FEATURE_phases
list
FEATURE_enrollmentCount
int64
FEATURE_allocation
string
FEATURE_interventionModel
string
FEATURE_primaryPurpose
class label
FEATURE_masking
class label
FEATURE_healthyVolunteers
bool
FEATURE_sex
class label
FEATURE_oversightHasDmc
bool
FEATURE_briefSummary
string
FEATURE_detailedDescription
string
FEATURE_conditions
string
FEATURE_conditionsKeywords
string
FEATURE_protocolPdfText
string
FEATURE_numArms
int64
FEATURE_armDescriptions
string
FEATURE_armGroupTypes
list
FEATURE_numInterventions
int64
FEATURE_interventionTypes
list
FEATURE_interventionDescriptions
string
FEATURE_interventionNames
string
FEATURE_numLocations
int64
FEATURE_locationDetails
string
LABEL_ct_level_ade_population
int64
LABEL_sum_dosing_errors
int64
LABEL_dosing_error_rate
float32
LABEL_wilson_label
int64
METADATA_nctId
string
METADATA_overallStatus
class label
METADATA_completionDate
date32
METADATA_startDate
date32
METADATA_leadSponsorName
string
METADATA_leadSponsorClass
class label
METADATA_hasProtocol
bool
METADATA_hasSap
bool
METADATA_hasIcf
bool
METADATA_protocolPdfLinks
string
METADATA_count_Accidental drug intake by child
int64
METADATA_count_Accidental overdose
int64
METADATA_count_Accidental overdose (therapeutic agent)
int64
METADATA_count_Accidental underdose
int64
METADATA_count_Deliberate overdose
int64
METADATA_count_Dose calculation error
int64
METADATA_count_Drug administration error
int64
METADATA_count_Drug overdose
int64
METADATA_count_Drug overdose accidental
int64
METADATA_count_Extra dose administered
int64
METADATA_count_Incorrect dosage administered
int64
METADATA_count_Incorrect dose administered
int64
METADATA_count_Incorrect drug administration duration
int64
METADATA_count_Incorrect drug administration rate
int64
METADATA_count_Incorrect product administration duration
int64
METADATA_count_Intentional overdose
int64
METADATA_count_Medication error
int64
METADATA_count_Medication monitoring error
int64
METADATA_count_Multiple drug overdose
int64
METADATA_count_Multiple drug overdose accidental
int64
METADATA_count_Multiple drug overdose intentional
int64
METADATA_count_Multiple use of single-use product
int64
METADATA_count_Non-accidental overdose
int64
METADATA_count_Overdose
int64
METADATA_count_Overdose NOS
int64
METADATA_count_Overmedication
int64
METADATA_count_Prescribed overdose
int64
METADATA_count_Treatment noncompliance
int64
METADATA_count_Underdose
int64
METADATA_count_Unintentional medical device removal
int64
METADATA_count_Unintentional medical device removal by patient
int64
METADATA_wilson_lower_bound
float32
[ 5 ]
8
RANDOMIZED
CROSSOVER
7BASIC_SCIENCE
0NONE
false
0ALL
true
Solid organ transplant recipients would greatly benefit from pharmacogenetic evaluation since immunosuppressive drug regimens consist of multiple medications with narrow therapeutic ranges and toxic adverse event profiles. Tacrolimus is a potent immunosuppressive agent utilized for rejection prophylaxis. Intensive phar...
Two mL of blood will be obtained for pharmacogenomic screening for CYP3A5 and ABCB1 genotypes. Patients with the CYP3A5\*3/\*3 genotype will be consented for the pharmacokinetic portion of the study. Volunteers from this patient cohort will participate in 2 overnight visits to the General Clinical Research Center (GCRC...
Kidney Transplantation
kidney transplantation tacrolimus P-glycoprotein ABCB1 genotyping
null
2
arm 1: Participants first received tacrolimus in combination with with ketoconazole. After a 1-2 week washout they received tacrolimus alone. arm 2: The participants first received tacrolimus alone. After a 1-2 week washout period they received tacrolimus in combination with ketoconazole.
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Pharmacokinetic profiling of tacrolimus (AUC0-24h) in subjects receiving tacrolimus + ketoconazole 200 mg every 12 hours x 3 doses. intervention 2: Pharmacokinetic profiling of subjects on a stable dose of tacrolimus (AUC 0-24h)
intervention 1: Tacrolimus + Ketoconazole, Then Tacrolimus alone intervention 2: Tacrolimus alone, Then Tacrolimus + Ketoconazole
1
Iowa City | Iowa | United States | -91.53017 | 41.66113
16
0
0
0
NCT01288521
1COMPLETED
2011-09-01
2008-10-01
Sony Tuteja
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 ]
14
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
Fragile X syndrome (FXS) is the most common inherited form of developmental disability. FXS is inherited from the carrier parent, most often the mothers. FXS is associated with severe interfering behavioral symptoms which include anxiety related symptoms, attention deficit hyperactivity, and aggressive behaviors. Appro...
null
Fragile X Syndrome Autism Spectrum Disorders
Fragile X Syndrome Acamprosate
null
2
arm 1: The maximum dose of acamprosate to be used in this study is 1998 mg per day for those subjects weighing greater than 60kg and 1332 mg per day for those less weighing less than 60kg. arm 2: This baseline comparison group will participated in only the psychophysiological and biomarker portion of subject characteri...
[ 1, 4 ]
1
[ 0 ]
intervention 1: None
intervention 1: Acamprosate
1
Indianapolis | Indiana | United States | -86.15804 | 39.76838
12
0
0
0
NCT01300923
1COMPLETED
2011-09-01
2010-08-01
Indiana 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 ]
23
RANDOMIZED
CROSSOVER
0TREATMENT
4QUADRUPLE
false
0ALL
false
The overarching objective of this pilot study is to apply both neuroimaging and pharmacogenetic tools to the study of alcohol dependence. This proposed research will provide a mechanistic test of the function of the genetic variation. The specific aims and hypotheses are to test whether Sulfasalazine, as compared to pl...
The overarching objective of this pilot study is to apply both neuroimaging and pharmacogenetic tools to the study of alcohol dependence. This proposed research will provide a mechanistic test of the function of the genetic variation. The specific aims and hypotheses are to test whether Sulfasalazine, as compared to pl...
Alcohol Dependence
Alcohol Sulfasalazine
null
2
arm 1: Sulfasalazine 1500 mg arm 2: Placebo capsule x 3 doses 12 hours apart
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 500mg capsules of Sulfasalazine x 3 doses 12 hours apart. intervention 2: Placebo capsule x 3 doses 12 hours apart
intervention 1: Sulfasalazine intervention 2: Placebo
1
Albuquerque | New Mexico | United States | -106.65114 | 35.08449
13
0
0
0
NCT01312129
1COMPLETED
2011-09-01
2010-03-01
The Mind Research Network
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
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
false
Background: \- The best treatment for ovarian and related female reproductive tract cancers is not yet known for patients whose disease has not responded to or has recurred after standard treatment. The cancer treatment drug pegaspargase (ONCASPAR (Trademark)), which works differently from standard chemotherapy, has b...
Background: * The bacterial enzyme L-asparaginase (L-ASP) catalyzes hydrolysis of asparagine to aspartate and is used to treat acute lymphoblastic leukemia (ALL).Studies demonstrated in vitro cytotoxic activity against solid tumor types including ovarian cancer. * Our laboratory demonstrated L-ASP inhibits vascular re...
Ovarian Neoplasms Fallopian Tube Neoplasms Primary Peritoneal Neoplasms
Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer Relapsed or Refractory Pegaspargase Pegylated L-Asparaginase
null
1
arm 1: Pegaspargase 2000 IU/m\^2 intramuscular or intravenously every 2 weeks
[ 0 ]
1
[ 0 ]
intervention 1: Pegaspargase 2000 IU/m\^2 intramuscular or intravenously every 2 weeks
intervention 1: Pegylated L-Asparaginase
1
Bethesda | Maryland | United States | -77.10026 | 38.98067
4
0
0
0
NCT01313078
1COMPLETED
2011-09-01
2010-01-01
National Cancer Institute (NCI)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
42
NON_RANDOMIZED
PARALLEL
7BASIC_SCIENCE
0NONE
true
0ALL
false
The steady-state pharmacokinetics of Dalfampridine-ER (extended release) 7.5 mg (milligram) tablets in healthy adult volunteers and those with mild and moderate renal impairment, and examine between group comparisons.
Pharmacokinetics in normal, mildly renally impaired, and moderately renally impaired subjects
Renal Insufficiency
null
3
arm 1: Dalfampridine-ER 7.5 mg single and steady-state dosing in healthy volunteers arm 2: Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with mild renal impairment arm 3: Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with moderate renal impairment
[ 1, 1, 1 ]
1
[ 0 ]
intervention 1: 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up
intervention 1: Dalfampridine-ER
2
Anaheim | California | United States | -117.9145 | 33.83529 South Miami | Florida | United States | -80.29338 | 25.7076
42
0
0
0
NCT01316055
1COMPLETED
2011-09-01
2011-01-01
Acorda Therapeutics
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
1,342
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
The purpose of this study was to assess the safety and efficacy of Nepafenac Ophthalmic Suspension, 0.3% for the prevention and treatment of inflammation (swelling and redness) and pain in the eye after cataract extraction.
null
Cataract
cataract inflammation pain inflammatory cells aqueous flare
null
3
arm 1: Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery. arm 2: Nepafenac Ophthalmic Suspension, 0....
[ 0, 1, 2 ]
3
[ 0, 0, 10 ]
intervention 1: Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days. An additional drop was administered between 30-120 minutes prior to surgery. intervention 2: Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye once daily, for 16 days. An additional drop was administer...
intervention 1: Nepafenac Ophthalmic Suspension, 0.3% intervention 2: Nepafenac Ophthalmic Suspension, 0.1% intervention 3: Nepafenac Vehicle 0.3%
1
Fort Worth | Texas | United States | -97.32085 | 32.72541
1,282
0
0
0
NCT01318499
1COMPLETED
2011-09-01
2011-03-01
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
0
0
0
0
0
0
0
0
0
[ 3 ]
39
RANDOMIZED
CROSSOVER
9OTHER
2DOUBLE
false
0ALL
false
To investigate the safety, efficacy and pharmacokinetics of single daily oral dose of LY2828360 in male and female subjects with osteoarthritic knee pain
null
Osteoarthritis, Knee
Osteoarthritis, knee pain, osteoarthritic knee pain
null
2
arm 1: 80 milligrams (mg) of LY2828360 daily by mouth for 4 weeks: placebo daily by mouth for 4 weeks. There is a washout period of 3 weeks between treatments. arm 2: Placebo daily by mouth for 4 weeks: LY2828360 daily by mouth for 4 weeks. There is a washout period of 3 weeks between treatments.
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Administered orally intervention 2: Administered orally
intervention 1: LY2828360 intervention 2: Placebo
1
Aalborg | N/A | Denmark | 9.9187 | 57.048
73
0
0
0
NCT01319929
1COMPLETED
2011-09-01
2011-03-01
Eli Lilly and Company
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
122
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The present study will test if administration of different concentrations of 1334H eyedrops will be effective in treatment of allergic conjunctivitis in people with 10 yrs of age or older.
null
Allergic Conjunctivitis
null
4
arm 1: 1334H 0.15% eye drops will be administered in both eyes at 3 occasions arm 2: 1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions arm 3: 1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions arm 4: Placebo eye drops (solution)will be administered in both ey...
[ 0, 0, 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: SPARC1102 I will be administered in both eyes intervention 2: SPARC1102 II will be administered in both eyes intervention 3: SPARC1102 III will be administered in both eyes intervention 4: Vehicle will be administered in both eyes
intervention 1: SPARC1102 I intervention 2: SPARC1102 II intervention 3: SPARC1102 III intervention 4: Vehicle
1
Andover | Massachusetts | United States | -71.137 | 42.65843
122
0
0
0
NCT01320553
1COMPLETED
2011-09-01
2011-06-01
Sun Pharma Advanced Research Company 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 ]
32
RANDOMIZED
PARALLEL
7BASIC_SCIENCE
1SINGLE
true
0ALL
false
The purposes of this study are to evaluate the following in healthy participants: 1) LY2928057 safety, including any side effects possibly associated with LY2928057; 2) how the body processes LY2928057; 3) effect of LY2928057 on blood iron levels; and 4) immune system reactions to LY2928057.
null
Healthy Volunteers
Anemia
null
5
arm 1: Single intravenous placebo dose. arm 2: Day 1: single 30-milligram (mg) LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 30-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 30-mg LY2928057 intravenous dose; Days 8-85: participant follow-...
[ 2, 0, 0, 0, 0 ]
2
[ 0, 0 ]
intervention 1: Single intravenous placebo dose. intervention 2: Single intravenous dose.
intervention 1: Placebo intervention 2: LY2928057
1
Singapore | N/A | Singapore | 103.85007 | 1.28967
32
0
0
0
NCT01330953
1COMPLETED
2011-09-01
2011-03-01
Eli Lilly and Company
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
176
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
1FEMALE
false
The primary objective is to assess the dose response versus placebo of a single treatment of Dysport RU (Dysport RU, Ready to Use, for injection), for the improvement in appearance of moderate to severe glabellar lines at maximum frown.
null
Glabellar Frown Lines
null
5
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
[ 0, 0, 0, 1, 2 ]
3
[ 2, 2, 0 ]
intervention 1: I.M. (in the muscle) injection on day 1 (single treatment cycle) intervention 2: I.M. on day 1 (single treatment cycle) intervention 3: I.M. on day 1 (single treatment cycle)
intervention 1: Botulinum toxin type A intervention 2: Botulinum toxin type A intervention 3: Placebo
8
Bordeaux | N/A | France | -0.5805 | 44.84044 Cannes | N/A | France | 7.01275 | 43.55135 Juan-les-Pins | N/A | France | 7.11309 | 43.56945 Paris | N/A | France | 2.3488 | 48.85341 Berlin | N/A | Germany | 13.41053 | 52.52437 Dresden | N/A | Germany | 13.73832 | 51.05089 Munich | N/A | Germany | 11.57549 | 48.13743 Starn...
176
0
0
0
NCT01333397
1COMPLETED
2011-09-01
2011-03-01
Ipsen
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
18
NON_RANDOMIZED
PARALLEL
null
0NONE
true
0ALL
false
The purpose of this study is to assess the pharmacokinetics of a single oral dose of 5 mg Apixaban in subjects with normal renal function and subjects with end stage renal disease (ESRD) maintained with hemodialysis.
Primary Purpose : To provide a clear understanding of the pharmacokinetics of Apixaban in subjects with ESRD and to determine the effect of hemodialysis on Apixaban pharmacokinetics .
End Stage Renal Disease
PHARMACOKINETIC NOS
null
2
arm 1: None arm 2: None
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Tablets, Oral, 5 mg, Once, 4 days intervention 2: Tablets, Oral, 5 mg, Twice, 15 days
intervention 1: Apixaban intervention 2: Apixaban
1
Orlando | Florida | United States | -81.37924 | 28.53834
24
0
0
0
NCT01340586
1COMPLETED
2011-09-01
2011-06-01
Bristol-Myers Squibb
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
50
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
false
0ALL
false
On 13 August 2008, this trial was submitted to ClinicalTrials.gov as modification to NCT00362297. On 28 April 2011, the two records were split for administrative purposes and each trial was given its own unique study record. Please refer to the "History of Changes" on posting NCT00362297 for a detailed summary of the m...
Screening Assessment Patients will be assessed for their eligibility to enter the study at a screening visit. After signing informed consent they will undergo a medical history and the following information will be recorded in the Case Report Form (CRF): * Demographic Data: Date of birth, sex, marital status, educati...
