currently depressed subjects; Randomized medication treatment with Fluoxetine tablets. Dosage 20-80mg/day for up to 6 months. arm 3: Non-psychi...	[ 1, 1, 4 ]	2	[ 0, 0 ]	intervention 1: Titrated to a minimum dose of 75mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 37.5 mg; Days 7-14: 75 mg; Days 15-180: 75-300mg based on clinician assessment. Titration rate is a maximu...	intervention 1: Venlafaxine ERT intervention 2: Fluoxetine	1	Madison \| Wisconsin \| United States \| -89.40123 \| 43.07305	50	NCT00909155	1COMPLETED	2009-12-01	2002-07-01	University of Wisconsin, Madison	7OTHER	false	false	false	null	0
[ 5 ]	32	NON_RANDOMIZED	SINGLE_GROUP	2DIAGNOSTIC	0NONE	false	0ALL	false	The purpose of this clinical research is to learn if DEFINITY® 416 will cause any adverse effects during Right Heart Catheterization. This research was requested by the FDA.	This Phase IV safety study will provide safety data on potential systemic and pulmonary hemodynamic effects caused by the administration of DEFINITY® in patients who are to undergo right heart cardiac catheterization for clinical reasons. Using a right heart catheter for direct measurements of pulmonary artery hemodyna...	Pulmonary Heart Disease	Phase 4 DEFINITY® hemodynamics pulmonary artery pressure	null	2	arm 1: Subjects with pulmonary arterial pressure (PAP) of \< or = to 35 mmHg. arm 2: Subjects with a PAP of \> or = to 35 mmHg.	[ 0, 0 ]	1	[ 0 ]	intervention 1: one bolus dose of Definity per intravenous injection, 30-60 second injection, dose value calculation = maximum of 10 microliter/kg patient weight	intervention 1: Definity	8	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Saint Louis Park \| Minnesota \| United States \| -93.34801 \| 44.9483 Kansas City \| Missouri \| United States \| -94.57857 \| 39.09973 Teaneck \| New Jersey \| United States \| -74.01597 \| 40.8976 Cleveland \| Ohio...	32	NCT00918866	1COMPLETED	2009-12-01	2009-07-01	Lantheus Medical Imaging	4INDUSTRY	false	false	false	null	0
[ 5 ]	35	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to determine whether using Taclonex ointment under a hydrogel patch is more effective than using the ointment alone in treating psoriasis. Taclonex ointment is currently FDA approved for use on psoriasis. The hydrogel patch is a type of adhesive pad and contains no medications. It is curren...	This will be an open label, bilaterally-controlled single center study. Thirty subjects with plaque type psoriasis will be enrolled in the study. All subjects will receive treatment on two target lesions that are similar in erythema, scaling and induration, and symmetric in anatomic location. The severity of their targ...	Plaque Psoriasis Psoriasis Vulgaris	Psoriasis Plaque psoriasis, with bilateral symmetrical lesions. A diagnosis of stable plaque-type psoriasis vulgaris with at least one pair of symmetric lesions on either the trunk, arms, or legs that would serve as target lesions.	null	2	arm 1: Taclonex ointment once daily used to treat one psoriatic plaque, along with the Hydrogel Patch used once daily. arm 2: None	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: Each patient will have bilateral symmetrical psoriatic plaques. One plaque will be treated with Taclonex Ointment daily along with Hydrogel Patch daily. All treatment will be for 4 weeks. intervention 2: Taclonex ointment daily for one psoriatic plaque.	intervention 1: Taclonex Ointment and Hydrogel Patch intervention 2: Taclonex Ointment	1	San Francisco \| California \| United States \| -122.41942 \| 37.77493	30	NCT00924950	6TERMINATED	2009-12-01	2009-06-01	University of California, San Francisco	7OTHER	false	false	false	null	0
