phases list | enrollmentCount int64 | allocation string | interventionModel string | primaryPurpose class label | masking class label | healthyVolunteers bool | sex class label | oversightHasDmc bool | briefSummary string | detailedDescription string | conditions string | conditionsKeywords string | protocolPdfText string | numArms int64 | armDescriptions string | armGroupTypes list | numInterventions int64 | interventionTypes list | interventionDescriptions string | interventionNames string | numLocations int64 | locationDetails string | target int64 | nctid string |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
[
4
] | 24 | RANDOMIZED | PARALLEL | 0TREATMENT | null | false | 0ALL | null | The purpose of this study is to evaluate the safety and efficacy of the CCR5 antagonist GW873140 or placebo in combination with an optimized background regimen in treatment-experienced HIV-infected subjects with R5-tropic virus | null | Infection, Human Immunodeficiency Virus I | HIV-1 GW873140 CCR5 antagonist experienced | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: 400 mg twice daily | intervention 1: GW873140 | 55 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Beverly Hills | California | United States | -118.40036 | 34.07362
Fountain Valley | California | United States | -117.95367 | 33.70918
Laguna Beach | California | United States | -117.78311 | 33.54225
Long Beach | California | United States | -118.18923 | 33.... | 0 | NCT00197145 |
[
3
] | 114 | RANDOMIZED | PARALLEL | 1PREVENTION | 2DOUBLE | false | 0ALL | true | The objective of this clinical study was to evaluate whether CXCL8 (CXC ligand 8 \[formerly interleukin (IL)-8\]) inhibition with repertaxin leads to reduced severity of primary graft dysfunction, as the result of improved functional and clinical outcomes in lung transplantation patients.
The safety of repertaxin in t... | This was a phase 2, multi-center, randomized, double-blind, placebo-controlled, parallel-group (two arms) study.
A total of 100 patients accepted and listed for lung transplantation, who met all of the study inclusion and none of the exclusion criteria described in Sections 9.3.1 and 9.3.2 of this report, were planned... | Ischemia-Reperfusion Injury Lung Transplantation | Lung transplantation Reperfusion Injury Survival | Prot_000.pdf:
Study REPO 104
Repertaxin in Lung Transplantation
Page 1 of73
PPD
CLINICAL STUDY PROTOCOL • CONFIDENTIAL
Study Number:
Investigational Product:
Title:
Protocol Version
Date of protocol:
REP0104
Repertaxin
A phase 2, multi-center, randomized, double-blind, placebo-
controlled, parallel-group s... | 2 | arm 1: Both repertaxin and placebo were aqueous solutions packaged into identical clear glass Type I ampoule single dose units. Each ampoule contained 10 mL of either repertaxin or placebo.The dosing solution for infusion was prepared aseptically at the designated Pharmacy within each center and dispensed as 12.65 mg/m... | [
0,
2
] | 2 | [
0,
10
] | intervention 1: An initial 'loading dose' of repertaxin was administered over 30 minutes by intravenous infusion followed by a maintenance dose lasting 47.5 hours.The infusion was to start approximately 2 hours prior to the anticipated time of reperfusion and was to continue during the ICU/hospital stay. The study medi... | intervention 1: Repertaxin intervention 2: Placebo | 6 | Los Angeles | California | United States | -118.24368 | 34.05223
Denver | Colorado | United States | -104.9847 | 39.73915
St Louis | Missouri | United States | -90.19789 | 38.62727
Durham | North Carolina | United States | -78.89862 | 35.99403
Cleveland | Ohio | United States | -81.69541 | 41.4995
Toronto | Ontario | C... | 0 | NCT00224406 |
[
5
] | 221 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The majority of asthma patients are not well controlled, despite the availability of asthma medication that could effectively treat the disease. In this study uncontrolled patients who are steroid-naive or on low dose inhaled corticosteroids will be treated with Seretide (salmeterol/fluticasone combination, SFC) 50/250... | null | Asthma | Asthma Asthma Control Test SERETIDE | null | 1 | arm 1: Participants received the combination product, fluticasone 250 microgram (mcg) plus salmeterol 50 mcg (SFC 50/250 mcg) for 12 weeks. Study treatment was received using DISKUS™ powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants... | [
0
] | 3 | [
0,
0,
1
] | intervention 1: Participant received salmeterol/fluticasone combination 50/250 mcg using DISKUS™ powder inhalers. intervention 2: This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. intervention 3: Participant received salmeterol and fluticasone using DISKUS™ powde... | intervention 1: Salmeterol/Fluticasone 50/250 mcg intervention 2: Salbutamol 100 mcg intervention 3: DISKUS™ powder inhalers | 32 | Erlangen | Bavaria | Germany | 11.00783 | 49.59099
Kaufbeuren | Bavaria | Germany | 10.62192 | 47.88238
Landsberg am Lech | Bavaria | Germany | 10.88282 | 48.04819
Munich | Bavaria | Germany | 11.57549 | 48.13743
Munich | Bavaria | Germany | 11.57549 | 48.13743
Rednitzhembach | Bavaria | Germany | 11.07997 | 49.30095
U... | 0 | NCT00363480 |
[
4
] | 22 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | Multicentric, open-label, randomized, pilot comparative study in parallel groups comparing 1 group of subjects receiving 0.057 milligram/kilogram/day (mg/kg/day) or 0.40 mg/kg/week of Saizen® during 1 year to 1 group receiving 0.035 mg/kg/day (0.24 mg/kg/week) of Saizen® during 1 year after an initial 3-year treatment ... | null | Small Gestational Age (SGA) | null | 2 | arm 1: Subjects who met all inclusion/exclusion criteria were randomly assigned to 0.057 mg/kg/day in this multi-center study. Subjects were stratified at randomization according to the Height-Standard Deviation Score (H-SDS) at this time (less than \[\<\] -2 SDS or greater than \[\>\] -2 SDS) arm 2: Subjects who met a... | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Saizen® \[somatropin (recombinant deoxyribonucleic acid \[rDNA\] origin) for injection\], a r-hGH, is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone. intervention 2: Saizen® \[somatropin (rDNA origin) for injection\], a r-hGH, is indi... | intervention 1: Saizen® intervention 2: Saizen® | 0 | null | 0 | NCT00249821 | |
[
5
] | 318 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | The study aims at identifying the predictive markers after one month of Saizen therapy in Growth Hormone Deficiency (GHD) and Turner Syndrome children. | null | Growth Hormone Deficiency Turner Syndrome | null | 2 | arm 1: None arm 2: None | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Subjects with TS will receive SAIZEN® as subcutaneous injection at a dose of 0.050 milligram per kilogram (mg/kg) of body weight per day (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month intervention 2: Subjects with GHD will receive SAIZEN® as subcutaneous injection ... | intervention 1: Saizen intervention 2: Saizen | 13 | Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Sydney | N/A | Australia | 151.20732 | -33.86785
Vienna | N/A | Austria | 16.37208 | 48.20849
Mississauga | N/A | Canada | -79.6583 | 43.5789
Paris | N/A | France | 2.3488 | 48.85341
Munich | N/A | Germany | 11.57549 | 48.13743
Rome | N/A | Italy | 12.51133 | 41.89... | 0 | NCT00256126 | |
[
2,
3
] | 23 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The reason for this study will be to find the safest maximum tolerated dose of oral vorinostat in combination with erlotinib \[Tarceva (TM)\] that can be given to patients with lung cancer who have relapsed or failed other therapy for the disease. Once the safest maximum tolerated dose of vorinostat is determined, pati... | null | Carcinoma, Non-Small-Cell Lung | Relapsed Non-Small-Cell Lung Cancer Refractory Non-Small-Cell Lung Cancer | null | 4 | arm 1: Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were ... | [
0,
0,
0,
0
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: Vorinostat 200 mg twice a day for 3 days a week. intervention 2: Vorinostat 300 mg once a day for 3 days a week. intervention 3: Vorinostat 300 mg twice a day for 3 days a week. intervention 4: Vorinostat 400 mg once a day for 21 out of 28 days. intervention 5: erlotinib 150 mg once a day. | intervention 1: Vorinostat intervention 2: Vorinostat intervention 3: Vorinostat intervention 4: Vorinostat intervention 5: erlotinib | 0 | null | 1 | NCT00251589 |
[
5
] | 537 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this study is to evaluate the effect of the Dialogues Time to Talk program in subjects treated with Venlafaxine Extended Release (ER). Dialogues Time to Talk Program is a patient management program, which aims to help patients achieve successful outcomes by reinforcing physician treatment efforts, provid... | null | Depressive Disorder, Major | Major Depressive Disorder Depression Anxiety | null | 0 | null | null | 2 | [
0,
5
] | intervention 1: None intervention 2: None | intervention 1: Venlafaxine ER intervention 2: Dialogues Time to Talk Program | 44 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Birmingham | Alabama | United States | -86.80249 | 33.52066
Mesa | Arizona | United States | -111.82264 | 33.42227
Little Rock | Arkansas | United States | -92.28959 | 34.74648
San Jose | California | United States | -121.89496 | 37.33939
Avon | Connecticut | ... | 1 | NCT00401726 |
[
3,
4
] | 439 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This is a Phase II/III, randomized, double-blind, parallel group, placebo controlled, multicenter study to evaluate the safety and efficacy of rituximab in adults with PPMS. The study will enroll approximately 435 subjects at up to 60 sites in the United States and Canada. | null | Multiple Sclerosis | PPMS Primary progressive MS Primary progressive multiple sclerosis Rituxan MS | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Intravenous repeating dose intervention 2: Intravenous repeating dose | intervention 1: placebo intervention 2: rituximab | 0 | null | 0 | NCT00087529 |
[
3
] | 3 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This is a multicenter, open label extension study. Subjects who have completed treatment in the parent study of pertuzumab, either alone or with a combination agent, and who received at least one dose of pertuzumab in the parent study are eligible for inclusion in this trial if they are continuing to receive clinical b... | null | Solid Cancers | Advanced solid cancers HER2 EGFR | null | 1 | arm 1: Participants received the same dose of pertuzumab that they received in their parent Phase II trial, either 420 mg or 1050 mg, intravenously on Day 1 of every 3 week cycle until disease progression. | [
0
] | 1 | [
0
] | intervention 1: Pertuzumab was supplied as a single-use liquid formulation. | intervention 1: Pertuzumab | 0 | null | 0 | NCT00096941 |
[
5
] | 179 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this trial is to study the safety of treating patients with multiple myeloma and at least one bone lesion with zoledronic acid 4mg intravenously (IV) every 3 - 4 weeks for 2 years. Patients will receive a zoledronic acid infusion for 15 minutes or 30 minutes. | null | Multiple Myeloma | Z-MAX, multiple myeloma, zoledronic acid, bone metastases | null | 2 | arm 1: Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks arm 2: Participants... | [
0,
0
] | 1 | [
0
] | intervention 1: 4 mg zoledronic acid in 250 mL of calcium-free solution (i.e., 0.9% sodium chloride or 5% glucose) administered intravenously. | intervention 1: zoledronic acid | 68 | Huntsville | Alabama | United States | -86.58594 | 34.7304
Glendale | Arizona | United States | -112.18599 | 33.53865
Tucson | Arizona | United States | -110.92648 | 32.22174
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Anaheim | California ... | 0 | NCT00104104 |
[
3,
4
] | 46 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | null | This study will determine the effectiveness of different treatments for panic disorder symptoms in individuals who still have symptoms after initial treatment with medication. | Panic disorder is a serious condition that may cause significant psychological and physical distress. Many patients with panic disorder remain symptomatic despite initial intervention. Unfortunately, little data is available to guide health care providers in "next-step" treatment approaches. This study will evaluate th... | Panic Disorder | Selective serotonin reuptake inhibitor Anxiety Pharmacotherapy Cognitive behavioral therapy CBT | null | 2 | arm 1: Participants in phase II will receive sertraline, or an equivalent medication, up to 100 mg plus a placebo pill. Participants in phase III will receive the same medication with cognitive behavioral therapy. arm 2: Participants in phase II will receive sertraline, or equivalent medication, up to 200 mg. Participa... | [
0,
0
] | 3 | [
0,
0,
5
] | intervention 1: Participants will receive clonazepam. intervention 2: Participants will receive sertraline. intervention 3: Participants will receive cognitive behavioral therapy | intervention 1: Clonazepam intervention 2: Sertraline intervention 3: Cognitive behavioral therapy | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00118417 |
[
4
] | 235 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This is a double-blind placebo-controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension. The primary outcome is the change in 6-minute walk distance from baseline to week 12. | Patients who have been on a stable dose of 125 mg twice daily (bid) of bosentan or any stable dose of sildenafil for at least three months prior to study start were randomized to either treprostinil inhalation solution or matching placebo.
