phases
list
enrollmentCount
int64
allocation
string
interventionModel
string
primaryPurpose
class label
masking
class label
healthyVolunteers
bool
sex
class label
oversightHasDmc
bool
briefSummary
string
detailedDescription
string
conditions
string
conditionsKeywords
string
protocolPdfText
string
numArms
int64
armDescriptions
string
armGroupTypes
list
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list
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numLocations
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locationDetails
string
target
int64
nctid
string
[ 5 ]
80
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
true
1FEMALE
false
Prospective open label, randomised, parallel group, comparative pilot.
Ongoing pregnancy rate, defined as positive fetal heart action 9 weeks after the first positive pregnancy test. Number/diameter of follicles, number of oocytes retrieved, number of pronuclear oocytes (referred to as zygotes or pre-embryos in the UK), quality of pronuclear stage oocytes, number of embryos transferred, q...
Infertility
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: 150 IU Menotrophin daily subcutaneous injection for a maximum of 13 days. In the event of hyperstimulation, the dose was reduced to 75 IU daily. intervention 2: 150 IU follitropin alfa daily by subcutaneous injection for a maximum of 13 days. In the event of hyperstimulation, the dose was reduced to 75 ...
intervention 1: Menotrophin intervention 2: Follitropin alfa
6
Dortmund | N/A | Germany | 7.466 | 51.51494 Heidelberg | N/A | Germany | 8.69079 | 49.40768 Hildesheim | N/A | Germany | 9.95112 | 52.15077 Edinburgh | N/A | United Kingdom | -3.19648 | 55.95206 Leeds | N/A | United Kingdom | -1.54785 | 53.79648 Sheffield | N/A | United Kingdom | -1.4659 | 53.38297
0
NCT00257556
[ 4 ]
360
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
This 2 arm study will compare the efficacy and safety of the standard chemotherapy of the East German Study Group for Hematology and Oncology versus standard chemotherapy plus MabThera (375mg/m2 iv, once monthly for 8 cycles) in patients with indolent non-Hodgkin's and mantle cell lymphoma. The anticipated time on stud...
null
Non-Hodgkin's Lymphoma
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: 375mg/m2 iv monthly for 8 cycles intervention 2: As prescribed
intervention 1: rituximab [MabThera/Rituxan] intervention 2: Standard chemotherapy
33
Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.52437 Bochum | N/A | Germany | 7.21648 | 51.48165 Bonn | N/A | Germany | 7.09549 | 50.73438 Borna | N/A | Germany | 12.49639 | 51.12416 Chemnitz | N/A | Germany | 12.92922 | 50.8357 Cottbus | N/A | Germany | 14.32888 | 51.75769 Dresden ...
0
NCT00269113
[ 3 ]
10
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving radiation therapy together with pemetrexed may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving whole-bra...
OBJECTIVES: Primary * Estimate the response in patients with intracranial brain metastases from non-small cell lung cancer treated with whole-brain radiotherapy and pemetrexed disodium. Secondary * Determine the toxicity of this regimen in these patients. * Estimate the overall survival of patients treated with thi...
Lung Cancer Metastatic Cancer
recurrent non-small cell lung cancer stage IV non-small cell lung cancer tumors metastatic to brain
null
1
arm 1: Single Arm Study
[ 5 ]
2
[ 0, 4 ]
intervention 1: 500 mg/m2 once every 21 days up to 126 days intervention 2: Patients will receive cranial irradiation at 2.5 Gy per fraction, 5 days a week, for 3 weeks to a total dose of 37.5 Gy
intervention 1: pemetrexed disodium intervention 2: radiation therapy
2
Burlington | North Carolina | United States | -79.4378 | 36.09569 Chapel Hill | North Carolina | United States | -79.05584 | 35.9132
0
NCT00280748
[ 4 ]
504
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
This study is to be conducted in subjects with mild-to-moderate COPD who are cigarette smokers with the intent of demonstrating differences in smoking cessation between varenicline and placebo.
null
Smoking Cessation
smoking cessation smoking cessation in COPD
null
2
arm 1: None arm 2: None
[ 2, 0 ]
2
[ 0, 0 ]
intervention 1: 1mg (placebo) by mouth twice daily for 12 weeks (first week is up titration schedule---0.5mg once daily for 3 days, 0.5mg twice daily for 4 days) intervention 2: 1 mg by mouth twice daily for 12 weeks (first week is up titration schedule---0.5mg once daily for 3 days, 0.5mg twice daily for 4 days)
intervention 1: placebo intervention 2: Varenicline Tartarate
32
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 Denver | Colorado | United States | -104.9847 | 39.73915 Farmington | Connecticut | United States | -72.83204 | 41.71982 Farmingto...
0
NCT00285012
[ 0 ]
11
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to see whether the medication mifepristone is an effective and tolerable treatment for increasing the clinical effectiveness of electroconvulsive therapy (ECT) and protecting cognitive function during ECT. Both Mifepristone and ECT appear to normalize hyperfunctioning of the hypothalmic-pit...
Patients referred to the Stanford ECT Service who provide informed consent for this study will be screened for eligibility. Day -4 to 0: Screening (visit 1) will occur three to six days prior to the first ECT treatment. Screening procedures will include: Psychiatric interviews and ratings (including MINI, Hamilton Dep...
Depression
null
2
arm 1: Patients receive mifepristone one day before and for 5 additional days after starting ECT arm 2: Patients receive a placebo capsule one day before and for 5 additional days after starting ECT
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Mifepristone is a glucocorticoid receptor antagonist. intervention 2: Placebo is a capsule without a pharmacological active ingredient
intervention 1: Mifepristone intervention 2: Placebo Oral Capsule
1
Stanford | California | United States | -122.16608 | 37.42411
0
NCT00285818
[ 5 ]
4
RANDOMIZED
PARALLEL
1PREVENTION
0NONE
false
0ALL
false
The purpose of the study is to evaluate the safety and efficacy of two dose levels of Naglazyme in infants under the age of one year who have MPS VI by monitoring physical appearance, x-ray of the skeletal system and growth.
The primary objective of the study was to evaluate the efficacy of two dose levels of Naglazyme in preventing the progression of skeletal dysplasia in infants under the age of one year who have MPS VI by monitoring physical appearance, x-ray of the skeletal system and growth. The secondary objective of the study was t...
Mucopolysaccharidosis VI Maroteaux-Lamy Syndrome
null
2
arm 1: Dose comparison arm 2: Dose Comparison
[ 5, 5 ]
1
[ 0 ]
intervention 1: Weekly infusion for minimum of 52 weeks. Naglazyme is diluted in sterile 0.9% sodium chloride solution
intervention 1: Naglazyme
4
Los Angeles | California | United States | -118.24368 | 34.05223 Oakland | California | United States | -122.2708 | 37.80437 Lyon | N/A | France | 4.84671 | 45.74846 Coimbra | N/A | Portugal | -8.41955 | 40.20564
0
NCT00299000
[ 5 ]
100
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
2MALE
false
We hypothesize that AndroGel may offer some relief to subjects with low or borderline testosterone levels who suffer from depression and have failed to respond to a trial of a standard antidepressant. During this nine week, outpatient, double-blind study, male subjects between the ages of 30 and 65 years with treatmen...
We will recruit 100 men between the ages of 30 and 65 years who have treatment-refractory depression and low or borderline low testosterone levels for participation in this study. For a period of nine weeks subjects will receive double-blind treatment with either AndroGel (testosterone gel) or placebo. During this doub...
Depressive Disorder, Major
null
2
arm 1: AndroGel (1% testosterone transdermal gel), 2.5 g to 10 g daily arm 2: Placebo gel
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: AndroGel 2.5g and 5g sachets at doses ranging from 10g/day for duration of trial. intervention 2: Placebo
intervention 1: Testosterone gel intervention 2: Placebo
2
Belmont | Massachusetts | United States | -71.17867 | 42.39593 Tel Litwinsky | N/A | Israel | 34.84588 | 32.05096
0
NCT00304746
[ 4 ]
92
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
Asthma can be caused by a variety of factors, including tobacco smoke, allergens, and respiratory airway infections. Many people use inhaled corticosteroid medications to treat their symptoms. These medications, however, are not effective for everyone. Clarithromycin is an antibiotic that may effectively treat asthma i...
Asthma prevalence has steadily increased in the United States since the early 1980s; currently, more than 20 million people are diagnosed with asthma. Individuals with this disease may experience periodic attacks of wheezing, shortness of breath, chest tightness, and coughing. While there are many known causes of asthm...
Asthma
null
2
arm 1: clarithromycin 500 mg twice daily (Biaxin) + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily) arm 2: placebo clarithromycin twice daily + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
[ 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: clarithromycin 500 mg twice daily (Biaxin) intervention 2: fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily) intervention 3: placebo clarithromycin twice daily
intervention 1: clarithromycin intervention 2: fluticasone propionate intervention 3: placebo clarithromycin
10
San Diego | California | United States | -117.16472 | 32.71571 San Francisco | California | United States | -122.41942 | 37.77493 Denver | Colorado | United States | -104.9847 | 39.73915 Boston | Massachusetts | United States | -71.05977 | 42.35843 St Louis | Missouri | United States | -90.19789 | 38.62727 New York | N...
0
NCT00318708
[ 4 ]
151
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
The present trial investigates the long-term safety, tolerability and efficacy of bosentan in patients with inoperable CTEPH.
null
Pulmonary Hypertension
pulmonary hypertension bosentan BENEFIT CTEPH inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
null
1
arm 1: Open label bosentan treatment
[ 0 ]
1
[ 0 ]
intervention 1: Oral bosentan * Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients * Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight \< 40 kg)
intervention 1: bosentan
0
null
0
NCT00319111
[ 3 ]
62
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
null
This study (EGF104911) is designed to evaluate the efficacy and safety of lapatinib in patients with advanced or metastatic breast cancer. Eligible subjects must have ErbB2 overexpressing tumors and are refractory to treatment with anthracycline, taxanes and trastuzumab containing regimens. The study data obtained from...
null
Neoplasms, Breast
Stage IV breast cancer Herceptin metastatic breast cancer ErbB1 ErbB2 trastuzumab lapatinib
null
1
arm 1: Lapatinib 1500mg QD
[ 0 ]
1
[ 0 ]
intervention 1: Lapatinib 1500mg QD
intervention 1: lapatinib
9
Ehime | N/A | Japan | N/A | N/A Fukuoka | N/A | Japan | 130.41667 | 33.6 Kanagawa | N/A | Japan | 139.91667 | 37.58333 Okayama | N/A | Japan | 133.93333 | 34.65 Tochigi | N/A | Japan | 139.73333 | 36.38333 Tokyo | N/A | Japan | 139.69171 | 35.6895 Tokyo | N/A | Japan | 139.69171 | 35.6895 Tokyo | N/A | Japan | 139.6917...
0
NCT00320411
[ 5 ]
535
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
null
This is a double blind, placebo-controlled clinical trial of 15 months duration designed to examine early Mirapex (pramipexole) treatment vs. delayed Mirapex (pramipexole) treatment in patients with new onset Parkinsons disease
null
Parkinson Disease
null
2
arm 1: Patients were treated with pramipexole for 6 to 9 months then up-titrated to target dose of pramipexole (2.25 mg/day). arm 2: Patients were treated with placebo for 6 to 9 months then up-titrated to target dose of pramipexole (2.25 mg/day).
[ 0, 0 ]
1
[ 0 ]
intervention 1: None
intervention 1: pramipexole
99
Brimingham | Alabama | United States | N/A | N/A Scottsdale | Arizona | United States | -111.89903 | 33.50921 La Jolla | California | United States | -117.2742 | 32.84727 La Jolla | California | United States | -117.2742 | 32.84727 New Haven | Connecticut | United States | -72.92816 | 41.30815 Bradenton | Florida | Uni...
0
NCT00321854
[ 3 ]
305
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
2MALE
null
This study will look at the safety, effectiveness, and tolerability of combination medications for the initial treatment of non-gonococcal urethritis (NGU). NGU is inflammation of the tube that carries urine from the bladder. NGU is caused by bacteria that may be passed from person to person during sex. This study will...
This study represents a clinical evaluation of the use of combination therapy for the initial treatment of non-gonococcal urethritis (NGU). This study will provide more current data on the comparison of cure rates between the 2 currently recommended therapies for NGU, doxycycline and azithromycin. Emerging clinical dat...
Urethritis
non-gonococcal urethritis, doxycycline, azithromycin, sexually transmitted, tinidazole
null
4
arm 1: Doxycycline 100 mg orally twice daily (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin orally single dose and placebo tinidazole. arm 2: Doxycycline 100 mg orally twice daily for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm orally single dose (4 tablets at 500 mg each). arm 3:...
[ 0, 0, 0, 0 ]
4
[ 0, 10, 0, 0 ]
intervention 1: 2 gm single dose (4 tablets orally at 500 mg each). intervention 2: Placebo capsule will be filled with lactose only and be identical in appearance to the capsule of Azithromycin, Tinidazole, Doxycycline. intervention 3: 100 mg orally, twice daily for 7 days. intervention 4: 1 gram (gm) (2 tablets orall...
intervention 1: Tinidazole intervention 2: Placebo intervention 3: Doxycycline intervention 4: Azithromycin
4
Birmingham | Alabama | United States | -86.80249 | 33.52066 New Orleans | Louisiana | United States | -90.07507 | 29.95465 Baltimore | Maryland | United States | -76.61219 | 39.29038 Chapel Hill | North Carolina | United States | -79.05584 | 35.9132
0
NCT00322465
[ 3 ]
8
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
Background: * Natural killer (NK) cells are large lymphocytes (a type of white blood cell) that are important in the immune response to cancer. * IL-2 (Aldesleukin) is a substance the body makes that controls the growth and function of many types of cells. The Food and Drug Administration has approved IL-3 for treatin...
Background: * Natural killer (NK) cells are large granular lymphocytes that are critical effector cells in the early innate immune response to pathogens and cancer. * Previous and current clinical investigations have clearly demonstrated that T lymphocytes can mediate the regression of metastatic melanoma. However, no...