Genital Herpes
null
2
arm 1: None arm 2: None
[ 1, 0 ]
2
[ 0, 0 ]
intervention 1: 1000 mg orally three times daily for 5 weeks intervention 2: 500 mg orally once daily for 5 weeks
intervention 1: valacyclovir intervention 2: Valacyclovir
1
Seattle | Washington | United States | -122.33207 | 47.60621
88
0
0
0
NCT01346475
1COMPLETED
2011-09-01
2008-11-01
University of Washington
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 ]
26
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
Irritable bowel syndrome is a complex condition with a high unmet medical need for effective and safe treatment options. Lacteol® is a lactobacillus product used for adjunctive and symptomatic treatment of diarrhea. In this study, Lacteol® 340 mg will be evaluated as a potential therapy for the treatment of diarrhea-pr...
This study will include the following phases: Screening Phase, Run-In Phase, Double-Blind Treatment Phase and Open-Label Treatment Phase. Screening: Eligibility of subjects will be evaluated following informed consent signature. Screening procedures/evaluations (physical exam, concomitant medications, clinical laborat...
Diarrhea-predominant Irritable Bowel Syndrome
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: LACTEOL® 340 mg will be taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening. intervention 2: Matched LACTEOL® 340 mg Placebo will be taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one ca...
intervention 1: LACTEOL® 340 mg intervention 2: PLACEBO
8
Bordeaux | N/A | France | -0.5805 | 44.84044 Colombes | N/A | France | 2.25404 | 48.91882 Marseille | N/A | France | 5.38107 | 43.29695 Nice | N/A | France | 7.26608 | 43.70313 Rouen | N/A | France | 1.09932 | 49.44313 Berlin | N/A | Germany | 13.41053 | 52.52437 Hamburg | N/A | Germany | 9.99302 | 53.55073 Mannheim | ...
43
0
0
0
NCT01358708
6TERMINATED
2011-09-01
2010-06-01
Forest Laboratories
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
12
RANDOMIZED
CROSSOVER
7BASIC_SCIENCE
0NONE
true
2MALE
true
To evaluate the pharmacokinetics of single oral dose of Amitriptyline hydrochloride film-coated tablet 10mg \& 25mg
Randomized, Single dose, 2-way crossover, Open Study to compare the pharmacokinetics profile of Etravil®(Amitriptyline Hydrochloride) Tablet 10mg and Etravil®(Amitriptyline Hydrochloride) Tablet 25mg after a single oral administration in healthy male volunteers
Depression Depressive State Enuresis
depression
null
2
arm 1: 1. 1st administration - DWETR10 2. 2nd administration - DWETR25 arm 2: 1. 1st administration - DWETR25 2. 2nd administration - DWETR10
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Amitriptyline hydrochloride 10mg(DWETR10) single dose intervention 2: Amitriptyline hydrochloride 25mg(DWETR25) single dose
intervention 1: DWETR10 intervention 2: DWETR25
1
Jeonju | Jeollabuk-do | South Korea | 127.14889 | 35.82194
24
0
0
0
NCT01367080
1COMPLETED
2011-09-01
2011-07-01
Dong Wha Pharmaceutical Co. Ltd.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
21
NA
SINGLE_GROUP
null
0NONE
true
1FEMALE
true
This study is being done to evaluate the use of a new technology (urine proteomics) - the study of proteins in the urine to identify urine markers of overactive bladder (OAB) from a simple voided urine specimen.
The objectives of the study are: 1. to improve the diagnosis of overactive bladder using a non-invasive technology (urine proteomics) and 2. to study how potential urine biomarkers changes with overactive bladder symptoms after patients have been treated with fesoterodine, an FDA approved drug for the treatment of ove...
Overactive Bladder
Urine proteomics overactive bladder
null
1
arm 1: Females with overactive bladder symptoms will be given Fesoterodine 4 mg. daily for six weeks.
[ 5 ]
1
[ 0 ]
intervention 1: Fesoterodine 4 mg. tablet by mouth daily for six weeks
intervention 1: fesoterodine
1
St Louis | Missouri | United States | -90.19789 | 38.62727
21
0
0
0
NCT01367886
1COMPLETED
2011-09-01
2010-08-01
Washington University School of Medicine
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
29
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
true
0ALL
null
Obtain interaction data between BI 201335 and Efavirenz to guide dosing for each drug when administered together. To predict drug interaction between BI 201335 and Cyp 3A4 y using Midazolam as cyp 3A4 probe , Efavirenz as enzyme inducer and BI 201335 as enzyme inhibitor.
null
Healthy
null
2
arm 1: low dose Efavirenz arm 2: normal dose Efavirenz
[ 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: efavirenz single dosing once daily intervention 2: efavirenz once daily intervention 3: Efavirenz single dosing once daily
intervention 1: low dose intervention 2: normal dose intervention 3: low dose
1
Basel | N/A | Switzerland | 7.57327 | 47.55839
101
0
0
0
NCT01371006
1COMPLETED
2011-09-01
2011-06-01
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 ]
29
RANDOMIZED
SINGLE_GROUP
0TREATMENT
2DOUBLE
true
0ALL
false
This is a single-centre, placebo-controlled, two-part study in healthy participants. Part A will be a single dose, single period, placebo-controlled pilot study to explore the safety, tolerability, absorption and pharmacodynamic \[effect of drug on a biological marker-phospho-S6 (pS6) levels in skin biopsies\] of a si...
null
Healthy Participants
null
6
arm 1: A single 25 mg dose of LY2584702 RF arm 2: Placebo taken orally arm 3: A single 10 mg dose of LY2584702 TF during the first intervention period, followed by placebo in the second intervention period, followed by a single dose of 50 mg TF in the third intervention period, followed by either an open-label single d...
[ 0, 2, 0, 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Administered orally intervention 2: Administered orally intervention 3: Administered orally
intervention 1: LY2584702 Reference Formulation intervention 2: LY2584702 Test Formulation intervention 3: Placebo
1
Singapore | N/A | Singapore | 103.85007 | 1.28967
75
0
0
0
NCT01372085
1COMPLETED
2011-09-01
2011-06-01
Eli Lilly and Company
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
300
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
true
0ALL
false
The objective is to evaluate pain relief of the extended release naproxen sodium 660 mg tablet compared to commercial naproxen sodium 220 mg tablet over 24 hours in patients with postsurgical dental pain.
null
Pain, Postoperative
Naproxen Sodium, dental pain
null
3
arm 1: 1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min) arm 2: 1 naproxen ...
[ 0, 1, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 660 mg Naproxen Sodium extended release tablet, orally administered once daily for 24 hours intervention 2: 220 mg Naproxen Sodium instant release tablet, orally administered 3 times daily (TID) for 24 hours intervention 3: Matching placebo of 660 mg Naproxen Sodium ER for 24 hours intervention 4: Match...
intervention 1: Naproxen Sodium ER (BAYH6689) intervention 2: Naproxen Sodium IR (Aleve, BAYH6689) intervention 3: Naproxen Sodium ER Placebo intervention 4: Naproxen Sodium IR Placebo
1
Austin | Texas | United States | -97.74306 | 30.26715
300
0
0
0
NCT01389284
1COMPLETED
2011-09-01
2011-06-01
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
[ 2 ]
48
RANDOMIZED
PARALLEL
null
4QUADRUPLE
true
0ALL
false
The purpose of this study is to assess the Pharmacokinetics and Pharmacodynamics of alogliptin after a single or multiple administrations, once daily (QD), of oral alogliptin in healthy Korean subjects.
Alogliptin is a selective, orally available inhibitor of dipeptidyl peptidase-4 being developed by Takeda Global Research \& Development Center, Inc. as a treatment for type 2 diabetes mellitus. Inhibition of dipeptidyl peptidase-4 (DPP-4) prolongs the action of 2 important incretin hormones, glucagon-like peptide-1 (G...
Pharmacokinetics and Pharmacodynamics
Drug Therapy
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days. intervention 2: Alogliptin 25 mg, tablets, orally, once daily for up to 7 days. intervention 3: Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
intervention 1: Alogliptin intervention 2: Alogliptin intervention 3: Alogliptin
1
Seoul | N/A | South Korea | 126.9784 | 37.566
48
0
0
0
NCT01391663
1COMPLETED
2011-09-01
2011-07-01
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
[ 2 ]
141
RANDOMIZED
CROSSOVER
null
0NONE
true
0ALL
false
The purpose of the study is to compare the blood levels of dasatinib in healthy participants who received tablet formulation with those of healthy participants who received liquid and tablet-dispersed formulations of the drug.
null
Pharmacokinetic Study in Healthy Participants
null
3
arm 1: Treatment A. Participants were randomized to and received treatment in 1 of 6 sequences (ABC, ACB, BCA, BAC, CAB, or CBA), administered over 3 1-day treatment periods (Days 1, 5, and 9), with treatment changing to next in the sequence at start of each new period. A 3-day washout period followed treatment periods...
[ 5, 5, 5 ]
3
[ 0, 0, 0 ]
intervention 1: 2 50-mg tablets plus 240 mL noncarbonated, nonrefrigerated water. Oral, single dose, 1 day intervention 2: 100 mg administered as 10 mL of liquid drug (10 mg/mL) plus 230 mL noncarbonated, nonrefrigerated water. Oral, single dose, 1 day intervention 3: 2 50-mg dispersed tablets in 30 mL of 100% orange j...
intervention 1: Dasatinib as tablets intervention 2: Dasatinib as liquid intervention 3: Dasatinib as dispersed tablets
1
San Antonio | Texas | United States | -98.49363 | 29.42412
232
0
0
0
NCT01392703
1COMPLETED
2011-09-01
2011-07-01
Bristol-Myers Squibb
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
15
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
true
0ALL
false
The purpose of this trial is to assess the effect of 3 formulations on the relative bioavailability of LY3009104. Participants will receive single dose of LY3009104 on 4 separate occasions with and without food. Safety evaluation and serial pharmacokinetic (PK) samples will be collected during each treatment period. Ap...
null
Chronic Inflammatory Disorder Arthritis, Rheumatoid
null
4
arm 1: 8 milligrams (mg) LY3009104 (two 4-mg phosphate salt capsules), administered orally in the fasted state, once only. There will be a washout period of 5 to 7 days between doses of study drug. arm 2: 8 mg LY3009104 (one 8-mg smaller particle free base tablet), administered orally in the fasted state, once only. Th...
[ 0, 0, 0, 0 ]
1
[ 0 ]
intervention 1: Administered orally
intervention 1: LY3009104
1
Singapore | N/A | Singapore | 103.85007 | 1.28967
60
0
0
0
NCT01398475
1COMPLETED
2011-09-01
2011-07-01
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
2MALE
false
This study compares LY2452473 taken orally as a 5 milligram (mg) capsule at the same time as a 5 mg tadalafil tablet with three different combination tablets (LY900010) of 5 mg LY2452473 and 5 mg tadalafil taken orally. The study will evaluate the amount of LY2452473 and tadalafil circulating in the blood for each trea...
null
Erectile Dysfunction
testosterone energy libido erectile function weak muscles
null
4
arm 1: 5-mg LY2452473 oral capsule and 5-mg tadalafil oral tablet, administered orally, once only. There will be a washout period of at least 7 days between doses of study drug. arm 2: Single combination tablet containing 5 mg tadalafil and 5 mg LY2452473 with a smaller particle size (d90 = 10 microns), administered or...
[ 1, 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Administered orally intervention 2: Administered orally intervention 3: Administered orally
intervention 1: LY2452473 intervention 2: Tadalafil intervention 3: LY900010
1
Madison | Wisconsin | United States | -89.40123 | 43.07305
96
0
0
0
NCT01401543
1COMPLETED
2011-09-01
2011-07-01
Eli Lilly and Company
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
87
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
true
0ALL
true
The purpose of this study is to determine the effectiveness of the anti-depressant Lexapro in the treatment of the Night Eating Syndrome.
This proposal explores the implications of our two recent major discoveries: the striking efficacy of the Selective Serotonin Reuptake Inhibitor (SSRI) sertraline in the control of the Night Eating Syndrome (NES) and the unprecedented elevation in the level of serotonin transporter (SERT) binding in the midbrain of per...
Night Eating Syndrome
null
2
arm 1: Subjects will be given a medical history, height and weight will be measured, and BMI calculated. Initial outpatient assessment will include diary measurement of food intake and nighttime awakenings (and associated food intake) together with psychological testing. For women, a pregnancy test will also be adminis...
[ 0, 4 ]
1
[ 0 ]
intervention 1: The purpose of this study is to determine the effectiveness of the anti-depressant Lexapro in the treatment of the Night Eating Syndrome. An ADAM SPECT-CT study of SERT binding will be conducted which will compare SERT binding in 31 night eaters with that of 10 control subjects. The first procedure will...
intervention 1: escitalopram oxalate
1
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
31
0
0
0
NCT01401595
1COMPLETED
2011-09-01
2009-12-01
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
[ 2 ]
12
RANDOMIZED
CROSSOVER
null
2DOUBLE
true
0ALL
false
The purpose of this study is to compare the sweetness of 2 new atazanavir powder for oral use (POU) formulations to the current atazanavir POU in healthy participants and to select 1 atazanavir POU that has the sweetness most similar to the current atazanavir POU.
This study is a taste assessment study designed to select a new atazanavir powder for oral use (POU) formulation that is similar in sweetness to the current POU formulation. Participants were to taste and then spit out the POU formulations, without swallowing them. Study Classification: Other. This is a taste study
HIV
null
3
arm 1: None arm 2: None arm 3: None
[ 1, 1, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Solution, oral, atazanavir 15 mg/5 mL with 10% aspartame, single dose intervention 2: Solution, oral, atazanavir 15 mg/5 mL with 4.2% aspartame, single dose intervention 3: Solution, oral, atazanavir 15 mg/5 mL with 4.2% aspartame and sucralose, single dose
intervention 1: Atazanavir (current formulation) intervention 2: Atazanavir, powder for oral use 1 (POU1) intervention 3: Atazanavir (POU2)
1
Lenexa | Kansas | United States | -94.73357 | 38.95362
36
0
0
0
NCT01404572
1COMPLETED
2011-09-01
2011-08-01
Bristol-Myers Squibb
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
400
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to determine whether lorazepam, which is used to lower preoperative anxiety, also improves postoperative recovery. This study data will also be used for further research aiming to identify vulnerable patients in the day-case surgery setting.
Since the early 1980s, the investigators have seen a shift towards day-case surgery. Before surgery, many patients have negative feelings about the surgical procedure. These anxieties have various negative effects. To reduce this resistance preoperative administration of an anxiolytic drug is administered, typically a ...
Anxiety
quality of life lorazepam anxiety premedication surgery Adult patients Ambulatory Surgical Procedures Postoperative Period
null
2
arm 1: Lorazepam 4mg/4ml arm 2: NaCl 0.9% 4ml
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Once 1mg \<75kg body weight, 1.5mg 75kg and \>75kg body weight, IV, before surgery intervention 2: Once 1ml \<75kg body weight, 1.5ml 75kg or \>75kg body weight, IV, before surgery
intervention 1: Lorazepam intervention 2: NaCl 0.9% (Sodium Chloride)
1
Rotterdam | N/A | Netherlands | 4.47917 | 51.9225
400
0
0
0
NCT01441843
1COMPLETED
2011-09-01
2010-10-01
Erasmus 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 ]
49
NA
SINGLE_GROUP
null
3TRIPLE
false
0ALL
true
This is a dose finding study to identify the minimum effective anesthetic concentration (MEAC) of ropivacaine to produce insensate body parts sufficient for surgery in supraclavicular and infraclavicular approaches to the brachial plexus, parasacral and popliteal approaches to the sciatic nerve, femoral nerve and trans...
null
Surgical Anesthesia
null
1
arm 1: Sequential allocation of ropivacaine concentration depending on the success or failure of surgical anesthesia of the previous patient
[ 0 ]
1
[ 0 ]
intervention 1: Single shot preoperative perineural injection of ropivacaine to achieve surgical anesthesia. The concentration of ropivacaine is lowered by 0.05% after every successful surgical anesthesia specific to that block and raised by 0.05% after every unsuccessful surgical anesthesia specific to that block
intervention 1: Ropivacaine concentration
1
Albuquerque | New Mexico | United States | -106.65114 | 35.08449
49
0
0
0
NCT01452126
6TERMINATED
2011-09-01
2011-06-01
University of New Mexico
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 ]
118
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
true
0ALL
false
A pilot study to determine the ability of a stannous fluoride containing toothpaste to provide immediate and short term relief from dentine Hypersensitivity compared to a control toothpaste.
null
Dentinal Sensitivity Hypersensitivity
dentinal hypersensitivity
null
2
arm 1: USA marketed toothpaste \[test\] arm 2: USA marketed toothpaste \[negative control\]
[ 1, 5 ]
2
[ 0, 0 ]
intervention 1: 0.454% stannous fluoride toothpaste intervention 2: 0.76% sodium monofluorophosphate toothpaste
intervention 1: Test Toothpaste intervention 2: Negative Control Toothpaste
1
Las Vegas | Nevada | United States | -115.13722 | 36.17497
118
0
0
0
NCT01494649
1COMPLETED
2011-09-01
2011-09-01
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
[ 0 ]
151
NA
SINGLE_GROUP
2DIAGNOSTIC
1SINGLE
true
0ALL
false
This study will investigate the performance of physician readers trained to read florbetapir-PET scans using electronic media training.
