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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
[
3
] | 50 | NON_RANDOMIZED | PARALLEL | 2DIAGNOSTIC | 0NONE | false | 1FEMALE | null | The purpose of this trial is to evaluate the efficacy, safety and pharmacokinetics of BIBW 2992, a dual, irreversible EGFR- and HER2-inhibitor, in two cohorts of patients with HER2-negative breast cancer after failure of no more than three regimen of prior chemotherapy. | null | Breast Neoplasms | null | 1 | arm 1: high dose once daily | [
0
] | 1 | [
0
] | intervention 1: high dose once daily | intervention 1: BIBW 2992 | 14 | Brussels | N/A | Belgium | 4.34878 | 50.85045
Brussels | N/A | Belgium | 4.34878 | 50.85045
Charleroi | N/A | Belgium | 4.44448 | 50.41136
Ghent | N/A | Belgium | 3.71667 | 51.05
Leuven | N/A | Belgium | 4.70093 | 50.87959
Wilrijk | N/A | Belgium | 4.39513 | 51.16734
Berlin | N/A | Germany | 13.41053 | 52.52437
Düsseld... | 0 | NCT00425854 | |
[
2,
3
] | 5 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to identify the maximum tolerated dosage of sodium phenylbutyrate in children with spinal muscular atrophy type I; and to determine if the drug has an effect on SMN mRNA and protein levels. | Spinal muscular atrophy (SMA) is a genetic, neuromuscular disorder caused by progressive degeneration of motor neurons in the spinal cord, which results from the loss of survival motor neuron (SMN) protein. The disorder is characterized by weakness and wasting of the voluntary muscles and is a leading cause of heredita... | Spinal Muscular Atrophy Type I | spinal muscular atrophy type I SMA type I spinal muscular atrophy SMA sodium phenylbutyrate motor neuron disease neuromuscular survival motor neuron SMN dose escalation | null | 1 | arm 1: Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The dosage of the next cohort was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study M... | [
0
] | 1 | [
0
] | intervention 1: 500 mg/kg/day, depending upon tolerability subsequent dosages may increase to 675, 900, or 1200 mg/kg/day to identify maximum tolerated dose (MTD) and then an additional 6 participants will enroll at the MTD. | intervention 1: sodium phenylbutyrate | 5 | Stanford | California | United States | -122.16608 | 37.42411
Boston | Massachusetts | United States | -71.05977 | 42.35843
New York | New York | United States | -74.00597 | 40.71427
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Dallas | Texas | United States | -96.80667 | 32.78306 | 0 | NCT00439218 |
[
5
] | 621 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This purpose of this study is to show the superiority and long term safety and efficacy of adding a long acting beta agonist (salmeterol) to constant dose of an inhaled corticosteroid (fluticasone propionate) in symptomatic subjects with asthma. The 12-month assessment of asthma control will provide key information on ... | null | Asthma | fluticasone propionate long-term study Salmeterol FLOVENT 250 Asthma ADVAIR 250 | null | 2 | arm 1: Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID arm 2: Fluticasone propionate 250 mcg BID | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID intervention 2: Fluticasone propionate 250 mcg BID | intervention 1: Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID intervention 2: Fluticasone propionate 250 mcg BID | 74 | Scottsdale | Arizona | United States | -111.89903 | 33.50921
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Fountain Valley | California | United States | -117.95367 | 33.70918
Los Angeles | California | United States | -118.24368 | 34.05223
Rancho Mirage | California | United States | -116.41279 | 33.73... | 0 | NCT00452699 |
[
5
] | 72 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | true | In the Psychiatric Emergency Room, agitated patients are treated routinely with an I.M. Haloperidol "cocktail" (Haloperidol 5 mg, Lorazepam 2 mg, Cogentin 2 mg), which has proved to be an effective treatment. However, since it is an intramuscular injection, it is more complicated and perhaps less acceptable to patients... | In the Psychiatric Emergency Room, agitated patients are treated routinely with an I.M. Haloperidol "cocktail" (Haloperidol 5 mg, Lorazepam 2 mg, Cogentin 2 mg), which has proved to be an effective treatment. However, since it is an intramuscular injection, it is more complicated and perhaps less acceptable to patients... | Agitation | null | 4 | arm 1: Quetiapine is being used in an ER setting on agitated patients, being administered orally. arm 2: "Haloperidol" is being used in an ER setting on agitated patients, administered IM. This is being used in combination with lorazepam and cogentin. We are comparing the use of this "cocktail" to quetiapine alone. arm... | [
1,
1,
1,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: Quetiapine 300mg PO/Initial dose and repeat dose at 2 hours if deemed clinically necessary up to a maximum dose of Quetiapine 600mg PO QD intervention 2: given in combination with Lorazepam 2 mg IM, Cogentin 2 mg IM; repeated at 2 hours as deemed clinically necessary intervention 3: given in combination... | intervention 1: Quetiapine intervention 2: Haloperidol intervention 3: Lorazepam intervention 4: Cogentin | 1 | Los Angeles | California | United States | -118.24368 | 34.05223 | 0 | NCT00457366 | |
[
0
] | 80 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | true | 0ALL | false | The purpose of this study is to determine if milk and molasses enema or PEG 3350 works better for treatment of fecal impaction in children who are constipated. | Constipation is a common condition in childhood and occurs without evidence of a pathological condition in most children. Symptoms range from decreased appetite to abdominal pain and constipation is frequently diagnosed in children evaluated in emergency departments. A general guideline for constipation treatment is fe... | Constipation | constipation treatment fecal impaction pediatric | null | 2 | arm 1: Rectal enema containing mixture of milk and molasses arm 2: Medication to be taken orally once each day for three consecutive days | [
1,
1
] | 2 | [
0,
0
] | intervention 1: PEG 3350 1.5 gram/kg for disimpaction then 0.8 gram/kg for maintenance intervention 2: enema 10 cc/kg per rectum (max 500 cc)then PEG 3350 0.8 gram/kg for maintenance | intervention 1: PEG 3350 intervention 2: milk and molasses enema | 1 | Kansas City | Missouri | United States | -94.57857 | 39.09973 | 0 | NCT00467350 |
[
0
] | 20 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Primary Objective:
1\. To determine whether the primary endpoint: the composite success rate, defined as the proportion of patients who are alive at day 100; and are without grade 3-4 Graft versus Host Disease (GVHD); and are without grade 4 toxicity (unrelated to infection); and have engrafted, is likely to be at lea... | The combination of drugs used for this study will help to weaken your immune system, which may help to allow the donor's blood stem cells to engraft (grow) in your body.
Anti-thymocyte globulin (also called ATG or thymoglobulin) is designed to help reduce the risk of transplant rejection and to help prevent graft vers... | Lymphoma Leukemia | Non-Hodgkin's Lymphoma Chronic Lymphocytic Leukemia Hodgkin's Lymphoma Lymphoma Leukemia Mycophenolate Mofetil Tacrolimus Thymoglobulin Total Lymphoid Irradiation | null | 1 | arm 1: Total Lymphoid Irradiation (2 times) at 80 cGy daily for five days + Thymoglobulin 1.5 mg/kg intravenous 5 days + Rituximab 375 mg/m\^2 intravenous on 4 different days + Blood stem cell transplant (BSCT) | [
0
] | 4 | [
0,
4,
3,
0
] | intervention 1: 1.5 mg/kg by vein on Days -11 to -7. intervention 2: 80 cGy daily on days -11 to -7 and -4 to 0. intervention 3: PBSC infusion administered on day 0. intervention 4: 375 mg/m\^2 by vein on days -13, -6, 1, \& 8. Only those patients whose tumors express CD20 will receive Rituximab. | intervention 1: Thymoglobulin intervention 2: Total Lymphoid Irradiation intervention 3: Peripheral Blood Stem Cell Infusion intervention 4: Rituximab | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00476229 |
[
4
] | 64 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of the study is to compare two types of treatment for atrial fibrillation (AF) that are designed to treat the symptoms of atrial fibrillation. The treatments being compared are:
* A single catheter ablation procedure with the investigational EAS, a visually-guided, light-energy catheter
* Standard drug the... | null | Atrial Fibrillation | AF PAF paroxysmal atrial fibrillation ablation failed drugs | null | 2 | arm 1: Single ablation procedure with Endoscopic Ablation System arm 2: Medication | [
0,
1
] | 2 | [
1,
0
] | intervention 1: Single ablation procedure with Endoscopic Ablation System intervention 2: Medication as prescribed by physician. | intervention 1: Endoscopic Ablation System intervention 2: Standard Anti-arrhythmic Drug (AAD) Therapy | 18 | Scottsdale | Arizona | United States | -111.89903 | 33.50921
Sacramento | California | United States | -121.4944 | 38.58157
San Francisco | California | United States | -122.41942 | 37.77493
Santa Monica | California | United States | -118.49138 | 34.01949
Atlantis | Florida | United States | -80.10088 | 26.5909
Orland... | 0 | NCT00477230 |
[
2,
3
] | 23 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The objective is to evaluate the cytogenetic response to Dasatinib (BMS-354825) administered for 24 weeks in subjects with Imatinib resistant or intolerant chronic phase chronic myeloid leukemia (CML) once daily (QD) or twice daily. (BID) | null | Myeloid Leukemia, Chronic | Imatinib resistant or intolerant chronic phase CML | null | 2 | arm 1: None arm 2: None | [
0,
0
] | 2 | [
0,
0
] | intervention 1: tablets, Oral, 100 mg, once daily intervention 2: tablets, Oral, 50 mg, twice daily | intervention 1: Dasatinib intervention 2: dasatinib | 9 | Nagoya | Aichi-ken | Japan | 136.90641 | 35.18147
Nishinomiya-Shi | Hyōgo | Japan | N/A | N/A
Kagoshima | Kagoshima-ken | Japan | 130.55 | 31.56667
Isehara-Shi | Kanagawa | Japan | N/A | N/A
Kyoto | Kyoto | Japan | 135.75385 | 35.02107
Hamamatsu | Shizuoka | Japan | 137.73333 | 34.7
Bunkyo-Ku | Tokyo | Japan | N/A | N/... | 0 | NCT00482703 |
[
3,
4
] | 291 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to assess the effects (good and bad) of golimumab (CNTO 148) therapy in participants with active ulcerative colitis (UC) (sores in the colon). | This is a randomized (study medication assigned by chance), double-blind (neither the Physician nor the participant know about the study medication), placebo-controlled (an inactive substance; a pretend treatment \[with no drug in it\] that is compared in a clinical trial with a drug to test if the drug has a real effe... | Colitis, Ulcerative | Colitis, ulcerative Golimumab CNTO 148 | null | 4 | arm 1: Matching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0 arm 2: Golimumab 1 mg per kg intravenous (IV) infusion administered at Week 0. arm 3: Golimumab 2 mg per kg intravenous (IV) infusion administered at Week 0. arm 4: Golimumab 4 mg per kg, intravenous (IV)... | [
2,
0,
0,
0
] | 4 | [
10,
0,
0,
0
] | intervention 1: Matching placebo for golimumab, intravenous infusion administered at Week 0 intervention 2: Golimumab 1 mg per kg intravenous (IV) infusion administered at Week 0 intervention 3: Golimumab 2 mg per kg intravenous (IV) infusion administered at Week 0 intervention 4: Golimumab 4 mg per kg intravenous (IV)... | intervention 1: Placebo intervention 2: Golimumab 1 mg per kg intervention 3: Golimumab 2 mg per kg intervention 4: Golimumab 4 mg per kg | 108 | Orange | California | United States | -117.85311 | 33.78779
Roseville | California | United States | -121.28801 | 38.75212
Littleton | Colorado | United States | -105.01665 | 39.61332
Bristol | Connecticut | United States | -72.94927 | 41.67176
Tampa | Florida | United States | -82.45843 | 27.94752
Fort Dodge | Iowa | ... | 0 | NCT00488774 |
[
4
] | 338 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to compare the safety and effectiveness of bevasiranib given either every 8 weeks or every 12 weeks after an initial pre-treatment with 3 injections of Lucentis® (ranibizumab injection) compared to Lucentis® given every 4 weeks to people with wet AMD. Patients will be assigned at random (li... | null | Macular Degeneration | AMD Macular Degeneration bevasiranib COBALT study age related macular degeneration wet AMD wet age related macular degeneration | null | 3 | arm 1: Lucentis® (0.5mg) every 4 weeks. arm 2: Bevasiranib (2.5mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 \& 6. arm 3: Bevasiranib (2.5mg) every 12 weeks beginning at week 12, after pre-treatment with 3 injections of Luc... | [
1,
0,
0
] | 2 | [
0,
0
] | intervention 1: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks intervention 2: Lucentis® (0.5 mg)administered intravitreally every 4 weeks. | intervention 1: bevasiranib intervention 2: ranibizumab | 60 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | United States | -110.92648 | 32.22174
Fresno | California | United States | -119.77237 | 36.74773
Mountain View | California | United States | -122.08385 | 37.38605
Pasadena | Californi... | 0 | NCT00499590 |
[
3
] | 101 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 1FEMALE | false | The purpose of this study is to examine the efficacy and safety of OPC-249 by once daily inhalation at 0 (placebo), 30, 60 or 120 IU for 4 weeks in patients with pain due to osteoporosis. | null | Pain Due to Osteoporosis | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
2,
1,
1,
1
] | 1 | [
0
] | intervention 1: 1 pugh/day for 4 weeks (30 IU, 60IU, or 90IU) | intervention 1: OPC-249 | 5 | Chubu Region | N/A | Japan | N/A | N/A
Hokkaido Region | N/A | Japan | N/A | N/A
Kanto Region | N/A | Japan | N/A | N/A
Kinki Region | N/A | Japan | N/A | N/A
Kyushu Region | N/A | Japan | N/A | N/A | 0 | NCT00504426 | |
[
4
] | 136 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to determine whether CG5503 (tapentadol) is effective and safe in the treatment of chronic tumor related pain compared to placebo. | Normally chronic tumor related pain is controlled when subjects receive repeated doses of opioid analgesics. However, opioid therapy is commonly associated with side effects such as nausea, vomiting, sedation, constipation, addiction, tolerance, and respiratory depression. Tapentadol, a newly synthesized drug with an P... | Pain Neoplasm Cancer | Chronic Tumor Related Pain Analgesic Tapentadol Extended Release Morphine Sulfate Controlled Release Pain assessment Placebo | null | 3 | arm 1: Oral Tapentadol 100 mg to 250 mg twice daily. Followed by matching placebo in the maintenance (i.e. randomized withdrawal phase). arm 2: Oral Morphine 45 mg to 90 mg twice daily. arm 3: Oral Tapentadol 100 mg to 250 mg twice daily. | [
2,
1,
0
