phases list | enrollmentCount int64 | allocation string | interventionModel string | primaryPurpose class label | masking class label | healthyVolunteers bool | sex class label | oversightHasDmc bool | briefSummary string | detailedDescription string | conditions string | conditionsKeywords string | protocolPdfText string | numArms int64 | armDescriptions string | armGroupTypes list | numInterventions int64 | interventionTypes list | interventionDescriptions string | interventionNames string | numLocations int64 | locationDetails string | target int64 | nctid string |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
[
3
] | 20 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | false | The purpose of this study is to assess the 1 month safety and tolerability after multiple oral doses of AZD1656 in patients with Type 2 Diabetes Mellitus Treated with Insulin | null | Type II Diabetes | Type II Diabetes | null | 2 | arm 1: Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days arm 2: Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dos... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Tolerable dose given twice daily intervention 2: Tolerable dose given twice daily | intervention 1: AZD1656 intervention 2: Placebo | 1 | Chula Vista | California | United States | -117.0842 | 32.64005 | 0 | NCT00856908 |
[
4
] | 71 | null | PARALLEL | 0TREATMENT | 0NONE | false | 2MALE | false | Testosterone replacement treatment is the most effective way of treating hypogonadism in men. Acrux has a propriety testosterone replacement product, Testosterone MD-Lotion and this study will assess the occurrence of skin safety events for a further two months of continuous use of the Testosterone MD-Lotion® (cutaneou... | null | Hypogonadism | null | 1 | arm 1: In this open-label extension of the MTE08 trial, participants received Testosterone Metered Dose (MD)-Lotion for 60 days (dosing from Day 121 of the MTE08 trial to Day 180 of the MTE09 trial). Participants in MTE08 initially received 3.0 milliliters (mL) (60 micrograms \[mg\]) of 2% Testosterone MD-Lotion, and m... | [
0
] | 1 | [
0
] | intervention 1: 30 mg to 120 mg administered topically once daily for 60 days | intervention 1: Testosterone MD-Lotion | 11 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Tuscon | Arizona | United States | N/A | N/A
Burbank | California | United States | -118.30897 | 34.18084
Colorado Springs | Colorado | United States | -104.82136 | 38.83388
New Britain | Connecticut | United States | -72.77954 | 41.66121
Ocala | Florida | Uni... | 0 | NCT00857454 | |
[
3
] | 127 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | The purpose of this study is to investigate if AZD2066 can relieve the pain arising from painful diabetic neuropathy compared to placebo. | null | Pain Diabetic Neuropathy | Pain Diabetic Neuropathy PDN Analgesia Efficacy | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Capsule, once daily, 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28. intervention 2: Capsule, once daily | intervention 1: AZD2066 intervention 2: Placebo | 19 | Bella Vista | Arkansas | United States | -94.27134 | 36.4807
National City | California | United States | -117.0992 | 32.67811
Walnut Creek | California | United States | -122.06496 | 37.90631
Clearwater | Florida | United States | -82.8001 | 27.96585
DeLand | Florida | United States | -81.30312 | 29.02832
Lauderdale L... | 0 | NCT00857623 |
[
3
] | 30 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | true | 0ALL | false | This study is being performed to evaluate the functionality of a device (Sufentanil NanoTab® PCA System) that has been developed for use by patients to self-administer the ARX-F01 pain medication (Sufentanil NanoTab 15 mcg) for the treatment of post-operative pain after undergoing knee replacement surgery.
Another goa... | null | Pain, Postoperative | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: 15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours | intervention 1: Sufentanil NanoTab PCA System/15 mcg | 3 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Vero Beach | Florida | United States | -80.39727 | 27.63864
Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00859313 | |
[
0
] | 20 | RANDOMIZED | PARALLEL | 7BASIC_SCIENCE | 4QUADRUPLE | true | 0ALL | true | The goal of this study is to determine if Echinacea purpurea stimulates the immune system. For the study, 20 healthy adults will be randomized to receive Echinacea purpurea or placebo for 10 days. Blood will be drawn to assess immune markers just before beginning the study medication, during the 10 day course of medica... | null | Upper Respiratory Tract Infections | Echinacea prevention immune modulation | null | 2 | arm 1: None arm 2: None | [
1,
2
] | 2 | [
2,
0
] | intervention 1: Echinacea purpurea 100 mg/ml, 25 ml daily in 2 divided doses for 10 days intervention 2: placebo 25 ml daily in 2 divided doses for 10 days | intervention 1: Echinacea purpurea intervention 2: placebo | 1 | Kenmore | Washington | United States | -122.24401 | 47.75732 | 0 | NCT00860795 |
[
3
] | 38 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This is an open label, multi-centre, dose ranging study to assess efficacy, safety and pharmacokinetics of eltrombopag in thrombocytopenic subjects with chronic liver disease. | null | Liver Diseases | null | 3 | arm 1: eltrombopag 12.5 mg/day arm 2: eltrombopag 25 mg/day arm 3: eltrombopag 37.5 mg/day | [
0,
0,
0
] | 2 | [
0,
0
] | intervention 1: eltrombopag 12.5 mg tablet once a day intervention 2: eltrombopag 25 mg tablet once a day | intervention 1: eltrombopag 12.5 milligrams (mg) tablet intervention 2: eltrombopag 25 mg tablet | 10 | Fukuoka | N/A | Japan | 130.41667 | 33.6
Fukuoka | N/A | Japan | 130.41667 | 33.6
Fukuoka | N/A | Japan | 130.41667 | 33.6
Fukuoka | N/A | Japan | 130.41667 | 33.6
Fukuoka | N/A | Japan | 130.41667 | 33.6
Kagoshima | N/A | Japan | 130.55 | 31.56667
Kumamoto | N/A | Japan | 130.69181 | 32.80589
Kumamoto | N/A | Japan | ... | 0 | NCT00861601 | |
[
2
] | 22 | null | CROSSOVER | null | 2DOUBLE | true | 0ALL | false | Insulin lispro and regular human insulin are Food and Drug Administration (FDA)-approved medications for the treatment of diabetes mellitus. Recombinant human hyaluronidase (rHuPH20) is approved by the FDA as an aid to the absorption and dispersion of other injectable drugs. In this study, rHuPH20 will be co-administer... | The purpose of this study is to compare the pharmacokinetics (absorption, distribution, breakdown and elimination) of regular human insulin + recombinant human hyaluronidase (rHuPH20) versus insulin lispro alone, and to compare the pharmacokinetics of insulin lispro + rHuPH20 versus insulin lispro alone. The effects of... | Diabetes Mellitus | rHuPH20 Recombinant Human Hyaluronidase Insulin Lispro Regular Human Insulin | null | 1 | arm 1: All participants were randomized to 1 of 6 treatment sequences (ABC, ACB, BAC, BCA, CAB, or CBA), each of which was comprised of the same 3 interventions (A, B, and C).
Intervention A: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg)... | [
0
] | 3 | [
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: None | intervention 1: Insulin Lispro intervention 2: Regular Human Insulin intervention 3: rHuPH20 | 1 | Chula Vista | California | United States | -117.0842 | 32.64005 | 0 | NCT00862849 |
[
5
] | 12 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This study evaluates the penetration through the blood-brain-barrier of trospium chloride at plasma steady state (Day 10) in elderly subjects with overactive bladder symptoms. Trospium levels in cerebrospinal fluid (CSF) and peak and trough plasma levels will be measured. Baseline and day 10 post-dose neurocognitive te... | null | Elderly Pharmacokinetics Overactive Bladder | null | 1 | arm 1: Trospium Chloride Extended Release, 60 mg | [
0
] | 1 | [
0
] | intervention 1: Extended release, 60 mg, oral daily | intervention 1: Trospium Chloride | 1 | Glendale | California | United States | -118.25508 | 34.14251 | 0 | NCT00863551 | |
[
4
] | 186 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This study will assess the safety and efficacy of aliskiren plus hydrochlorothiazide (HCTZ) in patients who do not achieve controlled blood pressure levels after treatment with another specified antihypertensive medication. There was an optional study extension for the first eligible 60 patients who wanted to participa... | Title of study extension: An open-label, multicenter extension to evaluate the efficacy and safety of a 4 week therapy with amlodipine 5 mg and aliskiren 300 mg plus HCTZ 25 mg in hypertensive patients not adequately responding to a 4 week therapy each with the combinations of candesartan 32 mg plus hydrochlorothiazide... | Hypertension | Hypertension aliskiren cardiovascular diseases | null | 1 | arm 1: None | [
0
] | 3 | [
0,
0,
0
] | intervention 1: 4 weeks treatment with candesartan 32 mg (two 16 mg tablets) plus hydrochlorothiazide 25 mg (two 12.5 mg tablets) taken orally with water in the morning between 7 and 10 am. intervention 2: Patients with uncontrolled mean sitting diastolic blood pressure (msDBP ≥ 90 mm Hg) at the end of Phase 1 were tre... | intervention 1: Candesartan+HCTZ - Phase 1 intervention 2: Aliskiren+HCTZ - Phase 2 intervention 3: Aliskiren+HCTZ+amlodipine - Phase 3 | 1 | Chemnitz | N/A | Germany | 12.92922 | 50.8357 | 0 | NCT00867490 |
[
2
] | 11 | NON_RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | true | 1FEMALE | false | The purpose of this study is to determine the oral dose level at which the investigative drug, Proellex, is able induce menstruation. | The purpose of this study is to determine the oral dose level at which the investigative drug, Proellex, is able to suppress endogenous progesterone in women. It is believed that giving Proellex in the early/mid-luteal phase of the cycle will suppress the effects of endogenous progesterone triggering the end of the cyc... | Amenorrhea | Menstruation | null | 5 | arm 1: Initiation-Placebo Cycle-Five (5) placebo capsules will be dispensed to subjects to self-administer for five days starting on cycle day 18. arm 2: First Cycle (3 mg)- Five (5) 3 mg capsules of Proellex will be dispensed to subjects to self-administer for five days starting on cycle day 18. arm 3: Second Cycle (6... | [
2,
0,
0,
0,
0
] | 2 | [
0,
0
] | intervention 1: Placebo, 1 capsule daily for five days intervention 2: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days | intervention 1: Placebo intervention 2: Proellex | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00881608 |
[
5
] | 12 | NA | SINGLE_GROUP | 7BASIC_SCIENCE | 0NONE | false | 0ALL | false | This study was designed to use a sensitive neuroendocrine probe, the Dexamethasone/Corticotropin-Releasing Hormone (DEX/CRH) test, in a sample of healthy adults with insomnia. The primary aim was to assess cortisol reactivity before and after long-term (6 weeks) administration of eszopiclone. It was hypothesized that t... | see above | Insomnia | null | 1 | arm 1: Standard dosing of drug for 6 weeks for insomnia | [
0
] | 1 | [
0
] | intervention 1: 6 weeks standard oral therapy | intervention 1: eszopiclone | 1 | Providence | Rhode Island | United States | -71.41283 | 41.82399 | 0 | NCT00889200 | |
[
2,
3
] | 65 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | false | This study is designed to evaluate the pharmacokinetics, tolerability, and safety of exenatide once weekly suspension in both healthy subjects and in subjects with type 2 diabetes. The study will also evaluate efficacy in the type 2 diabetes patients. Development of this exenatide once weekly presentation would elimina... | null | Type 2 Diabetes Mellitus | diabetes exenatide once weekly Byetta Amylin Lilly | null | 3 | arm 1: A single 10-mg dose of exenatide once weekly suspension given to healthy participants via 3 subcutaneous (SC) injections at Day 1. arm 2: On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, thiazolidinedione (TZD), or a combination of m... | [
0,
0,
2
] | 3 | [
0,
0,
10
] | intervention 1: subcutaneous injection, 10.0 mg, single injection intervention 2: subcutaneous injection, 2.0 mg, once a week for 12 weeks intervention 3: subcutaneous injection, volume equivalent to Cohort 2 experimental intervention, once a week for 12 weeks | intervention 1: exenatide once weekly intervention 2: exenatide once weekly intervention 3: Placebo | 1 | Lincoln | Nebraska | United States | -96.66696 | 40.8 | 0 | NCT00894322 |
[
0
] | 44 | RANDOMIZED | PARALLEL | null | 3TRIPLE | true | 0ALL | false | The purpose of this research is to validate the common administration of oral midazolam to children prior to voiding cystourethrogram (VCUG) to see if this will significantly decrease children's anxiety and make the experience less traumatic. | null | Vesicoureteral Reflux | Midazolam VCUG Anxiety | null | 2 | arm 1: Both patients who are VCUG naive and patients who have had a previous VCUG are given oral midazolam prior to undergoing the VCUG. arm 2: Both patients who are VCUG naive and patients who have had a previous VCUG are given an oral placebo prior to undergoing the VCUG. | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Children are randomized to receive oral midazolam .5 mg/kg prior to undergoing VCUG intervention 2: Children are randomized to receive a placebo prior to undergoing VCUG | intervention 1: midazolam intervention 2: placebo | 1 | St Louis | Missouri | United States | -90.19789 | 38.62727 | 0 | NCT00894465 |
