FEATURE_phases list | FEATURE_enrollmentCount int64 | FEATURE_allocation string | FEATURE_interventionModel string | FEATURE_primaryPurpose class label | FEATURE_masking class label | FEATURE_healthyVolunteers bool | FEATURE_sex class label | FEATURE_oversightHasDmc bool | FEATURE_briefSummary string | FEATURE_detailedDescription string | FEATURE_conditions string | FEATURE_conditionsKeywords string | FEATURE_protocolPdfText string | FEATURE_numArms int64 | FEATURE_armDescriptions string | FEATURE_armGroupTypes list | FEATURE_numInterventions int64 | FEATURE_interventionTypes list | FEATURE_interventionDescriptions string | FEATURE_interventionNames string | FEATURE_numLocations int64 | FEATURE_locationDetails string | LABEL_ct_level_ade_population int64 | LABEL_sum_dosing_errors int64 | LABEL_dosing_error_rate float32 | LABEL_wilson_label int64 | METADATA_nctId string | METADATA_overallStatus class label | METADATA_completionDate date32 | METADATA_startDate date32 | METADATA_leadSponsorName string | METADATA_leadSponsorClass class label | METADATA_hasProtocol bool | METADATA_hasSap bool | METADATA_hasIcf bool | METADATA_protocolPdfLinks string | METADATA_count_Accidental drug intake by child int64 | METADATA_count_Accidental overdose int64 | METADATA_count_Accidental overdose (therapeutic agent) int64 | METADATA_count_Accidental underdose int64 | METADATA_count_Deliberate overdose int64 | METADATA_count_Dose calculation error int64 | METADATA_count_Drug administration error int64 | METADATA_count_Drug overdose int64 | METADATA_count_Drug overdose accidental int64 | METADATA_count_Extra dose administered int64 | METADATA_count_Incorrect dosage administered int64 | METADATA_count_Incorrect dose administered int64 | METADATA_count_Incorrect drug administration duration int64 | METADATA_count_Incorrect drug administration rate int64 | METADATA_count_Incorrect product administration duration int64 | METADATA_count_Intentional overdose int64 | METADATA_count_Medication error int64 | METADATA_count_Medication monitoring error int64 | METADATA_count_Multiple drug overdose int64 | METADATA_count_Multiple drug overdose accidental int64 | METADATA_count_Multiple drug overdose intentional int64 | METADATA_count_Multiple use of single-use product int64 | METADATA_count_Non-accidental overdose int64 | METADATA_count_Overdose int64 | METADATA_count_Overdose NOS int64 | METADATA_count_Overmedication int64 | METADATA_count_Prescribed overdose int64 | METADATA_count_Treatment noncompliance int64 | METADATA_count_Underdose int64 | METADATA_count_Unintentional medical device removal int64 | METADATA_count_Unintentional medical device removal by patient int64 | METADATA_wilson_lower_bound float32 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
[
4
] | 186 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This study is designed to collect long term safety data of indacaterol (300 µg o.d.) in Japanese patients with moderate to severe COPD. Data from this study will be used for the registration of indacaterol in Japan. | null | Chronic Obstructive Pulmonary Disease (COPD) | COPD, Chronic Obstructive Pulmonary Disease, Indacaterol, long acting β2-agonist | null | 2 | arm 1: Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study. arm 2: Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monot... | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Indacaterol 300 µg once daily (od) via SDDPI intervention 2: Salmeterol 50 µg twice daily (bid) via Diskus® | intervention 1: Indacaterol 300 µg intervention 2: Salmeterol 50 µg | 37 | Asahikawa | N/A | Japan | 142.36489 | 43.77063
Bunkyō City | N/A | Japan | 139.4217 | 35.5331
Gifu | N/A | Japan | 136.76039 | 35.42291
Hamamatsu | N/A | Japan | 137.73333 | 34.7
Himeji | N/A | Japan | 134.7 | 34.81667
Hiroshima | N/A | Japan | 132.45 | 34.4
Iwata | N/A | Japan | 137.85 | 34.7
Kanazawa | N/A | Japan | ... | 186 | 0 | 0 | 0 | NCT00876694 | 1COMPLETED | 2010-10-01 | 2009-03-01 | Novartis Pharmaceuticals | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 202 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This single arm study will assess the efficacy, safety and tolerability of once monthly administration of subcutaneous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia. Patients will receive subcutaneous Mircera at a starting dose of 120, 200 or 360 micrograms every 4 week... | null | Anemia | null | 1 | arm 1: Eligible participants will be administered continuous erythropoietin receptor activator (C.E.R.A.\[Mircera\]) intravenously (IV) every 4 weeks for 44 weeks. The starting dose of 120, 200, or 360 micrograms (mcg) will be based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.... | [
0
] | 1 | [
0
] | intervention 1: Subcutaneous injection every 4 weeks (starting dose of 120, 200 or 360 micrograms, based on previous ESA therapy) | intervention 1: methoxy polyethylene glycol-epoetin beta [Mircera] | 12 | Agadir | N/A | Morocco | -9.59815 | 30.42018
Casablanca | N/A | Morocco | -7.61138 | 33.58831
Casablanca | N/A | Morocco | -7.61138 | 33.58831
Casablanca | N/A | Morocco | -7.61138 | 33.58831
FÉS | N/A | Morocco | N/A | N/A
Khouribga | N/A | Morocco | -6.9063 | 32.88108
Marrakesh | N/A | Morocco | -7.99994 | 31.63416
M... | 194 | 0 | 0 | 0 | NCT00882713 | 1COMPLETED | 2010-10-01 | 2009-02-01 | Hoffmann-La Roche | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
0
] | 42 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | true | The purpose of this study is to assess the clinical efficacy of proton pump inhibitors in comparison to aerosolized swallowed steroids for the treatment of eosinophilic esophagitis (EE). EE is an increasingly recognized disorder that has been associated with dysphagia and food impaction. The presence of anatomical abno... | null | Eosinophilic Esophagitis | Eosinophilic esophagitis acid reflux | null | 2 | arm 1: None arm 2: None | [
1,
1
] | 2 | [
0,
0
] | intervention 1: 440 µg twice daily for 8 weeks intervention 2: 40 mg once daily for 8 weeks | intervention 1: Swallowed fluticasone intervention 2: Esomeprazole | 1 | Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 | 42 | 0 | 0 | 0 | NCT00895817 | 1COMPLETED | 2010-10-01 | 2008-04-01 | Walter Reed Army Medical Center | 1FED | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 2,204 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | Both Olmesartan (OLM)/Amlodipine (AML) combination and Hydrochlorothiazide (HCTZ) have proven to be efficacious and safe in lowering blood pressure, but may not always be sufficient. This study is to test efficacy and safety of the combination of OLM/AML and HCTZ in hypertensive patients whose blood pressure is not ade... | null | Essential Hypertension | Add on treatment essential hypertension | null | 6 | arm 1: The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2. arm 2: Participants could start receiving this combination in randomized, double-blind, 8-week Pe... | [
0,
0,
0,
0,
0,
0
] | 6 | [
0,
0,
0,
0,
0,
0
] | intervention 1: Oral tablets containing Olmesartan medoxomil-Amlodipine 40-10 mg, given once daily intervention 2: Coated, oral tablets containing Olmesartan 40mg-Amlodipine 10mg + 1 Hydrochlorothiazide 12.5mg oral tablet + 1 Hydrochlorothiazide 12.5mg oral, placebo tablet. All tablets are given once a day. interventio... | intervention 1: Olmesartan medoxomil 40 mg - Amlodipine 10 mg intervention 2: Olmesartan 40mg-Amlodipine 10mg-Hydrochlorothiazide 12.5mg intervention 3: Olmesartan 40mg-Amlodipine 10mg-Hydrochlorothiazide 25mg intervention 4: OLM 40mg-AML 10mg-Hydrochlorothiazide 12.5mg intervention 5: OLM 40mg-AML 10mg-Hydrochlorothia... | 117 | Graz | N/A | Austria | 15.45 | 47.06667
Salzburg | N/A | Austria | 13.04399 | 47.79941
Vienna | N/A | Austria | 16.37208 | 48.20849
Antwerp | N/A | Belgium | 4.40026 | 51.22047
Lauwe | N/A | Belgium | 3.1869 | 50.79479
Leuven | N/A | Belgium | 4.70093 | 50.87959
Liège | N/A | Belgium | 5.56749 | 50.63373
Massemen | N/A... | 2,743 | 0 | 0 | 0 | NCT00902538 | 1COMPLETED | 2010-10-01 | 2009-04-01 | Daiichi Sankyo | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 78 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to determine if Amitiza (lubiprostone), a drug proven to be safe and effective for chronic constipation, will also improve constipation symptoms in Parkinson's Disease patients. We will also evaluate the impact of the drug on changes in bowel movement consistency, quality of life and motor ... | Parkinson's disease (PD) affects about one million people in the United States. It is a common neurological condition that is clinically defined by rigidity (muscle stiffness), bradykinesia (slowness of movement) and tremor. Parkinson's Disease , however, reveals numerous non-motor symptoms that have been underemphasiz... | Parkinson's Disease | constipation Parkinson's disease | null | 2 | arm 1: Amitiza arm 2: Matching Placebo | [
1,
2
] | 1 | [
0
] | intervention 1: Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily. | intervention 1: LUBIPROSTONE | 2 | Tampa | Florida | United States | -82.45843 | 27.94752
Houston | Texas | United States | -95.36327 | 29.76328 | 54 | 0 | 0 | 0 | NCT00908076 | 1COMPLETED | 2010-10-01 | 2009-02-01 | Baylor College of Medicine | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 98 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This study is being conducted to evaluate the efficacy and safety of icatibant compared to placebo in patients experiencing acute attacks of hereditary angioedema (HAE). | This Phase III study consisted of two parts: A controlled phase and an open label extension (OLE) phase.
The controlled phase describes the double blind part of the study and was intended to evaluate the efficacy and safety of icatibant compared with placebo for the first treated cutaneous and/or abdominal attack.
Pa... | Hereditary Angioedema | HAE Type I HAE Type II HAE | null | 2 | arm 1: Single subcutaneous injection of matching placebo arm 2: Single subcutaneous injection of icatibant, 30 mg | [
2,
0
] | 2 | [
0,
0
] | intervention 1: Single subcutaneous injection of icatibant, 30 mg intervention 2: Single subcutaneous injection of matching placebo | intervention 1: Icatibant intervention 2: Placebo | 64 | Alabaster | Alabama | United States | -86.81638 | 33.24428
Birmingham | Alabama | United States | -86.80249 | 33.52066
Scottsdale | Arizona | United States | -111.89903 | 33.50921
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Granada Hills | California | United States | -118.52314 | 34.26472
La Jolla | ... | 180 | 0 | 0 | 0 | NCT00912093 | 1COMPLETED | 2010-10-01 | 2009-07-16 | Shire | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 122 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose and (primary) objectives of this study are to evaluate the efficacy, safety, and tolerability of TS-022 in adults with atopic dermatitis who have moderate to very severe pruritus (itching), following a 28-day regimen of twice-daily topical application. | (none provided) | Atopic Dermatitis | Atopic Dermatitis Pruritus | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
2,
0,
0,
0
] | 2 | [
0,
0
] | intervention 1: Lotion intervention 2: Lotion | intervention 1: TS022 intervention 2: Vehicle | 15 | La Jolla | California | United States | -117.2742 | 32.84727
San Diego | California | United States | -117.16472 | 32.71571
Jacksonville | Florida | United States | -81.65565 | 30.33218
Kissimmee | Florida | United States | -81.41667 | 28.30468
Miramar | Florida | United States | -80.23227 | 25.98731
Ormond Beach | Flo... | 122 | 0 | 0 | 0 | NCT00914186 | 1COMPLETED | 2010-10-01 | 2009-06-01 | Taisho Pharmaceutical R&D Inc. | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 3 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The goal of this clinical research study is to learn if obatoclax mesylate can help to control systemic mastocytosis. The safety of this drug will also be tested. | The Study Drug:
Obatoclax mesylate is designed to block the growth of malignant mast cells. This may cause cancer cells to die.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive obatoclax mesylate through a peripheral intravenous catheter (a needle in the vein of... | Leukemia Systemic Mastocytosis | Leukemia Systemic Mastocytosis SM Obatoclax mesylate GX15-070MS | null | 1 | arm 1: 30 mg by vein over 3 hours Days 1-3, 14-day cycle | [
0
] | 1 | [
0
] | intervention 1: 30 mg given by vein over 3 hours on Days 1-3 of each 14-day study cycle. | intervention 1: Obatoclax Mesylate | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 3 | 0 | 0 | 0 | NCT00918931 | 6TERMINATED | 2010-10-01 | 2009-06-01 | M.D. Anderson Cancer Center | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
2,
3
] | 1 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | Background:
* This study will use cells called DMF5 to treat patients with metastatic melanoma (melanoma that has spread beyond the primary tumor site).
* The DMF5 cells were first obtained from a tumor of a patient with melanoma with HLA-A201 tissue type. The tumor cells were grown in the laboratory, and when the lab... | Background:
In previous trials in the Surgery Branch, a 51 percent objective response rate has been observed in heavily pre-treated patients with metastatic melanoma undergoing adoptive cell transfer therapy utilizing a non-myeloablative preparative regimen followed by administration of autologous tumor-reactive lymph... | Melanoma Malignant Melanoma Melanoma, Experimental | Clinical Response Immunotherapy Cancer Cytokines Adoptive Cell Therapy Melanoma Metastatic Melanoma | null | 1 | arm 1: Melanoma that has invaded deep into the skin, lymph nodes, or other parts of the body. | [
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: given intravenously over 20-30 minutes (between 1 x 10\^9 and 1 x 10\^11 lymphocytes) after expansion in interleukin-2 and OKT-3 intervention 2: 60 mg/kg/day x 2 days intravenously intervention 3: 25 mg/m\^2/day intravenously x 5 days intervention 4: 720,000 IU/kg/dose intravenously every 8 hours for up... | intervention 1: DMF5 Melanoma Reactive TIL intervention 2: Cyclophosphamide intervention 3: Fludarabine intervention 4: Aldesleukin | 1 | Bethesda | Maryland | United States | -77.10026 | 38.98067 | 1 | 0 | 0 | 0 | NCT00924001 | 6TERMINATED | 2010-10-01 | 2007-08-01 | National Cancer Institute (NCI) | 0NIH | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
2,
3
] | 24 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | null | Background:
* Blepharospasm is caused by excessive contraction of the muscles that close the eye. It can be treated with injections of botulinum neurotoxin (BoNT), which works by weakening those muscles.
* Acetyl Hexapeptide-8 (AH-8) is the active ingredient in a number of cosmetic creams used to treat wrinkles, and i... | OBJECTIVE:
To study the efficacy of cutaneous application of Acetyl Hexapeptide-8 (AH8) in the therapy of blepharospasm.
STUDY POPULATION:
22 patients with blepharospasm.
