FEATURE_phases
list
FEATURE_enrollmentCount
int64
FEATURE_allocation
string
FEATURE_interventionModel
string
FEATURE_primaryPurpose
class label
FEATURE_masking
class label
FEATURE_healthyVolunteers
bool
FEATURE_sex
class label
FEATURE_oversightHasDmc
bool
FEATURE_briefSummary
string
FEATURE_detailedDescription
string
FEATURE_conditions
string
FEATURE_conditionsKeywords
string
FEATURE_protocolPdfText
string
FEATURE_numArms
int64
FEATURE_armDescriptions
string
FEATURE_armGroupTypes
list
FEATURE_numInterventions
int64
FEATURE_interventionTypes
list
FEATURE_interventionDescriptions
string
FEATURE_interventionNames
string
FEATURE_numLocations
int64
FEATURE_locationDetails
string
LABEL_ct_level_ade_population
int64
LABEL_sum_dosing_errors
int64
LABEL_dosing_error_rate
float32
LABEL_wilson_label
int64
METADATA_nctId
string
METADATA_overallStatus
class label
METADATA_completionDate
date32
METADATA_startDate
date32
METADATA_leadSponsorName
string
METADATA_leadSponsorClass
class label
METADATA_hasProtocol
bool
METADATA_hasSap
bool
METADATA_hasIcf
bool
METADATA_protocolPdfLinks
string
METADATA_count_Accidental drug intake by child
int64
METADATA_count_Accidental overdose
int64
METADATA_count_Accidental overdose (therapeutic agent)
int64
METADATA_count_Accidental underdose
int64
METADATA_count_Deliberate overdose
int64
METADATA_count_Dose calculation error
int64
METADATA_count_Drug administration error
int64
METADATA_count_Drug overdose
int64
METADATA_count_Drug overdose accidental
int64
METADATA_count_Extra dose administered
int64
METADATA_count_Incorrect dosage administered
int64
METADATA_count_Incorrect dose administered
int64
METADATA_count_Incorrect drug administration duration
int64
METADATA_count_Incorrect drug administration rate
int64
METADATA_count_Incorrect product administration duration
int64
METADATA_count_Intentional overdose
int64
METADATA_count_Medication error
int64
METADATA_count_Medication monitoring error
int64
METADATA_count_Multiple drug overdose
int64
METADATA_count_Multiple drug overdose accidental
int64
METADATA_count_Multiple drug overdose intentional
int64
METADATA_count_Multiple use of single-use product
int64
METADATA_count_Non-accidental overdose
int64
METADATA_count_Overdose
int64
METADATA_count_Overdose NOS
int64
METADATA_count_Overmedication
int64
METADATA_count_Prescribed overdose
int64
METADATA_count_Treatment noncompliance
int64
METADATA_count_Underdose
int64
METADATA_count_Unintentional medical device removal
int64
METADATA_count_Unintentional medical device removal by patient
int64
METADATA_wilson_lower_bound
float32
[ 3 ]
24
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
true
2MALE
null
The purpose of this study is to compare the pharmacodynamics/pharmacokinetics of 5 mg, 10 mg, 20 mg and 40 mg of Rabeprazole sodium (E3810) when administered repeatedly once daily for 5 days to healthy adult male Japanese participants. This was a single-center, open-label, randomized, four-treatment, four-way crossover...
null
Healthy
Rabeprazole proton pump inhibitor pharmacokinetics pharmacodynamics healthy adult male Japanese subjects
null
4
arm 1: None arm 2: None arm 3: None arm 4: None
[ 0, 0, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Rabeprazole sodium Tablets, 5 mg administered for 5 days. Day 1 and Day 5: participants received a single dose with 200 mL of water in the morning while fasting for 10 hours or longer. Day 2 to Day 4: participants received a single dose with 200 mL of water \>= 2 hours after the completion of breakfas...
intervention 1: Rabeprazole sodium, 5 mg Tablets intervention 2: Rabeprazole sodium, 10 mg Tablets intervention 3: Rabeprazole sodium, 20 mg Tablets intervention 4: Rabeprazole sodium, 40 mg Tablets (two 20 mg Tablets)
1
Toshima-ku | Tokyo | Japan | N/A | N/A
96
0
0
0
NCT01202071
1COMPLETED
2010-12-01
2010-09-01
Eisai Co., Ltd.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
28
RANDOMIZED
CROSSOVER
0TREATMENT
3TRIPLE
false
0ALL
false
The purpose of this study is to investigate effects of inhaled AZD8683 compared to placebo in COPD patients.
A double-blind, placebo-controlled, randomised, multi-centre, 3-way cross-over, single-dose phase II study to investigate the local and systemic effects of inhaled AZD8683 in patients with chronic obstructive pulmonary disease (COPD)
Chronic Obstructive Pulmonary Disease (COPD)
Chronic Obstructive Pulmonary Disease (COPD) safety inhalation long-acting muscarinic receptor antagonist (LAMA)
null
6
arm 1: period 1: AZD8683 50 mcg, period 2: washout, period 3: AZD8683 200 mcg, period 4:washout, period5: placebo arm 2: period 1: AZD8683 50 mcg, period 2: washout, period 3: placebo, period 4: washout, period5:AZD8683 200 mcg arm 3: period 1: AZD8683 200 mcg, period 2: washout, period 3: placebo, period 4: washout, p...
[ 0, 0, 0, 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Dry powder for inhalation, single dose intervention 2: Dry powder for inhalation, single dose intervention 3: Dry powder for inhalation, single dose
intervention 1: AZD8683, 50 mcg intervention 2: Placebo intervention 3: AZD8683, 200 mcg
4
Bialystok | N/A | Poland | 23.16433 | 53.13333 Bydgoszcz | N/A | Poland | 18.00762 | 53.1235 Lodz | N/A | Poland | 19.47395 | 51.77058 Proszowice | N/A | Poland | 20.28909 | 50.19275
83
0
0
0
NCT01205269
1COMPLETED
2010-12-01
2010-10-01
AstraZeneca
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
2
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The safety and efficacy at 100 mg once daily for oral dose of sitaxentan sodium were demonstrated in the STRIDE clinical trial program. Sitaxentan sodium was approved in the EU, Canada and Australia. In this study, the long-term safety and efficacy after administrations of sitaxentan sodium at a dose of 100 mg alone or...
null
Hypertension, Pulmonary
sitaxentan sodium pulmonary hypertension
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: sitaxentan sodium 100 mg
intervention 1: Sitaxentan
2
Nagoya | Aichi-ken | Japan | 136.90641 | 35.18147 Shinjyuku-ku | Tokyo | Japan | N/A | N/A
2
0
0
0
NCT01210443
6TERMINATED
2010-12-01
2010-11-01
Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
16
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
true
0ALL
null
The objective of the current study is to determine the relative bioavailability of a BI 10773 / metformin fixed dose combination tablet compared to single tablets of BI 10773 and metformin when administered together and to assess the effect of food on the bioavailability the fixed dose combination tablet
null
Diabetes Mellitus, Type 2
null
3
arm 1: 3 treatments will be investigated in randomized order arm 2: 3 treatments will be investigated in randomized order arm 3: 3 treatments will be investigated in randomized order
[ 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: BI 10773 / metformin fixed dose combination tablet after a high fat, high caloric meal intervention 2: BI 10773 and metformin single tablets, administered together in fasted state intervention 3: BI 10773 / metformin fixed dose combination tablet in fasted state
intervention 1: C: BI 10773 / metformin tablet intervention 2: B: BI 10773 tablet and metformin tablet intervention 3: A: BI 10773 / metformin tablet
1
Biberach | N/A | Germany | 8.03333 | 48.33333
45
0
0
0
NCT01211197
1COMPLETED
2010-12-01
2010-10-01
Boehringer Ingelheim
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
50
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
This is an exploratory study that will evaluate the safety and pharmacodynamics of up to 3 doses of AGN-207281 based on an ongoing review of data during the study period compared with timolol ophthalmic solution or placebo in patients with ocular hypertension or primary open-angle glaucoma.
null
Glaucoma, Open-Angle Ocular Hypertension
null
3
arm 1: AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14 arm 2: timolol ophthalmic solution 0.5% arm 3: AGN-207281 vehicle ophthalmic solution (Placebo)
[ 5, 1, 2 ]
3
[ 0, 0, 0 ]
intervention 1: One drop of AGN-207281 ophthalmic solutions (0.1% on Days 1-7 and 0.3% on Days 8-14) instilled to both eyes in the morning followed by one drop of AGN-207281 vehicle ophthalmic solution (placebo) instilled to both eyes in the evening for 13 days. intervention 2: One drop of timolol ophthalmic solution 0...
intervention 1: AGN-207281 ophthalmic solutions (0.1% and 0.3%); AGN-207281 vehicle ophthalmic solution (placebo) intervention 2: timolol ophthalmic solution 0.5% intervention 3: AGN-207281 vehicle ophthalmic solution (Placebo)
1
Newport Beach | California | United States | -117.92895 | 33.61891
50
0
0
0
NCT01215786
1COMPLETED
2010-12-01
2010-10-01
Allergan
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
40
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
true
0ALL
null
The objective of the current study is to investigate the relative bioavailability of two different batches of a 2.5 mg linagliptin / 1000 mg metformin fixed dose combination tablet (FDC).
null
Healthy
null
2
arm 1: Fixed dose combination tablet arm 2: Fixed dose combination tablet
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Fixed dose combination tablet intervention 2: Fixed dose combination tablet
intervention 1: Linagliptin/Metformin (standard batch) intervention 2: Linagliptin/Metformin (side batch)
1
Ingelheim | N/A | Germany | 8.05883 | 49.97078
80
0
0
0
NCT01216397
1COMPLETED
2010-12-01
2010-09-01
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 ]
331
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
This is a one-year study to look at the safety of a dry powder inhaler with albuterol. After a one-week run in, for the first 3 months subjects will use an inhaler with either albuterol or a dummy drug at regular times four times a day. Then for the last nine months of the study, all subjects will be given the albutero...
The Sponsor terminated this study due to the need for a modification to the Spiromax device utilized in this study; the problem identified has no impact on patient safety. Exposure ranged from 3 to 49 days with the majority of subjects receiving ≤30 days of double-blind treatment.
Asthma
asthma dry powder inhaler short-acting beta2-agonist SABA bronchoconstriction bronchodilation bronchodilator metered dose inhaler
null
2
arm 1: Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler...
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Placebo as a dry-powder inhaled orally using the Spiromax inhaler. During the 12-week double-blind period, participants take two (2) inhalations four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime. intervention 2: Albuterol as a dry-powder inhaled orally using the Spiromax in...
intervention 1: Placebo Spiromax intervention 2: Albuterol Spiromax
30
Scottsdale | Arizona | United States | -111.89903 | 33.50921 Los Angeles | California | United States | -118.24368 | 34.05223 San Diego | California | United States | -117.16472 | 32.71571 Centennial | Colorado | United States | -104.87692 | 39.57916 Denver | Colorado | United States | -104.9847 | 39.73915 Miami | Flor...
331
0
0
0
NCT01218009
6TERMINATED
2010-12-01
2010-10-01
Teva Branded Pharmaceutical Products R&D, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
12
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of the study is to assess the safety of Xigris (Drotrecogin alfa) as an anticoagulant at different dose levels during dialysis treatment in patients with End Stage Renal Disease (ESRD).
In United States, there are over 300,000 patients with ESRD who require hemodialysis. Clinical hemodialysis takes place three times a week and is dependent on adequate anticoagulation throughout the three to four hour procedure. Infection is one of the most common causes of death for patients with ESRD treated with hem...
End Stage Renal Disease
Hemodialysis Anticoagulation Xigris PTT
null
1
arm 1: Drotrecogin alfa activated (Xigris) used as anticoagulant in patients treated with hemodialysis.
[ 0 ]
1
[ 0 ]
intervention 1: We will test different dose regimens of Drotrecogin alfa activated (Xigris) to determine the optimal dose to achieve PTT between 65 and 100 secs. The initial patients will receive Xigris dosed at an infusion rate of 12 mcg/kg/h via pre-filter arterial drip chamber via a standard IV pump. The PTT will be...
intervention 1: Drotrecogin alfa activated (Xigris)
1
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
12
0
0
0
NCT01227187
1COMPLETED
2010-12-01
2008-10-01
George Washington University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
90
RANDOMIZED
PARALLEL
4SUPPORTIVE_CARE
2DOUBLE
false
0ALL
null
The purpose of this randomized double-blind trial is to define the correct dosage of Remifentanil during operative and diagnostic endoscopic procedures. In particular we want to analyze if the administration of Remifentanil by PCSA (Patient Controlled Sedation and Analgesia) is a good method during colonoscopy, evaluat...
null
Colonoscopy
Colonoscopy Remifentanil Sedation
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Patient receive a bolus of Remifentanil (0,5 mcg/Kg) before the procedure and the PCSA pump is set to inject further bolus doses of 0,5 mcg/Kg every time the patient presses its button. intervention 2: Patient receive a bolus of Remifentanil (0,8 mcg/Kg) before the procedure and the PCSA pump is set to ...
intervention 1: Remifentanil intervention 2: Remifentanil intervention 3: Meperidine
1
Milan | N/A | Italy | 9.18951 | 45.46427
90
0
0
0
NCT01229527
1COMPLETED
2010-12-01
2009-04-01
Ospedale San Raffaele
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
30
RANDOMIZED
CROSSOVER
7BASIC_SCIENCE
0NONE
true
0ALL
false
This study is designed to determine differences in drug exposure in subjects after being administered 50 mg tablets of sertraline hydrochloride as compared to drug exposure after administering 50 mg capsules of sertraline hydrochloride under fasted (nonfed) conditions.
null
Healthy
bioequivalence study sertraline 50 mg capsules vs tablets
null
2
arm 1: None arm 2: None
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: 50 mg capsule, single-dose intervention 2: 50 mg tablet, single-dose
intervention 1: sertraline hydrochloride intervention 2: sertraline hydrochloride
1
Singapore | N/A | Singapore | 103.85007 | 1.28967
60
0
0
0
NCT01235195
1COMPLETED
2010-12-01
2010-11-01
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
[ 2 ]
21
RANDOMIZED
CROSSOVER
7BASIC_SCIENCE
0NONE
true
0ALL
false
The purpose of this study is to determine the effect of activated charcoal and dosing time on the absorption of LY2624803 in healthy subjects. In this crossover study, there are three treatments with a washout period of at least 7 days in between treatments. Each subject will participate in all three treatments with ra...
null
Insomnia
null
3
arm 1: Participants received 6 milligrams (mg) LY2624803 alone orally (po) at approximately 0800 hours following an overnight fast. arm 2: Participants received 6 mg LY2624803 po at approximately 0800 hours following an overnight fast, followed 1 hour later by a single po dose of 1 gram per kilogram (g/kg) body weight ...
