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_Intentional overdose int64	METADATA_count_Non-accidental overdose int64	METADATA_count_Overdose int64	METADATA_count_Overdose NOS int64	METADATA_wilson_lower_bound float32
[ 3 ]	70	RANDOMIZED	SEQUENTIAL	0TREATMENT	4QUADRUPLE	false	0ALL	true	This Phase II study is designed to determine whether a single 600 mg dose or 400mg/day for 3 days of tafenoquine is efficacious, and well tolerated for clearing P. vivax malaria infection (blood schizontocidal and gametocytocidal activity) and preventing P. vivax relapse (hypnozoite eradication). It will also further e...	This was a randomized, active-control, double-blind, double-dummy study to be conducted in 2 sequential cohorts. Cohort 1 was randomized 2:1 to receive tafenoquine, 400mg/day for 3 days, or the standard blood schizontocidal dosing regimen of chloroquine (1000mg for 2 days followed by 500mg for 1 day) followed by a stan...	Malaria Plasmodium Vivax	malaria Plasmodium vivax adults treatment tafenoquine	null	4	arm 1: Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days. arm 2: Chloroquine (1000 mg chloroquine phosphate) and t...	[ 0, 1, 0, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days. intervention 2: Chloroquine (1000 mg chloroquin...	intervention 1: Tafenoquine intervention 2: Chloroquine + Primaquine intervention 3: tafenoquine intervention 4: Chloroquine + Primaquine	1	Bangkok \| N/A \| Thailand \| 100.50144 \| 13.75398	70	0	0	0	NCT01290601	6TERMINATED	2005-01-10	2003-09-15	U.S. Army Medical Research and Development Command	1FED	false	false	false	null	0	0	0	0	0	0
[ 2, 3 ]	28	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The purpose of this trial is to determine the safety of zalutumumab as a treatment for head and neck cancer.	null	Head and Neck Neoplasms	Head and neck cancer squamous cell carcinoma of the head and neck	null	6	arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None	[ 0, 0, 0, 0, 0, 0 ]	1	[ 0 ]	intervention 1: Weekly infusion	intervention 1: Zalutumumab	5	Århus C \| N/A \| Denmark \| N/A \| N/A Copenhagen Ø \| N/A \| Denmark \| N/A \| N/A Odense \| N/A \| Denmark \| 10.38831 \| 55.39594 Lund \| N/A \| Sweden \| 13.19321 \| 55.70584 Uppsala \| N/A \| Sweden \| 17.63889 \| 59.85882	28	0	0	0	NCT00093041	1COMPLETED	2005-01-12	2003-12-01	Genmab	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 4 ]	39,876	RANDOMIZED	FACTORIAL	1PREVENTION	3TRIPLE	false	1FEMALE	true	The purpose of this study is to evaluate the effects of low-dose aspirin and vitamin E in primary prevention of cardiovascular disease and cancer in apparently healthy women.	BACKGROUND: Various doses of aspirin have been shown to be effective in preventing thrombosis or vascular occlusion in several clinical conditions. Short-term studies have documented the efficacy of aspirin in preventing occlusion of saphenous vein bypass grants, preventing myocardial infarction in patients with unsta...	Cardiovascular Diseases Cerebrovascular Disorders Coronary Disease Heart Diseases Myocardial Infarction Myocardial Ischemia Vascular Diseases		null	4	arm 1: Vitamin E (600 IU every other day) and aspirin (100 mg every other day) arm 2: Vitamin E (600 IU every other day) and placebo arm 3: Aspirin (100 mg every other day) and placebo arm 4: Placebo and placebo	[ 0, 0, 0, 2 ]	3	[ 0, 0, 5 ]	intervention 1: Participants will receive 100 mg of aspirin every other day. intervention 2: Participants will receive 600 IU of vitamin E every other day. intervention 3: Participants will receive placebo.	intervention 1: Aspirin intervention 2: Vitamin E intervention 3: Placebo	0	null	39,876	0	0	0	NCT00000479	1COMPLETED	2005-02-01	1992-09-01	Brigham and Women's Hospital	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 3 ]	13	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	RATIONALE: Current therapies for children with primitive neuroectodermal tumors that have not responded to standard therapy provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of children with primitive neuroectodermal t...	OBJECTIVES: * To determine the efficacy of Antineoplaston therapy in children with primitive neuroectodermal tumors that has not responded to standard therapy, as measured by an objective response to therapy (complete response, partial response or stable disease). * To determine the safety and tolerance of Antineoplas...	Childhood CNS Primitive Neuroectodermal Tumor	Recurrent primitive neuroectodermal tumor	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: Children with a primitive neuroectodermal tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).	intervention 1: Antineoplaston therapy (Atengenal + Astugenal)	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	13	0	0	0	NCT00003460	1COMPLETED	2005-02-01	1996-04-01	Burzynski Research Institute	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 3 ]	23	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	OBJECTIVES: I. Compare the efficacy of local care alone vs local care plus arginine butyrate in terms of healing rate in patients with refractory sickle cell ulcers. II. Determine the effect of arginine butyrate therapy on tissue factors related to promotion or inhibition of wound healing in these patients. III. Dete...	PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive arginine butyrate IV over 6-9 hours at night 5 days a week for 12 weeks, plus concurrent standard local therapy consisting of cleaning, saline irrigation, and dressing changes as pres...	Skin Ulcers Sickle Cell Anemia	dermatologic disorders genetic diseases and dysmorphic syndromes hematologic disorders rare disease sickle cell anemia skin ulcers thalassemia major	null	3	arm 1: Each subject provided his/her own dressing e.g,standard local care includes cleaning, saline irrigation, dressing changes only for 8 weeks twice a week. arm 2: Arginine Butyrate IV plus Standard local care dressing for a total of 12 weeks. Low dose 500 mg/kg or, increased dose 750 mg/kg. First week AB given 5 da...	[ 5, 0, 5 ]	2	[ 0, 10 ]	intervention 1: To determine if Arginine Butyrate accelerates healing of refractory leg ulcers over Standard Local Care alone. intervention 2: To heal leg ulcers.	intervention 1: Arginine Butyrate intervention 2: Standard local care dressing	4	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 New York \| New York \| United States \| -74.00597 \| 40.71427 Memphis \| Tennessee \| United States \| -90.04898 \| 35.14953	26	0	0	0	NCT00004412	1COMPLETED	2005-02-01	1997-09-01	Susan P. Perrine	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 3 ]	128	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The trial will study 2 doses of Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the number of relapses that occur in a 1 year treatment period.	This trial is designed as a multi-national, randomized, double-blind, placebo-controlled prospective trial with three parallel groups. One hundred twenty (120) patients, 40 per treatment arm, with relapsing-remitting (RR) multiple sclerosis will be enrolled in this trial. Eligible patients must have a diagnosis of MS ...	Multiple Sclerosis, Relapsing-Remitting		null	3	arm 1: IGIV-C 0.2 g/kg bw/infusion (2 ml/kg bw) arm 2: IGIV-C 0.4 g/kg bw/infusion (4 ml/kg bw) arm 3: placebo (0.1% albumin) 4 ml/kg bw/infusion	[ 0, 0, 2 ]	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified intervention 2: Albumin (Human) 25%, United States Pharmacopeia (USP)	37	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 New York \| New York \| United States \| -74.00597 \| 40.71427 Stony Brook \| New York \| United States \| -73.14094 \| 40.92565 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Burlington \| V...	128	0	0	0	NCT00220779	1COMPLETED	2005-02-01	2002-12-01	Grifols Therapeutics LLC	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 0 ]	40	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	true	0ALL	null	The purpose of this study is a prospective,double-blinded, randomized trial to compare the rate of healing following PRK after the use of two commercially available 4th generation fluoroquinolones, moxifloxacin and gatifloxacin.	null	Epithelium, Corneal	Removal of corneal epithelium followed by excimer laser treatment during prk	null	2	arm 1: Moxifloxacin eye drops; 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery arm 2: Gatifloxacin eyedrops; 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery intervention 2: 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery	intervention 1: Moxifloxacin intervention 2: Gatifloxacin	1	Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511	0	0	0	0	NCT00414011	1COMPLETED	2005-02-01	null	Walter Reed Army Medical Center	1FED	false	false	false	null	0	0	0	0	0	0
[ 4 ]	137	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	An extension study to evaluate the long-term safety, tolerability and efficacy of GW-1000-02 treatment in multiple sclerosis.	Patients who participated in the placebo controlled phase of this study and opted to continue receiving open label GW-1000-02 entered the follow-on extension of the study and completed symptom assessments to determine whether they were continuing to receive clinical benefit from GW-1000-02.	Multiple Sclerosis Spasticity		null	1	arm 1: Active treatment	[ 0 ]	1	[ 0 ]	intervention 1: Contained THC and CBD as extract of Cannabis sativa L. Each 100 μl actuation delivered a dose containing 2.7 mg THC and 2.5mg CBD. The maximum permitted dose was eight actuations (22 mg THC and 20 mg CBD) in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.	intervention 1: GW-1000-02	1	Oxford \| N/A \| United Kingdom \| -1.25596 \| 51.75222	137	0	0	0	NCT01610687	1COMPLETED	2005-02-01	2001-07-01	Jazz Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	8	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Current therapies for Cancer of Unknown Primary Origin provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Cancer of Unknown Primary Origin. PURPOSE: This study is being performed to determine the effects (good and b...	Cancer of Unknown Primary Origin patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity. OBJECTIVES: * To determine the eff...	Unknown Primary 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 Cancer of Unknown Primary Origin 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	8	0	0	0	NCT00003526	6TERMINATED	2005-02-02	1996-03-18	Burzynski Research Institute	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 3 ]	13	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Current therapies for Stage IV Melanoma 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 Melanoma. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therap...	Stage IV Melanoma patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity. OBJECTIVES: * To determine the efficacy of Antine...	Stage IV Melanoma	Stage IV melanoma of the skin	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 Melanoma 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	13	0	0	0	NCT00003509	6TERMINATED	2005-02-14	1996-03-27	Burzynski Research Institute	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 4 ]	436	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This was a Phase 3 multicenter randomized, open-label, safety study assessing the safety of repeat doses of Medisorb® naltrexone 380 mg (VIVITROL®) administered for up to 1 year to adults with alcohol and/or opioid dependence as defined by Diagnostic and Statistical Manual of Mental Health Disorders (DSM-IV) criteria. ...	Safety evaluations included physical examinations, electrocardiograms (ECGs), laboratory measures (including plasma concentrations of naltrexone and 6β-naltrexol), assessments of injection sites, and adverse events (AEs). All subjects received psychosocial support at each study visit for the duration of the study, wit...	Alcoholism	Alcoholism Alcohol dependence	null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Administered via intramuscular (IM) injection once every 4 weeks for up to 1 year. intervention 2: Tablet taken orally once daily for up to 1 year	intervention 1: Medisorb naltrexone 380 mg intervention 2: Oral naltrexone 50 mg	0	null	436	3	0.006881	1	NCT01218997	1COMPLETED	2005-03-01	2003-08-01	Alkermes, Inc.	4INDUSTRY	false	false	false	null	0	0	1	0	2	0.002343
[ 4 ]	612	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	This study evaluates the use of Targretin capsules (bexarotene) in combination with standard chemotherapy for the treatment of metastatic Non-Small Cell Lung Cancer (NSCLC) in patients who have not yet received chemotherapy for their lung cancer.	This study evaluates the use of Targretin capsules (bexarotene) in combination with Carboplatin and Paclitaxel for the treatment of metastatic non-small cell lung cancer in patients who have not yet received chemotherapy for their lung cancer. Every patient receives a platinum-containing chemotherapy every three weeks ...	Non-small Cell Lung Cancer	NSCLC Targretin Retinoid Bexarotene	null	2	arm 1: None arm 2: None	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: bexarotene capsules (400 mg/m\^2/day) in combination with carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m\^2) every 3 weeks. Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator. intervention 2: carboplatin IV (AUC 6) every 3 w...	intervention 1: bexarotene with carboplatin and paclitaxel intervention 2: carboplatin and paclitaxel	154	Montgomery \| Alabama \| United States \| -86.29997 \| 32.36681 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Concord \| California \| United States \| -122.03107 \| 37.97798 Fountain Valley \| California \| United States \| -117.95367 \| 33.70918 Fountain Valley \| California \| United States \| -117.95367 \| 33.70918 Gree...	588	0	0	0	NCT00050960	1COMPLETED	2005-03-01	2002-05-01	Eisai Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	53	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	Conjugated linoleic acid (CLA) is form of fat found in dairy foods, beef and other natural sources. When given to small animals, decreases of body fat have been noted.. Although weight loss is the best treatment for overweight and obesity, it is difficult to maintain the loss in the long term. Because of this, treatmen...	Subjects were screened and then underwent baseline evaluation. The substudy evaluation measured 24-h energy expenditure and substrate utilization by using a whole-room indirect calorimeter. Dietary fat oxidation was measured by mixing \[1-13C\]oleate and D31-palmitate into a breakfast meal and then collecting breath ca...	Obesity		null	2	arm 1: The group randomized to Conjugated Linoleic Acid (CLA) treatment at 4 grams per day of 39% cis-9, trans-11 CLA; 39% trans-10, cis-12 CLA; and 22% safflower oil for 6 months arm 2: The group randomized to control received 4 g/d of safflower oil.	