phases list | enrollmentCount int64 | allocation string | interventionModel string | primaryPurpose class label | masking class label | healthyVolunteers bool | sex class label | oversightHasDmc bool | briefSummary string | detailedDescription string | conditions string | conditionsKeywords string | protocolPdfText string | numArms int64 | armDescriptions string | armGroupTypes list | numInterventions int64 | interventionTypes list | interventionDescriptions string | interventionNames string | numLocations int64 | locationDetails string | target int64 | nctid string |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
[
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 an... | 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 (33... | [
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 th... | 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 furoa... | [
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 significan... | Asthma | Albuterol Forced expiratory volume in one second Dose at fifty percent of maximum effect Maximum effective dose Metered dose inhaler Nebulizer | null | 0 | null | null | 1 | [
0
] | intervention 1: Albuterol administered sequentially 180mcg (MDI), 90mcg (MDI), 90mcg(MDI), 90mcg (MDI), 90mcg (MDI), 2.5mg (nebulized) | intervention 1: albuterol | 1 | Jacksonville | Florida | United States | -81.65565 | 30.33218 | 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... | 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 S... | 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 thera... | [
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 plac... | [
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 admin... | 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 Septemb... | 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... | [
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 mainte... | 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 dipropi... | 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 rel... | [
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... | 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... | null | HIV Infections Cognition Disorders | Acquired Immunodeficiency Syndrome AIDS-Related Complex | null | 2 | arm 1: Peptide T given intranasally at a dosage of 2mg 3 times a day for 6 months arm 2: Placebo given intranasally at a dosage of 2mg 3 times a day for 6 months | [
1,
2
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: Peptide T intervention 2: Placebo | 3 | Los Angeles | California | United States | -118.24368 | 34.05223
San Diego | California | United States | -117.16472 | 32.71571
Miami | Florida | United States | -80.19366 | 25.77427 | 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 va... | 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 hemo... | 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 fo... | [
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 t... | 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 ... | 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 recurr... | 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 supplem... | 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: Placeb... | intervention 1: Buprenorphine transdermal patch intervention 2: Placebo oxycodone/acetaminophen tablets intervention 3: OXY/APAP intervention 4: Placebo transdermal patch (TDS) | 12 | Huntsville | Alabama | United States | -86.58594 | 34.7304
Phoenix | Arizona | United States | -112.07404 | 33.44838
Phoenix | Arizona | United States | -112.07404 | 33.44838
Gainesville | Florida | United States | -82.32483 | 29.65163
Miami | Florida | United States | -80.19366 | 25.77427
Plantation | Florida | United... | 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 ... | 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 wer... | [
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 o... | 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 Antineo... | 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 tim... | 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 autono... | null | Hypotension, Orthostatic | null | 0 | null | null | 1 | [
0
] | intervention 1: None | intervention 1: Midodrine Hydrochloride | 15 | Huntsville | Alabama | United States | -86.58594 | 34.7304
Miramar | Florida | United States | -80.23227 | 25.98731
St. Petersburg | Florida | United States | -82.67927 | 27.77086
Chicago | Illinois | United States | -87.65005 | 41.85003
Baltimore | Maryland | United States | -76.61219 | 39.29038
Ann Arbor | Michigan |... | 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 ... | 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 accou... | Cytomegalovirus Retinitis HIV Infections | null | 2 | arm 1: Ganciclovir device and oral dose of Ganciclovir 1 gm three times daily arm 2: cidofovir intravenous (IV) start off with 5 mg/kg once weekly for two doses then followed by 5 mg/kg every other week | [
0,
0
] | 2 | [
1,
0
] | intervention 1: oral ganciclovir, 1 gm three times daily intervention 2: intravenous, 5 mg/kg once weekly for two doses, followed by 5 mg/kg every other week | intervention 1: Ganciclovir implant and oral ganciclovir intervention 2: Cidofovir intravenous | 19 | Irvine | California | United States | -117.82311 | 33.66946
La Jolla | California | United States | -117.2742 | 32.84727
Los Angeles | California | United States | -118.24368 | 34.05223
Los Angeles | California | United States | -118.24368 | 34.05223
San Francisco | California | United States | -122.41942 | 37.77493
Mi... | 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 melli... | 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 wi... | 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 ... | 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 singl... | 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... | 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 Antineopl... | 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 Ant... | 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: B... | [
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 acetami... | [
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 ... | 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) tha... | 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 Antine... | 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 ... | 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 wit... | [
