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
[ 0 ]
60
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
Background: The J-Tip Device allows an intradermal needle-free jet injection of 1% buffered lidocaine. This study compares needle-free jet injection of lidocaine to saline in reducing pain prior to lumbar puncture in infants. Methods: Randomized, double-blinded, placebo controlled trial involving infants, less than 3 ...
Background: Lumbar puncture is an essential procedure in the emergency department for the evaluation of meningitis. Subcutaneous injection of lidocaine prior to lumbar puncture for local anesthesia is not a pain free procedure. The J-Tip Device allows an intradermal needle-free jet injection of 1% buffered lidocaine. T...
Pain
pain lidocaine lumbar puncture j-tip
null
2
arm 1: Needleless injection of buffered lidocaine prior to lumbar puncture versus placebo (Normal saline) arm 2: Needleless injection of normal saline (placebo) prior to lumbar puncture versus use of buffered lidocaine
[ 0, 2 ]
1
[ 0 ]
intervention 1: All patients were administered the J-tip and randomized to either treatment with 1% lidocaine or an equivalent amount of sterile normal saline prior to lumbar puncture. Vital signs were recorded during the procedure. Facial expressions were video recorded
intervention 1: Buffered Lidocaine J-tip
1
Phoenix | Arizona | United States | -112.07404 | 33.44838
60
0
0
0
NCT01224431
1COMPLETED
2010-06-01
2009-06-01
Phoenix Children's Hospital
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
48
RANDOMIZED
FACTORIAL
0TREATMENT
2DOUBLE
false
0ALL
false
Hypothesis: Ropivacaine, morphine and ketorolac injected after knee arthroscopy is as effective as this solution plus ropivacaine administered intra-articularly for twenty-four hours. Three groups were assigned random patients, each group provided a different method of pain medication in order to determine the effecti...
Arthroscopic knee patients were randomized to 1 of 3 groups. A) 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour; B) an identical solution plus a pain pump containing 100-mL of normal saline administered ...
Pain
null
3
arm 1: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour; arm 2: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline admin...
[ 0, 1, 1 ]
3
[ 1, 1, 0 ]
intervention 1: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour intervention 2: 30mL of ropivacaine(0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of nor...
intervention 1: pain pump containing ropivacaine intervention 2: saline pain pump with injectable medication intervention 3: ropivacaine, ketorolac , morphine sulfate
0
null
48
0
0
0
NCT01242644
1COMPLETED
2010-06-01
2006-10-01
University of South Alabama
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 ]
158
RANDOMIZED
CROSSOVER
1PREVENTION
0NONE
true
1FEMALE
true
For the contraceptive application a film-coated tablet has been developed which combines nomegestrol acetate (NOMAC) with estradiol (E2). This was an open-label, randomized, single-dose, four-way, replicate, cross-over study design conducted in 2 parallel parts at two sites, one site per study part. The primary objecti...
null
Healthy Postmenopausal Females
null
4
arm 1: Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Partic...
[ 0, 1, 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: 1 x 2.5 mg NOMAC/1.5 mg E2 fixed dose combination commercial tablet orally in the morning on Day 1 for all periods intervention 2: 1 x 2.5 mg NOMAC/1.5 mg E2 fixed dose combination tablet from the Phase 3 clinical trial program ("Batch A") orally in the morning on Day 1 for all periods intervention 3: 1...
intervention 1: Commercial NOMAC-E2 intervention 2: Phase 3 NOMAC-E2 "Batch A" intervention 3: Phase 3 NOMAC-E2 "Batch B"
0
null
301
0
0
0
NCT01345786
1COMPLETED
2010-06-01
2009-11-01
Organon and Co
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
3
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Background: * One way tumors are able to grow is by forming new blood vessels that supply it with nutrients and oxygen. * Vandetanib (ZD6474) is an experimental drug that blocks certain proteins on the surface of tumor and blood vessel cells that are involved with the formation of new blood vessels. * Blocking these p...
Background: * von Hippel-Lindau (VHL) inactivation by mutation or promoter hypermethylation is seen in a high proportion of sporadic clear cell renal cancers. * Inactivation of VHL leads to accumulation of proteins targeted for degradation through the ubiquitin pathway, which includes a group of transcriptionally acti...
Advanced Clear Cell Renal Carcinoma
Advanced Clear Cell Renal Cell Carcinoma Cancer Renal Renal Cell Carcinoma Kidney Cancer
null
1
arm 1: Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived gro...
[ 5 ]
1
[ 0 ]
intervention 1: Daily dose 300mg/day by mouth, 28 day cycle
intervention 1: vandetanib
1
Bethesda | Maryland | United States | -77.10026 | 38.98067
3
0
0
0
NCT01372813
6TERMINATED
2010-06-01
2007-12-01
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
[ 5 ]
38
RANDOMIZED
PARALLEL
7BASIC_SCIENCE
3TRIPLE
true
0ALL
false
The investigators tested whether pain decrease can be observed centrally with non-invasive brain imaging in CBP subjects receiving Lidoderm. The investigators first tested effects of 5% Lidoderm patched in an open labelled trial. Next the investigators compared the effects of Lidocaine versus Placebo patches. Three tim...
Previous data showed that Lidoderm patches that contain 5% Lidocaine applied to the affected area for a period of 1-2 weeks decreased chronic pain. We conducted a preliminary open-label trial in chronic back pain patients and found that the patients reported reduction in pain intensity and associated brain activity (me...
Low Back Pain
chronic back pain placebo fmri brain imaging
null
2
arm 1: 5% lidoderm patch arm 2: placebo patch
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: 5% lidoderm patch intervention 2: placebo
intervention 1: lidocaine intervention 2: placebo
1
Chicago | Illinois | United States | -87.65005 | 41.85003
38
0
0
0
NCT01515540
1COMPLETED
2010-06-01
2004-01-01
Northwestern University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
40
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
The purpose of this study is to investigate the tolerability and the effect of BIA 9-1067 at steady-state on the levodopa pharmacokinetics in Parkinson's Disease (PD) patients treated with levodopa/dopa-decarboxylase inhibitor.
Multicentre, double-blind, randomised, placebo-controlled study in four parallel groups of PD patients treated with standard-release levodopa/carbidopa 100/25 mg (Sinemet®) or levodopa/benserazide 100/25 mg (Madopar®/Restex®) and with motor fluctuations ("wearing-off" phenomenon)
Parkinson's Disease
Parkinson Disease BIA 9-1067
null
4
arm 1: PLC, Placebo Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half arm 2: 5 mg BIA 9-1067 (OPC, Opicapone) Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half arm 3: 15 mg BIA 9-1067 (OPC, Opicap...
[ 2, 0, 0, 0 ]
6
[ 0, 0, 0, 0, 0, 0 ]
intervention 1: once-daily intervention 2: BIA 9-1067 - 5 mg single-dose intervention 3: BIA 9-1067 - 15 mg single-dose intervention 4: BIA 9-1067 - 30 mg single-dose intervention 5: Levodopa 100 mg Carbidopa 25 mg intervention 6: Levodopa 100 mg Benzerazide 25 mg
intervention 1: Placebo intervention 2: BIA 9-1067 intervention 3: BIA 9-1067 intervention 4: BIA 9-1067 intervention 5: Levodopa/Carbidopa intervention 6: Levodopa/Benzerazide
7
Brasov | N/A | Romania | 25.60613 | 45.64861 Bucharest | N/A | Romania | 26.10626 | 44.43225 Craiova | N/A | Romania | 23.8 | 44.31667 Dnipropetrovsk | N/A | Ukraine | 35.04066 | 48.46664 Kharkiv | N/A | Ukraine | 36.25475 | 49.98177 Kharkiv | N/A | Ukraine | 36.25475 | 49.98177 Kyiv | N/A | Ukraine | 30.5238 | 50.4546...
40
0
0
0
NCT01568047
1COMPLETED
2010-06-01
2010-02-01
Bial - Portela C S.A.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
77
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
4QUADRUPLE
false
0ALL
true
* The present study was undertaken to assess the efficacy and safety of two different insulin sensitizers (namely Pioglitazone and Metformin) among subjects with type 2 diabetes mellitus (T2DM) in Bangladesh. * A prospective, double-blind, single group, 'within-subject' designed clinical trial of 77 diagnosed T2DM pati...
1. Introduction Thiazolidinediones and metformin are known drugs and especially metformin is widely used medicine to treat people with T2DM. Though pioglitazone has been suspended in many countries, its safety and efficacy is a matter of research for the drug investigators. Thiazolidinediones had been introduced in 199...
Type 2 Diabetes Mellitus
Bangladesh T2DM Pioglitazone Metformin Insulin secretion and Sensitivity
null
2
arm 1: The patients received pioglitazone hydrochloride tablet 30 mg (001 drug)once daily for first three months arm 2: The patients received metformin hydrochloride tablet 850 mg (002 drug)once daily for next three months.
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: 77 patients were treated with pioglitazone hydrochloride (B001) for 3 months.Biomedical parameters were measured each month. intervention 2: After the treatment with pioglitazone(001) for 3 months first and then patients were on one month washout period;in the washout period they were given metformin ta...
intervention 1: Pioglitazone hydrochloride intervention 2: Metformin hydrochloride
1
Dhaka | Dhaka Division | Bangladesh | 90.40744 | 23.7104
147
0
0
0
NCT01589445
1COMPLETED
2010-06-01
2008-11-01
University of Dhaka
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 ]
60
RANDOMIZED
PARALLEL
7BASIC_SCIENCE
2DOUBLE
true
1FEMALE
false
The purpose of this study is to determine if a single dose of LY2541546 has any side effects on the body and to determine how long and how much LY2541546 stays in the bloodstream of the body.
null
Healthy
Postmenopausal females Volunteers
null
9
arm 1: Single dose of 7.5 mg LY2541546 administered intravenously (IV) arm 2: Single dose of 25 mg LY2541546 administered IV arm 3: Single dose of 75 mg LY2541546 administered IV arm 4: Single dose of 225 mg LY2541546 administered IV arm 5: Single dose of 750 mg LY2541546 administered IV arm 6: Single dose of 150 mg LY...
[ 0, 0, 0, 0, 0, 0, 2, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Administered IV intervention 2: Administered SC intervention 3: Administered IV or SC
intervention 1: LY2541546 - IV intervention 2: LY2541546 - SC intervention 3: Placebo
2
Evansville | Indiana | United States | -87.55585 | 37.97476 Indianapolis | Indiana | United States | -86.15804 | 39.76838
60
0
0
0
NCT01742078
1COMPLETED
2010-06-01
2008-06-01
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
[ 3 ]
452
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This was a multinational, randomised, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of multiple doses of ESL as prophylactic treatment in subjects with migraine with or without aura. Subjects were randomised in a 1:1:1 ratio to receive placebo, ESL 800 mg/day ...
The study consisted of a Screening Period of 2 to 4 weeks, a 4-week placebo Baseline Period, a 2-week Titration Period, a 12-week Maintenance Period, and a 4-week Follow-up Period. During the entire study the subjects had a diary to document the occurrence, duration, and intensity of headaches, the occurrence or not of...
Migraine
migraine; ESL; eslicarbazepine acetate
null
3
arm 1: eslicarbazepine acetate 1200 mg arm 2: eslicarbazepine acetate 800 mg arm 3: Placebo tablets
[ 1, 1, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Tablets intervention 2: Eslicarbazepine acetate was supplied in 400-mg and 600-mg tablets and was administered with a dose of 800 or 1200 mg QD in the evening by the oral route. intervention 3: Eslicarbazepine acetate was supplied in 400-mg and 600-mg tablets and was administered with a dose of 800 or 1...
intervention 1: Placebo intervention 2: ESL 1200 mg intervention 3: ESL 800 mg
0
null
410
0
0
0
NCT01820559
1COMPLETED
2010-06-01
2009-04-01
Bial - Portela C S.A.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
7
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
A randomised, double-blind, placebo-controlled, parallel group study to evaluate the effect of treatment with GSK2190915, a FLAP inhibitor, as add-on to current inhaled corticosteroid therapy in patients with moderate to severe asthma with elevated sputum neutrophils.
null
Asthma
Sputum cell counts Neutrophils Severe Asthma ICS Inhaled corticosteroids
null
2
arm 1: 12 day repeat dosing with placebo arm 2: 12 day repeat dosing treatment phase with 100mg GSK2190915.
[ 2, 0 ]
2
[ 0, 0 ]
intervention 1: GSK2190915 is a high affinity 5-lipoxygenase-activating protein (FLAP) inhibitor. intervention 2: Placebo : 2% (w/w) Ethanol, sucralose (5 mg/100 mL of oral solution) to 100 % (w/w) aqueous sodium carbonate buffer (0.010 M, pH 9-10)
intervention 1: GSK2190195 100mg intervention 2: Placebo
8
Hamilton | Ontario | Canada | -79.84963 | 43.25011 Kingston | Ontario | Canada | -76.48098 | 44.22976 Montreal | Quebec | Canada | -73.58781 | 45.50884 Sainte-Foy | Quebec | Canada | -71.29217 | 46.78139 Glasgow | Lanarkshire | United Kingdom | -4.25763 | 55.86515 Leicester | Leicestershire | United Kingdom | -1.13169 ...
7
0
0
0
NCT00850642
6TERMINATED
2010-06-02
2009-06-26
GlaxoSmithKline
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3, 4 ]
53
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This study will assess the safety, tolerability of a single 1500 mg dose of famciclovir in 50 adolescents with recurrent herpes labialis. Eight of the 50 adolescents will also participate in the pharmacokinetics (PK) assessment of famciclovir single 1500 mg dose
Uncontrolled study
Herpes Labialis
Herpes labialis cold sores herpes simplex type 1
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Famciclovir 1500 mg (3 x 500 mg tablets) oral as a single dose.
intervention 1: Famciclovir
12
San Diego | California | United States | -117.16472 | 32.71571 Chicago | Illinois | United States | -87.65005 | 41.85003 Evansville | Indiana | United States | -87.55585 | 37.97476 St Louis | Missouri | United States | -90.19789 | 38.62727 Rochester | New York | United States | -77.61556 | 43.15478 Cincinnati | Ohio | ...
106
0
0
0
NCT00878072
1COMPLETED
2010-06-02
2009-03-25
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 ]
1
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
This is a phase I study using the Erwinia form of asparaginase in place of the E. coli form using a standard re-induction regimen (Vincristine, Dexamethasone, Doxorubicin) for patients with relapsed ALL who have developed an allergy to the E. coli formulation. This study will administer the drug intravenously instead o...
Significance 1. Substitution of Erwinase after E.coli asparaginase allergy has been standard practice despite the paucity of evidence regarding its efficacy and uncertainty about dose. Definition of an appropriate dose and schedule of Erwinase that provides reliable asparagine depletion may be useful for patients with...
Relapsed Acute Lymphoblastic Leukemia Allergy to PEG e.Coli Asparaginase Allergy to Native e.Coli Asparaginase
Relapsed Allergy Erwinia Acute Lymphoblastic Leukemia
null
1
arm 1: All patients receive Vincristine, Dexamethasone, Doxorubicin, and Cytarabine. Dexrazoxane optional on Day 1. Erwinase is started between Days 3-5 and is given every M-W-F for a total of 10 doses. Patients with CNS 1 or 2 receive Methotrexate intrathecally on Day 15. Patients with CNS 3 receive Triple Intrathecal...
[ 0 ]
8
[ 0, 0, 0, 0, 0, 0, 0, 0 ]
intervention 1: The dose of Erwinase will be assigned at study entry. The first dose of Erwinase wil be given between Days 3-5 and will continue on a M-W-F schedule for a total of 10 doses. Erwinase will be administered as a 2-hour intravenous infusion. intervention 2: 1.5 mg/m2/dose IV push (maximum single dose 2 mg)...
intervention 1: Erwinase intervention 2: Vincristine intervention 3: Dexamethasone intervention 4: Doxorubicin intervention 5: Cytarabine intervention 6: Methotrexate intervention 7: Triple Intrathecal Therapy intervention 8: Dexrazoxane
1
Los Angeles | California | United States | -118.24368 | 34.05223
1
0
0
0
NCT00928200
6TERMINATED
2010-06-04
2009-04-13
Therapeutic Advances in Childhood Leukemia Consortium
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 ]
183
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
true
The purpose of this study is to evaluate the objective response rate, safety and identify potential biomarkers in platinum-resistant ovarian cancer patients treated with voreloxin injection given on a 28-day cycle.
Other objectives of this study are to evaluate Progression-free survival and measure CA-125 response rate.