Avid has previously developed a florbetapir-PET scan binary read methodology and training program, which was successfully applied in studies 18F-AV-45-A08(NCT01565369), 18F-AV-45-A09(NCT01565382) and 18F-AV-45-A16(NCT01447719). In these previous studies, training was conducted in-person. Study 18F-AV-45-PT01 will evalu...
Alzheimer Disease Mild Cognitive Impairment Neurodegenerative Diseases
Amyloid imaging Positron Emission Tomography 18F-AV-45 florbetapir F 18 Diagnostic imaging
null
0
null
null
1
[ 0 ]
intervention 1: No study drug will be administered in this study - scans previously acquired in in Study A05(NCT00702143) and A07(NCT00857415) will be read
intervention 1: florbetapir F 18
0
null
0
0
0
0
NCT01550549
1COMPLETED
2011-09-01
2011-08-01
Avid Radiopharmaceuticals
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3, 4 ]
20
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The objective of the study is to determine the safety and efficacy of TNK infusion for the treatment of loculated pleural effusions in patients with known malignancy compared to normal saline infusion.
The design of the trial will be as a single-center, prospective, blinded, randomized trial comparing the infusion of TNKase versus saline for treatment of symptomatic loculated pleural effusion in patients with malignancy. Patients with known malignancy and symptomatic loculated pleural effusion who are referred for pe...
Pleural Effusion
pleural effusion malignancy loculated
null
2
arm 1: Loculated pleural effusion infused with normal saline twice a day for three days. arm 2: Loculated pleural effusion infused with TNK twice a day for three days.
[ 2, 1 ]
2
[ 0, 0 ]
intervention 1: Injection of 60 ml normal saline twice a day for three days using the existing chest tube. intervention 2: Injection of 4 mg of TNK with 59 ml normal saline into the existing chest tube twice a day for three days.
intervention 1: normal saline intervention 2: TNK (Tenecteplase)
1
Honolulu | Hawaii | United States | -157.85833 | 21.30694
20
0
0
0
NCT01580618
6TERMINATED
2011-09-01
2008-01-01
Kaiser Permanente
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 ]
296
NON_RANDOMIZED
PARALLEL
1PREVENTION
4QUADRUPLE
true
0ALL
false
The purpose of this study is to determine if adding daily application of CPP-ACP containing paste for one year is superior to regular fluoride tooth brushing in preventing dental caries in high caries risk Thai preschool children.
The 6th National Oral Health Survey in Thailand 2006-2007 reported that 3-year-old children who resided in central part have the highest dental caries prevalence of 69.8 percent with dmft affecting 3.63 teeth on average. Fluoride is widely accepted as the most effective tool to caries prevention for initial caries lesi...
Dental Caries
Caries detection/diagnosis/prevention Preventive Dentistry Casien Phosphopeptide Remineralization Clinical trial
null
2
arm 1: 10% w/v Calcium Phosphopeptide Amorphous Calcium Phosphate paste arm 2: the paste without Calcium phosphopeptide - Amorphous Calcium Phosphate
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Apply once a day at school by school teacher, following fluoride toothbrushing after lunch intervention 2: Apply once a day at school by school teacher, following fluoride toothbrushing after lunch.
intervention 1: 10 % w/v CPP-ACP paste intervention 2: the paste without CPP-ACP
1
Klongluang | Patumthani | Thailand | N/A | N/A
296
0
0
0
NCT01604109
1COMPLETED
2011-09-01
2010-07-01
Thammasat 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 ]
32
RANDOMIZED
CROSSOVER
7BASIC_SCIENCE
0NONE
true
0ALL
false
Moxifloxacin is routinely used as a probe to confirm assay sensitivity in thorough electrocardiogram (ECG) studies. It has been shown that a meal shortens the QT interval, which may affect pharmacokinetics (PK) and/or pharmacodynamics (PD) of the study drug. However, there is no published data clarifying this issue. Th...
This study was initially performed in 24 healthy Caucasian and Japanese volunteers with an option to increase the sample size to up to 54 volunteers. The decision to increase the sample size to 32 was based on the standard deviation of the ECG intervals observed in the first 24 volunteers. This analysis was performed b...
Effects of Different Meals on the QT/QTc Interval Insulin and Oral Hypoglycemic [Antidiabetic] Drugs Causing Adverse Effects in Therapeutic Use C-Peptide Effects on the QT/QTc Interval Moxifloxacin ECG Profile in Fed and Fasted State Japanese vs. Caucasian TQT Comparison
Insulin clamp Glucose clamp Moxifloxacin Fed Fasted QT/QTC interval TQT ECG Meal effects C Peptide Japanese Caucasian bridging TQT bridging FDA standard breakfast Adaptive study design
null
2
arm 1: Moxifloxacin 400 mg fasted was administered on Day 3. For Day 1 and 2, there were 4 different sequences: Placebo and Insulin Clamp; Insulin Clamp and Continental breakfast; Continental breakfast and FDA breakfast; FDA breakfast and Placebo. Additionally, Caucasian vs Japanese subjects were analysed. arm 2: Moxif...
[ 1, 0 ]
6
[ 0, 10, 10, 0, 3, 0 ]
intervention 1: Subjects receiving drug (400 mg moxifloxacin),having fasted overnight for 10 hours. This is the standard probe for the assessment of assay sensitivity in Thorough QT (TQT) studies. intervention 2: Calorie reduced FDA standard breakfast (58% fat, low carbohydrates)- On the assumption that increases in C...
intervention 1: Moxifloxacin 400 mg fasted intervention 2: FDA breakfast intervention 3: Continental breakfast intervention 4: Moxifloxacin 400 mg fed intervention 5: Insulin Clamp intervention 6: Placebo
1
London | Tooting | United Kingdom | -0.12574 | 51.50853
64
0
0
0
NCT01642485
1COMPLETED
2011-09-01
2011-07-01
Richmond Pharmacology 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 ]
244
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
This will be a multicenter, 52 week, open label study to assess the safety and tolerability of oral OPC-34712 (1 to 6 mg) as monotherapy in adult patients with schizophrenia. The study will be conducted on an outpatient basis. Enrollment into the study will be drawn from eligible subjects who have completed participati...
null
Schizophrenia
Schizophrenia
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: oral administered once daily
intervention 1: OPC-34712
68
Little Rock | Arkansas | United States | -92.28959 | 34.74648 Escondido | California | United States | -117.08642 | 33.11921 Garden Grove | California | United States | -117.94145 | 33.77391 Long Beach | California | United States | -118.18923 | 33.76696 Oceanside | California | United States | -117.37948 | 33.19587 Pa...
242
0
0
0
NCT01649557
1COMPLETED
2011-09-01
2009-08-01
Otsuka Pharmaceutical Development & Commercialization, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
272
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This open-label, non-randomized, single arm study will provide treatment or re-treatment with Pegasys (peginterferon alfa-2a) as monotherapy or in combination with Copegus (ribavirin) to patients with chronic hepatitis C infection. Patients who have received prior Pegasys monotherapy or combination therapy or who were ...
null
Hepatitis C, Chronic
null
1
arm 1: The treating investigator decided the most appropriate treatment. It was recommended that participants receive combination therapy.
[ 0 ]
2
[ 0, 0 ]
intervention 1: Both combination and monotherapy for both genotype 2/3 and genotype non-2/3: 180 μg subcutaneously once weekly. intervention 2: For genotype 2/3, 800 mg orally daily, in 2 split doses for 24 weeks. For genotype non-2/3, 1000 mg orally daily for participants weighing \< 75 kg or 1200 mg orally daily for ...
intervention 1: Peginterferon alfa-2a intervention 2: Ribavirin
67
Birmingham | Alabama | United States | -86.80249 | 33.52066 La Jolla | California | United States | -117.2742 | 32.84727 Long Beach | California | United States | -118.18923 | 33.76696 San Diego | California | United States | -117.16472 | 32.71571 San Diego | California | United States | -117.16472 | 32.71571 San Franc...
272
0
0
0
NCT01853254
1COMPLETED
2011-09-01
2003-09-01
Hoffmann-La Roche
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
55
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
true
0ALL
false
The purpose of this study is to determine whether docosahexaenoic acid (DHA) is effective in the treatment of periodontitis in adults.
1. The primary aim of this study is to investigate the effect of docosahexaenoic acid (DHA; 2 gm/day) plus low dose aspirin (ASA 81 mg/day)compared to ASA alone on periodontitis over three months. Our hypothesis is that DHA plus ASA will improve periodontitis as measured by objective periodontal exam, including decreas...
Periodontitis Gingivitis Inflammation
Docosahexaenoic acid DHA Periodontitis Gingivitis Omega-3 fatty acid Fish oil
null
2
arm 1: Aspirin 81 mg 1 tablet by mouth daily and Docosahexanoic acid (DHA) 500 mg 4 capsules by mouth daily (total daily dose of 2 grams DHA) for 3 months arm 2: Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months
[ 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules
intervention 1: Aspirin intervention 2: Docosahexaenoic acid intervention 3: Placebo (for Docosahexaenoic acid)
1
Boston | Massachusetts | United States | -71.05977 | 42.35843
55
0
0
0
NCT01976806
1COMPLETED
2011-09-01
2009-06-01
Beth Israel Deaconess Medical Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
3
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
This phase I/II trial studies the safety and best dose of melphalan and bortezomib when given prior to an autologous stem cell transplant and to see how well they work in treating patients with multiple myeloma. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, ei...
This is a phase I, dose-escalation study of melphalan and bortezomib followed by a phase II study. Patients receive melphalan intravenously (IV) continuously on days -5 to -2 and bortezomib IV over 3-5 seconds on days -4 and -1. Patients also receive dexamethasone IV on day -1 prior to the second dose of bortezomib. B...
Plasma Cell Myeloma Plasmacytosis Recurrent Plasma Cell Myeloma Smoldering Plasma Cell Myeloma
null
1
arm 1: Patients receive melphalan IV continuously on days -5 to -2 and bortezomib IV over 3-5 seconds on days -4 and -1. Patients also receive dexamethasone IV on day -1 prior to the second dose of bortezomib. Beginning two days after completion of melphalan infusion, patients undergo autologous hematopoietic stem cell...
[ 0 ]
4
[ 0, 0, 0, 3 ]
intervention 1: Given IV intervention 2: Given IV intervention 3: Given IV intervention 4: Undergo autologous hematopoietic stem cell transplant
intervention 1: Melphalan intervention 2: Bortezomib intervention 3: Dexamethasone intervention 4: Autologous Transplant
1
Aurora | Colorado | United States | -104.83192 | 39.72943
3
0
0
0
NCT02353572
6TERMINATED
2011-09-01
2009-11-01
University of Colorado, Denver
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 ]
394
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Primary Objective: To evaluate the safety and efficacy of a single 6 mL intraarticular (IA) injection of Synvisc-One in participants in India with symptomatic osteoarthritis (OA) of the knee(s). Secondary Objective: To evaluate the safety and short-term efficacy of a repeat treatment with Synvisc-One.
A period of approximately 19 months was anticipated from the time the first participants was enrolled in the study to the completion of the study (last participant out). Individual participant participation lasted from 7 to 13 months depending on the timing of repeat treatment.
Osteoarthritis
null
1
arm 1: Single 6 mL IA injection of Synvisc-One (48 mg of cross-linked hylan polymer) at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy (no major safety concerns and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 subscor...
[ 0 ]
1
[ 0 ]
intervention 1: intraarticular injection
intervention 1: Synvisc-One
0
null
788
0
0
0
NCT02389452
1COMPLETED
2011-09-01
2010-02-01
Genzyme, a Sanofi Company
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
804
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
MNTX 3201 is a Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of oral MNTX for the treatment of opioid induced constipation in participants with chronic, non-malignant pain.
null
Opioid-Induced Constipation
Treatment of Opioid-Induced Constipation in Participants with Chronic, Non-Malignant Pain
null
4
arm 1: Participants will receive methylnaltrexone (MNTX) 150 milligrams (mg) (1 tablet of MNTX 150 mg and 2 matching placebo tablets) orally once daily (QD) for 28 days (4 weeks), then MNTX tablets at a dose as needed (PRN) for remaining 56 days (8 weeks). arm 2: Participants will receive MNTX 300 mg (2 tablets of MNTX...
[ 0, 0, 0, 2 ]
2
[ 0, 0 ]
intervention 1: Methylnaltrexone will be administered as per the dose and schedule specified in the respective arms. intervention 2: Placebo matching to methylnaltrexone will be administered as per the schedule specified in the respective arms.
intervention 1: Methylnaltrexone intervention 2: Placebo
2
Raleigh | North Carolina | United States | -78.63861 | 35.7721 Raleigh | North Carolina | United States | -78.63861 | 35.7721
803
1
0.001245
1
NCT01186770
1COMPLETED
2011-09-08
2010-09-01
Bausch Health Americas, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
0
0
0
0
0
0
0
0.00022
[ 5 ]
216
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
The purpose of this study is to understand the utilization patterns of doripenem in Asia Pacific, including the profile of the patients treated with carbapenems.
This is a Phase 4, prospective, open-label, non-comparative, multicenter study to characterize the usage of doripenem in selected hospitals in the Asia Pacific region. Doripenem belongs to the carbapenem class which is a broad-spectrum antibiotic given to treat patients with serious infections, such as pneumonia and co...
Pneumonia Pneumonia, Ventilator-Associated Urinary Tract Infections
Carbapenem Doripenem Doribax Nosocomial pneumonia, Intra-abdominal infections Urinary tract infection
null
1
arm 1: doripenem 500mg vial by injection every 8 hours for 5 to 14 days
[ 5 ]
1
[ 0 ]
intervention 1: 500mg vial by injection every 8 hours for 5 to 14 days
intervention 1: doripenem
16
Hong Kong | N/A | Hong Kong | 114.17469 | 22.27832 Bandung | N/A | Indonesia | 107.60694 | -6.92222 Jakarta | N/A | Indonesia | 106.84513 | -6.21462 Surabaya | N/A | Indonesia | 112.75083 | -7.24917 Ipoh | N/A | Malaysia | 101.0829 | 4.5841 Johor Bahru | N/A | Malaysia | 103.7578 | 1.4655 Kota Bharu | N/A | Malaysia | ...
216
0
0
0
NCT00986102
1COMPLETED
2011-09-09
2009-07-17
Janssen Research & Development, 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 ]
297
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
The primary objectives of this study are to: 1) Evaluate the efficacy of CP 601,927 compared to placebo in the augmentation of antidepressant therapy (ADT) in patients with Major Depressive Disorder (MDD) using the Montgomery Asberg Depression Rating Scale (MADRS). 2) Evaluate the safety and tolerability of CP 601,927 ...
