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	LABEL_sum_dosing_errors int64	LABEL_dosing_error_rate float32	LABEL_wilson_label 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_count_Accidental overdose int64	METADATA_count_Overdose int64	METADATA_count_Treatment noncompliance int64	METADATA_wilson_lower_bound float32
[ 4 ]	78	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	The primary objective of this study is to compare the blood sodium level after 12 hours following the initiation of therapy with either 0.3% NaCl/dextrose 5% or 0.45% NaCl/dextrose 5%, in postsurgical hospitalized children requiring maintenance IV fluid administration.	Background: Despite prescription of maintenance IV fluids in hospitalized children is widely used since 1957 (Holiday \& Segar), it is not always adequate for children with acute diseases, leading to hyponatremia. This mainly occurs due to a non-physiologic ADH secretion in this group of patients due to nausea, stress,...	Hyponatremia	Hyponatremia Water-Electrolyte Imbalance	null	2	arm 1: Subjects in this arm will receive 0.45% NaCl/dextrose 5% intravenous (IV) maintenance fluids. arm 2: Subjects in this arm will receive 0.3% NaCl/dextrose 5% intravenous (IV) maintenance fluids.	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Subjects in this arm will receive 0.45% NaCl/dextrose 5% intravenous (IV) maintenance fluids.Total daily fluid infusion equal to: 80 ml/kg/day for those weighing up to 10 kg, and 1500 ml/m\^2 body surface. intervention 2: Drug: 0.3% NaCl/dextrose 5% IV maintenance fluids. Total daily fluid infusion equa...	intervention 1: 0.45% NaCl/dextrose 5% intervention 2: 0.3% NaCl/dextrose 5%	1	Buenos Aires \| Buenos Aires F.D. \| Argentina \| -58.37723 \| -34.61315	58	0	0	0	NCT01251770	1COMPLETED	2011-07-01	2010-12-01	Hospital General de Niños Pedro de Elizalde	7OTHER	false	false	false	null	0	0	0	0
[ 4 ]	14	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	true	1FEMALE	false	The purpose of this study is to compare the serum levels of estradiol, progesterone, FSH and LH in NPC-01 or IKH-01 one treatment cycle with those in before and after administration cycle.	null	Healthy	NPC-01 IKH-01 Pharmacodynamics Norethisterone Ethinyl Estradiol Estradiol Progesterone FSH LH	null	2	arm 1: 1mg norethisterone and 0.02mg ethinyl estradiol arm 2: 1mg norethisterone and 0.35mg ethinyl estradiol	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol intervention 2: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol	intervention 1: NPC-01 intervention 2: IKH-01	0	null	14	0	0	0	NCT01253824	1COMPLETED	2011-07-01	2011-01-01	Nobelpharma	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	44	RANDOMIZED	CROSSOVER	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to estimate the relative potency for bronchoprotective effect of formoterol Novolizer 12 µg (test) compared to formoterol Aerolizer 12 µg (reference).	null	Asthma		null	4	arm 1: 12µg Formoterol Novolizer#1 + 12µg Formoterol Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2 arm 2: 12µg Formoterol Novolizer#1 + Placebo Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2 arm 3: Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + 12µg Formoterol Aerolizer #...	[ 0, 0, 1, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 12µg Formoterol Novolizer#1 + 12µg Formoterol Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2 intervention 2: 12µg Formoterol Novolizer#1 + Placebo Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2 intervention 3: Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + ...	intervention 1: Formatris 24µg intervention 2: Formatris 12µg intervention 3: Foradil P 24µg intervention 4: Foradil P 12µg	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	167	0	0	0	NCT01256086	1COMPLETED	2011-07-01	2010-12-01	MEDA Pharma GmbH & Co. KG	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	334	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to determine whether buprenorphine hydrochloride (HCl) buccal film is effective and safe in the treatment of chronic low back pain (CLBP).	This is an enriched enrollment, randomized withdrawal study with an open label, dose-titration period followed by a randomized, double-blind, placebo-controlled treatment period of 12 weeks. During the double-blind treatment period, this study will evaluate the effectiveness of buprenorphine HCl buccal film versus plac...	Pain Low Back Pain	buccal soluble film enriched enrollment randomized withdrawal	null	2	arm 1: buprenorphine buccal soluble film arm 2: placebo buccal soluble film	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: buccal soluble film; applied to the buccal mucosa twice daily intervention 2: buccal soluble film; applied to the buccal mucosa twice daily	intervention 1: Buprenorphine intervention 2: Placebo	24	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Fresno \| California \| United States \| -119.77237 \| 36.74773 La Jolla \| California \| United States \| -117.2742 \| 32.84727 Long Beach \| California \|...	565	0	0	0	NCT01256450	1COMPLETED	2011-07-01	2010-11-01	BioDelivery Sciences International	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2 ]	61	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-04937319 following multiple (14 days) escalating oral doses in patients with type 2 diabetes.	null	Diabetes Mellitus, Type 2 NIDDM	Pharmacokinetics PK Pharmacodynamics PD T2DM Phase 1 Type 2 diabetes mellitus safety and tolerability	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Subjects will be dosed with PF-04937319 for 14 days. The doses planned are 10, 30, 100 and 300 mg QD. All doses will be administered as tablets (10 and 100 mg strengths). In each Cohort, 9 patients will receive PF 04937319 and 3 will receive placebo. An additional cohort of 12 patients (9 active, 3 plac...	intervention 1: PF-04937319 intervention 2: Placebo	4	Miami \| Florida \| United States \| -80.19366 \| 25.77427 South Miami \| Florida \| United States \| -80.29338 \| 25.7076 South Miami \| Florida \| United States \| -80.29338 \| 25.7076 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711	61	0	0	0	NCT01272804	1COMPLETED	2011-07-01	2011-02-01	Pfizer	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	204	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to evaluate the efficacy of DSG 1% compared with placebo applied four times a day in subjects with acute blunt soft tissue injuries/contusions of the limbs	null	Acute Blunt Soft Tissue Injuries/Contusions	Blunt soft tissue injury/contusion	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 10 ]	intervention 1: Topical gel 1%- 4 times daily intervention 2: Topical gel - 4 times daily	intervention 1: Diclofenac sodium intervention 2: Placebo	6	Brühl \| N/A \| Germany \| 6.90499 \| 50.82928 Butzbach \| N/A \| Germany \| 8.67122 \| 50.43395 Cologne \| N/A \| Germany \| 6.95 \| 50.93333 Essen \| N/A \| Germany \| 7.01228 \| 51.45657 Gilching \| N/A \| Germany \| 11.2936 \| 48.10755 Munich \| N/A \| Germany \| 11.57549 \| 48.13743	204	0	0	0	NCT01272947	1COMPLETED	2011-07-01	2011-01-01	Novartis	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	24	NA	SINGLE_GROUP	7BASIC_SCIENCE	0NONE	false	1FEMALE	false	The purpose of this study is to determine the pharmacokinetics (PK) of misoprostol acid for the MVI 200 in women requiring cervical ripening and induction of labor.	null	Cervical Ripening Induction of Labor	Pharmacokinetics Misoprostol Vaginal Insert Induction of labor Cervical Ripening Rate of Cesarean section	null	1	arm 1: MVI 200 mcg vaginal insert	[ 0 ]	1	[ 0 ]	intervention 1: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 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 200	1	Pasadena \| California \| United States \| -118.14452 \| 34.14778	24	0	0	0	NCT01283022	1COMPLETED	2011-07-01	2011-05-01	Ferring Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2 ]	84	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	This is a trial in subjects with Type 2 diabetes mellitus to study the safety, tolerability and pharmacokinetics and pharmacodynamics of single escalating doses of PF-05231023.	null	Diabetes Mellitus, Type 2	Type 2 diabetes intravenous single dose	null	2	arm 1: None arm 2: 0.9% w/v sodium chloride injection, USP	[ 0, 2 ]	8	[ 0, 0, 0, 0, 0, 0, 0, 10 ]	intervention 1: 0.5 mg QD IV x 1 day intervention 2: 1.5 mg QD IV x 1 day intervention 3: 5 mg QD IV x 1 day intervention 4: 15 mg QD IV x 1 day intervention 5: 50 mg QD IV x 1 day intervention 6: 100 mg QD IV x 1 day intervention 7: 200 mg QD IV x 1 day intervention 8: 0.9% w/v sodium chloride injection, USP QD IVx 1 ...	intervention 1: PF-05231023 intervention 2: PF-05231023 intervention 3: PF-05231023 intervention 4: PF-05231023 intervention 5: PF-05231023 intervention 6: PF-05231023 intervention 7: PF-05231023 intervention 8: Placebo	5	Chula Vista \| California \| United States \| -117.0842 \| 32.64005 Fort Meyers \| Florida \| United States \| N/A \| N/A Miami \| Florida \| United States \| -80.19366 \| 25.77427 Miramar \| Florida \| United States \| -80.23227 \| 25.98731 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412	84	0	0	0	NCT01285518	1COMPLETED	2011-07-01	2011-02-01	Pfizer	4INDUSTRY	false	false	false	null	0	0	0	0
[ 0 ]	69	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	1FEMALE	true	In previous studies the investigators have seen that the severity of pain one day after cesarean delivery can predict the presence of pain and depression 2 months later. The investigators believe those at risk for severe acute post-partum pain can be identified, and medical interventions can be tailored to manage posto...	This study is randomizing patients into 2 different groups and seeing if by altering our pain management with this group of patients their acute 24 hour evoked pain is less than anticipated; and the incidence of persistent pain and depression when contacted 2 months after delivery is decreased. This study is designed t...	Other Chronic Postoperative Pain	chronic pain post delivery postpartum depression tailored pain management	null	2	arm 1: Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care. arm 2: Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen...	[ 2, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses intervention 2: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses intervention 3: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses	intervention 1: Duramorph 150 intervention 2: Acetaminophen intervention 3: Duramorph 300	1	Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986	60	0	0	0	NCT01298778	1COMPLETED	2011-07-01	2010-08-01	Wake Forest University Health Sciences	7OTHER	false	false	false	null	0	0	0	0
[ 2 ]	45	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	true	0ALL	null	The purpose of this study is to evaluate how much of the investigational product gets into the blood stream and how long the body takes to get rid of it when given to subjects with a range of liver impairment compared to subjects with normal liver function.	This is a multi-center, open-label, parallel-arm study in 1 group of subjects with normal hepatic function and 3 groups of subjects with varying degrees of hepatic impairment (mild, moderate, and severe). Subjects will be confined to the clinic from Day -1 to Day 8. Subjects will be contacted via telephone 30 days (+ 2...	Schizophrenia		null	4	arm 1: None arm 2: None arm 3: None arm 4: None	[ 1, 1, 1, 1 ]	1	[ 0 ]	intervention 1: All groups will receive a single oral 2-mg OPC-34712 dose on Day 1 with 240 mL room temperature still water. Subjects will be administered the OPC-34712 dose in the fasted state (at least 8 hours of fasting) and no food will be allowed for 4 hours postdose. Water will be restricted as part of the dosing...	intervention 1: OPC-34712	3	Miami \| Florida \| United States \| -80.19366 \| 25.77427 Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412	45	0	0	0	NCT01299454	1COMPLETED	2011-07-01	2010-12-01	Otsuka Pharmaceutical Development & Commercialization, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2 ]	17	RANDOMIZED	PARALLEL	null	1SINGLE	true	2MALE	false	The purpose of this study is to evaluate the pharmacodynamics (the drug's effect on the body), the pharmacokinetics (the body's handling of the drug), and the safety and tolerability of vortioxetine, once daily (QD) in healthy men.	This study will look at an investigational medicine called vortioxetine to see how the drug affects the body and how the body handles the drug. The study enrolled 17 patients. Participants were randomly assigned at a 2:1 ratio to one of the following two treatment groups-which remained undisclosed to both the particip...	Healthy	Drug Therapy pharmacodynamic	null	2	arm 1: Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days. arm 2: Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Encapsulated tablet intervention 2: Vortioxetine placebo-matching capsules.	intervention 1: Vortioxetine intervention 2: Placebo	1	Glendale \| California \| United States \| -118.25508 \| 34.14251	17	0	0	0	NCT01299805	1COMPLETED	2011-07-01	2011-03-01	Takeda	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	40	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	2MALE	false	Watson's testosterone transdermal system delivers male sex hormone through skin for the treatment of men with sex hormone insufficiency.	The present study is designed to characterize efficacy and safety of testosterone from the Watson's testosterone matrix transdermal system (TMTS).	Hypogonadism	hypogonadism, testosterone, transdermal system	null	1	arm 1: Following a lead-in dose-proportionality phase (Days 1-2) and a site-to-site bioavailability phase (Days 2-9), subjects were dosed for efficacy analysis beginning on Day 9 at dose level B (a single 48 cm2 testosterone matrix transdermal system). Based on pharmacokinetic (PK) analysis of blood samples drawn on Da...	[ 0 ]	1	[ 0 ]	intervention 1: None	intervention 1: testosterone matrix transdermal system	2	Fort Meyers \| Florida \| United States \| N/A \| N/A Tacoma \| Washington \| United States \| -122.44429 \| 47.25288	40	0	0	0	NCT01323140	1COMPLETED	2011-07-01	2011-04-01	Watson Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2 ]	18	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	true	1FEMALE	null	The objective of this study is to investigate the possible effect of multiple oral doses of 25 mg BI 10773 on the steady state pharmacokinetics of ethinylestradiol (EE) and levonogestrel (LNG) (Microgynon®).	null	Healthy		null	2	arm 1: multiple doses of Microgynon arm 2: multiple doses of Microgynon + BI 10773	[ 0, 1 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: multiple doses intervention 2: multiple doses intervention 3: multiple doses intervention 4: multiple doses BI 10773 intervention 5: multiple doses	intervention 1: levonorgestrel intervention 2: levonorgestrel intervention 3: Ethinylestradiol intervention 4: Microgynon + BI 10773 intervention 5: Ethinylestradiol	1	Biberach \| N/A \| Germany \| 8.03333 \| 48.33333	36	0	0	0	NCT01328184	1COMPLETED	2011-07-01	2011-04-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	243	RANDOMIZED	FACTORIAL	0TREATMENT	4QUADRUPLE	true	0ALL	true	Relapse to smoking is a common problem affecting smokers who seek treatment. The purpose of this study is examine whether selegiline, given in the form of a skin patch, is effective in stopping smoking.	Most smokers relapse following smoking cessation treatment. More effective smoking cessation therapies are needed to prevent the high rates of relapse. Selegiline is a selective inhibitor of monoamine oxidase B (MAO B) and has been used clinically in combination with levodopa to treat Parkinson's disease. Selegiline pe...	Tobacco Use Disorder		null	2	arm 1: 6 mg selegiline patch (transdermal) worn for 24 hours for 8 weeks arm 2: matching placebo worn 24 hours for 8 weeks	[ 0, 2 ]	2	[ 0, 10 ]	intervention 1: 6mg/24 hrs for 8 weeks intervention 2: placebo/24hrs for 8 weeks	intervention 1: Selegiline intervention 2: matching placebo	1	Stanford \| California \| United States \| -122.16608 \| 37.42411	243	0	0	0	NCT01330030	1COMPLETED	2011-07-01	2005-07-01	Stanford University	7OTHER	false	false	false	null	0	0	0	0
