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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
[
5
] | 80 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to evaluate the analgesic effect of combination of tramadol hydrochloride and acetaminophen in participants for treatment of fibromyalgia pain (chronic widespread pain and presence of tender points). | This is an open-label (all people know the identity of the intervention) and multi-center (conducted in more than one center) study of combination of tramadol hydrochloride and acetaminophen in treatment of participants with pain of fibromyalgia. The duration of this study will be 56 days per participant. The study con... | Pain Fibromyalgia | Pain Fibromyalgia Ultracet Tramadol Hydrochloride Acetaminophen | null | 1 | arm 1: Tramadol hydrochloride/acetaminophen oral tablet will be administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56. | [
0
] | 2 | [
0,
0
] | intervention 1: Tramadol hydrochloride oral tablet will be administered at a dose of 37.5 milligram as, once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56. intervention 2: Acetaminophen oral tablet will be administered at a dose of 325 milligram as, once daily for Day 1-3, twice daily for Day... | intervention 1: Tramadol hydrochloride intervention 2: Acetaminophen | 0 | null | 0 | NCT00766675 |
[
3
] | 38 | RANDOMIZED | PARALLEL | 7BASIC_SCIENCE | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to investigate if treatment with AZD9668 for 28 days is effective in treating Bronchiectasis (Brx) and if so how it compares to placebo (a substance which does not have any action). | null | Bronchiectasis | bronchiectasis Phase II | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 2 x 30 mg, oral tablet, twice daily for 28 days intervention 2: 2 x Matched placebo, oral tablet, twice daily for 28 days | intervention 1: AZD9668 intervention 2: Placebo | 9 | Chemin Sainte-Foy | Quebec | Canada | N/A | N/A
Calgary | N/A | Canada | -114.08529 | 51.05011
Montreal | N/A | Canada | -73.58781 | 45.50884
Ontario | N/A | Canada | N/A | N/A
Vancouver | N/A | Canada | -123.11934 | 49.24966
Birmingham | N/A | United Kingdom | -1.89983 | 52.48142
Cambridge | N/A | United Kingdom | 0.1... | 0 | NCT00769119 |
[
0
] | 15 | RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | This is a 12 week bilateral study, consisting of 6 weeks of treatment and 6 weeks of follow-up. The purpose of the study is to compare the safety and effectiveness of combining and then following a high potency topical corticosteroid treatment with LCD treatment for moderate-to-severe localized plaque psoriasis. | Superpotent topical corticosteroids such as clobetasol propionate are highly effective in treating plaque psoriasis but are not indicated for long term use due to their side effects. Therefore, steroid-sparing combination and sequential regimens, in which the corticosteroid gets supplemented with a non-steroid medicati... | Psoriasis | chronic plaque psoriasis | null | 2 | arm 1: corticosteroid and LCD treatment (2 weeks), LCD alone treatment (4 weeks) arm 2: corticosteroid and placebo treatment (2 weeks), placebo alone treatment (4 weeks) | [
0,
2
] | 3 | [
0,
10,
0
] | intervention 1: One side of body:
clobetasol: 2 applications / day along with LCD application 2 applications/day intervention 2: One side of body:
Placebo Solution: 2 applications / day along with clobetasol 2 applications/day intervention 3: One side of body:
LCD Solution: 2 applications / day along with clobetasol... | intervention 1: Corticosteroid intervention 2: Placebo intervention 3: LCD | 1 | East Windsor | New Jersey | United States | -74.54043 | 40.268 | 0 | NCT00769184 |
[
5
] | 60 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This study enrolled 30 healthy volunteers and 30 patients with atopic asthma, for a total of 60 subjects. The study examined the tolerability of omalizumab and omalizumab excipients in two successive cohorts of subjects, healthy volunteers and patients with allergic asthma without prior exposure to omalizumab, accordin... | null | Healthy Asthma | Xolair Asthma Skin Tests | null | 2 | arm 1: Healthy participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and 1:1000, 1:100, 1:10 dilution and full concentrations of both omalizumab and omalizumab excipients. arm 2: Allergic asthma participants were tested sequentially in... | [
0,
0
] | 2 | [
0,
0
] | intervention 1: In sterile water for injection (SWFI), full concentration and 1:1000, 1:100, 1:10 dilutions of 125 mg/mL of standard solution of omalizumab and its excipients. Skin prick test of each dilution concentration of 1:1000, 1:100, 1:10 and full concentration and Intradermal tests of each dilution concentratio... | intervention 1: Cohort I intervention 2: Cohort 2 | 0 | null | 0 | NCT00777764 |
[
2
] | 30 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | true | 0ALL | false | The objective of this trial is to assess the pulmonary safety of 2 inhaled doses of Staccato Loxapine within a day. | The planned study is a multiple dose, double-blind, placebo-controlled, randomized, 2-sequence, 2-period crossover study investigating pulmonary safety in healthy volunteers. | Healthy | Healthy volunteers | null | 2 | arm 1: Inhaled Staccato Placebo, 2 inhalations, 8 hours apart; washout of at least 4 days; Inhaled Staccato Loxapine, 10 mg oses x 2, 8 hours apart arm 2: Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart; washout of at least 4 days; Inhaled Staccato Placebo, 2 inhalations, 8 hours apart; | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Inhaled Staccato Placebo, 2 inhalations, 8 hours apart intervention 2: Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart | intervention 1: Inhaled Placebo intervention 2: Inhaled Loxapine | 1 | North Dartmouth | Massachusetts | United States | -70.97032 | 41.63899 | 0 | NCT00789360 |
[
4
] | 2 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to evaluate the effect of milnacipran on how the brain processes pain in patients with fibromyalgia and to assess the relationship between this effect and brain activation patterns during functional magnetic resonance imaging. | null | Fibromyalgia | fibromyalgia milnacipran Forest Laboratories | null | 2 | arm 1: Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks. arm 2: Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks. | [
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: Twice daily oral administration of Milnacipran for 5 weeks. intervention 2: Twice daily oral administration of placebo for 5 weeks. intervention 3: Twice daily oral administration of placebo for 5 weeks. intervention 4: Twice daily oral administration of Milnacipran for 5 weeks. | intervention 1: Milnacipran intervention 2: Placebo intervention 3: Placebo intervention 4: Milnacipran | 1 | Ann Arbor | Michigan | United States | -83.74088 | 42.27756 | 0 | NCT00793520 |
[
0
] | 45 | RANDOMIZED | FACTORIAL | null | 0NONE | true | 0ALL | false | To date, no study has investigated whether there is a drug interaction between the protease inhibitor fosamprenavir and the integrase inhibitor raltegravir. COL112775 is a randomized, open-label, 6-arm, 3-period, drug interaction study to assess steady-state plasma amprenavir (APV) and raltegravir (RTG) pharmacokinetic... | This randomized, open-label, six-arm, three-period drug interaction study will recruit 48 healthy volunteers so as to obtain a minimum of 36 evaluable subjects at a single study center in the U.S. The study will have a screening visit, 3 treatment visits for pharmacokinetics (PK) sampling and a follow-up visit. The scr... | Healthy | Healthy Subjects Pharmacokinetics study Pharmacokinetics of medications | null | 6 | arm 1: Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID arm 2: Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID arm 3: Period 1-Raltegravir 400mg BID Period2- Fosamprenav... | [
1,
1,
1,
1,
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: 400mg BID intervention 2: 1400mg BID, 700 mg BID or 1400 mg QD intervention 3: 100 mg BID or QD | intervention 1: Raltegravir intervention 2: Fosamprenavir intervention 3: Ritonavir | 1 | Voorhees Township | New Jersey | United States | -74.49062 | 40.4795 | 0 | NCT00802074 |
[
3
] | 160 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | Warfarin is very effective for the prevention of blood clots (thrombosis). A test of coagulation, the prothrombin time (PT) is used to monitor the effect. The PT response to warfarin can fluctuate as a result of interactions with a large number of other drugs, food or herbal agents as well as for no apparent reason. Th... | Setting:
Thrombosis Service at HHS - General Hospital. This center monitors the warfarin treatment for 1300 patients in the region. These patient regularly go to a laboratory where they live. Test results (INR-results) are faxed to the Thrombosis Service, which calls the patient the same day to inform them of the resu... | Atrial Fibrillation Venous Thromboembolism Ischemic Stroke Myocardial Infarction | warfarin dosing prothrombin time Heart valve prosthesis | null | 2 | arm 1: Intervention Drug warfarin no change in the dose is performed arm 2: Intervention Drug Warfarin One dose increased if subtherapeutic level; one dose deleted or reduced if supratherapeutic level | [
0,
1
] | 2 | [
0,
0
] | intervention 1: No change: Continue without any change in spite of prothrombin time outside the therapeutic range. intervention 2: Change: Increase one dose in case prothrombin time is below the therapeutic range; delete or reduce one dose in case prothrombin time is above the therapeutic range. | intervention 1: warfarin intervention 2: warfarin | 1 | Hamilton | Ontario | Canada | -79.84963 | 43.25011 | 0 | NCT00814177 |
[
3
] | 55 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The purpose of this study is to evaluate the ocular safety and efficacy of a glaucoma drug delivery system in open-angle glaucoma or ocular hypertension. | null | Glaucoma, Open-Angle Ocular Hypertension | null | 3 | arm 1: device worn continuously for 14 days arm 2: device worn continuously for 14 days arm 3: device worn continuously for 14 days | [
0,
0,
2
] | 3 | [
0,
0,
1
] | intervention 1: inserted for 14 days intervention 2: inserted for 14 days intervention 3: inserted for 14 days | intervention 1: High Dose Device intervention 2: Low Dose Device intervention 3: Placebo Device | 4 | Artesia | California | United States | -118.08312 | 33.86585
Louisville | Kentucky | United States | -85.75941 | 38.25424
Baltimore | Maryland | United States | -76.61219 | 39.29038
Mt. Pleasant | South Carolina | United States | -79.86259 | 32.79407 | 0 | NCT00824720 | |
[
3
] | 78 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This is a Phase 2 single center study designed to compare the safety, local tolerability, and efficacy of 3 strengths of ivermectin treatment conditioner to placebo. | null | Pediculus Humanus Capitis (Head Lice) | head lice Pediculus humanus capitis ivermectin | null | 4 | arm 1: Participant on 0.15% ivermectin treatment conditioner arm 2: Participants on 0.25% ivermectin treatment conditioner arm 3: Participants on 0.50% ivermectin treatment conditioner arm 4: participants on Placebo (Vehicle control) | [
0,
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: Application followed by thorough rinsing of the hair and scalp with water. intervention 2: Application followed by thorough rinsing of the hair and scalp with water. | intervention 1: ivermectin treatment conditioner intervention 2: Placebo, vehicle control | 1 | Miami | Florida | United States | -80.19366 | 25.77427 | 0 | NCT00857948 |
[
5
] | 277 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | Pre-clinical studies have demonstrated that memantine can decrease the neuronal toxicity associated with excessive glutamate release and calcium overload in neurons. Previous studies have shown that memantine helps to treat the symptoms of Alzheimer's Disease (AD). In AD, the rate of brain tissue loss, or atrophy, is f... | The primary objective of this study was to evaluate the effects of memantine on the rate of brain atrophy compared to placebo in patients with AD (moderate severity) over a 1-year period. This was a multinational, randomised, double-blind, parallel-group, placebo-controlled, fixed-dose study (20 mg memantine). The stud... | Alzheimer's Disease | Memantine Neuroimaging MRI Brain atrophy | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 10 mg tablets twice daily intervention 2: Tablets twice daily | intervention 1: Memantine intervention 2: Placebo | 0 | null | 0 | NCT00862940 |
[
5
] | 156 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | Injection of propofol is associated with discomfort in subsets of patients. Local anesthetics have been shown to attenuate this response in some patients. This randomized, double-blind, placebo-controlled trial tests the hypothesis that lidocaine mixed with propofol will be superior to lidocaine administered directly i... | null | Pain | propofol lidocaine injection pain | null | 3 | arm 1: Saline pretreatment, saline admixture arm 2: Lidocaine pretreatment / saline-propofol admixture arm 3: saline pretreatment / Lidocaine-propofol admixture | [
2,
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: 3.3 mL normal saline intervention 2: lidocaine 50 mg plus propofol 50 mg intravenous (iv) intervention 3: lidocaine 50 mg iv under tourniquet-control | intervention 1: Saline intervention 2: Lidocaine / propofol admixture intervention 3: lidocaine pretreatment | 1 | Seattle | Washington | United States | -122.33207 | 47.60621 | 0 | NCT00864682 |
[
3
] | 5 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | This is an open label single arm feasibility trial. A combination of two oral agents (pravastatin and lonafarnib) and one intravenous (IV) agent (zoledronic acid) will be administered at doses and schedule currently applied in pediatrics. These agents all target farnesylation pathways at different points. Our goal is t... | Progerias are rare "premature aging" diseases in which children die of severe atherosclerosis leading to strokes and heart attacks. It is a multisystem disease with objective clinical markers for disease progression. These include abnormalities in growth and body composition, bone mineral density, join function, endocr... | Progeria Hutchinson-Gilford Syndrome | Hutchinson-Gilford Progeria Syndrome HGPS Progeria FTI Farnesyltransferase Inhibitor Lonafarnib Zoledronic Acid Pravastatin | null | 1 | arm 1: Lonafarnib;Zoledronic acid;Pravastatin | [