Metastatic Melanoma Metastatic Kidney Cancer
Adoptive Cell Therapy Cutaneous Melanoma Clinical Response Rate of Repopulation Toxicity Profile Metastatic Melanoma Metastatic Kidney Cancer
null
2
arm 1: Melanoma (skin cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m\^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy. arm 2: Ren...
[ 0, 0 ]
4
[ 0, 2, 0, 0 ]
intervention 1: Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy. intervention 2: IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. intervention 3: Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. intervention 4: Fludarabine 25 mg/m\^2 day intravenous ...
intervention 1: Natural Killer (NK) Lymphocytes intervention 2: IL-2 intervention 3: Cyclophosphamide intervention 4: Fludarabine
1
Bethesda | Maryland | United States | -77.10026 | 38.98067
0
NCT00328861
[ 3, 4 ]
229
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
null
This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of non-infectious intermediate or posterior uveitis.
null
Intermediate Uveitis Posterior Uveitis
null
3
arm 1: Dexamethasone 350 µg arm 2: Dexamethasone 700 µg arm 3: Sham
[ 1, 1, 3 ]
3
[ 0, 0, 0 ]
intervention 1: Dexamethasone 350 µg; injection drug delivery system at Day 0 intervention 2: Dexamethasone 700 µg injection drug delivery system at Day 0 intervention 3: Sham injection at Day 0
intervention 1: Dexamethasone intervention 2: dexamethasone intervention 3: Sham injection
18
Dallas | Texas | United States | -96.80667 | 32.78306 Sydney | N/A | Australia | 151.20732 | -33.86785 Vienna | N/A | Austria | 16.37208 | 48.20849 São Paulo | São Paulo/SP | Brazil | -46.63611 | -23.5475 Montreal | Quebec | Canada | -73.58781 | 45.50884 Prague | N/A | Czechia | 14.42076 | 50.08804 Paris | N/A | France...
0
NCT00333814
[ 3 ]
85
RANDOMIZED
PARALLEL
1PREVENTION
2DOUBLE
false
0ALL
null
This randomized phase II trial is studying atorvastatin calcium to see how well it works compared to oligofructose-enriched inulin, sulindac, or a placebo in preventing cancer in patients at increased risk of developing colorectal neoplasia. Chemoprevention is the use of certain drugs or substances to keep cancer from ...
PRIMARY OBJECTIVE: I. Percent change in number of rectal aberrant cryptic foci (ACF) as measured by magnification chromoendoscopy SECONDARY OBJECTIVES: I. Screening for possible phase III testing II. Effects on proliferation (Ki67 expression) and apoptosis (caspase-3 expression) as measured by biopsy samples obtaine...
Colon Cancer Precancerous Condition Rectal Cancer
null
4
arm 1: Patients receive oral atorvastatin once daily. arm 2: Patients receive oral sulindac twice daily. arm 3: Patients receive oral oligofructose-enriched inulin (Raftilose Synergy 1) twice daily. arm 4: Patients receive an oral placebo twice daily.
[ 0, 0, 0, 2 ]
5
[ 0, 0, 0, 0, 10 ]
intervention 1: Given orally intervention 2: Given orally intervention 3: Given orally intervention 4: Given orally intervention 5: Correlative studies
intervention 1: oligofructose-enriched inulin intervention 2: sulindac intervention 3: placebo intervention 4: atorvastatin calcium intervention 5: laboratory biomarker analysis
1
Rochester | Minnesota | United States | -92.4699 | 44.02163
0
NCT00335504
[ 5 ]
64
NON_RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
false
0ALL
null
This is a research study looking at Migranal (study drug) in the treatment of two migraine attacks in patients who have a history of cutaneous allodynia (pronounced q-tay-nee-us al-o-din-ee-a). Cutaneous allodynia is an increased skin sensitivity experienced during a headache. It has been noted in several studies that ...
This is a three visit trial consisting of a screening visit, one follow-up visit and a termination visit. Subjects will be screened using the Cutaneous Allodynia Screening Tool (Appendix A) and the investigator will determine whether or not the subject experiences episodic migraine headaches associated with cutaneous a...
Migraine
null
2
arm 1: All subjects were asked to treat one headache at 1 hour (early) and one headache at 4 hours after onset of throbbing (late). Dose of nasal spray constant for both time points. The subject could determine the order in which they could treat the headaches (early (first treatment phase) then late (second treatment ...
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Migranal® 4 mg. will be self administered by each subject in the following manner: one spray in each nostril, wait 15 minutes then follow with one spray in each nostril. This will deliver the desired 4 mg. dose. intervention 2: Migranal® 4 mg. will be self administered by each subject in the following m...
intervention 1: Migranal nasal spray at 1 hour intervention 2: Migranal nasal spray at 4 hour
1
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
0
NCT00335777
[ 3 ]
7
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays ...
OBJECTIVES: * Determine the pathologic complete response rate in patients with primary gastric adenocarcinoma treated with neoadjuvant chemoradiotherapy comprising oxaliplatin, capecitabine, and radiotherapy. (This will not be completed as this study was closed early due to poor accrual.) * Assess the frequency and se...
Gastric Cancer
adenocarcinoma of the stomach stage I gastric cancer stage II gastric cancer stage III gastric cancer
null
1
arm 1: Chemotherapy: Oxaliplatin, 130 mg/m2, 2 hour IV infusion on Days 1 and 22; Capecitabine 850 mg/m2/dose, PO q 12 hours on Days 1-14 and 22-35 Chemoradiation: Capecitabine 650 mg/m2/dose, PO q 12 hours on days 43-77; Radiation therapy 180 cGy/day, 5 days/week beginning on Day 43. Surgery: Distal subtotal gastrect...
[ 0 ]
4
[ 0, 0, 3, 4 ]
intervention 1: 850 mg/m2/dose PO q 12 hours Days 1-14 and 22-35. 650 mg/m2/dose PO q 12 hours Days 43-77. intervention 2: 130 mg/m2 by 2-hour infusion Days 1 and 22 intervention 3: Distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy intervention 4: Beginning Day 43, patients will be treated 5 days/...
intervention 1: capecitabine intervention 2: oxaliplatin intervention 3: conventional surgery intervention 4: radiation therapy
75
Little Rock | Arkansas | United States | -92.28959 | 34.74648 Burbank | California | United States | -118.30897 | 34.18084 Los Angeles | California | United States | -118.24368 | 34.05223 Palm Springs | California | United States | -116.54529 | 33.8303 Aurora | Colorado | United States | -104.83192 | 39.72943 Denver | ...
0
NCT00335959
[ 3 ]
120
RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
A phase II study to allow patients with advanced kidney cancer access to sunitinib malate treatment and to find out the good and bad effects of taking 37.5 mg sunitinib malate in a continuous daily regimen (once per day) for one year.
null
Carcinoma, Renal Cell
null
1
arm 1: Sunitinib malate starting dose 37.5 mg daily continuous daily schedule
[ 0 ]
1
[ 0 ]
intervention 1: Sunitinib malate starting dose 37.5 mg daily continuous daily schedule
intervention 1: Sunitinib malate
15
Córdoba | Córdoba Province | Argentina | -64.18853 | -31.40648 Rosario | Santa Fe Province | Argentina | -60.63932 | -32.94682 Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Adelaide | South Australia | Australia | 138.59863 | -34.92866 Clayton | Victoria | Australia | 145.11667 | -37.91667 East Bentleigh | Vic...
0
NCT00338884
[ 3 ]
18
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This study prospectively evaluates a multidisciplinary approach to patients with intraperitoneal carcinomatosis at Washington University. Patients with peritoneal carcinomatosis or pseudomyxoma peritonei will undergo debulking surgery with peritonectomy and placement of adhesive barrier film followed by repeated delaye...
null
Peritoneal Neoplasms
null
1
arm 1: * Surgical debulking with peritonectomy * IP 5FU 600 mg/m\^2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles. * FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m\^2 over 2 hours with leucovorin at 400 mg/m\^2 and IV 5-FU at...
[ 0 ]
3
[ 3, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: None
intervention 1: Surgical debulking with peritonectomy intervention 2: Intraperitoneal 5FU intervention 3: FOLFOX
1
St Louis | Missouri | United States | -90.19789 | 38.62727
0
NCT00352755
[ 3 ]
41
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to help answer: * Whether pemetrexed, gemcitabine and/or carboplatin can shrink tumor(s) or make tumor(s) disappear in patients with relapsed lung cancer (lung cancer that has come back after surgical removal and chemotherapy), and to determine how long this will last * Whether pemetrexed,...
null
Lung Neoplasms
null
4
arm 1: Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy arm 2: Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy arm 3: Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy arm 4: Disease relapse at one year or greater after neoadjuvant/...
[ 0, 0, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression intervention 2: 1500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression intervention 3: area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression int...
intervention 1: pemetrexed intervention 2: gemcitabine intervention 3: carboplatin intervention 4: Pemetrexed
17
Miami | Florida | United States | -80.19366 | 25.77427 Evanston | Illinois | United States | -87.69006 | 42.04114 Wichita | Kansas | United States | -97.33754 | 37.69224 Minneapolis | Minnesota | United States | -93.26384 | 44.97997 St Louis | Missouri | United States | -90.19789 | 38.62727 Omaha | Nebraska | United St...
0
NCT00356525
[ 5 ]
1,976
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to evaluate the long-term pulmonary and cardiovascular safety of Exubera in routine clinical practice.
Pfizer announced in October 2007 that it would stop marketing Exubera. At that time, Pfizer committed to continued marketing until it returned the licensing rights for the technology to Nektar. Following the announcement, enrollment was halted. Subjects already enrolled and receiving treatment at the time of the halt i...
Diabetes Mellitus
Large Simple Trial
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Subjects are randomized to use Exubera. Following initial use of randomized treatment, physicians and subjects are free to change regimens and dosing based on subject response to assigned treatment (as consistent with routine practice). Enrolling physicians are provided with the approved local label for...
intervention 1: Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Care intervention 2: Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Care
197
Bay Minette | Alabama | United States | -87.77305 | 30.88296 Fairhope | Alabama | United States | -87.90333 | 30.52297 Graysville | Alabama | United States | -86.97138 | 33.62066 Pell City | Alabama | United States | -86.28609 | 33.58621 Phoenix | Arizona | United States | -112.07404 | 33.44838 Phoenix | Arizona | Unit...
0
NCT00359801
[ 3, 4 ]
17
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This study will evaluate how heartburn may lead to different types of inflammation in one's airways. Additionally, the study will determine whether aggressive treatment of heartburn results in improvement in both symptoms of heartburn and asthma but also in documented improvement in airway inflammation as determined by...
Currently, many Americans suffer from asthma. The exact mechanism by which airway inflammation leads to asthma symptoms has yet to be clearly explained. In previous studies, persons with asthma appear to have different types of inflammation in their lungs. The reasons for this difference remain a mystery. Allergy is kn...
Gastroesophageal Reflux Asthma
null
2
arm 1: Lansoprazole 30 mg orally twice daily arm 2: placebo orally twice daily
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: 30 mg of lansoprazole twice daily for 6 weeks intervention 2: placebo comparator to lansoprazole 30 mg, twice daily for 6 weeks
intervention 1: lansoprazole intervention 2: placebo
1
Salt Lake City | Utah | United States | -111.89105 | 40.76078
0
NCT00361972
[ 5 ]
500
RANDOMIZED
FACTORIAL
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study, which is being conducted at 100 centers throughout the United States, is to determine whether Lantus, a long-acting insulin injection, either alone or in combination with metformin, is effective in reducing C-reactive protein (CRP) in adults with type 2 diabetes. CRP is a marker of chronic lo...
Study Rationale Low-grade systemic inflammation as indicated by elevated levels of C-reactive protein (CRP) is often present in patients with type 2 diabetes. Individuals with type 2 diabetes represent a vulnerable population in which cardiovascular event rates are high and among whom CRP reduction may have the greate...
Type 2 Diabetes
type 2 diabetes insulin insulin injection metformin C-reactive protein insulin sensitivity glycemic control inflammation
null
4
arm 1: Placebo pill arm 2: Metformin pill arm 3: Insulin glargine plus placebo pill arm 4: Insulin Glargine plus metformin pill
[ 2, 1, 1, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Once daily for 14 weeks intervention 2: Up to 4 pils per day (2g per day) maximum intervention 3: Up to 4 pills per day
intervention 1: Insulin glargine injection intervention 2: metformin intervention 3: Placebo pill
1
Boston | Massachusetts | United States | -71.05977 | 42.35843
0
NCT00366301
[ 5 ]
291
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
The purpose of this study is to learn whether or not all children with ear infections (acute otitis media or AOM) should be treated with antibiotics. The study will compare two treatment strategies, "watchful waiting" or treatment with antibiotics, to determine which is more appropriate for children with AOM. About 268...
The purpose of this randomized, double-masked, placebo-controlled, single-center clinical trial is to determine the efficacy of antimicrobials in young children with acute otitis media (AOM). The primary objectives are to compare time to resolution of symptoms (initial and sustained) in children receiving amoxicillin-c...
Acute Otitis Media
acute otitis media, infants, children
null
2
arm 1: Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days. arm 2: Reconstituted placebo in 2 divided doses for 10 days.
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Augmentin ES-600™: Amoxicillin-clavulanate potassium (600/42.9 mg per 5 mL), administered at a dose of 90/6.4 mg/kg/day in 2 divided doses for 10 days with strawberry cream flavor. intervention 2: Same base formulation of the licensed product Augmentin ES-600™, with the same strawberry cream flavor.
intervention 1: amoxicillin-clavulanate intervention 2: Placebo
1
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
0
NCT00377260
[ 3 ]
10
null
null
0TREATMENT
0NONE
false
0ALL
true
RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of abnormal cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well azacitidine works in treating patients with myelofibrosis.
OBJECTIVES: Primary * Determine the efficacy of azacitidine in patients with myelofibrosis (MF) with myeloid metaplasia. * Evaluate the safety of azacitidine in these patients. Secondary * Evaluate pertinent biologic characteristics of MF before and during therapy with azacitidine. * Assess the effects of study treat...