Epithelial Ovarian Cancer
second line treatment platinum resistant ovary ovaries cancer epithelial carcinomas tumor
null
1
arm 1: All patients will receive voreloxin injection
[ 0 ]
1
[ 0 ]
intervention 1: All patients in initial dose level receive voreloxin injection at 48 mg/m2 administered once every 21 days up to 6 cycles. Subsequent levels are of 60 mg/m2 or 75 mg/m2 every 28 days up to 6 cycles if safety acceptable.
intervention 1: Voreloxin Injection
20
Scottsdale | Arizona | United States | -111.89903 | 33.50921 Newport Beach | California | United States | -117.92895 | 33.61891 San Diego | California | United States | -117.16472 | 32.71571 Stanford | California | United States | -122.16608 | 37.42411 Washington D.C. | District of Columbia | United States | -77.03637 ...
274
0
0
0
NCT00408603
1COMPLETED
2010-06-09
2006-12-20
Sunesis 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 ]
44
NA
SINGLE_GROUP
4SUPPORTIVE_CARE
0NONE
false
0ALL
false
This phase II trial studies the side effects and how well sirolimus works as secondary therapy in treating patients with chronic graft-versus-host disease (GVHD) that did not respond to prior treatment. Sirolimus may be an effective treatment for chronic GVHD
PRIMARY OBJECTIVES: I. To assess the safety of sirolimus administered at a dose which provides steady-state, whole blood trough levels of 5-10 ng/mL in patients with chronic GVHD. II. To determine whether administration of sirolimus provides benefit for patients with chronic GVHD that has not responded adequately to ...
Graft Versus Host Disease
null
1
arm 1: Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is s...
[ 0 ]
1
[ 0 ]
intervention 1: Given PO
intervention 1: sirolimus
1
Seattle | Washington | United States | -122.33207 | 47.60621
44
0
0
0
NCT00079183
1COMPLETED
2010-06-10
2002-04-01
Fred Hutchinson 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 ]
481
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
This is a clinical trial to evaluate the safety and efficacy of OPC-67683 in the treatment of multidrug resistant tuberculosis (MDR TB) for 56 days. In addition to an optimized background regimen (OBR), participants will be randomized to receive: * 100 mg OPC-67683 twice daily (BID) * 200 mg OPC-67683 BID * Placebo BI...
This is a multi center, randomized, double-blinded, stratified, placebo-controlled clinical trial in three parallel groups. Participants will be randomized to one of the following three treatment groups: * OBR plus 100 mg OPC-67683 BID * OBR plus 200 mg OPC-67683 BID * OBR plus placebo BID The three treatment groups ...
Tuberculosis, Pulmonary Tuberculosis, Multidrug Resistant Extensively Drug-Resistant Tuberculosis
Tuberculosis Pulmonary Multidrug resistant Antitubercular Agents OPC 67683
null
3
arm 1: Participants received delamanid 100 milligrams (mg) (two 50 mg tablets), orally, BID with two matching placebo tablets plus optimized background regimen (OBR) for 56 consecutive days (from Day 1 to Day 56). Participants were administered OBR as directed by the given investigator based on World Health Organizati...
[ 0, 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Delamanid was administered orally twice daily as 50-mg tablets under fed conditions in the morning and evening. intervention 2: Selection and administration of the treatment medications (i.e., OBRs) was based on World Health Organization (WHO's) Guidelines for the programmatic management of drug-resista...
intervention 1: Delamanid intervention 2: Optimized Background Regimen (OBR) intervention 3: Placebo
17
San Antonio | Texas | United States | -98.49363 | 29.42412 Beijing | N/A | China | 116.39723 | 39.9075 Shanghai | N/A | China | 121.45806 | 31.22222 Cairo | N/A | Egypt | 31.24967 | 30.06263 Tallinn | N/A | Estonia | 24.75353 | 59.43696 Tartu | N/A | Estonia | 26.72509 | 58.38062 Osaka | N/A | Japan | 135.50107 | 34.69...
481
0
0
0
NCT00685360
1COMPLETED
2010-06-11
2008-05-08
Otsuka Pharmaceutical Development & Commercialization, 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 ]
437
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The purpose of this study is to determine if ACR16 is effective and safe in the symptomatic treatment of Huntington's disease.
The primary objective in the present study is to confirm whether ACR16 is efficacious in improving voluntary motor function in Huntington's disease based on the Unified Huntington"s Disease Rating Scale (UHDRS) subscale. These symptoms seem to be most important for the functional disability associated with the disorder...
Huntington's Disease
Huntington's Disease
null
3
arm 1: Participants will receive a placebo capsule matching to ACR16 once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 26), placebo capsule will be taken twice daily as 2 separate doses. arm 2: Participants will receive ACR16 45 milligrams (mg) capsule orally once daily for the first 4 weeks. After 4 weeks (W...
[ 2, 0, 0 ]
2
[ 0, 0 ]
intervention 1: Capsules will be swallowed whole with water. intervention 2: Capsules will be swallowed whole with water.
intervention 1: ACR16 intervention 2: Placebo
31
Graz | Styria | Austria | 15.45 | 47.06667 Innsbruck | Tyrol | Austria | 11.39454 | 47.26266 Leuven | Flemish Brabant | Belgium | 4.70093 | 50.87959 Lille | Hauts-de-France | France | 3.05858 | 50.63297 Toulouse | Midi-Pyrénées Region | France | 1.44367 | 43.60426 Amiens | Picardie | France | 2.3 | 49.9 Marseille | Pro...
790
2
0.002532
1
NCT00665223
1COMPLETED
2010-06-14
2008-04-24
Teva Branded Pharmaceutical Products R&D, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
0
0
0
0
0
0
0
1
0
0
0
0
0
0
0
0.000695
[ 2 ]
76
RANDOMIZED
SINGLE_GROUP
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to assess safety, and tolerability of multiple doses of ILV-094 administered to subjects with psoriasis
null
Psoriasis
null
1
arm 1: None
[ 2 ]
1
[ 0 ]
intervention 1: SC and IV administration on days 1, 14, 28, and 42
intervention 1: ILV-094
24
Beverly Hills | California | United States | -118.40036 | 34.07362 Santa Monica | California | United States | -118.49138 | 34.01949 South Miami | Florida | United States | -80.29338 | 25.7076 South Miami | Florida | United States | -80.29338 | 25.7076 Evansville | Indiana | United States | -87.55585 | 37.97476 Indiana...
76
0
0
0
NCT00563524
1COMPLETED
2010-06-14
2007-12-20
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 ]
234
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of this study is to evaluate the efficacy, safety, and tolerability of cariprazine in the treatment of outpatients with bipolar depression.
null
Bipolar Depression
bipolar depression
null
3
arm 1: 0.25 - 0.75 mg/day cariprazine capsules, oral administration, once daily dosing. arm 2: 1.5 - 3.0 mg/day cariprazine capsules, oral administration, once daily dosing. arm 3: Matching placebo capsules, oral administration, once daily dosing.
[ 0, 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Drug: cariprazine (0.25 - 0.75 mg/day) intervention 2: Drug: cariprazine (1.5 - 3.0 mg/day) intervention 3: placebo capsules, oral administration, once daily dosing
intervention 1: cariprazine intervention 2: cariprazine intervention 3: placebo
26
Encino | California | United States | -118.50119 | 34.15917 Garden Grove | California | United States | -117.94145 | 33.77391 National City | California | United States | -117.0992 | 32.67811 Newport Beach | California | United States | -117.92895 | 33.61891 Oceanside | California | United States | -117.37948 | 33.1958...
227
0
0
0
NCT00852202
1COMPLETED
2010-06-15
2009-06-30
Forest Laboratories
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 ]
82
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
The primary purpose of this randomized, two-arm parallel clinical study in 66 previously treated patients with severe or moderately severe hemophilia A is to compare the rate of bleeding episodes for standard prophylaxis (20-40 IU/kg every 48 ± 6 hours; actual dose determined by the investigator) with that of alternate...
null
Hemophilia A
null
2
arm 1: Standard prophylaxis arm 2: PK-driven prophylaxis
[ 1, 0 ]
2
[ 0, 0 ]
intervention 1: Standard prophylaxis: 20-40 IU/kg every 48+/-6 hours, actual dose determined by investigator intervention 2: PK-driven prophylaxis: 20-80 IU/kg every 72+/-6 hours, actual dose determined by Baxter using an algorithm and the patient´s pharmacokinetic data
intervention 1: Antihemophilic factor, recombinant, manufactured protein-free intervention 2: Antihemophilic factor, recombinant, manufactured protein-free
29
Los Angeles | California | United States | -118.24368 | 34.05223 Chicago | Illinois | United States | -87.65005 | 41.85003 Indianapolis | Indiana | United States | -86.15804 | 39.76838 Minneapolis | Minnesota | United States | -93.26384 | 44.97997 New York | New York | United States | -74.00597 | 40.71427 Oklahoma City...
140
0
0
0
NCT00243386
1COMPLETED
2010-06-16
2006-01-04
Baxalta now part of Shire
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
328
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
This is a 6-week, randomised, multicenter, double-blind, placebo controlled, fixed dose parallel group study to assess the efficacy and safety of orvepitant (30 and 60 mg/day) versus placebo in subjects with a diagnosis of a Major Depressive Disorder, whose symptoms are considered moderate or severe. Following an init...
The purpose of the current study is to test the safety and the anti-depressant effects of orvepitant, an investigational antidepressant. Efficacy will be assessed using standard depression symptom and severity rating scales (questionaires). The Hamilton Depression Rating Scale (HAM-D) will serve as the primary measure ...
Depressive Disorder, Major
depression QIDS-SR HAMD-17 orvepitant MDD neurokinin-1 antagonist double-blind Phase II randomized efficacy placebo safety
null
3
arm 1: inactive placebo to match orvepitant 30 and 60 mg dosage forms arm 2: 30 mg/day (low dose) arm 3: 60 mg/day (high dose)
[ 2, 0, 0 ]
2
[ 0, 10 ]
intervention 1: Neurokinin-1 (NK-1) antagonist intervention 2: inactive placebo to match orvepitant 30 and 60 mg dosage forms
intervention 1: orvepitant intervention 2: placebo
20
Birmingham | Alabama | United States | -86.80249 | 33.52066 Scottsdale | Arizona | United States | -111.89903 | 33.50921 Arcadia | California | United States | -118.03534 | 34.13973 Beverly Hills | California | United States | -118.40036 | 34.07362 National City | California | United States | -117.0992 | 32.67811 Uplan...
328
0
0
0
NCT00880399
6TERMINATED
2010-06-16
2009-03-01
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
[ 3 ]
150
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
1FEMALE
false
This six-week study will evaluate the efficacy, safety and tolerability of GSK561679 compared to placebo in female subjects with major depressive disorder
This is a double-blind placebo controlled study to assess the CRF1 receptor antagonist, GSK561679, for treatment of depression in adult females diagnosed with Major Depressive Disorder (MDD). A treatment regimen of 350mg/day will be utilized to assess both efficacy and tolerability. Subjects will be randomized in equal...
Depressive Disorder, Major
Depressive Disorder, Major
null
2
arm 1: Double blind GSK561679 arm 2: Double blind placebo
[ 0, 2 ]
2
[ 0, 10 ]
intervention 1: GSK561679 intervention 2: Placebo
intervention 1: GSK561679 intervention 2: Placebo
18
Cerritos | California | United States | -118.06479 | 33.85835 San Diego | California | United States | -117.16472 | 32.71571 Torrance | California | United States | -118.34063 | 33.83585 Jacksonville | Florida | United States | -81.65565 | 30.33218 Miami | Florida | United States | -80.19366 | 25.77427 Atlanta | Georgi...
150
0
0
0
NCT00733980
1COMPLETED
2010-06-18
2008-10-02
GlaxoSmithKline
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
25
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to determine the effect of short-term therapy using "VANOS Cream," a super-potent topical steroid cream on skin barrier function in patients with atopic dermatitis. This cream is already approved for this indication, but the investigators will further examine its effects on the skin barrier...
null
Atopic Dermatitis
Skin barrier Atopic Dermatitis Corticosteroid Effects on skin severity and barrier function
null
1
arm 1: glucocorticoid cream
[ 0 ]
1
[ 0 ]
intervention 1: Fluocinonide 0.1% cream topical daily for two weeks
intervention 1: Fluocinonide
1
Portland | Oregon | United States | -122.67621 | 45.52345
25
0
0
0
NCT00819507
1COMPLETED
2010-06-21
2009-01-01
Oregon Health and Science 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 ]
343
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
This is a 6-week, randomised, multicenter, double-blind, placebo controlled, fixed dose parallel group study to assess the efficacy and safety of orvepitant (30 and 60 mg/day) versus placebo in subjects with a diagnosis of a Major Depressive Disorder, whose symptoms are considered moderate or severe. Following an init...
The purpose of the current study is to test the safety and the anti-depressant effects of orvepitant, an investigational antidepressant. Efficacy will be assessed using standard depression symptom and severity rating scales (questionaires). The Hamilton Depression Rating Scale (HAM-D) will serve as the primary measure ...
Depressive Disorder
depression safety HAMD QIDS-SR NK-1 antagonist efficacy orvepitant placebo MDD video-rating
null
3
arm 1: orvepitant 30 mg (low dose) arm 2: orvepitant 60 mg (high dose) arm 3: inactive placebo to match orvepitant 30 mg and 60 mg dosage forms
[ 0, 0, 2 ]
2
[ 0, 10 ]
intervention 1: neurokinin-1 antagonist intervention 2: Placebo to match orvepitant 30 mg and 60 mg
intervention 1: orvepitant intervention 2: Placebo
32
Phoenix | Arizona | United States | -112.07404 | 33.44838 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Orange | California | United States | -117.85311 | 33.78779 Denver | Colorado | United States | -104.9847 | 39.73915 Norwich | Connecticut | United States | -72.07591 | 41.52426 Jacksonville | Florida...
343
0
0
0
NCT00880048
6TERMINATED
2010-06-21
2009-03-11
GlaxoSmithKline
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
60
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
true
0ALL
false
This was a 3-part study comparing the pharmacokinetics after administration of vaniprevir (MK-7009) for participants with mild, moderate or severe hepatic insufficiency with healthy matched control participants. The primary hypothesis is that the area under the curve (AUC) (0 to infinity) of vaniprevir for participants...
null
Hepatitis C
null
6
arm 1: Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir arm 2: Healthy, matched to mild HI, control participants administered a single 300 mg oral tablet of vaniprevir arm 3: Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir arm ...
[ 0, 0, 0, 0, 0, 0 ]
2
[ 0, 0 ]
intervention 1: single dose administration of 300 mg oral tablet intervention 2: single dose administration of 200 mg oral tablet
intervention 1: Vaniprevir 300 mg intervention 2: Vaniprevir 200 mg
0
null
60
0
0
0
NCT01010906
1COMPLETED
2010-06-21
2009-07-01
Merck Sharp & Dohme LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
132
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous Mircera for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia. Patients will receive 4-weekly intravenous injections of Mircera, at a starting dose of 120, 200 or 3...
null
Anemia
null
1
arm 1: Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythr...
[ 0 ]
1
[ 0 ]
intervention 1: 120, 200 or 360 micrograms iv every 4 weeks (starting dose)
intervention 1: methoxy polyethylene glycol-epoetin beta
20
Adana | N/A | Turkey (Türkiye) | 35.32531 | 36.98615 Ankara | N/A | Turkey (Türkiye) | 32.85427 | 39.91987 Ankara | N/A | Turkey (Türkiye) | 32.85427 | 39.91987 Ankara | N/A | Turkey (Türkiye) | 32.85427 | 39.91987 Ankara | N/A | Turkey (Türkiye) | 32.85427 | 39.91987 Ankara | N/A | Turkey (Türkiye) | 32.85427 | 39.919...
131
0
0
0
NCT00661505
1COMPLETED
2010-06-22
2008-05-14
Hoffmann-La Roche
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
75
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
This is a research study designed to look at the efficacy and safety of daptomycin given at a dose of 6 mg/kg or 8 mg/kg in subjects being treated for prosthetic hip or knee infections caused by Staphylococci. These types of bacteria are among the most common types of bacteria causing infections of prosthetic joints.
null
Osteomyelitis
Osteomyelitis Prosthetic Hip Prosthetic Knee MRSA Osteomyelitis Associated with an Infected Prosthetic Hip or Knee Joint Staphylococci
null
3
arm 1: Daptomycin (6 mg/kg every 24 hours \[q24h\]) as a 30 minute intravenous (IV) infusion for 6 weeks (± one week). arm 2: Daptomycin (8 mg/kg q24h) as a 30 minute IV infusion for 6 weeks (± one week). arm 3: Vancomycin was administered at 1 gram every 12 hours (q12h) as a 60-minute infusion and teicoplanin was admi...