DESIGN:
This will be a double blind, placebo-controlled trial. Patients receiving treatment of blepharospasm with botulinum neurotoxin (BoNT) wi... | Focal Dystonia | Dystonia Blepharospasm Botulinum Toxin Treatment Clinical Trial Focal Dystonia | null | 2 | arm 1: AH-8 containing topical intervention arm 2: topical intervention WITHOUT AH-8 | [
0,
2
] | 2 | [
0,
0
] | intervention 1: AH-8 containing topical treatment intervention 2: topical treatment NOT containing AH-8 | intervention 1: Acetyl-Hexapeptide Topical Treatment intervention 2: placebo | 1 | Bethesda | Maryland | United States | -77.10026 | 38.98067 | 24 | 0 | 0 | 0 | NCT00942851 | 1COMPLETED | 2010-10-01 | 2009-07-01 | National Institute of Neurological Disorders and Stroke (NINDS) | 0NIH | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 37 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This open-label randomized 2 arm study will determine the emergence of viral resistance in participants with seasonal influenza A infection treated with oseltamivir. Eligible participants less than or equal to (\</=) 5 years of age will be randomized to receive oseltamivir at either standard dose (30-75 milligrams \[mg... | null | Influenza | null | 2 | arm 1: Oseltamivir capsule will be administered orally at a dose of 75 mg BID in adult participants and children will receive oseltamivir powder for oral suspension dose (at 12 milligrams/ milliliter \[mg/mL\]) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days. arm ... | [
0,
1
] | 1 | [
0
] | intervention 1: Standard dose (30 - 75 mg orally bid) or double dose (60 - 150 mg orally bid); for 5 days | intervention 1: Oseltamivir | 3 | Curitiba | N/A | Brazil | -49.27306 | -25.42778
São Paulo | N/A | Brazil | -46.63611 | -23.5475
São Paulo | N/A | Brazil | -46.63611 | -23.5475 | 37 | 0 | 0 | 0 | NCT00949533 | 1COMPLETED | 2010-10-01 | 2009-08-01 | Hoffmann-La Roche | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
4
] | 494 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this trial was to evaluate the effectiveness and safety of Naturlose (Tagatose) for glycemic control in people with Type 2 diabetes who were not taking other medications for the condition and who were under diet control and exercise.
The study lasted approximately one year. HbA1c was monitored every 2 m... | This was a Phase 3, prospective, randomized, double-blind, placebo-controlled, multicenter clinical trial to evaluate the efficacy, safety, and tolerability of D-tagatose (as compared to placebo). Prior to the start of treatment, subjects participated in an 8-week run-in period during which diabetes education was provi... | Type 2 Diabetes | null | 2 | arm 1: 1.5 g Sugar Substitute Splenda, dissolved in 125 ml of water three times per day. If intestinal problems occur, the dose should be reduced to 1 g dissolved in water tid or additionally reduced to 0.5 g dissolved in 125 ml of water tid if problems still persisted, until patients adapted to treatment. arm 2: 15 g ... | [
2,
0
] | 2 | [
0,
0
] | intervention 1: powder; 15 grams three times daily; one year intervention 2: 1.5 g powder tid | intervention 1: Tagatose intervention 2: Sugar Substitute Splenda | 46 | Hueytown | Alabama | United States | -86.99666 | 33.45122
Huntsville | Alabama | United States | -86.58594 | 34.7304
Jonesboro | Arkansas | United States | -90.70428 | 35.8423
Huntington Park | California | United States | -118.22507 | 33.98168
Atlanta | Georgia | United States | -84.38798 | 33.749
Blue Ridge | Georgia... | 392 | 0 | 0 | 0 | NCT00955747 | 1COMPLETED | 2010-10-01 | 2007-04-01 | Robert Lodder | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
4
] | 18 | NA | SINGLE_GROUP | 4SUPPORTIVE_CARE | 0NONE | false | 0ALL | null | This was an open-label, single-dose study to assess the safety, tolerability, and absorption/distribution kinetics of a single 100 µg dose of fentanyl sublingual spray in opioid-tolerant cancer subjects, with or without oral mucositis. | RATIONALE: One dose of fentanyl sublingual spray may be effective in relieving pain in opioid-tolerant cancer patients.
PURPOSE: This phase III trial is studying the side effects of fentanyl sublingual spray and to see how well it works in treating opioid-tolerant cancer patients with or without oral mucositis.
OBJEC... | Mucositis Pain Unspecified Adult Solid Tumor, Protocol Specific | mucositis unspecified adult solid tumor, protocol specific pain | null | 1 | arm 1: Participants received a single administration of fentanyl sublingual spray 100 µg sublingually. | [
0
] | 1 | [
0
] | intervention 1: Fentanyl was supplied in single-dose glass vials assembled into a delivery device to be used as a sublingual spray. | intervention 1: Fentanyl sublingual spray | 1 | Scottsdale | Arizona | United States | -111.89903 | 33.50921 | 18 | 0 | 0 | 0 | NCT00956254 | 1COMPLETED | 2010-10-01 | 2009-10-01 | INSYS Therapeutics Inc | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
0
] | 14 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | Endorphins are released in response to breathing difficulty and can modify the perception of breathlessness. In this randomized placebo-controlled trial, resistive breathing loads are used to provoke breathlessness in patients with chronic obstructive pulmonary disease. The hypothesis of the study is that intravenous (... | Study Design:
The study is a randomized, double-blind, placebo-controlled investigation comparing the intravenous administration of:
* normal saline, considered a placebo, is expected to have no effect on patient ratings of dyspnea.
* naloxone, an opioid receptor antagonist with penetration into the central nervous s... | Chronic Obstructive Pulmonary Disease | breathlessness intensity breathlessness unpleasantness endorphins resistive breathing loads | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 10 mg naloxone in 25 ml total volume intervention 2: 25 ml | intervention 1: naloxone intervention 2: normal saline | 1 | Lebanon | New Hampshire | United States | -72.25176 | 43.64229 | 28 | 0 | 0 | 0 | NCT00958919 | 1COMPLETED | 2010-10-01 | 2009-08-01 | Dartmouth-Hitchcock Medical Center | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 282 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to compare reduction in A1C for subjects taking Saxagliptin and Metformin XR vs. uptitrated Metformin XR. | null | Type 2 Diabetes | T2DM Metformin A1c | null | 2 | arm 1: Saxagliptin arm 2: Metformin Extended Release | [
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: 5mg oral tablet once daily intervention 2: 500mg oral tablet once daily intervention 3: 750mg, 2 tablets once daily | intervention 1: Saxagliptin intervention 2: Metformin XR intervention 3: Metformin XR | 35 | Jonesboro | Arkansas | United States | -90.70428 | 35.8423
Anaheim | California | United States | -117.9145 | 33.83529
Fountain Valley | California | United States | -117.95367 | 33.70918
Los Angeles | California | United States | -118.24368 | 34.05223
Pasadena | California | United States | -118.14452 | 34.14778
Sacra... | 282 | 0 | 0 | 0 | NCT00960076 | 1COMPLETED | 2010-10-01 | 2009-08-01 | AstraZeneca | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
0
] | 49 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 1FEMALE | true | The purpose of this study is to compare the efficacy of calcium carbonate to fluoxetine in the treatment of moderate to severe PMS. Second, to compare each active agent to a placebo control. Third, to evaluate the efficacy of each treatment for specific symptom clusters (i.e. affective and somatic). Fourth, to determin... | This is a double blind, randomized, placebo controlled, parallel study that will randomize 60 women at the Yale site into treatment. Participants will be screened at various collaborating ob-gyn centers for possible PMS symptoms, and direct referrals from the community will also be accepted. Subject participation lengt... | Premenstrual Syndrome | Premenstrual syndrome PMS calcium | null | 3 | arm 1: Fluoxetine arm 2: Calcium arm 3: None | [
1,
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: Fluoxetine 20 mg per day for 4 menstrual cycles. For the fifth menstrual cycle, all women will receive calcium. Women on Fluoxetine will continue taking it in addition to 1200mg of calcium. intervention 2: 1200 mg of calcium to be taken for 5 menstrual cycles. intervention 3: For 5 cycles, women will re... | intervention 1: Fluoxetine intervention 2: Calcium intervention 3: Placebo | 1 | New Haven | Connecticut | United States | -72.92816 | 41.30815 | 32 | 0 | 0 | 0 | NCT00965562 | 1COMPLETED | 2010-10-01 | 2000-09-01 | Donaghue Medical Research Foundation | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
2
] | 67 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This is a two stage, Phase Ib study designed to describe the pharmacokinetics of GDC-0449 in patients with advanced solid tumors that are refractory to treatment or for whom no standard therapy exists. | null | Solid Cancers | Hedgehog BCC basal cell carcinoma | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Daily oral repeating dose intervention 2: Three times weekly oral repeating dose intervention 3: Once weekly oral repeating dose | intervention 1: GDC-0449 intervention 2: GDC-0449 intervention 3: GDC-0449 | 0 | null | 63 | 0 | 0 | 0 | NCT00968981 | 1COMPLETED | 2010-10-01 | 2009-09-01 | Genentech, Inc. | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 130 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | true | 0ALL | true | The primary objectives of this study are to assess the efficacy of levetiracetam XR in increasing the percentage of subjects with no heavy drinking days and in reducing the weekly percentage of heavy drinking days in subjects with alcohol dependence confirmed by DSM-IV criteria and who frequently consume 10 or more dri... | null | Alcoholism | Alcoholism Alcohol Drinking Alcoholic Intoxication Alcohol Abuse | null | 2 | arm 1: Group received Levetiracetam arm 2: Placebo | [
1,
2
] | 4 | [
5,
5,
0,
0
] | intervention 1: 11 BBCET sessions intervention 2: 11 BBCET Sessions intervention 3: 500mg - 2000mg Once per day 16 weeks intervention 4: 500mg - 2000mg Once per day 16 weeks | intervention 1: BBCET intervention 2: BBCET intervention 3: Levetiracetam XR intervention 4: Sugar Pill | 5 | Baltimore | Maryland | United States | -76.61219 | 39.29038
Boston | Massachusetts | United States | -71.05977 | 42.35843
Lebanon | New Hampshire | United States | -72.25176 | 43.64229
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Charlottesville | Virginia | United States | -78.47668 | 38.02931 | 130 | 0 | 0 | 0 | NCT00970814 | 1COMPLETED | 2010-10-01 | 2009-10-01 | National Institute on Alcohol Abuse and Alcoholism (NIAAA) | 0NIH | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 43 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of the study is to further investigate how much of the drug substance "mycophenolate mofetil" can be found in the blood of patients with kidney or renal transplants when treated with Myfenax® or CellCept®. Additionally, the safety and side effects of the two products will be compared. All information alread... | null | Stable Renal Transplant Recipients | renal transplantation mycophenolate mofetil pharmacokinetics immunosuppression | null | 2 | arm 1: The reference product was CellCept® and test product was Myfenax®. In period I, participants received CellCept on Days 1-14. In period II, participants crossed-over to receive Myfenax on Days 15-28. In period III, participants received Myfenax until the end of the study (Days 29-112).
Doses of mycophenolate mof... | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Each participant received at least 500 mg orally, twice daily (morning and evening) during those study periods labeled as 'T' (test drug). Participants receive the dose equivalent to the pre-study dose (within the recommended therapeutic range) of mycophenolate mofetil. intervention 2: Each participant ... | intervention 1: mycophenolate mofetil (Myfenax) intervention 2: mycophenolate mofetil (Cellcept) | 0 | null | 128 | 0 | 0 | 0 | NCT00991510 | 6TERMINATED | 2010-10-01 | 2009-08-01 | Teva Branded Pharmaceutical Products R&D, Inc. | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 17 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | true | 0ALL | true | Botulinum toxin-A (BTX-A) prevents the release of acetylcholine in presynaptic terminals of the neuromuscular junction. It has been proposed to be effective in spastic conditions of the head and neck including oromandibular dystonias, bruxism, and muscular hypertrophy (1,2,3,4). However, only one randomized, double-bli... | null | Face Pain | Bruxism Myofascial pain EMG Ultrasound Masticatory myofascial face pain from bruxism and clenching | null | 2 | arm 1: lidocaine injection group arm 2: None | [
1,
0
] | 2 | [
0,
0
] | intervention 1: 1cc 1% intervention 2: botulinum toxin | intervention 1: lidocaine intervention 2: chemodenervation | 1 | Los Angeles | California | United States | -118.24368 | 34.05223 | 17 | 0 | 0 | 0 | NCT00992108 | 6TERMINATED | 2010-10-01 | 2009-10-01 | University of California, Los Angeles | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
2
] | 43 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This clinical study is designed to evaluate the safety and tolerability of a single oral administration of a Metadoxine slow release formulation to subjects diagnosed as having ADHD. Study also assess cognitive effects of such drug administration. | Primary outcome measure is the safety and tolerability of study drug after a single dosing.
Additional outcomes include commission error rate from the TOVA test. The result is measured as standard score in % compared to the values of the normal population.