[ 0, 0, 0 ]
2
[ 0, 10 ]
intervention 1: Administered orally (po), once. intervention 2: Administered po
intervention 1: LY2624803 intervention 2: Activated Charcoal
1
Leeds | West Yorkshire | United Kingdom | -1.54785 | 53.79648
63
0
0
0
NCT01236105
1COMPLETED
2010-12-01
2010-10-01
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
[ 2 ]
24
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
true
0ALL
null
The objective of the study is to investigate the relative bioavailability of the final tablet formulation (FF) of BI 10773 in comparison to the tablet formulation 2 (TF2).
null
Healthy
null
2
arm 1: one single film-coated tablet in the morning arm 2: one single dose tablet in the morning
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: one single dose tablet in the morning intervention 2: one single film-coated tablet in the morning
intervention 1: BI 10773 XX (Trial Formulation 2) intervention 2: BI 10773 (Final Formulation)
1
Biberach | N/A | Germany | 8.03333 | 48.33333
45
0
0
0
NCT01242176
1COMPLETED
2010-12-01
2010-11-01
Boehringer Ingelheim
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
16
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
true
0ALL
false
Sitaxsentan has a low drug-drug interaction potential and it did not have a clinically relevant effect on pharmacokinetics of sildenafil (a CYP3A sensitive substrate and PDE5 inhibitor). Tadalafil did not have clinically relevant effect on pharmacokinetics of bosentan and ambrisentan. Based on overall clinical drug-dr...
null
Pulmonary Arterial Hypertension
A pharmacokinetic drug-drug interaction study between sitaxsentan and tadalafil and between sitaxsentan and sildenafil at the steady-state
null
4
arm 1: sitaxsentan 100 mg QD for 6 days (Treatment A) arm 2: tadalafil 40 mg QD for 6 days arm 3: sitaxsentan 100 mg QD co-administered with tadalafil 40 mg QD for 6 days arm 4: sitaxsentan 100 mg QD co-administered with sildenafil 20 mg TID for 6 days
[ 0, 0, 0, 0 ]
6
[ 0, 0, 0, 0, 0, 0 ]
intervention 1: sitaxsentan 100 mg QD for 6 days intervention 2: tadalafil 40 mg QD for 6 days intervention 3: sitaxsentan 100 mg QD for 6 days intervention 4: tadalafil 40 mg QD for 6 days intervention 5: sitaxentan 100 mg QD for 6 days intervention 6: sildenafil 20 mg TID for 6 days
intervention 1: sitaxentan intervention 2: tadalafil intervention 3: sitaxsentan intervention 4: tadalafil intervention 5: sitaxsentan intervention 6: sildenafil
1
Singapore | N/A | Singapore | 103.85007 | 1.28967
16
0
0
0
NCT01244620
6TERMINATED
2010-12-01
2010-11-01
Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
22
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
2MALE
false
This clinical trial will compare the pharmacokinetic profile of testosterone after repeated intranasal administration of TBS-1 of different strengths in subjects with hypogonadism
null
Hypogonadism
null
3
arm 1: TBS-1 syringes pre-filled with 125 μL 4.0% gel to deliver 5.0 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 30 mg/day) arm 2: TBS-1 syringes pre-filled with 150 μL 4.5% gel to deliver 6.75 mg of Testosterone per nostril (intra-nasal) given b.i.d. at 2100 and...
[ 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: None
intervention 1: 10.0 mg of Testosterone, 4.0% TID intervention 2: 13.5 mg of Testosterone, 4.5% B.I.D intervention 3: 11.25 mg of Testosterone, 4.5% T.I.D
3
Tucson | Arizona | United States | -110.92648 | 32.22174 Miami | Florida | United States | -80.19366 | 25.77427 Shreveport | Louisiana | United States | -93.75018 | 32.52515
22
0
0
0
NCT01252745
1COMPLETED
2010-12-01
2010-08-01
Acerus Pharmaceuticals Corporation
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
77
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
Infants handle ketorolac differently than adults. Study of handling of this pain medication given to infants following surgery. Detailed analysis of how the drug is eliminated from age 2 months to 18 months. Compared morphine use in infants who received the drug to the group getting placebo. Safety testing for kidney a...
Population kinetic analysis of ketorolac stereo-isomer concentrations after single dose given postoperatively in infants aged 2-18 months. Safety assessments of renal and hepatic function tests by blood tests before and after drug administration, urinalysis pre- and post-drug, continuous oximetry before and for 12 hour...
Postoperative Pain in Infants
ketorolac pharmacokinetics ketorolac stereo-isomers infants postoperative analgesia safety
null
3
arm 1: ketorolac 1 mg/kg iv given by 10 min infusion arm 2: ketorolac 0.5 mg/kg iv given by 10 min infusion arm 3: placebo group received D5W 10 min infusion
[ 0, 1, 3 ]
3
[ 0, 0, 0 ]
intervention 1: Ketorolac Tromethamine 1 mg/kg infusion over 10 minutes intravenous (IV) infusion. Blood sampling in for up to 12 hours after infusion for analysis of ketorolac concentrations and safety assessments. intervention 2: Ketorolac Tromethamine 0.5 mg/kg infusion over 10 minutes intravenous (IV) infusion. Blo...
intervention 1: Ketorolac Tromethamine 1 mg/kg intervention 2: Ketorolac Tromethamine 0.5 mg/kg intervention 3: Placebo
1
Seattle | Washington | United States | -122.33207 | 47.60621
51
0
0
0
NCT01260883
1COMPLETED
2010-12-01
2000-05-01
Seattle 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
[ 2 ]
24
RANDOMIZED
CROSSOVER
7BASIC_SCIENCE
0NONE
true
0ALL
false
A new formulation of methylprednisolone is being developed. A study is needed to determine the drug availability using the new formulation, a powder for reconstitution into a suspension, versus the current commercially available tablet formulation in healthy volunteers.
null
Biological Availability
Single dose bioavailability study of methylprednisolone powder for oral suspension (4mg/mL) versus methylprednisolone tablet (32 mg)
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: powder for oral suspension 4 mg/mL single dose (8 mL) intervention 2: powder for oral suspension 4 mg/mL singe dose (8 ml) intervention 3: tablet 32 mg single dose
intervention 1: methylprednisolone intervention 2: methylprednisolone intervention 3: methylprednisolone
1
Singapore | N/A | Singapore | 103.85007 | 1.28967
69
0
0
0
NCT01267201
1COMPLETED
2010-12-01
2010-11-01
Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
200
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The aim of this study is to subjectively assess symptoms in subjects suffering from the common cold following a single dose of paracetamol hot drink compared to paracetamol tablet
null
Common Cold
Paracetamol Common cold
null
2
arm 1: Hot drink containing paracetamol arm 2: Paracetamol tablets
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: Hot drink containing paracetamol intervention 2: Paracetamol tablets
intervention 1: Paracetamol hot drink intervention 2: Paracetamol tablets
1
Cardiff | Wales | United Kingdom | -3.18 | 51.48
200
0
0
0
NCT01277081
1COMPLETED
2010-12-01
2010-10-01
GlaxoSmithKline
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
48
RANDOMIZED
CROSSOVER
7BASIC_SCIENCE
4QUADRUPLE
false
0ALL
false
The investigators would like to investigate whether clopidogrel will help lower the level of harmful markers in patients with coronary artery disease, and at the same time will help increase the cells that are useful in repairing the damaged blood vessels. The investigators will give half of the patients clopidogrel an...
Blockages in the blood vessels of the heart are caused by atherosclerosis. Atherosclerosis is the main cause for chest pain and heart attacks. Gradual narrowing of the vessels of the heart caused by blockages causes chronic symptoms, such as chest pain. Those with these findings often have a cardiac catheterization to ...
Coronary Artery Disease
null
2
arm 1: Subjects were randomized to clopidogrel 75 mg daily for 6 weeks. Then immediately transitioned to a placebo daily for 6 weeks. arm 2: Subjects were randomized to a placebo daily for 6 weeks. Then immediately transitioned to clopidogrel 75 mg daily for 6 weeks.
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: Clopidogrel 75 mg PO qday for 6 weeks intervention 2: Placebo PO qday for 6 weeks
intervention 1: Clopidogrel intervention 2: Placebo
1
Atlanta | Georgia | United States | -84.38798 | 33.749
96
0
0
0
NCT01283282
1COMPLETED
2010-12-01
2008-01-01
Emory University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
34
RANDOMIZED
PARALLEL
null
2DOUBLE
true
0ALL
false
The main objective of this study was to assess subjective experiences related to secondary negative symptoms and cognitive performance in healthy volunteers in response to multiple doses of paliperidone ER and risperidone in a double-blind, placebo-controlled trial. Adverse events caused by these drugs were also evalua...
A new oral antipsychotic drug, paliperidone extended-release (ER), has recently been developed and might represent an innovative approach in the treatment of schizophrenia. Paliperidone is 9-hydroxyrisperidone, the chief active metabolite of risperidone. Although paliperidone possesses a pharmacological profile very si...
Schizophrenia
cognitive function subjective experiences neuroleptic-induced deficit syndrome paliperidone extended-release risperidone
null
3
arm 1: Drug: risperidone 3mg, PO two times Groups: risperidone arm 2: drug: lactose, PO 3 times group: placebo arm 3: drug : Paliperidone ER 6mg PO, two times group: paliperidone ER
[ 0, 2, 0 ]
3
[ 0, 0, 0 ]
intervention 1: risperidone 3mg, PO, 3 times intervention 2: paliperidone ER 6mg, PO,3 times intervention 3: lactose PO, 3times
intervention 1: risperidone intervention 2: paliperidone ER intervention 3: placebo
1
Jeonju | N/A | South Korea | 127.14889 | 35.82194
34
0
0
0
NCT01284959
1COMPLETED
2010-12-01
2010-06-01
Chonbuk National University 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 ]
34
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to determine if an herb called chamomile can help to treat insomnia (difficulty in going to sleep or getting enough sleep) by increasing the amount of time that you sleep and/or improving the quality of your sleep. The study will also be looking at the effect of chamomile on day time fatigu...
Insomnia, defined as the inability to initiate or maintain sleep or lack of restorative sleep, is the most prevalent sleep complaint in primary care. Insomnia is associated with decreased quality of life, work limitations and increased healthcare utilization. Currently there is no treatment for chronic insomnia that is...
Primary Insomnia Chronic Insomnia
Matricaria Chamomile Herb Insomnia
null
2
arm 1: Each capsule contains 90 mg dry extract of chamomile flowering tops \[6:1 (v/v) extraction solvent (ethanol 70%/30% water): flowering tops\] standardized up to 2.5 mg of (-)-α-bisabolol and ≥ 2.5 mg of apigenin per tablet arm 2: Contained lactose
[ 0, 2 ]
2
[ 7, 0 ]
intervention 1: three tablets each (equivalent to 7.5 g of dried herb) p.o. twice daily for 28 days intervention 2: None
intervention 1: Chamomile High Grade Extract intervention 2: Placebo Tablet
1
Ann Arbor | Michigan | United States | -83.74088 | 42.27756
34
0
0
0
NCT01286324
1COMPLETED
2010-12-01
2008-07-01
University of Michigan
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 ]
50
NA
SINGLE_GROUP
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of this study was to evaluate the effects of lisdexamfetamine dimesylate, a prodrug stimulant, on the behavioral, academic, and psychosocial functioning of college students with attention-deficit/hyperactivity disorder (ADHD). Twenty-five college students with ADHD from two universities (University of Rhode...
Objective: Evaluate stimulant medication on symptoms and functioning for college students with ADHD using double-blind, placebo-controlled, crossover design. Method: Participants included 24 college students with ADHD and 26 college students without psychopathology. Lisdexamfetamine dimesylate (LDX) examined for ADHD p...
Attention-deficit/Hyperactivity Disorder
null
1
arm 1: All participants will be assessed across five conditions (baseline, placebo, 30-mg, 50-mg, \& 70-mg) in a double-blind, crossover design
[ 0 ]
2
[ 0, 0 ]
intervention 1: 30-mg, 50-mg, 70-mg administered for one week in context of double-blind, placebo-controlled crossover design intervention 2: None
intervention 1: lisdexamfetamine dimesylate intervention 2: Placebo
2
Bethlehem | Pennsylvania | United States | -75.37046 | 40.62593 Kingston | Rhode Island | United States | -71.52256 | 41.48038
96
0
0
0
NCT01342445
1COMPLETED
2010-12-01
2009-09-01
University of Rhode Island
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 ]
611
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study was to determine the efficacy and safety of TAK-085, once daily (QD) or twice daily (BID), compared to ethyl eicosapentaenoate (EPA-E), three times daily (TID) in participants with hypertriglyceridemia undergoing lifestyle modification.
TAK-085 is an oral capsule medicine licensed to Takeda Pharmaceutical Company Ltd. TAK-085 contains omega-3 fatty acid ethyl (mainly, ethyl eicosapentaenoate (EPA-E) and ethyl docosahexaenoic acid (DHA-E)). This is a phase 3, double-blind, randomized study to evaluate the efficacy and safety of TAK-085 compared to EPA...
Hypertriglyceridemia
Drug Therapy
null
3
arm 1: TAK-085 2 g, orally, once daily for up to 12 weeks. arm 2: TAK-085 2 g, orally, twice daily for up to 12 weeks. arm 3: Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
[ 0, 0, 0 ]
2
[ 0, 0 ]
intervention 1: Omega-3-acid ethyl esters 90 (TAK-085) capsules. Each one gram of fatty acid in TAK-085 contains approximately 465 mg of EPA plus 375 mg of docosahexaenoic acid-ethyl as ethyl esters. intervention 2: EPA-E, 0.6 g, orally, three-times daily for up to 12 weeks.
intervention 1: Omega-3-acid ethyl esters 90 (TAK-085) intervention 2: Eicosapentaenoic acid-ethyl (EPA-E)
0
null
610
0
0
0
NCT01350973
1COMPLETED
2010-12-01
2009-11-01
Takeda
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
187
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This study is designed to evaluate the ability of a nicotine lozenge to relieve craving for a cigarette compared to a matched placebo (a placebo is like sugar pill and contains no active).
null
Smoking Smoking Cessation
Nicotine Nicotine craving
null
3
arm 1: lower dose nicotine lozenge arm 2: higher dose Nicotine lozenge arm 3: Placebo
[ 1, 1, 2 ]
3
[ 0, 0, 0 ]
intervention 1: lower dose nicotine lozenge intervention 2: higher dose nicotine lozenge intervention 3: placebo
intervention 1: Nicotine lower dose intervention 2: Nicotine higher dose intervention 3: Placebo
1
Burbank | California | United States | -118.30897 | 34.18084
187
0
0
0
NCT01466361
1COMPLETED
2010-12-01
2010-09-01
GlaxoSmithKline
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
17
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to evaluate the effects and tolerability (how well a participant can stand a particular medicine or treatment) of flexible dose Oxybutynin Extended-Release (OXY-ER, Lyrinel) including safety and quality of life assessment in participants with neurogenic detrusor overactivity (NDO - the nerv...
This is an open-label (all people know the identity of the intervention), single arm, prospective (study following participants forward in time), multi-center study of participants with NDO. The initial dose of Oxybutynin ER will be 10 milligram (mg) and will be titrated to a maximum of 30 mg. Dosage will be adjusted i...
Detrusor Function, Overactive
Detrusor function, overactive Urinary incontinence Oxybutynin Lyrinel
null
1
arm 1: Oxybutynin chloride 5, 10, 15 milligram (mg) per tablet 10-30 mg per day orally
[ 0 ]
1
[ 0 ]
intervention 1: Oxybutynin chloride 5, 10, 15 milligram (mg) per tablet 10-30 mg per day orally
intervention 1: Oxybutinin Extended-Release
3
Bangkok | N/A | Thailand | 100.50144 | 13.75398 Chiang Mai | N/A | Thailand | 98.98468 | 18.79038 Phathumwan | N/A | Thailand | N/A | N/A
15
0
0
0
NCT01796548
6TERMINATED
2010-12-01
2008-12-01
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
0
0
0
0
0
0
0
0
0
[ 5 ]
140
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
1. INTRODUCTION Through last couple of years the number of patients treated for acute coronary event without persistent ST segment elevation in ECG has been growing. This is probably an effect of improving diagnostics of myocardial infraction without persistent ST segment elevation in ECG, due to routine Tropon...
null
Non ST Elevation Myocardial Infarction
null
2
arm 1: Patients were given a bolus of eptifibatide (Integrillin; 180µg/kg of body weight) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg orally daily until the day of the procedure) and enoxaparin (1mg/kg subcutaneous - with the last dose 12 hours before surgery). arm 2: Patients wer...
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: Eptifibatide intervention 2: Placebo
6
New York | New York | United States | -74.00597 | 40.71427 Katowice | Silesian Voivodeship | Poland | 19.02754 | 50.25841 Katowice | N/A | Poland | 19.02754 | 50.25841 Katowice | N/A | Poland | 19.02754 | 50.25841 Katowice | N/A | Poland | 19.02754 | 50.25841 Krakow | N/A | Poland | 19.93658 | 50.06143
140
0
0
0
NCT01863134
1COMPLETED
2010-12-01
2005-01-01
Medical University of Silesia
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 ]
23
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
Oral administration of betaglucosylceramide was shown effective in reducing inflammation in animal models and was found safe in humans.
Patients with NASH to receive the treatment versus placebo for 40 weeks followed by a liver biopsy.