[ 0, 0, 1 ]
7
[ 0, 0, 0, 0, 0, 0, 0 ]
intervention 1: 6 mg/kg intervention 2: 8 mg/kg intervention 3: 1 gram intervention 4: 6 mg/kg; used only at UK sites intervention 5: 1-2 gram intervention 6: 1-2 gram intervention 7: 1-2 mg
intervention 1: daptomycin intervention 2: daptomycin intervention 3: vancomycin intervention 4: teicoplanin intervention 5: nafcillin intervention 6: oxacillin intervention 7: flucloxacillin
26
Little Rock | Arkansas | United States | -92.28959 | 34.74648 Englewood | Colorado | United States | -104.98776 | 39.64777 Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 Tampa | Florida | United States | -82.45843 | 27.94752 Idaho Falls | Idaho | United States | -112.03414 | 43.46658 Chic...
74
0
0
0
NCT00428844
1COMPLETED
2010-06-23
2007-06-26
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
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 ]
201
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
The purpose of this clinical study is to determine the effectiveness (ability to provide beneficial treatment of the disease) and safety of pralatrexate compared to erlotinib when given to non-small cell lung cancer (NSCLC) patients who are current or former cigarette smokers and who have received at least 1 prior trea...
null
Non-small Cell Lung Cancer
Stage IIIB/IV non-small cell lung cancer Non-small cell lung cancer NSCLC Lung Cancer Pralatrexate Erlotinib Tarceva PDX Smoking Smoker
null
2
arm 1: Intravenous (IV) push administration over 3-5 minutes into a patent IV line containing normal saline (0.9% sodium chloride). arm 2: 150 mg orally in tablet form Administered daily 1 hour before or 2 hours after ingestion of food until criteria for discontinuation per the protocol are met.
[ 0, 1 ]
4
[ 0, 0, 7, 7 ]
intervention 1: Intravenous (IV) push administration over 3-5 minutes into a patent IV line containing normal saline (0.9% sodium chloride). Initial dose: 230 mg/m2, increased to 270 mg/m2 if patient does not have specific adverse events (AEs) as per the protocol after receipt of 2 consecutive doses 2 weeks apart. Red...
intervention 1: Pralatrexate intervention 2: Erlotinib intervention 3: Vitamin B12 intervention 4: Folic Acid
47
Bakersfield | California | United States | -119.01871 | 35.37329 San Diego | California | United States | -117.16472 | 32.71571 Port Saint Lucie | Florida | United States | -80.35033 | 27.29393 Chicago | Illinois | United States | -87.65005 | 41.85003 Westwood | Kansas | United States | -94.6169 | 39.04056 Great Falls ...
198
0
0
0
NCT00606502
1COMPLETED
2010-06-24
2008-01-01
Spectrum Pharmaceuticals, Inc
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
1
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The primary objective of this protocol is to treat laboratory confirmed cutaneous leishmaniasis with WR 279,396 in military health care beneficiaries. In this study "cutaneous leishmaniasis" is defined as Old World Leishmaniasis if acquired in the Southwest Central Asia/Middle East.
Up to 10 volunteers, who are military health care beneficiaries, with a diagnosis of Old World cutaneous leishmaniasis who have failed pentavalent antimony or are not eligible to be treated with pentavalent antimony, will be treated with WR 279,396 (topical paromomycin-gentamicin-AQIC) twice a day for 20 days. Primary ...
Cutaneous Leishmaniasis
leishmaniasis cutaneous Old World Leishmania major Treatment
null
1
arm 1: WR279,396 topically twice a day for 20 days
[ 0 ]
1
[ 0 ]
intervention 1: WR297,396 for treatment of patients with parasitologically confirmed, primarily ulcerative, Old World CL, who had either failed pentavalent antimony treatment, or who where ineligible for pentavalent antimony therapy.
intervention 1: Paromomycin +Gentamicin topical cream
1
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
1
0
0
0
NCT00657917
6TERMINATED
2010-06-24
2006-12-20
U.S. Army Medical Research and Development Command
1FED
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
171
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
This 4 arm study in patients with advanced Stage IIIb/IV non-small cell cancer (NSCLC) who failed at least one standard chemotherapy regimen will determine the proportion of patients with progression-free survival at 12 weeks following combination therapy with R1507 and Tarceva or placebo and Tarceva. Patients will be ...
null
Non-Squamous Non-Small Cell Lung Cancer
null
4
arm 1: None arm 2: None arm 3: None arm 4: None
[ 2, 2, 0, 0 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: iv 9mg/kg weekly intervention 2: iv 16mg/kg every 3 weeks intervention 3: iv 9mg/kg weekly intervention 4: iv 16mg/kg every 3 weeks intervention 5: 150mg oral daily
intervention 1: Placebo intervention 2: Placebo intervention 3: RG1507 intervention 4: RG1507 intervention 5: erlotinib [Tarceva]
57
Beverly Hills | California | United States | -118.40036 | 34.07362 New Port Richey | Florida | United States | -82.71927 | 28.24418 Atlanta | Georgia | United States | -84.38798 | 33.749 Chicago | Illinois | United States | -87.65005 | 41.85003 Glenview | Illinois | United States | -87.78784 | 42.06975 Joliet | Illinoi...
171
0
0
0
NCT00760929
6TERMINATED
2010-06-25
2008-11-10
Hoffmann-La Roche
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
50
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
Research Hypothesis: Administration of BMS-663068, a prodrug for HIV attachment inhibitor BMS-626529, will result in a mean decrease of at least 1 log10 in HIV RNA at Day 9 following 8 days of therapy in at least one dosing regimen that is safe and well tolerated in Clade B HIV-1 infected subjects.
null
HIV Infections
HIV, HIV attachment inhibitor, attachment inhibitor
Prot_000.pdf: Page: 1 Protocol Number: AI438006 IND Number: N/A Ex-US Non IND EUDRACT Number 2009-013657-14 Date: 22-Jun-2009 Revised Date: 08-Mar-2010 Clinical Protocol AI438006 Randomized, Open label, Multiple-Dose Study to Evaluate the Pharmacodynamics, Safety and Pharmacokinetics of BMS-663068 in...
5
arm 1: All participants received BMS-663068 600 milligram (mg) and Ritonavir (RTV) 100 mg every 12 hours (Q12H) from Day 1 to Day 8. arm 2: All participants received BMS-663068 1200 mg and RTV 100 mg every night (quaque hora somni \[QHS\]) from Day 1 to Day 8. arm 3: All participants received BMS-663068 1200 mg and RTV...
[ 0, 0, 0, 0, 0 ]
2
[ 0, 0 ]
intervention 1: BMS-663068 will be administered as a tablet formulation intervention 2: Ritonavir will be administered as a capsule.
intervention 1: BMS-663068 intervention 2: Ritonavir
1
Berlin | N/A | Germany | 13.41053 | 52.52437
50
0
0
0
NCT01009814
1COMPLETED
2010-06-25
2009-11-23
ViiV Healthcare
4INDUSTRY
true
true
false
https://cdn.clinicaltrials.gov/large-docs/14/NCT01009814/Prot_000.pdf https://cdn.clinicaltrials.gov/large-docs/14/NCT01009814/SAP_001.pdf
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
132
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
This is a 12-week, randomized, multicenter, double-blind, placebo controlled, fixed-dose parallel group study to assess the efficacy and safety of orvepitant (60 mg/day) versus placebo in subjects with a diagnosis of noncombat-related Posttraumatic Stress Disorder (PTSD), whose symptoms are considered moderate or sever...
The purpose of the current study is to test the safety and effects of orvepitant, an investigational drug for the treatment of noncombat-related PTSD. Efficacy will be assessed using standard symptom and severity rating scales (questionnaires). The Clinicain Adminstered PTSD Scale (CAPS) will serve as the primary meas...
Post-Traumatic Stress Disorder
efficacy double-blind Clinician Administered PTSD Scale placebo Sleep safety CAPS neurokinin-1 antagonist orvepitant PTSD randomized Post traumatic stress disorder Phase II
null
2
arm 1: 60 mg/day arm 2: None
[ 0, 2 ]
2
[ 0, 10 ]
intervention 1: Neurokinin-1 (NK-1) antagonist intervention 2: Inactive placebo to match orvepitant 60 mg dosage form
intervention 1: orvepitant intervention 2: Placebo
26
Birmingham | Alabama | United States | -86.80249 | 33.52066 Scottsdale | Arizona | United States | -111.89903 | 33.50921 Beverly Hills | California | United States | -118.40036 | 34.07362 Torrance | California | United States | -118.34063 | 33.83585 Jacksonville | Florida | United States | -81.65565 | 30.33218 Orlando ...
129
0
0
0
NCT01000493
1COMPLETED
2010-06-28
2009-11-02
GlaxoSmithKline
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
34
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
This is a multicenter, placebo controlled, parallel group, double-blind, randomized comparison study to evaluate the efficacy and safety of ropinirole IR tablets orally administered for 12 weeks in patients with symptomatic restless legs syndrome associated with Chronic kidney disease (CKD) managed with haemodialysis (...
null
Restless Legs Syndrome
ropinirole haemodialysis restless legs syndrome
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Subjects completing the screening period will be randomized (1:1) to receive the IR or placebo for 12 weeks. The treatment will be started at the initial dose of 0.25 mg/day within 1 to 3 hours before bedtime. The maximum available dose is 3 mg/day. For all subjects completing short-term period and ente...
intervention 1: Ropinirole immediate release (IR) intervention 2: Placebo
19
Aichi | N/A | Japan | 130.62158 | 32.51879 Aichi | N/A | Japan | 130.62158 | 32.51879 Chiba | N/A | Japan | 140.11667 | 35.6 Chiba | N/A | Japan | 140.11667 | 35.6 Fukuoka | N/A | Japan | 130.41667 | 33.6 Hiroshima | N/A | Japan | 132.45 | 34.4 Hokkaido | N/A | Japan | N/A | N/A Hyōgo | N/A | Japan | 144.43333 | 43.366...
34
0
0
0
NCT00996944
6TERMINATED
2010-06-29
2009-11-30
GlaxoSmithKline
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
6
RANDOMIZED
PARALLEL
1PREVENTION
0NONE
false
0ALL
false
The purpose of this study is to determine whether temozolomide can be used as a prophylaxis against brain recurrence in participants with metastatic breast cancer.
Breast cancer is the second most common cause of brain metastases. Overall survival after the development of brain metastases tends to be poor (6-8 months). Over-expression of Human Epidermal Growth Factor Receptor 2 (HER-2/neu), negative estrogen receptor, and young age at diagnosis seem to be indicators of high risk ...
Breast Neoplasm Brain Neoplasm Second Neoplasm
null
2
arm 1: None arm 2: None
[ 0, 4 ]
1
[ 0 ]
intervention 1: Capsules to equal 75 mg/m\^2, orally, daily for 6 weeks, in 3 eight-week cycles
intervention 1: temozolomide
0
null
6
0
0
0
NCT00638963
6TERMINATED
2010-06-30
2008-10-02
Merck Sharp & Dohme LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
206
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This is a study that will investigate the safety and efficacy of an investigational drug in Human immunodeficiency virus (HIV) infected patients.
Participants who completed 48 weeks of the original 48-week double-blind study were invited to continue in two extensions: MK0518-004-10 (NCT00100048), which extended the study to 144 weeks, and MK0518-004-20 (NCT00100048), which extended the study to 240 weeks. Participants who had been randomized to MK0518 in the bas...
HIV Infections Acquired Immunodeficiency Syndrome
null
10
arm 1: MK0518 600 mg twice daily arm 2: MK0518 400 mg twice daily arm 3: MK0518 200 mg twice daily arm 4: MK0518 100 mg twice daily arm 5: Placebo to MK0518 twice daily arm 6: MK0518 600 mg + tenofovir + lamivudine arm 7: MK0518 400 mg + tenofovir + lamivudine arm 8: MK0518 200 mg + tenofovir + lamivudine arm 9: MK0518...
[ 0, 0, 0, 0, 2, 0, 0, 0, 0, 1 ]
6
[ 0, 0, 0, 0, 0, 0 ]
intervention 1: MK0518 twice daily for 10 days intervention 2: MK0518 twice daily for 48 weeks intervention 3: efavirenz 600 mg every night at bedtime for 48 weeks intervention 4: tenofovir 300 mg daily for 48 weeks intervention 5: lamivudine 300 mg daily for 48 weeks intervention 6: Placebo to MK0518 twice daily
intervention 1: Comparator: MK0518 monotherapy intervention 2: Comparator: MK0518 combination therapy intervention 3: Comparator: efavirenz intervention 4: Comparator: tenofovir intervention 5: Comparator: lamivudine intervention 6: Placebo monotherapy
0
null
198
4
0.020202
1
NCT00100048
1COMPLETED
2010-07-01
2005-01-01
Merck Sharp & Dohme LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
3
0
0
0
0
0
0
0
1
0
0
0
0
0
0
0
0.007884
[ 4 ]
1,088
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
The primary objective was to determine the effect of teriflunomide on the frequency of relapses in patients with relapsing multiple sclerosis (MS). Secondary objectives were: * to evaluate the effect of teriflunomide on the accumulation of disability as measured by Expanded Disability Status Scale \[EDSS\], the burde...
The study period per participant was approximatively 128 weeks broken down as follows: * Screening period up to 4 weeks, * 108-week double-blind treatment period (approximatively 2 years)\*, * 16-week post-treatment elimination follow-up period. '\*' Participants successfully completing the week 108 visit were offere...
Multiple Sclerosis
Multiple Sclerosis Relapsing Remitting Secondary Progressive Progressive Relapsing
null
3
arm 1: Teriflunomide 7 mg once daily for 108 weeks arm 2: Teriflunomide 14 mg once daily for 108 weeks arm 3: Placebo (for teriflunomide) once daily for 108 weeks
[ 0, 0, 2 ]
2
[ 0, 0 ]
intervention 1: Film-coated tablet Oral administration intervention 2: Film-coated tablet Oral administration
intervention 1: Teriflunomide intervention 2: Placebo (for teriflunomide)
21
Bridgewater | New Jersey | United States | -74.64815 | 40.60079 Vienna | N/A | Austria | 16.37208 | 48.20849 Laval | N/A | Canada | -73.692 | 45.56995 Santiago | N/A | Chile | -70.64827 | -33.45694 Prague | N/A | Czechia | 14.42076 | 50.08804 Hørsholm | N/A | Denmark | 12.50111 | 55.88098 Tallinn | N/A | Estonia | 24.7...
1,086
1
0.000921
1
NCT00134563
1COMPLETED
2010-07-01
2004-09-01
Sanofi
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
0
0
0
0
0
0
0
0
0
0
0
0
0.000163
[ 5 ]
1,032
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This study compared the safety and efficacy of combination therapy with adalimumab plus methotrexate (MTX) to that of MTX monotherapy (i.e., placebo plus MTX) in subjects with early rheumatoid arthritis (RA).
This was a 78-week, multicenter, randomized, double-blind, double-treatment period study designed to compare the safety and efficacy of adalimumab and MTX with placebo and MTX in subjects with early RA. Subjects were randomized to receive adalimumab 40 mg every other week (eow) or placebo subcutaneous injections in com...
Rheumatoid Arthritis
Early Rheumatoid Arthritis Tumor Necrosis Factor Optimization
null
5
arm 1: Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2 arm 2: Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2 arm 3: Combination therapy with methotrexate (MTX) and ...
[ 0, 0, 0, 0, 0 ]
3
[ 2, 0, 2 ]
intervention 1: Adalimumab 40 mg/0.8 mL prefilled syringe injected subcutaneously (SC) every other week (eow) intervention 2: Methotrexate 2.5 mg tablets administered orally once a week starting at 7.5 mg/week with dose escalation (weekly or every other week) by 2.5 mg intervals to 20 mg/week. intervention 3: Placebo f...
intervention 1: adalimumab intervention 2: methotrexate intervention 3: placebo
170
Birmingham | Alabama | United States | -86.80249 | 33.52066 Birmingham | Alabama | United States | -86.80249 | 33.52066 Huntsville | Alabama | United States | -86.58594 | 34.7304 Mobile | Alabama | United States | -88.04305 | 30.69436 Tuscaloosa | Alabama | United States | -87.56917 | 33.20984 Hemet | California | Unit...
1,958
2
0.001021
1
NCT00420927
1COMPLETED
2010-07-01
2006-12-01
Abbott
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
0
0
0
0
0
0
0
1
0
0
0
0
0
0
0
0.00028
[ 3 ]
13
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study was to determine clinical efficacy and safety of ruxolitinib (INCB018424), a small molecule Janus kinase 2 (JAK2)-inhibitor, in patients with refractory or relapsed multiple myeloma.
