sssohrab/ct-dosing-errors-benchmark · Datasets at Hugging Face

[ 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

0

NCT00000136

[ 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

0

NCT03855189

[ 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

0

NCT03861559

[ 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

0

NCT03882047

[ 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

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

0

NCT00940927

[ 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

0

NCT00000134

[ 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

0

NCT03855228

[ 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

0

NCT00000142

[ 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

0

NCT00911547

[ 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

0

NCT00897949

[ 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

0

NCT03879772

[ 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

0

NCT00000135

[ 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

0

NCT00000392

[ 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

0

NCT00897104

[ 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

0

NCT00898677

[ 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

0

NCT00389168

[ 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

0

NCT01286207

[ 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

0

NCT00003535

[ 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

0

NCT00315445

[ 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

0

NCT03780959

[ 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

0

NCT00003511

[ 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

0

NCT00963599

[ 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

1

[ 0 ]

intervention 1: None

intervention 1: Midodrine Hydrochloride

15

0

NCT00046475

[ 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

0

NCT00979901

[ 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

0

NCT00000143

[ 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

0

NCT01207934

[ 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

0

NCT00003479

[ 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

0

NCT02171195

[ 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

0

NCT00960141

[ 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

0

NCT00003492

[ 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

1

NCT00943683

[ 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

0

NCT01259102

[ 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

0

NCT03554005

[ 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

0

NCT00003487

[ 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

0

NCT02171234

[ 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

0

NCT00174967

[ 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

0

NCT00312195

[ 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

0

NCT00972738

[ 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

0

NCT01247272

[ 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

0

NCT01247285

[ 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

0

NCT01270555

[ 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

0

NCT00943397

[ 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

0

NCT00963469

[ 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

0

NCT02170649

[ 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

0

NCT01020877

[ 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

0

NCT01151098

[ 4 ]

60

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

To characterize further the effects of D-cycloserine augmentation of antipsychotic treatment on negative symptoms, performance on neurocognitive tasks, and on markers for glutamatergic, dopaminergic and serotonergic function in serum and cerebrospinal fluid. To determine if negative symptoms and cognitive function improve over time, if these improvements meaningfully impact quality of life factors, if they correlate with markers of neuronal function, and if subpopulations can be identified according to response. Dysfunction of glutamatergic neuronal systems has recently been implicated in the pathophysiology of schizophrenia based on the finding that non-competitive inhibitors of the NMDA receptor can reproduce in normals the positive symptoms, negative symptoms, and cognitive deficits of schizophrenia. Furthermore, glutamatergic dysfunction may alter forebrain dopaminergic neuronal activity, a system central to the antipsychotic action of typical neuroleptics. It is believed that enhancing NMDA receptor function by systemic treatment with D-cycloserine, a partial agonist at the glycine modulatory site of the NMDA receptor, will reduce symptoms in schizophrenia. Sixty schizophrenic outpatients with prominent, primary negative symptoms are treated with antipsychotic medication and are randomly assigned to D-cycloserine or placebo for a 6-month, fixed-dose trial. The primary outcome measure is the total score on the Scale for Assessment of Negative Symptoms (SANS). A neuropsychological battery, which emphasizes tests sensitive to prefrontal cortical function, is administered. Blood is obtained at several time points and CSF is obtained at Week 8 for assay of concentrations of D-cycloserine, glutamate, HVA, and 5HIAA.

To characterize further the effects of D-cycloserine augmentation of antipsychotic treatment on negative symptoms, performance on neurocognitive tasks, and on markers for glutamatergic, dopaminergic, and serotonergic function in serum and cerebrospinal fluid. To determine if negative symptoms and cognitive function improve over time, if these improvements meaningfully impact quality of life factors, if they correlate with markers of neuronal function, and if subpopulations can be identified according to response. Dysfunction of glutamatergic neuronal systems has recently been implicated in the pathophysiology of schizophrenia based on the finding that non-competitive inhibitors of the NMDA receptor can reproduce in normals the positive symptoms, negative symptoms and cognitive deficits of schizophrenia. Furthermore, glutamatergic dysfunction may alter forebrain dopaminergic neuronal activity, a system central to the antipsychotic action of typical neuroleptics. It is believed that enhancing NMDA receptor function by systemic treatment with D-cycloserine, a partial agonist at the glycine modulatory site of the NMDA receptor, will reduce symptoms in schizophrenia. Sixty schizophrenic outpatients with prominent, primary negative symptoms are treated with antipsychotic medication and are randomly assigned to D-cycloserine or placebo for a 6-month, fixed-dose trial. The primary outcome measure is the total score on the Scale for Assessment of Negative Symptoms (SANS). A neuropsychological battery, which emphasizes tests sensitive to prefrontal cortical function, is administered. Blood is obtained at several time points and CSF is obtained at Week 8 for assay of concentrations of D-cycloserine, glutamate, HVA, and 5HIAA.

Schizophrenia

Adult Cognition Cycloserine Dopamine Female Glutamic Acid Human Male Receptors, N-Methyl-D-Aspartate Schizophrenia Serotonin Quality of Life Cycloserine -- *therapeutic use Dopamine -- blood Dopamine -- cerebrospinal fluid Glutamic Acid -- blood Glutamic Acid -- cerebrospinal fluid Serotonin -- blood Serotonin -- cerebrospinal fluid

null

2

arm 1: Subjects were given 50 mg/day of D-Cycloserine for 24 weeks arm 2: Participants were given 50 mg/day of Placebo for 24 weeks.

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: 50 mg/daily by mouth intervention 2: 50 mg/day of placebo by mouth

intervention 1: D-cycloserine intervention 2: Placebo

0

null

0

NCT00000371

[ 4 ]

65

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

Photodynamic therapy (PDT) was the selective destruction of abnormal cells through light activation of a photosensitiser in the presence of oxygen. These cells accumulated more photosensitiser than normal cells. The photosensitiser generated reactive oxygen species upon illumination. For skin diseases, there had been an increasing interest in using precursors of the endogenous photosensitiser protoporphyrin IX (PpIX). The most commonly used precursors have been 5-aminolevulinic acid (ALA) and its derivatives. The present test drug, Metvix, contained the methyl ester of ALA, which penetrated the lesions well and shows high lesion selectivity. In vitro studies of animal and human tissues had shown significant intracellular formation of photoactive porphyrins after addition of Metvix. The increased photoactive porphyrins levels induced cytotoxic effects in tumour cells after photoactivation. The primary objective was to compare PDT with Metvix cream to PDT with placebo cream in terms of participants complete response rates based on histologically verified disappearance of the lesions at 6 months after last treatment cycle. Secondary objectives was to compare the two treatments in terms of histological and clinical mean participant response weighted by the number of lesions within a participant, lesion response rates across participants, clinical complete participant response, cosmetic outcome and adverse events.

A participants were randomised to PDT with Metvix cream or PDT with placebo cream. All eligible basal cell carcinoma (BCC) lesions within a participant received same treatment. All participants received two consecutive treatments one week apart. At the 3-months follow-up visit, lesions with no clinical response or progression were surgically excised. Lesions with partial response 50 percent (%) or greater reduction on lesion area) were re-treated; if they do not show complete response three months later, they were surgically excised. Lesions with complete response were surgically excised 6 months after the first or second PDT cycle. All excised tissue specimens were histologically examined.

Basal Cell Carcinoma

Nodular Basal Cell Carcinoma Basal Cell Carcinoma PDT with Metvix 160 mg/g cream PDT with placebo cream Histological verification

null

2

arm 1: Participants with BCC lesions were administered to PDT with Metvix® cream 160 mg/g applied topically for three hours, followed by illumination using noncoherent light with a fluency of 75 Joule per centimeter square (J/cm\*2) and fluency rate of less than 50-200 milliwatt per centimeter square (mW/cm\*2) up to 14 weeks. All participants received two consecutive treatments, one week apart thereby completing one PDT treatment cycle. arm 2: Participants with BCC lesions were administered to PDT with Placebo cream applied topically for three hours, followed by illumination using noncoherent light with a fluency of 75 J/cm\*2 and fluency rate of 50-200 mW/cm\*2 up to 14 weeks. All participants received two consecutive treatments, one week apart thereby completing one PDT treatment cycle.