Administration of study medication was performed by inhalation with the OPTINEB... | Pulmonary Hypertension | Pulmonary Arterial Hypertension | null | 2 | arm 1: 0.9 mg/mL treprostinil for inhalation supplied in 2.9mL ampoules for use in ultra sonic nebulizer arm 2: Placebo inhalation solution for use in ultrasonic nebulizer | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Doses are titrated to 9 breaths four times daily. Each breath produces an 18 mcg dose of inhaled treprostinil. intervention 2: Doses are titrated to 9 breaths four times daily. | intervention 1: Inhaled treprostinil intervention 2: Placebo inhalation solution | 30 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Tucson | Arizona | United States | -110.92648 | 32.22174
La Jolla | California | United States | -117.2742 | 32.84727
Torrance | California | United States | -118.34063 | 33.83585
Aurora | Colorado | United States | -104.83192 | 39.72943
Orlando | Florida | Un... | 0 | NCT00147199 |
[
4
] | 187 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | Schizophrenia is a brain disease. The primary features of schizophrenia are characterized by Positive symptoms (symptoms that should not be there, inability to think clearly, to distinguish reality from fantasy i.e., hearing voices) and Negative symptoms (a reduction or absence of normal behaviors or emotions, i.e., un... | null | Schizophrenia | null | 3 | arm 1: Haloperidol in original study (NCT00156104) and in current long-term extension. arm 2: Asenapine in original study and asenapine in current long-term extension. arm 3: Double-Blind subjects randomized to only placebo medication for 6 weeks in the short-term 041023 asenapine trial, were randomized (double-blind) ... | [
1,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: 2-8 mg BID intervention 2: 5 or 10 mg BID intervention 3: 5 or 10 mg BID | intervention 1: Haloperidol intervention 2: Asenapine intervention 3: Asenapine | 0 | null | 0 | NCT00156065 | |
[
5
] | 203 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This is an efficacy and safety study of Vytorin (ezetimibe (+) simvastatin) compared to atorvastatin (ezetimibe/simvastatin) at week 6 in primary hypercholesterolemia patients in Korea. The primary hypothesis being tested is that daily administration of Vytorin will result in a greater reduction of low density lipoprot... | null | Hypercholesterolemia | null | 2 | arm 1: Ezetimibe 10 mg/Simvastatin 20 mg arm 2: Atorvastatin 10 mg | [
0,
1
] | 2 | [
0,
0
] | intervention 1: simvastatin/ezetimibe 10/20 mg intervention 2: atorvastatin 10 mg | intervention 1: ezetimibe (+) simvastatin intervention 2: atorvastatin | 0 | null | 0 | NCT00166504 | |
[
5
] | 125 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | null | 1FEMALE | null | The purpose of this study is compare treatment with valsartan with the possible addition of a diuretic, hydrochlorothiazide, on high blood pressure with the drug amlodipine with the possible addition of a diuretic, hydrochlorothiazide. In particular, the effect of treatment on the stiffness of the blood vessels will be... | null | Hypertension | hypertension postmenopausal valsartan amlodipine hydrochlorothiazide | null | 2 | arm 1: None arm 2: None | [
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Patients received 160 mg valsartan for 4 weeks. Patients were then up-titrated to receive either 320 mg valsartan for the following 8 weeks. intervention 2: Patients received 5 mg amlodipine for four weeks. Patients were then up-titrated to receive 10 mg amlodipine for the following 8 weeks. interventio... | intervention 1: Valsartan 320 mg intervention 2: Amlodipine 10 mg intervention 3: Hydrochlorothiazide | 1 | Basel | N/A | Switzerland | 7.57327 | 47.55839 | 0 | NCT00171054 |
[
5
] | 47 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This study evaluates two different immunosuppression drug regimens in patients with a recent kidney transplant. Patients initially received a regimen of Sirolimus, Tacrolimus and Prednisone and then randomized to discontinue either Tacrolimus or Prednisone. | null | Kidney Failure Graft vs Host Disease | Kidney Transplant | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: None | intervention 1: Tacrolimus intervention 2: Sirolimus intervention 3: prednisone | 1 | São Paulo | N/A | Brazil | -46.63611 | -23.5475 | 0 | NCT00195429 |
[
5
] | 40 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | false | Ketamine, an FDA approved anesthetic agent, is becoming the sedative/analgesic of choice for emergency sedation in children because it causes deep sedation with minimal respiratory depression in comparison to other available agents. However, emergence reactions are an important adverse effect of ketamine, characterized... | The proposed study will be conducted using existing dedicated clinical and research space in St. Louis Children's Hospital's Emergency Department, Pediatric Clinical Research Center (PCRC), and Orthopedic Clinic. This project has 3 major aims and 1 exploratory aim addressed by a prospective randomized blinded placebo c... | Psychoses, Substance-Induced | NMDA antagonist-induced psychosis Children Memory Impairment Decreased cognitive function Increased memory impairment | null | 2 | arm 1: Ketamine without dexmedetomidine arm 2: Ketamine infusion plus dexmedetomidine | [
2,
0
] | 2 | [
0,
0
] | intervention 1: Ketamine without dexmedetomidine intervention 2: Ketamine plus dexmedetomidine | intervention 1: Ketamine intervention 2: Dexmedetomidine | 1 | St Louis | Missouri | United States | -90.19789 | 38.62727 | 0 | NCT00205712 |
[
4
] | 559 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This is a Phase III, randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy of retreatment with rituximab in subjects with active rheumatoid arthritis (RA) who are receiving Methotrexate (MTX). | null | Rheumatoid Arthritis | null | 2 | arm 1: 1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate. arm 2: 1000 mg rituximab intravenous initial treatment on day 1 a... | [
0,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: Intravenous repeating dose intervention 2: Intravenous repeating dose intervention 3: Oral or parenteral repeating dose intervention 4: Intravenous repeating dose | intervention 1: placebo intervention 2: rituximab intervention 3: methotrexate intervention 4: folate | 0 | null | 0 | NCT00266227 | |
[
3
] | 20 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | Intracavitary injection of low dose alteplase into loculated abdominopelvic abscesses will reduce the duration of percutaneous drainage and increase the proportion of successful drainages. | The use of fibrinolytics for the percutaneous drainage of loculated pleural effusions has been shown to reduce the catheter dwell time and to improve drainage of the effusions. Abscesses in the abdomen and pelvis are often loculated which makes percutaneous drainage difficult. We hypothesize that the infusion of altepl... | Abdominal Abscess Pelvic Abscess | null | 2 | arm 1: Multiple Alteplase injection into the abscess collection to improve percutaneous drainage arm 2: Multiple normal saline injection into the abscess collection to improve percutaneous drainage | [
0,
2
] | 2 | [
0,
10
] | intervention 1: 2mg or 4mg given twice daily for three days into loculated abscess intervention 2: saline injection twice daily for three days | intervention 1: Alteplase intervention 2: saline | 1 | Honolulu | Hawaii | United States | -157.85833 | 21.30694 | 0 | NCT00284739 | |
[
5
] | 725 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This study will last up to 6 weeks. Subjects will visit the clinic up to 5 times. Certain clinic visits will include a physical examination, medical history review, and lung function tests. All study related medications and medical examinations will be provided at no cost to the subject. The drugs used in this study ar... | A Multicenter, Randomized, Double-Blind, Triple-Dummy, Placebo-Controlled, Parallel Group, Four-Week Study Assessing the Efficacy of Fluticasone Propionate Aqueous Nasal Spray 200mcg QD versus Montelukast 10mg QD in Adolescent and Adult Subjects with Asthma and Seasonal Allergic Rhinitis Who are Receiving ADVAIR DISKUS... | Asthma | Allergic Rhinitis Asthma | null | 4 | arm 1: Fluticasone propionate/salmeterol DISKUS combination product (FSC) twice daily (BID) plus vehicle placebo nasal spray once daily (QD) plus montelukast capsule 10mg (MON) QD arm 2: FSC BID plus vehicle placebo nasal spray QD plus placebo capsule QD arm 3: Fluticasone propionate/salmeterol DISKUS combination produ... | [
1,
1,
1,
1
] | 7 | [
0,
0,
0,
0,
0,
0,
0
] | intervention 1: fluticasone propionate/salmeterol DISKUS combination intervention 2: montelukast capsule intervention 3: fluticasone propionate aqueous nasal spray intervention 4: vehicle placebo nasal spray intervention 5: ADVAIR DISKUS intervention 6: placebo capsule intervention 7: placebo DISKUS | intervention 1: fluticasone propionate/salmeterol (FSC) intervention 2: montelukast (MON) intervention 3: fluticasone propionate (FP) intervention 4: placebo nasal intervention 5: ADVAIR DISKUS intervention 6: placebo capsule intervention 7: placebo DISKUS | 121 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Glendale | Arizona | United States | -112.18599 | 33.53865
Scottsdale | Arizona | United States | -111.89903 | 33.50921
Tucson | Arizona | United States | -110.92648 | 32.22174
Hot Springs | Arkansas | United States | -93.05518 | 34.5037
Berkeley | California ... | 0 | NCT00296491 |
[
3
] | 30 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to determine how GMP IV Artesunate is metabolized and cleared by individuals with uncomplicated malaria infection and to determine how fast it eliminates malaria infection from the body. | This is an unblinded non-randomized phase II pharmacokinetic study of a new GMP formulation of intravenous artesunate. Artesunate has been used throughout Asia and Africa for many years. Its overall efficacy associated with the ability to lower parasitemia is well established. To date, pharmacokinetic studies have not ... | Malaria | Uncomplicated Malaria GMP artesunate | null | 1 | arm 1: Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure. | [
0
] | 2 | [
0,
0
] | intervention 1: Intravenous Artesunate (2.4 mg/kg) once a day for three days intervention 2: (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days) | intervention 1: Artesunate intervention 2: Malarone | 1 | Kisumu | New Nyanza | Kenya | 34.76171 | -0.10221 | 0 | NCT00298610 |
[
3
] | 97 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | true | Functional constipation (FC) is common with 14.3% estimated prevalence in Hong Kong, but treatment for this condition in conventional medicine is suboptimal. Complementary and alternative medicines, especially Chinese herbal medicine (CHM) are used frequently by patients with FC, but there is little research evidence a... | Functional constipation (FC) is a common complaint in clinical practice, with the estimated prevalence 14.3% in Hong Kong, as nearly affecting 1 million Hong Kong People in different extent. It is comparable with western population, which is 15% in North America. By the definition of Rome II criteria, FC comprises a gr... | Constipation | Randomized Controlled Trials Medicine, Chinese Traditional Medicine, Herbal Constipation | null | 3 | arm 1: MaZiRenWan (MZRW) Low dose 2.5g sachet by mouth, twice daily for 8 weeks arm 2: MaZiRenWan (MZRW) Median dose 5.0g sachet by mouth, twice daily for 8 weeks arm 3: MaZiRenWan (MZRW) High dose 7.5g sachet by mouth, twice daily for 8 weeks | [
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Dissolved MaZiRenWan (MZRW) granule (2.5g/sachet) in 150 ml hot water, take orally twice daily for 8 weeks intervention 2: Dissolved MaZiRenWan (MZRW) granule (5.0g/sachet) in 150 ml hot water, take orally twice daily for 8 weeks intervention 3: Dissolved MaZiRenWan (MZRW) granule (7.5g/sachet) in 150 m... | intervention 1: MaZiRenWan (MZRW) Low dose intervention 2: MaZiRenWan (MZRW) Median dose intervention 3: MaZiRenWan (MZRW) High dose | 1 | Hong Kong | N/A | China | 114.17469 | 22.27832 | 0 | NCT00299975 |
[
5
] | 216 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | To determine if duloxetine 60 mg once daily can work up to 6 months in treating pain from Diabetic Neuropathy. | null | Diabetic Neuropathies | null | 1 | arm 1: All subjects receive 30 mg once daily (QD), by mouth (per os - PO) for 1 week followed by duloxetine 60 mg QD, PO for 7 weeks, then maintenance at 60 mg QD, PO for responders to 6 months and rescue at 120 mg QD, PO for non-responders to 6 months. Patients beginning maintenance at the 60 mg QD dose could be incre... | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: Duloxetine | 19 | Fortaleza | N/A | Brazil | -38.54306 | -3.71722
Porto Alegre | N/A | Brazil | -51.23019 | -30.03283
Angers | N/A | France | -0.55202 | 47.47156
Annecy | N/A | France | 6.12565 | 45.90878
Bron | N/A | France | 4.91303 | 45.73865
Dijon | N/A | France | 5.01667 | 47.31667
Narbonne | N/A | France | 3.00141 | 43.18396
Never... | 0 | NCT00322621 | |
[
4
] | 584 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to compare the efficacy of cethromycin to clarithromycin for the treatment of mild to moderate community-acquired pneumonia (CAP). | Lower respiratory tract infections remain one of the leading causes of death worldwide. Increasing rates of antibiotic resistance and newer, more pervasive pneumonia-causative pathogens contribute to this statistic. Currently available macrolide antibiotics for the treatment of community-acquired pneumonia are slowly l... | Pneumonia | Pneumonia Respiratory Infection Infectious Advanced Life Sciences Lung Pulmonary Cethromycin Restanza Clarithromycin Biaxin | null | 2 | arm 1: None arm 2: None | [
1,
0
] | 2 | [
0,
0
] | intervention 1: Cethromycin 300 mg once per day (QD) for 7 days, administered orally intervention 2: Clarithromycin 250 mg twice per day (BID) for 7 days, administered orally | intervention 1: Cethromycin intervention 2: Clarithromycin | 3 | Woodridge | Illinois | United States | -88.05034 | 41.74697
Woodridge | Illinois | United States | -88.05034 | 41.74697
Woodridge | Illinois | United States | -88.05034 | 41.74697 | 0 | NCT00336505 |
[
3