The protocol was originally designed as a Simon two stage but after it was determined that the initial 13 patients enrolled did not meet the definition of a 'responder' according to the International Uniform Response Criteria for multiple myeloma the protocol was amended to allow patients who had disease progression at...
Multiple Myeloma
null
1
arm 1: Patients received ruxolitinib 25 mg orally twice daily (bid) in each treatment cycle of 28 days. For those patients who had disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion, or withdrew consent, then 40 mg of dexamethasone was added to ruxolitinib on Days 1 t...
[ 0 ]
2
[ 0, 0 ]
intervention 1: Ruxolitinib was supplied as 5 and 25 mg tablets. intervention 2: Dexamethasone was obtained commercially by Investigators in tablet strengths of 20 or 40 mg.
intervention 1: Ruxolitinib 25 mg intervention 2: Dexamethasone 40 mg
3
Highland | California | United States | -117.20865 | 34.12834 Boynton Beach | Florida | United States | -80.06643 | 26.52535 New York | New York | United States | -74.00597 | 40.71427
20
1
0.05
1
NCT00639002
1COMPLETED
2010-07-01
2008-03-01
Incyte 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
1
0
0
0
0
0
0
0
0.008881
[ 3 ]
137
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
false
The purpose of this study is to determine whether NXL104 plus ceftazidime is effective in the treatment of complicated urinary tract infections as compared to a comparator group.
null
Complicated Urinary Tract Infection
null
2
arm 1: NXL/104 ceftazidime arm 2: comparator 4 x daily
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: 125mg/500mg TID intervention 2: 4 x daily
intervention 1: NXL104/ceftazidime intervention 2: Imipenem/Cilastatin
59
Birmingham | Alabama | United States | -86.80249 | 33.52066 Dothan | Alabama | United States | -85.39049 | 31.22323 Mobile | Alabama | United States | -88.04305 | 30.69436 Phoenix | Arizona | United States | -112.07404 | 33.44838 Chula Vista | California | United States | -117.0842 | 32.64005 Escondido | California | U...
135
1
0.007407
1
NCT00690378
1COMPLETED
2010-07-01
2008-11-01
Pfizer
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
0.001309
[ 4 ]
663
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The purpose of this study is to determine the safety, efficacy and tolerability of using two regimens of telaprevir (with and without delayed start) with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C.
This is a randomized, double-blind, placebo-controlled Phase III trial with telaprevir in patients with chronic Hepatitis C Virus (HCV), genotype 1, infection who failed prior treatment with standard treatment. Standard treatment is defined as treatment with Peg-INF and RBV. The trial is designed to compare the efficac...
Hepatitis C, Chronic
Hepatitis C, Chronic Telaprevir Peg-IFN-alfa-2a Ribavirin
null
3
arm 1: Participants will receive 12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses. arm 2: Participants will receive 4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 we...
[ 0, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Participants will receive telaprevir tablets of 750 mg orally eight hourly for 12 weeks in group A and B. intervention 2: Participants will receive 180 µg subcutaneous (under the skin) injection of Peg-IFN-alfa-2a once weekly for 48 weeks in Group A, B and C. intervention 3: Participants will receive ri...
intervention 1: Telaprevir intervention 2: Peg-IFN-alfa-2a intervention 3: Ribavirin intervention 4: Placebo
91
Birmingham | Alabama | United States | -86.80249 | 33.52066 Coronado | California | United States | -117.18309 | 32.68589 La Jolla | California | United States | -117.2742 | 32.84727 Los Angeles | California | United States | -118.24368 | 34.05223 San Francisco | California | United States | -122.41942 | 37.77493 Auror...
1,324
2
0.001511
1
NCT00703118
1COMPLETED
2010-07-01
2008-10-01
Tibotec BVBA
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
2
0
0
0
0
0
0
0
0
0
0
0
0
0.000414
[ 2 ]
47
NON_RANDOMIZED
null
0TREATMENT
0NONE
false
0ALL
null
Study to determine the maximum tolerated dose of BIBW 2992 when combined with backbone chemotherapies consisting in cisplatin plus paclitaxel or cisplatin plus 5 FU. The overall safety, the pharmacokinetics and the anti-tumour efficacy will also be assessed.
null
Neoplasms
null
2
arm 1: daily oral dose of BIBW 2992 combined with 3-weekly infusion of cisplatin-paclitaxel arm 2: daily oral dose of BIBW 2992 combined with 3-weekly infusion of cisplatin-5FU
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: In each arm, BIBW 2992 dose will be escalated to determine MTD. Starting dose will be 20mg daily followed by 40 mg (with the option of an intermediary dose of 30 mg) then 50mg daily. Dose escalation will stop at 50 mg. No intra patient dose escalation. intervention 2: low to high dose, daily
intervention 1: BIBW 2992 intervention 2: BIBW 2992
3
Brussels | N/A | Belgium | 4.34878 | 50.85045 Edegem | N/A | Belgium | 4.44504 | 51.15662 Ghent | N/A | Belgium | 3.71667 | 51.05
47
1
0.021277
1
NCT00716417
1COMPLETED
2010-07-01
2008-07-01
Boehringer Ingelheim
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0.003766
[ 5 ]
491
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to evaluate the efficacy of paliperidone extended-release (ER) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).
This is an open-label (all people know the identity of the intervention), multi-centric (conducted in more than one center), prospective (study following participants forward in time), single arm, and non-comparative study of paliperidone Extended Release(ER) in participants with schizophrenia. The total study duration...
Schizophrenia
Paliperidone R076477 Schizophrenia
null
1
arm 1: Paliperidone extended-release (ER) tablet will be administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.
[ 0 ]
1
[ 0 ]
intervention 1: Paliperidone extended-release (ER) tablet will be administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.
intervention 1: Paliperidone
20
Bucheon-Si Gyeonggi-Do | N/A | South Korea | N/A | N/A Changnyung | N/A | South Korea | N/A | N/A Chunjoo | N/A | South Korea | N/A | N/A Daejeon | N/A | South Korea | 127.38493 | 36.34913 Daejun | N/A | South Korea | 126.74156 | 37.58221 Geonggi-Do | N/A | South Korea | N/A | N/A Gyeonggi-do | N/A | South Korea | 126....
491
2
0.004073
1
NCT00761189
1COMPLETED
2010-07-01
2008-02-01
Janssen Korea, Ltd., Korea
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
1
0
0
0
0.001118
[ 5 ]
270
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to assess the safety and efficacy of doripenem in participants with nosocomial pneumonia (inflammation of the lungs in which the lungs become heavy; pneumonia occurring at least 48 hours after hospital admission), complicated intra-abdominal (in belly) infections and complicated urinary tra...
This is an open-label (all people involved know the identity of the intervention), multi-center (conducted in more than 1 center) study, to evaluate the safety and effectiveness of doripenem in treating Thai participants with nosocomial pneumonia, complicated intra-abdominal and urinary tract infections. The study cons...
Infection Cross Infection Bacterial Infections Pneumonia, Ventilator-Associated Intra-abdominal Infections Urinary Tract Infections
Pneumonia, Ventilator-Associated Intra-abdominal Infections Urinary tract Infections Doripenem Doribax
null
3
arm 1: Doripenem will be administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with nosocomial pneumonia up to maximum of 14 days. arm 2: Doripenem will be administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated i...
[ 0, 0, 0 ]
1
[ 0 ]
intervention 1: Doripenem 500 mg will be administered as 1 or 4 hours intravenous infusion, after every 8 hours up to maximum of 14 days.
intervention 1: Doripenem
8
Bangkok | N/A | Thailand | 100.50144 | 13.75398 Chiang Mai | N/A | Thailand | 98.98468 | 18.79038 Chiang Rai | N/A | Thailand | 99.8325 | 19.90858 Chon Buri | N/A | Thailand | 100.98345 | 13.3622 Khon Kaen | N/A | Thailand | 102.833 | 16.44671 Nakhon Ratchasima | N/A | Thailand | 102.10196 | 14.97066 Nakornnayok | N/A ...
268
1
0.003731
1
NCT00965848
1COMPLETED
2010-07-01
2009-06-01
Janssen-Cilag Ltd.,Thailand
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
0.000659
[ 4 ]
240
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
1FEMALE
null
Randomized phase III trial to compare the effectiveness of methotrexate with that of dactinomycin in treating patients who have gestational trophoblastic neoplasia. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether methotrexate is mo...
OBJECTIVES: I. Compare the efficacy of methotrexate vs dactinomycin, as measured by complete response rate, in patients with low-risk gestational trophoblastic neoplasia. II. Compare the toxicity of these regimens in these patients. III. Determine whether the definition of persistent gestational trophoblastic neoplas...
Good Prognosis Metastatic Gestational Trophoblastic Tumor Hydatidiform Mole Non-Metastatic Gestational Trophoblastic Tumor Uterine Corpus Choriocarcinoma
null
2
arm 1: Patients receive methotrexate intramuscularly once weekly in the absence of disease progression or unacceptable toxicity. Patients continue on treatment until 1 beta HCG titer is below the institutional normal. Patients then receive 1 additional consolidation treatment. arm 2: Patients receive dactinomycin IV ov...
[ 0, 0 ]
2
[ 2, 0 ]
intervention 1: Given IV intervention 2: Given intramuscularly
intervention 1: Dactinomycin intervention 2: Methotrexate
1
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
214
0
0
0
NCT00003702
1COMPLETED
2010-07-01
1999-06-01
Gynecologic Oncology Group
5NETWORK
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
61
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
null
Phase II trial to study the effectiveness of irofulven in treating patients who have recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
OBJECTIVES: I. Determine the antitumor activity of irofulven in patients with persistent or recurrent platinum-sensitive ovarian epithelial or primary peritoneal cancer. II. Determine the toxicity of this drug in these patients. OUTLINE: Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat ...
Primary Peritoneal Cavity Cancer Recurrent Ovarian Epithelial Cancer
null
1
arm 1: Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.
[ 0 ]
1
[ 0 ]
intervention 1: Given IV
intervention 1: irofulven
1
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
55
0
0
0
NCT00053365
1COMPLETED
2010-07-01
2003-06-01
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 ]
26
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
null
This phase II clinical trial studies the side effects and how well imatinib mesylate works in treating patients with uterine cancer that has failed to respond to initial chemotherapy or has re-grown after therapy. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growt...
PRIMARY OBJECTIVES: I. To determine the activity of Gleevec\^trademark (TM) (imatinib mesylate) as measured by progression-free survival at six months. II. To determine the frequency and severity of adverse effects of Gleevec\^TM in this cohort of patients as assessed by the Common Terminology Criteria of Adverse Eve...
Recurrent Uterine Sarcoma Uterine Carcinosarcoma
null
1
arm 1: Patients receive imatinib mesylate PO QD or BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
[ 0 ]
2
[ 0, 10 ]
intervention 1: Given PO intervention 2: Correlative studies
intervention 1: imatinib mesylate intervention 2: laboratory biomarker analysis
1
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
23
0
0
0
NCT00075400
1COMPLETED
2010-07-01
2004-01-01
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 ]
140
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
BBR 2778 is a novel aza-anthracenedione that has activity in experimental tumors and shows reduced potential for cardiotoxicity in animal models. This cytotoxic agent has structural similarities with mitoxantrone as well as general similarities with anthracyclines (such as the tricyclic central quinoid chromophore).
The primary study objective is to compare the efficacy of BBR 2778 to a selection of single agents. Secondary objectives are to compare the safety and tolerability of BBR 2778 to a selection of single agents, and to assess the pharmacokinetic parameters of BBR 2778 in a subset of this patient population.
Lymphoma, Non-Hodgkin
Pixantrone Non-Hodgkins lymphoma
null
2
arm 1: Pixantrone (BBR2778) arm 2: To be chosen by the investigator, among vinorelbine, oxaliplatin, ifosfamide, etoposide or mitoxantrone
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Day 1: pixantrone (150 mg/m2), cyclophosphamide (750 mg/m2), vincristine (1.4 mg/m2), rituximab (375 mg/m2) Days 1-5: prednisone (100 mg/day) intervention 2: Day 1: cyclophosphamide (750 mg/m2), vincristine (1.4 mg/m2), rituximab (375 mg/m2) Days 1-5: prednisone (100 mg/day)
intervention 1: pixantrone, cyclophosphamide, vincristine, rituximab, prednisone intervention 2: Vinorelbine, Oxalplatin, Ifosfasmide, Etoposide, Mitoxatrone, Gemcitabine or Rituximab
99
Fountain Valley | California | United States | -117.95367 | 33.70918 Los Angeles | California | United States | -118.24368 | 34.05223 Lakeland | Florida | United States | -81.9498 | 28.03947 Chicago | Illinois | United States | -87.65005 | 41.85003 Albuquerque | New Mexico | United States | -106.65114 | 35.08449 Syracu...
135
0
0
0
NCT00088530
1COMPLETED
2010-07-01
2004-07-01
CTI BioPharma
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 ]
21
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This phase II trial is studying how well SB-715992 works in treating patients with recurrent or metastatic head and neck cancer. Drugs used in chemotherapy, such as SB-715992, work in different ways to stop tumor cells from dividing so they stop growing or die.
PRIMARY OBJECTIVES: I. To determine the antitumor activity of SB-715992 in recurrent and/or metastatic squamous cell carcinoma of the head and neck using objective response rates (partial and complete responses). SECONDARY OBJECTIVES: I. To determine the duration of objective response, rate and duration of stable di...
Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma Recurrent Metastatic Squamous Neck Cancer With Occult Primary Recurrent Salivary Gland Cancer Recurrent Squamous Cell Carcinoma of the Hypopharynx Recurrent Squamous Cell Carcinoma of the Larynx Recurrent Squamous Cell Carcinoma of the Lip and ...
null
1
arm 1: Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
[ 0 ]
3
[ 0, 10, 10 ]
intervention 1: Given IV intervention 2: Correlative studies intervention 3: Correlative studies
intervention 1: ispinesib intervention 2: laboratory biomarker analysis intervention 3: pharmacological study
1
Toronto | Ontario | Canada | -79.39864 | 43.70643
20
0
0
0
NCT00095628
1COMPLETED
2010-07-01
2005-01-01
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
[ 2, 3 ]
52
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This phase I/II trial studies lapatinib to see how well it works in treating young patients with recurrent or refractory central nervous system (CNS) tumors. Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PRIMARY OBJECTIVES: I. To estimate the MTD and describe the DLT of oral lapatinib (GW572016) administered twice daily for 28 days to children with recurrent or refractory malignant brain tumors who are not receiving steroids (Stratum 1) and to describe toxicities in those who are receiving steroids (Stratum 2). II. T...
Recurrent Childhood Anaplastic Astrocytoma Recurrent Childhood Brain Stem Glioma Recurrent Childhood Ependymoma Recurrent Childhood Giant Cell Glioblastoma Recurrent Childhood Glioblastoma Recurrent Childhood Gliosarcoma Recurrent Childhood Medulloblastoma Recurrent Childhood Oligodendroglioma
null
1
arm 1: Molecular Biology Phase: Patients randomized to receive lapatinib prior to surgery receive oral lapatinib twice daily for 7-14 days. Surgery is performed after 7-14 days of lapatinib treatment. For patients randomized to not receive lapatinib, surgery is performed within 3 weeks of registration. After surgical r...
[ 0 ]
6
[ 0, 3, 10, 10, 3, 3 ]
intervention 1: Given orally intervention 2: Undergo surgery intervention 3: Correlative studies intervention 4: Correlative studies intervention 5: Correlative studies intervention 6: Correlative studies
intervention 1: lapatinib ditosylate intervention 2: therapeutic conventional surgery intervention 3: laboratory biomarker analysis intervention 4: pharmacological study intervention 5: positron emission tomography intervention 6: magnetic resonance imaging
1
Memphis | Tennessee | United States | -90.04898 | 35.14953
51
0
0
0
NCT00095940
1COMPLETED
2010-07-01
2004-10-01
National Cancer Institute (NCI)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
74
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
RATIONALE: Gefitinib and everolimus may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Giving gefitinib together with everolimus may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects, best way to give, and best dose of giving gefitinib with everolimu...
OBJECTIVES: Primary * Determine the maximum tolerated dose of everolimus when administered with gefitinib in patients with stage IIIB or IV or recurrent non-small cell lung cancer. (Phase I) * Determine the efficacy of this regimen in these patients. (Phase II) Secondary * Assess the pharmacokinetics of everolimus,...
Lung Cancer
recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer
null
1
arm 1: Phase I: Patients receive oral everolimus once on day 1. Beginning on day 8, patients receive oral gefitinib once daily. Beginning on day 22, patients receive oral everolimus once daily. Both drugs are then given concurrently for the rest of the treatment. Treatment continues in the absence of disease progressio...