[ 1, 2 ]	1	[ 0 ]	intervention 1: 4 grams per day of 39% cis-9, trans-11 CLA; 39% trans-10, cis-12 CLA, and 22% safflower oil for 6 months	intervention 1: conjugated linoleic acid	1	Madison \| Wisconsin \| United States \| -89.40123 \| 43.07305	48	0	0	0	NCT00204932	1COMPLETED	2005-03-01	2004-07-01	University of Wisconsin, Madison	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 4 ]	168	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	The purpose of this study is to determine the safety, tolerability, and efficacy of AQUAVAN® Injection when used for mild-to-moderate sedation in patients undergoing minor surgical procedures.	Randomized, open label, multi-center,midazolam adaptive dose ranging study, in which several dose levels of AQUAVAN® Injection and fentanyl citrate injection will be investigated to produce a desired sedation level in patients undergoing minor surgical and/or therapeutic procedures. A desired sedative dose/dose range a...	Arthroscopy Bunionectomy Osteotomy Carpal Tunnel	AQUAVAN® Injection Midazolam Minor surgical procedures Sedation	null	0	null	null	1	[ 0 ]	intervention 1: None	intervention 1: fospropofol disodium	0	null	163	0	0	0	NCT00209560	6TERMINATED	2005-03-01	2004-10-01	Eisai Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 5 ]	40	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This study will evaluate the effectiveness of treatment with acetylcholinesterase inhibitors in improving cognitive function and overall rehabilitation in elderly stroke survivors.	Cognitive impairment is a common result of a stroke and can be detrimental to recovery. It can negatively affect both mental and physical functioning, thereby complicating the rehabilitation process. Although much research has targeted the effects of long-term cognitive impairment after a stroke, very little research h...	Cerebrovascular Accident	Cholinesterase Inhibitors Elderly Stroke Cognition	null	2	arm 1: Galantamine for 12 weeks arm 2: Donepezil for 12 weeks	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Participants assigned to receive galantamine will receive 4 mg twice a day for 4 weeks, 8 mg twice a day for the next 4 weeks, and 12 mg twice a day for the remainder of the study. intervention 2: Participants assigned to receive donepezil will receive 5 mg twice a day for 6 weeks, and then 10 mg twice ...	intervention 1: Galantamine intervention 2: Donepezil	1	Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062	40	0	0	0	NCT00227994	1COMPLETED	2005-03-01	2003-04-01	University of Pittsburgh	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 4 ]	107	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The original objective of this study was to assess the safety and efficacy of the buprenorphine transdermal system (BTDS) (5, 10, and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain. However, this study was terminated early with only 35% of the planned sample size...	Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.	Osteoarthritis	osteoarthritis opioid transdermal	null	2	arm 1: Buprenorphine transdermal patches 10 or 20 mcg/h arm 2: Placebo to match buprenorphine transdermal patch 10 or 20	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Buprenorphine transdermal patch applied for 7-day wear. intervention 2: Placebo to match buprenorphine transdermal patch 10 or 20.	intervention 1: Buprenorphine transdermal patch intervention 2: Placebo transdermal patch	48	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Haleyville \| Alabama \| United States \| -87.62141 \| 34.22649 Muscle Shoals \| Alabama \| United States \| -87.66753 \| 34.74481 Tuscaloosa \| Alabama \| United States \| -87.56917 \| 33.20984 Phoenix \| Arizona...	425	0	0	0	NCT00315458	6TERMINATED	2005-03-01	2003-12-01	Purdue Pharma LP	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	320	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this study is to evaluate the efficacy and safety of initial single and multiple subcutaneous injections of CNTO 1275 in the treatment of patients with moderate to severe plaque psoriasis.	This is a randomized (the study medication is assigned by chance), double blind (neither physician nor patient knows the treatment that the patient receives), parallel-group, multicenter study to determine the effectiveness and safety of two different doses of CNTO 1275 administered subcutaneously one time or as multip...	Psoriasis	Psoriasis CNTO 1275 Ustekinumab Stelara Interleukin-12 IL-12 Interleukin-23 IL-23	null	5	arm 1: Patients in the placebo group will receive placebo at Weeks 0, 1, 2, 3, and 16. At week 20, all patients will receive a single dose of ustekinumab 90 mg. arm 2: Patients will receive single dose ustekinumab at Week 0 and placebo at Weeks 1, 2, and 3. At Week 16, patients with Physician's Global Assessment (PGA) ...	[ 2, 0, 0, 0, 0 ]	2	[ 0, 0 ]	intervention 1: Patients will receive subcutaneous injections of ustekinumab (45 or 90 mg). intervention 2: Patients in the placebo group will receive placebo medication.	intervention 1: Ustekinumab intervention 2: Placebo	0	null	613	0	0	0	NCT00320216	1COMPLETED	2005-03-01	2003-11-01	Centocor, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 4 ]	188	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	The original objective of this study was to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 micrograms (mcg)/hour (h) in comparison to the buprenorphine transdermal system 5 mcg/h in subjects with moderate to severe osteoarthritis pain currently treated with oral opioids...	Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.	Osteoarthritis	Chronic pain osteoarthritis transdermal	null	2	arm 1: Buprenorphine transdermal patch 5 mcg/h, applied for 7-day wear arm 2: Buprenorphine transdermal patch 20 mcg/h, applied for 7-day wear	[ 1, 0 ]	2	[ 0, 0 ]	intervention 1: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear intervention 2: Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear	intervention 1: Buprenorphine transdermal patch intervention 2: Buprenorphine transdermal patch	66	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 Montgomery \| Alabama \| United States \| -86.29997 \| 32.36681 Scottsdale \| Arizona \| United States \| -111.89903 \| 33.50921 Searcy \| Arizona \| U...	472	0	0	0	NCT00320801	6TERMINATED	2005-03-01	2004-01-01	Purdue Pharma LP	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	45	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	true	0ALL	false	The purpose of this study is to assess the safety and efficacy of VEC-162 compared to matching placebo on circadian phase shift and sleep parameters.	null	Circadian Rhythm Sleep Disorders		null	0	null	null	1	[ 0 ]	intervention 1: None	intervention 1: VEC-162	2	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Detroit \| Michigan \| United States \| -83.04575 \| 42.33143	39	0	0	0	NCT00490945	1COMPLETED	2005-03-01	2004-07-01	Vanda Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 2 ]	34	RANDOMIZED	CROSSOVER	7BASIC_SCIENCE	1SINGLE	true	0ALL	false	The purpose of this study is to evaluate and compare the relative bioavailability of a test formulation of zonisamide capsules to an equivalent dose of a reference formulation, Zonegran® (zonisamide) capsules, after a single oral dose administered under fasting conditions.	The purpose of this study is to evaluate and compare the relative bioavailability of a test formulation of zonisamide capsules to an equivalent dose of a reference formulation, Zonegran® (zonisamide) capsules, after a single oral dose administered under fasting conditions. Thirty-four healthy, non-smoking, non-obese m...	Healthy	Therapeutic Equivalency	null	2	arm 1: A single dose of zonisamide 100 mg administered after an overnight fast. arm 2: A single dose of Zonegran® 100 mg administered after an overnight fast.	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: 100 mg capsule administered after an overnight fast. intervention 2: 100 mg capsule administered after an overnight fast.	intervention 1: Zonisamide 100 mg Capsule intervention 2: Zonisamide (Zonegran®) 100 mg Capsule	0	null	68	0	0	0	NCT00685139	1COMPLETED	2005-03-01	2005-01-01	Mutual Pharmaceutical Company, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 2 ]	34	RANDOMIZED	CROSSOVER	7BASIC_SCIENCE	1SINGLE	true	0ALL	false	The purpose of this study is to evaluate the relative bioavailability (rate and extent of absorption) of a test formulation of zonisamide capsules compared to the reference formulation, Zonegran® (zonisamide)capsules, after a single oral dose administered under non-fasting conditions.	The purpose of this study is to evaluate the relative bioavailability (rate and extent of absorption) of a test formulation of zonisamide capsules compared to the reference formulation, Zonegran® (zonisamide)capsules, after a single oral dose administered under non-fasting conditions. Thirty-four healthy, non-smoking,...	Healthy	Therapeutic Equivalency	null	2	arm 1: A single dose of zonisamide 100 mg administered 30 minutes after initiation of a standardized, high fat breakfast. arm 2: A single dose of Zonegran® 100 mg administered 30 minutes after initiation of a standardized, high fat breakfast.	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: 100 mg capsule administered 30 minutes after initiation of standardized, high-fat breakfast. intervention 2: 100 mg capsule administered 30 minutes after initiation of standardized, high-fat breakfast.	intervention 1: Zonisamide 100 mg Capsule intervention 2: Zonisamide (Zonegran®) 100 mg Capsule	1	Fargo \| North Dakota \| United States \| -96.7898 \| 46.87719	68	0	0	0	NCT00687167	1COMPLETED	2005-03-01	2005-01-01	Mutual Pharmaceutical Company, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 0 ]	276	NON_RANDOMIZED	SINGLE_GROUP	1PREVENTION	0NONE	false	0ALL	false	In a rural hospital in Tanzania the rate of surgical site infections (SSI) was 21.6%. Inappropriate choice of antibiotics and of administration time were determined as sole risk factors in this setting. After implementation of a standardized procedure with a single shot dose of Amoxicillin/Clavulanic Acid approximately...	Surgical Site Infections (SSIs) have an important socioeconomic impact prolonging the period of hospitalization and rehabilitation. Patients with SSIs are five times more likely to be readmitted and are even twice as likely to die compared to patients with similar interventions without SSI. In non-industrialized countr...	Surgical Site Infection	Postoperative wound infection surgical site infection antimicrobial prophylaxis developing countries Sub-Saharan Africa reduction of SSI using preoperative antibiotics	null	1	arm 1: single shot dose of Amoxicillin/Clavulanic Acid approximately 30 min. preoperatively	[ 0 ]	1	[ 0 ]	intervention 1: single shot dose of Amoxicillin/Clavulanic Acid approximately 30 min. preoperatively	intervention 1: Amoxicillin/Clavulanic Acid	1	Basel \| Canton of Basel-City \| Switzerland \| 7.57327 \| 47.55839	276	0	0	0	NCT00801099	1COMPLETED	2005-03-01	2004-12-01	Swiss Tropical & Public Health Institute	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 2 ]	26	RANDOMIZED	CROSSOVER	null	0NONE	true	0ALL	null	To determine whether the test product, Labopharm Tramadol HCl Once-A-Day (OAD) 200 mg film-coated tablets, and the reference product, Labopharm Tramadol HCl OAD 200 mg uncoated tablets, are bioequivalent.	null	Healthy	Healthy volunteers	null	2	arm 1: Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule. arm 2: Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.	[ 0, 0 ]	1	[ 0 ]	intervention 1: Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet or Tramadol HCl 200 mg Uncoated Tablets based on randomization schedule.	intervention 1: Tramadol HCl	0	null	50	0	0	0	NCT00834366	1COMPLETED	2005-03-01	2005-02-01	Labopharm Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 5 ]	58	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	To investigate the clinical and bacteriological efficacy of Fucidin® cream in the treatment of impetigo in paediatric patients. To assess the validity of in vitro susceptibility-testing of S. aureus to fusidic acid as a prediction of clinical and bacteriological outcome in impetigo patients treated with Fucidin® cream...	null	Impetigo		null	2	arm 1: None arm 2: None	[ 0, 2 ]	1	[ 0 ]	intervention 1: None	intervention 1: Fucidin® cream	2	Bergen \| N/A \| Norway \| 5.32415 \| 60.39299 Gothenburg \| N/A \| Sweden \| 11.96679 \| 57.70716	56	0	0	0	NCT00986856	6TERMINATED	2005-03-01	2004-05-01	LEO Pharma	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 2 ]	24	RANDOMIZED	CROSSOVER	null	0NONE	true	0ALL	null	The object of this study was to compare the relative bioavailability (rate and extent of absorption) of Pramipexole Dihydrochloride Tablets 0.25 mg by Barr Laboratories, Inc. with that of Mirapex® Tablets 0.25 mg distributed by Boehringer Ingelheim Pharmaceuticals, Inc. following a single oral dose in healthy adults un...	Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA Bioequivalence Statistical Methods	Healthy	Bioequivalence Healthy Subjects	null	2	arm 1: Pramipexole Dihydrochloride 0.25 mg Tablets arm 2: Mirapex® 0.25 mg Tablets	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 0.25 mg Tablet intervention 2: 0.25 mg Tablet	intervention 1: Pramipexole Dihydrochloride intervention 2: Pramipexole Dihydrochloride	1	Fargo \| North Dakota \| United States \| -96.7898 \| 46.87719	48	0	0	0	NCT01074450	1COMPLETED	2005-03-01	2005-02-01	Teva Pharmaceuticals USA	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 2 ]	24	RANDOMIZED	CROSSOVER	null	0NONE	true	0ALL	null	The object of this study was to compare the relative bioavailability (rate and extent of absorption) of Pramipexole Dihydrochloride Tablets 0.25 mg by Barr Laboratories, Inc. with that of Mirapex® Tablets 0.25 mg distributed by Boehringer Ingelheim Pharmaceuticals, Inc. following a single oral dose in healthy adults un...	Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA Bioequivalence Statistical Methods	Healthy	Bioequivalence Healthy Subjects	null	2	arm 1: Pramipexole Dihydrochloride 0.25 mg Tablets arm 2: Mirapex® 0.25 mg Tablets	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 0.25 mg Tablet intervention 2: 0.25 mg Tablet	intervention 1: Pramipexole Dihydrochloride intervention 2: Pramipexole Dihydrochloride	1	Fargo \| North Dakota \| United States \| -96.7898 \| 46.87719	48	0	0	0	NCT01074463	1COMPLETED	2005-03-01	2005-02-01	Teva Pharmaceuticals USA	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 5 ]	24	RANDOMIZED	CROSSOVER	0TREATMENT	4QUADRUPLE	false	0ALL	null	The purpose of this clinical study is to evaluate the clinical effect of midodrine hydrochloride (ProAmatine®) compared to placebo in patients with orthostatic hypotension by measuring the time to onset of near syncopal symptoms and assessing several cardiovascular measurements, such as heart rate, blood pressure, and ...	