FEATURE_phases
list
FEATURE_enrollmentCount
int64
FEATURE_allocation
string
FEATURE_interventionModel
string
FEATURE_primaryPurpose
class label
FEATURE_masking
class label
FEATURE_healthyVolunteers
bool
FEATURE_sex
class label
FEATURE_oversightHasDmc
bool
FEATURE_briefSummary
string
FEATURE_detailedDescription
string
FEATURE_conditions
string
FEATURE_conditionsKeywords
string
FEATURE_protocolPdfText
string
FEATURE_numArms
int64
FEATURE_armDescriptions
string
FEATURE_armGroupTypes
list
FEATURE_numInterventions
int64
FEATURE_interventionTypes
list
FEATURE_interventionDescriptions
string
FEATURE_interventionNames
string
FEATURE_numLocations
int64
FEATURE_locationDetails
string
LABEL_ct_level_ade_population
int64
LABEL_sum_dosing_errors
int64
LABEL_dosing_error_rate
float32
LABEL_wilson_label
int64
METADATA_nctId
string
METADATA_overallStatus
class label
METADATA_completionDate
date32
METADATA_startDate
date32
METADATA_leadSponsorName
string
METADATA_leadSponsorClass
class label
METADATA_hasProtocol
bool
METADATA_hasSap
bool
METADATA_hasIcf
bool
METADATA_protocolPdfLinks
string
METADATA_count_Accidental drug intake by child
int64
METADATA_count_Accidental overdose
int64
METADATA_count_Accidental overdose (therapeutic agent)
int64
METADATA_count_Accidental underdose
int64
METADATA_count_Deliberate overdose
int64
METADATA_count_Dose calculation error
int64
METADATA_count_Drug administration error
int64
METADATA_count_Drug overdose
int64
METADATA_count_Drug overdose accidental
int64
METADATA_count_Extra dose administered
int64
METADATA_count_Incorrect dosage administered
int64
METADATA_count_Incorrect dose administered
int64
METADATA_count_Incorrect drug administration duration
int64
METADATA_count_Incorrect drug administration rate
int64
METADATA_count_Incorrect product administration duration
int64
METADATA_count_Intentional overdose
int64
METADATA_count_Medication error
int64
METADATA_count_Medication monitoring error
int64
METADATA_count_Multiple drug overdose
int64
METADATA_count_Multiple drug overdose accidental
int64
METADATA_count_Multiple drug overdose intentional
int64
METADATA_count_Multiple use of single-use product
int64
METADATA_count_Non-accidental overdose
int64
METADATA_count_Overdose
int64
METADATA_count_Overdose NOS
int64
METADATA_count_Overmedication
int64
METADATA_count_Prescribed overdose
int64
METADATA_count_Treatment noncompliance
int64
METADATA_count_Underdose
int64
METADATA_count_Unintentional medical device removal
int64
METADATA_count_Unintentional medical device removal by patient
int64
METADATA_wilson_lower_bound
float32
[ 3 ]
111
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
The purpose of this trial is to determine the effectiveness of AMG 162 in reducing urinary N-telopeptide in advanced cancer subjects with bone metastases.
null
Bone Metastases in Men With Hormone-Refractory Prostate Cancer Bone Metastases in Subjects With Advanced Breast Cancer Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma
Bone Metastases AMG 162 Bisphosphonates Solid Tumor Carcinomas Advanced
null
3
arm 1: This is an open-label randomization to receive IV bisphosphonate (administered per package insert) every 4 weeks during the treatment phase. If subjects are enrolled into the extension phase, they will receive AMG 162 180mg (SC) every 4 weeks. arm 2: This is an open-label randomization to receive 180 mg AMG 162 ...
[ 1, 0, 0 ]
3
[ 6, 0, 6 ]
intervention 1: A 180 mg AMG 162 (SC) administered every 12 weeks for 2 doses (Day 1 and wk 13) in the treatment phase. If subjected are enrolled in the extension phase, they will continue to receive a 180 mg AMG 162 (SC) administered every 12 weeks for 9 doses. intervention 2: IV Bisphosphonate (eg pamidronate or zole...
intervention 1: AMG 162 180 mg (SC) q 12 weeks intervention 2: IV Bisphosphonate q 4 weeks intervention 3: AMG 162- 180 mg q 4 weeks
0
null
108
0
0
0
NCT00104650
1COMPLETED
2010-03-01
2005-01-01
Amgen
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
143
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
Children with Osteogenesis Imperfecta (OI) have bone pain, low bone mass and fractures. There are no approved drugs for the treatment of OI in children, even though some intravenous (IV) bisphosphonates are used off-label in some countries. In a single dose, pharmacokinetic study, data showed that risedronate was well ...
null
Osteogenesis Imperfecta
Primary disease: Osteogenesis Imperfecta
null
2
arm 1: placebo tablet, once a day for one year then for two years open label risedronate arm 2: risedronate tablet, once a day for one year then for two years open label risedronate once a day
[ 2, 0 ]
2
[ 0, 0 ]
intervention 1: risedronate tablet once a day for one year followed by risedronate once a day for two years intervention 2: placebo tablet once a day for one year followed by risedronate once a day for two years
intervention 1: risedronate sodium (Actonel) intervention 2: Placebo
20
Miami | Florida | United States | -80.19366 | 25.77427 Omaha | Nebraska | United States | -95.94043 | 41.25626 New York | New York | United States | -74.00597 | 40.71427 Dayton | Ohio | United States | -84.19161 | 39.75895 Portland | Oregon | United States | -122.67621 | 45.52345 Westmead | New South Wales | Australia ...
279
0
0
0
NCT00106028
1COMPLETED
2010-03-01
2004-11-01
Warner Chilcott
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
93
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
2MALE
false
This is a multi-center, open-label, Phase 1/2 study of SU011248 (sunitinib malate, SUTENT) in combination with docetaxel and prednisone for the first-line treatment of metastatic hormone-refractory prostate cancer (mHRPC).
null
Prostatic Neoplasms
First-line treatment of metastatic hormone-refractory prostate cancer SUTENT in combination with docetaxel and prednisone
null
1
arm 1: SU011248 in combination with docetaxel and prednisone
[ 0 ]
3
[ 0, 0, 0 ]
intervention 1: Docetaxel Phase 1 - escalating doses (60 and 75 mg/m2), intravenous therapy (IV), administered every 3 weeks. Phase 2 - Phase 1 optimal combination dose (75 mg/m2, IV, every 3 weeks). intervention 2: Prednisone Phase1/2 - 5 mg twice a day (BID), oral. intervention 3: SU011248 Phase 1 - escalating doses ...
intervention 1: Docetaxel intervention 2: Prednisone intervention 3: SU011248
24
Harvey | Illinois | United States | -87.64671 | 41.61003 Tinley Park | Illinois | United States | -87.78449 | 41.57337 Hobart | Indiana | United States | -87.25504 | 41.53226 Munster | Indiana | United States | -87.51254 | 41.56448 Durham | North Carolina | United States | -78.89862 | 35.99403 Portland | Oregon | Unite...
55
0
0
0
NCT00137436
1COMPLETED
2010-03-01
2005-10-01
Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
85
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This clinical study will help determine if giving OGX-011 (custirsen sodium) in combination with gemcitabine (GEM) and cisplatin (CIS) or carboplatin (CARB) is a safe and effective treatment for patients with lung cancer. This study will help to assess the safety and anti-tumor effect of OGX-011 when given to patients ...
OGX-011 is an experimental drug that has been shown to increase the effectiveness of commonly used cancer therapies such as chemotherapy, radiation and hormone therapy in several kinds of cancer types in animals. OGX-011 is being studied in the treatment of cancer patients in combination with chemotherapy. In humans, O...
Non-small Cell Lung Cancer
NSCLC custirsen sodium OGX-011 Stage IIIB or IV advanced non-small cell lung cancer
null
0
null
null
1
[ 0 ]
intervention 1: Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and 3 of Cycle 1 (pretreatment loading dose). OGX 011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused intravenously for 30 minutes on Days 1 and 8...
intervention 1: custirsen sodium
15
Los Angeles | California | United States | -118.24368 | 34.05223 Los Angeles | California | United States | -118.24368 | 34.05223 Albany | New York | United States | -73.75623 | 42.65258 Portland | Oregon | United States | -122.67621 | 45.52345 Greenville | South Carolina | United States | -82.39401 | 34.85262 Dallas |...
81
0
0
0
NCT00138658
1COMPLETED
2010-03-01
2004-11-01
Achieve Life Sciences
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
15
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
It has been accepted and proven that patients with unresectable lung cancer can benefit from systemic chemotherapy. Traditional platinum-based therapy has significant side effects. Oxaliplatin and docetaxel have both shown to be effective for lung cancer. The purpose of this study is to determine if oxaliplatin combine...
This study is a Phase II study designed to evaluate the toxicity profile for oxaliplatin and docetaxel and to determine the response rate to this study drug combination. The primary objective of the study is response rate by RECIST criteria. The secondary objective is time to progression, duration of response, and toxi...
Carcinoma, Non-Small-Cell Lung
Non small Cell Lung Cancer Stage IIIb and IV
null
1
arm 1: Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer. The primary objective of the trial is to determine the response rate by RECIST criteria to the combination of oxaliplatin and docetaxel in patients with previously untreated NSCLC.
[ 0 ]
1
[ 0 ]
intervention 1: Oxaliplatin 85mg/m2 Docetaxel 30mg.m2
intervention 1: Oxaliplatin + Docetaxel
1
Park Ridge | Illinois | United States | -87.84062 | 42.01114
15
0
0
0
NCT00145418
6TERMINATED
2010-03-01
2005-02-01
Oncology Specialists, S.C.
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
33
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
Safety and efficacy of Somatropin will be evaluated in short children born with a list weight below 1500 g and that did not catch up to normal height at the age of 4.
null
Growth Hormone Therapy Infant, Very Low Birth Weight
null
2
arm 1: None arm 2: None
[ 1, 4 ]
2
[ 0, 10 ]
intervention 1: Controlled, prospective, randomized, multicenter study with an untreated (control) group during the first year. The children will be randomized into treatment or untreated (control) group. After one year the control group will undergo GH-therapy, too. Children randomized to the control group will get th...
intervention 1: Somatropin intervention 2: Control Arm
8
Chemnitz | N/A | Germany | 12.92922 | 50.8357 Cologne | N/A | Germany | 6.95 | 50.93333 Erlangen | N/A | Germany | 11.00783 | 49.59099 Freiburg im Breisgau | N/A | Germany | 7.85222 | 47.9959 Heidelberg | N/A | Germany | 8.69079 | 49.40768 Homburg | N/A | Germany | 7.33867 | 49.32637 Leipzig | N/A | Germany | 12.37129 ...
33
0
0
0
NCT00174460
1COMPLETED
2010-03-01
2005-08-01
Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
33
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
false
The study seeks to compare the effectiveness of three preparations of BOTOX-A® in treating muscle tightness and spasms in the feet and ankles of people with stroke.
Spasticity is one of the most debilitating complications of neurologic conditions, such as stroke, brain injury, spinal cord injury, cerebral palsy, and multiple sclerosis. Although the exact pathophysiology is unknown, it is believed to result from an imbalance of ascending excitatory influences on and descending inhi...
Stroke Brain Injuries Spasticity
Stroke Brain Injuries Spasticity Botulinum Toxins
null
3
arm 1: Botox (onabotulinumtoxinA), 150 units prepared as 100 units per 1 ml of preservative-free normal saline arm 2: Botox (onabotulinumtoxinA), 150 units prepared as 50 units per 1 ml of preservative-free normal saline arm 3: Botox (onabotulinumtoxinA), 75 units prepared as 25 units per 1 ml of preservative-free norm...
[ 0, 1, 5 ]
1
[ 0 ]
intervention 1: Botox 75-150 units, single treatment only
intervention 1: Botox
2
West Orange | New Jersey | United States | -74.23904 | 40.79871 Houston | Texas | United States | -95.36327 | 29.76328
32
0
0
0
NCT00178646
1COMPLETED
2010-03-01
2002-01-01
The University of Texas Health Science Center, Houston
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
30
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
Brief summary TBD
This is a single institution phase 1-2 trial to evaluate the safety, feasibility and efficacy of CpG injections (4 intratumoral injections followed by 6 peri-tumoral injections) combined with local irradiation in patients with recurrent low-grade lymphomas. Patients will receive low-dose radiotherapy to a single tumor...
Non-Hodgkin Lymphoma Mycosis Fungoides
non-Hodgkin lymphoma mycosis fungoides
null
2
arm 1: Recurrent low-grade B-cell lymphoma patients (at least one prior treatment failure) arm 2: Mycosis fungoides patients must have failed or have been intolerant of at least 1 topical or 1 systemic treatment Recurrent mycosis fungoides patients (at least one prior failure of topical or systemic treatment)
[ 0, 0 ]
1
[ 0 ]
intervention 1: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections).
intervention 1: CPG 7909
1
Stanford | California | United States | -122.16608 | 37.42411
30
0
0
0
NCT00185965
1COMPLETED
2010-03-01
2004-07-01
Ronald Levy
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
17
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
2MALE
true
RATIONALE: Estrogen may cause the growth of prostate cancer cells. Hormone therapy using fulvestrant may fight prostate cancer by blocking the use of estrogen by the tumor cells. PURPOSE: This phase II trial is studying how well fulvestrant works in treating patients with recurrent prostate cancer.
OBJECTIVES: Primary * Determine whether fulvestrant can slow the rise of prostrate-specific antigen (PSA) level in patients with early recurrent adenocarcinoma of the prostate after radical prostatectomy or irradiation. Secondary * Determine the utility of monitoring serum PSA in patients treated with this drug. * ...
Prostate Cancer
adenocarcinoma of the prostate recurrent prostate cancer
null
1
arm 1: Fulvestrant will be provided as 250 mg in 5 mL as a pre-tilled syringe. Fulvestrant will be administered as 500 mg, that is, 2 injections of 5 mL, one into each buttock im on day 0. A single 250 mg in 5 mL injection will be administered on day 14 followed by a single 250 mg in 5 mL dose on day 28 and monthly the...
[ 0 ]
1
[ 0 ]
intervention 1: intramuscularly
intervention 1: fulvestrant
1
Buffalo | New York | United States | -78.87837 | 42.88645
17
0
0
0
NCT00217464
6TERMINATED
2010-03-01
2004-06-01
Roswell Park Cancer Institute
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
103
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
This phase II trial is studying how well vorinostat works in treating patients with progressive or recurrent glioblastoma multiforme. Drugs used in chemotherapy, such as vorinostat, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may al...
PRIMARY OBJECTIVES: I. Determine the efficacy of vorinostat (SAHA), in terms of 6-month progression-free survival, in patients with progressive or recurrent glioblastoma multiforme. II. Determine the safety and toxicity of this drug in these patients. SECONDARY OBJECTIVES: I. Determine the pharmacokinetics of this ...
Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Recurrent Adult Brain Tumor
null
2
arm 1: Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. arm 2: Beginning 3 days prior to surgery, patients receive oral SAHA once or twice daily for a total of 6 doses. Patients then undergo surgery to remove th...