[ 0 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: everolimus intervention 2: gefitinib
1
New York | New York | United States | -74.00597 | 40.71427
74
0
0
0
NCT00096486
1COMPLETED
2010-07-01
2004-05-01
Memorial Sloan Kettering Cancer Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
55
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
true
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying ho...
OBJECTIVES: * Determine the antitumor activity of paclitaxel and carboplatin in patients with persistent or recurrent stage III or IV uterine carcinosarcoma. * Determine the nature and degree of toxicity of this regimen in these patients. OUTLINE: This is a non-randomized, multicenter study. Patients receive paclita...
Sarcoma
recurrent uterine sarcoma stage III uterine sarcoma stage IV uterine sarcoma uterine carcinosarcoma
null
1
arm 1: Paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC = 6 IV over 30 minutes every 21 days until disease progression or adverse effects prohibit further therapy
[ 0 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: carboplatin intervention 2: paclitaxel
110
Birmingham | Alabama | United States | -86.80249 | 33.52066 Los Angeles | California | United States | -118.24368 | 34.05223 New Britain | Connecticut | United States | -72.77954 | 41.66121 Lewes | Delaware | United States | -75.13935 | 38.77456 Newark | Delaware | United States | -75.74966 | 39.68372 Jacksonville | Fl...
46
0
0
0
NCT00112489
1COMPLETED
2010-07-01
2005-05-01
Gynecologic Oncology Group
5NETWORK
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
28
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
The purpose of this study is to examine the safety and efficacy of duloxetine for the treatment of social anxiety disorder.
An expanding body of clinical experience and controlled trials has established the efficacy of serotonin selective reuptake inhibitors (SSRIs) and the serotonin norepinephrine reuptake inhibitor (SNRI) venlafaxine, for the treatment of social anxiety disorder, with paroxetine, sertraline and venlafaxine extended-releas...
Anxiety Disorder
social anxiety disorder social phobia duloxetine serotonin norepinephrine reuptake inhibitor SNRI double blind
null
3
arm 1: In Phase 2 participants were randomized to 60mg Duloxetine + Placebo or 120mg Duloxetine. arm 2: In Phase 2 participants were randomized to 60mg Duloxetine + Placebo or 120mg Duloxetine. arm 3: In Phase 1 all participants entered an open trial.
[ 2, 1, 1 ]
3
[ 0, 0, 0 ]
intervention 1: 60 mg duloxetine 1x per day intervention 2: 60 mg duloxetine 1x per day + 60mg duloxetine 1x per day intervention 3: 60mg placebo 1x per day
intervention 1: Duloxetine intervention 2: Duloxetine intervention 3: Placebo
1
Boston | Massachusetts | United States | -71.05977 | 42.35843
28
0
0
0
NCT00114127
1COMPLETED
2010-07-01
2004-06-01
Massachusetts General Hospital
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
28
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
null
This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with recurrent or persistent uterine cancer. Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping ...
OBJECTIVES: I. Determine the antitumor activity of gemcitabine and docetaxel in patients with recurrent or persistent uterine carcinosarcoma. II. Determine the nature and degree of toxicity of this regimen in these patients. OUTLINE: This is a non-randomized, multicenter study. Patients receive gemcitabine IV over 3...
Recurrent Uterine Corpus Sarcoma Uterine Carcinosarcoma
null
1
arm 1: Patients receive gemcitabine IV over 30 minutes followed by docetaxel IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
[ 0 ]
2
[ 0, 0 ]
intervention 1: Given IV intervention 2: Given IV
intervention 1: Gemcitabine Hydrochloride intervention 2: Docetaxel
1
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
24
0
0
0
NCT00114218
1COMPLETED
2010-07-01
2005-03-01
Gynecologic Oncology Group
5NETWORK
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
95
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to compare the efficacy of oral risperidone (Risperdal) to risperidone long-acting (Consta) in reducing alcohol use in persons diagnosed with schizophrenia or schizoaffective disorder.
Comorbid alcohol/substance use disorder (SUD) in people with schizophrenia is a major concern, both in view of the high frequency of SUD among patients with schizophrenia and the difficulty in managing such patients. Though antipsychotic medications are effective in reducing symptoms and impairment in persons with schi...
Schizophrenia Psychotic Disorders Substance Abuse Alcohol Abuse
Risperidone Schizophrenia Substance Use Disorder Alcohol Use Disorder Treatment Schizoaffective Disorder
null
2
arm 1: Risperidone Long Acting; aka Risperdal Consta; injectable form arm 2: Oral Risperidone; aka Risperdal; oral form
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Dose 25.00, 37.50 or 50.00 mg q two weeks intervention 2: 0.50-6.00 mg oral risperidone daily
intervention 1: Risperidone Long Acting intervention 2: oral risperidone
8
Miami | Florida | United States | -80.19366 | 25.77427 Kansas City | Missouri | United States | -94.57857 | 39.09973 St Louis | Missouri | United States | -90.19789 | 38.62727 Lebanon | New Hampshire | United States | -72.25176 | 43.64229 Manchester | New Hampshire | United States | -71.45479 | 42.99564 Nashua | New Ha...
95
0
0
0
NCT00130923
1COMPLETED
2010-07-01
2005-09-01
Dartmouth-Hitchcock Medical Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
40
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to determine the effectiveness and side effects of a new combination and schedule of chemotherapy drugs in the treatment of head and neck cancer. Patients with advanced or recurrent head and neck cancer, which is untreatable by surgery or radiation therapy are eligible for this study. Stand...
Approximately 28,900 patients will be diagnosed with squamous cell cancers of the oral cavity and pharynx in the year 2002. Of these, an estimated 7,400 patients will present with metastases or develop recurrent disease, which is not amenable to surgery or radiation therapy. Palliative chemotherapy is thus the only tre...
Head and Neck Cancer
Squamous cell cancer of the oral cavity and pharynx
null
1
arm 1: Docetaxel (1000mg PO BID days 5-18 of each Cycle) and Capecitabine (30mg/m2/week IV days 1, 8, \&15)
[ 0 ]
2
[ 0, 0 ]
intervention 1: Each four-week cycle consists of three infusions through a vein of docetaxel, on days 1, 8, and 15. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule. If the subject's disease has not decreased significantly but there is no ev...
intervention 1: Docetaxel intervention 2: Capecitabine
1
Ann Arbor | Michigan | United States | -83.74088 | 42.27756
38
0
0
0
NCT00148122
1COMPLETED
2010-07-01
2002-11-01
University of Michigan Rogel 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 ]
16
NA
SINGLE_GROUP
2DIAGNOSTIC
0NONE
false
0ALL
true
The purposes of this study are: to determine the feasibility of administering adjuvant cisplatin plus ALIMTA to patients who undergo surgery with heated cisplatin during surgery; to determine the effects (good and bad) of this combined modality approach in patients with mesothelioma; to evaluate cisplatin effects by de...
OBJECTIVES: Primary * To determine the feasibility of administering adjuvant cisplatin plus Alimta to patients undergoing surgery with hyperthermic cisplatin. Secondary * To determine the morbidity and mortality of this treatment protocol * To determine time to tumor recurrence and patient survival * To evaluate th...
Pleural Mesothelioma Malignant Pleural Mesothelioma
pleurectomy decortication cisplatin ALIMTA
null
1
arm 1: Participants undergo surgery, Pleurectomy/Decortication, followed by heated cisplatin given as a one-hour lavage of the chest and abdominal cavity then sodium thiosulfate given intravenously over 6 hours. The adjuvant chemotherapy regimen beginning 6-10 weeks after surgery is a combination of cisplatin and Alimt...
[ 0 ]
3
[ 0, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: None
intervention 1: Cisplatin intervention 2: Sodium Thiosulfate intervention 3: ALIMTA
2
Boston | Massachusetts | United States | -71.05977 | 42.35843 Boston | Massachusetts | United States | -71.05977 | 42.35843
16
0
0
0
NCT00165503
6TERMINATED
2010-07-01
2004-04-01
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
[ 3 ]
12
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This research study is for subjects with squamous cell cancer of the head and neck which is not solely treatable with surgery or radiation. This research study involves treatment with an experimental chemotherapy combination of oxaliplatin and Taxotere. Tha main purpose of this study is to assess the effectiveness of t...
null
Carcinoma of the Head and Neck
null
1
arm 1: On Day 1 of each day treatment cycle, patients receive Taxotere 60 mg/m2 as a 1-hour IV infusion, followed by the administration of oxaliplatin 100 mg/m2. Oxaliplatin will be administered IV over 2 hours at a rate of 10mg/m2/min. This treatment regimen will be repeated every 21 days.
[ 0 ]
2
[ 0, 0 ]
intervention 1: Taxotere is given at 60 mg/m2 as a 1-hour intravenous infusion. intervention 2: Oxaliplatin will be administered intravenously over 2 hours at a rate of 10mg/m2/min. on day 1 every 3 weeks.
intervention 1: Taxotere intervention 2: Oxaliplatin
1
Los Angeles | California | United States | -118.24368 | 34.05223
12
0
0
0
NCT00184028
6TERMINATED
2010-07-01
2004-09-01
University of Southern California
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 ]
36
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This trial will evaluate the combination of modified infusional 5-fluorouracil/ leucovorin, oxaliplatin (FOLFOX6), bevacizumab, and cetuximab in patients with metastatic colorectal cancer. FOLFOX6 has proven to be a safe and effective regimen in first line treatment of advanced colorectal cancer. The role of epidermal ...
All patients received cetuximab: 400 mg/m2 (first cycle only) administered intravenously (IV) on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8. Day 1 cetuximab was immediately followed by bevacizumab 5 mg/kg IV, oxaliplatin 85 mg/m2 IV, and 5-fluorouracil 400 mg/m2 IV bolus, fo...
Colon Cancer
Colon Cancer
null
1
arm 1: Bevacizumab 5 mg/kg IV Cetuximab 400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8 5-Fluorouracil 400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient) Leucovorin 350 m...
[ 0 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: 5 mg/kg IV intervention 2: 400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8 intervention 3: 400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient) intervention 4:...
intervention 1: Bevacizumab intervention 2: Cetuximab intervention 3: 5-fluorouracil intervention 4: Leucovorin intervention 5: Oxaliplatin
10
Evansville | Indiana | United States | -87.55585 | 37.97476 Louisville | Kentucky | United States | -85.75941 | 38.25424 Portland | Maine | United States | -70.2589 | 43.65737 Bethesda | Maryland | United States | -77.10026 | 38.98067 Jackson | Mississippi | United States | -90.18481 | 32.29876 Chesterfield | Missouri ...
36
0
0
0
NCT00193219
1COMPLETED
2010-07-01
2005-07-01
SCRI Development Innovations, LLC
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 ]
123
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
Cocaine addiction is a serious health problem with no available medical treatment for preventing relapse. Modafinil, a medication that enhances mood, increases energy, and improves concentration, may be useful in preventing relapse among individuals with cocaine addiction. This study will evaluate the effectiveness of ...
The development of a medication to treat cocaine addiction specifically by lessening withdrawal symptoms has been a primary focus of research. Common cocaine withdrawal symptoms include depression, lack of energy, and poor concentration. Modafinil, a central nervous system stimulant, is a medication that can speed up p...
Cocaine Dependence
Cocaine Dependence
null
3
arm 1: 200mg Modafinil arm 2: 400mg Modafinil arm 3: Matching Placebo
[ 0, 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: 200mg Modafinil intervention 2: 400mg Modafinil intervention 3: Matching Placebo
intervention 1: Modafinil intervention 2: Modafinil intervention 3: Matching Placebo
1
Charleston | South Carolina | United States | -79.93275 | 32.77632
123
0
0
0
NCT00218387
1COMPLETED
2010-07-01
2004-04-01
Medical University of South Carolina
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, 4 ]
34
RANDOMIZED
CROSSOVER
1PREVENTION
0NONE
false
0ALL
null
The objective of this study is to assess whether prophylactic therapy with an activated prothrombin complex concentrate (FEIBA)will result in a significant reduction in the number of bleeds in patients with hemophilia and persistent high responding inhibitors.
null
Hemophilia A With Inhibitors
null
2
arm 1: Patients receive 6 months of on-demand therapy with study drug followed by 6 months of prophylaxis therapy with study drug arm 2: Patients receive 6 months of prophylaxis therapy with study drug followed by 6 months on-demand therapy with study drug
[ 5, 5 ]
1
[ 0 ]
intervention 1: FEIBA for prophylaxis therapy dosed at 85 U/Kg +/- 15% on three non-consecutive days each week for 6 months FEIBA for on-demand therapy dosed at 85 U/Kg +/- 15% for bleeding episodes for 6 months
intervention 1: activated prothrombin complex concentrate (FEIBA)
1
New Orleans | Louisiana | United States | -90.07507 | 29.95465
91
0
0
0
NCT00221195
1COMPLETED
2010-07-01
2003-06-01
Tulane University School of Medicine
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
48
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
1FEMALE
false
Our aim is to compare the safety and efficacy of 2 different empiric levothyroxine dose adjustment recommendations to be made at the first confirmation of pregnancy in women with a history of hypothyroidism. Subjects will be women with a prior diagnosis of hypothyroidism who are taking thyroid hormone replacement and w...
Our aim is to compare the safety and efficacy of 2 different empiric levothyroxine dose adjustment recommendations to be made at the first confirmation of pregnancy in women with a history of hypothyroidism. Subjects will be women with a prior diagnosis of hypothyroidism who are taking thyroid hormone replacement and w...
Pregnancy Hypothyroidism
pregnancy hypothyroidism levothyroxine
null
2
arm 1: Patients will increase their current levothyroxine dose by 2 extra tablets per week (\~29% increase) arm 2: Patients will increase their levothyroxine dosage by 3 extra tablets per week (\~43%).
[ 1, 1 ]
3
[ 0, 0, 0 ]
intervention 1: as it is know that levothyroxine requirement increases in pregnancy, both study arms will increase levothyroxine dose, though by different amounts. intervention 2: patients will increase levothyroxine dosage by 2 extra tablets of their current dose per week intervention 3: patients will increase levothy...
intervention 1: Anticipatory dose increase of levothyroxine intervention 2: levothyroxine intervention 3: levothyroxine
1
Boston | Massachusetts | United States | -71.05977 | 42.35843
48
0
0
0
NCT00230802
1COMPLETED
2010-07-01
2005-07-01
Brigham and Women's Hospital
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
56
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
null
Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. This phase II trial is studying how well sorafenib works in treating patients with advanced or recurrent uterine cancer.
PRIMARY OBJECTIVES: I. Determine the objective response rate in patients with advanced or recurrent uterine cancer treated with sorafenib. II. Determine the toxic effects of this drug in these patients. SECONDARY OBJECTIVES: I. Determine progression-free survival of patients treated with this drug. OUTLINE: This i...
Recurrent Uterine Sarcoma Stage III Uterine Sarcoma Stage IV Uterine Sarcoma Uterine Carcinosarcoma
null
1
arm 1: Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
[ 0 ]
1
[ 0 ]
intervention 1: Given orally
intervention 1: sorafenib tosylate
7
Duarte | California | United States | -117.97729 | 34.13945 Los Angeles | California | United States | -118.24368 | 34.05223 Decatur | Illinois | United States | -88.9548 | 39.84031 Springfield | Illinois | United States | -89.64371 | 39.80172 Hamilton | Ontario | Canada | -79.84963 | 43.25011 Kingston | Ontario | Cana...
56
0
0
0
NCT00238121
1COMPLETED
2010-07-01
2005-02-01
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 ]
60
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The current study is to evaluate: Overall response rate for the combination of trastuzumab and SU011248 in metastatic or locally recurrent breast cancer; evaluate safety and tolerability of the combination; measure duration of tumor control and survival; assess patient reported outcomes; assess PK in combination with t...
null
Breast Neoplasms
Breast Cancer Metastatic
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: SU011248 will be administered orally, starting dose of 37.5 mg daily on a continuous regimen. Trastuzumab will be administered weekly (loading dose 4 mg/kg followed by weekly 2mg/kg) or every 3 weeks (loading dose 8 mg/kg followed by 6mg/kg q3w). Study treatment should continue until progression, withdr...
intervention 1: SU011248/Trastuzumab
27
Montgomery | Alabama | United States | -86.29997 | 32.36681 Newark | Delaware | United States | -75.74966 | 39.68372 Newark | Delaware | United States | -75.74966 | 39.68372 Wilmington | Delaware | United States | -75.54659 | 39.74595 Fort Lauderdale | Florida | United States | -80.14338 | 26.12231 Harvey | Illinois | ...