The study was stopped at interim analysis in August 2011, as stopping criteria for futility were met. There was no statistically significant change on the primary efficacy scale in favor of the drug. There was a very small chance that any additional data could change the study overall outcome. There were no concerns re...
Major Depressive Disorder
Antidepressant Augmentation
null
2
arm 1: CP-601,927 arm 2: Placebo
[ 0, 2 ]
2
[ 0, 10 ]
intervention 1: CP-601,927 1-2 mg twice per day, oral 1 mg tablets, for 6 weeks. intervention 2: Matching placebo tablets, taken orally, twice per day, for 6 weeks.
intervention 1: CP-601,927 intervention 2: Placebo
58
Little Rock | Arkansas | United States | -92.28959 | 34.74648 Beverly Hills | California | United States | -118.40036 | 34.07362 Garden Grove | California | United States | -117.94145 | 33.77391 National City | California | United States | -117.0992 | 32.67811 San Diego | California | United States | -117.16472 | 32.71...
459
1
0.002179
1
NCT01098240
6TERMINATED
2011-09-12
2010-06-14
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
0.000385
[ 3 ]
36
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This is a 12-week, international, multicenter, double-blind, three-group, dose-response study to assess the safety and efficacy of BPS-MR in patients with PAH. Eligible patients will have been previously diagnosed with PAH and will be on a stable course of an ERA and/or PDE-5 inhibitor for at least 60 days prior to Bas...
This is a 12-week, international, multicenter, double-blind, three-group, dose-response study to assess the safety and efficacy of BPS-MR in patients with PAH. Eligible patients will have been previously diagnosed with PAH and will be on a stable course of an ERA and/or PDE-5 inhibitor for at least 60 days prior to Bas...
Pulmonary Arterial Hypertension
PAH
null
3
arm 1: Patients in the MTD treatment group will dose escalate weekly by 60µg b.i.d. until they reach the maximum dose of 600µg b.i.d. or they reach an intolerable dose which requires them to down-titrate by 60µg b.i.d. In these instances and at the Investigator's discretion, further attempts at dose escalation may be m...
[ 0, 0, 0 ]
1
[ 0 ]
intervention 1: 60µg Tablets, twice a day for 12 weeks
intervention 1: Beraprost Sodium Modified Release
17
Torrance | California | United States | -118.34063 | 33.83585 Naperville | Illinois | United States | -88.14729 | 41.78586 New York | New York | United States | -74.00597 | 40.71427 The Bronx | New York | United States | -73.86641 | 40.84985 Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062 Dallas | Texa...
36
0
0
0
NCT00989963
1COMPLETED
2011-09-13
2010-02-01
Lung Biotechnology PBC
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 ]
246
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
1FEMALE
true
The study will evaluate the both the efficacy of odanacatib on Bone Mineral Density (BMD) and the safety of odanacatib for postmenopausal osteoporosis in patients previously treated with alendronate. The primary hypothesis of the trial is that treatment with odanacatib 50 mg once weekly will increase bone mineral densi...
null
Osteoporosis
null
2
arm 1: Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of 1200 mg. arm 2: Placebo to odanacatib 50 mg tablets once weekly for 24 month...
[ 0, 2 ]
4
[ 0, 0, 7, 7 ]
intervention 1: Odanacatib 50 mg tablets once weekly for 24 months intervention 2: Placebo to odanacatib 50 mg tablets once weekly for 24 months intervention 3: Vitamin D3, two 2800 IU tablets, taken once weekly for 24 months intervention 4: Participants will receive calcium carbonate supplements as needed to ensure a ...
intervention 1: Odanacatib intervention 2: Placebo intervention 3: Vitamin D3 intervention 4: Calcium
0
null
243
0
0
0
NCT00885170
1COMPLETED
2011-09-15
2009-04-13
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 ]
2,020
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
This study will establish the safety as well as demonstrate benefit of the addition of a LABA to an ICS by utilizing an endpoint (time to first severe asthma exacerbation) that informs on both safety and efficacy.
null
Asthma
null
2
arm 1: None arm 2: None
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Combination inhaled corticosteroid and long-acting beta2-agonist intervention 2: Inhaled corticosteroid
intervention 1: Fluticasone Furoate/GW642444 intervention 2: Fluticasone furoate
183
Birmingham | Alabama | United States | -86.80249 | 33.52066 Mobile | Alabama | United States | -88.04305 | 30.69436 Oxford | Alabama | United States | -85.83496 | 33.61427 Phoenix | Arizona | United States | -112.07404 | 33.44838 Scottsdale | Arizona | United States | -111.89903 | 33.50921 Tucson | Arizona | United Sta...
2,019
0
0
0
NCT01086384
1COMPLETED
2011-09-15
2010-02-22
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 ]
50
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
The primary objective of this trial is to evaluate the efficacy and safety of BI 6727 in patients with locally advanced, metastatic or recurrent urothelial cancer after failure of first line or adjuvant/neoadjuvant chemotherapy.
null
Neoplasms
null
1
arm 1: open label
[ 0 ]
1
[ 0 ]
intervention 1: phase II
intervention 1: BI 6727, IV infusion
21
Beverly Hills | California | United States | -118.40036 | 34.07362 Los Angeles | California | United States | -118.24368 | 34.05223 Miami | Florida | United States | -80.19366 | 25.77427 Orlando | Florida | United States | -81.37924 | 28.53834 Chicago | Illinois | United States | -87.65005 | 41.85003 Joliet | Illinois ...
50
0
0
0
NCT01023958
1COMPLETED
2011-09-19
2009-11-19
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 ]
193
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This single arm study will evaluate the efficacy and safety of repeated courses of MabThera in patients with active rheumatoid arthritis who have participated in ML19070, and have completed the week 24 visit. Eligible patients (DAS28 \>2.6 after week 24), will receive 2 infusions of 1g MabThera (Day 1 and day 15). For ...
null
Rheumatoid Arthritis
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: 1g iv on days 1 and 15
intervention 1: rituximab [MabThera/Rituxan]
51
Bad Aibling | N/A | Germany | 12.01055 | 47.8638 Bad Bramstedt | N/A | Germany | 9.88243 | 53.91827 Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.5...
193
0
0
0
NCT00502840
1COMPLETED
2011-09-20
2007-07-23
Hoffmann-La Roche
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
211
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
This will be a multicenter, randomized, double-blind study designed to assess the efficacy, safety and tolerability of an oral Aripiprazole/Escitalopram combination therapy in participants with MDD who have demonstrated an incomplete response to a prospective trial of Escitalopram, and report a treatment history for th...
The study will be organized as follows: * Screening Phase * Single-blind Prospective Treatment Phase * Single-blind Continuation Phase (Responder) or Double-blind Randomization Phase (non-Responder) * 30 day Post Treatment Follow-up Assigned Interventions: * Escitalopram monotherapy * Aripiprazole/Escitalopram combi...
Major Depressive Disorder (MDD)
Major Depressive Disorder MDD Depression
null
5
arm 1: Participants received initial dose of escitalopram 10 milligram (mg) blinded capsule (over-encapsulated tablet), orally, once daily, increased to 20 mg/day at the end of Week 1 based upon tolerability profile, for up to maximum of Week 8. No dose reductions were allowed after Week 4 and no dose increments were a...
[ 0, 0, 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Escitalopram capsule administered orally, once daily without regard to meals. intervention 2: Aripiprazole capsule administered orally, once daily without regard to meals. intervention 3: Blinded capsule administered orally, once daily.
intervention 1: Escitalopram intervention 2: Aripiprazole intervention 3: Blinded capsule
62
Cerritos | California | United States | -118.06479 | 33.85835 Costa Mesa | California | United States | -117.91867 | 33.64113 Irvine | California | United States | -117.82311 | 33.66946 San Diego | California | United States | -117.16472 | 32.71571 Santa Ana | California | United States | -117.86783 | 33.74557 Denver |...
339
0
0
0
NCT01111539
6TERMINATED
2011-09-20
2010-07-13
Otsuka Pharmaceutical Development & Commercialization, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
870
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This is a study comparing the incidence of hypoglycemia while using sitagliptin treatment versus sulfonylurea (SU) treatment in participants with type 2 diabetes mellitus (T2DM) who regularly take an SU drug, and choose to fast during the month of Ramadan. The primary hypothesis is that during the 30 days of Ramadan fa...
This study and NCT01131182 (MK-0431-263) have the same design but are conducted under separate protocols, in different countries, according to local guidelines.
Type 2 Diabetes Mellitus
Glucose metabolism disorders Metabolic diseases Peptidase inhibitors
null
2
arm 1: Sitagliptin 100mg taken orally once daily with or without metformin arm 2: Usual sulfonylurea therapy with or without metformin
[ 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: One 100 mg tablet taken orally once daily intervention 2: Participant continued pre-study sulfonylurea therapy (dose as prescribed by the physician). Pre-study sulfonylurea therapy consisted of either glibenclamide, glimepiride or gliclazide. intervention 3: Participants receiving metformin at enrollmen...
intervention 1: Sitagliptin intervention 2: Sulfonylurea intervention 3: Metformin
0
null
848
0
0
0
NCT01340768
1COMPLETED
2011-09-21
2010-06-22
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 ]
156
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
1FEMALE
null
This is a randomized, double-blind, placebo-controlled, phase 2 study. Subjects will include postmenopausal women with confirmed HR-positive, locally advanced or metastatic breast cancer, who have disease progression during or within 12 months after completing prior adjuvant endocrine therapy or during the first prior ...
null
Breast Cancer Breast Tumors Metastatic Cancer
postmenopausal hormone receptor positive locally advanced metastatic
Prot_SAP_000.pdf: Approved Product: AMG 479 Protocol Number: 20060362 Date: Amendment 2, 01 June 2011 Page 1 of 113 A ® An International, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of AMG 479 with Exemestane or Fulvestrant in Postmenopausal Women with Hormone Receptor Positive...
2
arm 1: None arm 2: None
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: AMG 479 administered with exemestane or fulvestrant intervention 2: Placebo administered with either exemestane or fulvestrant
intervention 1: AMG 479 intervention 2: Placebo
60
Chandler | Arizona | United States | -111.84125 | 33.30616 Anaheim | California | United States | -117.9145 | 33.83529 Beverly Hills | California | United States | -118.40036 | 34.07362 Concord | California | United States | -122.03107 | 37.97798 Duarte | California | United States | -117.97729 | 34.13945 Montebello | ...
155
0
0
0
NCT00626106
1COMPLETED
2011-09-23
2008-03-27
NantCell, Inc.
4INDUSTRY
true
true
false
https://cdn.clinicaltrials.gov/large-docs/06/NCT00626106/Prot_SAP_000.pdf
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
20
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This study will examine the effects of an experimental drug called UCN-01 (7-hydroxystaurosporine) on T-cell lymphomas. UCN-01 inhibits the growth of several different tumor cells, and, in laboratory studies, it has worked particularly well on tumor cells taken from patients with T cell lymphomas. Patients 9 years of ...
Background: * UCN-01 (7-hydroxystaurosporine), a non-specific protein kinase C (PKC) inhibitor appears to have several mechanisms of action including protein kinase C (PKC) isoenzyme inhibition and cyclin dependent kinase activation and inhibition. * We have demonstrated that cell lines derived from T-cell lymphomas, ...
Lymphoma, Large-Cell, Ki-1 Lymphoma, T-Cell
Protein Kinase Inhibition Soluble Tac Gene Expression Profiling ALK Expression Apoptosis Lymphoma Anaplastic Large Cell Lymphoma ALCL T-Cell Lymphoma
null
2
arm 1: Cycle 1: 45 mg/m\^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m\^2 Cycle 2: 45 mg/m\^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m\^2; Repeat cycles every 28 days. arm 2: Cycle 1: 45 mg/m\^2/day continuous intravenous infusion 1 ...
[ 0, 0 ]
1
[ 0 ]
intervention 1: UCN-01 for relapsed or refractory T-cell lymphomas - Cohort 1, Cycle 1: 45 mg/m\^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m\^2 Cycle 2: 45 mg/m\^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m\^2; Repeat cycles every 28 ...
intervention 1: UCN-01 (7-hydroxystaurosporine)
1
Bethesda | Maryland | United States | -77.10026 | 38.98067
20
0
0
0
NCT00082017
6TERMINATED
2011-09-27
2004-04-05
National Cancer Institute (NCI)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
237
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
This will be a multicenter, randomized, double-blind study designed to assess the efficacy, safety and tolerability of an oral Aripiprazole/Escitalopram combination therapy in participants with MDD who have demonstrated an incomplete response to a prospective trial of Escitalopram, and report a treatment history for th...
The study will be organized as follows: * Screening Phase * Single-blind Prospective Treatment Phase * Single-blind Continuation Phase (Responder) or Double-blind Randomization Phase (non-Responder) * 30 day Post Treatment Follow-up Assigned Interventions: * Escitalopram monotherapy * Aripiprazole/Escitalopram combi...
Major Depressive Disorder (MDD)
Major Depressive Disorder MDD Depression
null
5
arm 1: Escitalopram 10 mg capsule, orally, once daily increased to 20 mg/day at the end of Week 1 based upon tolerability profile, plus one matching placebo capsule, for 8 weeks. No dose reductions were allowed after Week 4 and no dose increments were allowed after Week 3. Participants with incomplete response at the e...
[ 1, 1, 1, 1, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Escitalopram oral capsules. intervention 2: Aripiprazole oral capsules. intervention 3: Study drug matching placebo capsule.
intervention 1: Escitalopram intervention 2: Aripiprazole intervention 3: Placebo
60
Birmingham | Alabama | United States | -86.80249 | 33.52066 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Carson | California | United States | -118.28202 | 33.83141 Garden Grove | California | United States | -117.94145 | 33.77391 Imperial | California | United States | -115.56944 | 32.84755 Mission Vi...
357
0
0
0
NCT01111552
6TERMINATED
2011-09-27
2010-07-29
Otsuka Pharmaceutical Development & Commercialization, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
173
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
This is a multicenter, 52-week, open-label study designed to assess the safety and tolerability of an oral aripiprazole/escitalopram combination therapy in outpatients with major depressive disorder (MDD). Enrollment into the study will be from eligible participants who have completed participation in Protocol 31-08-25...
null
Major Depressive Disorder (MDD)
Major Depressive Disorder MDD Depression
null
4
arm 1: Aripiprazole capsules, orally at the daily dose of 3, 6, or 12 mg, in combination with escitalopram 10 or 20 mg orally, once daily in combination with escitalopram 10 or 20 mg (i.e., the final dose taken during the previous study), orally, once daily, for 36 weeks. Participants were titrated to the aripiprazole ...
[ 0, 0, 0, 0 ]
2
[ 0, 0 ]
intervention 1: Aripiprazole oral capsules intervention 2: Escitalopram oral capsules
intervention 1: Aripiprazole intervention 2: Escitalopram
0
null
170
0
0
0
NCT01123707
6TERMINATED
2011-09-27
2010-11-18
Otsuka Pharmaceutical Development & Commercialization, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
99
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The primary purpose of the study is to evaluate the efficacy and safety of early postsurgery temozolomide chemotherapy followed by the standard temozolomide regimen, compared to the standard regimen alone, for the treatment of patients with newly diagnosed glioblastoma multiforme.
null
Glioblastoma
null
2
arm 1: Standard therapy regimen: Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m\^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will las...
[ 1, 0 ]
2
[ 0, 4 ]
intervention 1: None intervention 2: None
intervention 1: Temozolomide intervention 2: Radiotherapy
0
null
94
0
0
0
NCT00686725
1COMPLETED
2011-09-28
2008-06-24
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 ]
124
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
Use of PTH (1-84) a recombinant hormone in escalating doses for the treatment of adults with hypoparathyroidism. The use of PTH should result in a decrease of calcium and vitamin D supplements.
Patients with a history of hypoparathyroidism will be randomized to receive placebo or study drug for 24 weeks, which will be injected daily in either thigh. During that time they will be monitored for safety (specifically, calcium levels in the blood and urine). In addition, the patients' intake of Vitamin D and calci...