null	Hypotension, Orthostatic		null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: one dose, 10-30mg, given orally intervention 2: Placebo	intervention 1: Midodrine hydrochloride intervention 2: Placebo	11	Fort Wayne \| Indiana \| United States \| -85.12886 \| 41.1306 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756 Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 New York \| New Yo...	24	0	0	0	NCT00555880	1COMPLETED	2005-03-21	2004-09-08	Shire	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	51	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to determine if the study drug pertuzumab is effective in treating patients with advanced lung cancer that has recurred following prior chemotherapy.	null	Non-small Cell Lung Cancer	Lung cancer	null	1	arm 1: Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.	[ 0 ]	1	[ 0 ]	intervention 1: Pertuzumab was supplied as a single-use liquid formulation.	intervention 1: Pertuzumab	8	Scottsdale \| Arizona \| United States \| -111.89903 \| 33.50921 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Sacramento \| California \| United States \| -121.4944 \| 38.58157 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 New York \| N...	43	0	0	0	NCT00063154	1COMPLETED	2005-04-01	2003-07-01	Genentech, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 2 ]	21	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	The malignancies (advanced solid tumors) that have been chosen for evaluation of E7389 are those where E7389 has demonstrated significant pre-clinical anti-tumor activity, both in vitro and in vivo. The ultimate goal is to demonstrate the clinical activity of E7389 in the treatment of these, and potentially other, tumo...	null	Cancer	Cancer, tumors	null	0	null	null	1	[ 0 ]	intervention 1: None	intervention 1: E7389	3	Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Santa Monica \| California \| United States \| -118.49138 \| 34.01949 New Brunswick \| New Jersey \| United States \| -74.45182 \| 40.48622	21	0	0	0	NCT00069277	1COMPLETED	2005-04-01	2003-08-01	Eisai Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 4 ]	120	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study was to compare the efficacy of Photodynamic Therapy (PDT) methyl aminolevulinate (MAL) cream to cryotherapy, in treatment of participants with primary superficial basal cell carcinoma (BCC). Secondary objectives was to compare cosmetic outcome and tolerability (adverse events) in these partic...	BCC was a highly frequent skin malignancy, and accounts for approximately 75% of all non-melanoma skin cancers. It is the most common malignant tumour of any organ, mostly affecting head and neck (84%) in fair-skinned people. Several non-pharmacological treatment modalities was used for BCC, including excision surgery,...	Superficial Basal Cell Carcinoma	Methyl aminolevulinate Photodynamic therapy Primary Superficial Basal Cell Carcinoma	null	2	arm 1: Participants with basal cell carcinoma (BCC) lesions were administered to photodynamic therapy (PDT) with Metvix® cream 160 milligrams per gram (mg/g) applied for three hours, followed by illumination using non-coherent light with a fluency of 75 Joule per centimeter square (J/cm\*2) and fluency rate of 70-200 m...	[ 0, 1 ]	2	[ 0, 3 ]	intervention 1: None intervention 2: None	intervention 1: Metvix® cream intervention 2: Hand held liquid nitrogen spray cryotherapy	14	Graz \| N/A \| Austria \| 15.45 \| 47.06667 Leuven \| N/A \| Belgium \| 4.70093 \| 50.87959 Helsinki \| N/A \| Finland \| 24.93545 \| 60.16952 Marseille \| N/A \| France \| 5.38107 \| 43.29695 Paris \| N/A \| France \| 2.3488 \| 48.85341 Brescia \| N/A \| Italy \| 10.21472 \| 45.53558 Jönköping \| N/A \| Sweden \| 14.15618 \| 57.78145 Linköping \|...	118	0	0	0	NCT00469417	1COMPLETED	2005-04-01	1999-10-18	Galderma R&D	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 0 ]	553	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The objectives of this study were to demonstrate comparable safety and efficacy of Ciclopirox Olamine Topical Suspension (Test Product) and Ciclopirox Topical Suspension 0.77% (Reference Product) in the treatment of subjects with tinea pedis, and to show the superiority of the active treatments over that of the vehicle...	null	Tinea Pedis	Tinea Pedis Ciclopirox Olamine	null	3	arm 1: Ciclopirox Olamine Topical Suspension arm 2: Loprox® Topical Suspension 0.77% arm 3: placebo of test product	[ 0, 1, 2 ]	3	[ 0, 0, 0 ]	intervention 1: topical suspension intervention 2: topical suspension intervention 3: topical suspension	intervention 1: Ciclopirox Olamine Topical Suspension intervention 2: Ciclopirox Topical Suspension 0.77%-Reference Product intervention 3: Ciclopirox Olamine Topical Suspension-Placebo	0	null	553	0	0	0	NCT00804193	1COMPLETED	2005-04-01	2004-06-01	Padagis LLC	4INDUSTRY	false	false	false	null	0	0	0	0	0	-0
[ 5 ]	41	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This is a pilot investigational study of the appropriate therapeutic regimens to treat subjects experiencing inflammatory recurrence (rebound) of psoriatic disease upon discontinuation of efalizumab therapy and of the biological mechanisms involved in inflammatory disease recurrence and control.	null	Psoriasis	Psoriasis Discontinuation of efalizumab Managing inflammatory recurrence	null	5	arm 1: Starting dose 4.0 - 5.1 mg/kg/day until clinical improvement. Upon clinical improvement, cyclosporin dose to be tapered by 50% every two weeks. arm 2: Starting dose 25 - 50 mg/day until clinical improvement. Upon clinical improvement, retinoid dose to be reduced by 50%. Thereafter, treatment to be continued for ...	[ 0, 0, 0, 0, 0 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: Starting dose 4.0 - 5.1 mg/kg/day until clinical improvement. Upon clinical improvement, cyclosporin dose to be tapered by 50% every two weeks. intervention 2: Starting dose 25 - 50 mg/day until clinical improvement. Upon clinical improvement, retinoid dose to be reduced by 50%. Thereafter, treatment to...	intervention 1: Cyclosporins intervention 2: Retinoids intervention 3: Systemic corticosteroids intervention 4: Methotrexate intervention 5: Systemic corticosteroids/methotrexate	0	null	41	0	0	0	NCT01079988	1COMPLETED	2005-04-01	2004-02-01	Merck KGaA, Darmstadt, Germany	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 2 ]	24	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	true	0ALL	null	The objectives of this study were: * to compare the pharmacokinetic profiles of two prototype controlled-release (CR) trazodone hydrochloride (HCl) 300 mg tablets versus two reference products: Trittico® AC (2 x 150 mg CR tablets) and Desyrel® (3 x 100 mg IR (immediate-release) tablets) under fasting condition; * to a...	null	Healthy	Healthy subjects	null	4	arm 1: Test product 1 and Test product 2 are two different prototype formulations of Trazodone Contramid® OAD (once a day) arm 2: Test product 1 and Test product 2 are two different prototype formulations of Trazodone Contramid® OAD (once a day) arm 3: None arm 4: None	[ 0, 0, 1, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: The dosage of trazodone.HCl during this treatment phase was a single oral dose of 300 mg (one CR tablet) at 07:30 (after an overnight fast of at least 10 hours) on clinic days. intervention 2: The dosage of trazodone.HCl during this treatment phase was a single oral dose of 300 mg (one CR tablet) at 07:...	intervention 1: Trazodone HCl intervention 2: Trazodone HCl intervention 3: Trazodone HCl intervention 4: Trazodone HCl	0	null	85	0	0	0	NCT01121913	1COMPLETED	2005-04-01	2005-03-01	Labopharm Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 2 ]	28	RANDOMIZED	PARALLEL	7BASIC_SCIENCE	2DOUBLE	false	0ALL	false	This was a Phase 1 dose escalation study to evaluate the safety, tolerability and pharmacokinetics of 28-day treatment of CP-690,550 in stable renal allograft recipients. In Stage 1, ascending doses of CP-690,550 were to be administered sequentially to 3-4 cohorts of subjects. After Stage 1, one dose level was to be se...	null	Kidney Transplant	CP-690,550 kidney transplant	null	4	arm 1: None arm 2: None arm 3: None arm 4: None	[ 2, 0, 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Placebo tables twice daily (BID) for 28 days intervention 2: CP-690,550 5 mg BID for 28 days intervention 3: CP-690,550 15 mg BID for 28 days intervention 4: CP-690,550 30 mg BID for 28 days	intervention 1: Placebo intervention 2: CP-690,550 5 mg BID intervention 3: CP-690,550 15 mg BID intervention 4: CP-690,550 30 mg BID	11	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Minneapolis \|...	28	0	0	0	NCT01710033	1COMPLETED	2005-04-01	2003-09-01	Pfizer	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	79	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	1FEMALE	null	This study will evaluate the efficacy and safety of pertuzumab (rhuMAb 2C4) in participants with metastatic breast cancer which has progressed during or after standard chemotherapy and which is not amenable to curative therapy. Those who are maintaining a response to therapy or who have stable disease at the end of the...	null	Breast Cancer		null	2	arm 1: Participants will not receive a loading dose, but will receive pertuzumab 1050 milligrams (mg) via intravenous (IV) infusion every 3 weeks until unacceptable toxicity or disease progression. arm 2: Participants will receive a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by...	[ 0, 0 ]	1	[ 0 ]	intervention 1: Participants will receive one of two IV treatment regimens with pertuzumab: either 420 mg every 3 weeks, with an initial 840-mg loading dose, or 1050 mg every 3 weeks with no loading dose administered.	intervention 1: Pertuzumab	18	Camperdown \| N/A \| Australia \| 151.17642 \| -33.88965 Fitzroy \| N/A \| Australia \| 144.97833 \| -37.79839 Geelong \| N/A \| Australia \| 144.36069 \| -38.14711 Namur \| N/A \| Belgium \| 4.86746 \| 50.4669 Helsinki \| N/A \| Finland \| 24.93545 \| 60.16952 Tampere \| N/A \| Finland \| 23.78712 \| 61.49911 Hamburg \| N/A \| Germany \| 9.9930...	78	0	0	0	NCT02491892	1COMPLETED	2005-04-01	2003-02-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	8	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Current therapies for advanced Mesothelioma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of advanced Mesothelioma. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston the...	Advanced Mesothelioma patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity. OBJECTIVES: * To determine the efficacy of An...	Malignant Mesothelioma	advanced malignant mesothelioma recurrent malignant mesothelioma	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 advanced mesothelioma 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.hourly inte...	intervention 1: Antineoplaston therapy (Atengenal + Astugenal)	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	8	0	0	0	NCT00003508	6TERMINATED	2005-04-26	1996-03-08	Burzynski Research Institute	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 4 ]	1,395	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	1FEMALE	null	This study will assess the efficacy and safety of intravenous administration of Bonviva regimens in women with post-menopausal osteoporosis, compared to oral daily administration. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the ta...	null	Post Menopausal Osteoporosis		null	3	arm 1: oral placebo daily and IV ibandronate 2 mg q 2 mo arm 2: oral ibandronate 2.5 mg daily and IV placebo q 2 mo and q 3 mo arm 3: oral placebo daily and IV ibandronate 3 mg q 3 mo	[ 0, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: 2mg iv every 2 months intervention 2: 2.5mg po daily intervention 3: 3mg iv every 3 months	intervention 1: ibandronate [Bonviva/Boniva] intervention 2: ibandronate [Bonviva/Boniva] intervention 3: ibandronate [Bonviva/Boniva]	64	Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Irvine \| California \| United States \| -117.82311 \| 33.66946 Rancho Mirage \| California \| United States \| -116.41279 \| 33.73974 Leesburg \| Florida \| United States \| -81.87786 \| 28.81082 Gainesville \| Georgia \| United States \| -83.82407 \| 34.29788 Coeur d'Alen...	1,382	0	0	0	NCT00048074	1COMPLETED	2005-05-01	2002-06-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3, 4 ]	63	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This study will assess the safety and pharmacokinetics of Valcyte syrup in pediatric solid organ transplant recipients. The anticipated time on study treatment is 3-12 months and the target sample size is less than 100 individuals.	null	Cytomegalovirus Infections		null	3	arm 1: Eligible participants aged \<= 2 years received valganciclovir up to maximum of 900 milligrams (mg) once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose = 7 \* body surface area (BSA) \* creatinine clearance (CrCLS). arm 2: Eligible participa...	[ 0, 0, 0 ]	1	[ 0 ]	intervention 1: po daily (dose based on body surface area and CrCL)	intervention 1: valganciclovir [Valcyte]	17	Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 New York \| New York \| United States \| -74.00597 \| 40.71427 Salt Lake City ...	63	0	0	0	NCT00090766	1COMPLETED	2005-05-01	2004-05-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	96	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	This study will evaluate visual improvement in patients treated with Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified (IGIV-C) or placebo who have Age-Related Macular Degeneration (AMD) with occult Choroidal Neovascularization (CNV).	The purpose of this trial is to investigate the effect of IGIV-C in subjects suffering from AMD with occult CNV where fewer treatment options exist for patients with this disease form. This study is designed as a randomized, double-blind, parallel group, placebo-controlled prospective trial. Sixty patients, 30 per tre...	Macular Degeneration		null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: The dose per infusion cycle was 2 g/kg body weight over 5 consecutive days (= 4 mL/kg body weight/infusion). The infusion duration was approximately 1.5 - 2 h. intervention 2: Albumin (Human) 20% or 25% will be diluted with 5% glucose to a final concentration of 0.1%.	