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
[ 5 ]
128
NA
SINGLE_GROUP
4SUPPORTIVE_CARE
0NONE
true
0ALL
false
This study examined the possible sensitization and irritation effects of a moisturizer with sunscreen SPF 50+.
The design for this study is standard for human repeat insult patch tests. To test the moisturizer with sunscreen SPF 50+ for the potential to induce contact sensitization by repetitive applications, healthy subjects received 9 applications at 48 to 72 hour intervals of the moisturizer to the upper back. Patches were r...
Skin Irritation
Cetaphil Daily Facial Moisturizer with SPF 50+ Hypoallergenicity Skin Irritation
null
1
arm 1: All subjects received Cetaphil Daily Facial Moisturizer with SPF 50+
[ 0 ]
1
[ 0 ]
intervention 1: All subjects received applications of occlusive patches dosed with Cetaphil Daily Facial Moisturizer with SPF 50+
intervention 1: Facial Moisturizer with SPF 50+
1
Colorado Springs | Colorado | United States | -104.82136 | 38.83388
110
0
0
0
NCT01892657
1COMPLETED
2008-08-01
2008-03-01
Galderma R&D
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
11
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
false
0ALL
false
This study will evaluate the safety and side effects of two experimental vaccines in patients with kidney cancer and determine whether the vaccines "turn on" an immune response to the cancer. Each vaccine contains one of two peptides (pieces of proteins) from the fibroblast growth factor 5 (FGF-5) antigen, a protein pr...
Background: Several preliminary clinical results in the treatment of cancer lend credence to the hypothesis that augmented T-cell responses will improve IL-2 therapy. A peptide vaccine derived from the melanoma/melanosomal antigen, GP100, when given with high-dose IL-2 resulted in a response rate over 30% in a small P...
Kidney Cancer
Clinical Response Toxicity Immunologic Response Adjuvant IL-2 Renal Cancer
null
3
arm 1: Patients who do not need or are ineligible for treatment with interleukin-2 (IL-2) and patients who have previously had IL-2 therapy. A3 FGF-5 (Fibroblast growth factor 5): 172-176/217-220 peptide - two 1 ml injections in the anterior thigh deep subcutaneous tissue within 2c of each other. arm 2: Patients who r...
[ 0, 0, 0 ]
3
[ 0, 0, 10 ]
intervention 1: Two 1 ml injection in the anterior thigh deep subcutaneous tissue within 2c of each other. intervention 2: Two 1 ml injection in the anterior thigh deep subcutaneous tissue within 2c of each other. intervention 3: 720,000 IU/kg as an intravenous bolus over a 15 minute period every 8 hours beginning on t...
intervention 1: 117-126:Fibroblast growth factor 5 (FGF-5) intervention 2: Fibroblast growth factor 5 (FGF-5):172-176/217-220 intervention 3: IL-2
1
Bethesda | Maryland | United States | -77.10026 | 38.98067
11
0
0
0
NCT00089778
6TERMINATED
2008-08-05
2004-09-10
National Cancer Institute (NCI)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
83
RANDOMIZED
CROSSOVER
7BASIC_SCIENCE
4QUADRUPLE
true
0ALL
null
To assess the effect of immediate-release guanfacine hydrochloride, administered at therapeutic and supratherapeutic doses, on QT/QTc in healthy normal males and females
null
Healthy Volunteers
QT/QTc
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 1, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Subjects will receive 2x2mg immediate-release guanfacine on day 1. Subjects will receive 4x2mg immediate-release guanfacine on day 6. intervention 2: Subjects will receive 400mg of moxifloxacin on day 1. Subjects will receive 400mg of moxifloxacin on day 6. intervention 3: Subjects will receive placebo ...
intervention 1: immediate release guanfacine hydrochloride intervention 2: moxifloxacin intervention 3: Placebo
1
Tacoma | Washington | United States | -122.44429 | 47.25288
216
0
0
0
NCT00672984
1COMPLETED
2008-08-07
2008-04-18
Shire
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
526
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of this study is to determine if esmirtazapine (Org 50081) is a safe and effective treatment for insomnia. It was anticipated that esmirtazapine would increase mean Total Sleep Time (TST) as recorded in sleep diaries relative to placebo.
null
Insomnia
null
4
arm 1: Esmirtazapine 1.5 mg tablet, oral administration in the evening, once daily, for 2 weeks arm 2: Esmirtazapine 3.0 mg tablet, oral administration in the evening, once daily, for 2 weeks arm 3: Esmirtazapine 4.5 mg tablet, oral administration in the evening, once daily, for 2 weeks arm 4: Placebo to esmirtazapine
[ 0, 0, 0, 2 ]
2
[ 0, 0 ]
intervention 1: Esmirtazapine maleate was provided as tablets for oral use containing either 1.5, 3.0, or 4.5 mg of active compound. In addition, tablets contain the following excipients: hydroxypropyl cellulose, maize starch (United States Pharmacopeia \[USP\] name: corn starch), magnesium stearate, and lactose monohy...
intervention 1: Esmirtazapine intervention 2: Placebo
0
null
1,050
0
0
0
NCT00482612
1COMPLETED
2008-08-11
2006-12-07
Merck Sharp & Dohme LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
299
RANDOMIZED
PARALLEL
1PREVENTION
2DOUBLE
false
0ALL
true
The purpose of this study is to determine if the study drug is safe and effective in preventing hepatic encephalopathy (HE).
null
Hepatic Encephalopathy
null
2
arm 1: Participants were administered a single rifaximin 550 milligram (mg) tablet 2 times per day (approximately every 12 hours) for 6 months or until a breakthrough episode of hepatic encephalopathy or another reason for discontinuation. arm 2: Participants were administered a single matching placebo tablet 2 times p...
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Oral intervention 2: Oral
intervention 1: Rifaximin intervention 2: Placebo
0
null
299
0
0
0
NCT00298038
1COMPLETED
2008-08-15
2005-12-19
Bausch Health Americas, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
14
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The objective of this study was to identify neural correlates of cognitive improvement after 3 months of donepezil hydrochloride treatment using either or both of two functional magnetic resonance imaging (fMRI) measures - the functional Hippocampus Connectivity Index (HCI) and Cerebral Blood Flow (CBF) Perfusion; in t...
null
Alzheimer's Disease
Functional magnetic resonance imaging examination Alzheimer's Disease Donepezil hydrochloride Aricept
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Donepezil hydrochloride 5 mg per day orally, once daily for 4 weeks, followed by 10 mg per day (two 5-mg tablets) for 8 weeks
intervention 1: Donepezil hydrochloride
1
Milwaukee | Wisconsin | United States | -87.90647 | 43.0389
14
0
0
0
NCT00477659
1COMPLETED
2008-08-15
2007-07-23
Eisai Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
126
NON_RANDOMIZED
null
0TREATMENT
0NONE
false
0ALL
false
To evaluate the safety of the long-term use of pregabalin.
null
Neuralgia, Postherpetic
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Dosage: 150-600 mg/day (75-300 mg bid), oral administration, Treatment duration: 52 weeks
intervention 1: pregabalin
33
Nagoya | Aichi-ken | Japan | 136.90641 | 35.18147 Urayasu | Chiba | Japan | 139.90055 | 35.65879 Kasuya-gun | Fukuoka | Japan | N/A | N/A Maebashi | Gunma | Japan | 139.08333 | 36.4 Takasaki | Gunma | Japan | 139.01667 | 36.33333 Asahikawa | Hokkaido | Japan | 142.36489 | 43.77063 Asahikawa | Hokkaido | Japan | 142.364...
126
0
0
0
NCT00424372
1COMPLETED
2008-08-19
2007-01-12
Pfizer's Upjohn has merged with Mylan to form Viatris 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 ]
629
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
This is a comparative study to investigate the safety and efficacy of fidaxomicin versus vancomycin in subjects with Clostridium difficile-Associated Diarrhea (CDAD).
The primary objective of this pivotal study is to investigate the safety and efficacy of fidaxomicin versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD). The cure rates at end of therapy and recurrence rates will be evaluated and compared.
Clostridium Infections Diarrhea
CDAD, Clostridium difficile, diarrhea Clostridium difficile-Associated Diarrhea
null
2
arm 1: Participants receiving fidaxomicin 200 mg capsules orally two times daily (every 12 hours \[q12h\] regimen) with intermittent matching placebo to fidaxomicin arm 2: Participants receiving vancomycin 125 mg capsules orally four times daily (every 6 hours \[q6h\] regimen).
[ 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: 200 mg oral capsules two times daily (q12h regimen) intervention 2: 125 mg capsules q6hr (4 times a day) intervention 3: Matching Placebo to Fidaxomicin administered two times daily (intermittently with fidaxomicin dosing)
intervention 1: Fidaxomicin intervention 2: Vancomycin intervention 3: Matching Placebo to Fidaxomicin
0
null
623
1
0.001605
1
NCT00314951
1COMPLETED
2008-08-21
2006-05-02
Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
4INDUSTRY
false
false
false
null
0
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0.000283
[ 3, 4 ]
262
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This is a Phase II/III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of rituximab compared with placebo when combined with a single stable background immunosuppressive medication in subjects with moderate to severe systemic lupus erythematosus (SLE). The primary ef...
null
Lupus Erythematosus, Systemic
Rituxan SLE Lupus
null
2
arm 1: Participants will receive rituximab 1000 mg intravenously on Days 1, 15, 168, and 182. Participants will also receive an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants will also receive acetaminophen 100...
[ 0, 2 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: Rituximab will be supplied as a sterile liquid for IV administration. intervention 2: Placebo will be supplied as a sterile liquid for IV administration. intervention 3: None intervention 4: None intervention 5: None
intervention 1: Rituximab intervention 2: Placebo intervention 3: Prednisone intervention 4: Acetaminophen intervention 5: Diphenhydramine
65
Birmingham | Alabama | United States | -86.80249 | 33.52066 Huntsville | Alabama | United States | -86.58594 | 34.7304 Paradise Valley | Arizona | United States | -111.94265 | 33.53115 La Jolla | California | United States | -117.2742 | 32.84727 Los Angeles | California | United States | -118.24368 | 34.05223 Los Angel...
257
0
0
0
NCT00137969
1COMPLETED
2008-08-25
2005-05-10
Genentech, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
14
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
A 12-Week Efficacy Study in participants with Peripheral Arterial Disease. the primary hypothesis is that MK-0736 7 mg administered once daily for 12 weeks will result in a decrease in lower extremity atherosclerotic plaque macrophage content when compared to placebo (an approximate decrease of up to 30% is expected).
null
Peripheral Vascular Diseases
null
2
arm 1: Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks arm 2: Participants will be orally administered placebo once daily for 12 weeks.
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: MK-0736; 7mg once daily, orally at approximately the same time each morning for 12 weeks. intervention 2: Matching Placebo once daily, orally at approximately the same time each morning for 12 weeks.
intervention 1: MK-0736 intervention 2: Comparator: placebo (unspecified)
0
null
14
4
0.285714
1
NCT00679055
6TERMINATED
2008-08-26
2007-03-31
Merck Sharp & Dohme LLC
4INDUSTRY
false
false
false
null
0
4
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0.117214
[ 3 ]
27
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This study will evaluate the efficacy and safety of LBH589B in adult patients with chronic myeloid leukemia who are in accelerated phase or blast phase (blast crisis) with resistant disease following treatment with at least two BCR-ABL tyrosine kinase inhibitors
study was designed to assess the hematologic response associated with treatment of oral panobinostat. Hematologic response is defined as the overall of complete hematologic response (CHR), and of no evidence of leukemia (NEL) and of the return to chronic phase (RTC). Hematologic responses were to be confirmed after 4 w...
Leukemia, Myeloid, Chronic
Refractory Chronic Myeloid Leukemia accelerated phase blast phase (blast crisis) adults oral LBH589
null
1
arm 1: Participants received panobinostat 20 milligrams (mg) orally once daily (OD), three times a week as part of a 4 week (28 day) treatment cycle. Panobinostat was administered at the same time each morning, and with an 8oz/240 milliliter (ml) of water after a fasting period of at least two hours (water was allowed)...
[ 0 ]
1
[ 0 ]
intervention 1: None
intervention 1: LBH589
26
Duarte | California | United States | -117.97729 | 34.13945 Aurora | Colorado | United States | -104.83192 | 39.72943 Denver | Colorado | United States | -104.9847 | 39.73915 Chicago | Illinois | United States | -87.65005 | 41.85003 Chicago | Illinois | United States | -87.65005 | 41.85003 Chicago | Illinois | United S...
27
0
0
0
NCT00449761
6TERMINATED
2008-08-26
2007-02-23
Novartis Pharmaceuticals
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
339
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
Study to assess efficacy of Duloxetine 120 mg and Duloxetine 60 mg in patients hospitalized for severe depression after 4 weeks of treatment. To evaluate the rescue option in non-responding patients. Safety of Duloxetine will also be assessed.
null
Depressive Disorder, Major
null
2
arm 1: Duloxetine 60 mg arm 2: Duloxetine 120 mg
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Capsule intervention 2: Capsule
intervention 1: Duloxetine intervention 2: Placebo
0
null
338
0
0
0
NCT02229825
1COMPLETED
2008-08-26
2007-02-09
Boehringer Ingelheim
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 ]
72
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to compare the effectiveness and safety of experimental treatment matuzumab and ECX chemotherapy, with ECX chemotherapy. Participants invited to take part have metastatic cancer of the esophagus (gullet) or stomach.
null
Esophageal Cancer Gastric Cancer
Esophagus Gastric Adenocarcinoma EGFR matuzumab EMD 72000 randomized Epirubicin cisplatin capecitabine Metastatic Esophago-Gastric cancer
null
2
arm 1: None arm 2: None
[ 0, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Participants will receive matuzumab 800 milligrams (mg) intravenously (IV) every week, until disease progression (PD), unacceptable toxicity, death, or consent is withdrawn. intervention 2: Participants will receive epirubicin 50 milligrams per square meter (mg/m\^2) on Day 1 of 21-day cycle up to a max...
intervention 1: Matuzumab intervention 2: Epirubicin intervention 3: Cisplatin intervention 4: Capecitabine
22
Essen | N/A | Germany | 7.01228 | 51.45657 Hamburg | N/A | Germany | 9.99302 | 53.55073 Oldenburg | N/A | Germany | 8.21467 | 53.14118 Recklinghausen | N/A | Germany | 7.19738 | 51.61379 A Coruña | N/A | Spain | -8.396 | 43.37135 Barcelona | N/A | Spain | 2.15899 | 41.38879 Cadiz | N/A | Spain | -6.2891 | 36.52672 Vale...