] | 16 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | The purposes of this study in United Network for Organ Sharing (UNOS) Status 1B (or country equivalent) cardiac transplant candidates are to assess the safety and efficacy of Natrecor (nesiritide). The study will evaluate the drug's ability to prevent clinical worsening when administered as a 28-day continuous intraven... | Endogenous B-type natruretic peptide (BNP) concentrations correlate with heart failure (HF) severity and are significantly elevated in severe end-stage HF patients. However, normal biologic compensatory responsiveness to BNP is attenuated in patients with severe HF. Patients who are UNOS 1B cardiac transplant candidate... | Congestive Heart Failure Cardiac Transplantation Renal Insufficiency Renal Failure | Congestive heart failure cardiac transplantation renal insufficiency renal failure dialysis ultrafiltration vasodilator Natrecor (nesiritide) | null | 2 | arm 1: Natrecor (nesiritide)+Standard Care+dobutamine or milrinone 28-day continuous infusion no bolus 3-hour 0.005 mcg/kg/min may be titrated to 0.015 mcg/kg/min arm 2: Placebo+Standard Care+dobutamine or milrinone 28-day continuous infusion no bolus 3-hour 0.005 mcg/kg/min may be titrated to 0.015 mcg/kg/min | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min intervention 2: 28-day continuous infusion, no bolus | intervention 1: Natrecor (nesiritide)+Standard Care+dobutamine or milrinone intervention 2: Placebo+Standard Care+dobutamine or milrinone | 14 | Stanford | California | United States | -122.16608 | 37.42411
Tampa | Florida | United States | -82.45843 | 27.94752
Chicago | Illinois | United States | -87.65005 | 41.85003
Maywood | Illinois | United States | -87.84312 | 41.8792
Baltimore | Maryland | United States | -76.61219 | 39.29038
Boston | Massachusetts | Uni... | 0 | NCT00338455 |
[
4
] | 28 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This study evaluated the safety and efficacy of an increased frequency of octreotide acetate injections or an increase in dose in partially responsive acromegalic patients with persistently uncontrolled disease. | null | Acromegaly | acromegaly octreotide acetate partial responder patients | null | 2 | arm 1: Patients received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The in... | [
0,
0
] | 1 | [
0
] | intervention 1: Each vial of study medication contained octreotide acetate 30 mg in a microencapsulated biodegradable polymer, poly (DL-lactide-co-glycolide) (D-(+)glucose), with 17% w/w mannitol in an approximate octreotide:polymer ratio of 1:20. The vehicle contained 0.5% sodium carboxymethylcellulose. | intervention 1: Octreotide acetate 30 mg suspension | 1 | Brescia | N/A | Italy | 10.21472 | 45.53558 | 0 | NCT00372697 |
[
2
] | 16 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This is a clinical study to evaluate the safety and pharmacokinetics of an overseas determined maximum tolerated dose (MTD) of MK-0683 (vorinostat) in a Japanese patient population with solid tumors. | null | Tumors | null | 2 | arm 1: 600 mg daily (300 mg twice daily \[b.i.d.\]) for 3 consecutive days followed by 4 days of rest. arm 2: 400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days. | [
0,
0
] | 2 | [
0,
0
] | intervention 1: 600 mg daily (300 mg twice daily \[b.i.d.\]) for 3 consecutive days followed by 4 days of rest. intervention 2: 400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days. | intervention 1: Vorinostat intervention 2: Vorinostat | 0 | null | 0 | NCT00373490 | |
[
4
] | 300 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This study will examine the efficacy and safety of Xalacom comparing with those of Xalatan in Japanese patients with POAG or OH, in order to show superiority of Xalacom over Xalatan in efficacy and similarity of safety between Xalacom and Xalatan. | null | Glaucoma Ocular Hypertension | null | 2 | arm 1: None arm 2: None | [
0,
0
] | 2 | [
0,
0
] | intervention 1: latanoprost 0.005%, one rop once daily in evening intervention 2: latanoprost 0.005% adn timolol 0.5%, one drop, once daily | intervention 1: Xalatan intervention 2: Xalacom | 54 | Ichinomiya | Aichi-ken | Japan | 136.8 | 35.3
Ichinomiya | Aichi-ken | Japan | 136.8 | 35.3
Nagoya | Aichi-ken | Japan | 136.90641 | 35.18147
Nagoya | Aichi-ken | Japan | 136.90641 | 35.18147
Nagoya | Aichi-ken | Japan | 136.90641 | 35.18147
Narashino | Chiba | Japan | 140.04152 | 35.68184
Sapporo | Hokkaido | Japan | ... | 0 | NCT00383019 | |
[
4
] | 173 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This is a randomized, double-blind, placebo-controlled, crossover, two-attack, out-patient, early-intervention evaluation of subjects who have migraine with or without aura and who discontinued use of short acting triptan(s) within the past year due to non-response or intolerance. Subjects will treat 2 separate migrain... | This is a randomized, double-blind, placebo-controlled, crossover, two-attack, out-patient, early-intervention evaluation of subjects who have migraine with or without aura and who discontinued use of short acting triptan(s) within the past year due to non-response or intolerance. Subjects will treat 2 separate migrain... | Migraine Disorders | Combination Product naproxen sodium sumatriptan succinate short acting triptan migraine, acute Poor response | null | 2 | arm 1: Combination product (sumatriptan and naproxen sodium) \[Attack 1\] followed by placebo \[Attack 2\] arm 2: Placebo \[Attack 1\] followed by Combination Product (sumatriptan and naproxen sodium) \[Attack 2\] | [
5,
5
] | 2 | [
0,
0
] | intervention 1: Bilayer tablet containing 85mg sumatriptan (as 119mg sumatriptan succinate; fast disintegrating/rapid release formulation) active ingredient in one layer, and 500mg naproxen sodium active ingredient in the second layer. intervention 2: Matching placebo tablet. | intervention 1: Combination Product (sumatriptan succinate / naproxen sodium) intervention 2: Placebo | 26 | Fresno | California | United States | -119.77237 | 36.74773
Newport Beach | California | United States | -117.92895 | 33.61891
Santa Monica | California | United States | -118.49138 | 34.01949
Walnut Creek | California | United States | -122.06496 | 37.90631
Fairfield | Connecticut | United States | -73.26373 | 41.1412... | 0 | NCT00383162 |
[
5
] | 50 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | Both morphine and hydromorphone are pain medications commonly used after surgery. It is thought at the institution that hydromorphone causes less side effects but this has not been studied. The study proposes to treat the patients with either morphine or hydromorphone and determine how much nausea, vomiting, and itchin... | null | Post Operative Pain | pain morphine hydromorphone nausea vomiting pruritis | null | 2 | arm 1: Patients receive morphine 1mg/dose PCA for postsurgical pain; max 10 mg/hr; lockout 6 minutes. arm 2: Patients receive hydromorphone 0.2mg/dose PCA for postsurgical pain; max 10mg/hr; lockout 6 minutes. | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Morphine 1mg/mL, dose 1mL, lockout 6 minutes, max 10mL intervention 2: hydromorphone PCA 0.2mg/lml, dose 1ml, lockout 6min, max 10ml | intervention 1: Morphine PCA intervention 2: Hydromorphone PCA | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00385541 |
[
3
] | 56 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | This is a multicenter, randomized, double-blind, cross-over study to compare the pharmacodynamic response in subjects with Acute Coronary Syndrome receiving a 10-mg maintenance dose (MD) of prasugrel compared with a 150-mg maintenance dose of clopidogrel, following a 900-mg loading dose (LD) of clopidogrel. | null | Acute Coronary Syndrome | null | 2 | arm 1: Open label lead-in one time dose of Clopidogrel 900 mg oral tablets (a single or cumulative dose) and 250 mg to 500 mg aspirin loading dose (LD), either orally or intravenously. Patients are then assigned to maintenance dose (MD) prasugrel 10 mg and two placebo tablets, matched to clopidogrel, and 100 mg aspirin... | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Prasugrel 10-mg tablet taken orally as a daily maintenance dose for a 14-day treatment period. intervention 2: Clopidogrel two 75-mg tablets taken orally as a daily maintenance dose for a 14-day treatment period. | intervention 1: Prasugrel intervention 2: Clopidogrel | 2 | Créteil | N/A | France | 2.46569 | 48.79266
Paris | N/A | France | 2.3488 | 48.85341 | 0 | NCT00385944 | |
[
4
] | 218 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The primary purpose of the study is to evaluate the impact of treatment with fentanyl buccal tablets on the anxiety symptoms commonly associated with chronic pain in patients with breakthrough pain (BTP). Other purposes are to assess the management of BTP, to evaluate patient functioning, and to determine any influence... | null | Pain Chronic Pain Breakthrough Pain | null | 1 | arm 1: Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period. | [
0
] | 1 | [
0
] | intervention 1: Fentanyl buccal tablets (FBT) placed in the buccal cavity above a rear molar until disintegrated, approximately 14-25 minutes.
Dose titration: Participants self-administered FBT, starting at 100, 200 or 400 mcg (depending on analgesic used pre-study) and titrated to 600 and 800 mcg as needed. For each ... | intervention 1: Fentanyl Buccal Tablets | 33 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Phoenix | Arizona | United States | -112.07404 | 33.44838
Anaheim | California | United States | -117.9145 | 33.83529
Bakersfield | California | United States | -119.01871 | 35.37329
Beverly Hills | California | United States | -118.40036 | 34.07362
National C... | 0 | NCT00387010 | |
[
3
] | 1 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well everolimus works in treating patients with advanced or metastatic colorectal cancer that did not respond to previous... | OBJECTIVES:
* Determine response rate, time to tumor progression, and survival of patients with advanced or metastatic refractory colorectal cancer and mutations in the PI3K gene treated with everolimus.
* Determine the toxicity profile of this drug in these patients.
* Measure the signaling pathways activated in thes... | Colorectal Cancer | adenocarcinoma of the colon adenocarcinoma of the rectum recurrent colon cancer stage III colon cancer stage IV colon cancer recurrent rectal cancer stage III rectal cancer stage IV rectal cancer | null | 0 | null | null | 10 | [
0,
3,
3,
3,
3,
3,
3,
3,
3,
3
] | 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 10: None | intervention 1: everolimus intervention 2: antiangiogenesis therapy intervention 3: biopsy intervention 4: diagnostic procedure intervention 5: gene expression analysis intervention 6: immunohistochemistry staining method intervention 7: laboratory biomarker analysis intervention 8: mutation analysis intervention 9: pr... | 1 | Baltimore | Maryland | United States | -76.61219 | 39.29038 | 0 | NCT00390364 |
[
4
] | 83 | RANDOMIZED | CROSSOVER | 2DIAGNOSTIC | 1SINGLE | false | 0ALL | false | The purpose of this study is to determine if the contrast agent is effective and safe in the Magnetic Resonance Imaging (MRI) of vascular diseases in patients of Chinese origin. | The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial. | Vascular Diseases | Gadovist Gadavist MRI Imaging vascular diseases Chinese | null | 2 | arm 1: Period 1: Participant received Gadobutrol 1.0 M (iv: intravenous injection), at a dose of 0.2 mL/kg BW, up to 0.3 mL/kg BW if 3 Fields of View (FOVs) to be imaged; Period 2: Participant received Gadopentate 0.5 M (iv), at a dose of 0.4 mL/kg BW, up to 0.6 mL/kg BW if 3 FOVs to be imaged arm 2: Period 1: Particip... | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW) intervention 2: Participant received a single intravenous injection with Gadopentate (0.5 ... | intervention 1: Gadobutrol (Gadavist, Gadovist, BAY86-4875) intervention 2: Gadopentate dimeglumine (Magnevist, BAY86-4882) | 3 | Chengdu | Sichuan | China | 104.06667 | 30.66667
Beijing | N/A | China | 116.39723 | 39.9075
Shanghai | N/A | China | 121.45806 | 31.22222 | 0 | NCT00395733 |
[
3
] | 50 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The study was designed to obtain data about the efficacy and safety of 3 doses of indacaterol (150, 300, and 600 µg) in Japanese patients with chronic obstructive pulmonary disease (COPD) so that optimal dose(s) could be chosen for testing in later studies. | null | Chronic Obstructive Pulmonary Disease | chronic obstructive pulmonary disease COPD QAB149 indacaterol long acting β2-agonist | null | 4 | arm 1: In treatment period, 1 patients received 2 placebo capsules; in treatment period 2, patients received 1 indacaterol 150 μg capsule + 1 placebo capsule; in treatment period 3, patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; and in treatment period 4, patients received 2 indacaterol 300 μg caps... | [
0,
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Indacaterol 150 μg was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI). intervention 2: Indacaterol 300 μg was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI). intervention 3: Placebo to indacaterol was provided in powder filled capsules ... | intervention 1: Indacaterol 150 μg intervention 2: Indacaterol 300 μg intervention 3: Placebo | 8 | Kasukabe | N/A | Japan | 139.74966 | 35.98308
Kishiwada | N/A | Japan | 135.36667 | 34.46667
Kurume | N/A | Japan | 130.51667 | 33.31667
Obihiro | N/A | Japan | 143.20444 | 42.91722
Sagamihara | N/A | Japan | 139.24167 | 35.56707
Sapporo | N/A | Japan | 141.35 | 43.06667
Tokyo | N/A | Japan | 139.69171 | 35.6895
Wakaya... | 0 | NCT00403845 |
[
5
] | 278 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This 16 week study will examine the ability of olmesartan medoxomil to lower the blood pressure of patients with moderate to severe high blood pressure in comparison to placebo. The medication being tested has been approved by the FDA for the treatment of high blood pressure. | This study was to randomize an equal number of participants to either an olmesartan medoxomil based treatment or to placebo. The titration scheme was as follows:
* First 3 weeks (wks), all participants - olmesartan medoxomil 20 mg or placebo
* Next 3 wks, participants whose blood pressure was not controlled - olmesart... | Hypertension | Hypertension Angiotensin Receptor Blocker Calcium Channel Blocker Angiotensin Converting Enzyme Inhibitor Hydrochlorothiazide Stage I and II Hypertension | null | 2 | arm 1: Olmesartan medoxomil, plus hydrochlorothiazide, if necessary arm 2: Placebo tablets were taken once daily for 12 weeks | [
0,
2
] | 2 | [
0,
0
] | intervention 1: olmesartan medoxomil + hydrochlorothiazide, if necessary. Oral tablets administered for once daily for 12 weeks intervention 2: Oral tablets administered for once daily for 12 weeks | intervention 1: olmesartan medoxomil + hydrochlorothiazide, if necessary intervention 2: Placebo | 29 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Mobile | Alabama | United States | -88.04305 | 30.69436
Muscle Shoals | Alabama | United States | -87.66753 | 34.74481
Searcy | Arkansas | United States | -91.73625 | 35.25064
Carmichael | California | United States | -121.32828 | 38.61713
Spring Valley | Cali... | 0 | NCT00430638 |
[
5