Hypoparathyroidism
Hypoparathyroidism
null
2
arm 1: Sterile water for injection arm 2: Initial dose of 50mcg, to be titrated up to 75mcg and then 100mcg dependent upon response
[ 2, 0 ]
2
[ 0, 0 ]
intervention 1: Placebo for subcutaneous injection intervention 2: Parathyroid hormone 50, 75, or 100 mcg injectable subcutaneously daily
intervention 1: Placebo intervention 2: NPSP558
31
Scottsdale | Arizona | United States | -111.89903 | 33.50921 Lakewood | California | United States | -118.13396 | 33.85363 Orange | California | United States | -117.85311 | 33.78779 San Francisco | California | United States | -122.41942 | 37.77493 Hialeah | Florida | United States | -80.27811 | 25.8576 Jacksonville |...
124
0
0
0
NCT00732615
1COMPLETED
2011-09-28
2008-12-18
Shire
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
42
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
true
0ALL
null
This is a drug interaction study evaluating whether blood plasma concentrations of SSP-002358-base are altered when SSP-002358 is taken together with omeprazole.
null
Healthy
null
2
arm 1: None arm 2: SSP-002358 + omeprazole
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: 1 mg, oral, once intervention 2: SSP-002358 (1 mg) + omeprazole (40 mg) given orally, once
intervention 1: SSP-002358 intervention 2: SSP-002358 + omeprazole
1
Zuidlaren | N/A | Netherlands | 6.68194 | 53.09417
82
0
0
0
NCT01415349
1COMPLETED
2011-09-28
2011-08-11
Shire
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
347
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This is a phase III, multicenter, randomized, double-blind, parallel group, placebo-controlled study to compare the efficacy of 6-months therapy of ropinirole Prolonged Release (PR) with that of placebo as adjunctive therapy to L-dopa in Parkinson's disease patients not optimally controlled on L-dopa. This study will b...
null
Parkinson Disease
null
2
arm 1: Ropinirole PR tablets of 2.0 mg, 4.0mg and 8.0 mg arm 2: Placebo
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: If subjects are still eligible at the end of the placebo run-in period they will be randomized (1:1) to receive once daily doses of ropinirole PR or identical appearing placebo tablets. Dosing will start at 2 mg ropinirole PR, or placebo equivalent. During the 24 week treatment phase, the subjects dose ...
intervention 1: ReQuip PR intervention 2: Placebo
18
Guangzhou | Guangdong | China | 113.25 | 23.11667 Wuhan | Hubei | China | 114.26667 | 30.58333 Suzhou | Jiangsu | China | 120.59538 | 31.30408 Xi'an | Shaanxi | China | 108.92861 | 34.25833 Chengdu | Sichuan | China | 104.06667 | 30.66667 Chengdu | Sichuan | China | 104.06667 | 30.66667 Kunming | Yunnan | China | 102.7...
345
0
0
0
NCT01154166
1COMPLETED
2011-09-29
2010-02-15
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 ]
100
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
1FEMALE
false
This trial will evaluate whether the routine use of belladonna/opium (B\&O) suppositories improve patients' self-reported pain control in the first 24-hours after delivery.
Childbirth is commonly regarded as one of life's most painful experiences and, like childbirth, the postpartum period can also be painful for women. Pain in the immediate postpartum period may significantly affect a woman's overall delivery experience. Pain control is especially important in this period, as women are b...
Pain
Belladonna Opium Suppository
null
2
arm 1: Women assigned to this arm receive a glycerin suppository (placebo) every 8 hours after delivery during the first 24 hours postpartum arm 2: Women assigned to this arm receive a belladonna and opioid (B\&O) suppository every 8 hours after delivery during the first 24 hours postpartum
[ 2, 0 ]
2
[ 0, 0 ]
intervention 1: Belladonna and opioid suppository 16.2mg/30mg per rectum every 8 hours for 24 hours following delivery intervention 2: A vegetable oil suppository (placebo) per rectum every 8 hours for the first 24 hours following delivery.
intervention 1: Belladonna and opioid suppository intervention 2: Glycerin Suppository
2
Maywood | Illinois | United States | -87.84312 | 41.8792 Melrose Park | Illinois | United States | -87.85673 | 41.90059
100
0
0
0
NCT01271855
1COMPLETED
2011-09-29
2009-07-22
Loyola 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 ]
512
RANDOMIZED
PARALLEL
9OTHER
4QUADRUPLE
false
0ALL
true
The purpose of the assay is to assess the safety and the efficacy of TRO19622 330 mg QD as add-on therapy to riluzole 50 mg bid in the treatment of patients suffering from ALS, as compared to placebo, assessed by the 18-month survival rate.
A stand alone treatment with TRO19622 is not acceptable for ethical reasons. Riluzole is an approved and widely used ALS treatment in the European community, in Japan and in the USA. Therefore, in this study, TRO19622 will be assessed as add-on to riluzole in patients suffering from ALS. At the start of the study, pa...
Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis TRO19622 Trophos
null
2
arm 1: 2 Capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid arm 2: 2 Capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid
[ 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: 2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzol 50mg bid intervention 2: 2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid intervention 3: Riluzole given as add-on therapy 50mg bid
intervention 1: Olesoxime intervention 2: Placebo Comparator intervention 3: Riluzole
15
Leuven | N/A | Belgium | 4.70093 | 50.87959 Bron | N/A | France | 4.91303 | 45.73865 Lille | N/A | France | 3.05858 | 50.63297 Limoges | N/A | France | 1.24759 | 45.83362 Marseille | N/A | France | 5.38107 | 43.29695 Montpellier | N/A | France | 3.87635 | 43.61093 Nice | N/A | France | 7.26608 | 43.70313 Paris | N/A | ...
512
0
0
0
NCT00868166
1COMPLETED
2011-09-30
2009-04-30
Hoffmann-La Roche
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
253
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
null
The purpose of this study is to evaluate the efficacy and safety of T-614 versus placebo when added to ongoing, stable-dose methotrexate therapy in patients with persistently active rheumatoid arthritis
null
Rheumatoid Arthritis
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: T-614 is administered twice daily in combination with methotrexate. The daily dose of T-614 is 25 mg for the first 4 weeks and 50 mg for subsequent weeks. intervention 2: Placebo is administered twice daily in combination with methotrexate. In placebo group, patients will receive T-614 after completing ...
intervention 1: T-614 intervention 2: Placebo
72
Anjo | Aichi-ken | Japan | 137.08054 | 34.95828 Ichinomiya | Aichi-ken | Japan | 136.8 | 35.3 Nagoya | Aichi-ken | Japan | 136.90641 | 35.18147 Okazaki | Aichi-ken | Japan | 137.16667 | 34.95 Toyohashi | Aichi-ken | Japan | 137.38333 | 34.76667 Ichikawa | Chiba | Japan | 139.9065 | 35.73413 Matsudo | Chiba | Japan | 13...
320
0
0
0
NCT00965757
1COMPLETED
2011-09-30
2009-07-31
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
[ 4 ]
119
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
This is a prospective, multicenter, double-blind (DB), controlled, randomized, parallel group comparison Phase 3a study to evaluate the efficacy and safety of new mesalamine suppositories (MAX-002) as compared to placebo and active medicine after 6 weeks of treatment in adults with mild to moderate ulcerative proctitis...
The present study consists of screening period (2 weeks before randomization), DB phase (6 weeks), OL phase (8 weeks) and follow-up visits at Week 3, Week 6 and Week 14. Participants who are eligible will be randomized to receive 1g MAX-002, 1g Canasa® and placebo suppository once daily in the DB phase. Participants wh...
Proctitis, Ulcerative
Ulcerative proctitis Proctocolitis Inflammatory Bowel Disease Gastrointestinal Diseases Colonic Diseases Mesalamine 5-ASA
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 2, 1 ]
3
[ 0, 0, 0 ]
intervention 1: MAX-002 suppository 1 gram (g) rectally once daily at bedtime for 6 weeks during the DB phase. Participants will then receive either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the open-label (OL) phase. intervention 2: Matching placeb...
intervention 1: MAX-002 intervention 2: Placebo intervention 3: Canasa®
40
Birmingham | Alabama | United States | -86.80249 | 33.52066 Dothan | Alabama | United States | -85.39049 | 31.22323 Tucson | Arizona | United States | -110.92648 | 32.22174 Thornton | Colorado | United States | -104.97192 | 39.86804 Torrington | Connecticut | United States | -73.12122 | 41.80065 Boynton Beach | Florida...
235
0
0
0
NCT01016262
6TERMINATED
2011-09-30
2009-11-30
Forest Laboratories
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
33
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This open-label single-arm study will evaluate the efficacy, safety and tolerability of methoxy polyethylene glycol epoetin beta on long-term maintenance of haemoglobin levels in patients with chronic renal anaemia. Patients will receive methoxy polyethylene glycol-epoetin beta intravenously once monthly at initial dos...
null
Anemia
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: initial doses of either 120 micrograms or 200 micrograms or 360 micrograms, once monthly
intervention 1: methoxy polyethylene glycol-epoetin beta [Mircera]
12
Bandung | N/A | Indonesia | 107.60694 | -6.92222 Denpasar | N/A | Indonesia | 115.21667 | -8.65 Jakarta | N/A | Indonesia | 106.84513 | -6.21462 Jakarta | N/A | Indonesia | 106.84513 | -6.21462 Jakarta | N/A | Indonesia | 106.84513 | -6.21462 Jakarta | N/A | Indonesia | 106.84513 | -6.21462 Jakarta | N/A | Indonesia | ...
33
0
0
0
NCT01066000
6TERMINATED
2011-09-30
2009-10-31
Hoffmann-La Roche
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
667
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
This is a randomized, double-blind, double dummy, multicenter Phase 3 study of oral TR-701 FA 200 mg once daily for 6 days versus oral Zyvox® (linezolid) 600 mg every 12 hours for 10 days for the treatment of ABSSSI in adults. Approximately 75 to 100 sites globally will participate in this study. Patients with an ABSS...
The primary objective is to determine the noninferiority in the early clinical response rate of 6 day oral TR-701 FA compared with that of 10-day oral linezolid treatment at the 48-72 Hour Visit in the ITT analysis set in patients with ABSSSI.
Skin and Subcutaneous Tissue Bacterial Infections
ABSSSI Tedizolid Phosphate TR-701 Acute Bacterial Skin and Skin Structure Infections
null
2
arm 1: TR0-701 FA 200 mg tablets once a day for six days followed by 4 days of placebo arm 2: Linezolid 600 mg tablets oral twice a day for 10 days
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Oral TR-701 FA 200 mg once daily for six days followed by four days of placebo. intervention 2: Oral Linezolid 600 mg twice daily for 10 days
intervention 1: TR-701 FA intervention 2: Linezolid
84
Dothan | Alabama | United States | -85.39049 | 31.22323 Anaheim | California | United States | -117.9145 | 33.83529 Anaheim | California | United States | -117.9145 | 33.83529 Buena Park | California | United States | -117.99812 | 33.86751 Chula Vista | California | United States | -117.0842 | 32.64005 La Mesa | Califo...
666
0
0
0
NCT01170221
1COMPLETED
2011-09-30
2010-08-15
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
21
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The main purpose of this trial is to allow continued access to pregabalin to Canadian subjects who participated in global pregabalin epilepsy studies 1008-010; 1008-035; 1008-114 and 1008-164 and to continue to study the long term safety of pregabalin administered as adjunctive therapy at dosages from 150 mg/day to 600...
null
Epilepsy
null
1
arm 1: open label treatment
[ 0 ]
1
[ 0 ]
intervention 1: 150 mg up to a maximum of 600 mg per day bid or tid as required
intervention 1: pregabalin (LYRICA)
5
Calgary | Alberta | Canada | -114.08529 | 51.05011 Halifax | Nova Scotia | Canada | -63.57688 | 44.64269 Barrie | Ontario | Canada | -79.66634 | 44.40011 Toronto | Ontario | Canada | -79.39864 | 43.70643 Windsor | Ontario | Canada | -83.01654 | 42.30008
21
1
0.047619
1
NCT00372528
6TERMINATED
2011-10-01
2007-03-01
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
1
0
0
0
0
0
0
0
0.008456
[ 4 ]
1,015
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
1\) To evaluate the effectiveness of AST-120 (spherical carbon adsorbent) added to standard-of-care therapy in moderate to severe Chronic Kidney Disease (CKD), on time to first occurrence of any event of the triple composite outcome of initiation of dialysis, kidney transplant or doubling of serum creatinine (sCr) when...
null
Chronic Kidney Disease
Kidney Diseases
null
2
arm 1: None arm 2: None
[ 2, 0 ]
2
[ 0, 0 ]
intervention 1: 9g /day (3 times a day) intervention 2: 9g /day (3 times a day)
intervention 1: Placebo intervention 2: AST-120
106
Tuscaloosa | Alabama | United States | -87.56917 | 33.20984 Hot Springs | Arkansas | United States | -93.05518 | 34.5037 Bakersfield | California | United States | -119.01871 | 35.37329 Glendale | California | United States | -118.25508 | 34.14251 Los Angeles | California | United States | -118.24368 | 34.05223 Palo Al...
1,012
1
0.000988
1
NCT00501046
1COMPLETED
2011-10-01
2007-07-01
Mitsubishi Tanabe Pharma Corporation
4INDUSTRY
false
false
false
null
0
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0.000174
[ 4 ]
590
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to test if being treated with darunavir/ritonavir (DRV/rtv) 800/100 mg daily is as effective as being treated with DRV/rtv 600/100 mg twice daily, in early antiretroviral (ARV)-experienced patients when given along with selected optimized background regimen (OBR).
This is a randomized (the study medication is assigned by chance), open-label (all people know the identity of the intervention) study in which 590 patients will be randomly assigned to receive either DRV/rtv 800/100 mg daily or DRV/rtv 600/100 mg twice daily along with the selected OBR. An OBR will consist of at least...
Human Immunodeficiency Virus - Type 1
Human immunodeficiency virus - type 1 HIV-1 Infection TMC-114 Darunavir Ritonavir
null
2
arm 1: Two 400 mg darunavir (DRV) ie, TMC114 tablets + one 100 mg ritonavir (rtv) capsule once daily. arm 2: One 600 mg TMC114 tablet + one 100 mg capsule of rtv twice daily.
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: DRV/rtv 800/100 mg once daily group: 2 tablets of 400 mg of DRV administered orally once daily. DRV/rtv 600/100 mg twice daily group: 1 tablet of 600 mg DRV administered orally twice daily. intervention 2: DRV/rtv 800/100 mg once daily group: One capsule of 100 mg of ritonavir administered orally once d...
intervention 1: Darunavir (DRV) intervention 2: Ritonavir (rtv)
85
Phoenix | Arizona | United States | -112.07404 | 33.44838 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Beverly Hills | California | United States | -118.40036 | 34.07362 Oakland | California | United States | -122.2708 | 37.80437 Palm Springs | California | United States | -116.54529 | 33.8303 Fort Lau...
590
1
0.001695
1
NCT00524368
1COMPLETED
2011-10-01
2007-10-01
Tibotec Pharmaceuticals, Ireland
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
0.000299
[ 4 ]
913
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
The primary objective of the study was to demonstrate overall survival improvement for aflibercept + docetaxel compared to docetaxel + placebo as second line treatment for participants with locally advanced or metastatic non-small cell lung cancer (NSCLC). The secondary objectives were to compare other efficacy parame...
The study included: * A screening visit of up to 21 days prior to randomization * Randomization at baseline (Treatment was initiated with 3 days of randomization) * A treatment period with 3-week treatment cycles until the participant met the following discontinuation criteria: had progressive disease, had unacceptabl...
Carcinoma Non Small Cell Lung
lung cancer angiogenesis inhibitor chemotherapy
null
2
arm 1: Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Placebo immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal. arm 2: Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Aflibercept immediately foll...