[ 3 ]	105	RANDOMIZED	CROSSOVER	0TREATMENT	4QUADRUPLE	false	0ALL	null	To examine the post-dose changes in exhaled Nitric Oxide (eNO) following treatment with inhaled Advair in subjects with chronic but stable asthma as defined in Global Initiative for Asthma (GINA) guidelines.	null	Asthma		null	6	arm 1: Treatment cycle 1: Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for 7 days. Treatement Cycle 2 : Patient randomized to Fluticasone Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for 7 days. Treatment Cycle 3: Patient randomized to Fluticas...	[ 1, 1, 1, 1, 1, 1 ]	1	[ 0 ]	intervention 1: fluticasone propionate/salmeterol diskus	intervention 1: fluticasone propionate/salmeterol (Flu/Sal) : 100mcg/50mcg, 250mcg/50mcg,500mcg/50 mcg	3	Gainesville \| Florida \| United States \| -82.32483 \| 29.65163 Iowa City \| Iowa \| United States \| -91.53017 \| 41.66113 Madison \| Wisconsin \| United States \| -89.40123 \| 43.07305	56	NCT00927758	1COMPLETED	2009-12-01	2009-06-01	Sandoz	4INDUSTRY	false	false	false	null	0
[ 2 ]	63	RANDOMIZED	CROSSOVER	0TREATMENT	4QUADRUPLE	true	0ALL	false	OZ439 is a synthetic trioxolane that has potential value as a peroxide antimalarial agent. This was a Phase I, single-centre, multi-component, double-blind, randomised, placebo-controlled study in healthy male and female subjects. The study was conducted in 3 parts: * Part A investigated the safety, tolerability and ...	null	Malaria Falciparum Malaria Vivax Healthy Volunteers	Phase I Safety and tolerability Pharmacokinetic synthetic peroxide trioxolane treatment of erythrocytic stages of malaria	null	17	arm 1: OZ439 Single doses of 50mg (capsules) arm 2: OZ439 Single doses of 100mg (capsules) arm 3: OZ439 Single doses of 200mg (capsules) arm 4: OZ439 Single doses of 400mg (capsules) arm 5: OZ439 Single doses of 400mg (capsules) administered with food. arm 6: OZ439 Single doses of 400mg (aqueous dispersion) arm 7: OZ43...	[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 2, 0, 0, 0, 0, 0, 2 ]	11	[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]	intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: OZ439 100mg (2x50mg API capsules) intervention 6: OZ439 400mg (2x200mg API capsules) intervention 7: None intervention 8: OZ439 800mg (4x200 API capsules) intervention 9: OZ439 1200mg (6x200mg API capsules) intervention ...	intervention 1: OZ439 50mg API capsules intervention 2: OZ439 200mg API capsules intervention 3: OZ439 400mg aqueous dispersion intervention 4: OZ439 800mg aqueous dispersion intervention 5: OZ439 100mg API capsules intervention 6: OZ439 400mg API capsules intervention 7: OZ439 1600mg aqueous dispersion intervention 8:...	1	Miramar \| Florida \| United States \| -80.23227 \| 25.98731	133	NCT00928083	1COMPLETED	2009-12-01	2009-04-01	Medicines for Malaria Venture	7OTHER	false	false	false	null	0
[ 5 ]	2	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	true	0ALL	false	The primary objective of this study is to compare the effect of two different antipsychotic compounds which are used in the treatment of schizophrenia (paliperidone ER and risperidone) at their target sites in two specific areas of the brain in patients with schizophrenia. A specialized X-ray known as Positron Emission...	This is an open-label (all people involved know the identity of the intervention), non-randomized (patients are assigned to treatment groups), phase IV, monocentric (at one single study site) interventional study evaluating the blocking effects two different doses of paliperidone ER and oral risperidone have on the dop...	Schizophrenia	D2-receptor occupancy Antipsychotic drugs Paliperidone ER, Oral risperidone Dopamine Fallypride Plasma concentration Therapeutic window, Healthy controls	null	9	arm 1: Paliperidone ER 9 mg tablet once a day followed by PET scan in approximately 2 hours arm 2: Oral risperidone 4 mg tablet once a day followed by PET scan in approximately 2 hours arm 3: Oral risperidone 6 mg tablet once a day followed by PET scan in approximately 2 hours arm 4: Paliperidone ER 6 mg tablet once a ...	