intervention 1: Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified intervention 2: Albumin (Human) 25%, United States Pharmacopeia (USP)	7	Aachen \| N/A \| Germany \| 6.08342 \| 50.77664 Cologne \| N/A \| Germany \| 6.95 \| 50.93333 Duisburg \| N/A \| Germany \| 6.76516 \| 51.43247 Düsseldorf \| N/A \| Germany \| 6.77616 \| 51.22172 Essen \| N/A \| Germany \| 7.01228 \| 51.45657 Freiburg im Breisgau \| N/A \| Germany \| 7.85222 \| 47.9959 Tübingen \| N/A \| Germany \| 9.05222 \| 48....	57	0	0	0	NCT00220805	1COMPLETED	2005-05-01	2004-01-01	Grifols Therapeutics LLC	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 5 ]	52	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	This study compares the effect of Ferrlecit® (a form of intravenous iron) to ferrous sulfate (a form of oral iron) in treating anemia and iron deficiency in chronic kidney disease patients who are receiving erythropoietic agents, such as Procrit® and Aranesp®.	null	Anemia, Iron-Deficiency Kidney Failure, Chronic	Iron deficiency Anemia Chronic kidney disease Erythropoietic agents Sodium Ferric Gluconate Anemia, Iron-Deficiency/drug therapy/etiology Kidney Failure, Chronic/blood/complications/therapy Erythropoietin, Recombinant/adverse effects/therapeutic use	null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Sodium ferric gluconate complex in sucrose, 250 mg IV weekly for 4 doses intervention 2: ferrous sulfate 325 mg three times daily for 6 weeks	intervention 1: Sodium Ferric Gluconate complex in sucrose intervention 2: Ferrous sulfate tablets	24	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Palo Alto \| California \| United States \| -122.14302 \| 37.44188 San Diego \| California \| United States \| -117.16472 \| 32.71571 Hines \| Illi...	52	0	0	0	NCT00224042	1COMPLETED	2005-05-01	2003-04-01	Watson Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 5 ]	93	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	1FEMALE	null	This study will evaluate the effectiveness of fluoxetine versus placebo in reducing the rate of relapse of anorexia nervosa (AN) and enhancing the psychosocial and behavioral recovery of people who have been treated for AN.	Anorexia nervosa (AN), a type of eating disorder, is a serious psychiatric illness that is characterized by an extreme loss of appetite. People with AN view themselves as overweight and cannot bring themselves to eat, even though most are dangerously thin. Signs of the disorder include unusual eating habits, such as av...	Anorexia Nervosa Eating Disorders	Depression	null	2	arm 1: fluoxetine up to 80 mg per day arm 2: Placebo	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: Fluoxetine intervention 2: Placebo	1	New York \| New York \| United States \| -74.00597 \| 40.71427	93	0	0	0	NCT00288574	1COMPLETED	2005-05-01	2000-01-01	New York State Psychiatric Institute	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 4 ]	452	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This was a multi-center, open-label, non-comparative study that evaluated the long-term safety and efficacy profile of Adapalene/Benzoyl Peroxide Gel. Subjects were evaluated at Baseline, Weeks 1 and 2, and Months 1, 2, 4, 6, 8, 10, and 12. Safety was evaluated by spontaneous reports of Adverse Events (AEs), the Loca...	null	Acne Vulgaris	Acne Vulgaris Adapalene Benzoyl Peroxide	null	1	arm 1: Participants were treated with adapalene 0.1 percent (%) \[weight by weight (W/W)\] and benzoyl peroxide 2.5 percent (%) (W/W) gel topically to the face and trunk area once daily in the evening.	[ 0 ]	1	[ 0 ]	intervention 1: Adapalene 0.1 percent (%) \[weight by weight (W/W)\] and benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening.	intervention 1: Adapalene/Benzoyl Peroxide	1	Portland \| Oregon \| United States \| -122.67621 \| 45.52345	452	0	0	0	NCT00446043	1COMPLETED	2005-05-23	2004-02-17	Galderma R&D	4INDUSTRY	false	false	false	null	0	0	0	0	0	-0
[ 3 ]	50	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The primary objective of this study is to explore the dose-response relation of MK-8616 (Org 25969) given as a reversal agent of Zemuron® at 1 to 2 post tetanic counts (PTCs); both Zemuron® and MK-8616 are administered by intravenous (iv) infusion. Another goal of the study is to evaluate the safety of single doses of ...	null	Neuromuscular Blockade		null	10	arm 1: Participants (ASA Class 1 to 3) will receive an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 0.5 mg/kg iv during a single study session. MK-8616 will be administered once Zemuron®-induced neuromuscular blockade (NMB) reaches 1 to 2 PTCs. arm 2: Participants (ASA Class 1 to 3) will receive an iv bolus of Ze...	[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]	2	[ 0, 0 ]	intervention 1: MK-8616 will be administered at doses of 0.5, 1.0, 2.0, 4.0 and 8.0 mg/kg iv as a 30-second infusion. Doses are based on actual body weight. intervention 2: Zemuron® (0.6 or 1.2 mg/kg, iv) will be administered as a 10-second bolus infusion to achieve 1 to 2 PTCs. If needed, a maintenance dose of 0.15 mg...	intervention 1: MK-8616 intervention 2: Zemuron®	0	null	43	0	0	0	NCT03519867	1COMPLETED	2005-05-26	2004-08-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	91	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	This study will determine the appropriate dose and frequency of administration of iv Mircera maintenance therapy in hemodialysis patients with chronic renal anemia who were previously receiving iv epoetin. The anticipated time on study treatment is 3-12 months and the target sample size is \<100 individuals.	null	Anemia		null	6	arm 1: Eligible participant will be administered RO0503821 (methoxy polyethylene glycol-epoetin beta \[Mircera\]) intravenously (IV) using a dose conversion factor of 0.25/150 microgram (mcg)/kilogram (kg) of the previous weekly erythropoiesis stimulating agents (ESA) dose, (equal to 62.50% assumed equi-effective dose)...	[ 0, 0, 0, 0, 0, 0 ]	1	[ 0 ]	intervention 1: Differing doses and frequencies of iv administration	intervention 1: methoxy polyethylene glycol-epoetin beta [Mircera]	14	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Maywood \| Illinois \| United States \| -87.84312 \| 41.8792 Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424 Detroit \| Michigan \| United States \| -83.04575 \| 42.33143 Detroit \| Michigan ...	91	0	0	0	NCT00048035	1COMPLETED	2005-06-01	2002-03-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 5 ]	90	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	Atopic dermatitis is a chronic relapsing disease with acute flares. The standard therapy is to treat acute flares using topical medications. The two most common classes of topical medications for atopic dermatitis (AD) are topical corticosteroids and topical calcineurin inhibitors. Pimecrolimus and topical corticoster...	This trial is a double-blind controlled trial of fluticasone cream daily and pimecrolimus cream BID versus fluticasone cream daily and placebo cream BID for the treatment of acute flares of atopic dermatitis. While pimecrolimus cream 1% has been proven to be effective in mild and moderate Atopic dermatitis (AD), there...	Atopic Dermatitis	THerapy for acute moderate to severe flares	null	2	arm 1: Placebo cream arm 2: None	[ 2, 1 ]	2	[ 0, 0 ]	intervention 1: Pimecrolimus cream twice a day and fluticasone cream once a day intervention 2: apply daily with fluticasone cream for flares	intervention 1: Combination of pimecrolimus and fluticasone intervention 2: pimecrolimus	3	Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Houston \| Texas \| United States \| -95.36327 \| 29.76328	90	0	0	0	NCT00119158	1COMPLETED	2005-06-01	2004-10-01	Children's Hospital of Philadelphia	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 3 ]	270	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	To evaluate the clinical and microbial efficacy of ISV-403 administered three times a day (TID) for 5 days compared to vehicle three times a day for 5 days in the treatment of bacterial conjunctivitis	null	Bacterial Conjunctivitis		null	2	arm 1: ISV-403 0.6% arm 2: Vehicle of ISV-403	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 0.6% TID, 5 days intervention 2: Vehicle of ISV-403 TID, 5 days	intervention 1: ISV-403 intervention 2: Vehicle	0	null	269	0	0	0	NCT00622908	1COMPLETED	2005-06-01	2004-12-01	Bausch & Lomb Incorporated	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	63	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	Explore weight gain in HIV-positive patients who have weight loss associated with AIDS-related wasting (anorexia/cachexia). Patients are treated for 12 weeks with either megestrol acetate oral suspension nanocrystal dispersion formulation, or megestrol acetate oral suspension original formulation	null	HIV Infections Cachexia Anorexia AIDS Wasting Syndrome HIV Wasting Syndrome	Weight loss Cachexia Anorexia Megestrol acetate oral suspension Nanocrystal dispersion Nanocrystal technology Body weight changes AIDS wasting HIV wasting Emaciation Megace ES Megace Treatment Experienced	null	2	arm 1: Megestrol acetate oral suspension nanocrystal dispersion formulation 115 mg/mL arm 2: Megestrol acetate oral suspension micronized formulation 60 mg/mL	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL administered as 575 mg once per day (5 mL dose) intervention 2: Megestrol acetate oral suspension 40 mg/mL administered as 800 mg once per day (20 mL dose)	intervention 1: Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL intervention 2: Megestrol acetate oral suspension 40 mg/mL	12	Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Bangalore \| Karnataka \| India \| 77.59369 \| 12.97194 Bangalore \| Karnataka \| India \| 77.59369 \| 12.97194 Mangalore \| Karnataka \| India \| 74.85603 \| 12.91723 Pune \| Maharashtra \| India \| 73.85535 \| 18.51957 Private Bag \| Ashwood \| South Africa \| N/A \| N/A...	63	0	0	0	NCT00637572	1COMPLETED	2005-06-01	2004-12-01	Endo Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 2 ]	33	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	To determine the maximum tolerated dose of E7389 in patients with advanced solid tumors that have progressed following standard therapy or for which no standard therapy exists.	null	Advanced Solid Tumors	Metastatic Tumors Advanced Solid Tumors Stage IV Tumors Solid Tumors Recurrent Solid Tumors	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: E7389 Dose-escalation starting at 0.25 mg/m\^2 intravenous on Days 1, 8, and 15 of a 28 day cycle.	intervention 1: E7389	2	The Bronx \| New York \| United States \| -73.86641 \| 40.84985 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412	32	0	0	0	NCT00069264	1COMPLETED	2005-07-01	2003-09-01	Eisai Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 4 ]	170	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	This study will assess the effect of anemia correction with NeoRecormon on cardiac structure and function in patients with early diabetic nephropathy. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.	null	Anemia		null	2	arm 1: Along with their standard treatment participants will receive epoetin beta at a starting dose of 2000 International Units (IU) subcutaneously (SC) once weekly to reach and maintain target hemoglobin (Hb) between 13 and 15 grams per deciliter (g/dL), for 15 months. Epoetin beta doses will be adjusted according to...	[ 0, 1 ]	1	[ 0 ]	intervention 1: None	intervention 1: Epoetin beta	63	Linz \| N/A \| Austria \| 14.28611 \| 48.30639 São Paulo \| N/A \| Brazil \| -46.63611 \| -23.5475 Jihlava \| N/A \| Czechia \| 15.59124 \| 49.3961 Liberec \| N/A \| Czechia \| 15.05619 \| 50.76711 Copenhagen \| N/A \| Denmark \| 12.56553 \| 55.67594 Roskilde \| N/A \| Denmark \| 12.08035 \| 55.64152 Jyväskylä \| N/A \| Finland \| 25.72088 \| 62....	170	0	0	0	NCT00354341	1COMPLETED	2005-07-01	2002-09-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	137	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	This study will determine the appropriate dose and frequency of administration of sc Mircera maintenance therapy in dialysis patients with chronic renal anemia who were previously receiving sc epoetin alfa or beta. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.	null	Anemia		null	9	arm 1: Eligible participant will be administered RO0503821 (methoxy polyethylene glycol-epoetin beta \[Mircera\]) SC using a dose conversion factor of 0.4/150 microgram (mcg)/ kilogram (kg) of the previous weekly erythropoiesis stimulating agents (ESA) dose, (equal to 50% assumed equi-effective dose) once weekly up to ...	[ 0, 0, 0, 0, 0, 0, 0, 0, 0 ]	1	[ 0 ]	intervention 1: Differing doses and frequencies of sc administration	intervention 1: methoxy polyethylene glycol-epoetin beta [Mircera]	23	Los Angeles \| California \| United States \| -118.24368 \| 34.05223 San Jose \| California \| United States \| -121.89496 \| 37.33939 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Morgantown \| West Vir...	137	0	0	0	NCT00364832	1COMPLETED	2005-07-01	2001-10-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	15	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Current therapies for Stage IV Pancreatic 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 Pancreatic Cancer. PURPOSE: This study is being performed to determine the effects (good and bad) that Ant...	Stage IV Pancreatic Cancer patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity. OBJECTIVES: * To determine the efficacy ...	Stage IV Pancreatic Cancer	Adenocarcinoma of the pancreas	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 Pancreatic 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	15	0	0	0	NCT00003531	6TERMINATED	2005-07-18	1996-04-10	Burzynski Research Institute	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 4 ]	673	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	This study will assess the efficacy and safety of intravenous Mircera, given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv epoetin. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.	null	Anemia		null	3	arm 1: Participants received RO0503821 (Mircera \[methoxy polyethylene glycol-epoetin beta\]) once every two weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (60, 100, or 180 microgram \[mcg\]) that was based on the Epoetin dose (\<8000, 8000-16000, \>16000 International units \[IU\]...	[ 0, 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: intravenously 3 times weekly for 52 weeks, as prescribed intervention 2: 60, 100, or 180 microgram (mcg) (starting dose) once every two weeks intravenously for 52 weeks. intervention 3: 120, 200 or 360 mcg (starting dose) once every four weeks intravenously for 52 weeks.	