60
0
0
0
NCT00243503
1COMPLETED
2010-07-01
2006-02-01
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 ]
159
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
null
This is a prospective, randomized controlled clinical trial to evaluate the efficacy and safety of intravenous patient controlled analgesia (IVPCA) in patients following major intracranial surgery (e.g. brain tumors, vascular surgery). We will compare pain, opioid consumption, costs, sedation level, length of hospital ...
null
Intracranial Surgery
null
4
arm 1: None arm 2: None arm 3: None arm 4: None
[ 0, 1, 0, 1 ]
2
[ 0, 0 ]
intervention 1: PCA fentanyl 0.5 ug/kg with a dosing interval ("lockout") of 15 minutes and a maximal permitted dosage of 4 demand doses per hour, according to their randomized preoperative assignment. The PCA pump (CADD-Solis Ambulatory Infusion Pump; Smiths Medical, Dublin, OH) had a preprogrammed dose limit of 50 ug...
intervention 1: PCA fentanyl intervention 2: PRN fentanyl
1
Baltimore | Maryland | United States | -76.61219 | 39.29038
129
0
0
0
NCT00286221
1COMPLETED
2010-07-01
2006-03-01
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
[ 4 ]
676
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
The purpose of this study is to determine if the combination of VELCADE and rituximab improves progression free survival relative to rituximab alone in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma (B-NHL) who never received rituximab or who have previously responded to rituximab. This is an intern...
null
Non-Hodgkin's Lymphoma
B-cell Non-Hodgkin's Lymphoma
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: VELCADE for Injection will be administered weekly on Days 1,8,15, and 22 of a 35-day cycle in combination with 4 doses of rituximab once a week on Days 1,8,15, and 22 of Cycle 1 and in combination with a single dose of rituximab on Day 1 of Cycles 2 to 5. intervention 2: rituximab once a week on Days 1,...
intervention 1: Bortezomib + Rituximab intervention 2: Rituximab
206
Opelika | Alabama | United States | -85.37828 | 32.64541 Alhambra | California | United States | -118.12701 | 34.09529 Bakersfield | California | United States | -119.01871 | 35.37329 Burbank | California | United States | -118.30897 | 34.18084 Fullerton | California | United States | -117.92534 | 33.87029 La Verne | C...
673
0
0
0
NCT00312845
1COMPLETED
2010-07-01
2006-03-01
Millennium Pharmaceuticals, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
42
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
Although miglustat has been approved as a treatment for mild to moderate type 1 Gaucher disease in patients who are unsuitable for enzyme replacement therapy (ERT), more data are required to establish the long term efficacy, safety and tolerability of miglustat in maintaining diseases stability after a switch from ERT.
null
Gaucher Disease Type 1
enzyme replacement therapy Type 1 Gaucher Disease miglustat
null
1
arm 1: Oral administration of miglustat 100 mg t.i.d. for a period of 2 years
[ 0 ]
1
[ 0 ]
intervention 1: Oral capsules containing miglustat 100 mg, administered three times daily (t.i.d.)
intervention 1: Miglustat
0
null
42
0
0
0
NCT00319046
1COMPLETED
2010-07-01
2006-02-01
Actelion
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
1,142
RANDOMIZED
PARALLEL
1PREVENTION
3TRIPLE
false
0ALL
true
The purpose of this study is to determine if long-term administration of a macrolide antibiotic will reduce worsening of symptoms among individuals with chronic obstructive pulmonary disease (COPD).
BACKGROUND: The prevalence, morbidity, mortality, and treatment cost of COPD are high and increasing. COPD is the sixth leading cause of death worldwide and is the only condition in the top 10 causes of death that has an increasing prevalence and mortality. The cost of health care for patients with COPD in the U.S. is...
Pulmonary Disease, Chronic Obstructive
null
2
arm 1: Macrolide Antibiotic (Azithromycin) arm 2: Inactive
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Azithromycin (daily capsule, 250 mg for 12 months) intervention 2: Placebo taken on a daily basis
intervention 1: Macrolide Antibiotic (Azithromycin) intervention 2: Placebo
10
Birmingham | Alabama | United States | -86.80249 | 33.52066 San Francisco | California | United States | -122.41942 | 37.77493 Torrance | California | United States | -118.34063 | 33.83585 Denver | Colorado | United States | -104.9847 | 39.73915 Baltimore | Maryland | United States | -76.61219 | 39.29038 Boston | Massa...
1,142
0
0
0
NCT00325897
1COMPLETED
2010-07-01
2006-03-01
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
[ 2, 3 ]
68
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This study was an early-phase trial arranged into two phases. The Phase I portion was a dose-escalation study designed to assess the safety, tolerability and to identify the maximum tolerated dose of SB-743921 in patients with Non-Hodgkin Lymphoma and Hodgkin Lymphoma. Phase II was intended to assess the activity, safe...
null
Non-Hodgkin's Lymphoma Hodgkin's Disease
null
2
arm 1: Phase 1 dose escalation without and with GCSF support arm 2: Phase 2 fixed dose based on Phase I findings stratified by NHL type
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Phase 1: I.V. dose on Days 1 and 15 of a 28 day cycle starting at 2mg/m2 and increasing by 1 mg/m2 with possible prophylactic granulopoietic support until unacceptable toxicity develops. intervention 2: Phase 2: I.V. dose and regimen will be determined based on Phase 1 findings.
intervention 1: SB-743921 intervention 2: SB-743921
8
Hackensack | New Jersey | United States | -74.04347 | 40.88593 New York | New York | United States | -74.00597 | 40.71427 New York | New York | United States | -74.00597 | 40.71427 New York | New York | United States | -74.00597 | 40.71427 Chapel Hill | North Carolina | United States | -79.05584 | 35.9132 Nashville | T...
63
0
0
0
NCT00343564
1COMPLETED
2010-07-01
2006-04-01
Cytokinetics
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 ]
420
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
true
Emergency intubation of patients in intensive care is a high-risk endeavour. For many decades, succinylcholine has been the neuromuscular blocking agent of choice. However, succinylcholine may have life-threatening side effects and is contraindicated in a variety of diseases relevant in intensive care. The nondepolariz...
Objective: to compare succinylcholine and rocuronium with regard to 1) quality of intubating conditions, 2) length of the intubating sequence, 3) failed intubating attempts, 4) hemodynamic sequelae of intubation, and 5) desaturations. Design: prospective, randomized, single-blind study. Setting: Intensive care units o...
Intubation
intubation intensive care neuromuscular depolarizing agents neuromuscular nondepolarizing agents neuromuscular blocking agents
null
2
arm 1: None arm 2: None
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: 1mg/kg iv intervention 2: 0.6mg/kg iv
intervention 1: Succinylcholine intervention 2: Rocuronium
1
Basel | Canton of Basel-City | Switzerland | 7.57327 | 47.55839
420
0
0
0
NCT00355368
1COMPLETED
2010-07-01
2006-08-01
University Hospital, Basel, Switzerland
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
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This phase II trial is studying how well PXD101 works in treating patients with relapsed or refractory acute myeloid leukemia or older patients with newly diagnosed acute myeloid leukemia. PXD101 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the...
PRIMARY OBJECTIVES: I. Evaluate the response rate (complete response and partial response) in patients with acute myeloid leukemia treated with PXD101. SECONDARY OBJECTIVES: I. Evaluate the overall survival of these patients. II. Evaluate the duration of response in these patients. III. Evaluate the toxicity of this...
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Del(5q) Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) Recurrent Ad...
null
1
arm 1: Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 6-12 months in the absence of disease progression or unacceptable toxicity.
[ 0 ]
2
[ 0, 10 ]
intervention 1: Given IV intervention 2: Correlative studies
intervention 1: belinostat intervention 2: laboratory biomarker analysis
1
Duarte | California | United States | -117.97729 | 34.13945
12
0
0
0
NCT00357032
1COMPLETED
2010-07-01
2006-05-01
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 ]
81
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
This trial is studying two different schedules of docetaxel and bortezomib to compare how well they work in treating patients with progressive or recurrent non-small cell lung cancer. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or ...
PRIMARY OBJECTIVE: I. To compare the efficacy and tolerability of sequential vs concurrent docetaxel and bortezomib in patients with previously treated, progressive or recurrent, advanced non-small cell lung cancer (NSCLC). SECOND OBJECTIVES: I. To compare time to progression in patients with previously treated NSCL...
Non-small Cell Lung Cancer Recurrent Non-small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer
null
2
arm 1: Patients receive docetaxel IV over 60 minutes on day 1 and bortezomib IV over 3-5 seconds on days 1 and 8. arm 2: Patients receive docetaxel as in arm I and bortezomib IV over 3-5 seconds on days 2 and 8.
[ 0, 0 ]
6
[ 0, 0, 10, 10, 10, 10 ]
intervention 1: Given IV intervention 2: Given IV intervention 3: correlative study intervention 4: correlative study intervention 5: correlative study intervention 6: correlative study
intervention 1: docetaxel intervention 2: bortezomib intervention 3: laboratory biomarker analysis intervention 4: immunoenzyme technique intervention 5: immunohistochemistry staining method intervention 6: pharmacological study
1
Duarte | California | United States | -117.97729 | 34.13945
81
0
0
0
NCT00362882
1COMPLETED
2010-07-01
2006-07-01
National Cancer Institute (NCI)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
302
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
2MALE
true
The purpose of this study is to examine the effect of dutasteride on the inhibition of low-risk, localized prostate cancer progression in men who would otherwise receive no active therapy (expectant management).
null
Neoplasms, Prostate
Dutasteride Prostate Cancer Expectant management REDEEM
null
2
arm 1: Dutasteride 0.5mg arm 2: Matching placebo
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Dutasteride 0.5mg intervention 2: Matching placebo
intervention 1: Dutasteride intervention 2: Matching placebo
82
Little Rock | Arkansas | United States | -92.28959 | 34.74648 Beverly Hills | California | United States | -118.40036 | 34.07362 Laguna Hills | California | United States | -117.71283 | 33.61252 Mission Hills | California | United States | -120.43683 | 34.68609 Modesto | California | United States | -120.99688 | 37.639...
302
0
0
0
NCT00363311
1COMPLETED
2010-07-01
2006-07-01
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
[ 0 ]
48
RANDOMIZED
PARALLEL
1PREVENTION
1SINGLE
true
1FEMALE
false
We hypothesize that using "quick start" initiation of the contraceptive vaginal ring in adolescents seeking birth control will improve compliance compared to traditional start. We will conduct a randomized controlled trial comparing "quick start" to traditional start initiation of the contraceptive vaginal ring in adol...
Pregnancy prevention is an important aspect of adolescent healthcare. Adherence to a chosen contraception method is essential to its success. Adolescents are notoriously poor at complying with oral contraceptives (OCs), with continuation rates at one year as low as 12% (1). In those patients who continue their contrace...
Contraception Desired
Contraception Adolescents Contraceptive vaginal ring Quick start
null
2
arm 1: Start contraceptive method (NuvaRing) day of enrollment arm 2: Start contraceptive method (NuvaRing) after next menses (per package insert)
[ 0, 1 ]
1
[ 0 ]
intervention 1: Initiation of NuvaRing for contraception
intervention 1: NuvaRing
1
Richmond | Virginia | United States | -77.46026 | 37.55376
48
0
0
0
NCT00369967
6TERMINATED
2010-07-01
2007-02-01
Virginia Commonwealth 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 ]
1,055
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
This is a randomized, placebo-controlled, parallel-group, multi-site, double-blind study evaluating the efficacy of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 400/10 mcg twice daily (BID) and MF/F MDI 200/10 mcg BID compared with MF 400 mcg BID and F 10 mcg BID in adults at least 40 years ...
null
Chronic Obstructive Pulmonary Disease (COPD)
null
5
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
[ 0, 0, 0, 1, 2 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks intervention 2: MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks intervention 3: MF 400 mcg via metered dose inhaler twice daily for 52 weeks intervention 4: Formoterol 10 mcg via metered dose inhaler twic...
intervention 1: Mometasone furoate/formoterol (MF/F) combination intervention 2: Mometasone furoate/formoterol (MF/F) combination intervention 3: Mometasone furoate MDI (MF MDI) intervention 4: Formoterol MDI intervention 5: Placebo
0
null
1,055
0
0
0
NCT00383435
1COMPLETED
2010-07-01
2006-10-01
Organon and Co
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
1,196
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
This is a randomized, placebo-controlled, parallel-group, multi-site, double-blind study evaluating the efficacy of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 400/10 mcg twice daily (BID) and MF/F MDI 200/10 mcg BID compared with MF 400 mcg BID and F 10 mcg BID in adults at least 40 years ...
null
Chronic Obstructive Pulmonary Disease (COPD)
null
5
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
[ 0, 0, 0, 1, 2 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks intervention 2: MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks intervention 3: MF 400 mcg via metered dose inhaler twice daily for 52 weeks intervention 4: Formoterol 10 mcg via metered dose inhaler twic...
intervention 1: Mometasone furoate/formoterol (MF/F) combination intervention 2: Mometasone furoate/formoterol (MF/F) combination intervention 3: Mometasone furoate MDI (MF MDI) intervention 4: Formoterol MDI intervention 5: Placebo
0
null
1,196
0
0
0
NCT00383721
1COMPLETED
2010-07-01
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 ]
616
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
null
BUILD 3 is a prospective, multicenter, randomized, double-blind, parallel group, placebo-controlled, event-driven, group sequential, phase III superiority study. The primary objective is to demonstrate that bosentan delays disease worsening or death in patients with Idiopathic Pulmonary Fibrosis.
null
Idiopathic Pulmonary Fibrosis
BUILD 3 Idiopathic Pulmonary Fibrosis Tracleer Interstitial Lung Disease bosentan Actelion
null
2
arm 1: Subjects receive bosentan 62.5 mg twice daily (b.i.d.) for 4 weeks followed by bosentan 125 mg b.i.d (if body weight \> 40 kg) or bosentan 62.5 mg b.i.d. (if body weight \< 40 kg) arm 2: Subjects receive placebo matching the bosentan treatment regimen
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Bosentan 62.5 mg tablets twice daily (b.i.d.) for 4 weeks followed by bosentan 125 mg tablets b.i.d (if body weight \> 40 kg) or bosentan 62.5 mg tablets b.i.d. (if body weight \< 40 kg) intervention 2: Placebo matching bosentan 62.5 mg tablets and 125 mg tablets
intervention 1: Bosentan intervention 2: Placebo
0
null
615
0
0
0
NCT00391443
1COMPLETED
2010-07-01
2007-02-01
Actelion
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 ]
31
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to evaluate the safety and tolerability of IC83/LY2603618 for the treatment of cancer.
null
Cancer
null
6
arm 1: LY2603618 40 milligrams per square meter (mg/m\^2) was administered over the duration of 4.5 hours (30-minute bolus followed by a 4-hour infusion). Dose modifications were not allowed. arm 2: Based on pharmacokinetic (PK) data from Cohort 1 (LY2603618 40 mg/m\^2 \[4.5-hour infusion\]), the LY2603618 40 mg/m\^2 d...
[ 0, 0, 0, 0, 0, 0 ]
7
[ 0, 0, 0, 0, 0, 0, 0 ]
intervention 1: 40 mg/m\^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles. Dose finding study: dose is escalated after a minimum of 6 participants receive 40 mg/m\^2. intervention 2: 70 mg/m\^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles. intervention...
intervention 1: IC83/LY2603618 intervention 2: IC83/LY2603618 intervention 3: IC83/LY2603618 intervention 4: IC83/LY2603618 intervention 5: IC83/LY2603618 intervention 6: pemetrexed intervention 7: pemetrexed
1
Scottsdale | Arizona | United States | -111.89903 | 33.50921
31
0
0
0
NCT00415636
1COMPLETED
2010-07-01
2007-01-01
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 ]
48
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
The purpose of this study was to determine the effects of Aliskiren on insulin resistance (IR) and endothelial dysfunction (ED) in patients with high blood pressure and metabolic syndrome. The efficacy of Aliskiren was compared to Amlodipine.
null
High Blood Pressure Metabolic Syndrome Insulin Resistance Endothelial Dysfunction
High Blood pressure Hypertension metabolic syndrome insulin resistance endothelial dysfunction pre-diabetic amlodipine, aliskiren, IGT, IFG, MBF
null
2
arm 1: Eligible participants received oral Aliskiren 300 mg + Placebo Amlodipine once daily for 12 weeks. Study medication was taken with 200 mL of water in the morning. Breakfast was eaten 1 hour after taking study medication. Study medication was swallowed whole, and not chewed. arm 2: Eligible participants received ...