Compliance Behavior
null
2
arm 1: Normal saline administered orally daily as a placebo arm 2: Beta glucosylceramide administered orally daily
[ 2, 1 ]
2
[ 0, 0 ]
intervention 1: Beta Glucosylceramide intervention 2: normal saline
intervention 1: Beta Glucosylceramide intervention 2: Placebo
0
null
23
0
0
0
NCT02126306
1COMPLETED
2010-12-01
2006-01-01
Hadassah Medical Organization
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 ]
43
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This is a Phase 1/Phase 2 study of STI571 combined with docetaxel and cisplatin for treatment of patients with recurrent and metastatic Non-Small Cell Lung Cancer (NSCLC). This research study has 2 parts to it. The first part (Phase 1) is called a dose-escalation. Not all subjects enrolled into this phase of the study...
null
Non-small Cell Lung Cancer
non-small cell lung cancer
null
0
null
null
3
[ 0, 0, 0 ]
intervention 1: Treatment will consist of docetaxel plus cisplatin IV every 21days and oral STI571 given on Days -5 to 2 with each chemotherapy cycle. A maximum of 6 cycles will be given. Phase 1 dose levels are: * Level 1 Docetaxel/Cisplatin 60 mg/m2, STI571 300mg * Level 2 Docetaxel/Cisplatin 60 mg/m2, STI571 400mg...
intervention 1: Docetaxel, Cisplatin and STI571 intervention 2: Docetaxel intervention 3: Cisplatin
0
null
43
0
0
0
NCT02127372
6TERMINATED
2010-12-01
2004-11-01
Duke University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
35
RANDOMIZED
PARALLEL
2DIAGNOSTIC
1SINGLE
false
0ALL
null
Computed Tomography Angiogram (CTA) scans are performed routinely to look at the vessels in the body as an alternative to directly injecting contrast into the vessels and taking pictures. Different types of intravenous (into the vein, IV) contrast are available to fill the vessels and make them easier to see. The purpo...
null
Coronary Computed Tomographic Angiography
coronary computed tomographic angiography contrast
null
2
arm 1: Isovue 370 is a contrast agent with increased iodine concentration. arm 2: Standard protocol is Visipaque 320.
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: Isovue 370 is a contrast agent with increased iodine concentration. intervention 2: Visipaque 320 is standard protocol.
intervention 1: Isovue 370 intervention 2: Visipaque 320
0
null
33
0
0
0
NCT02171247
1COMPLETED
2010-12-01
2008-04-01
Duke University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
45
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
Patients with diabetic neuropathy and total symptoms score(TSS) \>7 points were invited to this open multicenter study. Patients were free of pain medications and severe diabetic complications .Patients started alpha lipoic acid (ALA)1800 mg for 4 weeks. Patients with a decrease \>3 points in the TSS were randomly allo...
This trial was conducted in accordance with the Declaration of Helsinki and was approved by the ethics committee of Universidad Popular Autónoma del Estado de Puebla, Mexico. All participants provided a written informed consent. Type 2 diabetic patients (according to American Diabetes Association (ADA) criteria) with s...
Diabetic Neuropathy
null
2
arm 1: After a decrease in the total symptoms score \>3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks 600 mg orally once a day of alpha lipoic acid arm 2: After a decrease in the total symptoms Score \>3 points with 600 mg orally tid of alpha lipoic acid...
[ 1, 4 ]
1
[ 0 ]
intervention 1: Alpha lipoic acid 1800 mg PO divided in 3 doses for 4 weeks . If total symptoms score decreased \>3 points patients received alpha lipoic acid 600 mg PO each day or no treatment for 16 weeks.
intervention 1: Alpha lipoic acid
0
null
33
0
0
0
NCT02439879
1COMPLETED
2010-12-01
2009-12-01
Universidad Popular Autónoma del Estado de Puebla
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 ]
178
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of this study is to evaluate the efficacy and safety of a range of doses of oral sumatriptan for the acute treatment of migraine in children ages 10 to 17.
null
Migraine Disorders
adolescent sumatriptan children migraine
null
3
arm 1: None arm 2: None arm 3: None
[ 1, 1, 2 ]
3
[ 0, 0, 0 ]
intervention 1: One Sumatriptan 25mg tablet and one Matching Placebo tablet should be administered as soon as possible (within 30 minutes) after the development of a migraine associated with 3 or more pain on a 5-grade scale. intervention 2: Two Sumatriptan 25mg tablets should be administered as soon as possible (withi...
intervention 1: Sumatriptan 25 mg intervention 2: Sumatriptan 50 mg intervention 3: Placebo
16
Aichi | N/A | Japan | 130.62158 | 32.51879 Aichi | N/A | Japan | 130.62158 | 32.51879 Hokkaido | N/A | Japan | N/A | N/A Hokkaido | N/A | Japan | N/A | N/A Hyōgo | N/A | Japan | 144.43333 | 43.36667 Hyōgo | N/A | Japan | 144.43333 | 43.36667 Kagoshima | N/A | Japan | 130.55 | 31.56667 Kanagawa | N/A | Japan | 139.91667...
218
0
0
0
NCT00963937
1COMPLETED
2010-12-03
2009-09-28
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 ]
231
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This is an outpatient study to evaluate the safety, and efficacy of RGH-188 as an add-on therapy to standard antidepressants in patients who did not respond to previous antidepressant therapy.
null
Major Depressive Disorder
Adjunctive Depression Major Depressive Disorder (MDD)
null
3
arm 1: Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo arm 2: Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR)+ cariprazine low dose arm 3: Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxin...
[ 2, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period. intervention 2: Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cari...
intervention 1: Antidepressant + placebo intervention 2: Antidepressant + cariprazine (0.1-0.3 mg/day) intervention 3: Antidepressant + cariprazine (1-2 mg/d)
41
Phoenix | Arizona | United States | -112.07404 | 33.44838 Scottsdale | Arizona | United States | -111.89903 | 33.50921 Arcadia | California | United States | -118.03534 | 34.13973 Encino | California | United States | -118.50119 | 34.15917 Garden Grove | California | United States | -117.94145 | 33.77391 Irvine | Calif...
732
1
0.001366
1
NCT00854100
1COMPLETED
2010-12-06
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
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0.000241
[ 2 ]
20
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purposes of this study were to assess the safety, tolerability, pharmacokinetic interactions, and the Human Anti-Human Antibody of dalotuzumab in combination with cetuximab and irinotecan in participants with advanced or metastatic colorectal cancer in Japan.
null
Colorectal Cancer
null
3
arm 1: After treatment with Cetuximab (Cetux) and Irinotecan (Irin), Dalotuzumab (Dmab) was administered as an intravenous infusion at 10 mg/kg in Cycle 1 on Days 22, 29 and 36; followed in subsequent cycles by treatment with 10 mg/kg on Days 1, 8, 15, 22, 29 and 36. Each cycle was 6 weeks long. arm 2: After treatment ...
[ 0, 0, 0 ]
4
[ 2, 2, 0, 2 ]
intervention 1: Dalotuzumab at 10 mg/kg was intravenously administered once weekly intervention 2: Following pre-treatment with a histamine-receptor antagonist, Cetuximab was administered with an initial intravenous infusion of 400 mg/m\^2, followed by subsequent once weekly intravenous infusions of 250 mg/m\^2 interve...
intervention 1: Dalotuzumab 10 mg/kg intervention 2: Cetuximab intervention 3: Irinotecan intervention 4: Dalotuzumab 15/7.5 mg/kg
0
null
20
0
0
0
NCT00925015
1COMPLETED
2010-12-06
2009-06-17
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 ]
36
NA
SINGLE_GROUP
1PREVENTION
0NONE
false
0ALL
false
This study is designed to assess the safety and efficacy of palonesetron in preventing chemotherapy-induced nausea and vomiting (CINV) when administered to participants who have experienced either vomiting and or at least moderate nausea during their last cycle of low emetogenic chemotherapy.
Palonosetron is currently approved for prevention of acute and delayed nausea and vomiting associated with initial and repeat CINV caused by moderate and highly emetogenic chemotherapy. This study is designed to assess the safety and efficacy of palonesetron in preventing CINV when administered to patients who have exp...
Patients With Confirmed Malignant Disease to Receive Low Emetogenic Chemotherapy (LEC) or Who Experienced at Least Nausea and Vomiting During Last Cycle of LEC
LEC Low Emetogenic Chemotherapy Nausea and Vomiting Nausea Vomiting Anti- emetic
null
1
arm 1: Participants will receive palonosetron 0.25 milligram (mg) per (/) 5 milliliter (mL) intravenous injection 30 minutes prior to receiving a low emetogenic chemotherapy (LEC) agent on Day 1.
[ 0 ]
1
[ 0 ]
intervention 1: One dose administered intravenously 30 minutes pre-chemotherapy
intervention 1: palonesetron
9
Sunrise | Florida | United States | -80.1131 | 26.13397 Galesburg | Illinois | United States | -90.37124 | 40.94782 Skokie | Illinois | United States | -87.73339 | 42.03336 Madisonville | Kentucky | United States | -87.49889 | 37.3281 Nyack | New York | United States | -73.91791 | 41.09065 Middletown | Ohio | United St...
36
0
0
0
NCT01054456
1COMPLETED
2010-12-08
2009-10-27
Eisai Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
31
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
null
This study was to evaluate the safety and efficacy of afamelanotide in patients suffering from polymorphic light eruption (PLE).
null
Polymorphic Light Eruption
null
2
arm 1: Afamelanotide implants were administered on Days 0 and 60. Patients returned to the clinic on Day 120 for the final visit. arm 2: Placebo implants were administered on Days 0 and 60. Patients returned to the clinic on Day 120 for the final visit.
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: Afamelanotide intervention 2: Placebo
0
null
31
0
0
0
NCT04704713
1COMPLETED
2010-12-09
2010-05-05
Clinuvel Pharmaceuticals Limited
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 ]
30
RANDOMIZED
PARALLEL
0TREATMENT
null
false
0ALL
null
The purpose of this study is to investigate the efficacy, safety, tolerability and the concentration/response relationship of E6201 in subjects with psoriasis vulgaris.
This is a single center, randomized, blinded, intra-individual comparison in two sequential cohorts of 15 subjects each (30 subjects in total) in an outpatient setting, in which each subject simultaneously receives five topical treatments (3 active, 1 vehicle, and 1 positive control) within one or two psoriatic plaques...
Psoriasis Vulgaris
Psoriasis vulgaris
null
2
arm 1: Three concentrations of E6201 topical gel (0.03%, 0.1%, and 0.2%) and active comparator, calcipotriene cream (0.005%), were applied once daily for 12 days to specific test fields determined at Baseline. The 3 concentrations of E6201 gel were dosed first in Cohort 1 to establish the safety and tolerability prior ...
[ 0, 0 ]
13
[ 0, 0, 0, 0, 0, 0, 10, 10, 10, 10, 10, 10, 0 ]
intervention 1: Topical 0.03% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque. intervention 2: Topical 0.1% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque. intervention 3: Topical 0.2% E6201 gel was applied once daily to individual specifi...
intervention 1: 0.03% E6201 intervention 2: 0.1% E6201 intervention 3: 0.2% E6201 intervention 4: 0.005% E6201 intervention 5: 0.01% E6201 intervention 6: 0.05% E6201 intervention 7: Placebo - 0.03% gel vehicle intervention 8: Placebo - 0.1% gel vehicle intervention 9: Placebo - 0.2% gel vehicle intervention 10: Placeb...
1
Berlin | N/A | Germany | 13.41053 | 52.52437
132
0
0
0
NCT01268527
1COMPLETED
2010-12-11
2010-03-15
Eisai Limited
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
26
null
SEQUENTIAL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study was to determine the safety and maximum tolerated dose (MTD) of ALXN6000 (samalizumab) in treating relapsing or refractory B-cell chronic lymphocytic leukemia (B-CLL) or multiple myeloma (MM) and to study how samalizumab may help the immune system fight tumors that express CD200.
This was an open-label multicenter study for participants with relapsing or refractory B-CLL or MM. The study was planned to be conducted in 2 parts: Part A and Part B. Both parts were to evaluate safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy (to the extent possible) of samalizumab in the target pa...
B-cell Chronic Lymphocytic Leukemia Multiple Myeloma
B-cell Chronic Lymphocytic Leukemia Leukemia Multiple Myeloma CD200 Anti-CD200
null
1
arm 1: All doses of samalizumab were individualized based on the participant's body surface area in mg/m\^2 based on screening height and weight. Participants were assigned to a dose cohort, ranging from 50 to 600 mg/m\^2, and received a single IV dose of samalizumab. Participants who tolerated the drug and demonstrate...
[ 0 ]
1
[ 0 ]
intervention 1: Samalizumab is a humanized anti-CD200 monoclonal antibody.
intervention 1: Samalizumab
4
Tucson | Arizona | United States | -110.92648 | 32.22174 Atlanta | Georgia | United States | -84.38798 | 33.749 Morristown | New Jersey | United States | -74.48154 | 40.79677 Durham | North Carolina | United States | -78.89862 | 35.99403
26
1
0.038462
1
NCT00648739
6TERMINATED
2010-12-14
2008-06-19
Alexion Pharmaceuticals, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0.006822
[ 4 ]
776
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of this study was to evaluate the efficacy and safety of Etoricoxib compared to placebo and ibuprofen in the treatment of postoperative pain associated with unilateral total knee replacement surgery. The hypotheses for this study were that the average pain intensity difference (at rest) in participants trea...
null
Pain, Postoperative
null
4
arm 1: Participants received etoricoxib 90 mg once daily, matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days. arm 2: Participants received etoricoxib 120 mg once daily, matching placebo to etoricoxib 90 mg once daily, and matching placebo to ibuprofen 600...
[ 0, 0, 1, 2 ]
8
[ 0, 0, 0, 0, 0, 0, 0, 0 ]
intervention 1: One 90 mg tablet once daily intervention 2: Two 60 mg tablets once daily intervention 3: One tablet three times daily intervention 4: Two tablets once daily intervention 5: One tablet once daily intervention 6: One tablet three times daily intervention 7: As needed via patient-controlled analgesia (PCA)...
intervention 1: Etoricoxib 90 mg intervention 2: Etoricoxib 120 mg intervention 3: Ibuprofen 600 mg intervention 4: Matching Placebo for Etoricoxib 120 mg intervention 5: Matching Placebo for Etoricoxib 90 mg intervention 6: Matching Placebo for Ibuprofen intervention 7: Morphine intervention 8: Oxycodone
0
null
773
0
0
0
NCT00820027
1COMPLETED
2010-12-14
2008-12-15
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
[ 5 ]
168
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
1FEMALE
false
This study will evaluate the safety/efficacy of zoledronic acid when given by intravenous infusion every 4 weeks in addition to letrozole as endocrine therapy in postmenopausal patients with hormone responsive breast cancer
Open-label, multicenter, randomized phase II trial over approx 6.5 months of neoadjuvant treatment with letrozole with or without zoledronic acid in postmenopausal patients with primary breast cancer. A total of approximately 850 patients were originally planned to be enrolled; primary study endpoint was the objective ...
Breast Neoplasms
Breast cancer Anti tumor potential Letrozole Zoledronic acid Neoadjuvant treatment Hormone responsive breast cancer
null
2
arm 1: Letrozole 2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvent treatment arm 2: 2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvant treatment plus zoledronic acid 4 mg i.v. q4w
[ 1, 0 ]
2
[ 0, 0 ]
intervention 1: 2.5 mg.tablet. intervention 2: 4 mg or an adjusted dose based on renal function in 100 ml physiologic (o.9%) normal saline, (as an intravenous infusion over no less than 15 minutes)
intervention 1: Letrozole intervention 2: Zolendronic Acid
27
Amberg | N/A | Germany | 11.86267 | 49.44287 Berlin | N/A | Germany | 13.41053 | 52.52437 Böblingen | N/A | Germany | 9.01171 | 48.68212 Celle | N/A | Germany | 10.08047 | 52.62264 Cologne | N/A | Germany | 6.95 | 50.93333 Ebersberg | N/A | Germany | 11.97063 | 48.0771 Erlangen | N/A | Germany | 11.00783 | 49.59099 Ess...