] | 266 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | null | Patients with glaucoma or ocular hypertension currently being treated with latanoprost 0.005%, and in need of additional IOP lowering, will be randomized to receive either bimatoprost 0.03% or travoprost 0.004% in place of latanoprost 0.005% | null | Glaucoma Ocular Hypertension | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: bimatoprost 0.03% 1 drop nightly for 3 months intervention 2: travoprost 0.004% 1 drop nightly for 3 months | intervention 1: bimatoprost 0.03% eye drops intervention 2: travoprost 0.004% eye drops | 1 | San Diego | California | United States | -117.16472 | 32.71571 | 0 | NCT00440011 | |
[
5
] | 191 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this study is to assess real-world effectiveness of montelukast in children (2 to 14 years) with asthma and allergic rhinitis. | null | Asthma Allergic Rhinitis | null | 2 | arm 1: Participants were treated for 12 months after randomization: Participants 2 to 5 years of age took one 4 mg chewable tablet and 6 to 14 years of age took one 5 mg chewable tablet daily in the evening. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added t... | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Montelukast 4/5 mg tablet (oral chewable), once daily, 12 weeks to up to 12 months intervention 2: Inhaled corticosteroid solution, 1-4 puffs daily, 12 weeks to up to 12 months | intervention 1: montelukast sodium intervention 2: inhaled corticosteroid | 0 | null | 0 | NCT00442559 | |
[
2
] | 43 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this research study is to determine how safe and effective subconjunctival injections of CGC-11047 are in subjects with wet age related macular degeneration at two different dosing intervals. | The purpose of this research study is to determine how safe and effective subconjunctival injections of CGC-11047 are in subjects with wet age related macular degeneration at two different dosing intervals. Half of the participants in the study will receive CGC-11047 every two weeks and half of the participants in the ... | Age Related Macular Degeneration | null | 2 | arm 1: 16.5 mg CGC-11047 as a subconjunctival injection once every two weeks. arm 2: 16.5 mg CGC-11047 as a subconjunctival injection once every four weeks. | [
0,
0
] | 1 | [
0
] | intervention 1: 16.5 mg (3.3%) subconjunctival injection | intervention 1: CGC-11047 | 8 | Baltimore | Maryland | United States | -76.61219 | 39.29038
Mexico City | District Federal | Mexico | -99.12766 | 19.42847
Cheboksary | N/A | Russia | 47.25194 | 56.13222
Moscow | N/A | Russia | 37.61556 | 55.75222
Rostov-on-Don | N/A | Russia | 39.72328 | 47.23135
Saint Petersburg | N/A | Russia | 30.31413 | 59.93863
... | 0 | NCT00446654 | |
[
4
] | 60 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | true | 2MALE | false | A research study to determine if acetaminophen (APAP) given intravenously (IV-a liquid given through a needle into a vein in your arm) is safe and effective in controlling fever when compared to placebo. Acetaminophen given this way is the investigational part of this study. | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Single-Dose Study of the Efficacy and Safety of Intravenous Acetaminophen (IVAPAP) Versus Placebo for the Treatment of Endotoxin-Induced Fever in Healthy Adult Males | Fever | null | 2 | arm 1: 1 g of acetaminophen in 100 mL of intravenous solution arm 2: 100 mL of intravenous placebo solution | [
0,
2
] | 3 | [
0,
0,
2
] | intervention 1: IV Placebo intervention 2: Intravenous acetaminophen solution 1 g / 100 ml intervention 3: Administration of Reference Standard Endotoxin (RSE) to induce fever. Applicable to both study arms: Administration of a 1 ng/kg body weight test dose of RSE to test for fever response. Observation period of at le... | intervention 1: IV Placebo intervention 2: IV Acetaminophen intervention 3: Reference Standard Endotoxin (RSE) | 1 | Austin | Texas | United States | -97.74306 | 30.26715 | 0 | NCT00493311 | |
[
4
] | 185 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | true | 0ALL | false | This study is a multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-comparison to determine the efficacy and safety of a standard-dose of colchicine (4.8 mg) versus low-dose colchicine (1.8 mg) or placebo for acute gout flares. | This study is a multi-center, randomized, double-blind, placebo-controlled, parallel group trial to compare the efficacy and safety of standard-dose colchicine (STD)(total dose = 4.8 mg) versus low-dose colchicine (total dose 1.8 mg) or placebo for the treatment of acute gout flares. Eight hundred and thirteen patients... | Gout | null | 3 | arm 1: After confirmation of a gout flare, patients were to begin standard dosing of colchicine 4.8mg (two capsules (1.8mg) initially followed by additional one capsule doses (0.6mg) every hour for an additional 6 doses). arm 2: Within 12 hours of a confirmed gout flare, patients were to begin the low dose colchicine r... | [
0,
0,
2
] | 3 | [
0,
0,
10
] | intervention 1: At randomization, patients were given an identical looking blister pack containing (8) over encapsulated colchicine 0.6 mg tablets identical in appearance to placebo capsules. Patients were instructed to take 2 capsules initially (1.2 mg) followed by an additional capsule (0.6 mg) every hour for a total... | intervention 1: High Dose Colchicine (4.8 mg total dose) intervention 2: Low Dose Colchicine (1.8mg total dose) intervention 3: Placebo Control | 83 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Birmingham | Alabama | United States | -86.80249 | 33.52066
Columbiana | Alabama | United States | -86.60721 | 33.17817
Huntsville | Alabama | United States | -86.58594 | 34.7304
Tucson | Arizona | United States | -110.92648 | 32.22174
Tucson | Arizona | Unite... | 0 | NCT00506883 | |
[
4
] | 105 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | true | 2MALE | false | To assess the rapidity of onset of antipyretic effect and the efficacy and safety of a single dose of IV acetaminophen (IV APAP) versus oral (PO) acetaminophen in the treatment of fever induced by a standard dose of endotoxin | A Phase III, Randomized, Double-Blind, Double-Dummy, Single-Dose Study of the Efficacy and Safety of Intravenous Acetaminophen Versus Oral Acetaminophen for the Treatment of Endotoxin-Induced Fever in Healthy Adult Males | Fever | null | 2 | arm 1: Administration of a 1 ng/kg body weight test dose of RSE to test for fever response. Observation period of at least 60 minutes to ensure no exaggerated systemic responses, followed by administration of a 4 ng/kg of RSE to induce fever. Randomization to receive 1 g of acetaminophen in 100 ml of intravenous soluti... | [
0,
1
] | 3 | [
0,
0,
2
] | intervention 1: Single dose of 1 gm IV acetaminophen intervention 2: Single dose of 1 g PO APAP intervention 3: To subjects in both study arms: Administration of a 1 ng/kg body weight test dose of RSE to induce fever and test for fever response. Observation period of at least 60 minutes to ensure no exaggerated systemi... | intervention 1: Intravenous acetaminophen plus oral placebo intervention 2: Oral acetaminophen plus IV placebo intervention 3: Reference standard endotoxin (RSE) | 1 | Knoxville | Tennessee | United States | -83.92074 | 35.96064 | 0 | NCT00564629 | |
[
3
] | 50 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving erlotinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well erlotinib works in treating patie... | OBJECTIVES:
Primary
* To determine the in situ antitumor effect of neoadjuvant erlotinib hydrochloride as measured by a reduction in Ki67 and/or an increase in terminal deoxynucleotidyl transferase-mediated deoxyuridine triphosphate-biotin nick end labeling (TUNEL)-positive tumor cells in patients with treatment-naiv... | Breast Cancer | stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer | null | 1 | arm 1: None | [
0
] | 9 | [
0,
6,
6,
10,
10,
10,
10,
10,
3
] | intervention 1: Tarceva will be given orally at a dose of 150 mg/day for 5-14 days. Patients are to undergo surgical resection of their tumor within 24 hours of the last dose of Tarceva. intervention 2: Used to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens ... | intervention 1: erlotinib hydrochloride intervention 2: TUNEL assay intervention 3: protein expression analysis intervention 4: immunohistochemistry staining method intervention 5: laboratory biomarker analysis intervention 6: liquid chromatography intervention 7: mass spectrometry intervention 8: matrix-assisted laser... | 5 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Boston | Massachusetts | United States | -71.05977 | 42.35843
Chapel Hill | North Carolina | United States | -79.05584 | 35.9132
Nashville | Tennessee | United States | -86.78444 | 36.16589
Nashville | Tennessee | United States | -86.78444 | 36.16589 | 0 | NCT00633750 |
[
5
] | 614 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This study evaluated safety, tolerability and efficacy of Fluvastatin XL® -extended release (80 mg once daily) in patients with metabolic syndrome | null | Metabolic Syndrome | Metabolic syndrome,dyslipidemia,fluvastatin extended release | null | 1 | arm 1: 80 mg once daily, at bedtime. | [
0
] | 1 | [
0
] | intervention 1: Fluvastatin extended release 80 mg | intervention 1: Fluvastatin XL® | 1 | Istanbul | N/A | Turkey (Türkiye) | 28.94966 | 41.01384 | 0 | NCT00664742 |
[
3
] | 120 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The study is designed to assess safety and effects of vorapaxar, when added to standard of care (aspirin and clopidigrel), in Japanese subjects with acute coronary syndrome. The study may also provide information about the effect of vorapaxar on preventing heart attack and stroke in this subject population. | The study drug (loading dose) is administered at least 1 hour before catheterization for diagnostic imaging or percutaneous coronary interventions (PCI). The incidence of bleeding is thought to be an important index to assess the safety of this drug, therefore thrombolysis in myocardial infarction (TIMI) is evaluated. | Atherosclerosis Myocardial Ischemia Myocardial Infarction | null | 5 | arm 1: Vorapaxar 20 mg loading dose + daily 1 mg maintenance dose + standard of care (Aspirin + Ticlopidine) arm 2: Vorapaxar 20 mg loading dose + daily 2.5 mg maintenance dose + standard of care (Aspirin + Ticlopidine) arm 3: Vorapaxar 40 mg loading dose + daily 1 mg maintenance dose + standard of care (Aspirin + Ticl... | [
0,
0,
0,
0,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: Oral tablets; single 20-mg or 40-mg loading dose on first day followed by daily 1-mg or 2.5-mg maintenance dose for 59 days intervention 2: Oral tablets; matching placebo for SCH 530348 loading and maintenance doses for 59 days intervention 3: Loading dose of 75-325 mg on Day 1, then 75-100 mg once dail... | intervention 1: Vorapaxar intervention 2: Placebo intervention 3: Aspirin intervention 4: Clopidogrel | 0 | null | 0 | NCT00684203 | |
[
3
] | 31 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | This study was conducted: 1) to assess the clinical effect of Navarixin on the Psoriasis Activity and Severity Index (PASI), 2) to determine the effects of Navarixin on the Physician's Global Assessment (PGA), 3) to evaluate the safety and tolerability of Navarixin, and 4) to determine the multiple-dose pharmacokinetic... | null | Psoriasis | null | 2 | arm 1: Navarixin 30 mg administered orally once daily for 28 days. arm 2: Matching placebo to Navarixin administered orally once daily for 28 days. | [
0,
2
] | 2 | [
0,
10
] | intervention 1: Navarixin capsules orally, once daily for 28 days. intervention 2: Matching placebo capsules to Navarixin orally, once daily for 28 days. | intervention 1: Navarixin 10 mg intervention 2: Placebo | 0 | null | 0 | NCT00684593 | |
[
0
] | 147 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | true | 0ALL | false | The purpose of this study is to determine whether rifaximin is effective in the treatment of tropical enteropathy in a population of African children at high risk for this disease. | null | Tropical Enteropathy | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 100mg of rifaxin for 7 consecutive days, twice daily intervention 2: twice daily for 7 consecutive days | intervention 1: Rifaximin intervention 2: Placebo | 1 | Limela | N/A | Malawi | 34.71667 | -14.88333 | 0 | NCT00858988 | |
[
3
] | 124 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This is a research study testing SABER-Bupivacaine (an experimental pain-relieving medication). SABER-Bupivacaine is designed to continuously deliver bupivacaine, a common local anesthetic, for a few days in order to treat local post-surgical pain. This study is testing SABER-Bupivacaine in people having surgery to rep... | null | Postoperative Pain Hernia Surgery | Post-operative pain hernia surgery opioid | null | 3 | arm 1: 2.5 mL SABER-Bupivacaine/Once arm 2: 5.0 mL SABER-Bupivacaine/Once arm 3: 2.5 mL or 5.0 mL SABER-Placebo/Once | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine/Once intervention 2: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once intervention 3: Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once | intervention 1: SABER-Bupivacaine intervention 2: SABER-Bupivacaine intervention 3: SABER-Placebo | 5 | Cairns | Queensland | Australia | 145.76613 | -16.92366
Sunnybank | Queensland | Australia | 153.06064 | -27.58003
Port Lincoln | South Australia | Australia | 135.87442 | -34.72625
Ringwood East | Victoria | Australia | 145.25 | -37.81667
Hamilton | N/A | New Zealand | 175.28333 | -37.78333 | 0 | NCT00974350 |
[
5
] | 16 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This study examines the effects of pioglitazone on renal sodium handling in subjects prone to insulin resistance, i.e. diabetic and/or hypertensive subjects. | Aim: Glitazones are powerful insulin sensitizers prescribed for the treatment of type 2 diabetes. Their use is however associated with fluid retention and an increased risk of congestive heart failure. We previously demonstrated that pioglitazone increases proximal sodium reabsorption in healthy volunteers. This study ... | Diabetes Hypertension | diabetes blood pressure pioglitazone sodium insulin resistance, renal function, sodium, pioglitazone | null | 2 | arm 1: placebo-controlled, randomized, cross-over study arm 2: placebo-controlled, randomized, cross-over study was to explore the effects of pioglitazone (45 mg q.d. for 6 weeks) on the renal, hormonal and blood pressure responses to changes in sodium intake in a population prone to insulin resistance | [
2,
2
] | 2 | [
0,
0
] | intervention 1: placebo-controlled, randomized, cross-over study was to explore the effects of pioglitazone (45 mg q.d. for 6 weeks) on the renal, hormonal and blood pressure responses to changes in sodium intake in a population prone to insulin resistance intervention 2: placebo-controlled, randomized, cross-over stud... | intervention 1: Pioglitazone intervention 2: Metformin | 1 | Geneva | Canton of Geneva | Switzerland | 6.14569 | 46.20222 | 0 | NCT01090752 |
[
3