[ 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 6 mg/kg Aflibercept administered intravenously (IV) over 1 hour once on Day 1, every 3 weeks. intervention 2: Matching placebo to Aflibercept administered intravenously (IV) over 1 hour once on Day 1, every 3 weeks. intervention 3: 75 mg/m² docetaxel in 250 mL dextrose 5% or NaCl 0.9% administered intra...
intervention 1: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) intervention 2: Placebo intervention 3: Docetaxel (Taxotere®) intervention 4: Dexamethasone (pre- and post-medication for docetaxel)
32
Bridgewater | New Jersey | United States | -74.64815 | 40.60079 Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Macquarie Park | New South Wales | Australia | 151.12757 | -33.78105 Vienna | N/A | Austria | 16.37208 | 48.20849 São Paulo | N/A | Brazil | -46.63611 | -23.5475 Sofia | N/A | Bulgaria | 23.32415 | 42....
905
1
0.001105
1
NCT00532155
1COMPLETED
2011-10-01
2007-09-01
Sanofi
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
0.000195
[ 4 ]
493
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of the study is to determine whether aripiprazole provides additional clinical benefit to patients with Bipolar I disorder when combined with lithium or valproate over 12 weeks.
null
Bipolar Disorder Mania
null
2
arm 1: Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. arm 2: Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was prov...
[ 2, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 5-, 10-, or 15-mg oral tablets in titrated doses for 12 weeks intervention 2: Tablets, Oral, 0 mg, once daily, 12 weeks intervention 3: Participant's ongoing dose intervention 4: Participant's ongoing dose
intervention 1: Aripiprazole intervention 2: Placebo intervention 3: Lithium intervention 4: Valproate
73
Salzburg | N/A | Austria | 13.04399 | 47.79941 Vienna | N/A | Austria | 16.37208 | 48.20849 Hradec Králové | N/A | Czechia | 15.83277 | 50.20923 Litoměřice | N/A | Czechia | 14.1318 | 50.53348 Prague | N/A | Czechia | 14.42076 | 50.08804 Prague | N/A | Czechia | 14.42076 | 50.08804 Prague | N/A | Czechia | 14.42076 | 5...
369
1
0.00271
1
NCT00665366
1COMPLETED
2011-10-01
2008-06-01
Otsuka Pharmaceutical Development & Commercialization, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
0
0
0
0
0
0
0
0.000479
[ 4 ]
337
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to assess whether duloxetine is superior to placebo in the treatment of children and adolescents with major depressive disorder (MDD)
null
Major Depressive Disorder
null
3
arm 1: None arm 2: None arm 3: None
[ 2, 1, 0 ]
3
[ 0, 0, 0 ]
intervention 1: 30-120 mg, PO, QD, for up to 38 weeks intervention 2: Capsules identical in appearance, color, taste and smell to study drug, orally (PO), once daily (QD). Dose: placebo, 6 capsules, QD for 10 weeks intervention 3: 10-40 milligram (mg), PO, QD, for up to 38 weeks
intervention 1: duloxetine intervention 2: Placebo intervention 3: fluoxetine
59
Costa Mesa | California | United States | -117.91867 | 33.64113 Irvine | California | United States | -117.82311 | 33.66946 Palo Alto | California | United States | -122.14302 | 37.44188 Altamonte Springs | Florida | United States | -81.36562 | 28.66111 Fort Lauderdale | Florida | United States | -80.14338 | 26.12231 M...
598
17
0.028428
1
NCT00849901
1COMPLETED
2011-10-01
2009-03-01
Eli Lilly and Company
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
16
0
0
0
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0.017824
[ 3 ]
200
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
Obesity is a condition affecting one-third off the U.S. population and is a major risk actor for the development of Type 2 diabetes, hyperlipidemia (increased levels of fat in the blood), hypertension (high blood pressure), and other disorders of the heart and lungs. Individuals with the onset of obesity during childho...
Obesity is a condition affecting one-third of the adult U.S. population and is a major risk factor for the development of Type 2 diabetes, hyperlipidemia, hypertension, and other cardiovascular and respiratory disorders. Individuals with the onset of obesity during childhood or adolescence are at increased risk for obe...
Diabetes Mellitus Hypertension Metabolic Disease Obesity Sleep Apnea Syndrome
Dyslipidemia Race Body Fat Visceral Fat Sleep Apnea Fat-Soluble Vitamins Type 2 Diabetes Obesity Childhood Obesity
null
2
arm 1: Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program arm 2: Orlistat 120 mg TID for 6 months plus a behavioral weight loss program
[ 2, 0 ]
2
[ 0, 0 ]
intervention 1: Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months. intervention 2: Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months...
intervention 1: Orlistat intervention 2: Placebo
1
Bethesda | Maryland | United States | -77.10026 | 38.98067
200
0
0
0
NCT00001723
1COMPLETED
2011-10-01
1998-05-01
Jack Yanovski
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 ]
4,110
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The purpose of this randomized clinical trial is to determine if lowering homocysteine levels in renal transplant recipients with a multivitamin will reduce the occurrence of cardiovascular disease outcomes.
The hypothesis of the trial is as follows: Treatment with a high dose combination of folic acid, vitamin B6, and vitamin B12 will reduce the rate of pooled arteriosclerotic cardiovascular disease outcomes (i.e., pooled occurrence of non-fatal and fatal arteriosclerotic outcomes, including coronary heart, cerebrovascula...
Chronic Kidney Disease Cardiovascular Disease Death
homocysteine multi-vitamin cardiovascular disease renal transplant recipients
null
2
arm 1: Multivitamin with increased folic acid, vitamin B6 and vitamin B12 arm 2: Multivitamin devoid of folic acid and with estimated average requirement amounts of vitamin B6 and vitamin B12
[ 0, 1 ]
2
[ 0, 1 ]
intervention 1: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg intervention 2: Vitamin B6 (Pyridoxine HCl): 1....
intervention 1: High Dose Multivitamin intervention 2: Low Dose Multivitamin
30
Birmingham | Alabama | United States | -86.80249 | 33.52066 Phoenix | Arizona | United States | -112.07404 | 33.44838 Los Angeles | California | United States | -118.24368 | 34.05223 Los Angeles | California | United States | -118.24368 | 34.05223 San Francisco | California | United States | -122.41942 | 37.77493 Chica...
4,110
0
0
0
NCT00064753
1COMPLETED
2011-10-01
2002-05-01
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
12
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of plasma cells, either by killing the cells or by stopping them from dividing. Having a stem cell transplant to replace the blood-forming cells destroyed by chemotherapy, allows higher doses of chemotherapy to be given so that more plasma ...
OBJECTIVES: * Determine the feasibility and tolerability of second autologous stem cell transplantation in patients with persistent or recurrent AL amyloidosis. * Determine the response rate and durability of response in patients treated with this regimen. * Determine immune reconstitution in patients treated with thi...
Multiple Myeloma Plasma Cell Neoplasm
primary systemic amyloidosis
null
1
arm 1: Mobilization with filgrastim autologous stem cell transplantation with melphalan conditioning stem cell infusion
[ 0 ]
4
[ 2, 0, 3, 3 ]
intervention 1: 16mcg/kg IV daily beginning three days prior to stem cell collection through last day of stem cell collection intervention 2: 140-200 mcg/kg IV over two days intervention 3: infusion of previously collected stem cells on Day 0 intervention 4: infusion of previously collected stem cells on Day 0
intervention 1: filgrastim intervention 2: melphalan intervention 3: autologous stem cell transplantation intervention 4: stem cell infusion
1
Boston | Massachusetts | United States | -71.05977 | 42.35843
12
0
0
0
NCT00075608
6TERMINATED
2011-10-01
2001-08-01
Boston 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
[ 4 ]
72
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
true
0ALL
false
The purpose of this study is to assess whether children with moderate to severe bronchiolitis treated with standard racemic epinephrine therapy via 70:30 helium-oxygen (heliox) driven nebulization will have improvements in measurements of airway more rapidly than those treated with conventional air-oxygen driven nebuli...
null
Bronchiolitis
heliox bronchiolitis racemic epinephrine
null
2
arm 1: heliox-driven nebulizations for children with moderate to severe bronchiolitis arm 2: oxygen-driven nebulizations for children with moderate to severe bronchiolitis
[ 5, 5 ]
2
[ 0, 0 ]
intervention 1: continuous heliox therapy intervention 2: continuous oxygen therapy
intervention 1: heliox intervention 2: oxygen
1
Louisville | Kentucky | United States | -85.75941 | 38.25424
69
0
0
0
NCT00116584
1COMPLETED
2011-10-01
2004-12-01
University of Louisville
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
66
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The purpose of this study is to see if a drug, called methylprednisolone, is safe and effective in people with Hantavirus infection. Individuals 2 years of age or older are invited to participate in this study if their doctor suspects or knows they have Hantavirus infection. Volunteers will either be given methylpredni...
This study is a phase II, randomized, double-blind, placebo-controlled evaluation of intravenous methylprednisolone versus placebo in treatment of hantavirus cardiopulmonary syndrome (HCPS). Patients with suspected or known hantavirus will be randomized to receive intravenous methylprednisolone or placebo over 3 days. ...
Hantavirus Infections
hantaviruses, methylprednisolone, cardiopulmonary syndrome
null
2
arm 1: Methylprednisolone arm 2: Placebo
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Intravenous methylprednisolone 16 mg/kg/day for 3 days as follows: 8 mg/kg (up to 500 mg) given over first hour followed by 8 mg/kg over the next 23 hours; then 16 mg/kg (up to 1000 mg) on days 2 and 3 administered over 24 hours. intervention 2: Placebo
intervention 1: Methylprednisolone intervention 2: Placebo
1
Santiago | N/A | Chile | -70.64827 | -33.45694
66
0
0
0
NCT00128180
1COMPLETED
2011-10-01
2003-01-01
University of New Mexico
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 ]
46
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
To show an increase in annual growth rate 3 years after Visit 2. Annual growth rate in standard deviation (SD) after 3 years will be compared to growth rate before the start of GH treatment.
null
Endocrine System Diseases
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Adapted dosage based on IGF 1 level and weight Form: liquid; Dosage and Frequency: from 0.0033mg/kg/day to 0.0067 mg/kg/day; Duration: 3 years
intervention 1: Somatropin
18
Annemasse | N/A | France | 6.23775 | 46.19439 Besançon | N/A | France | 6.01815 | 47.24878 Bordeaux | N/A | France | -0.5805 | 44.84044 Bordeaux | N/A | France | -0.5805 | 44.84044 Bron | N/A | France | 4.91303 | 45.73865 Dijon | N/A | France | 5.01667 | 47.31667 Grenoble | N/A | France | 5.71479 | 45.17869 Lorient | N...
46
0
0
0
NCT00163215
1COMPLETED
2011-10-01
2005-01-01
Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
21
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
* To evaluate the effect of increasing the growth hormone dose on the statural response * To assess the value of early treatment during the course of arthritic disease by comparing the height acquired in the medium term by children in the two groups: treated from the start, or 1 year to 15 months after the diagnosis of...
This trial terminated on 10-Jun-2011 due to prolonged issues with drug accountability and data collection discrepancies. The decision to terminate was not based on any safety concerns.
Endocrine System Diseases
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Liquid, daily to final height Maximum Dosage: 50 µg/kg/day
intervention 1: Somatropin
1
Paris | N/A | France | 2.3488 | 48.85341
21
0
0
0
NCT00174291
6TERMINATED
2011-10-01
2002-03-01
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 ]
27
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
true
Two thirds or more of breast cancers are dependent on estrogen for growth. We use a number of estrogen-blocking medicines for treatment of metastatic breast cancer. The treatment response to these agents is unpredictable, however, and approximately one-third of patients with metastatic breast cancer with receptors for ...
All patients must have stopped their endocrine two to four weeks or longer prior to entry on study. Upon enrollment, patients will begin lapatinib at 1500 mg once a day orally. The original endocrine therapy will resume two weeks later. The lapatinib will be continued for a maximum of 26 weeks. A history, physical exa...
Metastatic Breast Cancer
breast cancer endocrine therapy drug resistance lapatinib epidermal growth factor receptor
null
1
arm 1: Subjects will continue on their prior endocrine therapy with the addition of lapatinib at 1500 mg once daily for 26 weeks or longer.
[ 0 ]
1
[ 0 ]
intervention 1: 1500 mg po daily for 26 weeks or longer
intervention 1: Lapatinib
3
Aurora | Colorado | United States | -104.83192 | 39.72943 Lebanon | New Hampshire | United States | -72.25176 | 43.64229 Lake Success | New York | United States | -73.71763 | 40.77066
27
0
0
0
NCT00225758
6TERMINATED
2011-10-01
2006-01-01
Gary Schwartz
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
25
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The primary objective of this study was to evaluate the safety and efficacy of the combination of fludarabine and cyclophosphamide in previously untreated CLL patients. Participants will receive fludarabine and cyclophosphamide on days 1, 2, and 3 of six 28-day cycles.
This single-arm study evaluated the safety and efficacy of the combination of fludarabine 25 mg/m2/d IV and cyclophosphamide 250 mg/m2/d SC in previously untreated CLL patients. Participants received fludarabine and cyclophosphamide on days 1, 2, and 3 of six 28-day cycles, followed by a no-treatment rest period (obser...
Leukemia B-cell Leukemia Chronic Leukemia Chronic Lymphocytic Leukemia (CLL)
null
1
arm 1: Fludarabine and cyclophosphamide days 1 to 3 for six 28-day cycles. Minimal residual disease positive responders continued on-treatment to receive alemtuzumab 30 mg weekly. MRD negative responders were observed.
[ 0 ]
3
[ 0, 0, 0 ]
intervention 1: 3 to 30 mg, IV intervention 2: \[(2R,3R,4S,5R)-5-(6-amino-2-fluoro-purin-9-yl)- 3,4-dihydroxy-oxolan-2-yl\]methoxyphosphonic acid intervention 3: (RS)-N,N-bis(2-chloroethyl)-1,3,2-oxazaphosphinan-2-amine 2-oxide
intervention 1: Alemtuzumab intervention 2: Fludarabine intervention 3: Cytoxan
1
Stanford | California | United States | -122.16608 | 37.42411
25
0
0
0
NCT00230282
1COMPLETED
2011-10-01
2004-07-01
Steven E. Coutre
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 ]
62
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The primary objective will be to assess progression-free survival (PFS) measured at 16 weeks following initiation of therapy with the combination of Avastin and erlotinib in patients with unresectable hepatocellular carcinoma (HCC). Progression-free survival is defined as the time from initiation of therapy until docum...
Liver cancer growth may be affected by a protein in the body called "vascular epidermal growth factor" (VEGF). A drug that blocks VEGF may be an effective treatment for liver cancer. Avastin is designed to block VEGF. Erlotinib hydrochloride is an investigational drug believed to work on cancer cells by affecting epide...
Hepatocellular Carcinoma Liver Cancer
Hepatocellular Carcinoma Liver Cancer Bevacizumab Anti-VEGF monoclonal antibody rhuMAb-VEGF Erlotinib Hydrochloride OSI-774 Tarceva Erlotinib Avastin
null
1
arm 1: Bevacizumab 10 mg/kg intravenous every 14 days, repeat cycle every 28 days; Erlotinib 150 mg orally every day continuous dosing.
[ 0 ]
2
[ 0, 0 ]
intervention 1: 10 mg/kg IV every 14 days, repeat cycle every 28 days intervention 2: 150 mg orally every day continuous dosing, repeat cycle every 28 days
intervention 1: Bevacizumab (Avastin) intervention 2: Erlotinib
1
Houston | Texas | United States | -95.36327 | 29.76328
59
0
0
0
NCT00242502
1COMPLETED
2011-10-01
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 ]
10
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying the side effects of imatinib mesylate and how well it works in treating patients with myelofibrosis.
OBJECTIVES: Primary * Determine the safety, efficacy, and tolerability of imatinib mesylate in patients with myelofibrosis with myeloid metaplasia. * Determine the 3-, 6-, and 12-month major and minor erythroid response rates in patients treated with this drug. Secondary * Determine reduction in marrow fibrosis in ...
