FEATURE_phases
list
FEATURE_enrollmentCount
int64
FEATURE_allocation
string
FEATURE_interventionModel
string
FEATURE_primaryPurpose
class label
FEATURE_masking
class label
FEATURE_healthyVolunteers
bool
FEATURE_sex
class label
FEATURE_oversightHasDmc
bool
FEATURE_briefSummary
string
FEATURE_detailedDescription
string
FEATURE_conditions
string
FEATURE_conditionsKeywords
string
FEATURE_protocolPdfText
string
FEATURE_numArms
int64
FEATURE_armDescriptions
string
FEATURE_armGroupTypes
list
FEATURE_numInterventions
int64
FEATURE_interventionTypes
list
FEATURE_interventionDescriptions
string
FEATURE_interventionNames
string
FEATURE_numLocations
int64
FEATURE_locationDetails
string
LABEL_ct_level_ade_population
int64
LABEL_sum_dosing_errors
int64
LABEL_dosing_error_rate
float32
LABEL_wilson_label
int64
METADATA_nctId
string
METADATA_overallStatus
class label
METADATA_completionDate
date32
METADATA_startDate
date32
METADATA_leadSponsorName
string
METADATA_leadSponsorClass
class label
METADATA_hasProtocol
bool
METADATA_hasSap
bool
METADATA_hasIcf
bool
METADATA_protocolPdfLinks
string
METADATA_count_Accidental drug intake by child
int64
METADATA_count_Accidental overdose
int64
METADATA_count_Accidental overdose (therapeutic agent)
int64
METADATA_count_Accidental underdose
int64
METADATA_count_Deliberate overdose
int64
METADATA_count_Dose calculation error
int64
METADATA_count_Drug administration error
int64
METADATA_count_Drug overdose
int64
METADATA_count_Drug overdose accidental
int64
METADATA_count_Extra dose administered
int64
METADATA_count_Incorrect dosage administered
int64
METADATA_count_Incorrect dose administered
int64
METADATA_count_Incorrect drug administration duration
int64
METADATA_count_Incorrect drug administration rate
int64
METADATA_count_Incorrect product administration duration
int64
METADATA_count_Intentional overdose
int64
METADATA_count_Medication error
int64
METADATA_count_Medication monitoring error
int64
METADATA_count_Multiple drug overdose
int64
METADATA_count_Multiple drug overdose accidental
int64
METADATA_count_Multiple drug overdose intentional
int64
METADATA_count_Multiple use of single-use product
int64
METADATA_count_Non-accidental overdose
int64
METADATA_count_Overdose
int64
METADATA_count_Overdose NOS
int64
METADATA_count_Overmedication
int64
METADATA_count_Prescribed overdose
int64
METADATA_count_Treatment noncompliance
int64
METADATA_count_Underdose
int64
METADATA_count_Unintentional medical device removal
int64
METADATA_count_Unintentional medical device removal by patient
int64
METADATA_wilson_lower_bound
float32
[ 3 ]
80
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The investigators hypothesize that patients receiving citalopram in combination with lithium will have a greater reduction in depressive symptoms than patients receiving citalopram in combination with placebo.
null
Major Depressive Disorder Dysthymia Depression Not Otherwise Specified Borderline Personality Disorder
hopelessness alone sad troubled depression
null
2
arm 1: None arm 2: None
[ 2, 1 ]
3
[ 0, 0, 0 ]
intervention 1: 300 mg one time per day for 4 weeks intervention 2: Take one time daily for 4 weeks intervention 3: All patients will be administered Citalopram 20 mg to to be taken once daily, by mouth for the duration of the double-blind treatment phase (4 weeks)
intervention 1: Lithium Carbonate intervention 2: Placebo intervention 3: Citalopram
2
San Diego | California | United States | -117.16472 | 32.71571 Bellevue | Washington | United States | -122.20068 | 47.61038
80
0
0
0
NCT01189812
1COMPLETED
2011-01-01
2010-03-01
Columbia Northwest Pharmaceuticals
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
169
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy in topical administration of differing dosing regimens of ISV-303 compared to vehicle and Xibrom™ when dosed for 2 weeks in post-cataract-surgery volunteers.
null
Ocular Inflammation
null
4
arm 1: None arm 2: None arm 3: None arm 4: None
[ 0, 0, 1, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 0.075% of bromfenac in DuraSite dosed QD intervention 2: 0.075% of bromfenac in DuraSite dosed BID intervention 3: Vehicle dosed BID intervention 4: 0.09% bromfenac dosed BID
intervention 1: ISV-303 intervention 2: ISV-303 intervention 3: DuraSite Vehicle intervention 4: Xibrom™
0
null
169
0
0
0
NCT01190878
1COMPLETED
2011-01-01
2010-08-01
Sun Pharmaceutical Industries 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
[ 0 ]
52
RANDOMIZED
PARALLEL
4SUPPORTIVE_CARE
4QUADRUPLE
false
0ALL
false
The purpose of this study is to determine if the antisialagogues (anti-salivary agents), Atropine and Glycopyrrolate, are effective in reducing hypersalivation when sedating patients with Ketamine for procedural sedation in the emergency department or abscess clinic. The investigators will measure salivary flow rate by...
Ketamine is a common sedation agent used in the pediatric emergency department for a variety of procedures, used in clinical practice since 1970. One potential side effect of Ketamine is hypersalivation, potentially leading to laryngospasms. To prevent hypersalivation (and reduce the potential for laryngospasms), an an...
Sialorrhea
Hypersalivation Conscious Sedation Procedural Sedation Ketamine Atropine Glycopyrrolate
null
3
arm 1: Normal Saline 0.9% will act as a placebo. Two ml of normal saline 0.9% will be administered intravenously 30 minutes prior to the administration of the ketamine. arm 2: Atropine will be administered as a single dose of 0.01 mg/kg, with a minimum of dosage of 0.1 mg and a maximum dosage of 0.4 mg, intravenously 3...
[ 2, 1, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Atropine will be given at 0.01mg/kg with a minimum dosage of 0.1mg and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine. intervention 2: Glycopyrrolate will be given at 0.01mg/kg with no minimum dosage and a maximum dosage of 0.4mg. Thi...
intervention 1: Atropine (0.01mg/kg) intervention 2: Glycopyrrolate (0.01mg/kg) intervention 3: Normal saline 0.9%
1
Dallas | Texas | United States | -96.80667 | 32.78306
52
0
0
0
NCT01191398
1COMPLETED
2011-01-01
2010-06-01
Craig J. Huang
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 ]
120
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
efficacy study in patients with moderate to severe plaque psoriasis.
A Double-Blind, Vehicle-Controlled, Randomized, Parallel Design, Multiple-Site Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone 0.25% Topical Spray in Patients with Moderate to Severe Plaque Psoriasis
Psoriasis
null
2
arm 1: Desoximetasone Spray 0.25% arm 2: vehicle
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days intervention 2: Placebo administered to affected area twice a day for 28 days
intervention 1: Desoximetasone Spray 0.25% intervention 2: placebo comparator
0
null
120
0
0
0
NCT01206387
1COMPLETED
2011-01-01
2010-08-01
Sun Pharmaceutical Industries, 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 ]
120
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
The objective of this study is to demonstrate that desoximetasone 0.25% topical spray is effective for the treatment of patients with moderate to severe plaque psoriasis.
null
Psoriasis
null
2
arm 1: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days arm 2: Placebo administered to affected area twice a day for 28 days
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days intervention 2: Placebo administered to affected area twice a day for 28 days
intervention 1: Desoximetasone Spray 0.25% intervention 2: placebo
1
Hazleton | Pennsylvania | United States | -75.97465 | 40.95842
120
0
0
0
NCT01206660
1COMPLETED
2011-01-01
2010-08-01
Sun Pharmaceutical Industries, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
11
NA
SINGLE_GROUP
7BASIC_SCIENCE
0NONE
false
0ALL
false
The purpose of this study is to evaluate whether tasisulam acts as an inducer of CYP3A using midazolam as a sensitive and specific probe substrate of CYP3A. The study will also assess the safety and tolerability of tasisulam and midazolam given in combination and document any antitumor activity with tasisulam.
null
Advanced Cancer
Metastatic Tumors Lymphoma
null
1
arm 1: None
[ 0 ]
2
[ 0, 0 ]
intervention 1: Patient specific dose, administered intravenously, on Day 1 of a 28-day cycle. Minimum of one (1) 28-day cycle. Patients may continue to receive tasisulam until disease progression or until discontinuation criteria are met. intervention 2: 1.2 milligrams (mg), administered orally once prior to the initi...
intervention 1: Tasisulam intervention 2: Midazolam
3
Bordeaux | N/A | France | -0.5805 | 44.84044 Lille | N/A | France | 3.05858 | 50.63297 Rennes | N/A | France | -1.67429 | 48.11198
27
0
0
0
NCT01209832
6TERMINATED
2011-01-01
2010-09-01
Eli Lilly and Company
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
30
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to assess subjects' experiences using Adapalene BPO gel to treat mild to moderate acne vulgaris using efficacy measurements, quality of life instruments, and video diaries.
null
Acne Vulgaris
null
1
arm 1: None
[ 5 ]
1
[ 0 ]
intervention 1: Apply adapalene BPO gel once daily in the evening for 12 weeks
intervention 1: Adapalene 0.1% and Benzoyl Peroxide 2.5% gel
1
Carrollton | Texas | United States | -96.89028 | 32.95373
30
0
0
0
NCT01209949
1COMPLETED
2011-01-01
2010-10-01
Galderma R&D
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
24
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
true
2MALE
null
To establish bioequivalence at steady state of: 1)0.375 mg pramipexole extended release tablet q.d. in fasted status versus 0.125 mg pramipexole Immediate release tablet t.i.d. in fasted status 2)1.5 mg pramipexole extended release tablet q.d. in fasted status versus 0.5 mg pramipexole Immediate release tablet t.i.d. ...
null
Healthy
null
2
arm 1: 0.375mg once per day for 5 days (cross-over), 0.75mg once per day for 5 days (up-titration), 1.5mg once per day for 5 days (cross-over) arm 2: 0.125mg three times a day for 5 days (crossover), 0.5mg three times a day for 5 days (cross over)
[ 0, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 0.375mg once per day for 5 days (cross-over), 0.75mg once per day for 5 days (up-titration), 1.5mg once per day for 5 days (cross-over) intervention 2: 0.375mg once per day for 5 days (cross-over), 0.75mg once per day for 5 days (up-titration), 1.5mg once per day for 5 days (cross-over) intervention 3: ...