[ 5 ]	72	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this study is to evaluate the efficacy and safety of diclofenac 1.16% gel compared with placebo applied four times a day in subjects with acute neck pain.	null	Neck Pain		null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Diclofenac diethylamine 1.16% gel intervention 2: Placebo gel	intervention 1: Diclofenac diethylamine 1.16% gel intervention 2: Placebo gel	3	Cologne \| N/A \| Germany \| 6.95 \| 50.93333 Essen \| N/A \| Germany \| 7.01228 \| 51.45657 Munich \| N/A \| Germany \| 11.57549 \| 48.13743	72	0	0	0	NCT01335724	1COMPLETED	2011-07-01	2011-04-01	Novartis	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2 ]	64	RANDOMIZED	CROSSOVER	null	0NONE	true	2MALE	null	To investigate the bioequivalence of telmisartan administrated in two different ways: both in telmisartan 80 mg/amlodipine 5 mg fixed-dose combination tablets (T) and as telmisartan 80 mg tablet and amlodipine 5 mg tablets (R) in concomitant use	Purpose:	Healthy		null	2	arm 1: single-dose, four-period replicated crossover design arm 2: single-dose, four-period replicated crossover design	[ 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Telmisartan80mg/Amlodipin5mg FDC intervention 2: Telmisartan 80 mg tablet intervention 3: Amlodipin 5mg tablet	intervention 1: Telmisartan/Amlodipin FDC intervention 2: Telmisartan intervention 3: Amlodipin	1	Kumamoto, Kumamoto \| N/A \| Japan \| N/A \| N/A	64	0	0	0	NCT01344629	1COMPLETED	2011-07-01	2011-04-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	300	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	false	Eligible subjects undergoing a colonoscopy will randomly receive either PICOPREP or polyethylene glycol 4000 electrolyte lavage solution before the procedure to evaluate its effectiveness, tolerability and safety.	null	Colonoscopy		null	2	arm 1: "Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy. arm 2: PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets)...	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: PICOPREP intervention 2: PEG-ELS	7	Guangzhou \| N/A \| China \| 113.25 \| 23.11667 Guangzhou \| N/A \| China \| 113.25 \| 23.11667 Nanjing \| N/A \| China \| 118.77778 \| 32.06167 Shanghai \| N/A \| China \| 121.45806 \| 31.22222 Shanghai \| N/A \| China \| 121.45806 \| 31.22222 Shanghai \| N/A \| China \| 121.45806 \| 31.22222 Wuhan \| N/A \| China \| 114.26667 \| 30.58333	295	0	0	0	NCT01356407	1COMPLETED	2011-07-01	2011-01-01	Ferring Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2 ]	24	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	true	0ALL	null	A single-center, crossover study to evaluate the pharmacokinetics of dalcetrapib and atorvastatin from prototype fixed dose combination formulations in healthy volunteers. Volunteers will receive a single dose of dalcetrapib with atorvastatin in each of four treatment periods.	null	Healthy Volunteer		null	4	arm 1: RO5317116/F01 bilayer tablet arm 2: RO5317116/F03 bilayer tablet arm 3: RO5317116/F04 active-coated tablet arm 4: RO4607381/F49 tablet	[ 0, 0, 0, 0 ]	2	[ 0, 0 ]	intervention 1: single dose of atorvastatin on day 1 intervention 2: single dose of dalcetrapib on day 1	intervention 1: atorvastatin intervention 2: dalcetrapib	1	Christchurch \| N/A \| New Zealand \| 172.63333 \| -43.53333	24	0	0	0	NCT01363999	1COMPLETED	2011-07-01	2011-06-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	326	RANDOMIZED	PARALLEL	null	3TRIPLE	true	0ALL	false	The purpose of this trial is to see how safe the combination of naproxen sodium 440 mg and diphenhydramine hydrochloride (DPH) 50 mg (the investigational product) is compared to placebo (capsules containing no drug) when taken for 10 days.	null	Pain	Maximum Use Safety Trial	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days intervention 2: 2 placebo capsules are taken orally with a full glass of water 30 minutes prior to be...	intervention 1: Naproxen sodium 440 mg/DPH 50 mg (BAY98-7111) intervention 2: Placebo	19	Chandler \| Arizona \| United States \| -111.84125 \| 33.30616 Mesa \| Arizona \| United States \| -111.82264 \| 33.42227 Peoria \| Arizona \| United States \| -112.23738 \| 33.5806 Anaheim \| California \| United States \| -117.9145 \| 33.83529 Rancho Cucamonga \| California \| United States \| -117.59311 \| 34.1064 Sacramento \| Californ...	326	0	0	0	NCT01365052	1COMPLETED	2011-07-01	2011-05-01	Bayer	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2 ]	6	NA	SINGLE_GROUP	9OTHER	0NONE	true	2MALE	false	This open-label study is being conducted to determine the metabolism and physiological disposition of radiolabeled LY2886721 after a single dose in healthy male participants.	null	Healthy Volunteers	Absorption Distribution Metabolism Excretion	null	1	arm 1: Single 25 milligram (mg) oral dose containing 80 microCuries of radiolabeled LY2886721	[ 0 ]	1	[ 0 ]	intervention 1: Administered orally	intervention 1: LY2886721	1	Madison \| Wisconsin \| United States \| -89.40123 \| 43.07305	6	0	0	0	NCT01367262	1COMPLETED	2011-07-01	2011-06-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	20	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	2MALE	false	This is an open-label study of a single and repeated application of three dose levels of topical testosterone in hypogonadal males with morning serum testosterone concentrations \< 297 ng/dL.	null	Testicular Hypogonadism		null	6	arm 1: Subjects received a single application of 2.50 mL (two strokes) of the testosterone gel 2% applied to the inner thigh followed by a seven day washout period. arm 2: Subjects received a single application of 2.50 mL (two strokes) of the testosterone gel 2% applied to the abdomen followed by a seven day washout pe...	[ 0, 0, 0, 0, 0, 0 ]	1	[ 0 ]	intervention 1: None	intervention 1: Testosterone gel (FE 99903)	1	Garden City \| New York \| United States \| -73.6343 \| 40.72677	60	0	0	0	NCT01370369	1COMPLETED	2011-07-01	2011-05-01	Ferring Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2 ]	12	RANDOMIZED	CROSSOVER	0TREATMENT	3TRIPLE	false	2MALE	false	This was a four-period crossover study to assess the glycemic effects of a single dose of oxyntomodulin (OXM) on the glucose levels in participants with Type 2 diabetes mellitus (T2DM). Participants were randomly assigned to 1 of 6 treatment sequences consisting of 4 treatment periods, with a 7-day wash-out between eac...	null	Type 2 Diabetes Mellitus		null	6	arm 1: Participants received Oxyntomodulin 3.0 pmol/kg/min in the first, Liraglutide 0.6 mg in the second, Placebo in the third, and Liraglutide 1.2 mg in the fourth period arm 2: Participants received Liraglutide 0.6 mg in the first, Placebo in the second, Oxyntomodulin 3.0 pmol/kg/min in the third, and Placebo in the...	[ 0, 0, 0, 0, 0, 0 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: 3.0 pmol/kg/min as an intravenous (IV) infusion in the morning of the day of graded glucose infusion (GGI) (Day 1) intervention 2: Single subcutaneous dose in the evening of the day before the GGI (Day-1) intervention 3: Single subcutaneous dose in the evening of the day before the GGI (Day-1) intervent...	intervention 1: Oxyntomodulin intervention 2: Liraglutide 0.6 mg intervention 3: Liraglutide 1.2 mg intervention 4: Placebo for Oxyntomodulin intervention 5: Placebo for Liraglutide	0	null	42	0	0	0	NCT01373450	1COMPLETED	2011-07-01	2011-06-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2 ]	16	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	true	0ALL	false	The purposes of this study are to determine the pharmacokinetics and pharmacodynamics of LY2963016 compared to those of basal insulin. The study will also gather information on the safety and tolerability of LY2963016 in healthy subjects. The study is approximately 12 weeks.	null	Diabetes Mellitus		null	2	arm 1: A single 0.5-unit per kilogram (U/kg) dose of LY2963016 will be administered subcutaneously. arm 2: A single 0.5-U/kg dose of Lantus will be administered subcutaneously.	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Administered subcutaneously intervention 2: Administered subcutaneously	intervention 1: LY2963016 intervention 2: Lantus	1	Singapore \| N/A \| Singapore \| 103.85007 \| 1.28967	29	0	0	0	NCT01374178	1COMPLETED	2011-07-01	2011-06-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2 ]	14	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	true	0ALL	null	The objective of the current study is to investigate the effect of multiple oral daily doses of BI 201335 on the steady-state pharmacokinetics of darunavir co-administered with ritonavir.	null	HIV Infections		null	3	arm 1: capsule for oral administration arm 2: tablet for oral administration arm 3: tablet for oral administration	[ 0, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: 400 mg tablet for oral administration intervention 2: tablet for oral administration intervention 3: None	intervention 1: Darunavir intervention 2: Ritonavir intervention 3: BI 201335	1	Berlin \| N/A \| Germany \| 13.41053 \| 52.52437	28	0	0	0	NCT01374802	1COMPLETED	2011-07-01	2011-06-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	16	NON_RANDOMIZED	SEQUENTIAL	0TREATMENT	0NONE	false	0ALL	null	The purpose of this study is to obtain preliminary data regarding the safety and tolerability of apremilast in AD to support the design of larger controlled studies.	To investigate the preliminary safety and efficacy of apremilast, an oral phosphodiesterase 4 inhibitor, for atopic dermatitis.	Atopic Dermatitis		null	2	arm 1: Patients dosed with 20 mg orally of Apremilast BID for 3 months. arm 2: Patients dosed with 30 mg orally of Apremilast BID for 6 months.	[ 0, 0 ]	1	[ 0 ]	intervention 1: 20mg of Apremilast taken orally BID for 3 months or 30 mg of Apremilast taken orally BID for 6 months.	intervention 1: Apremilast	0	null	16	0	0	0	NCT01393158	1COMPLETED	2011-07-01	2009-05-01	Oregon Health and Science University	7OTHER	false	false	false	null	0	0	0	0
[ 5 ]	20	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The basic nerve deficit of Parkinson's disease (PD) leads to lower urinary tract symptoms of frequency, urgency and urge urinary incontinence. Lower urinary tract symptoms tend to occur at more advanced stages of PD. In the over-65 year old age group, where 1% of men suffer from this disease, they are also prone to dev...	This open-label pilot study will evaluate the safety and efficacy of intra-detrusor injections of botulinum-A toxin (BTX-A) in 20 male or female patients with Parkinson's disease and neurogenic overactive bladder with or without urinary incontinence, but without evidence of significant urinary retention (\>25% of bladd...	Parkinson's Disease Neurogenic Bladder Urinary Incontinence Clostridium Botulinum Toxin Adverse Reaction	Parkinson's Disease Neurogenic Bladder Urinary Incontinence botulinum toxin cystoscopy Effect of Other Parasympatholytics [Anticholinergics and Antimuscarinics] and Spasmolytics	null	1	arm 1: botulinum toxin treatment Injection of Botox into urinary bladder for neurogenic symptoms.	[ 0 ]	1	[ 0 ]	intervention 1: 100 U of Botox A injected transurethrally into the urinary bladder muscle and submucosa.	intervention 1: Cystoscopic injection of Botox into the urinary bladder	1	Stanford \| California \| United States \| -122.16608 \| 37.42411	20	0	0	0	NCT01421719	1COMPLETED	2011-07-01	2009-02-01	Stanford University	7OTHER	false	false	false	null	0	0	0	0
[ 5 ]	28	NON_RANDOMIZED	SINGLE_GROUP	null	0NONE	true	0ALL	false	This is a Phase 4, single-center, open-label, fixed-sequence, multiple-dose, 2-way drug-drug interaction study.	Each subject will qualify for entry into the study not more than 30 days prior to admission into the clinical unit. Subjects will check into the clinical unit on Day -1 for baseline assessments. During the treatment period, each subject will receive a once-daily dose of pitavastatin 4 mg on Days 1 through 5 and on Days...	Healthy	Healthy Volunteers	null	1	arm 1: There was 1 treatment period, with each subject receiving a once-daily dose of pitavastatin 4 mg on Days 1 through 5 and on Days 11 through 15 and a once-daily dose of diltiazem 240 mg on Days 6 through 15	[ 0 ]	2	[ 0, 0 ]	intervention 1: pitavastatin (NK-104) 4 mg once daily (QD) intervention 2: Diltiazem (Cardizem LA) 240 mg QD	intervention 1: Pitavastatin (NK-104) intervention 2: Diltiazem (Cardizem LA) 240 mg QD	1	Austin \| Texas \| United States \| -97.74306 \| 30.26715	28	0	0	0	NCT01422382	1COMPLETED	2011-07-01	2011-05-01	Kowa Research Institute, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	110	NA	SINGLE_GROUP	2DIAGNOSTIC	0NONE	false	0ALL	false	This study is designed to test the relationship between measurements of brain amyloid using florbetapir F 18 PET imaging and true levels of amyloid plaque density as measured by histopathological assessment. The study will address the following specific aims: 1. To expand the number of subjects included in the A07 (NC...	null	Alzheimer's Disease		null	0	null	null	1	[ 0 ]	intervention 1: No study drug administered in this trial. Study subjects previously dosed with 18F-AV-45 in study 18F-AV-45-A07 (NCT00857415) are followed to autopsy in this extension study.	intervention 1: florbetapir F 18	22	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Sun City \| Arizona \| United States \| -112.27182 \| 33.59754 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Irvine \| California \| United States \| -117.82311 \| 33.66946 Fort Myers \| Florida \| United States \| -81.84059 \| 26.62168 Miami \| Florida \| Uni...	0	0	0	0	NCT01447719	1COMPLETED	2011-07-01	2010-03-01	Avid Radiopharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0
[ 0 ]	8	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Hypothesis: The investigators postulate that patients with Wilson disease who are asymptomatic or who have been effectively treated for their symptoms and are in a maintenance phase therapy can be safely and effectively treated with a single daily dosage of the chelating agent trientine. Specific Aims: To demonstrate ...	Wilson disease is a genetic disorder of copper metabolism inherited in an autosomal recessive fashion that afflicts \~1/30,000 individuals. Treatment for these individuals consists of medical therapy, which is life-long, or liver transplantation. Medical therapy utilizes chelating agents, penicillamine and trientine, o...	Wilson Disease	Wilson Disease Trientine One Daily Dosage	null	1	arm 1: Patients receive once a day trientine	[ 0 ]	1	[ 0 ]	intervention 1: Trientine at a dosage of \~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year.	intervention 1: Once a day Trientine	1	New Haven \| Connecticut \| United States \| -72.92816 \| 41.30815	8	0	0	0	NCT01472874	1COMPLETED	2011-07-01	2010-01-01	Yale University	7OTHER	false	false	false	null	0	0	0	0