[
0
] | 4 | NA | SINGLE_GROUP | 7BASIC_SCIENCE | 0NONE | true | 0ALL | false | Hypothesis: Low dose aspirin does not change exhaled inflammatory breath mediators in normal subjects. | Aim:
1. To study the effect of low dose aspirin on exhaled breath inflammatory mediators
2. To compare the change to that seen in diseased states such as asthma and Lymphangioleiomyomatosis (LAM)
We will interview healthy volunteers to confirm that they do not have any major underlying medical conditions such as hear... | Healthy | healthy volunteers aspirin Normal healthy subjects | null | 1 | arm 1: Low dose daily aspirin in healthy volunteers for two weeks | [
0
] | 1 | [
0
] | intervention 1: 81 mg orally daily for two weeks | intervention 1: aspirin | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00898222 |
[
2
] | 24 | RANDOMIZED | CROSSOVER | null | 0NONE | true | 0ALL | false | To demonstrate bioequivalence of a 2.5 mg saxagliptin/500 mg metformin (glucophage) immediate release (IR) fixed dose combination (FDC) tablet to the 2.5 mg saxagliptin tablet and 500 mg metformin IR tablet co-administered to healthy subjects in a fasted and in a fed state. | null | Type 2 Diabetes Mellitus | null | 4 | arm 1: Participants were randomized to receive oral co-administration of a 2.5 mg tablet of saxagliptin plus a 500 mg tablet of metformin immediate release (IR) under fasted conditions (S + M \[fasted\]) followed by a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions (S/... | [
0,
0,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions intervention 2: Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under... | intervention 1: Co-administration of Saxagliptin and Metformin IR, Fasted intervention 2: Saxagliptin/Metformin, Fasting intervention 3: Co-administration of Saxagliptin and Metformin IR, Fed intervention 4: Saxagliptin/Metformin, Fed | 1 | Lincoln | Nebraska | United States | -96.66696 | 40.8 | 0 | NCT00899470 | |
[
4
] | 45 | RANDOMIZED | CROSSOVER | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The objective of this study was to establish that an optimal dose of Quillivant XR oral suspension would result in a significant reduction in signs and symptoms of ADHD compared to placebo treatment in pediatric patients ages 6-12 years with ADHD. | null | Attention Deficit Hyperactivity Disorder | Hyperactivity Attention Deficit Disorder ADHD Pediatric Patients Quillivant methylphenidate | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: Oral Suspension 25mg/5mL; 20-60 mg/day intervention 2: Matching Placebo Oral Suspension 25mg/5mL; 20-60 mg/day intervention 3: Matching placebo was a solution that was identical in taste and appearance to the Active drug that was used in this study. | intervention 1: Quillivant Oral Suspension XR intervention 2: Placebo intervention 3: Placebo | 2 | Irvine | California | United States | -117.82311 | 33.66946
Las Vegas | Nevada | United States | -115.13722 | 36.17497 | 0 | NCT00904670 |
[
5
] | 16 | RANDOMIZED | CROSSOVER | 9OTHER | 0NONE | true | 0ALL | false | This study will compare the amount of bronchial tube relaxation from the Formoterol medicine contained in the Symbicort pressure Metered Dose Inhaler(pMDI)(a combination of Budesonide, a steroid, and Formoterol, a drug which relaxes the bronchial smooth muscle. The comparison will be using the pMDI in the usual fashion... | Sixteen subjects will receive treatment in a cross-over design. They will inhale Symbicort 160/4.5 two inhalations in the manner prescribed in the approved package insert. The second intervention will be the inhalation of Symbicort 160/4.5 two inhalations through a valved holding chamber (Aero Chamber Plus). Breathing ... | Asthma | Asthma Formoterol Long Acting Beta Adrenergic Bronchodilator Symbicort Aerochamber | null | 2 | arm 1: The intervention in this group will use inhalation from the pMDI containing budesonide/formoterol pMDI 160/4.5 2 inhalations as approved. (FDA approved product information) without a spacer. The pulmonary function tests (PFTs) will be collected at baseline and for a period of 12 hours post inhalation of 2 inhala... | [
5,
0
] | 2 | [
0,
1
] | intervention 1: The asthmatic subjects will receive budesonide/formoterol pMDI 160/4.5 pMDI 2 inhalations used in conventional fashion, and have pulmonary function measured over 12 hours who are expected to show bronchodilation. intervention 2: Symbicort 160/4.5 2 inhalations will be administered through a valved holdi... | intervention 1: pMDI budesonide/formotrol 160/4.5 is in group 1 intervention 2: Symbicort 160/4.5 plus Aerochamber Plus included in group 2 | 1 | El Paso | Texas | United States | -106.48693 | 31.75872 | 0 | NCT00915538 |
[
3
] | 92 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to evaluate the antihypertensive efficacy and safety of Fimasartan (BR-A-657•K) during 24 hours by dose in patients with mild to moderate essential hypertension. | Fimasartan(BR-A-657-K), a selective blocker of AT1 receptor subtype, showed the rapid and potent antihypertensive effect in many hypertensive models. Phase I study, Fimasartan(BR-A-657-K) 20mg \~ 480mg single dosing with healthy subjects, demonstrated that the Fimasartan(BR-A-657-K) was very safe and well tolerated. An... | Essential Hypertension | Fimasartan Essential Hypertension 24hour ABPM Population PK | null | 3 | arm 1: Fimasartan 60 mg group arm 2: Fimasartan 120 mg group arm 3: Reference (Valsartan 80 mg) group | [
0,
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: Fimasartan 60 mg intervention 2: Fimasartan 120 mg intervention 3: Reference (Valsartan 80 mg) | intervention 1: Fimasartan 60 mg group intervention 2: Fimasartan 120 mg group intervention 3: Reference (Valsartan 80 mg) group | 0 | null | 0 | NCT00922441 |
[
5
] | 139 | RANDOMIZED | PARALLEL | null | 4QUADRUPLE | false | 0ALL | false | The purpose of the study is to compare the sedation profile one hour after dose administration between Seroquel IR and Seroquel XR. | null | Bipolar Depression | inpatient bipolar depression quetiapine Seroquel IR Seroquel XR safety tolerability | null | 2 | arm 1: Quetiapine 25, 100, 200 and 300 mg arm 2: Quetiapine 50, 200, 300 | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Oral, 3 tablets daily: (2 x 25 mg + 1 x 50 mg) at one time each day intervention 2: Oral, 3 tablets daily: (2 x 25 mg + 1 x 50 mg) at one time each day | intervention 1: Quetiapine Immediate Release intervention 2: Quetiapine Extended Release | 0 | null | 0 | NCT00926393 |
[
3
] | 122 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of this study was to evaluate analgesic efficacy and safety of hydrocodone/acetaminophen compared to placebo in moderate to severe pain following molar extraction. | Dosing started within 6 hours after completion of third molar extraction. Study drug was given once every 6 hours for 12 hours (for a total of 2 doses). Participants were randomized to receive placebo or active drug (either experimental drug or comparator). The total dose was the same for both groups receiving active d... | Pain | null | 3 | arm 1: 1 dose of 1 ABT-712 extended-release tablet plus 1 placebo tablet, followed by 1 dose of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses). arm 2: 2 doses of 1 hydrocodone/acetaminophen immediate-release tablet plus 1 placebo tablet, administered once every 6 hours for 12 h... | [
0,
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: ABT-712 extended-release tablet intervention 2: Hydrocodone/acetaminophen immediate-release tablet intervention 3: Placebo tablet | intervention 1: ABT-712 Extended-release intervention 2: Hydrocodone/Acetaminophen Immediate-release intervention 3: Placebo | 3 | Austin | Texas | United States | -97.74306 | 30.26715
San Marcos | Texas | United States | -97.94139 | 29.88327
Salt Lake City | Utah | United States | -111.89105 | 40.76078 | 0 | NCT00935311 | |
[
2
] | 24 | RANDOMIZED | CROSSOVER | 7BASIC_SCIENCE | 0NONE | true | 0ALL | false | The study will be an open-label, randomized, 2-period, 2-treatment, 2-sequence, cross-over, single-dose study employing administration of two PF-02341066 formulations in the fasted state to healthy adult volunteers. | null | Healthy | bioavailability, capsule, tablet, healthy volunteer | null | 2 | arm 1: None arm 2: None | [
0,
0
] | 2 | [
0,
0
] | intervention 1: A 250-mg single dose of PF-02341066 administered as 1 x 50-mg Powder-in-Capsule and 2 x 100-mg Powder-in-Capsules intervention 2: A 250-mg single dose of PF-02341066 administered as 1 x 50-mg Immediate Release Tablet and 2 x 100-mg Immediate Release Tablets | intervention 1: PF-02341066 intervention 2: PF-02341066 | 1 | New Haven | Connecticut | United States | -72.92816 | 41.30815 | 0 | NCT00939731 |
[
4
] | 473 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of the study is to assess the efficacy and safety of 300 IR sublingual tablet of grass pollen allergen extract compared to placebo in adult patient with allergic rhinoconjunctivitis. | Allergy is one of the most common chronic disease in the world currently affecting between 10% and 25% of the general population.
Allergies to pollens characteristically result in seasonal rhinitis symptoms and allergic rhinoconjunctivitis is characterized by sneezing, congestion, rhinorrhea, nasal or palatal itching ... | Allergic Rhinitis Due to Grass Pollens | allergic rhinoconjunctivitis | null | 2 | arm 1: 300 IR grass pollen allergen extract tablet arm 2: Pacebo tablet | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 300 IR grass pollen allergen extract tablet taken daily for approximately 6 months starting 4 months before the grass pollen season and over the grass pollen season intervention 2: Placebo sublingual tablet taken daily for approximately 6 months starting 4 months before the grass pollen season and over ... | intervention 1: 300 IR intervention 2: Placebo | 19 | Normal | Illinois | United States | -88.99063 | 40.5142
Lexington | Kentucky | United States | -84.47772 | 37.98869
Owensboro | Kentucky | United States | -87.11333 | 37.77422
Baltimore | Maryland | United States | -76.61219 | 39.29038
Ypsilanti | Michigan | United States | -83.61299 | 42.24115
Columbia | Missouri | Un... | 0 | NCT00955825 |
[
2
] | 40 | RANDOMIZED | CROSSOVER | 7BASIC_SCIENCE | 0NONE | true | 2MALE | false | The major aim of this study is to investigate and compare the drug amount delivered to the body after sequential application of 2 rotigotine transdermal patches from 2 different manufacturing sites. | null | Healthy Volunteers | Rotigotine Neupro® | null | 2 | arm 1: Two single applications of rotigotine patches from two different manufacturing sites in the order A-B separated by a washout phase of at least 5 days arm 2: Two single applications of rotigotine patches from two different manufacturing sites in the order B-A separated by a washout phase of at least 5 days | [
0,
0
] | 1 | [
0
] | intervention 1: Rotigotine 4.5 mg/10 cm\^2 patch applied for 24 hours | intervention 1: rotigotine transdermal patch (Neupro®) | 1 | Neuss | North Rhine-Westphalia | Germany | 6.68504 | 51.19807 | 0 | NCT00957944 |
[
3
] | 4 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | true | An open label, extension study for subjects completing the ZPU-003 Ext 1 study. | This is an open label, extension study for subjects completing the ZPU-003 Ext 1 study and an off-drug interval (menses), prior to the start of the first 16-week dosing cycle. Subjects will receive a 50 mg Proellex® daily dose. Total study participation for ZPU-003 Ext 2 (Extension 2) may be up to three 4 month drug cy... | Uterine Fibroids | Uterine fibroids | null | 1 | arm 1: 25 mg Proellex daily | [
0
] | 1 | [
0
] | intervention 1: one 25 mg capsules | intervention 1: 25 mg Proellex | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00958893 |
[
5
] | 53 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | true | 0ALL | false | This is a randomized, half-face study. On 1 side of the face, the subject will apply 1 of the 2 test products, clindamycin and benzoyl peroxide or dapsone gel and the contra lateral side of the face will remain non-treated to serve as a control. | This is a single-blind (blinded expert grader), parallel group, randomized, half-face study being conducted at one clinical site. On 1 side of the face, the subject will apply 1 of the 2 test products, clindamycin and benzoyl peroxide or dapsone gel and the contra lateral side of the face will remain non-treated to ser... | Acne Vulgaris | null | 2 | arm 1: Once-daily applications of clindamycin/BPO gel to the randomized side of the face either left or right. arm 2: Twice-daily applications of dapsone gel to one side of the face. | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide intervention 2: Twice-daily applications of dapsone gel | intervention 1: clindamycin and benzoyl peroxide intervention 2: Dapsone gel | 1 | Broomall | Pennsylvania | United States | -75.35658 | 39.9815 | 0 | NCT00964366 | |
[
3
] | 55 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | Background: Repeated episodes of bleeding from gastrointestinal vascular malformations refractory to endoscopic or surgical therapy often pose a major therapeutic challenge.