intervention 1: pramipexole extended release intervention 2: pramipexole extended release intervention 3: pramipexole immediate release intervention 4: pramipexole immediate release
1
Beijing | N/A | China | 116.39723 | 39.9075
168
0
0
0
NCT01214109
1COMPLETED
2011-01-01
2010-12-01
Boehringer Ingelheim
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
218
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
This study will compare the analgesic efficacy of a single-dose of a novel ibuprofen formulation to placebo and acetaminophen in the treatment of post-surgical dental pain following "wisdom" tooth (third molar) removal.
null
Pain
Pain following third molar extraction (wisdom tooth)
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 1, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Single-dose of novel ibuprofen (equal to 400 mg ibuprofen) intervention 2: Single-dose of acetaminophen (1000mg) intervention 3: Single-dose of placebo
intervention 1: Novel Ibuprofen intervention 2: Acetaminophen intervention 3: Placebo
1
Salt Lake City | Utah | United States | -111.89105 | 40.76078
218
0
0
0
NCT01216163
1COMPLETED
2011-01-01
2010-10-01
Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
32
RANDOMIZED
CROSSOVER
9OTHER
2DOUBLE
true
0ALL
false
The purpose of this study is to investigate the safety and tolerability of LY2623091 after multiple oral dosing in healthy men and women of non-childbearing potential. Two cohorts of 16 subjects will participate in 2 dosing periods. Treatment assignment will be double-blind for LY2623091 and placebo (negative control),...
null
Chronic Kidney Disease
Kidney Renal
null
6
arm 1: Daily by mouth for 7 days. arm 2: Daily by mouth for 7 days. arm 3: The anticipated dose of LY2623091 was revised down from the original proposed dose level of 100 mg based on safety and tolerability data. The 25 mg LY2623091 was administered daily by mouth for 7 days. arm 4: The anticipated dose of LY2623091 wa...
[ 0, 0, 0, 0, 2, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Administered orally. intervention 2: Administered orally. intervention 3: Administered orally.
intervention 1: LY2623091 intervention 2: Placebo intervention 3: Eplerenone
1
Zuidlaren | N/A | Netherlands | 6.68194 | 53.09417
63
0
0
0
NCT01237899
1COMPLETED
2011-01-01
2010-10-01
Eli Lilly and Company
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
20
NA
SINGLE_GROUP
0TREATMENT
0NONE
true
0ALL
false
The purpose of this study is to measure if there is any difference in how the body breaks down or inactivates either fluoxetine or LY2216684 when both of these medicines are given together. This study will look at how fluoxetine might affect LY2216684 and how giving LY2216684 might affect fluoxetine in the body. The d...
null
Major Depressive Disorder
null
1
arm 1: LY2216684: 18 milligrams (mg) oral (po) once daily (QD) on Days 1, 2, and 3 and Days 25-27 Fluoxetine: 60 mg po QD for 7 days (Days 4-10) then 20 mg po QD for 17 days (Days 11-27)
[ 0 ]
2
[ 0, 0 ]
intervention 1: LY2216684: 18 mg po QD on Days 1, 2, and 3 and Days 25-27 intervention 2: Fluoxetine: 60 mg po QD for 7 days (Days 4-10) then 20 mg po QD for 17 days (Days 11-27)
intervention 1: LY2216684 intervention 2: Fluoxetine
1
Evansville | Indiana | United States | -87.55585 | 37.97476
60
0
0
0
NCT01243957
1COMPLETED
2011-01-01
2010-10-01
Eli Lilly and Company
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
13
RANDOMIZED
CROSSOVER
7BASIC_SCIENCE
0NONE
true
0ALL
null
The primary objective of Part 1 of this study is to evaluate the safety and tolerability of the intravenous (IV) dose of GDC-0973. The primary objectives of Part 2 of this study are to evaluate the absolute bioavailability of GDC-0973 and to evaluate the pharmacokinetic (PK) of GDC-0973 following IV and oral administra...
null
Healthy Volunteers
null
3
arm 1: Participants will receive single dose of GDC-0973 2 milligrams (mg) IV infusion in first intervention period followed by single dose of GDC-0973 20 mg oral capsules (four 5-mg capsules) in second intervention period. The washout period between each period will be a minimum of 10 days. arm 2: Participants will re...
[ 0, 0, 0 ]
2
[ 0, 0 ]
intervention 1: IV infusion. intervention 2: Oral dose.
intervention 1: GDC-0973 IV Infusion intervention 2: GDC-0973 Oral Capsules
0
null
25
0
0
0
NCT01249118
1COMPLETED
2011-01-01
2010-11-01
Genentech, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
18
null
PARALLEL
null
0NONE
true
2MALE
false
The purpose of this study is to investigate the pharmacokinetics of single doses of PF-02341066 (150, 250, and 400 mg) in the fasted condition in Japanese healthy male volunteers.
The purpose of this study is to investigate the pharmacokinetics of single doses of PF-02341066 (150, 250, and 400 mg) in the fasted condition in Japanese healthy male volunteers.
Healthy
PK profile in Japanese healthy male volunteers
null
1
arm 1: This study will consist of three cohorts: PF-02341066 150 mg treatment group (n = 6), PF-02341066 250 mg treatment group (n = 6) and PF-02341066 400 mg treatment group (n = 6).
[ 0 ]
3
[ 0, 0, 0 ]
intervention 1: Cohort 1: a 150 mg single dose of PF-02341066 administered as 1 x 50 mg IRT and 1 x 100 mg IRT. intervention 2: Cohort 2: a 250 mg single dose of PF-02341066 administered as 1 x 50 mg IRT and 2 x 100 mg IRTs. intervention 3: Cohort 3: a 400 mg single dose of PF-02341066 administered as 4 x 100 mg IRTs.
intervention 1: PF-02341066 intervention 2: PF-02341066 intervention 3: PF-02341066
1
Hachioji-shi | Tokyo | Japan | N/A | N/A
18
0
0
0
NCT01250730
1COMPLETED
2011-01-01
2010-12-01
Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
20
NA
SINGLE_GROUP
0TREATMENT
0NONE
true
0ALL
false
LY2216684 is being studied as adjunctive treatment for major depressive disorder (MDD) in participants who are partial responders to selective serotonin reuptake inhibitors (SSRIs). Sertraline is a medication that is widely used to treat MDD and is a known substrate of cytochrome P450s (CYP450s), including CYP450 2D6 (...
null
Major Depressive Disorder
null
1
arm 1: Period 1: LY2216684 18 milligram (mg) oral (po) dose on Days 1-3. Period 2: Sertraline 50 mg po dose on Day 4 followed by sertraline 100 mg po dose on Days 5-10. Period 3: LY2216684 18 mg po dose + sertraline 100 mg po dose on Days 11-13.
[ 0 ]
2
[ 0, 0 ]
intervention 1: po administration intervention 2: po administration
intervention 1: LY2216684 intervention 2: Sertraline
1
Daytona Beach | Florida | United States | -81.02283 | 29.21081
56
0
0
0
NCT01250873
1COMPLETED
2011-01-01
2010-11-01
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 ]
12
RANDOMIZED
CROSSOVER
7BASIC_SCIENCE
0NONE
true
2MALE
false
This study will evaluate if an orally disintegrating tablet of sildenafil will have similar pharmacokinetic properties when given with food and without food.
null
Erectile Dysfunction
Bioavailability Food Effect Oral Dissolving Tablet (ODT)
null
2
arm 1: Treatment A: Sildenafil ODT tablet 50 mg, administered without water under fasted conditions. arm 2: Treatment B: Sildenafil ODT tablet 50 mg, administered without water under fed conditions.
[ 1, 0 ]
2
[ 0, 0 ]
intervention 1: Orally Disintegrating Tablet, 50 mg, Single Dose intervention 2: Orally Disintegrating Tablet, 50 mg, Single Dose
intervention 1: Sildenafil intervention 2: Sildenafil
1
Singapore | N/A | Singapore | 103.85007 | 1.28967
24
0
0
0
NCT01254396
1COMPLETED
2011-01-01
2010-12-01
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
21
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
true
0ALL
false
The primary objective of this study is to confirm that LY2216684 is not an inhibitor of cytochrome P450 1A2 (CYP1A2) in healthy participants using theophylline as a probe substrate for the enzyme. Because LY2216684 has been observed to increase heart rate in some healthy participants, this study will also assess heart ...
null
Major Depressive Disorder
null
2
arm 1: Period 1: single 200-milligram (mg) theophylline oral dose on Day 1; Washout period of at least 7 days; Period 2: 18 mg LY2216684 orally, once daily on Days 1-5 with single 200-mg theophylline oral dose coadministered on Day 3 arm 2: Period 1: 18 mg LY2216684 orally, once daily on Days 1-5 with single 200-mg the...
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: 18-mg LY2216684 oral dose intervention 2: 200-mg theophylline oral dose
intervention 1: LY2216684 intervention 2: Theophylline
1
Dallas | Texas | United States | -96.80667 | 32.78306
60
0
0
0
NCT01263106
1COMPLETED
2011-01-01
2010-12-01
Eli Lilly and Company
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
26
RANDOMIZED
SINGLE_GROUP
0TREATMENT
1SINGLE
true
0ALL
false
This study is to see if there's any difference in the amount of facial irritation when two acne products are used together on one side of the face, compared to one acne treatment product used alone on the other side of the face. All people participating in this trial will be required to return to the same study center ...
This is an investigator-blind, randomized, balanced study comparing two treatment regimens in a split-face model. All subjects will apply Retin-A Micro Gel (tretinoin) 0.1 % Pump, and Aczone Gel (dapsone) 5% daily to one side of the face (with 1 hour between applications, applying Aczone Gel first) and Retin-A Micro Ge...
Acne Vulgaris
Acne Irritation
null
2
arm 1: Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks - all subjects participate in both arms in a split-face model arm 2: Tretinoin gel applied once daily to the assigned side of the face for 2 weeks - all subjects participate in both arms in a sp...