0
] | 3 | [
0,
0,
0
] | intervention 1: Lonafarnib capsules are to be orally administered twice per day approximately every 12 hours. Lonafarnib dosing will begin at 150 mg/m2 by mouth twice daily. Dose levels are 150, 115, 90 and 70 mg/m2. Patients experiencing significant drug related grade 3 or 4 toxicity and not responding to therapy inte... | intervention 1: Lonafarnib intervention 2: Zoledronic Acid intervention 3: Pravastatin | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00879034 |
[
0
] | 102 | RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 4QUADRUPLE | true | 0ALL | true | Noxious stimuli occurring intraoperatively and postoperatively generate central sensitization, decreasing pain thresholds and ultimately increasing analgesic requirements. The pathophysiology of central sensitization is thought to involve excitatory amino acid receptors such as N-methyl-d-aspartate (NMDA) (1, 2). Ketam... | Noxious stimuli occurring intra-operatively and post-operatively generate central sensitization, decreasing pain thresholds and ultimately increasing analgesic requirements. The pathophysiology of central sensitization is thought to involve excitatory amino acid receptors that have been implicated in the prolongation o... | Chronic Low Back Pain | chronic pain back surgery opioid dependent NMDA receptor antagonism Ketamine Central sensitization | null | 2 | arm 1: None arm 2: None | [
2,
0
] | 2 | [
0,
10
] | intervention 1: Peripheral provision of 0.5mg/kg of ketamine on induction followed by a 10mcg/kg/min infusion until surgical wound closure intervention 2: Normal saline at same rate as the previously described ketamine infusion (10mcg/kg/min), same amount of ketamine/placebo syringe on induction (0.5mg/kg). | intervention 1: Ketamine intervention 2: Normal saline | 1 | Lebanon | New Hampshire | United States | -72.25176 | 43.64229 | 0 | NCT00899600 |
[
5
] | 101 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to determine whether periarticular multimodal drug injection (PMDI) would provide additional benefits in patients after total knee arthroplasty (TKA) for whom contemporary pain control protocols using the continuous femoral nerve block, intra-venous patient controlled analgesia (IV-PCA)and ... | The preemptive multimodal approaches are regarded as a current standard pain management protocol. Recently, periarticular multimodal drug injection (PMDI) has been considered to be one of the most effective and important component in multimodal approaches. Because the contemporary pain management protocol using the reg... | Osteoarthritis, Knee | periarticular multimodal drug injection | null | 2 | arm 1: Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime arm 2: usual postoperative care without periarticular injection | [
0,
4
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: 300mg (0.75%, 40cc) intraoperative periarticular injection intervention 2: 10mg intraoperative periarticular injection intervention 3: 30 mg intraoperative periarticular injection intervention 4: 300 microgram (1:1000) intraoperative periarticular injection intervention 5: 750mg intraoperative periartic... | intervention 1: ropivacaine intervention 2: morphine sulfate intervention 3: ketorolac intervention 4: epinephrine intervention 5: cefuroxime | 1 | Seongnam-si | Gyeonggi-do | South Korea | 127.13778 | 37.43861 | 0 | NCT00901628 |
[
0
] | 46 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The objective of the study is to assess the effect of standard versus aggressive inhibition of the renin-angiotensin system (RAS)in type 2 diabetic patients with microalbuminuria (MA) on; a)progression of microalbuminuria, b)estimated glomerular filtration rate (eGFR), c)endothelial dysfunction (measured by post-hypere... | Diabetic patients with confirmed MA (50-300 mg albumin per g creatinine) on a morning spot urine sample were entered into a one to three month run-in phase before randomization. (50 mg/g was used as the lower limit to allow room for improvement to reach normal.) Since hypertension and uncontrolled hyperglycemia will ca... | Microalbuminuria | Microalbuminuria Carotid intima media thickness Endothelial dysfunction Renin angiotensin system Diabetic nephropathy | null | 2 | arm 1: Standard low dose inhibition of the RAS with 10 mg of benazepril orally daily to treat microalbuminuria arm 2: 40-80 mg benazepril plus 25-100 mg losartan both orally once or twice daily | [
1,
0
] | 2 | [
0,
0
] | intervention 1: benazepril 10 mg orally once daily intervention 2: 40-80 mg benazepril plus 25-100 mg losartan orally once or twice daily | intervention 1: benazepril intervention 2: benazepril | 1 | Los Angeles | California | United States | -118.24368 | 34.05223 | 0 | NCT00907374 |
[
4
] | 462 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | At the end of the study, safety and efficacy outcome measures will be compared to determine a) if dosing with Generic Imiquimod cream, 5% is therapeutically equivalent to the currently marketed Aldara (imiquimod) cream, 5% and b) if both imiquimod 5% creams are superior in comparison to the Vehicle cream. | A nationwide, multicenter, double-blind, vehicle-controlled parallel group comparison study of a Generic Imiquimod cream, 5% (Actavis Mid-Atlantic LLC) and currently marketed Aldara (imiquimod) cream, 5% (distributed by Graceway Pharmaceuticals, LLC) was conducted in subjects with actinic keratoses (AKs) on the face an... | Actinic Keratoses | actinic keratoses imiquimod therapeutic equivalence bioequivalence | null | 3 | arm 1: imiquimod cream, 5% arm 2: Aldara™ (imiquimod) cream, 5% arm 3: Vehicle cream (Actavis) | [
1,
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: 5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks intervention 2: 5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks intervention 3: Topical cream vehicle matching Generic imiquimod dispensed in individual 0.25 g sachets appl... | intervention 1: imiquimod intervention 2: Aldara™ intervention 3: Vehicle Cream | 20 | Hot Springs | Arkansas | United States | -93.05518 | 34.5037
Fresno | California | United States | -119.77237 | 36.74773
San Diego | California | United States | -117.16472 | 32.71571
Denver | Colorado | United States | -104.9847 | 39.73915
Miami | Florida | United States | -80.19366 | 25.77427
Newnan | Georgia | Unite... | 0 | NCT00948428 |
[
2
] | 24 | NON_RANDOMIZED | SINGLE_GROUP | 7BASIC_SCIENCE | 0NONE | true | 0ALL | false | Seville orange juice is an inhibitor of the intestinal cytochrome P450 (CYP) 3A4 enzyme, one of the enzymes responsible for the metabolism of colchicine. This study will evaluate the effect of multiple daily consumptions of Seville orange juice on the pharmacokinetic profile of a single 0.6 mg dose of colchicine. A sec... | Seville orange juice is an inhibitor of the intestinal cytochrome P450 (CYP) 3A4 enzyme, one of the enzymes responsible for the metabolism of colchicine. This study will evaluate the effect of multiple daily consumptions of Seville orange juice on the pharmacokinetic profile of a single 0.6 mg dose of colchicine. Twent... | Healthy | blood levels over time colchicine seville orange juice pharmacokinetics | null | 2 | arm 1: baseline colchicine pharmacokinetics arm 2: colchicine pharmacokinetics in presence of Seville orange juice | [
1,
0
] | 2 | [
0,
10
] | intervention 1: A single dose of 0.6 mg colchicine administered alone in the morning on Day 1 and a single dose of 0.6 mg colchicine administered with Seville orange juice in the morning on Day 18 after an overnight fast of at least 10 hours. intervention 2: 240 mL of Seville orange juice administered in the morning an... | intervention 1: Colchicine intervention 2: Seville Orange Juice | 1 | Fargo | North Dakota | United States | -96.7898 | 46.87719 | 0 | NCT00960193 |
[
4
] | 133 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | null | The present study was designed to investigate, in hyporesponder subjects, that required in a previous assisted reproductive technologies (ART) cycle follicle stimulating hormone (FSH) \>3500 International Unit (IU), the possibility to decrease through recombinant human luteinizing hormone (r-hLH) supplementation, the F... | Recombinant human follicle stimulating hormone (r-hFSH), which totally lacks LH activity, is widely used to induce multiple follicle development in women under pituitary desensitization, in order to submit them to treatment with assisted reproduction techniques (ART). Clinical experience from hypogonadotropic-hypogonad... | Reproductive Techniques, Assisted | Reproductive Techniques, Assisted Recombinant human follicle stimulating hormone (r-hFSH) Recombinant leutinizing hormone (r-hLH) | null | 2 | arm 1: Subjects treated with r-hFSH and r-hLH (2:1 ratio of r-hFSH:r-hLH) arm 2: Subjects treated with r-hFSH alone | [
0,
1
] | 2 | [
0,
0
] | intervention 1: One r-hFSH and one r-hLH injection subcutaneously (s.c.) once daily during the treatment phase from Day 8 of stimulation until injection of human chorionic gonadotropin (hCG) or cancellation of the treatment cycle. intervention 2: One r-hFSH injection s.c. once daily during the treatment phase from Day ... | intervention 1: Recombinant human Follicle Stimulating Hormone (r-hFSH) and Recombinant human Luteinizing Hormone (r-hLH) intervention 2: r-hFSH | 1 | Roma | N/A | Italy | 11.10642 | 44.99364 | 0 | NCT01071200 |
[
0
] | 40 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | false | 0ALL | false | A comparison of three products for oral nicotine replacement with respect to pharmacokinetics after multiple-doses of nicotine. | This study compares a new oral Nicotine Replacement Therapy (NRT) product with NiQuitin™ lozenge 4 mg and Nicorette®gum 4 mg, after 12 hours of nicotine abstinence, with respect to steady-state nicotine pharmacokinetics, during 12 hours after start of the first administration. Multiple doses of each treatment are given... | Tobacco Dependence | Smoking Cessation, Nicotine pharmacokinetics | null | 5 | arm 1: 2 Self-administrations of Experimental Nicotine once every hour arm 2: 2 administrations of Experimental Nicotine by study personnel once every hour arm 3: 2 administrations of Experimental Nicotine by study personnel once every 30 minutes arm 4: 1 NiQuitin™ lozenge, administered by study personnel once every ho... | [
0,
0,
0,
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: Oral Nicotine either self-administered or provided by study personnel within 12 hours intervention 2: Nicotine lozenge marketed as NiQuitin™ 4 mg hourly within 12 hours intervention 3: Nicotine gum marketed as Nicorette® 4 mg hourly within 12 hours | intervention 1: Oral Nicotine intervention 2: Nicotine Lozenge intervention 3: Nicotine gum | 1 | Lund | N/A | Sweden | 13.19321 | 55.70584 | 0 | NCT01084707 |
[
5
] | 214 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This is an open-label, prospective, multicentric, non-comparative, non-randomized Phase IV interventional study in which subjects pre-diagnosed with Growth Hormone Deficiency (GHD) were treated for 4 weeks with Saizen to compare the response between GHD children born appropriate for gestational age (AGA) and those born... | The response to growth hormone (GH) treatment, short-term as well as long-term, displays considerable inter individual variability. This is particularly evident for the endpoint of paediatric GH administration, that is (i.e.) the growth response, which is pronounced in children who are affected by GHD. This is an open-... | Dwarfism, Pituitary | Dwarfism, pituitary Growth hormone | null | 0 | null | null | 1 | [
0
] | intervention 1: Recombinant human growth hormone (r-hGH) administered at dose of 0.033 milligram/kilogram (mg/kg) body weight (0.1 International Unit \[IU\]/kg body weight) per day by subcutaneous injection. | intervention 1: Recombinant human growth hormone (r-hGH) | 0 | null | 0 | NCT01187550 |
[
5
] | 52 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to check the T and B cells of the immune system in 50 newly transplanted patients whom have received a kidney (50 recipients and 50 donors totaling 100 anticipated participants). This will be done to see how the Standard of Care (SOC) anti-rejection medication, Alemtuzumab (Campath 1-H®) af... | The purpose of this study is to check the T and B cells of the immune system in 50 newly transplanted patients whom have received a kidney (50 recipients and 50 donors totaling 100 anticipated participants). This will be done to see how the Standard of Care (SOC) anti-rejection medication, Alemtuzumab (Campath 1-H®) af... | Kidney Transplant | null | 1 | arm 1: During Phase I Portion: Each kidney transplant recipient received one 30mg dose (IV push)of Alemtuzmab in the operating room per Standard of Care. | [
0
] | 1 | [
0
] | intervention 1: All kidney transplant recipients received one 30mg dose (IV push) of Alemtuzumab in operating room per Standard of Care. | intervention 1: Alemtuzumab | 1 | Chicago | Illinois | United States | -87.65005 | 41.85003 | 0 | NCT01213329 | |
[
3,
4
] | 312 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study was evaluate the efficacy and safety of alogliptin, once daily (QD) combined with an Sulfonylurea taken QD or twice daily (BID) in type 2 diabetic patients with uncontrolled blood glucose. | Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus.
Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV)... | Type 2 Diabetes Mellitus | Diabetes Mellitus - Type 2 Diabetes Mellitus Drug Therapy | null | 3 | arm 1: None arm 2: None arm 3: None | [
1,
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks. intervention 2: Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks. intervention 3: Glim... | intervention 1: Alogliptin and glimepiride intervention 2: Alogliptin and glimepiride intervention 3: Glimepiride | 0 | null | 0 | NCT01318083 |
[
3,
4
] | 288 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study was evaluate the efficacy and safety of alogliptin, once dairy (QD) combined with metformin taken twice daily (BID) or three times daily (TID) in type 2 diabetic patients with uncontrolled blood glucose. | Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus.
Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV)... | Type 2 Diabetes Mellitus | Diabetes Mellitus - Type 2 Diabetes Mellitus Drug Therapy | null | 3 | arm 1: None arm 2: None arm 3: None | [
1,
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks. intervention 2: Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks. intervention 3: Metformin 25... | intervention 1: Alogliptin and metformin intervention 2: Alogliptin and metformin intervention 3: Metformin | 0 | null | 0 | NCT01318109 |
[
3
] | 66 | RANDOMIZED | PARALLEL | 1PREVENTION | 3TRIPLE | false | 2MALE | false | The purpose of this research study is to compare the effects of a lycopene supplement made from tomatoes to a placebo (a capsule with no active ingredients) in men who have abnormal cells in the prostate, but have not yet had cancer detected. This study will allow us to see if taking lycopene for six months leads to fa... | null | Intraepithelial Prostatic Neoplasia Prostatic Neoplasms | Intraepithelial Prostatic Neoplasia Prostatic neoplasms Male urogenital disease Prostate | null | 2 | arm 1: Lycopene 30 mg/day arm 2: Placebo | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Lycopene 30 mg. intervention 2: Placebo | intervention 1: Lycopene 30mg intervention 2: Placebo | 2 | Chicago | Illinois | United States | -87.65005 | 41.85003
Chicago | Illinois | United States | -87.65005 | 41.85003 | 0 | NCT01443026 |
[
2
] | 64 | RANDOMIZED | FACTORIAL | 0TREATMENT | 2DOUBLE | true | 2MALE | false | The purpose of this study was to investigate the safety, tolerability, pharmacokinetics and catechol-O-methyltransferase (COMT) activity of BIA 9-1067 in healthy male subjects after single oral ascending doses. | Single centre, randomised, double-blind, placebo-controlled study of single ascending doses in up to 8 sequential groups of 8 healthy young male subjects. | Parkinson Disease | BIA 9-1067 | null | 9 | arm 1: BIA 9-1067 (Opicapone, OPC) - 10 mg arm 2: BIA 9-1067 (Opicapone, OPC) - 25 mg arm 3: BIA 9-1067 (Opicapone, OPC) - 50 mg arm 4: BIA 9-1067 (Opicapone, OPC) - 100 mg arm 5: BIA 9-1067 (Opicapone, OPC) - 200 mg arm 6: BIA 9-1067 (Opicapone, OPC) - 400 mg arm 7: BIA 9-1067 (Opicapone, OPC) - 800 mg arm 8: BIA 9-10... | [
0,
0,
0,
0,
0,
0,
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects intervention 2: single-dose | intervention 1: BIA 9-1067 intervention 2: Placebo | 1 | Rennes | N/A | France | -1.67429 | 48.11198 | 0 | NCT01520727 |
[
2,
3
] | 41 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | The primary objective of this study was to evaluate microbial density in eczematous lesions during two weeks of twice daily therapy with the investigational product, DPK-060 1% ointment, compared with placebo in patients with atopic dermatitis. This randomized, double-blind, placebo-controlled part of the study was pre... | null | Atopic Dermatitis | null | 2 | arm 1: None arm 2: None | [
2,
0
] | 2 | [
0,
0
] | intervention 1: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2 intervention 2: Placebo for DPK-060 ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2 | intervention 1: DPK-060 1% ointment intervention 2: Placebo for DPK-060 ointment | 1 | Luleå | N/A | Sweden | 22.15465 | 65.58415 | 0 | NCT01522391 | |
[
2
] | 25 | NON_RANDOMIZED | SINGLE_GROUP | 2DIAGNOSTIC | 1SINGLE | true | 0ALL | false | This study will test if two AV-45 PET scans up to 4 weeks apart in AD subjects and healthy volunteers provide the same results. The study will also test two different AV-45 injection methods in a small subgroup of enrolled AD subjects (slow vs. fast bolus group). | null | Alzheimer's Disease | Amyloid imaging Positron Emission Tomography 18F-AV-45 florbetapir F 18 Diagnostic imaging | null | 3 | arm 1: Two bolus IV injections followed by brain PET scan up to 4 weeks apart arm 2: Two bolus IV injections followed by a brain PET scan up to 4 weeks apart.
The first injection given as a rapid bolus (\< 5 second injection, with immediate flush). The second injection given as a slow bolus (approximately 20 to 30 sec... | [
0,
0,
0
] | 1 | [
0
] | intervention 1: IV injection, 370MBq (10mCi) | intervention 1: florbetapir F 18 | 4 | New Haven | Connecticut | United States | -72.92816 | 41.30815
Hallandale | Florida | United States | -80.14838 | 25.9812
West Palm Beach | Florida | United States | -80.05337 | 26.71534
North East | Maryland | United States | -75.94133 | 39.60011 | 0 | NCT01565343 |
[
5
] | 353 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to evaluate the effectiveness of paliperidone ER for the treatment of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) participants. | This is a multi-center (when more than one hospital or medical school team work on a medical research study), open-label (all people know the identity of the intervention), prospective (study following participants forward in time), non-comparative study. The total study duration will be 12 weeks for each participant a... | Schizophrenia | Schizophrenia Paliperidone Extended Release (ER) | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Participants will receive paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment will be done at Week 2, 4 and 8 as per investigator's discretion based upon participant's CGI-I score. | intervention 1: Paliperidone ER | 0 | null | 0 | NCT01577160 |
[
2
] | 12 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | false | A randomized, controlled, double blind exploratory study to explore the effects of two different potassium nitrate concentrations and water on exposed dentine in reducing dentinal hypersensitivity. Solutions will be applied for either 2, 5 or 10 minutes and assessed by visual analogue scale (VAS) scores following evapo... | null | Dentinal Hypersensitivity Dental Pain | dentinal sensitivity potassium nitrate dental pain | null | 3 | arm 1: Participants to receive 250 microlitres (μL) of sterile water. arm 2: Participants to receive 250 μL of potassium nitrate 5% solution. arm 3: Participants to receive 250 μL of potassium nitrate 2.5% solution. | [
2,
0,
0
] | 2 | [
0,
0
] | intervention 1: 250 μL of Potassium nitrate solution (either 5% or 2.5%) intervention 2: Sterile Water | intervention 1: Potassium Nitrate intervention 2: Placebo | 1 | Fort Wayne | Indiana | United States | -85.12886 | 41.1306 | 0 | NCT01587950 |
[
5
] | 35 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to evaluate the efficacy and safety of Transdermal Therapeutic System (TTS)-fentanyl patch (transdermal patch containing a drug that is put on the skin so the drug will enter the body through the skin) in participants with moderate (medium level of seriousness) to severe (very serious, life... | This is an open-label (a medical research study in which participants and researchers are told which treatments the participants are receiving, "unblinded"), single-arm, prospective (study following participants forward in time), study of TTS-fentanyl in participants with moderate to severe pain of osteoarthritis. The ... | Osteoarthritis | Osteoarthritis Transdermal Therapeutic System (TTS)-fentanyl Durogesic | null | 1 | arm 1: TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches will be replaced every 3 days until 30 days. | [
0
] | 1 | [
0
] | intervention 1: TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches will be replaced every 3 days until 30 days. | intervention 1: TTS-fentanyl | 1 | Bangkok | N/A | Thailand | 100.50144 | 13.75398 | 0 | NCT01774929 |
[
5
] | 5 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 1FEMALE | false | To determine the efficacy of escitalopram in treating depression in HIV seropositive women. | To determine the efficacy of escitalopram in treating depression in HIV seropositive women. | Depression HIV | Depression HIV | null | 2 | arm 1: Placebo arm 2: Escitalopram tablet, 10mg, daily, 9 weeks. | [
2,
1
] | 2 | [
0,
0
] | intervention 1: Placebo daily for duration of double-blind portion of trial intervention 2: Escitalopram 10 mg po daily for duration of double-blind portion of trial | intervention 1: Placebo intervention 2: Escitalopram | 1 | Durham | North Carolina | United States | -78.89862 | 35.99403 | 0 | NCT01797380 |
[
5
] | 90 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | true | 0ALL | false | Ninety American Society of Anesthesiologists (ASA) Physical Status classification system I-II patients were recruited for a randomised, placebo-controlled, double-blind study and were randomly divided into three groups to receive either 20 ml of 0.5% bupivacaine (Group B; n=30), 20 ml of 0.5% levobupivacaine (Group L; ... | Following approval from the Research Ethics Committee of the Medical Faculty of Uludağ University, (the date and protocol number assigned by this ethics committee were March 4, 2008 and 5/30, respectively),written informed consent was obtained from patients undergoing elective scheduled operations involving craniotomy ... | Hypertension | anaesthesia local anaesthesia hemodynamics bupivacaine levobupivacaine | null | 3 | arm 1: 20 ml of 0.5% bupivacaine 20 ml of 0.5% levobupivacaine arm 2: 20 ml of 0.5% levobupivacaine saline as a placebo arm 3: 20 ml of 0.5% bupivacaine saline as a placebo | [
0,
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: local injection intervention 2: local injection intervention 3: local injection | intervention 1: Levobupivacaine intervention 2: Bupivacaine intervention 3: placebo | 0 | null | 0 | NCT02497040 |
[
4
] | 89 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This multicenter, open-label trial will randomize participants with multiple myeloma to a regimen of ibandronate or zoledronate in order to compare the incidence of nephrotoxicity, measured as creatinine clearance (CrCl) reduction greater than (\>) 30 percent (%) or an absolute value of 30 milliliters per minute (mL/mi... | null | Multiple Myeloma | null | 2 | arm 1: Participants with multiple myeloma will be randomized to receive ibandronate every 4 weeks for a planned duration of 92 weeks. arm 2: Participants with multiple myeloma will be randomized to receive zoledronate every 4 weeks for a planned duration of 92 weeks. | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Ibandronate will be administered via 15-minute intravenous (IV) infusion as 6 milligrams (mg) every 4 weeks for 92 weeks. intervention 2: Zoledronate will be administered via 15-minute IV infusion as 4 mg every 4 weeks for 92 weeks. | intervention 1: Ibandronate intervention 2: Zoledronate | 56 | Ansbach | N/A | Germany | 10.5931 | 49.30481
Aschaffenburg | N/A | Germany | 9.15214 | 49.97704
Augsburg | N/A | Germany | 10.89851 | 48.37154
Berlin | N/A | Germany | 13.41053 | 52.52437
Berlin | N/A | Germany | 13.41053 | 52.52437
Berlin | N/A | Germany | 13.41053 | 52.52437
Bremen | N/A | Germany | 8.80717 | 53.0758... | 0 | NCT02739594 | |
[
4
] | 314 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The study will evaluate the efficacy of LDX treatment group compared to placebo on the change from Baseline ADHD-RS-IV score at endpoint. | null | Attention Deficit Hyperactivity Disorder (ADHD) | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
1,
1,
1,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: Eligible subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of LDX (30, 50, or 70mg/day) or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period. The test product is LDX, available in 30, 50, and 70mg capsules. All test prod... | intervention 1: LDX 30 mg intervention 2: LDX 50 mg intervention 3: LDX 70 mg intervention 4: Placebo | 45 | Little Rock | Arkansas | United States | -92.28959 | 34.74648
El Centro | California | United States | -115.56305 | 32.792
Rolling Hills Estates | California | United States | -118.35813 | 33.78779
San Diego | California | United States | -117.16472 | 32.71571
Wildomar | California | United States | -117.28004 | 33.598... | 0 | NCT00735371 | |
[
3
] | 270 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of the study is to explore the efficacy and safety of SUN13834 vs placebo in adult participants with atopic dermatitis. | null | Atopic Dermatitis | Atopic Dermatitis SUN13834 | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Low dose, orally 3 times a day (tid) for 28 days of SUN13834 intervention 2: Placebo, orally (tid) for 28 days of SUN13834 | intervention 1: SUN13834 intervention 2: Placebo | 28 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Mesa | Arizona | United States | -111.82264 | 33.42227
Peoria | Arizona | United States | -112.23738 | 33.5806
Hot Springs | Arkansas | United States | -93.05518 | 34.5037
San Diego | California | United States | -117.16472 | 32.71571
Denver | Colorado | Unite... | 0 | NCT00717769 |
[
5
] | 343 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | false | To demonstrate the efficacy/safety of Fosamax Plus D | null | Osteoporosis Postmenopausal | null | 2 | arm 1: Alendronate sodium/Cholecalciferol arm 2: Alendronate sodium | [
0,
1
] | 3 | [
0,
0,
7
] | intervention 1: Alendronate sodium/Cholecalciferol; tablet, once weekly, for 16 weeks intervention 2: Alendronate sodium; tablet, once weekly, for 16 weeks intervention 3: 500 mg oral tablet calcium once daily, for 16 weeks | intervention 1: alendronate sodium (+) cholecalciferol intervention 2: Comparator: Alendronate sodium (Fosamax) intervention 3: Comparator: Calcium | 0 | null | 0 | NCT00729651 | |
[
4
] | 710 | RANDOMIZED | PARALLEL | 4SUPPORTIVE_CARE | 2DOUBLE | false | 0ALL | false | This a Phase III trial designed to determine if IV casopitant plus dexamethasone and ondansetron is more effective in the prevention of vomiting and nausea then dexamethasone and ondansetrone alone following the administration of moderately emetogenic oxaliplatin-based chemotherapy. | null | Nausea and Vomiting, Chemotherapy-Induced | vomiting colorectal cancer nausea oxaliplatin | null | 2 | arm 1: Placebo + standard antiemetics arm 2: Casopitant + standard antiemetics | [
2,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: Experimental NK-1 receptor antagonist intervention 2: Standard antiemetics intervention 3: Placebo to match IV casopitant intervention 4: Standard antiemetics | intervention 1: Casopitant intervention 2: Dexamethasone intervention 3: Placebo intervention 4: Ondansetron | 96 | Hot Springs | Arkansas | United States | -93.05518 | 34.5037
Corona | California | United States | -117.56644 | 33.87529
Fountain Valley | California | United States | -117.95367 | 33.70918
Riverside | California | United States | -117.39616 | 33.95335
St. Petersburg | Florida | United States | -82.67927 | 27.77086
Tam... | 0 | NCT00601172 |
[
4