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: None intervention 2: Participant started the trials with 45 mg morphine controlled release twice daily. Upward titration could then occur at a minimum of 3-day intervals in increments of 15 mg morphine twice daily. The maximum dose of morphine controlled release was 90 mg twice daily. Downward titration... | intervention 1: Tapentadol in the Titration Phase intervention 2: Morphine in the Maintenance Phase intervention 3: Matching Placebo in the Maintenance Phase after Tapentadol in the Titration Phase intervention 4: Tapentadol in the Maintenance Phase intervention 5: Morphine in the Titration Phase | 37 | St. Petersburg | Florida | United States | -82.67927 | 27.77086
Elkhart | Indiana | United States | -85.97667 | 41.68199
Shreveport | Louisiana | United States | -93.75018 | 32.52515
Cedarhurst | New York | United States | -73.7243 | 40.62288
Glens Falls | New York | United States | -73.64401 | 43.30952
Winston-Salem |... | 0 | NCT00505414 |
[
4
] | 84 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The objective of this open-label extension is to assess the long-term effect of the 24-hour transdermal delivery of rotigotine on motor function, sleep quality, and nocturnal and non-motor symptoms of Parkinson's disease. The long-term safety and tolerability of the rotigotine transdermal patch will also be evaluated. | null | Parkinson's Disease | Neupro® Rotigotine Parkinson's Disease | null | 1 | arm 1: Rotigotine Transdermal Patch | [
0
] | 1 | [
0
] | intervention 1: Rotigotine transdermal patches:
10cm2 (2mg/24h); 20cm2 (4mg/24h); 30cm2 (6mg/24h); 40cm2 (8mg/24h)
Optimal dosing: The maximum rotigotine dose allowed is 16mg/24h | intervention 1: Rotigotine | 21 | St. Petersburg | Florida | United States | -82.67927 | 27.77086
Salisbury | North Carolina | United States | -80.47423 | 35.67097
Concord | N/A | Australia | 151.10381 | -33.84722
Oulu | N/A | Finland | 25.46816 | 65.01236
Berlin | N/A | Germany | 13.41053 | 52.52437
Dresden | N/A | Germany | 13.73832 | 51.05089
Kassel... | 0 | NCT00519532 |
[
2,
3
] | 20 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This study will test a new, extended release form of hydrocortisone called Chronocort in patients with congenital adrenal hyperplasia (CAH). People with CAH do not make enough of the adrenal hormones cortisol and aldosterone, and their adrenal glands make too much of the sex hormone androgen. Medicines called glucocort... | Congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency is a disease of the adrenal cortex characterized by cortisol deficiency with or without aldosterone deficiency, and androgen excess. The severe or classic form occurs in 1 in 15,000 births worldwide, while the mild non-classic form is a common cause ... | Congenital Adrenal Hyperplasia 21-Hydroxylase Deficiency Adrenogenital Syndrome | Congenital Adrenal Hyperplasia Hydrocortisone Pharmacokinetic Pharmacodynamic | null | 1 | arm 1: Cortef 3 times daily(total dose 30 mg)for minimum of 7 days followed by Chronocort 30 mg once daily nigh time dose for 28 +/- 3 days duration | [
0
] | 2 | [
0,
0
] | intervention 1: Chronocort 30 mg once daily nigh time dose for 28 +/- 3 days duration intervention 2: Cortef 3 times daily(total dose 30 mg)for minimum of 7 days | intervention 1: Chronocort intervention 2: Cortef | 1 | Bethesda | Maryland | United States | -77.10026 | 38.98067 | 0 | NCT00519818 |
[
3
] | 10 | RANDOMIZED | PARALLEL | 7BASIC_SCIENCE | 1SINGLE | true | 0ALL | false | With this study, the investigators will like to determine if taking a dose of the study medication, called Polypodium leucotomos (PL), prevents some of the changes in the skin caused by the adverse effects of UVA, a type of ultraviolet light. | null | Aging Skin Abnormalities | Polypodium leucotomos, Ultraviolet Rays, Heliocare, calaguala, anapsos Skin Aging and Damage | null | 2 | arm 1: Subject is given a 7.5 mg/kg dose of Polypodium leucotomos. arm 2: Subject is not given any treatment. | [
0,
4
] | 1 | [
0
] | intervention 1: Subject is given a 7.5 mg/kg oral dose of Polypodium leucotomos during Baseline visit, and again at 8 hours and 2 hours before the Follow-up visit #2. | intervention 1: Polypodium leucotomos | 1 | Miami | Florida | United States | -80.19366 | 25.77427 | 0 | NCT00520910 |
[
3
] | 31 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The study will test the safety and tolerability of Apremilast twice a day in participants with recalcitrant plaque type psoriasis. | This is a phase 2, multicenter, open-label, study to evaluate the safety, tolerability, pharmacodynamics, pharmacokinetics and efficacy of Apremilast in participants with recalcitrant plaque-type psoriasis.
Approximately 31 participants were enrolled and received 20 mg apremilast orally BID and, in participants who ar... | Psoriasis-Type Psoriasis Plaque-Type Psoriasis | Apremilast, Psoriasis, PASI-75, sPGA | null | 1 | arm 1: Apremilast 20 mg or 30 mg orally twice per day | [
0
] | 1 | [
0
] | intervention 1: 20 mg PO (by mouth) twice per day (BID) for 84 days and then an additional 84 days during the optional treatment extension period. For subjects meeting the dose escalation criteria, dosage during the optional treatment extension period can be increased to 30 mg BID. | intervention 1: Apremilast | 4 | Boston | Massachusetts | United States | -71.05977 | 42.35843
St Louis | Missouri | United States | -90.19789 | 38.62727
Portland | Oregon | United States | -122.67621 | 45.52345
Dallas | Texas | United States | -96.80667 | 32.78306 | 0 | NCT00521339 |
[
0
] | 12 | RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, abnormal cells are killed. Photodynamic therapy using topical aminolevulinic acid may be effective against actinic keratosis.
PURPOSE: This randomized clinical trial is studying how w... | OBJECTIVES:
Primary
* To determine, using fluorescence measurements, the protoporphyrin IX (PpIX) accumulation in thin actinic keratoses (AK) and actinically damaged skin on the face, scalp, and upper torso (stratum 1) and the PpIX accumulation in thick AK and actinically damaged skin on the arms and legs (stratum 2)... | Precancerous/Nonmalignant Condition | actinic keratosis | null | 5 | arm 1: Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT. arm 2: Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT arm 3: Patients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm,... | [
0,
0,
0,
0,
0
] | 2 | [
0,
3
] | intervention 1: None intervention 2: None | intervention 1: aminolevulinic acid intervention 2: laser therapy | 1 | Buffalo | New York | United States | -78.87837 | 42.88645 | 0 | NCT00524485 |
[
3
] | 52 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 2MALE | false | This exploratory study will be conducted open label in a single investigational clinical unit. Altogether 52 patients with benign prostate hyperplasia (BPH) will be randomly assigned to receive 4 different treatments with degarelix. | The present study aims at exploring the potential of the currently available formulation of degarelix to treat BPH with only a short transient lowering of the serum testosterone concentration to or below the castration level defined as 0.5 ng/mL. Two doses and two dosing regimens (32 and 64 mg administered either as a ... | BPH | Benign Prostate Hyperplasia BPH PK/PD GnRH antagonist | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
0,
0,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: Two doses of 16 mg each administered as two administrations (separated by 14 days) will be evaluated for 42 days. intervention 2: One dose of 32 mg administered as a single administration will be evaluated for 42 days. intervention 3: Two doses of 32 mg each administered as two administrations (separate... | intervention 1: Degarelix intervention 2: Degarelix intervention 3: Degarelix intervention 4: Degarelix | 1 | Mönchengladbach | N/A | Germany | 6.44172 | 51.18539 | 0 | NCT00527488 |
[
3
] | 98 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this Phase 2 randomized study is to evaluate the efficacy and safety of treatment with a regimen of VELCADE, dexamethasone, and thalidomide (VDT) or VELCADE, dexamethasone, thalidomide, and cyclophosphamide (VDTC) in subjects with newly diagnosed symptomatic multiple myeloma who have received no prior tr... | null | Multiple Myeloma | null | 2 | arm 1: bortezomib, dexamethasone, and thalidomide arm 2: bortezomib, dexamethasone, thalidomide, and cyclophosphamide | [
0,
0
] | 2 | [
0,
0
] | intervention 1: VELCADE (bortezomib) twice weekly for 4 cycles (4 doses per cycle), prior to high-dose chemotherapy (HDT) and stem cell transplantation(SCT). Subjects will receive VELCADE 1.3 mg/m2 as an intravenous (i.v.) bolus injection on Days 1,4,8, and 11, followed by a 10 day rest period (Days 12 to 21)
Dexameth... | intervention 1: bortezomib, dexamethasone, and thalidomide intervention 2: bortezomib, dexamethasone, thalidomide, and cyclophosphamide | 1 | Vienna | Vienna | Austria | 16.37208 | 48.20849 | 0 | NCT00531453 | |
[
4
] | 1,742 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | The purpose of this study is to determine whether 2 doses of the combination of naltrexone SR and bupropion SR are safe and effective in the treatment of obesity. | Two Phase II clinical trials demonstrated that a combination of bupropion SR and naltrexone is associated with greater weight loss than bupropion SR alone, naltrexone alone, or placebo in subjects with uncomplicated obesity. The current study investigated the safety and efficacy of 2 doses of the combination of naltrex... | Obesity Overweight | Obesity Antiobesity agents Antiobesity drugs Overweight drug therapy Obese drug therapy Weight loss drug effects Bupropion administration and dosage Naltrexone administration and dosage Double blind method Combination drug therapy Delayed action preparations | null | 3 | arm 1: Naltrexone SR 16 mg/Bupropion SR 360 mg /day with ancillary therapy arm 2: Naltrexone SR 32 mg/Bupropion SR 360 mg /day with ancillary therapy arm 3: Placebo with ancillary therapy | [
0,
0,
2
] | 4 | [
0,
0,
0,
5
] | intervention 1: None intervention 2: None intervention 3: None intervention 4: Ancillary therapy consisting of diet instruction, advice on behavior modification, and exercise counseling | intervention 1: Naltrexone SR 16 mg/Bupropion SR 360 mg /day intervention 2: Naltrexone SR 32 mg/Bupropion SR 360 mg /day intervention 3: Placebo intervention 4: Ancillary therapy | 34 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Fairhope | Alabama | United States | -87.90333 | 30.52297
Chandler | Arizona | United States | -111.84125 | 33.30616
Anaheim | California | United States | -117.9145 | 33.83529
Orange | California | United States | -117.85311 | 33.78779
San Diego | California ... | 0 | NCT00532779 |
[
3
] | 503 | RANDOMIZED | PARALLEL | 1PREVENTION | 0NONE | false | 0ALL | true | The primary objective is to evaluate the safety and feasibility of using M118 as an anticoagulant in the target population of subjects with stable coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI).
The secondary objectives are to evaluate the effect of M118 on procedural indices includi... | null | Coronary Artery Disease (CAD) | Percutaneous Coronary Intervention (PCI) | null | 4 | arm 1: Venous injection (IV) of 70 units per kilogram (U/kg) of unfractionated heparin prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given. arm 2: Venous injection of 50 international units per kilogram (IU/kg) of M118 prior to percu... | [
1,
0,
0,
0
] | 2 | [
0,
0
] | intervention 1: intravenous (IV) infusion intervention 2: IV infusion | intervention 1: M118 intervention 2: Unfractionated Heparin | 44 | Little Rock | Arkansas | United States | -92.28959 | 34.74648
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Fort Lauderdale | Florida | United States | -80.14338 | 26.12231
Jacksonville | Florida | United States | -81.65565 | 30.33218
Ormond Beach | Florida | United States | -81.05589 | ... | 0 | NCT00543400 |
[
5
] | 140 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 1FEMALE | null | This 2 arm study will investigate the efficacy and safety of Bonviva (150mg po monthly) in the prevention of glucocorticoid-induced osteoporosis in post-menopausal women. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly, with vitamin D and calcium supplementation. The anticipated time o... | null | Postmenopausal Osteoporosis | null | 2 | arm 1: Participants received monthly oral ibandronate (150 milligrams \[mg\]) for 12 months. arm 2: Participants received monthly oral placebo for 12 months. | [
0,
2
] | 2 | [
0,
0
] | intervention 1: po monthly for 12 months intervention 2: 150mg po monthly for 12 months | intervention 1: Placebo intervention 2: ibandronate | 15 | Hämeenlinna | N/A | Finland | 24.46434 | 60.99596
Helsinki | N/A | Finland | 24.93545 | 60.16952
Helsinki | N/A | Finland | 24.93545 | 60.16952
Helsinki | N/A | Finland | 24.93545 | 60.16952
Hyvinkää | N/A | Finland | 24.86667 | 60.63333
Jyväskylä | N/A | Finland | 25.72088 | 62.24147
Jyväskylä | N/A | Finland | 25.720... | 0 | NCT00545051 | |
[
5
] | 125 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This is a two-arm, parallel, randomized, double-blind, placebo-controlled Phase 4 multicenter trial to compare the whole day efficacy of atomoxetine versus placebo in children aged 6 through 12 years with Attention-Deficit/Hyperactivity Disorder (ADHD) treated in an inpatient, day-patient and outpatient setting in Germ... | null | Attention Deficit Hyperactivity Disorder | null | 2 | arm 1: 0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose. arm 2: Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine | [
0,
2
] | 2 | [
0,
0
] | intervention 1: A one-week atomoxetine treatment period with the 0.5 mg/kg per day lead-in dose will be succeeded by a 7 week period at the target dose of 1.2 mg/kg per day. 3 capsules of study medication have to be taken once daily in the morning, with or without food. intervention 2: 3 capsules of placebo have to be ... | intervention 1: Atomoxetine intervention 2: Placebo | 16 | Berlin | N/A | Germany | 13.41053 | 52.52437
Cologne | N/A | Germany | 6.95 | 50.93333
Datteln | N/A | Germany | 7.3453 | 51.65598
Dorsten | N/A | Germany | 6.96514 | 51.66166
Düsseldorf | N/A | Germany | 6.77616 | 51.22172
Eberswalde | N/A | Germany | 13.81951 | 52.83492
Freiburg im Breisgau | N/A | Germany | 7.85222 ... | 0 | NCT00546910 | |
[
3
] | 38 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The present pharmacokinetic (PK)-pharmacodynamic (PD) study will explore the toxicity and antileukemic response during the initial 3 months of individualised therapy of children and young adults with acute lymphoblastic leukemia (ALL). The investigators will on an individual toxicity-titrated basis attempt to increase ... | In addition to the details above we will also explore
* the relationship of the post-HD-MTX MRD-levels with the dose of 6MP, TPMT-activity, DNA-6TGN, E-6TGN, E-MeMP, E-MTX, and presence of ASP-antibodies,
* the early development of anti-ASP antibodies during continuous PEG-ASP therapy.