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks intervention 2: Tretinoin gel applied once daily to the assigned side of the face for 2 weeks
intervention 1: Dapsone plus Tretinoin Gel intervention 2: Tretinoin Gel
1
Broomall | Pennsylvania | United States | -75.35658 | 39.9815
25
0
0
0
NCT01313728
1COMPLETED
2011-01-01
2010-12-01
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
0
0
0
0
0
0
0
0
0
[ 2 ]
44
RANDOMIZED
PARALLEL
null
3TRIPLE
true
0ALL
false
This study will evaluate the safety, tolerability and pharmacokinetics of two formulations of cyclosporine ophthalmic emulsion in healthy adults (parallel-group phase). The parallel-group phase will be followed by a paired-eye phase which will evaluate the safety and tolerability of two formulations of cyclosporine oph...
null
Dry Eye Syndromes
null
5
arm 1: Parallel-Group Phase (PGP): cyclosporine ophthalmic emulsion Formulation A arm 2: PGP: cyclosporine ophthalmic emulsion Formulation B arm 3: Paired-Eye Phase (PEP): cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion 0.05% arm 4: PEP: cyclosporine ophthalmic emulsion Formulation B...
[ 0, 0, 5, 5, 0 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: One drop of cyclosporine ophthalmic emulsion Formulation A administered to each eye twice daily for 2 days and once in the morning of Day 3. intervention 2: One drop of cyclosporine ophthalmic emulsion Formulation B administered to each eye twice daily for 2 days and once in the morning of Day 3. interv...
intervention 1: cyclosporine ophthalmic emulsion Formulation A intervention 2: cyclosporine ophthalmic emulsion Formulation B intervention 3: cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion 0.05% intervention 4: cyclosporine ophthalmic emulsion Formulation B; cyclosporine ophthalmic emu...
1
Newport Beach | California | United States | -117.92895 | 33.61891
44
0
0
0
NCT01319773
1COMPLETED
2011-01-01
2010-11-01
Allergan
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
27
RANDOMIZED
CROSSOVER
0TREATMENT
3TRIPLE
false
0ALL
false
This study will investigate the effect of dosing with flutucasone furoate in asthmatic subjects aged 5-11 years of age. A randomized, two-way crossover, with placebo control, over a 14 day treatment period, it will investigate safety, tolerability, pharmacokinetics and serum cortisol levels.
This study will investigate the effect of dosing with fluticasone furoate 100 μg (micrograms) in asthmatic subjects aged 5-11 years of age. Fluticasone furoate is currently under development as the inhaled corticosteroid component of a combination product containing an inhaled corticosteroid and a long-acting beta-agon...
Asthma
inhalation profiles pharmacokinetics pharyngometry asthma pediatric subjects GW685698 Fluticasone furoate safety
null
4
arm 1: (8-11 years old) Repeat dose session: Fluticasone furoate 100µg; Day 1 and Day 14 = in house dosing; Day 2-13 = home dosing arm 2: (8-11 years old) Repeat dose session: matching placebo; Day 1 and Day 14 = in house dosing; Days 2-13 = home dosing arm 3: (5-7 years old) Repeat dose session: Fluticasone furoate 10...
[ 1, 2, 1, 2 ]
2
[ 0, 0 ]
intervention 1: Novel dry powder inhaler: 100µg per blister One blister strip containing fluticasone furoate micronised drug blended with lactose and a second blister strip containing lactose and magnesium stearate. intervention 2: Novel dry powder inhaler: One blister strip containing lactose and a second blister stri...
intervention 1: Fluticasone furoate intervention 2: Matching placebo
5
Cypress | California | United States | -118.03729 | 33.81696 Huntington Beach | California | United States | -117.99923 | 33.6603 Denver | Colorado | United States | -104.9847 | 39.73915 Normal | Illinois | United States | -88.99063 | 40.5142 Medford | Oregon | United States | -122.87559 | 42.32652
51
0
0
0
NCT01332292
1COMPLETED
2011-01-01
2010-05-01
GlaxoSmithKline
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
503
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to determine the safety and efficacy of TAK-085, once daily (QD) or twice daily (BID), compared to ethyl eicosapentaenoate (EPA-E), three times daily (TID) in participants with hypertriglyceridemia undergoing lifestyle modification.
TAK-085 is an oral capsule medicine licensed to Takeda Pharmaceutical Company Ltd. TAK-085 contains omega-3 fatty acid ethyl (mainly, ethyl eicosapentaenoate (EPA-E) and ethyl docosahexaenoic acid (DHA-E)). This is a phase 3, open-label, randomized study to evaluate the efficacy and safety of TAK-085. In addition, EPA...
Hypertriglyceridemia
Drug Therapy
null
3
arm 1: TAK-085 2 g, orally, once daily for up to 52 weeks. arm 2: TAK-085 2 g, orally, twice daily for up to 52 weeks. arm 3: Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
[ 0, 0, 1 ]
2
[ 0, 0 ]
intervention 1: Omega-3-acid ethyl esters 90 (TAK-085) capsules. Each one gram of fatty acid in TAK-085 contains approximately 465 mg of EPA plus 375 mg of docosahexaenoic acid-ethyl as ethyl esters. intervention 2: EPA-E capsules
intervention 1: omega-3-acid ethyl esters 90 (TAK-085) intervention 2: Eicosapentaenoic acid-ethyl (EPA)
0
null
503
0
0
0
NCT01350999
1COMPLETED
2011-01-01
2009-11-01
Takeda
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
19
NA
SINGLE_GROUP
6HEALTH_SERVICES_RESEARCH
0NONE
false
0ALL
true
This prospective study is designed to evaluate how lubiprostone may affect gastric motor and sensory function.
null
Chronic Idiopathic Constipation
constipation chronic idiopathic constipation no prior history of surgery to the colon not on any type of medication that could alter gastrointestinal motility or transit
null
1
arm 1: 24 micrograms of lubiprostone twice daily for one week.
[ 0 ]
1
[ 0 ]
intervention 1: 24 micrograms twice daily for 1 week
intervention 1: lubiprostone
1
Lebanon | New Hampshire | United States | -72.25176 | 43.64229
19
0
0
0
NCT01460225
1COMPLETED
2011-01-01
2007-09-01
Dartmouth-Hitchcock Medical Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
27
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
true
0ALL
false
The purpose of this study is to investigate the CYP2C8 inhibition by BIA 9-1067.
Single-centre, open-label, randomised, two-way crossover study in healthy young male and female volunteers
Parkinson Disease
Parkinson Disease BIA 9-1067
null
2
arm 1: Period 1: BIA 9-1067 + repaglinide Period 2: Repaglinide arm 2: Period 1: Repaglinide Period 2: BIA 9-1067 + repaglinide
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: 25 mg BIA 9-1067 (single-dose) intervention 2: 0.5 mg repaglinide (single-dose)
intervention 1: BIA 9-1067 intervention 2: Repaglinide
1
S. Mamede Do Coronado | N/A | Portugal | N/A | N/A
51
0
0
0
NCT01536366
1COMPLETED
2011-01-01
2009-06-01
Bial - Portela C S.A.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
133
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
true
0ALL
true
A quality colonoscopy examination remains as the gold standard for colorectal cancer screening, but effective large bowel cleansing prior to colonoscopy is still not achieved in all cases that undergo the procedure. Currently, the most widely used cleansing methods employ balanced electrolyte-polyethylene glycol (PEG) ...
Effective large bowel cleansing prior to colonoscopy is still not achieved in all cases that undergo the procedure. The use of balanced electrolyte-polyethylene glycol (PEG) solution have improved the cleansing results and shortened the time needed for preparing the bowel. The problem with using PEG solution alone is t...
Colonic Neoplasms
Colonoscopy Yoga Complementary and alternative medicine Bowel cleansing Large bowel preparation Cancer screening Colorectal cancer
null
2
arm 1: Patients will take a bolus intake of 8 oz. (240mL) to 16 oz. (480mL) of lukewarm saline water and perform yoga poses. arm 2: Patients followed the preparation method according to the manufacturer's standard instructions.
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: A total of 2L solution at lukewarm temperature (37.2-38.8 degrees Centigrade)consumed as bolus intake (8-16 oz in one to two minutes) alternating with yoga exercises. intervention 2: A total of 2L solution prepared as per manufacturers instructions and sipped until bowel movements are clear.
intervention 1: Normal (0.9%) saline intervention 2: HalfLytely
1
Middle Village | New York | United States | -73.88125 | 40.71649
133
0
0
0
NCT01547130
1COMPLETED
2011-01-01
2008-05-01
Arya, Vijaypal, M.D., P.C.
3INDIV
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
35
NA
SINGLE_GROUP
2DIAGNOSTIC
1SINGLE
false
0ALL
false
The purpose of this study is re-read of brain amyloid positron emission tomography (PET) scans acquired in previous florbetapir F 18 clinical studies by readers trained using updated reading methodology. The scans in this study came from subjects who had an autopsy to reveal the subject's true amyloid status.
null
Alzheimer's Disease
Amyloid imaging Positron Emission Tomography 18F-AV-45 florbetapir F 18 Diagnostic imaging
null
0
null
null
1
[ 0 ]
intervention 1: IV injection, 370MBq (10mCi), single dose
intervention 1: florbetapir F 18
0
null
0
0
0
0
NCT01565369
1COMPLETED
2011-01-01
2011-01-01
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
[ 5 ]
55
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to examine seizure control and tolerability of Topiramate after either transitioning from previous antiepileptic drug (AED) or adding on to previous AED.
This is a multicenter, randomized (treatment is assigned by chance), open-label (everyone who is involved in the trial knows the study drug), parallel group trial. The study has three phases: a retrospective baseline assessment of patients (4 weeks), titration period (8 weeks) and maintenance period (8 weeks). After qu...
Epilepsy
Epilepsy Topiramate Neuro-surgical patients Nervous disorder Seizures
null
2
arm 1: None arm 2: None
[ 1, 0 ]
2
[ 0, 0 ]
intervention 1: Type=range, unit=mg/day, number=25-200, form=tablet, route=oral use. intervention 2: Type= range, unit= mg/day, number= 25-200, form= tablet, route= oral use.
intervention 1: Topiramate add-on therapy intervention 2: Topiramate monotherapy
0
null
55
0
0
0
NCT01627860
1COMPLETED
2011-01-01
2010-02-01
Johnson & Johnson Taiwan 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
[ 5 ]
53
RANDOMIZED
PARALLEL
1PREVENTION
2DOUBLE
false
0ALL
true
Adequate growth during the neonatal period is critical for optimal long term outcomes. Despite maximal calorie intake, sixty percent of very low birth weight infants still fail to thrive suggesting that factors other than total calorie intake are important in ensuring consistent weight gain. Several reports have indica...