] | 34 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | The purpose of this study is to evaluate the efficacy and safety of AMG 531 compared with placebo in thrombocytopenic Japanese subjects with immune (idiopathic) thrombocytopenic purpura (ITP) . | null | Idiopathic Thrombocytopenic Purpura | AMG 531 Idiopathic Thrombocytopenic Purpura ITP Thrombocytopenia Japan Placebo controlled Phase 3 | null | 2 | arm 1: Double blinded placebo-controlled study arm 2: None | [
2,
2
] | 2 | [
0,
0
] | intervention 1: Subcutaneously administered, once a week, for 12 weeks intervention 2: Subcutaneously administered, once a week, for 12 weeks | intervention 1: Placebo intervention 2: AMG 531 | 0 | null | 0 | NCT00603642 |
[
3
] | 65 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to determine whether PF-04383119 is effective in the treatment of pain associated with interstitial cystitis. | null | Cystitis, Interstitial | Painful Bladder Syndrome monoclonal antibody | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: PF-04383119 200 mcg/kg IV, single dose intervention 2: placebo IV, single dose | intervention 1: PF-04383119 intervention 2: Placebo | 34 | Peoria | Arizona | United States | -112.23738 | 33.5806
Fresno | California | United States | -119.77237 | 36.74773
Glendora | California | United States | -117.86534 | 34.13612
San Diego | California | United States | -117.16472 | 32.71571
Boulder | Colorado | United States | -105.27055 | 40.01499
Hartford | Connectic... | 0 | NCT00601484 |
[
2
] | 4 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | true | 0ALL | false | This study will evaluate acute symptomatic improvements in cognitive performance in healthy elderly participants with mild-to-moderate Alzheimer's disease. A four-week pilot study will first evaluate the CogState computerized cognitive battery in participants who are not receiving treatment. After completion of the pil... | null | Alzheimer's Disease Dementia | null | 12 | arm 1: Treatment by single oral dose with Placebo (PBO) in the first crossover period; MK-0249 7.5 mg (MK-7.5) in the second crossover period; Donepezil 5 mg (DON) in the third crossover period; and MK-0249 25 mg (MK-25) in the fourth crossover period. arm 2: Treatment by single oral dose with MK-0249 7.5 mg in the fir... | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: 4 tablets (1 x 0.5 mg + 2 x 1 mg + 1 x 5 mg) totaling 7.5 mg, single oral dose during each crossover period intervention 2: 5 x 5 mg tablets totaling 25 mg, single oral dose during each crossover period intervention 3: One 5 mg tablet, single oral dose during each crossover period intervention 4: Five t... | intervention 1: MK-0249 7.5 mg intervention 2: MK-0249 25 mg intervention 3: Donepezil 5mg intervention 4: Placebo to MK-0249 intervention 5: Placebo to Donepezil | 0 | null | 0 | NCT00874939 | |
[
5
] | 97 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This is a study to determine the effectiveness and safety of donepezil hydrochloride (E2020) used to treat residents of assisted living facilities diagnosed with mild, moderate, or severe stage Alzheimer's disease. | null | Mild to Severe Alzheimer's Disease | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: One 5 mg tablet per day (for the first 6 weeks) with a full glass of water. For the last 6 weeks, one 10mg tablet per day with a full glass of water. | intervention 1: Donepezil HCl | 36 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Phoenix | Arizona | United States | -112.07404 | 33.44838
Phoenix | Arizona | United States | -112.07404 | 33.44838
Anaheim | California | United States | -117.9145 | 33.83529
Carson | California | United States | -118.28202 | 33.83141
Fresno | California | Un... | 0 | NCT00571064 | |
[
4
] | 2,149 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | The study is intended to test the efficacy, safety and tolerability of two doses of mirabegron against placebo to treat patients with symptoms of overactive bladder | null | Urinary Bladder, Overactive | Frequency YM178 Overactive bladder (OAB) Micturition Urgency Urinary urge incontinence Urinary incontinence | null | 3 | arm 1: Participants received matching placebo tablets orally once a day for 12 weeks arm 2: Participants received mirabegron 50 mg tablets orally once a day for 12 weeks arm 3: Participants received mirabegron 100 m tablets, orally once a day for 12 weeks | [
2,
0,
0
] | 2 | [
0,
0
] | intervention 1: Oral intervention 2: Oral | intervention 1: Mirabegron intervention 2: Placebo | 125 | Homewood | Alabama | United States | -86.80082 | 33.47177
Huntsville | Alabama | United States | -86.58594 | 34.7304
Mobile | Alabama | United States | -88.04305 | 30.69436
Montgomery | Alabama | United States | -86.29997 | 32.36681
Anchorage | Alaska | United States | -149.90028 | 61.21806
Phoenix | Arizona | United S... | 0 | NCT00662909 |
[
4
] | 1,246 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The purpose of this study is to investigate the efficacy and safety of an investigational treatment for type 2 diabetes mellitus. | null | Type 2 Diabetes Mellitus | null | 2 | arm 1: Arm 1: drug arm 2: Arm 2: active comparator | [
0,
1
] | 2 | [
0,
0
] | intervention 1: sitagliptin/Metformin HCl 50/500 mg tablet bid, titrating up to sitagliptin/Metformin HCl 50/1000 mg tablet over 4 weeks; for a 44-wk treatment period. intervention 2: metformin 500 mg tablet bid, titrating up to 1000 mg tablets bid for a 44-wk treatment period | intervention 1: sitagliptin phosphate (+) metformin hydrochloride intervention 2: metformin | 0 | null | 0 | NCT00482729 | |
[
3
] | 564 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This trial is conducted in Europe. The purpose of the 20-week trial is to investigate the efficacy of liraglutide to induce body weight loss and the purpose of the extension is to evaluate the long term safety and tolerability of liraglutide.
Trial has the following trial periods: A 20-week randomised, double-blind, p... | null | Metabolism and Nutrition Disorder Obesity | null | 6 | arm 1: Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104) arm 2: Liraglutide 1.2 mg once daily, weeks 0-20 (... | [
2,
0,
0,
0,
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: Injected s.c. (under the skin) once daily intervention 2: 120 mg capsule. Administered thrice daily intervention 3: Injected s.c. (under the skin) once daily | intervention 1: liraglutide intervention 2: orlistat intervention 3: placebo | 19 | Edegem | N/A | Belgium | 4.44504 | 51.15662
Prague | N/A | Czechia | 14.42076 | 50.08804
Prague | N/A | Czechia | 14.42076 | 50.08804
Århus C | N/A | Denmark | N/A | N/A
Frederiksberg C | N/A | Denmark | N/A | N/A
Hvidovre | N/A | Denmark | 12.47708 | 55.64297
Helsinki | N/A | Finland | 24.93545 | 60.16952
Kuopio | N/A... | 0 | NCT00422058 | |
[
3
] | 29 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The study is comprised of two parts. The first portion of this study will be a double-blind, Sponsor-unblinded, vehicle-controlled study with application of ruxolitinib or vehicle to paired lesions at least 15 cm apart in patients with active but stable plaque psoriasis. Part 2 of the study is a double-blind, sponsor u... | null | Psoriasis | null | 5 | arm 1: INCB018424 Ruxolitinib 0.5% vs vehicle applied once daily for 28 days arm 2: INCB018424 Ruxolitinib 1.0% vs vehicle applied once daily for 28 days arm 3: INCB018424 Ruxolitinib 1.5% vs vehicle applied twice for 28 days arm 4: INCB018424 up to 1.5% versus Dovonex® calcipotriene 0.005% cream applied BID for 28 day... | [
0,
0,
0,
0,
0
] | 6 | [
0,
0,
0,
0,
0,
0
] | intervention 1: Ruxolitinib phosphate cream 0.5% intervention 2: Cream applied once or twice daily for up to 56 days. intervention 3: Cream applied once or twice daily for up to 56 days intervention 4: Cream applied once or twice daily for 56 days intervention 5: Ruxolitinib phosphate cream 1.0% intervention 6: Ruxolit... | intervention 1: Ruxolitinib phosphate cream intervention 2: Dovonex® calcipotriene 0.005% intervention 3: Diprolene® AF betamethasone dipropionate 0.05% cream. intervention 4: Placebo cream intervention 5: Ruxolitinib phosphate cream intervention 6: Ruxolitinib phosphate cream | 6 | Vallejo | California | United States | -122.25664 | 38.10409
Boston | Massachusetts | United States | -71.05977 | 42.35843
Rochester | New York | United States | -77.61556 | 43.15478
Stony Brook | New York | United States | -73.14094 | 40.92565
Portland | Oregon | United States | -122.67621 | 45.52345
Philadelphia | Pe... | 0 | NCT00820950 | |
[
0
] | 60 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | true | 0ALL | false | Bipolar disorder (BD) is a common and severe psychiatric illness. Drug and alcohol abuse are very common in people with BD and other mood disorders and are associated with increased rates of hospitalization, violence towards self and others, medication non-adherence and cognitive impairment. However, few studies have i... | Sixty outpatients meeting the inclusion and exclusion criteria will be enrolled after completing an Institutional Review Board (IRB)-approved informed consent process. Baseline evaluation will include a medical and psychiatric history, structured clinical interview for Diagnostic and Statistical Manual (DSM-IV) (SCID),... | Amphetamine Abuse Amphetamine Dependence Bipolar Disorder Major Depressive Disorder | Amphetamine Abuse Amphetamine Dependence Bipolar Disorder Major Depressive Disorder Citicoline | null | 2 | arm 1: Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects. arm 2: Placebo matching active medication. | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects. Citicoline or placebo (identical in appearance) add-on therapy was given beginning at one tablet (500mg/day) with an increase to two tablets (1000 mg/day) at week 2, three tablets (... | intervention 1: Citicoline intervention 2: Placebo | 1 | Dallas | Texas | United States | -96.80667 | 32.78306 | 1 | NCT00377299 |
[
4
] | 224 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The primary objective of this study was to evaluate the safety and efficacy of ambrisentan in a broad population of participants with pulmonary hypertension (PH). Secondary objectives of this study were to evaluate the effects of ambrisentan on other clinical measures of pulmonary arterial hypertension (PAH), long-term... | This study was to enroll up to 200 participants with PH due to the following etiologies: 1) PAH including idiopathic and familial PAH and PAH associated with collagen vascular disease, congenital systemic-to-pulmonary shunts (including Eisenmenger's syndrome), human immunodeficiency virus (HIV) infection, drugs and tox... | Pulmonary Hypertension | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Oral tablets taken once daily. | intervention 1: Ambrisentan | 39 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Phoenix | Arizona | United States | -112.07404 | 33.44838
La Jolla | California | United States | -117.2742 | 32.84727
Los Angeles | California | United States | -118.24368 | 34.05223
Torrance | California | United States | -118.34063 | 33.83585
Aurora | Color... | 1 | NCT00380068 | |
[
4
] | 808 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | To evaluate the blood pressure efficacy between losartan and valsartan at equivalent dosage during a 3 months treatment. | null | Hypertension | null | 2 | arm 1: Drug Arm arm 2: active comparator | [
0,
1
] | 2 | [
0,
0
] | intervention 1: losartan potassium 50 mg/12.5 Hydrochlorothiazide (HCTZ) titrated as needed to losartan potassium 100 mg/25 mg Hydrochlorothiazide intervention 2: Valsartan 80 mg/ Hydrochlorothiazide 12.5 mg/day titrated as needed to valsartan 160 mg/25 mg Hydrochlorothiazide | intervention 1: losartan potassium (+) hydrochlorothiazide intervention 2: Comparator: Valsartan (+) Hydrochlorothiazide | 0 | null | 1 | NCT00546754 | |
[
3
] | 39 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
... | OBJECTIVES:
* Determine the response rate in patients with chronic lymphocytic leukemia treated with sequential fludarabine, high dose cyclophosphamide, and rituximab.
* Survival up to 5 years
* Utilize flow cytometry and polymerase chain reaction as sensitive measures of minimal residual disease in these patients.
O... | Leukemia | stage II chronic lymphocytic leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia | null | 1 | arm 1: This is a single-arm open-label pilot study designed to assess the antileukemic activity of a regimen containing sequential administration of fludarabine, high-dose cyclophosphamide, and rituximab. | [
0
] | 4 | [
2,
2,
0,
0
] | intervention 1: Filgrastim (300 μg for patients ≤ 70 kg or 480 μg for patients \> 70 kg) will be administered beginning two days after each cyclophosphamide dose and given for a total of eight subcutaneous daily doses. intervention 2: Approximately four weeks after the completion of the last cyclophosphamide dose, pati... | intervention 1: filgrastim intervention 2: rituximab intervention 3: cyclophosphamide intervention 4: fludarabine phosphate | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00003659 |
[
3
] | 84 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | null | Phase II trial to study the effectiveness of combination chemotherapy with or without trastuzumab in treating women who have metastatic breast cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor c... | PRIMARY OBJECTIVES:
I. To evaluate the safety and feasibility of the combination of liposomal doxorubicin (Doxil) and Taxotere (Taxotere) ± trastuzumab (Herceptin), particularly with respect to cardiotoxicity.
II. To evaluate the overall objective response rate, response duration, time to treatment failure, and media... | Recurrent Breast Cancer Stage IV Breast Cancer | null | 2 | arm 1: Patients receive doxorubicin hydrochloride liposome IV over 30 minutes followed by docetaxel IV over 1 hour. Treatment is repeated every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity.
Patients may receive maintenance therapy of docetaxel IV over 1 hour either weekly or eve... | [
0,
0
] | 4 | [
0,
0,
2,
10
] | intervention 1: Given IV intervention 2: Given IV intervention 3: Given IV intervention 4: Correlative studies | intervention 1: pegylated liposomal doxorubicin hydrochloride intervention 2: docetaxel intervention 3: trastuzumab intervention 4: laboratory biomarker analysis | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00004888 | |
[
3
] | 22 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating children who have advanced neuroblastoma or other solid tumors. | OBJECTIVES:
* Determine the response rates of patients with advanced neuroblastoma or other pediatric solid tumors treated with arsenic trioxide.
* Determine the toxicity of this drug in these patients.