The study could improve the und... | Leukemia, Lymphocytic, Acute | Leukemia, Lymphocytic, Acute [C04.557.337.428.511] 6-mercaptopurine methotrexate asparaginase | null | 1 | arm 1: All patients received basic daily 6MP (6-mercaptopurine) (25 mg/m\^2) and in addition high-dose methotrexate(HDM) every 3rd week (3 times HDM in total) and PEG-asparaginase every 14th day. Patients increased the dose of 6MP 2 weeks after each HDM if if the myelotoxicity had been acceptable. This means 2 incremen... | [
0
] | 1 | [
0
] | intervention 1: Standard dose 25 mg/m\^2/day. Can be increased up to 75 mg/m\^2/day if the myelosuppression is acceptable (ANC\>0.5 T-count \>50) | intervention 1: 6-mercaptopurine | 3 | Copenhagen | N/A | Denmark | 12.56553 | 55.67594
Odense | N/A | Denmark | 10.38831 | 55.39594
Gothenburg | N/A | Sweden | 11.96679 | 57.70716 | 0 | NCT00548431 |
[
0
] | 101 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to determine whether treating apathy with methylphenidate or medical Crisis counselling will increase adherence to weight loss programs thereby increasing their effectiveness | Title: The role of Apathy in the effectiveness of weight loss interventions in obese patients
Objective: Obesity is a major public health problem. Apathy is a common behavioral problem characterized by loss of initiative, poor motivation and persistence. Presence of apathy impairs the self-care behavior in obese patie... | Obesity Apathy | apathy obesity methylphenidate MOVE medical crisis counselling | null | 5 | arm 1: standard nutrition counselling arm 2: MOVE -weight loss intervention arm 3: MOVE plus medical crisis counselling arm 4: MOVE plus methylphenidate arm 5: MOVE plus methyphenidate plus medical crisis counselling | [
4,
0,
0,
0,
0
] | 8 | [
5,
5,
5,
0,
5,
0,
5,
5
] | intervention 1: is a VA based multidesciplinary weight loss intervention intervention 2: group counselling sessions intervention 3: is a VA based multidesciplinary weight loss intervention intervention 4: methyphenidate will be used to treat apathy dose 10mg bid intervention 5: is a VA based multidesciplinary weight lo... | intervention 1: MOVE intervention 2: medical crisis councelling intervention 3: MOVE intervention 4: methyphenidate intervention 5: MOVE intervention 6: methyphenidate intervention 7: medical crisis councelling intervention 8: MOVE | 1 | Omaha | Nebraska | United States | -95.94043 | 41.25626 | 0 | NCT00548652 |
[
3
] | 80 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | true | 0ALL | true | Cigarette smoking continues to be a major public health problem. Tobacco dependence interventions, as recommended by the USPHS Clinical Practice Guideline are not effective for all smokers. A need exists for new medications to treat various aspects of tobacco dependence, such as the reinforcing effects of nicotine, rel... | Once enrolled in study, the subject will be put in one of 2 groups by chance (as in the flip of a coin). They will either receive methylphenidate or a placebo. Everyone in study will receive nicotine dependence counseling based on the intervention manual "Smoke Free and Living It". Everyone will be asked to complete we... | Smoking | nicotine dependence tobacco dependence | null | 2 | arm 1: 54 mg Methylphenidate per day for 8 weeks. Allowing for a ramp up in the first two weeks (starting dose is 18 mg/day). arm 2: non-active (sugar pill)designed to be a look-alike to the methylphenidate. Given at the same frequency and dosage look-alike to the active comparator (methylphenidate 54 mg) | [
1,
2
] | 2 | [
0,
0
] | intervention 1: 54 mg Methylphenidate per day for 8 weeks. Allowing for a ramp up in the first two weeks (starting dose is 18 mg/day). intervention 2: non-active (sugar pill)designed to be a look-alike to the methylphenidate. Given at the same frequency and dosage look-alike to the active comparator (methylphenidate 54... | intervention 1: Methylphenidate intervention 2: Placebo | 1 | Rochester | Minnesota | United States | -92.4699 | 44.02163 | 0 | NCT00549640 |
[
4
] | 1,267 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | The purpose of this study is to evaluate the efficacy and safety of two doses of VI-0521 compared to placebo in treatment of obesity in an adult population with BMI ≥ 35. | null | Obesity | Obesity, morbid obesity | null | 3 | arm 1: VI-0521; low dose phentermine/topiramate (PHEN/TPM 3.75 mg/23 mg) arm 2: Top Dose VI-0521 consisting of 15 mg of Phentermine and 92 mg of Topiramate. arm 3: Placebo to match | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: 3.75 mg phentermine/23 mg topiramate intervention 2: 15 mg phentermine/92 mg topiramate intervention 3: Placebo matched phentermine/topiramate | intervention 1: VI-0521 intervention 2: VI-0521 intervention 3: Placebo matched phentermine/topiramate | 5 | San Diego | California | United States | -117.16472 | 32.71571
Ridgefield | Connecticut | United States | -73.49818 | 41.28148
Durham | North Carolina | United States | -78.89862 | 35.99403
Toledo | Ohio | United States | -83.55521 | 41.66394
Austin | Texas | United States | -97.74306 | 30.26715 | 0 | NCT00554216 |
[
5
] | 20 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | AD is a disease found in children; the focus of the study is the mechanisms associated in children with AD induced by food allergies.
This study will be a randomized, double-blind, placebo-controlled, parallel group trial conducted in participants diagnosed with atopic dermatitis and food allergies. The study duration... | null | Atopic Dermatitis | Atopic Dermatitis (Eczema) associated with food allergies | null | 2 | arm 1: Montelukast arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age intervention 2: Oral granules or chewable tablet, PO QD (given oral daily) | intervention 1: Montelukast intervention 2: Placebo | 2 | Centennial | Colorado | United States | -104.87692 | 39.57916
Thornton | Colorado | United States | -104.97192 | 39.86804 | 0 | NCT00557284 |
[
3
] | 52 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to assess the effect of telaprevir on early hepatitis (inflammation of the liver) C virus (HCV) viral kinetics in treatment-naive participants who are chronically (lasting a long time) infected with genotype 2 or 3 HCV. | This is a Phase 2a multicenter (when more than one hospital or medical school team work on a medical research study), partially blinded, randomized (study drug assigned by chance) stratified (arrange in groups for analysis of results e.g., stratify by age, sex, etc.) for genotype, multiple dose study. The trial will co... | Hepatitis C, Chronic | Hepatitis C, Chronic Genotype 2 Genotype 3 Telaprevir | null | 6 | arm 1: Participants who are never treated for chronic hepatitis C (inflammation of the liver) genotype 2 will receive telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants will then be treated with standard treatment regimen of pegylate... | [
0,
0,
1,
0,
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: Telaprevir 750 mg tablet will be administered three times a day orally for 2 weeks. intervention 2: Standard treatment of Peg-IFN-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (400 mg as oral tablet twice daily) will be administered from Day 15 to Week 24 or 26 in the T2 \& PR24 - ... | intervention 1: Telaprevir intervention 2: Peg-IFN-alfa-2a + Ribavirin (Standard Treatment) intervention 3: Placebo | 7 | Clichy | N/A | France | 2.30952 | 48.90018
Créteil | N/A | France | 2.46569 | 48.79266
Lyon | N/A | France | 4.84671 | 45.74846
Paris | N/A | France | 2.3488 | 48.85341
Vandœuvre-lès-Nancy | N/A | France | 6.17114 | 48.66115
Stockholm | N/A | Sweden | 18.06871 | 59.32938
London | N/A | United Kingdom | -0.12574 | 51.50... | 0 | NCT00561015 |
[
4
] | 294 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to evaluate the tolerability, safety and treatment response of flexible doses of paliperidone extended-release (ER; designed to slowly release a drug in the body over an extended period of time) tablets in participants with acute schizophrenia (psychiatric disorder with symptoms of emotiona... | This is an open-label (all people know the identity of the intervention), single-arm (getting one dose of medicine), multi-center (conducted in more than 1 center) study to evaluate tolerability, safety and efficacy of flexible daily doses of paliperidone ER in participants with acute schizophrenia. All participants wi... | Schizophrenia | Schizophrenia Paliperidone Extended Release (ER) Invega | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators' discretion will be given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase. | intervention 1: Paliperidone | 30 | Zagreb | N/A | Croatia | 15.97798 | 45.81444
Dieppe | N/A | France | 1.07772 | 49.9216
La Charité-sur-Loire | N/A | France | 3.01667 | 47.18333
Metz | N/A | France | 6.17269 | 49.11911
Augsburg | N/A | Germany | 10.89851 | 48.37154
Bonn | N/A | Germany | 7.09549 | 50.73438
Mainz | N/A | Germany | 8.2791 | 49.98419
Mann... | 0 | NCT00566631 |
[
2
] | 7 | NA | SINGLE_GROUP | 9OTHER | 0NONE | false | 0ALL | false | Many children with end stage renal disease develop hyperlipidemia. HMG-CoA (3-hydroxy-3-methylglutaryl-coenzyme A) reductase inhibitors, such as pravastatin, are typical treatments for hyperlipidemia. However, we do not know how pravastatin is metabolized in patients on dialysis. This study is designed to provide preli... | This is a single-dose pilot study to evaluate the pharmacokinetic profile of pravastatin in 7 pediatric and adolescent subjects ranging from 12 months to 16 years of age who are on dialysis. The study group will be comprised of healthy children receiving continuous cycling peritoneal dialysis (CCPD). Pravastatin dosing... | End Stage Renal Disease | pravastatin, peritoneal dialysis, pediatric patients | null | 1 | arm 1: PK profile of pravastatin | [
5
] | 1 | [
0
] | intervention 1: A single 10 mg dose of pravastatin will be administered 3 mL blood samples for pravastatin Pharmacokinetic evaluations will be collected at 0.5, 1, 2, 3, 4, 6, and 8 hours. 5 mL blood samples for pravastatin PK and laboratory evaluations will be drawn at pre-dose and 24 hours.