[ 0, 0 ]
2
[ 0, 3 ]
intervention 1: Given orally intervention 2: Patients undergo surgery to remove tumor
intervention 1: vorinostat intervention 2: conventional surgery
1
Rochester | Minnesota | United States | -92.4699 | 44.02163
101
0
0
0
NCT00238303
1COMPLETED
2010-03-01
2005-09-01
National Cancer Institute (NCI)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
25
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This phase II trial is studying how well AZD2171 works in treating patients with recurrent small cell lung cancer. AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PRIMARY OBJECTIVES: I. To determine the objective response rate of AZD 2171 in patients with recurrent small cell lung cancer (SCLC). SECONDARY OBJECTIVES: I. To determine the overall survival and time to progression. II. To assess the toxicities associated with the administration of AZD 2171 for patients with recur...
Recurrent Non-small Cell Lung Cancer
null
1
arm 1: Patients receive oral AZD2171 once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
[ 0 ]
3
[ 0, 10, 10 ]
intervention 1: Given PO intervention 2: Correlative studies intervention 3: Optional correlative studies
intervention 1: cediranib maleate intervention 2: laboratory biomarker analysis intervention 3: pharmacogenomic studies
1
Duarte | California | United States | -117.97729 | 34.13945
25
0
0
0
NCT00245063
1COMPLETED
2010-03-01
2006-03-01
National Cancer Institute (NCI)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
23
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to determine whether propofol or barbiturates should be preferred in the treatment of status epilepticus (continuous seizure activity) refractory to 2 standard antiepileptic agents.
Refractory status epilepticus (SE) develops in 31%-44% of patients with SE, with a mortality of 16%-23%. Coma induction is advocated for its management. Propofol and barbiturates are the most used agents, but no comparative study has been performed. In consideration of the uncertainty regarding the relative effectivene...
Status Epilepticus
Refractory status epilepticus, coma-induction, treatment, propofol, barbiturates, efficacy, safety.
null
2
arm 1: propofol, 2mg/kg as bolus, then titrated up to EEG burst-suppression as a continuous infusion; no maximum doses defined arm 2: thiopental/pentobarbital, 2mg/kg as bolus, then titrated up to EEG burst-suppression as a continuous infusion; no maximum doses defined
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: liquid, mg/kg.h, titrated after EEG intervention 2: liquid, mg/kg.h, titrated after EEG
intervention 1: propofol intervention 2: thiopental/pentobarbital
5
Boston | Massachusetts | United States | -71.05977 | 42.35843 Boston | Massachusetts | United States | -71.05977 | 42.35843 Bern | Canton of Bern | Switzerland | 7.44744 | 46.94809 Lausanne | Canton of Vaud | Switzerland | 6.63282 | 46.516 Geneva | N/A | Switzerland | 6.14569 | 46.20222
23
0
0
0
NCT00265616
6TERMINATED
2010-03-01
2006-05-01
Brigham and Women's Hospital
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
333
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
true
0ALL
false
The purpose of the proposed study is to conduct a randomized, double-blind clinical trial to compare adjunct treatment with 50 mg oral naltrexone vs. placebo in conjunction with standard smoking cessation treatment with nicotine patch and counseling. Hypotheses: 1. Naltrexone will improve smoking cessation quit rates...
Although women may be particularly susceptible to the damaging effects of chronic cigarette smoking, evidence indicates that they may have more difficulty in maintaining smoking cessation than men. Given women's reduced response to nicotine replacement and other traditional treatments to habitual cigarette smoking, mor...
Smoking Smoking Cessation
Smoking Smoking Cessation
null
4
arm 1: 50 mg Naltrexone tablet arm 2: Females receiving either naltrexone (50 mg) arm 3: Males receiving Placebo (sugar pill) arm 4: Females receiving placebo (sugar pill)
[ 0, 0, 2, 2 ]
2
[ 0, 0 ]
intervention 1: 50 mg q.d. for 13 weeks intervention 2: Sugar pill manufactured to mimic Naltrexone tablet
intervention 1: Naltrexone (drug) intervention 2: Placebo (for Naltrexone)
1
Chicago | Illinois | United States | -87.65005 | 41.85003
315
0
0
0
NCT00271024
1COMPLETED
2010-03-01
2005-12-01
University of Chicago
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
8
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This study will determine the safety of treatment of bullous pemphigoid in patients resistant to therapy with systemic corticosteroids, with rituximab plus systemic corticosteroids.
Bullous pemphigoid (BP) is an autoimmune blistering disease characterized clinically by the presence of severely itchy, tense blisters located over the trunk and extremities. BP is the most common of the autoimmune blistering diseases with an incidence of approximately 10 per 1,000,000 population(1;2). In addition, BP ...
Bullous Pemphigoid
null
1
arm 1: Open label study all subjects treated with rituximab
[ 0 ]
1
[ 0 ]
intervention 1: Infusion of 1000 mg of rituximab on day 0 and day 14
intervention 1: Rituximab
1
Durham | North Carolina | United States | -78.89862 | 35.99403
8
0
0
0
NCT00286325
1COMPLETED
2010-03-01
2005-03-01
Duke University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
528
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This study is designed to evaluate the efficacy of the intraperitoneal chemotherapy with early mitomycin administration and adding cisplatin to prolonged treatment with doxifluridine compared to mitomycin plus doxifluridine in resected advanced gastric cancer.
Stomach cancer is the most common cancer in Korea and one of the major health problems worldwide. The most effective treatment for gastric cancer is curative surgical resection of primary tumor. However, a substantial number of patients eventually die of recurrences after curative resection. A number of randomized tria...
Stomach Cancer
stomach cancer adjuvant chemotherapy mitomycin cisplatin doxifluridine
null
2
arm 1: Mf: Mitomycin-C 20mg/m2 intravenously (3-6 weeks after surgery) Doxifluridine 460-600mg/m2/day per oral for 3 months (started 4 weeks after surgery) arm 2: iceMFP: Cisplatin 100mg with 1L of normal saline intraperitoneally for 2 hours during surgery Mitomycin-C 15mg/m2 intravenously (1 day after surgery) Doxiflu...
[ 1, 1 ]
1
[ 0 ]
intervention 1: Mf: Mitomycin-C 20mg/m2 intravenously (3-6 weeks after surgery) Doxifluridine 460-600mg/m2/day per oral for 3 months (started 4 weeks after surgery) iceMFP: Cisplatin 100mg with 1L of normal saline intraperitoneally for 2 hours during surgery Mitomycin-C 15mg/m2 intravenously (1 day after surgery) Doxi...
intervention 1: cisplatin, mitomycin-C, doxifluridine
1
Seoul | N/A | South Korea | 126.9784 | 37.566
521
0
0
0
NCT00296322
1COMPLETED
2010-03-01
2001-10-01
Asan Medical Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
11
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
Othera Pharmaceuticals' Othera (OT)-551 antioxidant eye drop has the potential for chronic treatment of the dry form of age-related macular degeneration. This pilot study of up to 10 eye drop tolerant participants with bilateral geographic atrophy is designed to characterize the effect of 0.45% concentration of OT-551 ...
Age-related macular Degeneration (AMD), the leading cause of blindness in people over age 55 in the U.S., is a heterogeneous clinical entity in which retinal degeneration occurs predominantly in the macula in the context of aging and leads to impairment primarily of central visual acuity. AMD occurs in two general form...
Geographic Atrophy Age-Related Macular Degeneration AMD
Retinal Pigment Epithelium Dynamic Light Scattering (DLS) Visual Acuity Decrease Intra-ocular Pressure Autofluorescence of Retina Age-Related Macular Degeneration AMD
null
1
arm 1: The fellow eye was treated with OT-551 antioxidant eye drops over the course of the study.
[ 0 ]
1
[ 0 ]
intervention 1: 0.45% concentration of OT-551 eye drops were given three times a day on participants with geographic atrophy area for up to three years. Participants had one eye randomized to receive the eye drop and the fellow eye was observed.
intervention 1: OT-551 antioxidant eye drop
1
Bethesda | Maryland | United States | -77.10026 | 38.98067
11
0
0
0
NCT00306488
1COMPLETED
2010-03-01
2006-03-01
National Institutes of Health Clinical Center (CC)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
184
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
IgA nephropathy (IgAN) is the most common type of glomerulonephritis worldwide. 15-40% of individuals diagnosed with IgAN, including children, will eventually progress to chronic renal insufficiency (CRI) and end stage renal disease (ESRD). The study is to evaluate the safety and benefits of MMF in patients with IgAN w...
A multi-center, randomized, controlled clinical trial to test the hypothesis that treatment with mycophenolate mofetil (MMF) will lead to significant and sustained improvement in proteinuria in patients with IgA Nephropathy who have been pre-treated (and continue to be treated) with ACEi and FOS compared to a placebo c...
IgA Nephropathy
Proteinuria Immunoglobulin A
null
2
arm 1: Dose is based on body size (between 25mg/kg/day and 36mg/kg/day with a maximum dose 1gm BID; initial dose to be used in the first 2 weeks of therapy will be approximately 1/2-2/3 of the full dose). Route of administration is oral. Frequency is daily. MMF will be administered up to 12 months. arm 2: Subjects rece...
[ 1, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Oral administration of MMF; dose based on body size (between 25mg/kg/day and 36ng/kg/day); maximum dose 1gm BID. intervention 2: Placebo only, oral administration intervention 3: Administer same as pre-treatment regimen. intervention 4: Administer same as pre-treatment regimen
intervention 1: Mycophenolate Mofetil (MMF) intervention 2: MMF Placebo intervention 3: ACEi intervention 4: FOS
1
Phoenix | Arizona | United States | -112.07404 | 33.44838
52
0
0
0
NCT00318474
6TERMINATED
2010-03-01
2002-01-01
St. Joseph's Hospital and Medical Center, Phoenix
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
218
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
1FEMALE
false
This study evaluated outcomes in participants with advanced ovarian epithelial adenocarcinoma receiving aflibercept. The primary objective was to compare the objective response rate of Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) 4.0 mg/kg and 2.0 mg/kg, administered intravenously (IV) every 2 weeks wit...
The study included: * A screening period for 21 days * Randomization at baseline (Treatment was initiated with 5 days of randomization) * A treatment period with 14-day study treatment cycles until a study withdrawal criterion was met * A follow-up period up to 60 days after the end of treatment Withdrawal criteria t...
Neoplasms Cancer of the Ovary
ovarian cancer angiogenesis angiogenesis inhibition VEGF-Trap fusion recombinant protein Cancer and other neoplasms
null
2
arm 1: Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept. arm 2: Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept.
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Aflibercept 4.0 mg/kg administered intravenously (IV) over 1 hour once every 2 weeks. Aflibercept could be reduced by 1 dose level ( to 2.0 mg/kg) or 2 dose levels (to 1.0 mg/kg) in case of uncontrolled hypertension or urinary protein \>3.5 g/24 hours. Intrapatient dose escalation was not to be permitt...
intervention 1: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) intervention 2: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)
11
Bridgewater | New Jersey | United States | -74.64815 | 40.60079 Macquarie Park | N/A | Australia | 151.12757 | -33.78105 Laval | N/A | Canada | -73.692 | 45.56995 Paris | N/A | France | 2.3488 | 48.85341 Berlin | N/A | Germany | 13.41053 | 52.52437 Milan | N/A | Italy | 12.59836 | 42.78235 Gouda | N/A | Netherlands | 4...
215
0
0
0
NCT00327171
1COMPLETED
2010-03-01
2006-05-01
Sanofi
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
114
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
This is an extension study to Tercica study MS301 (NCT00125164) and is intended to collect long term safety and efficacy data on the continued use of recombinant human insulin-like growth factor-1 (rh IGF-1) in children and adolescents treated for primary IGF-1 deficiency (IGFD). The secondary objective is to use the d...
Primary IGFD is a term that has been used to describe patients with intrinsic cellular defects in GH action. In this protocol, subjects that have completed one year of mecasermin treatment on Tercica protocol MS301 (NCT00125164) will be allowed to enroll in this extension study. All subjects were planned to receive tre...
Growth Disorders
Insulin-like Growth Factor Deficiency IGF-1 Short Stature
null
1
arm 1: All subjects entering MS306 began recombinant human insulin-like growth factor-1 (rhIGF-1) twice a day (BID) treatment. Each subject treated in MS301 had an MS306 starting dose that was based on their dose at the completion of MS301 (i.e. subcutaneous injections of rhIGF-1 at 40, 80, or 120 micrograms \[μg\]/ ki...
[ 0 ]
1
[ 0 ]
intervention 1: Patients from untreated arm for prior study MS301 (NCT00125164) were randomized to a dose of either 80 or 120 mcg/kg twice daily. For patients receiving active treatment in previous study MS 301 (NCT00125164), they started on a dose of 80 or 120 mcg/kg twice daily based on the dose reached at end of the...
intervention 1: rh IGF-1 (mecasermin)
1
Paris | N/A | France | 2.3488 | 48.85341
114
0
0
0
NCT00330668
6TERMINATED
2010-03-01
2005-11-01
Ipsen
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
4
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The objective of this study is to determine the safety and effectiveness of intrarenal administration of brain natriuretic peptide (BNP) in improving renal function as measured by glomerular filtration rate (GFR) and sodium excretion in patients hospitalized with acute congestive heart failure (CHF) and deterioration o...
null
Cardiorenal Syndrome
null
1
arm 1: Subjects received an intrarenal infusion of nesiritide at 0.005 microgram/kg/min for 6 hours, 0.01 microgram/kg/min for 6 hours, 0.02 microgram/kg/min for 6 hours, and 0.03 microgram/kg/min for 6 hours.
[ 0 ]
1
[ 0 ]
intervention 1: Nesiritide 0.005 ug/kg/min IV for 6 hours, then to 0.01 ug/kg/min for 6 hours then to 0.02ug/kg/min for 6 hours then to 0.03 ug/kg/min for the last 6 hours.
intervention 1: Nesiritide
1
Rochester | Minnesota | United States | -92.4699 | 44.02163
4
0
0
0
NCT00348556
6TERMINATED
2010-03-01
2005-12-01
Horng Chen
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
31
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
Migraine is common in children and is one of the most common etiologies of headache leading to emergency room presentation in children. Despite this, few studies have investigated the treatment of acute migraine headache in the emergency room. We will perform a prospective, double-blind, placebo-controlled study of met...
Migraine is common in children and is one of the most common etiologies of headache leading to emergency room presentation of children \[1-3\]. Despite the high prevalence, there have been few pediatric studies of the acute treatment of migraine headache. Anti-dopaminergic medications such as metoclopramide are often c...
Migrainous Headache
null
2
arm 1: Standard care including intravenous fluid, but no metoclopramide. arm 2: Standard care including intravenous fluid PLUS metoclopramide.
[ 2, 1 ]
2
[ 0, 10 ]
intervention 1: Intravenous bolus administration. intervention 2: Standard care including intravenous fluid, but no metoclopramide.
intervention 1: Metoclopramide intervention 2: Placebo
1
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
31
0
0
0
NCT00355394
1COMPLETED
2010-03-01
2006-08-01
Children's Hospital of Philadelphia
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
20
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The main purpose of this study is to test the effectiveness of bevacizumab in combination with radiation therapy to see what effects (good or bad) they have on patients with soft tissue sarcoma. Bevacizumab is an antibody designed specifically to slow or stop the growth of cancerous tumors by decreasing the blood suppl...