Exploratory outcome measures include:
1. TOVA measures like ... | Attention Deficit Hyperactivity Disorder | ADHD ADD TOVA METADOXINE | null | 1 | arm 1: Metadoxine is a pyrolate salt of Pyridoxine | [
0
] | 1 | [
0
] | intervention 1: one oral 1400mg dose (2 tablets) | intervention 1: Extended Release Metadoxine | 1 | Petah Tikva | N/A | Israel | 34.88747 | 32.08707 | 38 | 0 | 0 | 0 | NCT00995085 | 1COMPLETED | 2010-10-01 | 2009-10-01 | Alcobra Ltd. | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 40 | RANDOMIZED | PARALLEL | 9OTHER | 2DOUBLE | true | 0ALL | false | The hypothesis is that treating hay fever patients who had daytime sleepiness and slowed thinking because of the hay fever will improve when treated with an effective anti-hay fever medication, an intranasal steroid, that is will have less daytime sleepiness and demonstrate better thinking. | In this study of patients with seasonal allergic rhinitis we will monitor daytime sleepiness as measured by validated daytime sleep score (Eppworth Daytime Sleepiness Scale) and cognitive performance weekly as measured by a validated test of cognitive performance (TOVA). The treatment group with intervention of flutica... | Seasonal Allergic Rhinitis | Hay Fever Daytime somnolence Cognition | null | 2 | arm 1: Placebo treatment given as a once daily dose intranasally.in subjects with active seasonal allergic rhinitis. arm 2: IFluticasone Furoate 110 mcg given intranasly once daily in am as an active treatment of seasonal allergic rhinitis | [
2,
0
] | 2 | [
0,
0
] | intervention 1: Fluticasone fuorate nasal spray 110 mcg 2 sprays each nostril am will be compared to similar appearing placebo given 2 sprays each nostril am. The subjects will receive one week placebo nasal spray to establish a baseline then they will then be switched to a nasal spray of fluticasone furoate 110 mcg on... | intervention 1: Fluticasone furoate Nasal Spray 110 mcg intervention 2: Placebo | 0 | null | 40 | 0 | 0 | 0 | NCT00997620 | 1COMPLETED | 2010-10-01 | 2010-03-01 | Western Sky Medical Research | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 528 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of this study is to find out if 60 mg of duloxetine given once a day by mouth for 8 weeks to patients diagnosed with major depressive disorder, who also report associated painful physical symptoms, is better than placebo when treating depression and its associated painful symptoms. | null | Major Depressive Disorder | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks. intervention 2: Participants received placebo QD, po for 8 weeks. | intervention 1: Duloxetine intervention 2: Placebo | 37 | Beverly Hills | California | United States | -118.40036 | 34.07362
Sherman Oaks | California | United States | -118.44925 | 34.15112
Jacksonville | Florida | United States | -81.65565 | 30.33218
West Palm Beach | Florida | United States | -80.05337 | 26.71534
Indianapolis | Indiana | United States | -86.15804 | 39.7683... | 528 | 0 | 0 | 0 | NCT01000805 | 1COMPLETED | 2010-10-01 | 2009-11-01 | Eli Lilly and Company | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 38 | RANDOMIZED | CROSSOVER | null | 0NONE | false | 0ALL | false | The purpose of this study is to compare the effect on systolic pressure of the 3 drugs given together in the cardiovascular combination pill (acetylsalicylic acid, simvastatin, and ramipril) to the effect on systolic pressure of ramipril given alone. | null | Hypertension | cardiovascular fixed dose combination pill hypertension | null | 2 | arm 1: A once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril) for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and... | [
0,
1
] | 2 | [
0,
0
] | intervention 1: A once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril) for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvast... | intervention 1: Combination pill intervention 2: Ramipril | 1 | New York | New York | United States | -74.00597 | 40.71427 | 60 | 0 | 0 | 0 | NCT01005290 | 6TERMINATED | 2010-10-01 | 2009-10-01 | Ferrer Internacional S.A. | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 190 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of this trial is to determine the efficacy and safety of A3309 administered to patients with chronic idiopathic constipation. | null | Constipation Chronic Constipation | Chronic idiopathic constipation A3309 | null | 4 | arm 1: Administered once daily for the duration of the study arm 2: Administered once daily for the duration of the study. arm 3: Administered once daily for the duration of the study arm 4: Administered once daily for the duration of the study | [
0,
0,
0,
2
] | 1 | [
0
] | intervention 1: A3309 in three different dosage levels or placebo once daily for the duration of the study | intervention 1: A3309 | 44 | Huntsville | Alabama | United States | -86.58594 | 34.7304
Chandler | Arizona | United States | -111.84125 | 33.30616
Phoenix | Arizona | United States | -112.07404 | 33.44838
Anaheim | California | United States | -117.9145 | 33.83529
Encinitas | California | United States | -117.29198 | 33.03699
San Diego | Californi... | 190 | 0 | 0 | 0 | NCT01007123 | 1COMPLETED | 2010-10-01 | 2009-11-01 | Albireo | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 230 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The purpose of the 12-week core study was to demonstrate that canakinumab given upon acute gout flares relieves the signs and symptoms and prevents recurrence of gout flares in patients with frequent flares of gout for whom non-steroidal anti-inflammatory drugs (NSAIDs) and/ or colchicine are contraindicated, not toler... | Masking:
Core: Double Blind (Subject, Investigator) Extension 1: Double Blind (Subject, Investigator) Extension 2: Open-label, terminated | Acute Gout | frequent flares gout anti-interleukin-1β monoclonal antibody | null | 2 | arm 1: Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive re-dose of study drug on demand upon occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after previous dos... | [
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: Canakinumab 150 mg was supplied in 6 mL glass vials each containing nominally 150 mg canakinumab (plus 20% overfill). intervention 2: Triamcinolone acetonide 40 mg was supplied as a suspension. intervention 3: Placebo to canakinumab was supplied in 6 mL glass vials containing placebo powder as a lyophil... | intervention 1: Canakinumab 150 mg intervention 2: Triamcinolone acetonide 40 mg intervention 3: Placebo to canakinumab intervention 4: Placebo to triamcinolone acetonide | 47 | Darlinghurst | New South Wales | Australia | 151.21925 | -33.87939
Fitzroy | Victoria | Australia | 144.97833 | -37.79839
Heidelberg | Victoria | Australia | 145.06667 | -37.75
Daw Park SA | N/A | Australia | N/A | N/A
Gozée | N/A | Belgium | 4.35273 | 50.33461
Mount Pearl | Newfoundland and Labrador | Canada | -52.781... | 444 | 0 | 0 | 0 | NCT01029652 | 1COMPLETED | 2010-10-01 | 2009-12-01 | Novartis Pharmaceuticals | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 1 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this research is to see the effects (good and bad) of Melatonin CR on sleep in 4-8 year old children with autism spectrum disorders and sleep problems. | The title of this acute, open-label pilot study is "Controlled Release Melatonin (Melatonin CR) for the treatment of impaired sleep maintenance (ISM) in 4-8 year old children with autism spectrum disorders (ASD)." Maintenance of sleep is a significant challenge in the treatment of children with neurodevelopmental disab... | Sleep Disorder | Impaired sleep maintenance Autism Spectrum Disorders Pediatric | null | 1 | arm 1: Subjects receive Natrol (sustained release melatonin) 5mg tablet 30 minutes prior to bedtime for 10 to 14 days | [
0
] | 1 | [
0
] | intervention 1: 5mg of sustained released melatonin. One tablet given 30 minutes prior to bedtime. | intervention 1: Natrol | 1 | Omaha | Nebraska | United States | -95.94043 | 41.25626 | 1 | 0 | 0 | 0 | NCT01033565 | 6TERMINATED | 2010-10-01 | 2010-03-04 | University of Nebraska | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 465 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This trial is conducted in Africa, Asia, Europe and the United States of America (USA).
The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart) with insulin glargine in patients with type 2 diabetes inadequately controlled with insulin and oral anti-diabetic drugs (OADs). Subjects continu... | null | Diabetes Diabetes Mellitus, Type 2 | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Treat-to-target dose titration scheme, injected subcutaneously (under the skin) once daily with main meal. Dose was individually adjusted. intervention 2: Treat-to-target dose titration scheme, injected subcutaneously (under the skin) once daily. Dose was individually adjusted. | intervention 1: insulin degludec/insulin aspart intervention 2: insulin glargine | 65 | Fresno | California | United States | -119.77237 | 36.74773
Waterbury | Connecticut | United States | -73.0515 | 41.55815
Boynton Beach | Florida | United States | -80.06643 | 26.52535
Clearwater | Florida | United States | -82.8001 | 27.96585
Jacksonville | Florida | United States | -81.65565 | 30.33218
Kissimmee | Fl... | 463 | 0 | 0 | 0 | NCT01045447 | 1COMPLETED | 2010-10-01 | 2010-01-01 | Novo Nordisk A/S | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
4
] | 530 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This trial is conducted in Asia, Europe and the United States of America (USA). The aim of this trial is to compare the efficacy and safety of NN5401 (insulin degludec/insulin aspart (IDegAsp)) with insulin glargine (IGlar), both as add-on to subject's ongoing treatment with metformin + at least one OAD (oral anti-diab... | null | Diabetes Diabetes Mellitus, Type 2 | null | 2 | arm 1: None arm 2: None | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Injected s.c. (under the skin) once daily with the breakfast meal. Dose was individually adjusted. intervention 2: Injected s.c. (under the skin) once daily. Dose was individually adjusted. | intervention 1: insulin degludec/insulin aspart intervention 2: insulin glargine | 92 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Vestavia Hills | Alabama | United States | -86.78777 | 33.44872
Concord | California | United States | -122.03107 | 37.97798
Greenbrae | California | United States | -122.5247 | 37.94854
Los Angeles | California | United States | -118.24368 | 34.05223
Waterbur... | 526 | 0 | 0 | 0 | NCT01045707 | 1COMPLETED | 2010-10-01 | 2010-01-01 | Novo Nordisk A/S | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
4
] | 407 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study is being conducted to compare the safety and efficacy of loteprednol etabonate to vehicle for the treatment of postoperative inflammation and pain following cataract surgery. | null | Inflammation Pain | null | 2 | arm 1: Loteprednol etabonate 0.5% ophthalmic suspension arm 2: Vehicle of loteprednol etabonate ophthalmic suspension | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Topical administration of loteprednol etabonate ophthalmic suspension 1-2 drops in study eye four times a day (QID), postoperative day 1-14. intervention 2: Topical administration of vehicle of loteprednol etabonate ophthalmic suspension 1-2 drops in study eye QID, postoperative day 1-14. | intervention 1: Loteprednol etabonate intervention 2: Vehicle of Loteprednol Etabonate | 1 | Rochester | New York | United States | -77.61556 | 43.15478 | 407 | 0 | 0 | 0 | NCT01060072 | 1COMPLETED | 2010-10-01 | 2010-02-01 | Bausch & Lomb Incorporated | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
4
] | 608 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | false | Subjects undergoing an elective complete colonoscopy will randomly receive either PicoPrep: 2-sachets for oral solution in two divided doses given a night before (first dose - sachet) and approximately 5 hours prior to procedure (second dose - sachet) or HalfLytely: for oral solution and two 5 mg Bisacodyl tablets, giv... | null | Bowel Preparation | Bowel Preparation Colonoscopy | null | 2 | arm 1: "Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy. arm 2: HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administrati... | [
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: PICOPREP (sodium picosulfate, magnesium oxide and citric acid) powder for oral solution consisted of 2 pouches of powder administered in a divided dose. Each PICOPREP pouch was reconstituted by mixing the contents in a cup with 5 ounces of cold water. The first pouch was taken between 5:00 PM and 9:00 P... | intervention 1: PicoPrep intervention 2: HalfLytely intervention 3: bisacodyl | 9 | Huntsville | Alabama | United States | -86.58594 | 34.7304
Sherwood | Arkansas | United States | -92.22432 | 34.81509
Bristol | Connecticut | United States | -72.94927 | 41.67176
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Shreveport | Louisiana | United States | -93.75018 | 32.52515
Winston-Salem | N... | 603 | 0 | 0 | 0 | NCT01073930 | 1COMPLETED | 2010-10-01 | 2010-05-01 | Ferring Pharmaceuticals | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 603 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | false | Subjects undergoing an elective complete colonoscopy will randomly receive either PicoPrep: 2-sachets for oral solution in two divided doses given in the afternoon (first dose - sachet) and 6 hours later in the evening (second dose - sachet), given the day before the procedure or HalfLytely: for oral solution and two 5... | null | Bowel Preparation | Bowel Preparation Colonoscopy | null | 2 | arm 1: "Day Before" method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy. arm 2: HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage... | [
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: PicoPrep (sodium picosulfate, magnesium oxide and citric acid) powder for oral solution consisted of 2 pouches of powder administered in a divided dose. Each PicoPrep pouch was reconstituted by mixing the contents in a cup with 5 ounces of cold water. Subjects randomized to the PicoPrep group will begin... | intervention 1: PicoPrep intervention 2: HalfLytely intervention 3: bisacodyl | 11 | Clearwater | Florida | United States | -82.8001 | 27.96585
Hollywood | Florida | United States | -80.14949 | 26.0112
Inverness | Florida | United States | -82.33037 | 28.83582
Baton Rouge | Louisiana | United States | -91.18747 | 30.44332
Shreveport | Louisiana | United States | -93.75018 | 32.52515
Annapolis | Marylan... | 598 | 0 | 0 | 0 | NCT01073943 | 1COMPLETED | 2010-10-01 | 2010-05-01 | Ferring Pharmaceuticals | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
0
] | 75 | RANDOMIZED | PARALLEL | 1PREVENTION | 3TRIPLE | false | 1FEMALE | false | The transversus abdominis plane (TAP) block involves the sensory nerve supply of the anterior -lateral abdominal wall where the T7-12 intercostal nerves, ilioinguinal, iliohypogastric and the lateral cutaneous branches of the dorsal rami of L1-3 are blocked with an injection of local anesthetic between the internal obl... | null | Postoperative Pain | Pain Post Operative Opioids Laparoscopic Surgery Hysterectomy | null | 3 | arm 1: sterile normal saline as placebo arm 2: Instillation of 20 cc of 0.5% ropivacaine arm 3: Instillation of 20 cc of 0.25% ropivacaine | [
2,
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: placebo injection intervention 2: .5% ropivacaine 20 mls on each side of abdomen intervention 3: Will receive a bilateral TAP block using 20 cc of 0.25% ropivacaine | intervention 1: Placebo intervention 2: Drug .5% Ropivacaine intervention 3: 20 cc of 0.25% ropivacaine | 1 | Chicago | Illinois | United States | -87.65005 | 41.85003 | 75 | 0 | 0 | 0 | NCT01074229 | 1COMPLETED | 2010-10-01 | 2010-03-01 | Northwestern University | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 3 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | true | 0ALL | true | Acne is a chronic inflammatory disease of the pilosebaceous unit that affects 80-90% of the population, especially teenagers, although adult acne is a significant problem for 3-6 % of adult men and 5-12% of adult women. Although acne is not a life-threatening disease, it produces significant psychological disturbances ... | The hypothesized sequence of events in inflammatory acne starts with the formation of a microcomedone with accumulation of cornified keratinocytes within the follicle. Presence and/or proliferation of P.acnes induces the production of IL-1 alpha, tumor necrosis factor (TNF)- alpha, IL-8 and granulocyte-macrophage colon... | Acne | acne | null | 1 | arm 1: apremilast 20 mgs twice a day for 12 weeks | [
0
] | 1 | [
0
] | intervention 1: apremilast 20 mgs orally twice a day for 12 weeks | intervention 1: apremilast | 1 | Chapel Hill | North Carolina | United States | -79.05584 | 35.9132 | 3 | 0 | 0 | 0 | NCT01074502 | 6TERMINATED | 2010-10-01 | 2010-02-01 | University of North Carolina, Chapel Hill | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 76 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | false | This is a multicentric, open, randomized, comparative trial aimed to assess the influence of recombinant luteinizing hormone (r-LH) supplementation during controlled ovarian stimulation (COS) in advanced reproductive age in terms of improved embryo competence which allows to transfer less embryos to avoid high grade mu... | This study will be carried out by the Grupo de Interés de Salud Embrionaria (GISE) group (part of the Spanish Fertility Society) who uses strict criteria to select the embryos most suitable for successful transference.