] | 127 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This was a randomized, double blind, placebo-controlled study in subjects who have undergone major surgery. Each subject's study participation consisted of a screening visit, a 2-day treatment period, and a follow-up visit. Following surgery, subjects were randomly assigned to receive intranasally (IN) ketorolac 10 mg,... | null | Postoperative Pain | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: 10 mg Intranasal (2 x 100 uL of a 5% solution) intervention 2: 30 mg Intranasal (2 x 100 uL of a 15% solution) intervention 3: Intranasal | intervention 1: Ketorolac tromethamine intervention 2: Ketorolac tromethamine intervention 3: Placebo | 1 | Hamilton | N/A | New Zealand | 175.28333 | -37.78333 | 0 | NCT01351090 | |
[
4
] | 1,380 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to investigate the efficacy and safety of telcagepant (MK-0974) compared to an approved medication for acute migraine. This study was conducted as a "triple-dummy" design; for each dose of study drug, participants each received 3 forms of study drug (2 capsules of active and/or placebo and ... | null | Migraine | null | 4 | arm 1: Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcag... | [
0,
0,
1,
2
] | 7 | [
0,
0,
0,
0,
0,
0,
0
] | intervention 1: Telcagepant 150 mg liquid-filled soft gel capsules intervention 2: Telcagepant 300 mg liquid-filled soft gel capsules intervention 3: Zolmitriptan 5 mg tablets intervention 4: Placebo to match telcagepant 150 mg liquid-filled soft gel capsules intervention 5: Placebo to match tecagepant 300 mg liquid-fi... | intervention 1: Telcagepant potassium 150 mg intervention 2: Telcagepant potassium 300 mg intervention 3: Zolmitriptan 5 mg intervention 4: Placebo to telcagepant 150 mg intervention 5: Placebo to tecagepant 300 mg intervention 6: Placebo to zolmitriptan 5 mg intervention 7: Rescue medication | 0 | null | 0 | NCT00442936 | |
[
3
] | 145 | RANDOMIZED | PARALLEL | 0TREATMENT | null | false | 0ALL | false | This clinical trial is a multi centre, randomised, single-blind, parallel group, placebo-controlled, single oral dose study with a positive control arm. Patients previously scheduled for 3rd molar tooth extraction, who are otherwise healthy, will be recruited. Upon completion of surgery, e.g. prior to established pain,... | null | Toothache | Acute Pain Dental Pain Vanilloid VR1 TRPV1 Inflammation | null | 4 | arm 1: Eligible participants received a single dose of SB705498 matching placebo capsules (4 placebo capsules) via oral route and were followed up to a maximum of 14 days. arm 2: Eligible participants received a single dose of SB705498 400 milligram (mg) capsules (2 x 200 mg capsules plus 2 placebo capsules) via oral r... | [
0,
0,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: SB705498 400 mg intervention 2: SB705498 1000 mg intervention 3: Placebo intervention 4: Co-Codamol | intervention 1: SB705498 400 mg intervention 2: SB705498 1000 mg intervention 3: Placebo intervention 4: Co-Codamol | 5 | Verona | Veneto | Italy | 10.9938 | 45.43854
Seoul | N/A | South Korea | 126.9784 | 37.566
Croydon | Surrey | United Kingdom | -0.1 | 51.38333
Leeds | N/A | United Kingdom | -1.54785 | 53.79648
Manchester | N/A | United Kingdom | -2.23743 | 53.48095 | 0 | NCT00281684 |
[
3
] | 23 | RANDOMIZED | PARALLEL | 2DIAGNOSTIC | null | false | 0ALL | false | GSK233705 is a high-affinity specific muscarinic receptor (mAChR) antagonist which is being developed for the treatment of chronic obstructive pulmonary disease. This is a randomised, double-blind, placebo-controlled, dose ascending, parallel group study to examine the safety, tolerability, pharmacokinetics and pharmac... | null | Pulmonary Disease, Chronic Obstructive | muscarinic receptor, bronchodilators Chronic obstructive pulmonary disease, | null | 0 | null | null | 1 | [
0
] | intervention 1: None | intervention 1: GSK233705B | 4 | Eindhoven | N/A | Netherlands | 5.47778 | 51.44083
Harderwijk | N/A | Netherlands | 5.62083 | 52.34167
Utrecht | N/A | Netherlands | 5.12222 | 52.09083
Zuidlaren | N/A | Netherlands | 6.68194 | 53.09417 | 0 | NCT00453479 |
[
3
] | 136 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | This study is a multicenter, double-blind, study to evaluate the safety and effectiveness of treatment with LY2127399 (in addition to the standard of care treatment, methotrexate) for participants with Rheumatoid Arthritis. Participants will receive three intravenous doses of LY2127399 or placebo. Participants will par... | null | Arthritis, Rheumatoid | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 30 mg, 60 mg or 160 mg, IV (in the vein) in weeks 0, 3 and 6. Treatment duration: 6 weeks. intervention 2: IV (in vein) in weeks 0, 3 and 6. Treatment duration: 6 weeks. | intervention 1: LY2127399 intervention 2: Placebo | 14 | Bacau | N/A | Romania | 26.91384 | 46.56718
Baia Mare | N/A | Romania | 23.56808 | 47.65729
Brasov | N/A | Romania | 25.60613 | 45.64861
Brăila | N/A | Romania | 27.97429 | 45.27152
Bucharest | N/A | Romania | 26.10626 | 44.43225
Cluj-Napoca | N/A | Romania | 23.6 | 46.76667
Constanța | N/A | Romania | 28.63432 | 44.18... | 0 | NCT00308282 | |
[
4
] | 40 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to test the safety and effectiveness of Losartan as compared to Losartan/HCTZ in pediatric patients (6 to 17 years) with high blood pressure. | Participants who meet eligibility requirements will enter the single-blind Filter Period. Participants with either sitting systolic blood pressure (SiSBP) or sitting diastolic blood pressure (SiDBP) \>=95th percentile for gender/age/height will be administered either losartan 25 mg or losartan 50 mg depending on body w... | Hypertension | null | 4 | arm 1: Losartan 50 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks arm 2: Losartan 100 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg/hydr... | [
1,
1,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: losartan/hydrochlorothiazide 12.5mg tablet po qd; for a 4 week study period. intervention 2: Losartan 50mg titrating up to Losartan 100mg tablet po qd; for a 4 week study period intervention 3: None intervention 4: losartan/hydrochlorothiazide 12.5mg Pbo tablet po qd; for a 4 week study period. | intervention 1: hydrochlorothiazide (+) losartan potassium intervention 2: losartan potassium intervention 3: Placebo for Losartan intervention 4: Placebo for Losartan/HCTZ | 0 | null | 0 | NCT00447603 | |
[
4
] | 371 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this study is to determine if lacosamide (SPM 927) is safe if taken for a longer period of time and whether it continues to work well to treat pain.
Subjects will receive lacosamide at a dose that will be individually determined to be the one that provides most pain relief with the least side effects. T... | null | Painful Diabetic Neuropathy | Painful diabetic neuropathy Lacosamide | null | 1 | arm 1: Open label active treatment | [
0
] | 1 | [
0
] | intervention 1: Lacosamide film-coated tablets; two times per day; up to 400 mg/day for 2.75 years | intervention 1: Lacosamide | 1 | Monheim | N/A | Germany | 10.85834 | 48.84389 | 0 | NCT00220337 |
[
3
] | 30 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to evaluate the safety of combination therapy of radiotherapy and temozolomide ("concomitant radiotherapy phase"), and then temozolomide monotherapy ("monotherapy phase"), in patients with newly diagnosed glioblastoma multiforme. Progression free survival and response rate will also be calc... | null | Glioblastoma | null | 1 | arm 1: It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy. | [
0
] | 2 | [
4,
0
] | intervention 1: Radiotherapy will be administered in combination with temozolomide during the concomitant radiotherapy phase. Radiotherapy will consist of a conventionally fractioned regimen, delivering a total dose of 60 Gy in 6 weeks, in a once daily schedule of 2 Gy per fraction, for a total of 30 fractions. Radiati... | intervention 1: Radiotherapy intervention 2: Temozolomide | 0 | null | 0 | NCT00684567 | |
[
4
] | 4,469 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The objective is to compare the safety and efficacy of the following three treatment regimens in previously untreated adult subjects with chronic hepatitis C infected with Genotype 1: (1) PegIntron 1.5 µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); (2) PegIntron 1µg/kg/wk in combination with weigh... | PegIntron Dose will be administered once weekly subcutaneously on the same day of the week:
Screening 2 Weight 40-50 kg Volume to Inject (mL) 0.22; Screening 2 Weight 51-60 kg Volume to Inject (mL) 0.28; Screening 2 Weight 61-75 kg Volume to Inject (mL) 0.33; Screening 2 Weight 76-85 kg Volume to Inject (mL) 0.41; Scr... | Hepatitis C, Chronic | null | 3 | arm 1: PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up arm 2: PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (... | [
0,
0,
1
] | 5 | [
2,
2,
0,
2,
0
] | intervention 1: 1.5 ug/kg/week subcutaneously (SC) for 48 weeks intervention 2: 1.0 ug/kg/week SC for 48 weeks intervention 3: weight based dose 800-1400 mg/day orally (PO) for 48 weeks intervention 4: 180 ug/week SC administered for 48 weeks intervention 5: 1000-1200 mg/day PO for 48 weeks | intervention 1: PegIntron (peginterferon alfa-2b; SCH 54031) intervention 2: PegIntron (peginterferon alfa-2b; SCH 54031) intervention 3: REBETOL (ribavirin; SCH 18908) intervention 4: PEGASYS (peginterferon alfa-2a) intervention 5: COPEGUS (ribavirin) | 0 | null | 1 | NCT00081770 | |
[
2
] | 151 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | To evaluate the safety and tolerability of oral SKI-606 (bosutinib) administered on a daily schedule to subjects with advanced malignant solid tumors and to define a maximum tolerated dose (MTD) in this subject population. | null | Neoplasms | Solid tumors | null | 4 | arm 1: Dose finding study of monotherapy bosutinib in patients with advanced solid tumors. arm 2: Enroll 30 patients at RP2D to further evaluate safety and efficacy in subgroup population. arm 3: Enroll 30 patients at RP2D to further evaluate safety and efficacy in subgroup population. arm 4: Enroll 30 patients at RP2D... | [
0,
0,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: Dose levels evaluated 50mg, 100mg, 200mg, 300mg, 400mg, 500mg and 600mg. 500mg was identified as MTD, however due to GI toxicities at that dose, 400mg was selected as the RP2D. Drug was administered as long as tolerable and disease under study did not worsen. intervention 2: 400mg QD bosutinib, as long ... | intervention 1: bosutinib intervention 2: bosutinib intervention 3: bosutinib intervention 4: bosutinib | 19 | Birmington | Alabama | United States | N/A | N/A
Scottsdale | Arizona | United States | -111.89903 | 33.50921
Los Angeles | California | United States | -118.24368 | 34.05223
Tampa | Florida | United States | -82.45843 | 27.94752
Atlanta | Georgia | United States | -84.38798 | 33.749
Indianpolis | Indiana | United Stat... | 1 | NCT00195260 |
[
4
] | 145 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | null | 0ALL | true | The purpose of the study is to assess the effect of everolimus initiation together with reduction or discontinuation of calcineurin inhibitor (CNI) on renal function in maintenance liver transplant recipients with CNI-related renal impairment, while maintaining efficacy. | null | Liver Transplantation | Liver transplantation, everolimus, calcineurin inhibitor, renal function | null | 2 | arm 1: Reduced CNI dose + everolimus (1.5 mg twice daily (b.i.d)) ± steroids arm 2: Standard CNI dose ± MPA/AZA ± steroids | [
1,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: 1.5 mg bid adjusted in order to achieve a trough level between 3 and 8 ng/mL while in combination with CNI and between 6 and 12 ng/mL after CNI discontinuation intervention 2: None intervention 3: None intervention 4: None | intervention 1: Everolimus intervention 2: Calcineurin inhibitors (CNI) intervention 3: Mycophenolate acid (MPA)/ Azathioprine (AZA) intervention 4: Steroids | 2 | Germany | N/A | Germany | N/A | N/A
Basel | N/A | Switzerland | 7.57327 | 47.55839 | 1 | NCT00267189 |
[
4
] | 107 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The primary objective is to assess the safety, efficacy and tolerability of the combination of PEG-Intron plus REBETOL in pediatric subjects with chronic hepatitis C. The secondary objective is to measure the multiple-dose pharmacokinetics of PEG-Intron and REBETOL in pediatric subjects with chronic hepatitis C. | This global, multicenter, open-label Phase 3 study will evaluate the safety, efficacy and tolerability of PEG-Intron plus REBETOL in previously untreated pediatric subjects, ages 3 through 17 years, with chronic hepatitis C. | Hepatitis C, Chronic | null | 1 | arm 1: PEG2b 1.5 μg/kg/wk given subcutaneously (once weekly) and RBV 400-1200 mg/day by mouth divided in 2 daily doses (administered twice daily with food, dosed 12 hours apart) for 48 weeks. Subjects treated up to 48 weeks and followed for additional 24 weeks after the end of treatment (total of 72 weeks study partici... | [
0
] | 2 | [
2,
0
] | intervention 1: PEG2b 1.5 μg/kg/wk given subcutaneously (once weekly) for 48 weeks. intervention 2: 15 mg/kg/day for up to 48 weeks | intervention 1: peginterferon alfa-2b (PEG2b) (SCH 54031) intervention 2: ribavirin (SCH 18908) | 0 | null | 0 | NCT00104052 | |
[
5
] | 50 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | The purpose of this study is to examine the safety and efficacy of quetiapine for generalized anxiety disorder patients who remain symptomatic despite treatment with paroxetine CR. | Generalized anxiety disorder (GAD) is a relatively common condition affecting 5% of the population, with a typically chronic course and associated with significant psychosocial impairment and decreased quality of life (Schweizer, 1995). Although a number of therapeutic agents demonstrate some efficacy in the treatment ... | Anxiety Disorder | generalized anxiety disorder pharmacotherapy treatment refractory double-blind | null | 2 | arm 1: Eleven individuals were randomized to plaecbo augmentation of continued paroxetine CR at the week 10 dose level. In the first phase of the study, individuals started at 12.5 mg/day of paroxetine and flexibly titrated up to a maximum of 62.5 mg/day by week 10. Individuals who did not achieve remission and were ra... | [
1,
0
] | 3 | [
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: None | intervention 1: Continued Paroxetine CR intervention 2: Quetiapine intervention 3: Placebo | 2 | Boston | Massachusetts | United States | -71.05977 | 42.35843
Durham | North Carolina | United States | -78.89862 | 35.99403 | 0 | NCT00113295 |
[
3
] | 175 | RANDOMIZED | PARALLEL | 9OTHER | 4QUADRUPLE | false | 0ALL | null | Recent studies have found that poor oral hygiene may foster the colonization of the oropharynx by potential respiratory pathogens in mechanically-ventilated (MV), intensive care unit (ICU) patients. Thus, improvements in oral hygiene in MV-ICU patients may prevent ventilator-associated pneumonia (VAP).