* The dose of bevacizumab and radiation therapy will be the same for all participants throughout the study. * Bevacizumab will be given as an intravenous infusion every 2 weeks for a total of 4 doses. * Radiation therapy will begin 2 weeks after the first bevacizumab infusion and will be delivered 5 days per week over ...
Soft Tissue Sarcoma Fibrous Histiocytoma Liposarcoma Leiomyosarcoma Fibrosarcoma Synovial Sarcoma
Avastin
null
1
arm 1: Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)
[ 0 ]
3
[ 0, 4, 3 ]
intervention 1: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses intervention 2: External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperi...
intervention 1: Bevacizumab intervention 2: Radiation Therapy intervention 3: Surgery
1
Boston | Massachusetts | United States | -71.05977 | 42.35843
20
0
0
0
NCT00356031
1COMPLETED
2010-03-01
2006-07-01
Massachusetts General Hospital
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
36
RANDOMIZED
CROSSOVER
7BASIC_SCIENCE
2DOUBLE
false
0ALL
false
The purpose of this study is to determine if Rizatriptan, a migraine medication, lowers motion sickness in migraine sufferers.
Migraine sufferers undergo vestibular tests and were excluded if there were clinically significant abnormalities. Following screening, there were 2 experimental visits in which migraine sufferers were pre-treated with either Rizatriptan or placebo. After taking the drug, subjects were idle for 2 hours. Baseline motion ...
Migraine
Migraine Triptans Motion Sickness
null
4
arm 1: This group received placebo on visit 1 and Rizatriptan on visit 2. arm 2: These subjects received Rizatriptan on visit 1 and placebo on visit 2. arm 3: This group received placebo on visit 1 and Rizatriptan on visit 2. arm 4: This group received Rizatriptan on visit 1 and placebo on visit 2.
[ 5, 5, 5, 5 ]
2
[ 0, 10 ]
intervention 1: 10 mg Rizatriptan in an unlabeled pill given once on one of two visits intervention 2: In an unlabeled pill given once on one of two visits.
intervention 1: Rizatriptan intervention 2: Placebo
1
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
53
0
0
0
NCT00360282
1COMPLETED
2010-03-01
2006-08-01
University of Pittsburgh
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
14
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
The purpose of this study is to assess whether DCE-MRI can detect changes of active disease in rheumatoid arthritis (RA) patients after 4, 8 and 12 weeks of etanercept.
The current literature shows the promise of magnetic resonance imaging (MRI) for assessing response to therapy in RA but the heterogeneity of the methodology and the semi-quantitative nature of the image analysis limits its applicability. To evaluate the ability of DCE-MRI to serve as a biomarker for treatment-induced ...
Rheumatoid Arthritis
Etanercept Enbrel DCE-MRI RA
null
1
arm 1: Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
[ 0 ]
1
[ 0 ]
intervention 1: None
intervention 1: Etanercept
3
Los Angeles | California | United States | -118.24368 | 34.05223 Seattle | Washington | United States | -122.33207 | 47.60621 London | N/A | United Kingdom | -0.12574 | 51.50853
13
0
0
0
NCT00361634
1COMPLETED
2010-03-01
2006-09-01
Amgen
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
36
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of pancreatic cancer by blocking blood flo...
OBJECTIVES: Primary * Evaluate the 6-month overall survival rate in patients with gemcitabine hydrochloride-refractory metastatic pancreatic cancer treated with bevacizumab and erlotinib hydrochloride. * Determine the safety and toxicity of this regimen in these patients. Secondary * Evaluate the objective response...
Pancreatic Cancer
stage IV pancreatic cancer adenocarcinoma of the pancreas recurrent pancreatic cancer
null
1
arm 1: A treatment cycle is 21 days: bevacizumab 15 mg/kg as a 60-90 min infusion once every 21 days, with erlotinib hydrochloride 150 mg by mouth daily
[ 0 ]
3
[ 2, 0, 10 ]
intervention 1: None intervention 2: None intervention 3: None
intervention 1: bevacizumab intervention 2: erlotinib hydrochloride intervention 3: laboratory biomarker analysis
1
San Francisco | California | United States | -122.41942 | 37.77493
36
0
0
0
NCT00365144
1COMPLETED
2010-03-01
2006-02-01
University of California, San Francisco
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
20
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Genistein may help gemcitabine and erl...
OBJECTIVES: Primary * Determine the 6-month survival rate of patients with locally advanced or metastatic pancreatic cancer treated with genistein, gemcitabine hydrochloride, and erlotinib hydrochloride. Secondary * Determine the frequency of objective tumor response rate in these patients. * Determine the time to ...
Pancreatic Cancer
adenocarcinoma of the pancreas stage III pancreatic cancer stage IV pancreatic cancer recurrent pancreatic cancer
null
1
arm 1: Novasoy® 396 mg (177 mg of Isoflavones) twice-daily starting daay -7 until day 28; Gemcitabine 1000 mg/m2 days 1, 8, \& 15; Erlotinib 150 mg day 1 until day 28
[ 0 ]
3
[ 7, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: None
intervention 1: genistein intervention 2: erlotinib hydrochloride intervention 3: gemcitabine hydrochloride
2
Detroit | Michigan | United States | -83.04575 | 42.33143 Houston | Texas | United States | -95.36327 | 29.76328
20
0
0
0
NCT00376948
1COMPLETED
2010-03-01
2005-05-01
Barbara Ann Karmanos Cancer Institute
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
5
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to determine whether the drug Bosentan improves exercise tolerance in scleroderma patients.
Pulmonary hypertension (PAH) is a common and usually fatal form of lung disease in systemic sclerosis (SSc). Multiple drugs have been approved for the treatment of New York Heart Association (NYHA)Class III/IV PAH in scleroderma. Bosentan is an endothelin-1 antagonist which showed significant improvement in distance wa...
Systemic Scleroderma Pulmonary Hypertension
scleroderma systemic sclerosis bosentan pulmonary hypertension PHAROS PHROS exercise echocardiogram
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 62.5 mg by mouth (PO) twice daily (Bid) for 1 month, followed by 125 mg PO Bid thereafter, for a total of 16 weeks intervention 2: 62.5 mg PO Bid for 1 month, followed by 125 mg PO Bid thereafter, for a total of 16 weeks
intervention 1: Bosentan intervention 2: Placebo
2
Farmington | Connecticut | United States | -72.83204 | 41.71982 Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
5
0
0
0
NCT00377455
6TERMINATED
2010-03-01
2006-09-01
Georgetown University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
20
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
true
0ALL
true
This is an 8 week study that compares two medications. One medication is olanzapine (5-20 mg daily) whereas the other medication is an orally disintegrating medication. Both medications are used to treat depressed bipolar patients. The main focus of this study is the comparison of these two medications on gastro-intest...
Olanzapine is undeniably one of the most effective treatments available for all phases of bipolar disorder. After FDA approval for bipolar mania, the drug became one of the most widely prescribed of treatments for this difficult-to-treat disorder. However, concerns about weight gain and the associated metabolic syndrom...
Bipolar Depression
Bipolar Depression Weight gain bipolar medicine side effects olanzapine gastrointestinal hormones bipolar medicine
null
2
arm 1: Orally disintegrating olanzapine arm 2: regular olanzapine
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: 5 to 20 mg (daily) orally disintegrating olanzapine for approx.8 weeks. intervention 2: 5-20 mg. olanzapine daily for approximately 8 weeks.
intervention 1: orally-disintegrating olanzapine intervention 2: regular olanzapine
1
Nashville | Tennessee | United States | -86.78444 | 36.16589
23
0
0
0
NCT00384332
1COMPLETED
2010-03-01
2007-01-01
Vanderbilt University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
25
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The primary endpoint of this study is to estimate morphologic complete remission rate. Estimation of response rate is also a secondary objection.
Myelodysplastic syndrome (MDS) is a hematological disorder characterized by ineffective hematopoiesis. The only known curative treatment for patients with MDS is allogeneic stem cell transplantation. However, only a minority of patients are candidates for this aggressive therapy. DNA hypomethylation agents have been sh...
Myelodysplastic Syndromes
MDS either de novo or secondary, fitting any of the WHO classifications.
null
1
arm 1: Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of respon...
[ 0 ]
1
[ 0 ]
intervention 1: None
intervention 1: Azacitidine
1
St Louis | Missouri | United States | -90.19789 | 38.62727
24
0
0
0
NCT00384956
1COMPLETED
2010-03-01
2006-08-01
Washington University School of Medicine
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
22
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This phase II trial is studying how well sunitinib works in treating patients with recurrent and/or metastatic head and neck cancer. Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
OBJECTIVES: I. Determine the overall response rate of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck treated with sunitinib malate. II. Determine the toxicity of this drug in these patients. III. Determine the feasibility of administering this drug to patients with ECOG perform...
Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma Recurrent Metastatic Squamous Neck Cancer With Occult Primary Recurrent Squamous Cell Carcinoma of the Hypopharynx Recurrent Squamous Cell Carcinoma of the Larynx Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity Recurrent Squamous C...
null
1
arm 1: Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
[ 0 ]
1
[ 0 ]
intervention 1: Given orally
intervention 1: sunitinib malate
1
Chicago | Illinois | United States | -87.65005 | 41.85003
22
0
0
0
NCT00387335
1COMPLETED
2010-03-01
2006-08-01
National Cancer Institute (NCI)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
111
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
The objective of this study is to examine the effects of aripiprazole on glucose metabolism in schizophrenic patients without hyperglycemia and diabetes mellitus or any history thereof.
null
Schizophrenia
OPC-14597 Schizophrenia
null
0
null
null
1
[ 0 ]
intervention 1: 1 or 2 times a day, p.o., 6 - 24mg a day
intervention 1: Aripiprazole
5
Hokkaido Region | N/A | Japan | N/A | N/A Kanto Region | N/A | Japan | N/A | N/A Kinki Region | N/A | Japan | N/A | N/A Kyushu Region | N/A | Japan | N/A | N/A Touhoku Region | N/A | Japan | N/A | N/A
111
0
0
0
NCT00392197
1COMPLETED
2010-03-01
2006-11-01
Otsuka Pharmaceutical Co., Ltd.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
31
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Background: * Bevacizumab is a genetically engineered antibody that blocks the growth of new blood vessels in tumors. It has shown activity against human brain tumors in laboratory tests and human clinical trials. * Irinotecan causes damage to the deoxyribonucleic acid (DNA) in cancer cells so that the cells cannot re...
Background: * Bevacizumab is a humanized IgG1 monoclonal antibody (MAb) that binds all biologically active isoforms of human vascular endothelial growth factor (VEGF, or VEGF-A) with high affinity (kd = 1.1 nM ). The antibody consists of a human IgG1 framework and the antigen-binding complementarity-determining region...
High-Grade Gliomas
Brain Tumor Chemotherapy Progression Radiotherapy Antiangiogenesis Glioma
null
1
arm 1: Bevacizumab - 10 mg/kg intravenous injection Irinotecan - 125 mg/m\^2 if patient is on a non-enzyme inducing anti-epileptic drugs 340 mg/m\^2 if patient is on enzyme inducing anti-epileptic drugs every two weeks on a 4 week cycle
[ 0 ]
2
[ 2, 0 ]
intervention 1: 10 mg/kg intravenous injection intervention 2: 125 mg/m\^2 if patient is on a non-enzyme inducing anti-epileptic drugs 340 mg/m\^2 if patient is on enzyme inducing anti-epileptic drugs every two weeks on a 4 week cycle
intervention 1: Bevacizumab intervention 2: Irinotecan hydrochloride
1
Bethesda | Maryland | United States | -77.10026 | 38.98067
30
0
0
0
NCT00393094
6TERMINATED
2010-03-01
2006-09-01
National Cancer Institute (NCI)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
34
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
true
0ALL
false
This study compares two different brands of thyroxine (thyroid hormone). Currently, pharmacists may be substituting generic formulations of thyroid hormone without your doctor knowing about this. Although a small difference in thyroid function is not significant in most healthy children, adolescents and adults, in infa...
This study is an unblinded, randomized controlled cross-over study, which involves taking 2 different forms of levothyroxine sequentially over a 16 week period. Subjects will have a total of 3 visits over this time period. At the first visit, subjects are randomized to receive either generic (Sandoz) levothyroxine or S...
Congenital Hypothyroidism Hypothyroidism
null
2
arm 1: Dose previously demonstrated to normalize thyroid function given daily for 2 months arm 2: Dosage previously determined to normalize thyroid function given daily for 2 months
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Randomized crossover study using 8 weeks of brand name levothyroxine (Synthroid, manufactured by Abbott), then 8 weeks of the generic formulation of levothyroxine (manufactured by Sandoz). The dose of medication does not change throughout the duration of the study. intervention 2: Randomized crossover s...
intervention 1: Brand Name Levothyroxine (Synthroid) intervention 2: Generic formulation of Levothyroxine
1
Boston | Massachusetts | United States | -71.05977 | 42.35843
31
0
0
0
NCT00403390
1COMPLETED
2010-03-01
2006-11-01
Boston Children's Hospital
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
76
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
RATIONALE: Drugs used in chemotherapy, such as carboplatin and ABI-007, 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. PURPOSE: This phase II trial is studying the s...
OBJECTIVES: Primary * Assess the safety and antitumor activity of carboplatin and paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) in patients with unresectable stage IV melanoma who have not received prior chemotherapy for their metastatic disease. (Cohort 1) * Assess the safety and antitumor activit...
Melanoma (Skin)
stage IV melanoma recurrent melanoma
null
1
arm 1: Patients receive paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) IV over 30 minutes followed by carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 8 courses in the absence of disease progression or unacceptable toxicity. Blood and tumor tissue samp...
[ 0 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: carboplatin intervention 2: paclitaxel albumin-stabilized nanoparticle formulation
156
Scottsdale | Arizona | United States | -111.89903 | 33.50921 Jacksonville | Florida | United States | -81.65565 | 30.33218 Aurora | Illinois | United States | -88.32007 | 41.76058 Bloomington | Illinois | United States | -88.99369 | 40.4842 Canton | Illinois | United States | -90.03512 | 40.55809 Carthage | Illinois | ...
73
0
0
0
NCT00404235
1COMPLETED
2010-03-01
2006-10-01
Alliance for Clinical Trials in Oncology
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
819
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active, autoantibody-positive systemic lupus erythematosus (SLE) disease.
null
Systemic Lupus Erythematosus
Antibodies Autoimmune Diseases Systemic Lupus Erythematosus SLE Belimumab Lupus
null
3
arm 1: Placebo arm 2: Belimumab 1 mg/kg arm 3: Belimumab 10 mg/kg
[ 2, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks. intervention 2: Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks. intervention 3: Belimumab ...
intervention 1: Placebo intervention 2: Belimumab 1 mg/kg intervention 3: Belimumab 10 mg/kg
146
Birmingham | Alabama | United States | -86.80249 | 33.52066 Paradise Valley | Arizona | United States | -111.94265 | 33.53115 Tucson | Arizona | United States | -110.92648 | 32.22174 Huntington Beach | California | United States | -117.99923 | 33.6603 Long Beach | California | United States | -118.18923 | 33.76696 Los ...