168
0
0
0
NCT00375752
6TERMINATED
2010-12-16
2006-06-01
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 ]
435
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This trial is conducted in Asia and Japan. The aim of this trial is to compare insulin degludec (NN1250) with insulin glargine both combined with oral antidiabetic drugs (OADs) in subjects with type 2 diabetes never treated with insulin.
null
Diabetes Diabetes Mellitus, Type 2
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Insulin degludec injected subcutaneously (under the skin) once daily. The doses will be individually adjusted intervention 2: Insulin glargine injected subcutaneously (under the skin) once daily. The doses will be individually adjusted
intervention 1: insulin degludec intervention 2: insulin glargine
53
Shatin, New Territories | N/A | Hong Kong | N/A | N/A Chuo-ku, Tokyo | N/A | Japan | N/A | N/A Kamakura-shi, Kanagawa | N/A | Japan | 139.91667 | 37.58333 Kawasaki-shi | N/A | Japan | N/A | N/A Miyazaki | N/A | Japan | 131.41667 | 31.91667 Naka-shi, Ibaraki | N/A | Japan | N/A | N/A Nishinomiya-shi, Hygo | N/A | Japan ...
430
0
0
0
NCT01059799
1COMPLETED
2010-12-16
2010-02-01
Novo Nordisk A/S
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
8
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
RATIONALE: Drugs used in chemotherapy, such as hydroxychloroquine, carboplatin, and paclitaxel and work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the...
OBJECTIVES: Primary * To determine the recommended phase II dose of hydroxychloroquine and carboplatin in combination with paclitaxel and bevacizumab in patients with advanced recurrent non-small cell lung cancer. (Phase I) * To assess the antitumor activity, as measured by tumor response rate, of this regimen in the...
Lung Cancer
adenocarcinoma of the lung large cell lung cancer recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer
null
2
arm 1: Cohort 1: Bevacizumab Eligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles arm 2: Cohort 2: Bevacizumab Ineligible Patients All on Day 1 Paclitaxel ...
[ 0, 0 ]
4
[ 2, 0, 0, 0 ]
intervention 1: Only patients eligible for bevacizumab will receive bevacizumab. Dose is at 15 mg/kg on day 1 of each cycle. intervention 2: Carboplatin will be given at AUC = 6 by IV over 15-30 minutes on Day 1 immediately following paclitaxel intervention 3: 200 mg orally BID (total daily dose of 400 mg) intervention...
intervention 1: bevacizumab intervention 2: carboplatin intervention 3: hydroxychloroquine intervention 4: paclitaxel
2
Hamilton | New Jersey | United States | -74.08125 | 40.20706 New Brunswick | New Jersey | United States | -74.45182 | 40.48622
8
0
0
0
NCT00728845
6TERMINATED
2010-12-21
2008-06-16
University of Medicine and Dentistry of New Jersey
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
4
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This is a Phase 1/1B, non-randomized, open-label, dose-escalation study of robatumumab (SCH 717454, MK-7454) administered in combination with chemotherapy in pediatric participants with solid tumors, to be conducted in conformance with Good Clinical Practices. This study will evaluate the safety, tolerability and dose-...
null
Neoplasms Solid Tumors Bone Cancer Kidney Tumor Neuroblastoma
null
3
arm 1: Participants receive temozolomide 100 mg/m\^2/day intravenously (IV) on Days 1-5 PLUS irinotecan 10 mg/m\^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle. arm 2: Participants receive vincristine 2 mg/m\^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1...
[ 0, 0, 0 ]
8
[ 0, 0, 0, 0, 2, 0, 0, 0 ]
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 1: Temozolomide intervention 2: Vincristine intervention 3: Ifosfamide intervention 4: Irinotecan intervention 5: Robatumumab intervention 6: Doxorubicin intervention 7: Cyclophosphamide intervention 8: Etoposide
0
null
4
0
0
0
NCT00960063
6TERMINATED
2010-12-22
2009-11-11
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 ]
424
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This trial is conducted in Asia. The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart (IDegAsp)) with biphasic insulin aspart (BIAsp) 30 in patients with type 2 diabetes not optimally controlled on once or twice daily insulin with or without metformin.
null
Diabetes Diabetes Mellitus, Type 2
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Injected subcutaneously twice daily. Dose was individually adjusted. intervention 2: Injected subcutaneously twice daily. Dose was individually adjusted.
intervention 1: insulin degludec/insulin aspart intervention 2: biphasic insulin aspart 30
46
Shatin, New Territories | N/A | Hong Kong | N/A | N/A Chūōku | N/A | Japan | 130.67068 | 33.63867 Imizu-shi | N/A | Japan | N/A | N/A Kamakura-shi | N/A | Japan | N/A | N/A Kashiwara-shi, Osaka | N/A | Japan | 135.50107 | 34.69379 Koriyama-shi, Fukushima | N/A | Japan | 140.46667 | 37.75 Kumamoto-shi, Kumamoto | N/A | ...
420
0
0
0
NCT01059812
1COMPLETED
2010-12-23
2010-02-01
Novo Nordisk A/S
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
31
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
false
2MALE
false
This was designed as a two part study comprising sequential double-dummy, placebo controlled 3-period randomized crossover studies. The study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of different doses and dose regimens of MK-8266. Only Part I of the study was completed.
null
Hypertension
High blood pressure
null
12
arm 1: Treatment A in Period 1, Treatment B in Period 2, and Treatment C in Period 3 arm 2: Treatment A in Period 1, Treatment C in Period 2, and Treatment B in Period 3 arm 3: Treatment B in Period 1, Treatment C in Period 2, and Treatment A in Period 3 arm 4: Treatment B in Period 1, Treatment A in Period 2, and Trea...
[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]
6
[ 0, 0, 0, 0, 0, 0 ]
intervention 1: MK-8266 1.3 mg orally twice daily (BID, 1 mg in the morning and 0.3 mg 8 hours later) plus placebo to match Treatment B on Days 1 through 3. On Day 4, single dose of 1 mg MK-8266. intervention 2: MK-8266 0.1 mg orally administered every 2 hours as frequent divided dosing (FDD, total dose of 0.9 mg) plus...
intervention 1: Treatment A intervention 2: Treatment B intervention 3: Treatment C intervention 4: Treatment D intervention 5: Treatment E intervention 6: Treatment F
0
null
104
0
0
0
NCT01244035
1COMPLETED
2010-12-23
2010-08-19
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 ]
146
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
The purpose of this study is to determine whether the safety, tolerability and pharmacodynamics of SB656933 in patients that have cystic fibrosis
This proof of mechanism study aims to evaluate the safety, tolerability and pharmacodynamics of SB-656933 following 28 days of daily administration of 20 and 50 mg SB-656933 in patients with CF compared to placebo. The primary endpoints of the study will be the effect of SB-656933 on safety and tolerability (adverse ev...
Cystic Fibrosis
cystic fibrosis
null
3
arm 1: 20 mg of SB656933 arm 2: 50 mg of SB656933 arm 3: Placebo
[ 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: 20 mg intervention 2: 50mg intervention 3: placebo
intervention 1: SB656933 intervention 2: SB656933 intervention 3: Placebo
33
Birmingham | Alabama | United States | -86.80249 | 33.52066 Tucson | Arizona | United States | -110.92648 | 32.22174 Palo Alto | California | United States | -122.14302 | 37.44188 Denver | Colorado | United States | -104.9847 | 39.73915 Atlanta | Georgia | United States | -84.38798 | 33.749 Chicago | Illinois | United ...
146
0
0
0
NCT00903201
1COMPLETED
2010-12-29
2009-09-28
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 ]
621
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
SP746 (NCT00546351) is a multi-center, open-label, follow-on trial. The purpose of this trial is to assess safety and tolerability of long-term exposure of lacosamide (previously referred to as SPM 927) in subjects with painful distal diabetic neuropathy.
null
Painful Diabetic Neuropathy
Lacosamide
null
1
arm 1: 50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
[ 0 ]
1
[ 0 ]
intervention 1: 50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years
intervention 1: Lacosamide
101
Vienna | N/A | Austria | 16.37208 | 48.20849 Vienna | N/A | Austria | 16.37208 | 48.20849 Antwerp | N/A | Belgium | 4.40026 | 51.22047 Bonheiden | N/A | Belgium | 4.54714 | 51.02261 Genk | N/A | Belgium | 5.50082 | 50.965 Leuven | N/A | Belgium | 4.70093 | 50.87959 Merksem | N/A | Belgium | 4.44903 | 51.24623 Roeselare...
621
1
0.00161
1
NCT00546351
1COMPLETED
2011-01-01
2004-05-01
UCB Pharma
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
0.000284
[ 3 ]
52
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
false
To determine how long Gemcitabine and Bevacizumab will stop the cancer from growing in patients with advanced breast cancer.
null
Metastatic Breast Cancer Locally Advanced Breast Cancer
Breast Neoplasm
null
1
arm 1: Gemcitabine 2500 milligrams per square meter (mg/m\^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity. Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable tox...
[ 0 ]
2
[ 0, 0 ]
intervention 1: Gemcitabine 2500 mg/m\^2 IV over 30 minutes given on Day 1 q 14 days prior to bevacizumab until PD or unacceptable toxicity. intervention 2: Bevacizumab 10 mg/kg IV over 90 minutes at Cycle 1; infusion time may have been decreased for subsequent cycles. (For example, if the first infusion was tolerated ...
intervention 1: Gemcitabine intervention 2: Bevacizumab
16
Fayetteville | Arkansas | United States | -94.15743 | 36.06258 Fresno | California | United States | -119.77237 | 36.74773 San Diego | California | United States | -117.16472 | 32.71571 Longmont | Colorado | United States | -105.10193 | 40.16721 Fairfield | Connecticut | United States | -73.26373 | 41.14121 Augusta | G...
52
1
0.019231
1
NCT00623233
1COMPLETED
2011-01-01
2008-03-01
Eli Lilly and Company
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
0
0
0
0
0
0
0
0.003403
[ 4 ]
389
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
The purpose of this study is to evaluate the efficacy, safety and tolerability of perampanel when given as an adjunctive therapy in subjects with refractory partial seizures.
null
Refractory Partial Seizures
E2007 (perampanel) refractory partial seizures adjunctive therapy seizure frequency reduction in seizure frequency partial onset seizures safety concomitant AED(s)
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: 8 mg perampanel in a 1:1:1 ratio, 125 subjects/arm. All subjects will take a maximum of 6 tablets daily for the duration of the study and will be up-titrated weekly in 2-mg increments to their randomized dose. intervention 2: 12 mg perampanel in a 1:1:1 ratio, 125 subjects/arm. All subjects will take a ...
intervention 1: E2007 (perampanel) intervention 2: E2007 (perampanel) intervention 3: Placebo
92
Huntsville | Alabama | United States | -86.58594 | 34.7304 Huntsville | Alabama | United States | -86.58594 | 34.7304 Phoenix | Arizona | United States | -112.07404 | 33.44838 Phoenix | Arizona | United States | -112.07404 | 33.44838 Tucson | Arizona | United States | -110.92648 | 32.22174 Tucson | Arizona | United Sta...
386
1
0.002591
1
NCT00699582
1COMPLETED
2011-01-01
2008-05-01
Eisai Inc.
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
0.000457
[ 5 ]
1,260
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
The purpose of this study was to assess local nasal adverse effects, as well as systemic effects, of PATANASE nasal spray when compared with Patanase Vehicle, pH 3.7 and Patanase Vehicle, pH 7.0 in patients with perennial allergic rhinitis (PAR).
null
Perennial Allergic Rhinitis
nasal allergy nasal spray seasonal allergy perennial allergy
null
3
arm 1: Olopatadine hydrochloride 0.6% nasal spray (PATANASE), two sprays in each nostril twice a day (morning and evening) for up to 12 months arm 2: Olopatadine nasal spray vehicle, pH 3.7, two sprays in each nostril twice a day (morning and evening) for up to 12 months arm 3: Olopatadine nasal spray vehicle, pH 7.0, ...
[ 0, 2, 2 ]
3
[ 0, 10, 10 ]
intervention 1: Two sprays in each nostril twice a day (morning and evening) for up to 12 months intervention 2: Two sprays in each nostril twice a day (morning and evening) for up to 12 months intervention 3: Two sprays in each nostril twice a day (morning and evening) for up to 12 months
intervention 1: Olopatadine hydrochloride 0.6% nasal spray (PATANASE) intervention 2: Olopatadine nasal spray vehicle, pH 3.7 intervention 3: Olopatadine nasal spray vehicle, pH 7.0
1
Fort Worth | Texas | United States | -97.32085 | 32.72541
1,260
1
0.000794
1
NCT00789555
1COMPLETED
2011-01-01
2008-11-01
Alcon Research
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
0.00014
[ 4 ]
795
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
This Phase 3 study is intended to provide evidence that CP-690,550 dosed 5 mg BID and 10 mg BID is safe and effective when used in combination with a variety of traditional disease modifying antirheumatic drugs in adult patients with rheumatoid arthritis. It is intended to confirm the benefits of CP-690,550 in improvin...
null
Arthritis, Rheumatoid
Arthritis Rheumatoid Antirheumatic Agents Clinical Trial
null
4
arm 1: None arm 2: None arm 3: Placebo non-responders advance to 5 mg CP-690,550 at Month 3 visit. All patients in this treatment arm advance to 5 mg CP-690,550 at Month 6 visit. arm 4: Placebo non-responders advance to 10 mg CP-690,550 at Month 3 visit. All patients in this treatment arm advance to 10 mg CP-690,550 at...
[ 0, 0, 2, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Film coated tablet, 5 mg PO BID, 1 year intervention 2: Film coated tablet, 10 mg PO BID, 1 year intervention 3: Film coated tablet, 1 tablet PO BID, 3-6 months intervention 4: Film coated tablet, 1 tablet PO BID, 3-6 months
intervention 1: CP-690,550 intervention 2: CP-690,550 intervention 3: Placebo intervention 4: Placebo
133
Huntsville | Alabama | United States | -86.58594 | 34.7304 Jonesboro | Arkansas | United States | -90.70428 | 35.8423 Palo Alto | California | United States | -122.14302 | 37.44188 Stanford | California | United States | -122.16608 | 37.42411 Boulder | Colorado | United States | -105.27055 | 40.01499 Denver | Colorado ...
2,376
1
0.000421
0
NCT00856544
1COMPLETED
2011-01-01
2009-05-01
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
1
0
0
0
0
0
0
0
0.000074
[ 3 ]
92
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to evaluate effectiveness, safety and pharmacokinetics (Explores what the body does to the medication) of TMC435350 in combination with Peginterferon Alfa-2a and Ribavirin in genotype 1 hepatitis C virus infected Japanese participants who have never received treatment for their hepatitis C ...
This is a Phase 2, randomized (The study medication is assigned by chance.), 5-arm, open label (All people know the identity of the intervention.), multicentre (study conducted at multiple sites) study. Approximately, 84 participants will be randomized to 5 different arms in a 2:2:1:1:1 ratio. In treatment arms 1 and 2...
Hepatitis C, Chronic
Hepatitis C Hepatitis C virus Interferon Alfa-2a Ribavirin Viral RNA
null
5
arm 1: Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels \<1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued al...
[ 0, 0, 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: One 50 or 100-mg capsule orally (by mouth), once daily for 12 or 24 weeks intervention 2: One subcutaneous injection of PegIFNα-2a 180 μg once weekly for 12, 24, or 48 weeks. intervention 3: 300, 400, or 500-mg tablets orally twice daily for 12, 24, or 48 weeks.
intervention 1: TMC435 intervention 2: PegIFNα-2a intervention 3: RBV
19
Amagasaki | N/A | Japan | 135.41667 | 34.71667 Hiroshima | N/A | Japan | 132.45 | 34.4 Kagoshima | N/A | Japan | 130.55 | 31.56667 Kawasaki | N/A | Japan | 139.71722 | 35.52056 Kitakyushu | N/A | Japan | 130.85034 | 33.85181 Kurume | N/A | Japan | 130.51667 | 33.31667 Kyoto | N/A | Japan | 135.75385 | 35.02107 Matsumot...
92
1
0.01087
1
NCT00996476
1COMPLETED
2011-01-01
2009-07-01
Janssen Pharmaceutical K.K.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0.001921
[ 4 ]
139
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
1FEMALE
null
Randomized phase III trial to compare the effectiveness of tamoxifen with that of thalidomide in treating women who have recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. Estrogen can stimulate the growth of some types of cancer cells. Hormone therapy using tamoxifen may fight ca...