This is a randomized, blinded, placebo-controlled trial in infants born at less than 32 weeks gestation, who are admitted to the Newborn Intensive Care Unit at University of Cincinnati Medical Center, Cincinnati, Ohio. Infants are randomized to receive either 4 meq/kg/day supplemental sodium or an equal amount of steri...
Extreme Immaturity
anthropometrics weight nutrition
null
2
arm 1: Sodium chloride 1 meq/kg (0.4 ml/kg of 2.5meq/ml formulation for injection)q6hrs on days of life 7-35. Intervention was given enterally if feedings were at least 100 ml/kg/day; otherwise medication was diluted in equal amounts of dextrose 5% water and administered intravenously. arm 2: Sterile water, 0.4 ml/kg q...
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: sterile water, 0.4 ml/kg every 6 hours on days of life 7-35.
intervention 1: Sodium chloride intervention 2: Placebo
1
Cincinnati | Ohio | United States | -84.51439 | 39.12711
53
0
0
0
NCT01795638
6TERMINATED
2011-01-01
2009-10-01
Children's Hospital Medical Center, Cincinnati
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
22
NA
SINGLE_GROUP
2DIAGNOSTIC
0NONE
false
0ALL
null
Heart transplantation is a life-sustaining therapy that allows patients with either congenital or acquired heart disease and severe cardiac dysfunction to survive. Over time, however, the transplanted heart can develop problems. One of the more common and troubling problems is the development of stenoses, or narrowings...
null
Orthotopic Heart Transplant
Orthotopic Heart Transplant
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Administration of intravenous adenosine infusion over 3 minutes (0.14 ml/kg, 3mg/ml concentration, total dose).
intervention 1: Adenosine
1
Ann Arbor | Michigan | United States | -83.74088 | 42.27756
22
0
0
0
NCT03231371
1COMPLETED
2011-01-01
2008-11-01
Bryan Goldstein
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 ]
78
RANDOMIZED
SEQUENTIAL
0TREATMENT
2DOUBLE
true
0ALL
null
This study is a single dose escalation study of tezepelumab (AMG 157) in healthy adults (Part A) and adults with moderate to severe atopic dermatitis (Part B). The purpose of the study is to evaluate the safety, tolerability, immunogenicity and pharmacokinetics of tezepelumab.
null
Atopic Dermatitis Healthy Volunteers
atopic dermatitis skin diseases healthy volunteer
null
2
arm 1: Participants will receive a single dose of tezepelumab administered subcutaneously or intravenously. The starting dose will be 2.1 mg tezepelumab. arm 2: Participants will receive matching placebo administered subcutaneously or intravenously.
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Administered by subcutaneous or intravenous injection intervention 2: Matching placebo administered by subcutaneous or intravenous injection.
intervention 1: Tezepelumab intervention 2: Placebo
0
null
76
0
0
0
NCT00757042
1COMPLETED
2011-01-05
2008-09-18
Amgen
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
66
RANDOMIZED
PARALLEL
2DIAGNOSTIC
3TRIPLE
true
0ALL
false
The purpose of this study is to find out more about cognitive functioning in people who are cannabis dependent, relative to people who do not use cannabis, and how their brains process information after one month of not using cannabis. An additional goal is to characterize the severity of cannabis dependence using prec...
null
Cannabis Dependence Cannabis Withdrawal
Cannabis Dependence Marijuana Dependence Cannabis Withdrawal Rimonabant cannabinoid receptor type 1 (CB1) inverse agonist Neuropsychology functional magnetic resonance imaging (fMRI) Endocannabinoids Cortisol
null
3
arm 1: Cannabis dependent young adults administered rimonabant 90 mg at Day 0 and followed for 28 days post. arm 2: Cannabis dependent young adults administered matched placebo at Day 0 and followed for 28 days post. arm 3: Non-cannabis using demographically similar young adults followed for 28 days.
[ 0, 2, 4 ]
2
[ 0, 0 ]
intervention 1: double blind, placebo controlled, single 90 mg dose intervention 2: matched placebo
intervention 1: rimonabant intervention 2: placebo
1
La Jolla | California | United States | -117.2742 | 32.84727
66
0
0
0
NCT00656487
1COMPLETED
2011-01-06
2008-04-30
The Scripps Research Institute
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
53
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The main objective of this study is to investigate whether administration of maintenance temozolomide following standard treatment could possibly prevent or delay the onset of brain metastases in patients with controlled non-small cell lung cancer (NSCLC).
This is a Phase 2, open-label, randomized, multicenter study of maintenance temozolomide versus observation in subjects with stable or responding stage III/IV NSCLC to be conducted in conformance with Good Clinical Practices. Subjects will be randomly assigned to a study drug (temozolomide) or observation arm. The stud...
Carcinoma, Non-Small-Cell Lung Adenocarcinoma Carcinoma, Large Cell Carcinoma, Squamous Cell
null
2
arm 1: Subjects will receive temozolomide at a dose of 75 mg/m\^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period, until progression or up to a maximum of 6 cycles, whichever occurs first. arm 2: Observation
[ 0, 4 ]
1
[ 0 ]
intervention 1: 5-mg, 20-mg, and 100-mg gel capsules, 75 mg/m\^2 PO daily for 21 consecutive days, followed by a 7-day rest period, until progression or up to a maximum of 6 cycles, whichever occurs first.
intervention 1: Temozolomide
0
null
53
0
0
0
NCT00632203
6TERMINATED
2011-01-07
2008-03-04
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
[ 2, 3 ]
128
RANDOMIZED
PARALLEL
1PREVENTION
2DOUBLE
true
1FEMALE
true
A double-blind, randomized, placebo-controlled Phase I/II trial to evaluate the safety of dapivirine Gel 4759, 0.05% 2.5 g and dapivirine Gel 4789, 0.05% 2.5 g formulations as compared to the vaginal HEC-based Universal placebo gel, 2.5 g in healthy HIV-negative women
This was a double-blind, randomized, placebo-controlled trial, to be conducted over 10 months at five research centers in the USA among 180 healthy, sexually active women, to assess the safety and acceptability of dapivirine Gel 4759, 0.05% 2.5 g, and dapivirine Gel 4789, 0.05% 2.5 g, both vaginal microbicides containi...
HIV-1 Infections
HIV-1 infections
null
3
arm 1: will be applied by participants once daily for 12-weeks treatment period arm 2: Will be applied by participants once daily for12-weeks treatment period arm 3: Will be applied once daily for 12-weeks treatment period
[ 1, 1, 2 ]
3
[ 0, 0, 0 ]
intervention 1: dapivirine gel 4789, 0.05%, 2.5g applied once daily intervention 2: dapivirine gel 4759, 0.05%, 2.5g applied once daily intervention 3: HEC-based universal placebo gel, 2.5g applied once daily
intervention 1: dapivirine 4789 intervention 2: dapivirine gel 4759 intervention 3: Drug placebo
5
Birmingham | Alabama | United States | -86.80249 | 33.52066 Torrance | California | United States | -118.34063 | 33.83585 Chicago | Illinois | United States | -87.65005 | 41.85003 Baltimore | Maryland | United States | -76.61219 | 39.29038 New York | New York | United States | -74.00597 | 40.71427
128
0
0
0
NCT00799058
1COMPLETED
2011-01-08
2009-07-06
International Partnership for Microbicides, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
49
RANDOMIZED
SEQUENTIAL
0TREATMENT
2DOUBLE
true
0ALL
null
The primary objective is to evaluate the safety, tolerability, and immunogenicity of multiple-dose administration of tezepelumab in healthy adults.
This study will follow a randomized, multiple-dose, double-blind, placebo-controlled, sequential dose-escalation study design. The study will consist of five subcutaneous (SC) cohorts and one intravenous (IV) cohort. Each dose cohort is planned to enroll 8 participants, randomized such that 6 participants will receive ...
Healthy Volunteers
healthy volunteers
null
2
arm 1: Tezepelumab will be administered subcutaneously (SC) at doses from 35 mg once every 28 days (Q28D) (cohort 1) up to 210 mg once every 7 days (Q7D) (cohort 5) and an intravenous (IV) dose cohort of 700 mg Q28D (cohort 6). arm 2: Two participants in each cohort (cohorts 1 to 6) will receive matching placebo admini...
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Administered by subcutaneous or intravenous injection. intervention 2: Administered by subcutaneous or intravenous injection
intervention 1: Placebo intervention 2: Tezepelumab
0
null
86
0
0
0
NCT00972179
1COMPLETED
2011-01-09
2009-09-15
Amgen
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
14
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
This study will examine MDMA-assisted psychotherapy in individuals aged 18 years or older diagnosed with PTSD, with PTSD symptoms not improving after trying at least one treatment. This objective of this study is to determine whether three eight-hour long sessions of MDMA-assisted psychotherapy, scheduled three to five...
Posttraumatic stress disorder (PTSD) occurs after experiencing a traumatic event or events. PTSD is a public health problem that causes a great deal of suffering. This study will examine MDMA-assisted psychotherapy in individuals aged 18 years or older diagnosed with PTSD, with PTSD symptoms not improving after trying...
Posttraumatic Stress Disorder
PTSD, MDMA, psychotherapy, Switzerland
ICF_000.pdf: ...