819
0
0
0
NCT00410384
1COMPLETED
2010-03-01
2006-12-01
Human Genome Sciences Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
51
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical PVD induction for treatment of patients with DME.
null
Diabetic Macular Edema
Diabetic Macular Edema PVD DME Diabetic Retinopathy
null
4
arm 1: 25µg ocriplasmin intravitreal injection versus sham injection arm 2: 75µg ocriplasmin intravitreal injection versus sham injection arm 3: 125µg ocriplasmin intravitreal injection versus sham injection arm 4: Sham injection
[ 0, 0, 0, 3 ]
2
[ 0, 10 ]
intervention 1: Intravitreal injection, single administration intervention 2: Sham intravitreal injection
intervention 1: ocriplasmin intervention 2: Sham injection
15
Antwerp | N/A | Belgium | 4.40026 | 51.22047 Ghent | N/A | Belgium | 3.71667 | 51.05 Leuven | N/A | Belgium | 4.70093 | 50.87959 Munich | N/A | Germany | 11.57549 | 48.13743 Milan | N/A | Italy | 9.18951 | 45.46427 Pisa | N/A | Italy | 10.4036 | 43.70853 Rome | N/A | Italy | 12.51133 | 41.89193 Varese | N/A | Italy | 8...
51
0
0
0
NCT00412451
1COMPLETED
2010-03-01
2006-12-01
ThromboGenics
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
795
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
This study will compare the effects of pemetrexed plus cisplatin versus cisplatin alone in head and neck cancer patients.
null
Head and Neck Neoplasms
null
2
arm 1: Pemetrexed 500 milligrams per meter square (mg/m\^2) administered intravenously (IV) plus cisplatin 75 mg/m\^2 IV on Day 1 every 21 days. Pretreatment, Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatme...
[ 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: 500 mg/m\^2, IV, every 21 days, six 21 day cycles intervention 2: 75 mg/m\^2, administered IV, every 21 days, six 21 day cycles intervention 3: Approximately 100 mL normal saline administered IV, every 21 days, six 21 day cycles
intervention 1: pemetrexed intervention 2: cisplatin intervention 3: placebo
94
Orange | California | United States | -117.85311 | 33.78779 Orlando | Florida | United States | -81.37924 | 28.53834 St. Petersburg | Florida | United States | -82.67927 | 27.77086 Atlanta | Georgia | United States | -84.38798 | 33.749 Chicago | Illinois | United States | -87.65005 | 41.85003 Beech Grove | Indiana | Un...
777
0
0
0
NCT00415194
1COMPLETED
2010-03-01
2006-12-01
Eli Lilly and Company
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
190
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
To provide continued treatment of Keppra XR (Levetiracetam XR) and to assess the long term safety of Keppra XR in subjects with partial onset seizures.
null
Epilepsy
Keppra XR Levetiracetam XR long term partial seizures
null
1
arm 1: 1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
[ 0 ]
1
[ 0 ]
intervention 1: 500 mg tablets, 1000 - 3000 mg/day, flexible dosing for duration of the study (planned: approximately 6 months-3 years).
intervention 1: Keppra XR (Levetiracetam XR)
35
Dothan | Alabama | United States | -85.39049 | 31.22323 Northport | Alabama | United States | -87.57723 | 33.22901 Phoenix | Arizona | United States | -112.07404 | 33.44838 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Bakersfield | California | United States | -119.01871 | 35.37329 Loxahatchee Groves |...
189
0
0
0
NCT00419393
1COMPLETED
2010-03-01
2007-12-01
UCB Pharma
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
12
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to determine the effectiveness and tolerability of aripiprazole in the treatment of children and adolescents with Fragile X Syndrome.
This 12-week prospective, open-label study design was chosen to gather pilot data for potential future lager scale, double-blind, placebo-controlled studies in Fragile X Syndrome. We hypothesize that aripiprazole will be effective in decreasing aggression, SIB, agitation, and interfering repetitive behavior commonly o...
Fragile X Syndrome
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: All subjects will initially receive 2.5 mg/day of aripiprazole during the first week. The dosage may be increased to a maximum of 20 mg/day over 8 weeks.
intervention 1: Aripiprazole
1
Indianapolis | Indiana | United States | -86.15804 | 39.76838
12
0
0
0
NCT00420459
1COMPLETED
2010-03-01
2007-04-01
Indiana University School of Medicine
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
865
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active, autoantibody-positive systemic lupus erythematosus (SLE) disease.
null
Systemic Lupus Erythematosus
Autoimmune Diseases Lupus SLE Systemic Lupus Erythematosus Belimumab Antibodies
null
3
arm 1: Placebo arm 2: Belimumab 1 mg/kg arm 3: Belimumab 10 mg/kg
[ 2, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through Week 48. intervention 2: Belimumab 1 mg/kg IV plus standard therapy on Days 0, 14, 28, and every 28 days thereafter through Week 48. intervention 3: Belimumab 10 mg/kg IV plus standard therapy ...
intervention 1: Placebo intervention 2: Belimumab 1 mg/kg intervention 3: Belimumab 10 mg/kg
92
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Buenos Aires | N/A | Argentina | -58.37723 | ...
865
0
0
0
NCT00424476
1COMPLETED
2010-03-01
2007-05-01
Human Genome Sciences Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
90
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This study will evaluate the safety and efficacy of amlodipine plus valsartan in patients with hypertension and left ventricular hypertrophy
null
Hypertension; Hypertrophy, Left Ventricular
Left ventricular hypertrophy, hypertension, valsartan, amlodipine
null
2
arm 1: Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication. arm 2: Partici...
[ 0, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 160 mg film coated tablets taken orally once daily in the morning. intervention 2: 5 mg or 10 mg tablets taken orally once daily in the morning. intervention 3: 12.5 mg or 25 mg tablets taken orally once daily in the morning. intervention 4: 100 mg tablets taken orally once daily in the morning.
intervention 1: Valsartan intervention 2: Amlodipine intervention 3: Hydrochlorothiazide intervention 4: Losartan
1
Ludwigshafen | N/A | Germany | 9.06138 | 47.81663
90
0
0
0
NCT00446563
1COMPLETED
2010-03-01
2007-03-01
Novartis
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
30
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study was to describe metabolic changes in the first 16 weeks of anti-psychotic treatment in previously drug-naïve patients with psychosis. We hypothesize that in drug-naive patients, greater insulin resistance prior to treatment predicts a disproportionately greater increase in insulin resistance ...
Antipsychotic medications are associated with an increased risk of diabetes. We focused on a description of early metabolic adverse effects and clinical and biochemical features that might predict these adverse effects.
Schizophrenia
Schizophrenia Schizoaffective psychosis olanzapine
null
1
arm 1: The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.
[ 0 ]
1
[ 0 ]
intervention 1: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge.
intervention 1: Olanzapine
1
Barcelona | N/A | Spain | 2.15899 | 41.38879
30
0
0
0
NCT00446992
1COMPLETED
2010-03-01
2006-04-01
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
25
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
RATIONALE: Drugs used in chemotherapy, such as floxuridine, leucovorin, oxaliplatin, and docetaxel, 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. PURPOSE: This phas...
OBJECTIVES: Primary * Determine the overall response rate in patients with unresectable stage IV gastric adenocarcinoma treated with floxuridine, leucovorin calcium, oxaliplatin, and docetaxel as first-line treatment. Secondary * Determine the feasibility of this regimen in managing patients with unresectable stage...
Gastric Cancer
recurrent gastric cancer stage IV gastric cancer adenocarcinoma of the stomach
null
1
arm 1: Treatment will be administered on an outpatient basis. Chemotherapy will be administered weekly, 3 out of 4 weeks, on days 1, 8 and 15: Day 1 and Day 15 Chemotherapy Administration: Patients will be administered oxaliplatin (85 mg/m2) and docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110 mg/kg//500 mg/m2) o...
[ 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: None intervention 4: None
intervention 1: Docetaxel intervention 2: Floxuridine intervention 3: Leucovorin intervention 4: Oxaliplatin
1
Miami | Florida | United States | -80.19366 | 25.77427
0
0
0
0
NCT00448682
6TERMINATED
2010-03-01
2005-06-01
University of Miami
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
25
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
RATIONALE: Drugs used in chemotherapy, such as irinotecan, floxuridine, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of...
For the purpose of this study treatment cycle consist of six weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29 according to the schedule. There will be no treatment deliv...
Colorectal Cancer
stage IV colon cancer stage IV rectal cancer adenocarcinoma of the colon adenocarcinoma of the rectum
null
1
arm 1: Treatment cycle is 6 weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29: * Bevacizumab: 7.5mg/kg via intravenous (IV) infusion on Days 1 and 22; * Irinotecan: 110 ...
[ 0 ]
4
[ 2, 0, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: None intervention 4: None
intervention 1: Bevacizumab intervention 2: Floxuridine intervention 3: Irinotecan intervention 4: Leucovorin
1
Miami | Florida | United States | -80.19366 | 25.77427
22
0
0
0
NCT00449163
6TERMINATED
2010-03-01
2006-03-01
University of Miami
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
26
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The goal of this clinical research study is to learn if giving pentostatin with alemtuzumab can help to control T-cell malignancy. The safety of this combination therapy will also be studied.
Alemtuzumab is an antibody protein that is directed towards a marker molecule on the surface of both B- and T- lymphoid cells. It is currently approved for use in treating patients with chronic lymphocytic leukemia and has been studied in treating patients with a number of T-cell malignancies. Alemtuzumab has been foun...
Lymphoma Leukemia
T-Cell Neoplasms Alemtuzumab Pentostatin Campath-1H Deoxycoformycin Lymphoma Leukemia
null
1
arm 1: Alemtuzumab 30 mg intravenous (IV) three times weekly; Pentostatin 4 mg/m\^2 IV weekly for 4 weeks then every 2 weeks
[ 0 ]
2
[ 0, 0 ]
intervention 1: 4 mg/m\^2 IV weekly for 4 weeks then every 2 weeks intervention 2: 30 mg IV three times weekly
intervention 1: Pentostatin intervention 2: Alemtuzumab
1
Houston | Texas | United States | -95.36327 | 29.76328
24
0
0
0
NCT00453193
6TERMINATED
2010-03-01
2004-09-01
M.D. Anderson Cancer Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
12
NA
SINGLE_GROUP
0TREATMENT
0NONE
true
1FEMALE
false
This investigation assessed the effects of asymptomatic BV on daily genital tract shedding of HSV-2 by determining shedding frequency before and after treatment of asymptomatic BV.
An important contributor to the epidemic spread of herpes simplex virus type 2 (HSV-2) is its high frequency of asymptomatic shedding in the genital tract, as transmission usually occurs during these periods of subclinical reactivation of the virus. Therefore, an improved understanding of the risk factors associated wi...
Bacterial Vaginosis
herpes simplex virus
null
1
arm 1: Observational before and after treatment Drug: Metronidazole 500 mg, taken by mouth, two times a day, 7 days
[ 5 ]
1
[ 0 ]
intervention 1: 500 mg, taken by mouth, two times a day, 7 days
intervention 1: Metronidazole
2
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062 Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
12
0
0
0
NCT00464542
1COMPLETED
2010-03-01
2007-12-01
University of Pittsburgh
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
40
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
Healthy children may develop symptoms of chronic sinusitis such as chronic cough, chronic runny nose, nasal congestion, even headaches. Such symptoms may persist long after the child gets over other symptoms of a cold and commonly result in the prescription of oral antibiotics. The purpose of this study is to evaluate ...
In the pediatric population, rhinosinusitis is a common concern resulting frequently in the frequent and unsuccessful prescription of systemic oral antibiotic therapy. Children typically experience an estimated 6-8 upper respiratory illnesses per year, usually viral, and only 13% are estimated to result in true sinusit...
Sinusitis
null
2
arm 1: Saline plus Gentamycin arm 2: Saline
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Intranasal Saline intervention 2: Intranasal irrigation
intervention 1: Saline intervention 2: Gentamycin
2
Kansas City | Kansas | United States | -94.62746 | 39.11417 Shawnee | Kansas | United States | -94.72024 | 39.04167
40
0
0
0
NCT00465530
1COMPLETED
2010-03-01
2007-03-01
Julie Wei, MD
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
14
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
RATIONALE: Lestaurtinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cytarabine and idarubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lestaurtinib...
OBJECTIVES: Primary * Determine a safe, tolerable, and biologically active dose of lestaurtinib in combination with chemotherapy comprising cytarabine and idarubicin in younger patients with relapsed or refractory FLT3-mutant acute myeloid leukemia. Secondary * Determine the overall response rate in patients treate...
Leukemia
recurrent childhood acute myeloid leukemia adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) recurrent a...
null
2
arm 1: DOSE-FINDING PHASE: COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of les...
[ 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: given IV intervention 2: Given IV intervention 3: Given orally
intervention 1: cytarabine intervention 2: idarubicin intervention 3: lestaurtinib
21
Birmingham | Alabama | United States | -86.80249 | 33.52066 Orange | California | United States | -117.85311 | 33.78779 Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 Atlanta | Georgia | United States | -84.38798 | 33.749 Chicago | Illinois | United States | -87.65005 | 41.85003 Indianapo...
14
0
0
0
NCT00469859
1COMPLETED
2010-03-01
2007-06-01
Children's Oncology Group
5NETWORK
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
15
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The purpose of this study is to evaluate the safety and efficacy of NIC5-15in the treatment of Alzheimer's Disease.
Recent epidemiologic evidence, has suggested that diabetes mellitus significantly increases risk for the development of Alzheimer's disease, independent of vascular risk factors. Moreover, even patients who are simply insulin resistant, without frank diabetes, have been shown to share this elevated risk for the develop...
Alzheimer Disease Dementia
Alzheimer Disease Alzheimer Type Senile Dementia Alzheimer's Disease clinical trial dementia diabetes dietary supplements Senile Dementia, Alzheimer Type Therapeutics
null
2
arm 1: Subjects with Alzheimer's Disease arm 2: Subjects with Alzheimer's Disease
[ 5, 2 ]
2
[ 0, 0 ]
intervention 1: a natural product, found in many foods and plants with mild insulin sensitizing effects intervention 2: placebo comparator
intervention 1: NIC5-15 intervention 2: Placebo
1
The Bronx | New York | United States | -73.86641 | 40.84985
10
0
0
0
NCT00470418
1COMPLETED
2010-03-01
2007-01-01
VA Office of Research and Development
1FED
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
9
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
null
This study will evaluate the safety and efficacy of lapatinib in combination with chemotherapy (capecitabine, docetaxel, nab-paclitaxel) in subjects with ErbB2-overexpressing breast cancer whose disease has progressed during or within 12 months after completion of trastuzumab-containing therapy in the neoadjuvant or ad...
null
Relapsed Breast Cancer Neoplasms, Breast
ErbB1 ErbB2 GW572016 lapatinib Relapsed breast cancer dual tyrosine kinase inhibitor MBC EGFR Her-2/neu FISH amplification
null
1
arm 1: Lapatinib is administered in combination with one of the following chemotherapies based on the discretion of the investigator : capecitabine, docetaxel or nab-paclitaxel.
[ 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Small molecule tyrosine kinase inhibitor intervention 2: Chemotherapy intervention 3: Chemotherapy intervention 4: Chemotherapy
intervention 1: Lapatinib intervention 2: Capecitabine intervention 3: Docetaxel intervention 4: nab-Paclitaxel
28
Hot Springs | Arkansas | United States | -93.05518 | 34.5037 Anaheim | California | United States | -117.9145 | 33.83529 Burbank | California | United States | -118.30897 | 34.18084 Highland | California | United States | -117.20865 | 34.12834 Long Beach | California | United States | -118.18923 | 33.76696 Sacramento |...