[ 1, 1, 1, 1, 1, 1, 1, 5, 1 ]	9	[ 0, 0, 10, 0, 0, 0, 0, 0, 0 ]	intervention 1: 9 mg tablet once a day followed by PET scan in approximately 2 hours intervention 2: 6 mg tablet once a day followed by PET scan in approximately 2 hours intervention 3: PET Scan intervention 4: 4 mg tablet once a day followed by PET scan in approximately 24 hours intervention 5: 4 mg tablet once a day ...	intervention 1: Paliperidone ER intervention 2: Oral risperidone intervention 3: PET Scan intervention 4: Oral risperidone intervention 5: Oral risperidone intervention 6: Paliperidone ER intervention 7: Paliperidone ER intervention 8: Oral risperidone intervention 9: Paliperidone ER	1	Aachen \| N/A \| Germany \| 6.08342 \| 50.77664	2	NCT00934635	6TERMINATED	2009-12-01	2009-09-01	Janssen-Cilag G.m.b.H	4INDUSTRY	false	false	false	null	0
[ 3 ]	61	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	true	0ALL	false	The purpose of this trial is to determine if XPF-001 is effective for the treatment of pain following third-molar/wisdom tooth extraction.	null	Dental Pain	Pain following 3rd molar/wisdom tooth extraction	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Single oral administration of 500 mg XPF-001 capsules (5 x 100 mg capsules) intervention 2: Single oral administration of 5 x 100 mg Placebo capsules.	intervention 1: XPF-001 intervention 2: placebo	1	Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078	61	NCT00954356	1COMPLETED	2009-12-01	2009-09-01	Xenon Pharmaceuticals Inc.	4INDUSTRY	false	false	false	null	0
[ 4 ]	242	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	The main purpose of this trial is to compare the efficacy and safety of diclofenac diethylamine 2.32% gel applied twice (b.i.d) or three times a day (t.i.d.) with placebo in the treatment of acute ankle sprains (distortions).	null	Grade I/II Ankle Sprain	Ankle sprain soft tissue injury	null	3	arm 1: drug arm 2: drug arm 3: placebo	[ 0, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: diclofenac diethylamine gel 2.32% twice a day intervention 2: diclofenac diethylamine gel 2.32% three times a day intervention 3: Placebo	intervention 1: diclofenac diethylamine gel 2.32% intervention 2: diclofenac diethylamine gel 2.32% intervention 3: Placebo	5	Cologne \| N/A \| Germany \| 6.95 \| 50.93333 Essen \| N/A \| Germany \| 7.01228 \| 51.45657 Gilching \| N/A \| Germany \| 11.2936 \| 48.10755 Grünwald \| N/A \| Germany \| 11.5232 \| 48.03947 München \| N/A \| Germany \| 13.31243 \| 51.60698	242	NCT00955513	1COMPLETED	2009-12-01	2009-07-01	Novartis	4INDUSTRY	false	false	false	null	0
[ 3 ]	36	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	The purpose of this study is to evaluate the safety, tolerability, and efficacy of LX4211 versus a placebo control in subjects with type 2 diabetes mellitus.	null	Type 2 Diabetes Mellitus		null	3	arm 1: A low dose of LX4211; daily oral intake for 28 days arm 2: A high dose of LX4211; daily oral intake for 28 days arm 3: Matching placebo dosing with daily oral intake for 28 days	[ 0, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: A low dose of LX4211; daily oral intake for 28 days intervention 2: A high dose of LX4211; daily oral intake for 28 days intervention 3: Matching placebo dosing with daily oral intake for 28 days	intervention 1: LX4211 Low Dose intervention 2: LX4211 High Dose intervention 3: Placebo	1	San Antonio \| Texas \| United States \| -98.49363 \| 29.42412	36	NCT00962065	1COMPLETED	2009-12-01	2009-08-01	Lexicon Pharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 3 ]	203	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	The purpose of