OUTLINE: Patients are stratified according to type of disease (neuroblastoma with progressive disease vs neuroblast... | Brain and Central Nervous System Tumors Childhood Germ Cell Tumor Extragonadal Germ Cell Tumor Kidney Cancer Liver Cancer Neuroblastoma Ovarian Cancer Retinoblastoma Sarcoma | metastatic osteosarcoma recurrent childhood rhabdomyosarcoma regional neuroblastoma disseminated neuroblastoma stage 4S neuroblastoma recurrent neuroblastoma stage III childhood liver cancer stage IV childhood liver cancer recurrent childhood liver cancer childhood hepatoblastoma stage III Wilms tumor stage IV Wilms tu... | null | 1 | arm 1: Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 and 8-12. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2-3 months for 1 year and then annually thereafter. | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: arsenic trioxide | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00024258 |
[
3
] | 389 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | null | The purpose of this study is to examine the effects of supplemental magnesium on the neurocognitive function of individuals undergoing coronary artery bypass graft (CABG) surgery. | BACKGROUND:
Approximately 400,000 individuals undergo heart operations each year and cognitive impairment occurs frequently following surgery. An increasing number of these individuals are elderly and are particularly susceptible to cognitive dysfunction following surgery. Cognitive impairment is most notable in the e... | Coronary Disease Heart Diseases Cardiovascular Diseases Neurologic Manifestations | null | 2 | arm 1: 100 mg/kg magnesium arm 2: 100 mg/kg 0.9 % saline | [
1,
2
] | 2 | [
0,
0
] | intervention 1: 100 mg/kg intervention 2: Placebo | intervention 1: Magnesium intervention 2: 0.9% saline | 1 | Durham | North Carolina | United States | -78.89862 | 35.99403 | 0 | NCT00041392 | |
[
3
] | 106 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This randomized phase II trial is studying how well giving combination chemotherapy together with rituximab works in treating patients with HIV-associated stage I, stage II, stage III, or stage IV non-Hodgkin's lymphoma. Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop g... | PRIMARY OBJECTIVES:
I. To determine the complete response rate after treatment with EPOCH given either concurrently or sequentially with rituximab.
SECONDARY OBJECTIVES:
I. To evaluate the toxicity of EPOCH given either concurrently or sequentially with rituximab.
II. To evaluate the effect of EPOCH given either co... | AIDS-related Diffuse Large Cell Lymphoma AIDS-related Immunoblastic Large Cell Lymphoma AIDS-related Peripheral/Systemic Lymphoma AIDS-related Small Noncleaved Cell Lymphoma | null | 2 | arm 1: Patients receive rituximab intravenously (IV) over 2-4 hours prior to each course of chemotherapy. Treatment repeats every 3 weeks for 4-6 courses. Patients who achieve a complete response after 4 courses of chemotherapy and rituximab receive additional rituximab alone weekly for 2 weeks. arm 2: Patients do not ... | [
0,
0
] | 7 | [
2,
0,
0,
0,
0,
0,
10
] | intervention 1: Given IV intervention 2: Given IV intervention 3: Given IV intervention 4: Given IV intervention 5: Given orally intervention 6: Given IV intervention 7: Correlative studies | intervention 1: rituximab intervention 2: etoposide intervention 3: doxorubicin hydrochloride intervention 4: vincristine sulfate intervention 5: prednisone intervention 6: cyclophosphamide intervention 7: laboratory biomarker analysis | 1 | Rockville | Maryland | United States | -77.15276 | 39.084 | 0 | NCT00049036 | |
[
4
] | 74 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether gemcitabine is more effective with or without radiation therapy in treating pancreatic cancer.
PURPOSE... | OBJECTIVES:
* Compare the overall survival and progression-free of patients with locally advanced, unresectable pancreatic cancer treated with gemcitabine with or without radiotherapy.
* Compare the objective response rate in patients treated with these regimens.
* Compare the toxicity of these regimens in these patie... | Pancreatic Cancer | stage III pancreatic cancer adenocarcinoma of the pancreas | null | 2 | arm 1: None arm 2: None | [
1,
0
] | 2 | [
0,
4
] | intervention 1: Induction: Patients receive the first cycle of gemcitabine 1000 mg/m\^2 intravenously once per week for 6 weeks followed by 1 week rest.
Consolidation: Following the week of rest, treatment resume with gemcitabine 1000 mg/m\^2 administered intravenously once per week for 3 weeks, followed by 1 week res... | intervention 1: Gemcitabine intervention 2: radiation therapy | 229 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Hot Springs | Arkansas | United States | -93.05518 | 34.5037
Fresno | California | United States | -119.77237 | 36.74773
Modesto | California | United States | -120.99688 | 37.6391
Modesto | California | United States | -120.99688 | 37.6391
Greeley | Colorado | ... | 0 | NCT00057876 |
[
3
] | 128 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The goal of this clinical research study is to learn if decitabine (given at 3 different doses) can help to control Myelodysplastic Syndrome (MDS). The safety of these 3 treatments will also be studied. | Treatment: Methylation is a change that occurs to Deoxyribonucleic acid (DNA) that has an effect on gene usage in human cells. Abnormal methylation is very common in leukemias. Decitabine is a new drug that blocks DNA methylation.
Before treatment starts, a physical exam, blood tests (between 4-6 tablespoons), and a b... | Myelodysplastic Syndrome Chronic Myelomonocytic Leukemia | Myelodysplastic Syndrome Chronic Myelomonocytic Leukemia MDS Decitabine Dacogen Methylation | null | 3 | arm 1: 10 mg/m\^2 intravenous (IV) over 1 hour daily for 10 days arm 2: 20 mg/m2 IV over 1 hour daily for 5 days arm 3: 20 mg/m2 subcutaneous (SQ) daily for 5 days | [
1,
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: 10 mg/m\^2 by vein over 1 hour daily for 10 days intervention 2: 20 mg/m2 by vein (IV) over 1 hour daily x 5 days intervention 3: 20 mg/m2 subcutaneous (SQ) daily x 5 days | intervention 1: Decitabine intervention 2: Decitabine intervention 3: Decitabine | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00067808 |
[
3,
4
] | 1,354 | RANDOMIZED | PARALLEL | 1PREVENTION | 3TRIPLE | true | 0ALL | true | Tuberculosis (TB) is highly endemic in sub-Saharan Africa. The increased burden of TB in settings with high prevalence of the Human Immunodeficiency Virus (HIV) is associated with high rates of transmission of Mycobacterium tuberculosis (M.tb) to both adults and children. Children infected with TB have a higher risk of... | Tuberculosis (TB) and the Human Immunodeficiency Virus (HIV) are major public health problems in southern Africa, and the incidence of TB in South Africa is among the highest in the world. TB is caused by the highly contagious bacterium Mycobacterium tuberculosis. The use of Isoniazid (INH) prophylaxis in adults has be... | HIV Infection Tuberculosis Pneumocystis Jiroveci Pneumonia | Treatment Naive INH Prophylaxis HIV Seronegativity | null | 4 | arm 1: Perinatally exposed, HIV-uninfected (HIVneg) children receiving Isoniazid (INH)10-20 mg/kg orally once a day for 96 weeks + Trimethoprim/Sulfamethoxazole (TMP/SMX) 5 mg/kg of TMP component orally once a day until HIV status is confirmed and child is no longer at risk of acquiring HIV through breastfeeding arm 2:... | [
0,
2,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: Antibiotic for the prevention and treatment of TB intervention 2: Antibiotic for the prevention and treatment of pneumocystis pneumonia (PCP) intervention 3: Isoniazid placebo and TMP/SMX | intervention 1: Isoniazid (INH) intervention 2: Trimethoprim/Sulfamethoxazole (TMP/SMX) intervention 3: Isoniazid Placebo (PL) | 6 | Gaborone | N/A | Botswana | 25.90859 | -24.65451
Cape Town | N/A | South Africa | 18.42322 | -33.92584
Cape Town | N/A | South Africa | 18.42322 | -33.92584
Durban | N/A | South Africa | 31.0292 | -29.8579
Johannesburg | N/A | South Africa | 28.04363 | -26.20227
Johannesburg | N/A | South Africa | 28.04363 | -26.20227 | 0 | NCT00080119 |
[
4
] | 24 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether radiation therapy alone is as effective as chemotherapy plus radiation therapy in treating germ cell tu... | OBJECTIVES:
Primary
* Compare event-free survival and overall survival of patients with newly diagnosed primary CNS germ cell tumor treated with conventional radiotherapy alone (regimen A) vs chemotherapy followed by tumor response-based radiotherapy (regimen B).
Secondary
* Determine the complete response rate in ... | Brain Tumor Central Nervous System Tumor | childhood central nervous system germ cell tumor | null | 2 | arm 1: Within 52 days of surgery, patients will undergo standard-dose radiation therapy 5 days a week for approximately 5-6 weeks. arm 2: Courses 1 and 2: Patients receive carboplatin IV over 1 hour on days 1 and 2 and etoposide IV over 2 hours on days 1-3. Treatment repeats every 21 days for 2 courses.
Within 3 weeks... | [
0,
0
] | 6 | [
2,
0,
0,
0,
0,
4
] | intervention 1: Given by infusion or injection intervention 2: Given IV over 1 hour intervention 3: Given IV over 6 hours intervention 4: Given IV over 1 hour intervention 5: Given IV over 2 hours intervention 6: Patients undergo radiotherapy 5 days a week | intervention 1: filgrastim intervention 2: carboplatin intervention 3: cisplatin intervention 4: cyclophosphamide intervention 5: etoposide intervention 6: radiation therapy | 107 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Phoenix | Arizona | United States | -112.07404 | 33.44838
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Downey | California | United States | -118.13257 | 33.94001
Loma Linda | California | United States | -117.26115 | 34.04835
Long Beach | Cal... | 0 | NCT00085098 |
[
3
] | 82 | RANDOMIZED | PARALLEL | 1PREVENTION | 4QUADRUPLE | false | 0ALL | true | Patients who have been diagnosed with clinically isolated syndrome (CIS) often develop problems related to the central nervous system, which controls the nerves in the body. Some of these patients may later be diagnosed with multiple sclerosis (MS), a progressive disease of the nervous system. The purpose of this study... | CIS is a single clinical event indicating temporary disruption of normal nerve function. CIS patients may have a loss of vision in one eye; trouble with balance; double vision; numbness in the face; and tingling, numbness, or weakness in the arms or legs. Some CIS patients may develop MS, but others may not. Studies ha... | Multiple Sclerosis | Early Multiple Sclerosis MS Clinically Isolated Syndrome | null | 2 | arm 1: 80 mg/day arm 2: Once daily. | [
0,
2
] | 2 | [
0,
0
] | intervention 1: atorvastatin at the dose of 80 mg/day. Participants will be allowed to decrease the daily dose to 40 mg/day if the higher dose is not well-tolerated intervention 2: tablet form | intervention 1: Atorvastatin intervention 2: Placebo | 14 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Los Angeles | California | United States | -118.24368 | 34.05223
San Francisco | California | United States | -122.41942 | 37.77493
New Haven | Connecticut | United States | -72.92816 | 41.30815
Baltimore | Maryland | United States | -76.61219 | 39.29038
St Loui... | 0 | NCT00094172 |
[
3
] | 26 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well lapatinib ditosylate works in treating patients with unresectable liver or biliary tract cancer | PRIMARY OBJECTIVES:
I. To evaluate the objective response rate (complete response \[CR\] + partial response \[PR\]) as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria in each group of patients.
SECONDARY OBJECTIVES:
I. To evaluate the progression free survival at 6 months. II. To evalua... | Adult Primary Hepatocellular Carcinoma Advanced Adult Primary Liver Cancer Localized Unresectable Adult Primary Liver Cancer Recurrent Adult Primary Liver Cancer Recurrent Extrahepatic Bile Duct Cancer Recurrent Gallbladder Cancer Unresectable Extrahepatic Bile Duct Cancer Unresectable Gallbladder Cancer | null | 1 | arm 1: Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. | [
0
] | 2 | [
0,
10
] | intervention 1: None intervention 2: Correlative studies | intervention 1: lapatinib ditosylate intervention 2: laboratory biomarker analysis | 1 | Columbus | Ohio | United States | -82.99879 | 39.96118 | 0 | NCT00107536 | |
[
4
] | 784 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | true | The purpose of this study is to evaluate the safety of XP12B in women with heavy menstrual bleeding associated with menorrhagia. | null | Menorrhagia Heavy Menstrual Bleeding | Menorrhagia Heavy Menstrual Bleeding | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Two 650 mg tranexamic acid tablets (XP12B) taken 3 times daily (3900 mg/Day) for a maximum of 5 days during monthly menstruation | intervention 1: Tranexamic acid tablets (XP12B) | 59 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Mobile | Alabama | United States | -88.04305 | 30.69436
Montgomery | Alabama | United States | -86.29997 | 32.36681
Phoenix | Arizona | United States | -112.07404 | 33.44838
Phoenix | Arizona | United States | -112.07404 | 33.44838
Jonesboro | Arkansas | Unite... | 0 | NCT00113568 |
[
4
] | 1,053 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this study is to assess whether treatment with the study drug, panitumumab given concomitantly with every 2 (Q2) week oxaliplatin-based chemotherapy and bevacizumab improves progression-free survival (PFS) compared to treatment Q2-week with oxaliplatin-based chemotherapy and bevacizumab alone. All subjec... | null | Colorectal Cancer | Panitumumab Advanced Colorectal Cancer Evaluation Study (PACCE Study) Colorectal, Colon, Rectal Cancer, Metastatic Colorectal Cancer EGFr, Clinical Trial Panitumumab, ABX-EGF Immunex, Abgenix, Amgen Metastatic Colorectal Cancer Oncology | null | 4 | arm 1: Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone. arm 2: Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6mg/kg Q2W arm 3: Irinotecan-based chemotherapy and Bevacizumab Q2W alone arm 4: Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6mg/kg Q2W | [
1,
0,
1,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: Oxaliplatin-based Chemotherapy Every 2 Week Regimens (Q2W Cycles) consisting of Oxaliplatin, Leucovorin (LV), 5-Fluorouracil (5-FU) - To be determined by physician. On Day 1 irinotecan and LV are given at the same time using different bags and a Y-line followed by 5-FU administration. intervention 2: Pa... | intervention 1: Oxaliplatin Based Chemotherapy intervention 2: Panitumumab intervention 3: Irinotecan Based Chemotherapy intervention 4: Bevacizumab | 0 | null | 0 | NCT00115765 |
[
3
] | 27 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This phase II trial is studying how well vorinostat works in treating patients with relapsed or refractory advanced Hodgkin's lymphoma. Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. | PRIMARY OBJECTIVES:
I. To evaluate the response probability (complete, complete unconfirmed, and partial) in patients with relapsed or refractory Hodgkin's lymphoma.