[ 4 ]	313	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	This randomized, open-label study will compare the efficacy and safety of MabThera/Rituxan (rituximab) alone, and in combination with Roferon-A (interferon alfa-2a) in patients with follicular or other CD20+ low-grade lymphoma. Patients will be randomized to receive either MabThera/Rituxan 375 mg/m2 intravenously weekl...	null	Lymphoma		null	2	arm 1: Participants received 375 milligrams per square meter (mg/m2) rituximab intravenously (i.v.) weekly for 4 weeks. Participants achieving minor response (MR), partial response (PR), or completer response (CR) received a second cycle of treatment. arm 2: Participants received 375 mg/m2 rituximab i.v. weekly for 4 w...	[ 1, 0 ]	2	[ 0, 0 ]	intervention 1: 375 mg/m2 rituximab i.v. weekly for 4 weeks intervention 2: 3 MIU/day interferon-a2a s.c. during Week 1, and 4.5 MIU/day s.c. 6 days per week during Weeks 2 through 5	intervention 1: rituximab intervention 2: interferon-a-2a	31	Copenhagen \| N/A \| Denmark \| 12.56553 \| 55.67594 Hillerød \| N/A \| Denmark \| 12.30081 \| 55.92791 Roskilde \| N/A \| Denmark \| 12.08035 \| 55.64152 Bergen \| N/A \| Norway \| 5.32415 \| 60.39299 Oslo \| N/A \| Norway \| 10.74609 \| 59.91273 Oslo \| N/A \| Norway \| 10.74609 \| 59.91273 Stavanger \| N/A \| Norway \| 5.73332 \| 58.97005 Trom...	313	0	0	0	NCT01609010	1COMPLETED	2011-07-01	2002-10-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3, 4 ]	239	RANDOMIZED	PARALLEL	1PREVENTION	4QUADRUPLE	true	1FEMALE	true	SPECIFIC AIMS * Assess risk factors for nausea and vomiting in c-section patients undergoing regional anesthesia * Quantify the incidence of nausea and vomiting intraoperatively and postoperatively in the ginger and placebo groups. * Quantify post-operative analgesia and pruritus in the ginger and placebo groups * Qua...	Two hundred and thirty nine ASA class I and II patients, scheduled for elective c-section will be assigned randomly to receive either 1g ginger tablet PO (Group 1) or 1 g placebo PO (Group 2) preoperatively, immediately before surgery. The usual preoperative anti-emetic and antacid regimen will be continued for both gr...	Nausea Vomiting	Nausea Vomiting Cesaraen Ginger cesarean section	null	2	arm 1: 2 gm powder of ginger filled in a capsule arm 2: 2 gm of placebo pill (A capsule)	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Ginger is an herb. The rhizome (underground stem) is used as a spice and also as a medicine. It can be used fresh, dried and powdered, or as a juice or oil. Two capsules (1g each) of dry powdered ginger are given, one capsule a half-hour before induction of anesthesia and the second 2h after surgery. in...	intervention 1: Ginger intervention 2: Placebo Oral Tablet	1	Brooklyn \| New York \| United States \| -73.94958 \| 40.6501	239	0	0	0	NCT01733212	1COMPLETED	2011-07-01	2010-06-01	Joel Yarmush	7OTHER	false	false	false	null	0	0	0	0
[ 5 ]	5	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The current study examines the effects of milnacipran in patients who have chronic persistent knee pain one year or longer after total knee arthroplasty (TKA) to evaluate for a pain-relieving effect.	The current study proposes to collect pilot data on the utility of open-label milnacipran for the treatment of pain and other outcomes in this unfortunate group of patients with chronic persistent pain after TKA. Among marketed serotonin norepinephrine reuptake inhibitors (SNRIs), milnacipran has a unique property in t...	Knee Pain After Total Knee Arthroplasty Osteoarthritis Pain	Knee Pain Osteoarthritis	null	1	arm 1: Open-label flexibly dosed milnacipran	[ 0 ]	1	[ 0 ]	intervention 1: None	intervention 1: Open-label flexibly dosed milnacipran	1	Durham \| North Carolina \| United States \| -78.89862 \| 35.99403	5	0	0	0	NCT01780389	1COMPLETED	2011-07-01	2010-10-01	Duke University	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	90	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to determine whether the combination of ibuprofen and acetaminophen, is more effective than either single agent alone in treating pain from acute musculoskeletal injuries in the emergency department.	The purpose of this study is to determine whether the combination of ibuprofen and acetaminophen, is more effective than either single agent alone in treating pain from acute musculoskeletal injuries in the emergency department. We hypothesize that the combination will be more effective than either agent alone in patie...	Pain	musculoskeletal pain acetaminophen ibuprofen	null	3	arm 1: Ibuprofen 800 mg arm 2: Acetaminophen 1 gm arm 3: Ibuprofen 800 mg plus acetaminophen 1 gm	[ 1, 1, 0 ]	3	[ 0, 0, 0 ]	intervention 1: single dose intervention 2: single dose intervention 3: single dose	intervention 1: Ibuprofen intervention 2: Acetaminophen intervention 3: Ibuprofen-acetaminophen combination	0	null	90	0	0	0	NCT01827475	1COMPLETED	2011-07-01	2010-07-01	Stony Brook University	7OTHER	false	false	false	null	0	0	0	0
[ 5 ]	99	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	null	The purpose of this study is to compare how well different anesthetic, or numbing, solutions injected under the skin work in reducing the discomfort associated with placing a catheter in a vein. Two different medications, lidocaine and normal saline with benzyl alcohol, have been found to be effective in reducing disco...	null	IV Insertion Pain	local anesthesia intravenous catheter	null	3	arm 1: 1% lidocaine intradermal injection arm 2: bacteriostatic normal saline (BNS) injection arm 3: usual care practice of no local anesthetic administration	[ 1, 1, 4 ]	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: 1% lidocaine intervention 2: bacteriostatic normal saline (BNS)	0	null	98	0	0	0	NCT02162680	1COMPLETED	2011-07-01	2010-03-01	Duke University	7OTHER	false	false	false	null	0	0	0	0
[ 2 ]	6	NA	SINGLE_GROUP	0TREATMENT	0NONE	true	2MALE	false	The purpose of this study is to determine the rate and routes of excretion of OPC and the mass balance in urine, faeces and expired air.	This was a single-centre, open-label ADME study in 6 healthy male subjects. Subjects received a single dose of 100 mg OPC, containing 3.39 MBq of \[14C\] OPC as oral capsules. The study consisted of an eligibility screening period within 3 weeks prior to drug administration, admission on Day -1, a treatment period inv...	Parkinson's Disease (PD)	Parkinson's disease (PD) BIA 9-1067 Opicapone	null	1	arm 1: 100 mg OPC	[ 0 ]	1	[ 0 ]	intervention 1: The drug substance of 100 mg OPC was administered as 1 capsule.	intervention 1: OPC	1	Zuidlaren \| N/A \| Netherlands \| 6.68194 \| 53.09417	6	0	0	0	NCT02169427	1COMPLETED	2011-07-01	2011-03-01	Bial - Portela C S.A.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	240	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) as monotherapy or in combination with Sulfonylurea (glimepiride) in Japanese patients with type 2 Diabetes for 52 weeks administration.	null	Type 2 Diabetes Mellitus	DPP-IV inhibitor	null	2	arm 1: Teneligliptin for 52 weeks arm 2: Teneligliptin for 52 weeks in combination with sulfonylurea	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Teneligliptin for 52 weeks intervention 2: Teneligliptin for 52 weeks in combination with sulfonylurea	intervention 1: Teneligliptin intervention 2: Teneligliptin + Sulfonylurea	1	Shikoku \| N/A \| Japan \| N/A \| N/A	240	0	0	0	NCT02314637	1COMPLETED	2011-07-01	2009-08-01	Mitsubishi Tanabe Pharma Corporation	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2 ]	24	RANDOMIZED	CROSSOVER	7BASIC_SCIENCE	0NONE	true	0ALL	false	Evaluate the pharmacokinetics (PK), Safety and tolerability of guaifenesin (Mucinex®) in an immediate-release formulation when a single dose is administered in adolescents and in adults when compared to Children.	null	Healthy Subjects		null	2	arm 1: 1 x 200 mg (10 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate-release formulation arm 2: 1 x 400 mg (20 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate-release formulation	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: 1 x 200 mg (10 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate-release formulation intervention 2: 1 x 400 mg (20 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate-release formulation	intervention 1: Children's Mucinex® Grape Flavor intervention 2: Children's Mucinex® Grape Flavor	0	null	48	0	0	0	NCT03633448	1COMPLETED	2011-07-01	2011-06-18	Reckitt Benckiser LLC	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	30	RANDOMIZED	FACTORIAL	7BASIC_SCIENCE	2DOUBLE	true	0ALL	false	Asthma is most effectively treated by delivering inhaled drugs from an inhaler (puffer) directly into the lungs. Inhaled steroids are used in asthmatic patients to dampen down lung inflammation, which unchecked, can often lead to patient symptoms. Inhalers deliver a mist containing particles of lots of different sizes ...	The clinical trial is to investigate the pharmacokinetic effects (that is how much drug is in the blood) of Fluticasone Propionate (Flixotide), a commonly used steroid drug that is inhaled in patients with asthma. We will use standard clinical Flixotide Nebules that are used with clinical nebulisers (machines used in h...	Healthy Asthma	Monodisperse aerosols Healthy Volunteers Asthmatics Pharmacokinetics Randomized	null	2	arm 1: Asthma patients arm 2: Healthy participants	[ 0, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Dose 50 micrograms (total dose), Monodisperse aerosol with particle size of drug 1.5 micros, inhaled intervention 2: Dose 50 micrograms (total dose), Monodisperse aerosol with particle size of drug 3.0 microns, inhaled intervention 3: Dose 50 micrograms (total dose), Monodisperse aerosol with particle s...	intervention 1: Fluticasone Propionate_1.5 intervention 2: Fluticasone Propionate_3 intervention 3: Fluticasone Propionate_6 intervention 4: FP From Active 250 ug MDI Inhaler	2	London \| N/A \| United Kingdom \| -0.12574 \| 51.50853 London \| N/A \| United Kingdom \| -0.12574 \| 51.50853	120	0	0	0	NCT00692978	1COMPLETED	2011-07-03	2008-08-01	Imperial College London	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	57	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This is an open-label, multicenter, phase 2 study of alisertib (MLN8237) in participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).	The drug being tested in this study is called alisertib (MLN8237). Alisertib is being tested to treat people who have acute myeloid leukemia (AML) or high-grade myelodysplastic syndrome (MDS). This study looked at the antitumor activity in people who received alisertib. The study enrolled 57 patients. Participants wer...	Acute Myelogenous Leukemia High-Grade Myelodysplastic Syndrome	Drug therapy	null	1	arm 1: Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles).	[ 0 ]	1	[ 0 ]	intervention 1: Alisertib capsules	intervention 1: Alisertib	1	Morristown \| New Jersey \| United States \| -74.48154 \| 40.79677	57	0	0	0	NCT00830518	1COMPLETED	2011-07-04	2009-02-10	Millennium Pharmaceuticals, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	23	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	This 96 week, Phase 2b study in 150 HIV-1 infected antiretroviral (ART) naive adult subjects consists of a dose-ranging evaluation of GSK2248761 at blinded doses of 100 mg and 200 mg once daily with a control arm of open-label efavirenz (EFV) 600 mg once daily. The background ART for all 3 arms will be chosen by the In...	Study SGN113404 is a phase 2b randomized, partially blinded, multicenter, parallel group, dose-ranging study. The study will be conducted in approximately 150 HIV-1 infected ART naïve subjects. The background NRTIs to be co-administered with GSK2248761 or EFV will be selected by Investigators prior to randomization and...	Infection, Human Immunodeficiency Virus	antiretroviral HAART NNRTI emtricitabine Sexually Transmitted Disease antiretroviral therapy (ART)-naive adults Immunologic Deficiency Syndrome tenofovir abacavir Retroviridae Infections GSK2248761 lamivudine Acquired ImmunoDeficiency Syndrome (AIDS) HIV infection efavirenz	null	3	arm 1: In combination with either abacavir/lamivudine FDC qd or tenofovir/emtricitabine FDC qd arm 2: In combination with either abacavir/lamivudine FDC qd or tenofovir/emtricitabine FDC qd arm 3: In combination with either abacavir/lamivudine FDC qd or tenofovir/emtricitabine FDC qd	[ 0, 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: 1x100 mg capsule plus matching placebo intervention 2: 2x100 mg capsules intervention 3: 1x600mg tablet	intervention 1: GSK2248761 100 mg once daily intervention 2: GSK2248761 200 mg once daily intervention 3: Efavirenz 600 mg once daily	12	Levallois-Perret \| N/A \| France \| 2.28864 \| 48.89389 Montpellier \| N/A \| France \| 3.87635 \| 43.61093 Nice \| N/A \| France \| 7.26608 \| 43.70313 Paris \| N/A \| France \| 2.3488 \| 48.85341 Frankfurt am Main \| Hesse \| Germany \| 8.68417 \| 50.11552 Hanover \| Lower Saxony \| Germany \| 9.73322 \| 52.37052 Berlin \| N/A \| Germany \| 1...	23	0	0	0	NCT01231555	6TERMINATED	2011-07-04	2010-11-18	ViiV Healthcare	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	6	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Current therapies for Stage IV adrenal gland cancer provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Stage IV adrenal gland cancer PURPOSE: This study is being performed to determine the effects (good and bad) tha...	OVERVIEW: This is a single arm, open-label study in which patients with Stage IV adrenal gland cancer receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to12 months in the absence of disease progression or ...	Stage IV Adrenocortical Carcinoma	recurrent adrenocortical carcinoma	null	1	arm 1: Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.	[ 0 ]	1	[ 0 ]	intervention 1: Patients with Stage IV Adrenal Gland Cancer will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.	intervention 1: Antineoplaston therapy (Atengenal + Astugenal)	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	6	0	0	0	NCT00003453	6TERMINATED	2011-07-05	1996-08-21	Burzynski Research Institute	7OTHER	false	false	false	null	0	0	0	0