Methods: The investigators performed a randomized, parallel controlled study of thalidomide as a therapy for recurrent gastrointestinal bleeding ... | Protocol Description:
This is an exploratory, randomized, parallel controlled study of thalidomide for recurrent gastrointestinal bleeding from vascular malformations. Informed consent was taken from all subjects and the Institute Ethics Committee approved the study protocol. All procedures were in accordance with the... | Obscure Gastrointestinal Bleeding Angiodysplasia Gastric Antral Vascular Ectasia Thalidomide | vascular malformation gastrointestinal bleeding thalidomide | null | 2 | arm 1: None arm 2: None | [
1,
5
] | 2 | [
0,
0
] | intervention 1: Patients were randomly assigned to receive a four-month course of 25 mg of thalidomide (Pharmaceutical Co., Ltd. of Chang-zhou, China). Medications were taken orally four times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m. intervention 2: Patients were randomly assigned to receive a four-month course of... | intervention 1: Thalidomide intervention 2: Iron | 0 | null | 0 | NCT00964496 |
[
2
] | 30 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | true | 0ALL | false | The primary objective was to investigate whether multiple-dose administration of ESL 800 mg once daily affects the pharmacokinetics of simvastatin, a substrate of CYP34A. | This was a single centre, two-way crossover, randomised, open-label study in 24 healthy volunteers. The volunteers will receive an oral single-dose of simvastatin 80 mg on two occasions - once administered alone and once after treatment with an oral once-daily dose of 800 mg of ESL for 14 days -, separated by a washout... | Epilepsy | Eslicarbazepine acetate simvastatin | null | 2 | arm 1: Simvastatin 80mg treatment period followed by Simvastatin 80 mg + eslicarbazepine acetate 800 mg treatment period arm 2: Simvastatin 80mg + eslicarbazepine acetate 800 mg treatment period followed by Simvastatin 80 mg treatment period | [
0,
0
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: Eslicarbazepine acetate intervention 2: Simvastatin | 1 | Rennes | N/A | France | -1.67429 | 48.11198 | 0 | NCT00987558 |
[
4
] | 10 | NON_RANDOMIZED | PARALLEL | 1PREVENTION | 1SINGLE | true | 0ALL | false | Study to determine the sunscreen protection factor (SPF) and ultraviolet A protection factor (PFA) of 2 sunscreen products containing the combination of zinc oxide and avobenzone with and without ensulizole. | null | Sun Protection | Sunscreens | null | 2 | arm 1: Following Food and Drug Administration (FDA) guidelines for SPF testing, exposure control and product-protected site erythema responses are scored after 16 to 24 hours post-exposure to full spectrum light (Ultraviolet B radiation \[UVB\] and UVA). arm 2: Determination of Ultraviolet A Protection Factor (PFA). Fo... | [
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Sunscreen formula containing 15% Zinc Oxide, 3% Avobenzone, and 1% Ensulizole intervention 2: Sunscreen formula containing 15% Zinc Oxide and 3% Avobenzone intervention 3: 8% Homosalate Standard SPF 4 Sunscreen | intervention 1: Sunscreen Test Code: V53-028 intervention 2: Sunscreen Test Code: V53-030 intervention 3: Standard SPF 4 Sunscreen | 0 | null | 0 | NCT01001975 |
[
0
] | 10 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | true | The purpose of this study is to determine the feasibility of a short term administration of a targeted therapy (i.e., anastrozole) in women with newly diagnosed early invasive or non invasive breast cancer during the interval between their breast biopsy and surgery. Anastrozole is a form of hormonal therapy which is pa... | Several clinical models are being explored for use in the phase I/II evaluation of targeted therapies for breast cancer. Biological markers can be measured in early stage invasive cancers in a presurgical model involving a short term intervention. In this model, women with newly diagnosed early invasive breast cancer r... | Invasive Breast Cancer | Postmenopausal women ER+ Estrogen positive PR+ Progesterone positive | null | 1 | arm 1: 1mg daily for two weeks in the interval between diagnostic breast biopsy and definitive breast surgery. | [
0
] | 1 | [
0
] | intervention 1: 1mg PO daily for two weeks prior to scheduled surgery | intervention 1: Anastrozole | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT01004744 |
[
5
] | 142 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to evaluate the safety and efficacy of Osmotic Release Oral System (OROS) methylphenidate in participants with Attention Deficit Hyperactivity Disorder (ADHD). | This is an open-label (all people involved know the identity of the intervention), single arm, multicenter (when more than one hospital or medical school team work on a medical research study), prospective study (study following participants forward in time) to evaluate the efficacy and safety of OROS methylphenidate i... | Attention Deficit Disorder With Hyperactivity | Attention Deficit Hyperactivity Disorder Methylphenidate Hydrochloride | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: OROS methylphenidate hydrochloride (HCL) will be given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose will be increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenan... | intervention 1: Osmotic Release Oral System (OROS) Methylphenidate Hydrochloride | 0 | null | 0 | NCT01012622 |
[
5
] | 270 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 1FEMALE | false | The purpose of this study is to determine if the 2 gram single dose of metronidazole is as effective as the 7 day 500 mg BID dose for treatment of Trichomonas vaginalis (TV) among HIV-infected women. | This is a Phase IV equivalency trial as both doses of metronidazole are listed in the the Centers for Disease Control and Prevention Treatment Guidelines for the treatment of T vaginalis. | Trichomonas Infections HIV Infections | null | 2 | arm 1: Metronidazole 2 gm single dose arm 2: Metronidazole 500 mg dose x 7 days | [
1,
1
] | 1 | [
0
] | intervention 1: 2 gm single dose versus 7 day 500 mg BID dose | intervention 1: Metronidazole | 5 | New Orleans | Louisiana | United States | -90.07507 | 29.95465
New Orleans | Louisiana | United States | -90.07507 | 29.95465
Jackson | Mississippi | United States | -90.18481 | 32.29876
Houston | Texas | United States | -95.36327 | 29.76328
Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT01018095 | |
[
4
] | 793 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The aim of this trial is to assess the efficacy of 0416 Ointment in the Treatment of Atopic Dermatitis.
Treatment medication will be administered as follows: Apply a thin layer of ointment to affected skin areas twice daily and rub in gently and completely. Study medication will be applied twice a day, approximately 1... | null | Atopic Dermatitis | Atopic Dermatitis | null | 3 | arm 1: Test product that contains the active pharmaceutical ingredient arm 2: Reference product that contains active pharmaceutical ingredient arm 3: Placebo that contains no active pharmaceutical ingredient | [
0,
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: Topical 0416 test product applied twice daily for 2 weeks intervention 2: Vehicle of 0416 test product applied twice daily for 2 weeks intervention 3: Reference Product for 0416 test product. Apply twice daily for 2 weeks. | intervention 1: 0416 intervention 2: Vehicle of 0416 test product intervention 3: tacrolimus ointment 0.1% | 1 | Melville | New York | United States | -73.41512 | 40.79343 | 0 | NCT01053247 |
[
4
] | 27 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | true | 1FEMALE | true | Safety and efficacy study of 25 and 50 mg doses of Proellex | The study is intended to provide more abundant safety and efficacy data of both the 25 and 50 mg doses of Proellex than ZPU-301, ZPU-302, ZPU-303 and ZPU-304 alone. | Uterine Fibroids | Uterine Fibroids | null | 2 | arm 1: 2, 25 mg capsules arm 2: 1, 25 mg capsule | [
1,
1
] | 2 | [
0,
0
] | intervention 1: 2, 25 mg capsules once per day intervention 2: 1, 25 mg capsule once per day | intervention 1: Proellex intervention 2: Proellex | 4 | Boynton Beach | Florida | United States | -80.06643 | 26.52535
Tampa | Florida | United States | -82.45843 | 27.94752
Houston | Texas | United States | -95.36327 | 29.76328
Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT01069120 |
[
4
] | 899 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The aim of this trial is to assess the efficacy of 0417 Ointment in the Treatment of Atopic Dermatitis.
Treatment medication will be administered as follows: Apply a thin layer of ointment to affected skin areas twice daily and rub in gently and completely. Study medication will be applied twice a day, approximately 1... | null | Atopic Dermatitis | Atopic Dermatitis | null | 3 | arm 1: Test product that contains the active pharmaceutical ingredient arm 2: Reference product that contains the active pharmaceutical ingredient arm 3: Placebo that contains no active pharmaceutical ingredient | [
0,
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: Topical 0417 test product applied twice daily for 4 weeks intervention 2: Vehicle of 0417 test product applied twice daily for 4 weeks intervention 3: Reference product for 0417 test product. Apply twice daily for 4 weeks | intervention 1: 0417 intervention 2: Vehicle of 0417 test product intervention 3: Tacrolimus Ointment 0.03% | 1 | Melville | New York | United States | -73.41512 | 40.79343 | 0 | NCT01139450 |
[
3,
4
] | 336 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study was to evaluate the long-term safety and efficacy of alogliptin and Thiazolidine administered once daily (QD) for 40 consecutive weeks in participants who completed a phase 2/3 Thiazolidine add on study. | 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 | 2 | arm 1: None arm 2: None | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks. intervention 2: Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks. | intervention 1: Alogliptin and pioglitazone intervention 2: Alogliptin and pioglitazone | 0 | null | 0 | NCT01318122 |
[
4
] | 571 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | false | The aim of the study is to evaluate the non-inferiority of BF-200 ALA (Ameluz) in the treatment of actinic keratosis (AK) with photodynamic therapy (PDT) compared to Metvix. | This was a randomized, observer-blind, multinational, comparator and placebo-controlled parallel group, (3:3:1 ratio) study to compare the efficacy and safety of BF-200 ALA with the comparator Metvix® (methyl-\[5-amino-4-oxopentanoate\]) and placebo, for the treatment of AK with PDT. | Actinic Keratosis | null | 3 | arm 1: Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin. arm 2: Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick laye... | [
1,
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source. intervention 2: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination ... | intervention 1: BF-200 ALA intervention 2: MAL Cream intervention 3: Vehicle | 0 | null | 0 | NCT02799069 | |
[
3
] | 196 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to assess the efficacy and safety of a single dose of an ibuprofen 600 mg extended release formulation in post-operative dental pain. There is concern that the manufacturing process may affect the performance characteristics of the selected prototype. Therefore, two formulations of this pro... | null | Pain | Extended-release ibuprofen | null | 4 | arm 1: 1 x 600 mg ibuprofen IR/ER-roller compaction caplet arm 2: 1 x 600 mg ibuprofen IR/ER-Wet granulation caplet arm 3: 1x 220 mg naproxen sodium (Aleve caplet) arm 4: 1 x placebo caplet | [
0,
0,
1,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: None intervention 4: None | intervention 1: ibuprofen intervention 2: ibuprofen intervention 3: naproxen intervention 4: Placebo | 1 | Salt Lake City | Utah | United States | -111.89105 | 40.76078 | 0 | NCT00913627 |
[
2,
3
] | 27 | NON_RANDOMIZED | SEQUENTIAL | 1PREVENTION | 0NONE | false | 0ALL | false | The purpose of this study is to explore a treatment that potentially enhances the delivery of chemotherapy to tumors in participants with superficial bladder cancer. The investigational medication to be studied is an enzyme called ChemophaseTM (recombinant human hyaluronidase, rHuPH20). Chemophase is being specifically... | The primary objectives of this study are to:
1. determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of escalating doses of Chemophase in combination with mitomycin (mitomycin C, MMC) administered as weekly intravesical instillations for five weeks, and
2. establish the dose of Chemophase wit... | Bladder Cancer | Non-invasive bladder cancer Chemophase Intravesical administration Superficial Bladder Cancer | Prot_000.pdf:
Halozyme Therapeutics, Inc.
Protocol HZ2-05-01
CONFIDENTIAL
Page 1 of 89
Version 4.0 26 Feb 2009
Clinical Trial Protocol
Title:
A Phase I-IIa, Multicenter, Open-Label, Multiple Dose,
Safety, Tolerability and Pharmacokinetic Study of
Recombinant Human Hyaluronidase (Chemophase)
in Combination ... | 5 | arm 1: Participants will receive 40 milligrams (mg) MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 20,000 U Chemophase intravesically once weekly from Weeks 2 through 6. arm 2: Participants will receive 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC ... | [
0,
0,
0,
0,
0
] | 2 | [
0,
0
] | intervention 1: intravesical administration intervention 2: intravesical administration | intervention 1: Mitomycin C intervention 2: Chemophase | 5 | Phoenix | Arizona | United States | -112.07404 | 33.44838
La Mesa | California | United States | -117.02308 | 32.76783
Gainesville | Florida | United States | -82.32483 | 29.65163
New Port Richey | Florida | United States | -82.71927 | 28.24418
Tampa | Florida | United States | -82.45843 | 27.94752 | 0 | NCT00318643 |
[
0
] | 28 | null | SEQUENTIAL | 0TREATMENT | 0NONE | false | 0ALL | false | This study is designed to compare four currently used types of anesthesia used prior to intravitreal injection in order to evaluate the most effective method of anesthesia in reducing pain and discomfort associated with intravitreal injections. | Over the last several years intravitreal injection of pharmacologic agents has become a common procedure in ophthalmology. Injected agents include steroid, antibiotics, and most recently anti-VEGF agents. There are many methods of preparing a patient for intravitreal injection. While there are guidelines for infection ... | Macular Degeneration | Macular Degeneration Intravitreal injections Eye anesthesia-Topical/subconjunctival Eye-surgical procedures Ophthalmologic anesthesia methods | null | 1 | arm 1: All Participants will be randomized to receive a unique sequence of one of the 4 anesthetic agents per month, prior to a standard of care monthly intravitreal injection (1 injection per month for a total of 4 months). At the end of study participation, each patient will have received each of the 4 anesthetic age... | [
5
] | 4 | [
0,
0,
0,
0
] | intervention 1: Drops of Proparacaine on the eye, administered as described in the package insert intervention 2: Drops of Tetracaine on the eye, administered as described in the package insert intervention 3: A cotton sponge(pledget)soaked with Lidocaine 4% placed over the conjunctiva intervention 4: A subconjunctival... | intervention 1: Proparacaine Ophthalmic intervention 2: Tetracaine Ophthalmic intervention 3: Lidocaine 4% intervention 4: Lidocaine 2% Injectable Solution | 3 | Arlington | Massachusetts | United States | -71.15644 | 42.41537
Burlington | Massachusetts | United States | -71.19561 | 42.50482
Peabody | Massachusetts | United States | -70.92866 | 42.52787 | 0 | NCT00769392 |
[
3
] | 63 | RANDOMIZED | SEQUENTIAL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study determined the maximum dose of LCI6999 with respect to effect on the ACTH-stimulated cortisol response in participants with hypertension. | null | Hypertension | Blood Pressure Hypertension Cortisol | null | 5 | arm 1: Participants received LCI699 0.5 mg, capsules, orally, once daily (QD), with or without food for up to 6 weeks. arm 2: Participants received LCI699 1.0 mg, capsules, orally, QD, with or without food for up to 6 weeks. arm 3: Participants received LCI699 1.0 mg, capsules, orally, twice daily (BID), with or withou... | [
0,
0,
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: LCI699-matching placebo oral capsules intervention 2: LCI699 oral capsules | intervention 1: LCI699-matching placebo intervention 2: LCI699 | 11 | Beverly Hills | California | United States | -118.40036 | 34.07362
Buena Park | California | United States | -117.99812 | 33.86751
Harbor City | California | United States | -118.29785 | 33.79002
Long Beach | California | United States | -118.18923 | 33.76696
Littleton | Colorado | United States | -105.01665 | 39.61332... | 0 | NCT00817414 |
[
3
] | 115 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This study will assess the long-term safety and tolerability of ACZ885 in patients with rheumatoid arthritis, as well as long-term efficacy, long-term preservation and/or improvement of joint structure and bone mineral density, and long term maintenance of health-related quality of life. | null | Rheumatoid Arthritis | Rheumatoid Arthritis Anti-interleukin-1 beta ACZ885 | null | 1 | arm 1: Participants received one single dose of 600 mg canakinumab via intravenous infusion on Day 1 and thereafter every 6 weeks until completion of the 54-week treatment period. | [
0
] | 1 | [
0
] | intervention 1: Canakinumab | intervention 1: Canakinumab | 51 | Huntsville | Alabama | United States | -86.58594 | 34.7304
Tuscaloosa | Alabama | United States | -87.56917 | 33.20984
Paradise Valley | Arizona | United States | -111.94265 | 33.53115
Trumbull | Connecticut | United States | -73.20067 | 41.24287
Jacksonville | Florida | United States | -81.65565 | 30.33218
South Miami... | 0 | NCT00554606 |
[
3
] | 9 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this randomized, double-blinded study is to test the safety of GSK1265744 and how well it works on reducing the amount of HIV in the blood. It will also look at how people react to and how a human body uses GSK1265744. This study will compare the effects of GSK1265744 and placebo.