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/d... | 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 ... | 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 ... | Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain. | Chronic Non-malignant Pain | Chronic pain opioid transdermal Butrans™ [BTDS] | null | 2 | arm 1: Buprenorphine transdermal patch arm 2: Placebo to match buprenorphine transdermal patch | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear. intervention 2: Placebo to match buprenorphine transdermal patch applied for 7-day wear. | intervention 1: Buprenorphine transdermal patch intervention 2: Placebo to match BTDS | 42 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Phoenix | Arizona | United States | -112.07404 | 33.44838
Trumbull | Connecticut | United States | -73.20067 | 41.24287
Clearwater | Florida | United States | -82.8001 | 27.96585
Coral Gables | Florida | United States | -80.26838 | 25.72149
DeLand | Florida | Un... | 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 breakf... | 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 ... | Chronic Nonmalignant Pain | Chronic nonmalignant pain Opioid Transdermal Butrans (BTDS) | null | 1 | arm 1: Buprenorphine transdermal patch | [
0
] | 1 | [
0
] | intervention 1: Buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear | intervention 1: Buprenorphine transdermal patch | 19 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Trumbull | Connecticut | United States | -73.20067 | 41.24287
Clearwater | Florida | United States | -82.8001 | 27.96585
Coral Gables | Florida | United States | -80.26838 | 25.72149
DeLand | Florida | United States | -81.30312 | 29.02832
Pembroke Pines | Florid... | 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 impr... | 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 imp... | 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 -- cereb... | 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 ... | 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 prog... | 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 1... | [
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 | Santa Monica | California | United States | -118.49138 | 34.01949
Minneapolis | Minnesota | United States | -93.26384 | 44.97997
Rochester | Minnesota | United States | -92.4699 | 44.02163
Albuquerque | New Mexico | United States | -106.65114 | 35.08449
Buffalo | New York | United States | -78.87837 | 42.88645
Portland... | 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 Oxcarbaze... | 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 ... | 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 o... | 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 -- adver... | 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 ... | 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... | [
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... | [
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 bet... | 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 2... | 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... | 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 2... | 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 1... | 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... | [
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... | [
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). interven... | intervention 1: Daclizumab intervention 2: Methylprednisolone intervention 3: Mycophenolate mofetil intervention 4: Placebo intervention 5: cyclosporine | 30 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Los Angeles | California | United States | -118.24368 | 34.05223
Tampa | Florida | United States | -82.45843 | 27.94752
Louisville | Kentucky | United States | -85.75941 | 38.25424
Baltimore | Maryland | United States | -76.61219 | 39.29038
Boston | Massachuse... | 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... | 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 h... | 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 tolerat... | 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... | [
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... | 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 pos... | 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 a... | 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 ... | 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 progres... | 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 th... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: PDT with Metvix 160 mg/g cream intervention 2: Placebo | 7 | Camperdown | New South Wales | Australia | 151.17642 | -33.88965
Kogarah | New South Wales | Australia | 151.13564 | -33.9681
Liverpool | New South Wales | Australia | 150.92588 | -33.91938
Benowa | Queensland | Australia | 153.38583 | -28.0077
Woolloongabba | Queensland | Australia | 153.03655 | -27.48855
Fitzroy | Vi... | 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 throu... | 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 ... | 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 linearit... | 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 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Anaheim | California | United States | -117.9145 | 33.83529
Sacramento | California | United States | -121.4944 | 38.58157
San Francisco | California | United States | -122.41942 | 37.77493
Denver | Colorado | United States | -104.9847 | 39.73915
Golden | Colo... | 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... | 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-mont... | 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 treatm... | 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... | 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 unacce... | 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 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Cerritos | California | United States | -118.06479 | 33.85835
Garden Grove | California | United States | -117.94145 | 33.77391
Glendale | California | United States | -118.25508 | 34.14251
La Mesa | California | United States | -117.02308 | 32.76783
Orange | ... | 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... | 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 t... | Opiate Dependence | 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 ... | 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 | Concord | New South Wales | Australia | 151.10381 | -33.84722
