Datasets:

ds4dh
/

ct-dosing-errors

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_Drug overdose int64	METADATA_wilson_lower_bound float32
[ 4 ]	234	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	true	To evaluate the relative safety and efficacy of ganciclovir and foscarnet as initial treatment of patients with cytomegalovirus (CMV) retinitis.	CMV retinitis is the most common intraocular infection in patients with AIDS and is estimated to affect 35 to 40 percent of patients with AIDS. Untreated CMV retinitis is a progressive disorder, the end result of which is total retinal destruction and blindness. The first two drugs approved by the United States Food and Drug Administration (FDA) for the treatment of CMV retinitis were ganciclovir (Cytovene) and foscarnet (Foscavir). At the time of this trial, both ganciclovir and foscarnet were available only as intravenous formulations. Both drugs were given in a similar two-step fashion: an initial 2-week course of high-dose therapy (induction) to control the infection followed by long-term lower dose therapy to prevent relapse (maintenance). The FGCRT compared foscarnet and ganciclovir as initial therapy for CMV retinitis. The FGCRT was a multicenter, randomized, controlled clinical trial comparing foscarnet and ganciclovir as initial therapy for CMV retinitis. Patients with previously untreated CMV retinitis were randomized to therapy with either intravenous ganciclovir or intravenous foscarnet. The outcome measures of this trial were survival, retinitis progression, loss of visual function (visual acuity and visual field), and morbidity.	HIV Infections Cytomegalovirus Retinitis		null	2	arm 1: The induction dose for foscarnet is 60 mg/kg every 8 hours. Full dose maintenance therapy for foscarnet is 90 mg/kg/day arm 2: The induction dose for ganciclovir is 5 mg/kg every 12 hours. Full dose maintenance therapy for ganciclovir is 5 mg/kg every 24 hours, 7 days a week.	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: 60 mg/kg every 8 hours, 90 mg/kg/day intervention 2: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours	intervention 1: Foscarnet intervention 2: Ganciclovir	0	null	234	0	0	0	NCT00000136	1COMPLETED	1991-10-01	1990-03-01	Johns Hopkins Bloomberg School of Public Health	7OTHER	false	false	false	null	0	0
[ 4 ]	345	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	The objectives of this study are to determine the safety and efficacy in seasonal allergic rhinitis of a four-week course of mometasone furoate compared to beclomethasone dipropionate or placebo.	null	Seasonal Allergic Rhinitis		null	3	arm 1: Participants receive 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days. arm 2: Participants receive 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days. arm 3: Participants receive nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.	[ 0, 1, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Mometasone furoate nasal spray administered as 200 mcg total dose per day for 4 weeks. intervention 2: Beclomethasone dipropionate nasal spray administered as 168 mcg twice daily (BID) \[336 mcg total dose per day\] for 4 weeks. intervention 3: Placebo nasal spray administered for 4 weeks.	intervention 1: Mometasone Furoate (MF) intervention 2: Beclomethasone Dipropionate (BDP) intervention 3: Placebo	0	null	344	0	0	0	NCT03855189	1COMPLETED	1993-10-22	1993-08-23	Organon and Co	4INDUSTRY	false	false	false	null	0	0
[ 4 ]	201	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	This study investigated the onset of symptom relief following initiation of treatment with mometasone furoate (MK-0887/SCH 032088) 200 mcg administered once daily compared with placebo for 14 days.	null	Rhinitis, Allergic, Seasonal		null	2	arm 1: Participants administered mometasone furoate nasal spray 200 mcg once daily (QD), as two 50 mcg sprays per nostril, for 14 consecutive days. arm 2: Participants administered placebo nasal spray QD, as two placebo sprays per nostril, for 14 consecutive days.	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: intranasal administration intervention 2: intranasal administration	intervention 1: mometasone furoate nasal spray intervention 2: placebo nasal spray	0	null	200	0	0	0	NCT03861559	1COMPLETED	1994-07-07	1994-03-30	Organon and Co	4INDUSTRY	false	false	false	null	0	0
[ 4 ]	313	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this study is to evaluate the efficacy and safety of mometasone furoate (SCH 32088) aqueous nasal spray 200 mcg once daily compared to placebo once daily in the treatment of participants with seasonal allergic rhinitis. Flonase (fluticasone propionate) nasal spray 200 mcg once daily has been chosen as the active control for this study.	null	Rhinitis, Allergic, Seasonal		null	3	arm 1: Participants receive 200 mcg of mometasone furoate nasal spray and fluticasone propionate placebo matching nasal spray once daily. arm 2: Participants receive 200 mcg of fluticasone propionate nasal spray and mometasone furoate placebo matching nasal spray once daily. arm 3: Participants receive mometasone furoate placebo matching nasal spray and fluticasone propionate placebo matching nasal spray once daily.	[ 0, 1, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Mometasone furoate nasal spray, 200 mg once daily intervention 2: Fluticasone propionate nasal spray, 200 mg once daily intervention 3: Mometasone furoate placebo matching nasal spray, once daily intervention 4: Fluticasone propionate placebo matching nasal spray, once daily	intervention 1: Mometasone furoate intervention 2: Fluticasone propionate intervention 3: Mometasone furoate placebo intervention 4: Fluticasone propionate placebo	0	null	311	0	0	0	NCT03882047	1COMPLETED	1994-09-16	1994-08-11	Organon and Co	4INDUSTRY	false	false	false	null	0	0
[ 5 ]	81	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study was to determine the lung function response after increasing doses of albuterol (a bronchodilator) in children and adults with asthma.	Inhaled short-acting b2-agonists (SABA) are the most potent bronchodilators used today to treat acute symptoms of asthma and albuterol, a partial b2-agonist, is the most frequently prescribed asthma medication in the US. Although universally used in for acute asthma symptoms, SABA have been associated with a significant degree of interpatient variability. Many studies have characterized the SABA dose to bronchodilator response relationship under controlled conditions. However, few studies have explored the magnitude and sources of bronchodilator response variability, and no studies have characterized the dose versus bronchodilator response relationship using population pharmacokinetic/pharmacodynamic (PPK/PD) modeling. In the present study, we characterized the relationship between inhaled doses of albuterol and bronchodilation in 81 children and adults with moderate to severe persistent asthma using a population pharmacodynamic approach. The purpose of this study was to obtain estimates of the pharmacodynamic parameters that characterize the dose-response curve, including maximal dose for bronchodilation, and to quantify and identify sources of interpatient pharmacodynamic variability.	Asthma	Albuterol Forced expiratory volume in one second Dose at fifty percent of maximum effect Maximum effective dose Metered dose inhaler Nebulizer	null	0	null	null	1	[ 0 ]	intervention 1: Albuterol administered sequentially 180mcg (MDI), 90mcg (MDI), 90mcg(MDI), 90mcg (MDI), 90mcg (MDI), 2.5mg (nebulized)	intervention 1: albuterol	1	Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218	81	0	0	0	NCT00940927	1COMPLETED	1994-10-01	1993-07-01	Nemours Children's Clinic	7OTHER	false	false	false	null	0	0