Chronic Myeloproliferative Disorders
chronic idiopathic myelofibrosis polycythemia vera essential thrombocythemia
null
0
null
null
1
[ 0 ]
intervention 1: Once daily oral administration of Imatinib Mesylate at a dose of 600mg for 12 months.
intervention 1: imatinib mesylate
1
Portland | Oregon | United States | -122.67621 | 45.52345
10
0
0
0
NCT00245128
6TERMINATED
2011-10-01
2005-08-01
OHSU Knight Cancer Institute
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
8
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The combination of oxaliplatin and gemcitabine is highly active in a wide variety of tumors including pancreatic, germ cell, breast, biliary, mesothelioma (Mitchell et al, 2002), and lung. In the last study which utilized days 1 and 8 gemcitabine 1000 mg/m2 and days 1 and 8 oxaliplatin 65 mg/m2 in poor prognosis lung c...
null
Cancer of the Head and Neck
Cancer of the Head and Neck
null
1
arm 1: Gemcitabine given 1000 mg/m2 IV over 100 minutes Every 21 days. Oxaliplatin given 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days.
[ 0 ]
2
[ 0, 0 ]
intervention 1: 1000 mg/m2 IV over 100 minutes Every 21 days intervention 2: 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days
intervention 1: Gemcitabine intervention 2: Oxaliplatin
1
Orange | California | United States | -117.85311 | 33.78779
7
0
0
0
NCT00256295
6TERMINATED
2011-10-01
2005-04-01
Sai-Hong Ignatius Ou
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 ]
6
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
Oxaliplatin-containing regimens have been safely and successfully used in combination with concurrent radiation in treatment of solid tumors such as rectal and esophageal cancers. The Lyon R0-04 phase II trial utilized the combination of Oxaliplatin, infusional 5-fluorouracil (5-FU) and radiation in the treatment of re...
Adjuvant treatment of resected head and neck cancers The incidence of locoregional failures and distant metastasis is high after primary resection of squamous cell carcinoma of the head and neck (HNSCC), especially in patients with unfavorable prognostic factors such as residual disease, histological evidence of extrac...
Head and Neck Cancer
Head and Neck Cancer oxaliplatin resected squamous cell carcinoma Eloxatin™
null
1
arm 1: Oxaliplatin-70mg/m2 IV over 120 min once a week during radiation. Radiation-200 centigray (cGy) per day - Megavoltage equipment with energy of Cobalt 60 or higher - Daily from Monday to Friday.
[ 0 ]
2
[ 0, 3 ]
intervention 1: 70mg/m2 IV over 120 min once a week during radiation intervention 2: 200 cGy/day - Megavoltage equipment with energy of Cobalt 60 or higher - Daily from Monday to Friday
intervention 1: Oxaliplatin intervention 2: Radiation
1
Orange | California | United States | -117.85311 | 33.78779
6
0
0
0
NCT00256308
6TERMINATED
2011-10-01
2005-02-01
University of California, Irvine
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 ]
817
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
This randomized phase III trial is studying fludarabine, cyclophosphamide, and rituximab to see how well they work compared to fludarabine and cyclophosphamide in treating patients with B-cell chronic lymphocytic leukemia.
null
Leukemia
B-cell chronic lymphocytic leukemia stage I chronic lymphocytic leukemia stage II chronic lymphocytic leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia
null
2
arm 1: None arm 2: None
[ 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Intravenous repeating dose intervention 2: Intravenous repeating dose intervention 3: Intravenous repeating dose
intervention 1: Rituximab intervention 2: Cyclophosphamide intervention 3: Fludarabine Phosphate
162
Gosford | New South Wales | Australia | 151.34399 | -33.4244 Westmead - Wentworthville | New South Wales | Australia | N/A | N/A Brisbane | Queensland | Australia | 153.02809 | -27.46794 Brisbane | Queensland | Australia | 153.02809 | -27.46794 East Melbourne | Victoria | Australia | 144.9879 | -37.81667 Frankston | Vi...
800
0
0
0
NCT00281918
1COMPLETED
2011-10-01
2003-07-01
Hoffmann-La Roche
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
32
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
2MALE
false
The purpose of this research study is to determine if an investigational drug called Exisulind will extend the "off-treatment" period of patients receiving Intermittent Androgen Suppression (ADT). There is evidence suggesting that alternating between periods of treatment and no treatment with androgen suppressants may...
A study doctor will meet with you and ask you about your medical history, examine you, and explain the study. We will draw some blood for tests (about 4-6 tablespoons), including Prostate-Specific Antigen (PSA). If not already obtained, you will have a bone scan and a computed tomography scan (CT scan) to establish a b...
Prostate Cancer
null
1
arm 1: Patients will receive intermittent dosing of hormone therapy with commercially supplied luteinizing hormone-releasing hormone (LHRH) agonist and anti-androgen to be chosen by physician per standard of care. Exisulind will be started 3 months prior to the end of the second cycle of hormone therapy. Patients will ...
[ 0 ]
3
[ 0, 0, 0 ]
intervention 1: Oral antineoplastic agent that induces apoptosis in cancerous cells. intervention 2: Hormonal therapy to suppress testosterone as a standard treatment for Prostate Cancer. intervention 3: Hormonal therapy used as lead in treatment with luteinizing hormone-releasing hormone (LHRH) agonist to prevent the ...
intervention 1: Exisulind intervention 2: luteinizing hormone-releasing hormone (LHRH) agonist intervention 3: Antiandrogen
1
Seattle | Washington | United States | -122.33207 | 47.60621
32
0
0
0
NCT00283803
1COMPLETED
2011-10-01
2002-03-12
University of Washington
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 ]
13
NON_RANDOMIZED
CROSSOVER
6HEALTH_SERVICES_RESEARCH
0NONE
true
0ALL
false
Examine the effects of cola on risks of kidney stones
Prospective crossover study examining the risks of cola on stone risk factors.
Kidney Stone
urolithiasis, cola
null
2
arm 1: Subjects will be given 500cc of Cola twice daily. arm 2: Subjects will be given 500cc of deionized water.
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Subjects will be given 500cc of Cola beverage twice daily to be ingested with breakfast and dinner for six days while on a metabolic diet.There will be a three weeks interval before crossover to the other treatment arm. intervention 2: Subjects will be given 500cc of deionized water to be ingested twice...
intervention 1: Cola beverage intervention 2: Deionized water
1
Atlanta | Georgia | United States | -84.38798 | 33.749
26
0
0
0
NCT00289120
1COMPLETED
2011-10-01
2003-11-01
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
[ 2 ]
20
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
1FEMALE
false
RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy in different ways, such as into the breast ducts, may kill more tumor cells. Giving chemotherapy before surge...
OBJECTIVES: Primary * Evaluate the feasibility, safety, and maximum tolerated dose of intraductal pegylated doxorubicin HCl liposome in women with invasive breast cancer awaiting mastectomy. Secondary * Determine the pharmacokinetics of intraductal pegylated doxorubicin HCl liposome, including serial plasma concent...
Breast Cancer
stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIC breast cancer stage IV breast cancer breast cancer in situ ductal breast carcinoma in situ
null
2
arm 1: Participants received intraductal administration of dextrose or dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD) prior to conventional surgery for breast cancer. arm 2: Participants receiving standard intravenous administration of pegylated liposomal doxorubicin prior to breast biopsy for dru...
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Patients will receive PLD intraductally according to the dose escalation schema (Dose Level -1=1 mg, Dose Level 1=2 mg, Dose Level 2= 5mg, Dose Level 3=10 mg). The PLD dose will be diluted in 5% dextrose in water and will be mixed for a total volume of 5 ml. The PLD will be administered via a breast duc...
intervention 1: Intraductal arm intervention 2: Intravenous arm
2
Indianapolis | Indiana | United States | -86.15804 | 39.76838 Baltimore | Maryland | United States | -76.61219 | 39.29038
15
0
0
0
NCT00290732
1COMPLETED
2011-10-01
2005-11-01
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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 ]
40
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
The purpose of this study is to determine if treating delirious intensive care unit patients with haloperidol improves mortality.
Intensive care unit delirium is a serious medical condition that is associated with increased morbidity and mortality. In this study, 304 delirious mechanically ventilated subjects will be randomized to haloperidol 5mg IV every 12 hours or placebo to determine if treatment with haloperidol improves short and long-term ...
Delirium
Delirium Mechanical ventilation Intensive care Haloperidol
null
2
arm 1: Once diagnosed as delirious, randomized to haloperidol 5 mg IV arm 2: once diagnosed as delirious, received 5 mg saline placebo
[ 0, 2 ]
2
[ 0, 10 ]
intervention 1: Aim #1. To conduct a RCT of IV haloperidol vs. placebo for the treatment of delirium in mechanically ventilated ICU patients. Patients in the cohort study that go on to develop delirium will be enrolled in a RCT comparing treatment with scheduled haloperidol vs. placebo. By comparing differences between...
intervention 1: haloperidol intervention 2: Saline placebo
0
null
29
0
0
0
NCT00300391
6TERMINATED
2011-10-01
2006-03-01
University of Pittsburgh
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
1,230
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
The primary objective of this study is to evaluate the efficacy and safety of ustekinumab (CNTO 1275) in the treatment of patients with moderate to severe plaque psoriasis.
Although numerous therapeutic options exist for the treatment of psoriasis, there is still a significant unmet medical need due to the limited effectiveness and/or significant side effect profile of current treatment options. Preclinical studies and early phase clinical studies suggest that interleukins-12 and -23, two...
Psoriasis
Moderate to Severe Plaque-Type Psoriasis interleukin 23 IL-12 interleukin-12 interleukin-23 CNTO1275 biologic Psoriasis CNTO 1275 IL23 interleukin 12 IL-23 IL12 ustekinumab
null
3
arm 1: None arm 2: None arm 3: None
[ 2, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Placebo at Weeks 0 and 4 and blinded SC injections of ustekinumab, 45 or 90 mg, at Weeks 12 and 16; followed by a dosing regimen to be determined by patient's response status for Weeks 28 to 52; followed by unblinded dosing that may be adjusted at the investigator's discretion for Weeks 52 to 264 interv...
intervention 1: Placebo; Ustekinumab (CNTO 1275) 45 or 90 mg intervention 2: Ustekinumab (CNTO 1275) 45 mg intervention 3: Ustekinumab (CNTO 1275) 90 mg
62
Birmingham | Alabama | United States | -86.80249 | 33.52066 Little Rock | Arkansas | United States | -92.28959 | 34.74648 La Jolla | California | United States | -117.2742 | 32.84727 Los Angeles | California | United States | -118.24368 | 34.05223 San Diego | California | United States | -117.16472 | 32.71571 Jacksonvi...
2,438
0
0
0
NCT00307437
1COMPLETED
2011-10-01
2005-05-01
Centocor Research & Development, 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 ]
1,779
RANDOMIZED
PARALLEL
4SUPPORTIVE_CARE
2DOUBLE
false
0ALL
true
The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid (Zometa®) in the treatment of bone metastases (lytic bone lesions from multiple myeloma) in subjects with advanced cancer and multiple myeloma (excluding breast and prostate cancer)
null
Bone Metastases
Bone metastases lytic bone lesions advanced cancer multiple myeloma lymphoma solid tumors skeletal related events skeletal fractures spinal cord compressions, radiation to bone surgery to bone, bisphosphonates denosumab
null
2
arm 1: denosumab placebo with active zoledronic acid arm 2: active denosumab with zoledronic acid placebo
[ 1, 0 ]
2
[ 2, 0 ]
intervention 1: 120 milligrams by subcutaneous injection every 4 weeks intervention 2: 4 milligrams intravenous Zoledronic Acid over minimum 15 minutes every 4 weeks
intervention 1: Denosumab intervention 2: Zoledronic Acid
0
null
1,756
0
0
0
NCT00330759
1COMPLETED
2011-10-01
2006-06-01
Amgen
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
36
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The primary objective of this study was to demonstrate the superiority of levodopa - carbidopa intestinal gel over treatment with optimized oral levodopa/carbidopa during 12 weeks.
Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387) were 2 identically designed, Phase 3, 12-week, randomized, double-blind, double-dummy, parallel-group, multicenter studies recruiting subjects from distinct sites. These studies evaluated the efficacy, safety, and tolerability of levodopa-carbidopa intes...
Advanced Parkinson's Disease
carbidopa levodopa-carbidopa levodopa levodopa/carbidopa suspension dyskinesia Duodopa levodopa-carbidopa intestinal gel Severe Motor Fluctuations DUOPA
null
2
arm 1: Participants were randomized to LCIG (levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG. arm 2: Participants were randomized to placebo intestinal gel a...
[ 0, 1 ]
7
[ 0, 0, 0, 0, 1, 1, 1 ]
intervention 1: infusion should be kept within a range of 0.5-10 mL/hour (10-200 mg levodopa/hour) and is usually 2-6 mL/hour (40-120 mg levodopa per/hour) intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: percutaneous endoscopic gastrostomy tube intervention 7: jejunal...
intervention 1: Levodopa carbidopa intestinal gel (LCIG) intervention 2: Placebo gel intervention 3: Levodopa carbidopa (LC) oral encapsulated immediate release (IR) tablets intervention 4: Placebo (PBO) oral capsules intervention 5: CADD-Legacy® 1400 ambulatory infusion pump intervention 6: PEG tube intervention 7: J-...
15
Los Angeles | California | United States | -118.24368 | 34.05223 Englewood | Colorado | United States | -104.98776 | 39.64777 Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 Bradenton | Florida | United States | -82.57482 | 27.49893 Gainesville | Florida | United States | -82.32483 | 29.65...
71
0
0
0
NCT00357994
1COMPLETED
2011-10-01
2009-01-01
AbbVie (prior sponsor, Abbott)
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
214
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
1FEMALE
true
This is a phase IIb, randomized, parallel-group, noncomparative, multicenter, pilot study designed to evaluate the safety and efficacy of bevacizumab with or without (+/-) trastuzumab administered with three different docetaxel-based combination regimens for the adjuvant treatment of participants with node positive or ...
In this study, participants were stratified according to HER2 status at the time of enrollment. HER2-negative participants were randomized in a 1:1 ratio to either stratum 1 (AC-\>T sequential + bevacizumab) or stratum 2 (TAC + bevacizumab). All HER2-positive participants were assigned to stratum 3 (TCH + bevacizumab)....
Breast Cancer
null
3
arm 1: HER2-negative participants administered * doxorubicin and cyclophosphamide (AC) + bevacizumab for 4 cycles followed by * docetaxel (T) + bevacizumab for 4 cycles followed by * bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed arm 2: HE...
[ 0, 0, 0 ]
6
[ 0, 0, 0, 0, 0, 0 ]
intervention 1: For every 3-week cycle * bevacizumab 15 mg/kg infused intravenously (IV) on Day 1 followed by * doxorubicin 60 mg/m\^2 IV push or infusion followed by cyclophosphamide 600 mg/m\^2 IV push or infusion * Prophylactic G-CSF was administered within 24 hours following each cycle of chemotherapy but no great...
intervention 1: Doxorubicin and cyclophosphamide (AC) + bevacizumab intervention 2: Docetaxel (T) + bevacizumab intervention 3: Docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab intervention 4: Docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab intervention 5: Bevacizumab and trastuzumab maintenance the...
1
Bridgewater | New Jersey | United States | -74.64815 | 40.60079
212
0
0
0
NCT00365365
1COMPLETED
2011-10-01
2006-08-01
Sanofi
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
416
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
null
To assess whether daily treatment with RAD001 could slow the growth and spread of metastatic carcinoma of the kidney. The safety of RAD001 was also to be studied in this trial.
null
Metastatic Renal Cell Carcinoma
advanced kidney cancer everolimus kidney cancer oral therapy
null
2
arm 1: The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in ...