OBJECTIVES
Primary objective:
* To determine the benefit of r-LH supplementation in COS prior to i... | Infertility Ovulation Induction | Infertility Ovulation induction Luveris Controlled ovarian stimulation Reproductive technologies, assisted | null | 2 | arm 1: Recombinant human luteinizing hormone (rhLH,Luveris®) injection 150 IU subcutaneously daily along with rFSH 300 IU subcutaneously daily from S1 to S4 and then rFSH dose can be adjusted depending on the ovarian response till r-hCG administration day. arm 2: rFSH injection 300 IU subcutaneously daily from S1 to S4... | [
0,
1
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: Recombinant human luteinizing hormone (rhLH) intervention 2: Recombinant follicle-stimulating hormone (rFSH) | 1 | Madrid | N/A | Spain | -3.70256 | 40.4165 | 75 | 0 | 0 | 0 | NCT01075815 | 6TERMINATED | 2010-10-01 | 2008-11-01 | Merck KGaA, Darmstadt, Germany | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 200 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This study will compare the ability of a single-dose of a novel ibuprofen formulation to relieve pain compared to placebo and standard ibuprofen in the treatment of episodic tension-type headache. | null | Pain | Headache | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: Single-dose of novel ibuprofen (equal to 400 mg ibuprofen) plus placebo intervention 2: Single-dose of standard ibuprofen (400mg) plus placebo intervention 3: Single-dose of placebo | intervention 1: Novel Ibuprofen intervention 2: Standard Ibuprofen intervention 3: Placebo | 0 | null | 200 | 0 | 0 | 0 | NCT01077973 | 1COMPLETED | 2010-10-01 | 2010-03-01 | Pfizer | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 93 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | false | Ovarian reserve is related to chronological age; 35 years of age is the accepted threshold for significant decline in assisted reproductive technologies (ART) success with scarce follicular recruitment and poor oocyte retrieval. New therapeutic schemes are sought to improve follicular response in ovarian ageing because... | Preclinical pharmacology studies have demonstrated that r-hLH has a LH/human chorionic gonadotropin (hCG) receptor affinity similar to pituitary human luteinizing hormone (p-hLH), and is biologically active in-vitro in stimulating steroidogenesis and in promoting oocyte germinal vesicle breakdown. Several clinical stud... | Infertility Ovulation Induction | Infertility Ovulation induction Luveris Lutropin alfa Controlled ovarian stimulation Reproductive technologies, Assisted | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: Recombinant human follicle stimulating hormone (r-hFSH) injection will be administered subcutaneously once daily from stimulation Day 1(S1) at a starting dose of 300-450 International Unit (IU) and then dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) adm... | intervention 1: r-hLH + r-hFSH intervention 2: r-hFSH intervention 3: Recombinant Human Choriogonadotropin (r-hCG) intervention 4: GnRH antagonist | 1 | Barcelona | N/A | Spain | 2.15899 | 41.38879 | 92 | 0 | 0 | 0 | NCT01079949 | 6TERMINATED | 2010-10-01 | 2007-11-01 | Merck KGaA, Darmstadt, Germany | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 385 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | The primary objective of the study is to determine whether armodafinil treatment is more effective than placebo treatment in patients with excessive sleepiness associated with shift work disorder (SWD) by measuring improved clinical condition late in the shift, including the commute home. | null | Excessive Sleepiness | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on n... | intervention 1: Armodafinil intervention 2: Matching Placebo | 63 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | United States | -110.92648 | 32.22174
Hot Springs | Arkansas | United States | -93.05518 | 34.5037
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Burlingame | California | United States | -122.36608 | 37.5841
Fountain Valley | C... | 371 | 0 | 0 | 0 | NCT01080807 | 1COMPLETED | 2010-10-01 | 2010-03-01 | Cephalon | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
0
] | 1 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The objective is to instill liposomes reconstituted with sterile water into the bladder as a compassionate use treatment in one patient with ulcerative interstitial cystitis (IC). | A physician sponsored Investigation New Drug (IN) has been acquired from the FDA for compassionate use of this non-approved treatment in one patient from Dr. Peters' private practice. Since this treatment has not been used previously in the US, we propose to evaluate the safety and efficacy of the treatment in this one... | Interstitial Cystitis | null | 1 | arm 1: Intravesical instillation of Liposomes in sterile water totally 40 cc at four weekly treatments. | [
0
] | 1 | [
0
] | intervention 1: Intravesical instillation | intervention 1: Liposomes | 1 | Royal Oak | Michigan | United States | -83.14465 | 42.48948 | 1 | 0 | 0 | 0 | NCT01083979 | 1COMPLETED | 2010-10-01 | 2010-08-01 | Kenneth Peters, MD | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
0
] | 100 | RANDOMIZED | PARALLEL | 1PREVENTION | 2DOUBLE | true | 0ALL | true | We intend to determine how effective the use of a 2% Chlorhexidine Cloth is in terms of eliminating the bacterial load on patients undergoing shoulder surgery. We will be comparing the Chlorhexidine Cloths with a control group which will be performing an ordinary shower prior to surgery. At this time, it is standard of... | The use of home preoperative chlorhexidine wash has been used in various surgical fields for the prevention of perioperative infections. However, it's use in shoulder surgery has not been published up to this point. The shoulder has a unique microbial flora due to the prevalence of Propionibacterium acnes, a bacteria i... | Post-operative Surgical Site Infections | Surgical site infections Chlorhexidine Shoulder surgery | null | 2 | arm 1: This group will perform an ordinary shower the night prior and the morning of their scheduled surgery date. arm 2: This group will use the 2% chlorhexidine wipes the night prior as well as the morning of their surgery date. | [
4,
0
] | 1 | [
0
] | intervention 1: The 2% Chlorhexidine cloth will be applied to the operative extremity the night prior and the the morning of their surgery. | intervention 1: 2% Chlorhexidine cloth | 1 | Chicago | Illinois | United States | -87.65005 | 41.85003 | 100 | 0 | 0 | 0 | NCT01090479 | 1COMPLETED | 2010-10-01 | 2010-01-01 | Northwestern University | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 20 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | true | 0ALL | true | Nitrous oxide is the oldest anaesthetic agent still in routine use today. Despite huge changes in the pharmacology of volatile anaesthetic agents and intravenous anaesthetics, the unique properties of nitrous oxide have maintained its place in modern practice, where it is used in combination with other, more powerful i... | Nitrous oxide is the oldest anaesthetic agent still in routine use today. Despite huge changes in the pharmacology of volatile anaesthetic agents and intravenous anaesthetics, the unique properties of nitrous oxide have maintained its place in modern practice, where it is used in combination with other, more powerful i... | Anesthesia | Nitrous Oxide washin washout second gas effect sevoflurane induction emergence | null | 2 | arm 1: Sevoflurane with Air/Oxygen Mix arm 2: None | [
0,
0
] | 2 | [
0,
0
] | intervention 1: sevoflurane on air/O2 intervention 2: sevoflurane in N2O/O2 | intervention 1: sevoflurane on air/O2 intervention 2: sevoflurane in N2O/O2 | 1 | Melbourne | Victoria | Australia | 144.96332 | -37.814 | 0 | 0 | 0 | 0 | NCT01092923 | 1COMPLETED | 2010-10-01 | 2009-10-01 | Austin Health | 2OTHER_GOV | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 45 | RANDOMIZED | SINGLE_GROUP | null | 3TRIPLE | false | 0ALL | false | The purpose of this study is to evaluate how Vitamin D affects endothelial function, inflammation, lipids, insulin resistance, vitamin D levels, and parathyroid hormone (PTH). | Randomized placebo controlled trial of vitamin D supplementation in HIV infected subjects with vitamin D deficiency | Human Immunodeficiency Virus (HIV) Vitamin D Deficiency HIV Infections | Vitamin D Human Immunodeficiency Virus (HIV) Complementary Therapies | null | 2 | arm 1: Participants that have been randomized into this arm will receive placebo pills. arm 2: Participants that have been randomized into this arm will receive Vitamin D 4000 IU (International Units) daily. | [
2,
1
] | 2 | [
0,
10
] | intervention 1: Vitamin D 4000 IU will be administered to enrollees on the active comparator arm intervention 2: Placebo pills will be administered to enrollees in this arm | intervention 1: Vitamin D intervention 2: Placebo | 1 | Cleveland | Ohio | United States | -81.69541 | 41.4995 | 45 | 0 | 0 | 0 | NCT01093417 | 1COMPLETED | 2010-10-01 | 2010-01-01 | University Hospitals Cleveland Medical Center | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
0
] | 162 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The objective of this study is to assess the efficacy and tolerability of metoclopramide added to standard antiemetic regimen for prophylaxis of cisplatin-induced emesis. | Ondansetron plus dexamethasone are standard emetic prophylactic agents for highly emetogenic chemotherapy. Metoclopramide is a dopamine antagonist, which may enhance efficacy of ondansetron and dexamethasone. | Cancer | chemotherapy induced nausea and vomiting, metoclopramide | null | 2 | arm 1: ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus metoclopramide 20 mg orally four times a day on day 2-5 arm 2: ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus placebo 20 mg oral four times a day ... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus metoclopramide 20 mg oral four times a day on day 2-5 intervention 2: ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus placebo 20 mg oral f... | intervention 1: metoclopramide intervention 2: placebo | 1 | Bangkok | Bangkok | Thailand | 100.50144 | 13.75398 | 162 | 0 | 0 | 0 | NCT01093690 | 1COMPLETED | 2010-10-01 | 2009-04-01 | Mahidol University | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 60 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | Experimental data have demonstrated favourable effects of statins on endothelial progenitor cell (EPC) mobilization from the bone marrow, and cardiac homing. The purpose of the present prospective randomized controlled trial is to determine the effects of aggressive atorvastatin treatment (40 mg daily 2-weeks prior to ... | Endothelial progenitor cells, a subgroup of hematopoietic stem cells have a significant role in vascular homeostasis. In animal models of ischemia, endothelial progenitor cells are rapidly incorporated into sites of neovascularization, have the potential to induce and augment vasculogenesis/ angiogenesis, prevent cardi... | Coronary Artery Bypass Surgery Elective Surgical Procedure | Endothelial progenitor cells Atorvastatin Coronary surgery | null | 2 | arm 1: Hydroxymethylglutaryl-CoA Reductase Inhibitors arm 2: Atorvastatin like pill | [
1,
2
] | 2 | [
0,
0
] | intervention 1: 40mg/day once daily for two weeks prior to surgery intervention 2: 1tb/day once daily for two weeks prior to surgery | intervention 1: Atorvastatin intervention 2: Placebo | 1 | Ankara | Cebeci | Turkey (Türkiye) | 32.85427 | 39.91987 | 59 | 0 | 0 | 0 | NCT01096875 | 1COMPLETED | 2010-10-01 | 2010-02-01 | Ankara University | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
2
] | 16 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | true | 0ALL | false | This study will evaluate if the mean value of brain neurokinin 1 (NK1)-receptor occupancy of participants treated with aprepitant is similar to that of participants treated with fosaprepitant at certain timepoints. | The third arm of the study (Aprepitant 250 mg) will only be conducted if the real-time assessment of the NK1-receptor occupancy data between fosaprepitant 150 mg \& aprepitant 165 mg reveals that the primary hypothesis will not be supported. | Chemotherapy-Induced Nausea and Vomiting (CINV) | NK1-receptor occupancy | null | 3 | arm 1: Fosaprepitant 150 mg arm 2: Aprepitant 165 mg arm 3: Aprepitant 250 mg | [
0,
0,
0
] | 7 | [
0,
0,
0,
0,
0,
0,
0
] | intervention 1: a single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes on Day 1 15 minutes after consumption of a standard light breakfast meal intervention 2: a single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal intervention 3: a single oral... | intervention 1: Fosaprepitant 150 mg intervention 2: Aprepitant 165 mg intervention 3: Aprepitant 250 mg intervention 4: Dexamethasone (12-8-16-16 mg) intervention 5: Dexamethasone (12-8-8-16 mg) intervention 6: Ondansetron intervention 7: MK0999 | 0 | null | 16 | 0 | 0 | 0 | NCT01111851 | 1COMPLETED | 2010-10-01 | 2010-04-01 | Merck Sharp & Dohme LLC | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 495 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | Evaluate the clinical efficacy and safety of WC2031 200 mg tablets taken orally once a day for 7 days versus Vibramycin (doxycycline) 100 mg capsules taken orally twice a day for 7 days, for the treatment of uncomplicated urogenital Chlamydia trachomatis infection. Primary efficacy endpoint is microbiological cure at D... | null | Urogential Chlamydia Trachomatis Infection | Chlamydia | null | 2 | arm 1: Once daily arm 2: Twice daily | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 200 mg tablet, once daily for 7 days intervention 2: 100 mg capsule, twice daily for 7 days, over-encapsulated | intervention 1: Doxycyline Hyclate tablet intervention 2: Vibramycin (doxycyline hyclate) capsule | 43 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Foley | Alabama | United States | -87.6836 | 30.40659
Tucson | Arizona | United States | -110.92648 | 32.22174
Anaheim | California | United States | -117.9145 | 33.83529
Fresno | California | United States | -119.77237 | 36.74773
Los Angeles | California | Un... | 494 | 0 | 0 | 0 | NCT01113931 | 1COMPLETED | 2010-10-01 | 2010-04-01 | Warner Chilcott | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | -0 |
[
3
] | 52 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | false | We propose to use an inhaled allergen challenge model to explore the individual contributions of the components of a novel long-acting beta agonist (LABA)/ inhaled corticosteroid (ICS) combination product on protection from allergic triggers in asthma. | null | Asthma | mild asthma allergen challenge early asthmatic response | null | 3 | arm 1: Placebo Inhaler arm 2: ICS/LABA inhaler arm 3: ICS inhaler | [
2,
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: FF intervention 2: FF/VI intervention 3: Placebo Inhaler | intervention 1: Fluticasone Furoate intervention 2: FF/Vilanterol (VI; GW642444M) intervention 3: Placebo | 4 | Berlin | State of Berlin | Germany | 13.41053 | 52.52437
Wellington | N/A | New Zealand | 174.77557 | -41.28664
London | N/A | United Kingdom | -0.12574 | 51.50853
Manchester | N/A | United Kingdom | -2.23743 | 53.48095 | 153 | 0 | 0 | 0 | NCT01128569 | 1COMPLETED | 2010-10-01 | 2010-01-01 | GlaxoSmithKline | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
2
] | 40 | RANDOMIZED | CROSSOVER | 7BASIC_SCIENCE | 2DOUBLE | true | 0ALL | false | This is a Phase 1 study in healthy subjects to evaluate the safety and tolerability of LY2886721 single doses, how the body handles the drug, and the drug's effect on the body. | This is a Phase 1 study with 2 parts, both in healthy subjects. Part 1 is a subject- and investigator-blind, placebo-controlled, randomized, 3-period, crossover study. Part 1 will assess the safety and tolerability of LY2886721 single doses, how the body handles the drug, and the drug's effect on the body. Part 2 is a ... | Alzheimer's Disease | null | 5 | arm 1: Single (7 milligram (mg), 15 mg, 25 mg, 35 mg) doses of LY2886721 administered orally in up to three of three study periods arm 2: Single dose in up to 1 period arm 3: Single 10 mg dose of LY2886721, dose determined by Part 1 arm 4: Single 35 mg dose of LY2886721, dose determined by Part 1 arm 5: Single dose | [
0,
2,
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: Oral capsules intervention 2: Oral capsules | intervention 1: LY2886721 intervention 2: Placebo | 1 | Beverly Hills | California | United States | -118.40036 | 34.07362 | 66 | 0 | 0 | 0 | NCT01133405 | 1COMPLETED | 2010-10-01 | 2010-06-01 | Eli Lilly and Company | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
4
] | 474 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of the study is to assess the efficacy and safety of an investigational nasal aerosol compared with placebo nasal aerosol in the treatment of perennial allergic rhinitis. | null | Rhinitis, Allergic, Perennial | null | 2 | arm 1: During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily. arm 2: During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily. | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Beclomethasone dipropionate (BDP) Hydrofluoroalkane (HFA) Nasal Aerosol intervention 2: HFA Vehicle Aerosol | intervention 1: Beclomethasone dipropionate hydrofluoroalkane HFA Nasal Aerosol intervention 2: Placebo Nasal Aerosol | 35 | Los Angeles | California | United States | -118.24368 | 34.05223
Mission Viejo | California | United States | -117.672 | 33.60002
San Diego | California | United States | -117.16472 | 32.71571
San Jose | California | United States | -121.89496 | 37.33939
Miami | Florida | United States | -80.19366 | 25.77427
Tallahasse... | 474 | 0 | 0 | 0 | NCT01134705 | 1COMPLETED | 2010-10-01 | 2010-05-01 | Teva Branded Pharmaceutical Products R&D, Inc. | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
4
] | 333 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This is a multicenter, randomized, parallel design, double-blind study of mometasone furoate (MF) in pediatric subjects with perennial allergic rhinitis. The subjects 5 to 15 years of age with perennial allergic rhinitis will enter a no-treatment observation period of 7 days at minimum and eligibility for inclusion in ... | null | Rhinitis, Allergic, Perennial | null | 2 | arm 1: The dose will be as follows:
* 5 to 11 years: one spray per nostril once daily (100 μg/day as MF) in the morning for 2 weeks
* 12 to 15 years: 2 sprays per nostril once daily (200 μg/day as MF) in the morning for 2 weeks arm 2: Administration will be as follows:
* 5 to 11 years: one spray per nostril once dail... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: The study drug is MFNS (50 μg spray device) and the dose will be:
* 5 to 11 years: one spray per nostril once daily (100 μg/day as MF) in the morning for 2 weeks
* 12 to 15 years: 2 sprays per nostril once daily (200 μg/day as MF) in the morning for 2 weeks intervention 2: MF Placebo nasal spray and ad... | intervention 1: Mometasone furoate intervention 2: Placebo | 0 | null | 333 | 0 | 0 | 0 | NCT01135134 | 1COMPLETED | 2010-10-01 | 2010-06-01 | Organon and Co | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
4
] | 1,555 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | The purpose of this study is to compare the efficacy and safety profiles of Perrigo Israel Pharmaceuticals, Ltd. Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel and Benzaclin® Topical Gel (Clindamycin- Benzoyl Peroxide Gel). | null | Acne Vulgaris | null | 3 | arm 1: None arm 2: None arm 3: None | [
1,
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: Applied to the entire face twice daily for 10 weeks intervention 2: Applied to the entire face twice daily for 10 weeks intervention 3: Placebo | intervention 1: Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo) intervention 2: Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin) intervention 3: Placebo | 0 | null | 1,555 | 0 | 0 | 0 | NCT01138514 | 1COMPLETED | 2010-10-01 | 2009-10-01 | Padagis LLC | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 162 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this dose-response study is to assess the safety and efficacy of CNS 7056 compared with midazolam to maintain suitable sedation levels in patients undergoing colonoscopy. | This is a double-blind, randomized, parallel group, dose-response study to assess the safety and efficacy of three dose levels of CNS 7056 compared with midazolam to maintain suitable sedation levels in patients undergoing colonoscopy.