this study is to determine whether Indomethacin Test Formulation Capsules are safe and effective for the treatment of dental pain.	null	Dental Pain		null	4	arm 1: None arm 2: Single dose arm 3: None arm 4: None	[ 0, 0, 1, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Capsules 2 x 200 mg Single-Dose intervention 2: Capsules 2 Single-Dose intervention 3: 20-mg single dose intervention 4: 40-mg single dose	intervention 1: Celecoxib 400 mg intervention 2: Placebo intervention 3: Indomethacin Test (lower dose) intervention 4: Indomethacin Test (upper dose)	1	Austin \| Texas \| United States \| -97.74306 \| 30.26715	203	NCT00964431	1COMPLETED	2009-12-01	2009-08-01	Iroko Pharmaceuticals, LLC	4INDUSTRY	false	false	false	null	0
[ 2 ]	12	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	false	0ALL	false	This study will assess the pharmacokinetics of two formulations of MK-1006. The primary hypothesis of this study is that the MK-1006 area under the curve (0 to infinity) and maximum concentration after administration of a single 80 mg dose of the dry filled capsule (DFC) and film coated tablet (FCT) formulations of MK-...	null	Type 2 Diabetes		null	2	arm 1: Participants received a single dose of four 20 mg dry filled capsules of MK-1006 arm 2: Participants received a single dose of two 40 mg film coated tablets of MK-1006	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Each dry filled capsule contains 20 mg MK-1006 intervention 2: Each film coated tablet contains 40 mg of MK-1006	intervention 1: MK-1006 DFC intervention 2: MK-1006 FCT	0	null	24	NCT00979459	1COMPLETED	2009-12-01	2009-09-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0
[ 2 ]	14	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	true	0ALL	false	The purpose of this study is to look at levels of both a new anti-HIV drug called raltegravir and an existing anti-hepatitis C drug called ribavirin to see if they affect the blood levels of each other when given separately and together. This is a phase I, open-label, prospective, three phase, pharmacokinetic study.	Phase I (study day 1 - 14): * 14 healthy volunteers with a documented negative HIV-1 antibody test during screening procedures will be enrolled. * On day 1, fasted subjects will be administered ribavirin 800 mg without food (witnessed dosing). This will be followed be a 12 hour detailed pharmacokinetic assessment; blo...	HIV Infections	Healthy Volunteers	null	3	arm 1: Treatment with Single dose ribavirin (800 mg) administered on day 1 arm 2: Treatment with Raltegravir (400 mg twice daily) administered from days 15-19 arm 3: Treatment with Ribavirin (800 mg) and Raltegravir (400 mg) administered day 20	[ 0, 0, 0 ]	2	[ 0, 0 ]	intervention 1: 800mg once daily intervention 2: 400mg twice daily	intervention 1: Ribavirin intervention 2: Raltegravir	1	London \| N/A \| United Kingdom \| -0.12574 \| 51.50853	14	NCT00982553	1COMPLETED	2009-12-01	2009-09-01	Imperial College London	7OTHER	false	false	false	null	0
[ 3 ]	202	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	The purpose of this study is to determine whether Diclofenac Test Formulation Capsules are safe and effective for the treatment of dental pain.	null	Dental Pain		null	4	arm 1: One 18-mg Diclofenac Test Capsule and 1 placebo capsule arm 2: One 35-mg Diclofenac Test Capsule and 1 placebo capsule arm 3: None arm 4: None	[ 0, 0, 1, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 18-mg Single dose intervention 2: 35-mg Single dose intervention 3: Capsules 2 x 200 mg Single-dose intervention 4: Capsules 2 Single-dose	intervention 1: Diclofenac Test (lower dose) intervention 2: Diclofenac Test (upper dose) intervention 3: Celecoxib 400 mg intervention 4: Placebo	1	Austin \| Texas \| United States \| -97.74306 \| 30.26715	202	NCT00985439	1COMPLETED	2009-12-01	2009-09-01	Iroko Pharmaceuticals, LLC	4INDUSTRY	false	false	false	null	0