9
0
0
0
NCT00479856
6TERMINATED
2010-03-01
2007-11-01
GlaxoSmithKline
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
7
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Primary Objective: * To determine the efficacy of the combination of imatinib mesylate and docetaxel in recurrent or metastatic head and neck squamous cell cancer by serial measurements of tumor response (extent, frequency, duration). Secondary Objectives: * To assess the safety and tolerability of imatinib mesylate...
Imatinib mesylate is designed to block certain proteins important in the growth of cancer. Docetaxel is designed to target and destroy cancer cells. If you are found to be eligible to take part in this study, you will take 4 imatinib mesylate tablets by mouth once a day with a meal and a large glass of water (about 8-...
Head and Neck Cancer Squamous Cell Cancer
Head and Neck Cancer Squamous Cell Cancer Imatinib Mesylate Gleevec Imatinib STI571 Docetaxel Taxotere
null
1
arm 1: Imatinib 400 mg orally daily; Docetaxel 60 mg/m\^2 by vein over 1 hour every 3 weeks
[ 0 ]
2
[ 0, 0 ]
intervention 1: 400 mg by mouth daily intervention 2: 60 mg/m\^2 by vein (IV) over 1 hour every 3 weeks
intervention 1: Imatinib Mesylate intervention 2: Docetaxel
1
Houston | Texas | United States | -95.36327 | 29.76328
7
0
0
0
NCT00485485
1COMPLETED
2010-03-01
2007-01-01
M.D. Anderson Cancer Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
12
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Primary Objectives: 1. Assess whether combined treatment with Levothyroxine and Liothyronine improves learning and memory. 2. Explore the relationship between T3 treatment and other domains of cognitive function, quality of life, and mood.
Hypothyroidism causes the body to not be able to produce enough thyroid hormones. Levothyroxine and liothyronine are synthetic (man-made) hormones that may help treat hypothyroidism by increasing the metabolism (activity) of cells of all tissues in the body. The combination treatment, given to patients with hypothyroid...
Hypothyroidism Brain Tumor
Hypothyroidism Brain Tumor Levothyroxine Liothyronine Synthroid Cytomel
null
1
arm 1: Levothyroxine 75 mcg by mouth (PO) Daily for 8 Weeks + Liothyronine 15 mcg PO Daily for 8 Weeks
[ 0 ]
2
[ 0, 0 ]
intervention 1: 75 mcg by mouth (PO) Daily for 8 Weeks intervention 2: 15 mcg PO Daily for 8 Weeks
intervention 1: Levothyroxine intervention 2: Liothyronine
1
Houston | Texas | United States | -95.36327 | 29.76328
12
0
0
0
NCT00488644
6TERMINATED
2010-03-01
2006-02-01
M.D. Anderson Cancer Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
60
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
true
2MALE
true
Studies demonstrate that methamphetamine (meth) use is associated with high-risk sexual behavior among MSM, putting meth-using MSM at extraordinarily high risk for transmitting or acquiring HIV. This study of intermediate size (60 participants) and length (3 months of follow-up) will assess the efficacy of mirtazapine ...
Methamphetamine use is especially prevalent among men who have sex with men (MSM). Population-based surveys report methamphetamine use rates 20 times higher among MSM compared with the general population. Methamphetamine use is also a driving force in the MSM HIV epidemic: methamphetamine use has been associated with i...
Substance Abuse HIV Infections
Methamphetamine HIV MSM HIV Seronegativity
null
2
arm 1: mirtazapine 30 mg daily arm 2: placebo 30 mg daily
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: mirtazapine 30 mg daily for 3 months intervention 2: placebo 30 mg daily for 3 months
intervention 1: mirtazapine intervention 2: placebo
1
San Francisco | California | United States | -122.41942 | 37.77493
60
0
0
0
NCT00497081
1COMPLETED
2010-03-01
2007-05-01
San Francisco Department of Public Health
2OTHER_GOV
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
224
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
The purpose of this study is to determine whether quetiapine fumarate extended release is effective in the treatment of alcohol dependence in very heavy drinkers.
This study will investigate quetiapine fumarate XR (SEROQUEL XR®), a dibenzothiazepine derivative, as a potential medication for treating alcohol dependence. The immediate release form of quetiapine fumarate, SEROQUEL XR®, is approved by the FDA for treatment of schizophrenia and acute manic episodes associated with bi...
Alcoholism Alcohol Abuse
Alcoholism Alcohol dependence Quetiapine
null
2
arm 1: Quetiapine fumarate plus medical management arm 2: Medical management plus placebo comparator
[ 0, 2 ]
2
[ 0, 10 ]
intervention 1: Quetiapine fumarate- taken daily, for 12 weeks intervention 2: Placebo
intervention 1: Quetiapine fumarate intervention 2: Placebo
7
Boston | Massachusetts | United States | -71.05977 | 42.35843 Lebanon | New Hampshire | United States | -72.25176 | 43.64229 Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 Providence | Rhode Island | United States | -71.41283 | 41.82399 White River Junction | Vermont | United States | -72.31926 | 43...
218
0
0
0
NCT00498628
1COMPLETED
2010-03-01
2007-12-01
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
36
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This single arm study will assess the safety and efficacy of MabThera in combination with methotrexate in patients with rheumatoid arthritis who have had an inadequate response or intolerance to one or more anti-TNF agents. Patients will receive MabThera 1000mg i.v. on days 1 and 15, and methotrexate (10-25mg/week p.o....
null
Rheumatoid Arthritis
null
1
arm 1: None
[ 0 ]
2
[ 0, 0 ]
intervention 1: 1000mg iv on days 1 and 15 intervention 2: 10-25mg/week po or parenteral
intervention 1: rituximab [MabThera/Rituxan] intervention 2: Methotrexate
10
Changhua | N/A | Taiwan | 120.5512 | 24.0692 Kaohsiung City | N/A | Taiwan | 120.31333 | 22.61626 Kaohsiung City | N/A | Taiwan | 120.31333 | 22.61626 Kaohsiung City | N/A | Taiwan | 120.31333 | 22.61626 Taichung | N/A | Taiwan | 120.6839 | 24.1469 Taichung | N/A | Taiwan | 120.6839 | 24.1469 Taichung | N/A | Taiwan | ...
36
0
0
0
NCT00504777
1COMPLETED
2010-03-01
2007-07-01
Hoffmann-La Roche
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
19
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Keppra injection is approved in the US as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. The objective of the current study is to assess the safety, tolerability, and pharmacokinetics, of this formulation in children aged 1 month to 4 years.
The primary objective of this study was to evaluate the safety and tolerability of levetiracetam intravenous 15-minute infusion administered every 12 hours, either as adjunctive treatment or monotherapy in children (1 month to 4 years old) with epilepsy (except status epilepticus), either after switching from the equiv...
Epilepsy
Epilepsy Child Levetiracetam Keppra® Infusion Intravenous
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Intravenous 100 mg/mL, twice a day, maximum of 4 days Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose within the following dose range, calculated on the basis of their age and weight:. * Ages ≥ 1 month to \< 6 months: 14 mg/kg/day (...
intervention 1: Levetiracetam
23
San Diego | California | United States | -117.16472 | 32.71571 Buffalo | New York | United States | -78.87837 | 42.88645 Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 Nashville | Tennessee | United States | -86.78444 | 36.16589 Fort Worth | Texas | United States | -97.32085 | 32.72541 Richmond | Vi...
19
0
0
0
NCT00505934
1COMPLETED
2010-03-01
2008-05-01
UCB Pharma SA
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
222
RANDOMIZED
PARALLEL
1PREVENTION
4QUADRUPLE
false
0ALL
true
Adults admitted to intensive care units are at risk for a variety of complications. Infections due to the fungus called candida are of particular concern. The study will test the possibility that caspofungin, a new therapy for fungal infections, can successfully reduce the rate of candida infections in subjects at risk...
null
Invasive Candidiasis
Candida Prophylaxis High risk adults Intensive care unit (ICU)
null
2
arm 1: Caspofungin 50 mg Intravenous (IV) daily up to 28 days of therapy arm 2: Normal Saline 100 cc IV daily
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: 50 mg IV daily intervention 2: 100 cc IV daily
intervention 1: Caspofungin intervention 2: Normal Saline
12
Birmingham | Alabama | United States | -86.80249 | 33.52066 Los Angeles | California | United States | -118.24368 | 34.05223 Denver | Colorado | United States | -104.9847 | 39.73915 Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 New Orleans | Louisiana | United States | -90.07507 | 29.954...
219
0
0
0
NCT00520234
1COMPLETED
2010-03-01
2007-08-01
Mycoses Study Group
5NETWORK
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
210
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
true
0ALL
true
The purpose of this study will be to examine the safety and efficacy of modafinil in increasing number of methamphetamine non-use weeks in subjects with methamphetamine dependence.
To evaluate the efficacy and safety of modafinil in reducing methamphetamine use in subjects with methamphetamine dependence. It is hypothesized that modafinil, compared to placebo, will be associated with an increase in the number of methamphetamine non-use weeks over time as measured by quantitative urine analysis fo...
Methamphetamine Dependence
Methamphetamine Dependence
null
2
arm 1: Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks arm 2: Participants will receive a matching Modafinil placebo 200 mg or 400 mg tablet one time per day for 12 weeks
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: 200 mg or 400 mg /daily intervention 2: Placebo / daily
intervention 1: Modafinil intervention 2: Placebo
8
San Diego | California | United States | -117.16472 | 32.71571 Tarzana | California | United States | -118.55397 | 34.17334 Torrance | California | United States | -118.34063 | 33.83585 Denver | Colorado | United States | -104.9847 | 39.73915 Honolulu | Hawaii | United States | -157.85833 | 21.30694 Des Moines | Iowa |...
210
0
0
0
NCT00520286
1COMPLETED
2010-03-01
2007-12-01
National Institute on Drug Abuse (NIDA)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
31
NON_RANDOMIZED
SEQUENTIAL
0TREATMENT
0NONE
false
0ALL
false
This was a phase 1/2, open-label, dose-escalation study of arginine deiminase linked via succinimidyl succinate to polyethylene glycol of 20,000 molecular weight (ADI-PEG 20) in subjects with advanced melanoma. ADI-PEG 20 was administered intramuscularly (IM) at escalating doses weekly for 9 weeks (cycle 1) or 8 weeks ...
A 3+3 design was implemented during phase 1, in which 3 to 6 subjects were enrolled sequentially into the following escalating dose cohorts: * Cohort 1 (40 IU/m\^2) * Cohort 2 (80 IU/m\^2) * Cohort 3 (160 IU/m\^2) Subjects were monitored for dose-limiting toxicity (DLT) during the first 2 weeks of cycle 1, with DLT d...
Metastatic Melanoma Skin Cancer Neoplasm
metastatic melanoma ADI ADI-PEG 20 ADI SS PEG 20,000mw arginine enzyme therapy
null
3
arm 1: Subjects received ADI-PEG 20 at a dose of 40 IU/m\^2 arm 2: Subjects received ADI-PEG 20 at a dose of 80 IU/m\^2 arm 3: Subjects received ADI-PEG 20 at a dose of 160 IU/m\^2
[ 0, 0, 0 ]
1
[ 0 ]
intervention 1: Intramuscular injections were administered into the deltoid, gluteal, or quadricep muscles once weekly (± 2 days) for 9 weeks during cycle 1 and 8 weeks during subsequent cycles
intervention 1: ADI PEG 20
2
New York | New York | United States | -74.00597 | 40.71427 New York | New York | United States | -74.00597 | 40.71427
31
0
0
0
NCT00520299
1COMPLETED
2010-03-01
2007-07-01
Ludwig Institute for Cancer Research
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
25
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This single arm study will assess the efficacy and safety of Avastin in combination with interferon alfa-2a and vinblastine as first line treatment in patients with metastatic renal cell cancer. Patients will receive Avastin (15mg/kg iv) every 3 weeks, interferon alfa-2a 3 times weekly (3 Mio IU sc escalating to 18 Mio...
null
Renal Cell Cancer
null
1
arm 1: None
[ 0 ]
3
[ 0, 0, 0 ]
intervention 1: 15mg/kg iv every 3 weeks intervention 2: 3 MioIU sc escalating to 18 MioIU sc, 3 times weekly intervention 3: 0.1mg/kg iv every 3 weeks
intervention 1: bevacizumab [Avastin] intervention 2: Interferon alfa-2a intervention 3: Vinblastine
16
Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.52437 Bremen | N/A | Germany | 8.80717 | 53.07582 Dessau | N/A | Germany | 12.24555 | 51.83864 Erlangen | N/A | Germany | 11.00783 | 49.59099 Frankfurt | N/A | Germany | 10.53333 | 49.68333 Halle | N/A | Germany | 11.97947 | 51.48158 Ha...
25
0
0
0
NCT00520403
1COMPLETED
2010-03-01
2007-09-01
Hoffmann-La Roche
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
364
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
false
0ALL
null
This study will see if there is a change in breathing after exercising when the child receives study drug ( montelukast or placebo). Breathing will be measured by a spirometer before exercising and measured again several times after exercising.
null
Exercise-induced Bronchoconstriction (EIB)
null
2
arm 1: Participants 4-5 years: A single dose of 4 mg Montelukast chewable tablet daily, crossing over to matching placebo (Pbo) after a 3- to 7-day washout period (no participants 4-5 years were enrolled) Participants 6-14 years: A single dose of 5 mg Montelukast chewable tablet daily, crossing over to matching Pbo af...
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Patients 4-5 years: 4 mg Montelukast chewable tablet daily Patients 6-14 years: 5 mg chewable tablet daily intervention 2: Patients 4-5 years: 4 mg Pbo chewable tablet daily Patients 6-14 years: 5 mg Pbo chewable tablet daily
intervention 1: Comparator: montelukast sodium intervention 2: Comparator: Comparator: placebo (unspecified)
0
null
131
0
0
0
NCT00534976
1COMPLETED
2010-03-01
2008-02-01
Organon and Co
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
62
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to assess the effect of ixabepilone plus capecitabine or docetaxel plus capecitabine on shrinking or slowing the growth of metastatic breast cancer in women. The safety of this combination therapy will also be evaluated.
null
Breast Neoplasms
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Ixabepilone, 40 mg/m\^2, administered as a 3-hour intravenous (IV) infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, self-administered on an outpatient basis twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle. intervention 2: Ixabepilone, 32 mg/m\^2, administered...
intervention 1: Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 intervention 2: Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 intervention 3: Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2
60
Tuscaloosa | Alabama | United States | -87.56917 | 33.20984 La Jolla | California | United States | -117.2742 | 32.84727 Southington | Connecticut | United States | -72.8776 | 41.59649 Newark | Delaware | United States | -75.74966 | 39.68372 Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 ...