intervention 1: Epoetin alfa or beta intervention 2: RO0503821 (1x/2 Weeks) intervention 3: RO0503821 (1x/4 Weeks)	99	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Montgomery \| Alabama \| United States \| -86.29997 \| 32.36681 Encino \| California \| United States \| -118.50119 \| 34.15917 Irvine \| California \| United States \| -117.82311 \| 33.66946 Los Angeles \| California...	666	0	0	0	NCT00077610	1COMPLETED	2005-08-01	2004-02-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 4 ]	313	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	This study will assess the efficacy and safety of intravenous (iv) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv darbepoetin alfa. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individu...	null	Anemia		null	2	arm 1: Eligible participants will be administered with RO0503821 (\[methoxy polyethylene glycol-epoetin beta\] {Mircera}) intravenously (IV), every 2 weeks during Weeks 1 through 52. The starting dose of RO0503821 (60, 100, or 180 micro gram \[µg\]) was based on the dose of darbepoetin alfa at the time of randomization...	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Darbepoetin alfa was administered IV, every week or every 2 weeks during Weeks 1 through 52. intervention 2: RO0503821 was administered IV, every 2 weeks during Weeks 1 through 52. The starting dose of RO0503821 (60, 100, or 180 micro gram \[µg\]) was based on the dose of darbepoetin alfa at the time of...	intervention 1: Darbepoetin alfa intervention 2: methoxy polyethylene glycol-epoetin beta [Mircera]	48	Blacktown \| N/A \| Australia \| 150.91667 \| -33.76667 Brisbane \| N/A \| Australia \| 153.02809 \| -27.46794 Clayton \| N/A \| Australia \| 145.11667 \| -37.91667 Gosford \| N/A \| Australia \| 151.34399 \| -33.4244 Parkville \| N/A \| Australia \| 144.95 \| -37.78333 Sydney \| N/A \| Australia \| 151.20732 \| -33.86785 Graz \| N/A \| Austria...	309	0	0	0	NCT00077766	1COMPLETED	2005-08-01	2004-03-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 2, 3 ]	28	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	false	Compatibility of the topotecan therapy in combination with carboplatin.	The aim of the study was to confirm the tolerability of 3-day topotecan therapy in combination with carboplatin in accordance with published data and to investigate the tolerability of continued therapy until disease progression or up to a maximum of 12 months.	Ovarian Cancer	platin-resistant	null	2	arm 1: dose level 0: Topotecan 1mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application) If dose limiting toxicity (DLT) is present then Topotecan dose will be reduced to dose level -1 (dose level -1: Topotecan 0.75 mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan app...	[ 0, 0 ]	1	[ 0 ]	intervention 1: Topotecan: 1,0 mg/m²/d, day 1-3; q21d Carboplatin: AUC 5 on day 3 after Topotecan, q21d	intervention 1: Hycamtin	0	null	26	0	0	0	NCT00170625	1COMPLETED	2005-08-01	2004-06-01	North Eastern German Society of Gynaecological Oncology	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 4 ]	418	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (20 mg) in comparison to the buprenorphine transdermal system (5 mg) and oxycodone immediate release in subjects with moderate to severe osteoarthritis pain currently treated with oral opioids. The d...	Buprenorphine is a synthetic opioid analgesic with over twenty-five years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.	Osteoarthritis	Osteoarthritis, opioid, transdermal	null	3	arm 1: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear arm 2: Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear arm 3: Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).	[ 1, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear intervention 2: Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear intervention 3: Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).	intervention 1: Buprenorphine intervention 2: Buprenorphine intervention 3: oxycodone immediate-release	23	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Chula Vista \| California \| United States \| -117.0842 \| 32.64005 Roseville \| California \| United States \| -121.28801 \| 38.75212 San Diego \| California \| United States \| -117.16472 \| 32.71571 Torrance \| California \| United States \| -118.34063 \| 33.83585 Pueblo \|...	1,070	0	0	0	NCT00312221	6TERMINATED	2005-08-01	2004-04-01	Purdue Pharma LP	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3, 4 ]	72	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to compare ziprasidone (Geodon) monotherapy for the treatment of psychotic major depression (PMD)with an antidepressant/antipsychotic combined therapy.	Psychotic depression is a well-established DSM-IV diagnostic subtype indicating the presence of hallucinations and/or delusions as part of the clinical presentation. Currently the treatment of choice for psychotic depression is either electroconvulsive therapy or combination of antipsychotic and antidepressant medicati...	Affective Disorders	Psychotic	null	2	arm 1: Subjects in this arm received ziprasidone with a placebo to maintain the blind arm 2: Subjects in this arm received a combination of sertraline and haloperidol with a placebo to maintain the blind. Sertraline dosage was 150-200mg/day and haloperidol was 6-8mg/day based on tolerance.	[ 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Target dosage 120-160mg/day based on tolerance intervention 2: Target dosage 150-200mg/day based on tolerance. intervention 3: Target dosage 6-8mg/day based on tolerance.	intervention 1: Ziprasidone intervention 2: Sertraline intervention 3: Haloperidol	3	Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Alexandria \| N/A \| Egypt \| 29.91582 \| 31.20176 Bangalore \| N/A \| India \| 77.59369 \| 12.97194	72	0	0	0	NCT00340379	1COMPLETED	2005-08-01	2003-04-01	Duke University	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 4 ]	196	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this phase is to evaluate the long-term safety and tolerability of BTDS. Qualified subjects are started on BTDS 5 and the dose may be titrated, if necessary, to a maximum of BTDS 20 to achieve stable pain control.	Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.	Osteoarthritis	Osteoarthritis Opioid Transdermal	null	1	arm 1: Buprenorphine transdermal patch	[ 0 ]	3	[ 0, 0, 0 ]	intervention 1: Buprenorphine transdermal patch 5 mcg/h applied transdermally for 7-day wear. intervention 2: Buprenorphine transdermal patch 10 mcg/h applied transdermally for 7-day wear. intervention 3: Buprenorphine transdermal patch 20 mcg/h applied transdermally for 7-day wear.	intervention 1: Buprenorphine transdermal patch intervention 2: Buprenorphine transdermal patch intervention 3: Buprenorphine transdermal patch	89	Alabaster \| Alabama \| United States \| -86.81638 \| 33.24428 Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Fairfield \| Alabama \| United States \| -86.91194 \| 33.48594 Phoenix \| Arizona \| Un...	196	0	0	0	NCT01135524	6TERMINATED	2005-08-01	2004-04-01	Purdue Pharma LP	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 5 ]	19	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to determine the effect of Pandel® (hydrocortisone probutate cream) Cream 0.1% on the Hypothalamic Pituitary Adrenal (HPA) axis in pediatric and adult subjects with either psoriasis or atopic dermatitis involving greater than 20% body surface area.	null	Psoriasis Atopic Dermatitis	Psoriasis Atopic Dermatitis	null	1	arm 1: Pandel Cream 0.1%	[ 0 ]	1	[ 0 ]	intervention 1: A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days	intervention 1: Pandel Cream 0.1%	3	Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626 Hilton Head Island \| South Carolina \| United States \| -80.73816 \| 32.19382 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589	19	0	0	0	NCT01137032	1COMPLETED	2005-08-01	2004-06-01	Fougera Pharmaceuticals Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	604	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	This is a study to evaluate the effectiveness and tolerability of a once-daily oral medication (MK-0873) for the treatment of COPD (chronic obstructive pulmonary disease) to determine whether the study drug leads to an improvement in pulmonary (lung) function, as well as symptoms, and quality of life.	Following a three-week run-in period (Period I) during which participants received placebo, participants entered into a 12-week double-blind treatment period (Period II) during which they received daily doses of either one of three doses of MK-0873 or placebo. Period I and Period II made up the Base Study. Following th...	Lung Diseases Pulmonary Disease, Chronic Obstructive		null	6	arm 1: Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1) arm 2: Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873...	[ 0, 0, 0, 2, 0, 1 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None	intervention 1: MK-0873 2.5 mg intervention 2: MK-0873 1.25 mg intervention 3: MK-0873 0.75 mg intervention 4: Placebo to MK-0873 intervention 5: Usual Care	0	null	1,286	21	0.01633	1	NCT00132730	6TERMINATED	2005-08-17	2004-06-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	21	0	0	0	0	0.010705
[ 4 ]	572	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	This study will assess the efficacy and safety of subcutaneous (sc) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving sc epoetin. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.	null	Anemia		null	3	arm 1: Eligible participants received RO0503821 (Mircera \[methoxy polyethylene glycol-epoetin beta\]) subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 microgram (mcg) which was based on the epoetin dose of\<8000, 8000-16000, or \>16000 international ...	[ 0, 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: iv 3 times weekly, as prescribed intervention 2: 60, 100 or 180 micrograms sc (starting dose) every 2 weeks intervention 3: 60, 100 or 180 micrograms sc (starting dose) every 4 weeks	intervention 1: epoetin alfa or beta intervention 2: methoxy polyethylene glycol-epoetin beta (Mircera) intervention 3: methoxy polyethylene glycol-epoetin beta (Mircera)	90	Hot Springs \| Arkansas \| United States \| -93.05518 \| 34.5037 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Riverside \| California \| United States \| -117.39616 \| 33.95335 Sacramento \| California \| United States \| -121.4944 \| 38.58157 San Jose \| California \| United States \| -121.89496 \| 37.33939 Boston...	571	1	0.001751	1	NCT00077623	1COMPLETED	2005-09-01	2004-03-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	0	1	0	0.000309
[ 4 ]	80	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	true	0ALL	true	Patients undergoing keyhole gall bladder removal will be divided into 3 groups, one control, one will have local anaesthetic and the third will have normal saline nebulised into their abdomen before closure of the wounds to reduce postoperative pain. These medications will be given on top of the standard pain managemen...	Pain post laparoscopic procedures can be divided into access related, operation site and distension related. The access type can be attenuated by the use of sub dermal infiltration of local anaesthetic and rarely causes significant discomfort. It has been advocated that placement of a peritoneal gas drain significantly...	Pain, Postoperative	Pain Nebulisation Cholecystectomy Laparoscopic Bupivacaine Local Anaesthetic	null	4	arm 1: No intraperitoneal therapeutics (No nebulised Bupivacaine) arm 2: Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine) arm 3: Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine) arm 4: Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine)	[ 3, 2, 0, 1 ]	4	[ 0, 0, 0, 10 ]	intervention 1: Nebulised Marcaine (Bupivacaine) intervention 2: Nebulised Normal Saline intervention 3: Injected Marcaine directly into the peritoneal cavity intervention 4: No Intraperitoneal Therapeutics given	intervention 1: Nebulised Bupivacaine intraperitoneally intervention 2: Normal Saline intervention 3: Injected Bupivacaine intraperitoneally intervention 4: No Intraperitoneal Therapeutics	1	London \| N/A \| United Kingdom \| -0.12574 \| 51.50853	80	0	0	0	NCT00180687	1COMPLETED	2005-09-01	2004-10-01	Imperial College London	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 0 ]	31	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	The study drug levetiracetam is FDA approved as an add-on medication in the treatment of partial onset seizures in adults with epilepsy. The trade name is Keppra®. This is an "open-label" trial, which means that all participating patients will receive active study drug. The Jefferson Headache Center has developed this...	null	Migraine		null	1	arm 1: Subject titrated open-label study drug to maximally tolerated dose: maximum: 3000 mg. per date. (minimum allowed daily dose to remain in study: 1000)	[ 0 ]	2	[ 0, 3 ]	intervention 1: Daily dose of open label levatiracetam was 3000 mg. or maximally tolerated dose. (Maximum daily dose: 3000 mg. Minimum daily dose allowed for study participation:1000 mg) intervention 2: None	intervention 1: levetiracetam intervention 2: Transcranial Magnetic Stimulation	1	Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	31	0	0	0	NCT00203216	1COMPLETED	2005-09-01	2002-09-01	Thomas Jefferson University	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 5 ]	28	RANDOMIZED	PARALLEL	null	4QUADRUPLE	null	0ALL	null	The purpose of this study is to determine if lamotrigine therapy is associated with improvement in mood, memory and hippocampal size and function in patients receiving chronic corticosteroid therapy. Standard care for mood changes associated with corticosteroid therapy, if severe, includes antidepressants or other medi...	null	Memory Impairment Due to Corticosteroid Use Hypomania Due to Corticosteroid Use Hippocampal Atrophy Due to Corticosteroid		null	0	null	null	1	[ 0 ]	intervention 1: None	intervention 1: Lamotrigine (Drug)	1	Dallas \| Texas \| United States \| -96.80667 \| 32.78306	19	0	0	0	NCT00223262	1COMPLETED	2005-09-01	2002-08-01	University of Texas Southwestern Medical Center	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 4 ]	660	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 in comparison to the buprenorphine transdermal system (BTDS) 5 and oxycodone immediate-release in subjects with moderate to severe low back pain currently treated with oral opioids. The dou...	Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.	Back Pain Lower Back Chronic	Low back pain opioid transdermal Butrans	null	3	arm 1: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear. arm 2: Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear. arm 3: Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).	[ 1, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear. intervention 2: Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear intervention 3: Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).	intervention 1: Buprenorphine intervention 2: Buprenorphine intervention 3: Oxycodone Immediate-Release	85	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Haleyville \| Alabama \| United States \| -87.62141 \| 34.22649 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Tuscon \| Arizona \| Unite...	1,820	0	0	0	NCT00313014	6TERMINATED	2005-09-01	2004-02-01	Purdue Pharma LP	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3, 4 ]	628	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	To evaluate the safety and efficacy of SLIT compared with placebo for reduction of symptoms and rescue medication usage	null	Allergy	Sublingual immunotherapy Grass pollen tablet Allergic rhinoconjunctivitis	null	4	arm 1: 100 IR grass pollen allergen extract tablet arm 2: 300 IR grass pollen allergen extract tablet arm 3: 500 IR grass pollen allergen extract tablet arm 4: Placebo tablet	[ 0, 0, 0, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: One sublingual tablet daily during 4 months before pollen season and during pollen season intervention 2: One sublingual tablet daily during 4 months before pollen season and during pollen season intervention 3: One sublingual tablet daily during 4 months before pollen season and during pollen season in...	intervention 1: 100 IR grass pollen allergen extract tablet intervention 2: 300 IR grass pollen allergen extract tablet intervention 3: 500 IR grass pollen allergen extract tablet intervention 4: Placebo tablet	0	null	628	0	0	0	NCT00367640	1COMPLETED	2005-09-01	2004-11-01	Stallergenes Greer	4INDUSTRY	false	false	false	null	0	0	0	0	0	-0