[ 3 ]	122	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	This is a randomized, double-blind, parallel-group, vehicle-controlled, dose-finding study to investigate the pharmacodynamics and the safety of three dosages of CD07805/47 topical gel (0.07%, 0.18%, and 0.50%), after a single application in subjects with a clinical diagnosis of stable moderate to severe erythematotela...	null	Erythematotelangiectatic Rosacea	Erythematotelangiectatic Rosacea	null	4	arm 1: 0.5% Topical Gel arm 2: 0.18% Topical Gel arm 3: 0.07% Topical Gel arm 4: Vehicle Topical Gel	[ 0, 0, 0, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 0.5% Topical Gel intervention 2: 0.18% Topical Gel intervention 3: 0.07% Topical Gel intervention 4: Vehicle Topical Gel	intervention 1: CD07805/47 intervention 2: CD07805/47 intervention 3: CD07805/47 intervention 4: CD07805/47 placebo	5	Hot Springs \| Arkansas \| United States \| -93.05518 \| 34.5037 Fort Washington \| Pennsylvania \| United States \| -75.20906 \| 40.14178 Austin \| Texas \| United States \| -97.74306 \| 30.26715 College Station \| Texas \| United States \| -96.33441 \| 30.62798 Lynchburg \| Virginia \| United States \| -79.14225 \| 37.41375	122	NCT00989014	1COMPLETED	2009-12-01	2009-09-01	Galderma R&D	4INDUSTRY	false	false	false	null	0
[ 3 ]	264	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to compare the safety and efficacy of a 0.5% ivermectin cream to a placebo in subjects infested with head lice when used in an "at home" environment.	null	Head Lice	PEDICULUS HUMANUS CAPITIS Head Lice	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Up to 4 ounces of topical 0.5% Ivermectin Cream applied to the hair and scalp on day 1. intervention 2: Up to 4 ounces of vehicle control applied to the hair and scalp on day 1	intervention 1: Ivermectin cream intervention 2: vehicle control	12	Yuma \| Arizona \| United States \| -114.6244 \| 32.72532 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Delray Beach \| Florida \| United States \| -80.07282 \| 26.46146 St. Petersburg \| Florida \| United States \| -82.67927 \| 27.77086 West Palm Beach \| Florida \| United States \| -80.05337 \| 26.71534 Fridley \| ...	247	NCT00994422	1COMPLETED	2009-12-01	2009-10-01	Topaz Pharmaceuticals Inc	4INDUSTRY	false	false	false	null	-0
[ 3 ]	6	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	2MALE	true	The purpose of this study is to determine if lenalidomide (Revlimid®)reduces proinflammatory cytokines including TNF-alpha and may actually alter the clinical course of autism for some children.	Autism currently affects 1:142 births and has no definite cause. Recent research has shown possible identifying markers in neuroglial inflammation with elevated cytokines IL-1, Il-6, and MCP-1 and elevated ratios of CSF/serum levels of TNF-alpha in patients with regressive autism. Lenalidomide (Revlimid®) is an analog...	Autism	autistic spectrum disorder lenalidomide	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: 2.5 mgs per day orally for 12 weeks	intervention 1: lenalidomide	0	null	6	NCT00996931	1COMPLETED	2009-12-01	2009-02-01	Sutter Medical Foundation	7OTHER	false	false	false	null	0