[ 4 ]	279	RANDOMIZED	FACTORIAL	0TREATMENT	2DOUBLE	false	0ALL	true	To compare the relative merits of three therapeutic regimens in patients with AIDS and CMV retinitis who have been previously treated but whose retinitis either is nonresponsive or has relapsed. These three therapeutic regimens were (1) foscarnet, (2) high-dose ganciclovir, and (3) combination foscarnet and ganciclovir. To compare two treatment strategies in patients with relapsed or nonresponsive CMV retinitis: (1) continuing the same anti-CMV drug or (2) switching to the alternate drug.	CMV retinitis is the most common intraocular infection in patients with AIDS and is estimated to affect 35 to 40 percent of patients with AIDS. Untreated CMV retinitis is a progressive disorder, the end result of which is total retinal destruction and blindness. At the time of this trial, drugs approved by the United States Food and Drug Administration (FDA) for the treatment of CMV retinitis were ganciclovir (Cytovene) and foscarnet (Foscavir). Although most retinitis responds well to initial therapy with systemically administered drugs, given enough time, nearly all patients will suffer a relapse of the retinitis. Relapsed retinitis generally responds to reinduction and maintenance therapy, but the interval between successive relapses progressively shortens. The CRRT addressed the issue of the management of relapsed CMV retinitis. The CRRT was a multicenter, randomized, controlled clinical trial comparing three regimens in patients with relapsed retinitis. Patients with AIDS and CMV retinitis that had relapsed or was nonresponsive to initial therapy were randomized to one of three regimens: (1) intravenous foscarnet reinduction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day; (2) intravenous ganciclovir reinduction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day; and (3) combination therapy, wherein patients continued their previous therapy and were reinduced with the second drug and then placed on maintenance therapy with foscarnet at 90 mg/kg/day and ganciclovir at 5 mg/kg/day.	HIV Infections Acquired Immunodeficiency Syndrome Cytomegalovirus Retinitis		null	3	arm 1: intravenous foscarnet reinduction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day arm 2: intravenous ganciclovir reinduction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day arm 3: combination therapy, wherein patients continued their previous therapy and were reinduced with the second drug and then placed on maintenance therapy with foscarnet at 90 mg/kg/day and ganciclovir at 5 mg/kg/day.	[ 0, 1, 1 ]	2	[ 0, 0 ]	intervention 1: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day intervention 2: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day	intervention 1: Ganciclovir intervention 2: Foscarnet	0	null	274	0	0	0	NCT00000134	1COMPLETED	1995-03-01	1992-12-01	Johns Hopkins Bloomberg School of Public Health	7OTHER	false	false	false	null	0	0
[ 4 ]	704	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	The purpose of this study is to evaluate the safety and efficacy of mometasone furoate nasal spray (MFNS) with the addition of loratadine vs MFNS alone, loratadine alone, or placebo, in the treatment of patients with seasonal allergic rhinitis.	null	Rhinitis, Allergic		null	4	arm 1: Daily administration of 200 µg of MFNS plus oral dose of 10 mg loratadine tablet. arm 2: Daily administration of 200 µg of MFNS plus oral placebo tablet. arm 3: Daily administration of oral dose of 10 mg loratadine tablet plus placebo nasal spray. arm 4: Daily administration of placebo nasal spray plus oral placebo tablet.	[ 0, 1, 1, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Daily dose of 200 µg of mometasone furoate administered as a nasal spray for 15 days. intervention 2: Daily dose of 10 mg of loratadine administered as an oral tablet for 15 days. intervention 3: Daily dose of placebo administered as a nasal spray for 15 days. intervention 4: Daily dose of placebo administered as an oral tablet for 15 days.	intervention 1: Mometasone furoate nasal spray (MFNS) intervention 2: Loratadine intervention 3: Placebo nasal spray intervention 4: Placebo tablet	0	null	702	0	0	0	NCT03855228	1COMPLETED	1995-08-07	1995-03-01	Organon and Co	4INDUSTRY	false	false	false	null	0	-0
[ 3, 4 ]	64	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	To test and evaluate the efficacy and safety of intravenous cidofovir (Vistide, previously known as HPMPC) for the treatment of retinitis.	CMV (cytomegalovirus) retinitis is the most common intraocular infection in patients with AIDS and is estimated to affect 35 percent to 40 percent of patients with AIDS. Untreated CMV (cytomegalovirus) retinitis is a progressive disorder, the end result of which is total retinal destruction and blindness. As of September 1997, drugs approved by the United States Food and Drug Administration (FDA) for the treatment of CMV (cytomegalovirus)retinitis were ganciclovir (Cytovene), foscarnet (Foscavir), and cidofovir (Vistide). Cidofovir has a prolonged duration of effect permitting intermittent administration. All systemically administered anti-CMV drugs are given in a similar fashion consisting of initial 2-week high-dose treatment (induction) to control the infection followed by long-term lower dose treatment (maintenance) to prevent relapse. Cidofovir is administered as an intravenous infusion once weekly for induction therapy and once every 2 weeks as maintenance therapy. The HPCRT evaluated the efficacy and safety of cidofovir therapy. The HPCRT was a multicenter, randomized, controlled clinical trial of cidofovir for the treatment of CMV (cytomegalovirus) retinitis. Patients with small peripheral CMV (cytomegalovirus) retinitis lesions (i.e., not at risk of immediate loss of visual acuity) were randomized to immediate treatment with cidofovir or deferred therapy until the retinitis had progressed. Patients randomized to immediate therapy received either 1) low-dose cidofovir at 5 mg/kg once weekly induction for 2 weeks, followed by 3 mg/kg once every 2 weeks for maintenance or 2) high-dose cidofovir at 5 mg/kg once weekly induction for 2 weeks followed by 5 mg/kg once every 2 weeks for maintenance. Patients whose retinitis progressed were given treatment according to best medical judgement, and those assigned to deferral were generally treated with cidofovir. Outcomes in this trial included retinitis progression, loss of retinal area, and morbidity.	HIV Infections CMV Cytomegalovirus Retinitis		null	3	arm 1: IV (in the vein) treatment deferred until retinitis progressed, either: 5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks, or 5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks. arm 2: 5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks arm 3: 5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.	[ 0, 0, 0 ]	1	[ 0 ]	intervention 1: Three groups: 1. the deferral group, treatment deferred until retinitis progressed 2. Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks. 3. High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.	intervention 1: Cidofovir	0	null	64	0	0	0	NCT00000142	1COMPLETED	1996-02-01	1994-04-01	Johns Hopkins Bloomberg School of Public Health	7OTHER	false	false	false	null	0	0
[ 4 ]	642	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	This study will investigate the additive effect of montelukast (MK0476) taken along with inhaled beclomethasone versus inhaled beclomethasone alone.	null	Asthma	chronic asthma	null	4	arm 1: Montelukast + Beclomethasone arm 2: Montelukast + Placebo inhaler arm 3: Placebo tablet + Beclomethasone arm 4: Placebo tablet + Placebo inhaler	[ 0, 0, 0, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 10 mg tablet taken once daily at bedtime for 16 weeks intervention 2: 200 ug inhaled, taken twice daily for 16 weeks intervention 3: placebo inhaler taken twice daily for 16 weeks intervention 4: placebo tablet taken once daily at bedtime for 16 weeks	intervention 1: montelukast sodium intervention 2: beclomethasone intervention 3: Placebo inhaler intervention 4: placebo tablet	0	null	642	0	0	0	NCT00911547	1COMPLETED	1996-05-01	1995-03-01	Organon and Co	4INDUSTRY	false	false	false	null	0	0
[ 4 ]	1,473	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	A study to evaluate rizatriptan/MK0462 (5 and 10 mg) for the treatment of acute migraine attack and treatment of up to two headache recurrences compared to placebo. The long term extension study which pools patients from MK0462-022, -025, and -029 is described in NCT01286207.	null	Migraine Headache		null	3	arm 1: None arm 2: None arm 3: None	[ 0, 0, 2 ]	2	[ 0, 0 ]	intervention 1: Single dose administration of 5 or 10 mg oral tablet of rizatriptan, taken immediately upon development of acute/severe migraine headache. intervention 2: Placebo to rizatriptan	intervention 1: rizatriptan benzoate (MK0462) intervention 2: Comparator: placebo	0	null	1,218	0	0	0	NCT00897949	1COMPLETED	1996-07-01	1995-03-01	Organon and Co	4INDUSTRY	false	false	false	null	0	-0
[ 4 ]	679	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	The purpose of this study was to identify the lowest dosage of mometasone furoate nasal spray (MFNS) that provided adequate efficacy with an acceptable safety profile for children (ages 6-11) with seasonal allergic rhinitis (SAR). The MFNS dose levels of 25, 100, and 200 mcg QD were compared with beclomethasone dipropionate (BDP), as an active control, and placebo.	null	Rhinitis, Allergic, Seasonal		null	5	arm 1: Mometasone furoate nasal spray 12.5 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms. arm 2: Mometasone furoate nasal spray 50 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms. arm 3: Mometasone furoate nasal spray 100 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms. arm 4: Beclomethasone dipropionate nasal spray 42 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms. arm 5: Matching placebo nasal spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.	[ 0, 0, 0, 1, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: intranasal administration intervention 2: intranasal administration intervention 3: intranasal administration intervention 4: oral administration	intervention 1: Mometasone furoate nasal spray intervention 2: Beclomethasone dipropionate nasal spray intervention 3: Placebo nasal spray intervention 4: Chlorpheniramine maleate syrup	0	null	679	0	0	0	NCT03879772	1COMPLETED	1996-07-01	1996-03-12	Organon and Co	4INDUSTRY	false	false	false	null	0	0