The specific ai... | Recent studies have found that poor oral hygiene may foster the colonization of the oropharynx by potential respiratory pathogens in mechanically-ventilated (MV), intensive care unit (ICU) patients. Thus, improvements in oral hygiene in MV-ICU patients may prevent ventilator-associated pneumonia (VAP). The Specific Aim... | Pneumonia | Ventilator-associated pneumonia | null | 3 | arm 1: Delivered Twice a day arm 2: Delivered twice a day arm 3: Delivered once a day, placebo once a day | [
2,
0,
0
] | 2 | [
0,
0
] | intervention 1: chlorhexidine gluconate oral rinse intervention 2: None | intervention 1: chlorhexidine gluconate oral rinse (0.12%) intervention 2: placebo | 1 | Buffalo | New York | United States | -78.87837 | 42.88645 | 0 | NCT00123123 |
[
4
] | 41 | RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this study is to characterize the PK profile, safety and tolerability of single and multiple doses of pantoprazole in children aged 1 through 11 years with endoscopically proven GERD. | null | Gastroesophageal Reflux | Gastrointestinal Reflux Disease | null | 0 | null | null | 1 | [
0
] | intervention 1: None | intervention 1: pantoprazole for approximately 9 weeks. | 23 | Little Rock | Arkansas | United States | -92.28959 | 34.74648
Orange | California | United States | -117.85311 | 33.78779
San Diego | California | United States | -117.16472 | 32.71571
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Gainesville | Florida | United States | -82.32483 | 29.65... | 0 | NCT00141817 |
[
2
] | 7 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to see how vincristine, when placed in an oil droplet called a liposome (VSLI), is absorbed, distributed (moved around) and excreted from the the body (pharmacokinetics). This study will also assess the safety of VSLI and to see if VSLI will slow the growth or shrink tumors in patients with... | OBJECTIVES:
Primary: To assess the pharmacokinetics of VSLI administered intravenously to patients with malignant melanoma and hepatic dysfunction secondary to metastases.
Secondary: To assess the safety and antitumor activity of VSLI in this population. | Malignant Melanoma | null | 1 | arm 1: Single armed study; all subjects received VSLI | [
0
] | 1 | [
0
] | intervention 1: Marqibo (VSLI) 1.0 mg/m2 delivered by intravenous infusion over 1 hour every 2 weeks. | intervention 1: Vincristine Sulfate Liposomes Injection | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00145041 | |
[
0
] | 96 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | true | 0ALL | false | This investigation will evaluate the subjective effect on postoperative pain of three catheter placements in the knee:
1. intraarticular infusion only,
2. patellar tendon harvest site only,
3. both intraarticular and patellar tendon harvest site. | There will be 96 subjects recruited into this study. Based on power analysis for repeated measures analysis of variance, the sample size required for this investigation is 24 subjects per group based on a 90% confidence interval and alpha of 0.05. There will be 24 subjects in Group 1 (intraarticular bupivicaine infusio... | Pain, Postoperative | anterior cruciate ligament reconstruction Pain Care 3000 Catheter Placement Pain Breg, Inc | null | 4 | arm 1: Breg Pain Care 3000 Catheter;Bupivicaine 0.5%;Intraaticular Only
Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) intraarticularly only via Breg Pain Care 3000 Catheter arm 2: Breg Pain Care 3000 Catheter;Bupivicaine 0.5%;Patellar Tendon Site Only
Continuous infusion of a local anesthetic age... | [
0,
0,
0,
2
] | 3 | [
1,
0,
0
] | intervention 1: Device: Breg Pain Care 3000 Catheter intervention 2: Drug: Bupivicaine 0.5 % intervention 3: Drug: Placebo | intervention 1: Breg Pain Care 3000 Catheter intervention 2: Bupivicaine 0.5% intervention 3: Placebo | 1 | Rochester | New York | United States | -77.61556 | 43.15478 | 0 | NCT00178178 |
[
3
] | 84 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of the study is to describe the tumor response rates for the two regimens being studied, and to determine how long patients live after receiving the treatment, how long patients are without return of their disease after they receive treatment, and how long the response they get from the treatment lasts. The... | null | Colorectal Cancer | null | 2 | arm 1: Avastin + Gemcitabine + 5-Fluorouracil (5FU)/Folinic Acid arm 2: Avastin + Oxaliplatin + 5-Fluorouracil (5FU)/Folinic Acid | [
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: 900 mg/m2 IV over 90 minutes after Folinic Acid weekly for 6 weeks every 8 weeks until progression. intervention 2: 5 milligrams per kilogram (mg/kg) intervention 3: Folinic Acid: 100 milligrams per square meter (mg/m2) intravenous (IV) over 60 minutes (A+FFG).
Folinic Acid: 200 mg/m2 as a 2-hr infusio... | intervention 1: Gemcitabine intervention 2: avastin intervention 3: 5FU/folinic acid intervention 4: oxaliplatin | 15 | Tucson | Arizona | United States | -110.92648 | 32.22174
Beverly Hills | California | United States | -118.40036 | 34.07362
Palm Springs | California | United States | -116.54529 | 33.8303
Stockton | California | United States | -121.29078 | 37.9577
Kansas City | Kansas | United States | -94.62746 | 39.11417
Springfiel... | 0 | NCT00192075 | |
[
4
] | 753 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to investigate whether a long-acting injectable formulation of risperidone provides better effectiveness over 2 years, as measured by the time to relapse, compared with quetiapine tablets in a routine psychiatric care setting. Aripiprazole will be investigated in a descriptive manner. | Although many schizophrenia patients currently take oral antipsychotic medications, it is estimated that up to 75% of them have difficulty adhering to the daily oral regimen. Long-acting injectable formulations may eliminate the need for daily medication and enhance patient compliance with the treatment regimen. This i... | Schizophrenia Psychotic Disorders | Schizophrenia, relapse prevention Antipsychotic agents Long-acting risperidone Quetiapine Aripiprazole | null | 3 | arm 1: Risperidone Long Acting Injectable (LAI) 25 mg injection every 2 weeks until week 104. Dosage may be increased or decreased in steps of 12.5 mg. Additional oral risperidone can be administered as required until a dose increase becomes effective. arm 2: Quetiapine Oral tablets are titrated from 50 mg daily to 300... | [
0,
1,
5
] | 3 | [
0,
0,
0
] | intervention 1: 10-30 mg oral once daily for 104 weeks intervention 2: 25 mg injection every 2 weeks until week 104. Dosage may be increased or decreased in steps of 12.5 mg. Additional oral risperidone can be administered as required until a dose increase becomes effective. intervention 3: Oral tablets are titrated fr... | intervention 1: Aripiprazole intervention 2: Risperidone Long Acting Injectable (LAI) intervention 3: Quetiapine | 96 | Hall in Tirol | N/A | Austria | 11.51667 | 47.28333
Linz | N/A | Austria | 14.28611 | 48.30639
Neunkirchen | N/A | Austria | 16.08107 | 47.72096
Pleven | N/A | Bulgaria | 24.61667 | 43.41667
Sofia | N/A | Bulgaria | 23.32415 | 42.69751
Sofia Sofia | N/A | Bulgaria | N/A | N/A
Osijek | N/A | Croatia | 18.69389 | 45.5511... | 0 | NCT00216476 |
[
4
] | 460 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | To compare the efficacy and safety of aliskiren in combination with losartan compared to losartan on the regression of the increased size of the left ventricle in overweight patients with high blood pressure. | null | Hypertension Left Ventricular Hypertrophy Overweight | null | 3 | arm 1: Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks. In order to adequately blind the study, patients were required to take a total of 2 tablets and 1 capsule of study medication or placebo per day. In t... | [
0,
1,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: Aliskiren 150 mg tablets intervention 2: Losartan 50 or 100 mg capsules intervention 3: Aliskiren 150 mg placebo tablet intervention 4: Losartan 50/100 mg placebo capsules | intervention 1: Aliskiren 150/300 mg intervention 2: Losartan 50/100 mg intervention 3: Aliskiren placebo intervention 4: Losartan 50/100 mg placebo | 9 | East Hanover | New Jersey | United States | -74.36487 | 40.8201
Argentina | N/A | Argentina | -62.26693 | -29.53532
Colombia | N/A | Colombia | -74.8015 | 3.37606
Finland | N/A | Finland | N/A | N/A
Germany | N/A | Germany | N/A | N/A
Italy | N/A | Italy | N/A | N/A
Russia | N/A | Russia | N/A | N/A
Spain | N/A | Spain... | 0 | NCT00219141 | |
[
3
] | 94 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | This is a multi-center trial to assess safety and efficacy of a combined regimen of oral valproic acid (VPA) and carnitine in patients with Spinal Muscular Atrophy (SMA) 2 to 17 years of age. Cohort 1 is a double-blind placebo-controlled randomized intention to treat protocol for SMA "sitters" 2 - 8 years of age. Cohor... | This is a multi-center phase II trial of a combined regimen of oral valproic acid (VPA) and carnitine in patients with Spinal Muscular Atrophy (SMA) 2 to 17 years of age. Cohort 1 is a double-blind placebo-controlled randomized intention to treat protocol for SMA "sitters" 2 - 8 years of age. Subjects will undergo two ... | Spinal Muscular Atrophy | Spinal Muscular Atrophy (SMA) SMA Type 2 SMA Type 3 | null | 3 | arm 1: Patients in Cohort 1a - Placebo Comparator, will be on a placebo for 6 months and then will switch to the active treatment. Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in... | [
2,
1,
0
] | 2 | [
0,
0
] | intervention 1: VPA,sprinkle cap; Levocarnitine, syrup; dosage is by weight intervention 2: None | intervention 1: Valproic Acid and Levocarnitine intervention 2: Placebo | 6 | Baltimore | Maryland | United States | -76.61219 | 39.29038
Detroit | Michigan | United States | -83.04575 | 42.33143
Columbus | Ohio | United States | -82.99879 | 39.96118
Salt Lake City | Utah | United States | -111.89105 | 40.76078
Madison | Wisconsin | United States | -89.40123 | 43.07305
Montreal | Quebec | Canada... | 0 | NCT00227266 |
[
3
] | 9 | NA | SINGLE_GROUP | 1PREVENTION | 0NONE | false | 0ALL | false | This study is designed to confirm the safety of the proposed dose and schedule of ABI-007 for hemodialysis patients with vascular access device failure, and to obtain preliminary data on the effectiveness of such treatment. | This is an open-label, pilot, phase II study to assess the feasibility of administering ABI-007 intravenously \[IV\] over 3-5 minutes to patients with hemodialysis graft dysfunction (i.e., either a thrombosed polytetrafluoroethylene (PTFE) graft, or a patent but dysfunctional PTFE graft). Patients with graft dysfunctio... | Hemodialysis Graft Dysfunction | Vascular Access Graft Failure Venous Neointimal Hyperplasia(VNH) Hemodialysis | null | 1 | arm 1: ABI-007 35 mg/m\^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21 | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: ABI-007 | 4 | Peoria | Illinois | United States | -89.58899 | 40.69365
Shreveport | Louisiana | United States | -93.75018 | 32.52515
Rochester | New York | United States | -77.61556 | 43.15478
Cincinnati | Ohio | United States | -84.51439 | 39.12711 | 0 | NCT00249002 |
[
3
] | 212 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 1FEMALE | null | The primary objective of this study is to assess the effect of AMG 162 (denosumab) treatment on the lumbar spine BMD at month 12 and safety profile across the dose range tested (14, 60 and 100 mg SC once every 6 months) in Japanese postmenopausal osteoporotic subjects compared with those treated with placebo over 12 mo... | null | Osteoporosis | RANKL RANK denosumab AMG 162 osteoporosis bone turnover bone mineral density Japanese | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
1,
1,
2,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: 100 mg AMG 162 (denosumab) SC every 6 months intervention 2: 60 mg AMG 162 (denosumab) SC every 6 months intervention 3: 14 mg AMG 162 (denosumab) SC every 6 months intervention 4: Placebo SC every 6 months | intervention 1: 100 mg AMG 162 intervention 2: 60 mg AMG 162 intervention 3: 14 mg AMG 162 intervention 4: Placebo | 0 | null | 0 | NCT00306189 |
[
4
] | 327 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The primary objective of this trial is to assess the maintenance of efficacy of gabapentin enacarbil (GEn, XP13512) taken once daily in the long-term treatment of patients suffering from Restless Legs Syndrome (RLS). | This study was a multicenter, blinded, randomized withdrawal study in subjects with primary Restless Legs Syndrome (RLS). Eligible subjects were initially enrolled in a 24-week single blind (SB) treatment period during which they received XP13512. Subjects who completed the initial treatment period and met the responde... | Restless Legs Syndrome | null | 2 | arm 1: GEn (XP13512) 1200 mg arm 2: Placebo | [
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: 1200 mg GEn (XP13512) orally, once daily for 24 weeks followed by either 1200 mg GEn (XP13512) or placebo, orally, once daily for an additional 12 weeks intervention 2: 1200 mg GEn (XP13512), orally, once daily for 24 weeks followed by either 1200 mg GEn (XP13512) or placebo, orally, once daily for an a... | intervention 1: GEn (XP13512) intervention 2: GEn (XP13512) intervention 3: Placebo | 0 | null | 0 | NCT00311363 | |
[
3
] | 30 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | true | 2MALE | true | Studies demonstrate that methamphetamine (meth) use is associated with high-risk sexual behavior among MSM, putting meth-using MSM at extraordinarily high risk for transmitting or acquiring HIV. No studies have tested the feasibility and acceptability of conducting pharmacologic interventions to reduce meth use and met... | The high rate of meth use among MSM is paralleled by evidence of rises in sexual risk behavior and HIV infection among this population. The MSM meth epidemic, and its link with HIV transmission, underscores the need to pilot test new, innovative modalities to reduce meth use and meth-associated sexual risk behavior. Ul... | Substance Abuse HIV Infections | Methamphetamine HIV | null | 2 | arm 1: buproprion XL 300mg daily arm 2: placebo 300mg daily | [
1,
2