II. To estimate 1-year progression-free survival and overall survival in patients with relapsed or refractory Hodgkin's lymphoma treated with SAHA.
III... | Adult Favorable Prognosis Hodgkin Lymphoma Adult Lymphocyte Depletion Hodgkin Lymphoma Adult Lymphocyte Predominant Hodgkin Lymphoma Adult Mixed Cellularity Hodgkin Lymphoma Adult Nodular Lymphocyte Predominant Hodgkin Lymphoma Adult Nodular Sclerosis Hodgkin Lymphoma Adult Unfavorable Prognosis Hodgkin Lymphoma Recurr... | null | 1 | arm 1: Patients receive oral vorinostat twice daily on days 1-14. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses of therapy beyond CR. | [
0
] | 2 | [
0,
10
] | intervention 1: Given orally intervention 2: Correlative studies | intervention 1: vorinostat intervention 2: laboratory biomarker analysis | 1 | San Antonio | Texas | United States | -98.49363 | 29.42412 | 0 | NCT00132028 | |
[
5
] | 4,484 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | To determine whether celecoxib is superior to combined therapy with diclofenac and omeprazole in the incidence of clinically significant upper and/or lower gastrointestinal (GI) events in high GI risk subjects with osteoarthritis and/or rheumatoid arthritis. | null | Osteoarthritis Arthritis, Rheumatoid | GI events in high risk GI arthritis patients | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Participants are assigned to one of two groups in parallel for the duration of the study intervention 2: Participants are assigned to one of two groups in parallel for the duration of the study | intervention 1: Celecoxib intervention 2: Diclofenac + Omeprazole | 194 | Genk | N/A | Belgium | 5.50082 | 50.965
Ghent | N/A | Belgium | 3.71667 | 51.05
Hasselt | N/A | Belgium | 5.33781 | 50.93106
Liège | N/A | Belgium | 5.56749 | 50.63373
Goiânia | Goiás | Brazil | -49.25389 | -16.67861
Goiânia | Goiás | Brazil | -49.25389 | -16.67861
Curitiba | Paraná | Brazil | -49.27306 | -25.42778
Cur... | 0 | NCT00141102 |
[
3,
4
] | 190 | RANDOMIZED | SEQUENTIAL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | This study will evaluate the safety and effectiveness of magnetic brain stimulation for the treatment of major depression in depressed adults with moderate treatment resistance. | Major depression is a type of depression that can interfere with the ability to work, study, sleep, eat, and enjoy once pleasurable activities. Because people often develop resistances to medications used to treat depression, new treatments are needed. Decreased electrical activity in the prefrontal region of the brain... | Depression | Electric Stimulation Magnetic Stimulation Prefrontal Cortex Brain | null | 4 | arm 1: Phase I participants receiving rTMS arm 2: Phase I participants receiving sham stimulation arm 3: rTMS. Phase II participants, all of whom did not meet remission requirements after phase 1. They all receive active open label rTMS arm 4: All patients who met remission who were then transitioned to medications aft... | [
0,
2,
0,
0
] | 3 | [
3,
0,
3
] | intervention 1: Participants receive 120% motor threshold (MT) over left and right prefrontal cortex. Treatments will be administered daily for 3 weeks. Participants who show signs of improvement may continue Phase I for up to 3 additional weeks. intervention 2: Particpants who acheive remission with rTMS may start ant... | intervention 1: Prefrontal rTMS intervention 2: Antidepressant Regimen intervention 3: Sham Stimulation | 4 | Atlanta | Georgia | United States | -84.38798 | 33.749
New York | New York | United States | -74.00597 | 40.71427
Charleston | South Carolina | United States | -79.93275 | 32.77632
Seattle | Washington | United States | -122.33207 | 47.60621 | 0 | NCT00149838 |
[
4
] | 196 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | This is an extension study of A7501013 (P05771/NCT00145496) to further test
the efficacy and safety of Asenapine compared with a
marketed agent (olanzapine) in the treatment of patients with
persistent negative symptoms of schizophrenia. | null | Schizophrenia | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 5-10 mg sublingually twice daily for 26 weeks intervention 2: 5-20 mg by mouth once daily for 26 weeks | intervention 1: asenapine intervention 2: olanzapine | 0 | null | 0 | NCT00174265 | |
[
2,
3
] | 42 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of the study is to investigate the safety and efficacy of adding simvastatin to the current conventional treatment regimen for the management of pulmonary hypertension. | Pulmonary arterial hypertension (PAH) is a disease that is characterised by progressive narrowing of the blood vessels of the lungs. This results in a pressure load on the heart and heart failure.
The narrowing is in part due to constriction but mostly due to structural changes in affected vessels. The structural chan... | Pulmonary Hypertension | Pulmonary hypertension Simvastatin Statins | null | 2 | arm 1: Placebo tablet once daily arm 2: Simvastatin 40mg od for 1 month, then uptitrated to 80mg od for 11 months. | [
2,
0
] | 2 | [
0,
0
] | intervention 1: Simvastatin 40mg od for 1 month, then 80mg od for 11 months intervention 2: Placebo tablet once daily. | intervention 1: Simvastatin intervention 2: Placebo | 3 | Giessen | N/A | Germany | 8.67554 | 50.58727
London | N/A | United Kingdom | -0.12574 | 51.50853
London | N/A | United Kingdom | -0.12574 | 51.50853 | 0 | NCT00180713 |
[
2,
3
] | 35 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | null | The purpose of this study is first to establish what is the ideal dose of gemcitabine, a chemotherapy agent, when given in combination with radiation. In addition, the investigators want to determine the side effects and the effectiveness of this combination. The investigators will also study several markers to try to ... | null | Uterine Cervical Cancer | Cervical Carcinoma | null | 1 | arm 1: Gemcitabine 350 mg/m2 IV weekly x 6 weeks with concurrent external radiation | [
0
] | 1 | [
0
] | intervention 1: Gemcitabine weekly x 6 wks with concurrent external radiation | intervention 1: Gemcitabine | 1 | Los Angeles | California | United States | -118.24368 | 34.05223 | 0 | NCT00184093 |
[
3
] | 123 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | false | In this trial we will evaluate ABI-007 with gemcitabine and epirubicin, utilizing the biweekly pegfilgrastim support, in order to further improve upon the effectiveness and favorable toxicity of this triplet. | Upon determination of eligibility, patients will be receive both induction neo-adjuvant regimen and a postoperative adjuvant regimen:
Induction Neo-adjuvant: Epirubicin + Gemcitabine + ABI-007 + Pegfilgrastim
Postoperative Adjuvant: Gemcitabine + ABI-007 + Pegfilgrastim
Upon completion of chemotherapy, all ER and/or... | Breast Cancer | Locally Advanced Breast Cancer Inflammatory Breast Cancer Breast Cancer Abraxane nab Paclitaxel Epirubicin Gemcitabine Gemzar | null | 1 | arm 1: Patients were treated with 6 doses of neoadjuvant gemcitabine 2000 mg/m2, epirubicin 50 mg/m2, and albumin-bound paclitaxel 175 mg/m2 intravenously administered at 14-day intervals. Following neoadjuvant chemotherapy, patients underwent either mastectomy or breast conservation surgery; pathologic response to tre... | [
0
] | 3 | [
0,
0,
0
] | intervention 1: Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles intervention 2: Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles intervention 3: ABI-007 175 mg/m2 D1 q 14 days x 6 cycles | intervention 1: Gemcitabine intervention 2: Epirubicin intervention 3: Albumin-bound Paclitaxel | 13 | Fort Myers | Florida | United States | -81.84059 | 26.62168
Jacksonville | Florida | United States | -81.65565 | 30.33218
Lakeland | Florida | United States | -81.9498 | 28.03947
Orlando | Florida | United States | -81.37924 | 28.53834
Gainesville | Georgia | United States | -83.82407 | 34.29788
Louisville | Kentucky |... | 0 | NCT00193206 |
[
5
] | 414 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | This is a study evaluating the effect on brain volume of daily glatiramer acetate (GA) and add-on pulse steroids. | One interim analysis was planned for possible early termination due to proven efficacy when 75% of the preplanned 500 (approx. 375 patients) recruited patients completed the entire study duration or early discontinued.
In addition to the stopping rule already given for proven efficacy, the sponsor was also interested ... | Relapsing Remitting Multiple Sclerosis | Multiple Sclerosis brain atrophy Glatiramer Acetate Copaxone Steroids Prednisone | null | 2 | arm 1: Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily. arm 2: Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily. | [
1,
0
] | 3 | [
0,
0,
0
] | intervention 1: 20mg glatiramer acetate (GA) administered by daily subcutaneous injections intervention 2: Placebo for prednisone given daily intervention 3: Prednisone 1250 mg taken daily | intervention 1: Glatiramer Acetate intervention 2: Placebo intervention 3: Prednisone | 0 | null | 0 | NCT00203047 |
[
0
] | 40 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to determine whether Campath-1H induction therapy and the associated lymphocyte depletion will permit long-term, rejection free renal allograft function in the absence of maintenance calcineurin inhibitor (CI) therapy. | null | Primary Renal Transplant | null | 2 | arm 1: Standard of Care CNI immunosuppression arm 2: Calcineurin inhibitor withdrawal | [
4,
0
] | 1 | [
0
] | intervention 1: stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy | intervention 1: Calcineurin inhibitor withdrawal | 1 | Madison | Wisconsin | United States | -89.40123 | 43.07305 | 0 | NCT00214201 | |
[
5
] | 60 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of the study is to learn if one year of treatment with parathyroid hormone (PTH), either alone or with risedronate, will increase the thickness of the bones in the hip and spine in subjects with osteoporosis from chronic low dose steroid use. During the second year, the study will also look at whether takin... | Dr. Nancy Lane and colleagues at the University of California, Davis and University of California, San Francisco will be conducting this 2-year study of human parathyroid hormone (rhPTH 1-34) alone, and rhPTH (1-34) with risedronate compared to risedronate alone in men and women with osteopenia on chronic low dose gluc... | Osteoporosis | Osteoporosis Steroids Prednisone | null | 4 | arm 1: First phase (year 1) - parathyroid hormone (rhPTH 1-34), 20 ug SC injections daily and risedronate placebo tablets for one year Second phase (year 2) - re-randomized to risedronate (35mg/wk) tablets for second year. arm 2: First phase (year 1) - parathyroid hormone (rhPTH 1-34), 20 ug SC injections daily and ris... | [
1,
1,
1,
1
] | 2 | [
0,
0
] | intervention 1: One 35mg tab of risedronate/placebo taken once a week for one year. intervention 2: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for o... | intervention 1: Risedronate intervention 2: Parathyroid Hormone | 1 | Sacramento | California | United States | -121.4944 | 38.58157 | 0 | NCT00221299 |
[
5
] | 129 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The objective of this prospective multicenter randomized study is to establish the effectiveness of treatment of persistent atrial fibrillation by encircling the pulmonary veins with radiofrequency (RF) ablation and creating additional lines of block with the aid of the NAVISTAR® THERMOCOOL® catheter in conjunction wit... | null | Atrial Fibrillation | null | 2 | arm 1: Catheter ablation arm 2: Antiarrhythmic drugs | [
0,
1
] | 2 | [
1,
0
] | intervention 1: Catheter ablation with NAVISTAR® THERMOCOOL® Catheter in conjunction with CARTO™ EP Navigation System intervention 2: Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study | intervention 1: RF ablation intervention 2: Antiarrhythmic drugs | 0 | null | 0 | NCT00227344 | |
[
4
] | 42 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This study will assess the efficacy of topiramate in the treatment of pathological gambling. Pathological gambling (PG) is a debilitating disorder, generally leading to severe personal, familial, financial, social, and occupational impairments. In PG, the patient experiences a progressive inability to resist impulses t... | This is a 14-week, outpatient, multicenter, randomized, double-blind, placebo-controlled, flexible-dose study of topiramate in subjects with pathological gambling. After giving informed consent, subjects who meet all the inclusion and exclusion criteria may be enrolled. The study will consist of three phases:
* Washou... | Pathological Gambling | Pathological Gambling Compulsive Gambling Gambling topiramate | null | 2 | arm 1: 25mg to 300mg daily dose arm 2: placebo equivalent tablets | [
0,
2
] | 2 | [
0,
0
] | intervention 1: minimum does of 50mg/day intervention 2: matching tablet | intervention 1: Topiramate intervention 2: Placebo | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00245583 |
[
3
] | 56 | RANDOMIZED | PARALLEL | 1PREVENTION | 2DOUBLE | false | 0ALL | false | The purpose of this study is to determine whether doxycycline (Periostat) at a sub-antimicrobial dose will decrease reperfusion injury after coronary artery bypass grafting (CABG) surgery with cardiopulmonary bypass (CPB). | This proposal is for a randomized, placebo-controlled, double-blinded study of the use of doxycycline in patients requiring CABG surgery. Patients will be randomized 1:1 to receive either doxycycline or placebo.