PRIMARY OBJECTIVES: I. To compare the recurrence-free survival of women receiving tamoxifen or thalidomide for epithelial ovarian cancer, cancer of the fallopian tube, or primary peritoneal carcinoma who are in complete clinical remission following front-line treatment but have a high risk of recurrence due to rising ...
Fallopian Tube Cancer Primary Peritoneal Cavity Cancer Recurrent Ovarian Epithelial Cancer Stage III Ovarian Epithelial Cancer Stage IV Ovarian Epithelial Cancer
null
2
arm 1: Patients receive oral thalidomide once daily on days 1-28. arm 2: Patients receive oral tamoxifen twice daily on days 1-28.
[ 0, 0 ]
3
[ 0, 0, 10 ]
intervention 1: Given orally intervention 2: Given orally intervention 3: Correlative studies
intervention 1: tamoxifen citrate intervention 2: thalidomide intervention 3: laboratory biomarker analysis
1
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
136
0
0
0
NCT00041080
1COMPLETED
2011-01-01
2003-02-01
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, 4 ]
432
RANDOMIZED
PARALLEL
4SUPPORTIVE_CARE
2DOUBLE
false
0ALL
true
RATIONALE: Buspirone may be effective in reducing dyspnea (shortness of breath) in patients with cancer who are undergoing chemotherapy. PURPOSE: Randomized clinical trial to study the effectiveness of buspirone in reducing shortness of breath in patients who are undergoing chemotherapy for cancer.
OBJECTIVES: * Assess the degree to which buspirone can decrease the sensation of dyspnea in patients with malignant disease. * Estimate the incidence of dyspnea in patients seen in community oncology practice settings. * Investigate interrelationships of fatigue, depression, anxiety, and patient report of dyspnea. * A...
Dyspnea Pulmonary Complications Unspecified Adult Solid Tumor, Protocol Specific
dyspnea pulmonary complications unspecified adult solid tumor, protocol specific
null
2
arm 1: buspirone hydrochloride arm 2: Placebo
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: The dose of buspirone will be 10 mg taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the 28 day study period intervention 2: Placebo
intervention 1: buspirone hydrochloride intervention 2: Placebo
15
Chicago | Illinois | United States | -87.65005 | 41.85003 Decatur | Illinois | United States | -88.9548 | 39.84031 Evanston | Illinois | United States | -87.69006 | 42.04114 Wichita | Kansas | United States | -97.33754 | 37.69224 Kalamazoo | Michigan | United States | -85.58723 | 42.29171 Kansas City | Missouri | Unite...
432
0
0
0
NCT00053846
1COMPLETED
2011-01-01
2002-11-01
University of Rochester
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 ]
143
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
This randomized phase II trial is studying bevacizumab, gemcitabine, and cetuximab to see how well they work compared to bevacizumab, gemcitabine, and erlotinib in treating patients with advanced pancreatic cancer. Monoclonal antibodies, such as cetuximab and bevacizumab, can locate tumor cells and either kill them or ...
OBJECTIVES: I. Compare the objective response rate in patients with advanced adenocarcinoma of the pancreas treated with bevacizumab and gemcitabine with cetuximab vs erlotinib. II. Compare the toxicity of these regimens in these patients. III. Compare median progression-free and overall survival of patients treated ...
Adenocarcinoma of the Pancreas Recurrent Pancreatic Cancer Stage II Pancreatic Cancer Stage III Pancreatic Cancer Stage IV Pancreatic Cancer
null
2
arm 1: Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22; gemcitabine IV over 30 minutes on days 1, 8, and 15; and bevacizumab IV over 30-90 minutes on days 1 and 15. arm 2: Patients receive gemcitabine and bevacizumab as in arm I. Patients also receive oral erlotinib once daily on days 1-5, 8-12, a...
[ 0, 0 ]
4
[ 2, 0, 2, 0 ]
intervention 1: Given IV intervention 2: Given IV intervention 3: Given IV intervention 4: Given orally
intervention 1: cetuximab intervention 2: gemcitabine hydrochloride intervention 3: bevacizumab intervention 4: erlotinib hydrochloride
1
Chicago | Illinois | United States | -87.65005 | 41.85003
139
0
0
0
NCT00091026
1COMPLETED
2011-01-01
2004-07-01
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
[ 3 ]
37
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This study will investigate the effects and side effects of BAY 43-9006 in patients with advanced, recurrent, or refractory non-small cell lung cancer (NSCLC). BAY 43-9006 is one of a new class of anticancer agents known as bi-aryl ureas. Patients 18 years of age and older with NSCLC that has recurred or progressed af...
Despite advances in systemic chemotherapy, patients with stage IV NSCLC will die from their disease. The median survival of all patients is 8-16 months, with a one year-survival rate of 33%. Chemotherapy is the mainstay of treatment of advanced disease. Based on available data from randomized trials, current treatment ...
Non-Small-Cell Lung Carcinoma
Non-Small Cell Molecular Targeted Therapies Cancer Non-Small Cell Lung Cancer NSCLC
null
1
arm 1: Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
[ 0 ]
1
[ 0 ]
intervention 1: Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
intervention 1: BAY 43-9006 (Sorafenib)
1
Bethesda | Maryland | United States | -77.10026 | 38.98067
37
0
0
0
NCT00098254
1COMPLETED
2011-01-01
2004-12-01
National Cancer Institute (NCI)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
296
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The purpose of this research of 400 participants is to determine whether a drug called risperidone can decrease symptoms of Post-Traumatic Stress Disorder (PTSD). It is a placebo-controlled study, meaning that half of the participants will be assigned to receive a pill that contains no drug. The treatment phase of the ...
Primary Hypothesis: Risperidone will reduce symptoms of PTSD, relative to placebo, in veterans with military service related chronic PTSD who have been partial or non-responders to antidepressant medications. Secondary Hypothesis: Risperidone is safe and well-tolerated in veterans with military service related chronic...
Stress Disorders Post-Traumatic
PTSD
null
2
arm 1: 1 mg/day tablet for week one, increasing by 1 mg/day weekly to a target dose of 3 mg/day to a maximum of 4 mg/day allowed after a minimum of 4 weeks at the target dose 3 mg/day arm 2: Placebo 1 mg/day tablet for week one, increasing by 1 mg/day weekly to a target dose of 3 mg/day to a maximum of 4 mg/day allowed...
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Initiate treatment with a low dose (1 mg/day HS) for week one, increasing by 1 mg/day weekly to a target dose of 3 mg/day. Escalation to a maximum of 4 mg/day will be allowed after a minimum of 4 weeks at the target dose (3 mg/day). Reduction to a lower dose will be allowed at any time, based on adverse...
intervention 1: Risperidone intervention 2: Placebo
20
Tuscaloosa | Alabama | United States | -87.56917 | 33.20984 San Diego | California | United States | -117.16472 | 32.71571 San Francisco | California | United States | -122.41942 | 37.77493 West Los Angeles | California | United States | -118.43068 | 34.0462 West Haven | Connecticut | United States | -72.94705 | 41.270...
267
0
0
0
NCT00099983
1COMPLETED
2011-01-01
2006-10-01
US Department of Veterans Affairs
1FED
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
81
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
1FEMALE
true
RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving topotecan in different dosing schedules may kill more tumor cells. PURPOSE: This phase II trial is studying how well topotecan works ...
OBJECTIVES: Primary * Determine the antitumor activity of topotecan, in terms of frequency and duration of tumor response, in patients with recurrent platinum-sensitive ovarian epithelial, fallopian tube, or primary peritoneal cancer. * Determine the nature and degree of toxicity of this regimen in these patients. S...
Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer
recurrent ovarian epithelial cancer fallopian tube cancer primary peritoneal cavity cancer
null
2
arm 1: Topotecan 1.25 mg/m2 IV days 1-5 of a 21 day cycle until disease progression or adverse effects prohibit further therapy arm 2: Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28 day cycle until disease progression or adverse effects prohibit further therapy
[ 1, 1 ]
1
[ 0 ]
intervention 1: None
intervention 1: topotecan hydrochloride
78
Hartford | Connecticut | United States | -72.68509 | 41.76371 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 Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 Au...
80
0
0
0
NCT00114166
1COMPLETED
2011-01-01
2005-01-01
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 ]
169
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
This is an open-label, randomized trial in relapsed refractory subjects with mantle cell lymphoma (MCL).
null
Lymphoma
Lymphoma
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Temsirolimus 175 mg IV once a week for 3 weeks; followed by 75 mg IV once a week intervention 2: Temsirolimus 175 mg IV once a week for 3 weeks; followed by 25 mg IV once a week intervention 3: Any of the following single agent treatments: 1. Fludarabine 25 mg/m2 IV over 30 minutes daily for 5 consecut...
intervention 1: Temsirolimus (CCI-779) intervention 2: Temsirolimus (CCI-779) intervention 3: Investigator's choice
73
Little Rock | Arkansas | United States | -92.28959 | 34.74648 Fountain Valley | California | United States | -117.95367 | 33.70918 Los Angeles | California | United States | -118.24368 | 34.05223 New Milford | Connecticut | United States | -73.40845 | 41.57704 Washington D.C. | District of Columbia | United States | -7...
174
0
0
0
NCT00117598
1COMPLETED
2011-01-01
2005-05-01
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
[ 4 ]
442
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
The purpose of this trial is to investigate the efficacy of cetuximab in combination with chemotherapy in comparison to chemotherapy alone in patients with recurrent or metastatic head and neck cancer. Overall survival will be taken as the primary measure of efficacy.
null
Head and Neck Cancer
Head and Neck Cancer
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Subjects in will receive initial dose of 400 mg/m\^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m\^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4)...
intervention 1: Cetuximab + Platinum (Cisplatin or Carboplatin) + 5Fluorouracil (5-FU) intervention 2: Platinum (Cisplatin or Carboplatin) + 5-FU
70
Innsbruck | N/A | Austria | 11.39454 | 47.26266 Vienna | N/A | Austria | 16.37208 | 48.20849 Brussels | N/A | Belgium | 4.34878 | 50.85045 Edegem | N/A | Belgium | 4.44504 | 51.15662 Ghent | N/A | Belgium | 3.71667 | 51.05 České Budějovice | N/A | Czechia | 14.47434 | 48.97447 Prague | N/A | Czechia | 14.42076 | 50.088...
434
0
0
0
NCT00122460
1COMPLETED
2011-01-01
2004-12-01
Merck KGaA, Darmstadt, Germany
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
-0
[ 3 ]
172
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
Little is known about the best ways to help young people stop smoking. Bupropion (a medication marketed as Wellbutrin or Zyban) has proved helpful in treating adult smokers. The purpose of this study is to determine if bupropion is also effective in treating smokers between the ages of 12 and 25 years old. This study a...
Cigarette smoking and other forms of tobacco exposure are one of the leading preventable causes of morbidity and mortality in the United States. Most smokers begin smoking during adolescence, and though they seem motivated to quit smoking, they frequently fail. Although behavioral treatments are available, they have no...
Tobacco Use Cessation Tobacco Use Disorder
adolescents, cigarettes, smoking, tobacco
null
2
arm 1: Using a double-blind, randomized, placebo-controlled design, smokers received active treatment with Bupropion-SR (150 mg. twice daily) in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period. arm 2: Using a double-blind, randomized, placebo-controlled design, s...
[ 1, 2 ]
2
[ 0, 10 ]
intervention 1: 150mg tablets taken orally twice daily for 9 weeks. intervention 2: Matching placebo (to Buproion-SR) twice daily for 9 weeks.
intervention 1: Bupropion-SR intervention 2: Placebo
1
Dallas | Texas | United States | -96.80667 | 32.78306
144
0
0
0
NCT00129272
1COMPLETED
2011-01-01
2004-05-01
National Institute on Drug Abuse (NIDA)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
79
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
The purpose of this study is to determine the effectiveness of teriparatide (FORTEO), which is human parathyroid hormone 1-34, for increasing bone mass and improving bone structure in adults affected with Osteogenesis Imperfecta (OI).
The purpose of this study is to determine the effectiveness of teriparatide (FORTEO), which is human parathyroid hormone 1-34, for increasing bone mass and improving bone structure in adults affected with Osteogenesis Imperfecta (OI). Osteogenesis imperfecta is an inherited disorder of type I collagen, a major componen...
Osteogenesis Imperfecta
Osteogenesis Imperfecta Brittle Bone Disease Fragility Fractures
null
2
arm 1: Once daily SQ administration of Teriparatide (FORTEO) 20 ug for 18 months arm 2: Daily SQ placebo for 18 months
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Teriparatide (FORTEO) 20mcg, subcutaneous injection, once daily intervention 2: None
intervention 1: Teriparatide (FORTEO) intervention 2: Placebos
3
Baltimore | Maryland | United States | -76.61219 | 39.29038 Portland | Oregon | United States | -122.67621 | 45.52345 Houston | Texas | United States | -95.36327 | 29.76328
78
0
0
0
NCT00131469
1COMPLETED
2011-01-01
2005-06-01
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
[ 2, 3 ]
26
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This was a Phase I/II, single-center, dose-escalation study. 177-Lutetium-1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid-cG250 (177-Lu-DOTA-cG250) was administered at a starting dose of 30 mCi/m\^2 of 177-Lu (fixed dose of 10 mg cG250) and escalated in increments of 10 mCi/m\^2 of 177-Lu in sequentially enrol...
Prior to administration of 177-Lu-DOTA-cG250, subjects received 5 mCi/10 mg of the 111-Indium-DOTA-cG250 (111-In-DOTA-cG250) antibody (an imaging dose). Whole body and blood measurements of radioactivity were obtained on at least 3 occasions for 1 week to determine targeting and dosimetry. If at least one known and eva...
Metastatic Renal Cell Carcinoma
Advanced Renal Cell Carcinoma Clear Cell Renal Cell Carcinoma (CCRCC) Lutetium-177 177-Lu cG250 DOTA-cG250 Monoclonal Antibody
null
6
arm 1: Subjects received an initial single dose of 10 mg of cG250 coupled to DOTA and labeled with 30 mCi/m\^2 of 177-Lu. arm 2: Subjects received an initial single dose of 10 mg of cG250 coupled to DOTA and labeled with 40 mCi/m\^2 of 177-Lu. arm 3: Subjects received an initial single dose of 10 mg of cG250 coupled to...
[ 0, 0, 0, 0, 0, 0 ]
2
[ 0, 0 ]
intervention 1: On Day 1, each subject received a single intravenous (IV) infusion of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In. intervention 2: On Day 8, 9, or 10, each subject received a single IV infusion of 10 mg of cG250 coupled to DOTA and labeled with a dose of 177-Lu at a starting dose of ...
intervention 1: 111-In-DOTA-cG250 intervention 2: 177-Lu-DOTA-cG250
1
Nijmegen | N/A | Netherlands | 5.85278 | 51.8425
52
0
0
0
NCT00142415
1COMPLETED
2011-01-01
2005-02-01
Ludwig Institute for Cancer Research
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
203
NA
SINGLE_GROUP
1PREVENTION
0NONE
false
0ALL
true
This study will consist of a six-week open-label treatment period with an extended duration methylphenidate (OROS MPH) followed by subsequent monthly visits for 24 months in a large sample of youths aged 12-17 who meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for ADHD. Th...
null
ADHD
cigarette smoking ADHD adolescents Concerta
null
1
arm 1: Single arm- open treatment with extended duration methylphenidate (OROS MPH)
[ 0 ]
1
[ 0 ]
intervention 1: OROS MPH will be openly prescribed to a maximum of 1.5 mg/kg/day (maximum 126 mg/day). Doses will be titrated according to clinical assessment of efficacy and tolerability.
intervention 1: methylphenidate HCl (Concerta)
1
Cambridge | Massachusetts | United States | -71.10561 | 42.3751
154
0
0
0
NCT00181714
1COMPLETED
2011-01-01
2003-11-01
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
[ 4 ]
60
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
true
0ALL
true
The purpose of this study is to look at the safety and effectiveness of aripiprazole (abilify) in children with bipolar disorder and to examine whether or not patients that respond to initial mood stabilization benefit from continued pharmacotherapy.