The study will consist... | null | Infection, Human Immunodeficiency Virus | HIV naive Phase II integrase inhibitor GSK1265744 newly diagnosed pharmacokinetics AIDS integrase HIV Infections Treatment naive | null | 3 | arm 1: GSK1265744 30 mg arm 2: Placebo to match GSK1265744 arm 3: GSK1265744 5 mg | [
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: GSK1265744 30 mg intervention 2: Placebo to match GSK1265744 intervention 3: GSK1265744 5mg | intervention 1: GSK1265744 30mg intervention 2: Placebo intervention 3: GSK1265744 5mg | 4 | Fort Lauderdale | Florida | United States | -80.14338 | 26.12231
Orlando | Florida | United States | -81.37924 | 28.53834
Vero Beach | Florida | United States | -80.39727 | 27.63864
Charlotte | North Carolina | United States | -80.84313 | 35.22709 | 0 | NCT00920426 |
[
3
] | 54 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This is a randomised, double-blind, placebo-controlled 4-period cross-over study to assess the efficacy and safety of repeat dose intranasal GSK1004723 (1000µg), oral GSK835726 (10mg) and cetirizine (10mg) in the environmental challenge chamber in subjects with seasonal allergic rhinitis. | null | Rhinitis, Allergic, Seasonal | Proof of concept | null | 4 | arm 1: 10mg oral dose arm 2: 1000mcg nasal spray solution arm 3: 10mg cetirizine as active comparator arm 4: placebo | [
1,
1,
1,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: GSK835726 10mg tablet intervention 2: GSK1004723 1000mcg nasal spray solution intervention 3: Cetirizine 10mg active comparator intervention 4: placebo to match actives | intervention 1: GSK835726 10mg intervention 2: GSK1004723 1000mcg intervention 3: Cetirizine 10mg intervention 4: placebo | 1 | Hanover | Lower Saxony | Germany | 9.73322 | 52.37052 | 0 | NCT00972504 |
[
5
] | 290 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | To evaluate the percentage of subjects with clinical recurrence of UC at 6 months using MMX mesalamine once daily. | null | Ulcerative Colitis | ulcerative colitis compliance mesalamine clinical study clinical trial clinical research maintenance long term uc study uc trial uc research open label once a day once daily daily dosing simple oral | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: MMX™ mesalamine 2.4g/day to 4.8g/day once-daily (QD) (two to four 1.2g tablets MMX™ mesalamine, dosed QD,respectively). | intervention 1: MMX Mesalamine | 62 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Jonesboro | Arkansas | United States | -90.70428 | 35.8423
Long Beach | California | United States | -118.18923 | 33.76696
San Diego | California | United States | -117.16472 | 32.71571
San Diego | California | United States | -117.16472 | 32.71571
Englewood |... | 0 | NCT00446849 |
[
4
] | 346 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This trial is a 52-week, open-label extension trial to investigate safety and to explore efficacy of Org 50081 (Esmirtazapine) in participants who completed Protocol 176001 (P05706) (NCT00482612) or 176002 (P05707) (NCT00506389). Participants who have completed Protocol P05706 or P05707, and are willing to continue tre... | null | Insomnia | Fifty two weeks Open label extension | null | 1 | arm 1: One tablet of Esmirtazapine, 4.5 mg orally, daily for up to 52 weeks | [
0
] | 1 | [
0
] | intervention 1: One tablet daily | intervention 1: Org 50081 | 0 | null | 0 | NCT00610675 |
[
4
] | 656 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This study was designed to determine long-term safety of TREXIMET (sumatriptan/naproxen sodium) in adolescents for the acute treatment of migraine. | This study was designed to determine long-term safety of TREXIMET (sumatriptan/naproxen sodium) in adolescents (aged 12 to 17 years) for the acute treatment of migraine. | Migraine Disorders | Long-term Safety Migraine Adolescent Migraine Headache sumatriptan succinate naproxen sodium | null | 1 | arm 1: Combination Tablet of Treximet (sumatriptan/naproxen sodium) | [
5
] | 1 | [
0
] | intervention 1: Combination Tablet of Treximet(sumatriptan/naproxen sodium) | intervention 1: Combination Tablet of Treximet (sumatriptan/naproxen sodium) | 77 | Gilbert | Arizona | United States | -111.78903 | 33.35283
Phoenix | Arizona | United States | -112.07404 | 33.44838
Jonesboro | Arkansas | United States | -90.70428 | 35.8423
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Chico | California | United States | -121.83748 | 39.72849
Fair Oaks | California |... | 0 | NCT00488514 |
[
2
] | 18 | NON_RANDOMIZED | SEQUENTIAL | 0TREATMENT | 0NONE | false | 0ALL | true | The primary purpose of this trial is to determine the maximum tolerated dose (MTD), or the maximum acceptable dose (MAD) and evaluate the dose limiting toxicity (DLT) of oral suberoylanilide hydroxamic acid in participants with solid tumors. | null | Tumors | Solid tumors | null | 4 | arm 1: During Cycle 1, participants receive a single oral dose of vorinostat 100 mg on Day 1 in a fasted state, Day 3 in a fed state, and Day 19 in a fed state. On Days 5-18, participants receive vorinostat 100 mg twice daily, in the morning and evening. If participants do not match to the discontinuation criteria, the... | [
0,
0,
0,
0
] | 1 | [
0
] | intervention 1: vorinostat 100 mg, 200 mg, 400 mg, or 500 mg single oral dose; once-daily or twice-daily administration | intervention 1: vorinostat | 0 | null | 0 | NCT00127127 |
[
2
] | 41 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The primary objective of this study is to evaluate the safety and tolerability of SK\&F-105517-D in japanese patients with chronic heart failure. | null | Heart Failure, Congestive | carvedilol phosphate ß-blocker SK&F-105517-D Chronic heart failure(CHF) | null | 2 | arm 1: SK\&F-105517-D 10-80 mg/day arm 2: Carvedilol-IR 5-20 mg/day | [
0,
5
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: 1 capsule once a day intervention 2: 1 or 2 tablet(s) twice a day intervention 3: 1 capsule once a day intervention 4: 1 or 2 capsule(s) once a day intervention 5: 1 tablet twice a day | intervention 1: SK&F-105517-D 10 mg capsule intervention 2: Carvedilol-immediate release (IR) 2.5 mg tablet intervention 3: SK&F-105517-D 20 mg capsule intervention 4: SK&F-105517-D 40 mg capsule intervention 5: Carvedilol-IR 10 mg tablet | 23 | Chiba | N/A | Japan | 140.11667 | 35.6
Ehime | N/A | Japan | N/A | N/A
Hiroshima | N/A | Japan | 132.45 | 34.4
Hokkaido | N/A | Japan | N/A | N/A
Hokkaido | N/A | Japan | N/A | N/A
Kanagawa | N/A | Japan | 139.91667 | 37.58333
Kanagawa | N/A | Japan | 139.91667 | 37.58333
Mie | N/A | Japan | 131.58333 | 32.96667
Nagano... | 0 | NCT00742508 |
[
3
] | 683 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study will test the safety and how effective telcagepant is when taken with ibuprofen or acetaminophen in participants with migraine with or without aura. The primary study hypothesis is that at least one drug combination is superior to telecagepant alone in the treatment of acute migraines. | null | Migraine | null | 4 | arm 1: Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine arm 2: Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine arm 3: Participants take one telcagepant 280 mg tablet, one placebo tablet, and ... | [
2,
0,
0,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: None intervention 4: None | intervention 1: placebo intervention 2: ibuprofen intervention 3: acetominophen intervention 4: telcagepant | 0 | null | 0 | NCT00758836 | |
[
3
] | 155 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 1FEMALE | false | This study is designed to see how elagolix works compared to placebo in women with endometriosis and to see the effect, if any, on bone mineral density. | This is a Phase II, multicenter, randomized, double-blind, placebo-controlled parallel-group study to assess the efficacy and safety of elagolix at two dose levels administered once daily for up to 6 months. Participants will be randomized (1:1:1) to one of the following treatment groups for the first 12 weeks of dosin... | Endometriosis, Pain | bone mineral density Pelvic Pain estradiol NBI-56418 | null | 3 | arm 1: Participants received placebo tablets once a day for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) QD for 12 weeks. arm 2: Participants received elagolix 150 mg tablets once a day for 12 weeks. At the end of 12 weeks participants c... | [
2,
0,
0
] | 2 | [
0,
0
] | intervention 1: Elagolix tablets administered orally intervention 2: Placebo tablet administered orally | intervention 1: Elagolix intervention 2: placebo | 0 | null | 0 | NCT00619866 |
[
4
] | 326 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This study will determine the relative efficacy and safety of up to 100 days Valcyte prophylaxis relative to up to 200 days Valcyte prophylaxis when given for the prevention of CMV disease in high-risk (D+/R-) kidney allograft recipients. The anticipated time on study treatment is 3-12 months and the target sample size... | null | Cytomegalovirus Infections | null | 2 | arm 1: Valganciclovir for up to 100 days post kidney transplant arm 2: Valganciclovir for up to 200 days post kidney transplant | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 900 mg orally daily for up to 100 days intervention 2: 900 mg orally daily for up to 200 days | intervention 1: Valganciclovir intervention 2: Valganciclovir | 80 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Los Angeles | California | United States | -118.24368 | 34.05223
Los Angeles | California | United States | -118.24368 | 34.05223
San Diego | California | United States | -117.16472 | 32.71571
San Francisco | California | United States | -122.41942 | 37.77493
... | 1 | NCT00294515 | |
[
3
] | 732 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This is a study to evaluate the safety, efficacy, and tolerability of cariprazine (RGH-188) relative to placebo in adult patients (18-60 years of age) with acute exacerbation of schizophrenia. | null | Schizophrenia | null | 5 | arm 1: Participants received placebo orally once a day for 6 weeks. arm 2: Participants received cariprazine 1.5 mg orally once a day for 6 weeks. arm 3: Participants received cariprazine 3.0 mg orally once a day for 6 weeks. arm 4: Participants received cariprazine 4.5 mg orally once a day for 6 weeks. arm 5: Particip... | [
2,
0,
0,
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: Placebo was supplied in capsules. intervention 2: Cariprazine was supplied in capsules intervention 3: Risperidone was supplied in capsules | intervention 1: Placebo intervention 2: Cariprazine intervention 3: Risperidone | 65 | Costa Mesa | California | United States | -117.91867 | 33.64113
Long Beach | California | United States | -118.18923 | 33.76696
Oceanside | California | United States | -117.37948 | 33.19587
Paramount | California | United States | -118.15979 | 33.88946
Riverside | California | United States | -117.39616 | 33.95335
Was... | 0 | NCT00694707 | |
[
3
] | 18 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | true | ZPE-201 Extension of treatment | This is an extension of the phase II, three-arm, parallel design, dose-ranging, placebo-controlled, randomized, double-blind, multicenter study in which placebo or one (1) of two (2) dose levels of Proellex® was administered once-daily for four (4) months. | Endometriosis | Endometriosis Pelvic pain Oral progesterone blocker | null | 1 | arm 1: 25 mg Proellex® | [
0
] | 1 | [
0
] | intervention 1: one (1) 25 mg capsule daily | intervention 1: Proellex® | 8 | Tucson | Arizona | United States | -110.92648 | 32.22174
San Diego | California | United States | -117.16472 | 32.71571
San Ramon | California | United States | -121.97802 | 37.77993
West Palm Beach | Florida | United States | -80.05337 | 26.71534
Cary | North Carolina | United States | -78.78112 | 35.79154
Miamisburg ... | 0 | NCT00958412 |
[
3
] | 3,000 | RANDOMIZED | PARALLEL | 1PREVENTION | 2DOUBLE | true | 0ALL | true | This study will test the safety and efficacy of an investigational Human Immunodeficiency Virus (HIV) vaccine. Efficacy will be measured by either prevention of HIV infection or control of HIV viral load in subjects who become HIV infected.