[ 0, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Aliskiren 300 mg tablets taken orally once daily intervention 2: Amlodipine 5 mg capsule taken orally once daily intervention 3: Placebo Aliskiren taken orally once daily. intervention 4: Placebo Amlodipine taken orally once daily
intervention 1: Aliskiren intervention 2: Amlodipine intervention 3: Placebo Aliskiren intervention 4: Placebo Amlodipine
1
Santa Monica | California | United States | -118.49138 | 34.01949
48
0
0
0
NCT00417170
1COMPLETED
2010-07-01
2007-10-01
Novartis Pharmaceuticals
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
1
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
1FEMALE
true
Primary Objective: * To determine the effectiveness of goserelin acetate (Zoladex) in preserving ovarian function in premenopausal women undergoing neoadjuvant and/or adjuvant chemotherapy for primary invasive breast cancer by documenting persistence or resumption of regular menses. Secondary Objectives: * To determ...
Goserelin is designed to block hormones that can regulate your menstruation by affecting the pituitary gland (part of brain). If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to one of two treatment groups. You will either be assigned to receive goser...
Breast Cancer
Breast Cancer Chemotherapy Ovarian Function Goserelin Zoladex Ovary function Fertility Early Menopause
null
2
arm 1: 3.6 mg subcutaneously 1 week before chemotherapy, then once a month until 3 weeks after chemotherapy. arm 2: None
[ 0, 4 ]
1
[ 0 ]
intervention 1: 3.6 mg subcutaneous injection 1 week before the start of chemotherapy, then once a month until 3 weeks after the last chemotherapy dose.
intervention 1: Goserelin
2
Houston | Texas | United States | -95.36327 | 29.76328 Tokyo | N/A | Japan | 139.69171 | 35.6895
1
0
0
0
NCT00429403
6TERMINATED
2010-07-01
2006-08-01
M.D. Anderson Cancer Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
515
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This study was designed to test the efficacy, safety, tolerability and durability of the antiviral response between atazanavir (ATV) + ritonavir (/r) + abacavir/lamivudine(ABC/3TC) Fixed dose combination (FDC) each administered once daily (QD) for 36 weeks followed by randomization to either a simplification regimen of...
Safety and Efficacy of an Initial Regimen of Atazanavir (ATV) + Ritonavir (/r) + the Abacavir/Lamivudine Fixed-Dose Combination Tablet (ABC/3TC FDC) for 36 weeks followed by Simplification to Atazanavir with ABC/3TC FDC or Maintenance of the Initial Regimen for an Additional 48 weeks in Antiretroviral-Naive HIV-1 Infec...
Infection, Human Immunodeficiency Virus I HIV Infection
NORVIR ARIES EPZICOM REYATAZ HIV simplification Antiretroviral-naive
null
2
arm 1: Atazanavir (ATV) 400 mg QD + abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) QD for 48 weeks followed by optional treatment extension for 60 weeks on the same regimen. arm 2: Atazanavir (ATV) 300 mg QD + ritonavir (/r) 100 mg QD + abacavir (ABC) 600mg/lamivuidine (3TC )300 mg FDC QD fo...
[ 5, 5 ]
2
[ 0, 0 ]
intervention 1: Abacavir (ABC)/lamivudine (3TC) FDC + atazanavir (ATV)+ ritoanvir (/r) for 36weeks followed by ABC/3TC + ATV + /r for 48wks followed by optional treatment extension for 60 weeks on the same regimen intervention 2: Abacavir (ABC)/lamivudine (3TC) FDC + atazanavir (ATV) + ritonavir (/r) for 36 weeks follo...
intervention 1: Abacavir (ABC)/lamivudine (3TC) + atazanavir (ATV) + ritonavir (/r) intervention 2: Abacavir (ABC)/lamivudine (3TC) + atazanavir (ATV)
72
Phoenix | Arizona | United States | -112.07404 | 33.44838 Long Beach | California | United States | -118.18923 | 33.76696 Los Angeles | California | United States | -118.24368 | 34.05223 Los Angeles | California | United States | -118.24368 | 34.05223 Newport Beach | California | United States | -117.92895 | 33.61891 O...
1,303
0
0
0
NCT00440947
1COMPLETED
2010-07-01
2007-03-01
ViiV 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 ]
333
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
The purpose of the study is to find out if treatment with an intravitreal injection of triamcinolone or an intravitreal injection of ranibizumab can prevent loss of vision caused by panretinal photocoagulation treatment. At the present time, it is not known whether intravitreal steroid or anti-vascular endothelial grow...
Proliferative diabetic retinopathy (PDR) is manifested in retinal neovascularization at the disc (NVD) or elsewhere (NVE). Vitreous hemorrhage or tractional detachment from PDR is a leading cause of severe visual loss and new onset blindness. Without intervention, 60 percent of individuals with diabetic retinopathy wil...
Proliferative Diabetic Retinopathy Diabetic Macular Edema
Diabetic Retinopathy Diabetic Macular Edema Lucentis Ranibizumab Triamcinolone Panretinal Photocoagulation Combination Therapy pdr
null
3
arm 1: Sham injection at baseline and 4 weeks. Focal/grid laser for diabetic macular edema was performed 3 days to 10 days after the injection for all treatment groups. arm 2: Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks. Focal/grid laser for diabetic macular edema was performed 3 days to 10 ...
[ 0, 0, 1 ]
4
[ 0, 0, 5, 3 ]
intervention 1: Intravitreal injection of 0.5 mg ranibizumab at baseline and 4 weeks intervention 2: Intravitreal injection of 4 mg triamcinolone acetonide at baseline and sham injection at 4 weeks intervention 3: Sham injection at baseline and 4 weeks intervention 4: Focal/grid laser for diabetic macular edema was per...
intervention 1: Ranibizumab intervention 2: Triamcinolone Acetonide intervention 3: Sham injection intervention 4: Focal/grid laser
56
Artesia | California | United States | -118.08312 | 33.86585 Beverly Hills | California | United States | -118.40036 | 34.07362 Irvine | California | United States | -117.82311 | 33.66946 Loma Linda | California | United States | -117.26115 | 34.04835 Palm Springs | California | United States | -116.54529 | 33.8303 San...
364
0
0
0
NCT00445003
1COMPLETED
2010-07-01
2007-03-01
Jaeb Center for Health Research
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
550
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
The purpose of this study is to examine the effects of etanercept (10 mg and 25 mg) compared with methotrexate (up to 8 mg per week) on the slowing of joint destruction.
null
Arthritis, Rheumatoid
Rheumatoid Arthritis Arthritis
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: 10 mg twice weekly, subcutaneous injection for 52 weeks intervention 2: 25 mg, twice weekly, subcutaneous injection for 52 weeks intervention 3: up to 8 mg per week, oral dosing for 52 weeks
intervention 1: Etanercept intervention 2: Etanercept intervention 3: Methotrexate
41
Nagoya | Aichi-ken | Japan | 136.90641 | 35.18147 Nagoya | Aichi-ken | Japan | 136.90641 | 35.18147 Goshogawara | Aomori | Japan | 140.44139 | 40.80444 Asahi | Chiba | Japan | 140.65 | 35.71667 Matsuyama | Ehime | Japan | 132.76574 | 33.83916 Fukui-shi | Fukui | Japan | 136.22257 | 36.06443 Fukuoka | Fukuoka | Japan | ...
550
0
0
0
NCT00445770
1COMPLETED
2010-07-01
2006-07-01
Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
1
null
null
0TREATMENT
0NONE
false
0ALL
false
RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell and donor natural killer cell transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When certain stem cells from a donor are infus...
OBJECTIVES: Primary * Determine the effect of haploidentical donor CD34+ purified peripheral blood stem cells and donor natural killer (NK) cells on the risk of developing grades III-IV acute graft-vs-host disease in patients with leukemia or other hematologic diseases. Secondary * Determine the risk for mortality ...
Graft Versus Host Disease Leukemia Myelodysplastic Syndromes
graft versus host disease adult acute lymphoblastic leukemia in remission recurrent adult acute lymphoblastic leukemia childhood acute lymphoblastic leukemia in remission recurrent childhood acute lymphoblastic leukemia adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia in remissio...
null
0
null
null
11
[ 2, 2, 0, 0, 0, 6, 10, 10, 3, 3, 4 ]
intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None intervention 8: None intervention 9: None intervention 10: None intervention 11: None
intervention 1: muromonab-CD3 intervention 2: natural killer cell therapy intervention 3: fludarabine phosphate intervention 4: methotrexate intervention 5: thiotepa intervention 6: gene expression analysis intervention 7: flow cytometry intervention 8: immunologic technique intervention 9: allogeneic hematopoietic ste...
2
Seattle | Washington | United States | -122.33207 | 47.60621 Seattle | Washington | United States | -122.33207 | 47.60621
1
0
0
0
NCT00450983
6TERMINATED
2010-07-01
2006-12-01
Fred Hutchinson 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 ]
158
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
This study will assess the safety and efficacy of Xeloda, given in combination with standard chemotherapy regimens, for the first-line treatment of advanced and/or metastatic gastric cancer. All patients will receive Xeloda in combination with one of 4 standard chemotherapy regimens; the dose of Xeloda will be from 625...
null
Gastric Cancer
null
4
arm 1: Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, oral, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks. arm 2: Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capeci...
[ 0, 0, 0, 0 ]
8
[ 0, 0, 0, 0, 0, 0, 0, 0 ]
intervention 1: 80 mg/m2/day, intravenous (IV), every 3 weeks intervention 2: 1,000 mg/m2, oral, twice daily for 2 weeks, followed by 1 week of rest in each cycle intervention 3: 50 mg/m2/day, IV, every 3 weeks intervention 4: 60 mg/m2/day, IV, every 3 weeks intervention 5: 625 mg/m2, oral, twice daily per 3-week cycle...
intervention 1: Cisplatin intervention 2: Capecitabine intervention 3: Epirubicin intervention 4: Cisplatin intervention 5: Capecitabine intervention 6: Oxaliplatin intervention 7: Docetaxel intervention 8: Capecitabine
51
Alcoy | Alicante | Spain | -0.47432 | 38.70545 Ávila | Avila | Spain | -4.69951 | 40.65724 Palma de Mallorca | Balearic Islands | Spain | 2.65024 | 39.56939 Palma de Mallorca | Balearic Islands | Spain | 2.65024 | 39.56939 Barcelona | Barcelona | Spain | 2.15899 | 41.38879 Burgos | Burgos | Spain | -3.70184 | 42.34106 ...
158
0
0
0
NCT00454636
1COMPLETED
2010-07-01
2007-03-01
Hoffmann-La Roche
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
24
null
null
0TREATMENT
0NONE
false
1FEMALE
true
RATIONALE: Progesterone can cause the growth of ovarian epithelial cancer , primary peritoneal cancer, or fallopian tube cancer. Hormone therapy using mifepristone may fight ovarian epithelial cancer and primary peritoneal cancer by lowering the amount of progesterone the body makes. PURPOSE: This phase II trial is st...
OBJECTIVES: Primary * Determine the antitumor activity of mifepristone in patients with recurrent or persistent ovarian epithelial, primary peritoneal, or fallopian tube carcinoma. * Determine the toxicity of this drug in these patients. Secondary * Determine the duration of progression-free survival and overall su...
Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer
recurrent ovarian epithelial cancer primary peritoneal cavity cancer fallopian tube cancer
null
1
arm 1: Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks is considered one cycle) until disease progression or adverse effects prohibit further therapy.
[ 0 ]
1
[ 0 ]
intervention 1: None
intervention 1: mifepristone
22
Los Angeles | California | United States | -118.24368 | 34.05223 Hartford | Connecticut | United States | -72.68509 | 41.76371 New Britain | Connecticut | United States | -72.77954 | 41.66121 Hinsdale | Illinois | United States | -87.93701 | 41.80086 Baton Rouge | Louisiana | United States | -91.18747 | 30.44332 Portla...
22
0
0
0
NCT00459290
1COMPLETED
2010-07-01
2007-05-01
Gynecologic Oncology Group
5NETWORK
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
50
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
RATIONALE: The general results of combining irinotecan and platin-based chemotherapies have been very encouraging. As the toxicity profile associated with carboplatin is preferable over cisplatin it is our expectation that patients and physicians would prefer to use this combination if it is equally or more efficacious...
OBJECTIVES: Primary * To examine the anti-tumor efficacy of the combination of Irinotecan (CPT-11) and Carboplatin as first-line therapy as assessed by response rate in patients with chemo-naïve extensive stage small cell lung cancer. Secondary * Determine the safety, tolerability, and feasibility of this regimen i...
Lung Cancer
extensive stage small cell lung cancer
null
1
arm 1: Lung cancer patients will be treated for four 3-week cycles (12 weeks) in the absence of progressive disease, unacceptable toxicity, or withdrawal of patient consent. Up to two additional cycles may be administered at the discretion of the treating physician. If at treatment withdrawal the disease has responded ...
[ 0 ]
2
[ 0, 0 ]
intervention 1: Carboplatin dosage calculation to be given on day 1, every 21 days: Carboplatin (mg) = (AUC of 5) x (GFR + 25) \*up to 6 cycles at physician's discretion intervention 2: 50 mg/m2 IV on days 1 and 8 every 21 days Should be infused IV over 30- 90 minutes.
intervention 1: Carboplatin intervention 2: irinotecan hydrochloride
8
Owensboro | Kentucky | United States | -87.11333 | 37.77422 Chattanooga | Tennessee | United States | -85.30968 | 35.04563 Jackson | Tennessee | United States | -88.81395 | 35.61452 Knoxville | Tennessee | United States | -83.92074 | 35.96064 Nashville | Tennessee | United States | -86.78444 | 36.16589 Nashville | Tenn...
50
0
0
0
NCT00469898
1COMPLETED
2010-07-01
2003-12-01
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
[ 4 ]
514
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The purpose of this study is to assess whether olanzapine is superior to placebo in patients with bipolar depression.
1. Dose range and administration mode: Oral Olanzapine 5mg - 20mg/day 2. Duration: 1. Screening phase is 2-28 days. 2. Double-blind treatment phase is 6 weeks 3. Open-label extension phase is 18 weeks
Depression, Bipolar
null
3
arm 1: During double-blind treatment, participants receive olanzapine at a dose of 5 milligram (mg) which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tol...
[ 0, 2, 0 ]
2
[ 0, 0 ]
intervention 1: 5-20 mg, oral, once daily, for 24 weeks (participants randomized to olanzapine in double-blind treatment period) or 18 weeks (participants randomized to placebo in double-blind treatment period). intervention 2: placebo tablets, oral, once daily at bedtime, 6 weeks
intervention 1: Olanzapine intervention 2: Placebo
16
Beijing | N/A | China | 116.39723 | 39.9075 Changsha | N/A | China | 112.97087 | 28.19874 Chengdu | N/A | China | 104.06667 | 30.66667 Guangzhou | N/A | China | 113.25 | 23.11667 Hangzhou | N/A | China | 120.16142 | 30.29365 Harbin | N/A | China | 126.65 | 45.75 Kunming | N/A | China | 102.71833 | 25.03889 Nanjing | N/...
903
0
0
0
NCT00510146
1COMPLETED
2010-07-01
2007-08-01
Eli Lilly and Company
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
-0
[ 4 ]
122
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This study is being conducted to determine the safety and tolerability of lamotrigine (LTG) in elderly patients with epilepsy. This study will be carried out using an extended-release formulation of lamotrigine (LTG-XR) that will allow once-a-day dosing.
null
Epilepsy
Epilepsy elderly seizure
null
1
arm 1: Open-label lamotrigine
[ 0 ]
1
[ 0 ]
intervention 1: Open-label
intervention 1: Lamotrigine
63
Birmingham | Alabama | United States | -86.80249 | 33.52066 Gilbert | Arizona | United States | -111.78903 | 33.35283 Litchfield Park | Arizona | United States | -112.35794 | 33.49337 Phoenix | Arizona | United States | -112.07404 | 33.44838 Phoenix | Arizona | United States | -112.07404 | 33.44838 Fresno | California ...
121
0
0
0
NCT00516139
1COMPLETED
2010-07-01
2007-08-01
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 ]
260
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to compare the combination of pemetrexed and carboplatin with the combination of docetaxel and carboplatin in terms of survival without Grade 3 or 4 toxicity in previously untreated patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).
null
Non-Small Cell Lung Cancer
null
2
arm 1: Drug: pemetrexed 500 milligrams per square meter (mg/m\^2), intravenous (IV), every (q) 21 days x 6 cycles maximum Drug: carboplatin Area Under the Curve (AUC) 5 milligram\*minute/milliLiter (mg\*min/mL), IV, q 21 days x 6 cycles maximum arm 2: Drug: docetaxel 75 mg/m\^2, IV, q 21 days x 6 cycles maximum Drug:...