[ 0, 2 ]

3

[ 4, 0, 0 ]

intervention 1: None intervention 2: None intervention 3: None

intervention 1: Photodynamic Therapy (PDT) intervention 2: Metvix cream intervention 3: Placebo Cream

9

0

NCT00472108

[ 2 ]

13

RANDOMIZED

CROSSOVER

0TREATMENT

0NONE

true

0ALL

false

To investigate the pharmacokinetics of a single 900 mg oral dose of BIA 2-093 and a single 900 mg oral dose of Oxcarbazepine in healthy volunteers and to assess the tolerability of a single 900 mg dose of BIA 2-093 and Oxcarbazepine.

Single centre, open label, balanced randomised, two-way crossover study in 12 healthy volunteers. The study consisted of 2 periods separated by a washout period of 7 days or more. On each of the study periods the volunteers received either a single 900 mg oral dose of BIA 2-093 or a single 900 mg oral dose of Oxcarbazepine.

Epilepsy

Eslicarbazepine acetate Epilepsy Oxcarbazepine

null

2

arm 1: Period 1 - Subjects recieved 900 mg of BIA 2-093 Period 2 - Subjects recieved 900 mg of oxcarbazepine arm 2: Period 1 - Subjects recieved 900 mg of oxcarbazepine Period 2 - Subjects recieved 900 mg of BIA 2-093

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Tablets containing BIA 2-093 in doses of 300 and 600 mg intervention 2: Tablets containing 300 mg and 600 mg of Trileptal®

intervention 1: BIA 2-093 intervention 2: Oxcarbazepine

1

S. Mamede Do Coronado | Trofa | Portugal | N/A | N/A

0

NCT01678976

[ 4 ]

1,365

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

This study will assess the ability of montelukast to improve the signs and symptoms of perennial allergic rhinitis compared to placebo. Cetirizine is included in the study as an active control.

null

Perennial Allergic Rhinitis

null

3

arm 1: montelukast arm 2: cetirizine arm 3: placebo

[ 0, 1, 2 ]

3

[ 0, 0, 0 ]

intervention 1: montelukast 10 mg tablet orally once daily at bedtime for 6 weeks intervention 2: cetirizine 10 mg tablet orally once daily at bedtime for 6 weeks intervention 3: placebo tablet orally once daily at bedtime for 6 weeks

intervention 1: montelukast sodium intervention 2: Comparator: cetirizine intervention 3: Comparator: placebo

0

null

0

NCT00974571

[ 5 ]

110

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

The purpose of this study is to compare the safety and effectiveness of a select serotonin re-uptake inhibitor (SSRI, sertraline) and a tricyclic antidepressant (TCA, nortriptyline) in outpatients over the age of 60 who have major depression. SSRIs are effective in the treatment of major depression. However, there is also evidence that SSRIs may be significantly less effective than TCAs for patients with late-life major depression with melancholia. Since SSRIs seem to be easier to take than TCAs and are more widely prescribed, it is important to determine which of these types of antidepressants works best to treat these patients. Patients will be assigned randomly to receive either sertraline (a SSRI) or nortriptyline (a TCA) for 12 weeks. Patients will be monitored for symptoms, side effects, and quality of life. If a patient responds to treatment, he/she will participate in a 6-month continuation phase in which he/she will continue to receive the same medication. An individual may be eligible for this study if he/she: Has unipolar major depression (with some exceptions) and is over 60 years old.

To compare the efficacy and safety of a select serotonin re-uptake inhibitor (SSRI, sertraline) and a tricyclic antidepressant (TCA, nortriptyline) in outpatients over the age of 60 who meet Diagnostic and Statistical Manuel-IV criteria for unipolar major depression, excluding patients who meet criteria for psychotic or atypical subtype. To test the hypothesis that medication condition interacts with diagnostic subtype (melancholic vs non-melancholic) in determining antidepressant response. To examine the roles of symptom severity and alternative diagnostic subtyping in contributing to this pattern. SSRIs are effective in the treatment of major depression. However, there is also evidence that SSRIs may be significantly less effective than TCAs for depressed patients with melancholia. This issue is of particular concern in late-life major depression. SSRIs have important safety advantages with respect to overdose and a benign cardiovascular profile. Furthermore, the SSRIs do not have significant anticholinergic effects, and appear to be better tolerated than the TCAs. Perhaps most important, the SSRIs currently are prescribed widely as the medication treatment of first choice for major depression in late life. Therefore, if it were determined that SSRIs are considerably less effective than TCAs in the treatment of melancholia in the elderly, there would be significant ramifications for clinical practice. Randomization to sertraline (a SSRI) or nortriptyline (a TCA) is stratified by the presence or absence of melancholia. Outcome measures for the 12-week acute phase include clinician and patient ratings of symptoms, side effects, and an evaluation of the health-related quality of life (HRQOL). At the end of the acute treatment phase, patients who meet criteria for clinical response participate in a 6-month continuation phase.

Depression Melancholia

Aged Antidepressive Agents, Tricyclic Depression Female Human Male Middle Age Nortriptyline Sertraline Serotonin Uptake Inhibitors Antidepressive Agents, Tricyclic -- *therapeutic use Antidepressive Agents, Tricyclic -- adverse effects Depression -- *drug therapy Nortriptyline -- *therapeutic use Nortriptyline -- adverse effects Sertraline -- *therapeutic use Sertraline -- adverse effects Serotonin Uptake Inhibitors -- *therapeutic use Serotonin Uptake Inhibitors -- adverse effects

null

2

arm 1: patients randomized to sertraline 12 week trial does up to 200mgs arm 2: patients randomized to nortriptyline dose adjusted to therapeutic level

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: 12 week trial dose up to 200mgs intervention 2: 12 week trial dose adjusted to therapeutic level

intervention 1: Sertraline intervention 2: Nortriptyline

1

New York | New York | United States | -74.00597 | 40.71427

0

NCT00000378

[ 2 ]

24

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

This study is designed to assess the pharmacokinetics (PK) and safety of oseltamivir and its metabolite oseltamivir carboxylate in participants undergoing routine HD and CAPD for end-stage renal disease (ESRD). Participants will receive 6.5 and 6 weeks of the marketed oral oseltamivir suspension dosed according to the HD or CAPD schedule, respectively.

null

End Stage Renal Disease

null

2

arm 1: Participants will receive 30 milligrams (mg) of oseltamivir via oral suspension approximately 1 hour after alternating HD sessions. Sessions will occur three times per week within the 6.5-week study period, and participants will receive a total of 9 doses of oseltamivir. arm 2: Participants will receive 30 mg of oseltamivir via oral suspension once weekly after dialysis exchange. CAPD sessions will occur four times every 24 hours, and participants will receive a total of 6 doses of oseltamivir within the 6-week study period.

[ 0, 0 ]

1

[ 0 ]

intervention 1: Oseltamivir will be given as marketed oral suspension, 30 mg after HD or CAPD treatment.

intervention 1: Oseltamivir

1

Christchurch | N/A | New Zealand | 172.63333 | -43.53333

0

NCT02617784

[ 4 ]

25

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

null

false

The primary objective of this study was to determine the efficacy of etanercept plus methotrexate vs methotrexate alone in pediatric patients with active polyarticular course juvenile rheumatoid arthritis (JRA).

null

Juvenile Rheumatoid Arthritis

null

2

arm 1: Participants received placebo subcutaneous injections twice weekly and methotrexate once a week at the same dose as prior to study entry for 6 months. After month 6 participants received open-label 0.4 mg/kg etanercept twice weekly plus methotrexate for an additional 6 months. arm 2: Participants received 0.4 mg/kg etanercept subcutaneous injections twice weekly and methotrexate once a week at the same dose as prior to study entry for 6 months. After month 6 participants received open-label 0.4 mg/kg etanercept twice weekly plus methotrexate for an additional 6 months.