[ 5 ]	313	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	Randomized Trial to Evaluate the Efficacy and Safety of Cinacalcet Treatment in Combination with Low Dose Vitamin D for the Treatment of Subjects with Secondary Hyperparathyroidism (SHPT) Recently Initiating Hemodialysis	null	Chronic Kidney Disease Secondary Hyperparathyroidism		null	2	arm 1: Cinacalcet plus low dose active Vitamin D (if prescribed) arm 2: Flexible active vitamin D dosing	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Cinacalcet is a calcimimetic agent, which is synthesized as a hydrochloride salt. intervention 2: Titration of active Vitamin D in accordance with treatment practice guidelines in order to treat Secondary Hyperparathyroidism.	intervention 1: Cinacalcet intervention 2: Vitamin D	0	null	309	0	0	0	NCT00803712	1COMPLETED	2011-07-05	2009-02-01	Amgen	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	93	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	1FEMALE	null	Pre-Term Labor (prior to 37 weeks gestation) is the largest single cause of infant morbidity and mortality and is frequently associated with long-term disability. Oxytocin is a hormone produced by the body during labor. GSK221149A is an experimental drug that will be used to block the effects of oxytocin, and therefore...	A randomized, double-blind, placebo-controlled, dose ranging study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK221149A administered intravenously and to investigate the pharmacokinetics of GSK221149A administered orally to healthy, pregnant females with uncomplicated pre-term la...	Obstetric Labour, Premature	Premature Labor Pre Term Labor intravenous fetal fibronectin	null	2	arm 1: GSK221149A arm 2: Placebo	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 6mg/h and 12 mg/h intervention 2: Matched Placebo to Drug	intervention 1: GSK221149A intervention 2: Placebo	57	Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Jonesboro \| Arkansas \| United States \| -90.70428 \| 35.8423 Colton \| California \| United Sta...	93	0	0	0	NCT00404768	1COMPLETED	2011-07-07	2007-10-12	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	70	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	false	This study is designed to look at the affect of SB-705498 on allergic rhinitis symptoms induced by an allergen chamber challenge.	null	Rhinitis		null	4	arm 1: Experimental arm 2: Active Comparator arm 3: Placebo Comparator arm 4: Experimental	[ 0, 1, 2, 0 ]	3	[ 0, 0, 0 ]	intervention 1: 12mg intranasal intervention 2: 200ug intranasal intervention 3: placebo intranasal	intervention 1: SB-705498 intervention 2: FP intervention 3: placebo	1	Vienna \| N/A \| Austria \| 16.37208 \| 48.20849	207	0	0	0	NCT01424397	1COMPLETED	2011-07-07	2011-04-14	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2 ]	104	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The primary purpose of this study is to investigate the Dose Limiting Toxicities (DLTs), pharmacokinetics (PK), and pharmacodynamics (PD) of MK-2206 administered orally to participants with advanced solid tumors. The preliminary efficacy of MK-2206 will also be investigated.	null	Locally Advanced Tumors Metastatic Solid Tumors Cancer Neoplasms		null	10	arm 1: Participants receive 30 mg oral MK-2206 every other day (QOD) in repeating 4-week treatment cycles. arm 2: Participants receive 60 mg oral MK-2206 QOD in repeating 4-week treatment cycles. arm 3: Participants receive 75 mg oral MK-2206 QOD in repeating 4-week treatment cycles. arm 4: Participants receive 90 mg o...	[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]	1	[ 0 ]	intervention 1: MK-2206 administered as an oral formulation in rising dose levels on a QOD schedule (30 mg, 60 mg, 75 mg, and 90 mg) or QW schedule (90 mg, 135 mg, 200 mg, 250 mg, and 300 mg) in repeating 4 week cycles, depending upon allocation.	intervention 1: MK-2206	0	null	104	8	0.076923	1	NCT00670488	1COMPLETED	2011-07-11	2008-04-15	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	8	0	0	0.039492
[ 4 ]	374	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	This is a randomized, double-blind, parallel-group, placebo-controlled, multi-center study. This study will compare an investigational new drug (crofelemer) to placebo for the control of HIV-associated diarrhea. The first stage of the study will determine the optimal dose of study drug based on safety and response to t...	null	HIV Associated Diarrhea	HIV AIDS Diarrhea HIV Associated Diarrhea	null	4	arm 1: None arm 2: None arm 3: None arm 4: None	[ 0, 0, 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Crofelemer 125 mg intervention 2: Crofelemer 250 mg intervention 3: Crofelemer 500 mg intervention 4: Placebo	intervention 1: Crofelemer 125 mg intervention 2: Crofelemer 250 mg intervention 3: Crofelemer 500 mg intervention 4: Placebo	82	Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Bakersfield \| California \| United States \| -119.01871 \| 35.37329 Beverly Hills \| California \| United States \| -118.40036 \| 34.07362 Beverly H...	363	0	0	0	NCT00547898	1COMPLETED	2011-07-11	2007-10-01	Bausch Health Americas, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	33	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	This is a Phase III, randomized, double blind, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy and safety of ocrelizumab compared to placebo when combined with a single stable background immunosuppressive medication and a corticosteroid regimen in patients with moderately to severely acti...	null	Systemic Lupus Erythematosus	SLE	null	3	arm 1: Ocrelizumab was administered i.v. at a dose on Days 1 and 15, followed by 1000 mg i.v. at Week 16 and then every 16 weeks arm 2: Ocrelizumab was administered at a dose 400 mg i.v. on Days 1 and 15, followed by 400 mg i.v. at Week 16 and then every 16 weeks arm 3: Placebo infusions were administered on Days 1 and...	[ 0, 0, 2 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: Oral repeating dose intervention 2: Oral repeating dose intervention 3: Intravenous repeating dose intervention 4: Intravenous repeating dose intervention 5: Intravenous repeating dose	intervention 1: Prednisone intervention 2: Immunosuppressive regime (azathioprine, mycophenolate mofetil or methotrexate) intervention 3: Methylprednisolone intervention 4: Ocrelizumab intervention 5: Placebo	0	null	33	0	0	0	NCT00539838	6TERMINATED	2011-07-12	2007-12-19	Genentech, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	807	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to determine the efficacy, safety, and tolerability of different doses of JNJ-27018966 (eluxadoline) compared with placebo in the treatment of patients with irritable bowel syndrome with diarrhea (IBS-d).	null	Irritable Bowel Syndrome	Irritable bowel syndrome with diarrhea Irritable bowel syndrome Diarrhea predominant irritable bowel syndrome Colonic diseases Colonic diseases, functional Digestive system disease Gastrointestinal disease Intestinal disease Colonic pseudo-obstruction Diarrhea Signs and Symptoms, Digestive	null	5	arm 1: Eluxadoline 5 mg tablets, orally, twice daily for up to 12 weeks. arm 2: Eluxadoline 25 mg tablets, orally, twice daily for up to 12 weeks. . arm 3: Eluxadoline 100 mg tablets, orally, twice daily for up to 12 weeks. arm 4: Eluxadoline 200 mg tablets, orally, twice daily for up to 12 weeks. arm 5: Eluxadoline pl...	[ 0, 0, 0, 0, 2 ]	2	[ 0, 0 ]	intervention 1: Tablets, orally, twice daily. intervention 2: Matching placebo oral tablets twice daily.	intervention 1: Eluxadoline intervention 2: Placebo	288	Anniston \| Alabama \| United States \| -85.83163 \| 33.65983 Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Dothan \| Alabama \| United States \| -85.39049 \| 31.22323 Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 Huntsville \| Alabama \| Unit...	771	0	0	0	NCT01130272	1COMPLETED	2011-07-14	2010-04-28	Furiex Pharmaceuticals, Inc	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	6	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	Clofarabine is a drug approved by the FDA (Food and Drug Administration) for treating children (age 1-21) with leukemia. This research study will use clofarabine with two other cancer fighting drugs. Clofarabine will be used together with etoposide (VePesid®, VP-16) and cyclophosphamide (Cytoxan®).	Clofarabine, etoposide and cyclophosphamide have been used together in a phase I study to find out the highest doses of these drugs that can be safely given to children with relapsed or refractory leukemia. This study is a phase II study which will use the drugs to study how well these drugs work against AML. This stud...	Relapsed Acute Myelogenous Leukemia	relapsed relapse refractory AML Acute myelogenous leukemia Relapsed AML	null	1	arm 1: All patients receive the same treatment regimen consisting of clofarabine, etoposide, cyclophosphamide, cytarabine, and filgrastim. Up to 4 courses of therapy may be given.	[ 0 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: 40 mg/m2/day IV over 2 hours (given at hours 0 to 2) on days 1 through 5. intervention 2: 100 mg/m2/day IV over 2 hours (given at hours 2 to 4) on days 1 through 5. intervention 3: 440 mg/m2/day IV as a 30-60 minute infusion (given at hours 4 to 5) on days 1 through 5. intervention 4: Administered in Co...	intervention 1: Clofarabine intervention 2: Etoposide intervention 3: Cyclophosphamide intervention 4: Filgrastim intervention 5: Cytarabine	4	Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997	6	0	0	0	NCT00939653	6TERMINATED	2011-07-15	2009-07-10	Therapeutic Advances in Childhood Leukemia Consortium	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	81	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	Morphine and related opioid analgesics are known to slow gastrointestinal (GI) motility and reduce intestinal secretion through their binding to μ opioid receptors (MORs) within the GI tract. The most common symptoms associated with the effects of opioids are constipation and nausea and/or vomiting. Moreover, constipat...	null	Constipation	opioid therapy constipation chronic noncancer pain mu opioid receptor antagonist ADL5945 Opioid Induced Constipation	null	2	arm 1: Each participant received 1 placebo capsule orally every day (QD) during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week). arm 2: During the Run-in Placebo Period, each participant received 1 placebo capsule orally QD for 1 week. Then during...	[ 2, 0 ]	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: Placebo intervention 2: ADL5945 0.25 mg	0	null	81	0	0	0	NCT01275755	1COMPLETED	2011-07-15	2011-01-19	Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	21	NON_RANDOMIZED	SEQUENTIAL	0TREATMENT	0NONE	false	0ALL	true	The investigators will investigate the effect of blood phenylalanine on Kuvan responsiveness in the same patients with PKU when their blood phenylalanine concentrations are altered by diet. Lowering blood phenylalanine concentrations in Kuvan non-responsive patients with PKU will increase the frequency of Kuvan respon...	null	Phenylketonuria	PKU Kuvan BH4 tetrahydrobiopterin	null	4	arm 1: Participants will receive one dose of Kuvan 20 mg/kg on Day 1 and assessed for Acute 24 hour Kuvan response. arm 2: After completion of acute 24 hour component, participants can enroll in Phase 1 and will receive Kuvan 20 mg/kg by mouth once daily for 28 consecutive days arm 3: Participants in Phase 1 that was n...	[ 0, 0, 0, 0 ]	2	[ 0, 10 ]	intervention 1: 20mg/kg by mouth once daily intervention 2: Phenylalanine-restricted diet (4-10 mg/kg/day phenylalanine) using the prescribed phenylalanine-free medical formula and low protein foods tested with the patients for taste and acceptance to lower blood phenylalanine levels below 600 umol/l.	intervention 1: Kuvan intervention 2: Diet	1	Miami \| Florida \| United States \| -80.19366 \| 25.77427	21	0	0	0	NCT00841100	1COMPLETED	2011-07-19	2008-12-01	University of Miami	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	30	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	This 48 week, phase 2b study in 150 HIV-1 infected antiretroviral therapy experienced adult subjects consists of a dose-ranging evaluation of GSK2248761 at blinded doses of 100 mg and 200 mg once daily with a control arm of open-label etravirine (ETV) 200 mg twice daily. The background ART for all three arms will be da...	Study SGN113399 is a Phase 2b randomized, partially-blinded, multicenter, parallel-group, dose-ranging study to be conducted in HIV-1 infected ART-experienced adults with documented NNRTI resistance. A minimum of 150 subjects will be randomized 1:1:1 to one of two GSK2248761 doses or a control regimen containing ETV (...	Infection, Human Immunodeficiency Virus	raltegravir NNRTI ritonavir darunavir HIV GSK2248761 antiretroviral HIV Infection HAART	null	3	arm 1: In combination with darunavir/ritonavir BID and raltegravir BID arm 2: In combination with darunavir/ritonavir BID and raltegravir BID arm 3: In combination with darunavir/ritonavir BID and raltegravir BID	[ 0, 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: 1 100mg capsule OAD plus matching placebo intervention 2: 2 100mg capsules OAD intervention 3: 2 100mg tablets twice daily	intervention 1: GSK2248761 100 mg once daily intervention 2: GSK2248761 200 mg once daily intervention 3: Etravirine	41	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Bakersfield \| California \| United States \| -119.01871 \| 35.37329 Beverly Hills \| California \| United States \| -118.40036 \| 34.07362 Fresno \| California \| United States \| -119.77237 \| 36.74773 Long Beach...	30	0	0	0	NCT01199731	6TERMINATED	2011-07-19	2010-10-05	ViiV Healthcare	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	234	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This study will evaluate the efficacy and safety of brief induction therapy with a chemotherapeutic regimen containing MabThera, followed by either maintenance therapy with MabThera or no further therapy. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.	null	Non-Hodgkin's Lymphoma		null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Intravenous repeating dose	intervention 1: rituximab [Mabthera/Rituxan]	45	Pescara \| Abruzzo \| Italy \| 14.20283 \| 42.4584 Bari \| Apulia \| Italy \| 16.86982 \| 41.12066 San Giovanni Rotondo \| Apulia \| Italy \| 15.7277 \| 41.70643 Reggio Calabria \| Calabria \| Italy \| 15.66129 \| 38.11047 Napoli \| Campania \| Italy \| 14.5195 \| 40.87618 Napoli \| Campania \| Italy \| 14.5195 \| 40.87618 Napoli \| Campania \|...	435	0	0	0	NCT01144364	1COMPLETED	2011-07-21	2004-01-19	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	105	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This single arm study will assess the effect of tocilizumab + DMARDs (Disease Modifying Anti-Rheumatic Drugs)on improvement of anemia and fatigue in patients with moderate to severe active rheumatoid arthritis. Eligible patients who have had an inadequate response to DMARDs will receive tocilizumab 8mg/kg iv every 4 we...	null	Rheumatoid Arthritis		null	1	arm 1: None	[ 0 ]	2	[ 0, 0 ]	intervention 1: 8mg/kg iv every 4 weeks for 6 months intervention 2: As prescribed	intervention 1: tocilizumab [RoActemra/Actemra] intervention 2: Standard DMARDs (Disease Modifying Anti Rheumatic Drugs)	27	Brindisi \| Apulia \| Italy \| 17.93607 \| 40.63215 Martina Franca \| Apulia \| Italy \| 17.33814 \| 40.70355 San Cesario di Lecce \| Apulia \| Italy \| 18.16098 \| 40.30221 Benevento \| Campania \| Italy \| 14.77816 \| 41.1307 Napoli \| Campania \| Italy \| 14.5195 \| 40.87618 Napoli \| Campania \| Italy \| 14.5195 \| 40.87618 Scafati \| Camp...	105	0	0	0	NCT00951275	1COMPLETED	2011-07-22	2009-10-31	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2 ]	92	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	This is a study to evaluate the safety, tolerability, and activity of OAP-189 in subjects with type 2 diabetes who are taking metformin for their diabetes.	null	Diabetes Mellitus		null	2	arm 1: None arm 2: None	[ 2, 2 ]	2	[ 0, 0 ]	intervention 1: Group 1: OAP-189 BID (0.2 mg BID) x 7 days Group 2: OAP-189 (0.4 mg BID) x 7 days Group 3: OAP-189 QD (0.9 mg x 7 days followed by 1.2 mg x 7 days; MR formulation) Group 4: OAP-189 QD (1.2 mg x 7 days followed by 1.6 mg x 7 days; MR formulation) Group 5: OAP-189 QD (1.2 mg x 7 days followed by 1.6 mg x ...	intervention 1: OAP-189 intervention 2: placebo comparator	2	Chula Vista \| California \| United States \| -117.0842 \| 32.64005 Miami Gardens \| Florida \| United States \| -80.2456 \| 25.94204	92	0	0	0	NCT00970593	1COMPLETED	2011-07-25	2009-09-02	Pfizer	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	14	RANDOMIZED	PARALLEL	1PREVENTION	2DOUBLE	true	0ALL	true	Angiotensin converting enzyme inhibitors (ACE-I) are a group of blood pressure-lowering medicines. Some studies suggest that ACE-I, such as ramipril, may help prevent Alzheimer's disease (AD). The purpose of the research is to see how ramipril affects a substance in the body called beta-amyloid. Beta-amyloid is found i...	High blood pressure (BP) in midlife is predictive of Alzheimer's disease (AD) in later life. Similarly, reductions in BP are associated with protection against AD. Treatment with antihypertensive medications, specifically angiotensin converting enzyme inhibitors (ACE-I) such as ramipril, is associated with up to a 55% ...	Alzheimer's Disease Hypertension	Alzheimer's Disease Hypertension	Prot_SAP_000.pdf: SEAIRA 2014-1353 Protocol Version 1, 12/5/2014 Page 1 of 25 Studying the Effects of Antihypertensives in Individuals at Risk for Alzheimer’s Disease (SEAIRA) Pilot Study NCT00980785 December 5, 2014 SEAIRA 2014-1353 Protocol Version 1, 12/5/2...	2	arm 1: Matching Placebo arm 2: Ramipril 5mg/day	[ 2, 0 ]	2	[ 0, 0 ]	intervention 1: Ramipril 5 mg/day intervention 2: Matching Placebo	intervention 1: Ramipril intervention 2: Placebo	1	Madison \| Wisconsin \| United States \| -89.40123 \| 43.07305	14	0	0	0	NCT00980785	1COMPLETED	2011-07-26	2009-04-09	University of Wisconsin, Madison	7OTHER	true	true	false	https://cdn.clinicaltrials.gov/large-docs/85/NCT00980785/Prot_SAP_000.pdf	0	0	0	0