62
0
0
0
NCT00546364
6TERMINATED
2010-03-01
2008-02-01
R-Pharm
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
46
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
CP 751,871 is a fully human monoclonal antibody against the Insulin-Like Growth Factor 1 Receptor (IGF-1R). Preclinical and clinical data indicate that CP 751,871 augments the anti-tumor activity of chemotherapy. This study will identify the Maximal Tolerated Dose of CP 751,871 (or the Maximal Feasible Dose) in combina...
null
Carcinoma, Non-Small-Cell Lung
null
1
arm 1: None
[ 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: CP-751,871 at doses ranging from 6 to 20 mg/Kg on Day 1 of each 21-day cycle. CP-751,871 may be administered even after active comparators discontinuation, for a total number of 17 cycles (1 year). intervention 2: Cisplatin 75\* mg/m2 or 80\* mg/m2, IV on Day 1 of each 21-day cycle up to 6 cycles. \* 7...
intervention 1: CP-751,871 intervention 2: Cisplatin intervention 3: Gemcitabine intervention 4: Pemetrexed
4
Charleroi | N/A | Belgium | 4.44448 | 50.41136 Dublin | N/A | Ireland | -6.24889 | 53.33306 Madrid | Madrid | Spain | -3.70256 | 40.4165 Seville | Sevilla | Spain | -5.97317 | 37.38283
45
0
0
0
NCT00560573
1COMPLETED
2010-03-01
2007-11-01
Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
27
RANDOMIZED
SINGLE_GROUP
0TREATMENT
2DOUBLE
false
0ALL
null
The objectives of this trial are: to establish a safety profile for use of Hydroxyurea in children with Types II and III Spinal Muscular Atrophy; to identify reliable outcome measures for HU treatment in Types II and III SMA; and to detect the clinical efficacy of HU treatment in children with Types II and III SMA.
SMA is a neuromuscular disorder characterized by degeneration of spinal cord motor neurons and muscular atrophy. SMA is classified into three clinical subtypes according to the severity and age of onset (Types I, II and III). Type II (intermediate) SMA has its onset in early childhood (prior to 18 months) and is charac...
Muscular Atrophy, Spinal
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: Hydroxyurea intervention 2: Placebo to match hydroxyurea
1
Stanford | California | United States | -122.16608 | 37.42411
0
0
0
0
NCT00568802
1COMPLETED
2010-03-01
2004-01-01
Stanford University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
8
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This is an open label pilot study to obtain information on the best way to study young adolescents with Attention Deficit Hyperactivity Disorder (ADHD)who may also be at risk of developing substance abuse, in part because of their ADHD. The plan is to recruit older children/young adolescents (age 11-15) who have ADHD a...
The study is a six month open-label treatment with Vyvanse, a novel preparation of the Attention Deficit Hyperactivity Disorder (ADHD) medication dextroamphetamine in which the drug is inactivated and only becomes reactivated when digested. Vyvanse is thought to be safer in youth at risk for substance use disorder beca...
Attention Deficit Hyperactivity Disorder
Attention Deficit Hyperactivity Disorder ADHD ADD Prevention Substance use Adolescent
null
1
arm 1: Open Label Vyvanse (lisdexamphetamine) in doses of 30-70 mgs over 8 weeks in younger siblings of substance abusing older siblings with a history of treatment for ADHD
[ 0 ]
1
[ 0 ]
intervention 1: Patients will be titrated from 30 mgs to 50 mgs to 70 mgs over four weeks, as tolerated and as needed to control ADHD symptoms
intervention 1: Vyvanse
0
null
8
0
0
0
NCT00573534
1COMPLETED
2010-03-01
2008-03-01
New York State Psychiatric Institute
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
469
null
CROSSOVER
4SUPPORTIVE_CARE
4QUADRUPLE
true
0ALL
false
Children surviving some types of cancer have a higher risk of developing learning problems after cancer treatment than do children who have not had cancer or its treatment. Cancer treatment may cause problems with learning, attention, and memory. The purpose of this study is to identify brain changes that may underlie ...
This study is a multi-phase, multi-site methylphenidate (MPH) trial in childhood cancer survivors. Study participants that meet inclusion and exclusion criteria are screened to ensure that they have adequate global cognitive functioning (IQ \> 50) and have academic and attention difficulties that might be managed with ...
Acute Lymphoblastic Leukemia Brain Tumors
Brain Tumor, Acute Lymphoblastic Leukemia, Methylphenidate, Cognitive Late Effects
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Please see detailed description for dosing information and study design.
intervention 1: Methylphenidate
3
Durham | North Carolina | United States | -78.89862 | 35.99403 Charleston | South Carolina | United States | -79.93275 | 32.77632 Memphis | Tennessee | United States | -90.04898 | 35.14953
469
0
0
0
NCT00576472
1COMPLETED
2010-03-01
2000-01-01
St. Jude Children's Research Hospital
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
27
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to evaluate the effects of Atorvastatin on the coronary atherosclerosis plaque morphology.
The primary goal of this project is to evaluate the effect of the cholesterol lowering drug Atorvastatin on the composition and character of coronary atherosclerosis (heart blockages). Atorvastatin is known to reduce cholesterol, reduce cardiac events, and halt the progression of coronary atherosclerosis. However, the ...
Atherosclerosis
Atherosclerosis, vulnerable plaque, IVUS, shear stress
null
1
arm 1: All patients in this arm are given atorvastatin therapy.
[ 0 ]
1
[ 0 ]
intervention 1: Atorvastatin 80 mg a day
intervention 1: Atorvastatin
1
Atlanta | Georgia | United States | -84.38798 | 33.749
27
0
0
0
NCT00576576
1COMPLETED
2010-03-01
2007-07-01
Emory University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
133
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This single arm study will assess the efficacy, safety and tolerability of subcutaneous C.E.R.A. for correction of anemia and maintenance of hemoglobin levels in patients with chronic kidney disease who are not on dialysis and are not treated with ESA. Eligible patients will receive C.E.R.A. by monthly subcutaneous inj...
null
Anemia
null
1
arm 1: Participants received methoxy polyethylene glycol-epoetin beta (Continuous Erythropoietin Receptor Activator \[C.E.R.A\]) subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 microgram per kilogram (mcg/kg) of C.E.R.A. Once the Hemoglobin (Hb) concentration was attained wit...
[ 0 ]
1
[ 0 ]
intervention 1: Recommended starting dose 1.2 micrograms/kg sc monthly
intervention 1: methoxy polyethylene glycol-epoetin beta [C.E.R.A.]
19
Irkutsk | N/A | Russia | 104.29585 | 52.29795 Khanty-Mansiysk | N/A | Russia | 69.00194 | 61.00417 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Nizhny Novgorod | N/A | Russia | 44.00205 | 5...
125
0
0
0
NCT00576628
1COMPLETED
2010-03-01
2008-05-01
Hoffmann-La Roche
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
96
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
The purpose of this study is to evaluate the effectiveness (change in level of irritability and related behaviors) and safety and tolerability of the administration of 2 different fixed dose levels of risperidone (an atypical antipsychotic drug) compared with placebo in children or adolescents who have autism, and to e...
Autistic Disorder is a condition that develops early in childhood and persists throughout life. Seventy-five percent of children and adolescents with autistic disorder have irritability symptoms such as aggression towards others, deliberate self-injurious behavior, temper tantrums, and quickly changing moods. These sym...
Autistic Disorder Autism
Irritability Risperidone Antipsychotic agent Autism Adolescents Children
null
3
arm 1: Risperidone low dose Risperidone oral solution 0.125 mg (if \<45 kg) or 0.175 mg (if \>=45 kg) qd or bid for 6 weeks arm 2: Risperidone high dose Risperidone oral solution 1.25 mg (if \<45 kg) or 1.75 mg (if \>=45 kg) qd or bid for 6 weeks arm 3: Placebo Oral solution qd or bid for 6 weeks
[ 0, 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Oral solution qd or bid for 6 weeks intervention 2: Risperidone oral solution 1.25 mg (if \<45 kg) or 1.75 mg (if \>=45 kg) qd or bid for 6 weeks intervention 3: Risperidone oral solution 0.125 mg (if \<45 kg) or 0.175 mg (if \>=45 kg) qd or bid for 6 weeks
intervention 1: Placebo intervention 2: Risperidone high dose intervention 3: Risperidone low dose
20
Dothan | Alabama | United States | -85.39049 | 31.22323 Phoenix | Arizona | United States | -112.07404 | 33.44838 Sacramento | California | United States | -121.4944 | 38.58157 Santa Ana | California | United States | -117.86783 | 33.74557 Boca Raton | Florida | United States | -80.0831 | 26.35869 Miami | Florida | Uni...
175
0
0
0
NCT00576732
1COMPLETED
2010-03-01
2007-12-01
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
22
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
rituximab and modified (hyperCVAD) administered every 28 days for 4-6 cycles followed by rituximab maintenance therapy consisting of four weekly doses every six months for two years
rituximab and modified hyperfractionated cyclophosphamide, vincristine doxorubicin, dexamethasone (hyperCVAD) administered every 28 days for 4-6 cycles followed by rituximab maintenance therapy consisting of four weekly doses every six months for two years
Mantle Cell Lymphoma
untreated mantle cell lymphoma
null
0
null
null
1
[ 0 ]
intervention 1: rituximab and modified hyperfractionated cyclophosphamide, vincristine doxorubicin, dexamethasone (hyperCVAD) administered every 28 days for 4-6 cycles followed by rituximab maintenance therapy consisting of four weekly doses every six months for two years
intervention 1: modified Hyper-CVAD
1
Madison | Wisconsin | United States | -89.40123 | 43.07305
22
0
0
0
NCT00581854
1COMPLETED
2010-03-01
2000-06-01
University of Wisconsin, Madison
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
18
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to evaluate whether patients with chronic heart failure not due to coronary artery disease who require use of a left ventricular assist device (LVAD) for refractory heart failure can recover sufficient heart function to allow the pump to be explanted. The study aims to avoid the need for tr...
The hypothesis of this study is that patients with dilated nonischemic cardiomyopathy who require support with an implanted left ventricular assist device (LVAD) for chronic refractory heart failure can, with a specific two-staged medical regimen designed to enhance maximal reverse remodeling (an angiotensin converting...
Heart Failure Dilated Cardiomyopathy
heart failure dilated cardiomyopathy heart assist device clenbuterol adrenergic beta agonists heart transplantation
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Clenbuterol 20 mcg tablets uptitrated from 20 mcg PO TID to a maximally tolerated dose not to exceed 700 mcg PO TID. Patients will then be switched to the equivalent dose of clenbuterol liquid 59 mcg/ml PO TID. Clenbuterol will be administered for a minimum of 3 months and a maximum of 12 months.
intervention 1: clenbuterol
7
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 Chicago | Illinois | United States | -87.65005 | 41.85003 Ann Arbor | Michigan | United States | -83.74088 | 42.27756 The Bronx | New York | United States | -73.86641 | 40.84985 Columbus | Ohio | United States | -82.99879 | 39.96118 Philadelp...
18
0
0
0
NCT00585546
6TERMINATED
2010-03-01
2007-07-01
Francis D. Pagani
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
20
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purpose of this research is to study a treatment program for patients with aggressive lymphoma that has come back after initial or first therapy (called relapsed) or that has not responded to first therapy (called refractory). Since 1993, we have used a combination of chemotherapy known as ICE (Ifosfamide, Carbopla...
The purpose of this study is to determine if dose escalation of the rituximab-ICE (RICEesc) program can improve the overall response rate of patients with primary refractory or poor risk relapsed aggressive B cell lymphoma. R-ICEesc will be administered for 2 cycles with peripheral blood progenitor cells (PBPCs) collec...
Lymphoma B-cell Non-Hodgkin's Lymphoma
Lymphoma ASCT B-cell non-Hodgkin's lymphoma Cancer Second line therapy ICE Stem cell transplant
null
1
arm 1: R-ICEesc will be administered with the intent of administering 2 cycles, each 21 days apart admixed with 4 doses of rituximab. G-CSF will be administered at 960 ug or 10 ug/kg if patient is \> 100 kg after cycles one and two for PBPC collection for the first 10 patients enrolled. G-CSF will be administered in st...
[ 0 ]
1
[ 0 ]
intervention 1: ANC must be ≥1000/µl and platelet count must be ≥50,000/µl. Rituximab will be administered at a dose of 375 mg/m2 IV on days 1 and 3 of the each cycle. Premedication will be given.ICE will be administered as follows: Day 3: Etoposide 200 mg/m2 IV q12 hrs x 3. Day 4: Ifosfamide 10 g/m2 and MESNA 10 g/m2 ...
intervention 1: Rituximab, Ifosfamide, Carboplatin, VP-16, Mesna, G-CSF, Stem Cell Transplant
1
New York | New York | United States | -74.00597 | 40.71427
20
0
0
0
NCT00588094
1COMPLETED
2010-03-01
2003-10-01
Memorial Sloan Kettering Cancer Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
146
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
true
0ALL
true
One dose of either gabapentin or placebo will be given to patients prior to thoracotomy. Patients will also receive an epidural infusion, intravenous patient-controlled analgesia with fentanyl, oral acetaminophen and intravenous ketorolac as needed to achieve optimal analgesia. Pain ratings and supplemental medication ...
The gabapentin dose utilized is 600 mg. The epidural infusion utilizes bupivacaine 0.075% with hydromorphone 10 mcg/cc infusing at 6 cc/hour. The settings for the fentanyl patient-controlled analgesia device start at 10 mcg every 10 minutes with a 200 mcg 4 hour maximum.
Pain
Preoperative gabapentin Acute pain Post-thoracotomy pain Epidural analgesia
null
2
arm 1: Preoperative gabapentin 600 mg orally within 2 hours prior to surgery. arm 2: Diphenhydramine 12.5 mg orally 2 hours preoperatively.
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: gabapentin 600 mg orally within 2 hours preoperatively, epidural infusion of 0.075% bupivacaine with 10 mcg/ml of hydromorphone at 6 ml/hour, fentanyl intravenous patient controlled analgesia at 10 mcg every 10 minutes as needed with a 200 mcg 4 hour lockout, oral acetaminophen 650 mg orally every 6 hou...
intervention 1: Gabapentin intervention 2: Diphenhydramine
1
Rochester | Minnesota | United States | -92.4699 | 44.02163
120
0
0
0
NCT00588159
1COMPLETED
2010-03-01
2007-06-01
Michelle Kinney
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
984
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to compare the efficacy and safety of TAK-491 (azilsartan medoxomil), once daily (QD), to valsartan 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 (WHO), hypertension is the most common attributable ...
Hypertension
Blood pressure blood pressure monitoring, ambulatory
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 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks. intervention 2: Azilsartan Medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks. intervention 3: ...
intervention 1: Azilsartan Medoxomil intervention 2: Azilsartan Medoxomil intervention 3: Valsartan
88
Huntsville | Alabama | United States | -86.58594 | 34.7304 Glendale | Arizona | United States | -112.18599 | 33.53865 Phoenix | Arizona | United States | -112.07404 | 33.44838 Scottsdale | Arizona | United States | -111.89903 | 33.50921 Tuscon | Arizona | United States | N/A | N/A Beverly Hills | California | United St...