Safety assessment will include physical examinations, vital signs, ECGs, pulse oxim... | Sedation | CNS 7056 Procedural Sedation Colonoscopy | null | 4 | arm 1: Initial 8 mg iv for sedation induction, and 3 mg iv top-ups for sedation maintenance.
Fentanyl pre-treatment: up to 100 μg (at the discretion of the investigator) and 25 μg top-up doses. arm 2: Initial 7 mg iv for sedation induction, and 2 mg iv top-ups for sedation maintenance.
Fentanyl pre-treatment: up to 1... | [
0,
0,
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: Initial low dose plus supplemental doses as necessary. intervention 2: Initial intermediate dose plus supplemental doses as necessary. intervention 3: Initial high dose plus supplemental doses as necessary. intervention 4: Initial standardized dose plus supplemental doses as necessary. | intervention 1: A. CNS 7056 intervention 2: B. CNS 7056 intervention 3: C. CNS 7056 intervention 4: D. Midazolam | 9 | Sheffield | Alabama | United States | -87.69864 | 34.76509
Phoenix | Arizona | United States | -112.07404 | 33.44838
Anaheim | California | United States | -117.9145 | 33.83529
Anaheim | California | United States | -117.9145 | 33.83529
South Miami | Florida | United States | -80.29338 | 25.7076
Stony Brook | New York ... | 161 | 0 | 0 | 0 | NCT01145222 | 1COMPLETED | 2010-10-01 | 2010-05-01 | Paion UK Ltd. | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
2
] | 15 | NON_RANDOMIZED | CROSSOVER | null | 0NONE | true | 0ALL | false | The purpose of this study is to estimate the effect of multiple doses of Rifampin on the single dose pharmacokinetics of Crizotinib in healthy volunteers. | null | Healthy | crizotinib healthy volunteers rifampin pharmacokinetics single dose | null | 1 | arm 1: There should be at least 14-day washout period between treatment A and B. | [
0
] | 3 | [
0,
0,
0
] | intervention 1: Treatment A: a single 250-mg dose of crizotinib will be administered in the fasted state on Day 1 as 1 × 50-mg and 2 × 100-mg Immediate Release Tablets. intervention 2: Treatment B: 600 mg once a day doses of rifampin will be orally administered after overnight fasting from Day 1 to Day 14. intervention... | intervention 1: crizotinib intervention 2: rifampin intervention 3: crizotinib | 1 | South Miami | Florida | United States | -80.29338 | 25.7076 | 29 | 0 | 0 | 0 | NCT01147055 | 1COMPLETED | 2010-10-01 | 2010-07-01 | Pfizer | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 12 | RANDOMIZED | CROSSOVER | null | 0NONE | true | 0ALL | false | The purpose of this study is to characterize and compare the concentration-time profiles and multiple dose pharmacokinetics of a 5 minute intravenous (IV) bolus of ertapenem 1 gram daily versus the standard 30 minute infusion in healthy volunteers. Safety and tolerability and pharmacodynamic target attainment using Mon... | null | Healthy | Pharmacokinetics Safety | null | 2 | arm 1: Participants received ertapenem 1 gram every 24 hours for 3 doses with each dose infused as a 5 minute IV bolus. arm 2: Participants received ertapenem 1 gram every 24 hours for 3 doses with each dose infused as a 30 minute infusion (i.e., the standard dose). | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 1 gram IV bolus every 24 hours (q24h) for 3 days intervention 2: 1 gram 30 minute infusion q24h for 3 days | intervention 1: ertapenem intervention 2: ertapenem | 1 | Hartford | Connecticut | United States | -72.68509 | 41.76371 | 23 | 0 | 0 | 0 | NCT01148771 | 1COMPLETED | 2010-10-01 | 2010-08-01 | Hartford Hospital | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 140 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | null | The primary objective was to evaluate the effect of a 6-week treatment with TAA-AQ (110 μg) and TAA-AQ (220 μg) once daily (QD) versus placebo on hypothalamic-pituitary-adrenal (HPA) axis function as measured by serum cortisol AUC(0-24 hr) in children (\>=2 to \<12 years old) with allergic rhinitis (AR). | The study consisted of a run-in single-blind screening phase (prerandomization) followed by an approximately 6-week double-blind treatment phase (postrandomization).
Total study duration per participant lasted from 7.5 to 13 weeks and consisted of:
* Screening and single-blind phases (these 2 phases ran concurrently,... | Rhinitis, Allergic, Perennial and/or Seasonal | null | 2 | arm 1: * placebo during the screening phase and
* placebo during the treatment phase.
All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR. arm 2: * placebo during the screening phase and
* TAA-AQ (Nasacort AQ) during the treatment phase.
All children had the option t... | [
2,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: 1 spray/nostril, once daily in the morning, for 8 to 24 days during the screening phase. intervention 2: Treatment assignment was randomized with stratification by sex and age group (\>=2 to \<6, \>=6 to \<12 years old).
* For children who were \>=2 to \<6 years old, 1 spray/nostril (110 µg TAA-AQ), on... | intervention 1: Placebo nasal spray intervention 2: Triamcinolone acetonide aqueous (TAA-AQ) nasal spray (NASACORT AQ) intervention 3: Placebo nasal spray intervention 4: Claritin® Syrup | 8 | Cypress | California | United States | -118.03729 | 33.81696
Stockbridge | Georgia | United States | -84.23381 | 33.54428
North Dartmouth | Massachusetts | United States | -70.97032 | 41.63899
Plymouth | Minnesota | United States | -93.45551 | 45.01052
Omaha | Nebraska | United States | -95.94043 | 41.25626
Raleigh | N... | 140 | 0 | 0 | 0 | NCT01154153 | 1COMPLETED | 2010-10-01 | 2010-06-01 | Sanofi | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 17 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Recombinant interferon alfa-2b may interfere with the growth of cancer cells and slow the growth of kidney cancer. Giving celecoxib together with recombinant interferon alpha-2b may kill more tumor cells and ... | PRIMARY OBJECTIVES:
I. To estimate the objective response rate of interferon alpha plus celecoxib in metastatic RCC patients with 3+ COX-2 tumor immunostaining.
SECONDARY OBJECTIVES:
I. To compare cellular immune parameters in metastatic RCC patients with 3+ COX-2 tumor immunostaining to patients with \< 1+ tumor im... | Renal Cell Cancer Stage IV Renal Cell Cancer | recurrent renal cell cancer | null | 1 | arm 1: Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. | [
0
] | 8 | [
0,
2,
10,
10,
10,
10,
10,
10
] | intervention 1: Given orally intervention 2: Given subcutaneously intervention 3: Correlative studies intervention 4: Correlative studies intervention 5: Correlative studies intervention 6: Correlative studies intervention 7: Correlative studies intervention 8: Correlative studies | intervention 1: celecoxib intervention 2: recombinant interferon alfa-2b intervention 3: polymerase chain reaction intervention 4: laboratory biomarker analysis intervention 5: reverse transcriptase-polymerase chain reaction intervention 6: immunologic technique intervention 7: immunohistochemistry staining method inte... | 1 | Cleveland | Ohio | United States | -81.69541 | 41.4995 | 17 | 0 | 0 | 0 | NCT01158534 | 1COMPLETED | 2010-10-01 | 2006-03-01 | Case Comprehensive Cancer Center | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 534 | RANDOMIZED | PARALLEL | 5SCREENING | 3TRIPLE | true | 0ALL | false | This study is being conducted to evaluate the safety of KetoNaph ophthalmic solution in healthy adult subjects and in pediatric subjects with a history or family history of ocular allergy. | null | Allergic Conjunctivitis | null | 2 | arm 1: KetoNaph Ophthalmic Solution arm 2: Vehicle of KetoNaph Ophthalmic Solution | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Ophthalmic Solution administered BID for 6 weeks intervention 2: Vehicle of KetoNaph ophthalmic solution administered bid for six weeks | intervention 1: KetoNaph intervention 2: Vehicle | 0 | null | 534 | 0 | 0 | 0 | NCT01159015 | 1COMPLETED | 2010-10-01 | 2010-07-01 | Bausch & Lomb Incorporated | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
5
] | 14 | RANDOMIZED | CROSSOVER | 9OTHER | 2DOUBLE | false | 0ALL | false | Obesity is a major public health concern, and the search for useful pharmacologic interventions is ongoing. This study aims to develop a comprehensive series of assessments to directly assess eating behavior, cognitive functioning, and psychological functioning under sibutramine and placebo conditions. | We will recruit 48 moderately obese men and women seeking weight-loss treatment to participate in a 3-week, randomized, double-blind, cross-over trial of sibutramine 15mg or placebo daily. At the end of weeks 1 and 3, subjects will be asked to participate in a two-day/three-night stay in the Residential Laboratory or B... | Obesity | Obesity sibutramine eating behavior | null | 2 | arm 1: Participants in this arm receive sibutramine 15mg for one week followed by two weeks of placebo. arm 2: Participants are prescribed two weeks of placebo, followed by one week of 15mg sibutramine. | [
0,
0
] | 2 | [
0,
0
] | intervention 1: 1 week of active sibutramine (15mg) intervention 2: 2 weeks of placebo | intervention 1: Sibutramine intervention 2: Placebo | 1 | New York | New York | United States | -74.00597 | 40.71427 | 18 | 0 | 0 | 0 | NCT01170364 | 6TERMINATED | 2010-10-01 | 2009-02-01 | New York State Psychiatric Institute | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
2
] | 42 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | true | 2MALE | false | To demonstrate the bioequivalence of 12.5 milliliters (mL) of atomoxetine oral solution (4 milligrams per milliliter \[mg/mL\]) compared with 2 capsules of atomoxetine (25 mg per capsule) in healthy adult male Japanese subjects. | null | Attention Deficit Hyperactivity Disorder | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 1 | [
0
] | intervention 1: Administered orally, once. | intervention 1: Atomoxetine | 1 | Fukuoka | N/A | Japan | 130.41667 | 33.6 | 82 | 0 | 0 | 0 | NCT01177943 | 1COMPLETED | 2010-10-01 | 2010-08-01 | Eli Lilly and Company | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
4
] | 121 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | Patients with heart failure (HF) have a limited exercise tolerance,few pharmacological interventions have been proven effective in improving exercise capacity. At the presence there i conflicting evidence on the effectiveness of beta-blockers on exercise capacity. Ivabradine has been shown to improve prognosis in patie... | Patients with chronic heart failure of ischemic origin (120) Stable coronary artery disease Acute coronary syndromes \> 3 months Revascularization procedures \> 3 months Naive on heart rate reducing agents New York Heart Association (NYHA) Class II III 6 minute walking test (6MW) tolerance between 200 and 400 m Stable ... | Heart Failure | heart failure heart rate ivabradine carvedilol | null | 3 | arm 1: 7.5 mg bd arm 2: up to 25 mg bd arm 3: up to 12.5/5 mg bd | [
0,
1,
0
] | 3 | [
0,
0,
0
] | intervention 1: 7.5 mg bd intervention 2: up to 12.5/5 mg bd intervention 3: 25 mg bd | intervention 1: ivabradine intervention 2: "Drug:Carvedilol" and "Drug:Ivabradine" intervention 3: Carvedilol | 2 | Roma | Italy | Italy | 11.10642 | 44.99364
Roma | Italy | Italy | 11.10642 | 44.99364 | 121 | 0 | 0 | 0 | NCT01178528 | 1COMPLETED | 2010-10-01 | 2009-09-01 | IRCCS San Raffaele | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
2
] | 24 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | false | This trial examines the way flibanserin is metabolized in postmenopausal women with Hypoactive Sexual Desire Disorder. | null | Sexual Dysfunctions, Psychological | null | 1 | arm 1: flibanserin 100 mg dose every evening | [
0
] | 1 | [
0
] | intervention 1: all subjects receive flibanserin | intervention 1: flibanserin 100 mg dose every evening | 4 | Orlando | Florida | United States | -81.37924 | 28.53834
Wichita | Kansas | United States | -97.33754 | 37.69224
Kalamazoo | Michigan | United States | -85.58723 | 42.29171
Knoxville | Tennessee | United States | -83.92074 | 35.96064 | 24 | 0 | 0 | 0 | NCT01188603 | 1COMPLETED | 2010-10-01 | 2010-07-01 | Sprout Pharmaceuticals, Inc | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
5
] | 38 | NON_RANDOMIZED | SINGLE_GROUP | 7BASIC_SCIENCE | 0NONE | true | 0ALL | false | The goal of this study is to evaluate the effect of multiple doses of Desvenlafaxine Sustained Release (SR) on the pharmacokinetics of Aripiprazole when coadministered to healthy adult subjects. This study will also evaluate the safety and tolerability of Desvenlafaxine SR and Aripiprazole when coadministered to health... | null | Pharmacokinetics Cytochrome P-450 CYP2D6 CYP3A4 Protein, Human | Pharmacokinetic safety and tolerability genetic testing CYP 2D6 and CYP 3A4 | null | 1 | arm 1: None | [
0
] | 2 | [
0,
0
] | intervention 1: Period 1-Aripiprazole 5mg on study day 1. intervention 2: Period 2-Desvenlafaxine SR 100mg on days 1-19 with coadministration of Aripiprazole 5mg on day 7. | intervention 1: Aripiprazole intervention 2: Aripiprazole + desvenlafaxine succinate sustained release | 2 | Miami | Florida | United States | -80.19366 | 25.77427
Miami | Florida | United States | -80.19366 | 25.77427 | 109 | 0 | 0 | 0 | NCT01188668 | 1COMPLETED | 2010-10-01 | 2010-08-01 | Pfizer | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 30 | NON_RANDOMIZED | SINGLE_GROUP | 7BASIC_SCIENCE | 0NONE | true | 1FEMALE | false | The goal of this study is to evaluate the effect of multiple doses of Desvenlafaxine SR on the pharmacokinetics of Tamoxifen and endoxifen when coadministered to healthy post-menopausal female subjects. This study will also evaluate the safety and tolerability of Desvenlafaxine SR and Tamoxifen when coadministered to h... | null | Pharmacokinetics | Pharmacokinetic safety and tolerability genetic testing CYP 2D6 | null | 1 | arm 1: None | [
0
] | 2 | [
0,
0