71
0
0
0
NCT00215644
1COMPLETED
2008-08-31
2005-08-31
Merck KGaA, Darmstadt, Germany
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
17,802
RANDOMIZED
PARALLEL
1PREVENTION
4QUADRUPLE
false
0ALL
true
The purpose of this study is to determine the safety and effectiveness of long-term therapy with rosuvastatin compared with a placebo, and to evaluate whether treatment with rosuvastatin might be effective in reducing the risk of major cardiovascular events.
AstraZeneca announced it has decided to stop the CRESTOR JUPITER clinical study early based on a recommendation from an Independent Data Monitoring Board and the JUPITER Steering Committee, which met on March 29, 2008. The study will be stopped early because there is unequivocal evidence of a reduction in cardiovascula...
Elevated High-sensitivity C-Reactive Protein (hsCRP)
Primary prevention Cardiovascular disease Statin therapy C-reactive protein
null
2
arm 1: Rosuvastatin 20 mg once daily arm 2: Placebo once daily
[ 0, 2 ]
2
[ 0, 10 ]
intervention 1: Oral intervention 2: Oral
intervention 1: Rosuvastatin intervention 2: Placebo
856
Birmingham | Alabama | United States | -86.80249 | 33.52066 Calera | Alabama | United States | -86.7536 | 33.1029 Columbiana | Alabama | United States | -86.60721 | 33.17817 Decatur | Alabama | United States | -86.98334 | 34.60593 Graysville | Alabama | United States | -86.97138 | 33.62066 Haleyville | Alabama | United...
17,733
1
0.000056
0
NCT00239681
6TERMINATED
2008-09-01
2003-02-01
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
1
0
0
0
0
0
0
0
0.00001
[ 4 ]
1,083
RANDOMIZED
PARALLEL
1PREVENTION
2DOUBLE
false
1FEMALE
false
The purpose of this study is to determine whether bazedoxifene/conjugated estrogens combinations are effective for the prevention of endometrial hyperplasia and for the prevention of osteoporosis in postmenopausal women.
null
Endometrial Hyperplasia Osteoporosis
Endometrium Uterus Menopause
null
4
arm 1: BZA 20mg/CE 0.625 arm 2: BZA 20mg/CE 0.45 arm 3: CE 0.45mg/MPA1.5mg arm 4: Placebo
[ 0, 0, 1, 2 ]
4
[ 0, 0, 0, 10 ]
intervention 1: Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study. intervention 2: Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study. intervention 3: Subjec...
intervention 1: Bazedoxifene/Conjugated Estrogen intervention 2: Bazedoxifene/Conjugated Estrogen intervention 3: CE 0.45 mg/MPA 1.5mg intervention 4: Placebo
9
Upland | California | United States | -117.64839 | 34.09751 Inverness | Florida | United States | -82.33037 | 28.83582 West Palm Beach | Florida | United States | -80.05337 | 26.71534 Decatur | Georgia | United States | -84.29631 | 33.77483 Honolulu | Hawaii | United States | -157.85833 | 21.30694 Lexington | Kentucky ...
1,061
5
0.004713
1
NCT00242710
1COMPLETED
2008-09-01
2005-09-01
Pfizer
4INDUSTRY
false
false
false
null
0
1
0
0
0
0
0
0
0
0
0
0
0
0
0
2
1
0
1
0
0
0
0
0
0
0
0
0
0
0
0
0.002015
[ 5 ]
550
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
The purpose of this study is to compare the safety and efficacy of the antibiotic tigecycline with other antibiotics, ampicillin-sulbactam, and amoxicillin-clavulanate in the treatment of a complicated skin and/or skin structure infection (cSSSI).
null
Skin Diseases, Bacterial
skin infection antibiotics
null
2
arm 1: Arm 1: Tigecycline arm 2: Arm 2: Ampicillin-Sulbactam or Amoxicillin-Clavulanate plus or minus a glycopeptide
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: Treatment A: Tigecycline every 12 hours intravenous (IV) (an initial dose of 100 mg followed by 50 mg every 12 hours) intervention 2: Ampicillin-sulbactam: 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (3 g ampicillin plus 1 g sulbactam) intravenous (IV) every 6 hrs or Amoxicillin-clavulanate: 1.2 ...
intervention 1: Tigecycline intervention 2: ampicillin-sulbactam
57
Scottsdale | Arizona | United States | -111.89903 | 33.50921 Jonesboro | Arkansas | United States | -90.70428 | 35.8423 Chula Vista | California | United States | -117.0842 | 32.64005 Mission Viejo | California | United States | -117.672 | 33.60002 National City | California | United States | -117.0992 | 32.67811 Denve...
531
1
0.001883
1
NCT00368537
1COMPLETED
2008-09-01
2006-09-01
Wyeth is now a wholly owned subsidiary of 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
1
0
0
0
0
0
0
0
0.000333
[ 0 ]
853
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This was an open-label, multicenter, extension study of intravitreally administered ranibizumab in two cohorts. The first cohort (reported here) enrolled patients with primary or recurrent Choroidal Neovascularization (CNV) secondary to Age-Related Macular Degeneration (AMD) who completed the treatment phase of a Genen...
null
Choroidal Neovascularization, Age-related Macular Degeneration
CNV Lucentis AMD Age-related macular degeneration RVO
null
1
arm 1: Ranibizumab 0.5 mg intravitreal injection 0.5 mg in the study eye on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment.
[ 0 ]
1
[ 0 ]
intervention 1: Ranibizumab intravitreal injection 0.5 mg in a single-dose regimen given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year)
intervention 1: Ranibizumab 0.5 mg
0
null
790
3
0.003797
1
NCT00379795
1COMPLETED
2008-09-01
2005-04-01
Genentech, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
0
0
0
0
0
0
2
0
0
0
0
0
0
0
0.001292
[ 4 ]
116
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
Octagam is a solvent/detergent-treated human normal immunoglobulin (IGIV) solution for intravenous administration. Octagam 5% is currently registered in about 80 countries. This study evaluated the efficacy and safety of Octagam 10% in Idiopathic Thrombocytopenic Purpura (ITP) in adults. As Octagam 10% is essentially s...
The primary objective of the study was to investigate the efficacy of Octagam® 10% in correcting platelet count. The blood count as well as laboratory chemistry were checked repeatedly up to day 21. The secondary objective of the study was to investigate the safety of Octagam® 10%. Safety was assessed by monitoring vi...
Immune Thrombocytopenic Purpura
null
1
arm 1: Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.
[ 0 ]
1
[ 0 ]
intervention 1: Octagam 10% was supplied as a ready-to-use solution in glass bottles.
intervention 1: Octagam 10%
1
Vienna | N/A | Austria | 16.37208 | 48.20849
116
1
0.008621
1
NCT00426270
1COMPLETED
2008-09-01
2006-06-01
Octapharma
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
0
0
0
0
0
0
0
0.001523
[ 4 ]
348
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This trial is conducted in Europe. The aim of this research is to compare the efficacy and safety of treatment with NPH insulin and insulin detemir. You will be treated with either insulin detemir or NPH insulin once or twice daily as basal insulin. Additionally you will receive insulin aspart as bolus insulin
null
Diabetes Diabetes Mellitus, Type 1
null
2
arm 1: insulin detemir + insulin aspart arm 2: NPH insulin + insulin aspart
[ 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: s.c. injection, once or twice daily. intervention 2: s.c. injection, once or twice daily. intervention 3: s.c. injection, at main meals.
intervention 1: insulin detemir intervention 2: insulin NPH intervention 3: insulin aspart
43
Pleven | N/A | Bulgaria | 24.61667 | 43.41667 Sofia | N/A | Bulgaria | 23.32415 | 42.69751 Varna | N/A | Bulgaria | 27.91667 | 43.21667 Olomouc | N/A | Czechia | 17.25175 | 49.59552 Pardubice | N/A | Czechia | 15.77659 | 50.04075 Prague | N/A | Czechia | 14.42076 | 50.08804 Glostrup Municipality | N/A | Denmark | 12.40...
347
1
0.002882
1
NCT00435019
1COMPLETED
2008-09-01
2007-02-01
Novo Nordisk A/S
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0.000509
[ 3 ]
50
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
The purpose of this study is to understand the safety and tolerability of INCB018424 in patients with rheumatoid arthritis
null
Rheumatoid Arthritis
Rheumatoid arthritis
null
5
arm 1: INCB018424 15 mg twice daily (BID) or matching placebo arm 2: INCB018424 5 mg BID or matching placebo arm 3: INCB018424 25 mg BID or matching placebo arm 4: INCB018424 50 mg once daily (QD) or matching placebo arm 5: Matching placebo, oral
[ 0, 0, 0, 0, 2 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: INCB018424 intervention 2: Placebo
15
Huntsville | Alabama | United States | -86.58594 | 34.7304 Upland | California | United States | -117.64839 | 34.09751 Gainesville | Florida | United States | -82.32483 | 29.65163 Palm Harbor | Florida | United States | -82.76371 | 28.07807 Kalispell | Montana | United States | -114.31291 | 48.19579 Hickory | North Car...
50
1
0.02
1
NCT00550043
1COMPLETED
2008-09-01
2007-10-01
Incyte Corporation
4INDUSTRY
false
false
false
null
0
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0.003539
[ 2 ]
104
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
The purpose of this study is to determine the best way to conduct clinical trials in patients with neuropathic pain (nerve pain). This study will see if generic pregabalin has any effect on neuropathic pain.
null
Neuralgia, Postherpetic Diabetic Neuropathy Painful Small-Fiber Neuropathy Idiopathic Distal Sensory Polyneuropathy
null
2
arm 1: Patients in Group A will remain on pregabalin (up to 600 mg/day po) treatment for the entire double-blind period. arm 2: Patients in Group B will be treated with placebo.
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: pregabalin (up to 600 mg/day by mouth (po)). Duration of Treatment: 6 Weeks intervention 2: pregabalin Pbo (up to 600 mg/day by mouth (po)). Duration of Treatment: 6 Weeks
intervention 1: Comparator: pregabalin intervention 2: Comparator: Placebo (unspecified)
0
null
104
1
0.009615
1
NCT00570310
1COMPLETED
2008-09-01
2007-12-01
Merck Sharp & Dohme LLC
4INDUSTRY
false
false
false
null
0
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0.001699
[ 4 ]
649
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
This 2-arm study will evaluate the efficacy and safety of Avastin versus placebo in combination with Roferon as first-line treatment in participants with metastatic renal cell cancer (clear cell type) who have had nephrectomy. The anticipated time of study treatment is 1-2 years, and the target sample size is greater t...
null
Renal Cell Cancer
null
2
arm 1: Bevacizumab infusions will be administered every 2 weeks at a dose of 10 milligram per kilogram (mg/kg) for 52 weeks or until disease progression or unacceptable toxicity. Interferon alfa-2a (IFN-Alfa-2A) will be administered 3 times per week as a subcutaneous injection at a dose of 9 million international units...
[ 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: 10 mg/kg IV every 2 weeks intervention 2: 9 MIU SC 3 times/week intervention 3: IV every 2 weeks
intervention 1: Bevacizumab [Avastin] intervention 2: Interferon alfa 2a [Roferon] intervention 3: Placebo
104
Adelaide | N/A | Australia | 138.59863 | -34.92866 Adelaide | N/A | Australia | 138.59863 | -34.92866 Brisbane | N/A | Australia | 153.02809 | -27.46794 Canberra | N/A | Australia | 149.12807 | -35.28346 Frankston | N/A | Australia | 145.12291 | -38.14458 Kurralta Park | N/A | Australia | 138.56702 | -34.95142 Melbourn...
641
1
0.00156
1
NCT00738530
1COMPLETED
2008-09-01
2004-06-01
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
1
0
0
0
0
0
0
0
0.000275
[ 3 ]
42
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This is a single arm study. The tumor specimen is analyzed for the presence of a fusion protein which corresponds to available peptides. Patients undergo T cell harvest 10 days after an initial priming peptide-pulsed antigen presenting cell (APC) vaccine is performed. Fresh APCs are utilized for initial priming vacci...
Eradication of low tumor burdens can occur in vivo when T-cell mediated responses are generated against specific tumor antigens. The Ewing's sarcoma family of tumors (ESFT) and alveolar rhabdomyosarcoma (AR) display several features which make them candidate diseases for trials of such immunotherapy. First, intensive c...
Ewing's Sarcoma Rhabdomyosarcoma
Rhabdomyosarcoma Ewing's Sarcoma Immunotherapy Tumor Vaccine Interleukin-2
null
1
arm 1: Patients receive oral indinavir sulfate 350 mg/m\^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10\^6 injection; harvested autologous T cells (minimum dose 1 x 10\^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 min...
[ 0 ]
3
[ 2, 0, 3 ]
intervention 1: 3 syringes containing 1 x 10\^6peptide pulsed dendritic cells intervention 2: Oral dose, 350 mg/m\^2 administered every 8 hours. Maximum dose is 800 mg every 8 hours. intervention 3: Harvested autologous T cells, minimum dose 1 x 10\^6/kg will be thawed rapidly in 37 degree water bath and infused sequen...
intervention 1: therapeutic autologous dendritic cells intervention 2: indinavir sulfate intervention 3: peripheral blood stem cell transplantation
1
Bethesda | Maryland | United States | -77.10026 | 38.98067
42
0
0
0
NCT00001566
1COMPLETED
2008-09-01
1996-12-01
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 ]
55
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This study will measure the effectiveness and any side effects of LY317615 in participants with diffuse large B-cell lymphoma (DLBCL: a sub-type of Non-Hodgkins Lymphoma).
null
Non-Hodgkin's Lymphoma
null
1
arm 1: 500 milligrams (mg), oral, daily (QD), up to six (6) 28-day cycles
[ 0 ]
1
[ 0 ]
intervention 1: 500 mg, oral, QD, up to six 28 day cycles
intervention 1: LY317615
3
Royal Oak | Michigan | United States | -83.14465 | 42.48948 Minneapolis | Minnesota | United States | -93.26384 | 44.97997 Rochester | Minnesota | United States | -92.4699 | 44.02163
55
0
0
0
NCT00042666
1COMPLETED
2008-09-01
2002-06-01
Eli Lilly and Company
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
630
null
PARALLEL
0TREATMENT
null
false
0ALL
null
Demonstrate the safety and efficacy of Tipranavir/Ritonavir versus an active treatment regimen in highly treatment experienced Human Immunodeficiency virus 1(HIV-1) infected patients.
null
HIV Infections
null
2
arm 1: None arm 2: None
[ 5, 5 ]
3
[ 0, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: None
intervention 1: Tipranavir intervention 2: Ritonavir(r) intervention 3: Comparator Protease Inhibitor (CPI)
117
Phoenix | Arizona | United States | -112.07404 | 33.44838 Tucson | Arizona | United States | -110.92648 | 32.22174 Berkeley | California | United States | -122.27275 | 37.87159 Beverly Hills | California | United States | -118.40036 | 34.07362 Fountain Valley | California | United States | -117.95367 | 33.70918 Long Be...