[ 2, 0 ]

3

[ 0, 0, 0 ]

intervention 1: Administered by subcutaneous injection twice a week intervention 2: Administered by subcutaneous injection twice a week intervention 3: Administered orally or subcutaneously once a week at the same dose as prior to study entry

intervention 1: Etanercept intervention 2: Placebo to Etanerceot intervention 3: Methotrexate

0

null

0

NCT03781375

[ 4 ]

160

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

A study to compare the efficacy of GW-1000-02 \[named Sativex® in Canada and also named Sativex® Oromucosal Spray\] with placebo in relieving five key symptoms of Multiple Sclerosis after six weeks of therapy.

Eligible subjects entered a one to two week baseline period; followed by a six week double blind, randomised, parallel group comparison of GW-1000-02 with placebo, self-titrated to symptom resolution or maximum tolerated dose. Existing medication continued at a constant dose. Primary efficacy comparisons were made between symptom scores recorded during baseline and scores recorded at the end of the parallel group period.

Multiple Sclerosis

null

2

arm 1: Active treatment arm 2: Control

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. The maximum permitted dose of study medication 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 2: Each actuation of placebo delivered the excipients only.

intervention 1: GW-1000-02 intervention 2: Placebo

1

Oxford | N/A | United Kingdom | -1.25596 | 51.75222

0

NCT01610700

[ 4 ]

154

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

An open-label extension study in which patients with multiple sclerosis received GW-1000-02 \[named Sativex® in Canada and also named Sativex® Oromucosal Spray\] for four weeks in an open-label manner.

Subjects who took part in GWMS0001 Part A were invited to continue to receive GW-1000-02 in this four-week open-label part of the study. Subjects received open-label cannabinoid extract (GW-1000-02) for four weeks, either with or without peppermint flavouring, according to their study centre. Subjects who completed the study could choose to continue receiving GW-1000-02 by entering the long-term safety extension follow-on study.

Multiple Sclerosis

null

1

arm 1: Active treatment.

[ 0 ]

1

[ 0 ]

intervention 1: Containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. The maximum permitted dose of study medication 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

0

NCT01610713

[ 2 ]

13

NA

SINGLE_GROUP

0TREATMENT

0NONE

true

0ALL

false

Multiple-dose, open-label, single-period study consisting of three consecutive phases

Multiple-dose, open-label, single-period study consisting of three consecutive phases: Phase A - run-in warfarin dose-finding phase Phase B - warfarin pharmacokinetics (PK) and international normalised ratio (INR) profiling Phase C - warfarin alone at their individualised doses

Epilepsy

null

1

arm 1: Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin

[ 0 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: BIA 2-093 intervention 2: Warfarin

0

null

0

NCT02287415

[ 2 ]

13

RANDOMIZED

CROSSOVER

0TREATMENT

3TRIPLE

true

0ALL

false

The purpose of this study is to investigate the effects of multiple-dose administration of BIA 2-093 on the steady-state pharmacokinetics of digoxin in healthy subjects.

Single centre, multiple-dose, double-blind, randomised, placebo-controlled, two-way crossover study in 12 healthy volunteers. The study consisted of two 8-day treatment periods separated by a washout of 10 or more days. During each of the treatment periods the volunteers received either a daily oral dose of BIA 2-093 1200 mg once-daily (od) or matching placebo, concomitantly with a dose of digoxin (days 1 and 2: loading dose of 0.5 mg/day; days 3 to 8: 0.25 mg/day).

Epilepsy

Eslicarbazepine acetate BIA 2-093

null

2

arm 1: BIA 2-093 1200 mg (2 tablets 600 mg) ESL, Eslicarbazepine acetate Concomitantly with a dose of digoxin (days 1 and 2: loading dose of 0.5 mg/day; days 3 to 8: 0.25 mg/day). arm 2: Placebo (2 tablets matching BIA 2-093 600 mg tablets) PLC, Placebo Concomitantly with a dose of digoxin (days 1 and 2: loading dose of 0.5 mg/day; days 3 to 8: 0.25 mg/day).

[ 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: BIA 2-093 1200 mg once-daily intervention 2: matching placebo intervention 3: Digoxin (days 1 and 2: loading dose of 0.5 mg/day; days 3 to 8: 0.25 mg/day).

intervention 1: BIA 2-093 intervention 2: Placebo intervention 3: Digoxin

1

Trofa | Coronado (S.Romão E S. Mamede) | Portugal | -8.5596 | 41.33729

0

NCT02172742

[ 5 ]

434

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

The purpose of the study is to compare the number of randomized participants in each treatment group who experience an acute rejection episode in the first 6 months after undergoing cardiac transplantation.

null

Heart Transplantation

null

2

arm 1: Daclizumab will be administered as a intravenous dose of 1 milligrams per kilogram \[mg/kg\] on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily \[BID\], cyclosporine 1-4 mg/kg IV or 2-6 mg/kg, and 500-1000 mg IV methylprednisolone peri operative switch to oral at 0.5-1 mg/kg/day followed by tapering. arm 2: Matching placebo will be administered on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily \[BID\], cyclosporine 1-4 mg/kg IV or 2-6 mg/kg orally, and 500-1000 mg IV methylprednisolone peri-op switch to oral at 0.5-1 mg/kg/day followed by tapering.

[ 0, 2 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: Daclizumab will be administered as 1 mg/kg IV within 12 hours post-op (Day 1), and Days 8, 22, 36 and 50. intervention 2: Methylprednisolone will be administered as 500-1000 mg IV and peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering till 0.0-0.15 mg/kg/day (up to 365 days). intervention 3: Mycophenolate mofetil will be administered as 1.5 grams bid begun post-op, either IV or orally as required up to 365 days. intervention 4: Matching placebo will be administered on Days 1, 8, 22, 36, and 50. intervention 5: Cyclosporine will be administered as 1-4 mg/kg IV or 2-6 mg/kg orally up to 365 days.

intervention 1: Daclizumab intervention 2: Methylprednisolone intervention 3: Mycophenolate mofetil intervention 4: Placebo intervention 5: cyclosporine

30

0

NCT00048165

[ 4 ]

66

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

To investigate the ability of Sativex to relieve central neuropathic pain in multiple sclerosis subjects.

Multiple sclerosis subjects with a clinical diagnosis of central neuropathic pain entered a seven to ten day baseline period, followed by a four week double blind, randomised, parallel group comparison of Sativex, with placebo. The study medication was self-titrated to symptom resolution or maximum tolerated or allowed dose. Visits occurred at the end of weeks one and four (end of the study) or earlier if they withdrew. A follow-up visit occurred 30 - 40 days after completion or withdrawal.

Multiple Sclerosis Neuropathic Pain

null

2

arm 1: Placebo control. arm 2: Active treatment.

[ 2, 0 ]

2

[ 0, 0 ]

intervention 1: Contained peppermint oil, 0.05% (v/v), quinoline yellow, 0.005% (w/v), sunset yellow, 0.0025% (w/v), in ethanol:propylene glycol (50:50) excipient. Each actuation delivered 100 μl. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period. intervention 2: Contained delta-9-tetrahydrocannabinol (THC), (25 mg/ml):cannabidiol (CBD), (25 mg/ml) as extract of Cannabis sativa L., with peppermint oil, 0.05% (v/v), in ethanol:propylene glycol (50:50) excipient. Each actuation delivered 100 μl (THC 2.5 mg and CBD 2.5 mg). The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.

intervention 1: Placebo intervention 2: Sativex

1

Liverpool | N/A | United Kingdom | -2.97794 | 53.41058

0

NCT01604265

[ 4 ]

70

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

To investigate the ability of a cannabis based medicine extract to relieve chronic refractory pain of neurological origin.

Patients with Multiple Sclerosis or other defect of neurological function with a qualifying symptom of chronic refractory pain, entered a seven day baseline period, followed by a 21 day randomised, double blind, parallel group comparison of GW-1000-02 with placebo, self-titrated to symptom resolution or maximum tolerated dose. The ability of the cannabis based medicine extract to relieve chronic refractory pain was assessed by the change from baseline in pain score using Box Scale-11 (BS-11) scores recorded in the patients' daily diary.