Chronic Myeloproliferative Disorders Secondary Myelofibrosis
primary myelofibrosis polycythemia vera essential thrombocythemia secondary myelofibrosis
null
0
null
null
1
[ 0 ]
intervention 1: None
intervention 1: azacitidine
2
Scottsdale | Arizona | United States | -111.89903 | 33.50921 Rochester | Minnesota | United States | -92.4699 | 44.02163
0
NCT00381693
[ 3, 4 ]
1
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
The primary objective of this protocol is to look at whether Lucentis (ranibizumab) is safe and effective when used for macular edema (retinal swelling) due to Eales' disease. The secondary objective is to see if macular edema comes back within three months after the last dose of study drug is given.
This is a six-month study. Eligible subjects will receive one injection of the study drug into one eye for each of three months. Visual acuity, blood pressure and eye pressure will be tested. Subjects' retinas will be examined and thickness measured by optical coherence tomography (OCT). Safety visits will be scheduled...
Eales' Disease
Eales
null
1
arm 1: Lucentis (ranibizumab)
[ 0 ]
1
[ 0 ]
intervention 1: Consented, enrolled subjects will receive open-label intravitreal injections of 0.5 mg ranibizumab administered once a month for 3 months
intervention 1: Ranibizumab
1
Portland | Oregon | United States | -122.67621 | 45.52345
0
NCT00384449
[ 4 ]
930
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
This is a randomised, placebo controlled study to evaluate the efficacy of a 3 week treatment period with Circadin® 2 mg in shortening sleep latency in patients with primary insomnia aged 18-80 with melatonin deficiency.
Studies throughout the world have shown that insomnia is a common complaint that occurs in 10-50% of the population depending on age, sex and country. Among the wide variety of available treatments of sleep disturbances, the most commonly prescribed hypnotics are the benzodiazepines (BZD) and non-BZD hypnotics. Howeve...
Primary Insomnia
Primary insomnia as defined by DSM IV criteria
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Prolonged release melatonin 2 mg intervention 2: placebo circadin tablets
intervention 1: Circadin intervention 2: placebo circadin
1
Glasgow | N/A | United Kingdom | -4.25763 | 55.86515
0
NCT00397189
[ 5 ]
6
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Sexual dysfunction is a common side effect of selective serotonin reuptake inhibitors (SSRIs). The hypotheses of this study are that:1. subjects with major depression or dysthymia who are being treated with an SSRI and experiencing treatment-related sexual dysfunction will experience less sexual dysfunction if they are...
In this study, subjects suffering from depression or dysthymia and experiencing treatment-emergent sexual dysfunction from an SSRI are switched from their SSRI to duloxetine to determine whether or not they experience improved sexual function and equal or improved antidepressant response. Study subjects are assigned to...
Depression
null
1
arm 1: Duloxetine 60 mg, by mouth, once daily or twice daily (as needed to control symptoms of major depression)
[ 0 ]
1
[ 0 ]
intervention 1: dosage form: capsule. dosage: 60 mg. frequency: once daily, or twice daily if 120 mg/day is needed to control symptoms of major depression. duration: 12 weeks
intervention 1: Duloxetine
1
Stanford | California | United States | -122.16608 | 37.42411
0
NCT00398632
[ 3 ]
1,101
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
null
The purpose of this study is to test the hypothesis that the inhibition of the renin-angiotensin-aldosterone system (RAAS) with the angiotensin receptor blocker valsartan or the renin antagonist aliskiren will improve ventricular hemodynamics, as reflected by a greater reduction in levels of N-terminal proB-type natriu...
null
Post Acute Coronary Syndrome Myocardial Ischemia
Post acute coronary syndrome Acute coronary syndrome B-type natriuretic peptide N-terminal pro-B-type natriuretic peptide myocardial infarctions
null
4
arm 1: Placebo tablets and capsules arm 2: Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study. arm 3: Following 1 week of treatment with 80 mg of valsartan (c...
[ 2, 0, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Placebo tablets and capsules. In order to adequately blind the study, patients were required to take a total of 1 tablet and 2 capsules during the first 4 weeks of the study. During the remainder of the study, patients were required to take 2 tablets and 2 capsules. Each dose was taken by mouth with wat...
intervention 1: Placebo intervention 2: Aliskiren 300 mg intervention 3: Valsartan 320 mg intervention 4: Aliskiren/valsartan 300/320 mg
11
Investigative Site | New Jersey | United States | N/A | N/A Investigative Site | N/A | Belgium | N/A | N/A Investigative Site | N/A | Canada | N/A | N/A Investigative Site | N/A | Czechia | N/A | N/A Investigative Site | N/A | Germany | N/A | N/A Investigative Site | N/A | Hungary | N/A | N/A Investigative Site | N/A |...
0
NCT00409578
[ 3 ]
465
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The PROVE3 trial is a partially double blinded, randomized, Phase 2 research study of an investigational drug, Telaprevir (VX-950) or Placebo, with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a, Pegasys®), and Ribavirin (RBV, Copegus®) in people with genotype 1 hepatitis C who have not achieved a Sustained Viral Respon...
null
Hepatitis C
Genotype 1
null
4
arm 1: Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at ...
[ 0, 0, 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: tablet intervention 2: tablet intervention 3: Solution for injection intervention 4: Tablet
intervention 1: Telaprevir intervention 2: Ribavirin intervention 3: Pegylated Interferon Alfa 2a intervention 4: Matching Placebo
53
Birmingham | Alabama | United States | -86.80249 | 33.52066 Los Angeles | California | United States | -118.24368 | 34.05223 Los Angeles | California | United States | -118.24368 | 34.05223 San Diego | California | United States | -117.16472 | 32.71571 San Diego | California | United States | -117.16472 | 32.71571 San ...
0
NCT00420784
[ 4 ]
32
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
The purpose of this study is to assess the difference between esomeprazole and placebo in the treatment of signs and symptoms as observed by 8-hour video and cardiorespiratory monitoring in neonatal patients.
null
GERD
neonates infants GERD reflux
null
0
null
null
1
[ 0 ]
intervention 1: None
intervention 1: Esomeprazole
3
North Adelaide | N/A | Australia | 138.59141 | -34.90733 Aachen | N/A | Germany | 6.08342 | 50.77664 Sheffield | N/A | United Kingdom | -1.4659 | 53.38297
0
NCT00427635
[ 4 ]
171
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
This study randomized patients with advanced pancreatic islet cell tumors to receive either sunitinib or placebo. Patients who were randomized to sunitinib received 37.5 mg of sunitinib daily, those randomized to placebo received a tablet that looked similar but had no active drug. Neither the patient or the doctor kne...
The study was terminated on 11 March 2009 because the independent Data Monitoring Committee determined that the study had met its primary endpoint in demonstrating improvement in progression-free survival. The decision to terminate the trial was not based on safety concerns related to sunitinib administration.
Carcinoma, Islet Cell Carcinoma, Pancreas
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: * sunitinib malate oral starting dose 37.5 mg daily (continuous dosing). * Dose may be decreased to 25 mg daily in case of adverse events. * It may be increased to 50 mg daily if no response is seen after 8 weeks on treatment. * Dosing to continue until unacceptable toxicity, progression of disease, dea...
intervention 1: sunitinib malate intervention 2: Placebo
54
Aurora | Colorado | United States | -104.83192 | 39.72943 Iowa City | Iowa | United States | -91.53017 | 41.66113 Worcester | Massachusetts | United States | -71.80229 | 42.26259 Worcester | Massachusetts | United States | -71.80229 | 42.26259 City of Saint Peters | Missouri | United States | -90.62651 | 38.80033 Creve...
0
NCT00428597
[ 4 ]
4
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
2MALE
true
The purpose of this research study is to determine if the study drug Dutasteride taken before and after Laser TURP(Transurethral Resection of the Prostate), can provide effective and safe, long term improvement of lower urinary tract symptoms.
Benign Prostatic Hyperplasia (BPH) is the most common neoplastic condition afflicting middle-aged and elderly men. BPH is a non-cancerous condition in which the prostate becomes enlarged which can cause lower urinary tract symptoms (LUTS). These symptoms include: frequency, urgency, weak urinary stream, difficulty star...
Benign Prostatic Hyperplasia
Benign Prostatic Hyperplasia Lower Urinary Track Symptoms Laser Transurethral Prostate
null
2
arm 1: Prior to and after standard treatment with laser TURP, dutasteride is applied to each patient arm 2: Prior to and after standard treatment with laser TURP, placebo is applied to each patient
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: Placebo before and after treatment of TURP
intervention 1: Dutasteride (Avodart) intervention 2: Placebo
0
null
0
NCT00431626
[ 3 ]
214
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
This Phase II, multicenter, randomized, double-blind, placebo-controlled trial was designed to estimate the efficacy and characterize the safety of bevacizumab when combined with carboplatin + paclitaxel chemotherapy compared with carboplatin + paclitaxel chemotherapy alone in patients with previously untreated metasta...
null
Melanoma
Avastin BEAM Metastatic melanoma
null
2
arm 1: None arm 2: None
[ 2, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 15 mg/kg by intravenous (IV) infusion on the first day of each 3-week cycle (dose was based on patient's weight at screening and remained the same throughout study) intervention 2: Dose based on patients' creatinine clearance (Calvert formula) and administered by intravenous (IV) infusion on the first d...
intervention 1: bevacizumab intervention 2: carboplatin intervention 3: paclitaxel intervention 4: placebo
0
null
0
NCT00434252
[ 4 ]
355
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
The purpose of this study is to investigate the efficacy, safety, and tolerability of an investigational treatment for patients with Human Immunodeficiency Virus (HIV).
null
HIV Infection
treatment experienced
null
2
arm 1: Raltegravir \& Placebo arm 2: Lopinavir (+) Ritonavir \& Placebo
[ 0, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: raltegravir 400 milligram (mg) by mouth (PO) twice daily (b.i.d) for up to 48 weeks of treatment intervention 2: lopinavir (+) ritonavir 400/100 mg by mouth (PO) twice daily (b.i.d.) Placebo for up to 48 weeks of treatment intervention 3: lopinavir (+) ritonavir 400/100 mg by mouth (PO) twice daily (b.i...
intervention 1: Comparator: raltegravir intervention 2: Comparator: placebo intervention 3: Comparator: lopinavir (+) ritonavir intervention 4: Comparator: placebo
0
null
0
NCT00443729
[ 3, 4 ]
40
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This study will investigate the hypothesis that the analgesic effect of a single injection of Dysport (200 MU) induces a significant reduction of symptoms in chronic cases of plantar fasciitis.
null
Chronic Plantar Fasciitis
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 2, 0 ]
intervention 1: Botulinum type A toxin (Dysport®): 200 Units injected at the root of the plantar fascia intervention 2: 0.9% sodium chloride: 2 ml injected at the root of the plantar fascia
intervention 1: Botulinum toxin type A intervention 2: Placebo
6
Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.52437 Karlsruhe | N/A | Germany | 8.40444 | 49.00937 Marburg | N/A | Germany | 8.77069 | 50.80904 Munich | N/A | Germany | 11.57549 | 48.13743 Weiden | N/A | Germany | 12.15613 | 49.67682
0
NCT00447876
[ 5 ]
628
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
null
This purpose of this study is to show the superiority and long term safety and efficacy of adding a long acting beta agonist (salmeterol) to constant dose of an inhaled corticosteroid (fluticasone propionate) in symptomatic subjects with asthma. The 12-month assessment of asthma control will provide key information on ...
null
Asthma
FLOVENT fluticasone 12 month salmeterol asthma ADVAIR
null
2
arm 1: Fluticasone propionate 250 mcg BID arm 2: Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID intervention 2: Fluticasone propionate 250 mcg BID
intervention 1: Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID intervention 2: Fluticasone propionate 250 mcg BID
81
Birmingham | Alabama | United States | -86.80249 | 33.52066 Birmingham | Alabama | United States | -86.80249 | 33.52066 Mobile | Alabama | United States | -88.04305 | 30.69436 Fresno | California | United States | -119.77237 | 36.74773 Fullerton | California | United States | -117.92534 | 33.87029 Huntington Beach | Ca...
0
NCT00452348
[ 5 ]
27
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This is a pilot study to evaluate the effect of dexmedetomidine in the prevention of delirium in non-cardiac surgical patients. The preliminary data regarding the effect of dexmedetomidine on delirium comes from a study underway at Stanford. We propose to randomize fifty patients into two different protocols, one using...
Elderly patients who undergo anesthesia and non-cardiac surgery are subject to deterioration of brain function including the development of postoperative delirium (PD) and postoperative cognitive dysfunction (POCD). These disorders cause disability, distress for both patients and their families, are associated with oth...
Postoperative Delirium PD Postoperative Cognitive Dysfunction POCD
Postoperative delirium PD Postoperative cognitive dysfunction POCD
null
2
arm 1: Participants will be randomized to either dexmedetomidine or placebo which will be started prior to surgery and continued for 24 hours postoperatively. Patients will receive dexmedetomidine until discharge from the PACU. arm 2: Participants will be randomized to either dexmedetomidine or placebo which will be st...
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Dexmedetomidine started prior to surgery and continued for 24 hours postoperatively. Patients will receive dexmedetomidine until discharge from the PACU. intervention 2: Matching placebo given prior to surgery and continued for 24 hours postoperatively
intervention 1: Precedex (Dexmedetomidine) intervention 2: Placebo
1
New York | New York | United States | -74.00597 | 40.71427
0
NCT00455143
[ 5 ]
62
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
Will metformin improve exercise capacity in chronic heart failure patients who has insulin resistance (pre-diabetic- means before they become diabetic)?
Exercise incapacity is one of the major debilitating symptoms of heart failure patients. Studies showed that heart failure patients will become insulin resistance (IR) or vice versa, severity of heart failure also correlates with the severity of insulin resistance. A recent study demonstrated that if we correct diabeti...
Congestive Heart Failure Insulin Resistance
Chronic Heart Failure Insulin Resistance Metformin Peak VO2
null
2
arm 1: Receiving Metformin for 4 months arm 2: Matched Placebo for 4 months
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Started at 500mg bd for 2 weeks. If well tolerated, increase to 1000mg bd for 14 weeks intervention 2: Similar dosing regime as active comparator
intervention 1: Metformin intervention 2: Matched Placebo (Capsules)
1
Dundee | Scotland | United Kingdom | -2.97489 | 56.46913
0
NCT00473876
[ 3 ]
2
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to determine the feasibility of treating relapsed follicular lymphoma with a combination of Bexxar and External Beam Radiotherapy (EBRT). Patients will receive EBRT (20 Gy in 10 fractions) followed by Bexxar.