620
0
0
0
NCT00054717
1COMPLETED
2008-09-01
2003-01-01
Boehringer Ingelheim
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 ]
106
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
To assess the safety and efficacy of SU011248 in patients with metastatic, refractory renal cell carcinoma
null
Carcinoma, Renal Cell
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: 50-mg orally taken daily for 4 weeks and off treatment for 2 weeks until progression or unacceptable toxicity
intervention 1: SU011248
15
Duarte | California | United States | -117.97729 | 34.13945 Pasadena | California | United States | -118.14452 | 34.14778 San Francisco | California | United States | -122.41942 | 37.77493 Boston | Massachusetts | United States | -71.05977 | 42.35843 Boston | Massachusetts | United States | -71.05977 | 42.35843 Boston ...
106
0
0
0
NCT00077974
1COMPLETED
2008-09-01
2004-02-01
Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3, 4 ]
469
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
This study will examine the effect of antidepressant medication on rates of death and disease in depressed people with chronic heart failure.
Comorbid depression in people with chronic medical illness is a serious public health concern. Depressive disorders lead to increased morbidity, mortality, and poorer outcomes in ischemic heart disease, a leading cause of chronic heart failure (CHF). Evidence suggests that a relationship exists between depression and C...
Heart Failure, Congestive Chronic Heart Failure Depression
Antidepressive Agents
null
2
arm 1: Participants will take sertraline for 12 weeks arm 2: Participants will take placebo for 12 weeks
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Dosage ranging from 50 mg to 200 mg once a day intervention 2: Dosage ranging from 50 mg to 200 mg once a day
intervention 1: Sertraline intervention 2: Placebo
1
Durham | North Carolina | United States | -78.89862 | 35.99403
469
0
0
0
NCT00078286
1COMPLETED
2008-09-01
2003-11-01
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
[ 3 ]
170
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
Current treatment of tuberculosis (TB) requires patients to take four drugs for 8 weeks and then two drugs for 4 months. New drug regimens that are shorter and effective against drug-resistant TB are needed. This study will evaluate whether using the drug moxifloxacin (MOX) in place of ethambutol (EMB) during the first...
Approximately one-third of the world's population is infected with Mycoplasma tuberculosis; 7 to 8 million new cases of active TB occur each year. TB is the second most common infectious cause of death worldwide. Appropriate treatment of persons with active TB is very important in limiting the transmission of M. tuberc...
Tuberculosis
null
2
arm 1: INH 300mg/RIF 600mg/PZA 20mg/kg/MOX 400mg/EMB placebo once daily for 8 weeks arm 2: INH 300mg/RIF 600mg/PZA 20mg/kg/MOX placebo/EMB 15-20mg/kg once daily for 8 weeks
[ 0, 2 ]
1
[ 0 ]
intervention 1: 400mg daily for 8 weeks
intervention 1: Moxifloxacin
1
Rio de Janeiro | Rio de Janeiro | Brazil | -43.18223 | -22.90642
146
0
0
0
NCT00082173
1COMPLETED
2008-09-01
2004-10-01
Johns Hopkins 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 ]
33
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
true
This phase II trial is studying how well giving tipifarnib together with fulvestrant works as second-line therapy in treating postmenopausal women with hormone receptor-positive inoperable locally advanced or metastatic breast cancer that has progressed after previous first-line endocrine therapy. Tipifarnib may stop t...
PRIMARY OBJECTIVES: I. To determine the efficacy of tipifarnib (R115777, Zarnestra™) in combination with fulvestrant based on clinical benefit rate (CBR, a combination of complete response rate, partial response rate, and stable disease for more than 24 weeks) in postmenopausal women with hormone receptor-positive met...
Estrogen Receptor-positive Breast Cancer Recurrent Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Stage IV Breast Cancer
null
1
arm 1: Patients receive fulvestrant intramuscularly on day 1 and oral tipifarnib twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity\*.
[ 0 ]
2
[ 0, 0 ]
intervention 1: Given intramuscularly intervention 2: Given IV
intervention 1: fulvestrant intervention 2: tipifarnib
1
The Bronx | New York | United States | -73.86641 | 40.84985
33
0
0
0
NCT00082810
1COMPLETED
2008-09-01
2004-03-01
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 ]
750
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to test whether SU011248 has activity and is safe compared to interferon-alfa as first-line therapy in patients with metastatic renal cell carcinoma (RCC).
null
Carcinoma, Renal Cell
null
2
arm 1: None arm 2: None
[ 1, 0 ]
2
[ 0, 0 ]
intervention 1: 3 MIU first week, 6 MIU second week, and 9 MIU thereafter three times a week (non-consecutive days) until progression or unacceptable toxicity intervention 2: 50 mg orally daily for 4 weeks and 2 weeks off treatment until progression or unacceptable toxicity
intervention 1: Interferon-alfa intervention 2: SU011248
123
Jonesboro | Arkansas | United States | -90.70428 | 35.8423 La Jolla | California | United States | -117.2742 | 32.84727 La Jolla | California | United States | -117.2742 | 32.84727 Los Angeles | California | United States | -118.24368 | 34.05223 San Diego | California | United States | -117.16472 | 32.71571 San Francis...
735
0
0
0
NCT00083889
1COMPLETED
2008-09-01
2004-08-01
Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
341
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to determine the prevalence and clinical course of orthostatic hypotension (OH) on a rehabilitation and nursing home unit during their inpatient stay and to initiate a standardized, interdisciplinary treatment plan for patients with OH and determine the effect of treatment on the clinical c...
This study is a prospective, quasi-experiment conducted in two consecutive phases. During the observation phase, eligible patients are identified and followed through their usual course of care in the nursing home/rehabilitation unit. During the intervention phase, patients enrolled who have OH will receive the interve...
Hypotension, Orthostatic
Aging Blood pressure Hypotension Orthostatic Rehabilitation
null
1
arm 1: Stepped intervention consisting of treatment phase 1, 2 and 3. Subjects whose orthostatic hypotension is resolved after treatment phase 1 will not receive new treatments (phase 2 and 3)
[ 5 ]
3
[ 10, 0, 10 ]
intervention 1: * Patient Education * Physical Therapy Exercises * Increased Salt Intake * Elevation of head of bed with 2-4 inch wedge * Medication Review by MD, Pharma intervention 2: Subjects receive Treatment Phase 2 if they are still orthostatic after receiving Treatment Phase 1. * Fludrocortisone * Salt tablet i...
intervention 1: Treatment Phase 1 intervention 2: Treatment Phase 2 intervention 3: Treatment Phase 3
1
Portland | Oregon | United States | -122.67621 | 45.52345
341
0
0
0
NCT00117585
1COMPLETED
2008-09-01
2005-11-01
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
[ 4 ]
515
NA
SINGLE_GROUP
2DIAGNOSTIC
0NONE
true
0ALL
true
The study is designed to study the utility of 123I-mIBG as a diagnostic imaging agent to predict cardiac outcome in subjects with heart failure and in comparison to subjects without cardiovascular disease.
null
Heart Failure, Congestive
Heart Failure nuclear cardiology sympathetic innervation 123I-mIBG
null
1
arm 1: Single dose
[ 0 ]
1
[ 0 ]
intervention 1: Single Dose
intervention 1: 123I-mIBG (meta-iodobenzylguanidine)
1
Princeton | New Jersey | United States | -74.65905 | 40.34872
515
0
0
0
NCT00126438
1COMPLETED
2008-09-01
2005-07-01
GE Healthcare
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 ]
208
RANDOMIZED
PARALLEL
1PREVENTION
2DOUBLE
false
0ALL
true
Primary end points * incidence of depression defined as a Montgomery Asberg Depression Scale Score (MADRS) of 13 or higher during antiviral therapy (up to 48 weeks, depending on genotype) * effect of an antidepressive pre-treatment over two weeks and a continuously concomitant treatment with Escitalopram (S-citalopram...
null
Depression
Pegasys-Induced depression
null
2
arm 1: After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram. arm 2: After the preobservation period, patients received placebo. ...
[ 1, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: Patients with HCV genotype 1 or 4 received treatment for 48 weeks with PEGinterferon-alfa2a, 180 mcg weekly. Patients with genotype 2 or 3 received PEGinterferon-alfa2a, 180 mcg weekly. intervention 4: Patients with HCV genotype 1 or 4 received treatment for 48 ...
intervention 1: Escitalopram intervention 2: Placebo intervention 3: Peginterferon alfa-2a intervention 4: Ribavirin
1
Leipzig | N/A | Germany | 12.37129 | 51.33962
181
0
0
0
NCT00136318
1COMPLETED
2008-09-01
2004-01-01
Charite University, Berlin, Germany
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 ]
66
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
Bortezomib (Velcade) has just recently been approved by the FDA for the treatment of multiple myeloma in patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. This study will determine if Velcade is effective in treating patients with multiple myeloma tha...
Primary Objective • To evaluate the objective response rate (CR + PR) to bortezomib alone in patients with newly diagnosed multiple myeloma. Secondary Objectives * To evaluate the tolerability and toxicity. * To evaluate time to progression. * To assess the frequency and severity of peripheral neuropathy. * To evalu...
Multiple Myeloma
multiple myeloma Velcade bortezomib
null
1
arm 1: Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
[ 0 ]
1
[ 0 ]
intervention 1: None
intervention 1: bortezomib
6
Atlanta | Georgia | United States | -84.38798 | 33.749 Boston | Massachusetts | United States | -71.05977 | 42.35843 Boston | Massachusetts | United States | -71.05977 | 42.35843 Boston | Massachusetts | United States | -71.05977 | 42.35843 Buffalo | New York | United States | -78.87837 | 42.88645 New York | New York |...
64
0
0
0
NCT00153920
1COMPLETED
2008-09-01
2003-12-01
Dana-Farber 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
[ 5 ]
300
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
The purpose of this study is to assess whether a calcineurin inhibitor (CNI)-free regimen with enteric-coated mycophenolate sodium (EC-MPS) and everolimus is as safe and well-tolerated as the standard regimen containing enteric-coated mycophenolate sodium (EC-MPS) and cyclosporine microemulsion, but results in better r...
null
Renal Transplantation
Renal transplantation, everolimus, immunosuppressants, CNI-free
null
2
arm 1: Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5 mg prednisolone or equivalent and had to be continued t...
[ 0, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL. intervention 2: Tablets orally twice a day to maintain protocol specific target blood levels intervention 3: Enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. intervention 4: Corticost...
intervention 1: Everolimus intervention 2: Cyclosporine intervention 3: Enteric-coated mycophenolate sodium intervention 4: Corticosteroids
3
Nuremberg | N/A | Germany | 11.07752 | 49.45421 Basel | N/A | Switzerland | 7.57327 | 47.55839 Bern | N/A | Switzerland | 7.44744 | 46.94809
300
0
0
0
NCT00154310
1COMPLETED
2008-09-01
2005-06-01
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 ]
89
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
The study objective is to evaluate the maximum tolerated dose, safety and efficacy of patupilone in patients with NSCLC who have progressed after prior chemotherapy.
null
Carcinoma, Non-Small-Cell Lung
EPO EPO906 Brain metastasis Lung cancer Lung metastasis NSCLC
null
0
null
null
1
[ 0 ]
intervention 1: Patupilone (2.5 mg/mL) was supplied as a clear, colorless concentrate for solution for infusion in glass vials containing 5 mg/2 mL in Phase I and 10 mg/4 mL in Phase II part of the study. Patupilone was administered as a single intravenous (i.v.) infusion over 5 to 10 minutes (Amendment 1) till Amendme...
intervention 1: Patupilone
4
Louisville | Kentucky | United States | -85.75941 | 38.25424 Columbia | Missouri | United States | -92.33407 | 38.95171 Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062 Houston | Texas | United States | -95.36327 | 29.76328
89
0
0
0
NCT00171834
1COMPLETED
2008-09-01
2003-08-01
Novartis Pharmaceuticals
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
60
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this research study is to identify better ways to treat children and young adults with acute lymphocytic leukemia (ALL). At the same time, doctors hope to define methods to identify those patients at higher risk for certain side effects, as well as those who are at higher risk for relapse of their leukem...
Outline of Therapy: Combinations of chemotherapy drugs will be given orally, intravenously and intrathecally (directly into the cerebrospinal fluid by spinal tap) over a period of roughly two and a half years. Therapy will be divided into five phases: Induction (4 weeks): chemotherapy given to produce a clinical rem...
Acute Lymphocytic Leukemia
Acute Lymphocytic Leukemia Leukemia
null
2
arm 1: 6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE METHOTREXATE Leucovorin arm 2: 6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C
[ 0, 0 ]
12
[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]
intervention 1: Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation intervention 2: Therapy will be divided into five phases: Induction, Consolidation, De...
intervention 1: aminopterin intervention 2: L-asparaginase intervention 3: cyclophosphamide intervention 4: cytarabine intervention 5: daunomycin intervention 6: dexamethasone intervention 7: 6-mercaptopurine intervention 8: methotrexate intervention 9: 6-thioguanine intervention 10: vincristine intervention 11: Triple...
2
Neptune City | New Jersey | United States | -74.02792 | 40.20011 New Brunswick | New Jersey | United States | -74.45182 | 40.48622
60
0
0
0
NCT00176462
1COMPLETED
2008-09-01
2001-02-01
Rutgers, The State University of New Jersey
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 ]
554
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This trial is conducted globally. The purpose of the trial is to evaluate that activated recombinant human factor VII (eptacog alfa (activated)) is safe and effective in severely injured trauma patients by assessing mortality and morbidity. Please note that this trial and trial F7TRAUMA-1648 (NCT00323570) have been me...
The decision to discontinue the F7TRAUMA-1711 trial is not due to any safety concerns. The result of the pre-planned futility analysis performed in June 2008 predicted a very low likelihood of reaching a successful outcome on the primary efficacy endpoint at the end of the trial and as a consequence, the company has de...