[ 2 ]	48	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	true	2MALE	false	This study is being conducted to determine if 5 mg amlodipine 3rd Orally-Disintegrating (OD) tablet (new formulation) and 5 mg amlodipine 2nd OD tablet (commercial formulation) are bioequivalent.	null	Healthy		null	2	arm 1: 24 subjects (12 subjects per sequence) will receive treatment A) one 5 mg amlodipine 3rd OD tablet (test) with water and treatment B) one 5 mg amlodipine 2nd OD tablet (reference) with water. arm 2: 24 subjects (12 subjects per sequence) will receive treatment C) one 5 mg amlodipine 3rd OD tablet (test) without ...	[ 0, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 3rd OD 5 mg tablet single oral dose administered with water intervention 2: 2nd OD 5 mg tablet single oral dose administered with water intervention 3: 3rd OD 5 mg tablet single oral dose administered without water intervention 4: 2nd OD 5 mg tablet single oral dose administered without water	intervention 1: Amlodipine intervention 2: Amlodipine intervention 3: Amlodipine intervention 4: Amlodipine	1	Minato-ku \| Tokyo \| Japan \| N/A \| N/A	95	NCT01004614	1COMPLETED	2009-12-01	2009-11-01	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	4INDUSTRY	false	false	false	null	0
[ 5 ]	131	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	Dosing methods for digoxin, a drug used to treat heart failure, have not been updated in decades despite evidence in recent years suggesting that blood levels of digoxin achieved with traditional dosing practices may increase the risk of adverse events. We developed a simple dosing tool that targets lower blood levels ...	Digoxin is recommended as adjunctive therapy in patients with left ventricular dysfunction and symptoms of heart failure despite treatment with standard therapy. Recently, the therapeutic range for digoxin in patients with heart failure has been redefined to a narrower therapeutic window (0.5 - 0.9 ng/ml) because lower...	Heart Failure	Digoxin Pharmacokinetics Dosing Heart Failure	null	2	arm 1: Subjects will have their digoxin maintenance dose determined according to the nomogram we have developed. arm 2: This arm represents historical control subjects in whom the dose of digoxin was determined at the physician's discretion using traditional dosing methods.	[ 0, 5 ]	2	[ 10, 0 ]	intervention 1: Simplified dosing nomogram for digoxin. The dose is determined by plotting a subject's creatinine clearance (x-axis) and ideal body weight (y-axis) on the nomogram. Alternatively, the dose may be determined by plotting creatinine clearance (x-axis) and gender/height (z-axis). intervention 2: All patient...	intervention 1: Digoxin Dosing per Nomogram intervention 2: Digoxin	1	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003	131	NCT01005602	1COMPLETED	2009-12-01	2006-12-01	University of Illinois at Chicago	7OTHER	false	false	false	null	0
[ 0 ]	96	RANDOMIZED	PARALLEL	7BASIC_SCIENCE	1SINGLE	true	0ALL	false	This study is 8 weeks long. People participating in this study will be asked to brush their teeth two times a day. Some people will get a mouthwash. People with a mouthwash will rinse two times a day after brushing their teeth. The mouth, teeth, tongue and gums will be looked at by a dentist. The dentist will look at t...	This is an 8-week, randomized, observer-blind, controlled, parallel group clinical study design to assess the oral tissue tolerance of a potassium oxalate containing mouthrinse. Subjects will have their oral soft/hard tissues assessed and will be evaluated for stain levels and tooth color shades at Screening/Baseline (...	Dental Health	Mouthwashes	null	2	arm 1: 1.5% potassium oxalate sensitive mouthwash arm 2: Sodium Fluoride Dentifrice	[ 0, 1 ]	2	[ 1, 0 ]	intervention 1: Rinse with 10 mL for 60 seconds, twice daily after brushing in usual manner with a sodium fluoride dentifrice intervention 2: Brush in usual manner, twice daily, with a sodium fluoride dentifrice	intervention 1: Potassium Oxylate Mouthwash intervention 2: Sodium Fluoride Dentifrice	1	Paramus \| New Jersey \| United States \| -74.07542 \| 40.94454	96	NCT01009554	1COMPLETED	2009-12-01	2009-10-01	Johnson & Johnson Consumer and Personal Products Worldwide	4INDUSTRY	false	false	false	null	0

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