Total dose delivered and tumor size are important predictors of local control in the treatment of low-grade Non-Hodgkin's Lymphoma (NHL). The basic principle is that larger nodal masses require increased doses of External Beam Radiotherapy (EBRT) to achieve local control. Radioimmunotherapy (RIT) seems to share this sa...
Non-Hodgkin's Lymphoma Follicular Lymphoma
null
0
null
null
2
[ 0, 3 ]
intervention 1: Patients will be treated in two dosing phases, each phase includes two infusions. The first phase, termed "dosimetric dose," involves an intravenous administration of 450 mg unlabeled tositumomab followed by an intravenous administration of 5 mCi (0.18 GBq) of I-131 tositumomab for the purpose of determ...
intervention 1: Iodine I -01 Tositumomab (Bexxar) intervention 2: External Beam Radiation Therapy
1
Gainesville | Florida | United States | -82.32483 | 29.65163
0
NCT00475332
[ 3 ]
49
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
This study evaluated the safety and efficacy of omalizumab in adult patients with moderate to severe chronic urticaria who exhibit IgE against thyroperoxidase.
null
Chronic Urticaria
Chronic urticaria, omalizumab, thyroperoxidase, IgE
null
2
arm 1: Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose. arm 2: Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in...
[ 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 ml vial designed to deliver 150 mg of omalizumab upon reconstitution with 1.4 ml sterile water for injection. intervention 2: Placebo to omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 ml vial designed to...
intervention 1: Omalizumab 75-375 mg intervention 2: Placebo to omalizumab intervention 3: Loratadine intervention 4: Clemastine
11
Berlin | N/A | Germany | 13.41053 | 52.52437 Bonn | N/A | Germany | 7.09549 | 50.73438 Cologne | N/A | Germany | 6.95 | 50.93333 Dresden | N/A | Germany | 13.73832 | 51.05089 Giessen | N/A | Germany | 8.67554 | 50.58727 Hamburg | N/A | Germany | 9.99302 | 53.55073 Hanover | N/A | Germany | 9.73322 | 52.37052 Leipzig | ...
0
NCT00481676
[ 3 ]
12
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
RATIONALE: Lenalidomide may stop the growth of tumor cells by blocking blood flow to the tumor. Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by k...
OBJECTIVES: Primary * Determine the response rate in patients with stage IV ocular melanoma treated with lenalidomide, sunitinib malate, and low-dose metronomic cyclophosphamide. Secondary * Determine the toxicity of this regimen in these patients. * Determine the progression-free survival of patients treated with ...
Intraocular Melanoma Malignant Conjunctival Neoplasm
recurrent intraocular melanoma metastatic intraocular melanoma ciliary body and choroid melanoma, medium/large size extraocular extension melanoma iris melanoma conjunctival melanoma
null
2
arm 1: Participants first started on 2 Interventions (Dose A-QD) in Cycle 1, with 10 mg Lenalidomide (Len) once daily and 50 mg Cyclophosphamide (Cyc) once daily; 25 mg Sunitinib (Sun) was added once daily as a 3rd Intervention (Dose B-QD) from Cycle 2 onwards. Doses were adjusted in subsequent cycles depending on toxi...
[ 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: 25-50 mg by mouth once daily on days 1-28. intervention 2: 10 mg by mouth once daily on days 1-28. intervention 3: 12.5 - 25 mg by mouth once daily on days 1-28.
intervention 1: cyclophosphamide intervention 2: lenalidomide intervention 3: sunitinib malate
1
Bethesda | Maryland | United States | -77.10026 | 38.98067
0
NCT00482911
[ 3 ]
295
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This is a multi-center, open-label extension trial conducted at the same European sites that participated in trial SP 709 (NCT00243217). The trial is designed to collect long-term safety and tolerability, efficacy correlates, and quality of life data in subjects with idiopathic Restless Leg Syndrome (RLS). The duration...
null
Restless Legs Syndrome
Rotigotine Neupro®
null
1
arm 1: Rotigotine trans-dermal patch
[ 0 ]
1
[ 0 ]
intervention 1: Rotigotine transdermal patches once daily: 2.5cm2 (0.5mg/24 hours) 5cm2 (1mg/24 hours) 10cm2 (2mg/24 hours) 15cm2 (3mg/24 hours) 20cm2 (4mg/24 hours)
intervention 1: Rotigotine
24
Innsbruck | N/A | Austria | 11.39454 | 47.26266 Bamberg | N/A | Germany | 10.90067 | 49.89873 Berlin | N/A | Germany | 13.41053 | 52.52437 Bielefeld | N/A | Germany | 8.53333 | 52.03333 Gelsenkirchen | N/A | Germany | 7.09654 | 51.50508 Gera | N/A | Germany | 12.08187 | 50.88029 Halle | N/A | Germany | 11.97947 | 51.48...
0
NCT00498186
[ 3 ]
64
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
The primary objectives of this study are to assess, in patients with Type 2 diabetes mellitus (DM) and presumed nonalcoholic fatty liver disease (NAFLD), the following: * The safety and tolerability of multiple doses of INT 747; * The effects of 2 dose levels (25 mg and 50 mg) of INT 747 on insulin resistance and gluc...
This is a multi-center, double-blind, randomized, placebo-controlled, multiple-dose, parallel-group study. Three (3) cohorts of 12 patients each will receive either placebo, 25 mg INT-747, or 50 mg INT-747 by mouth daily for 6 weeks. The primary objective of assessing changes in insulin resistance and glucose homeosta...
Diabetes Mellitus, Type II Fatty Liver
Farnesoid X receptor agonist Metabolic Disorder Diabetes NAFLD
null
3
arm 1: None arm 2: None arm 3: None
[ 1, 1, 2 ]
2
[ 0, 0 ]
intervention 1: 25 mg by mouth once daily, 50 mg by mouth once daily intervention 2: Placebo
intervention 1: INT-747 intervention 2: Placebo
4
Chula Vista | California | United States | -117.0842 | 32.64005 San Diego | California | United States | -117.16472 | 32.71571 San Antonio | Texas | United States | -98.49363 | 29.42412 Richmond | Virginia | United States | -77.46026 | 37.55376
0
NCT00501592
[ 5 ]
53
RANDOMIZED
PARALLEL
1PREVENTION
2DOUBLE
false
1FEMALE
false
The purpose of this study is to evaluate the changes in bone structure as determined by magnetic resonance imaging measurements among early postmenopausal women after 24 months of treatment with alendronate, 70 mg once a week as compared to placebo
This is a randomized, double-blind, 24-month study. Fifty-five postmenopausal women, age range of 45-65 years, with low bone density will be recruited, with half of the subjects receiving alendronate + 2800 IU of vitamin D once weekly, the other half receiving placebo + 2800 IU of vitamin D once weekly. All study subje...
Osteopenia Osteoporosis
null
2
arm 1: alendronate sodium 70 mg tablet once a week for 24 months arm 2: placebo to match alendronate sodium
[ 1, 2 ]
2
[ 0, 10 ]
intervention 1: alendronate sodium 70 mg tablet once week for 24 months intervention 2: placebo to match alendronate sodium one tablet once a week for 24 months
intervention 1: alendronate sodium intervention 2: placebo comparator
1
San Francisco | California | United States | -122.41942 | 37.77493
0
NCT00504166
[ 3 ]
63
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
The TURNS is a NIMH-funded contract for the evaluation of new compounds for the treatment of cognitive impairments in schizophrenia (HHSN 27820044 1003C; P.I.: Steve Marder, M.D.). Despite advances in the safety, tolerability, and effectiveness of antipsychotic medications for the treatment of schizophrenia, many patie...
Background AL-108 is an intranasal drug product containing NAP, an 8 amino-acid peptide (Asn-Ala-Pro-Val-Ser-Ile-Pro-Gln; NAPVSIPQ, MW=824.9) fragment of the much larger (approx. 124KD) Activity-Dependent Neuroprotective Protein (ADNP), which participates in neurodevelopment and neuroprotection. In mice, ADNP knockout...
Schizophrenia
Cognition Schizophrenia
null
4
arm 1: AL-108, 30 mg/day- 3 sprays in each nostril, twice per day arm 2: AL-108, 5 mg/day- one spray in each nostril once per day arm 3: Placebo- 3 sprays in each nostril, twice per day arm 4: Placebo- one spray in each nostril, once per day
[ 0, 0, 2, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: AL-108, 5 mg/day- one spray in each nostril once per day intervention 2: AL-108, 30 mg/day- 3 sprays in each nostril, twice per day intervention 3: Placebo- 3 sprays in each nostril, twice per day intervention 4: Placebo- one spray in each nostril, once per day
intervention 1: AL-108 intervention 2: AL-108 intervention 3: Placebo intervention 4: Placebo
8
Los Angeles | California | United States | -118.24368 | 34.05223 Catonsville | Maryland | United States | -76.73192 | 39.27205 Boston | Massachusetts | United States | -71.05977 | 42.35843 Boston | Massachusetts | United States | -71.05977 | 42.35843 St Louis | Missouri | United States | -90.19789 | 38.62727 New York |...
0
NCT00505765
[ 4 ]
92
RANDOMIZED
CROSSOVER
0TREATMENT
4QUADRUPLE
false
0ALL
false
This study will look at the effectiveness of Methylphenidate Transdermal System (MTS) in treating adult ADHD. MTS has received FDA approval for childhood ADHD but this is the first trial for adult ADHD. Subjects will experience two screening visits and one baseline visit. Those who meet admission criteria will enter th...
ADHD affects from 3 to 5% of children, persists into adolescence in 40 to 70% of these children and continues into adulthood in at least 50% of affected adolescents. Methylphenidate was the first medication shown to be effective in treatment for adults with ADHD and continues to be widely used. While the extended relea...
Attention Deficit Hyperactivity Disorder
Attention Deficit Hyperactivity Disorder ADHD Adult Methylphenidate Transdermal System Daytrana
null
2
arm 1: This arm was 4 weeks long. Subjects were treated using Methylphenidate Transdermal System. Patients were seen weekly, phone contact was made between visits and dosing could be adjusted as a result of the phone contact. MTS was initiated using a 12.5 cm patch. The dose was increased during the first 2 weeks based...
[ 0, 2 ]
2
[ 0, 10 ]
intervention 1: MTS is an advanced patch product that provides methylphenidate evenly mixed with the adhesive. This formulation allows good adhesion and a wide range of dose sizes. MTS patch sizes of 12.5, 18.75, 25 and 37.5cm2 are equivalent to nominal doses over a 9-hour wear time of 10, 15, 20 and 30mg of MPH. inter...
intervention 1: Methylphenidate Transdermal System (MTS) intervention 2: placebo patch
1
Salt Lake City | Utah | United States | -111.89105 | 40.76078
0
NCT00506285
[ 3 ]
1
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
Primary Objectives: 1.1 Estimate rate of response and define acute toxicity to etanercept used in an up-front phase II window in newly diagnosed or relapsed JMML. 1.2 Determine if response to Tumor Necrosis Factor (TNF) blockade correlates with genetic basis of Juvenile Myelomonocytic Leukemia (JMML) \[mutations in N...
Etanercept blocks a hormone called Tumor Necrosis Factor (TNF), which has been shown to play a role in helping the growth of leukemic cells in JMML. Before participants can start treatment on this study, they will have what are called "screening tests". These tests will help the doctor decide if patients are eligible ...
Leukemia
Juvenile Myelomonocytic Leukemia JMML Leukemia Etanercept Enbrel
null
1
arm 1: 0.8 mg/kg subcutaneously weekly for 90 days
[ 0 ]
1
[ 0 ]
intervention 1: 0.8 mg/kg Subcutaneously Once A Week for 90 Days
intervention 1: Etanercept
1
Houston | Texas | United States | -95.36327 | 29.76328
0
NCT00509600
[ 4 ]
467
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the effect on glycaemic control of liraglutide or exenatide when added to subject's ongoing OAD (oral anti-diabetic drug) treatment of either metformin, sulphonylurea or a combination of both in subjects with t...
null
Diabetes Diabetes Mellitus, Type 2
null
2
arm 1: Liraglutide 1.8 mg once daily + subject's own OAD treatment arm 2: Exenatide 10 mcg twice daily + subject's own OAD treatment
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: 1.8 mg once daily for s.c. (under the skin) injection. intervention 2: 10 mcg twice daily for s.c. (under the skin) injection.
intervention 1: liraglutide intervention 2: exenatide
125
Birmingham | Alabama | United States | -86.80249 | 33.52066 Goodyear | Arizona | United States | -112.35821 | 33.43532 Artesia | California | United States | -118.08312 | 33.86585 Encino | California | United States | -118.50119 | 34.15917 Escondido | California | United States | -117.08642 | 33.11921 Los Angeles | Cal...
0
NCT00518882
[ 5 ]
10
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to find out what parts of the brain have increased or decreased activity when people are depressed and how antidepressant medicine changes this activity in depressed patients. The genetic samples collected are to look at variation in a gene (serotonin transporter gene), which affects the fu...
This study will measure the activity in different parts of the brain, while the patients are seeing some pictures, using Magnetic Resonance Imaging (MRI) scan. For this study three MRI scans will be conducted. One before the patient begins on any medication, one during the study after 3 weeks of treatment and one after...