On September 18, 2007 the Protocol V520-023 DSMB (Data \& Safety Monitoring Bo... | No further treatment was given in V520-023, however participants were followed. V520-023 protocol ended earlier than originally planned per protocol and participants (HIV infected and uninfected) had the option of participating in an observational long term follow up protocol called V520-030/HVTN 504, which served as a... | AIDS HIV Infections | null | 2 | arm 1: Participants randomized to receive three 1.0-ml intramuscular (IM) injections of Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) Vaccine at a dose of 1.5x10\^10 adenovirus genomes (Ad vg) per dose at Day 1, Week 4, and Week 26. arm 2: Participants randomized to receive three 1.... | [
0,
2
] | 2 | [
2,
0
] | intervention 1: Trivalent MRKAd5 HIV-1 gag/pol/nef (1.5x10\^10 adenovirus genomes \[ad-vg\]/dose).
This dose is equivalent to 3x10\^10 vp/dose used in study V520-016. intervention 2: Placebo to Trivalent MRKAd5 HIV-1 gag/pol/nef in three 1 mL doses at Day 1, Week 4, and Week 26 administered intramuscularly. | intervention 1: Trivalent MRKAd5 HIV-1 gag/pol/nef (1.5x10^10 ad-vg/dose) intervention 2: Comparator: placebo | 0 | null | 0 | NCT00095576 | |
[
4
] | 382 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | In the proposed study 450 veterans with a primary diagnosis of schizophrenia who had at least one psychiatric hospitalization for schizophrenia in the previous 2 years would be randomly assigned at 16 VA medical centers to long-acting injectable risperidone or doctor's choice of oral antipsychotic medication (i.e., exc... | The purpose of the study is to assess the effectiveness of long-acting injectable risperidone on psychiatric inpatient hospitalization, schizophrenia symptoms, quality of life, medication adherence, side effects, and health care costs.
Objectives:
Primary: To evaluate the impact of long-acting intramuscular (IM) risp... | Schizoaffective Disorder Schizophrenia | null | 2 | arm 1: long-acting injectable risperidone arm 2: oral antipsychotic medication | [
0,
1
] | 2 | [
0,
0
] | intervention 1: long-acting injectable risperidone intervention 2: doctor's choice (excluding other long-acting injectable medications but not specifying any particular oral agents or dosages) | intervention 1: IM risperidone intervention 2: oral antipsychotic medication | 19 | Tuscaloosa | Alabama | United States | -87.56917 | 33.20984
Long Beach | California | United States | -118.18923 | 33.76696
Palo Alto | California | United States | -122.14302 | 37.44188
West Haven | Connecticut | United States | -72.94705 | 41.27065
Miami | Florida | United States | -80.19366 | 25.77427
Augusta | Geor... | 1 | NCT00132314 | |
[
3
] | 524 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | This study was conducted to assess the safety and tolerability of Abatacept combined with Methotrexate in participants with active rheumatoid arthritis (RA). The secondary objectives were to assess efficacy, pharmacodynamic marker activity, and immunogenicity of Abatacept combined with Methotrexate. | All participants who completed the 12-month double-blind study period were eligible to continue in the open-label study. Participants received placebo, Abatacept 2 mg/kg, or Abatacept 10 mg/kg in the double-blind study. Participants receiving placebo in the double-blind study were switched 1:1 to continued treatment wi... | Rheumatoid Arthritis | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
0,
0,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: IV, 10 mg/Kg, monthly, for the duration of the trial intervention 2: Intravenous (IV) infusion, 2 mg/kg, infused intravenously for approximately 30 min, infusions on Days 1, 15, 30 and monthly thereafter for 12 months intervention 3: Intravenous (IV) infusion, 10 mg/kg, infused intravenously for approxi... | intervention 1: Abatacept (BMS-188667) intervention 2: Abatacept (BMS-188667) intervention 3: Abatacept (BMS-188667) intervention 4: Placebo | 57 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Huntsville | Alabama | United States | -86.58594 | 34.7304
Long Beach | California | United States | -118.18923 | 33.76696
Highlands Ranch | Colorado | United States | -104.96943 | 39.55388
Largo | Florida | United States | -82.78842 | 27.90979
Titusville | Fl... | 1 | NCT00162266 | |
[
4
] | 524 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | To compare the health outcome of patients with schizophrenia, who are at risk for relapse, when treated with a long acting injection form of olanzapine versus treatment with oral olanzapine. | null | Schizophrenia | null | 2 | arm 1: Olanzapine pamoate depot arm 2: Oral olanzapine | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 10 milligrams (mg), oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks. intervention 2: 405 milligrams (mg), intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramus... | intervention 1: olanzapine intervention 2: olanzapine pamoate depot | 49 | Escondido | California | United States | -117.08642 | 33.11921
National City | California | United States | -117.0992 | 32.67811
Orange | California | United States | -117.85311 | 33.78779
San Diego | California | United States | -117.16472 | 32.71571
Washington D.C. | District of Columbia | United States | -77.03637 |... | 1 | NCT00320489 | |
[
4
] | 25,086 | RANDOMIZED | FACTORIAL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to evaluate whether a higher dosage of clopidogrel with aspirin (two doses) will decrease the risk of ischemic complications (cardiac death (CV death), myocardial infarction (MI), stroke) after a percutaneous coronary intervention (PCI). | null | Acute Coronary Disease Angina Unstable | platelet aggregation inhibitors acute coronary disease percutaneous coronary | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
0,
0,
1,
1
] | 2 | [
0,
0
] | intervention 1: oral administration intervention 2: oral administration | intervention 1: Clopidogrel intervention 2: acetylsalicyclic acid (ASA) | 38 | Bridgewater | New Jersey | United States | -74.64815 | 40.60079
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Macquarie Park | N/A | Australia | 151.12757 | -33.78105
Vienna | N/A | Austria | 16.37208 | 48.20849
Diegem | N/A | Belgium | 4.43354 | 50.89727
São Paulo | N/A | Brazil | -46.63611 | -23.5475
Sofia |... | 0 | NCT00335452 |
[
4
] | 755 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 2MALE | null | This is a randomized, open-label, multi-center study comparing the safety and efficacy of XRP6258 plus prednisone to mitoxantrone plus prednisone in the treatment of hormone refractory metastatic prostate cancer previously treated with a Taxotere®-containing regimen. The primary objective is overall survival. Secondary... | null | Neoplasms Prostatic Neoplasms | Cancer Prostate | null | 2 | arm 1: Mitoxantrone + Prednisone arm 2: Cabazitaxel + Prednisone | [
1,
0
] | 3 | [
0,
0,
0
] | intervention 1: 25 mg/m\^2 administered by intravenous (IV) route over 1 hour on day 1 of each 21-day cycle intervention 2: 12 mg/m\^2 administered by intravenous (IV) route over 15-30 minutes on day 1 of each 21-day cycle intervention 3: 10 mg daily administered by oral route | intervention 1: cabazitaxel (XRP6258) (RPR116258) intervention 2: mitoxantrone intervention 3: prednisone | 26 | Bridgewater | New Jersey | United States | -74.64815 | 40.60079
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Diegem | N/A | Belgium | 4.43354 | 50.89727
São Paulo | N/A | Brazil | -46.63611 | -23.5475
Laval | Quebec | Canada | -73.692 | 45.56995
Santiago | N/A | Chile | -70.64827 | -33.45694
Prague | N/A | Cz... | 1 | NCT00417079 |
[
4
] | 5,407 | RANDOMIZED | PARALLEL | 1PREVENTION | 2DOUBLE | false | 0ALL | true | The purpose of this study is to learn whether apixaban can prevent the blood clots in the leg (deep vein thrombosis) and lung (pulmonary embolism) that sometimes occur after hip replacement surgery and to learn how apixaban compares with enoxaparin in preventing these clots. The safety of apixaban will also be studied | null | Deep Vein Thrombosis Pulmonary Embolism | Prevention of deep vein thrombosis and pulmonary embolism after total hip replacement surgery | null | 2 | arm 1: Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD) arm 2: Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID | [
1,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: Subcutaneous, 40 mg, once daily, 5 weeks intervention 2: Oral tablets, 2.5 mg, twice daily, 5weeks intervention 3: Administered as injection intervention 4: Administered as oral tablets | intervention 1: Enoxaparin intervention 2: Apixaban intervention 3: Enoxaparin-matching placebo intervention 4: Apixaban-matching placebo | 143 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Birmingham | Alabama | United States | -86.80249 | 33.52066
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Sacramento | California | United States | -121.4944 | 38.58157
Aurora | Colo... | 1 | NCT00423319 |
[
4
] | 129 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | To evaluate the tolerability of a new formulation of rebif and Betaseron in subjects with relapsing-remitting multiple sclerosis (RRMS) by comparing the mean change in injection site pain scores from pre-injection to 30 minutes post therapy administration. | null | Relapsing Remitting Multiple Sclerosis (RRMS) | null | 2 | arm 1: interferon beta-1a arm 2: interferon beta-1b | [
0,
1
] | 2 | [
0,
0
] | intervention 1: New Formulation of rebif- 44 mcg, SC (sub-cutaneous) thrice weekly (tiw) injection. intervention 2: Betaseron - 250 mcg, SC (sub-cutaneous) every other day injection. | intervention 1: New Formulation of rebif - human interferon beta-1a intervention 2: Interferon beta -1b | 1 | Rockland | Massachusetts | United States | -70.91616 | 42.13066 | 1 | NCT00428584 | |
[
5
] | 201 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | The primary objective of this study is to evaluate efficacy, arterial stiffness measured by Pulse Wave Velocity (PWV) of Losartan potassium group compared to Carvedilol group after 24 weeks of treatment in patients with the essential hypertension. | null | Hypertension | null | 2 | arm 1: Losartan or Losartan/HCTZ arm 2: Carvedilol or Carvedilol/HCTZ | [
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg/ hydrochlorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose st... | intervention 1: losartan potassium intervention 2: Comparator: carvedilol intervention 3: Comparator: losartan (+) hydrochlorothiazide (HCTZ) intervention 4: Comparator: carvedilol (+) hydrochlorothiazide | 0 | null | 1 | NCT00496834 | |
[
4
] | 439 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | This purpose of this study is to determine the efficacy and safety of a grass sublingual (under-the-tongue) tablet. | This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study in participants 18 to 65 years of age, of either sex, and of any race with a history of grass pollen induced rhinoconjunctivitis with or without asthma. While receiving treatment, participants will receive either grass sublingual ... | Rhinoconjunctivitis Rhinitis Conjunctivitis Allergy | rhinoconjunctivitis rhinitis conjunctivitis allergy allergen immunotherapy | null | 2 | arm 1: Matching Placebo arm 2: None | [
2,
0
] | 9 | [
0,
2,
0,
0,
0,
0,
0,
0,
0
] | intervention 1: Placebo sublingual tablet intervention 2: SCH 697243 (2800 Bioequivalent Allergen Units \[BAU\] of Phleum pratense extract, containing approximately 15 mcg Phl p 5), administered sublingually once daily. intervention 3: Loratadine 10 mg RediTabs tablets were dosed orally once daily as rescue medication ... | intervention 1: Placebo intervention 2: SCH 697243 intervention 3: Loratadine 10 mg Rescue Treatment intervention 4: Olopatadine 0.1% Rescue Treatment intervention 5: Mometasone 50 mcg Rescue Treatment intervention 6: Prednisone 5 mg Rescue Treatment intervention 7: Albuterol sulfate 108 mcg intervention 8: Fluticasone... | 0 | null | 1 | NCT00562159 |
[
4
] | 326 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | Objectives of the study are to evaluate the safety, tolerability, and efficacy of two different doses of AVP-923 (capsules containing either 30 mg of dextromethorphan hydrobromide and 10 mg of quinidine sulfate \[AVP-923-30\] or 20 mg of dextromethorphan hydrobromide and 10 mg of quinidine sulfate \[AVP-923-20\]) when ... | null | Pseudobulbar Affect (PBA) | Amyotrophic Lateral Sclerosis (Lou Gehrig's disease, ALS) Multiple Sclerosis (MS) | null | 3 | arm 1: AVP-923-30/10 Capsules (30 mg dextromethorphan/10 mg quinidine)administered once daily for 1 week and then twice daily for 11 weeks arm 2: AVP-923-20/10 Capsules (20 mg dextromethorphan/10 mg quinidine)administered once daily for 1 week and then twice daily for 11 weeks arm 3: Placebo Capsules once daily for 1 w... | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: Dextromethorphan hydrobromide (DM) and quinidine sulfate (Q) capsules (AVP-923 capsules), containing DM 20 mg/ Q 10 mg, taken once daily for 1 week and then twice daily for 11 consecutive weeks to complete a 12-week period intervention 2: Dextromethorphan hydrobromide (DM) and quinidine sulfate (Q) caps... | intervention 1: dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg intervention 2: dextromethorphan hydrobromide 30 mg and quinidine sulfate 10 mg intervention 3: Placebo | 62 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Scottsdale | Arizona | United States | -111.89903 | 33.50921
Anaheim | California | United States | -117.9145 | 33.83529
Irvine | California | United States | -117.82311 | 33.66946
La Jolla | California | United States | -117.2742 | 32.84727
Los Angeles | Califo... | 1 | NCT00573443 |
[
2
] | 45 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The study will compare the effects of prednisone vs placebo on synovial blood flow and overall DAS (disease activity score) in patients with rheumatoid arthritis. | null | Rheumatoid Arthritis | null | 4 | arm 1: Prednisone 15 mg tablets once daily for 15 days arm 2: Prednisone 15 mg placebo tablets once daily for 15 days arm 3: Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days
As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo ... | [
0,
2,
0,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: Prednisone 15 mg tablets once daily for 15 days. intervention 2: Prednisone placebo tablets once daily for 15 days. intervention 3: Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days intervention 4: Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days | intervention 1: Prednisone 15 mg intervention 2: Placebo Tablets intervention 3: Prednisone 7.5 mg intervention 4: Placebo Over-Encapsulated Tablets | 0 | null | 1 | NCT00746512 | |
[
3
] | 222 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | To assess the effect of two doses of Apixaban (2.5 mg BID and 5 mg BID) versus Warfarin on the composite endpoint of major and clinically relevant non-major bleeding during the treatment period. | null | Atrial Fibrillation | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: Apixaban 5 mg tablet BID for 12 weeks intervention 2: Apixaban 2.5 mg tablet BID for 12 weeks intervention 3: At each visit, the subject to take appropriate Warfarin tablet (on investigator's order) once a day every morning for 12 weeks | intervention 1: Apixaban intervention 2: Apixaban intervention 3: Warfarin sodium | 18 | Nagoya | Aichi-ken | Japan | 136.90641 | 35.18147
Seto | Aichi-ken | Japan | 137.1 | 35.23333
Touon | Ehime | Japan | N/A | N/A
Fukuoka | Fukuoka | Japan | 130.41667 | 33.6
Kitakyushu | Fukuoka | Japan | 130.85034 | 33.85181
Ōgaki | Gifu | Japan | 136.61667 | 35.35
Isesaki | Gunma | Japan | 139.2 | 36.31667
Shibukawa |... | 1 | NCT00787150 | |
[
4
] | 193 | RANDOMIZED | PARALLEL | 1PREVENTION | 2DOUBLE | false | 0ALL | true | The purpose of this study is to determine if hydroxyurea therapy is effective in the prevention of chronic end organ damage in pediatric patients with sickle cell anemia. | BACKGROUND:
In 1995, the Multicenter Study of Hydroxyurea (MSH) demonstrated that hydroxyurea is effective in decreasing the frequency of painful crises, hospitalizations for crises, acute chest syndrome, and blood transfusions by 50%. The recently completed phase II study of hydroxyurea in children (PED HUG) demonstr... | Hematologic Diseases Anemia, Sickle Cell | Blood Diseases Sickle Cell Anemia | Prot_SAP_000.pdf:
_________________________________________________________________________________________________________
SLC/F:/BABY-HUG/BHUG Protocol/August-09/B-CoverPageOnly.wpd — 8/09
PEDIATRIC HYDROXYUREA PHASE III CLINICAL TRIAL
BABY HUG
PROTOCOL
August 2009
.