Acquired Bleeding Disorder Trauma
null
4
arm 1: None arm 2: None arm 3: None arm 4: None
[ 0, 2, 0, 2 ]
2
[ 0, 0 ]
intervention 1: Sterile, freeze-dried powder in single-use vials to be reconstituted with sterile water for injection. Three doses of 200, 100 and 100 mcg/kg to be administered bolus i.v. (intravenous) over approx. three hours. intervention 2: placebo
intervention 1: eptacog alfa (activated) intervention 2: placebo
14
Princeton | New Jersey | United States | -74.65905 | 40.34872 Säo Paulo | N/A | Brazil | N/A | N/A Prague | N/A | Czechia | 14.42076 | 50.08804 Paris La Défense Cedex | N/A | France | N/A | N/A Mainz | N/A | Germany | 8.2791 | 49.98419 Vouliagment | N/A | Greece | N/A | N/A Kowloon | N/A | Hong Kong | 114.18333 | 22.31...
560
0
0
0
NCT00184548
6TERMINATED
2008-09-01
2005-10-01
Novo Nordisk A/S
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
47
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
true
0ALL
false
Approximately 1/4 of the US population has insulin resistance and the associated risk factors such as elevated lipid levels -triglycerides (type of fat from what we eat and what the liver produces and low HDL cholesterol which is the good cholesterol helping to protect against heart disease. Currently one known treatme...
It has been estimated that approximately ¼ of the US population has the Insulin Resistant Syndrome (IRS). The notion that insulin resistance and compensatory hyperinsulinemia lead to a cluster of abnormalities that increase CVD risk was first introduced in 1988, and central to the changes identified was a dyslipidemia ...
Insulin Resistance Hypertriglyceridemia
Insulin resistance Insulin resistance syndrome dyslipidemia atherogenic dyslipidemia triglyceride/HDL-C ratio
null
3
arm 1: 160 mg daily for 12 weeks arm 2: 4 mg/daily 4 weeks followed by 4 mg 2 x daily for 8 weeks arm 3: calorie restricted to achieve 0.5 kg weight loss/week x 12 weeks
[ 1, 1, 1 ]
3
[ 0, 0, 5 ]
intervention 1: None intervention 2: None intervention 3: None
intervention 1: Rosiglitazone intervention 2: Fenofibrate intervention 3: Weight Loss
1
Stanford | California | United States | -122.16608 | 37.42411
47
0
0
0
NCT00186537
1COMPLETED
2008-09-01
2003-09-01
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
[ 4 ]
107
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to evaluate the effectiveness of insulin delivered in the peritoneum (abdomen)by an implantable pump in Type 1 diabetics.
Implantable insulin delivery pumps have been shown to reduce the occurrence of severe hypoglycemia in Type 1 DM subjects, as demonstrated in numerous European studies. Glycemic control is difficult to attain in subjects using exogenous insulin due to the risk of severe hypoglycemia. This study is aimed at comparing the...
Type 1 Diabetes
Diabetes Implantable Insulin Pump Intraperitoneal Insulin Delivery
null
2
arm 1: The experimental group will receive intraperitoneally (IP) delivered insulin via the Medtronic MiniMed Implantable Pump (MIP). At the time of implant, the pump will be filled with Aventis HOE21PH U400 insulin and the subject will be treated with this insulin for the first 180 days post implant. During the refill...
[ 0, 4 ]
3
[ 0, 1, 0 ]
intervention 1: 400 IU per ml - dosage based on the Investigators clinical judgement and the individual subject requirements. intervention 2: The implantable pump system is intended to provide continuous intraperitoneal delivery of insulin in subjects with diabetes. intervention 3: 400 IU per ml - dosage based on the I...
intervention 1: Medtronic MiniMed Implantable Pump Human Recombinant Insulin intervention 2: Medtronic MiniMed Implantable Pump System intervention 3: Aventis HOE21PH U400
5
Santa Barbara | California | United States | -119.69819 | 34.42083 Aurora | Colorado | United States | -104.83192 | 39.72943 North Kansas City | Missouri | United States | -94.56218 | 39.13 Wooser | Ohio | United States | N/A | N/A San Antonio | Texas | United States | -98.49363 | 29.42412
107
0
0
0
NCT00211536
1COMPLETED
2008-09-01
2002-06-01
Medtronic Diabetes
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 ]
20
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
true
0ALL
true
Although nasal polyposis has been recognized as an inflammatory process for many years, the true etiology of nasal polyposis mainly unknown. Despite surgical removal, the recurrence rate after surgery has been reported as high as 87% within the first year after surgery. Anecdotally the Principal Investigator found an i...
Although nasal polyposis has been recognized as an inflammatory process for many years, the true etiology of nasal polyposis mainly unknown. Despite surgical removal, the recurrence rate after surgery has been reported as high as 87% within the first year after surgery. Anecdotally the Principal Investigator found an i...
Nasal Polyps Gastroesophageal Reflux
Nasal polyps Gastroesophageal Reflux
null
0
null
null
1
[ 0 ]
intervention 1: Lansoprazole 30 mg BID for 1 year
intervention 1: lansoprazole
1
Indianapolis | Indiana | United States | -86.15804 | 39.76838
0
0
0
0
NCT00215787
1COMPLETED
2008-09-01
2005-09-01
Head and Neck Surgery Associates
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 ]
57
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This study will evaluate the safety and effectiveness of an anticholinergic drug treatment administered by transdermal patch to treat overactive bladder in children who have a neurological condition (e.g. spina bifida) that contributes to their overactive bladder.
This study will use a multicenter, randomized, open-label, active-controlled, dose-titration, parallel group design, in approximately pediatric patients with detrusor overactivity associated with a neurological condition.
Detrusor Hyperreflexia
null
2
arm 1: Oxybutynin Transdermal System 1.3 mg/day, 2.6 mg/day, or 3.9 mg/day arm 2: 5 to 15 mg/day immediate release or extended release tablets, or syrup
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: 1.3, 2.6, 3.9 mg/day transdermal intervention 2: 5 to 15 mg/day immediate release or extended release tablets, or syrup
intervention 1: Oxybutynin intervention 2: Oxybutynin
23
Little Rock | Arkansas | United States | -92.28959 | 34.74648 Orange County | California | United States | N/A | N/A San Diego | California | United States | -117.16472 | 32.71571 Denver | Colorado | United States | -104.9847 | 39.73915 Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 Detro...
55
0
0
0
NCT00224016
1COMPLETED
2008-09-01
2004-12-01
Watson Pharmaceuticals
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
473
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
This is a study of the safety and efficacy of tigecycline to ceftriaxone sodium plus metronidazole in hospitalized subjects with cIAI. Subjects will be followed for efficacy through the test-of-cure assessment. Safety evaluations will occur through the treatment and post-treatment periods and continue through resolutio...
null
Appendicitis Cholecystitis Diverticulitis Intra-Abdominal Abscess Intra-Abdominal Infection Peritonitis
Intra-Abdominal Infections Abscess
null
2
arm 1: None arm 2: None
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours) intervention 2: Ceftriaxone sodium 2 g once daily intravenously plus metronidazole 1 g to 2 g daily given in divided doses intravenously. Test article should be administered for a minimum of 4 days and up to 14 days at the di...
intervention 1: tigecycline intervention 2: ceftriaxone plus metronidazole
68
Nambour | Queensland | Australia | 152.95941 | -26.62613 Cairns | N/A | Australia | 145.76613 | -16.92366 Parkville | N/A | Australia | 144.95 | -37.78333 Shanghai | N/A | China | 121.45806 | 31.22222 Odense | N/A | Denmark | 10.38831 | 55.39594 Lahti | N/A | Finland | 25.66151 | 60.98267 Seinäjoki | N/A | Finland | 22...
467
0
0
0
NCT00230971
1COMPLETED
2008-09-01
2005-10-01
Wyeth is now a wholly owned subsidiary of Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
52
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
Randomized clinical trial of sertraline vs. placebo for post-TBI depression
Purpose: The purpose of this study is to document the efficacy of sertraline (Zoloft) in the treatment of depression (major depressive disorder) after TBI, including the impact on quality of life. Researchers will also explore the effects of sertraline on anxiety disorders, which often accompany post-TBI depression. B...
Depression
Sertraline TBI depression SSRI brain injury
null
2
arm 1: Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg). arm 2: Placebo for 10 weeks.
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Sertraline arm intervention 2: Placebo
intervention 1: Sertraline intervention 2: Placebo
1
New York | New York | United States | -74.00597 | 40.71427
41
0
0
0
NCT00233103
1COMPLETED
2008-09-01
2003-06-01
Icahn School of Medicine at Mount Sinai
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 ]
52
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This research project is an open-label, randomized study for the use of Nitric Oxide in pediatric patients with acute respiratory distress syndrome (ARDS). The study examines whether nitric oxide (NO) treatment impacts the the P:F ratio (arterial partial pressure of oxygen (PaO2) divided by fraction of inspired oxygen ...
At low concentrations, nitric oxide(NO) functions as a cellular messenger and regulator of microcirculation. NO may have an important role in the pathogenesis of ARDS as well as its treatment. NO may be primarily useful in improving matching of ventilation and perfusion in the lung. The aims of the study are to attempt...
Acute Respiratory Distress Syndrome
Acute Respiratory Distress Syndrome ARDS Nitric Oxide
null
2
arm 1: Subjects will be randomized to receive Nitric Oxide (NO) immediately after study entry, given at 10 parts per million (ppm) for the first 4 hours of study participation. Blood gases will be monitored once an hour for 4 hours. After the first 4 hours of study participation, the nitric oxide (NO) will be turned of...
[ 1, 1 ]
2
[ 0, 10 ]
intervention 1: Subjects will receive inhaled Nitric Oxide at a dose of 10 parts per million (ppm) for a 4 hour study period. Blood gases will be collected once an hour. intervention 2: Subjects will receive no intervention (i.e., no nitric oxide treatment) for a 4 hour study period. Blood gases will be collected once ...
intervention 1: Nitric Oxide intervention 2: No Intervention
1
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
52
0
0
0
NCT00240487
1COMPLETED
2008-09-01
2000-09-01
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
[ 5 ]
39
RANDOMIZED
SINGLE_GROUP
0TREATMENT
2DOUBLE
true
2MALE
true
This study will look at the effects of a soy supplement called Revival on memory, quality of life, and hot flashes in men with prostate cancer who are being treated with testosterone suppression therapy. Hypothesis: Treating men who have prostate CA with daily Revival will result in at least a 50% reduction in hot flas...
This research study will look at the effects of a soy supplement called Revival on memory, quality of life, and hot flashes in men with prostate cancer who are undergoing (ADT) androgen deprivation therapy. Participants will be given either placebo or Revival. Participants will be asked to take their supplement once/da...
Hot Flashes
prostate cancer soy androgen deprivation quality of life isoflavones
null
2
arm 1: Isoflavone arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: Isoflavone intervention 2: Placebos
1
Baltimore | Maryland | United States | -76.61219 | 39.29038
33
0
0
0
NCT00245518
1COMPLETED
2008-09-01
2005-06-01
Johns Hopkins 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 ]
93
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
This study will evaluate the effectiveness of atomoxetine in reducing the symptoms of attention deficit hyperactivity disorder (ADHD) in young children.
Attention deficit hyperactivity disorder (ADHD) is one of the most common mental disorders in children. Children with ADHD often have impaired functioning in home and school and usually experience difficulty relating to peers. If left untreated, the disorder can have long-term adverse effects into adolescence and adult...
Attention Deficit Disorder With Hyperactivity
ADHD Atomoxetine
null
2
arm 1: atomoxetine capsules, dose 0.5mg/kg/day to 1.8mg/kg/day administered once daily for 8 weeks arm 2: matching placebo capsules, dose 0.5mg/kg/day to 1.8mg/kg/day administered once daily for 8 weeks
[ 0, 2 ]
3
[ 0, 0, 5 ]
intervention 1: Participants will receive atomoxetine for 8 weeks up to a maximum of 1.8 mg/kg/day. Dosed once daily in capsule formulation. intervention 2: Participants will receive placebo for 8 weeks. Dosed once daily, capsule formulation. intervention 3: All children will receive parent training for the duration of...
intervention 1: Atomoxetine intervention 2: Placebo intervention 3: Parent Training
3
Omaha | Nebraska | United States | -95.94043 | 41.25626 New York | New York | United States | -74.00597 | 40.71427 Durham | North Carolina | United States | -78.89862 | 35.99403
93
0
0
0
NCT00254462
1COMPLETED
2008-09-01
2005-10-01
University of Nebraska
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
7
RANDOMIZED
PARALLEL
4SUPPORTIVE_CARE
0NONE
false
0ALL
true
RATIONALE: Epoetin alfa may cause the body to make more red blood cells. It is used to treat anemia caused by cancer and chemotherapy. It may also help relieve fatigue in patients with anemia. PURPOSE: This randomized clinical trial is studying how well epoetin alfa works in treating patients with anemia who are under...
OBJECTIVES: Primary * Determine the efficacy, in terms of maintenance of target hemoglobin and hematocrit levels, of interval dosing with epoetin alfa in treating patients with anemia undergoing chemotherapy for nonhematologic cancer. Secondary * Determine the pharmacokinetics and pharmacodynamics of this drug in t...
Anemia Fatigue Unspecified Adult Solid Tumor, Protocol Specific
fatigue anemia unspecified adult solid tumor, protocol specific
null
3
arm 1: Weekly dosing schedule subjects will get the study drug once every week until the end of the study. arm 2: Interval-dosing schedule subjects will get the study drug once every week until hematocrit is greater than 36% or Hemoglobin reaches a value of 12 g/dl, then they will get study drug once every other week. ...
[ 1, 0, 0 ]
2
[ 0, 0 ]
intervention 1: The dose is standard of care, the investigational piece is the dosing schedule itself. Either weekly or Interval-dosing schedule subjects will get the study drug once every week until hematocrit is greater than 36% or Hemoglobin reaches a value of 12 g/dl, then they will get study drug once every other ...
intervention 1: Weekly procrit dosing intervention 2: Interval Dosing
1
Portland | Oregon | United States | -122.67621 | 45.52345
7
0
0
0
NCT00258440
6TERMINATED
2008-09-01
2003-05-01
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
[ 5 ]
406
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
Omalizumab will be given as add-on treatment to optimized asthma therapy in patients with severe persistent asthma, who demonstrate inadequate asthma symptom control. Response to omalizumab over time will be assessed by physicians and patients evaluating the overall improvement in control of their asthma. THIS STUDY I...
null
Asthma
Asthma omalizumab Severe persistent allergic asthma
null
2
arm 1: During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection...