Major Depression
Depression Duloxetine fMRI pictures
null
1
arm 1: Open-label duloxetine 30 - 60 mg oral administration
[ 5 ]
1
[ 0 ]
intervention 1: 60 mg capsules
intervention 1: Duloxetine
1
Indianapolis | Indiana | United States | -86.15804 | 39.76838
0
NCT00532480
[ 5 ]
314
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
This study will investigate the effectiveness of desloratadine at doses higher (10 mg and 20 mg) than currently approved (5 mg) for the treatment of chronic idiopathic urticaria. Subjects with chronic urticaria who are currently taking a second generation antihistamine will be treated with desloratadine (5, 10, or 20 m...
null
Chronic Idiopathic Urticaria
null
3
arm 1: 5-mg Desloratadine once daily arm 2: 10-mg Desloratadine once daily arm 3: 20-mg Desloratadine once daily
[ 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: 5-mg desloratadine tablets, once daily for four weeks. intervention 2: 10-mg desloratadine tablets, once daily for four weeks. intervention 3: 20-mg desloratadine tablets, once daily for four weeks.
intervention 1: 5-mg Desloratadine intervention 2: 10-mg Desloratadine intervention 3: 20-mg Desloratadine
0
null
0
NCT00536380
[ 4 ]
70
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
This study is meant to assess the effectiveness of idebenone on neurological outcome measures in patients with Friedreich's Ataxia over a 6 months period.
The study involves 6 clinic visits and upon completion the possibility to join a 12 months extension study where all patients will receive high dose Idebenone.
Friedreich's Ataxia
Friedreich's Ataxia Idebenone ICARS
null
3
arm 1: mid dose Idebenone arm 2: high dose Idebenone arm 3: Placebo
[ 0, 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Patients ≤ 45 kg/99 lbs: idebenone 450 mg/day; Patients \> 45 kg/99 lbs: idebenone 900 mg/day intervention 2: Patients ≤ 45 kg/99 lbs: idebenone 1350 mg/day; Patients \> 45 kg/99 lbs: idebenone 2250 mg/day intervention 3: Placebo was provided as film-coated tablets that were the same size, weight and ap...
intervention 1: Idebenone intervention 2: Idebenone intervention 3: Placebo
2
Los Angeles | California | United States | -118.24368 | 34.05223 Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
0
NCT00537680
[ 3 ]
14
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This study is designed to evaluate the efficacy and safety of monotherapy pazopanib (a small molecule tyrosine kinase inhibitor of VEGFR-1, VEGFR-2, VEGFR-3, PDGF, and c-kit) in subjects with advanced (Stage IIIB or IV) non-small cell lung cancer.
Study 109609 is a single-arm, non-randomized, single-stage Phase II study of pazopanib in subjects with Stage IIIB or IV non-small cell lung cancer who have progressed after one or two prior regimens of systemic therapy. The study will be conducted at a limited number of institutions in the US. A total of 40 evaluable ...
Lung Cancer, Non-Small Cell
anti-angiogenesis Non-small cell lung cancer, pazopanib (GW786034)
null
1
arm 1: Single-arm, non-randomised, single-stage pazopanib monotherapy.
[ 0 ]
1
[ 0 ]
intervention 1: Pazopanib monotherapy
intervention 1: Pazopanib (GW786034)
13
Scottsdale | Arizona | United States | -111.89903 | 33.50921 Fort Myers | Florida | United States | -81.84059 | 26.62168 Orlando | Florida | United States | -81.37924 | 28.53834 Baton Rouge | Louisiana | United States | -91.18747 | 30.44332 Duluth | Minnesota | United States | -92.10658 | 46.78327 Buffalo | New York | ...
0
NCT00549328
[ 5 ]
142
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
This study used two doses of rivastigmine transdermal patch (5 cm\^2, 10 cm\^2) to establish the feasibility of 2 switch schedules (with transdermal patch one-step dose titration or without dose titration) from rivastigmine capsules (3 mg bid (bis in die, twice a day), 4,5 mg bid, 6 mg bid) to rivastigmine transdermal ...
null
Alzheimer's Disease
Alzheimer's rivastigmine transdermal safety randomized switch patch
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months). intervention 2: Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of trea...
intervention 1: Rivastigmine patch (4.6 mg/day switch to 9.5 mg/day) intervention 2: Rivastigmine patch (9.5 mg/day) intervention 3: Rivastigmine capsules (6 mg to 12 mg/day)
1
Barcelona | N/A | Spain | 2.15899 | 41.38879
0
NCT00549601
[ 5 ]
18
RANDOMIZED
PARALLEL
1PREVENTION
2DOUBLE
false
1FEMALE
false
This randomized prospective study will specifically investigate the efficacy of a 24 hour post-operative course of broad-spectrum prophylactic antibiotics - namely Cefazolin - in preventing wound infection and wound breakdown following vulvectomy.
Infectious morbidity in gynecologic oncology has not been thoroughly investigated to date. Included in the literature are several studies that highlight substantial numbers of post-surgical infectious complications. Specifically among patients undergoing radical vulvectomy, the incidence of post-operative wound complic...
Wound Infection
vulvectomy wound infection wound complication prophylactic antibiotic Post-operative wound complications following vulvectomy
null
2
arm 1: Participants received Cefazolin 2 grams intravenously within 30 minutes prior to incision arm 2: Participants received Cefazolin 2 gram intravenous within 30 minutes prior to incision and 1 gram Cefazolin every 8 hours for the first 24 hours post-op
[ 1, 0 ]
2
[ 0, 0 ]
intervention 1: Cefazolin 1 gram IV every 8 hours for a total of 3 doses. Patients in both arms will receive an initial pre-operative 2 gram dose of Cefazolin within 30 minutes prior to incision. In penicillin/cephalosporin allergic patients, the substitute of Clindamycin 900 mg IV q 8 hrs will be used. intervention 2:...
intervention 1: Cefazolin PostOperatively intervention 2: Cefazolin Preoperatively
1
Canton | Ohio | United States | -81.37845 | 40.79895
0
NCT00550290
[ 4 ]
2,221
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
1FEMALE
true
The purpose of this study is to assess the safety and efficacy of CDB-2914 in comparison to levonorgestrel for preventing pregnancy up to 5 days after unprotected sexual intercourse.
null
Contraception
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Single dose intervention 2: Single dose
intervention 1: CDB-2914 intervention 2: Levonorgestrel
33
Los Angeles | California | United States | -118.24368 | 34.05223 Santa Monica | California | United States | -118.49138 | 34.01949 Boulder | Colorado | United States | -105.27055 | 40.01499 Denver | Colorado | United States | -104.9847 | 39.73915 Littleton | Colorado | United States | -105.01665 | 39.61332 Lake Worth |...
0
NCT00551616
[ 3 ]
253
RANDOMIZED
PARALLEL
1PREVENTION
4QUADRUPLE
false
0ALL
false
This trial will test the hypothesis that the addition of CF101, a novel anti-inflammatory agent, will improve the clinical condition of patients with rheumatoid arthritis who still have active joint inflammation despite taking methotrexate for at least 6 months.
This will be a multi-center, randomized, double-blind, parallel-group, placebo-controlled, dose-finding study in which patients with active RA despite receiving methotrexate for at least 6 months (at unchanged doses for \>=2 months) will be randomized to the addition of either CF101 0.1 mg, CF101 1 mg, or placebo given...
Rheumatoid Arthritis
null
3
arm 1: CF101 0.1 mg was given orally q12h arm 2: CF101 1 mg was given orally q12h arm 3: Matched placebo was given orally q12h
[ 0, 0, 2 ]
2
[ 0, 0 ]
intervention 1: orally q12h intervention 2: orally q12h
intervention 1: CF101 intervention 2: Placebo
26
Plovdiv | N/A | Bulgaria | 24.75 | 42.15 Sofia | N/A | Bulgaria | 23.32415 | 42.69751 Sofia | N/A | Bulgaria | 23.32415 | 42.69751 Stara Zagora | N/A | Bulgaria | 25.64194 | 42.43278 Varna | N/A | Bulgaria | 27.91667 | 43.21667 Hradec Králové | N/A | Czechia | 15.83277 | 50.20923 Prague | N/A | Czechia | 14.42076 | 50....
0
NCT00556894
[ 2 ]
2
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to explore the safety and efficacy of ranibizumab to treat non-arteritic ischemic optic neuropathy based on clinical and anatomical findings.
Nonarteritic anterior ischemic optic neuropathy (NAION) is the most common acute optic neuropathy in people older than 50 years. It is characterized by sudden partial loss of vision in one eye and has an increased risk of vision loss in the fellow eye. Although cause has not been determined, NAION is thought to occur f...
Nonarteritic Anterior Ischemic Optic Neuropathy
non-arteritic ischemic optic neuropathy ranibizumab naion
null
1
arm 1: To determine the mean change in best corrected visual acuity (BCVA) using the Early Treatment Diabetic Retinopathy Study testing system at 6 months in NAION patients treated as needed (PRN) with ranibizumab.
[ 0 ]
1
[ 0 ]
intervention 1: All patients (n=15) will be treated with open label 0.5mg ranibizumab given intravitreally monthly as needed for 6 months.
intervention 1: ranibizumab
1
Aurora | Colorado | United States | -104.83192 | 39.72943
0
NCT00561834
[ 3, 4 ]
6
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
The purpose of this study is to learn whether atacicept treatment leads to improvement in kidney function in subjects with active lupus nephritis in combination with mycophenolate mofetil (MMF) and corticosteroids. The study was sponsored by Merck Serono International; operational oversight was provided by ZymoGenetics...
null
Lupus Nephritis
nephritis atacicept
null
2
arm 1: None arm 2: None
[ 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Atacicept will be administered at a dose of 150 milligram (mg) subcutaneously (SC) twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. intervention 2: MMF will be administered orally with a starting dose of 500 mg twice daily for 1 week, will be increased to 1000...
intervention 1: Atacicept intervention 2: Mycophenolate mofetil intervention 3: Placebo intervention 4: Corticosteroids
20
New Orleans | Louisiana | United States | -90.07507 | 29.95465 Shreveport | Louisiana | United States | -93.75018 | 32.52515 Detroit | Michigan | United States | -83.04575 | 42.33143 Manhasset | New York | United States | -73.69957 | 40.79788 New York | New York | United States | -74.00597 | 40.71427 Winston-Salem | No...
0
NCT00573157
[ 3 ]
1
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to compare methadone with morphine in the management of moderate to severe cancer pain.
Treatment of cancer pain is based on the World Health Organization (WHO) step ladder approach to the use of analgesic drugs. Medication potency increases at each step of the WHO ladder, from nonopioid (step 1; e.g., aspirin and nonsteroidal anti-inflammatory drugs) through weak opioids (step 2; e.g. codeine) plus a non...
Neoplasms Pain
Neoplasms Pain Methadone Morphine
null
2
arm 1: Oral methadone 2.5 mg every 8 hours, and oral methadone 2.5 mg every 4 hours as needed for breakthrough pain. arm 2: Oral slow-release morphine (15 mg) every 8 hours, and immediate-release morphine (10 mg) every 4 hours as needed for breakthrough pain.
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: Oral methadone 2.5 mg every 8 hours, and oral methadone 2.5 mg every 4 hours as needed for breakthrough pain. intervention 2: Oral slow-release morphine 15 mg every 8 hours, and oral immediate-release morphine 10 mg every 4 hours as needed for breakthrough pain.
intervention 1: Methadone intervention 2: Morphine
1
Scottsdale | Arizona | United States | -111.89903 | 33.50921
0
NCT00573937
[ 3 ]
4
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This study is being done in an attempt to improve the remission rate and the survival time for subjects with high-risk myeloma. It is hoped that by giving higher doses of commonly used chemotherapy drugs and by giving courses closer together (before the myeloma comes back or gets worse), subjects in this study will hav...
This study has the following goals: * To find out how many subjects treated with high dose DTPACE (Dexamethasone, Thalidomide, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide. (HD DTPACE) on this protocol will have a complete response or near complete response that lasts for 6 months or longer. * In subjects ac...
Multiple Myeloma
null
1
arm 1: DTPACE
[ 0 ]
1
[ 0 ]
intervention 1: * Dexamethasone 200 mg Intravenous Infusion "Piggy-Back" (IVPB) Days 1-7 * Thalidomide 200 mg by mouth (PO) Days 1-7 * Cisplatin 15mg/m2 Days 1-4 (modify for renal insufficiency) * Adriamycin 15 mg/m2 Days 1-4 * Cyclophosphamide 600 mg/m2 Days 1-4 * Etoposide 60 mg/m2 Days 1-4
intervention 1: DTPACE
1
Little Rock | Arkansas | United States | -92.28959 | 34.74648
0
NCT00577512
[ 0 ]
75
NON_RANDOMIZED
PARALLEL
7BASIC_SCIENCE
0NONE
true
0ALL
false
The purpose of the study is to investigate the functional state of dopamine cells and the dopamine transporter in ADHD subjects and controls to assess the effects of chronic methylphenidate treatment on dopamine cell function and dopamine transporter levels in ADHD subjects.
null
Attention Deficit Hyperactivity Disorder
Brookhaven ADHD Dopamine methylphenidate PET
null
2
arm 1: intervention is methylphenidate once daily for 12 months, doses individually titrated arm 2: no methylphenidate treatment for non ADHD
[ 0, 4 ]
1
[ 0 ]
intervention 1: subjects received mehtylphenidate treatment for 12 months
intervention 1: Experimental: methylphenidate treatment
1
Irvine | California | United States | -117.82311 | 33.66946
0
NCT00580814
[ 3 ]
241
RANDOMIZED
FACTORIAL
1PREVENTION
0NONE
false
0ALL
true
The primary hypothesis tested in this project is that the preoperative behavioral stress response predicts postoperative behavioral and clinical recovery of children undergoing surgery.
null
Care, Postoperative Pain, Postoperative Surgical Procedures, Operative Otorhinolaryngologic Surgical Procedures Tonsillectomy Adenoidectomy
null
4
arm 1: None arm 2: None arm 3: None arm 4: None
[ 1, 1, 1, 1 ]
4
[ 5, 0, 5, 10 ]
intervention 1: This group will receive the standard preoperative visit to the hospital with Child Life intervention intervention 2: 0.5 mg/kg oral midazolam intervention 3: One parent will be present during induction of anesthesia of the child. The parent will be accompanied out of the OR by a nurse once the induction...
intervention 1: Preoperative Preparation Program (Child Life Specialist) intervention 2: Midazolam intervention 3: Parental Presence during Induction of Anesthesia intervention 4: PPIA preparation program PLUS Midazolam premedication
1
New Haven | Connecticut | United States | -72.92816 | 41.30815
0
NCT00581139
[ 3 ]
96
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
The purpose of this research study is:(1) to determine if high doses of chemotherapy without total body irradiation can allow selected stem cells to take and grow,(2) to determine if selected stem cells from the blood or marrow can take and not cause a complication called graft-versus-host disease (GvHD) and (3) to eva...