[ 3, 4 ]	209	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	To evaluate the efficacy and safety of a human anti-CMV monoclonal antibody, MSL-109, as adjunct therapy for controlling CMV retinitis.	CMV retinitis is the most common intraocular infection in patients with AIDS and is estimated to affect 35 to 40 percent of patients with AIDS. Untreated CMV retinitis is a progressive disorder, the end result of which is total retinal destruction and blindness. As of September 1996, drugs approved by the United States Food and Drug Administration (FDA) for the treatment of CMV retinitis were ganciclovir (Cytovene), foscarnet (Foscavir), and cidofovir (Vistide). All systemically administered anti-CMV drugs are given in a similar fashion consisting of initial 2-week high-dose treatment (induction) to control the infection followed by long-term lower dose treatment (maintenance) to prevent relapse. Ganciclovir is available in both intravenous and oral formulations, foscarnet only in an intravenous formulation, and cidofovir is given by intermittent intravenous administration. A surgically implanted intraocular sustained-release ganciclovir device (Vitrasert) is also approved by the FDA for the treatment of CMV retinitis. Despite the use of continuous maintenance therapy, given enough time, all patients with CMV retinitis on systemically administered drugs relapse. Preliminary studies suggested that the anti-CMV monoclonal antibody, MSL-109, when administered in conjunction with ganciclovir, markedly prolonged the time to relapse. Therefore, a randomized controlled clinical trial evaluating MSL-109 as adjunct therapy was conducted. The MACRT was a randomized, placebo-controlled, multicenter clinical trial evaluating the efficacy and safety of MSL-109 as adjunct therapy for the treatment of CMV retinitis. Patients with CMV retinitis, both those newly diagnosed and those suffering a relapse with active retinitis, were eligible. Primary therapy (e.g., ganciclovir, foscarnet, etc.) was determined by the treating local physician. The patients enrolled in the trial were randomized to either MSL-109 or placebo, administered as a rapid intravenous infusion every 2 weeks. Outcomes included survival, retinitis progression, change in amount of retinal area involved by CMV, loss of visual function (acuity and field), and morbidity.	HIV Infections Cytomegalovirus Retinitis		null	2	arm 1: The dose MSL-109 administered by intravenous infusion every 2 weeks 60 mg. arm 2: Placebo administered intravenous infusion every 2 weeks 60 mg.	[ 0, 2 ]	2	[ 0, 10 ]	intervention 1: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout. intervention 2: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout.	intervention 1: MSL-109 intervention 2: Placebo	0	null	209	0	0	0	NCT00000135	1COMPLETED	1996-08-01	1995-09-01	Johns Hopkins Bloomberg School of Public Health	7OTHER	false	false	false	null	0	0
[ 3 ]	215	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	To evaluate the chemical efficacy and safety of intranasally administered peptide T on neurocognitive function in HIV seropositive individuals. Previous studies have shown that treatment with peptide T can result in cognitive improvement in HIV-infected patients. Patients are randomized to receive either peptide T or placebo for the first 6 months. All patients then receive open-label peptide T for approximately 6 additional months. Neuropsychologic tests are used to determine drug effects.	null	HIV Infections Cognition Disorders	Acquired Immunodeficiency Syndrome AIDS-Related Complex	null	2	arm 1: Peptide T given intranasally at a dosage of 2mg 3 times a day for 6 months arm 2: Placebo given intranasally at a dosage of 2mg 3 times a day for 6 months	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: Peptide T intervention 2: Placebo	3	Los Angeles \| California \| United States \| -118.24368 \| 34.05223 San Diego \| California \| United States \| -117.16472 \| 32.71571 Miami \| Florida \| United States \| -80.19366 \| 25.77427	215	0	0	0	NCT00000392	1COMPLETED	1996-08-01	1990-01-01	National Institute of Mental Health (NIMH)	0NIH	false	false	false	null	0	0
[ 4 ]	933	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	A study to compare rizatriptan (MK0462) 5 mg by mouth (p.o.) and sumatriptan 50 mg p.o. for the acute treatment of a migraine attack.	null	Migraine Headache		null	3	arm 1: Rizatriptan arm 2: Sumatriptan arm 3: Placebo	[ 0, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: single dose 5 mg rizatriptan p.o. intervention 2: single dose 50 mg sumatriptan p.o. intervention 3: Placebo to rizatriptan or sumatriptan, single dose placebo tablet taken orally	intervention 1: rizatriptan benzoate (MK0462) intervention 2: Comparator: sumatriptan intervention 3: Comparator: Placebo	0	null	792	0	0	0	NCT00897104	1COMPLETED	1996-09-01	1995-08-01	Organon and Co	4INDUSTRY	false	false	false	null	0	0
[ 4 ]	1,268	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	A study to compare rizatriptan 10 mg verse sumatriptan 100 mg in the treatment of migraine attacks and duration of relief provided. This study will also provide additional efficacy data on rizatriptan 5 mg and 10 mg for the treatment of migraine.	null	Migraine Headache		null	4	arm 1: rizatriptan 5 mg arm 2: rizatriptan 10 mg arm 3: sumatriptan 100 mg arm 4: placebo	[ 0, 0, 1, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: single dose administration of 5mg rizatriptan (by Mouth) p.o. intervention 2: single dose administration of 10 mg rizatriptan p.o. intervention 3: single dose administration of sumatriptan 100 p.o. intervention 4: placebo to rizatriptan	intervention 1: rizatriptan benzoate intervention 2: rizatriptan benzoate intervention 3: Comparator: sumatriptan intervention 4: Comparator: Placebo	0	null	1,099	0	0	0	NCT00898677	1COMPLETED	1996-09-01	1995-09-01	Organon and Co	4INDUSTRY	false	false	false	null	0	0
[ 3, 4 ]	115	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	true	0ALL	false	The renin-angiotensin-aldosterone system has been implicated in the control of structural changes of the heart and the vasculature, beyond the effects on blood pressure. This projects examines the importance of the renin-angiotensin-aldosterone system and the sympathetic nervous system in the control of cardiac and vascular structure and function in subjects with hypertension.Patients with hypertension and left ventricular hypertrophy were randomized to an angiotensin receptor blocker or a beta adrenergic receptor blocker for 48 weeks. Repeat investigations of blood pressure, structure and function of the heart and the vascular tree, and neurohormones were performed. Two control groups, consisting of normotensive subjects and of hypertensive subjects with no cardiac hypertrophy were also examined for comparison.	We included 115 patients with hypertension and cardiac hypertrophy, established by echocardiography. Extensive echocardiographic examinations, ultrasonography of the carotid arteries, 24h Holter registrations, 24h ambulatory blood pressure monitoring monitoring, neurohormones and blood samples for inflammation and hemostasis markers and endothelial function were done at weeks 0, 12, 24, and 48. Matched control groups (1:3, i.e. 38 normotensive subjects and 38 hypertensive subjects with no signs of hypertensive heart disease were examined at one occasion. All patients obtained irbesartan or atenolol for 12 weeks; a diuretic and a calcium antagonist was added when needed thereafter in order to obtained a blood pressure below 140/90 mm Hg. All analyses were performed central in a core laboratory.	Hypertension	Hypertension Cardiac hypertrophy Angiotensin Human	null	2	arm 1: Irbesartan per os titrated to 300 mg od, 48 weeks arm 2: Atenolol per os titrated to 100 mg od, 48 weeks	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Titrated to 300 mg od, 48 weeks. intervention 2: Titrated to 100 mg od, 48 weeks.	intervention 1: Irbesartan intervention 2: Atenolol	1	Stockholm \| N/A \| Sweden \| 18.06871 \| 59.32938	114	0	0	0	NCT00389168	1COMPLETED	1997-04-01	1995-04-01	Karolinska Institutet	7OTHER	false	false	false	null	0	0
[ 4 ]	1,959	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	false	This record describes pooled data for three extension studies: MK-0462-022 (NCT00897949); MK-0462-025 (NCT00899379); and MK-0462-029 (NCT00897104). These studies examined the long-term safety and efficacy of rizatriptan used for the treatment of acute migraine and migraine recurrence.	null	Migraine Disorders	Migraine headache	null	3	arm 1: Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s) arm 2: Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s) arm 3: Standard care at onset of migraine attack	[ 0, 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s) intervention 2: Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s) intervention 3: Active standard care	intervention 1: Rizatriptan 5 mg intervention 2: Rizatriptan 10 mg intervention 3: Standard Care	0	null	1,879	0	0	0	NCT01286207	1COMPLETED	1997-05-01	1995-03-01	Organon and Co	4INDUSTRY	false	false	false	null	0	0