This study will be conducted in a blinded manner. The pharmacy will randomize patients and will have the ra... | Coronary Artery Bypass Grafting Cardiopulmonary Bypass Reperfusion Injury | Doxycycline coronary artery bypass grafting | null | 2 | arm 1: Patients received oral administration of matching placebo pills, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it). arm 2: Patients received oral administration of 20 mg of doxycycline, twice a... | [
2,
0
] | 2 | [
0,
0
] | intervention 1: In addition to standard care, patients received oral administration of 20 mg of doxycycline twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3. intervention 2: In addition to standard care, patients received oral administration of placebo twice a d... | intervention 1: Periostat intervention 2: Placebo Oral Tablet | 1 | Edmonton | Alberta | Canada | -113.46871 | 53.55014 | 0 | NCT00246740 |
[
4
] | 139 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | The efficacy and safety of the extended treatment to patients with most recent episode manic or mixed who completed previous double blind study (F1D-JE-BMAC \[Study BMAC\]) will be examined. | null | Manic or Mixed Episode Associated With Bipolar I Disorder | null | 2 | arm 1: Olanzapine extension for Study BMAC patients who completed Visit 8.
Patients received olanzapine 5-20 mg for 18 weeks. arm 2: Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5.
Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 m... | [
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: oral, daily intervention 2: Dose adjusted according to local package insert intervention 3: Dose adjusted according to local package insert intervention 4: Dose adjusted according to local package insert | intervention 1: olanzapine intervention 2: lithium intervention 3: valproate intervention 4: carbamazepine | 11 | Akita | N/A | Japan | 140.11667 | 39.71667
Chiba | N/A | Japan | 140.11667 | 35.6
Fukuoka | N/A | Japan | 130.41667 | 33.6
Gunma | N/A | Japan | N/A | N/A
Hokkaido | N/A | Japan | N/A | N/A
Hyōgo | N/A | Japan | 144.43333 | 43.36667
Nara | N/A | Japan | 135.80485 | 34.68505
Okayama | N/A | Japan | 133.93333 | 34.65
Oki... | 0 | NCT00266630 | |
[
3,
4
] | 25 | RANDOMIZED | CROSSOVER | 0TREATMENT | 3TRIPLE | false | 1FEMALE | false | The study was a randomized, double-blinded, crossover trial of topical diclofenac and placebo (10 weeks of each) for the treatment of noncyclic breast pain. | A prospective, randomized, double-blinded crossover trial comparing topical diclofenac and placebo for 10 weeks in the treatment of 30 women with noncyclic mastalgia and surgical scar-related breast pain. | Breast Pain Non-cyclical Mastalgia Surgical Scar-Related Breast Pain | null | 2 | arm 1: Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks, then compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks. arm 2: Compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks, then placebo for Diclofenac in to... | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Compounded topical diclofenac cream applied to the skin three times daily for 10 weeks intervention 2: Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks | intervention 1: Diclofenac intervention 2: Placebo | 1 | Rochester | Minnesota | United States | -92.4699 | 44.02163 | 0 | NCT00276419 | |
[
3
] | 86 | RANDOMIZED | null | 0TREATMENT | 0NONE | false | 0ALL | null | RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving erlotinib togeth... | OBJECTIVES:
* Compare the major objective response (complete and partial response) rates in patients with stage IIIB or IV or recurrent non-small cell lung cancer treated with high- versus low-dose erlotinib hydrochloride combined with paclitaxel and carboplatin.
* Compare the duration of response, time to progression... | Lung Cancer | recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer | null | 3 | arm 1: Erlotinib 150mg on days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200 mg/m2 arm 2: Erlotinib 1500mg on Days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200mg/m2 arm 3: Carboplatin AUC6, Paclitaxel 200 mg/m2 followed by Erlotinib 1500mg days 2 and 3. | [
0,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: None intervention 2: 150mg intervention 3: 200mg/m2 intervention 4: 1500mg | intervention 1: Carboplatin intervention 2: erlotinib hydrochloride intervention 3: Paclitaxel intervention 4: erlotinib hydrochloride | 2 | Baltimore | Maryland | United States | -76.61219 | 39.29038
New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00287989 |
[
3
] | 50 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The primary objective of the study was to assess the clinical efficacy of talimogene laherparepvec in terms of tumor response rates. | null | Melanoma | gene transfer gene therapy oncolytic virus GM-CSF melanoma | null | 1 | arm 1: Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every... | [
0
] | 1 | [
0
] | intervention 1: Up to 4 mL of 10⁸ pfu/mL/per intratumoral injection | intervention 1: Talimogene Laherparepvec | 8 | La Jolla | California | United States | -117.2742 | 32.84727
Los Angeles | California | United States | -118.24368 | 34.05223
Aurora | Colorado | United States | -104.83192 | 39.72943
Robbinsdale | Minnesota | United States | -93.33856 | 45.03219
Montclair | New Jersey | United States | -74.20903 | 40.82593
New York | ... | 0 | NCT00289016 |
[
4
] | 2,564 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The purpose of this trial is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin as needed (pro re nata - prn) to maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute symptomatic venous thromboembolism (VTE), followin... | null | Thromboembolism | null | 2 | arm 1: twice daily arm 2: prn to maintain INR (2-3) | [
0,
1
] | 2 | [
0,
0
] | intervention 1: twice daily intervention 2: prn to maintain INR (2-3) | intervention 1: dabigatran etexilate 150 mg intervention 2: warfarin (INR 2-3) | 250 | Mobile | Alabama | United States | -88.04305 | 30.69436
Hartford | Connecticut | United States | -72.68509 | 41.76371
Clearwater | Florida | United States | -82.8001 | 27.96585
Sarasota | Florida | United States | -82.53065 | 27.33643
Sarasota | Florida | United States | -82.53065 | 27.33643
Augusta | Georgia | United ... | 0 | NCT00291330 | |
[
5
] | 124 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to compare the response of veterans with PTSD without an optimal response to paroxetine to quetiapine augmentation versus placebo. | This is a two-site study designed to evaluate the efficacy and safety of quetiapine augmentation of paroxetine treatment in veterans with PTSD who have failed to respond to paroxetine treatment.
In Phase I, eligible patients will take open-label paroxetine (up to 60 mg daily) for 8 weeks. Patients who are refractory (... | Combat Disorders Stress Disorders, Post-Traumatic | Atypical Antipsychotics Controlled Trial Paroxetine Quetiapine Stress Disorders, Post-Traumatic Treatment refractory Treatment resistant | null | 3 | arm 1: Open-label Paroxetine In Phase I, eligible participants will take open-label (OL) Paroxetine (up to 60 mg) daily for 8 weeks. Participants who are refractory (less than 30% reduction in CAPS scores or a minimum CAPS of 50 at week 8) and have PTSD symptoms of at least moderate severity on CGI-S will be eligible f... | [
5,
2,
0
] | 3 | [
0,
0,
0
] | intervention 1: Open-label Paroxetine intervention 2: Double-blind placebo taken with OL paroxetine intervention 3: Double-blind quetiapine taken with OL paroxetine | intervention 1: Open Label (OL) Paroxetine intervention 2: Placebo intervention 3: Quetiapine | 3 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Tuscaloosa | Alabama | United States | -87.56917 | 33.20984
Charleston | South Carolina | United States | -79.93275 | 32.77632 | 0 | NCT00292370 |
[
5
] | 127 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The primary objectives of this Phase 4, open label, prospective U.S. surveillance study are to evaluate the health outcomes of Alpha 1-Antitrypsin (AAT)-deficient subjects who are initiating treatment with ARALAST on patient-related outcomes (PRO), i.e., health-related quality of life (HRQoL), healthcare resource utili... | null | Alpha1-antitrypsin Deficiency | null | 0 | null | null | 1 | [
0
] | intervention 1: Weekly ARALAST infusions for 2 years, dose and mode of administration as prescribed by the physician | intervention 1: ARALAST Alpha1-Proteinase Inhibitor | 1 | San Marino | California | United States | -118.10646 | 34.1214 | 0 | NCT00313144 | |
[
3
] | 33 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This study was designed to find the safest and most effective dose of a combination of two chemotherapy drugs, Hycamtin® (topotecan) and Paraplatin® (carboplatin), in people with extensive disease small cell lung cancer. | null | Lung Cancer, Small Cell | chemonaive small cell lung cancer untreated Lung cancer HYCAMTIN first-line extensive disease | null | 1 | arm 1: None | [
0
] | 2 | [
0,
0
] | intervention 1: Hycamtin and Carboplatin as first-line treatment of chemonaive subjects with EX-SCLC. intervention 2: Hycamtin and Carboplatin as first-line treatment of chemonaive subjects with EX-SCLC. | intervention 1: topotecan intervention 2: carboplatin | 13 | Tucson | Arizona | United States | -110.92648 | 32.22174
Concord | California | United States | -122.03107 | 37.97798
Sacramento | California | United States | -121.4944 | 38.58157
Boca Raton | Florida | United States | -80.0831 | 26.35869
Hollywood | Florida | United States | -80.14949 | 26.0112
Chicago | Illinois | U... | 0 | NCT00316186 |
[
0
] | 242 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | true | Aggressive intraoperative and postoperative management of blood glucose may substantially decrease perioperative cardiovascular and infectious complications in diabetic and non-diabetic patients undergoing vascular surgery.
The purpose of this study is to compare the tight versus traditional blood glucose control in d... | This is a randomized, prospective controlled trial in both diabetic and non diabetic patients undergoing vascular surgery such as abdominal aortic, infra inguinal vascular bypass procedures and amputations, comparing tight versus standard blood glucose control regimens in the operating room, post anesthesia care unit a... | Peripheral Vascular Disease Abdominal Aortic Aneurysm | Tight Glycemic control outcomes peripheral vascular disease infection cardiovascular morbidity mortality | null | 2 | arm 1: Continuous intravenous insulin infusion to control glucose to \<150 mg/dL in patients undergoing open peripheral vascular bypass surgery arm 2: Intermittent intravenous insulin insulin boluses to a blood glucose target of \<150mg/dL in patients undergoing peripheral vascular bypass surgery | [
0,
1
] | 1 | [
0
] | intervention 1: Tight glucose control versus standard of care | intervention 1: continuous intravenous insulin infusion | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00328094 |
[
4
] | 61 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The main purpose is to explore whether atazanavir/ritonavir (ATV/RTV) single enhanced protease inhibitor therapy can maintain virologic suppression without a marked increase in virologic failure. | null | Human Immunodeficiency Virus (HIV) Infections | HIV-Infected Patients Evidencing Virologic Suppression | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Capsules, Oral, ATV 300mg + RTV 100mg, once daily, 96 weeks | intervention 1: Atazanavir + Ritonavir | 7 | Córdoba | N/A | Spain | -4.77275 | 37.89155
Madrid | N/A | Spain | -3.70256 | 40.4165
Madrid | N/A | Spain | -3.70256 | 40.4165
Madrid | N/A | Spain | -3.70256 | 40.4165
Madrid | N/A | Spain | -3.70256 | 40.4165
Madrid | N/A | Spain | -3.70256 | 40.4165
Málaga | N/A | Spain | -4.42034 | 36.72016 | 0 | NCT00337467 |
[
3
] | 44 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This is a Phase II trial of the combination of oxaliplatin (Eloxatin) and capecitabine (Xeloda), known as XELOX, in participants with unresectable or recurrent cholangiocarcinoma, including carcinoma of the gallbladder or biliary tract, both intrahepatic and extrahepatic. Participants may be either previously untreated... | Oxaliplatin causes death of cancer cells and other actively dividing cells by interfering with DNA function. Capecitabine causes death of cancer cells by interfering with certain molecules that are important in cell division.
After the screening portion of the study, if you are eligible to continue, you will begin tre... | Cancer of the Gallbladder Cancer of the Biliary Tract | Gastrointestinal Capecitabine Oxaliplatin Carcinoma of the Gallbladder Carcinoma of the Intrahepatic or Extrahepatic Biliary Tract Xeloda Eloxatin | null | 1 | arm 1: Combination of intravenous (IV) oxaliplatin 100 mg/m\^2 Day 1 and oral (PO) capecitabine 750 mg/m\^2 twice daily (total daily dose 1500 mg/m2) on Days 1-14. | [
0
] | 2 | [
0,
0
] | intervention 1: 1500 mg/m\^2 PO twice daily x 14 days. intervention 2: 130 mg/m\^2 IV over 2 hours on day 1 of cycle. | intervention 1: Capecitabine intervention 2: Oxaliplatin | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00338988 |
[
3
] | 80 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This is a Phase 2, randomized, double-masked, placebo-controlled, parallel-group study in adult males and females, aged 18 years and over, with a diagnosis of moderate-to-severe keratoconjunctivitis sicca (KCS). Patients will be randomized to receive either CF101 1 mg or matching placebo, given orally every 12 hours (q... | At a Screening Visit, patients who provide written informed consent will have screening procedures performed, including a complete medical history, medication history, physical examination, including height, weight, sitting blood pressure, pulse rate and temperature, and clinical laboratory tests. Disease activity will... | Keratoconjunctivitis Sicca | Keratoconjunctivitis Sicca KCS Dry Eye | null | 2 | arm 1: CF101 1 mg given orally every 12 hours for 12 weeks arm 2: Placebo given orally every 12 hours for 12 weeks | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Orally CF101 1mg intervention 2: Orally matching Placebo | intervention 1: CF101 intervention 2: Placebo | 3 | Kfar Saba | N/A | Israel | 34.90694 | 32.175
Tel Litwinsky | N/A | Israel | 34.84588 | 32.05096
Ẕerifin | N/A | Israel | 34.84852 | 31.95731 | 0 | NCT00349466 |
[
5
] | 83 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | The purpose of this study is to determine whether the use of perioperative intravenous S (+) ketamine reduces the amount and degree of postoperative pain.