[ 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: 500 mg/m\^2, IV, q 21 days x 6 cycles maximum intervention 2: 75 mg/m\^2, IV, q 21 days x 6 cycles maximum intervention 3: AUC 5 mg\*min/mL, IV, q 21 days x 6 cycles maximum
intervention 1: pemetrexed intervention 2: docetaxel intervention 3: carboplatin
20
Ballarat | Victoria | Australia | 143.84957 | -37.56622 Frankston | Victoria | Australia | 145.12291 | -38.14458 Wendouree | Victoria | Australia | 143.82838 | -37.53078 Bunbury | Western Australia | Australia | 115.64137 | -33.32711 Barretos | N/A | Brazil | -48.56778 | -20.55722 Goiânia | N/A | Brazil | -49.25389 | -...
211
0
0
0
NCT00520676
1COMPLETED
2010-07-01
2007-10-01
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 ]
457
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
A 24 week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 18mcg of tiotropium inhalation capsules administered by Handihaler once daily plus Pro Re Nata (PRN) albuterol (salbutamol) vs. placebo plus PRN albuterol (salbutamol) in chronic obstructive pulmonary disea...
null
Pulmonary Disease, Chronic Obstructive
null
2
arm 1: Oral inhalation once daily of placebo matching tiotropium via handihaler arm 2: Oral inhalation once daily of 18mcg tiotropium via handihaler
[ 2, 0 ]
2
[ 0, 0 ]
intervention 1: Oral inhalation once daily of 18mcg tiotropium via handihaler intervention 2: Oral inhalation once daily of placebo matching tiotropium via handihaler
intervention 1: tiotropium intervention 2: Placebo
62
Birmingham | Alabama | United States | -86.80249 | 33.52066 Birmingham | Alabama | United States | -86.80249 | 33.52066 Jasper | Alabama | United States | -87.27751 | 33.83122 Palo Alto | California | United States | -122.14302 | 37.44188 San Diego | California | United States | -117.16472 | 32.71571 Lexington | Kentuc...
457
0
0
0
NCT00523991
1COMPLETED
2010-07-01
2007-04-01
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 ]
1,067
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of this clinical research study is to determine whether dapagliflozin can improve (decrease) blood glucose values in patients with Type 2 diabetes who have never been treated with medication or have been taking medication for less than 24 weeks since their original diabetes diagnosis. The safety of this tre...
All eligible participants will receive single-blind placebo medication during the 2-week lead-in period. All participants may receive additional open-label treatment with metformin, 500-2000 mg, as needed for rescue, based on protocol specific criteria.
Type 2 Diabetes
null
9
arm 1: Participants with hemoglobin A1c (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. arm 2: Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. arm 3: Participants with HbA1c...
[ 0, 0, 0, 0, 0, 0, 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Tablets; oral; 2.5, 5.0, or 10 mg; once daily in the morning or evening for up to 102 weeks intervention 2: Tablets, oral, 0 mg, once daily in the morning or evening for up to 102 weeks intervention 3: None
intervention 1: Dapagliflozin intervention 2: Dapagliflozin placebo intervention 3: Metformin
78
Phoenix | Arizona | United States | -112.07404 | 33.44838 Tempe | Arizona | United States | -111.90931 | 33.41477 Tempe | Arizona | United States | -111.90931 | 33.41477 Fresno | California | United States | -119.77237 | 36.74773 Los Gatos | California | United States | -121.97468 | 37.22661 San Diego | California | Un...
485
0
0
0
NCT00528372
1COMPLETED
2010-07-01
2007-09-01
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
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to learn if PET scanning can predict the degree of tumor shrinkage with the study drug RAD001 in subjects who have advanced renal cancer.
null
Carcinoma, Renal Cell
metastatic renal cell carcinoma cancer
null
1
arm 1: All patients were to receive 10mg everolimus (RAD001) daily.
[ 0 ]
1
[ 0 ]
intervention 1: take 2 tablets of RAD001 once a day by mouth (10 mg per day)
intervention 1: RAD001
5
Chicago | Illinois | United States | -87.65005 | 41.85003 Peoria | Illinois | United States | -89.58899 | 40.69365 Boston | Massachusetts | United States | -71.05977 | 42.35843 St Louis | Missouri | United States | -90.19789 | 38.62727 Chapel Hill | North Carolina | United States | -79.05584 | 35.9132
56
0
0
0
NCT00529802
1COMPLETED
2010-07-01
2007-09-01
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
[ 5 ]
147
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Prospective, non-randomized, multi-center study to assess the efficacy and safety of paricalcitol injection or oral administered over 6 months to patients with secondary hyperparathyroidism on dialysis.
null
Secondary Hyperparathyroidism Dialysis
Dialysis Hyperparathyroidism Zemplar
null
2
arm 1: ABT-358 Zemplar arm 2: ABT-358 Zemplar
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: Most recent iPTH level in pg/mL divided by 100 = dose in mcg; dose is rounded down to nearest mcg and administered 3x weekly intervention 2: Most recent iPTH level in pg/mL divided by 80 = dose in mcg; dose is rounded down to nearest mcg and administered 3x weekly
intervention 1: Paricalcitol injection intervention 2: Paricalcitol capsules
12
Jojutla Morelos | N/A | Mexico | N/A | N/A Mexico City | N/A | Mexico | -99.12766 | 19.42847 Mexico City | N/A | Mexico | -99.12766 | 19.42847 Mexico City | N/A | Mexico | -99.12766 | 19.42847 Mexico City | N/A | Mexico | -99.12766 | 19.42847 Mexico City | N/A | Mexico | -99.12766 | 19.42847 Mexico City | N/A | Mexico ...
147
0
0
0
NCT00537979
1COMPLETED
2010-07-01
2007-09-01
Abbott
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 ]
17
NON_RANDOMIZED
PARALLEL
2DIAGNOSTIC
0NONE
true
0ALL
false
The primary purpose of this exploratory study is to measure orocecal transit time using the SmartPill ambulant capsule technology and to compare this with the lactulose hydrogen breath test. Additionally, the ability of the SmartPill GI Monitoring System to discriminate between healthy human subjects and patients with ...
Small bowel bacterial overgrowth (SBBO), an increasingly recognized malabsorptive condition caused by the excessive growth of bacteria in the small bowel, results in a spectrum of symptoms such as diarrhea, bloating abdominal discomfort and weight loss. Multiple factors both internal and external to the individual prev...
Small Bowel Bacterial Overgrowth Gastrointestinal Diseases Stomach Diseases Digestive System Diseases
SmartPill Capsule Digestive System Diseases Small Bowel Bacterial Overgrowth Gastrointestinal Device Oro-cecal
null
2
arm 1: Healthy Participants will report for simultaneous lactulose hydrogen breath test (H\_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal ...
[ 1, 1 ]
3
[ 0, 1, 3 ]
intervention 1: Open-Label Treatment at 400 mg by mouth, 3 times a day, for 7 days; only for those symptomatic and positive SBBO patients. intervention 2: The SmartPill is a single-use, ingestible capsule that utilizes sensor technology to measure pressure, pH and temperature throughout the entire GI tract. The ACT-1 (...
intervention 1: Xifaxan intervention 2: SmartPill intervention 3: Lactulose hydrogen breath test (H_2BT)
1
Scottsdale | Arizona | United States | -111.89903 | 33.50921
17
0
0
0
NCT00577772
6TERMINATED
2010-07-01
2007-11-01
Mayo Clinic
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
26
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
The purpose of this study is to determine if the combination of 2 chemotherapy drugs called pemetrexed and gemcitabine might be effective treatment for head and neck squamous cell cancer. The researchers want to find out what effects, good and/or bad, that this treatment has on head and neck cancer.
Pemetrexed (500 mg/m2) and gemcitabine (1250 mg/m2) will be given together on Days 1 and 15 of a 28 day cycle in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). Patients will not have received more than 2 prior chemotherapy regimens in the recurrent/metastatic disease setting. Vitam...
Head and Neck Cancer
Head and Neck Cancer GEMCITABINE PEMETREXED ALTIMA epidermoid/squamous cell carcinoma pharynx larynx paranasal sinus head/neck squamous cell carcinoma
null
1
arm 1: Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle.
[ 0 ]
1
[ 0 ]
intervention 1: Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle. Vitamin supplementation will be as follows: Vitamin B12: 1000 µg IM injection no ...
intervention 1: Pemetrexed plus Gemcitabine
1
New York | New York | United States | -74.00597 | 40.71427
25
0
0
0
NCT00589667
1COMPLETED
2010-07-01
2006-09-01
Memorial Sloan Kettering Cancer Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
19
NA
SINGLE_GROUP
9OTHER
0NONE
false
0ALL
false
This is a pilot study to investigate the ability of fluorodeoxyglucose-positron emission tomography (FDG-PET) and Positron emission tomography-computed tomography (PET/CT) as a direct method of detecting infection and/or inflammation of the gallbladder.
Hepatobiliary iminodiacetic acid (HIDA) scan scintigraphy is a nuclear medicine scan used to evaluate patients suspected of having acute cholecystitis (infection/inflammation of the gallbladder). Because it is an indirect test that looks for obstruction of the cystic duct structure, there are many causes for a false-po...
Cholecystitis
Cholecystitis FDG PET/CT HIDA scan
null
1
arm 1: 19 patients with suspected acute cholecystitis and a positive HIDA will be included in the study. This is purposely a highly selective population which most likely will have surgical proof of the findings. Subjects will receive an FDG PET/CT exam to determine the presence of gallbladder inflammation/infection(ch...
[ 0 ]
1
[ 0 ]
intervention 1: Route: Intravenous, Dosage: 5-10mCi, frequency: Single Administration
intervention 1: 18FDG (an FDA-approved radiopharmaceutical)
1
Los Angeles | California | United States | -118.24368 | 34.05223
19
0
0
0
NCT00590395
1COMPLETED
2010-07-01
2007-07-01
Alan D. Waxman, M.D.
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 ]
168
RANDOMIZED
CROSSOVER
1PREVENTION
0NONE
true
1FEMALE
true
A new approach to HIV prevention currently being studied includes the use of microbicides, substances that kill microbes. Tenofovir disoproxil fumarate (TDF) is an oral, FDA-approved, anti-HIV drug, and tenofovir gel is an experimental microbicide. The purpose of this study is to determine the adherence and acceptabili...
It is necessary to monitor both the adherence and blood levels of microbicides in order to gauge its efficacy in a study population. Utilizing an experimental microbicide (tenofovir gel) and an anti-HIV drug (TDF), this study will measure the adherence and acceptability to and blood levels of the two interventions in t...
HIV Infections
Microbicide HIV Seronegativity
null
6
arm 1: Oral tenofovir disoproxil fumarate (TDF) for Weeks 1 through 6, vaginal tenofovir gel application for Weeks 8 through 13, and oral TDF and vaginal tenofovir gel application for Weeks 15 through 20 arm 2: Vaginal tenofovir gel application for Weeks 1 through 6, oral TDF for Weeks 8 through 13, and oral TDF and va...
[ 0, 0, 0, 0, 0, 0 ]
2
[ 0, 0 ]
intervention 1: 300 mg tablet daily intervention 2: 1 gm/100 ml of 1% gel vaginally daily
intervention 1: Tenofovir disoproxil fumarate intervention 2: Tenofovir gel
7
Birmingham | Alabama | United States | -86.80249 | 33.52066 The Bronx | New York | United States | -73.86641 | 40.84985 Cleveland | Ohio | United States | -81.69541 | 41.4995 Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062 Durban | KwaZulu-Natal | South Africa | 31.0292 | -29.8579 Durban | KwaZulu-Nata...
504
0
0
0
NCT00592124
1COMPLETED
2010-07-01
2008-06-01
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
[ 0 ]
18
RANDOMIZED
CROSSOVER
0TREATMENT
3TRIPLE
false
0ALL
false
This study is a methodology study designed to discover whether a brain imaging technology is a better way of compare the relative sensitivities of fMRI and subjective psychometric assessments of pain to multiple doses of pregabalin and tramadol SR in a cross-over clinical study design.
null
Pain
null
3
arm 1: None arm 2: None arm 3: None
[ 2, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: BID intervention 2: Dose 75 mg titrated to 150 mg, bid intervention 3: Dose 50mg titrated to 200 mg, bid
intervention 1: Placebo intervention 2: Pregabalin intervention 3: Tramadol SR
2
Portsmouth | Hampshire | United Kingdom | -1.09125 | 50.79899 Solihull | West Midlands | United Kingdom | -1.78094 | 52.41426
52
0
0
0
NCT00610155
1COMPLETED
2010-07-01
2008-09-01
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
[ 0 ]
40
RANDOMIZED
PARALLEL
null
2DOUBLE
false
0ALL
false
We hypothesize that those patients with purely seasonal allergic rhinitis will decongest better than those subjects with another cause contributing to their symptoms. These latter patients will not improve as well on an intranasal steroid as those who decongest well, potentially explaining the 60% response rate in prio...
null
Seasonal Allergic Rhinitis
null
2
arm 1: 2 weeks of treatment arm 2: 2 weeks of treatment
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: 2 puffs in each nostril once a day for 2 weeks intervention 2: 2 puffs in each nostril once a day for 2 weeks
intervention 1: mometasone furoate nasal spray intervention 2: placebo
1
Chicago | Illinois | United States | -87.65005 | 41.85003
40
0
0
0
NCT00618332
1COMPLETED
2010-07-01
2008-04-01
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
[ 0 ]
60
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
This placebo-controlled trial will test the effectiveness of Seroquel XR™ for the treatment of cocaine dependence in non-psychotic individuals who are cocaine dependent.
Cocaine abuse continues to be an epidemic. Co-morbid psychiatric disorders and high risks behaviors compound the morbidity, economic costs, and social destruction associated with this public health crisis. This is a 12 week, prospective, intent-to-treat, double-blind, randomized, placebo-controlled study of Seroquel XR...
Cocaine Dependence Cocaine Abuse Cocaine Addiction Drug Abuse Substance Abuse
cocaine quetiapine fumarate dependence abuse addiction treatment
null
2
arm 1: Subjects randomized to the experimental arm of the study will be initially administered 50mg/day quetiapine fumarate (Seroquel XR) to be titrated up to 400mg/day by the end of the second week. Subjects will be stabilized at a dose of 400mg/day or alternatively 300, 200, 100, or 50mg/day or quetiapine fumarate as...
[ 0, 2 ]
3
[ 0, 0, 5 ]
intervention 1: At baseline, subjects in the experimental group will initially be administered 50 mg/day of Seroquel XR™ (extended release formulation of quetiapine fumarate), to be titrated up to 400 mg/day of Seroquel XR™ by the end of the second week. By the end of week 2, subjects will be stabilized on a dose of 40...
intervention 1: quetiapine fumarate intervention 2: Matched Placebo intervention 3: Cognitive-behavioral Therapy
1
Tacoma | Washington | United States | -122.44429 | 47.25288
60
0
0
0
NCT00631748
1COMPLETED
2010-07-01
2008-02-01
Seattle Institute for Biomedical and Clinical Research
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
48
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
This study involves the use of oxaliplatin, capecitabine, and sorafenib which are all drugs approved by the Food and Drug Administration (FDA) for use in the treatment of different cancers. Their use in this exact combination is considered experimental for the treatment of pancreas and biliary tract; however the combin...
Primary Objectives * To assess the overall safety of sorafenib when administered with "the 2DOC regimen" capecitabine and oxaliplatin in patients with advanced or metastatic pancreas or biliary tract cancers. * To define the dose limiting toxicity and maximally tolerated dose of this combination. * To assess the clini...
Pancreatic Neoplasms Bile Duct Neoplasms
advanced pancreatic and biliary tract carcinomas
null
4
arm 1: Cohort 1: 200mg Sorafenib+2DOC Oxaliplatin + Oral Capecitabine + Sorafenib arm 2: Cohort 2: 400mg Sorafenib+2DOC Oxaliplatin + Oral Capecitabine + Sorafenib arm 3: Oxaliplatin + Oral Capecitabine + Sorafeni arm 4: Oxaliplatin + Oral Capecitabine + Sorafeni
[ 0, 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: On days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Following the infusion of oxaliplatin, the infusion line should be flushed with Dextrose 5% in Water. intervention 2: Each course of oral capecitabine administration will commence following ad...
intervention 1: Oxaliplatin intervention 2: Capecitabine intervention 3: Sorafenib
1
Madison | Wisconsin | United States | -89.40123 | 43.07305
48
0
0
0
NCT00634751
1COMPLETED
2010-07-01
2008-02-01
University of Wisconsin, Madison
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0