[ 2 ]	10	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	true	0ALL	false	The purpose of this study is to determine the receptor occupancy (RO) associated with telcagepant (MK-0974) administration based on displacement of \[11C\]MK-4232 from the CGRP receptors in the brain using PET. The study enrolled healthy participants (Part I) and migraine patients (Part III). Due to a protocol amendmen...	For the 1120 mg (i.e., maximal) telcagepant dose, \[11C\]MK-4232 was administered and PET scan was started \~3 hours post telcagepant to coincide with the Tmax of the 1120 mg dose. For the 140 mg (i.e., therapeutic) telcagepant dose, \[11C\]MK-4232 was administered and PET scan was started \~2 hours post telcagepant to...	Migraine		null	2	arm 1: Baseline PET imaging of the brain using \[11C\]MK-4232 tracer (\~300 megabecquerel \[MBq\]) was performed in healthy participants; this PET data served as the baseline for both Period 1 and 2 of Part I. Subsequently in study Part I, Period 1 the healthy participants received a single 1120 mg dose of telcagepant ...	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Single oral doses of telcagepant 1120 mg (Part I - Period 1) and 140 mg (Part I - Period 2; Part III - Period 1 and 2) intervention 2: Single intravenous doses of \~300 MBq \[11C\]MK-4232 administered as a 5 minute infusion (Part I - Baseline, Period 1 and 2; Part III - Period 1 Baseline and Period 1, a...	intervention 1: telcagepant intervention 2: [11C]MK-4232	0	null	10	0	0	0	NCT01315847	1COMPLETED	2011-07-26	2010-01-14	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	6	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The drugs FEC 100 (5-fluorouracil, epirubicin, and cyclophosphamide) are one of the approved options to treat Locally Advanced or Primary Metastatic Breast Cancer. In this study, the investigators will add another drug called Valproic Acid (VPA) to see whether this makes the treatment better. The addition of Valproic A...	Each year, more than 200,000 patients are diagnosed with breast cancer. While recent advances in diagnosis and treatment have rendered a large proportion of these patients curable, many patients still present with either locally advanced or metastatic breast cancer that is not amenable to potentially curative surgery. ...	Breast Cancer	breast cancer advanced local	null	1	arm 1: Valproic Acid with FEC100	[ 0 ]	1	[ 0 ]	intervention 1: oral VPA (60 mg/kg bid) q 12h X 6 with IV 5-Fluorouracil (500 mg/m2) Epirubicin (100 mg/m2) and Cyclophosphamide (500 mg/m2)	intervention 1: VPA FEC100	1	San Francisco \| California \| United States \| -122.41942 \| 37.77493	6	0	0	0	NCT01010854	6TERMINATED	2011-07-29	2008-12-10	University of California, San Francisco	7OTHER	false	false	false	null	0	0	0	0
[ 4 ]	96	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This single-arm study will assess the efficacy and safety of monthly administration of SC Mircera for the maintenance of hemoglobin levels in participants with chronic kidney disease on peritoneal dialysis. Participants currently receiving maintenance treatment with SC erythropoietin stimulating agents (ESAs) will rece...	null	Anemia		null	1	arm 1: Participants will receive SC methoxy polyethylene glycol-epoetin beta (Mircera) every 4 weeks for a total of 48 weeks in this single-arm study. The first dose of 120 or 200 micrograms (mcg) will be determined by the dose of ESA received prior to administration of study treatment, while subsequent doses will be a...	[ 0 ]	1	[ 0 ]	intervention 1: Mircera will be administered SC every 4 weeks for a total of 48 weeks. The first dose of 120 or 200 mcg will be determined by the dose of ESA received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within the target range.	intervention 1: Methoxy polyethylene glycol-epoetin beta	52	Ajaccio \| N/A \| France \| 8.73812 \| 41.91886 Annonay \| N/A \| France \| 4.6707 \| 45.23992 Arras \| N/A \| France \| 2.78186 \| 50.29301 Auxerre \| N/A \| France \| 3.57033 \| 47.7996 Besançon \| N/A \| France \| 6.01815 \| 47.24878 Beuvry \| N/A \| France \| 2.68541 \| 50.51674 Bordeaux \| N/A \| France \| -0.5805 \| 44.84044 Cabestany \| N/A...	96	0	0	0	NCT00737477	1COMPLETED	2011-07-31	2008-09-30	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	1,083	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	This study assessed the safety, tolerability and efficacy of two doses of oral fingolimod compared to placebo on efficacy parameters in patients with relapsing-remitting multiple sclerosis (RRMS).	This randomized, multicenter, parallel-group study consisted of 2 phases: a 24-month double-blind, randomized, multicenter, placebo-controlled, parallel-group study and an Extension phase which consisted of a dose-blinded period and an open-label period. In the Core phase, patients were randomized to receive a fixed d...	Multiple Sclerosis	fingolimod FTY720 relapsing-remitting multiple sclerosis MS RRMS	null	3	arm 1: Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally once a day. Note: Upon implementation of a protocol amendment all patients taking 1.25 mg fingolimod were switched to 0.5 mg fi...	[ 0, 0, 0 ]	2	[ 0, 0 ]	intervention 1: Fingolimod capsules for oral administration intervention 2: Matching placebo capsules for oral administration.	intervention 1: Fingolimod intervention 2: Placebo	112	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Cullman \| Alabama \| United States \| -86.84361 \| 34.17482 Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Berkeley \| California \| United States \| -122.27275 \| 37.87159 Irvine \| California \| Unite...	1,715	2	0.001166	1	NCT00355134	1COMPLETED	2011-08-01	2006-06-01	Novartis	4INDUSTRY	false	false	false	null	0	2	0	0.00032
[ 4 ]	1,417	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	To determine if treatment with BG00012 can decrease the number of MS relapses during a certain time period. Other goals of the study are to determine if, over time, BG00012 treatment can decrease the number of certain types of brain lesions commonly seen in MS patients and slow down the time it takes for MS to get wors...	Multiple sclerosis (MS) is a chronic disease of the central nervous system that affects approximately 400,000 persons in North America and 365,000 persons in Europe. It is predominantly a disease of young adults, primarily women, with disease onset typically occurring between the ages of 20 and 40.	Relapsing-Remitting Multiple Sclerosis	relapsing multiple sclerosis oral remitting	null	4	arm 1: Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD) arm 2: Participants received two 120 mg BG00012 capsules orally three times daily (TID) arm 3: Participants received two placebo capsules orally three times daily (TID) arm 4: Participants r...	[ 0, 0, 2, 1 ]	3	[ 0, 0, 0 ]	intervention 1: None intervention 2: None intervention 3: None	intervention 1: BG00012 intervention 2: Placebo intervention 3: Glatiramer Acetate	195	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Cullman \| Alabama \| United States \| -86.84361 \| 34.17482 Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 La Jolla \| California \| United States \| -117.2742 \| 32.84727 Loma Linda \| California \|...	2,120	2	0.000943	1	NCT00451451	1COMPLETED	2011-08-01	2007-06-01	Biogen	4INDUSTRY	false	false	false	null	0	2	0	0.000259
[ 2, 3 ]	119	RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This study is for patients with lymphoproliferative malignancies that have progressed after receiving a previous treatment (relapsed) or are no longer responding to treatment (refractory). To be in this study, patients must have certain types of Hodgkin's lymphoma (HL), peripheral T-cell lymphoma (PTCL), or B-cell lymp...	null	Relapsed or Refractory Lymphoproliferative Malignancies Hodgkin's Lymphoma Peripheral T-cell Lymphoma B-cell Lymphoma Waldenstrom's Macroglobulinemia	Lymphoproliferative malignancies Lymphoma Hodgkin's lymphoma (HL) Non-Hodgkin's lymphoma (NHL) PTCL T/NK-cell leukemia/lymphoma T-cell lymphoma/leukemia (HTLV 1+) Angioimmunoblastic T-cell lymphoma Blastic NK lymphoma Anaplastic large cell lymphoma T/NK-cell lymphoma Enteropathy-type intestinal lymphoma Hepatosplenic T...	null	2	arm 1: None arm 2: None	[ 0, 0 ]	4	[ 0, 0, 7, 7 ]	intervention 1: Intravenous (IV) push administration over 30 seconds to 5 minutes into a patent IV line containing normal saline (0.9% sodium chloride). Sequential Dosing: 10 mg/m2 every 2 weeks (days 1 and 15) of a 4-week cycle until criteria for discontinuation per the protocol are met. Same Day Dosing: 15 mg/m2 ev...	intervention 1: Pralatrexate Injection intervention 2: Gemcitabine Hydrochloride intervention 3: Vitamin B12 intervention 4: Folic Acid	15	Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Stanford \| California \| United States \| -122.16608 \| 37.42411 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 St Louis \| Misso...	107	1	0.009346	1	NCT00481871	1COMPLETED	2011-08-01	2007-05-01	Acrotech Biopharma Inc.	4INDUSTRY	false	false	false	null	1	0	0	0.001652
[ 3 ]	103	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to determine the safety and antiviral activity of etravirine in treatment-experienced human immunodeficiency virus (HIV) infected children and adolescents.	The study design is a single arm treatment (all patients assigned to receive etravirine), open label (patients will know the identity of the treatments they are receiving) safety and antiviral activity of Etravirine (TMC125) in treatment-experienced, HIV infected children and adolescents 6 to 17 years of age. Etravirin...	HIV-1	HIV-1 TMC125-TiDP35-C213 TMC125-C213	null	1	arm 1: None	[ 0 ]	2	[ 0, 0 ]	intervention 1: Patients will be dosed by body weight , i.e. 5.2 mg/kg twice daily (b.i.d.) up to a maximum of 200 mg b.i.d. for 48 weeks. intervention 2: An investigator-selected optimized background regimen (OBR) comprising of a low-dose ritonavir (rtv)-boosted protease inhibitor (PI) (either lopinavir \[LPV\], darun...	intervention 1: Etravirine (TMC125) intervention 2: Optimized background regimen (OBR)	42	Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 New Orleans \| Louisiana \| United States \| -90.07507 \| 29.95465 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727...	101	2	0.019802	1	NCT00665847	1COMPLETED	2011-08-01	2008-11-01	Tibotec Pharmaceuticals, Ireland	4INDUSTRY	false	false	false	null	0	1	1	0.005447
[ 4 ]	234	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	This is a Phase 3, open-label, randomized study of the antiviral activity, safety, and tolerability of intravenous Peramivir in hospitalized subjects with confirmed or suspected influenza infection.	null	Seasonal Influenza Cough Sore Throat Nasal Congestion Myalgia Headache Fatigue	influenza hospitalized flu antiviral	null	2	arm 1: Peramivir 300 mg twice daily arm 2: Peramivir 600 mg once daily	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: 300 mg twice daily intervention 2: 600 mg once daily	intervention 1: Peramivir intervention 2: Peramivir	110	Dothan \| Alabama \| United States \| -85.39049 \| 31.22323 Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Jonesboro \| Arkansas \| United States \| -90.70428 \| 35.8423 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Fountain Valley \| California \| United States \| -117.95367 \| 33.70918 Harbor City \| Cali...	230	2	0.008696	1	NCT00957996	1COMPLETED	2011-08-01	2009-10-01	BioCryst Pharmaceuticals	4INDUSTRY	false	false	false	null	1	1	0	0.002388
[ 3 ]	463	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The purpose of this study is to determine the efficacy, safety and tolerability of different regimens of TMC435 with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C virus (HCV) infection who has failed previous treatment with pegylated interferon (Peg-INF-al...	The study is a randomized (study drug assigned by chance), double-blind (neither physician nor participant knows the name of the assigned drug), placebo-controlled Phase IIb trial with TMC435 in participants with chronic, genotype 1, hepatitis C virus (HCV) infection who have failed standard treatment with pegylated in...	Hepatitis C	Hepatitis C Peginterferon alpha-2a PegIFNalpha-2a RBV Ribavirin Placebo TMC435-TIDP16-C206 TMC435-C206 TMC435 HCV	null	7	arm 1: Participants will receive TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks. arm 2: Participants willl receive TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks f...	[ 0, 0, 0, 0, 0, 0, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: One TMC435 100-mg capsule or two 75-mg capsules orally (by mouth) once daily for 12, 24, or 48 weeks. intervention 2: One or 2 capsules of placebo identical in appearance to TMC435 taken orally once daily for 24, 36, or 48 weeks. intervention 3: 180 micrograms taken as one 0.5 mL subcutaneous injection ...	intervention 1: TMC435 intervention 2: Placebo intervention 3: Peg-IFN-alfa-2a (P) intervention 4: Ribavirin (R)	78	La Jolla \| California \| United States \| -117.2742 \| 32.84727 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 Palm Harbor \| Florid...	462	1	0.002165	1	NCT00980330	1COMPLETED	2011-08-01	2009-10-01	Tibotec Pharmaceuticals, Ireland	4INDUSTRY	false	false	false	null	0	1	0	0.000382
[ 4 ]	376	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	The hypothesis of this study is that SER120 is safe and well tolerated for use in nocturic patients.	null	Nocturia	decrease in the number of nocturic episodes for patients with nocturia	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: once a day treatment of nocturia	intervention 1: SER120	1	Newport Beach \| California \| United States \| -117.92895 \| 33.61891	376	1	0.00266	1	NCT00981682	1COMPLETED	2011-08-01	2009-08-01	Serenity Pharmaceuticals, Inc.	4INDUSTRY	false	false	false	null	0	1	0	0.00047
[ 4 ]	997	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The main objective of this study is to demonstrate the efficacy and safety of an investigational intravenous (IV) iron, ferric carboxymaltose (FCM), compared to oral iron in subjects who have iron deficiency anemia (IDA) and have shown an unsatisfactory response to oral iron.	null	Iron Deficiency Anemia	IDA	null	4	arm 1: Intravenous (IV) iron arm 2: Oral iron - Ferrous Sulfate tablets arm 3: Other IV iron arm 4: Intravenous (IV) iron	[ 0, 1, 1, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: A total maximum cumulative dose of 1500 mg administered on Days 0 and 7. intervention 2: 325 mg Ferrous Sulfate tablets taken orally three times a day intervention 3: IV standard of care (other IV iron) per the Investigator's discretion intervention 4: A total maximum cumulative dose of 1500 mg administ...	intervention 1: Ferric Carboxymaltose (FCM) intervention 2: Ferrous Sulfate Tablets intervention 3: IV Iron (standard of care) intervention 4: Ferric Carboxymaltose (FCM)	1	Norristown \| Pennsylvania \| United States \| -75.3399 \| 40.1215	997	1	0.001003	1	NCT00982007	1COMPLETED	2011-08-01	2009-09-01	American Regent, Inc.	4INDUSTRY	false	false	false	null	1	0	0	0.000177