] | intervention 1: Period 1-Tamoxifen 40mg on study day 1. intervention 2: Period 2-Desvenlafaxine SR 100mg on days 1-28 with coadministration of Tamoxifen 40mg on day 7. | intervention 1: Tamoxifen intervention 2: Tamoxifen and Desvenlafaxine Succinate Sustained Release | 2 | Miami | Florida | United States | -80.19366 | 25.77427
Miami | Florida | United States | -80.19366 | 25.77427 | 88 | 0 | 0 | 0 | NCT01189500 | 1COMPLETED | 2010-10-01 | 2010-08-01 | Pfizer | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
0
] | 16 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | Our overall objective is to model a pediatric Acute Asthma Clinical Decision Rule (ADR) for personalized medicine by identification of treatment-response phenotypes that are important determinants of outcome. The Specific Aim of this study is to determine the feasibility of this approach by enrolling a pilot cohort of ... | The objective of this study is to determine the feasibility of this approach by enrolling a pilot cohort of 16 participants in this DBRCT of 4 different albuterol treatment regimens, 2 of which will use 10mg/hr and 2 of which will use 25mg/hr. Participants are randomized in randomly permuted blocks of four. Within thes... | Acute Asthma | Asthma Acute asthma Pediatrics | null | 4 | arm 1: Active control arm, 10mg/hr continuous. arm 2: Experimental 10mg/hr pulsed albuterol regimen. arm 3: Experimental 25mg/hr continuous albuterol. arm 4: Experimental 25mg/hr pulsed albuterol | [
1,
0,
0,
0
] | 1 | [
0
] | intervention 1: Nebulized albuterol | intervention 1: Albuterol | 0 | null | 16 | 0 | 0 | 0 | NCT01196377 | 1COMPLETED | 2010-10-01 | 2010-09-01 | Vanderbilt University Medical Center | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 62 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | false | This study will evaluate the safety and efficacy of LATISSE® (bimatoprost 0.03%) in the augmentation of eyelashes in Korean women. | null | Eyelash Hypotrichosis | null | 1 | arm 1: bimatoprost 0.03% (LATISSE®) | [
0
] | 1 | [
0
] | intervention 1: One drop of bimatoprost 0.03% (LATISSE®) applied evenly to each upper eyelid in the evening. Treatment is once daily for up to 40 weeks. | intervention 1: bimatoprost 0.03% | 1 | Seoul | N/A | South Korea | 126.9784 | 37.566 | 62 | 0 | 0 | 0 | NCT01229423 | 1COMPLETED | 2010-10-01 | 2009-11-01 | Allergan | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
4
] | 958 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | true | 0ALL | true | The objective will be to assess clinical bioequivalence of 0.1% Retin-A Micro® Gel and Spear Pharmaceutical's generic 0.1% Tretinoin Microsphere Gel with a placebo arm. | Acne study | Acne | null | 3 | arm 1: Treatment of acne for 12 weeks with generic tretinoin arm 2: Treatment of acne for 12 weeks with Placebo arm 3: Treatment of acne over 12 weeks with tretinoin Brand | [
1,
2,
1
] | 2 | [
0,
0
] | intervention 1: Treatment of acne intervention 2: treatment of acne | intervention 1: Tretinoin intervention 2: placebo | 1 | Mountain Lakes | New Jersey | United States | -74.43293 | 40.89482 | 940 | 0 | 0 | 0 | NCT01243450 | 1COMPLETED | 2010-10-01 | 2009-10-01 | Spear Pharmaceuticals | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
0
] | 3 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | The primary objectives of this study are to investigate the potential for ketamine anesthesia to increase the antidepressant efficacy of Electroconvulsive therapy (ECT) and to decrease acute ECT-induced adverse cognitive effects. | Electroconvulsive therapy (ECT) is one of the most robust antidepressant treatments available. However, there is the potential for significant acute and longer term adverse cognitive effects with ECT and the antidepressant response requires multiple treatment sessions, increasing risk of adverse effects. Further, antid... | Major Depression Bipolar Depression | depression electroconvulsive therapy ketamine antidepressant | null | 2 | arm 1: Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic). arm 2: Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic). | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Ketamine 1-2 mg/kg IV as indicated for ECT intervention 2: Methohexital 1 mg/kg IV as indicated for ECT | intervention 1: Ketamine intervention 2: Methohexital | 1 | New York | New York | United States | -74.00597 | 40.71427 | 3 | 0 | 0 | 0 | NCT01309581 | 6TERMINATED | 2010-10-01 | 2010-04-01 | James Murrough | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 86 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to demonstrate that the rosiglitazone/glimepiride fixed-dose combination tablet will safely and effectively control glycemia as first-line oral therapy in drug naïve subjects with type 2 diabetes. This 24-week study will compare the effects of treatment with rosiglitazone/glimepiride to tre... | The antihyperglycemic effect of the thiazolidinedione (TZD) class of oral antidiabetic agents is due to their ability to increase insulin sensitivity at the cellular level, which in turn improves the ability of endogenous insulin to regulate glucose utilization by the tissues. Compounds of the sulfonylurea (SU) class a... | Diabetes Mellitus, Type 2 | rosiglitazone/glimepiride, fix dose, type 2 diabetes | null | 2 | arm 1: 4mg/1mg, 4mg/2mg, 4mg/4mg arm 2: 1mg, 2mg, 4mg | [
0,
1
] | 2 | [
0,
0
] | intervention 1: oral, once daily, dosage is titrated according to FPG and hypoglycemia events intervention 2: oral, once daily, dosage is titrated according to FPG and hypoglycemia | intervention 1: rosiglitazone/glimepiride fix dose combination intervention 2: glimepiride | 12 | Wuhan | Hubei | China | 114.26667 | 30.58333
Suzhou | Jiangsu | China | 120.59538 | 31.30408
Dalian | Liaoning | China | 121.60222 | 38.91222
Hangzhou | Zhejiang | China | 120.16142 | 30.29365
Hangzhou | Zhejiang | China | 120.16142 | 30.29365
Beijing | N/A | China | 116.39723 | 39.9075
Beijing | N/A | China | 116.3972... | 83 | 0 | 0 | 0 | NCT01453049 | 6TERMINATED | 2010-10-01 | 2010-04-01 | GlaxoSmithKline | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 185 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The aims of the trial are to assess the safety and the efficacy of SPM 962 following once-a-daily transdermal administration within a range of 2.25 to 6.75 mg/day in Japanese patients with restless legs syndrome (RLS) in a multi-center, open-label trial. The maximum treatment period is 53 weeks. The trial is an extensi... | null | Idiopathic Restless Legs Syndrome | null | 1 | arm 1: Rotigotine transdermal patch | [
0
] | 1 | [
0
] | intervention 1: Tansdermal patch | intervention 1: SPM 962 | 0 | null | 185 | 0 | 0 | 0 | NCT01562743 | 1COMPLETED | 2010-10-01 | 2008-08-01 | Otsuka Pharmaceutical Co., Ltd. | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
5
] | 40 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | true | Evaluation of the Safety and Efficacy of Humalog® Mix50/50TM administered as 3 injections daily to Humalog® plus Humulin N® insulin administered as 6 separate injections daily in terms of glucose control for women with Gestational Diabetes. | Controlling hyperglycemia during pregnancy decreases the risk of adverse neonatal and maternal outcomes. Not only must fasting glucose be normalized, but clinical evidence also indicates that controlling postprandial hyperglycemia will significantly reduce the risk of adverse neonatal and maternal outcomes.
Standard t... | Gestational Diabetes Mellitus | gestational diabetes mellitus insulin analogues in pregnancy | Prot_000.pdf:
Amendment 2, 11/24/08
PROTOCOL
HUMALOG® MIX50/50TM FOR THE TREATMENT OF INSULIN REQUIRING
GESTATIONAL DIABETES
RATIONALE
Controlling hyperglycemia during pregnancy decreases the risk of adverse neonatal and
maternal outcomes. Not only must fasting glucose be normalized, but clinical evidence
a... | 2 | arm 1: Insulin LISPRO: 3 doses of Humalog® Mix50/50™ at mealtime. arm 2: Usual insulin regimen of insulin, Long-Acting and Insulin: 3 injections of Humalog(r) daily with meals; 3 injections of Humulin N (r) daily on rising, mid-afternoon, and at bedtime | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Humalog® Mix50/50™ \[50% insulin lispro protamine suspension and 50% insulin lispro injection, (rDNA origin)\], three times daily at mealtime. Dose determined by blood glucose history. intervention 2: Usual insulin regimen: Long-acting insulin three times daily on rising, mid-afternoon, and before bed, ... | intervention 1: Insulin LISPRO intervention 2: Insulin, Long-Acting and Insulin | 0 | null | 40 | 0 | 0 | 0 | NCT01613807 | 1COMPLETED | 2010-10-01 | 2008-10-01 | Sansum Diabetes Research Institute | 7OTHER | true | false | false | https://cdn.clinicaltrials.gov/large-docs/07/NCT01613807/Prot_000.pdf | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3,
4
] | 143 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Safety of SPM 962 in a once-daily repeated long-term treatment in Parkinson's disease patients who are not concomitantly treated with L-dopa will be investigated with a doses. | null | Parkinson's Disease | SPM 962 rotigotine Parkinson's disease monotherapy | null | 1 | arm 1: SPM 962 transdermal patch | [
0
] | 1 | [
0
] | intervention 1: SPM 962 transdermal patch once a daily up to 36.0 mg/day | intervention 1: SPM 962 | 7 | Chubu Region | N/A | Japan | N/A | N/A
Hokkaido Region | N/A | Japan | N/A | N/A
Kanto Region | N/A | Japan | N/A | N/A
Kinki Region | N/A | Japan | N/A | N/A
Kyushu Region | N/A | Japan | N/A | N/A
Shikoku Region | N/A | Japan | N/A | N/A
Tohoku Region | N/A | Japan | N/A | N/A | 143 | 0 | 0 | 0 | NCT01628965 | 1COMPLETED | 2010-10-01 | 2008-01-01 | Otsuka Pharmaceutical Co., Ltd. | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 45 | RANDOMIZED | PARALLEL | 1PREVENTION | 4QUADRUPLE | false | 0ALL | true | Low triiodothyronine (T3) syndrome defines as decrease of T3 levels during critically ill. This decrease of T3 levels was observed after congenital heart surgery using cardiopulmonary bypass. Previous largest study,Triiodothyronine for Infants and Children Undergoing Cardiopulmonary bypass (TRICC) study showed T3 suppl... | The Research Ethics Board at the National Cardiovascular Center Harapan Kita approved this study and written, informed consent was obtained from the parents or legal guardians before randomization. Randomization by block permutation was performed to determine treatment group assignment. Randomization occured on the day... | Low T3 Syndrome | congenital heart surgery, thyroid hormones | null | 3 | arm 1: Oral T3 low dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) starting on induction of anesthesia and then every 24 hours alternating with placebo, which was given 12 hours after the first dose of oral T3 and then every 24 hours until 60 hours post anesthesia induction (3 doses oral T3, 3 doses pl... | [
1,
2,
0
] | 3 | [
0,
0,
0
] | intervention 1: Comparison of different dosages of drug. Low dose group oral T3 is 0.5 mcg/kg q24h intervention 2: Comparison of different dosages of drug. In low dose group, placebo was given alternately with oral T3 every 12h with a total 3 doses for placebo and 3 doses for oral T3 intervention 3: Comparison of diffe... | intervention 1: Oral T3 Low dose intervention 2: Placebo intervention 3: Oral T3 high dose | 1 | Jakarta | DKI Jakarta | Indonesia | 106.84513 | -6.21462 | 45 | 0 | 0 | 0 | NCT01780584 | 1COMPLETED | 2010-10-01 | 2010-04-01 | National Cardiovascular Center Harapan Kita Hospital Indonesia | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 52 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This study will evaluate the efficacy and safety of Tarceva in two groups of patients with non-small cell lung cancer who have not been pre-treated with chemotherapy. One group, consisting of patients who have never smoked, will receive Tarceva 150 mg/day, and the other group, consisting of current/former smokers, will... | null | Non-Small Cell Lung Cancer | null | 2 | arm 1: Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib \[Tarceva\] 150 mg orally daily until disease progression or unacceptable toxicity. arm 2: Current Smokers (participants who smoked \> 100 cigarettes in entire lifetime and either quit sm... | [
0,
0
] | 1 | [
0
] | intervention 1: Erlotinib tablets taken orally once daily in the morning. | intervention 1: erlotinib [Tarceva] | 11 | Marseille | N/A | France | 5.38107 | 43.29695
Villejuif | N/A | France | 2.35992 | 48.7939
Hamburg | N/A | Germany | 9.99302 | 53.55073
Milan | N/A | Italy | 12.59836 | 42.78235
Rozzano | N/A | Italy | 9.1559 | 45.38193
Amsterdam | N/A | Netherlands | 4.88969 | 52.37403
Maastricht | N/A | Netherlands | 5.68889 | 50.848... | 49 | 0 | 0 | 0 | NCT02013206 | 1COMPLETED | 2010-10-01 | 2006-09-01 | Hoffmann-La Roche | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
2
] | 6 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study was to determine the metabolism and elimination of 14C-lenvatinib in participants with advanced solid tumors or lymphomas, who were unsuitable for, or had failed, existing therapies. | The study comprised of two phases, the Study Phase and Extension Phase. Participants received 14C-lenvatinib on Day 1 of the Study Phase. Thereafter participants were given daily oral doses of 24 mg of lenvatinib over a 28 day cycle. During the Study Phase, participants received an initial single dose of 14C-lenvatinib... | Advanced Solid Tumors Lymphomas | Advanced Solid Tumors Lymphomas | null | 1 | arm 1: Participants with advanced solid tumors or lymphomas, who are unsuitable for, or had failed, existing therapies. | [
0
] | 1 | [
0
] | intervention 1: Study phase dosing: participants received an initial single dose of radiolabelled 14C-lenvatinib oral patient dosing solution containing 24 mg of lenvatinib as anhydrous free base and radioactivity of 3.7 millibecquerel (MBq) on Day 1.