The trial proposed is a single arm, phase II treatment protocol designed to examine the engraftment, toxicity, graft-versus-host disease and ultimate disease-free survival following transplants derived from (1) HLA-matched siblings or related donors, (2) HLA-compatible unrelated donors or (3) HLA haplo-type mismatched ...
Leukemia Myelodysplastic Syndrome Non-Hodgkin's Lymphoma Allogeneic Marrow Transplant
Cancer Donors Leukemia Myelodysplastic Syndrome Non-Hodgkin's Lymphoma Lymphoma AML ALL CML Allogeneic marrow transplant Bone marrow transplant
null
3
arm 1: 25 research participants with HLA Identical Related Donor using PBSC, 6 with BMT arm 2: 70 research participants with HLA-Matched Unrelated Donor using PBSC, 17 with BMT arm 3: 25 research participants with HLA-Mismatched Related Donor using PBSC, no BMT
[ 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: All research participants will be conditioned for transplantation with intravenous busulfan (busulfex®) (0.8- 1.0 mg/Kg/dose Q6H x 10 doses), melphalan (70 mg/m2/dose x 2 doses) and fludarabine (25 mg/m2/day x 5 doses). Doses of busulfan will be adjusted according to plasma levels. All research particip...
intervention 1: BUSULFAN, MELPHALAN, FLUDARABINE, G-CSF intervention 2: BUSULFAN, MELPHALAN, FLUDARABINE, G-CSF intervention 3: BUSULFAN, MELPHALAN, FLUDARABINE, G-CSF
1
New York | New York | United States | -74.00597 | 40.71427
0
NCT00582933
[ 2 ]
9
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
This purpose of this study is to evaluate the use of two medications, docetaxel and lovastatin to determine the highest dose of lovastatin and docetaxel that can be given safely as well as the safety of combining the two drugs and the effect on the subject's tumor. Subjects can have any cancer.
The primary objective of this study is to determine the maximum tolerated dose (MTD) of lovastatin and docetaxel in patients with various different cancers.
Any Cancer Breast Cancer
Any cancer Breast cancer Lovastatin Docetaxel
null
1
arm 1: Determine the maximum tolerated dose (MTD) of escalating doses of lovastatin in combination with docetaxel in patients with any type of solid tumor.
[ 0 ]
2
[ 0, 0 ]
intervention 1: Given PO intervention 2: Given IV
intervention 1: Lovastatin intervention 2: Docetaxel
1
Iowa City | Iowa | United States | -91.53017 | 41.66113
0
NCT00584012
[ 4 ]
413
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to evaluate the effectiveness and safety of azilsartan medoxomil compared to placebo, once daily (QD), in African-American participants with essential hypertension.
Hypertension affects approximately 50 million individuals in the United States. As the population ages, the prevalence of hypertension will continue to increase if broad and effective preventive measures are not implemented. According to the World Health Organization, hypertension is the most common attributable cause ...
Hypertension
Blood pressure blood pressure monitoring ambulatory Drug Therapy
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks. intervention 2: Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks. intervention 3: Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
intervention 1: Azilsartan medoxomil intervention 2: Azilsartan medoxomil intervention 3: Placebo
64
Alabaster | Alabama | United States | -86.81638 | 33.24428 Huntsville | Alabama | United States | -86.58594 | 34.7304 Tempe | Arizona | United States | -111.90931 | 33.41477 Freemont | California | United States | N/A | N/A Garden Grove | California | United States | -117.94145 | 33.77391 Long Beach | California | Unit...
0
NCT00591253
[ 4 ]
566
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to evaluate the efficacy and safety of azilsartan medoxomil, once daily (QD), co-administered with amlodipine in treating individuals with essential hypertension, compared to treatment with amlodipine alone.
Hypertension affects approximately 50 million individuals in the United States. As the population ages, the prevalence of hypertension will continue to increase if broad and effective preventive measures are not implemented. According to the World Health Organization, hypertension is the most common attributable cause ...
Hypertension
Blood pressure blood pressure monitoring ambulatory Drug Therapy
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks. intervention 2: Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks. intervention 3: Azilsartan medoxomil pla...
intervention 1: Azilsartan Medoxomil and amlodipine intervention 2: Azilsartan Medoxomil and amlodipine intervention 3: Amlodipine
50
Mesa | Arizona | United States | -111.82264 | 33.42227 Phoenix | Arizona | United States | -112.07404 | 33.44838 Anaheim | California | United States | -117.9145 | 33.83529 Beverly Hills | California | United States | -118.40036 | 34.07362 Burbank | California | United States | -118.30897 | 34.18084 Burlingame | Califo...
0
NCT00591266
[ 3 ]
8
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The present protocol proposes study of the recently approved compound sodium oxybate (Xyrem), a gamma-aminobutyric acid type b (GABAB) and a g-hydroxybutyric acid (GHB) receptor agonist, for the study of persistent symptoms of schizophrenia. Sodium oxybate is a central nervous system depressant currently approved for t...
Rationale/Study Hypothesis: Rationale for study of sodium oxybate is twofold: first, sleep dysfunction is an important and overlooked aspect of schizophrenia intrinsically linked to cognitive and functional impairments, and, second, GABAB receptors regulate dopaminergic and glutamatergic systems in vivo, suggesting th...
Schizophrenia Insomnia Related to Schizophrenia (307.42)
Schizophrenia Sleep Architecture Sodium Oxybate Insomnia Cognition
null
1
arm 1: Active treatment
[ 0 ]
1
[ 0 ]
intervention 1: Patients will undergo a one-week evaluation period, which will include a taper and discontinuation of any currently prescribed sedative/hypnotics, as well as baseline diagnostic, psychopathology, neurocognitive and polysomnographic measurements (see below for details). Hypnotic taper may be extended or ...
intervention 1: Sodium Oxybate
1
Orangeburg | New York | United States | -73.94958 | 41.04649
0
NCT00594256
[ 3 ]
3
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This is a phase II, multi-center, open-label, single-arm clinical trial to be conducted in the United States. In approximately 55 centers, approximately 75 eligible locally advanced unresectable or metastatic pancreatic cancer subjects will be enrolled to receive first-line therapy of gemcitabine and panitumumab.
Enrollment closed after 3 patients were enrolled. This voluntary action was prompted by the announcement that the Southwest Oncology Group (SWOG) S0205 trial (NCT00075686), A Phase III Randomized Open Label Study Comparing Gemcitabine Plus Cetuximab (IMC-C225) Versus Gemcitabine as First-Line Therapy of Patients with A...
Cancer of Pancreas Cancer of the Pancreas Pancreas Cancer Pancreatic Cancer
null
1
arm 1: Panitumumab 6 mg/kg was administered intravenously (IV) before gemcitabine on Day 1 of Weeks 1, 3, 5, and 7, and then every 2 weeks (day 1 and 15) of each subsequent 4-week chemotherapy cycle. Gemcitabine 1000 mg/m\^2 was administered IV once weekly (on Day 1) for 7 weeks, followed by a 1-week rest period. In su...
[ 0 ]
2
[ 0, 0 ]
intervention 1: Intravenous administration intervention 2: Intravenous administration
intervention 1: Gemcitabine intervention 2: panitumumab
0
null
0
NCT00613730
[ 4 ]
613
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
The purpose of this study is to show the efficacy and safety of formoterol for the maintenance treatment of patients with COPD compared with placebo in patients in Japan and in European countries during 12 weeks.
null
Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease COPD
null
3
arm 1: Formoterol 4.5 ug twice daily (bid) arm 2: Formoterol 9.0 ug bid arm 3: Placebo
[ 0, 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: 4.5 mg inhaled twice daily intervention 2: 9 mg inhaled twice daily intervention 3: placebo inhaled twice daily
intervention 1: Formoterol Turbuhaler® 4.5mg intervention 2: Formoterol Turbuhaler® 9 mg intervention 3: Turbuhaler® placebo
47
Gabrovo | N/A | Bulgaria | 25.33417 | 42.87472 Lovech | N/A | Bulgaria | 24.71667 | 43.13333 Pleven | N/A | Bulgaria | 24.61667 | 43.41667 Rousse | N/A | Bulgaria | 25.9534 | 43.84872 Sofia | N/A | Bulgaria | 23.32415 | 42.69751 Stara Zagora | N/A | Bulgaria | 25.64194 | 42.43278 Troyan Municipality | N/A | Bulgaria | ...
0
NCT00628862
[ 2 ]
25
RANDOMIZED
CROSSOVER
0TREATMENT
1SINGLE
false
0ALL
null
A 2-period, crossover study to assess the effects of MK0683 (vorinostat) on the QTc interval in patients with relapsed or refractory advanced cancer.
Merck Duration of Treatment : vorinostat; treatment will continue until disease progression or intolerable toxicity is reached
Advanced Cancer Relapsed Advanced Cancer Refractory
null
2
arm 1: Arm A: Drug/Placebo arm 2: Arm B: Placebo/Drug
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: A 2-part, crossover study. Part 1: Arm A: Single dose of vorinostat 800 mg capsules (Period 1) crossing over to Single dose of vorinostat Placebo capsules (Period 2) Arm B: Single dose of vorinostat Placebo capsules (Period 1) crossing over to Single dose of vorinostat 800 mg capsules (Period 2). Part 2...
intervention 1: vorinostat intervention 2: Comparator: placebo (unspecified)
0
null
0
NCT00632931
[ 3 ]
7
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of this study is to demonstrate whether use of glucarpidase facilitates administration of the next cycle of chemotherapy as scheduled and improves safety and tolerability of HDMTX given with LV
null
Osteosarcoma
osteosarcoma high dose methotrexate leucovorin
null
3
arm 1: HDMTX-LV with glucarpidase arm 2: HDMTX-LV with placebo arm 3: compassionate use group to treat or prevent life threatening toxicity in the event of delayed elimination of MTX and/or renal impairment
[ 0, 1, 0 ]
2
[ 0, 0 ]
intervention 1: IV dose based on weight, two doses given for 5 minutes, 24 hours apart intervention 2: IV or po given every 6 hours
intervention 1: glucarpidase intervention 2: leucovorin
0
null
0
NCT00634322
[ 5 ]
143
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to compare the effectiveness of tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg maintenance with that of non-steroidal anti-inflammatory drugs (NSAIDs) maintenance in participants with knee osteoarthritis (a progressive and degenerative joint disease, in which the joint...
This is a multicenter (when more than one hospital or medical school team work on a medical research study), randomized (the study drug is assigned by chance), open-label (all people know the identity of the intervention), comparative study to compare the efficacy of tramadol hydrochloride plus acetaminophen maintenanc...
Osteoarthritis
WOMAC Knee osteoarthritis pain Pain intensity Tramadol Acetaminophen Meloxicam Aceclofenac
null
2
arm 1: Participants will receive fixed dose combination of tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who will have the numeric rating scale score 4 ...
[ 1, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Meloxicam 7.5 mg or 15 mg per day along with fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day from Day 1 to Day 28, and meloxicam 7.5 mg or 15 mg per day from Day 29 to Day 85. intervention 2: Aceclofenac 100 mg twice a day along with fixed dose ...
intervention 1: Meloxicam intervention 2: Aceclofenac intervention 3: Tramadol Hydrochloride Plus Acetaminophen
0
null
0
NCT00635349
[ 3 ]
158
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of this study is to determine whether RX-1741, an oxazolidinone antibiotic, is safe and effective in the treatment of mild to moderate community acquired pneumonia (CAP).
null
Community-Acquired Pneumonia (CAP)
null
3
arm 1: Radezolid 300 mg arm 2: Radezolid 450 mg arm 3: Radezolid 450 mg BID
[ 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: 300 mg/day, orally for 7-10 days intervention 2: 450 mg/day orally for 7-10 days intervention 3: 900 mg/day orally for 7-10 days
intervention 1: Radezolid intervention 2: Radezolid intervention 3: Radezolid
30
San Diego | California | United States | -117.16472 | 32.71571 Sylmar | California | United States | -118.44925 | 34.30778 Detroit | Michigan | United States | -83.04575 | 42.33143 Keego Harbor | Michigan | United States | -83.34382 | 42.60809 Butte | Montana | United States | -112.53474 | 46.00382 Belvidere | New Jers...
0
NCT00640926
[ 4 ]
462
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this 6 month study is to compare the metabolic effects of paliperidone ER and olanzapine in patients with schizophrenia, using the ratio of the concentration of lipids (triglycerides (TG)) in the blood to the concentration of good cholesterol (high density lipoproteins (HDL)) in the blood as the primary ...
This is a prospective randomized (study medication is assigned by change) open-label, parallel-group, multicenter, 6 month study to compare the metabolic effects of paliperidone ER and olanzapine in patients with schizophrenia using the ratio of the concentration of lipids (triglycerides) in the blood to the concentrat...
Schizophrenia
Paliperidone ER Olanzapine Schizophrenia
null
2
arm 1: paliperidone ER 6-mg or 9-mg tablet once daily flexible dosing for 6 months arm 2: olanzapine 10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: 10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months intervention 2: 6-mg or 9-mg tablet once daily flexible dosing for 6 months
intervention 1: olanzapine intervention 2: paliperidone ER
46
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Córdoba | N/A | Argentina | -64.18853 | -31.40648 Mendoza | N/A | Argentina | -68.84582 | -32.88946 Alexandria | N/A | Egypt | 29.91582 | 31.20176 Cairo | N/A | Egypt | 31.24967 | 30.06263 El Banfaig 2 District | N/A | Egypt | N/A | N/A Pärnu | N/A | Estonia | 24.4...
0
NCT00645099
[ 4 ]
420
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
To demonstrate the efficacy of 80 mg adalimumab monthly dosing compared with placebo and demonstrate the non-inferiority of monthly dosing of 80 mg adalimumab compared with dosing of 40 mg adalimumab every other week.
The objective of this study is to demonstrate the efficacy of 80 mg adalimumab monthly dosing compared with placebo as measured by ACR20 response criteria following 12 weeks of therapy. The study is also designed to demonstrate the non-inferiority of monthly dosing of 80 mg adalimumab compared with dosing of 40 mg adal...