Pain Multiple Sclerosis

null

2

arm 1: Each 100 μl actuation contains 2.5 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). The maximum permitted dose was 48 actuations in any 24 hour period (120 mg THC/120 mg CBD). arm 2: Each 100 μl actuation contains the excipients only. The maximum permitted dose was 48 actuations in any 24 hour period

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Each actuation of GW-1000-02 (100 μl) delivered a dose containing 2.5 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). The maximum permitted dose of study medication was eight actuations in any three hour period (20 mg THC/20 mg CBD) and 48 actuations in any 24 hour period (120 mg THC/120 mg CBD). intervention 2: Each actuation of placebo (100 μl) delivered the excipients only. The maximum permitted dose of study medication was eight actuations in any three hour period and 48 actuations in any 24 hour period.

intervention 1: GW-1000-02 intervention 2: Placebo

1

Norfolk | N/A | United Kingdom | N/A | N/A

0

NCT01606176

[ 4 ]

48

RANDOMIZED

CROSSOVER

0TREATMENT

4QUADRUPLE

false

0ALL

false

A study to compare the efficacy of two sublingual cannabinoid based medicine extracts with placebo in the treatment of chronic pain due to brachial plexus injury.

This study used a three way crossover study design. Eligible patients recorded their symptoms during a one to two week baseline period, then entered a three period, double blind, randomised crossover of GW-1000-02, GW-2000-02 and placebo. Each period lasted two weeks, with no washout between periods. There were six possible treatment sequences. The primary analysis was based on Box Scale-11 pain severity scores recorded throughout the study in patient daily diary booklets. Blood samples were taken from patient-volunteers at the beginning of each period, for measurement of plasma cannabinoid concentration.

Pain

null

3

arm 1: Active treatment. arm 2: Active treatment. arm 3: Placebo control.

[ 0, 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: Contains delta-9-tetrahydrocannabinol (THC) (25 mg/ml) and cannabidiol (CBD) (25mg/ml) as extract of Cannabis sativa L, with peppermint oil, 0.05% (v/v), in ethanol:propylene glycol (50:50) excipient. Each actuation delivered 100 μl (THC 2.5 mg and CBD 2.5 mg). The maximum daily exposure was set at 48 actuations per day. intervention 2: Contains THC (25 mg/ml) as extract of Cannabis sativa L, with peppermint oil, 0.05% (v/v), in ethanol:propylene glycol (50:50) excipient. Each actuation delivered 100 μl (THC 2.5 mg). The maximum daily exposure was set at 48 actuations per day. intervention 3: Contains peppermint oil, 0.05% (v/v), quinoline yellow, 0.005% (w/v), sunset yellow, 0.0025% (w/v), in ethanol:propylene glycol (50:50) excipient. Each actuation delivered 100 μl. The maximum daily exposure was set at 48 actuations per day.

intervention 1: GW-1000-02 intervention 2: GW-2000-02 intervention 3: Placebo

1

Middlesex | N/A | United Kingdom | -0.26856 | 51.53174

0

NCT01606189

[ 4 ]

66

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

Photodynamic therapy (PDT) was the selective destruction of abnormal cells through light activation of a photosensitiser in the presence of oxygen. These cells accumulated more photosensitiser than normal cells. The photosensitiser generated reactive oxygen species upon illumination. For skin diseases, there had been an increasing interest in using precursors of the endogenous photosensitiser protoporphyrin IX (PpIX). The most commonly used precursors had been 5-aminolevulinic acid (ALA) and its derivatives. The present test drug, Metvix®, contained the methyl ester of ALA, which penetrated the lesions well and shows high lesion selectivity . In vitro studies of animal and human tissues had shown significant intracellular formation of photoactive porphyrins after addition of Metvix®. The increased levels of photoactive porphyrins induced cytotoxic effects in tumour cells after photoactivation. The primary objective was to compare PDT with Metvix® cream to PDT with placebo cream in terms of participant complete response rates based on histologically verified disappearance of the lesions at 6 months after last treatment cycle. Secondary objectives were to compare the two treatments in terms of histological and clinical mean participant response weighted by the number of lesions within a participant, lesion response rates across participants, clinical complete participant response, cosmetic outcome and adverse events.

A participant was randomised to PDT with Metvix® cream or PDT with placebo cream. All eligible Basal cell carcinoma (BCC) lesions within a participant had got the same treatment. All participants got two consecutive treatments one week apart. At the 3-months follow-up visit, lesions with no clinical response or progression had been surgically excised. Lesions with partial response (50% or greater reduction on lesion area) had been re-treated, if they do not show complete response three months later they would have been be surgically excised. Lesions with complete response had been surgically excised 6 months after the first or second PDT cycle. All excised tissue specimens had been histologically examined.

Basal Cell Carcinoma

Nodular Basal Cell Carcinoma Basal Cell Carcinoma Photodynamic therapy (PDT) Metvix Histological verification PDT with Metvix cream PDT with Placebo cream

null

2

arm 1: Methyl aminolevulinate hydrochloride 160 milligram (mg)/gram (g) cream were received by participants with primary nodular basal cell carcinoma. A thick layer of study cream was applied directly on the lesion and on 5 mm of the surrounding tissue. An approximately 1 mm thick layer of cream was applied to cover the lesion completely. The study cream was applied for at least 3 hours followed by illumination using non-coherent red (570-670 nm) light at a fluence of 50- 75 J/cm\^2. arm 2: Participants with primary nodular basal cell carcinoma received Metvix® matching placebo cream. A thick layer of study cream was applied directly on the lesion and on 5 mm of the surrounding tissue. An approximately 1 mm thick layer of cream was applied to cover the lesion completely. The study cream was applied for at least 3 hours followed by illumination using non-coherent red (570-670 nm) light at a fluence of 50- 75 J/cm\^2.

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: PDT with Metvix 160 mg/g cream intervention 2: Placebo

7

0

NCT00472043

[ 2 ]

24

RANDOMIZED

CROSSOVER

null

0NONE

true

0ALL

false

The objective of this study was to compare the rate and extent of absorption of venlafaxine hydrochloride 150 mg extended-release capsules (test) versus Effexor® XR (reference) administered as 1 x 150 mg extended-release capsule under fasting conditions.

null

Healthy

Bioequivalence Healthy Subjects

null

2

arm 1: 150 mg Venlafaxine Hydrochloride Extended-Release Capsules arm 2: 150 mg Effexor® XR Extended-Release Capsules

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: 150 mg Extended-Release Capsule intervention 2: 150 mg Extended-Release Capsule

intervention 1: Venlafaxine Hydrochloride intervention 2: Effexor® XR

1

Sainte-Foy | Quebec | Canada | -71.29217 | 46.78139

0

NCT01260896

[ 2 ]

18

RANDOMIZED

CROSSOVER

null

0NONE

true

0ALL

null

The objective of this study was to compare the rate and extent of absorption of venlafaxine hydrochloride 150 mg extended-release capsules (test) versus Effexor® XR (reference) administered as 1 x 150 mg extended-release capsule under fed conditions.

null

Healthy

Bioequivalence Healthy Subjects

null

2

arm 1: Venlafaxine Hydrochloride 150 mg Extended-Release Capsules arm 2: Effexor® XR 150 mg Extended-Release Capsules

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: 150 mg Extended-Release Capsule intervention 2: 150 mg Extended-Release Capsule

intervention 1: Venlafaxine Hydrochloride intervention 2: Effexor® XR

1

Sainte-Foy | Quebec | Canada | -71.29217 | 46.78139

0

NCT01282801

[ 4 ]

431

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

A randomised, multi-centre, double-blind, double dummy, two arm parallel design study to compare the efficacy, safety, and clinical benefit of the test and reference product after treatment for 84 days in patients with osteoarthritis of the knee.

null

Osteoarthritis, Knee Pain

null

2

arm 1: None arm 2: None

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: The patients orally self-administered the study medication: either 100, 200, 300 or 400 mg Tramadol HCl Contramid® Once A Day. Each patient was titrated to his or her optimum dose (up to a maximum of 400 mg) during the Titration Phase, which lasted between 4 and 12 days. The optimum dose was taken throughout the study. intervention 2: The patients orally self-administered the study medication: either 200, 300 or 400 mg Tramadol HCl Twice a day. Each patient was titrated to his or her optimum dose (up to a maximum of 400 mg) during the Titration Phase, which lasted between 4 and 12 days. The optimum dose was taken throughout the study.

intervention 1: Tramadol HCl Contramid® Once A Day intervention 2: Tramadol HCl Twice a day

0

null

0

NCT00950651

[ 3 ]

144

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

The purpose of this study is to determine the efficacy of BIA 2 093 in the treatment of epileptic patients with refractory simple or complex partial seizures with or without secondary generalization.