[ 3 ]	17	NON_RANDOMIZED	PARALLEL	1PREVENTION	0NONE	false	0ALL	false	To evaluate the feasibility, safety and tolerability of aerosolized lucinactant delivered by nasal continuous positive airway pressure (nCPAP) for the prevention of respiratory distress syndrome (RDS) in premature infants.	Use of a device in the early treatment of RDS that permits the effective aerosolization of an exogenous surfactant that also allows for the simultaneous delivery of continuous positive airway pressure would permit the delivery of surfactant to the distal airways without intubation. This approach could reduce the freque...	Respiratory Distress Syndrome	Lucinactant Nasal continuous positive airway pressure (nCPAP) Respiratory distress syndrome (RDS) Pediatric Premature	null	2	arm 1: None arm 2: None	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Aerosolized lucinactant via nCPAP over 3 hours. Up to 3 retreatments will be allowed over a 48 hour period with each retreatment separated by at least 3 hours. intervention 2: Aerosolized lucinactant via nCPAP over 3 hours. Up to 3 retreatments will be allowed over a 48 hour period with each retreatment...	intervention 1: Aerosolized lucinactant intervention 2: Aerosolized lucinactant	1	San Diego \| California \| United States \| -117.16472 \| 32.71571	17	0	0	0	NCT00807235	6TERMINATED	2005-09-01	2005-01-01	Windtree Therapeutics	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 4 ]	55	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	null	In-vitro fertilization (IVF) of human oocytes followed by the replacement of embryo in the uterine cavity has become a well established treatment for female infertility attributable to damaged fallopian tubes, endometriosis or unexplained causes where alternative forms of therapy have failed. The most commonly used pro...	Luteinizing hormone is a heterodimeric glycoprotein composed of a non-covalent association of an α and a β subunit. Prior to the generation of human-LH (hLH) through recombinant technology, hLH had only been available for therapeutic use as human menopausal gonadotropins (hMG), a co-extracted, purified preparation of h...	Infertility Ovarian Stimulation	Infertility Ovarian Stimulation Luveris Lutropin alpha Controlled ovarian stimulation Reproductive techniques, assisted	null	0	null	null	1	[ 0 ]	intervention 1: Recombinant Human-Luteinizing Hormone (Luveris) was administered once daily subcutaneously at a starting dose of 150 IU per day beginning on stimulation Day 6.	intervention 1: Recombinant Human-Luteinizing Hormone (Luveris)	0	null	52	0	0	0	NCT01121991	1COMPLETED	2005-09-01	2004-09-01	EMD Serono	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 2 ]	22	RANDOMIZED	CROSSOVER	null	0NONE	true	1FEMALE	false	The objective of this study is to evaluate the comparative bioavailability between Anastrozole 1 mg Tablets (Teva Pharmaceuticals USA) and Arimidex® 1 mg Tablets (AstraZeneca Pharmaceuticals LP, USA), after a single-dose in healthy subjects under fasting conditions.	Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA Bioequivalence Statistical Methods	Healthy	Healthy Subjects Bioequivalence	null	2	arm 1: Anastrozole Tablets, 1 mg arm 2: Arimidex® Tablets, 1 mg	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 1 mg Tablets intervention 2: 1 mg Tablets	intervention 1: Anastrozole (Teva Pharmaceuticals USA) intervention 2: Anastrozole (Arimidex®)	1	Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643	44	0	0	0	NCT01182181	1COMPLETED	2005-09-01	2005-08-01	Teva Pharmaceuticals USA	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	68	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	2MALE	null	This study will evaluate the efficacy and safety of intravenous (IV) pertuzumab in participants with hormone-refractory prostate cancer who have had no previous chemotherapy. Participants will be enrolled in two stages, the first (Cohort A) at a lower 420-mg dose and the second (Cohort B) at a higher 1050-mg dose based...	null	Prostate Cancer		null	2	arm 1: Participants in Cohort B will receive 1050 mg pertuzumab via IV infusion on Day 1 of each 3-week cycle. At the end of 3 treatment cycles, response will be evaluated to determine whether additional participants will be enrolled for treatment. If a second stage of enrollment occurs, participants may continue treat...	[ 0, 0 ]	1	[ 0 ]	intervention 1: Participants will receive pertuzumab on Day 1 of each 3-week cycle. In Cohort A, an 840-mg loading dose will be administered prior to the 420-mg IV infusion. In Cohort B, the 1050-mg IV infusion will be administered with no loading dose.	intervention 1: Pertuzumab	11	Lyon \| N/A \| France \| 4.84671 \| 45.74846 Montpellier \| N/A \| France \| 3.87635 \| 43.61093 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Parma \| N/A \| Italy \| 10.32618 \| 44.79935 Roma \| N/A \| Italy \| 11.10642 \| 44.99364 Rotterdam \| N/A \| Netherlands \| 4.47917 \| 51.9225 Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879 Valencia...	68	0	0	0	NCT02480010	6TERMINATED	2005-09-01	2003-09-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 2 ]	19	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	This study will evaluate the safety, tolerability, and pharmacokinetics of the combination of rhuMab 2C4(Perjeta) and capecitabine (Xeloda) in participants with advanced solid tumors that have progressed during or after standard therapy, or for which no standard therapy is available. Participants will be enrolled and e...	null	Solid Tumor		null	3	arm 1: Participants will receive a single 1000-mg/m\^2 dose of oral (PO) capecitabine on Day -7 for pretreatment assessment. Capecitabine will then be administered on Days 1 to 14 of each 3-week cycle at a dose of 1000 mg/m\^2 twice daily, and rhuMab 2C4 will be given on Day 1 of each 3-week cycle as a fixed-dose 1050-...	[ 0, 0, 0 ]	2	[ 0, 0 ]	intervention 1: Participants will receive capecitabine on Days 1 to 14 of each 3-week cycle as 825, 1000, or 1250 mg/m\^2 PO twice daily. Treatment may continue until disease progression, unacceptable toxicity, or consent withdrawal. intervention 2: Participants will receive rhuMab 2C4 on Day 1 of each 3-week cycle as ...	intervention 1: Capecitabine intervention 2: RhuMab 2C4	2	Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879 Manchester \| N/A \| United Kingdom \| -2.23743 \| 53.48095	18	0	0	0	NCT02494596	1COMPLETED	2005-09-01	2004-01-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 5 ]	301	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	To examine the efficacy of continued administration of rebamipide following bacteria eradication therapy in patients with H. pylori-positive active gastric ulcer in a placebo-controlled, double-blind study	null	Stomach Ulcer		null	0	null	null	1	[ 0 ]	intervention 1: None	intervention 1: Rebamipide	1	Tokyo \| N/A \| Japan \| 139.69171 \| 35.6895	301	0	0	0	NCT00233389	1COMPLETED	2005-09-09	2004-04-30	Otsuka Pharmaceutical Co., Ltd.	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 4 ]	326	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The primary objective of the study is to determine if Serostim® 4 mg administered daily for 12 weeks as treatment for the abnormal fat accumulation and distribution associated with HIV-associated Adipose Redistribution Syndrome (HARS) reduces Visceral Adipose Tissue (VAT, measured by CT scan) more effectively than plac...	null	HIV Infections Lipodystrophy	Growth hormone Serostim® Human Adipose Redistribution Syndrome Human Immunodeficiency Virus lipodystrophy	null	5	arm 1: Subjects will receive placebo matched to serostim® as subcutaneous injection daily for a period of 12 weeks. arm 2: Subjects will receive Serostim® as subcutaneous injection at a maximum dose of 4 milligram (mg) per day based on body weight for a period of 12 weeks. arm 3: All subjects who will be initially rand...	[ 2, 0, 0, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Placebo matched to serostim® as subcutaneous injection. intervention 2: Serostim® as subcutaneous injection at a maximum dose of 4 milligram (mg) per day based on body weight. intervention 3: Serostim® 2 mg as subcutaneous injection on alternate days.	intervention 1: Placebo intervention 2: Serostim® 4 mg intervention 3: Serostim® 2 mg	31	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Palm Springs \| California \| United States \| -116.54529 \| 33.8303 Sacramento \| California \| United States \| -121.4944 \| 38.58157 San Diego \| California \| United States \| -117.16472 \| 32.71571 San ...	656	0	0	0	NCT00082628	1COMPLETED	2005-09-28	2004-05-28	EMD Serono	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	265	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to determine the safety and efficacy of alogliptin, once daily (QD), compared to diet and exercise, sulfonylurea, metformin and a combination of sulfonylurea and metformin for treating subjects with type 2 diabetes.	Of the approximately 19 million people in the United States who have been diagnosed with diabetes mellitus, 90% to 95% have type 2 diabetes mellitus. The prevalence of type 2 diabetes mellitus varies among racial and ethnic populations and has been shown to increase with age, obesity, family history, history of gestati...	Diabetes Mellitus	Diabetes Mellitus Drug Therapy Diabetes Mellitus, Type II Type 2 Diabetes Mellitus Hyperinsulinism Insulin Resistance	null	6	arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None	[ 0, 0, 0, 0, 0, 2 ]	6	[ 0, 0, 0, 0, 0, 0 ]	intervention 1: Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks intervention 2: Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks. intervention 3: Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks. intervention 4: Alogliptin 50 mg, tablets, orally, once daily for up to...	intervention 1: Alogliptin intervention 2: Alogliptin intervention 3: Alogliptin intervention 4: Alogliptin intervention 5: Alogliptin intervention 6: Placebo	0	null	259	1	0.003861	1	NCT00755846	1COMPLETED	2005-10-01	2005-03-01	Takeda	4INDUSTRY	false	false	false	null	0	1	0	0	0	0.000682
[ 3 ]	22	null	null	0TREATMENT	null	false	2MALE	null	The primary purpose of this study is to determine the safest dose of ZD4054 (Zibotentan)in men with prostate cancer	null	Prostatic Neoplasms Metastases, Neoplasm	prostate cancer Metastatic prostate cancer bone metastases	null	3	arm 1: 1 x 10 mg oral tablets once daily arm 2: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily arm 3: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily	[ 0, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: 1 x 10 mg oral tablets once daily intervention 2: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily intervention 3: 2 x 10 mg + 2 x 2.5 mg oral tablets once daily	intervention 1: ZD4054 10 mg intervention 2: ZD4054 15 mg intervention 3: ZD4054 22.5 mg	2	Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Madison \| Wisconsin \| United States \| -89.40123 \| 43.07305	16	0	0	0	NCT00055471	1COMPLETED	2005-10-01	2003-06-01	AstraZeneca	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	61	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	A 1-year outpatient study to test the safety and tolerability of a new medication in the treatment of schizophrenia	Study will evaluate long-term safety and tolerability of a new compound in the treatment of patients with schizophrenia as assessed by adverse events (AEs), measures of extra pyramidal symptoms (EPS; Abnormal Involuntary Movement Scale \[AIMS\], Barnes Akathisia Scale \[BAS\], and Simpson-Angus Rating Scale \[SAS\]), v...	Schizophrenia	Schizophrenia Latuda Lurasidone	null	1	arm 1: Lurasidone 80mg oral tablet taken once a day	[ 0 ]	1	[ 0 ]	intervention 1: None	intervention 1: Lurasidone 80mg tablet	21	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Cerritos \| California \| United States \| -118.06479 \| 33.85835 Garden Grove \| California \| United States \| -117.94145 \| 33.77391 La Mesa \| California \| United States \| -117.02308 \| 32.76783 San Diego...	59	0	0	0	NCT00088621	1COMPLETED	2005-10-01	2004-07-01	Sumitomo Pharma America, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 4 ]	743	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	The purpose of this study is to evaluate the clinical and microbial efficacy and safety of AzaSite compared to tobramycin for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye are eligible. Subjects will be randomly assigned to the AzaSite group or...	null	Bacterial Conjunctivitis	Bacterial Conjunctivitis Pink Eye Conjunctivitis Eye Infection	null	2	arm 1: 1.0% azithromycin in DuraSite arm 2: 0.3% tobramycin	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: AzaSite ophthalmic solution; one topical drop to the infected eye or eyes twice daily (in the morning and at bedtime) on Days 1 and 2 followed by once daily (in the morning between 7 and 10am) on Days 3 through 5. intervention 2: Tobramycin ophthalmic solution; one topical drop to the infected eye or ey...	intervention 1: AzaSite intervention 2: Tobramycin	26	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Littleton \| Colorado \| United States \| -105.01665 \| 39.61332 Atlantis \| Florida \| United States \| -80.10088 \| 26.5909 Bradenton \| Florida \| United States \| -82.57482 \| 27.49893 Jupiter \| Florida \| United States \| -80.09421 \| 26.93422 New Port Richey \| Florida ...	