[ 3 ]	9	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	RATIONALE: Current therapies for children with recurrent/progressive high grade gliomas 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 recurrent/progressive high grade gliomas. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on children (\> 6 months of age) with recurrent/progressive high grade gliomas.	OBJECTIVES: * To determine the efficacy of Antineoplaston therapy in children with recurrent/progressive high grade gliomas, as measured by an objective response to therapy (complete response, partial response or stable disease). * To determine the safety and tolerance of Antineoplaston therapy in children with recurrent/progressive high grade gliomas. OVERVIEW: This is a single arm, open-label study in which children with recurrent/progressive high grade gliomas receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity. After 12 months, patients with a complete or partial response or with stable disease may continue treatment. To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.	High Grade Glioma	childhood anaplastic astrocytoma childhood glioblastoma multiforme	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 recurrent/progressive high grade glioma will receive Antineoplaston therapy (Atengenal + Astugenal).	intervention 1: Antineoplaston therapy (Atengenal + Astugenal)	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	9	0	0	0	NCT00003535	6TERMINATED	1998-01-01	1994-04-01	Burzynski Research Institute	7OTHER	false	false	false	null	0	0
[ 4 ]	134	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The objective of this study is to assess the safety of the buprenorphine transdermal system (5, 10, and 20) in comparison to placebo transdermal system and immediate release oxycodone/ acetaminophen in subjects with chronic back pain. The double-blind treatment intervention duration is 84 days during which time supplemental analgesic medication (non-steroidal anti-inflammatory drugs) will be allowed for all subjects in addition to study drug.	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.	Back Pain	chronic back pain opioid transdermal	null	3	arm 1: Placebo oxycodone (OXY)/acetaminophen (APAP) tablets and placebo transdermal patch (TDS) 5, 10, or 20 arm 2: 5 mg oxycodone/325 mg acetaminophen tablets arm 3: Buprenorphine transdermal patch 5, 10, or 20 mcg/hour	[ 2, 1, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Buprenorphine 5, 10, or 20 mcg/hour patch applied transdermally for 7-day wear. intervention 2: Placebo oxycodone/acetaminophen tablets; 1, 2, or 3 tablets taken four times/day. intervention 3: 5 mg oxycodone / 325 mg acetaminophen tablets; 1, 2, or 3 tablets taken four times/day. intervention 4: Placebo transdermal patch 5, 10, or 20 applied transdermally for 7-day wear	intervention 1: Buprenorphine transdermal patch intervention 2: Placebo oxycodone/acetaminophen tablets intervention 3: OXY/APAP intervention 4: Placebo transdermal patch (TDS)	12	Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Gainesville \| Florida \| United States \| -82.32483 \| 29.65163 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Plantation \| Florida \| United States \| -80.23184 \| 26.13421 Decatur \| Georgia \| United States \| -84.29631 \| 33.77483 Kansas City \| Missouri \| United States \| -94.57857 \| 39.09973 Linwood \| New Jersey \| United States \| -74.57516 \| 39.33984 Raleigh \| North Carolina \| United States \| -78.63861 \| 35.7721 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Dallas \| Texas \| United States \| -96.80667 \| 32.78306	134	0	0	0	NCT00315445	1COMPLETED	1998-05-01	1997-12-01	Purdue Pharma LP	4INDUSTRY	false	false	false	null	0	0
[ 3, 4 ]	69	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	The primary objective of this study was to determine the efficacy of etanercept in children with polyarticular course JRA.	This was a two-part study. In the first part of the study, all participants received open-label etanercept twice a week for 90 days. At the end of the 90 days, participants with disease response as defined by the JRA Definition of Improvement (DOI) using the JRA Core Set Criteria were randomized in part 2 of the study to receive placebo or continued administration of etanercept until either disease flare occurred or 4 months elapsed, whichever was earlier. Participants who did not meet the DOI at day 90, participants who had disease flare during part 2 and participants who completed the blinded part of the study were eligible to receive open-label treatment with etanercept under protocol 16.0018 (NCT00357903).	Juvenile Rheumatoid Arthritis		null	2	arm 1: Participants received 0.4 mg/kg etanercept twice weekly for 90 days during Part 1. In Part 2 participants were randomized to receive placebo subcutaneous injection twice weekly for up to 4 months. arm 2: Participants received 0.4 mg/kg etanercept twice weekly for 90 days during Part 1. In Part 2 participants were randomized to continue receiving etanercept twice weekly for up to 4 additional months.	[ 2, 0 ]	2	[ 0, 0 ]	intervention 1: Administered twice weekly by subcutaneous injection intervention 2: Administered twice weekly by subcutaneous injection	intervention 1: Etanercept intervention 2: Placebo	0	null	120	0	0	0	NCT03780959	1COMPLETED	1998-07-08	1997-05-01	Amgen	4INDUSTRY	false	false	false	null	0	0
[ 3 ]	5	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Current therapies for Multiple Myeloma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Multiple Myeloma. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Multiple Myeloma.	Multiple Myeloma 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 Antineoplaston therapy in patients with Multiple Myeloma, as measured by an objective response to therapy (complete response, partial response or stable disease). * To determine the safety and tolerance of Antineoplaston therapy in patients with Multiple Myeloma. * To determine objective response, tumor size is measured utilizing physical examination, radiologic studies, and bone marrow biopsies as necessary, performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.	Multiple Myeloma	Stage I multiple myeloma Stage II multiple myeloma Stage III multiple myeloma	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 Multiple Myeloma 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	5	0	0	0	NCT00003511	6TERMINATED	1999-10-21	1996-04-04	Burzynski Research Institute	7OTHER	false	false	false	null	0	0
[ 4 ]	907	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	This study will evaluate the ability of oral montelukast/loratadine to improve the signs and symptoms of seasonal allergic rhinitis compared with loratadine alone, montelukast alone and placebo.	null	Seasonal Allergic Rhinitis		null	4	arm 1: montelukast/loratadine arm 2: loratadine arm 3: montelukast arm 4: placebo	[ 0, 0, 0, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: montelukast 10 mg/loratadine 10 mg tablet taken once daily at bed time for 2 weeks intervention 2: montelukast 10 mg tablet taken once daily at bed time for 2 weeks intervention 3: loratadine 10 mg tablet taken once daily at bed time for 2 weeks intervention 4: placebo tablet taken once daily at bed time for 2 weeks	intervention 1: Comparator: montelukast/loratadine intervention 2: Comparator: montelukast intervention 3: Comparator: loratadine intervention 4: Comparator: placebo	0	null	907	0	0	0	NCT00963599	1COMPLETED	1999-11-01	1999-09-01	Organon and Co	4INDUSTRY	false	false	false	null	0	0
[ 5 ]	140	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	null	We are seeking male and female patients to voluntarily take part in a clinical research study. Patients must be aged 18 or older and diagnosed with symptomatic orthostatic hypotension (low blood pressure while in the upright position) due to Parkinson's disease, multiple system atrophy, pure autonomic failure or autonomic neuropathies (i.e. neurogenic orthostatic hypotension). Symptoms of low blood pressure include dizziness, lightheadedness, changes in vision and generalized weakness upon standing. The main effect of the drug being studied is to increase blood pressure in the upright position so symptoms will decrease. The purpose of this clinical study is to further assess the clinical benefit of midodrine hydrochloride (ProAmatine®), an approved treatment for orthostatic hypotension. During the course of the study, participants will receive either ProAmatine® or a placebo. Assessments will be made using questionnaires that measure symptom and activity levels. Blood pressure in the lying down and standing positions will be measured at each visit.	null	Hypotension, Orthostatic		null	0	null	null	1	[ 0 ]	intervention 1: None	intervention 1: Midodrine Hydrochloride	15	Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 Miramar \| Florida \| United States \| -80.23227 \| 25.98731 St. Petersburg \| Florida \| United States \| -82.67927 \| 27.77086 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756 Lebanon \| New Hampshire \| United States \| -72.25176 \| 43.64229 New York \| New York \| United States \| -74.00597 \| 40.71427 Toledo \| Ohio \| United States \| -83.55521 \| 41.66394 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Greensburg \| Pennsylvania \| United States \| -79.53893 \| 40.30146 Upland \| Pennsylvania \| United States \| -75.38269 \| 39.85261 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Norfolk \| Virginia \| United States \| -76.28522 \| 36.84681 Morgantown \| West Virginia \| United States \| -79.9559 \| 39.62953	625	0	0	0	NCT00046475	1COMPLETED	1999-11-24	1997-12-01	Shire	4INDUSTRY	false	false	false	null	0	0