This outpatient study will be conducted in 3 phases. Phase 1: Patients meeting entry criteria will be treated with open label aripiprazole (APZ) in order to achieve therapeutic doses of this agent. The primary objective of this phase is to stabilize the patient's mood prior to randomization in phase 2. Adjunctive treat...
Bipolar Disorder
null
2
arm 1: Phase I and Phase III are open label Abilify phases where all subjects receive active Abilify arm 2: in Phase 2 subjects are randomized to either placebo or abilify for up to 72 weeks
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: dosing will occur at 2mg, 5mg, 7mg, 10 mg, 12mg, or 15 mg based on weight, side effects and efficacy intervention 2: subjects in phase 2 will be randomized to active abilify or placebo
intervention 1: Aripiprazole intervention 2: Placebo
1
Cleveland | Ohio | United States | -81.69541 | 41.4995
60
0
0
0
NCT00194077
1COMPLETED
2011-01-01
2004-08-01
University Hospitals Cleveland Medical Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
47
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
true
This phase II trial is studying how well AZD2171 works in treating patients with recurrent ovarian, peritoneal, or fallopian tube cancer. AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor
PRIMARY OBJECTIVES: I. To determine the efficacy of AZD2171 in platinum sensitive and platinum insensitive disease, based on either RECIST criteria (for patients with measurable cancer radiographically) or clinical response benefit (modified Gynecologic Cancer Intergroup \[GCIG\] CA-125 response or stable disease for ...
Fallopian Tube Cancer Primary Peritoneal Serous Adenocarcinoma Recurrent Ovarian Epithelial Cancer Stage I Ovarian Epithelial Cancer Stage II Ovarian Epithelial Cancer
null
1
arm 1: Patients receive oral AZD2171 once 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: cediranib maleate
1
Boston | Massachusetts | United States | -71.05977 | 42.35843
46
0
0
0
NCT00275028
1COMPLETED
2011-01-01
2005-10-01
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
[ 3 ]
109
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
This randomized phase II trial is studying how well giving sorafenib together with either temsirolimus or tipifarnib works in treating patients with stage IV melanoma that cannot be removed by surgery. Sorafenib, temsirolimus, and tipifarnib may stop the growth of tumor cells by blocking some of the enzymes needed for ...
PRIMARY OBJECTIVES: I. Compare the response rate (confirmed and unconfirmed and complete and partial) in patients with unresectable stage IV malignant melanoma treated with sorafenib in combination with either temsirolimus or tipifarnib. II. Compare the 4-month progression-free survival rate of patients treated with ...
Recurrent Melanoma Stage IV Melanoma
null
2
arm 1: Patients receive oral sorafenib twice daily on days 1-28 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. arm 2: Patients receive oral sorafenib as in arm I and oral tipifarnib twice daily on days 1-21
[ 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Given orally intervention 2: Given orally intervention 3: Given IV
intervention 1: sorafenib tosylate intervention 2: tipifarnib intervention 3: temsirolimus
173
Little Rock | Arkansas | United States | -92.28959 | 34.74648 Castro Valley | California | United States | -122.08635 | 37.6941 Castro Valley | California | United States | -122.08635 | 37.6941 Castro Valley | California | United States | -122.08635 | 37.6941 Fremont | California | United States | -121.98857 | 37.54827...
102
0
0
0
NCT00281957
1COMPLETED
2011-01-01
2007-08-01
National Cancer Institute (NCI)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
30
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, 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. Monoclonal antibodies, such as cetuximab a...
OBJECTIVES: Primary * Determine the response rate in patients with unresectable metastatic or recurrent colorectal adenocarcinoma treated with capecitabine, cetuximab, oxaliplatin, and bevacizumab. Secondary * Determine the safety and tolerability of this regimen in these patients. * Determine the progression-free ...
Colorectal Cancer
adenocarcinoma of the colon recurrent colon cancer stage IV colon cancer adenocarcinoma of the rectum recurrent rectal cancer stage IV rectal cancer
null
1
arm 1: Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle. Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequen...
[ 0 ]
4
[ 2, 2, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: None intervention 4: None
intervention 1: bevacizumab intervention 2: cetuximab intervention 3: capecitabine intervention 4: oxaliplatin
2
Durham | North Carolina | United States | -78.89862 | 35.99403 Winston-Salem | North Carolina | United States | -80.24422 | 36.09986
30
0
0
0
NCT00290615
1COMPLETED
2011-01-01
2006-01-01
Herbert Hurwitz
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 ]
21
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The primary purpose of this study is to define the maximum tolerated dose of combination docetaxel, gemcitabine, and capecitabine in patients with pancreatic cancer. Adverse effects will be measured in study participants. In addition, researchers will assess data about preliminary efficacy in patients with this treatme...
Rationale: Single agent gemcitabine is considered standard care for patients with advanced pancreatic cancer. However, better treatments offering improved outcomes are needed for people with this disease. The combination of docetaxel and capecitabine has shown significant and broad clinical activity in a variety of tum...
Pancreatic Cancer
Advanced Pancreatic Cancer
null
1
arm 1: Dose escalation study of mGTX using three dose levels (DL1-3). Patients received docetaxel on days 1 and 8, gemcitabine on days 8 and 15, and capcitabine on days 8 through 21. Gemcitabine fixed dose at 750 mg/m2 over 75 min, capecitabine twice daily and escalated from 500 to 650 mg/m2 at DL2 and docetaxel increa...
[ 0 ]
3
[ 0, 0, 0 ]
intervention 1: Will be give on days 8-21 intervention 2: Will be given on days 1 and 8, intervention 3: A fixed dose rate will be give on days 8 and 15.
intervention 1: Capecitabine intervention 2: Docetaxel intervention 3: Gemcitabine
2
Ann Arbor | Michigan | United States | -83.74088 | 42.27756 Columbus | Ohio | United States | -82.99879 | 39.96118
21
0
0
0
NCT00320749
1COMPLETED
2011-01-01
2005-12-01
Tony Bekaii-Saab
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
20
RANDOMIZED
SINGLE_GROUP
1PREVENTION
3TRIPLE
false
0ALL
null
We propose an eight-week, double-blind, placebo-controlled trial of rosiglitazone in schizophrenia subjects treated with clozapine using Bergman's Minimal Model (MINMOD) intravenous glucose tolerance test. Bergman's Minimal Model analysis with frequent sampled intravenous glucose tolerance test (FSIVGTT) provides a sen...
This study is an eight-week, double-blind, placebo-controlled trial of rosiglitazone in schizophrenia subjects treated with clozapine using Bergman's Minimal Model Analysis (MINMOD) frequent sampled intravenous glucose tolerance test (FSIVGTT) for examination of glucose metabolism. Rosiglitazone, used for the treatment...
Schizophrenia
Schizophrenia Glucose Metabolism Insulin Resistance
null
2
arm 1: rosiglitazone 4mg/day arm 2: matched placebo for 4mg rosiglitazone
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Rosiglitazone 4mg, one capsule per day for eight weeks intervention 2: matched placebo for rosiglitazone 4mg/day
intervention 1: rosiglitazone intervention 2: placebo
1
Boston | Massachusetts | United States | -71.05977 | 42.35843
20
0
0
0
NCT00337350
1COMPLETED
2011-01-01
2003-09-01
Massachusetts General Hospital
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
1
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
To determine whether once a day administration of Mesalamine is at least as safe and efficacious and administration of multiple doses a day in preventing clinical relapse of ulcerative colitis in children and adolescence.
Is taking total dose in mg/kg once a day, as safe as taking total dose divided in mg/kg spreadout during the day in preventing clinical relapse of ulcerative colitis in children and adolescence.
Ulcerative Colitis
Mesalamine Ulcerative Colitis
null
2
arm 1: Asacol total dose in mg/kg given once a day arm 2: Asacol total dose split BID or TID
[ 0, 1 ]
1
[ 0 ]
intervention 1: Asacol is given once a day versus twice or three times a day
intervention 1: Asacol
1
Morristown | New Jersey | United States | -74.48154 | 40.79677
1
0
0
0
NCT00349388
6TERMINATED
2011-01-01
2006-07-01
Annette Langseder
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 ]
89
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
A comparative trial where all patients will receive daily doses of tacrolimus (TAC) until day +60 when tapering will begin, in the absence of graft-versus-host disease (GVHD), and discontinued by day +180. In addition patients will be randomized to methotrexate (MTX) or mycophenolate mofetil (MMF) and again, in the abs...
The randomization for this comparative trial will be stratified by conditioning regimen and, for those patients enrolled on MCC-14178, by busulfan AUC level. All patients will receive daily doses of TAC beginning day -3 (day 0 being the day of hematopoietic stem cell transplant (HCT)) and will be given until day +60 w...
Mucositis Graft-versus-host Disease
Tacrolimus Methotrexate Mycophenolate mofetil Mucositis Acute graft-versus-host disease (aGVHD) Engraftment hemolytic/uremic syndrome (HUS) Thrombotic thrombocytopenic purpura (TTP)
null
2
arm 1: Tacrolimus and Mycophenolate arm 2: Tacrolimus and Methotrexate
[ 5, 5 ]
2
[ 0, 0 ]
intervention 1: Tacrolimus- 0.03mg/kg/24h IV beginning day-3 Methotrexate- 15mg/m2 IV day +1 then 10mg/m2 IV on days 3, 6, 11 post transplant. intervention 2: Tacrolimus- 0.03 mg/kg/24h as a continuous IV infusion, beginning day -3. Mycophenolate Mofetil- 30 mg/kg/day IV in 2 divided doses (q12 hours) beginning day 0 a...
intervention 1: Tac+MTX intervention 2: TAC + MMF
1
Tampa | Florida | United States | -82.45843 | 27.94752
89
0
0
0
NCT00360685
1COMPLETED
2011-01-01
2005-09-01
H. Lee Moffitt Cancer Center and Research Institute
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
44
NON_RANDOMIZED
SINGLE_GROUP
1PREVENTION
0NONE
true
0ALL
null
Chemoprevention is the use of certain substances to keep cancer from forming, growing, or coming back. Curcumin is a compound found in plants that may prevent colon cancer from forming. This phase II trial is studying how well curcumin works in preventing colon cancer in smokers with aberrant crypt foci.
PRIMARY OBJECTIVES: I. To determine mean percentage change from baseline in prostaglandin E2 (PGE2) within ACF pre and post 30 days of curcumin administration at a specified dose. SECONDARY OBJECTIVS: I. To determine mean percentage change from baseline in 5-hydroxy-eicosatetraenoic acid (5-HETE) within ACF pre and ...
Healthy, no Evidence of Disease Tobacco Use Disorder
null
2
arm 1: Patients receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression. arm 2: Patients receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progres...
[ 0, 0 ]
3
[ 10, 10, 0 ]
intervention 1: Correlative studies intervention 2: Correlative studies intervention 3: Given orally
intervention 1: laboratory biomarker analysis intervention 2: pharmacological study intervention 3: curcumin
1
Orange | California | United States | -117.85311 | 33.78779
43
0
0
0
NCT00365209
1COMPLETED
2011-01-01
2006-10-01
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
[ 3 ]
223
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
The purpose of this study is to evaluate whether erythropoietin can help limit the damage to the heart in patients with acute heart attacks.
REVEAL is a randomized, double-blinded, placebo-controlled, parallel phase II clinical study that will evaluate the effects of erythropoietin administration on infarct size, left ventricular remodeling and circulating endothelial progenitor cells in patients with large myocardial infarctions (MI). The study will be con...
Acute ST Elevation Myocardial Infarction
Acute Myocardial Infarction Left Ventricular Remodeling Cardiac Magnetic Resonance Imaging Endothelial Progenitor Cells Infarct Size
null
2
arm 1: The objective of the first phase is to evaluate the safety of escalating doses of Epoetin alfa in patients with STEMIs. arm 2: Single parenteral administration of 60000 U of epoetin alfa. The objectives of the second phase are to investigate the effects of the highest safe dose on infarct size, left ventricular ...
[ 2, 2 ]
1
[ 0 ]
intervention 1: Randomized
intervention 1: Epoetin alfa
16
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 Miami | Florida | United States | -80.19366 | 25.77427 Atlanta | Georgia | United States | -84.38798 | 33.749 Detroit | Michigan | United States | -83.04575 | 42.33143 Royal Oak | Michigan | United States | -83.14465 | 42.48948 Rochester | Mi...
222
0
0
0
NCT00378352
1COMPLETED
2011-01-01
2005-09-01
National Institute on Aging (NIA)
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 ]
18
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This phase II trial is studying how well sunitinib works in treating patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. Sunitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.
PRIMARY OBJECTIVES: I. Assess the response rate (complete response \[CR\] and partial response) in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma treated with sunitinib malate. II. Assess the toxicity of this drug in these patients. III. Assess duration of response, ti...
B-cell Chronic Lymphocytic Leukemia Recurrent Small Lymphocytic Lymphoma Refractory Chronic Lymphocytic Leukemia
null
1
arm 1: Patients receive oral sunitinib malate daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
[ 0 ]
3
[ 0, 10, 10 ]
intervention 1: Given orally intervention 2: Correlative studies intervention 3: Correlative studies
intervention 1: sunitinib malate intervention 2: pharmacological study intervention 3: laboratory biomarker analysis
1
Rochester | Minnesota | United States | -92.4699 | 44.02163
18
0
0
0
NCT00398112
1COMPLETED
2011-01-01
2007-08-01
National Cancer Institute (NCI)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
66
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This phase II trial is studying how well E7389 works in treating patients with recurrent or progressive stage IIIB or stage IV non-small cell lung cancer. Drugs used in chemotherapy, such as E7389, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
OBJECTIVES: I. Evaluate the antitumor activity of E7389 (eribulin mesylate), in terms of objective response rate, in patients with recurrent or progressive stage IIIB or IV non-small cell lung cancer. II. Evaluate the time to progression and overall survival of patients treated with this drug. III. Evaluate the toxi...
Recurrent Non-small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer
null
1
arm 1: Patients receive 1.4 mg/m2 eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
[ 0 ]
1
[ 0 ]
intervention 1: Given IV
intervention 1: eribulin mesylate
2
Duarte | California | United States | -117.97729 | 34.13945 Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
66
0
0
0
NCT00400829
1COMPLETED
2011-01-01
2006-11-01
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 ]
12
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Overall response rate and Time to disease progression using this regimen in patients with low-grade B-Cell Non-Hodgkin's Lymphoma.
This is a phase II open label study that is looking at the VRCD combination regimen in patients with previously untreated low-grade Non-Hodgkin's Lymphoma. Treatment will start by combining oral dexamethasone and cyclophosphamide with intravenous VELCADE, rituximab. Chemotherapy cycles will be given as outlined below e...
Lymphoma, Non-Hodgkin Lymphoma, B-Cell
NHL
null
1
arm 1: Velcade 375 mg/m\^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
[ 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 1.6 mg/m\^2 of Velcade® given intravenously on days 1, 8, 15 and 22. intervention 2: 375 mg/m\^2 of Rituximab given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle. intervention 3: 400 mg/m\^2 of Cyclophosphamide given orally on days 1-4 of each cycle....
intervention 1: VELCADE® intervention 2: Rituximab intervention 3: Cyclophosphamide intervention 4: Decadron
2
Niles | Illinois | United States | -87.80284 | 42.01892 Park Ridge | Illinois | United States | -87.84062 | 42.01114
12
0
0
0
NCT00413959
6TERMINATED
2011-01-01
2006-08-01
Oncology Specialists, S.C.
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
109
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
This study is a multinational study to compare enzastaurin versus placebo in the treatment of patients with brain metastases of lung cancer. Approximately 108 patients will be randomly assigned to receive either enzastaurin or placebo after having completed whole brain radiotherapy.
null
Non Small Cell Lung Cancer Small Cell Lung Cancer
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 1125 mg loading dose then 500 mg, oral, daily, until disease progression intervention 2: oral, daily
intervention 1: enzastaurin intervention 2: placebo
7
Copenhagen | N/A | Denmark | 12.56553 | 55.67594 Bergen | N/A | Norway | 5.32415 | 60.39299 Trondheim | N/A | Norway | 10.39506 | 63.43049 Olsztyn | N/A | Poland | 20.49416 | 53.77995 Cluj-Napoca | N/A | Romania | 23.6 | 46.76667 Gothenburg | N/A | Sweden | 11.96679 | 57.70716 Umeå | N/A | Sweden | 20.25972 | 63.82842
107
0
0
0
NCT00415363
1COMPLETED
2011-01-01
2006-12-01
Eli Lilly and Company
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
19
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The aim of this project is to study the use of gabapentin in reducing benzodiazepine abuse in methadone maintenance patients. A second aim is to study the effects of gabapentin on craving, mood, anxiety, and sleep disturbance in methadone maintenance patients abusing benzodiazepines. The proposed protocol is a randomiz...