[ 2 ]	40	RANDOMIZED	SINGLE_GROUP	0TREATMENT	1SINGLE	true	2MALE	null	Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 137882 in Healthy Male Volunteers	As a transition from preclinical investigations to clinical development in this first-in-man trial, safety, tolerability, and pharmacokinetics of BI 137882 will be assessed in healthy male volunteers using single rising oral doses in order to provide the basis for a potential ongoing clinical development of BI 137882 i...	Healthy		null	10	arm 1: Powder for oral solution arm 2: Powder for oral solution arm 3: Powder for oral solution arm 4: Powder for oral solution arm 5: Powder for oral solution arm 6: Powder for oral solution arm 7: Powder for oral solution arm 8: Powder for oral solution arm 9: Powder for oral solution arm 10: Powder for oral solution	[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 2 ]	2	[ 0, 0 ]	intervention 1: Powder for oral solution intervention 2: Powder for oral solution	intervention 1: BI 137882 intervention 2: Placebo	0	null	40	2	0.05	1	NCT01348165	6TERMINATED	2011-08-01	2011-05-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0	2	0	0.013821
[ 3 ]	98	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and fluorouracil, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Oxaliplatin and fluorouracil may make tumor cells more sensitive to radiation therapy and ma...	OBJECTIVES: Primary * Determine the pathologic complete response probability in patients with stage II or III adenocarcinoma of the esophagus or gastroesophageal junction treated with neoadjuvant oxaliplatin, fluorouracil, and radiotherapy followed by definitive surgical resection. Secondary * Determine the frequen...	Esophageal Cancer	adenocarcinoma of the esophagus stage II esophageal cancer stage III esophageal cancer	null	1	arm 1: neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin	[ 0 ]	4	[ 0, 0, 3, 4 ]	intervention 1: Before surgery: 180 mg/m2/day by 24-hour infusion days 8 through 43. After surgery:180 mg/m2/day by 24-hour infusion days 1 through 36. intervention 2: Before surgery: 85 mg/m2 by 2-hour IV infusion days 1, 15, and 29. After surgery: 85 mg/m2 by 2-hour IV infusion days 1, 15, and 29. intervention 3: The...	intervention 1: fluorouracil intervention 2: oxaliplatin intervention 3: conventional surgery intervention 4: radiation therapy	143	Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Anchorage \| Alaska \| United States \| -149.90028 \| 61.21806 Bentonville \| Arkansas \| United States \| -94.20882 \| 36.37285 Castro Valley \| California \| United States \| -122.08635 \| 37.6941 Castro Valley \| California \| United States \| -122.08635 \| 37.6941 Castro Vall...	93	0	0	0	NCT00086996	1COMPLETED	2011-08-01	2004-09-01	SWOG Cancer Research Network	5NETWORK	false	false	false	null	0	0	0	0
[ 3 ]	447	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	2MALE	null	This study is being carried out to see if ZD4054 (Zibotentan) is effective in treating prostate cancer and spread of cancer to the bone, and if so, how it compares with placebo (sugar pill). The study will also provide further information on the safety of ZD4054 (Zibotentan).	null	Prostate Cancer	rising PSA bone metastases Clinical study pain-free or mildly symptomatic	null	3	arm 1: Matching placebo oral tablet once daily, with best supportive care arm 2: ZD4054 10 mg oral tablet once daily, with best supportive care arm 3: ZD4054 15 mg oral tablet once daily, with best supportive care	[ 2, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: 15 mg oral tablet once daily intervention 2: None intervention 3: 10mg oral tablet once daily	intervention 1: ZD4054 15 mg intervention 2: Placebo intervention 3: ZD4054 10 mg	60	Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Gainsville \| Florida \| United States \| N/A \| N/A Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Cleveland \| Ohio \| United State...	312	0	0	0	NCT00090363	1COMPLETED	2011-08-01	2004-07-01	AstraZeneca	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	1,050	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	2MALE	null	This randomized phase III trial is studying docetaxel, prednisone, and bevacizumab to see how well they work compared to docetaxel and prednisone in treating patients with prostate cancer that did not respond to hormone therapy. Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to sto...	PRIMARY OBJECTIVES: I. To determine if the addition of bevacizumab to docetaxel and prednisone increases overall survival compared to docetaxel and prednisone alone in patients with HRPC. SECONDARY OBJECTIVES: I. To compare the progression-free survival of these two regimens in patients with HRPC. II. To compare th...	Adenocarcinoma of the Prostate Hormone-resistant Prostate Cancer Recurrent Prostate Cancer Stage IV Prostate Cancer		null	2	arm 1: Patients receive docetaxel IV over 1 hour and placebo IV over 30-90 minutes on day 1. Patients also receive oral prednisone once daily on days 1-21. arm 2: Patients receive docetaxel and prednisone as in arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1.	[ 0, 0 ]	5	[ 0, 10, 0, 2, 10 ]	intervention 1: Given IV intervention 2: Given IV intervention 3: Given orally intervention 4: Given IV intervention 5: Correlative studies	intervention 1: docetaxel intervention 2: placebo intervention 3: prednisone intervention 4: bevacizumab intervention 5: laboratory biomarker analysis	2	New Haven \| Connecticut \| United States \| -72.92816 \| 41.30815 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003	1,009	0	0	0	NCT00110214	1COMPLETED	2011-08-01	2005-04-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0	0	0	0
[ 2, 3 ]	25	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	true	1FEMALE	false	The primary hypothesis is that a 100mg single dose of sildenafil citrate (Viagra) will have a higher improvement rate when compared to placebo in the treatment of moderate to severe primary dysmenorrhea.	It is well established that excess prostaglandin production in primary dysmenorrhea leads to ischemia of the uterine muscle, which consequently causes pelvic pain. A large number of drugs have been studied for pain relief in dysmenorrhea patients, with non-steroid anti-inflammatory drugs (NSAIDS) being the most effecti...	Dysmenorrhea	Sildenafil	null	2	arm 1: A single vaginal dose of Viagra 100 mg. arm 2: A single vaginal dose of placebo.	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: A single vaginal dose of sildenafil citrate 100 mg and monitored for 4 hours. intervention 2: A single vaginal dose of placebo and monitored for 4 hours.	intervention 1: Sildenafil Citrate intervention 2: Placebo	1	Strossmayerova 17 \| Zagreb \| Croatia \| N/A \| N/A	25	0	0	0	NCT00123162	1COMPLETED	2011-08-01	2007-05-01	Milton S. Hershey Medical Center	7OTHER	false	false	false	null	0	0	0	0
[ 4 ]	200	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	true	This study will compare the short- and long-term effectiveness of two different treatments for people with post-traumatic stress disorder.	Exposure to traumatic events, such as automobile accidents and assault, can cause individuals to develop persistent psychological difficulties such as post-traumatic stress disorder (PTSD). PTSD is an anxiety disorder characterized by avoidance, hyperarousal symptoms, and mental re-experiencing of the traumatic event. ...	Post-Traumatic Stress Disorder	Antidepressants Cognitive behavior therapy	null	4	arm 1: Participants will receive no choice cognitive behavioral therapy (CBT no choice) arm 2: Participants will receive choice cognitive behavioral therapy (CBT choice) arm 3: Participants will receive no choice sertraline (sertraline no choice) arm 4: Participants will receive choice sertraline (sertraline choice)	[ 1, 1, 1, 1 ]	2	[ 0, 5 ]	intervention 1: The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist. intervention 2: CBT will include 10 weekly sessions of individual cognitive behavioral therapy.	intervention 1: Sertraline intervention 2: Cognitive behavioral therapy (CBT)	1	Seattle \| Washington \| United States \| -122.33207 \| 47.60621	200	0	0	0	NCT00127673	1COMPLETED	2011-08-01	2004-09-01	Case Western Reserve University	7OTHER	false	false	false	null	0	0	0	0
[ 2, 3 ]	282	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	Phase 1b Dose Excalation/Expansion: Identify and characterize safety and tolerability of recommended phase 2 dose of CP-751,871 when administered with paclitaxel and carboplatin Phase 1b Erlotinib Extension: To characterize the safety and tolerability of CP751,871 when administered with paclitaxel, carboplatin and erlo...	null	Carcinoma, Non-Small-Cell Lung	non-small cell lung cancer chemotherapy figitumumab insulin-like growth 1 factor receptor IGF-IR monoclonal antibody	null	2	arm 1: CP-751,871 + paclitaxel + carboplatin arm 2: 1. Phase 1b Dose Escalation /Expansion: CP-751,871 + paclitaxel + carboplatin 2. Phase 1b Erlotinib Extension: CP-751,871 + paclitaxel + carboplatin + erlotinib	[ 0, 0 ]	7	[ 0, 0, 0, 0, 0, 0, 0 ]	intervention 1: Phase 2 Arm A: CP-751,871 20 mg/kg IV over 2.5 hours up to 17 cycles intervention 2: Phase 2 Arm A: Paclitaxel 200 mg/m2, IV over 3 hours up to 6 cycles Phase 2 Arm B: Paclitaxel 200 mg/m2, IV over 3 hours up to 6 cycles intervention 3: Phase 2 Arm A: Carboplatin AUC 6, IV over 15-60 minutes up to ...	intervention 1: CP-751,871 intervention 2: paclitaxel intervention 3: carboplatin intervention 4: CP-751,871 intervention 5: paclitaxel intervention 6: carboplatin intervention 7: erlotinib	31	Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Greenbrae \| California \| United States \| -122.5247 \| 37.94854 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Jacksonville \| Florida...	300	0	0	0	NCT00147537	1COMPLETED	2011-08-01	2005-02-01	Pfizer	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	81	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to find out what effects the preoperative combination therapies of herceptin/navelbine or herceptin/taxotere/carboplatin will have on patients with early stage HER-2 positive breast cancer.	Before starting treatment, a clip will be placed via catheter into the tumor bed, so the surgeon can locate the site of the tumor. During clip placement, tissue biopsy will be taken of the tumor. One to two weeks after the first dose of herceptin another biopsy will be performed. Patients will be placed into one of 2 ...	Breast Cancer	HER-2 Positive Breast Cancer herceptin navelbine taxotere carboplatin Early stage Breast Cancer	null	2	arm 1: Herceptin/navelbine arm 2: Taxotere/carboplatin/herceptin	[ 1, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: One dose given followed by an MRI, then weekly injections beginning week 3 and ending week 14. intervention 2: Weekly injections given starting week 3 and ending week 14 intervention 3: Given every three weeks starting week 3 and ending on week 14 intervention 4: Given every three weeks starting week 3 ...	intervention 1: Herceptin intervention 2: Navelbine intervention 3: Taxotere intervention 4: Carboplatin	4	New Haven \| Connecticut \| United States \| -72.92816 \| 41.30815 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	81	0	0	0	NCT00148668	1COMPLETED	2011-08-01	2003-12-01	Eric Winer, MD	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	260	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	This study will evaluate the efficacy, tolerability and safety of the topical application of mechlorethamine (MCH) formulations in patients with stage I or IIA mycosis fungoides (MF).	The successful use of mechlorethamine (MCH) as a topical agent in the treatment of mycosis fungoides, a form of cutaneous T-cell lymphoma, was first reported in the late 1950s, and provided a rationale for skin-directed chemotherapy that minimized systemic toxicity. Since then, multiple investigators have demonstrated ...	Mycosis Fungoides	Mycosis Fungoides Nitrogen Mustard Cutaneous T-Cell Lymphoma CTCL - Mycosis Fungoides	null	2	arm 1: PG - mechlorethamine-MCH (nitrogen mustard) 0.02% gel To evaluate the tolerability and safety of topical mechlorethamine-MCH (nitrogen mustard) 0.02% ointment formulations in patients with stage I or IIA MF arm 2: AP - mechlorethamine-MCH (nitrogen mustard) 0.02% compounded in Aquaphor To evaluate the tolerabili...	[ 1, 1 ]	1	[ 0 ]	intervention 1: All affected areas (lesions) are to be treated once daily for twelve months with mechlorethamine-MCH (nitrogen mustard) 0.02% PG or NM 0.02% AP ointment	intervention 1: mechlorethamine-MCH (nitrogen mustard)	12	Stanford \| California \| United States \| -122.16608 \| 37.42411 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 New York \| New York \| United States \| -74.00597 \| 40.71427 New York \| New York \| United States \| -74.00597 \| 40.71427 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403 Tulsa \| Oklahoma \| ...	255	0	0	0	NCT00168064	1COMPLETED	2011-08-01	2006-05-01	Yaupon Therapeutics	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	11	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This clinical research study is for patients with acute myelogenous leukemia (in short AML) that did not respond to previous treatment or unable to receive chemotherapy. Arsenic has been used as a drug for many centuries. While arsenic containing drugs were used in the past for cancer treatments, the major use of arse...	null	Acute Myelogenous Leukemia		null	1	arm 1: Arsenic Trioxide (ATO) given at 0.25 mg/kg/day intravenously for 25 days over a 35-day period. Ascorbic Acid given at 1000 mg/day intravenously every other day that ATO is given	[ 0 ]	2	[ 0, 0 ]	intervention 1: Arsenic Trioxide .25 mg/kg/day intervention 2: Ascorbic Acid 1000 mg every other day for 25 days	intervention 1: Arsenic Trioxide (ATO) intervention 2: Ascorbic Acid	1	Los Angeles \| California \| United States \| -118.24368 \| 34.05223	11	0	0	0	NCT00184054	6TERMINATED	2011-08-01	2002-04-01	University of Southern California	7OTHER	false	false	false	null	0	0	0	0
[ 5 ]	55	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	1. The primary objective of this study is to examine the efficacy of quetiapine (Seroquel) in treatment of dysphoric hypomania in patients with Bipolar II disorder. 2. To evaluate the utility of Seroquel add-on treatment to decrease mixed depressive and hypomanic symptoms.	Bipolar disorder is recognized as a severe and treatment-refractory illness. Recent work from multiple research centers in both Europe and the U.S. have found the percentage of patients experiencing hypomania that are also experiencing depressive symptoms is substantial. In a recent Stanley Foundation Bipolar Network s...	Bipolar II Disorder		null	2	arm 1: Quetiapine/Seroquel up to 800 mg/day arm 2: Placebo	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Quetiapine/Seroquel intervention 2: Placebo	intervention 1: Quetiapine/Seroquel intervention 2: Placebo	1	Stanford \| California \| United States \| -122.16608 \| 37.42411	55	0	0	0	NCT00186043	1COMPLETED	2011-08-01	2008-08-01	Stanford University	7OTHER	false	false	false	null	0	0	0	0
[ 2, 3 ]	94	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This phase I/II trial will evaluate the bevacizumab/erlotinib combination with the addition of imatinib (Gleevec). The combined inhibition greatly enhances the anti-tumor effects. Although the safety of the bevacizumab/erlotinib/imatinib combination has not yet been demonstrated, the mild to moderate side effects of al...	Upon determination of eligibility, patients will be receive: Bevacizumab + Erlotinib + Imatinib A brief phase I dose escalation study will be performed to define the imatinib dose that will be used.	Clear Cell Renal Cell Carcinoma	Recurrent clear cell renal cell carcinoma Bevacizumab Erlotinib Imatinib	null	1	arm 1: In the phase I portion: Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course Erlotinib 150 mg orally daily Imatinib 300 mg orally daily or 400 mg orally daily In the phase II portion: Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle Erlotinib 150 ...	[ 0 ]	3	[ 0, 0, 0 ]	intervention 1: 10mg/kg IV infusion every 2 weeks intervention 2: 150 mg po daily intervention 3: 400-600mg daily	intervention 1: Bevacizumab intervention 2: Erlotinib intervention 3: Imatinib	0	null	94	0	0	0	NCT00193258	1COMPLETED	2011-08-01	2004-06-01	SCRI Development Innovations, LLC	7OTHER	false	false	false	null	0	0	0	0