This clinical trial was performed as a multicentre, add-on, double-blind, randomised, placebo-controlled, phase II study. During the double-blind treatment phase (12 weeks) patients were assigned to three treatment groups receiving BIA 2 093 once daily (ODG - once-daily group), BIA 2 093 twice daily (TDG - twice-daily group) or placebo (PLG - placebo group), respectively. Daily doses of BIA 2 093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg). On completion of the 12-week double-blind treatment period, a 1-week tapering period was scheduled.

Epilepsy

Epilepsy BIA 2-093

null

3

arm 1: BIA 2-093 once-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg). arm 2: BIA 2-093 twice-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg). arm 3: placebo

[ 0, 0, 2 ]

2

[ 0, 0 ]

intervention 1: BIA 2-093 (tablets) administered at increasing daily doses of 400 mg, 800 mg and 1200 mg once-daily or twice-daily, oral route intervention 2: Placebo tablets administered orally

intervention 1: BIA 2-093 intervention 2: Placebo

1

S. Mamede Do Coronado | S. Mamede Do Coronado | Portugal | N/A | N/A

0

NCT02170077

[ 2 ]

27

RANDOMIZED

CROSSOVER

null

0NONE

true

2MALE

null

The purposes of this study were: * To evaluate the plasma pharmacokinetic profile of tramadol and its principal metabolite, the O-desmethyltramadol, after a single oral administration of 100, 200 and 300 mg of tramadol as the Labopharm extended-release formulation prepared with Contramid. * To assess the dose linearity of tramadol and its principal metabolite, the O-desmethyltramadol, between 100 mg and 300 mg following a single dose administration of the Labopharm extended-release formulation prepared with Contramid under fasting conditions in young healthy volunteers.

null

Healthy

Healthy volunteers

null

3

arm 1: None arm 2: None arm 3: None

[ 0, 0, 0 ]

1

[ 0 ]

intervention 1: One single oral administration of Tramadol HCl 100 mg, 200 mg or 300 mg as per randomization schedule.

intervention 1: Tramadol HCl

0

null

0

NCT00834808

[ 2 ]

36

RANDOMIZED

CROSSOVER

0TREATMENT

0NONE

true

0ALL

null

This study will establish the bioequivalence of the 20%, milled, roller compaction final market image (FMI) etoricoxib tablets and 30% unmilled, roller compaction (UMC) etoricoxib tablets.

null

Pain

null

2

arm 1: Etoricoxib, 20% tablet arm 2: Etoricoxib, 30% tablet

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: Single dose etoricoxib 120 mg 20% final market image tablet in one of two treatment periods. intervention 2: Single dose etoricoxib 120 mg 30% unmilled, roller compaction tablet in one of two treatment periods.

intervention 1: etoricoxib intervention 2: Comparator: etoricoxib

0

null

0

NCT00945035

[ 3 ]

8

RANDOMIZED

CROSSOVER

7BASIC_SCIENCE

0NONE

false

0ALL

false

A trial to compare if one 15 mg under the tongue tablet is equal to three 5 mg under the tongue tablets of Org 5222 (asenapine) in subjects with schizophrenia or schizoaffective disorder delivered.

null

Schizophrenia Schizoaffective Disorder

null

2

arm 1: None arm 2: None

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Three 5 mg sublingual tablets (15 mg) given twice daily for 2 days followed by one 15 mg sublingual tablet given twice daily for 1.5 days intervention 2: One 15 mg sublingual tablet given twice daily for 2 days followed by three 5 mg sublingual tablets (15 mg) given twice daily for 1.5 days.

intervention 1: Asenapine 3x5mg followed by 1x15mg intervention 2: Asenapine 1x15mg followed by 3x5mg

0

null

0

NCT01101464

[ 4 ]

301

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The purpose of this study is to evaluate the safety and efficacy of Asacol 4.8 g/day (800 mg tablet) versus Asacol 2.4 g/day (400 mg tablet

This study is designed to evaluate the safety and efficacy of 4.8 g/day using 800 mg Asacol tablets as compared to 2.4g/day using 400 mg Asacol tablets in newly- and previously-diagnosed patients who are experiencing a flare-up of mildly to moderately active ulcerative colitis.

Ulcerative Colitis

null

2

arm 1: mesalamine 2.4 g/day (400 mg tablet) for 6 weeks arm 2: mesalamine 4.8 g/day (800 mg tablet) for 6 weeks

[ 1, 0 ]

2

[ 0, 0 ]

intervention 1: mesalamine 2.4 g/day (400 mg tablet) for 6 weeks intervention 2: mesalamine 4.8 g/day (800 mg tablet) for 6 weeks

intervention 1: mesalamine intervention 2: mesalamine

44

0

NCT00577473

[ 3 ]

35

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

Conventional therapy is effective for diffuse aggressive lymphomas and low grade lymphomas, but is limited by relapse occurs in 40 to 50% of subjects. This study assesses autologous stem cell transplant (ASCT) supplemented with high-dose therapy increases the event-free survival in diffuse aggressive lymphomas and low grade lymphomas, as an alternative to the limitations of conventional therapy. Preliminary studies with rituximab in low grade lymphomas indicate a response rate of about 50% with very little toxicity. Rituximab is hypothesized to be a candidate for post-transplant therapy because the majority of malignant lymphomas express the CD20 antigen; rituximab has impressive independent anti-tumor activity; and the antibody has little toxicity outside of the acute administration.

The first 4 subjects received rituximab weekly for 4 weeks at the standard dose of 375 mg/m2, starting 6 weeks after ASCT transplant. After an observation period to assess acute and late toxicity for the first 4 subjects, subsequent subjects received induction as above followed by an additional 4 week course at 6-months post-ASCT.

Non-Hodgkin's Lymphoma Diffuse Large Cell Lymphoma Mantle Cell Lymphoma Transformed Lymphoma Other Subtypes of B-cell Lymphoma Lymphoma

non-Hodgkin's lymphoma diffuse large cell lymphoma mantle cell lymphoma transformed lymphoma other subtypes of B cell lymphoma recurrent lymphoma

null

1

arm 1: Rituximab 375 mg/m2 starting 6 weeks after ASCT transplant, and for the 5th and subsequent subjects, a second course at the same dose 6 months after ASCT.

[ 0 ]

1

[ 0 ]

intervention 1: None

intervention 1: Rituximab 375 mg/m2

1

Stanford | California | United States | -122.16608 | 37.42411

0

NCT00225212

[ 2 ]

24

RANDOMIZED

CROSSOVER

null

0NONE

true

0ALL

null

The objective of this study was to compare the rate and extent of absorption of venlafaxine hydrochloride 150 mg capsules (test) versus Effexor® XR (reference) administered as the content of 1 x 150 mg extended-release capsule mixed with applesauce under fasting conditions.

null

Healthy

Bioequivalence Healthy Subjects

null

2

arm 1: Venlafaxine Hydrochloride 150 mg Extended-Release Capsules. arm 2: Effexor® XR 150 mg Extended-Release Capsules

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: 150 mg Extended-Release Capsule intervention 2: 150 mg Extended-Release Capsule

intervention 1: Venlafaxine Hydrochloride intervention 2: Effexor® XR

1

Sainte-Foy | Quebec | Canada | -71.29217 | 46.78139

0

NCT01282814

[ 3 ]

306

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

true

0ALL

true

This was a placebo controlled, randomised, double-blind, double-dummy study of the efficacy of weekly tafenoquine compared with weekly mefloquine or placebo in the chemosuppression of P. falciparum in Nyanza Province, western Kenya.

Subjects were treated for 3 days with halofantrine to clear any existing parasitaemia. At the end of the clearance period, subjects free from malaria parasitaemia were randomized and received a loading dose of the study treatment (tafenoquine 200 mg, Mefloquine 250 mg or placebo) for tree days, followed by study treatment (tafenoquine 200 mg, mefloquine 250 mg or placebo, respectively) once a week for 24 weeks. After the treatment period subjects attended weekly follow-up safety visits until week 28.