Furthermore the purpose of this study is to determine whether the use of perioperative intravenous S (+) ketamine effects cognitive function in the early postoperat... | The mechanism of development of postoperative pain is complex. Central and peripheral sensitization are playing an important role and this can lead to postoperative hypersensitization. Several studies have shown, that S (+) ketamine can be effective to reduce sensitization and postoperative pain. Ketamine (2-O-chloroph... | Hemorrhoids Pain | hemorrhoids hemorrhoidectomy S (+) ketamine pain | null | 2 | arm 1: Saline 0,9% arm 2: None | [
2,
1
] | 2 | [
0,
0
] | intervention 1: 0,35 mg/kg bolus after induction of anaesthesia; 5 ug/kg/min. continuous until the end of surgery intervention 2: isotonic saline | intervention 1: S (+) Ketamine intervention 2: Placebo | 1 | Rud | N/A | Norway | 11.63333 | 60.43333 | 0 | NCT00354029 |
[
2
] | 7 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | false | This research is being done to look at the effects of an experimental drug, ranibizumab, on a condition called "predominantly hemorrhagic subfoveal choroidal neovascularization (CNV)" due to wet age-related macular degeneration.
A predominantly hemorrhagic CNV lesion is diagnosed when at least 50% of the choroidal neo... | This study is a randomized, interventional case series. A total of 10 patients, seen in the Retina Division of the Wilmer Eye Institute, will be enrolled. Subjects will be randomized to either 0.3 mg or 0.5 mg intravitreal injections of ranibizumab, which will be performed monthly for 3 doses. Further monthly injection... | Choroidal Neovascularization | Hemorrhagic Choroidal Neovascularization | null | 2 | arm 1: 0.3 mg/0.05 ml dose of ranibizumab arm 2: 0.5 mg/0.05 ml dose of ranibizumab | [
0,
0
] | 2 | [
0,
0
] | intervention 1: 0.3 mg/0.05 ml dose intervention 2: 0.5 mg/0.05 ml dose | intervention 1: Ranibizumab intervention 2: Ranibizumab | 1 | Baltimore | Maryland | United States | -76.61219 | 39.29038 | 0 | NCT00363168 |
[
0
] | 3 | NA | SINGLE_GROUP | 9OTHER | 0NONE | false | 0ALL | true | During the pre-transplantation phase (following completion of consolidation chemotherapy), patients will begin to receive G-CSF at 10 mcg/kg twice daily; leukapheresis will also be given until a target goal for recipient body weight is obtained, or up to a maximum of 5 days. Conditioning/Preparative therapy will follow... | 1. Pre- Transplantation Phase -
1. Twenty-four to 48 hours following completion of consolidation chemotherapy, patients will begin to receive G-CSF at 10 mcg/kg twice daily subcutaneously. Alternatively, patients may receive G-CSF alone (same dose) as mobilization therapy.
2. Leukapheresis will begin day 4 of G-... | Acute Myeloid Leukemia (AML) | Busulfan Acute myeloid leukemia (AML) Hematopoietic Stem Cell Transplantation (HSCT) Dendritic cells Bone marrow transplantation PBSC mobilization Autologous stem cells | null | 1 | arm 1: G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion | [
5
] | 4 | [
0,
0,
0,
3
] | intervention 1: Mobilization Option 1:Twenty-four to 48 hours following completion of consolidation chemotherapy, patients will begin to receive G-CSF at 10 mcg/kg twice daily subcutaneously.
Mobilization Option 2: If patients have recovered hematologically from consolidation chemotherapy, they may receive G-CSF at 10... | intervention 1: G-CSF intervention 2: Leukapheresis intervention 3: Busulfan intervention 4: Stem cell reinfusion | 1 | Tampa | Florida | United States | -82.45843 | 27.94752 | 0 | NCT00363467 |
[
3
] | 92 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | false | This study will determine whether the investigational drug dasatinib is effective in treatment of women with progressive advanced ER+/PR+ or Her2/neu+ breast cancer | null | Breast Cancer Metastasis | Recurrent, locally-advanced, or metastatic breast cancer | null | 1 | arm 1: Participants with either a Human epidermal growth factor (Her2/neu)-amplified tumor type or ER and/or PgR positive tumor types received oral dasatinib twice daily (BID). | [
0
] | 2 | [
0,
0
] | intervention 1: Tablets, Oral, 70 mg, twice daily, as long as the participant benefits (average \<6 months) intervention 2: Tablets, Oral, 100mg, twice daily, as long as the participant benefits (average \<6 months) | intervention 1: Dasatinib intervention 2: Dasatinib 100 mg | 23 | San Francisco | California | United States | -122.41942 | 37.77493
Jacksonville | Florida | United States | -81.65565 | 30.33218
Boston | Massachusetts | United States | -71.05977 | 42.35843
The Bronx | New York | United States | -73.86641 | 40.84985
Chapel Hill | North Carolina | United States | -79.05584 | 35.9132
Ph... | 0 | NCT00371345 |
[
3
] | 133 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This is a two-arm, parallel, open-label, Phase 2 multicenter study of pemetrexed as first line combination therapy with either cisplatin or carboplatin in the palliative setting of stage IIIb and IV non-small cell lung cancer patients. Approximately 130 patients will be included in about 15 centers in Germany and rando... | null | Non-Small-Cell Lung Cancer | null | 2 | arm 1: None arm 2: None | [
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles intervention 2: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles intervention 3: Area under the concentration curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles | intervention 1: Pemetrexed intervention 2: Cisplatin intervention 3: Carboplatin | 12 | Coswig | N/A | Germany | 13.58312 | 51.13204
Frankfurt | N/A | Germany | 10.53333 | 49.68333
Großhansdorf | N/A | Germany | 10.28333 | 53.66667
Halle | N/A | Germany | 11.97947 | 51.48158
Hamburg | N/A | Germany | 9.99302 | 53.55073
Hofheim | N/A | Germany | 8.41385 | 49.65749
Homburg/Saar | N/A | Germany | N/A | N/A
I... | 0 | NCT00402051 | |
[
3,
4
] | 128 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | This study will examine whether Fx-1006A is effective in halting the progression of Familial Amyloid Polyneuropathy (FAP).
Deposition of TTR amyloid is associated with a variety of human diseases. Deposition of amyloid fibrils of variant TTR (primarily V30M) in peripheral nerve tissue produces the condition called FAP... | Deposition of TTR amyloid is associated with a variety of human diseases. Deposition of amyloid fibrils of variant TTR (primarily V30M) in peripheral nerve tissue produces the condition called FAP.
The prevention of the formation of amyloid by stabilization of the TTR native state should constitute an effective therap... | Familial Amyloid Polyneuropathy | FAP Fx-1006A transthyretin TTR amyloid polyneuropathy V30M familial hereditary amyloidosis FoldRx | null | 2 | arm 1: Fx-1006A arm 2: Placebo | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Fx-1006A 20mg or matched placebo once daily (at the same time each day) for a period of 18 Months intervention 2: Fx-1006A 20mg or matched placebo once daily (at the same time each day) for a period of 18 Months | intervention 1: Fx-1006A intervention 2: Placebo | 10 | Boston | Massachusetts | United States | -71.05977 | 42.35843
Ciudad de Buenos Aires | Buenos Aires | Argentina | N/A | N/A
Rio de Janeiro | Southeast | Brazil | -43.18223 | -22.90642
Le Kremlin-Bicêtre | Île-de-France Region | France | 2.36073 | 48.81471
Münster | North Rhine-Westphalia | Germany | 7.62571 | 51.96236
... | 0 | NCT00409175 |
[
3
] | 33 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this research study is to investigate if RAD001 is an effective treatment for pancreatic cancer that has spread and not responded to treatment. Experiments have shown that RAD001 can prevent cells from multiplying. RAD002 has also been tested in laboratory experiments imitating cancer conditions and the ... | * Participants taking part in this research study will be given a study medication-dosing calendar for each treatment cycle. Each cycle lasts four weeks during which you will be taking the study drug, RAD001, orally every day.
* Participants will come into the clinic every other week during the time of enrollment. At e... | Pancreatic Cancer | RAD001 metastatic pancreatic cancer | null | 1 | arm 1: RAD001 was administered continuously at a dose of 10 mg daily by mouth until disease progression, unacceptable toxicity, or withdrawal of consent.
Four weeks of study drug was considered to be one cycle of treatment. | [
0
] | 1 | [
0
] | intervention 1: Taken orally daily for as long as the participant continues to receive a benefit. | intervention 1: RAD001 | 3 | Boston | Massachusetts | United States | -71.05977 | 42.35843
Boston | Massachusetts | United States | -71.05977 | 42.35843
Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00409292 |
[
2,
3
] | 30 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | Primary Objectives:
* Safety of palonosetron administered for control of nausea and vomiting in patients with metastatic melanoma receiving biochemotherapy.
* To determine the patterns and severity of nausea and vomiting in two groups of patients with metastatic melanoma receiving biochemotherapy with palonosetron pre... | Palonosetron is designed to work by blocking the substance serotonin from binding to the brain and gastrointestinal tract, which may help to decrease nausea and vomiting.
Participants in this study will be receiving biochemotherapy treatment as part of their routine care. This treatment will include 3 chemotherapy dru... | Melanoma | Melanoma Nausea Vomiting Palonosetron Cisplatin Vinblastine Loss of Appetite Weight loss | null | 2 | arm 1: 2 Days Palonosetron 0.25 mg intravenous (IV) arm 2: 3 Days Palonosetron 0.25 mg IV | [
1,
1
] | 1 | [
0
] | intervention 1: 0.25 mg IV (By Vein) Daily for 2 Days or 0.25 mg IV Daily for 3 Days. | intervention 1: Palonosetron | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00412425 |
[
5
] | 82 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | Evaluation of the efficacy and safety of etanercept (Enbrel) in patients with active, severe and advanced ankylosing spondylitis. | null | Ankylosing Spondylitis | Axial Ankylosing Spondylitis Adult | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
10
] | intervention 1: 50 mg injection once weekly intervention 2: placebo | intervention 1: Etanercept (Enbrel) intervention 2: Placebo | 21 | Amiens | N/A | France | 2.3 | 49.9
Arles | N/A | France | 4.63031 | 43.67681
Avignon | N/A | France | 4.80892 | 43.94834
Bordeaux | N/A | France | -0.5805 | 44.84044
Cabestany | N/A | France | 2.9409 | 42.68141
Corbeil-Essonnes | N/A | France | 2.48757 | 48.60603
Montpellier | N/A | France | 3.87635 | 43.61093
Nice | N... | 0 | NCT00420238 |
[
4
] | 8 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This open-label study will assess the medication Geodon® (Ziprasidone) in pediatric patients, aged 13-17, diagnosed with psychotic disorder. Eligible adolescents will receive Geodon® for 7 weeks and stay at the NYSPI Children's Day Unit (CDU) during the day. If clinically appropriate, they may also stay at the New York... | This study is an open-label assessment of the feasibility of treating adolescents with psychotic disorders (schizophreniform disorder, schizoaffective disorder, psychosis not otherwise specified \[NOS\], major depressive disorder with psychotic features, and bipolar disorder with psychotic features) in an inpatient and... | Schizophreniform Disorder Schizoaffective Disorder Psychosis Depressive Disorder, Major Bipolar Disorder | psychosis NOS MDD w/ psychotic features bipolar disorder w. psychotic features | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: subjects will use ziprasidone | intervention 1: Ziprasidone | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00421954 |
[
4
] | 16 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | To evaluate the safety of posaconazole (POS) in the treatment of coccidioidomycosis. Period A consisted of 2 blinded arms, posaconazole and fluconazole. Recruitment was stopped, and participants in Period A may have been eligible to roll over to an open-label, non-comparitive Period B. During Period B, participants rec... | null | Coccidioidomycosis | null | 2 | arm 1: Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg orally (PO) (oral suspension 40 mg/mL) administered twice daily with meals or oral ... | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Posaconazole 400 mg orally (PO) (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months intervention 2: Fluconazole 400 mg PO (given as two 200-mg oral encapsulated tablets) administered once daily for 12 months | intervention 1: Posaconazole intervention 2: Fluconazole | 0 | null | 0 | NCT00423267 | |
[
4
] | 181 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This is a long-term, double-blind, placebo-controlled study of MCI-186 to treat ALS. This study is the long-term extension of Study NCT00330681; Study NCT00330681 is a Phase 3, randomized, double-blind, placebo control, parallel assignment, 24-week study in the treatment of ALS. The objectives of this study are to asse... | null | Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic lateral sclerosis (ALS) | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Two ampoules (60 mg) of MCI-186 injection are intravenously administered once a day for 10 days during 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days ) - observation (14 days) cycle is repeated eight times. intervention 2: Two ampoul... | intervention 1: MCI-186 intervention 2: Placebo of MCI-186 | 1 | Watari-gun | Miyagi | Japan | N/A | N/A | 0 | NCT00424463 |
[
4
] | 30 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | null | 0ALL | null | Efficacy and safety of 2 groups of treatment: everolimus in association with cyclosporine microemulsion and steroids versus everolimus in association with Enteric-coated Mycophenolate Sodium (EC-MPS) and steroids. The study population consists of patients having taken part in study CRAD001A2420 (NCT00154297) until the ... | null | Renal Transplantation | Everolimus, calcineurine inhibitor, renal transplantation in maintenance, chronic allograft nephropathy | null | 2 | arm 1: Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids arm 2: Everolimus dose has been adjusted to reach in Group 1, assessme... | [
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: None | intervention 1: Everolimus + Cyclosporine intervention 2: Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS) intervention 3: Steroids | 1 | Paris | N/A | France | 2.3488 | 48.85341 | 0 | NCT00425308 |
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