[ 0, 1 ]
2
[ 0, 10 ]
intervention 1: Omalizumab administered by subcutaneous injection. The dosage received was individualized based on body weight and serum IgE level. intervention 2: Optimized asthma therapy (OAT) according to Global Initiative for Asthma (GINA) 2004 guidelines during the first 4 weeks of the run-in period of the study.
intervention 1: Omalizumab intervention 2: Optimized asthma therapy
17
Brussels | N/A | Belgium | 4.34878 | 50.85045 Montreal | N/A | Canada | -73.58781 | 45.50884 Hvidovre | N/A | Denmark | 12.47708 | 55.64297 Berlin | N/A | Germany | 13.41053 | 52.52437 Athens | N/A | Greece | 23.72784 | 37.98376 Budapest | N/A | Hungary | 19.04045 | 47.49835 Dublin | N/A | Ireland | -6.24889 | 53.33306...
402
0
0
0
NCT00264849
1COMPLETED
2008-09-01
2005-11-01
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
[ 4 ]
1,565
RANDOMIZED
PARALLEL
1PREVENTION
3TRIPLE
true
1FEMALE
true
This is a multicenter, randomized, double-masked, controlled, phase III study of repeated use of C31G vaginal gel compared to Conceptrol® Vaginal Gel as the primary method of contraception over six months (183 days) and at least six cycles of use. In addition, there is an opportunity for subjects to continue with study...
Approximately 85% of American women (52 million) between the ages of 15 and 44 are sexually active . Approximately two-thirds or 38 million women use some form of birth control and/or STD prevention. With growing awareness of the risk of STDs, increasing numbers of women will require contraceptive methods that provide ...
Pregnancy
contraception
null
2
arm 1: C31G vaginal gel contains 35mg (1% concentration) of C31G in 3.5 mL volume of gel arm 2: Conceptrol® Vaginal gel contains 100mg (4% concentration) of nonoxynol-9 (N-9) in 2.5 mL volume of gel.
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: The subject will insert one applicator of C31G prior to each episode of vaginal intercourse during her participation in the study. intervention 2: The subject will insert one applicator of Conceptrol® vaginal gel (nonoxynol-9) prior to each episode of vaginal intercourse during her participation in the ...
intervention 1: C31G intervention 2: nonoxynol-9 (N-9)
15
Berkeley | California | United States | -122.27275 | 37.87159 Los Angeles | California | United States | -118.24368 | 34.05223 Aurora | Colorado | United States | -104.83192 | 39.72943 Baltimore | Maryland | United States | -76.61219 | 39.29038 Springfield | Massachusetts | United States | -72.58981 | 42.10148 New York...
1,396
0
0
0
NCT00274261
1COMPLETED
2008-09-01
2004-06-01
Health Decisions
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 ]
40
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
true
0ALL
false
The purpose of this research study is to investigate different doses of proton pump inhibitors in reducing cough symptoms felt to be associated with Gastroesophageal reflux disease (GERD). Proton pump inhibitors are medicines used to treat GERD, which work by lowering the amount of acid in the stomach. The proton pump...
This study will be a randomized, double-blind, placebo controlled, comparative parallel-group trial of subjects with chronic cough of unknown origin presenting to the Otolaryngology/ Head and Neck Surgery, Pulmonary Medicine, and Gastroenterology outpatient clinics at the University of North Carolina Hospital system. ...
Cough GERD
Cough GERD
null
2
arm 1: 40mg Esomeprazole BID arm 2: placebo capsules
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 40mg capsule BID for 12 weeks intervention 2: placebo capsule BID for 12 weeks
intervention 1: Esomeprazole intervention 2: Placebo
1
Chapel Hill | North Carolina | United States | -79.05584 | 35.9132
40
0
0
0
NCT00287339
1COMPLETED
2008-09-01
2005-09-01
University of North Carolina, Chapel Hill
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
1,523
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The aim of the study is to investigate the effect of roflumilast on exacerbation rate and pulmonary function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be administered orally once daily in the morning at one dose level. The study duration will last up to 56 weeks. The study will pro...
null
Chronic Obstructive Pulmonary Disease (COPD)
Roflumilast COPD Chronic obstructive pulmonary disease
null
2
arm 1: 500 mcg, once daily, oral administration in the morning arm 2: once daily
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: 500 mcg, once daily, oral administration in the morning intervention 2: once daily
intervention 1: Roflumilast intervention 2: Placebo
179
Fullerton | California | United States | -117.92534 | 33.87029 Los Angeles | California | United States | -118.24368 | 34.05223 Los Angeles | California | United States | -118.24368 | 34.05223 Palmdale | California | United States | -118.11646 | 34.57943 Rancho Mirage | California | United States | -116.41279 | 33.7397...
1,524
0
0
0
NCT00297102
1COMPLETED
2008-09-01
2006-02-01
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
[ 4 ]
37
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
The aim of this study is to compare the responsiveness of lower airways in adult patients with stable asthma after treatment with ciclesonide and fluticasone propionate. Treatment medication will be administered as follows: ciclesonide will be inhaled once daily at one dose level, fluticasone propionate will be inhaled...
null
Asthma
Asthma AMP Ciclesonide Fluticasone propionate
null
2
arm 1: Ciclesonide 160 µg arm 2: Fluticasone 100 µg
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: inhaled Ciclesonide 160 µg, once daily in the morning intervention 2: inhaled Fluticasone 100 µg, twice daily
intervention 1: Ciclesonide intervention 2: Fluticasone
1
RB Groningen | N/A | Netherlands | N/A | N/A
37
0
0
0
NCT00306163
1COMPLETED
2008-09-01
2006-05-01
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 ]
60
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
false
0ALL
null
The purpose of this study is to determine whether food has any effect on a single dose of Cediranib (AZD2171, Recentin™)followed by an assessment of the safety and tolerability of fixed daily dosing in comparison to varying dose levels on a patient-by-patient basis.
null
Cancer
Advanced solid tumours Advanced cancer tumor tumour RECENTIN
null
4
arm 1: Part A: Cediranib 45 mg Fed State arm 2: Part A: Cediranib 45 mg Fasted State arm 3: Part B: Cediranib 45 mg Fixed Dose arm 4: Part B: Cediranib 30 - 90 mg Dose Escalation
[ 0, 0, 0, 0 ]
2
[ 0, 0 ]
intervention 1: 45 mg oral dose intervention 2: oral tablet dose escalation
intervention 1: Cediranib intervention 2: Cediranib 30 - 90 mg
4
Glasgow | N/A | United Kingdom | -4.25763 | 55.86515 Headington | N/A | United Kingdom | -1.21974 | 51.75737 London | N/A | United Kingdom | -0.12574 | 51.50853 Manchester | N/A | United Kingdom | -2.23743 | 53.48095
86
0
0
0
NCT00306891
1COMPLETED
2008-09-01
2006-06-01
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
[ 4 ]
677
RANDOMIZED
PARALLEL
1PREVENTION
0NONE
false
0ALL
null
The purpose of this 13 month study (12 month treatment period and 1 month follow-up period) is to determine whether inhaled insulin is safe and effective in the treatment of type 2 diabetes.
null
Diabetes Type 2
null
2
arm 1: Technosphere® Insulin Inhalation Powder + insulin glargine arm 2: 70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Inhalation, 15U/30U intervention 2: BPR 70/30, which is a premix of intermediate acting and rapid acting insulin given sc
intervention 1: Technosphere® Insulin Inhalation Powder intervention 2: 70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
151
Mobile | Alabama | United States | -88.04305 | 30.69436 Tucson | Arizona | United States | -110.92648 | 32.22174 Tucson | Arizona | United States | -110.92648 | 32.22174 Tucson | Arizona | United States | -110.92648 | 32.22174 Chula Vista | California | United States | -117.0842 | 32.64005 Fresno | California | United ...
654
0
0
0
NCT00309244
1COMPLETED
2008-09-01
2006-02-01
Mannkind Corporation
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
-0
[ 3 ]
11
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
Sarcoidosis is a rare disease that can affect any organ in the body. It is characterized by the buildup of immune-system (fights off infection in the body) cells in organs. These cells form small groups called granulomas, which lead to inflammation of the surrounding tissue. Sarcoidosis most commonly affects the lung a...
This study consists of 11 visits (including screening). Screening Procedures: A chest radiograph (PA and lateral) must be obtained within 3 months prior to the first study injection. It must indicate that subject is free of tuberculosis (TB). The chest radiograph will also be used to confirm the stage of the disease....
Sarcoidosis
Sarcoidosis Humira Adalimumab Tumor Necrosis Factor Inhibitors
null
1
arm 1: Patients received adalimumab 40 mg weekly for 45 weeks, with a final follow-up at Week 52
[ 0 ]
1
[ 0 ]
intervention 1: Subjects will give themselves a dose of Adalimumab at 40 mg/every week by subcutaneous injection for a total of 45 weeks.
intervention 1: Adalimumab
1
Chicago | Illinois | United States | -87.65005 | 41.85003
11
0
0
0
NCT00311246
6TERMINATED
2008-09-01
2006-04-01
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
[ 4 ]
768
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
The purpose of this trial is to understand if adding saxagliptin to a sulfonylurea is safe and works better than increasing the amount of sulfonylurea a patient takes
All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requ...
Diabetes
null
3
arm 1: Metformin 500-2500 mg (as needed) arm 2: Metformin 500-2500 mg (as needed) arm 3: Metformin 500-2500 mg (as needed)
[ 0, 0, 2 ]
6
[ 0, 0, 0, 0, 0, 0 ]
intervention 1: Tablets, Oral, 2.5 mg, Daily AM, (24 weeks short-term \[ST\], 12 months long-term \[LT\]) intervention 2: Tablets, Oral, 5 mg, Daily AM (24 weeks ST, 12 months LT). intervention 3: Capsules, Oral, OL, 7.5 mg, Daily, AM (24 weeks ST, 12 months LT) intervention 4: Tablets, Oral, 0 mg, Daily AM/PM, (24 wee...
intervention 1: Saxagliptin intervention 2: Saxagliptin intervention 3: Glyburide intervention 4: Placebo intervention 5: Glyburide intervention 6: Metformin
115
Jonesboro | Arkansas | United States | -90.70428 | 35.8423 Searcy | Arkansas | United States | -91.73625 | 35.25064 Alhambra | California | United States | -118.12701 | 34.09529 Fountain Valley | California | United States | -117.95367 | 33.70918 Fresno | California | United States | -119.77237 | 36.74773 Los Angeles |...
768
0
0
0
NCT00313313
1COMPLETED
2008-09-01
2006-04-01
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
[ 5 ]
220
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
Efficacy and Safety of flexibly dosed pregabalin compared to placebo among subjects with central post stroke pain (CPSP)
null
Central Neuropathic Pain
Post-stroke pain, pregabalin
null
2
arm 1: The change from in pain scores from baseline to endpoint among stroke subjects receiving pregabalin will be compared to change in pain scores from baseline to endpoint among stroke subjects receiving matched placebo. arm 2: The change in pain scores from baseline to endpoint will be compared among the two treatm...
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Eligible subjects with post-stroke central pain will be randomized to receive double blinded treatment using pregabalin or matched placebo. The effects of pregabalin as compared to placebo on pain pain symptoms will be compared over the 13 week clinical trial. At baseline following pain ratings and clin...
intervention 1: Pregabalin intervention 2: Placebo
33
Darlinghurst | New South Wales | Australia | 151.21925 | -33.87939 East Gosford | New South Wales | Australia | 151.35338 | -33.43874 St Leonards | New South Wales | Australia | 151.19836 | -33.82344 Warrawong | New South Wales | Australia | 150.88833 | -34.485 Herston | Queensland | Australia | 153.01852 | -27.44453 F...
219
0
0
0
NCT00313820
1COMPLETED
2008-09-01
2006-08-01
Pfizer's Upjohn has merged with Mylan to form Viatris 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 ]
225
RANDOMIZED
PARALLEL
1PREVENTION
3TRIPLE
false
0ALL
true
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of budesonide may keep lung cancer from forming in patients with lung nodules. PURPOSE: This randomized phase II trial is studying how well inhalation budesonide works in treating patients with lung nod...
OBJECTIVES: Primary * Evaluate the effect, in terms of size and number reduction of computed tomography (CT) scan-detected undetermined lung nodules, in asymptomatic subjects with lung nodules at high-risk for developing lung cancer treated with inhaled budesonide vs placebo. Secondary * Compare average modificatio...
Lung Cancer
Small cell lung cancer Non-small cell lung cancer Budesonide Entocort EC Pulmicort Respules Rhinocort aqua Aerosol budesonide treatment Smoking
null
2
arm 1: Inhaled Budesonide 800 ug twice daily for 1 year arm 2: Inhaled placebo twice daily for 1 year
[ 0, 2 ]
2
[ 0, 10 ]
intervention 1: Inhaled Budesonide 800 micrograms (ug) twice daily for one year. intervention 2: Inhaled placebo twice daily for one year.
intervention 1: Budesonide intervention 2: Placebo
1
Milan | N/A | Italy | 9.18951 | 45.46427
199
0
0
0
NCT00321893
1COMPLETED
2008-09-01
2006-01-01
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 ]
92
NON_RANDOMIZED
SINGLE_GROUP
2DIAGNOSTIC
0NONE
false
0ALL
false
The purpose of this study was to assess the safety and enhancing properties of the magnetic resonance imaging (MRI) contrast agent MultiHance in children aged 2 to 17 years having central nervous system (CNS) disorders.
null
Central Nervous System Diseases
disease of the central nervous system (brain or spine)
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: A dose of 0.10 mmol/kg (i.e., 0.2 mL/kg) of 0.5 molar MultiHance was injected intravenously at a rate of 2 mL/sec as a single dose.
intervention 1: gadobenate dimeglumine
1
Princeton | New Jersey | United States | -74.65905 | 40.34872
92
0
0
0
NCT00323310
6TERMINATED
2008-09-01
2006-04-01
Bracco Diagnostics, Inc
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
404
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This is an initial placebo-controlled study followed by open treatment evaluating the effectiveness and tolerability of ropinirole long-term in patients with moderate to severe Restless Legs Syndrome.
A randomised, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of ropinirole for 26 weeks and to further evaluate the incidence of augmentation and rebound for a further 40 weeks open-label extension treatment period in subjects suffering from moderate to severe Restless Legs S...
Restless Legs Syndrome
Moderate Restless Legs Syndrome Severe ropinirole
null
2
arm 1: Double-blind (Ropinirole:Placebo) for 12 to 26 weeks arm 2: Open label ropinirole for 40 weeks
[ 2, 5 ]
2
[ 0, 0 ]
intervention 1: Matching Placebo intervention 2: Ropinirole IR 0.25mg/day to 4mg/day for RLS
intervention 1: Placebo intervention 2: Ropinirole
39
Camperdown | New South Wales | Australia | 151.17642 | -33.88965 Kippa-Ring | Queensland | Australia | 153.0835 | -27.22586 Woodville | South Australia | Australia | 138.54291 | -34.877 Clayton | Victoria | Australia | 145.11667 | -37.91667 East Melbourne | Victoria | Australia | 144.9879 | -37.81667 Olomouc | N/A | Cz...