2
arm 1: Three 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA arm 2: Three 8-hour sessions of MDMA-assisted therapy with 25 mg of MDMA, followed by a supplemental dose of 12.5 mg MDMA
[ 0, 1 ]
3
[ 0, 0, 5 ]
intervention 1: Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally. intervention 2: Participants will receive a 25 mg MDMA orally, and if investigator and participant agree, 2.5 hours later they wil...
intervention 1: 3,4-methylenedioxymethamphetamine (125 mg) intervention 2: 3,4-methyelendioxymethamphetamine (25 mg) intervention 3: Therapy
1
Biberist | Canton of Solothurn | Switzerland | 7.56246 | 47.18009
21
0
0
0
NCT00353938
1COMPLETED
2011-01-10
2006-09-13
Lykos Therapeutics
4INDUSTRY
true
true
true
https://cdn.clinicaltrials.gov/large-docs/38/NCT00353938/Prot_001.pdf https://cdn.clinicaltrials.gov/large-docs/38/NCT00353938/SAP_002.pdf https://cdn.clinicaltrials.gov/large-docs/38/NCT00353938/ICF_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
[ 2 ]
20
RANDOMIZED
CROSSOVER
7BASIC_SCIENCE
0NONE
true
0ALL
null
This study will be an open-label, randomized, 3-way, 6-sequence crossover study in healthy participants for determining the relative bioavailability of the tablet formulation to the capsule formulation and the effect of food on the relative bioavailability of the tablet formulation.
null
Healthy Volunteers
null
6
arm 1: Treatment A: One 20-mg tablet of cobimetinib will be administered orally with 240 milliliter (mL) room temperature water after at least an 8-hour fast, in first intervention period. Treatment B: Four 5-mg capsules of cobimetinib will be administered orally with 240 mL room temperature water after at least an 8-h...
[ 0, 0, 0, 0, 0, 0 ]
1
[ 0 ]
intervention 1: Cobimetinib 20 mg will be given orally as tablet formulation in fasted or fed state, or as capsule formulation in fasted state.
intervention 1: Cobimetinib
0
null
58
0
0
0
NCT01249131
1COMPLETED
2011-01-10
2010-12-01
Genentech, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
2,720
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The purpose of this study is to investigate the long-term analgesic efficacy and safety of tanezumab for patients with osteoarthritis (OA) of the knee or hip currently experiencing partial benefit from, and are tolerating, non-steroidal anti-inflammatory drug (NSAID) therapy.
This study was terminated on 28 October 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.
Osteoarthritis Arthritis
monoclonal antibody nerve growth factor (NGF) anti-NGF tanezumab PF-04383119 RN624 osteoarthritis (OA)
null
5
arm 1: Oral NSAID arm 2: IV tanezumab 5 mg every 8 weeks (through Week 48) arm 3: IV tanezumab 10 mg every 8 weeks (through Week 48) arm 4: IV doses of tanezumab 5 mg every 8 weeks (through Week 48) plus oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks arm 5: IV doses of tanezumab 10 mg e...
[ 1, 0, 0, 0, 0 ]
7
[ 0, 2, 2, 2, 0, 2, 0 ]
intervention 1: IV doses of placebo (to match tanezumab) every 8 weeks (through Week 48) plus oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks intervention 2: IV tanezumab 5 mg every 8 weeks (through Week 48) and oral placebo for NSAID BID from Weeks 2 through 56 intervention 3: IV tanezu...
intervention 1: NSAID intervention 2: tanezumab intervention 3: tanezumab intervention 4: tanezumab intervention 5: NSAID intervention 6: tanezumab intervention 7: NSAID
333
Birmingham | Alabama | United States | -86.80249 | 33.52066 Birmingham | Alabama | United States | -86.80249 | 33.52066 Birmingham | Alabama | United States | -86.80249 | 33.52066 Birmingham | Alabama | United States | -86.80249 | 33.52066 Huntsville | Alabama | United States | -86.58594 | 34.7304 Huntsville | Alabama ...
2,700
0
0
0
NCT00809354
6TERMINATED
2011-01-12
2009-02-12
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 ]
107
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This single-arm, open-label, multicenter study evaluated the safety and tolerability and the efficacy in reducing disease activity of tocilizumab \[RoActemra/Actemra\] as monotherapy or in combination with methotrexate in patients with active moderate to severe rheumatoid arthritis (RA). Patients were eligible to parti...
null
Rheumatoid Arthritis
null
1
arm 1: Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
[ 0 ]
2
[ 0, 0 ]
intervention 1: 8 mg/kg intravenous infusion every 4 weeks. intervention 2: methotrexate as per standard of care in clinical practice.
intervention 1: tocilizumab [RoActemra/Actemra] intervention 2: Methotrexate
9
Alexandria | N/A | Egypt | 29.91582 | 31.20176 Alexandria | N/A | Egypt | 29.91582 | 31.20176 Banhā | N/A | Egypt | 31.1842 | 30.45977 Cairo | N/A | Egypt | 31.24967 | 30.06263 Cairo | N/A | Egypt | 31.24967 | 30.06263 Cairo | N/A | Egypt | 31.24967 | 30.06263 Cairo | N/A | Egypt | 31.24967 | 30.06263 Cairo | N/A | Egy...
105
0
0
0
NCT01063062
1COMPLETED
2011-01-17
2010-02-28
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
[ 2 ]
80
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
true
0ALL
false
This study will examine the effects of co-administration of SPD489 and the antidepressant EFFEXOR XR on the pharmacokinetics of lisdexamfetamine, d-amphetamine, and EFFEXOR XR. In addition, serial blood pressure and pulse measures will be obtained and examined to ensure that there are no unexpected changes in vital sig...
null
Healthy
null
2
arm 1: None arm 2: None
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: * Day 1-5 LDX 30mg * Day 6-10 LDX 50mg * Day 11-15 LDX 70mg * Day 16-20 LDX 70mg and Venlafaxine XR 75mg daily * Day 21-25 LDX 70mg and Venlafaxine XR 150mg daily * Day 26-30 LDX 70mg and Venlafaxine XR 225mg daily * Day 31-34 Venlafaxine XR 150mg daily * Day 35-38 Venlafaxine XR 75mg daily. interventio...
intervention 1: LDX + Venlafaxine XR intervention 2: Venlafaxine XR + LDX
1
Miami | Florida | United States | -80.19366 | 25.77427
211
0
0
0
NCT01235338
1COMPLETED
2011-01-17
2010-10-28
Shire
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
-0
[ 3 ]
84
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
This study will determine the safety, tolerability and efficacy of GSK1322322 verses Linezolid in subjects with Acute Bacterial Skin and Skin Structure Infection (ABSSSI).
This is a phase IIa, multicenter, randomized, parallel group, double-blind, double dummy study to assess the safety, tolerability, and efficacy of GSK1322322 when given as 1500mg twice daily over a 10-day period versus linezolid (600mg twice daily for 10 days) in adults with suspected Gram positive Acute Bacterial Skin...
Skin Infections, Bacterial
methicillin-resistant Staphylococcus aureus linezolid repeat dose GSK1322322
null
2
arm 1: GSK1322322 1500mg and Placebo Linezolid given twice a day (BID) for 10 days arm 2: Linezolid 600mg and placebo GSK1322322 given BID for 10 days
[ 0, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: GSK1322322 1500mg BID intervention 2: Linezolid 600mg intervention 3: Placebo intervention 4: placebo
intervention 1: GSK1322322 intervention 2: Linezolid intervention 3: GSK1322322 placebo intervention 4: Linezolid placebo
7
Anniston | Alabama | United States | -85.83163 | 33.65983 Chula Vista | California | United States | -117.0842 | 32.64005 La Mesa | California | United States | -117.02308 | 32.76783 Long Beach | California | United States | -118.18923 | 33.76696 Oceanside | California | United States | -117.37948 | 33.19587 Honolulu |...
84
1
0.011905
1
NCT01209078
1COMPLETED
2011-01-18
2010-08-17
GlaxoSmithKline
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
0
0
0
0
0
0
0
0
0
0
0
0
0.002105
[ 1 ]
9
NA
SINGLE_GROUP
7BASIC_SCIENCE
0NONE
false
1FEMALE
true
The purpose of this study is to evaluate how the liver receives and uses fats for energy. This will help the investigators further understand the physical and chemical processes responsible for Non-Alcoholic Fatty Liver Disease (NAFLD) in overweight females with or without NAFLD who are scheduled to undergo gastric byp...
This study involves a multidisciplinary approach that will address the metabolic mechanisms responsible for Non-alcoholic Fatty Liver Disease (NAFLD) in humans. Nonalcoholic fatty liver disease (NAFLD) has become an important public health problem in many industrialized countries because of its high prevalence, potenti...
Fatty Liver
Non-Alcoholic Fatty Liver disease
null
1
arm 1: Twenty obese females (18-45 years of age, BMI \> or equal to 45) who are scheduled to undergo bariatric surgery at Barnes-Jewish Hospital will be screened for enrollment over 2 years. They will be imaged with PET/CT and radiopharmaceuticals C-11 Acetate and C-11 Palmitate will be injected.
[ 0 ]
1
[ 0 ]
intervention 1: injection of C-11 Palmitate and C-11 Acetate during PET/CT to determine Liver metabolism
intervention 1: Radio pharmaceuticals C-11 Acetate, and C-11 Palmitate
2
St Louis | Missouri | United States | -90.19789 | 38.62727 St Louis | Missouri | United States | -90.19789 | 38.62727
9
0
0
0
NCT00949403
1COMPLETED
2011-01-19
2010-07-01
Washington University School of Medicine
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
2
RANDOMIZED
PARALLEL
9OTHER
4QUADRUPLE
false
0ALL
false
To evaluate the causal relationship between Rho/Rho kinase overactivity and mechanisms of vascular dysfunction in patients with atherosclerosis.
null
Carotid Stenosis
Patients scheduled for elective carotid endarterectomy
null
2
arm 1: Fasudil hydrochloride 40 mg three times a day X 14 days arm 2: Placebo 1 tablet three times daily x 14 days
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Fasudil 40 mg three times a day x 14 days intervention 2: Placebo oral tablet manufactured to mimic fasudil three times a day x 14 days
intervention 1: Fasudil Hydrochloride intervention 2: Placebo Oral Tablet
1
Boston | Massachusetts | United States | -71.05977 | 42.35843
2
0
0
0
NCT00670202
6TERMINATED
2011-01-20
2008-03-13
Brigham and Women's Hospital
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
92
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
To explore the efficacy of SPD489, as adjunctive therapy to a stable dose of atypical antipsychotic medication, on negative symptoms in adult subjects with clinically stable schizophrenia and predominant negative symptoms, as measured by the Scale for the Assessment of Negative Symptoms (SANS).
null
Schizophrenia and Predominant Negative Symptoms
Schizophrenia
null
2
arm 1: None arm 2: Placebo
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: oral, 20, 30, 40, 50, 60, or 70 mg once daily intervention 2: oral, once daily
intervention 1: SPD489 (lisdexamfetamine dimesylate) intervention 2: Placebo matching SPD489 (lisdexamfetamine dimesylate)
27
Little Rock | Arkansas | United States | -92.28959 | 34.74648 Anaheim | California | United States | -117.9145 | 33.83529 Anaheim | California | United States | -117.9145 | 33.83529 Costa Mesa | California | United States | -117.91867 | 33.64113 Garden Grove | California | United States | -117.94145 | 33.77391 Long Bea...