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: Bupropion intervention 2: Placebo | 1 | San Francisco | California | United States | -122.41942 | 37.77493 | 0 | NCT00318409 |
[
4
] | 1,355 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This study is a long-term follow-up protocol for patients who participated in study NK-104-3.01EU or study NK-104-3.02EU. | Patients from the NK-104-3.01EU and NK-104-3.02EU studies will continue to receive either pitavastatin or the comparator statin for 1 year. | Hypercholesterolemia Dyslipidemia | Kowa Hypercholesterolemia dyslipidemia pitavastatin NK-104 Hypercholesterolemia or combined dyslipidemia | null | 1 | arm 1: Pitavastatin 4 mg once daily | [
0
] | 1 | [
0
] | intervention 1: Pitavastatin 4 mg once daily | intervention 1: Pitavastatin | 186 | Copenhagen | N/A | Denmark | 12.56553 | 55.67594
Copenhagen | N/A | Denmark | 12.56553 | 55.67594
Copenhagen Nv | N/A | Denmark | N/A | N/A
Frederiksberg | N/A | Denmark | 12.53463 | 55.67938
Hellerup | N/A | Denmark | 12.57093 | 55.73204
Vejle | N/A | Denmark | 9.5357 | 55.70927
Helsinki | N/A | Finland | 24.93545 | 6... | 0 | NCT00325780 |
[
4
] | 747 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study, will compare pregabalin with placebo for the duration of 14 weeks to evaluate the efficacy and safety of pregabalin in patients with fibromyalgia. | null | Fibromyalgia | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
0,
0,
0,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: 600mg/day intervention 2: 450mg/day intervention 3: 300mg/day intervention 4: placebo | intervention 1: pregabalin intervention 2: pregabalin intervention 3: pregabalin intervention 4: placebo | 74 | Warrawong | New South Wales | Australia | 150.88833 | -34.485
Maroochydore | Queensland | Australia | 153.09953 | -26.66008
Clayton | Victoria | Australia | 145.11667 | -37.91667
Fitzroy | Victoria | Australia | 144.97833 | -37.79839
Kelowna | British Columbia | Canada | -119.48568 | 49.88307
Winnipeg | Manitoba | Cana... | 0 | NCT00333866 | |
[
3
] | 19 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The objective of the study is to determine whether mifepristone (VGX-410) has anti-HIV-1 activity at doses of either 300 mg or 600 mg per day after oral administration for 14 days at each dose level. | VT004 is a double-blind, randomized, placebo-controlled Phase II study of two doses of orally administered mifepristone (VGX-410) (300 and 600 mg) taken as a twice daily (BID) dosage (150mg BID and 300mg BID) in a dose-escalating fashion for 14 days at each dose level to determine antiviral activity and safety in HIV-1... | HIV Infections | HIV-1 | null | 2 | arm 1: 150mg twice daily of VGX-410 for 14 days and, if well tolerated, a dose escalation to 300mg twice daily of VGX-410 for 14 days arm 2: 150mg twice daily of placebo for VGX-410 for 14 days and, if well tolerated, a dose escalation to 300mg twice daily of placebo for VGX-410 for 14 days | [
1,
2
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: VGX-410 (Mifepristone) intervention 2: Placebo for VGX-410 (Mifepristone) | 3 | Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 0 | NCT00352911 |
[
3
] | 125 | NON_RANDOMIZED | PARALLEL | 2DIAGNOSTIC | 0NONE | true | 0ALL | false | This phase II, open-label research study was conducted in 129 healthy volunteers. Each subject will be given one initial oral dose of one of 7 FDA-approved medications (probe drugs), followed by a 7 day period where subjects receive the study medication AEGR-733 at 10 or 60 mg. On study day 8 subjects will receive the ... | Objectives:
Primary: To evaluate the effects of low and high doses of AEGR-733 on the pharmacokinetics of 6 FDA-approved medications that are likely to be used in combination with AEGR-733 as assessed by:
• Pharmacokinetic parameters: Cmax, Tmax, T1/2, and AUC (area under the curve).
Secondary: To evaluate the safet... | Healthy | healthy volunteers | null | 0 | null | null | 6 | [
0,
0,
0,
0,
0,
0
] | intervention 1: Atrovastatin 20 mg and AEGR-733 10 mg or 60 mg intervention 2: Simvastatin 20 mg and AEGR-733 10 mg or 60 mg intervention 3: Ezetimibe 10 mg and AEGR-733 10 mg intervention 4: Micronized Fenofibrate 145 mg and AEGR-733 10 mg intervention 5: Dextromethorphan 30 mg and AEGR-733 10 mg intervention 6: 1000 ... | intervention 1: atorvastatin intervention 2: simvastatin intervention 3: ezetimibe intervention 4: fenofibrate intervention 5: dextromethorphan intervention 6: Extended Release Niacin | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 0 | NCT00359281 |
[
4
] | 404 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to evaluate the long-term safety of mometasone furoate/formoterol (MF/F) metered dose inhaler (MDI) 200/10 mcg twice-a-day (BID) and MF/F MDI 400/10 mcg BID and two doses of fluticasone/salmeterol combination (F/SC) (250/50 mcg BID and 500/50 mcg BID) in subjects with persistent asthma who ... | null | Asthma | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
0,
0,
1,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year intervention 2: MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year intervention 3: F/SC 250/50 twice daily for 1 year intervention 4: F/SC 500/50 twice daily for 1 year | intervention 1: mometasone furoate combination MDI 200/10 mcg BID intervention 2: mometasone furoate combination MDI 400/10 mcg BID intervention 3: Fluticasone/Salmeterol 250/50 mcg BID intervention 4: Fluticasone/Salmeterol 500/50 mcg BID | 0 | null | 0 | NCT00379288 | |
[
4
] | 169 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This is a randomized, double-blind, placebo-controlled, crossover, two-attack, out-patient, early-intervention evaluation of subjects who have migraine with or without aura and who discontinued use of short acting triptan(s) within the past year due to non-response or intolerance. Subjects will treat 2 separate migrain... | This is a randomized, double-blind, placebo-controlled, crossover, two-attack, out-patient, early-intervention evaluation of subjects who have migraine with or without aura and who discontinued use of short acting triptan(s) within the past year due to non-response or intolerance. Subjects will treat 2 separate migrain... | Migraine Disorders | migraine with or without aura naproxen sodium combination product sumatriptan succinate poor response short acting triptan migraine, acute | null | 2 | arm 1: Combination Product (sumatriptan and naproxen sodium) \[Attack 1\] followed by Placebo \[Attack 2\] arm 2: Placebo \[Attack 1\] followed by Combination Product (sumatriptan and naproxen sodium) \[Attack 2\] | [
5,
5
] | 2 | [
0,
0
] | intervention 1: Matching placebo tablet intervention 2: Bilayer tablet containing 85mg sumatriptan (as 119mg sumatriptan succinate; fast disintegrating/rapid release formulation) active ingredient in one layer, and 500mg naproxen sodium active ingredient in second layer. | intervention 1: Placebo intervention 2: Combination Product (sumatriptan succinate/naproxen sodium) | 28 | Jasper | Alabama | United States | -87.27751 | 33.83122
Oceanside | California | United States | -117.37948 | 33.19587
San Francisco | California | United States | -122.41942 | 37.77493
Hartford | Connecticut | United States | -72.68509 | 41.76371
Aventura | Florida | United States | -80.13921 | 25.95648
Augusta | Geor... | 0 | NCT00382993 |
[
4
] | 422 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | The primary purpose of this study is to evaluate the blood pressure lowering effects of ramipril, an FDA-approved drug for the treatment of hypertension in adults, in children and adolescents aged 6 to 16 years with hypertension. | Information is needed on the treatment of hypertension in children and adolescents with antihypertensive drugs like ramipril. The study will assess the safety and blood pressure effects of several doses of the antihypertensive drug ramipril in children and adolescents age 6-16 years. Approximately 450 children will be ... | Hypertension | Hypertension/*etiology Blood Pressure Pediatric Adolescent Child | null | 4 | arm 1: once per day arm 2: 0.3125, 0.625, or 1.25 mg once a day, based on subject weight arm 3: 1.25, 2.5, or 5 mg once a day, based on subject weight arm 4: 5, 10, or 20 mg once a day, based on subject weight | [
2,
0,
0,
0
] | 2 | [
0,
0
] | intervention 1: once a day oral ramipril capsules given for 4 weeks intervention 2: once a day oral placebo capsule for 4 weeks | intervention 1: ramipril intervention 2: placebo | 100 | Little Rock | Arkansas | United States | -92.28959 | 34.74648
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Beverly Hills | California | United States | -118.40036 | 34.07362
Los Angeles | California | United States | -118.24368 | 34.05223
Orange | California | United States | -117.85311 | 33.78779
Coco... | 0 | NCT00389519 |
[
4
] | 372 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The purpose of this study is to evaluate efficacy and safety of pregabalin in the treatment of postherpetic neuralgia in a dose-ranging manner. | null | Neuralgia, Postherpetic | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
2,
0,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: placebo, oral administration for 13 weeks (1 week titration and 12-week fixed dose). intervention 2: Pregabalin 150mg/day (75mg BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose). intervention 3: Pregabalin 300mg/day (150mg/BID), oral administration for 13 weeks (1-week tit... | intervention 1: Placebo intervention 2: Pregabalin intervention 3: Pregabalin intervention 4: Pregabalin | 39 | Nagoya | Aichi-ken | Japan | 136.90641 | 35.18147
Ichikawa | Chiba | Japan | 139.9065 | 35.73413
Urayasu | Chiba | Japan | 139.90055 | 35.65879
Kasuga | Fukuoka | Japan | 130.4611 | 33.52594
Kasuya-gun | Fukuoka | Japan | N/A | N/A
Maebaru-chūō | Fukuoka | Japan | 130.20148 | 33.55916
Maebashi | Gunma | Japan | 139.083... | 0 | NCT00394901 | |
[
4
] | 394 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The purpose of this study is to evaluate the effectiveness and safety of Extended Release Osmotic Controlled-Release Oral Delivery System (OROS) Paliperidone compared to placebo in patients with Schizophrenia. Olanzapine will be used as a reference drug in the study. | This is a multicenter, double blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), randomized (patients are assigned different treatments based on chance), placebo- and active-controlled, parallel-group study. Patients will be randomized into 1 of 3 treatment gr... | Schizophrenia | Schizophrenia JNS007ER Positive and Negative Syndrome Scale (PANSS) Paliperidone Extended Release Osmotic Controlled-Release Oral Delivery System (OROS) paliperidone | null | 3 | arm 1: Extended Release (ER) Osmotic Controlled-Release Oral Delivery System (OROS) paliperidone arm 2: None arm 3: None | [
0,
2,
1
] | 3 | [
0,
0,
0
] | intervention 1: Type= exact number, unit= mg, number= 3, form= tablet, route= oral use. Two tablets once daily for 6 weeks. intervention 2: Form= tablet, route= oral use. Two tablets once daily for 6 weeks. intervention 3: Type= exact number, unit= mg, number= 2.5, form= tablet, route= oral use. Four tablets once daily... | intervention 1: ER OROS paliperidone intervention 2: Placebo intervention 3: Olanzapine | 56 | Aizu-Wakamatsu | N/A | Japan | 139.94546 | 37.49142
Fujioka | N/A | Japan | 139.07204 | 36.24624
Fujisawa | N/A | Japan | 139.47666 | 35.34926
Fukui | N/A | Japan | 135.54836 | 34.84214
Hadano | N/A | Japan | 139.22361 | 35.37111
Himeji | N/A | Japan | 134.7 | 34.81667
Hiratsuka | N/A | Japan | 139.33735 | 35.32785
Hir... | 0 | NCT00396565 |
[
3
] | 41 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This study was designed to provide data about the safety and efficacy of 3 doses of indacaterol (150, 300, and 600 µg) in Japanese asthma patients so that an optimal dose, or doses, could be chosen for testing in later studies. | null | Asthma | asthma QAB149 indacaterol long acting β2-agonist bronchodilator | null | 4 | arm 1: In treatment period 1: patients received 2 placebo capsules; in treatment period 2: patients received 1 indacaterol (Ind) 150 μg capsule + 1 placebo capsule; in treatment period 3: patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; and in treatment period 4: patients received 2 indacaterol 300 μ... | [
0,
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: In the morning, powder filled capsules inhaled using a single dose dry powder inhaler (SDDPI). intervention 2: Placebo to indacaterol was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI). intervention 3: Salmeterol 100 μg total dose taken on Day 1. 50 μg in the morning an... | intervention 1: Indacaterol intervention 2: Placebo intervention 3: Salmeterol | 8 | Kasukabe | N/A | Japan | 139.74966 | 35.98308
Kishiwada | N/A | Japan | 135.36667 | 34.46667
Shimotsuga | N/A | Japan | N/A | N/A
Suita | N/A | Japan | 135.51567 | 34.76143
Tokyo | N/A | Japan | 139.69171 | 35.6895
Tokyo | N/A | Japan | 139.69171 | 35.6895
Wakayama | N/A | Japan | 135.16667 | 34.23333
Yokohama | N/A | ... | 0 | NCT00403754 |
[
4
] | 547 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This study will investigate the effectiveness of desloratadine in treating subjects with allergic rhinitis (AR) who meet the criteria for intermittent allergic rhinitis. | null | Rhinitis, Allergic, Seasonal Rhinitis, Allergic, Perennial | Allergic Rhinitis Intermittent Allergic Rhinitis | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 5-mg Desloratadine tablet, once daily for 15 days intervention 2: Placebo tablet, once daily for 15 days | intervention 1: 5-mg Desloratadine intervention 2: Placebo | 0 | null | 0 | NCT00406783 |
[
4
] | 404 | RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The primary purpose of your participation in this study is to help answer the following research question, and not to provide you treatment for your condition--Whether duloxetine once daily can help patients with Chronic Low Back Pain. | null | Back Pain Without Radiation | null | 4 | arm 1: duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks arm 2: duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks arm 3: duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO ... | [
0,
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: Duloxetine intervention 2: Placebo | 4 | Fort Myers | Florida | United States | -81.84059 | 26.62168