[ 4 ]	1,577	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	This study will evaluate the ability of montelukast to improve the signs and symptoms of seasonal allergic rhinitis compared with loratadine and placebo.	null	Seasonal Allergic Rhinitis		null	4	arm 1: montelukast arm 2: loratadine arm 3: placebo arm 4: montelukast/loratadine	[ 0, 0, 2, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 10 mg montelukast tablet given once daily at bedtime for 2 weeks intervention 2: 10 mg loratadine tablet given once daily at bedtime for 2 weeks intervention 3: placebo tablet given once daily at bedtime for 2 weeks intervention 4: montelukast 10-mg/loratadine 10-mg combination tablet taken orally once daily at bedtime for 2 weeks	intervention 1: Comparator: montelukast intervention 2: Comparator: loratadine intervention 3: Comparator: placebo intervention 4: Comparator: montelukast/loratadine	0	null	1,577	0	0	0	NCT00979901	1COMPLETED	2000-05-01	2000-03-01	Organon and Co	4INDUSTRY	false	false	false	null	0	0
[ 4 ]	61	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	To compare the newest CMV retinitis drug, cidofovir, with a regimen of the ganciclovir intraocular device plus oral ganciclovir with respect to efficacy in preventing vision loss. To compare a treatment regimen that incorporates highly active local therapy (ganciclovir device) with a treatment regimen that does not.	Cytomegalovirus (CMV) is among the most frequently encountered opportunistic infections in patients with AIDS. In the era of prophylaxis for pneumocystic pneumonia, CMV disease is estimated to affect 45 percent of patients with AIDS sometime between the diagnosis of AIDS and death. Retinitis has been estimated to account for up to 85 percent of CMV disease in these patients, making CMV retinitis the most common ocular infection encountered. CMV retinitis is a relatively late-stage manifestation, associated with cluster of differentiation 4 (CD4) + T-cell counts \< 100 cells/µL and often \< 50 cells/µL. All currently available treatments for CMV suppress viral replication but do not eliminate the virus from the body. Discontinuation of therapy is associated with a prompt relapse of the retinitis. Despite the use of chronic suppressive therapy, relapse of the retinitis generally occurs, at least with systemically administered anti-CMV drugs. The first two treatments approved for CMV retinitis were intravenous ganciclovir and intravenous foscarnet. Both are given by daily intravenous infusions and therefore require central venous catheters. The development of newer treatments has focused not only on efficacious treatments, but also on treatments that do not require central venous catheters. Available treatments now include oral ganciclovir, the ganciclovir intraocular device, and intravenous cidofovir. In vitro data suggest that combination therapies are synergistic in inhibiting viral replication; these therapies include a foscarnet-ganciclovir combination and a cidofovir-ganciclovir combination. In the SOCA--CMV Retinitis Retreatment Trial, the combination of intravenous ganciclovir and foscarnet was more effective than either drug alone for the treatment of relapsed retinitis. Therefore, the combination of intermittent intravenous cidofovir and daily oral ganciclovir may be an attractive therapy for relapsed disease because it may provide synergy for controlling both ocular and visceral disease while not necessitating either a central venous catheter or an intraocular surgical procedure. The Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT) is a randomized, multicenter clinical trial. Patients will be assigned to receive one of two regimens: (1) ganciclovir intraocular device plus oral ganciclovir or (2) intravenous cidofovir. The intraocular device will be surgically implanted at baseline and again every 6 to 8 months in eyes with CMV retinitis. Oral ganciclovir is taken at a dose of 1 gram three times daily. Cidofovir will be administered intravenously at 5 mg/kg once weekly for 2 consecutive weeks and once every 2 weeks thereafter. If disease progression occurs in patients receiving cidofovir, patients will be given reinduction therapy, and oral ganciclovir at a dose of 1 gram three times per day will be added to the treatment. If patients assigned to cidofovir are unable to tolerate that regimen, an alternative systemic regimen will be recommended. Study outcome variables include a decrease of three or more lines from baseline in best corrected visual acuity and rate of visual field loss. The study will also assess other variables including mortality, blood CMV and HIV load, quality of life, and medical costs. Treatment assignment will not be masked to either patients or clinicians; however, reading of fundus photographs to determine both change in retinal involvement and progression will be masked.	Cytomegalovirus Retinitis HIV Infections		null	2	arm 1: Ganciclovir device and oral dose of Ganciclovir 1 gm three times daily arm 2: cidofovir intravenous (IV) start off with 5 mg/kg once weekly for two doses then followed by 5 mg/kg every other week	[ 0, 0 ]	2	[ 1, 0 ]	intervention 1: oral ganciclovir, 1 gm three times daily intervention 2: intravenous, 5 mg/kg once weekly for two doses, followed by 5 mg/kg every other week	intervention 1: Ganciclovir implant and oral ganciclovir intervention 2: Cidofovir intravenous	19	Irvine \| California \| United States \| -117.82311 \| 33.66946 La Jolla \| California \| United States \| -117.2742 \| 32.84727 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 San Francisco \| California \| United States \| -122.41942 \| 37.77493 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 New Orleans \| Louisiana \| United States \| -90.07507 \| 29.95465 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Newark \| New Jersey \| United States \| -74.17237 \| 40.73566 New York \| New York \| United States \| -74.00597 \| 40.71427 New York \| New York \| United States \| -74.00597 \| 40.71427 New York \| New York \| United States \| -74.00597 \| 40.71427 Chapel Hill \| North Carolina \| United States \| -79.05584 \| 35.9132 Houston \| Texas \| United States \| -95.36327 \| 29.76328	61	0	0	0	NCT00000143	1COMPLETED	2000-06-01	1997-05-01	Johns Hopkins Bloomberg School of Public Health	7OTHER	false	false	false	null	0	0
[ 0 ]	18	RANDOMIZED	PARALLEL	7BASIC_SCIENCE	1SINGLE	false	0ALL	true	Leptin therapy improves insulin sensitivity in people with leptin-deficiency but it is not known whether it improves insulin action in persons who are not leptin deficient. The purpose of the present study was to determine whether leptin therapy has effects on insulin action in obese subjects with type 2 diabetes mellitus (T2DM). A randomized, placebo controlled trial was conducted in obese subjects with newly-diagnosed T2DM. Subjects were randomized to treatment with placebo, low-dose, or high-dose leptin. Insulin sensitivity was measured.	Leptin therapy improves insulin sensitivity in people with leptin-deficiency but it is not known whether it improves insulin action in persons who are not leptin deficient. The purpose of the present study was to determine whether leptin therapy has weight loss-independent effects on insulin action in obese subjects with type 2 diabetes mellitus (T2DM). A randomized, placebo controlled trial was conducted in obese subjects with newly-diagnosed T2DM. Subjects were randomized to treatment with placebo (saline), low-dose (30 mg/d), or high-dose (80 mg/d) recombinant methionyl human (r-met hu) leptin for 14 days. Multi-organ insulin sensitivity before and after treatment was evaluated by using the hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotopically labelled tracer infusions to measure glucose, glycerol and fatty acid kinetics.	Type Two Diabetes Mellitus	diabetes obesity	null	3	arm 1: saline placebo for fourteen days arm 2: 30mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days arm 3: 80mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days	[ 2, 0, 0 ]	3	[ 7, 0, 0 ]	intervention 1: saline placebo intervention 2: 30mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days intervention 3: 80mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days	intervention 1: placebo intervention 2: low-dose leptin intervention 3: high-dose leptin	1	St Louis \| Missouri \| United States \| -90.19789 \| 38.62727	18	0	0	0	NCT01207934	1COMPLETED	2000-07-01	1998-08-01	Washington University School of Medicine	7OTHER	false	false	false	null	0	0