673
0
0
0
NCT00329602
1COMPLETED
2008-09-01
2006-03-01
GlaxoSmithKline
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
206
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The primary objective of this study is to confirm the efficacy of 60 mg of MCI-186 via intravenous drip once a day in patients with ALS based on the changes in the revised ALS functional rating scale (ALSFRS-R) scores after 24 weeks administration in double-blind, placebo-controlled manner. And in addition, this study ...
null
Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic lateral sclerosis free radical scavenger
null
2
arm 1: MCI-186 arm 2: Placebo of MCI-186
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Two ampoules (60 mg) of MCI-186 injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles). intervention 2...
intervention 1: MCI-186 intervention 2: Placebo of MCI-186
0
null
206
0
0
0
NCT00330681
1COMPLETED
2008-09-01
2006-05-01
Mitsubishi Tanabe Pharma Corporation
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 ]
95
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
A comparison of prophylactic treatment with reactive treatment for skin toxicity observed in patients with metastatic colorectal cancer (mCRC) who are receiving second-line irinotecan-based chemotherapy concomitantly with panitumumab.
null
Metastatic Colorectal Cancer Skin Rash Skin Toxicities Colon Cancer Colorectal Cancer
STEPP STEP STEEP mCRC Skin Toxicities Skin Rash Metastatic Colorectal Cancer Anti-EGFr Skin Rash colon cancer colorectal cancer rectal cancer
null
2
arm 1: Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to c...
[ 0, 0 ]
5
[ 2, 0, 0, 0, 0 ]
intervention 1: Administered by intravenous infusion intervention 2: Recommended dosage regimen and administration of irinotecan was based on local standard of care, the package insert, and institutional guidelines. intervention 3: Chemotherapy consisting of irinotecan with infusional 5-fluorouracil and leucovorin. Rec...
intervention 1: Panitumumab intervention 2: Irinotecan intervention 3: FOLFIRI intervention 4: Pre-emptive Skin Treatment intervention 5: Reactive Skin Treatment
0
null
95
0
0
0
NCT00332163
1COMPLETED
2008-09-01
2006-04-01
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 ]
25
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
The goal of the proposed study is to evaluate the efficacy and safety of naltrexone in kleptomania.
The proposed study will consist of 8 weeks of treatment with either naltrexone or placebo in 20 subjects with kleptomania. The hypothesis to be tested is that naltrexone will be effective in reducing the urges to steal in patients with kleptomania. The proposed study will provide needed data on the treatment of a disab...
Kleptomania
Compulsive Shoplifting Kleptomania Compulsive Stealing
null
2
arm 1: Naltrexone arm 2: Placebo
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: daily intervention 2: daily
intervention 1: Naltrexone intervention 2: Placebo
1
Minneapolis | Minnesota | United States | -93.26384 | 44.97997
25
0
0
0
NCT00332579
1COMPLETED
2008-09-01
2006-05-01
University of Minnesota
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 ]
64
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
To evaluate in combination with corticosteroid and local standard medical care the efficacy and safety of long-acting octreotide compared to placebo for the treatment of symptoms of inoperable bowel obstruction in patients with peritoneal carcinomatosis
null
Peritoneal Neoplasms Intestinal Obstruction Carcinomatosis
bowel obstruction, peritoneal carcinomatosis Octreotide inoperable
null
2
arm 1: Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection o...
[ 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Octreotide long-acting release (LAR) 30 mg intramuscular injection. intervention 2: Immediate-release Octreotide supplied in 100 µg/mL ampules. intervention 3: methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections). intervention 4: Physiologic saline solution
intervention 1: Octreotide LAR intervention 2: Octreotide (Immediate release) intervention 3: methylprednisolone intervention 4: Placebo
1
Créteil | N/A | France | 2.46569 | 48.79266
64
0
0
0
NCT00332696
1COMPLETED
2008-09-01
2005-09-01
Novartis Pharmaceuticals
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
16
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
The primary objective of this study is to determine the maximum tolerated dose (MTD) or the maximum administered dose (MAD) of Dasatinib (BMS-354825) in patients in Japan.
null
Tumors
Solid tumors (including relapsed disease) that are refractory to standard therapies or for which no effective standard therapy exists
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: tablets, Oral, 100 mg, once daily for 4 weeks intervention 2: tablets, Oral, 150 mg, once daily, 4 weeks intervention 3: tablets, Oral, 200 mg, once daily for 4 weeks
intervention 1: Dasatinib intervention 2: Dasatinib intervention 3: Dasatinib
2
Sayama | Osaka | Japan | 135.56298 | 34.51685 Koto-Ku | Tokyo | Japan | N/A | N/A
16
0
0
0
NCT00339144
1COMPLETED
2008-09-01
2007-01-01
Bristol-Myers Squibb
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 ]
388
null
PARALLEL
0TREATMENT
null
false
0ALL
null
This is a 16 week multicentre, multinational, randomised, double-blind, double-dummy, placebo-controlled, parallel group study to evaluate the long-term efficacy and safety of tiotropium compared to salmeterol in moderate persistent asthmatic (GINA step 3) patients homozygous for arginine at the 16th amino acid positio...
null
Asthma
null
0
null
null
3
[ 0, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: None
intervention 1: Tiotropium bromide intervention 2: Placebo intervention 3: Salmeterol xinafoate
109
Graz | N/A | Austria | 15.45 | 47.06667 Trofaiach | N/A | Austria | 15.00681 | 47.42524 Vienna | N/A | Austria | 16.37208 | 48.20849 Vienna | N/A | Austria | 16.37208 | 48.20849 Vienna | N/A | Austria | 16.37208 | 48.20849 Vienna | N/A | Austria | 16.37208 | 48.20849 Wels | N/A | Austria | 14.03333 | 48.16667 Anderlech...
388
0
0
0
NCT00350207
1COMPLETED
2008-09-01
2006-07-01
Boehringer Ingelheim
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 ]
8
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
This is a Phase I/II trial of elderly patients (\> 70 years of age). Patients in this age group with previously un-treated Advanced Stage Non-Squamous Non-Small Cell Lung Cancer (NSCLC) with Stage IIIB (with malignant pleural effusion) and stage IV disease will be enrolled. Therapy consists of three drugs (Premetrexed\...
This is a Phase I/II trial of elderly patients (\> 70 years of age) with previously un-treated Advanced Stage Non-Squamous NSCLC with Stage IIIB (with malignant pleural effusion) and stage IV disease will be enrolled. Treatment Regimen: Premetrexed (Alimta™) 500 milligrams(mg)/Meter squared(m20 Intravenous(I.V.) Day ...
Non-Small Cell Lung Cancer
null
1
arm 1: Single Arm Phase II trial in elderly patients with advanced stage Non-Squamous Non-Small Cell Lung Cancer
[ 0 ]
3
[ 0, 0, 0 ]
intervention 1: Treatment Regimen Item 1: Bevacizumab 10 mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days. intervention 2: Treatment Regimen Item 2: Erlotinib 150mg Per Orally (PO) Once Daily (QD) for 7 days starting day 2 and day 15. Repeat cycles every 28 days. intervention 3: Treatment Regimen Item 3: Preme...
intervention 1: Bevacizumab intervention 2: Erlotinib intervention 3: Pemetrexed
1
Tampa | Florida | United States | -82.45843 | 27.94752
8
0
0
0
NCT00351039
6TERMINATED
2008-09-01
2006-07-01
H. Lee Moffitt Cancer Center and Research 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
[ 4 ]
42
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
Reactive arthritis, also known as Reiter's syndrome, is a form of arthritis that occurs as a reaction to an infection elsewhere in the body. It is characterized by inflammation of the joints, tendons, urogenital tract, and eyes. Pain and swelling in the knees, ankles, and feet are common. This study will determine the ...
The initial infection that causes reactive arthritis is caused by one of two bacteria: Chlamydia trachomatis, which is usually acquired through sexual contact, or Chlamydia pneumoniae, which can cause respiratory infections. Most people recover fully from the initial flare of arthritis symptoms. However, about 20% of p...
Arthritis, Reactive Reiter Disease
Chlamydia
null
3
arm 1: Participants received Azithromycin and Rifampin arm 2: Participants received Doxycycline and Rifampin arm 3: Participants received placebo
[ 1, 1, 2 ]
3
[ 0, 0, 0 ]
intervention 1: doxycycline 100mg daily; rifampin 300mg daily (both for 6 months) intervention 2: Azithromycin 500mg daily for 5 days and then twice weekly; Rifampin 300mg daily (both for 6 months) intervention 3: Methylcellulose
intervention 1: Doxycycline and Rifampin intervention 2: Azithromycin and Rifampin intervention 3: Placebo
3
Tampa | Florida | United States | -82.45843 | 27.94752 New Orleans | Louisiana | United States | -90.07507 | 29.95465 Toronto | Ontario | Canada | -79.39864 | 43.70643
42
0
0
0
NCT00351273
1COMPLETED
2008-09-01
2006-05-01
University of South Florida
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 ]
50
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
This is a 12-week, double-blind study of N-Acetyl Cysteine in the treatment of trichotillomania
The goal of the proposed study is to evaluate the efficacy and safety of N-Acetyl Cysteine (NAC) in trichotillomania. Forty subjects with DSM-IV trichotillomania will receive 12 weeks of double-blind NAC or placebo. The hypothesis to be tested is that NAC will be effective and well tolerated in patients with trichotill...
Trichotillomania
Trichotillomania Hair-pulling
null
2
arm 1: N-Acetyl Cysteine arm 2: Placebo
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: daily intervention 2: 600mg capsules in varying doses for 12 weeks.
intervention 1: Placebo intervention 2: N-Acetyl Cysteine
1
Chicago | Illinois | United States | -87.65005 | 41.85003
50
0
0
0
NCT00354770
1COMPLETED
2008-09-01
2006-07-01
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
[ 3 ]
10
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
We are doing this research study to evaluate the effectiveness and safety of fluphenazine decanoate when injected with a needle into psoriasis lesions in adults. Fluphenazine decanoate is FDA (U.S. Food and Drug Administration) approved for use in people who have schizophrenia and psychotic symptoms. Fluphenazine decan...
Psoriasis is a hyperproliferative, inflammatory, immune-mediated skin disease that affects approximately 2% of the United States and European populations (Tutrone 2001, Kipnis 2005). This disease manifests as red, scaly plaques that are itchy and/or painful. Patients with psoriasis may be socially stigmatized because o...
Psoriasis
null
2
arm 1: Treated with fluphenazine arm 2: Treated with Placebo
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Fluphenazine decanoate marketed by APP Pharmaceuticals (25 mg/mL, 5 mL vial) was used in this study. This was an ascending dose study with the first cohort of 5 subjects dosed at 10 µg/mL, followed by 5 subject dosed in the second cohort at 100 µg/mL. Note: "APP Pharmaceuticals" is the name of the pharm...
intervention 1: Fluphenazine Decanoate intervention 2: Placebo
1
Boston | Massachusetts | United States | -71.05977 | 42.35843
10
0
0
0
NCT00356200
6TERMINATED
2008-09-01
2006-07-01
Tufts 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
[ 2 ]
12
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
Phase I trial, dose escalating, prospective, open-label, non-randomized, multicenter study. The purpose is to determine the safety, tolerability, dose limiting toxicity (DLT) and recommended dose (RD) of PM00104, administered intravenously over 1 hour daily for 5 days every 3 weeks (this is considered as 1 cycle) to su...
Phase I trial, dose escalating, prospective, open-label, non-randomized, multicenter study. The purpose is to determine the safety, tolerability, dose limiting toxicity (DLT) and recommended dose (RD) of PM00104, administered intravenously over 1 hour daily for 5 days every 3 weeks (this is considered as 1 cycle) to su...
Solid Tumors Lymphoma
Tumor Lymphoma Zalypsis PharmaMar PM00104
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Intravenously over 1 hour daily for 5 days, every 3 weeks.
intervention 1: PM00104
2
Boston | Massachusetts | United States | -71.05977 | 42.35843 Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
11
0
0
0
NCT00359294
6TERMINATED
2008-09-01
2006-05-01
PharmaMar
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 ]
171
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of this study is to investigate efficacy and safety of different doses of AC-3933 in patients with mild to moderate Alzheimer's Disease.
null
Alzheimer's Disease
Alzheimer Dementia
null
3
arm 1: AC-3933, 5mg twice daily arm 2: AC-3933, 20 mg twice daily arm 3: Sugar Pill twice daily
[ 0, 0, 2 ]
3
[ 0, 0, 10 ]
intervention 1: 5mg twice daily intervention 2: AC-3933, 20 mg twice daily intervention 3: Sugar Pill twice daily
intervention 1: AC-3933 intervention 2: AC-3933 intervention 3: Sugar Pill
34
LIttle Rock | Alaska | United States | N/A | N/A 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 Berkeley | California | United States | -122.27275 | 37.87159 Fresno | California | Un...
154
0
0
0
NCT00359944
1COMPLETED
2008-09-01
2006-02-01
Sumitomo Pharma America, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
-0
[ 5 ]
17
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
true
0ALL
false
People with allergies frequently complain of a loss or reduction in the sense of smell. In this study, the investigators propose to perform a randomized, double blind, placebo controlled parallel study of subjects with nasal allergies and decreased smell to determine the effect of a treatment for allergies on the sens...
null
Seasonal Allergic Rhinitis
null
2
arm 1: Mometasone intranasal steroid therapy daily for 2 weeks arm 2: 2 puffs of placebo spray in each nostril once daily
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: 2 puffs in each nostril once daily of nasal spray intervention 2: 2 puffs in each nostril once daily of nasal spray
intervention 1: Mometasone intervention 2: Placebo
1
Chicago | Illinois | United States | -87.65005 | 41.85003
17
0
0
0
NCT00361439
6TERMINATED
2008-09-01
2006-08-01
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
[ 4 ]
39
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to determine if the study drug is effective and safe in the treatment of Multiple Sclerosis (MS) in patients of Chinese origin.
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.