Prepared by:
Clinical Trials & Surveys Corp.
100... | 2 | arm 1: Participants will receive hydroxyurea. arm 2: Participants will receive placebo. | [
1,
2
] | 2 | [
0,
0
] | intervention 1: Participants will receive hydroxyurea. intervention 2: Participants will receive placebo. | intervention 1: Hydroxyurea intervention 2: Placebo | 14 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Miami | Florida | United States | -80.19366 | 25.77427
Atlanta | Georgia | United States | -84.38798 | 3... | 0 | NCT00006400 |
[
4
] | 738 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The purpose of this clinical research study is to determine whether abatacept treatment on a background of Disease Modifying Antirheumatic Drugs (DMARDs) will relieve the symptoms of rheumatoid arthritis (RA) in participants who are currently receiving anti-tumor necrosis factor (TNF) therapy for at least 3 months and ... | null | Rheumatoid Arthritis | null | 3 | arm 1: Short Term Portion of Study arm 2: Short Term Portion of Study arm 3: Long Term Portion of Study:
All participants receive Active Drug | [
1,
2,
1
] | 3 | [
0,
0,
0
] | intervention 1: Vials, intravenous (IV), \~10mg/kg abatacept, One every 2 weeks for first month then every 4 weeks thereafter, 6 months. intervention 2: Vials, IV, 0mg, One every 2 weeks for first month then every 4 weeks thereafter, 6 months. intervention 3: Vials, IV, \~10mg/kg abatacept, every 4 weeks, 5.5 years | intervention 1: Abatacept intervention 2: Placebo intervention 3: Abatacept | 42 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Mobile | Alabama | United States | -88.04305 | 30.69436
Paradise Valley | Arizona | United States | -111.94265 | 33.53115
La Jolla | California | United States | -117.2742 | 32.84727
Long Beach | California | United States | -118.18923 | 33.76696
Palo Alto | C... | 0 | NCT00048581 | |
[
4
] | 247 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | The purpose of this study is to determine if therapy with pioglitazone or vitamin E will lead to an improvement in liver histology in non-diabetic adult patients with non-alcoholic steatohepatitis (NASH). | The purpose of this study is to determine if therapy with pioglitazone or vitamin E will lead to an improvement in liver histology in non-diabetic adult patients with non-alcoholic steatohepatitis (NASH). | Liver Diseases | Non alcoholic steatohepatitis Steatohepatitis | null | 3 | arm 1: Pioglitazone arm 2: Vitamin E arm 3: Placebo Pioglitazone or Placebo Vitamin E | [
1,
1,
2
] | 3 | [
0,
7,
0
] | intervention 1: 30 mg daily intervention 2: 800 IU daily intervention 3: Daily | intervention 1: Pioglitazone intervention 2: Vitamin E intervention 3: Matching placebo | 8 | San Diego | California | United States | -117.16472 | 32.71571
San Francisco | California | United States | -122.41942 | 37.77493
Indianapolis | Indiana | United States | -86.15804 | 39.76838
St Louis | Missouri | United States | -90.19789 | 38.62727
Durham | North Carolina | United States | -78.89862 | 35.99403
Clevel... | 0 | NCT00063622 |
[
3
] | 21 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | OVERVIEW
Essential tremor (ET) is a common movement disorder affecting 0.4% of the general population and up to 14% of people 65 years and older. Response to medications such as beta blockers and primidone may be of benefit, but are often accompanied by intolerable side effects. Response to ethanol, on the other hand,... | OVERVIEW
Essential tremor (ET) is a common movement disorder affecting 0.4% of the general population and up to 14% of people 65 years and older. Response to medications such as beta blockers and primidone may be of benefit, but are often accompanied by intolerable side effects. Response to ethanol, on the other hand,... | Essential Tremor | Ethanol Alcohol Responsive Movement Disorder Gas Chromatography Bioavailability Pharmacokinetics Essential Tremor | null | 0 | null | null | 1 | [
0
] | intervention 1: 1-Octanol is an long-chain alcohol with potential therapeutic benefits in treating alcohol-responsive tremors based on unknown mechanisms. The intervention consisted of either 1) 1-octanol adsorbed to microcrystalline cellulose, NF (Avicel PH 102, FMC Corp., Philadelphia, PA), and fine particle silica (... | intervention 1: 1-Octanol | 1 | Bethesda | Maryland | United States | -77.10026 | 38.98067 | 0 | NCT00102596 |
[
3
] | 108 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | The purpose of this study is to determine whether gabapentin is efficacious as an analgesic for chronic low back pain. | Chronic low back pain (CLBP) is a major health problem for the VA, affecting up to 15% of all veterans. Nationally, its medical and disability costs exceed $50 billion annually. Despite its impact, relatively little research evaluates treatment for CLBP. Wide variation in patterns of care suggests uncertainty over effe... | Chronic Low Back Pain | analgesia antidepressant agents back pain pain | null | 2 | arm 1: Gabapentin 300 mg orally three times daily up to a maximum of 1200 mg orally three times daily for 12 weeks arm 2: Inert placebo capsules identical in size and shape to the experimental capsules, one to three capsules taken orally three times daily for 12 weeks | [
0,
3
] | 2 | [
0,
0
] | intervention 1: Gabapentin 300m on Day 1, with daily or weekly increase to 3600 mg (maximum) by mouth by Week 5 of the 12-week trial intervention 2: Inactive placebo capsule, one capsule on Day 1 with daily or weekly increase to 9 capsules daily by Week 5 of the 12-week trial | intervention 1: gabapentin intervention 2: Inert placebo | 1 | San Diego | California | United States | -117.16472 | 32.71571 | 0 | NCT00108550 |
[
3
] | 226 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This phase II trial is studying how well giving bevacizumab together with combination chemotherapy works in treating patients who have undergone surgery for breast cancer that has spread to the lymph nodes. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of t... | PRIMARY OBJECTIVES:
I. To determine the incidence of clinically apparent cardiac dysfunction in patients with lymph node positive breast cancer treated with bevacizumab and dose dense doxorubicin/cyclophosphamide followed by paclitaxel (ddAC \> T).
SECONDARY OBJECTIVES:
I. To evaluate changes in LVEF during treatmen... | Male Breast Cancer Stage II Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer | null | 2 | arm 1: See detailed description. arm 2: See detailed description. | [
0,
1
] | 9 | [
0,
0,
2,
0,
2,
2,
4,
0,
0
] | intervention 1: Given IV intervention 2: Given IV intervention 3: Given IV intervention 4: Given IV intervention 5: Given SC intervention 6: Given SC intervention 7: Undergo radiation therapy intervention 8: Given orally intervention 9: Receive aromatase inhibition therapy | intervention 1: doxorubicin hydrochloride intervention 2: cyclophosphamide intervention 3: bevacizumab intervention 4: paclitaxel intervention 5: filgrastim intervention 6: pegfilgrastim intervention 7: radiation therapy intervention 8: tamoxifen citrate intervention 9: aromatase inhibition therapy | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00119262 | |
[
5
] | 110 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | The overall objective of the study was to describe the long-term effectiveness and safety of etanercept in patients with psoriatic arthritis in a Canadian clinical practice setting. | null | Psoriatic Arthritis | Psoriatic Arthritis PsA Commercial product American College of Rheumatology ACR/PASI | null | 1 | arm 1: Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months. | [
5
] | 1 | [
0
] | intervention 1: Administered according to the product monograph by subcutaneous (SC) injection | intervention 1: Etanercept | 0 | null | 0 | NCT00127842 |
[
4
] | 364 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to determine whether an alternative drug, (rifampin) given daily, is better at treating tuberculosis (TB) and more tolerable than the usual drug treatment, isoniazid (INH). Study participants will include 972, TB infected, San Francisco Jail inmates, aged 18 or older. One group of volunteer... | The purpose of this project is to evaluate the effect of two accepted regimens for treating latent tuberculosis infection (LTBI) in jail. Tuberculosis (TB) in incarcerated populations continues to be a serious problem, due to the large proportion of persons who are at high risk of both having latent tuberculosis infect... | Tuberculosis | LTBI, tuberculosis, rifampin, isoniazid, prisoners | null | 2 | arm 1: isoniazid (INH) (900 mg orally) given twice weekly for 9 months arm 2: rifampin (600 mg orally) given daily for 4 months | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Isoniazid 900 mg twice weekly intervention 2: Rifampin 600mg once per day | intervention 1: Isoniazid intervention 2: Rifampin | 1 | San Francisco | California | United States | -122.41942 | 37.77493 | 0 | NCT00128206 |
[
4
] | 321 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | To see if Disease Free Survival (DFS) is improved when complete surgical resection of liver metastases (R0) is followed by chemotherapy with CPT-11 and 5-FU/FA as FOLFIRI regimen, compared to 5-FU/FA alone. | null | Colorectal Neoplasms Liver Neoplasms | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: irinotecan 180 mg/m2 folinic acid 400 mg/m2 (DL) followed by 5 FU bolus 400 mg/m2 5 FU continuous infusion (2400 mg/m2 over 46 hours) every 2 weeks intervention 2: folinic acid 400 mg/m2(DL) followed by bolus 5 FU 400mg/m2 5 FU continuous infusion (2400 mg/m2 over 46 hours) every 2 weeks | intervention 1: Irinotecan + 5 FU + folinic acid intervention 2: Folinic Acid + 5 FU | 66 | Ghent | N/A | Belgium | 3.71667 | 51.05
Roeselare | N/A | Belgium | 3.12269 | 50.94653
Copenhagen | N/A | Denmark | 12.56553 | 55.67594
Herlev | N/A | Denmark | 12.43998 | 55.72366
Odense | N/A | Denmark | 10.38831 | 55.39594
Amiens | N/A | France | 2.3 | 49.9
Avignon | N/A | France | 4.80892 | 43.94834
Boulogne-Billan... | 0 | NCT00143403 | |
[
0
] | 24 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to see if a medication called prazosin is useful in the treatment of agitation and aggression in persons with Alzheimer's disease (AD) and other types of dementia in late life. | Although the occurrence of disruptive agitation behaviors likely are influenced by environmental/ interpersonal factors, it is also likely that behaviorally relevant neurobiologic abnormalities lower the threshold for the expression of such behavior in Alzheimer's disease. Because of the success prazosin has had in the... | Alzheimer Disease Psychomotor Agitation | double-blind treatment prazosin | null | 2 | arm 1: None arm 2: None | [
1,
2
] | 2 | [
0,
0
] | intervention 1: Participants taking prazosin. Prazosin was administered as 1 or 2 mg capsules. Doses were initiated at 1 mg at bedtime. Titration based on tolerability was conducted up to a dose of 2 mg in the morning plus 4mg at bedtime.