1,152
0
0
0
NCT00591578
1COMPLETED
2010-03-01
2007-12-01
Takeda
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
5
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to determine whether local injection of bevacizumab might halt and or cause regression of pterygium growth. This may enable earlier treatment and prevention of pterygium growth into the patient's line of sight thereby limiting the need for surgery and improving quality of life for patients ...
null
Pterygium
null
1
arm 1: Bevacizumab injection: 0.1ml, 6 monthly doses plus baseline and 1 week post baseline
[ 0 ]
1
[ 0 ]
intervention 1: Upon enrollment into the study: - initial injection of bevacizumab, a 1 week post-injection visit,and monthly visits thereafter for a total of 6 months. At the 1-month and 3-month visit post-injection visit, an additional bevacizumab injection will be offered if pterygium regression has not occurred. Al...
intervention 1: local injection of bevacizumab
1
Birmingham | Alabama | United States | -86.80249 | 33.52066
5
0
0
0
NCT00592176
1COMPLETED
2010-03-01
2007-08-01
University of Alabama at Birmingham
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
25
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
This study involves people who have schizophrenia or schizoaffective disorder who are currently taking antipsychotic medications. Some antipsychotic medications may cause weight gain and may increase the risk of diabetes mellitus and heart disease.The purpose of this study is to find out what happens if another medicat...
This is an 8-week randomized, double blind, placebo-controlled pilot study with 4- week follow up assessment, of ramelteon 8 mg/day, administered to subjects for 8 consecutive weeks as an adjunctive therapy in 40 non-diabetic schizophrenia subjects to examine ramelteon effects on body composition, glucose and lipid met...
Schizophrenia Schizoaffective Disorder Schizophreniform Disorders
schizophrenia metabolism antipsychotics diabetes rozerem
null
2
arm 1: Ramelteon 8mg/day arm 2: sugar pill
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Two week supply of ramelteon 8mg/day first dispensed at baseline. New two week supply of study medication dispensed at each biweekly visit for 8 consecutive weeks. intervention 2: Two week supply of placebo tablets first dispensed at baseline. New two week supply of placebo dispensed at each biweekly vi...
intervention 1: Ramelteon intervention 2: Placebo
1
Boston | Massachusetts | United States | -71.05977 | 42.35843
25
0
0
0
NCT00595504
1COMPLETED
2010-03-01
2008-01-01
Massachusetts General Hospital
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
37
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
1FEMALE
true
The goal of the main trial was to evaluate the effect of low dose hormone replacement therapy with 1 mg norethindrone/10mcg ethinyl estradiol in postmenopausal women with a history of chest discomfort, myocardial ischemia and no obstructive CAD. For the purposes of this study as a core lab coordinating center, the inve...
See Brief Summary above.
Myocardial Ischemia
null
2
arm 1: Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE) arm 2: 1mg placebo
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE) intervention 2: 1 mg placebo
intervention 1: 1/10 NA/EE intervention 2: Placebo
1
Los Angeles | California | United States | -118.24368 | 34.05223
37
0
0
0
NCT00600106
1COMPLETED
2010-03-01
1999-12-01
Cedars-Sinai Medical Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
16
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
true
0ALL
false
Asthma is a common chronic disease characterized by airway inflammation and bronchoconstriction. This study utilizes the drug rosiglitazone (Avandia)to treat the effects of airway inflammation in patients with asthma. The study will be conducted on 14 adult steroid naive patients with asthma. Patients with qualifying ...
The current standard-of-care utilizes corticosteroids to down-regulate the inflammatory state in patients with asthma. However, corticosteroids have many side effects and are not universally effective. New safe anti-inflammatory agents are needed to help modulate the disease. Peroxisome proliferator-activated receptor ...
Asthma
Asthma Avandia
null
1
arm 1: Subjects took rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks
[ 0 ]
1
[ 0 ]
intervention 1: 2mg, 4mg, 8mg
intervention 1: rosiglitazone
1
Omaha | Nebraska | United States | -95.94043 | 41.25626
16
0
0
0
NCT00614874
1COMPLETED
2010-03-01
2008-12-01
Creighton University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
572
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to test the efficacy of once daily saxagliptin in renally impaired patients.
null
Type 2 Diabetes
DPP-4 inhibitors HbA1c incretins Renal Impairment
null
2
arm 1: Saxagliptin arm 2: Placebo to match
[ 0, 4 ]
2
[ 0, 0 ]
intervention 1: 2.5 mg once daily oral dose intervention 2: Placebo
intervention 1: Saxagliptin intervention 2: Placebo
74
Concord | California | United States | -122.03107 | 37.97798 Sacramento | California | United States | -121.4944 | 38.58157 Denver | Colorado | United States | -104.9847 | 39.73915 Topeka | Kansas | United States | -95.67804 | 39.04833 Baltimore | Maryland | United States | -76.61219 | 39.29038 Great Falls | Montana | ...
170
0
0
0
NCT00614939
1COMPLETED
2010-03-01
2008-01-01
AstraZeneca
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
123
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The primary objective of the study is to evaluate the clinical activity of interferon beta-1a in participants with moderate to severe ulcerative colitis (UC). Secondary objectives of this study are to determine (i) the safety and tolerability of interferon beta-1a in participants with moderate to severe UC, and (ii) th...
null
Active Ulcerative Colitis
null
2
arm 1: Interferon beta-1a 30 µg intramuscular (IM) injection twice weekly for 12 weeks arm 2: Placebo IM injection twice weekly for 12 weeks
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Avonex IM injection, self-administered per protocol intervention 2: Placebo IM injection, self-administered per protocol.
intervention 1: BG9418 (Interferon beta-1a) intervention 2: Placebo
35
Birmingham | Alabama | United States | -86.80249 | 33.52066 Lakewood | Colorado | United States | -105.08137 | 39.70471 Bristol | Connecticut | United States | -72.94927 | 41.67176 Wellesley Hills | Massachusetts | United States | -71.27867 | 42.30843 Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756 Calg...
123
0
0
0
NCT00616434
1COMPLETED
2010-03-01
2008-05-01
Biogen
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
35
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
This clinical trial is studying the side effects of combination chemotherapy and to see how well they work in treating patients with newly diagnosed localized Ewing sarcoma family of tumors. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping t...
PRIMARY OBJECTIVES: I. To assess the feasibility and safety of adding interval-compressed vincristine, topotecan hydrochloride, and cyclophosphamide to a treatment protocol utilizing interval compression of vincristine, doxorubicin hydrochloride, cyclophosphamide, ifosfamide, and etoposide in patients with localized E...
Ewing Sarcoma of Bone Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
null
1
arm 1: See Detailed Description
[ 0 ]
9
[ 10, 10, 0, 0, 0, 0, 0, 0, 2 ]
intervention 1: Undergo radiation therapy intervention 2: Undergo surgery intervention 3: Given IV intervention 4: Given IV intervention 5: Given IV intervention 6: Given IV intervention 7: Given IV intervention 8: Given IV intervention 9: Given SC
intervention 1: radiation therapy intervention 2: therapeutic conventional surgery intervention 3: etoposide intervention 4: ifosfamide intervention 5: doxorubicin hydrochloride intervention 6: cyclophosphamide intervention 7: vincristine sulfate intervention 8: topotecan hydrochloride intervention 9: filgrastim
1
Monrovia | California | United States | -117.99895 | 34.14806
35
0
0
0
NCT00618813
1COMPLETED
2010-03-01
2008-03-01
Children's Oncology Group
5NETWORK
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
72
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This was an open-label study to provide an opportunity for participants with Ulcerative Colitis (UC) who previously completed Study C13002 (NCT01177228), and for treatment-naïve participants with UC or Crohn's Disease (CD) to receive treatment with vedolizumab, and to determine the long term safety of vedolizumab in pa...
This was a phase 2, multiple-dose, open-label study of vedolizumab administered intravenously (IV) every 8 weeks. The study population included treatment-naïve ulcerative colitis (UC) or Crohn's Disease (CD) participants, as well as 38 UC participants who had tolerated vedolizumab well during Study C13002 (NCT01177228)...
Ulcerative Colitis Crohn's Disease
null
2
arm 1: Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks. arm 2: Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks.
[ 0, 0 ]
1
[ 0 ]
intervention 1: Vedolizumab for intravenous (IV) infusion
intervention 1: vedolizumab
1
London | Ontario | Canada | -81.23304 | 42.98339
72
0
0
0
NCT00619489
1COMPLETED
2010-03-01
2007-12-01
Millennium Pharmaceuticals, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
57
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
This is a 12-week, open label trial of lamotrigine for older adults (age 60 and older) with type I or type II Bipolar depression. Non-demented older adults with Bipolar I or II depression, confirmed via the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (DSM) - Patient edit...
null
Bipolar Disorder Depression, Bipolar
Geriatric Psychiatry Aged lamotrigine
null
1
arm 1: None
[ 0 ]
2
[ 0, 0 ]
intervention 1: Day 0 lamotrigine regular tablet formulation or lamotrigine novel formulation will be initiated at 25 mg/day and upward titrated as per package insert to targeted maximum dose of 200 mg/day. Dosing will be reduced for individuals who experience adverse effects. Dosing will be modified as per package ins...
intervention 1: Lamotrigine regular tablet formulation intervention 2: Lamotrigine novel formulation
5
White Plains | New York | United States | -73.76291 | 41.03399 Cleveland | Ohio | United States | -81.69541 | 41.4995 Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062 Houston | Texas | United States | -95.36327 | 29.76328
57
0
0
0
NCT00621842
1COMPLETED
2010-03-01
2008-01-01
University Hospitals Cleveland Medical Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
26
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
null
The purpose is to determine if: 1) Escitalopram treatment will be associated with less oral corticosteroid use than placebo in outpatients with severe asthma and moderate or severe major depressive disorder (MDD). 2) Escitalopram treatment will be associated with greater improvement in asthma symptoms than placebo in o...
Primary Aim 1\) Determine if escitalopram treatment is associated with less oral corticosteroid use for asthma symptom control than placebo in asthma outpatients with moderate or MDD. Secondary Aims 1. Determine if escitalopram treatment is associated with greater improvement in asthma symptoms than placebo in outpa...
Severe Asthma Moderate or Severe Major Depressive Disorder
Asthma Depression Escitalopram
null
2
arm 1: Placebo Matching Escitalopram given orally daily (for a 12-week duration). arm 2: Once daily oral administration (for a 12-week duration) of 10 mg escitalopram tablets with an increase to 20 mg in those with a less than 30% decrease in HAM-D scores at week 4.
[ 2, 1 ]
2
[ 0, 0 ]
intervention 1: Placebo Matching Escitalopram intervention 2: Active Escitalopram
intervention 1: Placebo intervention 2: Escitalopram
1
Dallas | Texas | United States | -96.80667 | 32.78306
25
0
0
0
NCT00621946
1COMPLETED
2010-03-01
2008-03-01
University of Texas Southwestern Medical Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
18
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This single arm study will assess the pharmacokinetics, safety and activity of saquinavir (Invirase hard gel capsules, film coated tablets or opened capsules) boosted by combination with ritonavir, in HIV-1 infected infants and children between the ages of 4 months and 6 years. Patients will commence treatment with saq...
null
HIV Infections
null
1
arm 1: None
[ 0 ]
2
[ 0, 0 ]
intervention 1: 2.5-3.0mg/kg po bid (starting dose) for 48 weeks intervention 2: 50mg/kg po bid (starting dose) for 48 weeks
intervention 1: ritonavir intervention 2: saquinavir [Invirase]
10
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Santa Fe | N/A | Argentina | -60.70868 | -31.64881 Madrid | Madrid | Spain | -3.70256 | 40.4165 Madrid | Madrid | Spain | -3.70256 | 40.4165 Valencia | Valencia | Spain | -0.37966 | 39.47391 Bangkok | N/A | Tha...
36
0
0
0
NCT00623597
1COMPLETED
2010-03-01
2008-06-01
Hoffmann-La Roche
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
30
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
1FEMALE
true
Our hypothesis is that with comparison of effectiveness of two most common techniques of treatment for myofascial pain syndrome (injection of local anesthesia and ischemic compression) we could choice the most adequate to treat this disease. This way we could decrease the expenses with medicines, examinations, consulta...
After evaluation and diagnostic confirmation, the patients will be randomized and submitted to the treatment with lidocaine injection or ischemic compression. Each treatment will be placed once a week, for four weeks. Women randomized for treatment with Ischemic compression, will be first subjected to transcutaneal ele...
Pelvic Pain
lidocaine ischemic compression chronic pelvic pain myofascial pain syndrome
null
2
arm 1: Lidocaine injection. Women randomized for this treatment was submitted to 2 milliliters of lidocaine 0,5% without vasoconstrictor, directly and perpendicularly on trigger point. Patients received lidocaine injections once a week for 4 weeks arm 2: Women randomized for treatment with ischemic compression will be...
[ 0, 0 ]
2
[ 0, 3 ]
intervention 1: Women randomized for this treatment was submitted to 2mL of lidocaine 0,5% without vasoconstrictor, directly and perpendicularly on trigger point. Patients received lidocaine injections once a week for 4 weeks intervention 2: Women randomized for treatment with ischemic compression will be first subject...
intervention 1: lidocaine intervention 2: Ischemic compression
1
Ribeirão Preto | São Paulo | Brazil | -47.81028 | -21.1775
30
0
0
0
NCT00628355
6TERMINATED
2010-03-01
2008-02-01
University of Sao Paulo
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
12
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
To assess the safety and tolerability of sunitinib when administered in combination with modified FOLFOX6 in Japanese patients with metastatic colorectal cancer in the first-line treatment setting.
null
Colorectal Neoplasms
Phase 1 CRC SU011248 Sunitinib FOLFOX Colorectal cancer metastatic carcinoma of the colon or rectum
null
2
arm 1: None arm 2: None
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: 37.5 mg/day, oral, administered on an outpatient basis for 4 weeks on, 2 weeks off (Schedule 4/2) intervention 2: 50 mg/day, oral, administered on an outpatient basis for 2 weeks on, 2 weeks off (Schedule 2/2)
intervention 1: sunitinib + mFOLFOX6 intervention 2: sunitinib + mFOLFOX6
3
Kashiwa | Chiba | Japan | 139.97732 | 35.86224 Suntougun | Shizuoka | Japan | N/A | N/A Chuo-ku | Tokyo | Japan | N/A | N/A
12
0
0
0
NCT00631410
1COMPLETED
2010-03-01
2008-01-01
Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
30
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The purpose of this study is to determine whether treatment with Raltegravir further decreases HIV viral replication in HAART-suppressed, HIV-infected patients, potentially improving immune response to antiretroviral therapy.
null
HIV Infections
HIV Treatment intensification Low level viremia Suboptimal CD4+ T cell response treatment experienced
null
2
arm 1: For subjects assigned to the raltegravir group, subjects will receive raltegravir 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines. arm 2: For subjects assigned to the placebo group, subjects will receive a matching placebo pill 400 mg to be...
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: For subjects assigned to the raltegravir group, subjects will receive raltegravir 400 mg to be taken by mouth twice daily, in addition to continuing to take their current anti-HIV medicines. intervention 2: For subjects assigned to the placebo group, subjects will receive a matching placebo pill 400 mg ...
intervention 1: Raltegravir intervention 2: Placebo
2
San Francisco | California | United States | -122.41942 | 37.77493 San Francisco | California | United States | -122.41942 | 37.77493
30
0
0
0
NCT00631449
1COMPLETED
2010-03-01
2008-02-01
University of California, San Francisco
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
419
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
To evaluate the safety profile of ropinirole XL during long-term treatment in subjects with early and advanced Parkinson's disease
null
Parkinson Disease Parkinson's Disease
ropinirole XL REQUIP Parkinson's disease long term safety efficacy safety ropinirole CR ropinirole IR open-label
null
1
arm 1: Ropinirole XL (formerly CR)
[ 1 ]
1
[ 0 ]
intervention 1: None
intervention 1: Ropinirole XL (formerly CR)
75
Birmingham | Alabama | United States | -86.80249 | 33.52066 Fountain Valley | California | United States | -117.95367 | 33.70918 San Francisco | California | United States | -122.41942 | 37.77493 Englewood | Colorado | United States | -104.98776 | 39.64777 Boca Raton | Florida | United States | -80.0831 | 26.35869 Pana...