743	0	0	0	NCT00105469	1COMPLETED	2005-10-01	2004-07-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 4 ]	288	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	To investigate the efficacy and safety of a 4-week treatment of 5 mg/day or 10 mg/day of E3810 (Pariet (Rabeprazole Sodium)) in patients with non-erosive gastroesophageal reflux disease in a multicenter, randomized, double-blind, comparative study.	null	Non-erosive Gastroesophageal Reflux Disease	non-erosive gastroesophageal reflux disease NERD proton pump inhibitor rabeprazole	null	3	arm 1: None arm 2: None arm 3: None	[ 0, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: E3810 5mg: once daily orally for 4 weeks intervention 2: E3810 10mg: once daily orally for 4 weeks intervention 3: Placebo: once daily orally for 4 weeks	intervention 1: E3810 intervention 2: E3810 intervention 3: Placebo	35	Aichi-Gun \| Aichi-ken \| Japan \| N/A \| N/A Nagoya \| Aichi-ken \| Japan \| 136.90641 \| 35.18147 Nagoya \| Aichi-ken \| Japan \| 136.90641 \| 35.18147 Chikushino-shi \| Fukuoka \| Japan \| 130.5156 \| 33.49631 Chikushino-shi \| Fukuoka \| Japan \| 130.5156 \| 33.49631 Fukuoka \| Fukuoka \| Japan \| 130.41667 \| 33.6 Kitakyushu \| Fukuoka \| ...	286	0	0	0	NCT00165646	1COMPLETED	2005-10-01	2004-09-01	Eisai Co., Ltd.	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 4 ]	26	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	null	To investigate esophageal reflux condition in patients with non-erosive gastroesophageal reflux disease by assessing with a 24-hour esophageal pH monitoring or effects of a 4-week treatment with 5 mg/day or 10 mg/day of E3810 (Pariet (Rabeprazole Sodium)).	null	Non-erosive Gastroesophageal Reflux Disease	24-hour esophageal pH monitoring non-erosive gastroesophageal reflux disease NERD proton pump inhibitor rabeprazole	null	2	arm 1: None arm 2: None	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: rabeprazole sodium 5 mg: once daily orally for 4 weeks intervention 2: rabeprazole sodium 10 mg: once daily orally for 4 weeks	intervention 1: RABEPRAZOLE SODIUM intervention 2: RABEPRAZOLE SODIUM	13	Nagoya \| Aichi-ken \| Japan \| 136.90641 \| 35.18147 Fukuoka \| Fukuoka \| Japan \| 130.41667 \| 33.6 Fukuoka \| Fukuoka \| Japan \| 130.41667 \| 33.6 Yukuhashi \| Fukuoka \| Japan \| 130.983 \| 33.72873 Hiroshima \| Hiroshima \| Japan \| 132.45 \| 34.4 Osaka \| Osaka \| Japan \| 135.50107 \| 34.69379 Osaka \| Osaka \| Japan \| 135.50107 \| 34.6...	26	0	0	0	NCT00165672	1COMPLETED	2005-10-01	2005-05-01	Eisai Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 4 ]	451	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The purpose of this study is to determine which dose of voclosporin is effective in the treatment of plaque psoriasis compared to placebo.	Psoriasis is a chronic skin condition that can have a significant impact on patient's physical and mental well being. The most common form of psoriasis is plaque psoriasis. Targeted treatments in psoriasis have been reported recently, yet cyclosporine, a calcineurin inhibitor (CNi) remains one of the treatments which h...	Psoriasis	Randomized Controlled Trials Immunosuppression Adult Chronic Disease Dermatologic Agents Female Humans Male Middle Aged Severity of Illness Index Treatment Outcome Quality of Life Double-Blind Method	null	4	arm 1: Placebo arm 2: Voclosporin 0.2 mg/kg po BID arm 3: Voclosporin 0.3 mg/kg po BID arm 4: Voclosporin 0.4 mg/kg po BID	[ 2, 1, 1, 1 ]	2	[ 0, 0 ]	intervention 1: voclosporin 0.2, 0.3, or 0.4 mg/kg po BID intervention 2: Placebo	intervention 1: voclosporin intervention 2: Placebo	31	Calgary \| Alberta \| Canada \| -114.08529 \| 51.05011 Edmonton \| Alberta \| Canada \| -113.46871 \| 53.55014 Edmonton \| Alberta \| Canada \| -113.46871 \| 53.55014 Vancouver \| British Columbia \| Canada \| -123.11934 \| 49.24966 Vancouver \| British Columbia \| Canada \| -123.11934 \| 49.24966 Victoria \| British Columbia \| Canada \| -1...	451	0	0	0	NCT00244842	1COMPLETED	2005-10-01	2004-12-01	Aurinia Pharmaceuticals Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	64	RANDOMIZED	CROSSOVER	null	3TRIPLE	false	0ALL	false	Despite preclinical evidence supporting the role of the endogenous opioid system in the reinforcing effects of nicotine, the efficacy of the opioid antagonist naltrexone (NTX) as a tobacco dependence treatment remains unresolved. Research is needed to identify those smokers for whom NTX will have the strongest benefici...	The study was a within-subject double-blind study of the effects of naltrexone versus placebo on the reinforcing value of nicotine, using a validated cigarette choice paradigm. A key question was whether smokers differ in their responses based on the mu opioid receptor gene (OPRM1) Asn40Asp (A118G) variant. Following ...	Tobacco Dependence	within-subjects, crossover, laboratory study Naltrexone vs. Placebo	null	2	arm 1: All participants took naltrexone during one of the two 4-day study medication periods. Both 4-day study medication periods were randomized and counterbalanced between naltrexone and placebo; all study medication periods were separated by a 5-7 day washout period. Dosing of the naltrexone was the same for all pa...	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: All participants took naltrexone during one of the two 4-day study medication periods. Both 4-day study medication periods were randomized and counterbalanced between naltrexone and placebo; all study medication periods were separated by a 5-7 day washout period. Dosing of the naltrexone was the same f...	intervention 1: Naltrexone intervention 2: Placebo	1	Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	128	0	0	0	NCT00270231	1COMPLETED	2005-10-01	2004-03-01	University of Pennsylvania	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 3 ]	75	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	true	0ALL	false	Development of Staccato Prochlorperazine for the treatment of migraine headache.	null	Migraine Headache, With or Without Aura	Migraine, Staccato Prochlorperazine Migraine headache with or without aura.	null	3	arm 1: Inhaled Staccato Placebo arm 2: Inhaled Staccato Prochlorperazine 5 mg arm 3: Inhaled Staccato Prochlorperazine 10 mg	[ 2, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Inhaled Staccato Placebo intervention 2: Inhaled Prochlorperazine 5 mg intervention 3: Inhaled Prochlorperazine10 mg	intervention 1: Staccato Placebo intervention 2: Staccato Prochlorperazine 5 mg intervention 3: Staccato Prochlorperazine 10 mg	1	Mount Vernon \| New York \| United States \| -73.83708 \| 40.9126	75	0	0	0	NCT00610428	1COMPLETED	2005-10-01	2005-03-01	Alexza Pharmaceuticals, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 4 ]	135	RANDOMIZED	PARALLEL	4SUPPORTIVE_CARE	4QUADRUPLE	false	0ALL	false	The purpose of this study is to evaluate the efficacy of Sativex® compared with placebo in reducing the daily number of episodes on incontinence.	This is a ten week, multicentre, double blind, randomised, placebo controlled parallel group study to evaluate the efficacy of Sativex® on urge incontinence associated with neurogenic unstable bladder. Multiple sclerosis patients with incontinence symptoms are screened to determine eligibility and complete a two-week b...	Detrusor Overactivity Multiple Sclerosis	Detrusor overactivity Multiple Sclerosis	null	2	arm 1: Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period. arm 2: Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in a...	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Containing ∆9 tetrahydrocannabinol (THC), 27 mg/ml and cannabidiol (CBD), 25 mg/ml as extract of Cannabis sativa L. Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three-hour period and 48 actuations...	intervention 1: Sativex® intervention 2: Placebo	1	Nottingham \| Notts \| United Kingdom \| -1.15047 \| 52.9536	135	0	0	0	NCT00678795	1COMPLETED	2005-10-01	2002-08-01	Jazz Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 5 ]	217	RANDOMIZED	CROSSOVER	9OTHER	0NONE	true	0ALL	false	This was a randomized, open-label, 2-way cross-over study, comparing desloratadine RediTab 2.5 mg to a marketed chewable antihistamine oral medication (Zyrtec® 5 mg Chewable Tablet). Subject preference for one product or the other was determined. Acceptability of product attributes (Taste and Feeling in the Mouth) was...	null	Allergies		null	2	arm 1: Subjects received a single dose of desloratadine RediTab followed 8-10 minutes later by a single dose of Zyrtec chewable tablet followed thereafter by a statement of preference. arm 2: Subjects received a single dose of Zyrtec chewable tablet followed 8-10 minutes later by a single dose of desloratadine RediTab ...	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: SCH 34117: desloratadine RediTabs, 1 tablet (2.5 mg), oral administration, single dose, single day intervention 2: Zyrtec® (cetirizine) Chewable Tablets, 1 tablet (5 mg), oral administration, single dose, single day	intervention 1: Desloratadine intervention 2: Zyrtec® (cetirizine)	0	null	217	0	0	0	NCT00779116	1COMPLETED	2005-10-01	2005-09-01	Organon and Co	4INDUSTRY	false	false	false	null	0	0	0	0	0	-0
[ 5 ]	220	RANDOMIZED	CROSSOVER	9OTHER	0NONE	true	0ALL	false	The primary objective of this study was to determine whether children ages 6-11 years prefer desloratadine RediTabs (2.5 mg) or a marketed competitor (Zyrtec® 5 mg Chewable Tablets). The secondary objectives of this study were to compare acceptance of the two attributes, taste and feeling in the mouth, of desloratadine...	null	Allergies		null	2	arm 1: Subjects received a single dose of desloratadine RediTab followed 8-10 minutes later by a single dose of Zyrtec chewable tablet followed thereafter by a statement of preference. arm 2: Subjects received a single dose of Zyrtec chewable tablet followed 8-10 minutes later by a single dose of desloratadine RediTab ...	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: desloratadine RediTabs, 1 tablet (2.5 mg),oral administration, single day intervention 2: Zyrtec® (cetirizine) Chewable Tablets, 1 tablet (5 mg), oral administration, single day	intervention 1: Desloratadine intervention 2: Zyrtec® (cetirizine)	0	null	220	0	0	0	NCT00780403	1COMPLETED	2005-10-01	2005-08-01	Organon and Co	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 2 ]	22	RANDOMIZED	CROSSOVER	null	0NONE	true	1FEMALE	false	The objective of this study is to evaluate the comparative bioavailability between Anastrozole 1 mg Tablets (Teva Pharmaceuticals, USA) and Arimidex® 1 mg Tablets (AstraZeneca Pharmaceuticals LP, USA), after a single-dose in healthy subjects under fed conditions.	Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA Bioequivalence Statistical Methods	Healthy	Bioequivalence Healthy Subjects	null	2	arm 1: Anastrozole 1 mg Tablets arm 2: Arimidex® 1 mg Tablets	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 1 mg Tablets intervention 2: 1 mg Tablets	intervention 1: Anastrozole intervention 2: Anastrozole	1	Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643	44	0	0	0	NCT01183390	1COMPLETED	2005-10-01	2005-09-01	Teva Pharmaceuticals USA	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	182	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The purpose of this study is to determine the effects of SPD503 compared to placebo on tasks of sustained attention in children and adolescents aged 6-17 diagnosed with ADHD.	null	Attention Deficit Disorder With Hyperactivity		null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: SPD503 (Guanfacine HCl) intervention 2: Placebo	0	null	178	0	0	0	NCT00150592	1COMPLETED	2005-10-05	2005-05-12	Shire	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 4 ]	83	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	true	0ALL	null	This study will establish the best dose of the drug naltrexone to treat patients with Pathological Gambling Disorder (PGD) and severe urge symptoms.	PGD is a prominent and growing social problem. Unfortunately, there is no established drug treatment for this disorder. Preliminary investigations demonstrate that naltrexone in doses up to 250 mg/day is well tolerated and safe during an 11-week period and may be a viable treatment option for PGD patients with severe u...	Gambling	Impulse Control Disorders	null	2	arm 1: 17 weeks of double-blind Naltrexone. Subjects were randomized into one of these three conditions (if they weren't randomized to placebo): naltrexone 50mg/day, 100mg/day, 150mg/day. To minimize nausea, treatment for all subjects was initiated at 25mg/day naltrexone for two days, then the dose was increased to 50m...	[ 2, 2 ]	2	[ 0, 0 ]	intervention 1: For subjects who were randomly assigned to naltrexone 50mg/day, 100mg/day, or 150mg/day. intervention 2: For subjects who were randomly assigned to placebo.	intervention 1: Naltrexone intervention 2: Placebo	1	Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997	77	0	0	0	NCT00053677	1COMPLETED	2005-11-01	2002-12-01	University of Chicago	7OTHER	false	false	false	null	0	0	0	0	0	-0
[ 5 ]	60	RANDOMIZED	CROSSOVER	0TREATMENT	3TRIPLE	false	0ALL	false	To study the effect of Xyrem (9 g), Xyrem (9 g) plus modafinil 200 mg administered the morning prior to Xyrem, positive control (zolpidem 10 mg), and placebo on the frequency and outcome of events of sleep-disordered breathing in patients with obstructive sleep apnea syndrome (OSAS).	This study will be conducted as a randomized, crossover study of the effect of Xyrem (9 g), Xyrem (9 g) plus modafinil 200 mg administered the morning prior to Xyrem, positive control (zolpidem 10 mg), and placebo on the frequency and outcome of events of sleep-disordered breathing in patients with obstructive sleep ap...	Obstructive Sleep Apnea Syndrome	Sleep-disordered breathing Obstructive sleep apnea syndrome	null	4	arm 1: Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later arm 2: Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later. arm 3: Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours la...	[ 0, 1, 0, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Xyrem (Sodium Oxybate) Oral Solution intervention 2: Zolpidem 10 mg oral tablets intervention 3: Modafinil Oral Tablets intervention 4: Placebo Oral Solution	intervention 1: Xyrem (X) intervention 2: Zolpidem (Z) intervention 3: Modafinil (M) intervention 4: Placebo (P)	2	St. Petersburg \| Florida \| United States \| -82.67927 \| 27.77086 London \| Ontario \| Canada \| -81.23304 \| 42.98339	218	0	0	0	NCT00086281	1COMPLETED	2005-11-01	2003-11-01	Jazz Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 4 ]	353	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The purpose of this study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.	null	Diabetes Mellitus, Type 2		null	2	arm 1: Sitagliptin 100 mg arm 2: Placebo	[ 1, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Sitagliptin 100 mg once daily, from Visit 4 through Visit 8. Day 1 through week 24 intervention 2: Placebo (to match Sitagliptin 100 mg) once daily, from Visit 4 through Visit 8. Day 1 through Week 24 intervention 3: Pioglitazone 30 mg or 45 mg once daily, Visit 2 through Visit 8 intervention 4: Metform...	intervention 1: Comparator: Sitagliptin intervention 2: Comparator: Placebo intervention 3: Comparator: Pioglitazone intervention 4: Metformin	0	null	353	0	0	0	NCT00086502	1COMPLETED	2005-11-01	2004-06-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0	0	0	-0