[ 5 ]	224	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	This study will compare the benefits and side effects of lithium and divalproex in the treatment of older adults with bipolar mania.	This is the first controlled acute treatment study of bipolar disorder in adults 60 years or older with current DSM-IV manic, mixed, or hypomanic episodes. The number of older adults with severe and disabling bipolar disorder is increasing, and information to guide the management of the treatment of the disease is lack...	Bipolar Disorder Mania		null	2	arm 1: Participants will receive 9 weeks of treatment with lithium arm 2: Participants will receive 9 weeks of treatment with divalproex	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: The starting LI dose will be 150 mg in the morning and evening. The dose of medication will be adjusted to achieve plasma LI level ranges between 0.40 and 0.99 mEq/L (target 0.80 to 0.99 mEq/L). intervention 2: Dosage of DV will be 250 mg in the morning and evening. The dose of medication will be adjust...	intervention 1: Lithium (LI) intervention 2: Divalproex (DV)	8	Flowood \| Mississippi \| United States \| -90.13898 \| 32.30959 White Plains \| New York \| United States \| -73.76291 \| 41.03399 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Pittsburgh ...	224	0	0	0	NCT00254488	1COMPLETED	2011-08-01	2005-11-01	Weill Medical College of Cornell University	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	23	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to...	OBJECTIVES: Primary * Determine the effect of neoadjuvant chemoradiotherapy and interferon alfa on converting patients with locally advanced unresectable adenocarcinoma of the pancreas to resectability. Secondary * Determine the rate and severity of early and late toxic effects of these regimens in these patients. ...	Pancreatic Cancer	stage I pancreatic cancer stage II pancreatic cancer stage III pancreatic cancer adenocarcinoma of the pancreas	null	1	arm 1: Pancreatic Adenocarcinoma Patients treated with chemotherapy regimen and radiation (and or surgery).	[ 0 ]	5	[ 2, 0, 0, 4, 3 ]	intervention 1: administered subcutaneously (SQ)at a dose of 3 million units Day 1,3, and 5 each week in Cycle 1 intervention 2: administered at a dose of 30 mg/m2 intravenously (IV) day 1 each week in Cycle 1 intervention 3: administered at a dose of 175 mg/m\^2/day continuous infusion (CI) for 38 days in Cycle 1 and ...	intervention 1: recombinant interferon alfa intervention 2: cisplatin intervention 3: fluorouracil intervention 4: radiation therapy intervention 5: Resection of tumor	1	Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997	23	0	0	0	NCT00262951	6TERMINATED	2011-08-01	2005-01-01	Masonic Cancer Center, University of Minnesota	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	58	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with recurrent or metastatic esophageal or gastroesophageal junction cancer.	OBJECTIVES: Primary * Explore the activity of single agent gefitinib, in terms of response rate, in a patient population with recurrent or metastatic esophageal or gastroesophageal junction cancer. Secondary * Assess the toxicity of this drug in these patients. OUTLINE: Patients are stratified according to prior t...	Esophageal Cancer	adenocarcinoma of the esophagus recurrent esophageal cancer squamous cell carcinoma of the esophagus stage IV esophageal cancer	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: ZD1839 treatment will be taken once a day PO, every day about the same time	intervention 1: ZD1839	1	Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995	58	0	0	0	NCT00268346	1COMPLETED	2011-08-01	2005-10-01	Case Comprehensive Cancer Center	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	30	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	false	The purpose of this study is to evaluate the effectiveness and tolerability of the combination of the following medications given every two weeks in HER2 positive breast cancer patients: * trastuzumab (Herceptin) * epirubicin (Ellence) * cyclophosphamide (Cytoxan) * docetaxel (Taxotere)	This is an investigator-initiated, Phase II, non-randomized, single-arm, prospective treatment study. The study will consist of neoadjuvant treatment period (weeks 1 to 20), surgical evaluation period (weeks 20 to 24), and a post-surgical/follow-up period (approximately 3 years). Subjects will be treated on an outpatie...	Breast Neoplasm	neoadjuvant chemotherapy HER2 positive breast cancer stage II - III breast cancer	null	1	arm 1: Neoadjuvant therapy will consist of epirubicin (100 mg/m\^2) + cyclophosphamide (600 mg/m\^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m\^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg \[loading dose\] once then 4 mg/kg \[maintenance dose\]) every 2 weeks for 4 t...	[ 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: epirubicin (100 mg/m\^2) every 2 weeks for 4 cycles intervention 2: cyclophosphamide (600 mg/m\^2) every 2 weeks for 4 cycles intervention 3: docetaxel (75 mg/m\^2) every 2 weeks for 4 cycles intervention 4: trastuzumab (6 mg/kg \[loading dose\] once then 4 mg/kg \[maintenance dose\]) every 2 weeks for ...	intervention 1: epirubicin intervention 2: cyclophosphamide intervention 3: docetaxel intervention 4: trastuzumab	7	Miami \| Florida \| United States \| -80.19366 \| 25.77427 Augusta \| Georgia \| United States \| -81.97484 \| 33.47097 Macon \| Georgia \| United States \| -83.6324 \| 32.84069 Marietta \| Georgia \| United States \| -84.54993 \| 33.9526 Billings \| Montana \| United States \| -108.50069 \| 45.78329 Great Neck \| New York \| United States ...	30	0	0	0	NCT00270894	1COMPLETED	2011-08-01	2005-11-01	Accelerated Community Oncology Research Network	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	132	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	false	Feasibility study to assess a novel combination of cytotoxic agents, docetaxel and oxaliplatin, as first-line therapy in the treatment of ovarian cancer and the impact of angiogenesis inhibition for the progression and prognosis of ovarian cancer by concurrent addition of bevacizumab (Avastin®).	Participants were * administered study medication approximately 28 days after initial surgery for ovarian cancer * received the study treatment regimen of up to one year unless there was disease progression, unacceptable toxicity, death, participant refusal, or treatment delay beyond the time frame permitted for each ...	Ovarian Cancer		null	1	arm 1: Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery	[ 0 ]	3	[ 0, 0, 0 ]	intervention 1: 15 mg/kg bevacizumab administered intravenously (IV) over 30 to 90 minutes on Day 1 of every 3 week cycle for 12 months or until disease progression or unacceptable toxicity intervention 2: 75 mg/m\^2 docetaxel was administered IV over 1 hour on Day 1 of every 3 week cycle for 6 cycles or until disease ...	intervention 1: Bevacizumab (Avastin®) intervention 2: Docetaxel (Taxotere®) intervention 3: Oxaliplatin (Eloxatin®)	1	Bridgewater \| New Jersey \| United States \| -74.64815 \| 40.60079	132	0	0	0	NCT00296816	1COMPLETED	2011-08-01	2006-03-01	Sanofi	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3, 4 ]	2	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	true	0ALL	false	The purpose of this study is to evaluate the rate of response when administering rituximab to suppress or eliminate the anti-body in a patient's blood that inhibits the effectiveness of their factor replacement product compared to treatment using cyclophosphamide. This is a Phase 2/3 study to find out what effects (goo...	This is a prospective Phase II randomized multi-institutional controlled pilot trial comparing the regimen of single agent rituximab with 6 weeks cytotoxic therapy with oral cyclophosphamide to eradicate or suppress autoimmune anti-factor VIII antibodies in individuals with acquired hemophilia A. Patients will be rando...	Hemophilia A	Acquired Hemophilia A Anti-Factor VIII antibodies Anti-Factor VIII inhibitors Hemophilia A Factor VIII inhibitors	null	2	arm 1: Patients will receive rituximab. arm 2: Patients will receive oral cyclophosphamide.	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Acquired Hemophilia A Patients Who Have Developed Anti-Factor VIII Antibodies intervention 2: \<30 mg/day	intervention 1: Rituxan intervention 2: prednisone	0	null	0	0	0	0	NCT00306670	6TERMINATED	2011-08-01	2006-04-01	Georgetown University	7OTHER	false	false	false	null	0	0	0	0
[ 5 ]	181	RANDOMIZED	PARALLEL	1PREVENTION	0NONE	false	0ALL	true	The purpose of this study is to compare the safety and effectiveness of two different anti-rejection drug regimens.	This multicenter prospective, randomized controlled clinical trial compared the open label use of sirolimus with that of azathioprine in a tacrolimus-based immunosuppression regimen. Eligible patients were identified during a 90-day screening period immediately after transplantation and randomized via a computer-genera...	Delayed Graft Function Acute Graft Rejection	Rejection in lung transplant	null	2	arm 1: (tacrolimus,azathioprine/prednisone) arm 2: tacrolimus/sirolimus/prednisone	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: azathioprine 2mg/kg intervention 2: sirolimus 2-4mg daily	intervention 1: azathioprine intervention 2: sirolimus	1	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003	181	0	0	0	NCT00321906	1COMPLETED	2011-08-01	2002-04-01	University of Chicago	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	40	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	false	The purpose of this study is to evaluate the clinical safety and toxicity of intravenous bevacizumab (Days 1 and 15 of a 28 day cycle) in combination with weekly topotecan (Days 1, 8, 15 of a 28 day cycle) in patients with platinum resistant recurrent ovarian, fallopian tube and primary peritoneal cancer.	This study is designed as a Phase 2 study. There are no published data on the toxicity of the combination of bevacizumab and topotecan therapy. Based on data combining bevacizumab with other chemotherapy agents in non-gynecologic solid tumors, it is not likely that the toxicity of the combination of the two drugs will ...	Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer	platinum resistant ovarian cancer recurrent ovarian cancer platinum resistant cancer	null	1	arm 1: Subjects received standard topotecan with the addition of bevacizumab. Cycles were 28 days and continued until toxicity, progression or subject wish to discontinue treatment. Topotecan administered 4 mg/m2 IV on days 1, 8 and 15 and bevacizumab IV 10 mg/kg, days 1 and 15 of each cycle.	[ 0 ]	2	[ 0, 0 ]	intervention 1: Topotecan administered days 1, 8, and 15 of each 28 day cycle. Dose was 4 mg/m2 administered IV. intervention 2: bevacizumab administered IV 10 mg/kg, days 1 and 15 of 28 day cycle.	intervention 1: Topotecan intervention 2: Bevacizumab	2	Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Seattle \| Washington \| United States \| -122.33207 \| 47.60621	40	0	0	0	NCT00343044	1COMPLETED	2011-08-01	2006-06-01	Benaroya Research Institute	7OTHER	false	false	false	null	0	0	0	0
[ 4 ]	407	RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	true	The objective is to show superior efficacy of PTH (1-84) over risedronate in treating osteoporotic women for 12 months after having previously been treated with PTH (1-84) for 12 months followed by 12 months treatment with risedronate.	null	Osteoporosis	Lumbar Spine Bone Mineral Density (BMD)	null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Self-administered (100 μg in a volume of 71.4 μL) daily as a subcutaneous injection in the abdomen using the Preotact pen. intervention 2: Orally once weekly as one 35 mg tablet.	intervention 1: Parathyroid Hormone (PTH) intervention 2: Risedronate	1	Roskilde \| N/A \| Denmark \| 12.08035 \| 55.64152	687	0	0	0	NCT00365456	1COMPLETED	2011-08-01	2006-07-01	Takeda	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	286	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to investigate if zalutumumab in combination with Best Supportive Care (BSC) is superior to BSC in non-curable patients with head and neck cancer	This is an open parallel group trial. Patients will be randomized in a 2:1 manner to receive either treatment with zalutumumab in combination with Best Supportive Care (BSC) or BSC. Patients randomized to treatment with zalutumumab in combination with BSC will receive weekly infusions with zalutumumab starting with a ...	Head and Neck Cancer Squamous Cell Cancer		null	2	arm 1: Zalutumumab in combination with Best Supportive Care arm 2: Best Supportive Care	[ 1, 5 ]	2	[ 0, 10 ]	intervention 1: Individual dose titration weekly i.v doses intervention 2: Best Supportive Care	intervention 1: Zalutumumab intervention 2: Control	82	Antwerp \| N/A \| Belgium \| 4.40026 \| 51.22047 Brussels \| N/A \| Belgium \| 4.34878 \| 50.85045 Charleroi \| N/A \| Belgium \| 4.44448 \| 50.41136 Ghent \| N/A \| Belgium \| 3.71667 \| 51.05 Leuven \| N/A \| Belgium \| 4.70093 \| 50.87959 Ottignies \| N/A \| Belgium \| 4.56679 \| 50.66535 Belo Horizonte \| N/A \| Brazil \| -43.93778 \| -19.920...	283	0	0	0	NCT00382031	1COMPLETED	2011-08-01	2006-11-01	Genmab	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3, 4 ]	554	RANDOMIZED	SEQUENTIAL	0TREATMENT	3TRIPLE	false	0ALL	true	The primary purpose of this protocol is to assess the efficacy, tolerability, and safety of MGA031 when administered according to 3 different MGA031 dosing regimens in children and adults with recent-onset (diagnosis within past 12 weeks) type 1 diabetes mellitus. All regimens will be administered as an addition to ins...	The Protégé Study - A Multinational Clinical Trial of MGA031 for Preserving the Capability to Produce Insulin, Reducing Insulin Usage and Improving Blood Sugar Levels in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus	Type 1 Diabetes Mellitus	Randomized Double Blind Parallel Group Controlled Clinical Trial	null	5	arm 1: Full dose of teplizumab IV for 14 days, repeated at Week 26 arm 2: One third full dose of teplizumab IV for 14 days, repeated at Week 26 arm 3: Full dose of teplizumab IV for 6 days followed by placebo for 8 days, repeated at Week 26 arm 4: Placebo IV dosing daily for 14 days repeated at Week 26 arm 5: Full dose...	[ 0, 0, 0, 2, 0 ]	2	[ 2, 0 ]	intervention 1: Daily IV dosing for 14 days, repeated at Week 26 intervention 2: Daily IV dosing for 14 days, repeated at Week 26	intervention 1: Teplizumab intervention 2: Placebo	115	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Jonesboro \| Arkansas \| United States \| -90.70428 \| 35.8423 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Northridge \| California \| United States \| -118.53675 \| 34.22834 San Francisco \| California \| United States \| -122.41942 \| 37.77493 Aurora \|...	