419
0
0
0
NCT00632736
1COMPLETED
2010-03-01
2004-02-01
GlaxoSmithKline
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
99
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
false
This study will provide data on the addition of narrow band ultra violet B (nbUVB) phototherapy to participants who have not shown an excellent response to three months of etanercept.
All participants will receive etanercept 50 mg twice a week for 12 weeks. Participants who reach PASI-90 at Day 84 will be discontinued from the study (they can continue receiving commercial etanercept outside the study). Participants remaining in the study at Day 84 will decrease etanercept to 50 mg weekly for another...
Psoriasis Vulgaris
Etanercept, UVB, Enbrel, Psoriasis.
null
3
arm 1: All participants received etanercept 50 mg twice a week for 12 weeks. arm 2: Participants who did not reach a 90 percent reduction in psoriasis area and severity index (PASI-90) after 12 weeks and were randomized to the narrow band ultra violet B (nbUVB) group. They received nbUVB treatments three times a week a...
[ 1, 1, 1 ]
2
[ 0, 1 ]
intervention 1: Etanercept 50 mg, subcutaneous (SC) injection. intervention 2: None
intervention 1: Etanercept intervention 2: nbUVB
10
Winnipeg | Manitoba | Canada | -97.14704 | 49.8844 Greater Sudbury | Ontario | Canada | -80.99001 | 46.49 London | Ontario | Canada | -81.23304 | 42.98339 London | Ontario | Canada | -81.23304 | 42.98339 Markham | Ontario | Canada | -79.2663 | 43.86682 Niagara Falls | Ontario | Canada | -79.06627 | 43.10012 Laval | Que...
174
0
0
0
NCT00640393
1COMPLETED
2010-03-01
2008-04-01
Innovaderm Research Inc.
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
16
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The goal of this clinical research study is to learn if the combination of RAD001 and erlotinib hydrochloride can slow the growth of advanced pancreatic cancer. The safety of this drug combination will also be studied. Primary Objectives: -Determine the overall survival (OS) at 6 months of the combination of erlotini...
The Study Drugs: RAD001 is designed to stop cancer cells from multiplying. It may also stop the growth of new blood vessels that help tumor growth, which may cause the tumor cells to die. Erlotinib hydrochloride is designed to block the activity of a protein found on the surface of many tumor cells that may control t...
Pancreatic Cancer
Pancreatic Cancer Advanced Pancreatic Cancer Unresectable Metastatic RAD001 Everolimus Erlotinib OSI-774 Erlotinib Hydrochloride Tarceva
null
1
arm 1: Erlotinib 150 mg orally daily for 28 Days + RAD001 (Everolimus) 30 mg orally weekly for 4 Weeks
[ 0 ]
2
[ 0, 0 ]
intervention 1: 30 mg orally weekly for 4 weeks intervention 2: 150 mg by mouth daily for 28 Days
intervention 1: RAD001 intervention 2: Erlotinib
1
Houston | Texas | United States | -95.36327 | 29.76328
16
0
0
0
NCT00640978
6TERMINATED
2010-03-01
2008-03-01
M.D. Anderson Cancer Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
258
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
The purpose of the study is to investigate safety and efficacy of duloxetine for patients with painful diabetic neuropathy at long-term use.
null
Diabetic Neuropathies
null
2
arm 1: Duloxetine 40 milligrams (mg) once daily (QD), orally (PO), 1 year arm 2: Duloxetine 60 mg QD, PO, 1 year
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Duloxetine 40 mg QD, PO, 1 year intervention 2: Duloxetine 60 mg QD, PO, 1 year
intervention 1: Duloxetine hydrochloride intervention 2: Duloxetine hydrochloride
25
Aichi | N/A | Japan | 130.62158 | 32.51879 Aomori | N/A | Japan | 140.73333 | 40.81667 Chiba | N/A | Japan | 140.11667 | 35.6 Fukui | N/A | Japan | 135.54836 | 34.84214 Fukuoka | N/A | Japan | 130.41667 | 33.6 Fukushima | N/A | Japan | 140.46667 | 37.75 Gunma | N/A | Japan | N/A | N/A Hiroshima | N/A | Japan | 132.45 |...
258
0
0
0
NCT00641719
1COMPLETED
2010-03-01
2008-03-01
Eli Lilly and Company
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
28
RANDOMIZED
PARALLEL
7BASIC_SCIENCE
4QUADRUPLE
true
0ALL
false
A study to compare the rate of complete wound closure and quality of resulting scar at 3, 6 and 9 months, between dermatome-induced skin wounds treated with Collagenase Santyl Ointment versus vehicle alone.
null
Scarring Impaired Wound Healing
wound healing scarring collagenase Santyl
null
2
arm 1: Dermatome-induced skin wounds treated with drug active (collagenase). arm 2: Dermatome-induced skin wounds treated with Vehicle alone.
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Dermatome-induced skin wounds treated with drug active. Each subject serves as his own control receiving both treatments in parallel. intervention 2: Dermatome-induced skin wounds treated with Vehicle alone. Each subject serves as his own control receiving both treatments in parallel.
intervention 1: Collagenase Santyl intervention 2: Collagenase Santyl Vehicle
1
Dallas | Texas | United States | -96.80667 | 32.78306
28
0
0
0
NCT00651820
1COMPLETED
2010-03-01
2008-04-01
Healthpoint
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
116
NON_RANDOMIZED
PARALLEL
2DIAGNOSTIC
0NONE
false
0ALL
true
Combidex (ferumoxtran-10) is an ultra-small iron oxide particle covered with a sugar coating. It has been evaluated as an MRI contrast agent for use in imaging well perfused organs such as the liver and spleen and for imaging lymph nodes. In this study, Combidex is being used to compare the standard imaging agent, Gado...
Subjects are recruited as patients in one of the neurology, neurosurgery or neuro-oncology clinics at OHSU. There are four groups of the study: * Subjects receive the combidex infusion only. * Subjects receive Combidex and undergo a previously schedule neurosurgery. * Subjects undergo surgery only and provide a sample...
Brain Neoplasms
Combidex Diagnostic imaging
null
7
arm 1: Adults with brain tumor to receive Combidex infusion only arm 2: Adults with brain tumors to receive Combidex infusion and neurosurgery arm 3: Adults with brain tumors to receive neurosurgery only (NO Combidex) arm 4: Children with brain tumors to receive Combidex only arm 5: Children with brain tumors to receiv...
[ 1, 1, 5, 1, 1, 5, 1 ]
2
[ 0, 3 ]
intervention 1: 2.6 mg/kg intervention 2: neuro-surgical tumor biopsy or resection to assess particle localization. Biopsy (stereotactic, when possible) will take place following the 24 hour post- Combidex MR and within 48 hrs of i.v. Combidex administration. Biopsies will be taken from the tumor, brain around tumor (B...
intervention 1: Ferumoxtran-10 (Combidex) intervention 2: Neurosurgery
1
Portland | Oregon | United States | -122.67621 | 45.52345
116
0
0
0
NCT00659334
6TERMINATED
2010-03-01
2000-08-01
OHSU Knight Cancer Institute
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
115
RANDOMIZED
PARALLEL
4SUPPORTIVE_CARE
2DOUBLE
false
0ALL
false
Recent evidence suggests multiple drug therapy is superior to single agents. The study compares the incidence of nausea, vomiting, need for rescue medication, prolonged PACU time, and unplanned hospital admission in patients with high risk for PONV treated with oral aprepitant with or without transdermal scopolamine pr...
Postoperative nausea and vomiting (PONV) is a serious problem complicating surgery. PONV has an overall incidence of 30% and a 70% incidence in high-risk patients. PONV yields unplanned hospital admission, pulmonary aspiration, esophageal rupture, electrolyte abnormalities, dehydration, and delayed discharge from the p...
Nausea Vomiting
Post-operative Nausea and Vomiting (PONV)
null
2
arm 1: Oral Aprepitant pill and placebo transdermal patch at least 1 hour prior to surgical procedure. Emend (Aprepitant) + Placebo arm 2: Oral Aprepitant pill and Scopolamine transdermal patch at least 1 hour prior to surgical procedure.
[ 2, 1 ]
2
[ 0, 0 ]
intervention 1: 40mg tablet intervention 2: 1.5 mg patch delivering transdermally in vivo approx. 1.0mg over 3 days
intervention 1: Aprepitant intervention 2: Scopolamine
1
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
115
0
0
0
NCT00659737
1COMPLETED
2010-03-01
2008-04-01
Drexel University College of Medicine
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
13
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
Myelofibrosis is the gradual replacement of bone marrow (place where most new blood cells are produced) by fibrous tissue which reduces the body's ability to produce new blood cells and results in the development of chronic anemia (low red blood cell count). One of the main distinctions of myelofibrosis is "extramedull...
null
Myelofibrosis
Myelofibrosis Idiopathic Bevacizumab Avastin bone marrow fibrosis bone marrow angiogenesis JAK2
null
1
arm 1: Use of bevacizumab (Avastin) in the treatment of myelofibrosis.
[ 0 ]
1
[ 0 ]
intervention 1: 15 mg/kg of bevacizumab by IV infusion once every 3 weeks (1 cycle) for 12 weeks (4 cycles)
intervention 1: bevacizumab (Avastin)
5
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 Chicago | Illinois | United States | -87.65005 | 41.85003 Ithaca | New York | United States | -76.49661 | 42.44063 New York | New York | United States | -74.00597 | 40.71427 Houston | Texas | United States | -95.36327 | 29.76328
13
0
0
0
NCT00667277
6TERMINATED
2010-03-01
2008-03-01
Ronald Hoffman
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
283
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
true
This study evaluated whether lithium included as part of optimized medication treatment improved overall level of illness, symptoms of mania and depression, and quality of life in people with bipolar disorder.
Bipolar illness, a brain disorder that causes dramatic changes in a person's mood and energy, affects about 2.6% of adults in the United States. Bipolar disorder is characterized by cyclical periods of extreme highs and lows, known as episodes of mania and depression. A person undergoing an episode of mania often exper...
Bipolar Disorder
Lithium Symptoms Medication Changes
null
2
arm 1: Participants received lithium plus optimized medication treatment, as needed. arm 2: Participants only received optimized medication treatment, as needed; lithium was not be used.
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Lithium was started at 300 mg and then increased to 600 mg after 3 days. Lithium doses were maintained at 600 mg per day for 8 weeks, but may have been adjusted after that time as needed up to a serum level of 1.2 mEq/L. intervention 2: The foundation of OPT was to maintain treatment that will typically...
intervention 1: Lithium Carbonate intervention 2: Optimized Treatment (OPT)
6
Stanford | California | United States | -122.16608 | 37.42411 Boston | Massachusetts | United States | -71.05977 | 42.35843 Cleveland | Ohio | United States | -81.69541 | 41.4995 Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062 San Anton...
283
0
0
0
NCT00667745
1COMPLETED
2010-03-01
2008-04-01
National Institute of Mental Health (NIMH)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
349
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
Metoclopramide is an effective intravenous treatment for acute migraine attacks, but we do not know the best dose to administer. This study compares three different doses of metoclorpamide.
Patients with acute migraine attacks are eligible for enrollment if they present to the emergency department of Montefiore Medical Center. Pain scores are assessed at baseline and every 30 minutes for two hours, and then again by telephone 48 hours after discharge
Migraine
null
3
arm 1: Metoclopramide 10 mg+ diphenhydramine 25 mg. This medication was administered as an intravenous drip over 20 minutes arm 2: metoclopramide 20 mg + diphenhydramine 25 mg. Administered as an intravenous drip over 20 minutes. arm 3: metoclopramide 40 mg + diphenhdyramine 25mg. Administered as an intravenous drip ov...
[ 1, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: metoclopramide 20 mg intervention 2: metoclopramide 40 mg intervention 3: metoclopramide 10 mg intervention 4: Diphenhydramine 25mg, administered as an intravenous drip over 20 minutes
intervention 1: metoclopramide intervention 2: metoclopramide intervention 3: metoclopramide intervention 4: Diphenhydramine 25mg
1
The Bronx | New York | United States | -73.86641 | 40.84985
349
0
0
0
NCT00682734
1COMPLETED
2010-03-01
2008-04-01
Montefiore Medical Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
108
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
This study will compare the effect of a new oral agent for type 2 diabetes, sitagliptin, in comparison to thiazolidinediones as the third-line oral agent, in patients with type 2 diabetes mellitus.
The aim of this protocol is to determine the non-inferiority of the effectiveness of sitagliptin compared to a control group of patients treated with thiazolidinediones as add-on therapy, in low-income ethnic minority type 2 diabetic patients who are failing to maintain adequate control with maximal doses of metformin ...
Type 2 Diabetes Mellitus
sitagliptin type 2 diabetes combination therapy
null
1
arm 1: Sitagliptin 100 mg once daily
[ 0 ]
1
[ 0 ]
intervention 1: Sitagliptin 100 mg by mouth once daily
intervention 1: Sitagliptin
1
Los Angeles | California | United States | -118.24368 | 34.05223
108
0
0
0
NCT00686634
1COMPLETED
2010-03-01
2008-01-01
Charles Drew University of Medicine and Science
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
60
RANDOMIZED
PARALLEL
2DIAGNOSTIC
1SINGLE
false
0ALL
false
A large population-based study has shown diabetes to be an independent risk factor for colon cancer compared to the general population. Thus, the completion of an adequately prepped colonoscopy is requisite in providing diabetics with adequate colon cancer screening. Recent data has shown that diabetic patients have p...
STUDY DESIGN This is an investigator-initiated, single site (MCG only), single-blinded prospective study comparing the efficacy of Lubiprostone and 4L PEG (Nulytely) to 4 Liters (4L) PEG alone on preparation quality in patients with known diabetes undergoing colonoscopy. Diabetic outpatients who require a colonoscopy ...
Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2
Colonoscopy Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Cleansing Preparation PEG Quality
null
2
arm 1: The lubiprostone group will receive an additional two 24 mcg lubiprostone capsules, which will be taken orally the morning and evening of the day of the 4L PEG prep (before and after the 4L PEG prep). arm 2: All patients in the study will receive a standard oral dosing of 4L Polyethylene glycol with electrolytes...
[ 0, 1 ]
2
[ 0, 10 ]
intervention 1: Two 24 mcg lubiprostone capsules, which will be taken orally the morning and evening of the day of the 4L PEG prep (before and after the 4L PEG prep). intervention 2: Standard oral dosing of 4L Polyethylene glycol colonoscopy preparation the day prior to their scheduled colonoscopy.
intervention 1: Lubiprostone intervention 2: Polyethylene glycol with electrolytes
1
Augusta | Georgia | United States | -81.97484 | 33.47097
41
0
0
0
NCT00689026
6TERMINATED
2010-03-01
2008-05-01
Augusta University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0