Vital Signs and Physical ... | intervention 1: pravastatin | 1 | Little Rock | Arkansas | United States | -92.28959 | 34.74648 | 0 | NCT00571194 |
[
3
] | 80 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | true | 0ALL | false | Gabapentin is an anti-epileptic agent that has shown preliminary evidence of efficacy for improving symptoms of cocaine and alcohol withdrawal in pilot studies. Since the neurobiology of alcohol, cocaine and nicotine withdrawal is similar, the preliminary evidence of efficacy of gabapentin for symptoms of alcohol and c... | A total of 120 participants will be recruited in this study and randomly assigned to one of the three groups. Participants in group A will receive gabapentin 1800-mg/day orally for 12-weeks while participants in group B will receive gabapentin 2700-mg/day orally for 12-weeks. Participants in group C will receive a matc... | Cigarette Smoking Tobacco Use | tobacco smoking gabapentin abstinence | null | 3 | arm 1: Non active placebo pill arm 2: Gabapentin - 1800 mg/day arm 3: Gabapentin - 2700 mg/day | [
2,
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: Placebo pill - non active sugar pill designed to look alike to the gabapentin medication intervention 2: gabapentin - 1800 mg/day for 12 weeks. intervention 3: gabapentin - 2700 mg/day for 12 weeks. | intervention 1: Placebo intervention 2: Gabapentin - 1800 mg/day intervention 3: Gabapentin - 2700 mg/day | 1 | Rochester | Minnesota | United States | -92.4699 | 44.02163 | 0 | NCT00578552 |
[
0
] | 11 | RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | To determine whether intensive glucose control results in improved mortality and reduced hospital stay length by performing a randomized trial of intensive glucose management (blood glucose goal 110 mg/dl) using continuous IV insulin and glucose vs. non-intensive glucose management (goal 200 mg/dl) | TO determine whether there are fewer infections, days without a fever, days on antibiotics given for an infection and time to marrow engraftment are improved by intensive glucose management; and to determine whether there is evidence of a reduction in measures of inflammation in patients randomized to intensive glucose... | Hyperglycemia Hematopoietic Stem Cell Transplantation | Hyperglycemia Hematopoietic stem cell transplantation Bone marrow transplant High blood sugar | null | 2 | arm 1: Regular Sliding Scale Insulin administration for hyperglycemia arm 2: MiniMed Paradigm monitoring device for hyperglycemia | [
1,
0
] | 2 | [
0,
1
] | intervention 1: Use of sliding scale insulin as per Appendix 1 intervention 2: Automated insulin delivery system | intervention 1: Regular Insulin intervention 2: Deployment of the MiniMed Paradigm monitoring device | 1 | Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756 | 0 | NCT00582036 |
[
0
] | 12 | NA | SINGLE_GROUP | 2DIAGNOSTIC | 0NONE | false | 0ALL | null | The purpose of this study is to find out whether the monoclonal antibody 8H9 is useful in finding tumors in your body. Antibodies are protein found naturally in blood. They can fasten themselves to bacteria and viruses. They can stimulate white cells and blood proteins to kill tumors. The antibody 8H9 was made from mou... | To test if intravenous injections of iodine-131 labeled murine monoclonal antibody 8H9 can detect primary and metastatic solid tumors. A total of 60 patients will be accrued over a period of 2 years. | CNS Cancer Neuroblastoma Sarcoma | null | 1 | arm 1: This is an open-label single arm study of 131 I-8H9. injected intravenously at 10mCi/1.73m\^2 dose \[intended specific activity of '20mCi/mg protein\] preceded by administration of 50mg/1.73m2 of unlabeled -8H9. | [
0
] | 2 | [
0,
0
] | intervention 1: This is an open-label single arm study of 131I-8H9, injected intravenously at 10 mCi/1.73 m\^2 dose \[intended specific activity of \~20 mCi/mg protein\] intervention 2: administration of 50mg/1.73m\^2 of unlabeled 8H9. | intervention 1: 131I-8H9 intervention 2: 8H9 | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00582608 | |
[
3,
4
] | 49 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | Autism is a complex neurodevelopmental disorder that is thought to involve an interaction between multiple and variable susceptibility genes, environmental factors, and epigenetic effects. Great concern has been raised about the marked increase in the prevalence of autism spectrum disorders in the last decade. Risperid... | For this study, we will identify 40 children (4 to 18 years old) with autism who also have serious behavioral problems. We will then treat them with risperidone. Blood samples will be obtained prior to treatment and at eight weeks of treatment or study exit. At that time, efficacy will be assessed using the Clinical Gl... | Autism | null | 1 | arm 1: Risperidone was started at 0.5mg at bedtime for 4 days. If that dosage was tolerated and there were continued behavioral symptoms, the dose was increased to 1mg at bedtime for an additional 4 days. If tolerated and indicated, 0.5mg was added in the morning for a daily total of 1.5 mg. | [
0
] | 1 | [
0
] | intervention 1: Dose will start at 0.5 mg and may be increased throughout the course of the study if no adverse events occur | intervention 1: Risperidone | 1 | San Francisco | California | United States | -122.41942 | 37.77493 | 0 | NCT00584701 | |
[
5
] | 39 | NON_RANDOMIZED | PARALLEL | null | 0NONE | true | 0ALL | false | This will be an open label study using daily does of up to 126mg/day of Concerta in the treatment of children and adolescents, ages 12-17, who meet DSM-IV criteria for ADHD. Specific hypotheses are as follows:
Hypothesis 1: Children and adolescents with ADHD will have significantly higher ACC and DLPFC Glutamate/myo-I... | The primary objective of this study is to use 1H MRS to assess Glutamate (Glu), myo-Inositol (Ino), and creatine + phosphocreatine (Cr) levels in brain regions of interest in 20 children with ADHD between the ages of 12-17 years old, before and after a six-week open treatment trial with OROS methylphenidate. For compar... | ADHD | HMRS Scanning ADHD Child Adolescent HMRS Scans | null | 2 | arm 1: None arm 2: Healthy Volunteer Control group | [
0,
5
] | 2 | [
0,
10
] | intervention 1: Concerta is given in capsule form with a minimum dose of 18 mg/day and a max of 126 mg/day. Subjects take Concerta once per day for 6 weeks. intervention 2: No intervention | intervention 1: OROS methylphenidate intervention 2: No intervention | 1 | Cambridge | Massachusetts | United States | -71.10561 | 42.3751 | 0 | NCT00593112 |
[
3
] | 70 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to determine whether the gentamicin-collagen sponge when combined with standard of daily wound care is safe and effective in treating mildly infected skin ulcers compared to treatment with an oral antibiotic (levofloxacin) and standard daily wound care. | Infected skin ulcers in patients with diabetes can be very debilitating because they are difficult to heal. Diabetic ulcers are responsible for frequent health care visits, and are a major predictor of amputation. Diabetic ulcers can be caused by a patient's inability to sense pain or warmth as well as peripheral vascu... | Diabetic Foot Ulcer | Diabetic Foot Ulcer | null | 2 | arm 1: Daily topical gentamicin sponge and standard daily wound care arm 2: Daily oral levofloxacin 750 mg and standard daily wound care | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Inserted daily into open ulcer intervention 2: 750mg oral levofloxacin daily | intervention 1: gentamicin-collagen sponge intervention 2: Levofloxacin | 1 | Pasadena | Maryland | United States | -76.57108 | 39.119 | 0 | NCT00593567 |
[
5
] | 40 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | This is a pilot study designed to examine the potential efficacy and tolerability of zonisamide compared to placebo for the treatment of alcohol dependence. | Zonisamide is an antiepileptic medication which has similar clinical and pharmacologic effects to topiramate, a medication that has demonstrated efficacy in a randomized clinical trial for treatment of alcoholism. Because zonisamide is potentially better tolerated and easier to titrate in the outpatient setting than to... | Alcoholism Alcohol Abuse Alcohol Dependence | Zonisamide Pharmacotherapy Alcohol dependence anticonvulsant | null | 2 | arm 1: Zonisamide arm 2: placebo | [
0,
2
] | 2 | [
0,
0
] | intervention 1: flexible dosages of 100-500mg/day intervention 2: Placebo | intervention 1: zonisamide intervention 2: Placebo | 1 | Farmington | Connecticut | United States | -72.83204 | 41.71982 | 0 | NCT00595556 |
[
3
] | 121 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The primary purpose of this study is to determine the efficacy and safety of three dose levels of cobiprostone as compared to placebo in OA/RA patients treated with an NSAID for 20 months. | null | NSAID-induced Gastroduodenal Injury Ulcers Rheumatoid Arthritis Osteoarthritis | null | 4 | arm 1: Participants receive matching placebo capsules for 20 months arm 2: Participants receive 18 mcg cobiprostone once daily (QD) for 20 months arm 3: Participants receive 18 mcg cobiprostone twice daily (BID) for 20 months arm 4: Participants receive 18 mcg cobiprostone three times daily (TID) for 20 months | [
2,
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: 18 mcg cobiprostone capsules for oral administration intervention 2: Matching placebo capsules for oral administration intervention 3: Any marketed non-steroidal anti-inflammatory drug used by the participants as standard care. | intervention 1: Cobiprostone intervention 2: Placebo intervention 3: Non-steroidal anti-inflammatory drug | 19 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Chula Vista | California | United States | -117.0842 | 32.64005
Loma Linda | California | United States | -117.26115 | 34.04835
Mission Hills | California | United States | -120.43683 | 34.68609
Palm Springs | California | United States | -116.54529 | 33.8303
Se... | 0 | NCT00597818 | |
[
4
] | 51 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The primary objective of this study is to explore the efficacy of Nasonex (mometasone furoate nasal spray) in comparison with placebo in improving the quality of life of subjects with moderate to severe persistent allergic rhinitis and intermittent asthma. A secondary objective is to evaluate the efficacy of Nasonex in... | The primary objective is to explore the efficacy of mometasone furoate nasal spray (MFNS) in comparison with placebo in improving the quality of life of subjects with moderate to severe persistent allergic rhinitis and intermittent asthma as measured by the Rhinasthma Questionnaire (Global Summary Score). In addition, ... | Allergic Rhinitis Asthma | null | 2 | arm 1: Mometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning. arm 2: Placebo nasal spray once daily (two puffs per nostril) in the morning. | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Mometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning. intervention 2: Placebo nasal spray once daily (two puffs per nostril) in the morning. | intervention 1: Mometasone furoate nasal spray (MFNS) intervention 2: Placebo nasal spray | 0 | null | 0 | NCT00599027 | |
[
4
] | 701 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control | null | Diabetes Mellitus, Type 2 | null | 2 | arm 1: Patients receive linagliptin 5 mg tablets once daily arm 2: Patients receive placebo tablets matching linagliptin 5 mg tablets once daily | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Patients receive linagliptin 5 mg tablets once daily intervention 2: Patients receive linagliptin 5 mg tablets once daily | intervention 1: linagliptin intervention 2: linagliptin | 82 | Chula Vista | California | United States | -117.0842 | 32.64005
Spring Valley | California | United States | -116.99892 | 32.74477
Walnut Creek | California | United States | -122.06496 | 37.90631
Northglenn | Colorado | United States | -104.9872 | 39.88554
Hollywood | Florida | United States | -80.14949 | 26.0112
Miam... | 0 | NCT00601250 | |
[
4
] | 1,058 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to metformin in combination with a sulphonylurea in patients with type 2 diabetes mellitus with insufficient glycaemic control. | null | Diabetes Mellitus, Type 2 | null | 2 | arm 1: linagliptin 5 mg once daily arm 2: placebo matching linagliptin 5 mg tablets | [
0,
2
] | 2 | [
0,
0
] | intervention 1: active intervention 2: placebo to linagliptin 5 mg | intervention 1: linagliptin intervention 2: placebo | 100 | Capital Federal | N/A | Argentina | N/A | N/A
Capital Federal | N/A | Argentina | N/A | N/A
Capital Federal | N/A | Argentina | N/A | N/A
Capital Federal | N/A | Argentina | N/A | N/A
Capital Federal | N/A | Argentina | N/A | N/A
Corrientes | N/A | Argentina | -58.8344 | -27.46784
Córdoba | N/A | Argentina | -64.18853 ... | 0 | NCT00602472 | |
[
2
] | 19 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | Investigate safety, tolerability and pharmacokinetics of CP-751,871 when given in combination with carboplatin and paclitaxel in patients with advanced non-small cell lung cancer | null | Carcinoma, Non-Small-Cell Lung | CP-751,871, Non-small cell lung cancer, Phase 1 | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Chemotherapy (carboplatin and paclitaxel) and CP-751,871 (6, 10 or 20mg/kg) will be administered by intravenous infusion every three weeks. | intervention 1: CP-751,871 + carboplatin + paclitaxel | 1 | Chuo-ku | Tokyo | Japan | N/A | N/A | 0 | NCT00603538 |
[
5
] | 241 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | Post-marketing commitment to the European Medicines Agency to conduct a prospective, controlled study of the transfer from Subutex to Suboxone. | null | Opiate Dependence Drug Dependence | null | 2 | arm 1: Double-blind, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) plus matching Subutex placebo during Week 1 followed by open-label, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) during Weeks 2-4 with weekly access to take-home doses as of Week 2. ar... | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Suboxone sublingual tablet 4 mg/1 mg - 24 mg/6 mg, daily for 28 days intervention 2: Subutex sublingual tablet 4-24 mg, daily for 28 days | intervention 1: Suboxone, Buprenorphine Hydrochloride + Naloxone, SCH 484 intervention 2: Subutex, Buprenorphine Hydrochloride, SCH 28444 | 0 | null | 0 | NCT00605033 | |
[
4
] | 61 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The primary objective of this study of Caldolor administered to hospitalized adult and pediatric burn patients is to determine the efficacy of Caldolor on reducing fever when compared to placebo when administered every 6 hours for at least 24 hours. | null | Burns | null | 2 | arm 1: None arm 2: None | [
2,
0
] | 2 | [
0,
0
] | intervention 1: 800 milligrams of intravenous ibuprofen (patients greater 12 years of age) or 10 milligrams/kilograms (patients greater than 12 years; maximum of 400 milligrams) every 6 hours intervention 2: Placebo | intervention 1: Caldolor intervention 2: Placebo | 5 | Orlando | Florida | United States | -81.37924 | 28.53834
Winston-Salem | North Carolina | United States | -80.24422 | 36.09986
Baroda | Kothi | India | 76.65 | 25.5
Mumbai | Sion | India | 72.88261 | 19.07283
Pune | N/A | India | 73.85535 | 18.51957 | 0 | NCT00606489 | |
[
4
] | 12 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | To evaluate the effects of paricalcitol injection on cardiac structure and function over 48 weeks in subjects with Stage 5 Chronic Kidney Disease (CKD) receiving hemodialysis who have left ventricular hypertrophy (LVH). | null | Chronic Kidney Disease (CKD) Stage 5 Hypertrophy, Left Ventricular | Zemplar, paricalcitol, PRIMO II | null | 2 | arm 1: Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis arm 2: Placebo Injection 4 mcg/mL given intravenously three times a week during dialysis | [
1,
2
] | 2 | [
0,
0
] | intervention 1: Paricalcitol Injection 4 mcg/mL intravenously three times a week during dialysis intervention 2: Placebo Injection 4 mcg/mL given intravenously three times a week during dialysis | intervention 1: paricalcitol injection 4 mcg/mL intervention 2: Placebo Injection 4 mcg/mL | 76 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Tempe | Arizona | United States | -111.90931 | 33.41477
Bakersfield | California | United States | -119.01871 | 35.37329
Los Angeles | California | United States | -118.24368 | 34.05223
Los Angeles | California | United States | -118.24368 | 34.05223
San Dimas |... | 0 | NCT00616902 |
[
0
] | 15 | RANDOMIZED | CROSSOVER | 7BASIC_SCIENCE | 4QUADRUPLE | true | 0ALL | false | Clopidogrel is a medication that is used to decrease the ability of platelets to form blood clots.