Rheumatoid Arthritis
null
3
arm 1: Placebo 12 weeks, 40mg adalimumab remaining 12 weeks arm 2: 40 mg every other week arm 3: 80 mg monthly
[ 2, 1, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Pre-filled syringe. See arm for more detail intervention 2: Pre-filled syringe. See arm for more detail intervention 3: Pre-filled syringe. See arm for more detail
intervention 1: adalimumab intervention 2: Placebo intervention 3: adalimumab
86
Huntsville | Alabama | United States | -86.58594 | 34.7304 Tuscaloosa | Alabama | United States | -87.56917 | 33.20984 Paradise Valley | Arizona | United States | -111.94265 | 33.53115 Hemet | California | United States | -116.97307 | 33.74761 Long Beach | California | United States | -118.18923 | 33.76696 Santa Monica...
0
NCT00647270
[ 4 ]
55
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to determine if Lupron (leuprolide acetate) is safe and effective in treating children with Central Precocious Puberty (CPP), and to assess long term effects of leuprolide acetate treatment after therapy is discontinued.
This study includes a Prestudy Period; a treatment period where subjects will receive treatment every 4 weeks until the initiation of puberty (age 12 for males and age 11 for females); a follow-up period where subjects will be observed every 6 months until physical and laboratory observations are at pubertal levels, th...
Puberty, Precocious
CPP central precocious puberty pediatrics suppression of LH Lupron leuprolide acetate depot formulation GnRHa GnRH agonist GNRH analog LH Tanner staging
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Leuprolide acetate was administered monthly by intramuscular injection starting at 300 mcg/kg with adjustments of 3.75 mg upward, at subsequent clinic visits based on physical and laboratory parameters. Dosing continued until NDA was approved, or until subject no longer required leuprolide acetate to tr...
intervention 1: Lupron (leuprolide acetate)
9
Phoenix | Arizona | United States | -112.07404 | 33.44838 San Francisco | California | United States | -122.41942 | 37.77493 Stanford | California | United States | -122.16608 | 37.42411 Aurora | Colorado | United States | -104.83192 | 39.72943 St. Petersburg | Florida | United States | -82.67927 | 27.77086 Indianapoli...
0
NCT00660010
[ 4 ]
36
RANDOMIZED
CROSSOVER
0TREATMENT
4QUADRUPLE
false
2MALE
true
Sitagliptin is a potent and selective inhibitor of dipeptidyl peptidase IV (DPP-4), and has been shown to reduce fasting and postprandial glucose levels in patients with type 2 diabetes mainly through incretin hormone-mediated improvements in islet function. Although clinical studies to date indicate that fasting lipid...
null
Diabetes Mellitus Postprandial Lipemia
Diabetes mellitus Postprandial Hyperlipidemia Atherosclerosis
null
2
arm 1: Sitagliptin 100 mg/d for 6 weeks arm 2: Placebo for 6 weeks
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Sitagliptin 100 mg/d for 6 weeks intervention 2: Placebo for 6 weeks
intervention 1: Sitagliptin intervention 2: Placebo
1
Québec | Quebec | Canada | -71.21454 | 46.81228
0
NCT00660075
[ 4 ]
44
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This study is for people at least 21 years old who have signs of problems, like swollen gums and shrinking bones, by dental implants.
At Visit 1, the dentist will: * do an oral exam * ask some questions * decide if the person qualifies for being in the study * make an appointment for Visit 2 if they qualify At Visit 2 (Baseline), the dentist will: * do a special cleaning of the implants * examine the whole mouth * collect some fluid * take x-rays ...
Periodontitis
Peri-implantitis; antibiotic
null
2
arm 1: 1 mg microspheres of minocycline hydrochloride arm 2: Control group receiving no drug intervention
[ 0, 4 ]
1
[ 0 ]
intervention 1: 1mg microspheres for professional subgingival administration into periodontal pockets two times throughout the duration of the trial
intervention 1: Minocycline HCl
4
Aurora | Colorado | United States | -104.83192 | 39.72943 Ann Arbor | Michigan | United States | -83.74088 | 42.27756 Hazlet | New Jersey | United States | -74.19098 | 40.41566 Seattle | Washington | United States | -122.33207 | 47.60621
0
NCT00662532
[ 5 ]
8
NON_RANDOMIZED
SINGLE_GROUP
null
0NONE
false
0ALL
false
Daptomycin is an antibiotic that is affective against many strains of antibiotic resistant microorganisms. This antibiotic would be appropriate for use in the intensive care unit (ICU) considering the severity of illness and high risk for infection within this hospital environment. While in the ICU, patients may develo...
Daptomycin is a FDA approved antibiotic. This pharmacokinetic trial will monitor daptomycin drug concentrations during continuous hemodialysis. The daptomycin concentration profiles developed from this study will assist in developing a dose recommendation that will result in daptomycin levels that are safe and within t...
Critically Ill Hemodialysis
daptomycin pharmacokinetics renal replacement therapy critical illness intensive care units
null
0
null
null
1
[ 0 ]
intervention 1: Daptomcyin 8 mg/kg infused intravenously every 48 hours
intervention 1: Daptomycin
1
Ann Arbor | Michigan | United States | -83.74088 | 42.27756
0
NCT00663403
[ 2 ]
99
NON_RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
false
0ALL
false
Phase 1 safety, pharmacokinetics, and pharmacodynamics trial of the focal adhesion kinase (FAK) inhibitor PF-00562271 in patients with positive Positron Emission Tomography \[PET\] scans due to advanced non-hematologic malignancies, including pancreatic, head and neck, and prostatic neoplasms, and patients with other m...
null
Head and Neck Neoplasm Prostatic Neoplasm Pancreatic Neoplasm
Pancreatic Neoplasm Head and Neck neoplasm Prostatic neoplasms; Focal Adhesion Kinase Phase 1 Pharmacodynamics FDG-PET
null
4
arm 1: None arm 2: None arm 3: None arm 4: None
[ 0, 0, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 125 mg twice daily \[BID\] with food, tablet intervention 2: 125 mg BID with food, tablet intervention 3: 125 mg BID with food, tablet intervention 4: 125 mg BID with food, tablet
intervention 1: PF00562271 intervention 2: PF00562271 intervention 3: PF00562271 intervention 4: PF00562271
4
Aurora | Colorado | United States | -104.83192 | 39.72943 Nashville | Tennessee | United States | -86.78444 | 36.16589 East Melbourne | Victoria | Australia | 144.9879 | -37.81667 Toronto | Ontario | Canada | -79.39864 | 43.70643
0
NCT00666926
[ 5 ]
293
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This trial is conducted in Asia. This single arm trial aims to evaluate the blood glucose control with twice daily biphasic insulin aspart 30 in combination with metformin in Chinese subjects with type 2 diabetes inadequately controlled with once or twice daily basal insulin.
null
Diabetes Diabetes Mellitus, Type 2
null
1
arm 1: Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
[ 0 ]
2
[ 0, 0 ]
intervention 1: Subcutaneous (under the skin) injection, twice daily intervention 2: Tablets, 1000 - 2000 mg daily
intervention 1: biphasic insulin aspart 30 intervention 2: metformin
1
Beijing | Beijing Municipality | China | 116.39723 | 39.9075
0
NCT00669864
[ 4 ]
458
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
false
This study will compare efficacy and safety of once daily treatment of calcipotriol plus betamethasone dipropionate gel (LEO 80185) with tacalcitol ointment and LEO 80185 vehicle alone in subjects with psoriasis vulgaris. Subjects will be treated for up to 8 weeks followed by an observation period of up to 8 weeks to i...
null
Psoriasis Vulgaris
null
3
arm 1: None arm 2: None arm 3: None
[ 1, 1, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Once daily application intervention 2: Once daily application intervention 3: Once daily application
intervention 1: calcipotriol and betamethasone (LEO 80185 gel) intervention 2: LEO 80185 vehicle intervention 3: Tacalcitol ointment
1
Halifax | Nova Scotia | Canada | -63.57688 | 44.64269
0
NCT00670241
[ 2, 3 ]
9
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
The purpose of this trial is to determine the safety and efficacy of Zalutumumab alone or in combination with Irinotecan for the treatment of patients with Colorectal Cancer
null
Colorectal Cancer
Colorectal Neoplasms Colorectal Tumors Colorectal Carcinoma
null
2
arm 1: Zalutumumab in combination with Irinotecan arm 2: Zalutumumab in combination with Irinotecan
[ 0, 0 ]
1
[ 0 ]
intervention 1: Solution for infusion
intervention 1: Zalutumumab
3
Brussels | N/A | Belgium | 4.34878 | 50.85045 Brussels | N/A | Belgium | 4.34878 | 50.85045 Brussels | N/A | Belgium | 4.34878 | 50.85045
0
NCT00677924
[ 5 ]
75
RANDOMIZED
PARALLEL
1PREVENTION
0NONE
false
0ALL
false
The purpose of this study is: to explore the potential for different dosing strategies of posaconazole oral suspension (POS) to increase plasma levels and to profile the pharmacokinetics of these dosing strategies in patients with compromised gastrointestinal function and at high risk for Invasive Fungal Infection.
null
Fungal Infection Acute Myelogenous Leukemia Neutropenia
Antifungal Agents Anti-Infective Agents
null
3
arm 1: POS 200 mg three times a day (TID) on Days 1-8 followed by continued randomized dosing regimen of POS 200 mg TID on Days 9-15, administered with food or oral nutritional supplements. arm 2: POS 200 mg TID on Days 1-8 followed by randomized dosing regimen of POS 400 mg twice a day (BID) on Days 9-15, administered...
[ 0, 0, 0 ]
1
[ 0 ]
intervention 1: Posaconazole will be used for prophylaxis
intervention 1: Posaconazole
0
null
0
NCT00686543
[ 2, 3 ]
2
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
RATIONALE: Drugs used in chemotherapy, such as clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and sp...
OBJECTIVES: Primary * To determine the maximum tolerated dose of clofarabine in adult patients with relapsed CD20-positive B-cell non-Hodgkin lymphoma (NHL). * To estimate objective response rates of clofarabine in combination with rituximab in these patients. Secondary * To determine the 1-year progression-free su...
Lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma recurrent adult Burkitt lymphoma recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma re...
null
1
arm 1: Phase I: Oral Clofarabine x 14 days for up to 8 cycles at assigned dose level below (1 cycle equals 14 days on drug, 14 days off). Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV Dose Level 1: 2 mg Dose Level 2: 4 mg Dose Level 3: 6 mg Phase II: Oral Clofarabine x ...
[ 0 ]
8
[ 2, 0, 6, 6, 6, 6, 10, 10 ]
intervention 1: Administered weekly times 4 weeks and then monthly during the study for up to 8 cycles and will be given on day 1 of clofarabine. A peripheral or central intravenous (IV) line will be established. The initial dose rate at the time of the first infusion should be 50/mg/hr for the first hour. If no toxici...
intervention 1: rituximab intervention 2: clofarabine intervention 3: DNA methylation analysis intervention 4: gene expression analysis intervention 5: microarray analysis intervention 6: polymerase chain reaction intervention 7: high performance liquid chromatography intervention 8: laboratory biomarker analysis
1
Portland | Oregon | United States | -122.67621 | 45.52345
0
NCT00691652
[ 4 ]
418
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to determine the long term safety and tolerability of azilsartan medoxomil, once daily (QD), in participants with Essential Hypertension.
Hypertension affects approximately 50 million individuals in the United States. As the population ages, the prevalence of hypertension will continue to increase if broad and effective preventive measures are not implemented. According to the World Health Organization, hypertension is the most common attributable cause ...
Hypertension
Essential Hypertension Cardiovascular Disease High Blood Pressure Drug Therapy
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: All subjects initiated azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks, force-titrated to 80 mg, tablets, orally, once daily. After Week 8, chlorthalidone, 25 mg, tablets, orally, once daily as needed and other antihypertensive medications as needed to achieve target blood pressur...
intervention 1: Azilsartan medoxomil intervention 2: Azilsartan medoxomil, with or without chlorthalidone and other non-angiotensin II receptor blocker antihypertensive medications. intervention 3: Placebo
45
Huntsville | Alabama | United States | -86.58594 | 34.7304 Chandler | Arizona | United States | -111.84125 | 33.30616 Mesa | Arizona | United States | -111.82264 | 33.42227 Tempe | Arizona | United States | -111.90931 | 33.41477 Los Gatos | California | United States | -121.97468 | 37.22661 Sacramento | California | Un...
0
NCT00696384
[ 5 ]
70
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
To assess the safety of transitioning subjects to Raptiva therapy from standard oral systemic or phototherapy by overlapping with Raptiva whilst tapering the initial systemic therapy or phototherapy dose.
null
Chronic Plaque Psoriasis
Efalizumab Chronic Plaque Psoriasis Transition from systemic therapies on to Efalizumab
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1mg/kg/week for up to 12 weeks.
intervention 1: Efalizumab - anti CD11a recombinant human monoclonal antibody (mAb)
1
City Waterloo | Ontario | Canada | N/A | N/A
0
NCT00697593
[ 3 ]
100
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
This is an open, multicenter phase Ⅱ clinical trial on cetuximab (C225) combined with IMRT + concurrent chemotherapy of cisplatin in locoregionally advanced nasopharyngeal carcinoma.
null
Nasopharyngeal Carcinoma
Radiotherapy chemotherapy Drug Targeting loco-regionally advanced nasopharyngeal carcinoma Safety. efficacy
null
1
arm 1: 400mg/m\^2 intravenous infusion one week before radiotherapy, then 250mg/m\^2 intravenous infusion weekly during radiotherapy
[ 0 ]
1
[ 0 ]
intervention 1: one week before and then weekly during radiotherapy
intervention 1: C225 (cetuximab)
1
Guangzhou | Guangdong | China | 113.25 | 23.11667
0
NCT00700440
[ 4 ]
12
RANDOMIZED
CROSSOVER
0TREATMENT
3TRIPLE
false
0ALL
false
This is a randomized double-blind study to determine if the administration of a small-dose of ketamine (an anesthetic)added to morphine (an opioid) contributes to reducing pain intensity during open wound care procedure (WCP)in patients who have had a traumatic injury and are in an Intensive Care Unit. Patients will be...