Orlando | Florida | United States | -81.37924 | 28.53834
South Miami | Florida | United States | -80.29338 | 25.7076
Tampa | Florida | United States | -82.45843 | 27.94752 | 0 | NCT00408876 | |
[
4
] | 698 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This study will evaluate the safety and efficacy of the fixed combination of valsartan/amlodipine in adult patients with mild to moderate hypertension | null | Hypertension | Hypertension, valsartan, amlodipine, high blood pressure | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures. intervention 2: 1 amlodip... | intervention 1: Valsartan/amlodipine 80/5 mg intervention 2: Amlodipine 5 mg | 12 | Beijing | N/A | China | 116.39723 | 39.9075
Beijing | N/A | China | 116.39723 | 39.9075
Changsha | N/A | China | 112.97087 | 28.19874
Chongqing | N/A | China | 106.55771 | 29.56026
Chongqing | N/A | China | 106.55771 | 29.56026
Fuzhou | N/A | China | 119.30611 | 26.06139
Fuzhou | N/A | China | 119.30611 | 26.06139
Nanc... | 0 | NCT00413049 |
[
4
] | 1,134 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This study evaluated the safety and efficacy of the fixed combination of valsartan/amlodipine in adult patients with mild to moderate hypertension. | null | Hypertension | Hypertension, valsartan, amlodipine, high blood pressure | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: 1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily intervention 2: 1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily intervention 3: 1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once dail... | intervention 1: Valsartan/amlodipine 80/5 mg intervention 2: Valsartan 80 mg intervention 3: Valsartan 160 mg | 19 | Beijing | N/A | China | 116.39723 | 39.9075
Beijing | N/A | China | 116.39723 | 39.9075
Beijing | N/A | China | 116.39723 | 39.9075
Hangzhou | N/A | China | 120.16142 | 30.29365
Hangzhou | N/A | China | 120.16142 | 30.29365
Hangzhou | N/A | China | 120.16142 | 30.29365
Nanjing | N/A | China | 118.77778 | 32.06167
Nanji... | 0 | NCT00413413 |
[
4
] | 547 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The purpose of this study is to evaluate the efficacy of Kadian NT (ALO-01) compared with placebo for treating moderate to severe chronic pain over a 12 week period. | The primary objective of this study is to evaluate the efficacy of ALO-01 compared with placebo for the treatment of chronic moderate to severe pain (focusing on osteoarthritis of the hip or knee) as measured by mean change in diary Brief Pain Inventory (BPI) score of average pain (daily scores of average pain averaged... | Osteoarthritis Chronic Pain | hip knee pain osteoarthritis OA Kadian Alpharma naltrexone Opioid morphine Embeda ALO-01 | null | 2 | arm 1: Up to 80 mg twice a day (bid) arm 2: Twice a day (bid) | [
0,
2
] | 2 | [
0,
0
] | intervention 1: capsules, up to 80 mg bid intervention 2: capsules, bid | intervention 1: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release) intervention 2: Placebo | 81 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Mobile | Alabama | United States | -88.04305 | 30.69436
Peoria | Arizona | United States | -112.23738 | 33.5806
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tempe | Arizona | United States | -111.90931 | 33.41477
Anaheim | California | United Stat... | 0 | NCT00420992 |
[
4
] | 698 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin infections in adults. | Additional purpose of the study is to compare ceftaroline effectivity versus Vancomycin plus Aztreonam in the treatment of complicated skin infections in adults. | Bacterial Infections | Abscess Antibacterial Antibiotic Antimicrobial Bacterial infection, skin Ceftaroline Ceftaroline acetate Cellulitis Cephalosporin Complicated skin and skin structure infection cSSSI Intravenous Methicillin-resistant Staphylococcus Aureus (MRSA) PPI-0903 Prodrug Skin disease, bacterial Skin infection Staphylococcal skin... | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: vancomycin at 1 g parenteral infused over 60 minutes followed by aztreonam 1 g infused over 60 minutes, every 12 hours, for 5 to 14 days. intervention 2: 600 mg parenteral infused over 60 minutes, every 12 hours for 5 to 14 days | intervention 1: IV Vancomycin plus IV Aztreonam intervention 2: Ceftaroline | 52 | Dothan | Alabama | United States | -85.39049 | 31.22323
Long Beach | California | United States | -118.18923 | 33.76696
Los Angeles | California | United States | -118.24368 | 34.05223
Sacramento | California | United States | -121.4944 | 38.58157
Sacramento | California | United States | -121.4944 | 38.58157
San Diego... | 0 | NCT00424190 |
[
4
] | 1,183 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | This study was designed to compare the efficacy, tolerability, and safety of the combination valsartan/amlodipine 160/5 mg versus amlodipine 10 mg in patients with essential hypertension not adequately controlled (defined as mean sitting systolic blood pressure \[msSBP\] ≥ 130 mmHg and ≤ 160 mmHg) on amlodipine 5 mg al... | null | Essential Hypertension | Essential hypertension blood pressure edema valsartan amlodipine combination treatment | null | 2 | arm 1: Twelve (12) weeks treatment with the combination of valsartan/amlodipine 160/5 mg. Together with the active medication, patients received a placebo that matched amlodipine 5 mg. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take ... | [
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: capsules | intervention 1: Valsartan 160 mg capsules intervention 2: Amlodipine 5 mg capsules intervention 3: placebo | 12 | Agentina | N/A | Argentina | N/A | N/A
Chile | N/A | Chile | N/A | N/A
Ecuador | N/A | Ecuador | -79.8904 | -2.25741
Finland | N/A | Finland | N/A | N/A
France | N/A | France | -0.84802 | 45.60366
Germany | N/A | Germany | N/A | N/A
Italy | N/A | Italy | N/A | N/A
Norway | N/A | Norway | N/A | N/A
Spain | N/A | Spain |... | 0 | NCT00437645 |
[
4
] | 243 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | null | 0ALL | null | The study will evaluate the efficacy of cyclosporine at 2, 5 mg/kg/day bid (i.e. bis in a day), when administered twice a week compared to continuous administration, in patients with chronic plaque psoriasis. | null | Chronic Plaque Psoriasis | Cyclosporine, chronic plaque psoriasis, intermittent therapy | null | 2 | arm 1: Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations arm 2: Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations | [
1,
2
] | 2 | [
0,
0
] | intervention 1: Oral soft gelatin capsules of Cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations intervention 2: Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily admini... | intervention 1: Cyclosporine A microemulsion intervention 2: Placebo | 1 | Bari | N/A | Italy | 16.86982 | 41.12066 | 0 | NCT00438360 |
[
5
] | 120 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | To demonstrate efficacy and safety of TachoSil® in cardiovascular surgery | null | Haemorrhage Haemostasis Cardiovascular Surgery | Surgical treatment of haemorrhage | null | 2 | arm 1: None arm 2: Standard Treatment of haemorrhage in cardiovascular surgery | [
1,
1
] | 2 | [
0,
0
] | intervention 1: None intervention 2: Any haemostatic fleece material without additional active coagulation stimulating compounds (primarily Surgicel®) | intervention 1: fibrinogen (human) + thrombin (human) intervention 2: Standard haemostatic treatment in cardiovascular surgery | 1 | Roskilde | N/A | Denmark | 12.08035 | 55.64152 | 0 | NCT00440401 |
[
5
] | 132 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | false | 0ALL | false | This study will compare the effects of high and low level sodium (salt) diets on blood pressure in patients with hypertension (high blood pressure) who are taking aliskiren 300 mg. | null | Hypertension | High blood pressure, hypertension, aliskiren, low sodium diet | null | 2 | arm 1: Patients on low sodium diet ( \<= 100 mmol/day) for the first 4 weeks and high sodium (\>= 200 mmol/day) diet for the next 4 weeks. \[with Aliskiren 300 mg\] arm 2: Patients on high sodium (\>= 200 mmol/day) diet for the first 4 weeks and on low sodium diet ( \<= 100 mmol/day) for the next 4 weeks. \[with Aliski... | [
0,
0
] | 1 | [
0
] | intervention 1: None | intervention 1: Aliskiren | 19 | Orangevale | California | United States | -121.22578 | 38.67851
Brooklyn Center | Minnesota | United States | -93.33273 | 45.07608
Butte | Montana | United States | -112.53474 | 46.00382
Missoula | Montana | United States | -113.994 | 46.87215
Lincoln | Nebraska | United States | -96.66696 | 40.8
Johnson City | New Yor... | 0 | NCT00441064 |
[
3
] | 4 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to evaluate the safety of a protein called BPI that is naturally made by the body's white blood cells to fight infection. | This study will initially evaluate an FDA approved investigational dosage and will measure the blood levels over time while BPI is being infused through a vein to see if the dose is potentially enough to obtain the desired effect. The drug will be started within 8 hours of burn injury and continued for 48 hours. Patien... | Burns | null | 1 | arm 1: BPI will be infused by bolus for 30 minutes followed by continuous infusion for 47.5 hours | [
0
] | 1 | [
0
] | intervention 1: BPI will be give IV with an initial bolus given over 30 minutes and then a continuous infusion for the next 47.5 hours | intervention 1: BPI | 1 | Dallas | Texas | United States | -96.80667 | 32.78306 | 0 | NCT00462904 | |
[
5
] | 52 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This study will evaluate the safety and efficacy of daptomycin against complicated skin and skin-structure infections in adults | null | Staphylococcal Skin Infections | Complicated Skin and Skin-Structure Infections, Daptomycin, MRSA, Diabetic Foot, Abscess, Cellulitis Complicated skin and skin-structure infections | null | 1 | arm 1: 350 mg of Daptomycin was supplied as sterile lyophilized powder in glass vials. Each vial was to be reconstituted with 7 mL of normal saline or water for injection, to give a 50 mg/mL drug concentration. Daptomycin was to be administered as a 30-minute intravenous infusion, once daily for at least 7 days, at the... | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: Daptomycin | 2 | Novartis Italy | N/A | Italy | N/A | N/A
Saronno | N/A | Italy | 9.03517 | 45.62513 | 0 | NCT00463801 |
[
4
] | 295 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of the study is to evaluate sleep onset following administration of zolpidem tartrate sublingual tablet (Intermezzo) versus placebo in adult insomnia patients. | null | Insomnia | Insomnia | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 3.5 milligram zolpidem tartrate sublingual tablet taken as needed following a middle-of-the-night awakening over the 28-night study period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved. intervention 2: Placebo su... | intervention 1: zolpidem tartrate sublingual tablet intervention 2: Placebo | 1 | Durham | North Carolina | United States | -78.89862 | 35.99403 | 0 | NCT00466193 |
[
5
] | 680 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The primary objective of the study is to compare nighttime symptom relief of fluticasone furoate nasal spray versus oral fexofenadine | null | Rhinitis, Allergic, Seasonal | ragweed once daily fexofenadine fluticasone furoate allergic rhinitis | null | 0 | null | null | 1 | [
0
] | intervention 1: None | intervention 1: fluticasone furoate, fexofenadine | 42 | Little Rock | Arkansas | United States | -92.28959 | 34.74648
Albany | Georgia | United States | -84.15574 | 31.57851
Columbus | Georgia | United States | -84.98771 | 32.46098
Lawrenceville | Georgia | United States | -83.98796 | 33.95621
Chicago | Illinois | United States | -87.65005 | 41.85003
Normal | Illinois | Uni... | 0 | NCT00502775 |
[
0
] | 9 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The current use of telepsychiatry, or psychiatric care using videoconferencing, is very limited. The present study investigates the use of this method with a depressed Chinese American population in a nursing home. It is believed that this population can benefit from telepsychiatric treatment when used in collaboration... | Individuals at the South Cove Manor nursing home will be referred to this study if they are experiencing depression. After meeting with the Principal Investigator (a psychiatrist), he will collaborate with the primary care physician and the nursing home staff to establish a treatment plan for the patient. Videoconferen... | Major Depressive Disorder | Major Depressive Disorder Telepsychiatry Chinese American Nursing Home | null | 0 | null | null | 2 | [
0,
5
] | intervention 1: Antidepressant medication, prescribed at discretion of psychiatrist intervention 2: Regular care visits from health workers | intervention 1: Psychotropic medication (at discretion of psychiatrist) intervention 2: Collaborative psychiatric and primary medical care | 2 | Boston | Massachusetts | United States | -71.05977 | 42.35843
Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00505518 |
[
3
] | 20 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study will involve the use of a new compound, GW642444 that is being developed for the treatment of asthma and chronic obstructive pulmonary disease (COPD). It works by acting on cells in the lungs, causing some of the muscles around the lungs to relax and open up better (bronchodilation), making breathing easier.... | null | Pulmonary Disease, Chronic Obstructive | pharmacodynamics, Chronic Obstructive Pulmonary Disease (COPD) safety, COPD patients pharmacokinetics, tolerability, GW642444, | null | 5 | arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None | [
0,
0,
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: drug intervention 2: drug intervention 3: None | intervention 1: GW642444M intervention 2: GW642444H intervention 3: placebo | 4 | Wiesbaden | Hesse | Germany | 8.24932 | 50.08258
Mainz | Rhineland-Palatinate | Germany | 8.2791 | 49.98419
Berlin | State of Berlin | Germany | 13.41053 | 52.52437
Berlin | State of Berlin | Germany | 13.41053 | 52.52437 | 0 | NCT00519376 |
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