161
0
0
0
NCT00922272
1COMPLETED
2011-01-20
2009-09-14
Shire
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
375
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
MK-8835-016 (B1521006) is designed to evaluate the safety and efficacy of an investigational drug, ertugliflozin (MK-8835, PF-04971729) in participants with Type 2 diabetes mellitus. Participants in the study will receive 1 of 6 treatments for 12 weeks including 1 treatment with an approved drug (sitagliptin) for the t...
null
Diabetes Mellitus, Type 2
Phase 2 safety and efficacy study with ertugliflozin (PF-04971729, MK-8835) Type 2 diabetes mellitus
null
6
arm 1: Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days arm 2: Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days arm 3: Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg an...
[ 2, 0, 0, 0, 0, 1 ]
7
[ 0, 0, 0, 0, 0, 0, 0 ]
intervention 1: Tablet(s), 1 or 2, matching placebo to 1-mg, 5-mg and/or 25-mg tablets, once daily for 84 days intervention 2: Tablet, 1 mg, once daily for 84 days intervention 3: Tablet(s), 1 or 2, 5-mg tablets once daily for 84 days intervention 4: Tablet, 25 mg, once daily for 84 days intervention 5: Tablet, 100 mg,...
intervention 1: Placebo to Ertugliflozin intervention 2: Ertugliflozin 1 mg intervention 3: Ertugliflozin 5 mg intervention 4: Ertugliflozin 25 mg intervention 5: Sitagliptin 100 mg intervention 6: Placebo to Sitagliptin intervention 7: Metformin
0
null
703
0
0
0
NCT01059825
1COMPLETED
2011-01-20
2010-02-24
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
[ 2 ]
96
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
This study will investigate safety, antiviral activity, and pharmacokinetics of BI 201335 NA in HCV genotype 1 infected patients treated for 14 days monotherapy followed by BI 201335 NA combination therapy with PegIFN/RBV for an additional 14 days for treatment-naïve patients; or for 28 days as BI 201335 NA combination...
null
Hepatitis C, Chronic
null
5
arm 1: patient to receive 20mg solution BI201335 qd +/- PegIFN/RBV fore 28 days arm 2: patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV fore 28 days arm 3: patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV fore 28 days arm 4: patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV fore 28 day...
[ 0, 0, 0, 0, 2 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: patient to receive rising doses of BI201335 solution qd +/- PegIFN/RBV fore 28 days intervention 2: patient to receive rising doses of BI201335 solution qd +/- PegIFN/RBV fore 28 days intervention 3: patient to receive rising doses of BI201335 solution qd +/- PegIFN/RBV fore 28 days intervention 4: pati...
intervention 1: BI201335 intervention 2: BI201335 intervention 3: BI201335 intervention 4: BI201335 intervention 5: Placebo
16
San Francisco | California | United States | -122.41942 | 37.77493 San Francisco | California | United States | -122.41942 | 37.77493 Baltimore | Maryland | United States | -76.61219 | 39.29038 New York | New York | United States | -74.00597 | 40.71427 New York | New York | United States | -74.00597 | 40.71427 Austin |...
96
0
0
0
NCT00793793
1COMPLETED
2011-01-25
2007-09-01
Boehringer Ingelheim
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
86
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
Teduglutide is an investigative medicine being evaluated as a possible treatment for people with parenteral nutrition (PN) dependent Short Bowel Syndrome (SBS). Teduglutide is similar to a protein the body makes. When people have SBS, their bodies do not make enough of the protein and they have trouble getting nutrient...
null
Short Bowel Syndrome
SBS short bowel syndrome TPN parenteral nutrition PN
null
2
arm 1: 0.05 mg/kg/day sc dose of teduglutide arm 2: Matching subcutaneous dose of placebo to teduglutide
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 0.05 mg/kg/day sc injection for 24 weeks intervention 2: Matching daily subcutaneous dose of placebo to teduglutide for 24 weeks
intervention 1: teduglutide intervention 2: placebo
35
La Jolla | California | United States | -117.2742 | 32.84727 Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 Jacksonville | Florida | United States | -81.65565 | 30.33218 Atlanta | Georgia | United States | -84.38798 | 33.749 Kansas City | Kansas | United States | -94.62746 | 39.11417 New ...
85
0
0
0
NCT00798967
1COMPLETED
2011-01-25
2008-11-25
Shire
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
31
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
false
The purpose of this study is to evaluate the anti-tumour activity of alisertib (MLN8237) in the treatment of participants with platinum-refractory or platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinomas.
The drug being tested in this study is called alisertib (MLN8237). Alisertib is being tested to treat people who have platinum-refractory or platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. This study looked at the antitumor activity by response rate who would take alisertib. The...
Ovarian Carcinoma
Drug therapy
null
1
arm 1: Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles).
[ 0 ]
1
[ 0 ]
intervention 1: Alisertib capsules
intervention 1: Alisertib
1
Berkeley Heights | New Jersey | United States | -74.44265 | 40.68343
31
0
0
0
NCT00853307
1COMPLETED
2011-01-27
2009-03-23
Millennium Pharmaceuticals, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
132
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
This 2 arm study will investigate the effects of tocilizumab on lipids, arterial stiffness, and markers of atherogenic risk in patients with moderate to severe active rheumatoid arthritis. In Part 1 of the study, patients will be randomized to receive either tocilizumab 8mg/kg intravenously or placebo every 4 weeks, in...
null
Rheumatoid Arthritis
null
2
arm 1: Participants received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for the first 24 weeks. From Week 24 to Week 104, participants received open-label TCZ 8 mg/kg every 4 weeks plus 7.5-25 mg MTX weekly. arm 2: Participants rece...
[ 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Administered by intravenous infusion, 8 mg/kg every 4 weeks. intervention 2: Placebo to tocilizumab administered by intravenous infusion every 4 weeks. intervention 3: Administered orally or parenterally, 7.5-25 mg weekly.
intervention 1: Tocilizumab intervention 2: Placebo intervention 3: Methotrexate
40
Anniston | Alabama | United States | -85.83163 | 33.65983 Huntsville | Alabama | United States | -86.58594 | 34.7304 Scottsdale | Arizona | United States | -111.89903 | 33.50921 Tucson | Arizona | United States | -110.92648 | 32.22174 Los Angeles | California | United States | -118.24368 | 34.05223 Aventura | Florida |...
262
1
0.003817
1
NCT00535782
1COMPLETED
2011-01-31
2007-10-31
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
1
0
0
0
0
0
0
0
0
0
0
0
0
0.000674
[ 3 ]
42
RANDOMIZED
PARALLEL
9OTHER
1SINGLE
false
0ALL
false
The purpose of this study is to is to test increasing repeat doses of GSK249320 compared to placebo in patients with stroke.
GSK249320 is a humanised monoclonal antibody (mAb) that binds with high specificity to myelin-associated glycoprotein (MAG) and antagonises or neutralises MAG-mediated inhibition and has been shown to improve functional recovery after stroke in pre-clinical models, possibly by promoting neuroregeneration and plasticity...
Ischaemic Attack, Transient
null
2
arm 1: None arm 2: None
[ 2, 0 ]
2
[ 0, 0 ]
intervention 1: I.V. infusion intervention 2: Placebo
intervention 1: GSK249320 intervention 2: PLACEBO
15
Los Angeles | California | United States | -118.24368 | 34.05223 Orange | California | United States | -117.85311 | 33.78779 Fort Collins | Colorado | United States | -105.08442 | 40.58526 Detroit | Michigan | United States | -83.04575 | 42.33143 Portland | Oregon | United States | -122.67621 | 45.52345 Toronto | Ontar...
42
0
0
0
NCT00833989
1COMPLETED
2011-01-31
2009-07-08
GlaxoSmithKline
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
117
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
null
The primary objective of the study is to determine whether armodafinil treatment is more effective than placebo treatment in patients with excessive sleepiness associated with mild or moderate closed traumatic brain injury (TBI).
null
Traumatic Brain Injury
null
4
arm 1: Armodafinil 50 mg/day arm 2: Armodafinil 150 mg/day arm 3: Armodafinil 250 mg/day arm 4: Placebo
[ 0, 0, 0, 2 ]
4
[ 0, 0, 0, 10 ]
intervention 1: Armodafinil 50 mg/day intervention 2: Armodafinil 150 mg/day intervention 3: Armodafinil 250 mg/day intervention 4: Placebo
intervention 1: Armodafinil intervention 2: Armodafinil intervention 3: Armodafinil intervention 4: Placebo
73
Birmingham | Alabama | United States | -86.80249 | 33.52066 Tucson | Arizona | United States | -110.92648 | 32.22174 Tucson | Arizona | United States | -110.92648 | 32.22174 Hot Springs | Arkansas | United States | -93.05518 | 34.5037 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Fountain Valley | Calif...
117
0
0
0
NCT00893789
6TERMINATED
2011-01-31
2009-04-30
Cephalon, 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 ]
49
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
The primary objective of this study is to evaluate the safety and tolerability of long-term (12 months) armodafinil treatment in patients with excessive sleepiness associated with mild or moderate closed traumatic brain injury (TBI).
null
Traumatic Brain Injury
null
1
arm 1: Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
[ 0 ]
1
[ 0 ]
intervention 1: None
intervention 1: Armodafinil
61
Birmingham | Alabama | United States | -86.80249 | 33.52066 Tucson | Arizona | United States | -110.92648 | 32.22174 Hot Springs | Arkansas | United States | -93.05518 | 34.5037 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Fountain Valley | California | United States | -117.95367 | 33.70918 La Palma | ...