The theory has been proposed that, in patients with coronary artery disease or stroke, increased platelet function after discontinuation of clopidogrel therapy is associated with an increased clotting risk. However, this... | In this study, we will address the question: does discontinuation of clopidogrel result in platelet hyperreactivity? We will perform a double-blind, placebo-controlled, crossover study in normal subjects, in whom platelet reactivity will be measured before clopidogrel or placebo, during clopidogrel or placebo, and at v... | Blood Platelets Clopidogrel | blood platelets platelet aggregation inhibitors antiplatelet drugs clopidogrel | null | 2 | arm 1: The subjects will be randomized to clopidogrel 75 mg plus aspirin 81 mg orally daily for 14 days. The study drug (i.e., clopidogrel) will then be discontinued and aspirin continued for another 43 days. arm 2: The subjects will be randomized to placebo plus aspirin 81 mg orally daily for 14 days. The study drug (... | [
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: Clopidogrel 75mg plus aspirin 81mg, tablet by mouth daily for 14 days. intervention 2: Placebo plus aspirin 81 mg, tablet by mouth daily for 14 days. intervention 3: Aspirin 81mg tablet by mouth continued daily alone for 43 days after day 14. | intervention 1: clopidogrel + aspirin intervention 2: placebo intervention 3: Aspirin | 1 | Worcester | Massachusetts | United States | -71.80229 | 42.26259 | 0 | NCT00619073 |
[
4
] | 503 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | To investigate efficacy, safety and tolerability of BI 1356 versus placebo | null | Diabetes Mellitus, Type 2 | null | 2 | arm 1: linagliptin 5 mg once daily arm 2: placebo matching linagliptin 5 mg tablets | [
0,
2
] | 2 | [
0,
0
] | intervention 1: active intervention 2: placebo | intervention 1: linagliptin intervention 2: placebo | 69 | Krapinske Toplice | N/A | Croatia | 15.84333 | 46.09333
Slavonski Brod | N/A | Croatia | 18.01556 | 45.16028
Andhra Pradesh | N/A | India | N/A | N/A
Bangalore | N/A | India | 77.59369 | 12.97194
Bangalore | N/A | India | 77.59369 | 12.97194
Chennai | N/A | India | 80.27847 | 13.08784
Ghaziabad | N/A | India | 77.43915... | 0 | NCT00621140 | |
[
4
] | 540 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The primary objective of this study is to evaluate the efficacy of esomeprazole 20 mg once daily for 24 weeks on maintenance of Reflux Esophagitis in patients with healed reflux esophagitis in comparison with omeprazole 10 mg once daily and esomeprazole 10 mg once daily by assessment of presence/absence of recurrence o... | null | Reflux Esophagitis | Reflux Esophagitis | null | 2 | arm 1: Esomeprazole and Omeprazole arm 2: Esomeprazole | [
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: 10mg once daily oral administration intervention 2: 20mg once daily oral administration intervention 3: 10mg once daily oral administration | intervention 1: Esomeprazole intervention 2: Esomeprazole intervention 3: Omeprazole | 44 | Akita | Akita | Japan | 140.11667 | 39.71667
Kashiwa | Chiba | Japan | 139.97732 | 35.86224
Kisarazu | Chiba | Japan | 139.93254 | 35.38329
Kōriyama | Fukishima | Japan | 140.38333 | 37.4
Nihonmatsu | Fukishima | Japan | 139.26427 | 37.96201
Nishishirakawa | Fukishima | Japan | N/A | N/A
Fukuoika | Fukuoka | Japan | N/... | 0 | NCT00634114 |
[
5
] | 14 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | The purpose of this study is to test the effects of carbidopa/levodopa/entacapone compared to the effects of immediate-release carbidopa/levodopa on non-motor symptoms of end-of-dose wearing off in persons who have Parkinson's disease. | null | Parkinson's Disease | Idiopathic Parkinson's disease carbidopa/levodopa/entacapone non-motor symptoms motor-symptoms | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study. intervention 2: Immedi... | intervention 1: Carbidopa/levodopa/entacapone intervention 2: Immediate release carbidopa/levodopa | 21 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Aliso Viejo | California | United States | -117.72712 | 33.56504
Irvine | California | United States | -117.82311 | 33.66946
La Jolla | California | United States | -117.2742 | 32.84727
Washington D.C. | District of Columbia | United States | -77.03637 | 38.8951... | 0 | NCT00642356 |
[
3
] | 523 | NON_RANDOMIZED | PARALLEL | 1PREVENTION | 0NONE | false | 0ALL | true | The purpose of this study is to provide safety and tolerability data for AZD0837 during long-term treatment (5 years) in patients with non-valvular atrial fibrillation (AF) and one or more additional risk factors for stroke and systemic embolic events (moderate to high risk patients). | null | Persistent or Permanent Nonvalvular Atrial Fibrillation | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od and then switching to one general common dose, 300 mg od intervention 2: Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5 | intervention 1: AZD0837 intervention 2: VKA INR 2-3 | 0 | null | 0 | NCT00645853 | |
[
4
] | 350 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of the study is to compare the safety and efficacy, with regards to the signs and symptoms, of MR prednisone (Lodotra®) versus placebo in combination with standard Disease Modifying Anti-Rheumatic Drug (DMARD) treatment in patients with active rheumatoid arthritis. | Study with completed results acquired from Horizon in 2024. | Rheumatoid Arthritis | Signs and Symptoms Autoimmune Diseases Joint Diseases Arthritis Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases Predniso(lo)ne | null | 2 | arm 1: Modified Release (MR) prednisone 5 mg arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 1 x 5 mg daily intervention 2: 1x daily | intervention 1: MR prednisone intervention 2: Placebo | 52 | Huntsville | Alabama | United States | -86.58594 | 34.7304
Phoenix | Arizona | United States | -112.07404 | 33.44838
Los Angeles | California | United States | -118.24368 | 34.05223
Los Angeles | California | United States | -118.24368 | 34.05223
Pacific Palisades | California | United States | -118.52647 | 34.04806
Sa... | 0 | NCT00650078 |
[
3
] | 102 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | To examine the clinical efficacy of sertraline (200 mg/day) alone or sertraline in combination with gabapentin. The purpose of this study is to examine whether the antidepressant sertraline alone or combined with gabapentin delays time to relapse relative to placebo in recently abstinent cocaine-dependent volunteers wh... | Subjects enrolled in this 12-wk, double blind, randomized, placebo-controlled, clinical trial are admitted to a residential facility in North Little Rock (RCA-NLR) and randomized by depressive symptom severity to receive one of the following: sertraline alone (200 mg/day), sertraline (200 mg/day) plus gabapentin (1200 ... | Cocaine Dependence Depressive Symptoms | cocaine dependence depressive symptoms relapse sertraline gabapentin | null | 3 | arm 1: Placebo capsules arm 2: sertraline (200 mg/day) arm 3: sertraline (200 mg/day) plus gabapentin (1,200 mg/day) | [
2,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Sertraline hydrochloride (200 mg/day) will be administered once daily. While subjects are at RCA-NLR they initially receive 50 mg/day of sertraline. This dose is gradually increased over a 3-week period until subjects receive 200 mg. When subjects are transferred to the outpatient program, they will be ... | intervention 1: sertraline intervention 2: Placebo intervention 3: gabapentin | 1 | Little Rock | Arkansas | United States | -92.28959 | 34.74648 | 0 | NCT00654953 |
[
2
] | 21 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of the study is to evaluate the gastrointestinal absorption of nepadutant after single dose as oral solution (and the effect of age on its oral absorption) in infants. Oral absorption is evaluated through the drug recovery in urine. | This trial aims to evaluate the oral adsorption of nepadutant (0.1 or 0.5 mg/Kg given as one single dose as oral solution) in infants divided in three age strata (from 6 to 24 weeks old). Oral absorption is evaluated by measuring the amount of nepadutant in the urine output collected during the 24 hours after oral admi... | Infantile Colic Infantile Functional Gastrointestinal Disorders | Infantile colic Abdominal Cramps Colicky Pain Functional gastrointestinal disorders | null | 2 | arm 1: Nepadutant 0.1 mg/kg arm 2: Nepadutant 0.5 mg/kg | [
0,
0
] | 2 | [
0,
0
] | intervention 1: 0.1 mg/Kg as one single oral dose divided in three age strata (from 6 to 24 weeks old) intervention 2: 0.5 mg/Kg as one single oral dose divided in three age strata (from 6 to 24 weeks old) | intervention 1: Nepadutant intervention 2: Nepadutant | 3 | Little Rock | Arkansas | United States | -92.28959 | 34.74648
Louisville | Kentucky | United States | -85.75941 | 38.25424
Cleveland | Ohio | United States | -81.69541 | 41.4995 | 0 | NCT00655083 |
[
3
] | 141 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The effectiveness objective of this study is to evaluate whether Fibrin Patch is superior to SURGICEL™ as an adjunct to achieving hemostasis during surgical procedures involving soft tissue bleeding in abdominal, pelvic, retroperitoneal and (non-cardiac) thoracic surgery. | null | Hemostasis | null | 2 | arm 1: None arm 2: SURGICEL™ Absorbable Hemostat | [
0,
1
] | 2 | [
0,
1
] | intervention 1: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). intervention 2: Absorbable hemostat | intervention 1: Fibrin Pad intervention 2: SURGICEL™ | 11 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Jacksonville | Florida | United States | -81.65565 | 30.33218
Miami | Florida | United States | -80.19366 | 25.77427
Atlanta | Georgia | United States | -84.38798 | 33.749
Augusta | Georgia | United States | -81.97484 | 33.47097
Baltimore | Maryland | United S... | 0 | NCT00658723 | |
[
5
] | 15 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | With Institutional Ethics Board approval and signed informed consent, a pilot investigation was conducted in which 15 adult patients scheduled to undergo a thoractomy were randomly assigned to receive 1) 150 mg pregabalin 1 hour preoperatively and then 7 days postoperatively (BID) or 2) 300 mg pregabalin 1 hour preoper... | Chronic post thoracotomy pain syndrome (CPTPS) is a significant problem that has important effects on patients' daily activities. The severity of postoperative pain and the central sensitization associated with it are thought to play a role in the chronification of acute pain. Gabapentin has been shown to be effective ... | Chronic Pain | Thoracotomy Post-surgical Pregabalin | null | 2 | arm 1: Pregabalin 150mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-operatively (n=3) or Pregabalin 300mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-operatively (n=4). arm 2: An identical placebo admin... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: PHASE 1 (N=3) Pregabalin 150mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op.
PHASE 2 (N=4) Pregabalin 300mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. intervention 2: An identica... | intervention 1: Pregabalin intervention 2: Placebo | 1 | Kingston | Ontario | Canada | -76.48098 | 44.22976 | 0 | NCT00663962 |
[
4
] | 99 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | false | 0ALL | false | This study is being carried out to see if budesonide with HFA is effective, safe and well tolerated compared with budesonide CFC. Budesonide HFA has been already given in other research studies, in both healthy volunteers and subjects with asthma. | null | Asthma | Asthma hyperreactivity | null | 4 | arm 1: Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks arm 2: Budesonide HFA 400 mcg twice daily for 2 weeks arm 3: Budesonide Chlorofluorocarbon(CFC) 100 mcg twice daily for 2 weeks arm 4: Budesonide CFC 400 mcg twice daily for 2 weeks | [
1,
1,
1,
1
] | 2 | [
0,
0
] | intervention 1: standard daily inhaled dose intervention 2: standard daily inhaled dose | intervention 1: Budesonide HFA intervention 2: Budesonide CFC | 3 | King of Prussia | Pennsylvania | United States | -75.39602 | 40.08927
Dundee | Scotland | United Kingdom | -2.97489 | 56.46913
Perth | Scotland | United Kingdom | -3.43139 | 56.39522 | 0 | NCT00667992 |
[
0
] | 57 | NON_RANDOMIZED | PARALLEL | 1PREVENTION | 0NONE | true | 1FEMALE | true | The purpose of this study is to see if women presenting for emergency contraception (EC) are willing to accept the copper intrauterine device (IUD). This study will also compare the use of effective methods of contraception between women who selected the copper IUD or Plan B 6 months after they received EC. | This study seeks to estimate the acceptance of Copper IUD use amongst people presenting for EC. This will be accomplished by offering all women who present for EC at participating Planned Parenthood Association of Utah (PPAU) clinics during the study period the option of having the copper IUD or Plan B. Women who agree... | Pregnancy | contraception emergency contraception pregnancy prevention after unprotected intercourse | null | 2 | arm 1: IUD arm 2: Oral levonorgestrel | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Copper T380 IUD intervention 2: 1.5 mg | intervention 1: Copper T380 IUD intervention 2: levonorgestrel | 1 | West Valley City | Utah | United States | -112.00105 | 40.69161 | 0 | NCT00669396 |
[
2,
3
] | 25 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | true | 0ALL | false | The objectives of the study are:
1. To evaluate the effect of ABT-335 (choline fenofibrate) on several parameters of RCT (reverse cholesterol transport) in men and post-menopausal women diagnosed with dyslipidemia (i.e., low high-density lipoprotein \[HDL\] cholesterol levels and elevated triglyceride \[TG\] concentra... | This trial assesses the effects of ABT-335 on RCT as measured by cholesterol efflux or rate of appearance of cholesterol (Ra in mg/kg/hr), cholesterol excretion (%/day), RCT efflux (mg/kg/day) and de novo cholesterol synthesis (%) during a baseline period (7 days) and during a treatment period (94 days).