The investigators will recruit individuals with current benzodiazepine abuse or dependence, as defined by the DSM-IV, who are receiving methadone maintenance treatment at the Bridge Plaza Treatment and Rehabilitation Clinic. The initial step in recruitment for all patients will be a referral from a clinic counselor. T...
Benzodiazepine Dependence Opioid Dependence
Benzodiazepine Gabapentin Methadone
null
2
arm 1: gabapentin treatment 1200 mg three times daily arm 2: Placebo condition received pills identical in appearance to experimental arm.
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: For the first week, one 400 mg Gabapentin capsule taken 3 times per day. For the second week, two 400 mg Gabapentin capsules taken 3 times per day. For the third week through the eighth week, three 400 mg Gabapentin capsules taken 3 times per day. For the ninth and last week, two 400 mg Gabapentin capsu...
intervention 1: Gabapentin intervention 2: Placebo
1
Long Island City | New York | United States | -73.94875 | 40.74482
16
0
0
0
NCT00420771
1COMPLETED
2011-01-01
2007-01-01
New York State Psychiatric Institute
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
73
NON_RANDOMIZED
SEQUENTIAL
0TREATMENT
0NONE
false
2MALE
false
The purpose is to see how quickly two different types of prostate cancer participants respond when taking enzastaurin. Cohort 1 - asymptomatic participants with androgen-independent prostate-specific antigen (PSA)-progressive disease without clinical or radiographic evidence of metastatic disease. Cohort 2 - particip...
null
Prostate Cancer
null
2
arm 1: Chemo-naive participants who had androgen-independent prostate cancer with rising prostate-specific antigen (PSA) levels but no clinical or radiographic evidence of metastatic disease. Participants were given 1125 mg loading dose of enzastaurin on Day 1 of Cycle 1 (28-day cycle) only, and thereafter 500 mg enzas...
[ 0, 0 ]
1
[ 0 ]
intervention 1: Administered orally
intervention 1: enzastaurin
11
Los Angeles | California | United States | -118.24368 | 34.05223 Stanford | California | United States | -122.16608 | 37.42411 New Haven | Connecticut | United States | -72.92816 | 41.30815 Ann Arbor | Michigan | United States | -83.74088 | 42.27756 Las Vegas | Nevada | United States | -115.13722 | 36.17497 Buffalo | N...
73
0
0
0
NCT00428714
1COMPLETED
2011-01-01
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
[ 2, 3 ]
48
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Primary Objectives: 1. Determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of oxaliplatin in combination with fludarabine, Ara-C and rituximab in patients with Richter's transformation, prolymphocytic leukemia (PLL), or refractory/relapsed B-cell chronic lymphocytic leukemia (CLL). 2. Assess th...
Oxaliplatin, fludarabine, cytarabine and rituximab are anticancer drugs. Oxaliplatin is a platinum compound that has been shown to be effective in fighting other cancers. Oxaliplatin is a third generation platinum compound with higher activity and less toxicity in colon cancer and other tumors compared to other platinu...
Leukemia
B-cell chronic lymphocytic leukemia Chronic Lymphocytic Leukemia CLL Prolymphocytic Leukemia PLL Richter's Transformation High-grade non-Hodgkin's lymphoma Hodgkin's disease Acute leukemia Small lymphocytic lymphoma Oxaliplatin Eloxatin Fludarabine Cytarabine Ara-C Cytosar DepoCyt Cytosine arabinosine hydrochloride Rit...
null
1
arm 1: Starting dose oxaliplatin 17.5mg/m\^2/day intravenous (IV) for 4 days; Fludarabine 30 mg/m\^2 IV and Cytarabine 1 g/m\^2 IV for two days, + Rituximab 375 mg/m\^2 IV on Day 3, Cycle 1 then Day 1 following cycles.
[ 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 1 g/m\^2 given IV for two days (Days 2 and 3). intervention 2: 30 mg/m\^2 given IV for two days (Days 2 and 3). intervention 3: Starting dose of 17.5 mg/m\^2 IV for 4 days (Days 1 through 4). intervention 4: 375 mg/m\^2 IV on Day 3 of the first cycle over 4-6 hours and on Day 1 on every cycle following.
intervention 1: Cytarabine intervention 2: Fludarabine intervention 3: Oxaliplatin intervention 4: Rituximab
2
La Jolla | California | United States | -117.2742 | 32.84727 Boston | Massachusetts | United States | -71.05977 | 42.35843
48
0
0
0
NCT00452374
1COMPLETED
2011-01-01
2004-11-01
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 ]
256
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
The purpose of the study is to compare the efficacy, safety and tolerability of darunavir/ritonavir 800/100 mg once a day (O.D.) as a monotherapy versus a triple combination therapy containing 2 nucleosides and darunavir/ritonavir in 250 HIV-1 infected patients who have been on Highly Active Antiretroviral Therapy (HAA...
This study is randomised (patients are assigned different treatments based on chance), controlled, open-label trial to compare the efficacy, safety and tolerability of darunavir/ritonavir (DRV/r) 800/100 mg once a day (O.D.) as a monotherapy versus a triple combination therapy containing 2 nucleosides and DRV/r in 250 ...
HIV Infections AIDS Virus Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Virus
HIV Monotherapy Darunavir Protease inhibitor Early pre-treated Undetectable Treatment Experienced
null
2
arm 1: darunavir (DRV, TMC114) 800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks arm 2: darunavir (DRV, TMC114) 800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: 800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks intervention 2: 800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
intervention 1: darunavir (DRV, TMC114) intervention 2: darunavir (DRV, TMC114)
27
Vienna | N/A | Austria | 16.37208 | 48.20849 Antwerp | N/A | Belgium | 4.40026 | 51.22047 Brussels | N/A | Belgium | 4.34878 | 50.85045 Aarhus | N/A | Denmark | 10.21076 | 56.15674 Copenhagen | N/A | Denmark | 12.56553 | 55.67594 Hvidovre | N/A | Denmark | 12.47708 | 55.64297 Odense | N/A | Denmark | 10.38831 | 55.3959...
512
0
0
0
NCT00458302
1COMPLETED
2011-01-01
2007-06-01
Janssen-Cilag International NV
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 ]
71
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
true
0ALL
false
We plan to use a metabolomics lipid platform to map biochemical signatures in unmedicated schizophrenic patients prior to and 4 weeks post treatment with the antipsychotic drug aripiprazole and compare that to lipid perturbations induced by risperidone. These drugs have inherently different risk for metabolic adverse e...
Schizophrenia (SCH) is a devastating mental disease that affects the human population worldwide with an incidence of about 1%. Most individuals with this illness benefit from long-term pharmacotherapy, however, the therapeutic effects of antipsychotic treatment are inconsistent, incomplete, and often countered by signi...
Schizophrenia
Schizophrenia Metabolomics
null
3
arm 1: Blood is drawn for baseline. 20 Subjects are randomly assigned to receive Aripiprazole for weeks weeks with a starting dose of 10mg/day and the dose will be titrated to a maximum of 30mg /day based on effectiveness and tolerability. After 4 weeks of treatment, blood will be drawn again for metabolomics. arm 2: B...
[ 1, 1, 5 ]
3
[ 0, 0, 10 ]
intervention 1: Aripiprazole for 4 weeks intervention 2: Subjects will be randomized to risperidone for 4 weeks intervention 3: Healthy volunteers
intervention 1: Aripiprazole intervention 2: Risperidone intervention 3: Healthy volunteers
1
Butner | North Carolina | United States | -78.75667 | 36.13209
71
0
0
0
NCT00466310
1COMPLETED
2011-01-01
2007-02-01
Duke University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
583
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
This is a two-arm, randomized, double-blind, non-inferiority study using a flexible dosing regime to allow optimal zonisamide or carbamazepine therapy for individual subjects. Assessment of eligibility will take place at the Screening Visit. The subjects will be randomized to either the carbamazepine or zonisamide arm ...
null
Epilepsy
Epilepsy
null
2
arm 1: None arm 2: None
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: Week 1 and 2 either 100mg zonisamide or 200 mg carbamazepine Week 3 and 4 either 200mg zonisamide or 4800 mg carbamazepine Week 5 and 6 either 300mg zonisamide or 600 mg carbamazepine; this dose then to be maintained unless a subject has a seizure more than two weeks post a dose increase. intervention 2...
intervention 1: Zonisamide intervention 2: Carbamazepine
79
Camperdown | N/A | Australia | 151.17642 | -33.88965 Clayton | N/A | Australia | 145.11667 | -37.91667 Fitzroy | N/A | Australia | 144.97833 | -37.79839 Flinders | N/A | Australia | 150.85516 | -34.58333 Heidelberg West | N/A | Australia | 145.04034 | -37.73922 Parkville | N/A | Australia | 144.95 | -37.78333 Queenslan...
581
0
0
0
NCT00477295
1COMPLETED
2011-01-01
2007-05-01
Eisai Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
8
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The goal of this clinical research study is to find out if IL-11 (NeumegaTM) may increase the platelet count in patients with Chronic myeloid leukemia (CML) who develop low platelet counts while receiving therapy with imatinib mesylate (Gleevec, STI571), or other tyrosine kinase inhibitors such as AMN107, dasatinib, or...
IL-11 is a hormone normally produced in your body that plays a role in stimulating the production of platelets. Before you can start treatment on this study, you will have what are called "screening tests". These tests will help the doctor decide if you are eligible to take part in the study. You will have a blood sam...
Leukemia Chronic Myelogenous Leukemia Chronic Myeloid Leukemia
oprelvekin tyrosine kinase inhibitor Chronic Myelogenous Leukemia Leukemia CML Thrombocytopenia Imatinib IL-11 Interleukin 11 Neumega
null
1
arm 1: Starting dose 10 mcg/kg subcutaneously 3 times a week
[ 0 ]
1
[ 0 ]
intervention 1: 10 mcg/kg under the skin (usually of the arms, legs or abdomen) three times weekly. If the treatment is well tolerated but there is not enough of a platelet improvement, the dose and frequency of injections may be increased.
intervention 1: Interleukin-11 (IL-11 or Neumega)
1
Houston | Texas | United States | -95.36327 | 29.76328
8
0
0
0
NCT00493181
1COMPLETED
2011-01-01
2005-10-01
M.D. Anderson Cancer Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3, 4 ]
25
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of the study is to evaluate the efficacy and safety of the combination treatment of tacrolimus and corticosteroid in polymyositis/dermatomyositis patients with interstitial pneumonitis with comparison against corticosteroid-treated historical controls.
Interstitial pneumonia (IP) is a common complication of and has a significant impact on the prognosis of patients with polymyositis (PM) and dermatomyositis (DM). Reported prevalence of IP in PM/DM patients varies between 23 to 65% depending on criteria applied as well as on clinical settings of studied cohorts, and an...
Interstitial Pneumonitis Polymyositis Dermatomyositis
Interstitial pneumonitis Polymyositis Dermatomyositis Tacrolimus Corticosteroids
null
1
arm 1: Tacrolimus treatment is to be initiated at the starting dose of 0.075mg/kg/day, adjusted to maintain its whole blood trough levels between 5 and 10 ng/mL for 52 weeks. All patients are to receive glucocorticoids with the starting doses equivalent to between 0.6 and 1.0 mg/kg/day of prednisolone which are to be c...
[ 0 ]
1
[ 0 ]
intervention 1: Start at the standard starting dose of 0.075mg/kg/day divided into two doses, then adjust doses based on clinical response and tolerability, but maintain whole blood trough levels between 5 to 10 ng/mL and total daily doses equal to or below 0.3mg/kg.
intervention 1: Tacrolimus
11
Sapporo | Hokkaido | Japan | 141.35 | 43.06667 Tsukuba | Ibaraki | Japan | 140.11667 | 36.08333 Kawachi-Nagano | Osaka | Japan | 135.58283 | 34.44108 Bunkyo-ku | Tokyo | Japan | N/A | N/A Bunkyo-ku | Tokyo | Japan | N/A | N/A Bunkyo-ku | Tokyo | Japan | N/A | N/A Shinjuku-ku | Tokyo | Japan | N/A | N/A Shinjuku-ku | To...
25
0
0
0
NCT00504348
1COMPLETED
2011-01-01
2007-07-01
Tokyo Medical and Dental 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
[ 0 ]
24
NA
SINGLE_GROUP
0TREATMENT
0NONE
true
0ALL
null
Purpose: To determine the efficacy and safety of one commonly used VEGF inhibitor, bevacizumab (Avastin, Genentech), as a topical agent for the treatment of corneal neovascularization.
null
Corneal Neovascularization
null
0
null
null
1
[ 0 ]
intervention 1: Bevacizumab 10mg/mL 1 drop BID x 3 weeks
intervention 1: Bevacizumab (Avastin)
1
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
24
0
0
0
NCT00512876
1COMPLETED
2011-01-01
2007-08-01
Walter Reed Army Medical Center
1FED
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
37
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
Myfortic (enteric-coated mycophenolate sodium) has been shown to have similar effectiveness to CellCept (mycophenolate mofetil) in preventing rejection in kidney transplant recipients. However, enteric coated mycophenolate sodium has been thought to possibly be associated with fewer gastrointestinal side effects. Mycop...
African American patients often experience more gastrointestinal (GI) complications after kidney transplant than Caucasian patients. In addition, African American kidney transplant recipients also experience a higher incidence of acute rejection and have worse outcomes compared with all other ethnic groups. Reasons acc...
Transplants and Implants
African American Kidney Transplant
null
2
arm 1: Patients in this group will receive Myfortic (enteric-coated mycophenolate sodium) at a target dose of 720 mg orally twice daily for 6 months after transplant. arm 2: Patients in this group will receive CellCept (mycophenolate mofetil) or its generic equivalent manufactured by Sandoz, at a target dose of 1000 mg...
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: Patients in this group will receive Myfortic (enteric-coated mycophenolate sodium) in combination with Thymoglobulin (rabbit Anti-thymocyte globulin) induction immunosuppression, Prograf (tacrolimus) or its generic equivalent, and corticosteroid immunosuppression. intervention 2: Patients in this group ...
intervention 1: Enteric coated mycophenolate sodium intervention 2: Mycophenolate mofetil
1
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
37
0
0
0
NCT00522548
6TERMINATED
2011-01-01
2007-03-01
University of Pennsylvania
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 ]
1
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
RATIONALE: Tretinoin may help cancer cells become more like normal cells, and to grow and spread more slowly. Drugs used in chemotherapy, such as arsenic trioxide and idarubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving tretinoin to...
OBJECTIVES: Primary * To determine the rate of molecular remission after induction therapy comprising tretinoin (ATRA) and arsenic trioxide (ATO) (along with idarubicin in patients with leukocytosis) in patients with acute promyelocytic leukemia (APL). Secondary * To determine the rate of clinical complete remissio...
Leukemia
adult acute promyelocytic leukemia (M3) adult acute myeloid leukemia with t(15;17)(q22;q12) untreated adult acute myeloid leukemia
null
1
arm 1: See Outline for details
[ 0 ]
3
[ 0, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: None
intervention 1: arsenic trioxide intervention 2: idarubicin intervention 3: tretinoin
1
New York | New York | United States | -74.00597 | 40.71427
1
0
0
0
NCT00528450
6TERMINATED
2011-01-01
2007-09-01
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
[ 2, 3 ]
23
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
Because the activity of CC-4047 addresses numerous mechanisms of carcinoma growth inhibition - including, but not limited to anti-angiogenesis - CC-4047 has been selected for development as part of induction chemotherapy regimens for solid tumors. This study in pancreatic cancer is designed to determine the appropriate...
Phase I Primary: • To determine the maximum tolerated dose (MTD) and evaluate the safety profile of oral CC-4047 given on days 1-21 in combination with gemcitabine on days 1, 8, and 15 every 28 days in subjects with advanced pancreatic carcinoma. Secondary: • To explore the anti-tumor activity of the combination of...