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: The dose of RAD001 was 10 mg/day. Patients were instructed to take two tablets (5 mg each) by mouth every day. intervention 2: None
intervention 1: RAD001 intervention 2: Placebo
93
Fayetteville | Arkansas | United States | -94.15743 | 36.06258 Duarte | California | United States | -117.97729 | 34.13945 Sacramento | California | United States | -121.4944 | 38.58157 San Francisco | California | United States | -122.41942 | 37.77493 Santa Monica | California | United States | -118.49138 | 34.01949 O...
411
0
0
0
NCT00410124
1COMPLETED
2011-10-01
2006-11-01
Novartis Pharmaceuticals
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
19
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
null
The main purpose of this study is to begin to collect information and try to learn whether or not the combination of oxaliplatin, gemcitabine and bevacizumab works in treating women with recurrent mullerian carcinoma. We will also collect more information about the safety and side effects of this combination of drugs. ...
* The study treatment is divided into periods called cycles. Each cycle is 28 days long. Participants will be given the study drugs intravenously on day 1 and day 15 of each cycle. * Gemcitabine will be given first, over a period of 30 minutes. Then oxaliplatin over a period of 2 hours. Finally, bevacizumab will be giv...
Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer
mullerian carcinoma
null
1
arm 1: All patients received oxaliplatin, gemcitabine, and bevacizumab
[ 0 ]
3
[ 0, 0, 0 ]
intervention 1: Given intravenously over 30 minutes on day 1 and day 15 of a 28-day cycle. Participants can continue study treatment as long as there is no disease progression. intervention 2: Given intravenously over 2 hours on day 1 and day 15 of a 28-day cycle. Participants can continue study treatment as long as th...
intervention 1: Gemcitabine intervention 2: Oxaliplatin intervention 3: Bevacizumab
2
Boston | Massachusetts | United States | -71.05977 | 42.35843 Boston | Massachusetts | United States | -71.05977 | 42.35843
19
0
0
0
NCT00418093
6TERMINATED
2011-10-01
2006-09-01
Dana-Farber Cancer Institute
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
483
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
The purpose of the study is to assess the overall survival and progression free survival of patients treated with Litx™ + chemotherapy versus chemotherapy alone in the treatment of Colorectal Cancer with recurrent liver metastases, and to demonstrate the safety of Litx™ therapy. Litx™ consists of a light-activated dru...
Randomized, stratified, two arm study: * Litx™ and chemotherapy arm (FOLFOX4 or FOLFIRI) * Chemotherapy only arm (FOLFOX4 or FOLFIRI) For patients who have progressed on FOLFIRI, they will be treated with Litx™ plus FOLFOX4 versus FOLFOX4 alone; and for patients who have progressed on FOLFOX, they will be treated wit...
Liver Metastases Colorectal Neoplasms Neoplasm Metastasis Neoplasm Recurrence, Local
Liver neoplasms Liver metastases MCRC Litx™ LS11 Colorectal cancer with recurrent liver metastases
null
2
arm 1: None arm 2: None
[ 0, 1 ]
5
[ 0, 3, 1, 0, 0 ]
intervention 1: LS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes). intervention 2: Light Source placement will be conducted under placement imaging using ultrasound or CT guidance. No more than four Light Sources will be used at a single treatment session. The Light Sources may ...
intervention 1: Talaporfin sodium intervention 2: Percutaneous placement of device in liver metastases intervention 3: Interstitial light emitting diodes intervention 4: FOLFOX4 regimen intervention 5: FOLFIRI regimen
57
Feldkirch | N/A | Austria | 9.6 | 47.23306 Vienna | N/A | Austria | 16.37208 | 48.20849 Mostar | N/A | Bosnia and Herzegovina | 17.80806 | 43.34333 Sarajevo | N/A | Bosnia and Herzegovina | 18.35644 | 43.84864 Karlovac | N/A | Croatia | 15.55 | 45.49167 Zagreb | N/A | Croatia | 15.97798 | 45.81444 Zagreb | N/A | Croati...
454
0
0
0
NCT00440310
1COMPLETED
2011-10-01
2007-02-01
Light Sciences Oncology
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 ]
299
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
The primary objective of the study was to characterize the difference in prepubescent growth velocity in children 3 to 9 years of age with perennial allergic rhinitis (PAR) treated with triamcinolone acetonide (TAA) nasal spray (NASACORT® AQ 110 μg treatment group) or placebo (NASACORT® AQ placebo group) for 12-months....
The study consisted of: * a 4- to 6-month screening/baseline period * a 12-month (up to Day 360+/-5 days) double-blind treatment period starting on Day 1 * a 2-month follow-up period (up to Day 420+/-5 days)
Rhinitis, Allergic, Perennial
null
2
arm 1: 3 to 9 year old participants with Perennial Allergic Rhinitis (PAR) administered * Placebo in the baseline/screening period to demonstrate administration of investigational product (IP) with the nasal spray bottle * Placebo in the double-blind treatment period All participants were provided Children's Claritin...
[ 2, 1 ]
4
[ 10, 10, 0, 0 ]
intervention 1: Placebo to TAA-AQ was administered once at the study site in each nostril during the baseline/screening period to demonstrate intranasal IP administration intervention 2: Placebo to TAA-AQ was administered intranasally once daily in each nostril during the double-blind period intervention 3: 110 μg TAA-...
intervention 1: Placebo intervention 2: Placebo intervention 3: TAA-AQ, Nasacort® AQ intervention 4: Claritin®
1
Bridgewater | New Jersey | United States | -74.64815 | 40.60079
293
0
0
0
NCT00449072
1COMPLETED
2011-10-01
2007-03-01
Sanofi
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
-0
[ 4 ]
41
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to examine the pharmacokinetics, pharmacodynamics, and pharmacogenomics of dexmedetomidine in the following three pediatric patient populations: patients with bi-directional cavopulmonary anastomosis or a Fontan procedure, patients who have had a cardiac transplant, and patients with otherw...
While opioid analgesia is currently the mainstream for management of pain in the perioperative setting, it often leads to significant morbidity, including opioid tolerance and hyperalgesia. Looking at ways to decrease the need for opioids with the use of adjunct medications allows for the long-term goal of decreasing p...
Cardiac Transplant Patent Ductus Arterious Atrial Septal Defect Bidirectional Cavopulmonary Anastomosis
Dexmedetomidine Congenital heart disease pharmacokinetics pharmacodynamics pediatric Bidirectional cavopulmonary anastomosis Fontan physiology Cardiac transplant
null
3
arm 1: diagnostic cardiac catheterization in children with a transplanted heart arm 2: diagnostic cardiac catheterization in children with a transplanted ventricle arm 3: diagnostic cardiac catheterization in children with normal cardiac physiology
[ 0, 0, 5 ]
1
[ 0 ]
intervention 1: Dexmedetomidine load of 1 microgram/kilogram over 10 minutes, followed by a 1 microgram/kilogram/hour infusion during the time of catheterization
intervention 1: Dexmedetomidine
1
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
41
0
0
0
NCT00480740
1COMPLETED
2011-10-01
2006-12-01
Children's National 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
[ 2, 3 ]
120
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
The primary purpose of this study is to determine the 2-year survival rate of both of the chemotherapy regimens in patients with inoperable non-small-cell lung cancer.
null
Non-Small-Cell Lung Cancer
null
2
arm 1: Pemetrexed + Carboplatin arm 2: Pemetrexed + Cisplatin
[ 0, 0 ]
4
[ 0, 0, 0, 4 ]
intervention 1: Phase 1 - 500 milligram/meter squared (mg/m²), administered intravenously, every 21 days for 3 cycles Phase 2 - 500 mg/m², administered intravenously, every 21 days for 3 cycles Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after...
intervention 1: pemetrexed intervention 2: cisplatin intervention 3: carboplatin intervention 4: radiation therapy
11
Los Angeles | California | United States | -118.24368 | 34.05223 Wichita | Kansas | United States | -97.33754 | 37.69224 St Louis | Missouri | United States | -90.19789 | 38.62727 Las Vegas | Nevada | United States | -115.13722 | 36.17497 Burlington | North Carolina | United States | -79.4378 | 36.09569 Memphis | Tenne...
120
0
0
0
NCT00482014
1COMPLETED
2011-10-01
2007-05-01
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 ]
58
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
2MALE
false
The purpose of this study is to evaluate the efficacy and safety of abiraterone acetate in participants with advanced prostate cancer (a disease in which cells in the prostate gland become abnormal and start to grow uncontrollably, forming tumors).
This is an open-label (all people know the identity of the intervention), single-arm, multicenter (when more than one hospital or medical school team work on a medical research study) study to evaluate the anti-tumor activities and safety of abiraterone acetate in participants with prostate cancer who have failed andro...
Prostatic Neoplasms Prostate Cancer
Prostatic Neoplasms Prostate cancer Abiraterone acetate CB7630 Prednisone
null
1
arm 1: Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) will be administered once daily along with 5 mg oral prednisolone tablet administered twice daily for 28-days dosing cycle and will be continued until disease progression or unacceptable toxicity.
[ 0 ]
2
[ 0, 0 ]
intervention 1: Abiraterone acetate oral tablets 250 milligram (mg) each will be administered at a total dose of 1000 mg until documented disease progression or unacceptable toxicity. intervention 2: Prednisone/Prednisolone 5 mg tablet will be taken orally twice daily.
intervention 1: Abiraterone acetate intervention 2: Prednisone
14
Los Angeles | California | United States | -118.24368 | 34.05223 Los Angeles | California | United States | -118.24368 | 34.05223 San Francisco | California | United States | -122.41942 | 37.77493 San Francisco | California | United States | -122.41942 | 37.77493 Baltimore | Maryland | United States | -76.61219 | 39.29...
58
0
0
0
NCT00485303
1COMPLETED
2011-10-01
2007-06-01
Cougar Biotechnology, 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 ]
1,020
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
1\) To evaluate the effectiveness of AST-120 (spherical carbon adsorbent) added to standard-of-care therapy in moderate to severe Chronic Kidney Disease (CKD), on time to first occurrence of any event of the triple composite outcome of initiation of dialysis, kidney transplant or doubling of serum creatinine (sCr) when...
null
Chronic Kidney Disease
Kidney Diseases
null
2
arm 1: None arm 2: None
[ 2, 0 ]
2
[ 0, 0 ]
intervention 1: 9g /day (3 times a day) intervention 2: 9g /day (3 times a day)
intervention 1: Placebo intervention 2: AST-120
105
Phoenix | Arizona | United States | -112.07404 | 33.44838 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Alhambra | California | United States | -118.12701 | 34.09529 Covina | California | United States | -117.89034 | 34.09001 Glendale | California | United States | -118.25508 | 34.14251 Los Angeles | Ca...
1,016
0
0
0
NCT00500682
1COMPLETED
2011-10-01
2007-07-01
Mitsubishi Tanabe Pharma Corporation
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
5
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The goal of this clinical research study is to learn if giving Avastin (bevacizumab) with standard chemotherapy and a blood stem cell transplant, in patients with an advanced solid tumor, can help to shrink the tumor or slow its growth. The safety of this treatment will also be studied.
The Study Drugs: Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels. The combination of standard chemotherapy drugs (fludarabine and melphalan) used for this study may help to improve the chances of your body accepting the stem cell transplant. Fludarabi...
Breast Cancer Ovarian Cancer
Breast Cancer Ovarian Cancer Stem Cell Transplantation Bevacizumab Fludarabine Melphalan Avastin Thymoglobulin ATG Antithymocyte Globulin Allogeneic Hematopoietic Stem Cell Transplantation AHSCT
null
1
arm 1: Bevacizumab 10 mg/kg intravenous (IV) on Day 1; Fludarabine 25 mg/m\^2 IV Daily over 5 Days; Melphalan 70 mg/m\^2 IV Daily over 2 Days; Thymoglobulin 0.5 mg/kg IV on Day - 3, 1.5 mg/kg IV on Day - 2, and 2 mg/kg IV on Day -1; plus Allogeneic Hematopoietic Stem Cell Transplantation on Day 8.
[ 0 ]
5
[ 0, 3, 0, 0, 0 ]
intervention 1: 10 mg/kg IV Daily Over 30 Minutes for 1 Day intervention 2: Stem Cell Transplantation on Day 8. intervention 3: 25 mg/m\^2 IV Daily Over 30 Minutes for 5 Days intervention 4: 70 mg/m\^2 IV Daily Over 30 Minutes for 2 Days intervention 5: 0.5 mg/kg IV on Day - 3, 1.5 mg/kg IV on Day - 2, and 2 mg/kg IV o...
intervention 1: Bevacizumab intervention 2: Allogeneic Hematopoietic Stem Cell Transplantation intervention 3: Fludarabine intervention 4: Melphalan intervention 5: Thymoglobulin
1
Houston | Texas | United States | -95.36327 | 29.76328
5
0
0
0
NCT00523809
6TERMINATED
2011-10-01
2007-08-01
M.D. Anderson Cancer Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
22
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving erlotinib together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving erlotinib t...
OBJECTIVES: Primary * Assess the overall survival of older patients with stage I-IV squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction treated with erlotinib hydrochloride in combination with radiotherapy. Secondary * Assess the proportion of patients achieving mucosal complete ...
Esophageal Cancer
adenocarcinoma of the esophagus squamous cell carcinoma of the esophagus stage I esophageal cancer stage II esophageal cancer stage III esophageal cancer stage IV esophageal cancer
null
1
arm 1: Patients receive oral erlotinib hydrochloride once daily for 1 year
[ 0 ]
3
[ 0, 10, 4 ]
intervention 1: Oral intervention 2: Correlative Study intervention 3: Radiation Treatment
intervention 1: erlotinib hydrochloride intervention 2: immunohistochemistry staining method intervention 3: radiation therapy
1
Buffalo | New York | United States | -78.87837 | 42.88645
17
0
0
0
NCT00524121
1COMPLETED
2011-10-01
2006-03-01
Roswell Park Cancer Institute
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
157
NA
SINGLE_GROUP
0TREATMENT
1SINGLE
false
0ALL
false
Rollover study for subjects in prior VEGF Trap-Eye Phase I and II studies. Primary objective is to assess long-term safety and tolerability of continuing intravitreal treatment in subjects with wet age-related macular degeneration.
Randomized, Single-Masked Phase II study for subjects previously enrolled in Phase I and II studies for wet age-related macular degeneration with VEGF Trap-Eye intravitreal injection as treatment.Long term (3 years) treatment is intended to measure safety and tolerability, as well as frequency of re-treatment and the e...
Macular Degeneration
VEGF Trap-Eye Macular Degeneration AMD Neovascular Age-Related Macular Degeneration
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Intravitreal injection
intervention 1: VEGF Trap Eye
33
Peoria | Arizona | United States | -112.23738 | 33.5806 Phoenix | Arizona | United States | -112.07404 | 33.44838 Tucson | Arizona | United States | -110.92648 | 32.22174 Beverly Hills | California | United States | -118.40036 | 34.07362 Loma Linda | California | United States | -117.26115 | 34.04835 Palm Springs | Cal...
157
0
0
0
NCT00527423
1COMPLETED
2011-10-01
2007-08-01
Regeneron 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
[ 0 ]
33
NA
SINGLE_GROUP
7BASIC_SCIENCE
0NONE
false
0ALL
true
Asthma is a common respiratory disease of unknown etiology which currently affects approximately 7.5 % of the adult population ( ). Asthma is an inflammatory disorder of the airways. Airway inflammation is evident not only in patients with fatal asthma but also in mild asthmatics ( ). Oxidant stress, defined as inadequ...
null
Allergic Asthma
Asthma Allergy Atopy Vitamin E GSTP1 Oxidative stress
null
1
arm 1: 1500 units daily for 16 weeks
[ 0 ]
1
[ 0 ]
intervention 1: 1500 units daily for 16 weeks
intervention 1: Natural source d-α-tocopheryl acetate
1
Nashville | Tennessee | United States | -86.78444 | 36.16589
33
0
0
0
NCT00581048
1COMPLETED
2011-10-01
2006-12-01
Vanderbilt University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0