Parkville | Victoria | Australia | 144.95 | -37.78333
De Pintelaan 185 | Gent | Belgium | N/A | N/A
Hvidovre | Denmark | Denmark | 12.47708 | 55.64297
Oulu | Finland | Finland | 25.46816 | 65.01236
Siena | Italy | Italy | 11.33064 | 43.31822
Warsaw | Poland ... | 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. I... | 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 | Orlando | Florida | United States | -81.37924 | 28.53834
Minneapolis | Minnesota | United States | -93.26384 | 44.97997 | 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 ... | 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 afte... | [
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 acc... | 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 Antineopl... | 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 1... | 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... | 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 perfor... | 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 d... | 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 infusio... | 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 evalua... | null | Neoplasms | null | 0 | null | 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-desmethyltr... | 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 repla... | 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 enoxapa... | [
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 fo... | 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... | 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 pat... | 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 |
[
3
] | 63 | RANDOMIZED | PARALLEL | 2DIAGNOSTIC | 0NONE | false | 0ALL | false | The purpose of this study is to determine \[for patients with previously treated well-differentiated thyroid cancer and evidence of residual disease based on serum thyroglobulin (Tg) level\] whether positron emission tomography-computed tomography (PET-CT) fusion scanning performed after recombinant thyroid-stimulating... | PET/CT was performed before (basal PET) and 24 - 48 h after rhTSH administration (rhTSH-PET) in 63 patients (52 papillary and 11 follicular thyroid cancers). Images were blindly analyzed by two readers. The proposed treatment plan was prospectively assessed before basal PET, after basal PET, and again after rhTSH-PET. | Thyroid Cancer | thyroid cancer PET scan recombinant thyrotropin thyroglobulin Thyroid cancer, differentiated epithelial | null | 2 | arm 1: Euthyroid Group: Subjects received rhTSH to prepare for radioiodine therapy. arm 2: Hypothyroid Group: Thyroid hormone treatment was withheld before radioiodine therapy. | [
0,
4
] | 1 | [
0
] | intervention 1: Euthyroid Group: Received rhTSH to prepare for radioiodine therapy. | intervention 1: Euthyroid Group | 3 | Baltimore | Maryland | United States | -76.61219 | 39.29038
Houston | Texas | United States | -95.36327 | 29.76328
Paris | N/A | France | 2.3488 | 48.85341 | 0 | NCT00181168 |
[
2
] | 50 | RANDOMIZED | CROSSOVER | null | 0NONE | true | 0ALL | null | The object of this study is to compare the relative bioavailability of lansoprazole 30 mg delayed-release capsules (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA Pharmaceuticals USA) with that of PREVACID® capsules (TAP Pharmaceuticals, Inc.) in healthy, adult, subjects under non-fasting ... | Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA Bioequivalence Statistical Methods | Healthy | Bioequivalence Healthy Subjects | null | 2 | arm 1: Lansoprazole 30 mg Delayed-Release Capsule arm 2: Prevacid® 30 mg Delayed-Release Capsule | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 30 mg Delayed-Release Capsule intervention 2: 30 mg Delayed-Release Capsule | intervention 1: Lansoprazole intervention 2: Prevacid® | 1 | Saint Charles | Missouri | United States | -90.48123 | 38.78394 | 0 | NCT01046084 |
[
4
] | 249 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 1FEMALE | false | Multicenter, double-blind, controlled, parallel group, randomized study to compare the clinical benefit of Estradiol acetate tablets, estradiol tablets and conjugated equine estrogen tablets, each administered orally, once daily, to postmenopausal women. | null | Hormone Replacement Therapy | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: Tablet containing 0.9 mg E3A, daily oral administration. intervention 2: Tablet containing 1 mg estradiol, daily oral administration. intervention 3: Tablet containing 0.625 mg CEE, daily oral administration. | intervention 1: Estradiol acetate intervention 2: Estradiol intervention 3: Conjugated equine estrogens | 32 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Carmichael | California | United States | -121.32828 | 38.61713
San Diego | California | United States | -117.16472 | 32.71571
San Diego | California | United States | -117.16472 | 32.71571
Aventura | Florida | United States | -80.13921 | 25.95648
Boynton Beach ... | 0 | NCT01070979 | |
[
4
] | 624 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study conducted in subjects diagnosed with alcohol dependence as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Ed. (DSM-IV). Subjects were randomized (2:2:1:1) to receive intramuscular (IM) injections of Medisorb® ... | All subjects received standardized biopsychosocial support therapy (BRENDA Approach \[Volpicelli, JR \[2001\]; Guilford Press: New York\]) at each visit.
Subjects who completed this study (ie, received 6 injections of study drug and completed all study visits) and continued to meet eligibility criteria were given the ... | Alcoholism | Alcoholism | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
0,
0,
2,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: Intramuscular (IM) injection once every 4 weeks for a total of 6 administrations. intervention 2: IM injection once every 4 weeks for a total of 6 administrations. intervention 3: IM injection once every 4 weeks for a total of 6 administrations. intervention 4: IM injection once every 4 weeks for a tota... | intervention 1: Medisorb naltrexone 190 mg intervention 2: Medisorb naltrexone 380 mg intervention 3: Placebo matching Medisorb naltrexone 190 mg intervention 4: Placebo matching Medisorb naltrexone 380 mg | 0 | null | 0 | NCT01218958 |
[
3
] | 31 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Current therapies for Low-grade Non-Hodgkin's Lymphoma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Low-grade Non-Hodgkin's Lymphoma.