Pancreatic Cancer
Pancreas Untreated Advanced Gemcitabine CC-4047
null
1
arm 1: All patients received gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of a 28 day cycle. Pomalidomide was administered orally on days 1-21 at doses escalated from 2 mg to 10 mg daily.
[ 0 ]
2
[ 0, 0 ]
intervention 1: Phase 1: Subjects will be enrolled in dose-escalating cohorts to be treated with CC-4047 on days 1-21 Phase II: Subjects will be enrolled to receive oral CC-4047 at the MTD days 1 - 21 intervention 2: 1000 mg/m2 IV on days 1, 8, and 15 of 28 day cycle
intervention 1: Pomalidomide intervention 2: Gemcitabine
2
Aurora | Colorado | United States | -104.83192 | 39.72943 Nashville | Tennessee | United States | -86.78444 | 36.16589
23
0
0
0
NCT00540579
1COMPLETED
2011-01-01
2007-11-01
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
[ 2 ]
32
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
Development of new treatments for diseases such as multiple myeloma is a focus for research. The research being conducted is on treatment called Anti-KIR (1-7F9), which activates the body's own cells to kill tumor cells. This is different from many other treatments where chemicals are given to kill tumor cells. The pur...
Trial Design: The trial is an open-label, dose-escalation trial to determine the safety and tolerability of Anti-KIR (1-7F9) in subjects with relapsed or refractory multiple myeloma (RRMM). A 3+3 design will be employed for the first dosing cycle at each dose level. The 7 planned dose levels are 0.0003 mg/kg, 0.003 mg...
Multiple Myeloma
multiple myeloma Anti-KIR (1-7F9)
null
0
null
null
1
[ 0 ]
intervention 1: human monoclonal antibody
intervention 1: Anti-KIR (1-7F9)
4
Indianapolis | Indiana | United States | -86.15804 | 39.76838 New York | New York | United States | -74.00597 | 40.71427 Columbus | Ohio | United States | -82.99879 | 39.96118 San Antonio | Texas | United States | -98.49363 | 29.42412
32
0
0
0
NCT00552396
1COMPLETED
2011-01-01
2007-05-01
Innate Pharma
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
21
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
The primary objective of this study is to evaluate the safety of long-term administration of GSK1325760A in patients with PAH. The secondary objectives of this study are to evaluate long-term administration of GSK1325760A on: * Improvement in exercise capacity (six-minutes walk distance: 6MWD), change in WHO Function...
null
Pulmonary Arterial Hypertension Hypertension, Pulmonary
Pulmonary Arterial Hypertension Ambrisentan
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: 2.5mg, 5mg or 10mg/day, po, GSK1325760A treatment will be continued until its approval by the MHLW.
intervention 1: GSK1325760A
11
Aichi | N/A | Japan | 130.62158 | 32.51879 Hokkaido | N/A | Japan | N/A | N/A Hokkaido | N/A | Japan | N/A | N/A Ishikawa | N/A | Japan | 127.82139 | 26.42333 Kanagawa | N/A | Japan | 139.91667 | 37.58333 Kyoto | N/A | Japan | 135.75385 | 35.02107 Okayama | N/A | Japan | 133.93333 | 34.65 Okinawa | N/A | Japan | 127.80...
21
0
0
0
NCT00554619
1COMPLETED
2011-01-01
2008-02-01
GlaxoSmithKline
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
70
NON_RANDOMIZED
SINGLE_GROUP
7BASIC_SCIENCE
0NONE
true
0ALL
false
The purpose of this study is to better understand the link between obesity and diabetes or pre-diabetes.
Obesity is the most common and powerful force for creating insulin resistance and metabolic syndrome, however, the molecular basis of this association is not well understood. In this proposal, three independently funded researchers-Philip Kern, MD a clinical investigator, and Charlotte Peterson, PhD and Robert McGehee,...
Metabolic Syndrome Insulin Resistance Prediabetes
obesity inflammation diabetes
null
2
arm 1: Baseline studies (OGTT, DXA, RMR, FSIGT, and biopsies) on normal control subjects. Oral glucose tolerance tests, body composition assessment, resting metabolic rate, insulin sensitivity measurement with the frequently sampled method and Minimal Model. These studies will establish baseline data in lean subjects o...
[ 4, 1 ]
1
[ 0 ]
intervention 1: Pioglitazone 30mg for 2 weeks, then Pioglitazone 45mg for 8 weeks.
intervention 1: Pioglitazone
2
Little Rock | Arkansas | United States | -92.28959 | 34.74648 Lexington | Kentucky | United States | -84.47772 | 37.98869
70
0
0
0
NCT00579813
1COMPLETED
2011-01-01
2005-04-01
Philip Kern
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 ]
1
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to determine a dose of the investigational drug betahistine dihydrochloride that is both well tolerated and potentially effective in treating the symptoms of atypical depression. Atypical depression is characterized by the ability of the person's mood to improve temporarily in response to p...
All patients will start taking 50 mg of betahistine dihydrochloride on treatment day 1 (after baseline visit). Starting on day 4, the daily dose will be increased by adding a 50 mg dose. If tolerated, the daily dose will be titrated to 200 mg. At the end of week 3, the dose will be titrated to 300 mg.
Recurrent Major Depressive Disorder With Atypical Features
Depression Betahistine Dihydrochloride
null
1
arm 1: Oral betahistine dihydrochloride; daily dose 50-300 mg
[ 0 ]
1
[ 0 ]
intervention 1: oral, 50-300 mg, daily
intervention 1: betahistine dihydrochloride
1
Cincinnati | Ohio | United States | -84.51439 | 39.12711
1
0
0
0
NCT00585585
6TERMINATED
2011-01-01
2007-07-01
University of Cincinnati
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 ]
13
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purpose of this research study was to evaluate how effective the combination of Carboplatin, Bevacizumab (Avastin™) and, Pemetrexed (Alimta™) is in the treatment of patients with Malignant Pleural Mesothelioma (MPM). A combination of cisplatin and pemetrexed is considered standard for this disease and typically off...
This was a planned Phase I/II dose escalation study. Patients were enrolled in a cohort of 3. Eligible patients with unresectable pleural mesothelioma received frontline treatment consisting of carboplatin AUC 5, bevacizumab 15 mg/kg, and pemetrexed 500 mg/m\^2 every 21 days (Tier-1). Dose escalation continued to achi...
Mesothelioma
Carboplatin Bevacizumab Avastin Pemetrexed Alimta
null
1
arm 1: A: Tiered Dose Escalation/Phase II Dose - * Tier -1: Carboplatin AUC 4 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m\^2. * Tier 1: Carboplatin AUC 5 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m\^2. * Tier 2: Carboplatin AUC 6 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m\^2. B: Maintenance Therapy - * Patient was mai...
[ 0 ]
1
[ 0 ]
intervention 1: Chemotherapy was given for 2 cycles after maximal response. Patients were taken off study at the time of progression. If the patient had stable disease or better, as a response, then the patient was maintained on pemetrexed plus bevacizumab for a total of one year after initiation of maintenance or unti...
intervention 1: Carboplatin, Bevacizumab and Pemetrexed
1
Tampa | Florida | United States | -82.45843 | 27.94752
13
0
0
0
NCT00604461
6TERMINATED
2011-01-01
2007-10-01
H. Lee Moffitt Cancer Center and Research Institute
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
23
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
Primary objective To estimate 6-month progression free survival probability of pts w recurrent GBM treated w bev + either daily temozolomide/etoposide following progression on bev + irinotecan Secondary Objectives To evaluate safety \& tolerability of bev + either daily temozolomide/etoposide among pts w recurrent GBM ...
This is exploratory, two-arm, phase II study designed to assess anti-tumor activity of bev + either daily temozolomide/etoposide among GBM pts w progressive disease following bev + irinotecan. About 48 participants w recurrent GBM will take part in this study. Approximately 24 participants will receive bev plus temozol...
Glioblastoma Gliosarcoma
Glioblastoma Gliosarcoma GBM Bevacizumab Avastin Etoposide Brain tumor Irinotecan Glioblastoma multiforme Temodar Temozolomide Etopophos Toposar VePesid VP-16 Camptosar
null
2
arm 1: Patients treated with bevacizumab + temozolomide arm 2: Patients treated with bevacizumab and VP-16 (etoposide)
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Patients have progressed/had gr3/\> toxicity related to etoposide, with no had progression/gr 3/\> toxicity related to temozolomide, will only be considered for bevacizumab and temozolomide. Bevacizumab intravenously at dose 10mg/kg every other wk. For patients on bevacizumab and temozolomide, temozolom...
intervention 1: Temo + Avastin intervention 2: VP-16 + Avastin
1
Durham | North Carolina | United States | -78.89862 | 35.99403
23
0
0
0
NCT00613028
1COMPLETED
2011-01-01
2008-04-01
Duke University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
16
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The goal of this study is to determine the progression-free survival rate in patients with extensive-stage small cell lung cancer who had achieved complete response, partial response, or stable disease with their previous platinum chemotherapy regimen, such as cisplatin or carboplatin in combination with etoposide or i...
Despite a high initial response rate, all patients with extensive-stage small cell lung cancer treated with standard chemotherapy will develop disease progression, usually within one year of initial treatment. Therefore, prolonging progression-free survival in this disease is meaningful for clinical trials exploring ag...
Extensive-Stage Small Cell Lung Cancer
null
1
arm 1: Main interventional arm of study. Subjects who received maintenance sunitinib experimentally on this study were from a population of (consenting) patients with histologically or cytologically documented Extensive-State Small Cell Lung Cancer (ES-SCLC) who did not progress (were classified as Complete Response or...
[ 0 ]
1
[ 0 ]
intervention 1: Sunitinib will be given at 50 mg/day as a single agent for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
intervention 1: sunitinib
1
Ann Arbor | Michigan | United States | -83.74088 | 42.27756
16
0
0
0
NCT00616109
1COMPLETED
2011-01-01
2007-09-01
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 ]
46
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
true
1FEMALE
true
The goal of the study is to identify and treat women with midlife weight gain who have normal blood sugars, but increased insulin levels (hyperinsulinemia) following the performance of a glucose tolerance test. The study will evaluate effects of a unique carbohydrate modified diet alone and in combination with metformi...
Progressive weight gain that starts in the fourth and fifth decades is commonly reported by women from all ethnic and socio-economic groups. Our previous data suggest that, in large and diverse subpopulations of healthy-appearing women this midlife weight gain may represent the earliest clinical manifestation of insuli...
Hyperinsulinemia Insulin Resistance Obesity
hyperinsulinemia insulin resistance perimenopause obesity overweight women
null
3
arm 1: EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day. arm 2: Metfor...
[ 2, 1, 1 ]
1
[ 0 ]
intervention 1: 4 week dosage escalation of metformin, 500 mg/day (or placebo) to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day(or placebo) added at weeks 3 and weeks 4 to a a total dose of 4 mg/day
intervention 1: metformin and rosiglitazone
1
The Bronx | New York | United States | -73.86641 | 40.84985
46
0
0
0
NCT00618072
1COMPLETED
2011-01-01
2008-01-01
New York Medical College
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 ]
83
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
Sorafenib is a new drug, which is approved under the brand name Nexavar for the treatment of advanced kidney cancer. It is also currently being tested in various other cancers. Sorafenib works by stopping the development of new cancer cells and new blood vessels. By stopping the growth of new blood vessels around a tum...
Issues on Outcome Measure "Safety and tolerability" will be addressed in the Adverse Events section.
Carcinoma, Renal Cell
Kidney cancer, Sorafenib, Dose escalation, No previous treatment
null
1
arm 1: Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle, 600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.
[ 0 ]
1
[ 0 ]
intervention 1: The initial dose of sorafenib will be 400 mg bid administered orally, on a continuous basis. A treatment cycle is considered to be 28 days. Intrapatient dose escalation will occur according to the following schedule, providing no grade 3 or 4 toxicities are observed (except for alopecia, nausea and vomi...
intervention 1: Sorafenib (Nexavar, BAY43-9006)
22
Bordeaux | N/A | France | -0.5805 | 44.84044 La Roche-sur-Yon | N/A | France | -1.42757 | 46.66974 Marseille | N/A | France | 5.38107 | 43.29695 Nantes | N/A | France | -1.55336 | 47.21725 Paris | N/A | France | 2.3488 | 48.85341 Tours | N/A | France | 0.70398 | 47.39484 Tübingen | Baden-Wurttemberg | Germany | 9.05222...
83
0
0
0
NCT00618982
1COMPLETED
2011-01-01
2008-02-01
Bayer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
902
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
This is a randomized, double blind, placebo controlled, parallel group study of MAP0004 in adult migraineurs. Subjects will self administer study drug in the outpatient setting.
null
Migraine Disorders
Migraine
null
2
arm 1: MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks. arm 2: Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to ...
[ 0, 5 ]
2
[ 0, 0 ]
intervention 1: MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks. Placebo treated patients will receive MAP0004 1.0mg inhaled to treat qualifying migraines for up to 52 weeks only. intervention 2: Placebo ...
intervention 1: MAP0004 intervention 2: Placebo
1
Seattle | Washington | United States | -122.33207 | 47.60621
1,452
0
0
0
NCT00623636
1COMPLETED
2011-01-01
2008-07-01
Allergan
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
34
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
This study was intended to evaluate the efficacy, safety and tolerability of atacicept compared to placebo and to explore the neuroprotective effect of atacicept as assessed by OCT in subjects with ON as CIS. The study was randomized. Study medication was administered via subcutaneous (under the skin) injections.
null
Optic Neuritis
atacicept neuritis
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Atacicept will be administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks. intervention 2: Placebo matched to atacicept will be administered subcutaneously twice a week for initial 4 weeks, follo...
intervention 1: Atacicept intervention 2: Placebo matched to atacicept
28
Birmingham | Alabama | United States | -86.80249 | 33.52066 Aurora | Colorado | United States | -104.83192 | 39.72943 Fairfield | Connecticut | United States | -73.26373 | 41.14121 Jacksonville | Florida | United States | -81.65565 | 30.33218 East Lansing | Michigan | United States | -84.48387 | 42.73698 Philadelphia |...
61
0
0
0
NCT00624468
6TERMINATED
2011-01-01
2008-06-01
EMD Serono
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
33
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
true
The purpose of this study is to test a treatment that tries to reduce the amount of fluid in the lungs of subjects with acute lung injury to see if this is helpful.
The objective of this study is to conduct a randomized, controlled trial of a goal directed therapy designed to improve outcome in patients with acute lung injury (ALI). The investigators are comparing two algorithmic approaches in managing patients with ALI - one, the control arm, attempts to reduce the amount of flui...
Acute Lung Injury
Acute Lung Injury Extravascular Lung Water Acute Respiratory Distress Syndrome
null
2
arm 1: The investigators control arm consists of a simplified algorithm for conservative management of fluids in patients with ALI, as to be published by the ARDSnet group, based on the protocol used in the FACTT trial. The protocol calls for strict adherence to ARDSnet ventilation, our weaning protocol and use of only...
[ 1, 0 ]
10
[ 0, 10, 10, 0, 0, 0, 0, 10, 0, 3 ]
intervention 1: Goal: Overall I/O net negative 50ml/hour Initiation: 1. Continuous IV furosemide at 3mg/hour or last known protocol specified dose 2. Titrate up or down by 3mg/hour increments every hour as needed to establish diuresis goal 3. Do not exceed 30mg/hour Furosemide Bolus: 1. If unable to establish adequ...
intervention 1: Diuresis (furosemide) part I intervention 2: Fluid Bolus (crystalloid or albumin) intervention 3: Fluid Bolus (crystalloid or albumin) intervention 4: Vasopressors (Norepinephrine, Vasopressin, Phenylephrine, Epinephrine) intervention 5: Vasopressors (Norepinephrine, Vasopressin, Phenylephrine, Epinephr...
3
Clackamas | Oregon | United States | -122.57037 | 45.40762 Portland | Oregon | United States | -122.67621 | 45.52345 Portland | Oregon | United States | -122.67621 | 45.52345
33
0
0
0
NCT00624650
1COMPLETED
2011-01-01
2008-02-01
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