Falciparum Parasitaemia

Falciparum Parasitaemia, Malaria

null

3

arm 1: Tafenoquine 200 mg for three days followed by Tafenoquine 200 once a week for 24 weeks. arm 2: Mefloquine 250 mg for three days followed by Mefloquine 250 once a week for 24 weeks. arm 3: Placebo

[ 0, 1, 2 ]

3

[ 0, 0, 0 ]

intervention 1: Tafenoquine 200 mg for three days followed by Tafenoquine 200 mg once a week for 24 weeks. intervention 2: Mefloquine 250 mg for three days followed by Mefloquine 250 mg once a week for 24 weeks. intervention 3: Placebo for three days followed by placebo once a week for 24 weeks

intervention 1: Tafenoquine intervention 2: Mefloquine intervention 3: Placebo

0

null

0

NCT02488980

[ 3 ]

4

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

RATIONALE: Current therapies for childhood Rhabdoid tumors provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of childhood Rhabdoid tumors. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on children (\> 6 months of age) with Rhabdoid tumors.

OVERVIEW: This is a single arm, open-label study in which children with Rhabdoid tumors 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. OBJECTIVES: * To determine the efficacy of Antineoplaston therapy in children with a Rhabdoid tumor, 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 a Rhabdoid tumor. * 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.

Rhabdoid Neoplasm of CNS

childhood rhabdoid 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 Rhabdoid tumor will receive Antineoplaston therapy (Atengenal + Astugenal).

intervention 1: Antineoplaston therapy (Atengenal + Astugenal)

1

Houston | Texas | United States | -95.36327 | 29.76328

0

NCT00003469

[ 3 ]

356

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

The purpose of this study is to evaluate the efficacy of the drug SM-13496 compared to a placebo and to haloperidol in patients with schizophrenia.

null

Schizophrenia

Schizophrenia Latuda Lurasidone

null

5

arm 1: Lurasidone 20 mg tablets arm 2: Lurasidone 40 mg tablets arm 3: Lurasidone 2 40 mg tablets arm 4: Haloperidol 10mg tablets arm 5: Matching Placebo to Lurasidone and Haloperidol

[ 0, 0, 0, 1, 2 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: Lurasidone 20mg/day tablets intervention 2: Lurasidone 40mg/day tablets intervention 3: Lurasidone 80mg/day - 2 40mg tablets intervention 4: Haloperidol 10mg/day tablets intervention 5: Matching Placebo to Lurasdione and Haloperidol

intervention 1: Lurasidone 20 mg intervention 2: Lurasidone 40mg intervention 3: Lurasidone 80 mg intervention 4: Haloperidol 10mg intervention 5: Placebo

34

0

NCT00044044

[ 3 ]

27

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

true

0ALL

false

This was a Phase 2, multicenter, randomized, double-blind pilot study in opioid-using adults to assess the presence, duration, and degree of opiate blockade as well as the safety and tolerability of Medisorb® naltrexone (VIVITROL®). Subjects were randomized in a 1:1:1 ratio to receive a single gluteal intramuscular (IM) injection of Medisorb naltrexone 75, 150, or 300 mg.

Potential subjects were screened within 21 days prior to dosing of study drug (Medisorb naltrexone or placebo) on Day 0. Screening evaluations included a baseline hydromorphone challenge session in which increasing doses of hydromorphone (0 mg \[placebo\], 3 mg, 4.5 mg, and 6 mg) were administered at hourly intervals to produce a cumulative dose-response curve. Throughout the 4-hour challenge period, subject-rated measures (Visual Analog Scale \[VAS\] questions) and physiological measures (ie, pupil size) were recorded. As a safety measure, at least 7 days after the baseline hydromorphone challenge, a naloxone challenge was performed followed by a 1-day oral naltrexone tolerability assessment. On Day 0, eligible subjects were administered a single dose of study drug. To assess the level of opiate blockade and surmountability attributable to Medisorb naltrexone, experimental hydromorphone challenge sessions were conducted postdose at Days 7, 14, 21, 28, 42, and 56, with a single placebo hydromorphone challenge administered at a randomly selected visit. Pupil size was measured 15 minutes prior to the first hydromorphone dose and at 15, 30, 45, and minutes after each ascending hydromorphone/placebo for hydromorphone dose. Blood samples for measurement of naltrexone and 6B-naltrexol were obtained at screening and before hydromorphone/placebo administration on Days 7, 14, 21, 28, 42, and 56. Subjects were monitored for safety through Day 56.

Opiate Dependence

null

3

arm 1: None arm 2: None arm 3: None

[ 0, 0, 0 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: Single administration via intramuscular (IM) injection. intervention 2: Single administration via IM injection. intervention 3: Single administration via IM injection. intervention 4: Increasing doses of 0, 3, 4.5, and 6 mg were administered at baseline (pre-study drug administration). After study drug administration, additional hydromorphone challenge sessions consisting of administering 0, 3, 4.5, and 6 mg were administered at 1-hr intervals at each of the postdose evaluation visits. In addition, at a randomly selected evaluation visit, subjects received four 0 mg (placebo) doses at 1-hour intervals. intervention 5: Administered according to the instructions provided by the respective manufacturer. Testing occurred at least 7 days after the baseline hydromorphone challenge and prior to study drug administration.

intervention 1: Medisorb naltrexone 75 mg intervention 2: Medisorb naltrexone 150 mg intervention 3: Medisorb naltrexone 300 mg intervention 4: Hydromorphone (10 mg/mL) intervention 5: Naloxone Challenge and Oral Naltrexone Tolerability Testing

0

null

0

NCT01218984

[ 4 ]

61

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

1FEMALE

false

The effects of stopping long-term (7 years) and short term (2 years) risedronate therapy on BMD (bone mineral density) and BTMs (bone turnover markers) will be summarized.

null

Postmenopausal Women With Osteoporosis

Postmenopausal Women Osteoporosis

null

2

arm 1: Placebo years 1-5, Risedronate 5mg/day years 6 \& 7, no drug year 8 arm 2: Risedronate 5mg years 1-7, no drug year 8

[ 2, 1 ]

2

[ 0, 0 ]

intervention 1: 5 mg/day intervention 2: placebo years 1-5 followed by 5 mg risedronate years 6 \& 7 and no drug year 8

intervention 1: Risedronate intervention 2: Placebo/Risedronate

13

0

NCT01249261

[ 2 ]

20

RANDOMIZED

CROSSOVER

null

2DOUBLE

true

0ALL

false

The purpose of this study is to assess the pharmacokinetics of buprenorphine and its metabolites in the presence and absence of ketoconazole.

To assess the pharmacokinetics of buprenorphine and its metabolites (nor-buprenorphine, buprenorphine 3 glucuronide and nor-buprenorphine glucuronide) in the presence and absence of ketoconazole. Safety evaluation of BTDS and ketoconazole in healthy subjects.

Healthy

Healthy subjects Opioid Transdermal

null

2

arm 1: BTDS 10 with ketoconazole 200 mg tablets twice daily in period 1 and BTDS 10 with ketoconazole placebo tablets twice daily in period 2. arm 2: BTDS 10 with ketoconazole placebo tablets twice daily in period 1 and BTDS 10 with ketoconazole 200 mg twice daily in period 2.