Multiple Sclerosis
MS
null
1
arm 1: Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
[ 0 ]
1
[ 0 ]
intervention 1: Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
intervention 1: Interferon beta-1b (Betaseron, BAY86-5046)
3
Beijing | N/A | China | 116.39723 | 39.9075 Beijing | N/A | China | 116.39723 | 39.9075 Shanghai | N/A | China | 121.45806 | 31.22222
39
0
0
0
NCT00370071
1COMPLETED
2008-09-01
2006-11-01
Bayer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
19
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Patients affected by non-small cell lung cancer (NSCLC) will be treated in pemetrexed monochemotherapy regimen for a maximum of 8 cycles. Pemetrexed is an enhancer of some biomolecules involved in the gemcitabine mechanism of action. Purpose of the trial is to monitor the blood values of these biomolecules at different...
null
Non Small Cell Lung Cancer
null
2
arm 1: None arm 2: None
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: 500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles or disease progression, unacceptable toxicity or patient decision to discontinue intervention 2: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 6 cycles or disease progression, unacceptable to...
intervention 1: Pemetrexed - Before Protocol Amendment intervention 2: Pemetrexed - After Protocol Amendment
1
Milan | N/A | Italy | 12.59836 | 42.78235
19
0
0
0
NCT00370292
1COMPLETED
2008-09-01
2006-09-01
Eli Lilly and Company
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
55
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
false
This study will determine whether the investigational drug dasatinib is effective in treatment of women with progressive advanced triple-negative breast cancer.
null
Breast Cancer Metastasis
Recurrent, locally-advanced, or 'triple negative' metastatic breast cancer
null
2
arm 1: None arm 2: None
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Tablets, Oral, 100 mg, twice daily as long as the patient benefits (avg \<6 months) intervention 2: Tablets, Oral, 70 mg, twice daily as long as the patient benefits (avg \<6 months)
intervention 1: Dasatinib intervention 2: Dasatinib
10
San Francisco | California | United States | -122.41942 | 37.77493 Jacksonville | Florida | United States | -81.65565 | 30.33218 Boston | Massachusetts | United States | -71.05977 | 42.35843 The Bronx | New York | United States | -73.86641 | 40.84985 Houston | Texas | United States | -95.36327 | 29.76328 Paris | N/A | ...
44
0
0
0
NCT00371254
1COMPLETED
2008-09-01
2006-12-01
Bristol-Myers Squibb
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 ]
26
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
true
0ALL
null
The purpose of this study is to investigate whether aripiprazole will decrease cocaine self-administration, subjective effects and cravings compared to placebo.
Despite the recent increase in data about cocaine's basic neurochemical mechanisms of action, progress towards the development of an effective pharmacological treatment for cocaine abuse has been disappointing. We are proposing to use our laboratory model of repeated dose cocaine self-administration to assess the poten...
Cocaine Abuse
Aripiprazole Cocaine abuse
null
2
arm 1: Aripiprazole (15 mg/day) in conjunction with a smoked cocaine dose-response curve (0, 12, 25, 50 mg). arm 2: Placebo (0 mg/day) in conjunction with a smoked cocaine dose-response curve (0, 12, 25, 50 mg)
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Participants received aripiprazole (15mg/day) in conjunction with a dose-response of cocaine (0, 12, 25, 50 mg). intervention 2: Placebo (0 mg/day) in conjunction with a dose-response of cocaine (0, 12, 25, 50 mg).
intervention 1: Aripiprazole + Cocaine intervention 2: Placebo + Cocaine
1
New York | New York | United States | -74.00597 | 40.71427
16
0
0
0
NCT00373880
1COMPLETED
2008-09-01
2005-04-01
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
[ 3 ]
99
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
Palifermin is a modified version of a naturally occurring human growth factor that is currently approved by the FDA to treat blood cancers. The purpose of this study is to determine whether palifermin can increase CD4 counts in treatment-experienced HIV infected adults.
Antiretroviral therapy (ART) has dramatically improved the clinical outcome for HIV infected adults; however, some people on potent ART experience poor recovery of CD4 counts despite maximum suppression of viral load. Such uncontrolled HIV infection is associated with the reduced ability by the human body to create new...
HIV Infections
Treatment Experienced
null
4
arm 1: Participants will receive palifermin placebo injection on Days 1, 2, and 3 arm 2: Participants will receive palifermin 20 mcg/kg injection on Days 1, 2, and 3 arm 3: Participants will receive palifermin 40 mcg/kg injection on Days 1, 2, and 3 arm 4: Participants will receive palifermin 60 mcg/kg injection on Day...
[ 2, 0, 0, 0 ]
2
[ 0, 0 ]
intervention 1: Keratinocyte growth factor administered via injection intervention 2: Keratinocyte growth factor placebo administered via injection
intervention 1: Palifermin intervention 2: Palifermin placebo
22
Los Angeles | California | United States | -118.24368 | 34.05223 Los Angeles | California | United States | -118.24368 | 34.05223 Palo Alto | California | United States | -122.14302 | 37.44188 San Diego | California | United States | -117.16472 | 32.71571 Torrance | California | United States | -118.34063 | 33.83585 Mi...
99
0
0
0
NCT00376935
1COMPLETED
2008-09-01
2006-12-01
National Institute of Allergy and Infectious Diseases (NIAID)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
27
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
true
The intent of this protocol is to screen a new agent for activity in patients with advanced or recurrent endometrial carcinoma. This phase II trial is studying how well pemetrexed disodium works in treating patients with advanced or recurrent endometrial carcinoma.
null
Neoplasms Neoplasms by Site Urogenital Neoplasms Genital Neoplasms, Female Uterine Neoplasms Endometrial Neoplasms Cancer of Endometrium Endometrial Cancer Cancer of the Endometrium Endometrium Cancer Neoplasms, Endometrial
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: 900 mg/m2, intravenous (IV), every 21 days, until disease progression
intervention 1: pemetrexed
1
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
26
0
0
0
NCT00377520
1COMPLETED
2008-09-01
2006-09-01
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 ]
484
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
A study of patients with type 2 diabetes and inadequate glycemic control on two or more oral antihyperglycemic agents comparing adding insulin lispro mid mixture to the oral antihyperglycemic agents to adding insulin glargine to the oral antihyperglycemic agents.
null
Diabetes Mellitus, Type 2
diabetes type 2
null
2
arm 1: Insulin lispro mid mixture (MM) up to three times a day (TID) arm 2: Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Patient specific adjusted dose, three times a day (TID), subcutaneous (SC) injection x 36 weeks intervention 2: Patient specific adjusted dose, every day (QD), subcutaneous (SC) injection x 36 weeks
intervention 1: Insulin lispro mid mixture (MM) intervention 2: Insulin glargine
25
Keswick | South Australia | Australia | 138.57459 | -34.94178 Fitzroy | Victoria | Australia | 144.97833 | -37.79839 Fremantle | Western Australia | Australia | 115.74557 | -32.05632 London | Ontario | Canada | -81.23304 | 42.98339 Granby | Quebec | Canada | -72.73243 | 45.40008 Sherbrooke | Quebec | Canada | -71.89908...
479
0
0
0
NCT00377858
1COMPLETED
2008-09-01
2006-08-01
Eli Lilly and Company
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
17
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This is a Phase II prospective, multicenter study evaluating Progression Free Survival (PFS) after first line treatment with the combination of gemcitabine, docetaxel, and bevacizumab in subjects with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC). PFS will be measured from the date of registration (ie, assi...
null
Non-small Cell Lung Cancer
null
1
arm 1: Single arm treatment with docetaxel, gemcitabine and bevacizumab
[ 0 ]
3
[ 0, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: None
intervention 1: docetaxel intervention 2: gemcitabine intervention 3: bevacizumab
1
Bridgewater | New Jersey | United States | -74.64815 | 40.60079
17
0
0
0
NCT00378573
6TERMINATED
2008-09-01
2007-01-01
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 ]
781
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This is a randomized, multi-center, double-blind, double-dummy, placebo-controlled, parallel-group study, evaluating the efficacy of mometasone furoate (MF) /formoterol fumarate (F)\[MF/F\] metered dose inhaler (MDI) versus MF for 26 weeks. Prior to the 26-week double-blind Treatment Period, subjects will receive open-...
null
Asthma
null
4
arm 1: None arm 2: None arm 3: None arm 4: None
[ 0, 0, 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 26 weeks intervention 2: MF 200 mcg via metered dose inhaler twice daily for 26 weeks intervention 3: F via metered dose inhaler 10 mcg twice a day for 26 weeks intervention 4: Placebo metered dose inhaler twice a day for 26 weeks
intervention 1: mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BID intervention 2: Mometasone furoate MDI (MF MDI) 200 mcg intervention 3: formoterol fumarate 10 mcg intervention 4: Placebo
0
null
1,765
0
0
0
NCT00383240
1COMPLETED
2008-09-01
2006-09-01
Organon and Co
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
339
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of this study is to find out if cannabis-based medicine compared to a dummy medicine (placebo that contains no active ingredient) can help the central neuropathic pain patients experience as a result of multiple sclerosis. This type of pain "central neuropathic pain" is described as shooting, stabbing, burn...
GW has shown in phase II and III studies that Sativex has analgesic properties that are effective in relieving neuropathic pain. These studies suggested that Sativex is well tolerated and may also improve sleep and quality of life. GW is conducting this study to further demonstrate these effects.
Multiple Sclerosis
Central Neuropathic Pain
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Containing D9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L. Delivered in 100 µl actuations by a pump action oromucosal spray. Maximum dose within any 24-hour interval 12 sprays (THC 32.5 mg: CBD 30 mg. intervention 2: Containing colourants and exci...
intervention 1: Sativex intervention 2: Placebo
6
Calgary | Alberta | Canada | -114.08529 | 51.05011 Vancouver | British Columbia | Canada | -123.11934 | 49.24966 Halifax | Nova Scotia | Canada | -63.57688 | 44.64269 London | Ontario | Canada | -81.23304 | 42.98339 Ottawa | Ontario | Canada | -75.69812 | 45.41117 Montreal | Quebec | Canada | -73.58781 | 45.50884
339
0
0
0
NCT00391079
1COMPLETED
2008-09-01
2006-09-01
GW Pharmaceuticals 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
[ 4 ]
1,683
NON_RANDOMIZED
SINGLE_GROUP
1PREVENTION
0NONE
true
1FEMALE
false
This is a non-comparative study. The primary objective of the study is to assess the efficacy of a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are to assess the incidence of intracyclic bleeding; and to assess the safety and tolerability of the product.
null
Contraception
Contraception
null
1
arm 1: Norethindrone/Ethinyl Estradiol
[ 0 ]
1
[ 0 ]
intervention 1: one tablet per day
intervention 1: Norethindrone acetate/ethinyl estradiol
66
Phoenix | Arizona | United States | -112.07404 | 33.44838 Phoenix | Arizona | United States | -112.07404 | 33.44838 Phoenix | Arizona | United States | -112.07404 | 33.44838 Phoenix | Arizona | United States | -112.07404 | 33.44838 Tempe | Arizona | United States | -111.90931 | 33.41477 Tempe | Arizona | United States ...
1,660
0
0
0
NCT00391807
1COMPLETED
2008-09-01
2006-11-01
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
[ 3 ]
53
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
The primary objective of the trial is to estimate the activity of BMS-354825 (Dasatinib) in de novo adult Ph+ ALL patients in terms of hematological complete remission (HCR) rate.
This open label phase II study of Dasatinib will enroll adult de novo Ph+ ALL patients. A minimum of 48 cases will be required to complete the study. Accrual is expected to be completed in 18 months. The study will be considered completed for patients in HCR after completion of a total of 12 weeks of treatment. After c...
Lymphoblastic Leukemia, Acute
Ph+ Acute Lymphoblastic Leukaemia Dasatinib targeted therapy Patients with Ph positive and or BCR ABL positive ALL
null
0
null
null
1
[ 0 ]
intervention 1: None
intervention 1: Dasatinib
36
Arezzo | Arezzo | Italy | 11.88068 | 43.46276 Bari | Bari | Italy | 16.86982 | 41.12066 Bologna | Bologna | Italy | 11.33875 | 44.49381 Brescia | Brescia | Italy | 10.21472 | 45.53558 Brindisi | Brindisi | Italy | 17.93607 | 40.63215 Cagliari | Cagliari | Italy | 9.11917 | 39.23054 Catania | Catania | Italy | 15.07041 ...
53
0
0
0
NCT00391989
1COMPLETED
2008-09-01
2006-09-01
Gruppo Italiano Malattie EMatologiche dell'Adulto
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 ]
44
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The combination of capecitabine and oxaliplatin as 'backbone' regimen, adding a newer biologic agent, cetuximab, is a reasonable strategy of further chemotherapy development in advanced gastric cancer, which is the investigators study rationale.
There is presently no chemotherapy regimen considered to be the global standard of care for patients with AGC, and there is still a need for new agents and/or regimens to improve the efficacy and safety of chemotherapy in advanced stomach cancers. The combination of 5-fluorouracil plus cisplatin (FP) has been widely u...
Gastric Cancer
gastric cancer chemotherapy cetuximab capecitabine oxaliplatin
null
1
arm 1: Capecitbine, oxaliplatin and cetuximab every three week; Capecitabine 1,000 mg/m2 was administered twice daily on days 1-14. Oxaliplatin 130 mg/m2 i.v. for 2 h was given on day 1 after cetuximab infusion. Cetuximab at an initial loading dose of 400 mg/m2 i.v. for 2 h and, thereafter, maintenance dose of 250 mg/m...
[ 0 ]
1
[ 0 ]
intervention 1: Xelox(Capecitbine, Oxaliplatin) and Cetuximab every three week; Capecitabine 1,000 mg/m2 was administered twice daily on days 1-14. Oxaliplatin 130 mg/m2 i.v. for 2 h was given on day 1 after cetuximab infusion. Cetuximab at an initial loading dose of 400 mg/m2 i.v. for 2 h and, thereafter, maintenance ...
intervention 1: Capecitabine, Oxaliplatin, Cetuximab
3
Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566
44
0
0
0
NCT00398398
1COMPLETED
2008-09-01
2006-11-01
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
[ 5 ]
312
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
null
Primary objective: to assess the efficacy of pramipexole given two times daily compared to placebo. Secondary objectives: to assess the effects of pramipexole on mood, cognition, fatigue, impulse control, daytime sleepiness and nighttime sleep compared to placebo; to compare the tolerability among the treatment groups...
null
Parkinson Disease
null
4
arm 1: None arm 2: Pramipexole 0.5 mg tid (three times a day) arm 3: Pramipexole 0.5 mg bid (bis in die (two times a day)) arm 4: Pramipexole 0.75 mg bid (bis in die (two times a day))
[ 5, 5, 5, 5 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: Pramipexole intervention 2: Placebo
39
Phoenix | Arizona | United States | -112.07404 | 33.44838 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Fountain Valley | California | United States | -117.95367 | 33.70918 La Jolla | California | United States | -117.2742 | 32.84727 Oxnard | California | United States | -119.17705 | 34.1975 Sacramento ...