551	0	0	0	NCT00385697	1COMPLETED	2011-08-01	2006-10-01	MacroGenics	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	22	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The main purpose of this study is to see if Tarceva® (erlotinib) is effective in shrinking tumors. A high resolution CT scan (CT scanner that can view 3 dimensional images of the tumor) will be used to measure the tumor before and after treatment with Tarceva®(erlotinib) . This type of CT scan will measure the tumor by...	Tarceva® (erlotinib) is a drug that blocks a receptor called the Epidermal Growth Factor Receptor (EGFR) on certain cells including tumor cells. Blocking this receptor has been shown to shrink tumors in some patients. Tarceva®(erlotinib) is approved for commercial use by the U.S. Food and Drug Administration for treatm...	Carcinoma, Non-small Cell Lung	Carcinoma,non-small cell lung preoperative Tarceva Response rate	null	1	arm 1: Erlotinib 150mg/day for 3 weeks followed by surgical resection at week 4 then daily Tarceva® at 150 mg/day for 2 years for those patients who had a response rate of at least 50% tumor volume reduction and/or have EGFR-positive tumor tissue determined by IHC and/or FISH.	[ 0 ]	1	[ 0 ]	intervention 1: Patients will receive daily erlotinib at 150 mg/day for 3 weeks followed by surgical resection at week 4 then daily Tarceva® at 150 mg/day for 2 years for those patients who had a response rate of at least 50% tumor volume reduction and/or have EGFR-positive tumor tissue determined by IHC and/or FISH.	intervention 1: Tarceva (Erlotinib)	1	New York \| New York \| United States \| -74.00597 \| 40.71427	22	0	0	0	NCT00385996	1COMPLETED	2011-08-01	2006-10-01	Weill Medical College of Cornell University	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	621	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The primary objective of this study is to determine whether DAC HYP, when compared to placebo, is effective in reducing the rate of relapses between baseline and Week 52. The secondary objectives are to determine whether DAC HYP is effective in reducing the number of new gadolinium (Gd)-enhancing lesions, reducing the ...	null	Relapsing-Remitting Multiple Sclerosis	MS multiple sclerosis	null	3	arm 1: Participants will receive 3 subcutaneous (SC) injections of placebo every 4 weeks for up to 52 weeks. arm 2: Participants will receive 3 SC injections every 4 weeks for up to 52 weeks. arm 3: Participants will receive 3 SC injections every 4 weeks for up to 52 weeks.	[ 2, 0, 0 ]	2	[ 2, 0 ]	intervention 1: SC injection intervention 2: Placebo SC injection	intervention 1: BIIB019 (Daclizumab High Yield Process) intervention 2: Placebo	56	Brno \| N/A \| Czechia \| 16.60796 \| 49.19522 Olomouc \| N/A \| Czechia \| 17.25175 \| 49.59552 Pilsen \| N/A \| Czechia \| 13.37759 \| 49.74747 Teplice \| N/A \| Czechia \| 13.82451 \| 50.6404 Erlangen \| N/A \| Germany \| 11.00783 \| 49.59099 Marburg \| N/A \| Germany \| 8.77069 \| 50.80904 Osnabrück \| N/A \| Germany \| 8.0498 \| 52.27264 Reg...	1,038	0	0	0	NCT00390221	1COMPLETED	2011-08-01	2008-02-01	Biogen	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	72	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	This is a randomized, double-blind, multi-centered study to compare 6 months of medical treatment with digoxin or propranolol in infants with SVT Background: SVT is the most common sustained arrhythmia of infancy. Neither digoxin nor propranolol has been evaluated for pediatric use in a controlled trial in the context ...	The purpose of the proposed research is to conduct a randomized double-blind, multi-centre study of two antiarrhythmic medications, digoxin and propranolol, to evaluate whether one of these medications is more effective in reducing risk of recurrent supraventricular tachycardia (SVT) in infants. SVT is the most common...	Supraventricular Tachycardia		null	2	arm 1: Single dose of 0.5 mg/kg per dose and increased to 1.0 mg/kg per dose ITD for the second and subsequent doses. arm 2: First 2 doses at 0.010 mg/kg per dose TID, then 0.0035 mg/kg per dose TID for the third and subsequent doses	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: Digoxin intervention 2: Propranolol	14	Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Orange \| California \| United States \| -117.85311 \| 33.78779 Kansas City \| Missouri \| United States \| -94.57857 \| 39.09973 New Hyde Park \| New York \| United States \| -73.68791 \| 40.7351 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403 Columbu...	61	0	0	0	NCT00390546	1COMPLETED	2011-08-01	2006-10-01	University of British Columbia	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	62	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to see if adding two targeted drugs (bevacizumab and erlotinib) further improves the response to chemotherapy (5-FU, paclitaxel, carboplatin) and radiation therapy in patients with operable esophageal cancer. Side effects (toxicity) information will also be collected.	Surgical removal has been the standard treatment for operable esophageal cancer. However, recent studies have shown improved results when patients receive a short course of chemotherapy and radiation therapy prior to surgery. Prior to surgery study treatment will be given over a 6 weeks (Days 1-42) period. Beginning D...	Esophageal Cancer		null	1	arm 1: Prior to surgery study treatment will be given over a 6 weeks (Days 1-42) period. Beginning Day 1 and continuing through Day 35 patients will receive a continuous infusion of 5-FU by vein. A small portable pump will be used to administer this drug into a tube that has been surgically inserted into the patient's ...	[ 0 ]	7	[ 0, 0, 0, 0, 0, 3, 3 ]	intervention 1: Erlotinib intervention 2: Bevacizumab intervention 3: Paclitaxel intervention 4: Carboplatin intervention 5: 5-FU intervention 6: Radiation therapy intervention 7: Surgery	intervention 1: Erlotinib intervention 2: Bevacizumab intervention 3: Paclitaxel intervention 4: Carboplatin intervention 5: 5-FU intervention 6: Radiation therapy intervention 7: Surgery	9	Fort Myers \| Florida \| United States \| -81.84059 \| 26.62168 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Gainesville \| Georgia \| United States \| -83.82407 \| 34.29788 Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424 Morristown \| New Jersey \| United States \| -74.48154 \| 40.79677 Canton \| Ohio...	62	0	0	0	NCT00393068	1COMPLETED	2011-08-01	2007-02-01	SCRI Development Innovations, LLC	7OTHER	false	false	false	null	0	0	0	0
[ 5 ]	17	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This study will recruit 100 depressed patients to test whether the previous finding of an association between treatment response (with treatment groups including placebo, imipramine, and fluoxetine) and preferences of hemispheric laterality in perceptual processing are also found with a different type of commonly used ...	Preliminary data suggest that depressed patients with increased left hemispheric laterality of perceptual processing are unlikely to improve during 6 weeks' treatment with placebo, while being very responsive to either imipramine or fluoxetine. Depressed patients who do not show evidence of poor right hemispheric funct...	Major Depressive Disorder Dysthymia	Depression	null	3	arm 1: escitalopram 10 mg/d for 1 week, then increasing by 10 mg/week if tolerated and not remitted to maximal dose of 40 mg/d arm 2: bupropion extended release (XL) 150 mg/d for a week, then 300 mg/d for a week and then 450 mg/d; all dose increases if tolerated and not remitted arm 3: imipramine 50 mg/d increasing twi...	[ 0, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Escitalopram: wk 1: 10 mg/d; wks 2-3: 20 mg/d; wk4: 30 mg/d; wks 5-6: 40 mg/d intervention 2: bupropion XL 150 mg/d increasing as tolerated and not remitted by 150 mg/d to maximal dose of 450 mg/d intervention 3: imipramine 50 mg/d increasing twice weekly by 50 mg/increase to 200 mg/d, then 50 mg increa...	intervention 1: escitalopram intervention 2: bupropion intervention 3: imipramine	1	New York \| New York \| United States \| -74.00597 \| 40.71427	31	0	0	0	NCT00404755	1COMPLETED	2011-08-01	2006-07-01	New York State Psychiatric Institute	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	126	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	This study is being done to see if the investigational drug Ranibizumab (RBZ) given by injection into the eye, is safe and effective to use in people with diabetic macular edema (DME). The investigators want to compare RBZ to laser treatment which is the current standard way to treat DME. RBZ blocks a growth factor th...	The READ-2 Study is a phase 2 randomized, multi-center clinical trial to be conducted under an investigator-initiated investigational new drug (IND). The study aims to enroll 126 patients, who will be randomized into 3 different groups. The primary objectives of the READ-2 Study are: (a) to obtain data on the bioactivi...	Diabetic Macular Edema	DME	null	3	arm 1: Ranibizumab (RBZ) intravitreal injection alone arm 2: Laser photocoagulation arm 3: Laser following intravitreal injection of RBZ	[ 0, 1, 0 ]	2	[ 0, 3 ]	intervention 1: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and pro re nata (PRN) with dosing criteria. intervention 2: Laser photocoagulation in either focal or grid pattern as determined by investigator.	intervention 1: Ranibizumab intervention 2: Laser photocoagulation	20	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Beverly Hills \| California \| United States \| -118.40036 \| 34.07362 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Oakland \| California \| United States \| -122.2708 \| 37.80437 Pasadena \| California \| United States \| -118.14452 \| 34.14778 San Fran...	126	0	0	0	NCT00407381	1COMPLETED	2011-08-01	2006-12-01	Johns Hopkins University	7OTHER	false	false	false	null	0	0	0	0
[ 5 ]	19	RANDOMIZED	CROSSOVER	0TREATMENT	3TRIPLE	false	0ALL	false	This study will determine whether treatment with an extended-release opioid or topical lidocaine is effective in relieving distal symmetric lower extremity burning pain associated with multiple sclerosis (MS). If treatment with topical lidocaine is efficacious, it will have important implications for understanding this...	This study is a single-center, double-blind, 15-week, 3-period crossover clinical trial. Subjects will complete each of the following 5-week long periods (unless they withdraw from the trial): 1) placebo pills and topical lidocaine patches, 2)extended-release oxycodone pills and placebo(vehicle) patches, and 3)placebo ...	Neuropathic Pain Chronic Pain Multiple Sclerosis	Neuropathic pain Chronic pain Multiple sclerosis Central neuropathic pain Peripheral neuropathic pain Opioid analgesic Lidocaine	null	1	arm 1: 5% lidocaine patch used as intervention placebo patch used with extended release oxycodone or with placebo pills and placebo patches a randomized subjects given extended release oxycodone and placebo patches during this treatment placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pil...	[ 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: lidocaine 5% patch; 12 hours on, 12 hours off intervention 2: extended-release oxycodone titrating schedule intervention 3: placebo pills with titrating schedule intervention 4: used with extended release oxycodone group; used with placebo pills/placebo patches	intervention 1: Lidocaine patch 5% intervention 2: Extended-release oxycodone intervention 3: Placebo extended-release oxycodone pills intervention 4: Placebo lidocaine patches	1	Rochester \| New York \| United States \| -77.61556 \| 43.15478	0	0	0	0	NCT00414453	6TERMINATED	2011-08-01	2007-01-01	University of Rochester	7OTHER	false	false	false	null	0	0	0	0
[ 4 ]	179	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	This study will determine the effectiveness of tropisetron plus risperidone in improving cognitive symptoms in Chinese people with schizophrenia.	Schizophrenia is a chronic and disabling brain disorder. People with schizophrenia may experience hallucinations, delusions, disordered thinking, movement disorders, social withdrawal, and cognitive deficits. In considering the high rate of cigarette smoking among people with schizophrenia, it is also likely that they ...	Smoking Cessation Schizophrenia		null	2	arm 1: Tropisetron (10mg/day) + risperidone(6mg/day) arm 2: Placebo + risperidone (6mg/day)	[ 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: 10 mg/day intervention 2: placebo intervention 3: 6mg/day	intervention 1: Tropisetron intervention 2: Placebo intervention 3: Risperidone	2	Houston \| Texas \| United States \| -95.36327 \| 29.76328 Beijing \| N/A \| China \| 116.39723 \| 39.9075	179	0	0	0	NCT00435370	1COMPLETED	2011-08-01	2006-11-01	Baylor College of Medicine	7OTHER	false	false	false	null	0	0	0	0
[ 4 ]	274	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	A comparison of Orthovisc to corticosteroid injections in the shoulder for pain due to osteoarthritis.	This multicenter, prospective double-blinded, randomized trial will study two treatment groups. Subjects will be randomized to receive either Orthovisc or corticosteroids/anesthetic injection into the shoulder in a 2:1 schema. The trial will assess safety and efficacy of pain relief in the osteoarthritic shoulder.	Glenohumeral Osteoarthritis	Orthovisc Osteoarthritis Shoulder Randomized	null	2	arm 1: Subjects randomized to the control arm injection of prescribed anesthetic and corticosteroid, shall receive an equivalent volume (8 mL's). arm 2: Subjects randomized to the active treatment in this study will receive a one-time dose of 8 mL's of Orthovisc derived from non-animal source bacterial fermentation, S....	[ 1, 0 ]	2	[ 1, 0 ]	intervention 1: Orthovisc injection intervention 2: Celestone (betamethasone sodium phosphate and acetate) - 2 mL	intervention 1: Orthovisc intervention 2: Control	13	Encinitas \| California \| United States \| -117.29198 \| 33.03699 Fresno \| California \| United States \| -119.77237 \| 36.74773 Coral Gables \| Florida \| United States \| -80.26838 \| 25.72149 Gulf Breeze \| Florida \| United States \| -87.16386 \| 30.35714 New Orleans \| Louisiana \| United States \| -90.07507 \| 29.95465 Worcester \|...	270	0	0	0	NCT00436969	1COMPLETED	2011-08-01	2006-12-01	DePuy Mitek	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	361	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	In this clinical trial patients with newly diagnosed focal epilepsy aged 60 years or older receive three different antiepileptic drugs in a double-blind, randomized design over a period of 58 weeks. All drugs are licensed for the treatment of epilepsy. The primary endpoint of this study will be retention rate at 58-wee...	Indication: Focal Epilepsy Objectives: To evaluate the tolerability and efficacy of levetiracetam (LEV) in newly diagnosed elderly patients (aged 60 yrs or above) with focal epilepsy compared to lamotrigine (LTG) or carbamazepine slow release (CBZ). Primary Outcome: The primary outcome will be the 58-week retention ra...	Focal Epilepsy	elderly focal epilepsy anticonvulsive treatment levetiracetam lamotrigine carbamazepine	null	3	arm 1: Levetiracetam arm 2: Carbamazepine arm 3: Lamotrigine	[ 1, 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: LEV 250 mg capusles: week 1 and 2 0-0-1, week 3 and 4 1-0-1, week 5: 1-0-2, week 6: 2-0-2. Patients may take 2 to 12 per day (500 - 3000 mg)during maintenance. intervention 2: CBZ 100 mg capusles: week 1 and 2: 0-0-1, week 3 and 4: 1-0-1, week 5: 1-0-2, week 6: 2-0-2. Patients may take 2 to 12 per day (...	intervention 1: Levetiracetam intervention 2: Carbamazepine intervention 3: Lamotrigine	1	Mainz \| N/A \| Germany \| 8.2791 \| 49.98419	360	0	0	0	NCT00438451	1COMPLETED	2011-08-01	2007-01-01	Johannes Gutenberg University Mainz	7OTHER	false	false	false	null	0	0	0	0

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