PURPOSE: This study is being performed to determine the effects (good and bad) t... | Low-grade Non-Hodgkin's Lymphoma patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity.
OBJECTIVES:
* To determine the eff... | Low-Grade Lymphoma | Low-grade non-Hodgkin's lymphoma | 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 Low-grade non-Hodgkin's lymphoma 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 | NCT00003499 |
[
3
] | 8 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | false | 0ALL | false | The objective of this study is to determine if the safety and tolerability of Immune Globulin Intravenous (Human), 10% Caprylate/Chromatograph Purified (IGIV-C) is similar when infused at two different infusion rates. | This is a prospective, randomized, single-center, open, cross-over trial in patients with a confirmed diagnosis of Idiopathic Thrombocytopenia Purpura (ITP). ITP is defined as isolated thrombocytopenia in a patient with no other clinically apparent associated conditions or factors that are known to cause thrombocytopen... | Purpura, Thrombocytopenic, Idiopathic | Idiopathic (Immune) Thrombocytopenic Purpura Immunoglobulin G | null | 2 | arm 1: Infusion #1 (Week 0) IGIV-C (0.08 mL/kg/min); Infusion #2 (Week \<6) IGIV-C (0.14 mL/kg/min) arm 2: Infusion #1 (Week 0) IGIV-C (0.14 mL/kg/min); Infusion #2 (Week \<6) IGIV-C (0.08 mL/kg/min) | [
0,
0
] | 1 | [
0
] | intervention 1: IGIV-C 10% at a dose of 1.0g/kg was to be given on 2 occasions as a single daily infusion: Group 1 were to receive their first IGIV-C, 10-% infusion at a rate of 0.08 mL/kg/min and a second infusion at 0.14 mL/kg/min. and Group 2 were to receive their first IGIV-C, 10-% infusion at a rate of 0.14 mL/kg/... | intervention 1: Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00220727 |
[
5
] | 463 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | true | 0ALL | false | The purpose of this study was to determine if bupropion plus counseling was more effective than bupropion alone or counseling alone in helping smokers quit smoking. | null | Tobacco Dependence Smoking | smoking cessation medications smoking cessation counseling | null | 4 | arm 1: Active bupropion SR plus eight 10-minute individual counseling sessions. arm 2: Active bupropion, No counseling, only medication checks arm 3: Placebo bupropion plus eight 10-minute individual counseling sessions arm 4: Placebo bupropion, No counseling, just medication checks | [
1,
1,
2,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: Medications-Pre-quit: 150 mg bupropion per day 7 days before quit attempt, then 150 mg twice daily for 4 days before quit attempt; then 150 mg bupropion twice daily for eight weeks.
Counseling-Pre-quit: two 10 minutes sessions before quit date; eight 10-minute sessions post quit date. intervention 2: M... | intervention 1: Active bupropion + counseling intervention 2: Active bupropion, No counseling intervention 3: Placebo medication + counseling intervention 4: Placebo medication, No counseling | 1 | Madison | Wisconsin | United States | -89.40123 | 43.07305 | 0 | NCT01621009 |
[
4
] | 51 | RANDOMIZED | CROSSOVER | 1PREVENTION | 2DOUBLE | false | 0ALL | false | The purpose of this study is to determine the effect of an approved medication being studied in support of a new approach in the prevention of exercise-induced asthma (a worsening of asthma caused by exercise, also known as exercise-induced bronchospasm), in participants who have a history of worsening asthma after exe... | null | Asthma, Exercise-Induced | null | 2 | arm 1: Montelukast - Placebo arm 2: Placebo - Montelukast | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Montelukast 10 mg tablet administered orally as a single witnessed dose before exercise challenge intervention 2: Placebo tablet administered orally as a single witnessed dose before exercise challenge | intervention 1: Comparator: Montelukast intervention 2: Comparator: Placebo | 0 | null | 0 | NCT00092131 | |
[
2
] | 80 | RANDOMIZED | CROSSOVER | null | 0NONE | true | 0ALL | false | The objective of this study is to compare the rate and extent of absorption of losartan 100 mg tablets (test) versus Cozaar® (reference), administered as 1 \* 100 mg tablet under fasting conditions. | Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA Bioequivalence Statistical Methods | Healthy | Bioequivalence Healthy Subjects | null | 2 | arm 1: Losartan 100mg Tablets arm 2: Cozaar® 100 mg Tablets | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 100 mg Tablet intervention 2: 100 mg Tablet | intervention 1: Losartan intervention 2: Cozaar® | 1 | Montreal | Quebec | Canada | -73.58781 | 45.50884 | 0 | NCT01124162 |
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