Duration was 8 weeks. intervention 2: Placebo is an inert substance used as a st... | intervention 1: prazosin intervention 2: placebo (inert substance) | 1 | Seattle | Washington | United States | -122.33207 | 47.60621 | 0 | NCT00161473 |
[
3
] | 29 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of this study is to find out if omalizumab is effective in treating non-allergic asthma. The US Food and Drug Administration has approved the use of omalizumab to treat moderate to severe allergic asthma. | Asthma is a chronic inflammatory disease of the lower airways. The inflammatory process is associated with changes in airway hyperresponsiveness (irritability), and airflow limitations caused by bronchoconstriction, edema, and mucous plugging. Mast cells, basophils, eosinophils, activated T-lymphocytes, macrophages, ne... | Asthma | asthma | null | 2 | arm 1: water injection arm 2: Other Names:
Xolair 150-375 milligrams administered by subcutaneous injection every 2-4 weeks depending on body weight and serum IgE. | [
2,
0
] | 2 | [
0,
10
] | intervention 1: 150-375 milligrams administered by subcutaneous injection every 2-4 weeks depending on body weight and serum IgE. intervention 2: 150-375 milligrams depending on body weight and serum IgE. | intervention 1: omalizumab intervention 2: Placebo | 1 | Baltimore | Maryland | United States | -76.61219 | 39.29038 | 0 | NCT00162773 |
[
5
] | 220 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | true | 0ALL | true | This study will determine the effectiveness of combining escitalopram, venlafaxine, or duloxetine with donepezil, a medication used in Alzheimer's disease, in improving memory, concentration, attention, and problem solving abilities, and reducing the risk of depressive relapse in older individuals with depression. | The purpose of this research study is to learn if combining an antidepressant medication (escitalopram, venlafaxine, or duloxetine) with a medication used in Alzheimer's Disease (donepezil), in elderly patients age 65 and older with major depression, will help to 1) improve and/or maintain memory, concentration, attent... | Depression Dementia | Depression Dementia Alzheimer's Disease Cognitive Donepezil Memory Function Elderly Late-Life | null | 2 | arm 1: escitalopram plus donepezil (DNP)in the experimental maintenance phase of the study.
For subjects failing to respond to escitalopram during the initial open phase of acute treatment we allowed the use of duloxetine or venlafaxine to bring about remission and establish eligibility for randomized assignment to ma... | [
0,
2
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: Escitalopram, 10mg to 20mg daily. intervention 2: Donepezil, 5mg to 10mg daily. intervention 3: Venlafaxine, 150mg to 300mg daily. intervention 4: None intervention 5: None | intervention 1: Escitalopram intervention 2: Donepezil intervention 3: Venlafaxine intervention 4: Placebo intervention 5: Duloxetine | 1 | Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062 | 0 | NCT00177671 |
[
5
] | 268 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | This study will assess the effectiveness of venlafaxine XR, randomized to either venlafaxine XR or placebo in preventing the relapse of generalized anxiety disorder after 6 months of treatment versus 12 months of treatment. | Generalized anxiety disorder (GAD) is a highly prevalent, chronic psychiatric disorder. Despite the fact that GAD frequently demands prolonged treatment with medication, very little is known about the benefits of long-term treatment. GAD is characterized by 6 months or more of exaggerated worry and tension that is unfo... | Anxiety Disorders | Generalized Anxiety Disorder Chronic Mediation Treatment Double-Blind Placebo Controlled Venlafaxine XR Relapse | null | 6 | arm 1: 6-month randomized phase of Venlafaxine XR at a flexible dose of 75 - 225 mg/d arm 2: 6-month randomized, double-blind phase of Venlafaxine XR at a flexible dose of 75 - 225 mg/d occurring between months 6 - 12 of the study arm 3: 6-month randomized, double blind phase of placebo occurring between months 6 - 12 ... | [
1,
1,
2,
1,
2,
2
] | 2 | [
0,
0
] | intervention 1: Six month intervention of Venlafaxine XR treatment with flexible range of 75 to 225 mg/d intervention 2: six month intervention with placebo drug | intervention 1: Venlafaxine XR intervention 2: Placebo | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 0 | NCT00183274 |
[
4
] | 64 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | Data have suggested that consensus interferon (CIFN) has greater antiviral activity in vitro compared with interferon alfa-2a or alfa-2b. Several clinical studies also suggest that CIFN has greater antiviral activity in patients with genotype 1 hepatitis C infection, particularly if given as a daily injection. These da... | Current treatment for hepatitis C is a pegylated interferon alfa plus ribavirin. This treatment is inadequate for patients with HCV genotype 1, since the majority of patients do not respond (termed non-responders) or respond but relapse (termed relapsers) following termination of these treatments. Data from the Veteran... | Chronic Hepatitis C | Hepatitis C interferon alfa ribavirin interferon alfacon-1 antiviral therapy | null | 2 | arm 1: Daily CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given 52 weeks (group A) arm 2: CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given for 52-72 weeks (from time of viral response +48 weeks) (group B) | [
1,
0
] | 2 | [
0,
0
] | intervention 1: CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given for either 52 weeks (group A, n = 33) or 52-72 weeks (from time of viral response +48 weeks) (group B) intervention 2: CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given for either 52 weeks (group A, n = 33) or 52-72 weeks (from time of viral response +48... | intervention 1: consensus interferon (Interferon Alfacon-1) and ribavirin intervention 2: Consensus Interferon alfa (CIFN) and ribavirin | 0 | null | 0 | NCT00211692 |
[
3
] | 18 | NON_RANDOMIZED | SINGLE_GROUP | null | 0NONE | false | 0ALL | true | The purpose of this study is to examine the effect of imatinib on dermatofibrosarcoma protuberan tumors. | null | Dermatofibrosarcoma Protuberans | newly diagnosed or recurrent | null | 1 | arm 1: None | [
5
] | 1 | [
0
] | intervention 1: 400 mg orally twice a day for 10 - 14 days | intervention 1: imatinib mesylate | 4 | Tampa | Florida | United States | -82.45843 | 27.94752
Ann Arbor | Michigan | United States | -83.74088 | 42.27756
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00243191 |
[
3
] | 112 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | The purpose of this study is to determine which of 3 different doses of tenecteplase (TNK) is better for treating stroke patients and if TNK offers an advantage over currently available treatment with tissue plasminogen activator (tPA). | Stroke is the third leading cause of death and a leading cause of adult disability in the United States and worldwide. To date, the only scientifically-proven and FDA-approved treatment for acute stroke is the clot-busting drug, tissue plasminogen activator (tPA). A newer clot-busting drug, tenecteplase (TNK), has chem... | Stroke | stroke tenecteplase TNK ischemic tissue plasminogen activator tPA | null | 2 | arm 1: tenecteplase arm 2: tissue plasminogen activator, tPA | [
1,
1
] | 2 | [
0,
0
] | intervention 1: This study will compare 3 different doses of tenecteplase to tPA. intervention 2: To date, tissue plasminogen activator (tPA) is the only scientifically-proven and FDA-approved treatment for acute stroke. | intervention 1: tenecteplase intervention 2: tissue plasminogen activator, tPA | 9 | San Diego | California | United States | -117.16472 | 32.71571
Englewood | Colorado | United States | -104.98776 | 39.64777
Baltimore | Maryland | United States | -76.61219 | 39.29038
Ann Arbor | Michigan | United States | -83.74088 | 42.27756
New Hyde Park | New York | United States | -73.68791 | 40.7351
New York | Ne... | 0 | NCT00252239 |
[
3
] | 48 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 1FEMALE | false | The purpose of this study is to determine the effects of Plavix and aspirin in women with metastatic breast cancer. | null | Breast Neoplasms | Breast Cancer Metastatic Platelet | null | 2 | arm 1: Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary w... | [
0,
4
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: Plavix intervention 2: Aspirin | 1 | St Louis | Missouri | United States | -90.19789 | 38.62727 | 0 | NCT00263211 |
[
3,
4
] | 26 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to explore the potential benefit of the medication, pentoxifylline, for the treatment of NASH. | This is an investigational study looking at subjects who have been diagnosed with nonalcoholic steatohepatitis (NASH) or 'fatty liver disease'. There is currently no FDA approved available treatment for NASH. The purpose of this study is to explore the potential benefit of the medication, pentoxifylline, for the treatm... | Nonalcoholic Steatohepatitis Liver Diseases | Fatty Liver Disease Liver NASH Nonalcoholic Steatohepatitis Nonalcoholic Fatty Liver Disease (NAFLD) Pentoxifylline | null | 2 | arm 1: 400mg PO TID arm 2: 1 pill PO TID | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 400mg PO TID intervention 2: 1 pill PO TID | intervention 1: Pentoxifylline intervention 2: Placebo | 1 | Chicago | Illinois | United States | -87.65005 | 41.85003 | 0 | NCT00267670 |
[
4
] | 64 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this study is to evaluate the efficacy and safety of zonisamide for anti-epilepsy drugs (AEDs) treated subjects with refractory simple partial, complex partial or partial with secondary generalized seizures. | null | Epilepsy | Epilepsy seizures | null | 2 | arm 1: tablet arm 2: tablet | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Tablet once or twice daily orally for 16 weeks intervention 2: Tablet once daily orally for 16 weeks | intervention 1: Zonisamide intervention 2: Lamotrigine | 8 | Changhua | Taiwan | China | 118.61765 | 29.90718
Kaohsiung | Taiwan | China | N/A | N/A
Linkou | Taiwan | China | 130.27332 | 45.2762
Taichun | Taiwan | China | N/A | N/A
Tainan | Taiwan | China | 120.26944 | 32.76205
Taipei | Taiwan | China | N/A | N/A
Taipei | Taiwan | China | N/A | N/A
Taipei | Taiwan | China | N/A ... | 0 | NCT00292461 |
[
2,
3
] | 70 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This is a phase 1/2 open-label, dose-escalation study investigating single-agent therapy with VELCADE in patients with previously treated systemic AL-amyloidosis who require further treatment. | null | Amyloidosis | null | 1 | arm 1: VELCADE | [
0
] | 1 | [
0
] | intervention 1: Once weekly at: 0.7, 1.0, 1.3 or 1.6 mg/m2
Or
Twice-weekly at: 0.7, 1.0, or 1.3 mg/m2 | intervention 1: VELCADE | 4 | Los Angeles | California | United States | -118.24368 | 34.05223
Atlanta | Georgia | United States | -84.38798 | 33.749
Boston | Massachusetts | United States | -71.05977 | 42.35843
New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00298766 | |
[
3
] | 54 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | true | Lay Language Summary: High cholesterol levels are common in persons with HIV infection. However, conventional cholesterol-lowering medications may have harmful side effects when given to HIV-infected persons. Therefore, we plan to evaluate the safety and effectiveness of policosanol, a dietary supplement derived from s... | As per Brief Summary | Dyslipidemia HIV Infections | HIV lipids dyslipidemia policosanol treatment experienced | null | 2 | arm 1: 20 mg daily of policosanol arm 2: 20 mg of microcrystalline cellulose daily | [
0,
2
] | 2 | [
0,
7
] | intervention 1: 20 mg of policosanol in capsular form daily intervention 2: Two capsules of 10 mg of microcrystalline cellulose daily | intervention 1: Policosanol intervention 2: Placebo | 1 | Chicago | Illinois | United States | -87.65005 | 41.85003 | 0 | NCT00312923 |
[
4
] | 374 | RANDOMIZED | PARALLEL | 1PREVENTION | 3TRIPLE | true | 0ALL | true | The purpose of this study is to see whether giving acetaminophen (the medicine in Tylenol) for routine infant vaccinations is helpful in preventing fever or other symptoms. | Post-vaccination fever occurs in up to 40% of infants receiving routinely recommended childhood vaccinations. Although serious events are rare, post-vaccination fever causes discomfort for the child, can lead to medical utilization, can rarely result in febrile seizure, and can cause a working parent to miss time from ... | Fever | Acetaminophen Vaccination Immunization | null | 2 | arm 1: Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations. arm 2: Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations. | [
1,
2
] | 2 | [
0,
10
] | intervention 1: Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations. intervention 2: Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations. | intervention 1: Acetaminophen intervention 2: placebo | 1 | Seattle | Washington | United States | -122.33207 | 47.60621 | 0 | NCT00325819 |
[
0
] | 3 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | To explore the hypothesis that the use of Lopinavir/ritonavir will be associated with improved CD4 immune reconstitution in volunteers who fail to demonstrate a significant CD4 cell increase (while on their first antiretroviral treatment regimen) despite sustained viral suppression by a non-Lopinavir/ritonavir-containi... | This is an open-labeled, non-randomized exploratory trial in selected volunteers who meet the stated enrollment criteria. This study will assess the impact of Lopinavir/ritonavir on CD4 immune reconstitution. All volunteers must have been on antiretroviral therapy with sustained viral load suppression of \< 400 copies/... | HIV | null | 1 | arm 1: lopinavir/ritonavir (Kaletra)400/100mg tablets by mouth twice a day for 48 weeks. | [
0
] | 1 | [
0
] | intervention 1: Dosing of Kaletra will be per package insert and BID with food. A three-drug standard of care antiretroviral regimen will be used in this study. Subjects will enter the study already on an effective, virally-suppressive treatment regimen. One of these drugs will be substituted for Lopinavir/ritonavir (K... | intervention 1: Lopinavir/Ritonavir | 1 | Baltimore | Maryland | United States | -76.61219 | 39.29038 | 0 | NCT00344487 | |
[
5
] | 155 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This 36-month open-label study of adefovir dipivoxil investigates the clinical benefits of the therapy in chronic hepatitis B patients with advanced fibrosis or cirrhosis confirmed with biopsy. Primary endpoint is histological improvement defined as a decrease of Ishak Fibrosis Score by one point or more from baseline ... | null | Hepatitis B, Chronic Cirrhosis Fibrosis Chronic Hepatitis B | Cirrhosis Advanced Fibrosis Chronic Hepatitis B Adefovir Dipivoxil | null | 1 | arm 1: 10mg once daily in patients with CHB related advanced fibrosis/cirrhosis. | [