[ 3 ]	9	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	RATIONALE: Current therapies for patients with ependymoma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of patients with ependymoma . PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with ependymoma.	OBJECTIVES: * To determine the efficacy of Antineoplaston therapy in patients with ependymoma as measured by an objective response to therapy (complete response, partial response) or stable disease. * To determine the safety and tolerance of Antineoplaston therapy in patients with ependymoma OVERVIEW: This is a single arm, open-label study in which patients with ependymoma receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity. After 12 months, patients with a complete or partial response or with stable disease may continue treatment. To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued to this study	Ependymoma	Ependymoma Anaplastic Ependymoma	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 an ependymoma will receive Antineoplaston therapy (Atengenal + Astugenal).	intervention 1: Antineoplaston therapy (Atengenal + Astugenal)	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	9	0	0	0	NCT00003479	6TERMINATED	2000-10-01	1966-07-01	Burzynski Research Institute	7OTHER	false	false	false	null	0	0
[ 2 ]	64	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	true	2MALE	false	The purpose of this study is to determine the safety and tolerability of single rising oral doses of BIA 2-093 (proposed doses 20mg, 50mg, 100mg, 200mg, 400mg, 600mg, 900mg and 1200mg) in groups of 8 healthy male adult volunteers.	Single centre, Phase I, double-blind, randomised, placebo-controlled study to investigate single rising oral doses of BIA 2-093 up to 1200 mg in sequential groups of eight healthy male adult subjects. Within each group of eight subjects two subjects were randomised to receive placebo and the remaining six subjects were randomised to receive BIA 2-093. No subject was a member of more than one treatment group. Doses of 20mg, 50mg, 100mg, 200mg, 400mg, 600mg, 900mg and 1200mg were investigated in ascending order. Progression to each dose occurred only after the previous dose level was deemed to be safe and well tolerated by the investigator and the sponsor.	Epilepsy	Eslicarbazepine acetate BIA 2-093 Epilepsy	null	8	arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None arm 8: None	[ 0, 0, 0, 0, 0, 0, 0, 0 ]	2	[ 0, 0 ]	intervention 1: BIA 2-093 20mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg, 1200 mg intervention 2: Identical placebo administered as oral tablets with 200 ml potable water.	intervention 1: BIA 2-093 intervention 2: Placebo	1	London \| N/A \| United Kingdom \| -0.12574 \| 51.50853	64	0	0	0	NCT02171195	1COMPLETED	2000-10-01	2000-07-01	Bial - Portela C S.A.	4INDUSTRY	false	false	false	null	0	0
[ 4 ]	829	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	A study of the ability of montelukast to improve signs and symptoms of seasonal allergic rhinitis compared with placebo. Loratadine is included in the study as an active control.	null	Seasonal Allergic Rhinitis		null	3	arm 1: montelukast arm 2: loratadine arm 3: placebo	[ 0, 1, 2 ]	3	[ 0, 0, 0 ]	intervention 1: montelukast 10 mg tablet, taken orally once daily at bed time for 2 weeks intervention 2: loratadine 10 mg tablet, taken orally once daily at bed time for 2 weeks intervention 3: placebo tablet, taken orally once daily at bed time for 2 weeks	intervention 1: montelukast sodium intervention 2: Comparator: loratadine intervention 3: Comparator: placebo	0	null	829	0	0	0	NCT00960141	1COMPLETED	2000-11-01	2000-08-01	Organon and Co	4INDUSTRY	false	false	false	null	0	0
[ 3 ]	9	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Current therapies for Stage IV Lung 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 Antineoplaston therapy has on patients with Stage IV Lung Cancer.	Stage IV Lung 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 of Antineoplaston therapy in patients with Stage IV Lung Cancer, as measured by an objective response to therapy (complete response, partial response or stable disease). * To determine the safety and tolerance of Antineoplaston therapy in patients with Stage IV Lung Cancer. * To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter. 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.	Stage IV Lung Cancer	Stage IV large cell lung cancer Stage IV non-small cell lung cancer	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 Lung 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	9	0	0	0	NCT00003492	6TERMINATED	2000-12-01	1996-04-10	Burzynski Research Institute	7OTHER	false	false	false	null	0	0
[ 0 ]	256	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	A study of Montelukast compared to placebo in asthmatic children aged 6-24 months.	null	Asthma		null	2	arm 1: Montelukast arm 2: Placebo	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks intervention 2: Placebo oral granules mixed with applesauce once daily at bedtime for 6 weeks	intervention 1: montelukast sodium intervention 2: Comparator: Placebo	0	null	256	1	0.003906	1	NCT00943683	1COMPLETED	2001-02-01	2000-08-01	Organon and Co	4INDUSTRY	false	false	false	null	1	0.00069
[ 2 ]	70	NON_RANDOMIZED	PARALLEL	null	0NONE	true	0ALL	false	The purpose of this study is to determine the pharmacokinetics of BTDS following same-site patch reapplication after rest intervals.	The purpose of this study is to determine the minimum application site rest period that ensures that reapplication of BTDS 10 to the same site in the deltoid region does not result in increased absorption of drug in normal healthy subjects.	Healthy	Healthy subjects Opioid Transdermal	null	5	arm 1: BTDS 10 with no application site rest period prior to application of second BTDS arm 2: BTDS 10 with 7-day rest period prior to application of second BTDS arm 3: BTDS 10 with 14-day rest period prior to application of second BTDS arm 4: BTDS 10 with 21-day rest period prior to application of second BTDS arm 5: BTDS 10 with 28-day rest period prior to application of second BTDS	[ 0, 0, 0, 0, 0 ]	1	[ 0 ]	intervention 1: Buprenorphine 10 mcg/hour patch applied transdermally for 7-day wear.	intervention 1: Buprenorphine transdermal patch	1	Columbus \| Ohio \| United States \| -82.99879 \| 39.96118	70	0	0	0	NCT01259102	1COMPLETED	2001-03-01	2000-11-01	Purdue Pharma LP	4INDUSTRY	false	false	false	null	0	0
[ 2 ]	29	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This study is an extension study to base study protocol C/I97-188 (MK-4031-006). Its primary purpose is to assess the safety and tolerability of extended administration of polyethylene glycol (PEG) interferon alfa-2b in participants with solid tumors.	null	Neoplasms		null	6	arm 1: Participants receive PEG interferon alfa-2b 0.75 mcg/kg by subcutaneous (SC) injection OW for up to 40 weeks. They also receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen should not exceed 3000 mg. arm 2: Participants receive PEG interferon alfa-2b 1.5 mcg/kg by SC injection OW for up to 40 weeks. They also receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen should not exceed 3000 mg. arm 3: Participants receive PEG interferon alfa-2b 3 mcg/kg by SC injection OW for up to 40 weeks. They also receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen should not exceed 3000 mg. arm 4: Participants receive PEG interferon alfa-2b 4.5 mcg/kg by SC injection OW for up to 40 weeks. They also receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen should not exceed 3000 mg. arm 5: Participants receive PEG interferon alfa-2b 6 mcg/kg by SC injection OW for up to 40 weeks. They also receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen should not exceed 3000 mg. arm 6: Participants receive PEG interferon alfa-2b 7.5 mcg/kg by SC injection OW for up to 40 weeks. They also receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen should not exceed 3000 mg.	[ 0, 0, 0, 0, 0, 0 ]	2	[ 0, 0 ]	intervention 1: Participants receive PEG interferon alfa-2b administered by SC injection, in doses ranging from 0.75 mcg/kg OW up to 7.5 mcg/kg OW, for up to 40 weeks of treatment. intervention 2: Participants receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and continue acetaminophen 500 to 1000 mg after administration every 4 to 6 hours as needed. The total daily dose of acetaminophen should not exceed 3000 mg.	intervention 1: PEG Interferon Alfa-2b intervention 2: Acetaminophen	0	null	29	0	0	0	NCT03554005	1COMPLETED	2001-03-16	1997-12-29	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0