The goal of u... | Dyslipidemia | null | 1 | arm 1: ABT-335 (choline fenofibrate) | [
0
] | 1 | [
0
] | intervention 1: 135 mg choline fenofibrate daily(oral, capsule) | intervention 1: choline fenofibrate | 1 | Chicago | Illinois | United States | -87.65005 | 41.85003 | 0 | NCT00673881 | |
[
5
] | 61 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | This study aims to compare the efficacy of ranibizumab and verteporfin PDT combination treatment and verteporfin PDT monotherapy vs.ranibizumab monotherapy alone in achieving complete regression of polyps in patients with symptomatic macular polypoidal choroidal vasculopathy. | null | Polypoidal Choroidal Vasculopathy | Polypoidal choroidal vasculopathy PCV Age-related macular degeneration (AMD) variant vision polyps indocyanine green angiography verteporfin ranibizumab photodynamic therapy | null | 3 | arm 1: Photodynamic therapy with verteporfin in combination with ranibizumab injection. Patients received one treatment at baseline with verteporfin photodynamic therapy (PDT) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranib... | [
0,
1,
1
] | 2 | [
0,
0
] | intervention 1: After a 10-minute intravenous infusion of verteporfin at a dose of 6 mg/m\^2 body surface area, light application of 50 J/cm\^2 to the study eye was begun 15 minutes after the start of infusion. intervention 2: Ranibizumab at dose of 0.5 mg administered as an intravitreal injection. | intervention 1: Verteporfin Photodynamic Therapy intervention 2: Ranibizumab | 5 | Hong Kong | N/A | Hong Kong | 114.17469 | 22.27832
Singapore | N/A | Singapore | 103.85007 | 1.28967
Seoul | N/A | South Korea | 126.9784 | 37.566
Taipei | N/A | Taiwan | 121.52639 | 25.05306
Bangkok | N/A | Thailand | 100.50144 | 13.75398 | 0 | NCT00674323 |
[
0
] | 10 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | true | 1FEMALE | false | Urinary tract infection (UTI) is the most common complication after surgery for prolapse or urinary incontinence. UTIs are painful and have the potential to turn into kidney infections. We are asking women who self-catheterize after surgery to try either an antibiotic or a placebo pill so we can see if we can prevent U... | Abstract:
Specific aim: to determine if extended release nitrofurantoin antibiotic prophylaxis administered to patients performing clean intermittent self-catheterization (CISC) after pelvic organ prolapse and/or urinary incontinence surgery decreases the incidence of symptomatic urinary tract infection (UTI) compared... | Urinary Tract Infections | urinary catheterization urinary tract infection urinary incontinence pelvic floor prolapse antibiotics | null | 2 | arm 1: extended release nitrofurantoin 100mg to be taken daily while performing clean intermittent self-catheterization (CISC) and for three more days after stopping CISC arm 2: identical appearing placebo capsule to be taken daily while performing clean intermittent self-catheterization (CISC) and for three more days ... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: nitrofurantoin 100mg to be taken daily while performing clean intermittent self-catheterization (CISC) and for three more days after stopping CISC intervention 2: Placebo capsule to be taken daily while performing clean intermittent self-catheterization (CISC) and for three more days after stopping CISC | intervention 1: Nitrofurantoin intervention 2: Placebo | 1 | Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062 | 0 | NCT00678041 |
[
5
] | 3 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This was a Phase IV, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the effect of Pulmozyme on pulmonary function, health-related quality of life (HRQOL), and respiratory symptoms in 3- to 5-year-old children with cystic fibrosis (CF). Approximately 40 patients were planned to be e... | null | Cystic Fibrosis | Pulmozyme CF | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 2.5 mL (2.5 mg) dornase alfa nebulized once daily for 16 (+/-2) days intervention 2: 2.5 mL (2.5 mg) placebo nebulized once daily for 16 (+/-2) days | intervention 1: Dornase alfa intervention 2: Placebo | 0 | null | 0 | NCT00680316 |
[
4
] | 1,649 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to demonstrate the safety and effectiveness of CT Gel in subjects with acne vulgaris. The hypothesis is that CT Gel is superior to Clindamycin Gel, Tretinoin Gel and Vehicle Gel for the treatment of acne vulgaris. | CT Gel is a fixed-combination product that addresses the multifactorial factors of acne vulgaris pathogenesis. Based on numerous nonclinical pharmacology studies of each active ingredient, it is expected that this new product will have three biological actions: 1) comedolytic, 2) antimicrobial, and 3) anti-inflammatory... | Acne Vulgaris Acne | Acne Vulgaris Acne | null | 4 | arm 1: CT Gel arm 2: Clindamycin Gel (clindamycin) arm 3: Tretinoin Gel (tretinoin) arm 4: Vehicle Gel | [
0,
1,
1,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: Topical gel consisting of clindamycin 1% and tretinoin 0.025%, applied once daily in the evening for 12 weeks intervention 2: Clindamycin 1% gel applied topically once daily in the evening for 12 weeks intervention 3: Tretinoin 0.025% gel applied topically once daily in the evening for 12 weeks interven... | intervention 1: CT Gel intervention 2: Clindamycin Gel (clindamycin ) intervention 3: Tretinoin Gel (tretinoin) intervention 4: Vehicle Gel | 32 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Mobile | Alabama | United States | -88.04305 | 30.69436
Hot Springs | Arkansas | United States | -93.05518 | 34.5037
Fremont | California | United States | -121.98857 | 37.54827
San Diego | California | United States | -117.16472 | 32.71571
Longmont | Colorado... | 0 | NCT00689117 |
[
4
] | 726 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of the study is to compare two ophthalmic solutions in patients with open-angle glaucoma or ocular hypertension. | null | Open-angle Glaucoma Ocular Hypertension | null | 2 | arm 1: One drop self-administered in the study eye(s) once daily for 90 days arm 2: One drop self-administered in the study eye(s) once daily for 90 days | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 90 days. Referred to as travoprost. intervention 2: Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 90 days. R... | intervention 1: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®) intervention 2: Latanoprost ophthalmic solution 0.005% (XALATAN®) | 0 | null | 0 | NCT00690794 | |
[
4
] | 965 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | To characterize the safety, tolerability, and efficacy profile of amlodipine/valsartan 5/80 mg as compared to amlodipine/valsartan 5/40 mg (with optional titration to 5/80 mg) and amlodipine 5 mg monotherapy in elderly patients (≥ 65 years of age) with essential hypertension. All three regimens are expected to be well ... | null | Hypertension | Blood pressure hypertension elderly | null | 3 | arm 1: 1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily arm 2: 1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily arm 3: 1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily | [
0,
1,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: 1 capsule amlodipine 5 mg orally once daily intervention 2: 1 capsule valsartan 80 mg orally once daily intervention 3: 1 capsule valsartan 40 mg orally once daily intervention 4: 1 capsule placebo to match valsartan orally once daily | intervention 1: Amlodipine 5 mg intervention 2: Valsartan 80 mg intervention 3: Valsartan 40 mg intervention 4: Placebo | 18 | Brno | N/A | Czechia | 16.60796 | 49.19522
Chrudim | N/A | Czechia | 15.79558 | 49.95109
Hodonín | N/A | Czechia | 17.13244 | 48.84893
Jičín | N/A | Czechia | 15.35162 | 50.43723
Náchod | N/A | Czechia | 16.16289 | 50.4167
Prague | N/A | Czechia | 14.42076 | 50.08804
Helsinki | N/A | Finland | 24.93545 | 60.16952
Joens... | 0 | NCT00699192 |
[
0
] | 3 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to determine whether cysteamine bitartrate, an FDA-approved drug for a non-psychiatric condition, is safe and effective for the treatment of major depression. | Major depressive disorder (MDD) is a chronic, disabling illness affecting about 17% of the general population. Despite advances in treatment, about two-thirds of patients fail to respond to an initial trial of pharmacotherapy. Brain-derived neurotrophic factor (BDNF) is a neural growth-promoting polypeptide found in th... | Major Depressive Disorder | Major depressive disorder, depression neurotrophic brain-derived neurotrophic factor antidepressant cysteamine | null | 1 | arm 1: Participants received cysteamine bitartrate by mouth up to 300 mg three times daily. | [
0
] | 1 | [
0
] | intervention 1: All enrolled participants will begin open treatment with cysteamine on the first visit of the experimental period (after screening, medical clearance and medication washout period if necessary). The dosing schedule is a flexible regimen starting at 150 mg PO three times daily. After one week, patients w... | intervention 1: cysteamine bitartrate | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00715559 |
[
3,
4
] | 12 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | null | This study tests the hypothesis that mifepristone will diminish cognitive distortion and alleviate psychosis in patients with schizoaffective disorder. | You are invited to participate in a research study which evaluates the effectiveness of mifepristone (RU 486) in rapidly reducing the symptoms associated with schizoaffective disorder. Our group believes that the cognitive deficits (a decline in the ability to think clearly) and psychosis (hallucinations or delusions) ... | Psychotic Disorders Depressive Disorder, Major Depressive Disorder | null | 2 | arm 1: Patients will be randomized to placebo arm 2: Patients will be randomized to mifepristone | [
2,
0
] | 2 | [
0,
0
] | intervention 1: 600 mg of mifepristone intervention 2: Placebo comparator | intervention 1: Mifepristone intervention 2: Placebo Oral Tablet | 1 | Stanford | California | United States | -122.16608 | 37.42411 | 0 | NCT00725270 | |
[
0
] | 63 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | Blinded study using oral gabapentin in load pre-operative (15mg/kg) and maintenance 5mg/kg three times a day (TID) for 5 days or discharge, Patient Controlled Analgesia (PCA) morphine and placebo group with similar pills, also PCA morphine. The goal is to measure morphine usage and incidence of morphine side effects (p... | Healthy, American Society of Anesthesia (ASA) 1-2 Idiopathic Scoliosis patients for spinal fusion.
Blinded, drug only known by hospital pharmacist. Study group 1- Gabapentin 15mg/kg with premed, 5/kg TID for 5 days of discharge, standard PCA morphine with dose and basal Study Group 2- Capsules resembling neurontin, wi... | Postoperative Pain | Gabapentin Pediatric Spinal Fusion Narcotic Use | null | 2 | arm 1: Gabapentin arm 2: Placebo Comparator -- pill matched in appearance to gabapentin | [
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: oral gabapentin in load pre-op (15mg/kg) and maintenance 5mg/kg TID for 5 days or discharge intervention 2: None intervention 3: Administered as needed | intervention 1: Gabapentin intervention 2: Placebo intervention 3: Morphine | 0 | null | 0 | NCT00726999 |
[
3
] | 16 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | true | 0ALL | true | The investigators hypothesize that varenicline will dose dependently attenuate the subjective effects of cigarettes after a period of abstinence. Also, treatment with varenicline will dose dependently weaken the severity of nicotine withdrawal symptoms. Thirdly, we hypothesize that treatment with varenicline will dose ... | Tobacco use is the leading preventable cause of death in the U.S.A. Every year 400,000 people die from cigarette smoking and in 2006, one out of every five deaths in the US were smoking related. Recent advances in laboratory studies of tobacco effects in humans and in understanding the effects of nicotine on the brain ... | Nicotine Dependence | null | 4 | arm 1: Each participant participates in 4 consecutive interventions in random order.
1. Placebo, 1 capsule before the session
2. 0.5 mg varenicline, 1 capsule before the session 3.1 mg varenicline, 1 capsule before the session
4\. 2 mg varenicline, 1 capsule before the session arm 2: Each participant participates in ... | [
0,
0,
0,
0
] | 2 | [
0,
0
] | intervention 1: 4 doses of Varenicline. 1 capsule of either dose (0mg, 0.5mg, 1mg, 2 mg) in the morning on days at least 5 days apart. intervention 2: 1 dose of placebo | intervention 1: Varenicline intervention 2: Placebo | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00731055 | |
[
4
] | 479 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | true | 0ALL | true | The main goals of the study are to assess benefits of higher doses of the nicotine patch prior to smoking cessation for high- and low-dependent smokers, and to investigate the potential relationship between genetic factors and smoking cessation success. There will be a two-week double-blind pre-cessation exposure to ni... | null | Cigarette Smoking | Cigarette Nicotine | null | 2 | arm 1: None arm 2: None | [
0,
0
] | 1 | [
0
] | intervention 1: Groups 1 \& 3 1-21mg Nicotine patch and 1-placebo for 2 wks pre quit day and 4 wks post quit day
Groups 2 \& 4 2-21mg Nicotine Patches for 2 wks pre quit day and 4 wks post quit day | intervention 1: Nicotine Patch | 1 | Durham | North Carolina | United States | -78.89862 | 35.99403 | 0 | NCT00734617 |
[
4
] | 2,694 | RANDOMIZED | FACTORIAL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | Evaluate the efficacy (blood pressure lowering effect) and safety of aliskiren alone and in combination with amlodipine in patients with essential hypertension. | null | Hypertension | Hypertension, Aliskiren, Amlodipine | null | 9 | arm 1: Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 table... | [
2,
0,
0,
0,
0,
0,
0,
0,
0
] | 9 | [
0,
0,
0,
0,
0,
0,
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None intervention 8: None intervention 9: None | intervention 1: Placebo intervention 2: Aliskiren 150 mg tablet intervention 3: Aliskiren 300 mg tablet intervention 4: Amlodipine 5 mg capsule intervention 5: Amlodipine 10 mg capsule intervention 6: Aliskiren/amlodipine 150/5 mg tablet intervention 7: Aliskiren/amlodipine 150/10 mg tablet intervention 8: Aliskiren/am... | 18 | East Hanover | New Jersey | United States | -74.36487 | 40.8201
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Canberra | N/A | Australia | 149.12807 | -35.28346
Toronto | N/A | Canada | -79.39864 | 43.70643
Bogotá | N/A | Colombia | -74.08175 | 4.60971
Copenhagen | N/A | Denmark | 12.56553 | 55.67594
Oslo | N/... | 0 | NCT00739973 |