47
0
0
0
NCT00983437
6TERMINATED
2011-01-31
2009-08-31
Cephalon, 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 ]
9,779
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
1FEMALE
true
To compare the effects of exemestane for 5 years versus tamoxifen and exemestane given sequentially over 5 years in the adjuvant treatment of postmenopausal women with early breast cancer. This Pfizer sponsored trial is part of an international collaboration of investigators conducting 7 similar yet independent studie...
null
Breast Neoplasms
null
2
arm 1: None arm 2: None
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: exemestane, orally, 25 mg, for 5 years intervention 2: tamoxifen, 20 mg, orally, daily, 2-3 years; followed by exemestane, orally, 25 mg, for a total of 5 years of therapy
intervention 1: exemestane (Aromasin) intervention 2: tamoxifen + exemestane
179
Bessemer | Alabama | United States | -86.95444 | 33.40178 Birmingham | Alabama | United States | -86.80249 | 33.52066 Birmingham | Alabama | United States | -86.80249 | 33.52066 Birmingham | Alabama | United States | -86.80249 | 33.52066 Birmingham | Alabama | United States | -86.80249 | 33.52066 Birmingham | Alabama |...
9,666
2
0.000207
0
NCT00036270
1COMPLETED
2011-02-01
2001-08-01
Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
2
0
0
0
0
0
0
0
0.000057
[ 3 ]
20
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to collect data on the clinical management of Argatroban in patients with suspected or confirmed heparin-induced thrombocytopenia Type II, with or without ongoing thrombosis who require parenteral antithrombotic therapy
null
Heparin-induced Thrombocytopenia Type II
Argatroban heparin induced thrombocytopenia (HIT) direct thrombin inhibitor (DTI)
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: None
intervention 1: argatroban
1
Saint-Etienne | N/A | France | 4.39 | 45.43389
20
4
0.2
1
NCT00861692
1COMPLETED
2011-02-01
2009-04-01
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
1
0
0
0
0
0
0
3
0
0
0
0
0
0
0
0.080658
[ 4 ]
565
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
1FEMALE
true
The purpose of this study is to compare the effectiveness and tolerability of two medications, calcitonin nasal spray and a tablet containing calcitonin, in postmenopausal women with osteoporosis. Osteoporosis is the term used to describe a large group of diseases, which are characterized by loss of bone density, which...
This was a randomized, double-blind, double-dummy, multiple dose, placebo-controlled, parallel group, 48- week, Phase III study. Women age 45 and over who were postmenopausal and had a diagnosis of osteoporosis were eligible for the study and were randomly allocated to one of three treatment groups; placebo tablets, or...
Osteoporosis, Postmenopausal
null
3
arm 1: Intervention: Oral calcitonin tablet (along with placebo intranasal spray) arm 2: Intervention: Commercially available, active comparator, intranasal calcitonin-salmon (plus matching oral placebo tablet). arm 3: Intervention: Both oral matching placebo tablets and matching intranasal placebo spray
[ 0, 1, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Oral Calcitonin tablets along with matching placebo intranasal spray intervention 2: Intranasal Calcitonin Spray intervention 3: Oral Placebo Tablets/Intranasal placebo spray
intervention 1: Oral Calcitonin Tablets intervention 2: Intranasal Calcitonin intervention 3: Placebo tablets and placebo intranasal spray
20
Huntsville | Alabama | United States | -86.58594 | 34.7304 Oakland | California | United States | -122.2708 | 37.80437 Palm Desert | California | United States | -116.37697 | 33.72255 Bethesda | Maryland | United States | -77.10026 | 38.98067 Omaha | Nebraska | United States | -95.94043 | 41.25626 Albuquerque | New Mex...
549
2
0.003643
1
NCT00959764
1COMPLETED
2011-02-01
2009-06-01
Tarsa Therapeutics, Inc.
4INDUSTRY
false
false
false
null
0
2
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0.001
[ 5 ]
165
RANDOMIZED
FACTORIAL
0TREATMENT
3TRIPLE
false
0ALL
true
This study will evaluate naltrexone and cognitive-behavioral therapy treatments for alcohol dependence and post-traumatic stress disorder (PTSD). Subjects will be randomly assigned a 6-month treatment of either: 1) naltrexone alone, 2) naltrexone with PTSD psychosocial therapy, 3) a placebo with PTSD psychosocial thera...
null
Alcoholism Alcohol Dependence Post-Traumatic Stress Disorder
Alcoholism Alcohol Dependence Post-Traumatic Stress Disorder Naltrexone Cognitive Behavior Therapy
null
4
arm 1: Naltrexone alone arm 2: Naltrexone with CBT for PTSD arm 3: Placebo with CBT for PTSD arm 4: Placebo alone
[ 1, 1, 1, 2 ]
3
[ 5, 0, 0 ]
intervention 1: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week intervention 2: Daily dosing 100 mg for 24 weeks intervention 3: Pill Placebo daily dosing 24 weeks
intervention 1: Cognitive-Behavioral Therapy intervention 2: Naltrexone intervention 3: Placebo
1
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
165
0
0
0
NCT00006489
1COMPLETED
2011-02-01
2000-12-01
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
[ 4 ]
91
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
This study involves patients 12 years and older who have been diagnosed with herpes simplex encephalitis (HSE) by a specific laboratory test and have completed treatment or are being treated with intravenous (given through a needle inserted into a vein) acyclovir. The purpose of the study is to determine if treatment w...
Herpes simplex encephalitis (HSE) remains the most common cause of sporadic fatal encephalitis in the world. This study is a phase III, double-blind, placebo controlled study of long term therapy with valacyclovir as a treatment of herpes encephalitis. The primary objective of this study is to assess the impact of vala...
Encephalitis
encephalitis, herpes simplex, valacyclovir
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Valacyclovir is a L-valyl ester of acyclovir. Valacyclovir is provided in 500 mg tablets, 4 tablets (500 mg tablets) 3 times a day (every 8 hours) for 90 days. intervention 2: Placebo (identical to active drug in appearance) 500 mg tablets, 4 tablets 3 times daily for 90 days.
intervention 1: Valacyclovir intervention 2: Placebo
21
Birmingham | Alabama | United States | -86.80249 | 33.52066 Phoenix | Arizona | United States | -112.07404 | 33.44838 Sacramento | California | United States | -121.4944 | 38.58157 Denver | Colorado | United States | -104.9847 | 39.73915 Chicago | Illinois | United States | -87.65005 | 41.85003 Kansas City | Kansas | U...
87
0
0
0
NCT00031486
1COMPLETED
2011-02-01
2000-09-01
National Institute of Allergy and Infectious Diseases (NIAID)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
124
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
2MALE
null
Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well ixabepilone works in treating patients with metastatic prostate cancer that has not responded to previous hormone therapy.
PRIMARY OBJECTIVE: I. To determine the effect on percent with a 50% decrease in PSA response in patients with metastatic prostate cancer who have progressed on androgen ablation therapy and are classified into 1 of 3 separate categories: 1. Never received prior chemotherapy/cytotoxic therapy 2. Received prior taxane-...
Adenocarcinoma of the Prostate Recurrent Prostate Cancer Stage IV Prostate Cancer
null
1
arm 1: Patients are stratified according to prior chemotherapy (none vs 1 prior taxane-containing regimen vs 2 prior cytotoxic regimens). Patients receive ixabepilone IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
[ 0 ]
1
[ 0 ]
intervention 1: Given IV
intervention 1: ixabepilone
162
Aurora | Colorado | United States | -104.83192 | 39.72943 Boulder | Colorado | United States | -105.27055 | 40.01499 Colorado Springs | Colorado | United States | -104.82136 | 38.83388 Denver | Colorado | United States | -104.9847 | 39.73915 Denver | Colorado | United States | -104.9847 | 39.73915 Denver | Colorado | U...
123
0
0
0
NCT00087139
1COMPLETED
2011-02-01
2004-09-01
National Cancer Institute (NCI)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
74
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different...
OBJECTIVES: Primary * Determine the effect of induction therapy comprising cetuximab, paclitaxel, and carboplatin followed by chemoradiotherapy comprising cetuximab, paclitaxel, carboplatin, and radiotherapy and maintenance therapy comprising cetuximab on 1-year event-free survival (freedom from surgery at the primar...
Head and Neck Cancer
Stage III head and neck cancer Stage IV head and neck cancer Cetuximab Paclitaxel Carboplatin
null
1
arm 1: Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly. Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation therapy at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. ...
[ 0 ]
4
[ 2, 0, 0, 4 ]
intervention 1: Induction: An initial dose of cetuximab (C225) 400 mg/m2 (over 2 hours) was given week 1 only. Then, C225 was administered at dose of 250 mg/m2 (over 1 hour) weekly for 5 weeks. Concurrent Chemoradiation (Weeks 9-13): C225 was administered at 250 mg/m2/wk (over 1 hour). Restaging Biopsy of Primary Sit...
intervention 1: Cetuximab intervention 2: Carboplatin intervention 3: Paclitaxel intervention 4: Radiation therapy
0
null
70
0
0
0
NCT00089297
1COMPLETED
2011-02-01
2005-01-06
Eastern Cooperative Oncology Group
5NETWORK
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
745
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
1FEMALE
true
Non-nucleoside reverse transcriptase inhibitors (NNRTIs) are commonly included in anti-HIV drug regimens. However, HIV infected women who have previously taken the single dose NNRTI nevirapine (SD NVP) for the prevention of mother-to-child transmission (MTCT) of HIV may not respond as well to NNRTIs as women who have n...
NVP is the NNRTI of choice to prevent MTCT of HIV, especially in resource-limited settings. However, prolonged use of NVP may result in drug resistance, decreasing the efficacy of future anti-HIV regimens containing NVP. PIs are more expensive and cause different adverse effects than NNRTIs, but PI-containing regimens ...
HIV Infections
Treatment Experienced Treatment Naive MTCT HIV Seronegativity
null
4
arm 1: For participants who had SD NVP exposure prior to study entry. FTC, TDF, and NVP daily the first 14 days, then twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV twice daily plus two more NRTIs. arm 2: For participants who had SD NVP ex...