[ 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: Buprenorphine 10 mcg/hour patch applied transdermally for 7-day wear. intervention 2: Ketoconazole 200 mg tablets taken orally twice daily. intervention 3: Placebo to match ketoconazole 200 mg tablets taken orally twice daily.

intervention 1: Buprenorphine transdermal patch intervention 2: Ketoconazole tablet intervention 3: Placebo to match ketoconazole tablet

1

New Orleans | Louisiana | United States | -90.07507 | 29.95465

0

NCT01259115

[ 2 ]

12

NON_RANDOMIZED

SINGLE_GROUP

7BASIC_SCIENCE

0NONE

false

0ALL

false

There were 2 study periods in this study. In the Period 1, CP-690,550 was to be administered approximately 1 to 2 hours following hemodialysis. If significant non-renal clearance of the drug occurred such that dialyzability of CP-690,550 could not be assessed in Period 1, a second period (Period 2) will be conducted. In Period 2, a single dose of drug will be administered approximately 4 hours prior to hemodialysis.

null

End-Stage Renal Disease Hemodialysis

CP-690 550 pharmacokinetics end-stage renal disease

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: CP-690,550 10 mg oral powder for constitution

intervention 1: CP-690,550

2

0

NCT01710020

[ 3 ]

99

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

2MALE

false

This study investigates the efficacy, safety, and pharmacokinetics of sugammadex (Org 25969; MK-8616) when administered for the reversal of neuromuscular blockade in male participants receiving surgery, classified as American Society of Anesthesiologists (ASA) class 1 (otherwise normal, healthy participant) to class 2 (participant with mild systemic disease). The primary objective of this study is to explore the dose-response relation of sugammadex given as a reversal agent at 3, 5, or 15 minutes following administration of 0.6 mg/kg Esmeron®.

null

Neuromuscular Blockade

null

18

arm 1: Placebo (single intravenous (IV) bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. arm 2: Sugammadex (1 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. arm 3: Sugammadex (2 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. arm 4: Sugammadex (4 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. arm 5: Sugammadex (6 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. arm 6: Sugammadex (8 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. arm 7: Placebo (single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. arm 8: Sugammadex (1 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. arm 9: Sugammadex (2 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. arm 10: Sugammadex (4 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. arm 11: Sugammadex (6 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. arm 12: Sugammadex (8 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. arm 13: Placebo (single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. arm 14: Sugammadex (1 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. arm 15: Sugammadex (2 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. arm 16: Sugammadex (4 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. arm 17: Sugammadex (6 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®. arm 18: Sugammadex (8 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.

[ 2, 0, 0, 0, 0, 0, 2, 0, 0, 0, 0, 0, 2, 0, 0, 0, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: 0.9% NaCl administered as a fast IV bolus dose (within 30 seconds). intervention 2: Sugammadex administered as a fast IV bolus dose (within 30 seconds), dosed according to participant actual body weight. intervention 3: Esmeron® administered at 0.6 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.

intervention 1: Placebo intervention 2: Sugammadex intervention 3: Esmeron®

0

null

0

NCT03519854

[ 3 ]

40

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

RATIONALE: Current therapies for Glioblastoma Multiforme provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of brain tumors. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults (≥ 18 years of age) with residual/recurrent/progressive Glioblastoma Multiforme.

OVERVIEW: This is a single arm, open-label study in which adults (≥ 18 years of age) with residual/recurrent/progressed Glioblastoma Multiforme 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. OBJECTIVES: * To determine the efficacy of Antineoplaston therapy in adults (≥ 18 years of age) with residual/recurrent/progressive Glioblastoma Multiforme following initial therapy, including radiotherapy, 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 adults (≥ 18 years of age) with residual/recurrent/progressive Glioblastoma Multiforme. * 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.

Glioblastoma Multiforme of the Brain

adult glioblastoma recurrent glioblastoma

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: Adults with a residual/recurrent/progressive Glioblastoma Multiforme 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

0

NCT00003474

[ 3 ]

7

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

RATIONALE: Current therapies for adult recurrent/progressive low grade astrocytoma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of adult recurrent/progressive low grade astrocytoma. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults with a recurrent/progressive low grade astrocytoma.

OVERVIEW: This is a single arm, open-label study in which adults with a recurrent/progressive low grade astrocytoma 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. OBJECTIVES: * To determine the efficacy of Antineoplaston therapy in adults with a recurrent/progressive low grade astrocytoma, 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 adults with a recurrent/progressive low grade astrocytoma. * 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.

Low-Grade Astrocytoma, Nos

Recurrent/progressive adult low grade astrocytoma

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: Adults with a recurrent/progressive low grade astrocytoma 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

0

NCT00003471

[ 4 ]

238

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to evaluate the long-term safety (up to one year) of Tramadol Once-A-Day (OAD) tablets at the highest doses: 200-400 mg

null

Pain Osteoarthritis, Knee

null

4

arm 1: None arm 2: None arm 3: None arm 4: Despite provision in the protocol that the minimum daily dose was 200 mg, 2 patients took 100 mg against instructions.

[ 0, 0, 0, 5 ]

4

[ 0, 0, 0, 0 ]

intervention 1: None intervention 2: None intervention 3: None intervention 4: None

intervention 1: Tramadol OAD intervention 2: Tramadol OAD intervention 3: Tramadol OAD intervention 4: Tramadol OAD 100mg

0

null

0

NCT00912015

[ 2 ]

21

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

The purpose of this Phase I study is to test the safety of rhuMAb 2C4 to see what effects (good and bad) it has on patients with certain types of cancer, and also to find the highest dose of rhuMAb that can be given without causing severe side effects. All study participants will be assigned to specific group to evaluate different dosages of rhuMAb 2C4. The study is scheduled to run for up to one year depending on how patients respond to the study treatment.

null

Neoplasms

null

0

null

1

[ 0 ]

intervention 1: None

intervention 1: rhuMAb 2C4

1

Los Angeles | California | United States | -118.24368 | 34.05223

0

NCT00027027

[ 3 ]

54

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

null

This study will assess an investigational medication for patients with chronic renal insufficiency (pre-dialysis) who have secondary hyperparathyroidism.

null

Secondary Hyperparathyroidism Chronic Renal Insufficiency

null

2

arm 1: None arm 2: None

[ 0, 2 ]

1

[ 0 ]

intervention 1: Initially receive 1 tablet of study medication (cinacalcet or placebo) once daily. Possible sequential dose titrations are 30, 60, 90, 120, 180mg cinacalcet or placebo) daily. The titration phase was 12 weeks and the efficacy assessment phase was 6 weeks.

intervention 1: cinacalcet (AMG 073)

0

null

0

NCT00042432

[ 4 ]

565

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

The purpose of this study is to compare the analgesic efficacy and safety of Tramadol Once a Day 100, 200, 300 mg and Placebo

null

Pain Osteoarthritis, Knee

null

4

arm 1: None arm 2: None arm 3: None arm 4: None

[ 0, 0, 0, 0 ]

2

[ 0, 0 ]

intervention 1: One Tramadol Once A Day tablet at randomized dose daily. intervention 2: One Placebo tablet daily.

intervention 1: Tramadol Once A Day intervention 2: Placebo

0

null

0

NCT00832416

[ 2 ]

26

RANDOMIZED

CROSSOVER

0TREATMENT

0NONE

true

0ALL

null

The purpose of this study was to compare the pharmacokinetic profiles at steady-state of the test product, Tramadol HCl Once-A-Day (OAD) 200 mg tablets and the reference product, Tramadol HCl 50 mg (IR) tablets (Ortho-McNeil Ultram®). For this purpose, the extent of absorption of tramadol and formation of O-desmethyltramadol (measures of systemic exposure) after multiple administration of 50 mg 6-hourly at 07:30, 13:30, 19:30 and 01:30 (reference product) and 200 mg 24-hourly at 07:30 (test product), were compared.

null

Healthy Subjects Pharmacokinetics Bioavailability

Healthy subjects Pharmacokinetics Bioavailability

null

2

arm 1: None arm 2: None

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: 1x200 mg Tramadol HCl OAD tablet daily intervention 2: 1x50 mg Tramadol HCl IR (Ultram®) tablet 6-hourly

intervention 1: Tramadol HCl intervention 2: Tramadol HCl

0

null

0

NCT00834288

[ 3 ]

1,973

RANDOMIZED

PARALLEL

1PREVENTION

2DOUBLE

false

0ALL

null

The primary objective of this study is to establish the dose-response relationship with regard to efficacy and safety of BIBR 1048 (50 mg bis in die(b.i.d), 150 mg b.i.d, 225 mg b.i.d. and 300 mg quaque die(q.d) ) in preventing venous thromboembolism(VTE) in patients undergoing primary elective total hip and knee replacement.