[
2
] | 39 | NA | PARALLEL | 9OTHER | 0NONE | false | 0ALL | false | To evaluate pharmacokinetics, pharmacodynamics, safety and tolerability of atorvastatin in children and adolescents with heterozygous familial hypercholesterolemia | null | Pediatric Heterozygous Hypercholesterolemia | heterozygous familial hypercholesterolemia (HeFH); atorvastatin; pediatric | null | 2 | arm 1: 6-10 years will be administered with atorvastatin tablet formulation with initial doses based on age cohort. arm 2: 10-17 years will be administered 10-mg daily dose of atorvastatin tablet formulation. | [
5,
5
] | 2 | [
0,
0
] | intervention 1: 6-10 years Tanner Stage 1 will be administered 5-mg daily dose of an atorvastatin pediatric tablet formulation. Dose may be doubled if subjects have not attained target LDL (\<3.35 mmol/L) after 4-week treatment. intervention 2: 10-17 years Tanner Stage 2 will be administered 10-mg daily dose of atorvas... | intervention 1: Atorvastatin intervention 2: Atorvastatin | 3 | Québec | Quebec | Canada | -71.21454 | 46.81228
Athens | N/A | Greece | 23.72784 | 37.98376
Oslo | N/A | Norway | 10.74609 | 59.91273 | 0 | NCT00739999 |
[
0
] | 27 | RANDOMIZED | CROSSOVER | 7BASIC_SCIENCE | 4QUADRUPLE | false | 0ALL | false | This study will measure the effect of the agent tadalafil on glucose and insulin homeostasis in people with metabolic syndrome in the presence and absence of an ACE inhibitor. | null | Metabolic Syndrome | null | 12 | arm 1: placebo+tadalafil for three weeks, washout, placebo+ramipril for three weeks, washout, ramipril + tadalafil, washout, placebo+placebo for three weeks arm 2: placebo+ramipril for three weeks, washout, placebo+tadalafil for three weeks, washout, placebo+placebo for three weeks, washout, ramipril+tadalafil for thre... | [
1,
1,
1,
1,
1,
1,
1,
1,
1,
1,
1,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: Ramipril 10 mg per day for three weeks intervention 2: tadalafil 10 mg every other day for three weeks intervention 3: placebo matching ramipril intervention 4: placebo matching tadalafil | intervention 1: Ramipril intervention 2: Tadalafil intervention 3: placebo intervention 4: placebo | 0 | null | 0 | NCT00750308 | |
[
5
] | 20 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | Previous studies suggest that treadmill exercise may be a more relevant exercise stimulus than the cycle ergometer to demonstrate benefits with bronchodilator therapy in patients with COPD. The hypothesis of the study is that patients with COPD will exhibit greater improvements in exercise endurance and breathlessness ... | The study is a randomized trial with crossover of consecutively recruited patients with symptomatic COPD. Each patient will participate in seven visits over a 3-4 week period. At the first visit patients will provide informed consent and then be familiarized with equipment and testing protocols. At visits 2 and 3 patie... | Chronic Obstructive Pulmonary Disease | exercise; treadmill; cycle ergometer; breathlessness; leg discomfort | null | 2 | arm 1: Bronchodilator therapy with arformoterol solution 15 mcg arm 2: Placebo using normal saline | [
1,
2
] | 4 | [
0,
0,
10,
10
] | intervention 1: 15 mcg in two ml solution administered via nebulizer intervention 2: Normal saline was nebulized. intervention 3: None intervention 4: None | intervention 1: Arformoterol tartrate intervention 2: Placebo: Normal Saline intervention 3: Treadmill Exercise intervention 4: Cycle Exercise | 1 | Lebanon | New Hampshire | United States | -72.25176 | 43.64229 | 0 | NCT00754546 |
[
5
] | 299 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of the study is to explore the maintained efficacy, tolerability, and safety of flexibly dosed paliperidone extended-release (ER) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal ... | This is an open-label (all people know the identity of the intervention), non-randomized (the study drug is not assigned by chance), single arm, multicenter (when more than one hospital or medical school team work on a medical research study), 24-week study. Participants can be transitioned to an effective dose of pali... | Schizophrenia | Schizophrenia Paliperidone Extended-Release | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Participants will receive paliperidone ER tablet in dose range of 3 to12 milligram (mg) per day orally once daily for 24 weeks as per Investigator's discretion based on the individual participant's clinical response to and tolerability of the study drug. | intervention 1: Paliperidone ER | 0 | null | 0 | NCT00757705 |
[
3
] | 55 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The primary aim of this study is to investigate the effects of AZD1236 compared with placebo ("inactive substance") in COPD patients by analysing biomarkers for inflammation and tissue degradation in blood, urine and sputum. | null | Chronic Obstructive Pulmonary Disease | COPD | null | 2 | arm 1: oral tablet, 75 mg, twice daily during 6 weeks arm 2: Dosing to match AZD1236 | [
0,
2
] | 2 | [
0,
0
] | intervention 1: oral tablet, 75 mg, twice daily during 6 weeks intervention 2: Dosing to match AZD1236 | intervention 1: AZD1236 intervention 2: Placebo | 10 | Aalborg | N/A | Denmark | 9.9187 | 57.048
Arhus C | N/A | Denmark | N/A | N/A
København NV | N/A | Denmark | 12.52343 | 55.71258
Odense C | N/A | Denmark | 10.39538 | 55.40841
Helsinki | N/A | Finland | 24.93545 | 60.16952
Tampere | N/A | Finland | 23.78712 | 61.49911
Eindhoven | N/A | Netherlands | 5.47778 | 51.44083
... | 0 | NCT00758706 |
[
5
] | 34 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | true | 0ALL | false | The purpose of this study is to compare the efficacy of a Vytorin 10/80 tablet, an approved agent for the treatment of elevated LDL cholesterol which combines the cholesterol absorption inhibitor Ezetimibe 10 mg and simvastatin 80 mg, when split into 4 using a tablet splitter, versus a whole simvastatin 20 milligram ta... | null | Hypercholesterolemia | Hypercholesterolemia Statins Ezetimibe | null | 2 | arm 1: Vytorin 10/80 divided into 4 arm 2: Simvastatin 20 milligrams | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Vytorin 10/80 split into 4 intervention 2: Simvastatin 20 milligrams | intervention 1: Vytorin intervention 2: Simvastatin | 1 | The Bronx | New York | United States | -73.86641 | 40.84985 | 0 | NCT00762164 |
[
4
] | 305 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to compare pioglitazone and metformin combination therapy, twice daily (BID), to glimepiride and metformin combination therapy for treating diabetic subjects with dyslipidemia. | Insulin resistance is a major endocrinopathy preceding the development of hyperglycemia, diabetic dyslipidemia and cardiovascular disease in type 2 diabetes. The most common pattern of dyslipidemia in patients with type 2 diabetes are elevated triglyceride levels, decreased hih-density lipoprotein cholesterol and a pre... | Diabetes Mellitus Dyslipidemias | Glucose Metabolism Disorder Dysmetabolic Syndrome Type II Diabetes Diabetes Mellitus, Lipoatrophic Dyslipidemia Hyperlipidemias Drug Therapy | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks. intervention 2: Pioglitazone/metformin placebo-matching combination tablets, orally, t... | intervention 1: Pioglitazone and Metformin intervention 2: Glimepiride and Metformin | 64 | Bretten | Baden-Wurttemberg | Germany | 8.70745 | 49.03685
Deggingen | Baden-Wurttemberg | Germany | 9.71891 | 48.5971
Dettenheim | Baden-Wurttemberg | Germany | N/A | N/A
Künzelsau | Baden-Wurttemberg | Germany | 9.68352 | 49.2818
Rottweil | Baden-Wurttemberg | Germany | 8.62719 | 48.16783
Spaichingen | Baden-Wurttemb... | 0 | NCT00770653 |
[
5
] | 20 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This will be a double-blind crossover trial in 20 patient with stable COPD. Data from this study will provide proof-of-concept information on whether the (anticipated) additional bronchodilator effect of Brovana added to tiotropium will lead to a meaningful improvement in the patient-centered outcome, exercise capacity... | Hypotheses to be tested:
Brovana nebulized twice daily added to maintenance inhaled tiotropium therapy in stable COPD patients increases:
1. Forced expiratory volume in 1 second (FEV1) at peak dose effect (approximately 2 hours after AM dosing in the laboratory)
2. Resting and exercise hyperinflation at peak dose eff... | COPD | COPD Bronchodilator arformoterol tiotropium | null | 2 | arm 1: Arformoterol twice daily for 1 week via nebulizer arm 2: Placebo twice daily for 1 week | [
0,
2
] | 2 | [
0,
0
] | intervention 1: twice daily via nebulizer added to maintenance daily tiotropium intervention 2: Placebo twice daily for 1 week (added to maintenance tiotropium) | intervention 1: Arformoterol (Brovana) intervention 2: Placebo | 1 | Hartford | Connecticut | United States | -72.68509 | 41.76371 | 0 | NCT00773786 |
[
4
] | 381 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 1FEMALE | false | NT 201, also known as IncobotulinumtoxinA (Xeomin®/Bocouture®), is a Botulinum toxin type A preparation free of complexing proteins (150 kiloDalton). Injected into the muscle, NT201 causes a reversible local relaxation of the injected muscle. Botulinum toxin type A is used for aesthetic treatment of mimic wrinkles and ... | null | Glabellar Frown Lines | null | 2 | arm 1: IncobotulinumtoxinA (Xeomin®/Bocouture®), 24 units; mode of administration: intramuscular injection. arm 2: OnabotulinumtoxinA (Vistabel®), 24 units; mode of administration: intramuscular injection. | [
0,
1
] | 2 | [
0,
0
] | intervention 1: NT201, also known as IncobotulinumtoxinA (Xeomin®/Bocouture®), active ingredient: Clostridium botulinum neurotoxin type A free from complexing proteins, powder for solution for injection dose, 24 units; one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (Na... | intervention 1: NT 201 (IncobotulinumtoxinA (Xeomin®/Bocouture®)) intervention 2: OnabotulinumtoxinA (Vistabel®) | 17 | Baden | N/A | Austria | 16.23264 | 48.00543
Krems | N/A | Austria | 15.61415 | 48.40921
Salzburg | N/A | Austria | 13.04399 | 47.79941
Vienna | N/A | Austria | 16.37208 | 48.20849
Bad Soden | N/A | Germany | 9.36404 | 50.28857
Böblingen | N/A | Germany | 9.01171 | 48.68212
Cologne | N/A | Germany | 6.95 | 50.93333
Darm... | 0 | NCT00777803 | |
[
4
] | 818 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients not adequately controlled with aliskiren alone | null | Hypertension | Aliskiren, Amlodipine, Non-responder to aliskiren | null | 3 | arm 1: Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks. arm 2: Participants received 1 Aliskiren/Amlodipine 300/10 mg tablet + 1 Placebo to Aliskiren tablet orally once daily in the morning for 8 weeks. arm 3: Participants received 1 Alis... | [
0,
0,
1
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: Aliskiren 300 mg tablet taken orally once a day with a glass of water. intervention 2: Aliskiren/Amlodipine 300/5 mg tablet taken orally once a day with a glass of water. intervention 3: Aliskiren/Amlodipine 300/10 mg taken orally once a day with a glass of water. intervention 4: Placebo to Aliskiren ta... | intervention 1: Aliskiren 300 mg intervention 2: Aliskiren/Amlodipine 300/5 mg intervention 3: Aliskiren/Amlodipine 300/10 mg intervention 4: Placebo to Aliskiren intervention 5: Placebo to Aliskiren/Amlodipine | 9 | Estonia | N/A | Estonia | N/A | N/A
France | N/A | France | -0.84802 | 45.60366
Iceland | N/A | Iceland | N/A | N/A
India | N/A | India | 75.36261 | 23.01533
Italy | N/A | Italy | N/A | N/A
Lithuania | N/A | Lithuania | N/A | N/A
Republic of Korea | N/A | South Korea | N/A | N/A
Spain | N/A | Spain | N/A | N/A
Venezuel... | 0 | NCT00777946 |
[
4
] | 55 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to assess the pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time) of itraconazole (ITCZ) oral solution in participants with Systemic Fungal Infection (SFI) and those with febrile (with fever) neutropenia (FN, de... | This is an open-label (all people know the identity of the intervention), multicenter (conducted in more than 1 center) and uncontrolled (no competitive drugs involved) study. Participants with SFI will receive treatment with ITCZ oral solution or switch treatment from intravenous (into a vein) infusion of itraconazole... | Mycoses Candidiasis Aspergillosis Cryptococcosis Blastomycosis Histoplasmosis Neutropenia | Mycoses Candidiasis Aspergillosis Cryptococcosis Blastomycosis Histoplasmosis Neutropenia Itraconazole JK1211 | null | 3 | arm 1: Participants with deep-seated mycosis (Systemic Fungal Infection \[SFI\]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator's discretion. arm 2: Participants with SFI received 200 milligram (mg) twice daily itraconazole in... | [
0,
0,
0
] | 2 | [
0,
0
] | intervention 1: ITCZ syrup product containing ITCZ 10 mg per ml in dose range of 20 ml to 40 ml daily for 7 days up to 12 weeks intervention 2: 200 mg IV twice daily for 2 days and once daily for the next 1 to 12 days | intervention 1: ITCZ Oral Solution intervention 2: ITCZ-IV | 1 | Fukuoka | N/A | Japan | 130.41667 | 33.6 | 0 | NCT00784368 |
[
4
] | 366 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to determine whether AG-1749 (lansoprazole), once daily (QD), is effective in preventing the recurrence of gastric and duodenal ulcers in patients receiving long term treatment with nonsteroid anti-inflammatory drug, compared to gefarnate, twice daily (BID). | In Japan, nonsteroid anti-inflammatory drug is one of common prescribed drugs for patients as an analgesic antipyretic, treating symptoms of cold, antiphlogistic and management of pain with rheumatoid arthritis, osteoarthrosis, lumbago. On the other hand, this nonsteroid anti-inflammatory drug sometimes causes gastric ... | Stomach Ulcer Duodenal Ulcer | Curling Ulcer Gastric Ulcer Nonsteroid anti-inflammatory drug Drug Therapy | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months. intervention 2: Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months. | intervention 1: Lansoprazole intervention 2: Gefarnate | 68 | Kasugai-shi | Aichi-ken | Japan | N/A | N/A
Yotsukaido-shi | Chiba | Japan | N/A | N/A
Matsuyama | Ehime | Japan | 132.76574 | 33.83916
Fukui-shi | Fukui | Japan | 136.22257 | 36.06443
Chikushi-gun | Fukuoka | Japan | N/A | N/A
Fukuoka | Fukuoka | Japan | 130.41667 | 33.6
Kurume-shi | Fukuoka | Japan | N/A | N/A
Munaka... | 0 | NCT00787254 |
[
3
] | 68 | RANDOMIZED | PARALLEL | 1PREVENTION | 3TRIPLE | false | 0ALL | null | Brief Summary: A randomized, single administration, double-blind, parallel- group Phase 2 dose finding study to assess the efficacy, tolerability, and safety of TRG in patients with chemotherapy-induced nausea and vomiting (CINV) associated with the administration of highly emetogenic chemotherapy.