5
] | 1 | [
0
] | intervention 1: 10mg once daily | intervention 1: adefovir dipivoxil | 12 | Pokfulam | N/A | Hong Kong | N/A | N/A
Singapore | N/A | Singapore | 103.85007 | 1.28967
Daegu | N/A | South Korea | 128.59111 | 35.87028
Pusan | N/A | South Korea | 128.3681 | 36.3809
Seoul | N/A | South Korea | 126.9784 | 37.566
Seoul | N/A | South Korea | 126.9784 | 37.566
Seoul | N/A | South Korea | 126.9784 | 37.5... | 0 | NCT00347009 |
[
4
] | 643 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to assess the clinical effectiveness and safety of golimumab intravenous (IV) infusions every 12 weeks with or without Methotrexate (MTX), compared with MTX alone, in patients with active rheumatoid arthritis (RA) despite concurrent MTX treatment. In addition, the safety of subcutaneous (SC... | This is a Phase III, double blind (neither investigator nor participant knows the treatment received), placebo-controlled (an inactive substance that is compared with the study medication to test whether the study medication has a real effect in clinical study), multicenter, 5-arm (treatment groups) study of golimumab ... | Rheumatoid Arthritis | Rheumatoid arthritis Golimumab Methotrexate Tumor Necrosis Factor-alpha Immunology | null | 5 | arm 1: Intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter with early escape (an additional 2mg/kg IV infusion of golimumab) and dose regimen adjustment (switch to 4mg/kg IV golimumab), depending on joint assessment results, at Week 16 and 24, respectively. The duration of the combine... | [
0,
0,
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: 2mg/kg or 4mg/kg will be administered as an IV infusion over 30 minutes intervention 2: Active MTX capsules, filled with microcrystalline cellulose (Avicel PH 102) and a 2.5 mg MTX tablet, will be administered at the same dose as before the study entry. intervention 3: Placebo solution will be administe... | intervention 1: Golimumab intervention 2: Methotrexate intervention 3: Placebo | 72 | Peoria | Arizona | United States | -112.23738 | 33.5806
Aventura | Florida | United States | -80.13921 | 25.95648
Orlando | Florida | United States | -81.37924 | 28.53834
Tampa | Florida | United States | -82.45843 | 27.94752
Atlanta | Georgia | United States | -84.38798 | 33.749
Lincoln | Nebraska | United States | -9... | 0 | NCT00361335 |
[
5
] | 688 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This study will evaluate the longer-term glycemic effect of two medicines approved for initial treatment of type 2 diabetes. The study consists of a 2 week screening period (2 study visits), followed by an 80 week double-blind treatment period (11 study visits). Also, a sub-study was included to look at changes in bone... | This was a phase IV, randomized, double-blind, global, multi-centre study. The study consisted of a 2 week screening period followed by an 80 week double-blind treatment period. Subjects who met all eligibility requirements were randomized in a 1:1 ratio, stratified by country, gender (male and female) and pre-screenin... | Diabetes Mellitus, Type 2 | Fasting Plasma Glucose Dual energy X ray absorptiometry (DXA) Drug-naive Type 2 diabetes mellitus Bone Mineral Density Hyperglycemia HbA1c | null | 2 | arm 1: MET began at a total daily dose of 500 mg and could be increased up to a maximum dose of MET 2000 mg. The dose level was to be increased unless a tolerability issue existed at the current dose level. arm 2: AVM began at a total daily dose of 4 mg/500 mg and could be increased up to a maximum dose of AVM 8 mg/200... | [
2,
1
] | 8 | [
0,
0,
0,
0,
0,
0,
0,
0
] | intervention 1: One 2 mg/ 500 mg capsule will be taken in the AM with the morning meal Two 2 mg/ 500 mg capsules will be taken in the PM with the evening meal intervention 2: One 2 mg/500 mg capsule will be taken in the AM with the morning meal. One 2 mg/500 mg capsule will be taken in the PM with the evening meal. int... | intervention 1: Avandamet 6 mg/1500 mg (ttd) intervention 2: Avandamet 4 mg/1000 mg (ttd) intervention 3: Avandamet 2 mg/500 mg (ttd) intervention 4: Avandamet 8 mg/ 2000 mg (ttd) intervention 5: Metformin 500 mg (ttd) intervention 6: Metformin 1000 mg (ttd) intervention 7: Metformin 1500 mg (ttd) intervention 8: Metfo... | 116 | Tuscaloosa | Alabama | United States | -87.56917 | 33.20984
Gilbert | Arizona | United States | -111.78903 | 33.35283
Glendale | Arizona | United States | -112.18599 | 33.53865
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | United States | -110.92648 | 32.22174
Tucson | Arizona | United St... | 0 | NCT00386100 |
[
4
] | 161 | RANDOMIZED | PARALLEL | 1PREVENTION | 4QUADRUPLE | false | 1FEMALE | false | The primary purpose of the protocol is to evaluate the sensitivity of 3D-pQCT (3D-Peripheral Quantitative Computed Tomography) technology to detect minute changes in bone microarchitecture. | The 3D-pQCT equipment allows the evaluation of changes occurring within the bone at "microarchitecture" level, without the need for invasive bone biopsies. The primary objective is to evaluate the sensitivity of the technology to detect a difference between those treated with risedronate 35mg OAW (once a week) or place... | Osteopenia | null | 2 | arm 1: Placebo dose arm 2: 35 mg risedronate, orally, once weekly | [
2,
0
] | 2 | [
0,
0
] | intervention 1: oral weekly for one year intervention 2: 35 mg risedronate, once a week for one year | intervention 1: Placebo comparator intervention 2: risedronate | 9 | Buenos Aires | Buenos Aires | Argentina | N/A | N/A
Heidelberg | Victoria | Australia | 145.06667 | -37.75
Toronto | Ontario | Canada | -79.39864 | 43.70643
Lyon | Lyon | France | 4.84671 | 45.74846
Saint-Etienne | Saint-Etienne | France | 4.39 | 45.43389
Toulouse | Toulouse | France | 1.44367 | 43.60426
Berlin | State... | 0 | NCT00386360 | |
[
5
] | 31 | RANDOMIZED | FACTORIAL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | The primary objective of this study is to examine the efficacy of topiramate in combination with olanzapine for the prevention of weight gain in youth with bipolar disorder. The secondary objective is to examine the tolerability of topiramate in combination with olanzapine for the prevention of weight gain in youth wit... | After consent and screening, patients will be initiated on 5mg or 10mg per day of olanzapine. Olanzapine doses will be titrated to 10-20 mg of olanzapine over one week, to a maximum of 20mg by day 21. Patients will also receive either topiramate (25mg bid titrated over 18 days to 150 mg bid. with flexibility to titrate... | Bipolar Disorder Weight Gain | Bipolar Disorder Weight Gain | null | 2 | arm 1: Patients' initial dose of topiramate 25mg bid, which was titrated over 18 days to 150 mg bid (with flexibility to titrate to 200mg bid) as tolerated. arm 2: Sugar pill | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Oral topiramate 300-400mg/day for 12 weeks intervention 2: Matched placebo to Experimental arm | intervention 1: Topiramate intervention 2: Placebo | 1 | Cincinnati | Ohio | United States | -84.51439 | 39.12711 | 0 | NCT00394095 |
[
3
] | 3 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of abnormal cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as darbepoetin alfa and G-CSF, may increase the number of red blood cells and white blood cells found i... | OBJECTIVES:
Primary
* Determine the hematological response rate in patients with myelodysplastic syndromes treated with azacitidine, darbepoetin alfa, and filgrastim (G-CSF).
Secondary
* Determine the time to leukemia progression, survival, and changes in apoptotic index of bone marrow in patients treated with this... | Leukemia Myelodysplastic Syndromes | de novo myelodysplastic syndromes refractory anemia with ringed sideroblasts refractory anemia with excess blasts refractory anemia refractory cytopenia with multilineage dysplasia chronic myelomonocytic leukemia secondary myelodysplastic syndromes childhood myelodysplastic syndromes | null | 1 | arm 1: Combination of Azacitadine andHematopoietic Growth Factors | [
0
] | 1 | [
0
] | intervention 1: Combination of Azacitadine and Hematopoietic Growth Factors | intervention 1: Azacitadine and Hematopoietic Growth Factors | 1 | Winston-Salem | North Carolina | United States | -80.24422 | 36.09986 | 0 | NCT00398047 |
[
3
] | 14 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | This is a Phase II study designed to test the efficacy of chemotherapy with docetaxel, cisplatinum (cisplatin) and 5-fluorouracil in patients with squamous cell carcinoma of the oral cavity to determine what effects these agents may have on cancer cells. | This is a Phase II study designed to test the efficacy of chemotherapy with docetaxel, cisplatinum, and 5-fluorouracil in patients with squamous cell carcinoma of the oral cavity to determine what effects these agents may have on cancer cells.
Approximately 60 patients will take part at multi-sites with potentially 20... | Squamous Cell Carcinoma Oral Cancer | Squamous Cell Carcinoma of the Oral Cavity | null | 1 | arm 1: Participants with squamous cell carcinoma receiving chemotherapy with docetaxel, cisplatinum, and 5-fluorouracil. | [
0
] | 3 | [
0,
0,
0
] | intervention 1: Docetaxel 75 mg/m2, intravenous infusion over 1 hour, mixed with normal saline per institutional standard, day 1 and then every 3 weeks. intervention 2: Cisplatin 100 mg/m2, intravenous infusion over 30 minutes to 3 hours, day 1 and then every 3 weeks. intervention 3: 5-fluorouracil 1000 mg/m2/day, 24 h... | intervention 1: Docetaxel intervention 2: Cisplatin intervention 3: 5-fluorouracil | 1 | Atlanta | Georgia | United States | -84.38798 | 33.749 | 0 | NCT00400205 |
[
3
] | 11 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this research study is to test the safety and effectiveness of VELCADE® in the treatment of acute graft-versus-host disease (GVHD) that has not responded to steroids or has worsened when the steroid dose was decreased. VELCADE® is a drug that inhibits certain immune reactions that happen when lymphocytes... | Graft-versus-host disease (GVHD) is a serious complication after bone marrow transplantation from another donor. GVHD is caused by certain cells called lymphocytes. Normally these cells make immune reactions that help protect the body from foreign substances that cause infection. Here, these cells attack the normal tis... | Graft-versus-Host Disease | Graft-versus-Host Disease bortezomib | null | 1 | arm 1: To determine if bortezomib (VELCADE®) will successfully inhibit T-cell responses in clinically acute graft-versus-host disease (GVHD) after allogeneic hematopoietic stem cell transplantation (HSCT). | [
0
] | 1 | [
0
] | intervention 1: Bortezomib at 1.3 mg/m2/dose given twice weekly for two weeks followed by a 10-day rest period. If patients have a complete response, they will receive additional cycles of bortezomib. | intervention 1: Bortezomib | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 0 | NCT00408928 |
[
0
] | 40 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | This study will investigate whether etanercept will result in improved inflammatory indices, glucose tolerance and endothelial function in patients with the metabolic syndrome. | Metabolic syndrome is an increasingly prevalent disorder associated with elevated risks of type II DM (diabetes mellitus) and cardiovascular morbidity and mortality. A subclinical inflammatory state is thought to contribute to the pathophysiology of metabolic syndrome, insulin resistance, and coronary artery disease (C... | Metabolic Syndrome | Inflammation Visceral adiposity TNF Adiponectin glucose tolerance endothelial function metabolic syndrome | null | 2 | arm 1: None arm 2: None | [
2,
1
] | 2 | [
0,
0
] | intervention 1: 50 mg one syringe sc 2X per week for three months followed by 50 mg one syringe sc 1X per week for three months intervention 2: 50 mg one syringe sc 2x per week for three months followed by 50 mg one syringe sc 1X per week for three months | intervention 1: Etanercept intervention 2: Placebo | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00413400 |
[
4
] | 228 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The primary objective of this study is to assess the efficacy of two doses of Keppra XR compared with a historical control as the placebo, in the monotherapy treatment of partial onset seizures. | null | Epilepsy | Keppra XR conversion to monotherapy partial seizures | null | 2 | arm 1: 1000 mg/day once daily for 18 weeks (administered as two levetiracetam XR tablets and two placebo tablets once daily) arm 2: 2000 mg/day once daily for 18 weeks (administered as four levetiracetam XR tablets once daily) | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Administered as two 500 mg tablets (1000 mg) and two placebo tablets once daily for 18 weeks intervention 2: Administered as four 500 mg tablets (2000 mg) once daily for 18 weeks | intervention 1: Keppra XR intervention 2: Keppra XR | 45 | Dothan | Alabama | United States | -85.39049 | 31.22323
Northport | Alabama | United States | -87.57723 | 33.22901
Phoenix | Arizona | United States | -112.07404 | 33.44838
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Bakersfield | California | United States | -119.01871 | 35.37329
Jacksonville | Flori... | 0 | NCT00419094 |
[
3
] | 21 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder characterized by progressive deterioration in the function of the pancreatic beta-cells, which are the cells that produce and secrete insulin (the hormone primarily responsible for the handling of glucose in the body). The investigators propose a double-bl... | Medications currently used in the treatment of T2DM have not been shown to modify the progressive decline in beta-cell function that occurs over time. Recent evidence, however, suggests that a new class of anti-diabetic medications, called dipeptidyl peptidase-IV (DPP-IV) inhibitors, may be able to protect beta cells a... | Type 2 Diabetes Mellitus | Type 2 diabetes beta-cell function sitagliptin intensive insulin therapy | null | 2 | arm 1: Sitagliptin 100mg once a day (od) by mouth (po) arm 2: Placebo once a day (od) by mouth (po) | [
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: sitagliptin 100 mg once a day intervention 2: placebo once a day intervention 3: metformin 1000 mg twice a day (bid) by mouth (po) | intervention 1: Sitagliptin intervention 2: Placebo intervention 3: metformin | 1 | Toronto | Ontario | Canada | -79.39864 | 43.70643 | 0 | NCT00420511 |
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