[ 3 ]	8	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Current therapies for Adenocarcinoma of the Esophagus provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Adenocarcinoma of the Esophagus. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Adenocarcinoma of the Esophagus.	Esophageal 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 of Antineoplaston therapy in patients with esophageal cancer, as measured by an objective response to therapy (complete response, partial response or stable disease). * To determine the safety and tolerance of Antineoplaston therapy in patients with Esophageal Cancer. * To determine objective response, tumor size is measured utilizing physical examination, and radiologic studies performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.	Adenocarcinoma of the Esophagus	esophageal cancer recurrent esophageal cancer stage IV esophageal cancer	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 Adenocarcinoma of the Esophagus 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	NCT00003487	6TERMINATED	2001-04-27	1996-05-30	Burzynski Research Institute	7OTHER	false	false	false	null	0	0
[ 2 ]	32	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	true	2MALE	false	The purpose of this study is to investigate the safety and tolerability of multiple dose regimens of BIA 2-093 in healthy young male volunteers	Single centre, Phase I, double-blind, randomised, placebo-controlled study investigating 4 multiple rising oral doses of BIA 2-093 in 4 groups of 8 young healthy male subjects. Within each group, 2 subjects were randomised to receive placebo and the remaining 6 subjects to receive BIA 2-093. No subject was a member of more than one group. The dose regimens investigated were: 200 mg b.i.d.(twice daily), 400 mg o.d.(once daily; this was changed from 400 mg b.i.d. in protocol amendment 1, on the basis of interim pharmacokinetic analysis of Group 1 data), 800 mg o.d, and 1200 mg o.d. BIA 2-093/placebo was administered orally once daily on Days 1-8, or twice a day (at 12-hour intervals) on Days 1-7 with a final dose in the morning of Day 8. The multiple dose regimens were to be investigated in ascending order. Progression to each higher dose level was only to occur if the previous dose level was deemed by the investigator and the sponsor to be safe and well tolerated.	Epilepsy	Epilepsy BIA 2-093 Eslicarbazepine acetate	null	4	arm 1: BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets. arm 2: BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets. arm 3: BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets. arm 4: BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets.	[ 0, 0, 0, 0 ]	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: Placebo intervention 2: BIA 2-093	1	London \| N/A \| United Kingdom \| -0.12574 \| 51.50853	32	0	0	0	NCT02171234	1COMPLETED	2001-06-01	2001-02-01	Bial - Portela C S.A.	4INDUSTRY	false	false	false	null	0	0
[ 3 ]	153	RANDOMIZED	PARALLEL	2DIAGNOSTIC	3TRIPLE	false	0ALL	false	The purpose of this study is to determine the efficacy of febuxostat, once daily (QD), in reducing serum urate levels in subjects with gout.	Gout is a chronic urate crystal deposition disorder, which if left untreated may result in progressive disease characterized by joint and bone destruction from tophaceous deposits and renal impairment due to gouty nephropathy. Hyperuricemia, defined as a serum urate concentration of \>7.0 milligrams per deciliter (mg/dL), is the underlying metabolic aberration leading to urate crystal deposition in gout. Gout has several clinical presentations, including: recurrent acute attacks of inflammatory arthritis; deposition of monosodium urate monohydrate crystals in joints, bones and even parenchymal organs (tophaceous gout); renal impairment; and uric acid nephrolithiasis. As serum urate levels increase beyond \>7.0 mg/dL, the risks for gouty arthritis or for renal calculi increase. Currently allopurinol is the only xanthine oxidase inhibitor available. Allopurinol is the agent of choice for reduction of serum urate levels in patients with: uric acid overproduction; unresponsive or intolerant to uricosuric agents; impaired renal function; uric acid urolithiasis; or tophi. Febuxostat (TMX-67) is a non-purine selective xanthine oxidase inhibitor being developed as an orally administered agent for management of hyperuricemia in patients with gout.	Gout	Uric Acid xanthine oxidase tophi Drug Therapy	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: Febuxostat placebo-matching tablets, orally, once daily for up to 4 weeks. intervention 2: Febuxostat 40 mg, tablets, orally, once daily for up to 4 weeks. intervention 3: Febuxostat 80 mg, tablets, orally, once daily for up to 4 weeks. intervention 4: Febuxostat 120 mg, tablets, orally, once daily for up to 4 weeks.	intervention 1: Placebo intervention 2: Febuxostat intervention 3: Febuxostat intervention 4: Febuxostat	0	null	153	0	0	0	NCT00174967	1COMPLETED	2001-07-01	2001-01-01	Takeda	4INDUSTRY	false	false	false	null	0	0
[ 4 ]	267	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (5, 10 and 20) in comparison to matching placebo transdermal system in subjects with chronic nonmalignant pain syndromes currently controlled by oral opioids. The double-blind treatment intervention duration is 2 weeks during which time supplemental analgesic medication (acetaminophen) will be provided to all subjects in addition to study drug.	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.	Chronic Non-malignant Pain	Chronic pain opioid transdermal Butrans™ [BTDS]	null	2	arm 1: Buprenorphine transdermal patch arm 2: Placebo to match buprenorphine transdermal patch	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear. intervention 2: Placebo to match buprenorphine transdermal patch applied for 7-day wear.	intervention 1: Buprenorphine transdermal patch intervention 2: Placebo to match BTDS	42	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Trumbull \| Connecticut \| United States \| -73.20067 \| 41.24287 Clearwater \| Florida \| United States \| -82.8001 \| 27.96585 Coral Gables \| Florida \| United States \| -80.26838 \| 25.72149 DeLand \| Florida \| United States \| -81.30312 \| 29.02832 Pembroke Pines \| Florida \| United States \| -80.22394 \| 26.00315 Plantation \| Florida \| United States \| -80.23184 \| 26.13421 Tamarac \| Florida \| United States \| -80.24977 \| 26.21286 Evansville \| Indiana \| United States \| -87.55585 \| 37.97476 Terre Haute \| Indiana \| United States \| -87.41391 \| 39.4667 Crestview Heights \| Kentucky \| United States \| N/A \| N/A Kalamazoo \| Michigan \| United States \| -85.58723 \| 42.29171 Charlotte \| North Carolina \| United States \| -80.84313 \| 35.22709 High Point \| North Carolina \| United States \| -80.00532 \| 35.95569 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Chardon \| Ohio \| United States \| -81.14899 \| 41.61422 Memphis \| Tennessee \| United States \| -90.04898 \| 35.14953 Austin \| Texas \| United States \| -97.74306 \| 30.26715 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 New Berlin \| Wisconsin \| United States \| -88.10842 \| 42.9764 Newtownabbey \| Belfast \| United Kingdom \| -5.90858 \| 54.65983 Lame \| Co Antrim \| United Kingdom \| N/A \| N/A Portglenone \| CO Antrim \| United Kingdom \| -6.47146 \| 54.87147 Magherafelt \| Co Derry \| United Kingdom \| -6.60656 \| 54.75356 Bangor \| Co Down \| United Kingdom \| -5.66802 \| 54.66079 Keresley End \| Coventry \| United Kingdom \| N/A \| N/A Bexhill-on-Sea \| E Sussex \| United Kingdom \| 0.47095 \| 50.85023 Bexhill-on-Sea \| E Sussex \| United Kingdom \| 0.47095 \| 50.85023 Hastings \| E Sussex \| United Kingdom \| 0.58009 \| 50.85568 Glenrothes \| Fife \| United Kingdom \| -3.17316 \| 56.19514 High Valleyfield \| Fife \| United Kingdom \| -3.59913 \| 56.06357 Glasgow \| Glasgow \| United Kingdom \| -4.25763 \| 55.86515 Glasgow \| Glasgow \| United Kingdom \| -4.25763 \| 55.86515 Aldershot \| Hants \| United Kingdom \| -0.76389 \| 51.24827 Coatbridge \| Lanarkshire \| United Kingdom \| -4.02469 \| 55.86216 Sunbury-on-Thames \| Middx \| United Kingdom \| -0.41817 \| 51.40424 Houston \| Renfrewshire \| United Kingdom \| -4.55201 \| 55.86859 Doncaster \| S Yorkshire \| United Kingdom \| -1.13116 \| 53.52285 Royal Tunbridge Wells \| W Sussex \| United Kingdom \| 0.26256 \| 51.13321 Coventry \| Warwickshire \| United Kingdom \| -1.51217 \| 52.40656 Bradford \| West Yorkshire \| United Kingdom \| -1.75206 \| 53.79391	855	0	0	0	NCT00312195	1COMPLETED	2001-07-01	2001-03-01	Purdue Pharma LP	4INDUSTRY	false	false	false	null	0	0
[ 4 ]	1,214	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	This study will assess the treatment effect of montelukast versus placebo over a 2 week period in patients with seasonal allergic rhinitis. Loratadine is included in the study as an active comparator.	null	Seasonal Allergic Rhinitis		null	3	arm 1: montelukast arm 2: loratadine arm 3: placebo	[ 0, 1, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Montelukast 10-mg tablet orally once daily at bedtime for 2 weeks. intervention 2: Loratadine 10-mg tablet orally once daily at bedtime for 2 weeks. intervention 3: placebo tablet orally once daily at bedtime for 2 weeks	intervention 1: montelukast sodium intervention 2: Comparator: loratadine intervention 3: Comparator: Placebo	0	null	1,214	0	0	0	NCT00972738	1COMPLETED	2001-07-01	2001-04-01	Organon and Co	4INDUSTRY	false	false	false	null	0	0