Extension phase dosing: 24 mg of 14C-lenvatinib: 2 x 10mg, and 4 x ... | intervention 1: Lenvatinib | 1 | Amsterdam | N/A | Netherlands | 4.88969 | 52.37403 | 6 | 0 | 0 | 0 | NCT02578316 | 1COMPLETED | 2010-10-01 | 2009-06-01 | Eisai Inc. | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
0
] | 12 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | true | The primary objective of this study is to compare two treatment strategies for symptomatic venous stasis disease with and without venous ulcer. These treatments are compression therapy alone vs. sclerotherapy of refluxing perforating veins with compression. | Symptomatic venous disease is a widespread problem, affecting millions of patients per year, an estimated 1.0 - 1.5% of the population. This costs up to 1% of the total health care budget1-3. Venous problems account for almost 3000 patient visits in the UPP vascular surgery group per year. Although great progress has b... | Venous Disease | Venous Ulceration Refluxing Perforator Veins | null | 3 | arm 1: None arm 2: None arm 3: None | [
4,
0,
1
] | 2 | [
0,
1
] | intervention 1: Ultrasound-guided injection with sodium tetradecyl sulfate foam of refluxing perforating veins intervention 2: 20-30 mmHg compression stockings | intervention 1: sodium tetradecyl sulfate intervention 2: Compression | 1 | Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062 | 12 | 0 | 0 | 0 | NCT03363633 | 6TERMINATED | 2010-10-01 | 2010-03-01 | Ellen Dillavou | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 28 | RANDOMIZED | PARALLEL | 1PREVENTION | 0NONE | true | 0ALL | null | The purpose of this study is to evaluate the safety and reactogenicity of one booster dose of a HIV candidate vaccine after administration of one oral dose of chloroquine. | The Protocol Posting has been updated following Protocol amendment 1, October 2009. | AIDS | Chloroquine Human Immunodeficiency Virus | null | 2 | arm 1: Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine. arm 2: Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm. | [
0,
1
] | 2 | [
2,
0
] | intervention 1: 1 dose intramuscular injection intervention 2: One dose of 300 mg | intervention 1: GSK Biologicals' HIV vaccine (732461) intervention 2: Chloroquine | 1 | Ghent | N/A | Belgium | 3.71667 | 51.05 | 28 | 0 | 0 | 0 | NCT00972725 | 1COMPLETED | 2010-10-04 | 2009-12-01 | GlaxoSmithKline | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 30 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This study will assess, over a 4-week treatment period, the safety and efficacy of the addition of sitagliptin to metformin in participants with type 2 diabetes mellitus (T2DM) who failed to achieve glycemic control on metformin monotherapy. | null | Type 2 Diabetes | null | 1 | arm 1: Sitagliptin as add-on therapy to a stable dose of metformin | [
0
] | 2 | [
0,
0
] | intervention 1: Sitagliptin 100 mg tablet by mouth once daily for 4 weeks. intervention 2: Stable dose of metformin tablet(s) by mouth (at least 1000 mg/day) for 4 weeks. | intervention 1: Sitagliptin phosphate intervention 2: Metformin | 0 | null | 30 | 0 | 0 | 0 | NCT01034111 | 1COMPLETED | 2010-10-04 | 2010-03-01 | Merck Sharp & Dohme LLC | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
4
] | 45 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 1FEMALE | true | The purpose of this study is to find out whether Maca Root is effective for treating sexual dysfunction in females that is caused by antidepressant drugs. An additional aim of the study is to document the safety and tolerability of maca root, as well as any potential side effects that it causes. | This is a 12-week, double-blind, placebo-controlled trial comparing maca root (3.0 g/day) versus an inactive placebo in female outpatients with SSRI/SNRI-induced sexual dysfunction whose depression had remitted with SSRI treatment. Outcome measures include improvement in sexual functioning as per the Arizona Sexual Exp... | Antidepressant Induced Sexual Dysfunction | Antidepressant Induced Sexual Dysfunction Depression Sexual Dysfunction | null | 2 | arm 1: Subjects in this arm will be given 3g/day of maca root for 12 weeks arm 2: Subjects in this arm will receive inactive placebo for 12 weeks. | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 3g/day of Maca Root for 12 weeks. intervention 2: Placebo provided by research pharmacy daily for 12 weeks. | intervention 1: Maca Root intervention 2: Placebo | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 45 | 0 | 0 | 0 | NCT00568126 | 1COMPLETED | 2010-10-05 | 2007-12-27 | Massachusetts General Hospital | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 340 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | The primary purpose is to assess the efficacy of once daily dosing with optimized SPD503 (1, 2, 3 and 4mg/day), dosed either in the morning or evening, compared to placebo, in children with ADHD as measured by change from baseline score at endpoint on the ADHD-RS-IV. | null | Attention-Deficit/Hyperactivity Disorder | ADHD | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: dosed in AM intervention 2: dosed in the AM or PM intervention 3: Dosed in the PM | intervention 1: extended-release guanfacine hydrochloride (SPD503) intervention 2: placebo intervention 3: extended-release guanfacine hydrochloride | 46 | Little Rock | Arkansas | United States | -92.28959 | 34.74648
El Centro | California | United States | -115.56305 | 32.792
Rolling Hills Estates | California | United States | -118.35813 | 33.78779
San Diego | California | United States | -117.16472 | 32.71571
Wildomar | California | United States | -117.28004 | 33.598... | 554 | 0 | 0 | 0 | NCT00997984 | 1COMPLETED | 2010-10-09 | 2009-11-17 | Shire | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 210 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | false | This is an open-label, multinational, randomized, multicenter trial designed to compare pegylated liposomal doxorubicin with capecitabine as first line chemotherapy of metastatic breast cancer. The primary objective of the study is to compare the time to disease progression, although overall response rates, overall sur... | null | Breast Cancer | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: pegylated liposomal doxorubicin (50 mg/m\^2 q 28 days) was administered intravenously until disease progression or unacceptable toxicity intervention 2: capecitabine (1250 mg/m\^2 BID x 14 days q 21 days) in tablets of 150 mg and 500 mg was administered orally, until disease progression or unacceptable ... | intervention 1: Pegylated liposomal doxorubicin (SCH 200746) intervention 2: Capecitabine | 0 | null | 200 | 0 | 0 | 0 | NCT00266799 | 1COMPLETED | 2010-10-18 | 2006-01-13 | Merck Sharp & Dohme LLC | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
2
] | 13 | RANDOMIZED | SEQUENTIAL | 0TREATMENT | 2DOUBLE | true | 2MALE | true | When humans eat, the bowels naturally secrete chemicals into the bloodstream which make people feel full and which stop eating. One of these chemicals is known as "Pancreatic Polypeptide" (PP). We have previously shown that injections of human PP reduces appetite and food intake. We have now developed a very similar ch... | More than 20 percent of people in the UK are obese. People with obesity have a shorter life expectancy, and have a higher risk of having heart attacks, strokes, high blood pressure, diabetes, and certain cancers.
At the moment, there is no treatment for obesity that is both effective and safe. Advising people to chang... | Obesity | obesity pancreatic polypeptide gut hormones | null | 4 | arm 1: PP 1420 single dose, subcutaneous arm 2: PP 1420 single dose, subcutaneous arm 3: PP 1420 single dose, subcutaneous arm 4: 0.9% saline | [
0,
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: Single dose of PP 1420, administered subcutaneously at either 2mg, 4mg or 8mg. intervention 2: 0.9% saline | intervention 1: PP 1420 intervention 2: Placebo | 1 | London | N/A | United Kingdom | -0.12574 | 51.50853 | 36 | 0 | 0 | 0 | NCT01052493 | 1COMPLETED | 2010-10-18 | 2010-04-01 | Imperial College London | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 390 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to evaluate the safety, efficacy and tolerability of perampanel when given as an adjunctive therapy in subjects with refractory partial seizures. | null | Refractory Partial Seizures | E2007 perampanel refractory partial seizures adjunctive therapy seizure frequency partial onset seizures reduction in seizure frequency safety concomitant AED(s) | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: 8 mg perampanel in a 1:1:1 ratio, 125 subjects/arm. All subjects will take a maximum of 6 tablets daily for the duration of the study and will be up-titrated weekly in 2-mg increments to their randomized dose. intervention 2: 12 mg perampanel in a 1:1:1 ratio, 125 subjects/arm. All subjects will take a ... | intervention 1: E2007 (perampanel) intervention 2: E2007 (perampanel) intervention 3: Placebo | 97 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Birmingham | Alabama | United States | -86.80249 | 33.52066
Phoenix | Arizona | United States | -112.07404 | 33.44838
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Los Angeles | California | United States | -118.24368 | 34.05223
San Francisco |... | 388 | 1 | 0.002577 | 1 | NCT00699972 | 1COMPLETED | 2010-10-19 | 2008-04-30 | Eisai Inc. | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.000455 |
[
3
] | 81 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This study will investigate clinical activity, safety, and tolerability of the anti-angiogenic compound cilengitide (EMD 121974) in the treatment of first recurrence of glioblastoma multiforme (GBM). | null | Glioblastoma Multiforme | Brain cancer Brain tumor | null | 2 | arm 1: None arm 2: None | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Subjects will receive 1-hour intravenous infusion of 500 mg cilengitide twice weekly on Day 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent... | intervention 1: Cilengitide 500 mg intervention 2: Cilengitide 2000 mg | 17 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Phoenix | Arizona | United States | -112.07404 | 33.44838
Los Angeles | California | United States | -118.24368 | 34.05223
Aurora | Colorado | United States | -104.83192 | 39.72943
Chicago | Illinois | United States | -87.65005 | 41.85003
Indianapolis | Indian... | 81 | 0 | 0 | 0 | NCT00093964 | 1COMPLETED | 2010-10-21 | 2004-10-13 | EMD Serono | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 79 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to provide open-label vicriviroc (VCV) to human immunodeficiency virus (HIV) treatment-experienced participants who successfully completed 48 weeks of treatment on Acquired Immunodeficiency Syndrome (AIDS) Clinical Trial Group (ACTG) protocol A5211 (or who responded favorably to treatment b... | null | HIV HIV Infections | Treatment Experienced | null | 1 | arm 1: Participants take VCV 30 mg once daily. | [
0
] | 1 | [
0
] | intervention 1: VCV 30 mg tablet once daily by mouth. | intervention 1: Vicriviroc maleate | 0 | null | 79 | 0 | 0 | 0 | NCT00686829 | 1COMPLETED | 2010-10-21 | 2005-06-30 | Merck Sharp & Dohme LLC | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 11 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This is a multi-center, open-label, extension study of patients with late infantile MLD who have previously completed clinical study HGT-MLD-048 (NCT00633139), defined as the completion of all Week 52 procedures. This group of patients will be offered ongoing treatment with HGT-1111 in this protocol. One infusion will ... | The primary objective of this study is to provide ongoing treatment of HGT-1111 to patients who have completed study HGT-MLD-048 (previously study rhASA-03 - NCT00633139) until HGT-1111 is commercially available or the study is terminated by the Sponsor, provided no safety concerns have emerged. The secondary objective... | Late Infantile Metachromatic Leukodystrophy | Metazyme Late Infantile Metachromatic Leukodystrophy | null | 2 | arm 1: None arm 2: None | [
0,
0
] | 1 | [
0
] | intervention 1: Patients currently dosed with 100 U/kg or 200 U/kg will continue this treatment. Patients dosed with 50 U/kg will be equally randomized to treatment on 100 U/kg or 200 U/kg. The dose will be adjusted every 6-week to account for changes in body weight.The infusion length will be dependent on the dose. In... | intervention 1: HGT-1111 | 1 | Copenhagen | N/A | Denmark | 12.56553 | 55.67594 | 11 | 0 | 0 | 0 | NCT00681811 | 6TERMINATED | 2010-10-22 | 2008-02-20 | Shire | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
2
] | 28 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | true | 0ALL | false | The purpose of this study is to assess bioequivalence of 2 capsule strengths. | This will be a randomised, open-label, two-period, single dose, crossover bioequivalence study in healthy subjects under fasting conditions to assess bioequivalence of 1 x 60 mg capsule methylphenidate compared to 2 x 30 mg capsules methylphenidate. Pharmacokinetics and safety will be assessed. | ADHD | null | 2 | arm 1: None arm 2: None | [
0,
0
] | 2 | [
0,
0
] | intervention 1: two 30mg capsules, single oral dose intervention 2: one 60mg capsule, single oral dose | intervention 1: SPD544 intervention 2: Methylphenidate hydrochloride | 1 | London | N/A | United Kingdom | -0.12574 | 51.50853 | 55 | 0 | 0 | 0 | NCT01183234 | 1COMPLETED | 2010-10-22 | 2010-08-27 | Shire | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
4
] | 1,006 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This trial is conducted in Africa, Asia, Europe, and the United States of America (USA).
The aim of this clinical trial is to compare NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) plus insulin aspart (IAsp) with/without metformin and with/without pioglitazone in subjects with type 2 diabetes (main per... | null | Diabetes Diabetes Mellitus, Type 2 | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: Injected subcutaneously (under the skin) with main evening meal. Dose was individually adjusted. intervention 2: Injected subcutanoeusly (under the skin) according to approved label. Dose was individually adjusted. intervention 3: Injected subcutaneously (under the skin) at each main meal. Dose was indi... | intervention 1: insulin degludec intervention 2: insulin glargine intervention 3: insulin aspart | 136 | Alexander City | Alabama | United States | -85.95385 | 32.94401
Birmingham | Alabama | United States | -86.80249 | 33.52066
Goodyear | Arizona | United States | -112.35821 | 33.43532
Peoria | Arizona | United States | -112.23738 | 33.5806
Anaheim | California | United States | -117.9145 | 33.83529
Huntington Beach | Ca... | 1,004 | 1 | 0.000996 | 1 | NCT00972283 | 1COMPLETED | 2010-10-28 | 2009-09-01 | Novo Nordisk A/S | 4INDUSTRY | false | false | false | null | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.000176 | |
[
2,
3
] | 130 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | Over the last 40 years, corticosteroids (steroids) have been an important part of drug regimens used to prevent organ rejection and to maintain the immune health of individuals who have received organ transplants. Unfortunately, the negative physical effects of steroids can be severe, especially in children. The purpos... | Corticosteroids (steroids) have been a cornerstone of immunosuppressive therapy for kidney (renal) transplantation for over 40 years. However, poor growth and bone loss caused by the use of steroids are devastating to pediatric kidney recipients. The negative physical implications of steroid use also greatly impacts pa... | Kidney Diseases Kidney Transplantation Kidney Transplant Renal Transplantation Renal Transplant | Organ Rejection Corticosteroids Child Adolescent Immunosuppression Steroids | null | 2 | arm 1: Subjects will receive prednisone immunosuppression (10 mg/kg peri-operatively followed by 2 mg/kg/day in subjects weighing \<40kg and 1.5 mg/kg/day in subjects weighing \>40 kg) and proceed with a prednisone taper according to the trial's protocol. arm 2: Subjects will receive extended daclizumab induction until... | [
1,
0
] | 7 | [
0,
0,
0,
0,
0,
0,
0
] | intervention 1: Steroid-Based Immunosuppression(Prednisone) arm: 1 mg/kg pre-transplant followed by 1 mg/kg at weeks 2, 4, 6, and 8 (e.g., standard dose of daclizumab induction until the second month post-transplant)
Steroid-Free Immunosuppression (Extended daclizumab induction) arm: 2 mg/kg pre-transplant followed by... | intervention 1: Daclizumab intervention 2: Mycophenolate mofetil (MMF) intervention 3: Prednisone intervention 4: Tacrolimus intervention 5: Ganciclovir intervention 6: Valganciclovir intervention 7: Trimethoprim and sulfamethoxazole | 12 | 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
Palo Alto | California | United States | -122.14302 | 37.44188
San Francisco | California | United States | -122.41942 | 37.77493
... | 130 | 1 | 0.007692 | 1 | NCT00141037 | 1COMPLETED | 2010-11-01 | 2004-03-01 | National Institute of Allergy and Infectious Diseases (NIAID) | 0NIH | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0.001359 |
[
4
] | 527 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | null | Post-menopausal breast cancer patients will receive letrozole 2.5 mg daily for the treatment of breast cancer and will be randomized to a treatment group to receive either upfront zoledronic acid 4 mg IV 15-minute infusion every 6 months or delayed start zoledronic acid 4 mg IV 15-minute infusion every 6 months. Delaye... | null | Breast Cancer | breast cancer letrozole zoledronic acid adjuvant postmenopausal | null | 2 | arm 1: Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1 arm 2: Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BM... | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Zoledronic acid 4 mg Intravenous (IV)15 minute infusion every 6 months. intervention 2: Letrozole tablets 2.5 mg/day/taken orally for 5 years. | intervention 1: Zoledronic acid intervention 2: Letrozole | 49 | Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Rosario - Santa Fe | N/A | Argentina | N/A | N/A
Aalst | N/A | Belgium | 4.0355 | 50.93604
Anderlecht | N/A | Belgium | 4.31454 | 50.83619
Bonheiden | N/A | Belgium | 4.54714 | 51.02261
Brasschaat | N/A | Belgium | 4.49182 | 51.2912
Brussels | N/A | Belgium | 4.348... | 523 | 1 | 0.001912 | 1 | NCT00171314 | 1COMPLETED | 2010-11-01 | 2004-03-01 | Novartis Pharmaceuticals | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.000338 |
[
4
] | 1,186 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this study is to evaluate the treatment effect of panitumumab plus FOLFIRI compared to FOLFIRI alone as second line therapy for metastatic colorectal cancer. | null | Metastatic Colorectal Cancer | Oncology Cancer Metastatic Colorectal Cancer EGFr Panitumumab Clinical Trial Amgen | null | 2 | arm 1: Participants received panitumumab as an intravenous (IV) infusion at a dose of 6 mg/kg plus a standard chemotherapy regimen (FOLFIRI) consisting of 5-fluorouracil (5-FU), leucovorin and irinotecan. Treatment was administered in cycles every two weeks. arm 2: Participants received standard chemotherapy regimen (F... | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Panitumumab was administered by IV infusion on Day 1 of each 14-day cycle, just before administration of FOLFIRI chemotherapy. intervention 2: FOLFIRI chemotherapy was initiated on Day 1 of each treatment cycle at the following starting doses: irinotecan 180 mg/m\^2, leucovorin 400 mg/m\^2 racemate (or ... | intervention 1: Panitumumab intervention 2: FOLFIRI | 0 | null | 1,181 | 2 | 0.001693 | 1 | NCT00339183 | 1COMPLETED | 2010-11-01 | 2006-06-30 | Amgen | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.000465 |
[
4
] | 630 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | The purpose of this study is to determine whether investigational study drug, AG-013736, and gemcitabine are effective in the first-line treatment of advanced pancreatic cancer. | This study was prematurely discontinued for futility on 23 January 2009, based on a planned interim analysis by an independent Data Safety Monitoring Board (DSMB) that found no evidence of improvement in the primary endpoint (survival) in patients treated with axitinib and gemcitabine compared to gemcitabine alone. Enr... | Carcinoma, Pancreatic Ductal | Randomized Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine Plus Placebo For Advanced Pancreatic Cancer. | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: oral administration, starting dose 5 mg twice daily \[BID\] every day until unacceptable toxicity or tumor progression. intervention 2: intravenous administration at 1,000 mg/m\^2 day 1, day 8 and day 15 every 4 weeks (conventional dose) until unacceptable toxicity or tumor progression. intervention 3: ... | intervention 1: AG-013736 intervention 2: Gemcitabine intervention 3: Gemcitabine intervention 4: placebo | 204 | Antioch | California | United States | -121.80579 | 38.00492
Corona | California | United States | -117.56644 | 33.87529
Glendora | California | United States | -117.86534 | 34.13612
La Jolla | California | United States | -117.2742 | 32.84727
La Jolla | California | United States | -117.2742 | 32.84727
LaVerne | Calif... | 613 | 3 | 0.004894 | 1 | NCT00471146 | 1COMPLETED | 2010-11-01 | 2007-07-01 | Pfizer | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.001666 |
[
4
] | 8,101 | RANDOMIZED | PARALLEL | 1PREVENTION | 4QUADRUPLE | false | 0ALL | true | This study will evaluate if extended therapy with oral rivaroxaban can prevent blood clots in the leg and lung that can occur with patients hospitalized for acute medical illness, and compare these results with those of the standard enoxaparin dose and duration regimen. The safety of rivaroxaban will also be studied. | The treatment period was followed by a follow-up period starting the day after the last intake of study medication, regardless of the actual duration of study drug administration and ended on Day 90 (+ 7 days). Participants who did not complete the treatment period also entered the follow-up period. It was also possibl... | Venous Thromboembolism | Acute medical illnesses with increased risk for VTE. Deep vein thrombosis (DVT) Pulmonary embolism (PE), Venous Thromboembolic disease (VTE), Medical illness | null | 2 | arm 1: Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days arm 2: Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 ... | [
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: Oral rivaroxaban 10 mg once daily administered for 35 +/- 4 days intervention 2: Subcutaneous enoxaparin 40 mg once daily (OD) administered for 10 +/- 4 days intervention 3: Oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days intervention 4: Subcutaneous enoxaparin-matched placebo solution OD f... | intervention 1: Rivaroxaban (Xarelto, BAY59-7939) intervention 2: Enoxaparin intervention 3: Rivaroxaban placebo intervention 4: Enoxaparin placebo | 676 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Birmingham | Alabama | United States | -86.80249 | 33.52066
Dothan | Alabama | United States | -85.39049 | 31.22323
Geneva | Alabama | United States | -85.86382 | 31.03296
Mobile | Alabama | United States | -88.04305 | 30.69436
Montgomery | Alabama | United St... | 7,998 | 3 | 0.000375 | 1 | NCT00571649 | 1COMPLETED | 2010-11-01 | 2007-12-01 | Bayer | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.000128 |
[
3
] | 137 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | true | OncoGel is a new experimental drug delivery system that allows the slow continuous release of paclitaxel (an approved intravenous anticancer drug), from a gel (ReGel) over a long period of time. The gel will disappear in 4 to 6 weeks as it releases the paclitaxel.