[ 3 ]	106	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	This study will look at whether this new drug is effective in the treatment of rheumatoid arthritis, and at whether it is safe and well-tolerated by participants with the disease.	null	Rheumatoid Arthritis		null	2	arm 1: MK-0873 1.25 mg twice daily for 12 weeks arm 2: Matching placebo to MK-0873 1.25 mg twice daily for 12 weeks	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: MK-0873 1.25 mg twice daily for 12 weeks intervention 2: Matching placebo to MK-0873 1.25 mg twice daily for 12 weeks	intervention 1: MK-0873 intervention 2: Comparator: Placebo	0	null	106	0	0	0	NCT00132769	1COMPLETED	2005-11-01	2005-01-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 4 ]	216	RANDOMIZED	PARALLEL	1PREVENTION	2DOUBLE	false	0ALL	false	A new intravenous medication is being tested for the prevention of the nausea and vomiting that occurs after surgery. This new medication is being compared to another intravenous medication that is already available to patients for this indication.	null	Post-Operative Nausea and Vomiting		null	2	arm 1: 40 mg MK0517 IV arm 2: 4 mg ondansetron IV	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: a single administration of 40 mg MK0517 by IV immediately prior to surgery intervention 2: a single administration of 4 mg ondansetron by IV immediately prior to surgery	intervention 1: Comparator: MK0517 intervention 2: Comparator: ondansetron	0	null	211	0	0	0	NCT00231777	1COMPLETED	2005-11-01	2005-07-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0	0	0	-0
[ 2 ]	50	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	true	0ALL	false	The objective of this study was to assess the safety, tolerability and pharmacokinetics of a single inhaled dose of (administered in 1 or 2 puffs) Staccato Loxapine in healthy volunteers.	Safety and pharmacokinetic data obtained from 50 subjects (between the ages of 18 to 55 years) entered into this randomized, placebo-controlled study. To obtain 50 enrolled subjects, screening procedures and inclusion/exclusion criteria were evaluated for 126 subjects during a variable screening period of up to 21 days...	Schizophrenia	Schizophrenia, Staccato Loxapine	null	5	arm 1: Single 0.625 mg dose of inhaled loxapine or Single Placebo dose of inhaled loxapine arm 2: Single 1.25 mg dose of inhaled loxapine or Single Placebo dose of inhaled loxapine arm 3: Single 2.5 mg dose of inhaled loxapine or Single Placebo dose of inhaled loxapine arm 4: Single 5 mg dose of inhaled loxapine or Sin...	[ 0, 0, 0, 0, 0 ]	6	[ 0, 0, 0, 0, 0, 0 ]	intervention 1: Single 0.625 mg (lowest) dose of inhaled loxapine intervention 2: Single 1.25 mg (2nd) dose of inhaled loxapine intervention 3: Single 2.5 mg (3rd) dose of inhaled loxapine intervention 4: Single 5 mg (4th) dose of inhaled loxapine intervention 5: Single 10 mg (5th) dose of inhaled loxapine intervention...	intervention 1: inhaled Loxapine 0.625 mg intervention 2: inhaled Loxapine 1.25 mg intervention 3: inhaled Loxapine 2.5 mg intervention 4: inhaled Loxapine 5 mg intervention 5: inhaled Loxapine 10 mg intervention 6: inhaled Placebo (0 mg)	1	Evansville \| Indiana \| United States \| -87.55585 \| 37.97476	50	0	0	0	NCT00444028	1COMPLETED	2005-11-01	2005-09-01	Alexza Pharmaceuticals, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	30	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The primary purpose of this thirteen-week, open-label study is to test the hypothesis that quetiapine in combination with Oros methylphenidate will reduce aggressive symptoms in children and adolescents who have shown inadequate response to OROS methylphenidate alone.	Informed consent will be obtained from the subject and parent or legal guardian before any study procedures begin. Study procedures will include the verification of inclusion and exclusion criteria, and completion of assessments and safety measures (physical examination, vital signs, adverse events and concomitant medi...	Attention Deficit Disorder With Hyperactivity	ADHD-Combined TypeDisruptive behavior Disorder	null	1	arm 1: Oros Methylphenidate and Quetiapine	[ 0 ]	2	[ 0, 0 ]	intervention 1: Oros methylphenidate will be titrated over 3 visits according to the following schedule: * Visit 2 dose of 18 mg QAM * Visit 3 dose of 36mg QAM * Visit 4 dose of 54mg QAM. intervention 2: Quetiapine will be titrated according to the following schedule as determined by efficacy and safety assessments (S...	intervention 1: Oros Methylphenidate intervention 2: quetiapine	1	Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838	24	0	0	0	NCT00550147	1COMPLETED	2005-11-01	2004-02-01	Indiana University School of Medicine	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 3 ]	92	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	This study is to determine the effectiveness and safety of WR 279,396, a topical cream for the treatment of cutaneous leishmaniasis. This study is to be conducted with a placebo control under double-blind conditions in a local population group in Tunisia where leishmaniasis is endemic.	WR 279,396 is a paromomycin-based topical cream that has shown some suggestion of being effective for the treatment of non-serious, non-complicated cutaneous leishmaniasis in previous clinical studies. The goal of this study is to expand those observations in a larger, more rigorous study to clearly define the efficacy...	Cutaneous Leishmaniasis	cutaneous leishmaniasis topical treatment safety efficacy	null	2	arm 1: WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin arm 2: Topical cream vehicle containing all of the components in WR 279,396 except the active ingredients.	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion intervention 2: Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion	intervention 1: WR 279,396 intervention 2: Placebo	2	Paris \| N/A \| France \| 2.3488 \| 48.85341 Tunis \| N/A \| Tunisia \| 10.16579 \| 36.81897	92	0	0	0	NCT00703924	1COMPLETED	2005-11-01	2003-03-01	U.S. Army Medical Research and Development Command	1FED	false	false	false	null	0	0	0	0	0	0
[ 3 ]	21	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	Non-randomized open label Phase II clinical trial in which subjects meeting criteria for RLS were assigned to 1 of 3 treatment cohorts. The first cohort received one 500 mg IV iron sucrose infusion in 500 mL normal sterile saline (NSS) administered over four hours. The second cohort received two 500 mg IV iron sucrose ...	null	Restless Legs Syndrome		null	3	arm 1: 500 mg dose Venofer over 4 hours arm 2: 500 mg Venofer infusion over 4-6 hours on Day 0 and repeated on Day 2 to 7 arm 3: 500 mg Venofer over 6 hours, followed within 24 hours by 500 mg Venofer over 6 hours	[ 0, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: None intervention 2: None intervention 3: None	intervention 1: Cohort I intervention 2: Cohort II intervention 3: Cohort III	0	null	21	0	0	0	NCT00895232	1COMPLETED	2005-11-01	2003-11-01	American Regent, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	52	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This is a multi-center, open-label, preference study of two sublingual formulations of buprenorphine HCl, in opioid-dependent patients on buprenorphine maintenance therapy. The objectives of this study are to evaluate the overall preference between two buprenorphine sublingual formulations, after a switch from the mar...	null	Opioid Dependency	Buprenorphine tablet Fast dissolving tablet Opioid dependant patients	null	1	arm 1: None	[ 0 ]	2	[ 0, 0 ]	intervention 1: 8 mg or 16 mg daily, sublingual route on Days 1 and 2 intervention 2: 8 mg or 16 mg daily, sublingual route on Days 3, 4, and 5	intervention 1: Buprenorphine hydrochloride marketed sublingual tablet (Subutex) intervention 2: Buprenorphine hydrochloride fast dissolving tablet (FDT)	0	null	52	0	0	0	NCT01075971	1COMPLETED	2005-11-01	2005-09-01	Indivior Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	283	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	The purpose of this study is to evaluate the safety and efficacy of 3 different doses of belimumab, administered in addition to standard therapy, in patients with rheumatoid arthritis (RA).	The purpose of this study is to evaluate the safety and efficacy of three different doses of belimumab (1 mg/kg, 4 mg/kg, and 10 mg/kg), administered in addition to standard therapy, compared to placebo plus standard therapy in patients with RA. All patients were to be dosed on Days 0, 14, and 28, then every 28 days fo...	Arthritis, Rheumatoid	RA	null	4	arm 1: None arm 2: None arm 3: None arm 4: None	[ 2, 0, 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Placebo IV plus standard therapy (SOC) for RA; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 24 weeks in the double-blind period. In the open-label extension period, placebo patients who opted to participate received belimumab 10 mg/kg IV plus SOC every 28 days for an addi...	intervention 1: Placebo intervention 2: Belimumab 1 mg/kg intervention 3: Belimumab 4 mg/kg intervention 4: Belimumab 10 mg/kg	63	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Paradise Valley \| Arizona \| United States \| -111.94265 \| 33.53115 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 La Jolla \| California \| United States \| -117.2742 \| 32.84727 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Los Angeles...	520	0	0	0	NCT00071812	1COMPLETED	2005-12-01	2003-12-01	Human Genome Sciences Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 5 ]	188	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The effects of treatment with different doses of PEGASYS in combination with different doses of ribavirin will be evaluated in patients with CHC genotype 1 who have a high viral titer, body weight greater than 85kg (187lbs) and no prior treatment with interferon. The anticipated time on study treatment is 3-12 months a...	null	Hepatitis C, Chronic		null	4	arm 1: Participants received 180 μg of PEG-IFN \[peginterferon\] alfa-2a in 1 mL solution administered \[subcutaneously\] sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered \[orally \] po daily in split doses for 48 weeks arm 2: Participants received 180 μg of PEG-IFN \[...	[ 1, 0, 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 600mg po bid for 48 weeks intervention 2: 800mg po bid for 48 weeks intervention 3: 180 micrograms sc weekly for 48 weeks intervention 4: 270 micrograms sc weekly for 48 weeks	intervention 1: ribavirin [Copegus] intervention 2: ribavirin [Copegus] intervention 3: peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys] intervention 4: peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys]	25	La Jolla \| California \| United States \| -117.2742 \| 32.84727 Long Beach \| California \| United States \| -118.18923 \| 33.76696 San Diego \| California \| United States \| -117.16472 \| 32.71571 San Diego \| California \| United States \| -117.16472 \| 32.71571 Farmington \| Connecticut \| United States \| -72.83204 \| 41.71982 Brade...	187	0	0	0	NCT00077649	1COMPLETED	2005-12-01	2004-01-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 4 ]	511	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The purpose of this study is to determine whether an experimental anti-anxiety medication is effective in the treatment of Generalized Anxiety Disorder.	Protocol 04-001-01 The primary objective of the study is to assess, under controlled conditions, the safety and efficacy of an experimental anti-anxiety medication relative to placebo in subjects with generalized anxiety disorder (GAD). The secondary objective of the study is to study algorithms for discontinuation o...	Anxiety Disorder	Double Blind, Placebo controlled, Safety and Efficacy Generalized Anxiety Disorder	null	0	null	null	1	[ 0 ]	intervention 1: None	intervention 1: experimental anti-anxiety drug	50	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Anaheim \| California \| United States \| -117.9145 \| 33.83529 Beverly Hills \| California \| United States \| -118.40036 \| 34.07362 Burbank \| California \| United States \| -118.30897 \| 34.18084 San Diego \| California \| United States \| -117.16472 \| 32.71571 Santa Ana...	507	0	0	0	NCT00097708	1COMPLETED	2005-12-01	2004-11-01	Jazz Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	606	NON_RANDOMIZED	PARALLEL	1PREVENTION	0NONE	false	0ALL	null	Patients who undergo total hip replacement surgery are at greater risk of getting deep vein thrombosis (blood clots). This study evaluates the safety, tolerability and effectiveness of the study drug, DU-176b, in reducing the occurrence of deep vein thrombosis in patients having total hip replacement surgery.	The primary study objective is to demonstrate prevention of venous thromboembolism in patients undergoing total hip replacement surgery. The secondary objective is to assess the safety and tolerability of DU-176.	Arthroplasty, Replacement, Hip Thrombosis	Deep Vein Thrombosis, Anticoagulant, Venous thromboembolic	null	6	arm 1: 15mg edoxaban administered twice daily (BID) arm 2: 30mg edoxaban administered once daily (QD) arm 3: 30mg edoxaban administered twice daily (BID) arm 4: 60mg edoxaban administered once daily (QD) arm 5: 60mg edoxaban administered twice daily (BID) arm 6: 120mg edoxaban administered once daily (QD)	[ 0, 0, 0, 0, 0, 0 ]	1	[ 0 ]	intervention 1: None	intervention 1: DU-176b	1	Decatur \| Georgia \| United States \| -84.29631 \| 33.77483	606	0	0	0	NCT00107900	1COMPLETED	2005-12-01	2005-01-01	Daiichi Sankyo	4INDUSTRY	false	false	false	null	0	0	0	0	0	0

Subsets and Splits

No community queries yet

The top public SQL queries from the community will appear here once available.