[ 2 ]	26	RANDOMIZED	CROSSOVER	null	0NONE	true	0ALL	false	This study compared the relative bioavailability (rate and extent of absorption) of 90 mg Fluoxetine Hydrochloride Capsules by Teva Pharmaceuticals, USA with that of 90 mg PROZAC WEEKLY® Capsules by Eli Lilly and Company following a single oral dose (1 x 90 mg) in healthy adult volunteers under fasting conditions.	null	Healthy	Bioequivalence Healthy Subjects	null	2	arm 1: 90 mg PROZAC WEEKLY® Capsules (Eli Lilly) arm 2: 90 mg Fluoxetine Hydrochloride Capsules (Teva)	[ 1, 0 ]	2	[ 0, 0 ]	intervention 1: 90 mg Capsules intervention 2: 90 mg Capsules	intervention 1: Fluoxetine Hydrochloride intervention 2: PROZAC WEEKLY®	1	Fargo \| North Dakota \| United States \| -96.7898 \| 46.87719	52	0	0	0	NCT01247272	1COMPLETED	2001-07-01	2001-05-01	Teva Pharmaceuticals USA	4INDUSTRY	false	false	false	null	0	0
[ 2 ]	26	RANDOMIZED	CROSSOVER	null	0NONE	true	0ALL	false	This study compared the relative bioavailability (rate and extent of absorption) of 90 mg Fluoxetine Hydrochloride Capsules by Teva Pharmaceuticals, USA with that of 90 mg PROZAC WEEKLY® Capsules by Eli Lilly and Company following a single oral dose (1 x 90 mg) in healthy adult volunteers under non-fasting conditions.	null	Healthy	Bioequivalence Healthy Subjects	null	2	arm 1: 90 mg Fluoxetine Hydrochloride Capsules (Teva) arm 2: 90 mg PROZAC WEEKLY® Capsules (Eli Lilly)	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 90 mg Capsules intervention 2: 90 mg Capsules	intervention 1: Fluoxetine Hydrochloride intervention 2: PROZAC WEEKLY®	1	Fargo \| North Dakota \| United States \| -96.7898 \| 46.87719	52	0	0	0	NCT01247285	1COMPLETED	2001-07-01	2001-05-01	Teva Pharmaceuticals USA	4INDUSTRY	false	false	false	null	0	0
[ 0 ]	32	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The investigators propose to conduct an open study to evaluate the efficacy and tolerability of Bupropion SR using clinically relevant doses in ADHD adults with a recent history of or current substance use disorders. We hypothesize that Bupropion SR will be effective in treating ADHD in this population.	null	Attention Deficit Hyperactivity Disorder (ADHD) Substance Use Disorder (SUD)		null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: 100mg capsules Initial dosing 100mgSR every morning, to be titrated to 200mgSR twice daily maximum	intervention 1: Bupropion SR	0	null	32	0	0	0	NCT01270555	1COMPLETED	2001-07-01	1999-05-01	Massachusetts General Hospital	7OTHER	false	false	false	null	0	0
[ 4 ]	190	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	Patients were treated with either montelukast 4 mg oral granules or usual care. Patients who completed Protocol MK0476-176-01 (NCT00943683) had the option to enroll in this study. Additionally, patients with asthma who were 6 to 11 months of age and who had not participated in Protocol MK0476-176-01, could also enroll.	null	Asthma		null	2	arm 1: Montelukast arm 2: Usual Care	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Montelukast 4 mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks intervention 2: Usual care defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator's usual clinical practice for 52 weeks	intervention 1: montelukast sodium intervention 2: Comparator: Usual Care	0	null	190	0	0	0	NCT00943397	1COMPLETED	2001-11-01	2001-04-01	Organon and Co	4INDUSTRY	false	false	false	null	0	0
[ 4 ]	1,079	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	This is a study to evaluate the treatment effect of montelukast 10 mg taken in the morning, versus placebo, in patients with seasonal allergic rhinitis. Loratadine is included in the study as an active control.	null	Seasonal Allergic Rhinitis		null	3	arm 1: montelukast arm 2: loratadine arm 3: placebo	[ 0, 1, 2 ]	3	[ 0, 0, 0 ]	intervention 1: montelukast 10 mg tablet orally once daily in the morning for 4 weeks intervention 2: loratadine 10 mg tablet orally once daily in the morning for 4 weeks intervention 3: placebo tablet orally once daily in the morning for 4 weeks	intervention 1: montelukast sodium intervention 2: Comparator: loratadine intervention 3: Comparator: placebo	0	null	1,079	0	0	0	NCT00963469	1COMPLETED	2001-11-01	2001-08-01	Organon and Co	4INDUSTRY	false	false	false	null	0	0
[ 2 ]	12	NA	SINGLE_GROUP	0TREATMENT	0NONE	true	2MALE	false	The purpose of this study is to investigate the effect of food on the pharmacokinetics of a single 800 mg oral dose of BIA 2-093 in healthy volunteers.	Single centre, open label, randomized, two-way crossover study in 12 healthy male volunteers. The study consisted of 2 periods separated by a washout period of 14 days or more. On each of the study periods the volunteers received a single 800 mg oral dose of BIA 2-093 following either a standard high fat content breakfast or 10 hours of fasting.	Epilepsy	BIA 2-093 Eslicarbazepine acetate	null	1	arm 1: the volunteers received a single 800 mg BIA 2-093 following either a standard high fat content breakfast or 10 hours of fasting. Fed and fasting periods were separated by a washout period	[ 0 ]	1	[ 0 ]	intervention 1: None	intervention 1: BIA 2-093	0	null	12	0	0	0	NCT02170649	1COMPLETED	2001-11-01	2001-09-01	Bial - Portela C S.A.	4INDUSTRY	false	false	false	null	0	0
[ 2 ]	38	RANDOMIZED	CROSSOVER	null	0NONE	true	1FEMALE	false	The primary object of this study was to evaluate the relative bioavailability of the test formulation of metronidazole vaginal gel with the already marketed reference formulation MetroGel-Vaginal Gel® in healthy adult female subjects.	Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA Bioequivalence Statistical Methods	Healthy	Bioequivalence Healthy Subjects Healthy, Normal Subjects	null	2	arm 1: Metronidazole Vaginal Gel arm 2: MetroGel-Vaginal®	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Vaginal Gel, 0.75% intervention 2: Vaginal Gel, 0.75%	intervention 1: Metronidazole intervention 2: Metronidazole	1	Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062	76	0	0	0	NCT01020877	1COMPLETED	2002-01-01	2001-11-01	Teva Pharmaceuticals USA	4INDUSTRY	false	false	false	null	0	0
[ 4 ]	189	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	The objective of this study was to evaluate the long-term safety and tolerability of 7-day BTDS in a 28-week open-label extension phase in subjects with chronic nonmalignant pain syndromes whose pain had been previously controlled by oral opioid combination therapy.	Upon entering the extension phase (BUP3201S), subjects will receive BTDS 5, regardless of their dose level at discontinuation or completion of the BUP3201 core study. Subjects are allowed to titrate after 48 hours to BTDS 10 or 20 that provided stable pain control with minimal tolerability problems. Additional medical therapies are permitted if necessary, and there is no restriction on concomitant analgesic medications. The subjects have weekly visits for 4 consecutive weeks, and every 4 weeks thereafter, until the end of the scheduled extension phase.	Chronic Nonmalignant Pain	Chronic nonmalignant pain Opioid Transdermal Butrans (BTDS)	null	1	arm 1: Buprenorphine transdermal patch	[ 0 ]	1	[ 0 ]	intervention 1: Buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear	intervention 1: Buprenorphine transdermal patch	19	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Trumbull \| Connecticut \| United States \| -73.20067 \| 41.24287 Clearwater \| Florida \| United States \| -82.8001 \| 27.96585 Coral Gables \| Florida \| United States \| -80.26838 \| 25.72149 DeLand \| Florida \| United States \| -81.30312 \| 29.02832 Pembroke Pines \| Florida \| United States \| -80.22394 \| 26.00315 Plantation \| Florida \| United States \| -80.23184 \| 26.13421 Tamarac \| Florida \| United States \| -80.24977 \| 26.21286 Evansville \| Indiana \| United States \| -87.55585 \| 37.97476 Terre Haute \| Indiana \| United States \| -87.41391 \| 39.4667 Crestview Heights \| Kentucky \| United States \| N/A \| N/A Kalamazoo \| Michigan \| United States \| -85.58723 \| 42.29171 Charlotte \| North Carolina \| United States \| -80.84313 \| 35.22709 High Point \| North Carolina \| United States \| -80.00532 \| 35.95569 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Memphis \| Tennessee \| United States \| -90.04898 \| 35.14953 Austin \| Texas \| United States \| -97.74306 \| 30.26715 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 New Berlin \| Wisconsin \| United States \| -88.10842 \| 42.9764	189	0	0	0	NCT01151098	1COMPLETED	2002-02-01	2001-04-01	Purdue Pharma LP	4INDUSTRY	false	false	false	null	0	0

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ds4dh/ct-dosing-errors

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This repository contains dataset version 0.2.3.

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This dataset is licensed under CC BY 4.0 (cc-by-4.0).

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