311
0
0
0
NCT00402233
1COMPLETED
2008-09-01
2006-11-01
Boehringer Ingelheim
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 ]
34
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients. This study will assess if a switch from MMF to enteric-coated mycophenolate sodium (EC-MPS) results in improved GI and/or health-related quality of life in liver transplant recipient...
null
Liver Transplantation
Liver transplantation, mycophenolate, GI problems, Quality of Life
null
1
arm 1: Enteric-coated Mycophenolate sodium (EC-MPS), administered orally twice a day to achieve a dose equimolar to the dose of Mycophenolate mofetil (MMF) the patient was taking at the time of study entry up to a maximum dose of 1440 mg.
[ 0 ]
1
[ 0 ]
intervention 1: experimental
intervention 1: Enteric-coated Mycophenolate sodium (EC-MPS)
1
Nuremberg | N/A | Germany | 11.07752 | 49.45421
34
0
0
0
NCT00405652
1COMPLETED
2008-09-01
2007-01-01
Novartis Pharmaceuticals
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
26
RANDOMIZED
FACTORIAL
0TREATMENT
3TRIPLE
false
0ALL
false
This study is examining the safety and effectiveness of two medications, ketamine and riluzole, in treating patients with treatment resistant major depressive disorder. This study will also examine the effectiveness of an FDA approved drug called lamotrigine in decreasing the potential side effects associated with keta...
This research proposal will investigate a glutamate-modulating agent, riluzole, in treatment-resistant patients who exhibit an acute, sustained response to a single dose of intravenous (IV) racemic ketamine. Fifty ketamine-responders will be randomized to riluzole or placebo in a 4-week, randomized, double-blind, conti...
Major Depression
null
2
arm 1: Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. 300 mg of lamotrigine 2 hrs prior to ketamine infusion. Re...
[ 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: anticonvulsant medication intervention 2: subanesthetic dose of NMDAR antagonist intervention 3: glutamate release inhibitor
intervention 1: Lamotrigine intervention 2: Ketamine intervention 3: Riluzole
1
New York | New York | United States | -74.00597 | 40.71427
66
0
0
0
NCT00419003
1COMPLETED
2008-09-01
2006-12-01
Baylor College of Medicine
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
24
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
To assess the efficacy and safety of Etanercept in patients with spondylarthropathy and refractory heel enthesitis.
null
Spondylarthropathies, Enthesitis
Refractory Heel Enthesitis in Spondylarthropathy Spondylarthropathy Refractory Heel Enthesitis
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 10 ]
intervention 1: 50 mg injection once weekly intervention 2: placebo
intervention 1: Etanercept intervention 2: Placebo
15
Arles | N/A | France | 4.63031 | 43.67681 Avignon | N/A | France | 4.80892 | 43.94834 Bordeaux | N/A | France | -0.5805 | 44.84044 Grenoble | N/A | France | 5.71479 | 45.17869 Montpellier | N/A | France | 3.87635 | 43.61093 Nice | N/A | France | 7.26608 | 43.70313 Orléans | N/A | France | 1.90389 | 47.90289 Paris (Bich...
24
0
0
0
NCT00420303
1COMPLETED
2008-09-01
2007-01-01
Wyeth is now a wholly owned subsidiary of Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
92
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
1FEMALE
false
The main purpose of this study is to compare the effects of treatment of two different formulations of Angeliq® and Prempro on blood pressure in post-menopausal women with prehypertension.
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc. is the sponsor of the trial.
Postmenopause Hypertension Pre-Hypertension
Pre-Hypertension in Postmenopausal Women
null
3
arm 1: 0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) arm 2: 2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) arm 3: 1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 w...
[ 0, 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: SH K 00641 A -Active study medication encapsulated tablet intervention 2: SH K 00641 B - Active study medication encapsulated tablet intervention 3: Active control encapsulated tablet
intervention 1: Drospirenone/17ß-estradiol (Angeliq, BAY86-4891) intervention 2: Drospirenone/17ß-estradiol (Angeliq, BAY86-4891) intervention 3: SH K 00641 C - Medroxyprogesterone acetate / conjugated equine (Prempro TM)
9
Greenbrae | California | United States | -122.5247 | 37.94854 San Diego | California | United States | -117.16472 | 32.71571 Daytona Beach | Florida | United States | -81.02283 | 29.21081 Miami | Florida | United States | -80.19366 | 25.77427 Paw Paw | Michigan | United States | -85.89112 | 42.21782 Las Vegas | Nevada ...
90
0
0
0
NCT00420342
1COMPLETED
2008-09-01
2007-01-01
Bayer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
121
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The study will evaluate the effectiveness and safety of multiple dosing regimens of IV conivaptan in subjects with euvolemic or hypervolemic hyponatremia
null
Hyponatremia Euvolemia Hypervolemia
Hyponatremia Euvolemia Hypervolemia Conivaptan Vaprisol® YM087
null
4
arm 1: Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule arm 2: Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule arm 3: Placebo loading dose + 20mg/day continuous infusion conivaptan per premix bag arm 4: Conivaptan loading dose (20mg) + 20mg/day continuous in...
[ 0, 0, 0, 0 ]
2
[ 0, 0 ]
intervention 1: ampoule or premix bag intervention 2: ampoule or premix bag
intervention 1: Conivaptan intervention 2: placebo
18
Charleston | South Carolina | United States | -79.93275 | 32.77632 Bangalore | N/A | India | 77.59369 | 12.97194 Bangalore | N/A | India | 77.59369 | 12.97194 Bhopal | N/A | India | 77.40289 | 23.25469 Hyderabaad | N/A | India | N/A | N/A Karnāl | N/A | India | 76.98448 | 29.69197 Afula | N/A | Israel | 35.2892 | 32.60...
117
0
0
0
NCT00435591
1COMPLETED
2008-09-01
2007-01-01
Cumberland Pharmaceuticals
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
32
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
Skin photoaging or skin photodamage were terms used to describe the change in the structure, function and appearance of skin caused by prolonged and repeated exposure to sunlight or other ultraviolet light sources. The visible effects of skin photodamage were fine lines, skin sagging, skin roughness, liver spots and a...
Different application times of the study treatment were being investigated.
Photoaged Skin
PDT Photoaging Galderma
null
3
arm 1: Participants were topically treated with 160 milligrams per gram (mg/g) Metvix cream on one half-face or Metvix vehicle cream on the other half-face for 1 hour at Baseline, Weeks 4 and 8. The target area was then exposed to red light \[using a large-field light emitting diode (LED) light source: Aktilite 128 lam...
[ 0, 0, 0 ]
2
[ 0, 0 ]
intervention 1: Participants were treated with topical administration of Metvix cream. intervention 2: Participants were treated with topical administration of Metvix Vehicle cream.
intervention 1: Metvix Cream 160 mg/g intervention 2: Metvix Vehicle Group
3
Madrid | N/A | Spain | -3.70256 | 40.4165 London | N/A | United Kingdom | -0.12574 | 51.50853 Manchester | N/A | United Kingdom | -2.23743 | 53.48095
32
0
0
0
NCT00437320
1COMPLETED
2008-09-01
2007-04-18
Galderma R&D
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 ]
456
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
The purpose of this study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (Pyramax®, PA) (180:60 mg) with that of standard chloroquine therapy in children and adults with acute, uncomplicated Plasmodium vivax malaria.
This is a multi-centre, randomised, double-blind, double-dummy, parallel-group, non-inferiority study comparing the efficacy and safety of the fixed combination of pyronaridine/artesunate (ie, PP/AS \[PA\]) (180:60 mg) with that of standard chloroquine therapy in children and adults with acute uncomplicated P. vivax ma...
Malaria
P vivax malaria artemisinin based combination therapy (ACT) antimalarial pyronaridine artesunate (Pyramax)
null
2
arm 1: The tablet strength is 180:60 mg oral PA plus chloroquine-placebo. Depending on their body weight, patients receive 1 to 4 tablets once a day, for 3 days. The actual dose-level range covered by this regimen is 7.2: 2.4 mg/kg to 13.8:4.6 mg/kg pyronaridine artesunate. arm 2: The tablet strength is 155 mg oral chl...
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: Pyronaridine artesunate intervention 2: Chloroquine
5
Pailin | Pailin | Cambodia | 102.60928 | 12.84895 Mangalore | N/A | India | 74.85603 | 12.91723 Maumere | Nusa Tenggara Timur | Indonesia | 122.2111 | -8.6199 Mae Ramat | Changwat Tak | Thailand | 98.51665 | 16.98403 Mae Sot | Changwat Tak | Thailand | 98.56667 | 16.71667
456
0
0
0
NCT00440999
1COMPLETED
2008-09-01
2007-03-01
Medicines for Malaria Venture
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
60
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
null
To determine efficacy and tolerability of inhaled Formoterol vs nebulized Ipatropioum Bromide plus Fenoterol in cumulative sequential doses in asthmatic children (5-\<12 years) with acute bronchial obstruction attending emergency services
null
Acute Bronchial Obstruction, Asthma
Asthma, Formoterol, Bronchial Obstruction, Children
null
2
arm 1: Formoterol (Foradil®) 12 micrograms administered through Aerolizer®. arm 2: Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: 12 micrograms stat (twice if necessary). Inhaled via aerolizer intervention 2: 0.5 micrograms/0.25 milligrams (20 drops) inhaled via nebulization diluted in 3cc of 0.9% saline.
intervention 1: Formoterol fumerate intervention 2: fenoterol/ipratropium bromide
2
Caracas | N/A | Venezuela | -66.87919 | 10.48801 Maracaibo | N/A | Venezuela | -71.61089 | 10.64232
60
0
0
0
NCT00460577
1COMPLETED
2008-09-01
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
[ 5 ]
171
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
null
This is a 7 day study to evaluate the safety and efficacy of topical gatifloxacin ophthalmic solution for the treatment of bacterial conjunctivitis in subjects from birth to 31 days of age
null
Bacterial Conjunctivitis
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Day 1-6 = 1 drop of study medication three times a day intervention 2: Day 1-6 = 1 drop of study medication three times a day
intervention 1: gatifloxacin intervention 2: moxifloxacin 0.5% eye drops
2
Sacramento | California | United States | -121.4944 | 38.58157 Whitby | Ontario | Canada | -78.93287 | 43.88342
170
0
0
0
NCT00464438
1COMPLETED
2008-09-01
2007-06-01
Allergan
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
34
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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-killin...
OBJECTIVES: Primary * Determine the overall response rate, response duration, and frequency of progression-free survival at 6 months in patients with stage IV melanoma treated with erlotinib hydrochloride and bevacizumab. * Determine objective responses in patients treated with this regimen. Secondary * Determine t...
Melanoma
stage IV melanoma recurrent melanoma
null
1
arm 1: Tarceva and Avastin: * Tarceva: 150mg PO, days 1-28 * Avastin: 10mg/kg, IV infusion, days 1,15 Regimen will be repeated every 28 days = 1 course
[ 0 ]
7
[ 2, 0, 6, 6, 10, 10, 3 ]
intervention 1: 10mg/kg, slow IV infusion, Days 1 and 14 intervention 2: 150mg PO qd intervention 3: Targeting multiple genetic aberrations in isolated tumor cells. intervention 4: gene expression analysis intervention 5: immunologic technique intervention 6: laboratory biomarker analysis intervention 7: biopsy
intervention 1: bevacizumab intervention 2: erlotinib hydrochloride intervention 3: fluorescence in situ hybridization intervention 4: gene expression analysis intervention 5: immunologic technique intervention 6: laboratory biomarker analysis intervention 7: biopsy
4
Nashville | Tennessee | United States | -86.78444 | 36.16589 Nashville | Tennessee | United States | -86.78444 | 36.16589 Nashville | Tennessee | United States | -86.78444 | 36.16589 Nashville | Tennessee | United States | -86.78444 | 36.16589
34
0
0
0
NCT00466687
1COMPLETED
2008-09-01
2004-09-01
Vanderbilt-Ingram 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 ]
12
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
false
0ALL
true
The purpose of this study is to determine the safety of intravenous cocaine in subjects receiving oral donepezil.
This is a randomized, double-blind, double-dummy, placebo controlled, inpatient, single-center, parallel group evaluation of the potential for oral donepezil to attenuate cocaine-induced craving. Non-treatment-seeking cocaine-experienced volunteers will receive baseline treatment with intravenous cocaine (30Mg). Forty-...
Cocaine Abuse and Dependence
Acetylcholine Acetylcholinesterase Butyrylcholinesterase Cholinesterase Inhibitor
null
2
arm 1: Three days of daily treatment with oral placebo, followed by three days of daily treatment with 5 mg of donepezil arm 2: Three days of daily treatment with 5 mg of donepezil, followed by three days of daily treatment with oral placebo.
[ 0, 0 ]
2
[ 0, 10 ]
intervention 1: This is a commercially available cholinesterase inhibitor that is approved for use in Alzheimer's disease. intervention 2: Inactive Comparator with Similar Appearance to Active Medication
intervention 1: Donepezil, 5 mg daily intervention 2: Oral Placebo
1
Kansas City | Missouri | United States | -94.57857 | 39.09973
24
0
0
0
NCT00467389
1COMPLETED
2008-09-01
2007-02-01
US Department of Veterans Affairs
1FED
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
385
RANDOMIZED
PARALLEL
1PREVENTION
2DOUBLE
true
1FEMALE
false
The purpose of this study is to determine whether the study drug is safe and effective
Acronym is used in result section: suspected/diagnosed (susp/diag)
Neural Tube Defects Contraception Oral Contraceptives (OC)
Healthy women requesting contraception Folic Acid
null
2
arm 1: 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks arm 2: 1 tablet 0.020 mg EE/3.0 mg DRSP \[YAZ\] given orally/daily for 24 days followed by 1 placeb...
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: 0.020 mg ethinylestradiol with 3.0 mg drospirenone and 0.451 mg L-5-methyltetrahydrofolate (L-5-MTHF) intervention 2: 0.020 mg ethinylestradiol with 3.0 mg drospirenone
intervention 1: Drospirenone/Ethinylestradiol/Methyltetrahydrofolate intervention 2: Drospirenone/Ethinylestradiol (Yaz)
9
Anaheim | California | United States | -117.9145 | 33.83529 San Diego | California | United States | -117.16472 | 32.71571 Baltimore | Maryland | United States | -76.61219 | 39.29038 New York | New York | United States | -74.00597 | 40.71427 Morrisville | North Carolina | United States | -78.82556 | 35.82348 Winston-Sa...
379
0
0
0
NCT00468481
1COMPLETED
2008-09-01
2007-04-01
Bayer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0