Primary Objective: ... | null | Chemotherapy-Induced Nausea and Vomiting | Highly emetogenic chemotherapy induced nausea and vomiting | null | 3 | arm 1: 0.5 mg dose, intranasal powder, single spray, administered once arm 2: 1.0 mg dose, intranasal powder, songle spray, administered once arm 3: 2.0 mg dose, intranasal powder, single spray, administered once | [
0,
0,
0
] | 1 | [
0
] | intervention 1: 0.5 mg, 1.0 mg or 2.0 mg dose of TRG prior to the administration of a highly-emetogenic chemotherapy regimen | intervention 1: Intranasal granisetron | 1 | The Study Is Managed by Kendle International, in Wilmington | North Carolina | United States | N/A | N/A | 0 | NCT00787566 |
[
5
] | 236 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to compare two ophthalmic solutions in patients with open-angle glaucoma or ocular hypertension. | null | Open-angle Glaucoma Ocular Hypertension | Open-angle glaucoma Ocular hypertension | null | 2 | arm 1: One drop self-administered in the study eye(s) once daily at night for 12 weeks arm 2: One drop self-administered in the study eye(s) once daily at night for 12 weeks | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 12 weeks (84 days). Referred to as travoprost. intervention 2: Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for... | intervention 1: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®) intervention 2: Latanoprost ophthalmic solution 0.005% (XALATAN®) | 0 | null | 0 | NCT00798759 |
[
3
] | 3 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | This study is designed to assess the safety and efficacy of twice-daily oral dosing of 6R-BH4 to improve endothelial function, reduce systolic blood pressure and reduce arterial stiffness. | By comparing values measured at different timepoints, the study is expected to provide insight regarding the ability of 6R-BH4, administered along with their currently prescribed antihypertension medications, to improve endothelial function, reduce SBP, and reduce arterial stiffness in patients with ISH and endothelial... | Isolated Systolic Hypertension Endothelial Dysfunction | Isolated Systolic Hypertension with Endothelial Dysfunction | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
10
] | intervention 1: 6R-BH4 5mg/kg or Placebo BID for four weeks and then 8 week dose-escalation period intervention 2: placebo given BID for entire length of study | intervention 1: 6R-BH4 intervention 2: Placebo | 1 | Baltimore | Maryland | United States | -76.61219 | 39.29038 | 0 | NCT00802893 |
[
3
] | 120 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | true | 0ALL | false | This is a Phase 2, multicenter, randomized, double-blind, placebo and active comparator-controlled study of LY2590443 in approximately 200 participants with migraines. | null | Migraine Headache | Migraine Headache | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
2,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: 200 milligrams (mg) as four 50-mg capsules, oral, once intervention 2: saline solution, injection, once intervention 3: 6 milligrams (mg) injection (0.5 milliliter \[mL\] of 12 mg/mL solution), once intervention 4: 4 capsules, once | intervention 1: LY2590443 intervention 2: Placebo injection intervention 3: Sumatriptan intervention 4: Placebo capsule | 19 | Beverly Hills | California | United States | -118.40036 | 34.07362
Chula Vista | California | United States | -117.0842 | 32.64005
Fresno | California | United States | -119.77237 | 36.74773
Garden Grove | California | United States | -117.94145 | 33.77391
Imperial | California | United States | -115.56944 | 32.84755
S... | 0 | NCT00804973 |
[
3
] | 80 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | true | 0ALL | false | The purpose of this study is to determine how VI-0521 affect speed and reaction time on specific tasks that require eye and hand coordination, compared to placebo. | null | Overweight Obesity | Overweight Obesity coordination psychomotor | null | 4 | arm 1: Dosed first with alcohol, then active VI-0521, and last, VI-0521 placebo arm 2: First dosed with alcohol placebo (fruit juice), then active VI-0521, and last, placebo VI-0521 arm 3: First dosed with alcohol, then VI-0521 placebo, and last, active VI-0521 arm 4: First dosed with alcohol placebo, then VI-0521 plac... | [
0,
0,
0,
0
] | 4 | [
0,
0,
10,
10
] | intervention 1: Phentermine 3.75 mg and topiramate 23 mg daily for the 1st week; Phentermine 7.5 mg and topiramate 46 mg daily for the 2nd week; Phentermine 11.25 mg and topiramate 69 mg daily for the 3rd week; Phentermine 15 mg and topiramate 92 mg daily for the 4th week intervention 2: Placebo daily for 4 weeks inter... | intervention 1: VI-0521 intervention 2: Placebo intervention 3: Alcohol intervention 4: alcohol placebo | 1 | Lincoln | Nebraska | United States | -96.66696 | 40.8 | 0 | NCT00806260 |
[
3
] | 369 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | The purpose of this research study is to determine whether AstraZeneca's drug AZD7325 is safe and effective in the treatment of generalized anxiety disorder. | null | Anxiety Disorders | Generalized Anxiety Disorder GAD Anxiety | null | 4 | arm 1: AZD7325 5mg twice daily arm 2: AZD7325 15mg twice daily arm 3: Lorazepam 2mg twice daily arm 4: Placebo | [
0,
0,
1,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: 4 tablets and 1 capsule taken twice a day for 28 days intervention 2: 4 tablets and 1 capsule taken twice a day for 28 days intervention 3: 4 tablets and 1 capsule taken twice a day for 28 days intervention 4: 4 tablets and 1 capsule taken twice a day for 28 days | intervention 1: AZD7325 intervention 2: AZD7325 intervention 3: Lorazepam intervention 4: Placebo | 51 | Mesa | Arizona | United States | -111.82264 | 33.42227
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Carson | California | United States | -118.28202 | 33.83141
Escondido | California | United States | -117.08642 | 33.11921
Glendale | California | United States | -118.25508 | 34.14251
Irvine | Californi... | 0 | NCT00807937 |
[
2,
3
] | 172 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The study will evaluate the safety and efficacy of AGN-210669 ophthalmic solution in comparison with AGN-210669 vehicle and bimatoprost ophthalmic solution dosed once-daily each morning, in subjects with ocular hypertension or primary open-angle glaucoma. Subjects will be followed for 2 weeks. | null | Ocular Hypertension Glaucoma | null | 5 | arm 1: AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks. arm 2: AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks. arm 3: AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eye... | [
0,
0,
0,
1,
2
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks. intervention 2: AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks. intervention 3: AGN-210669 non-preserved ophthalmic solution, 0... | intervention 1: AGN-210669 ophthalmic solution, 0.075% intervention 2: AGN-210669 ophthalmic solution, 0.05% intervention 3: AGN-210669 ophthalmic solution, 0.025% intervention 4: bimatoprost ophthalmic solution 0.03% intervention 5: AGN-210669 vehicle ophthalmic solution | 1 | Artesia | California | United States | -118.08312 | 33.86585 | 0 | NCT00809848 | |
[
5
] | 12 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | false | 1FEMALE | false | The objective of this study is to compare the pharmacokinetics of lopinavir tablets administered to pediatric patients as either whole or crushed tablets. The study is a randomized,open-label, crossover study of pediatric subjects already taking lopinavir/ritonavir tablets as part of their clinical care. THe investigat... | By the end of 2005, approximately 2.3 million children worldwide were living with HIV/AIDS.1 At least 660,000 children worldwide have advanced HIV/AIDS and are in dire need of antiretroviral treatment. While many barriers exist to scaling up HIV/AIDS care and treatment globally, access to life-saving treatments for chi... | HIV/AIDS Treatment HIV Infections | HIV/AIDS pediatrics resource-limited settings lopinavir ritonavir Kaletra® antiretroviral treatment crushed tablets treatment experienced | null | 2 | arm 1: These subjects will take whole lopinavir tablets at Study Visit 1, and crushed tablets at Study Visit 2. arm 2: These subjects will take crushed tablets at Study Visit 1, and whole tablets at Study Visit 2. | [
0,
0
] | 1 | [
0
] | intervention 1: The subject will bring their own prescription of lopinavir/ritonavir. The patient will take a witnessed dose of lopinavir/ritonavir with an 6 ounce glass of cool water (if taken whole) or mixed in 4 ounces of Jell-O brand pudding (if crushed). | intervention 1: lopinavir/ritonavir (Kaletra®) tablets | 2 | San Diego | California | United States | -117.16472 | 32.71571
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 | 0 | NCT00810108 |
[
2
] | 29 | RANDOMIZED | PARALLEL | 2DIAGNOSTIC | 2DOUBLE | true | 1FEMALE | false | The purpose of this study is to examine the effect of two different dose levels of estrogen or placebo in healthy postmenopausal women by measuring the changes in hormone levels and examining the changes in the uterine lining (endometrium). | null | Postmenopausal Symptoms | null | 3 | arm 1: Estrace 2.0 mg tablet arm 2: Estrace 0.5 mg tablet arm 3: Placebo | [
1,
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: 0.5 mg tablet taken once daily for 28 days intervention 2: 2 mg tablets taken once daily for 28 days. intervention 3: Placebo 0 mg capsule taken once daily for 28 days | intervention 1: Comparator: Estrace 0.5 mg intervention 2: Comparator: Estrace 2 mg intervention 3: Comparator: Placebo | 0 | null | 0 | NCT00820664 | |
[
5
] | 30 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to determine whether cetirizine (zyrtec), levocetirizine (xyzal), and placebo differ in the degree of sedation they produce and their relief of allergy symptoms. | Levocetirizine, the R-enantiomer of cetirizine, has been found to be less sedating relative to placebo than was cetirizine in separate trials. We plan to examine whether patients who did not tolerate cetirizine due to sedation are able to tolerate levocetirizine. This study will utilize a randomized, double-blind, plac... | Allergic Rhinitis | Allergic Rhinitis | null | 3 | arm 1: 5 mg daily x 7 days (note = cross over = all participants receive active comparators and placebo) arm 2: 10 mg daily x 7 days. Note = crossover study, so all participants recieve all active comparators and placebo. arm 3: one tablet daily x 7 days; note that this is a crossover study so all participants receive ... | [
1,
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: Cetirizine 10 mg tab daily x 7 days intervention 2: 5 mg tab daily x 7 days intervention 3: Placebo tablet daily x 7 days | intervention 1: Cetirizine intervention 2: Levocetirizine intervention 3: Placebo | 1 | Nashville | Tennessee | United States | -86.78444 | 36.16589 | 0 | NCT00826943 |
[
2
] | 425 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The primary objectives are to establish the therapeutic equivalence of imiquimod cream 5%, manufactured by Taro Pharmaceuticals Inc. and Aldara (imiquimod) cream, manufactured by 3M, and to show superiority over vehicle in the treatment of AK.
The secondary objective is to compare the adverse event (AE) profiles of th... | null | Actinic Keratosis | Actinic Keratosis | null | 3 | arm 1: Imiquimod 5% manufactured by Taro applied for 16 weeks arm 2: Aldara, Imiquimod 5% applied for 16 weeks arm 3: Imiquimod vehicle applied for 16 weeks | [
0,
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks intervention 2: Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks intervention 3: Treatment applied as a thin layer to target area once daily, 2 days each week, for 16 we... | intervention 1: Imiquimod 5% manufactured by Taro intervention 2: Aldara - Imiquimod 5% intervention 3: Imiquimod Vehicle manufactured by Taro | 20 | Gilbert | Arizona | United States | -111.78903 | 33.35283
Tempe | Arizona | United States | -111.90931 | 33.41477
Tuscon | Arizona | United States | N/A | N/A
Denver | Colorado | United States | -104.9847 | 39.73915
Jacksonville | Florida | United States | -81.65565 | 30.33218
Miami | Florida | United States | -80.1936... | 0 | NCT00828568 |
[
3
] | 65 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This trial is conducted in Japan. The aim of this clinical trial is to investigate the safety (with emphasis on hypoglycaemia) after switching from long-acting insulin analogue or intermediate-acting insulin to insulin degludec (NN1250, SIBA) on a basal-bolus regimen in subjects with type 1 diabetes mellitus. | null | Diabetes Diabetes Mellitus, Type 1 | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: The insulin NN1250 (insulin degludec) injected subcutaneously at bedtime intervention 2: Injection subcutaneously at bedtime intervention 3: Injection subcutaneously immediately before each meal. | intervention 1: insulin degludec intervention 2: insulin detemir intervention 3: insulin aspart | 8 | Chuo-ku, Tokyo | N/A | Japan | N/A | N/A
Ebina-shi | N/A | Japan | N/A | N/A
Koriyama-shi, Fukushima | N/A | Japan | 140.46667 | 37.75
Kumamoto-shi,Kumamoto | N/A | Japan | N/A | N/A
Ōita | N/A | Japan | 131.6 | 33.23333
Sapporo-shi, Hokkaido | N/A | Japan | 141.35 | 43.06667
Sapporo-shi, Hokkaido | N/A | Japan | 141.3... | 0 | NCT00841087 | |
[
5
] | 150 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of this study is to compare the efficacy of Olopatadine Nasal Spray with Azelastine Nasal Spray when treatments are utilized in conjunction with Fluticasone Nasal Spray for the treatment of seasonal allergic rhinitis. | null | Seasonal Allergic Rhinitis | Rhinitis Allergy Nasal Spray Antihistamine Intranasal Corticosteroid | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 2 sprays/nostril, twice daily (in addition to Fluticasone Propionate Nasal Spray 50 mcg 2 sprays/nostril once daily) for 14 +/- 3 days intervention 2: 2 sprays/nostril, twice daily (in addition to Fluticasone Propionate Nasal Spray 50 mcg 2 sprays/nostril once daily) for 14 +/- 3 days | intervention 1: Olopatadine HCl Nasal Spray, 0.6% intervention 2: Azelastine HCl Nasal Spray, 0.1% | 1 | Fort Worth | Texas | United States | -97.32085 | 32.72541 | 0 | NCT00845195 |
[
3
] | 24 | RANDOMIZED | SINGLE_GROUP | 9OTHER | 1SINGLE | false | 0ALL | false | The purpose of the study is to compare the anti-psoriatic effect of marketed products with Daivobet® ointment in a plaque test | null | Psoriasis Vulgaris | null | 1 | arm 1: None | [
0
] | 6 | [
0,
0,
0,
0,
0,
0
] | intervention 1: Once daily application 6 days a week for 3 weeks intervention 2: Once daily application 6 days a week for 3 weeks intervention 3: Once daily application 6 days a week for 3 weeks intervention 4: Once daily application 6 days a week for 3 weeks intervention 5: Once daily application 6 days a week for 3 w... | intervention 1: Daivobet® ointment intervention 2: Betnovat® ointment intervention 3: Diprosalic ointment intervention 4: Dermovat ointment intervention 5: Elocon ointment intervention 6: Daivobet® ointment vehicle | 1 | Saint Quentin Yvelines Cedex | N/A | France | N/A | N/A | 0 | NCT00845481 | |
[
3
] | 487 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This is a phase 2, randomized, double-blind, placebo-controlled, parallel-group, 2-week, multi-center, dose-range-finding study in male or female patients (12 years and older) with SAR. | null | Seasonal Allergic Rhinitis Hayfever | Seasonal Allergic Rhinitis Hayfever | null | 4 | arm 1: During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 micrograms (µg) BDP HFA and two actuations of placebo HFA once daily. arm 2: During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40... | [
0,
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: Beclomethasone dipropionate (BDP) Hydrofluoroalkane (HFA) Nasal Aerosol intervention 2: HFA Vehicle Aerosol | intervention 1: Beclomethasone dipropionate HFA Nasal Aerosol intervention 2: Placebo | 26 | Mission Viejo | California | United States | -117.672 | 33.60002
San Diego | California | United States | -117.16472 | 32.71571
San Diego | California | United States | -117.16472 | 32.71571
Colorado Springs | Colorado | United States | -104.82136 | 38.83388
Denver | Colorado | United States | -104.9847 | 39.73915
Gain... | 0 | NCT00854360 |
[
3
] | 33 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This study was intended to assess how well inhaled NVA237 opens up the airways of patients with mild, moderate or severe COPD over a 24 hour period after a 14 day treatment period. | null | Chronic Obstructive Pulmonary Disease | COPD Bronchodilator | null | 2 | arm 1: Placebo 50 μg capsules followed by NVA237 50 μg capsules for inhalation once daily with Concept 1 device. arm 2: NVA237 50 μg capsules followed by matching placebo 50 μg capsules for inhalation once daily with Concept 1 device. | [
2,
0
] | 2 | [
0,
0
] | intervention 1: Matching placebo capsules were supplied for inhalation once daily with Concept 1 device. intervention 2: NVA237 50 μg capsules were supplied for inhalation once daily with Concept 1 device. | intervention 1: Placebo intervention 2: NVA237 | 2 | Spartanburg | South Carolina | United States | -81.93205 | 34.94957
Albrechtstrasse 14 | Munich | Germany | N/A | N/A | 0 | NCT00856193 |
[
4
] | 136 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | false | To evaluate the safety and efficacy of BLI800 vs an FDA approved bowel preparation before colonoscopic examination in adult subjects. | null | Colonoscopy | colonoscopy bowel preparation | null | 2 | arm 1: Polyethylene glycol 3350 based bowel preparation arm 2: BLI800 | [
1,
0
] | 2 | [
0,
0
] | intervention 1: Solution for oral administration prior to colonoscopy intervention 2: Solution for oral administration prior to colonoscopy | intervention 1: BLI800 intervention 2: Polyethylene glycol 3350 based bowel preparation | 5 | Mobile | Alabama | United States | -88.04305 | 30.69436
Jupiter | Florida | United States | -80.09421 | 26.93422
Miami | Florida | United States | -80.19366 | 25.77427
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Great Neck | New York | United States | -73.72846 | 40.80066 | 0 | NCT00856843 |
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