The protocol is directed towards evaluating the effica... | The primary objective of this study is to evaluate the efficacy of OncoGel given in combination with standard chemotherapy (cisplatin and 5-FU) and radiation therapy in patients with previously untreated, resectable, local or local-regional adenosarcoma or squamous cell carcinoma.
All patients will receive IV cisplati... | Esophageal Cancer Adenocarcinoma of the Esophagus Squamous Cell Carcinoma | Esophageal cancer Localized esophageal cancer Operable esophageal cancer Loco-regional esophageal cancer Esophagectomy Phase 2 Paclitaxel Tumor Local Chemotherapy radiation therapy surgery OncoGel Squamous cell carcinoma of the esophagus | null | 2 | arm 1: OncoGel, radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection. arm 2: Radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection. | [
0,
1
] | 5 | [
0,
0,
0,
4,
3
] | intervention 1: 6.3 mg/mL tumor volume, injected into the esophagus during endoscopy, once, before starting chemoradiotherapy intervention 2: 75 mg/m2 IV (in the vein) once on Day 1 and Day 29 intervention 3: 1000 mg/m2/day, IV (in the vein) for 4 days (96 hours) for two cycles starting on Day 1 and Day 29 intervention... | intervention 1: OncoGel (Paclitaxel gel) intervention 2: cisplatin intervention 3: 5-FU intervention 4: radiation therapy intervention 5: esophageal resection | 20 | San Diego | California | United States | -117.16472 | 32.71571
Chicago | Illinois | United States | -87.65005 | 41.85003
Chicago | Illinois | United States | -87.65005 | 41.85003
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Kansas City | Kansas | United States | -94.62746 | 39.11417
Philadelphia | Penn... | 137 | 1 | 0.007299 | 1 | NCT00573131 | 6TERMINATED | 2010-11-01 | 2008-01-01 | Boston Scientific Corporation | 4INDUSTRY | false | false | false | null | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.00129 |
[
4
] | 583 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this study is to provide long-term safety data for rivastigmine capsule and transdermal patch treatments, in particular the effect of rivastigmine on worsening of the underlying motor symptoms of Parkinson's Disease (PD), in patients with mild to moderately severe dementia associated with PD. | null | Parkinson's Disease Dementia | Parkinson's disease dementia cholinesterase inhibitor rivastigmine | null | 2 | arm 1: Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally). The 12 mg/day dose or the highest dose tolerated was maintained until week 76. arm 2: Rivastigmine patch once a day in th... | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Rivastigmine capsules orally twice a day. Target dose 12 mg/day. intervention 2: Rivastigmine patch once a day in the morning, worn for 24 hours. Target dose 10 cm\^2/day delivering 9.5 mg over a 24 hour period. | intervention 1: Rivastigmine capsule intervention 2: Rivastigmine transdermal patch | 127 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Phoenix | Arizona | United States | -112.07404 | 33.44838
Reseda | California | United States | -118.53647 | 34.20112
Ventura | California | United States | -119.29317 | 34.27834
Hollywood | Florida | United States | -80.14949 | 26.0112
Naples | Florida | Unit... | 582 | 1 | 0.001718 | 1 | NCT00623103 | 1COMPLETED | 2010-11-01 | 2008-01-01 | Novartis | 4INDUSTRY | false | false | false | null | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.000303 |
[
4
] | 639 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to compare the benefits and risks of lixisenatide (AVE0010) in comparison to exenatide (Byetta®), as an add-on treatment to metformin, over a period of 24 weeks of treatment, followed by an extension.
The primary objective is to assess the effects of lixisenatide in comparison to exenatide... | Patients who complete the 24-week main open-label treatment would undergo a variable open-label extension treatment, which ends for all patients at approximately the scheduled date of Week 76 visit (Visit 24) for the last randomized patient. | Diabetes Mellitus, Type 2 | hyperglycemia, GLP-1, metformin | null | 2 | arm 1: 2-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment. arm 2: 1-step initiation regimen of exenatide: 5 mcg twice daily (BID) for 4 weeks, followed by 10 mcg BID up to the end of treatment. | [
0,
1
] | 5 | [
0,
1,
0,
1,
0
] | intervention 1: Self administered by subcutaneous injections once daily within the hour preceding breakfast. intervention 2: None intervention 3: Self administered by subcutaneous injections twice daily within the hour preceding breakfast and within the hour preceding dinner. intervention 4: None intervention 5: Metfor... | intervention 1: Lixisenatide (AVE0010) intervention 2: Pen auto-injector intervention 3: Exenatide intervention 4: Prefilled pen injector intervention 5: Metformin | 18 | Bridgewater | New Jersey | United States | -74.64815 | 40.60079
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Vienna | N/A | Austria | 16.37208 | 48.20849
São Paulo | N/A | Brazil | -46.63611 | -23.5475
Bogotá | N/A | Colombia | -74.08175 | 4.60971
Hørsholm | N/A | Denmark | 12.50111 | 55.88098
Helsinki | N/A ... | 634 | 1 | 0.001577 | 1 | NCT00707031 | 1COMPLETED | 2010-11-01 | 2008-06-01 | Sanofi | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.000278 |
[
4
] | 1,254 | RANDOMIZED | PARALLEL | 2DIAGNOSTIC | 2DOUBLE | false | 0ALL | false | This study will compare the safety and efficacy of initial combination treatment with aliskiren + amlodipine to sequential add-on treatment strategies with aliskiren or amlodipine in patients with hypertension. | This study was designed to evaluate if patients with hypertension treated early with a combination therapy would achieve better blood pressure (BP) control, than patients being treated with a classical sequential add-on therapy.
The study compared the effects of the two treatment strategies: Treatment initiation on a ... | Hypertension | Aliskiren Amlodipine Hypertension SPA1000 Norvasc | null | 3 | arm 1: Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10... | [
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Amlodipine (5 mg and 10 mg) was provided as capsules taken orally once daily. intervention 2: Hydrochlorothiazide 12.5 mg capsules were taken orally once daily intervention 3: Aliskiren 150 mg and aliskiren 300 mg were provided as film-coated tablets, taken orally once daily. | intervention 1: Amlodipine intervention 2: hydrochlorothiazide intervention 3: Aliskiren | 10 | Toronto | N/A | Canada | -79.39864 | 43.70643
San José | N/A | Costa Rica | -84.08489 | 9.93388
Paris | N/A | France | 2.3488 | 48.85341
Bonn | N/A | Germany | 7.09549 | 50.73438
Athens | N/A | Greece | 23.72784 | 37.98376
Guatemala City | N/A | Guatemala | -90.51327 | 14.64072
Cape Town | N/A | South Africa | 18.42322... | 1,247 | 1 | 0.000802 | 1 | NCT00797862 | 1COMPLETED | 2010-11-01 | 2008-11-01 | Novartis | 4INDUSTRY | false | false | false | null | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.000142 |
[
4
] | 665 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of the study is long-term safety, tolerability and efficacy of nalmefene in patients with alcohol dependence. | Alcohol dependence is a maladaptive pattern of alcohol use, leading to clinically significant impairment or distress, as manifested by at least three of a number of criteria such as tolerance, withdrawal symptoms, frequent use of alcohol in larger amounts or over longer periods than was intended, and others. Excessive ... | Alcohol Dependence | Pharmacologic Actions Alcohol-Related Disorders Alcoholism Mental Disorders Central Nervous System Agents | null | 2 | arm 1: None arm 2: None | [
2,
0
] | 2 | [
0,
0
] | intervention 1: as-needed use, tablets, orally, 52 weeks intervention 2: 18.06 mg as-needed use, tablets, orally, 52 weeks. 18.06 mg nalmefene equals 20 mg nalmefene hydrochloride. | intervention 1: Placebo intervention 2: Nalmefene | 60 | Litoměřice | N/A | Czechia | 14.1318 | 50.53348
Lnáře | N/A | Czechia | 13.78406 | 49.4579
Prague | N/A | Czechia | 14.42076 | 50.08804
Prague | N/A | Czechia | 14.42076 | 50.08804
Ústí nad Labem | N/A | Czechia | 14.03227 | 50.6607
Pärnu | N/A | Estonia | 24.49711 | 58.38588
Tallinn | N/A | Estonia | 24.75353 | 59.436... | 665 | 18 | 0.027068 | 1 | NCT00811941 | 1COMPLETED | 2010-11-01 | 2009-03-01 | H. Lundbeck A/S | 4INDUSTRY | false | false | false | null | 0 | 18 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.017189 |
[
4
] | 824 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | 6-month safety extension study in subjects who have completed Study 060-633 (NCT00953147). Evaluating the long-term safety of ciclesonide HFA nasal aerosol 160 μg administered once-daily in patients with Perennial Allergic Rhinitis. | This is a 6-month multi-center, open-label, long-term safety extension study in subjects who have completed Study 060-633 (NCT00953147). This study is designed to evaluate the long-term safety of ciclesonide HFA nasal aerosol 160 μg administered once-daily to male and female subjects 12 years or older diagnosed with pe... | Perennial Allergic Rhinitis | Perennial allergic rhinitis allergic rhinitis ciclesonide | null | 1 | arm 1: ciclesonide HFA 160 μg once daily | [
0
] | 1 | [
0
] | intervention 1: ciclesonide HFA 160 μg once daily | intervention 1: ciclesonide HFA 160 μg | 44 | Huntington Beach | California | United States | -117.99923 | 33.6603
Los Angeles | California | United States | -118.24368 | 34.05223
Mission Viejo | California | United States | -117.672 | 33.60002
Orange | California | United States | -117.85311 | 33.78779
Palmdale | California | United States | -118.11646 | 34.57943... | 824 | 1 | 0.001214 | 1 | NCT01067105 | 1COMPLETED | 2010-11-01 | 2010-02-01 | Sumitomo Pharma America, Inc. | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.000214 |
[
2,
3
] | 25 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | RATIONALE: Radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining high-dose radiation with chemotherapy may kil... | OUTLINE: Cohorts of 10 patients receive the following treatment to assess for dose-limiting toxicity.
Phase I
* Radiotherapy: Patients receive radiotherapy once daily 5 days a week for 6 weeks beginning on day 1.
* Concurrent chemotherapy: Patients receive cisplatin IV over 20-30 minutes on days 1-5 and 22-26.
* Adju... | Head and Neck Cancer | stage II lymphoepithelioma of the nasopharynx stage II squamous cell carcinoma of the nasopharynx stage III lymphoepithelioma of the nasopharynx stage III squamous cell carcinoma of the nasopharynx stage IV lymphoepithelioma of the nasopharynx stage IV squamous cell carcinoma of the nasopharynx | null | 1 | arm 1: Phase I
* Radiotherapy: Patients receive radiotherapy once daily 5 days a week for 6 weeks beginning on day 1.
* Concurrent chemotherapy: Patients receive cisplatin IV over 20-30 minutes on days 1-5 and 22-26.
* Adjuvant chemotherapy: Approximately 2-5 weeks after the completion of radiotherapy, patients receiv... | [
0
] | 4 | [
0,
0,
3,
4
] | intervention 1: None intervention 2: None intervention 3: None intervention 4: None | intervention 1: cisplatin intervention 2: fluorouracil intervention 3: adjuvant therapy intervention 4: radiation therapy | 1 | New York | New York | United States | -74.00597 | 40.71427 | 25 | 0 | 0 | 0 | NCT00052429 | 1COMPLETED | 2010-11-01 | 2002-09-01 | Memorial Sloan Kettering Cancer Center | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 167 | RANDOMIZED | FACTORIAL | 0TREATMENT | 4QUADRUPLE | true | 2MALE | true | The purpose of this study is to evaluate the effects of testosterone supplementation (AndroGel) on body composition, strength, endurance, cognition, and function in older men. | Studies suggest that testosterone (T) replacement in healthy elderly men has beneficial effects on body composition, muscle, bone, memory, and behavior, but the risks of chronic treatment, especially on the prostate, heart, and sleep quality, are not entirely clear. Therefore, it is most desirable to supplement into th... | Healthy | andropause hypogonadism AndroGel exercise PRT Testosterone T supplementation | null | 6 | arm 1: Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml)
1 year standard Progressive Resistance Training(PRT) program arm 2: Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target bl... | [
0,
0,
0,
0,
1,
2
] | 4 | [
0,
5,
0,
0
] | intervention 1: Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml)during the first 12 weeks. Total exposure duration is 52 weeks. intervention 2: Weight training 45-60 minutes 3 times per week intervention 3: 2.5 gm gel packets applied... | intervention 1: LowT intervention 2: Resistance Training intervention 3: Placebo intervention 4: HighT | 1 | Denver | Colorado | United States | -104.9847 | 39.73915 | 143 | 0 | 0 | 0 | NCT00112151 | 1COMPLETED | 2010-11-01 | 2005-01-01 | University of Colorado, Denver | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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