An open wound care procedure causes pain and sometimes the use of medication such as morphine alone does not adequately help to alleviate pain during this procedure. This study is being done to learn if the administration of another medication named ketamine by the vein in addition to morphine is more effective in alle...
Wound Care Pain Intensity Hyperalgesia Nausea Vomiting Hallucinations
wound care procedural pain intensity procedural hyperalgesia wound care pain intensity wound care hyperalgesia Wound care pain quality Level of drowsiness level of nausea Level of vomiting Level of hallucinations Level of dysphoria
null
2
arm 1: During the first wound care procedure, patients received morphine 0.05 mg/kg (a maximum dose of 4 mg) plus ketamine 0.25 mg/kg (MK). Then, during the second wound care procedure, patients received morphine 0.1 mg/kg (a maximum dose of 8 mg) plus saline (MS). arm 2: During the first wound care procedure, patients...
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Morphine 0.05 mg/kg (maximum dose of 4 mg) IV plus Ketamine 0.25 mg/kg IV. Then, Morphine 0.1 mg/kg (maximum dose of 8 mg) IV plus Saline IV intervention 2: Morphine 0.1 mg/kg (maximum dose of 8 mg) IV plus Saline IV. Then, Morphine 0.05 mg/kg (maximum dose of 4 mg) IV plus Ketamine 0.25 mg/kg IV.
intervention 1: Morphine plus Ketamine intervention 2: Morphine plus Saline (placebo)
2
San Francisco | California | United States | -122.41942 | 37.77493 San Juan | N/A | Puerto Rico | -66.10572 | 18.46633
0
NCT00701909
[ 4 ]
688
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
This study will compare the efficacy and safety of once daily dosing of aliskiren monotherapy to once daily dosing of aliskiren and hydrochlorothiazide combination therapy in patients with Stage II hypertension over a period of 12 weeks.
null
Hypertension
Essential Hypertension Stage II
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. intervention 2: During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
intervention 1: Aliskiren/hydrochlorothiazide (HCTZ) (300/25 mg) intervention 2: Aliskiren (300 mg)
8
East Hanover | New Jersey | United States | -74.36487 | 40.8201 Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Quito | N/A | Ecuador | -78.52495 | -0.22985 Berlin | N/A | Germany | 13.41053 | 52.52437 Guatemala City | N/A | Guatemala | -90.51327 | 14.64072 Rome | N/A | Italy | 12.51133 | 41.89193 Basel | N/A | ...
0
NCT00705575
[ 4 ]
756
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
This study will evaluate the efficacy and safety of aliskiren 75 mg, 150 mg, and 300 mg in elderly patients with essential hypertension when given with a light meal.
null
Hypertension
Hypertension ≥ 65 years aliskiren placebo light meal
null
4
arm 1: None arm 2: None arm 3: None arm 4: None
[ 2, 0, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Placebo tablet taken once daily in the morning with a light meal. intervention 2: Aliskiren 75 mg tablet taken once daily in the morning with a light meal. intervention 3: Aliskiren 150 mg tablet taken once daily in the morning with a light meal. intervention 4: Aliskiren 300 mg tablet taken once daily ...
intervention 1: Placebo intervention 2: Aliskiren 75 mg intervention 3: Aliskiren 150 mg intervention 4: Aliskiren 300 mg
8
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Prague | N/A | Czechia | 14.42076 | 50.08804 Berlin | N/A | Germany | 13.41053 | 52.52437 Reykjavik | N/A | Iceland | -21.89541 | 64.13548 Rome | N/A | Italy | 12.51133 | 41.89193 Amsterdam | N/A | Netherlands | 4.88969 | 52.37403 Warsaw | N/A | Poland | 21.01178 |...
0
NCT00706134
[ 4 ]
402
RANDOMIZED
CROSSOVER
2DIAGNOSTIC
4QUADRUPLE
false
0ALL
false
This study involves the use of Magnetic Resonance Imaging (MRI) contrast agents called gadobutrol (Gadavist) Injection and ProHance Injection. The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of gadobutrol when used for taking MR images of the brain and...
Issues on safety will be addressed in Adverse Events section.
Diagnostic Imaging Central Nervous System Diseases
Patients referred for a contrast-enhanced MRI of the CNS CNS Imaging
null
2
arm 1: Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) in Period 1 and a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v. in Period 2. arm 2: Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v. i...
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) intervention 2: Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
intervention 1: Gadobutrol (Gadavist, Gadovist, BAY86-4875) intervention 2: Gadoteridol (ProHance)
79
Birmingham | Alabama | United States | -86.80249 | 33.52066 Tuscaloosa | Alabama | United States | -87.56917 | 33.20984 Los Gatos | California | United States | -121.97468 | 37.22661 Newport Beach | California | United States | -117.92895 | 33.61891 Santa Rosa | California | United States | -122.71443 | 38.44047 Jackso...
0
NCT00709852
[ 3 ]
373
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
This study is being carried out to investigate if AZD5672 is effective in treating Rheumatoid Arthritis (RA) and if so how it compares to placebo (a substance which does not have any action) and etanercept (a medicine already available to treat Rheumatoid Arthritis) when added to treatment with methotrexate. The purpos...
null
Rheumatoid Arthritis
Rheumatoid Arthritis RA AZD5672
null
6
arm 1: None arm 2: 20mg arm 3: 50mg arm 4: 100mg arm 5: 150mg arm 6: None
[ 1, 0, 0, 0, 0, 2 ]
6
[ 0, 0, 0, 0, 0, 0 ]
intervention 1: 20 mg oral, once daily intervention 2: 50 mg, subcutaneous injection, weekly intervention 3: placebo, oral, once daily intervention 4: 50 mg oral, once daily intervention 5: 100 mg oral, once daily intervention 6: 150 mg oral, once daily
intervention 1: AZD5672 intervention 2: Etanercept intervention 3: Placebo intervention 4: AZD5672 intervention 5: AZD5672 intervention 6: AZD5672
49
Blagoevgrad | N/A | Bulgaria | 23.1 | 42.01667 Plovdiv | N/A | Bulgaria | 24.75 | 42.15 Sofia | N/A | Bulgaria | 23.32415 | 42.69751 Medellín | Colombia | Colombia | -75.57151 | 6.245 Bogotá | N/A | Colombia | -74.08175 | 4.60971 Bucaramanga | N/A | Colombia | -73.11895 | 7.125 Česká Lípa | N/A | Czechia | 14.53764 | 5...
0
NCT00713544
[ 4 ]
279
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to evaluate the efficacy of 2 fixed dosages of Prolonged Release (PR) OROS methylphenidate (54 and 72 mg/day) compared with placebo in adult patients with attention deficit/hyperactivity disorder (ADHD).
The primary objective of this study is to evaluate the efficacy of 2 fixed dosages of Prolonged Release (PR) OROS methylphenidate (54 and 72 mg/day) compared with placebo in adult patients with attention deficit/hyperactivity disorder (ADHD). The primary efficacy criterion will be the change in the sum of the inattenti...
Attention Deficit/ Hyperactivity Disorder
Adult ADHD Concerta
null
3
arm 1: prolonged release (PR) OROS methylphenidate 54 mg 18+36mg once daily for 13 weeks arm 2: prolonged release (PR) OROS methylphenidate 72 mg 2x36mg once daily for 13 weeks arm 3: Placebo 2xplacebo once daily for 13 weeks
[ 0, 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: 18+36mg once daily for 13 weeks intervention 2: 2x36mg once daily for 13 weeks intervention 3: 2xplacebo once daily for 13 weeks
intervention 1: prolonged release (PR) OROS methylphenidate 54 mg intervention 2: prolonged release (PR) OROS methylphenidate 72 mg intervention 3: Placebo
42
Antwerp | N/A | Belgium | 4.40026 | 51.22047 Brussels | N/A | Belgium | 4.34878 | 50.85045 Kortenberg | N/A | Belgium | 4.54353 | 50.88982 Mechelen | N/A | Belgium | 4.47762 | 51.02574 Mons | N/A | Belgium | 3.95229 | 50.45413 Aarhus | N/A | Denmark | 10.21076 | 56.15674 Hjørring | N/A | Denmark | 9.98229 | 57.46417 Ho...
0
NCT00714688
[ 3 ]
32
RANDOMIZED
CROSSOVER
0TREATMENT
4QUADRUPLE
false
0ALL
null
This study is being conducted to compare the pharmacodynamics (bronchodilation, onset and duration of action), of a single dose of formoterol fumarate in combination with mometasone furoate to placebo in children of 5-11 years with persistent asthma. The study will also assess the bronchodilatory effect of a single dos...
null
Asthma
Asthma Children Persistent asthma
null
4
arm 1: Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI; Period 2: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate v...
[ 0, 0, 0, 0 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: Formoterol fumarate dihydrate / mometasone furoate combination product 10 μg / 100 μg delivered via Pressurized Metered Dose Inhaler (pMDI). One dose consisted of 2 puffs x 5 μg / 50 μg. intervention 2: Formoterol fumarate dihydrate 12 μg delivered via Pressurized Metered Dose Inhaler (pMDI) (1 dose = 2...
intervention 1: Mometasone furoate/formoterol fumarate (MFF) intervention 2: Formoterol fumarate 12 μg pMDI (F12M) intervention 3: Formoterol fumarate 12 μg DPI (F12D) intervention 4: Placebo to F12D intervention 5: Placebo to F12M/MFF
9
Mobile | Alabama | United States | -88.04305 | 30.69436 Huntington Beach | California | United States | -117.99923 | 33.6603 Orange | California | United States | -117.85311 | 33.78779 Hialeah | Florida | United States | -80.27811 | 25.8576 Pensacola | Florida | United States | -87.21691 | 30.42131 Oklahoma City | Okla...
0
NCT00746330
[ 3 ]
60
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The objective of this study is to assess the safety and efficacy of testosterone 0.03% ophthalmic solution compared to vehicle for the treatment of meibomian gland dysfunction.
Meibomian gland secretion plays a crucial role in the health of the ocular surface and function of the tear film. The lipid secreted by the meibomian glands has many crucial roles: 1) to retard evaporation from the preocular surface; 2) lower the surface tension of tears; 3) prevent spill-over of tears from the lid mar...
Meibomian Gland Dysfunction
Meibomian Gland Dysfunction Dry Eye Syndrome
null
2
arm 1: testosterone ophthalmic solution 0.03% arm 2: vehicle of testosterone ophthalmic solution
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: testosterone ophthalmic solution for 128 days intervention 2: vehicle of testosterone ophthalmic solution for 128 days
intervention 1: testosterone ophthalmic solution intervention 2: vehicle of testosterone ophthalmic solution
1
Andover | Massachusetts | United States | -71.137 | 42.65843
0
NCT00755183
[ 4 ]
885
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to determine the efficacy and safety of azilsartan medoxomil, once daily (QD), compared to ramipril for treating Essential Hypertension.
A major component of blood pressure regulation is the renin-angiotensin-aldosterone system, a system of hormone-mediated feedback interactions that results in the relaxation or constriction of blood vessels in response to various stimuli. Angiotensin II, a polypeptide hormone, is formed from angiotensin I in a reaction...
Hypertension
Essential Hypertension Hypertension Drug Therapy Blood Pressure, High Vascular Disease Cardiovascular Disease
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks. intervention 2: Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks. ...
intervention 1: Azilsartan medoxomil intervention 2: Azilsartan medoxomil intervention 3: Ramipril
72
Pleven | N/A | Bulgaria | 24.61667 | 43.41667 Plovdiv | N/A | Bulgaria | 24.75 | 42.15 Rousse | N/A | Bulgaria | 25.9534 | 43.84872 Sofia | N/A | Bulgaria | 23.32415 | 42.69751 Varna | N/A | Bulgaria | 27.91667 | 43.21667 Paide | N/A | Estonia | 25.55722 | 58.88556 Tallinn | N/A | Estonia | 24.75353 | 59.43696 Tartu | ...
0
NCT00760214
[ 5 ]
451
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
The purpose of the study is to evaluate the efficacy and safety of initial use of a fixed dose combination of aliskiren Hydrochlorothiazide (HCTZ) compared to Hydrochlorothiazide in older population with Stage 2 systolic hypertension.
null
Hypertension
Hypertension older population aliskiren hydrochlorothiazide systolic blood pressure diastolic blood pressure amlodipine, stage 2
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Aliskiren 150 mg for 1 week, Aliskiren 300 mg (with or without amlodipine)for 7 weeks intervention 2: Hydrochlorothiazide (HCTZ) 12.5 mg for week 1; Hydrochlorothiazide (HCTZ) 25 mg (with or without amlodipine)for 7 weeks
intervention 1: Aliskiren intervention 2: Hydrochlorothiazide
1
East Hanover | New Jersey | United States | -74.36487 | 40.8201
0
NCT00760266
[ 4 ]
287
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The primary purpose of the study is to test the efficacy of 2 tablets (twice daily) of ABT-712, compared to placebo, administered over a 4-week period in participants with moderate to severe mechanical chronic low back pain (CLBP).
The study used a randomized withdrawal design with an open label (OL) period prior to a double-blind (DB) period. Participants who were receiving benefit and were tolerating ABT-712 during the OL period were randomized into the DB period. Study drug was given for a total of 8 weeks, which included up to 3 weeks in OL, ...
Chronic Low Back Pain
Effect on sleep interference by pain
null
3
arm 1: 2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period). arm 2: 2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period). arm 3: 2 placebo tablets, twice daily, for 4 weeks (double-blind period).
[ 0, 0, 2 ]
2
[ 0, 0 ]
intervention 1: ABT-712 extended-release tablet intervention 2: Placebo tablet
intervention 1: ABT-712 intervention 2: Placebo
31
Huntsville | Alabama | United States | -86.58594 | 34.7304 Burbank | California | United States | -118.30897 | 34.18084 San Diego | California | United States | -117.16472 | 32.71571 Atlantis | Florida | United States | -80.10088 | 26.5909 Hollywood | Florida | United States | -80.14949 | 26.0112 Kissimmee | Florida | ...
0
NCT00763321