null

Venous Thromboembolism

null

5

arm 1: BIBR 1048 50 mg b.i.d twice a day plus two capsules of placebo matching BIBR 1048 0 mg twice a day plus one placebo matching enoxaparin 0 mg once a day for the treatment period arm 2: BIBR 1048 150 mg b.i.d twice a day plus two capsules of placebo matching BIBR 1048 0 mg twice a day plus placebo matching enoxaparin 0 mg once a day for the treatment period arm 3: BIBR 1048 225 mg b.i.d twice a day plus two capsules of placebo matching BIBR 1048 0 mg twice a day plus placebo matching enoxaparin 0 mg once a day for the treatment period arm 4: BIBR 1048 150 mg q.d once a day plus placebo matching BIBR 1048 0 mg twice a day plus placebo matching enoxaparin 0 mg once a day for the treatment period arm 5: placebo matching BIBR 1048 0 mg twice a day plus enoxaparin 40 mg s.c once a day for the treatment period

[ 0, 0, 0, 0, 1 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: Enoxaparin 40 mg s.c once a day for 5-10 days of treatment period intervention 2: 50 mg b.i.d BIBR 1048 capsule twice a day for 5-10 days of treatment period intervention 3: 150 mg b.i.d BIBR 1048 capsule twice a day for 5-10 treatment period intervention 4: 225 mg b.i.d BIBR 1048 capsule twice a day for 5-10 treatment period intervention 5: 300 mg q.d BIBR 1048 capsule for 5-10 treatment period

intervention 1: Enoxaparin intervention 2: BIBR 1048 intervention 3: BIBR 1048 intervention 4: BIBR 1048 intervention 5: BIBR 1048

59

Linz | N/A | Austria | 14.28611 | 48.30639 Vienna | N/A | Austria | 16.37208 | 48.20849 Wiener Neustadt | N/A | Austria | 16.23196 | 47.80485 Brussels | N/A | Belgium | 4.34878 | 50.85045 Ghent | N/A | Belgium | 3.71667 | 51.05 Ghent | N/A | Belgium | 3.71667 | 51.05 Huy | N/A | Belgium | 5.23284 | 50.51894 La Louvière | N/A | Belgium | 4.18785 | 50.48657 Brno-Bohunice | N/A | Czechia | N/A | N/A Kladno | N/A | Czechia | 14.10285 | 50.14734 Mladá Boleslav | N/A | Czechia | 14.90318 | 50.41135 Ostrava | N/A | Czechia | 18.28204 | 49.83465 Pilsen | N/A | Czechia | 13.37759 | 49.74747 Prague | N/A | Czechia | 14.42076 | 50.08804 Frederiksberg | N/A | Denmark | 12.53463 | 55.67938 Hellerup | N/A | Denmark | 12.57093 | 55.73204 Herlev | N/A | Denmark | 12.43998 | 55.72366 Hørsholm | N/A | Denmark | 12.50111 | 55.88098 Silkeborg | N/A | Denmark | 9.54508 | 56.1697 Jyväskylä | N/A | Finland | 25.72088 | 62.24147 Oulu | N/A | Finland | 25.46816 | 65.01236 Illkirch-Graffenstaden | N/A | France | 7.71523 | 48.52894 La Rochelle | N/A | France | -1.15222 | 46.16308 Lyon | N/A | France | 4.84671 | 45.74846 Saint-Etienne | N/A | France | 4.39 | 45.43389 Saint-Herblain | N/A | France | -1.651 | 47.21154 Budapest | N/A | Hungary | 19.04045 | 47.49835 Gyula | N/A | Hungary | 21.28333 | 46.65 Kecskemét | N/A | Hungary | 19.69128 | 46.90618 Szeged | N/A | Hungary | 20.14824 | 46.253 Székesfehérvár | N/A | Hungary | 18.41034 | 47.18995 Bergamo | N/A | Italy | 9.66721 | 45.69601 Bologna | N/A | Italy | 11.33875 | 44.49381 Milan | N/A | Italy | 12.59836 | 42.78235 Pavia | N/A | Italy | 9.15917 | 45.19205 Varese | N/A | Italy | 8.82511 | 45.82058 Amsterdam | N/A | Netherlands | 4.88969 | 52.37403 Hilversum | N/A | Netherlands | 5.17639 | 52.22333 Nijmegen | N/A | Netherlands | 5.85278 | 51.8425 Sittard | N/A | Netherlands | 5.86944 | 50.99833 Zwolle | N/A | Netherlands | 6.09444 | 52.5125 Ålesund | N/A | Norway | 6.15492 | 62.47225 Bodø | N/A | Norway | 14.37513 | 67.28267 Bærum Postterminal | N/A | Norway | N/A | N/A Bærum Postterminal | N/A | Norway | N/A | N/A Elverum | N/A | Norway | 11.56231 | 60.88191 Haugesund | N/A | Norway | 5.268 | 59.41378 Skien | N/A | Norway | 9.60897 | 59.20962 Johannesburg | N/A | South Africa | 28.04363 | -26.20227 Johannesburg | N/A | South Africa | 28.04363 | -26.20227 Falköping | N/A | Sweden | 13.55068 | 58.17347 Gothenburg | N/A | Sweden | 11.96679 | 57.70716 Halmstad | N/A | Sweden | 12.85676 | 56.67446 Kalmar | N/A | Sweden | 16.36163 | 56.66157 Kungälvs | N/A | Sweden | N/A | N/A Lidköping | N/A | Sweden | 13.15765 | 58.50517 Linköping | N/A | Sweden | 15.62157 | 58.41086 Mölndal | N/A | Sweden | 12.01378 | 57.6554 Varberg | N/A | Sweden | 12.25078 | 57.10557

0

NCT01225822

[ 3, 4 ]

71

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The aim of this study is to investigate the effect of genistein administration on coronary arteries in humans. We will measure the size of a coronary artery and the speed and amount of blood flow in response after subjects have ingested Supro® drinks (a soy protein drink containing genistein).

null

Coronary Artery Disease

arteries blood flow coronary artery disease diet

null

2

arm 1: Supro drink once daily for 3 days arm 2: Drink identical to Supro but containing no genistein, once daily for 3 days

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Drink taken once daily intervention 2: Drink taken once daily

intervention 1: Genistein intervention 2: Placebo

1

London | N/A | United Kingdom | -0.12574 | 51.50853

0

NCT00287690

[ 4 ]

345

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

The purpose of this study is to assess the safety and efficacy of SPD503 (Guanfacine hydrochloride) compared to placebo in the treatment of ADHD in children and adolescents aged 6-17

null

Attention Deficit Disorder With Hyperactivity

null

4

arm 1: None arm 2: None arm 3: None arm 4: None

[ 0, 0, 0, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: None intervention 2: None intervention 3: None intervention 4: None

intervention 1: SPD503 (Guanfacine hydrochloride) (2 mg) intervention 2: SPD503 (3 mg) intervention 3: SPD503 (4 mg) intervention 4: Placebo

0

null

0

NCT00152009

[ 4 ]

103

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

Based on previous studies comparing Duteplase\[a recombinant tissue plasminogen activator (rt-PA) very similar to alteplase\] doses, we performed a clinical trial with 0.6mg/kg, which is lower than the internationally approved dosage of 0.9mg/kg, aiming to assess the efficacy and safety of alteplase for the Japanese.

Based on previous studies comparing Duteplase ( an rt-PA very similar to alteplase) doses, we performed a clinical trial with 0.6mg/kg, which is lower than the internationally approved dosage of 0.9mg/kg, aiming to assess the efficacy and safety of alteplase for the Japanese. The primary endpoints were the rate of patients with mRS score of 0-1 at 3 months and the incidence of sICH within 36 hours. Thresholds for these endpoints were determined by calculating 90% confidence intervals of weighted averages derived from published reports. The protocol was defined according to the National Institute of Neurological Disorders and Stroke (NINDS) rt-PA stroke study with slight modifications.

Cerebral Infarction Brain Ischemia

acute stroke thrombolytic therapy tissue plasminogen activator

null

1

arm 1: 0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour

[ 0 ]

1

[ 0 ]

intervention 1: 0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour

intervention 1: Alteplase

1

Suita | Osaka | Japan | 135.51567 | 34.76143

0

NCT00147316