[ 0, 0, 0, 0 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: 200 mg taken orally intervention 2: 200/300 mg taken orally intervention 3: 400/100 mg taken orally intervention 4: 200 mg taken orally intervention 5: 300 mg taken orally
intervention 1: Emtricitabine intervention 2: Emtricitabine/Tenofovir disoproxil fumarate intervention 3: Lopinavir/Ritonavir intervention 4: Nevirapine intervention 5: Tenofovir disoproxil fumarate
11
Bontleng | Gaborone | Botswana | N/A | N/A Bontleng Gaborone | N/A | Botswana | N/A | N/A Eldoret | N/A | Kenya | 35.26993 | 0.52036 Kericho | N/A | Kenya | 35.28314 | -0.36774 Lilongwe | N/A | Malawi | 33.78725 | -13.96692 Durban | KZN | South Africa | 31.0292 | -29.8579 Johannesburg | N/A | South Africa | 28.04363 | ...
741
0
0
0
NCT00089505
1COMPLETED
2011-02-01
2006-11-01
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
5NETWORK
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
102
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This phase II trial is studying how well giving fludarabine together with rituximab followed by alemtuzumab works in treating patients with chronic lymphocytic leukemia. Monoclonal antibodies, such as rituximab and alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow an...
PRIMARY OBJECTIVES: I. To determine the rate of complete response and toxicity of concurrent treatment with fludarabine and rituximab followed by consolidative alemtuzumab in patients with previously untreated, but symptomatic, CLL. II. To determine if alemtuzumab improves the CR rate with acceptable toxicity when ad...
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
1
arm 1: Patients receive induction therapy comprising rituximab IV over 4 hours on days 1, 3, and 5 of course 1 and day 1 of all subsequent courses and fludarabine IV over 30 minutes on days 1-5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression. Approximately 4 months after comp...
[ 0 ]
3
[ 2, 2, 0 ]
intervention 1: Given SC intervention 2: Given IV intervention 3: Given IV
intervention 1: alemtuzumab intervention 2: rituximab intervention 3: fludarabine phosphate
2
Chicago | Illinois | United States | -87.65005 | 41.85003 Columbus | Ohio | United States | -82.99879 | 39.96118
160
0
0
0
NCT00098670
1COMPLETED
2011-02-01
2004-10-01
National Cancer Institute (NCI)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
1,735
RANDOMIZED
PARALLEL
1PREVENTION
0NONE
true
0ALL
true
Giving anti-HIV medications to babies born of HIV positive mothers right after birth can lower the babies' risk of contracting HIV. This study will assess the safety and efficacy of two different combinations of anti-HIV medications compared to a one drug standard regimen in preventing mother to baby transmission. The ...
Despite the notable reductions in perinatal transmission of HIV-1 with antiretroviral therapy and other interventions, perinatal transmission continues to occur at rates of 20-30% among pregnant women who are not identified as HIV-1-infected and/or are not provided with antiretroviral therapy. The optimum treatment str...
Disease Transmission, Vertical Vertical Human Immunodeficiency Virus Transmission HIV Infections
HIV Perinatal Prevention Transmission Nevirapine Epivir Zidovudine Nelfinavir ZDV NVP 3TC NFV Viracept Viramune HIV Seronegativity Treatment Naive
null
3
arm 1: Standard of care ( Zidovudine only) arm 2: Standard of care (Zidovudine) plus Nevirapine arm 3: Standard of Care (Zidovudine) plus 2 weeks of Epivir and Nelfinavir
[ 0, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Given for 6 weeks. 12mg PO BID if birthweight (BW) \> 2000 grams 8 mg PO BID if BW \< 2000 grams intervention 2: Standard of Care (Zidovudine) plus NVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second...
intervention 1: Zidovudine intervention 2: Nevirapine (NVP) intervention 3: Epivir (3TC) intervention 4: Nelfinavir (NFV)
17
Long Beach | California | United States | -118.18923 | 33.76696 Gainesville | Florida | United States | -82.32483 | 29.65163 Jacksonville | Florida | United States | -81.65565 | 30.33218 Newark | New Jersey | United States | -74.17237 | 40.73566 Houston | Texas | United States | -95.36327 | 29.76328 Buenos Aires | N/A ...
1,735
0
0
0
NCT00099359
1COMPLETED
2011-02-01
2004-02-01
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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 ]
267
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to determine the effect of short cycles of recombinant interleukin-2 (also known as rIL-2 or aldesleukin) given with or without anti-HIV drugs in HIV infected patients. The effects will be compared with a study group that receives no IL-2 or antiretroviral therapy. Study hypothesis: Interm...
Highly active antiretroviral therapy (HAART) has dramatically improved prognosis and lowered morbidity and mortality rates for HIV infected patients. However, significant drug toxicities, difficulties with patient compliance to HAART regimens, and development of drug resistance highlight the need for less toxic, immune...
HIV Infections
Treatment Naive IL-2 rIL-2
null
3
arm 1: Participants will receive no aldesleukin or HAART arm 2: Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level. Some Group 2 participants may take part in additional cycles of aldesleukin ...
[ 4, 0, 0 ]
1
[ 0 ]
intervention 1: 7.5 MIU injected intramuscularly; one arm uses Proleukin together with HAART of choice (protease inhibitor and at least 2 nucleoside/nucleotide reverse transcriptase inhibitors)
intervention 1: IL-2
36
Los Angeles | California | United States | -118.24368 | 34.05223 Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 Bethesda | Maryland | United States | -77.10026 | 38.98067 Detroit | Michigan | United States | -83.04575 | 42.33143 New York | New York | United States | -74.00597 | 40.71427 T...
267
0
0
0
NCT00110812
1COMPLETED
2011-02-01
2005-09-01
National Institute of Allergy and Infectious Diseases (NIAID)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
6
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this research is to conduct an open, pilot trial to assess the efficacy and safety of fluoxetine in the treatment of Juvenile Primary Fibromyalgia Syndrome (JPFS).
Fibromyalgia is a common condition that is often challenging to treat. It is defined by the American College of Rheumatology (ACR) as widespread pain of at least 3 months duration in combination with tenderness at 11 or more of 18 specific tender point sites on the body. The prevalence of JPFS in children and adolescen...
Juvenile Primary Fibromyalgia Syndrome (JPFS) Fibromyalgia
Fibromyalgia Juvenile
null
1
arm 1: All eligible patients were started on Fluoxetine at 10 mg once daily. The dose was flexibly dosed based on pain efficacy and tolerability to a final dose between 10 and 60 mg once daily.
[ 0 ]
1
[ 0 ]
intervention 1: Fluoxetine po 10-60 mg/day for 12 weeks. Fluoxetine was started at 10 mg once daily. The dose was flexibly dosed based on pain efficacy and tolerability to a final dose between 10 and 60 mg once daily
intervention 1: Fluoxetine
1
Cincinnati | Ohio | United States | -84.51439 | 39.12711
6
0
0
0
NCT00115804
1COMPLETED
2011-02-01
2005-06-01
University of Cincinnati
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
35
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving capecitabine after surgery, radiation therapy, and/or chemotherapy may kill any remaining tumor cells. PURPOSE: This phase II tria...
OBJECTIVES: Primary * Determine the feasibility of adjuvant low-dose capecitabine in patients with squamous cell carcinoma of the head and neck who have undergone prior curative surgery, radiotherapy, and/or chemotherapy. Secondary * Determine the time to recurrence, local-regional control, and survival rate in pat...
Head and Neck Cancer
stage I squamous cell carcinoma of the hypopharynx stage I squamous cell carcinoma of the larynx stage I squamous cell carcinoma of the lip and oral cavity stage I squamous cell carcinoma of the nasopharynx stage I squamous cell carcinoma of the oropharynx stage II squamous cell carcinoma of the hypopharynx stage II sq...
null
1
arm 1: Surgery, chemotherapy and/or radiotherapy, prior to administration of Capecitabine 1000mg/day for one year.
[ 0 ]
2
[ 0, 3 ]
intervention 1: Capecitabine 1000mg/day for one year intervention 2: Surgery, chemotherapy and/or radiotherapy
intervention 1: capecitabine intervention 2: Surgery, chemotherapy and/or radiotherapy
1
Detroit | Michigan | United States | -83.04575 | 42.33143
35
0
0
0
NCT00258310
1COMPLETED
2011-02-01
2003-12-01
Barbara Ann Karmanos Cancer Institute
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
32
NON_RANDOMIZED
SEQUENTIAL
0TREATMENT
0NONE
false
0ALL
true
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses ...
OBJECTIVES: Primary * Assess the safety and feasibility of erlotinib hydrochloride, paclitaxel, and carboplatin in combination with accelerated hyperfractionated radiotherapy in patients with stage IIIA or IIIB non-small cell lung cancer. * Determine the maximum tolerated dose and recommended phase II dose of erlotin...
Lung Cancer
stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer
null
3
arm 1: Erlotinib, Paclitaxel, and Carboplatin with Radiation Dose Level A: 50 mg OSI-774/50 mg/m2 Paclitaxel/2 AUC Carboplatin arm 2: Erlotinib, Paclitaxel, and Carboplatin with Radiation Dose Level B: 100 mg OSI-774/50 mg/m2 Paclitaxel/2 AUC Carboplatin arm 3: Erlotinib, Paclitaxel, and Carboplatin with Radiation D...
[ 0, 0, 0 ]
5
[ 0, 0, 0, 3, 4 ]
intervention 1: AUC2 weekly x 3 weeks intervention 2: Daily intervention 3: 50mg/m2/weekly x 3 weeks intervention 4: conventional surgery intervention 5: 150 cGy bid
intervention 1: carboplatin intervention 2: Erlotinib intervention 3: paclitaxel intervention 4: conventional surgery intervention 5: radiation therapy
1
Cleveland | Ohio | United States | -81.69541 | 41.4995
32
0
0
0
NCT00278148
1COMPLETED
2011-02-01
2005-10-01
Nathan Pennell, MD, PhD
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 ]
98
RANDOMIZED
PARALLEL
1PREVENTION
2DOUBLE
false
1FEMALE
false
This randomized phase II trial is studying green tea extract to see how well it works compared to a placebo in preventing cervical cancer in patients with human papillomavirus and low-grade cervical intraepithelial neoplasia. Chemoprevention is the use of certain substances to keep cancer from forming, growing, or comi...
PRIMARY OBJECTIVES: I. Assess the effect of green tea extract (Polyphenon E®) in patients with human papillomavirus (HPV) expression and low-grade cervical intraepithelial neoplasia (CIN 1) in a pre- and post-treatment setting. SECONDARY OBJECTIVES: I. Compare the toxicity of green tea extract vs placebo among patie...
Cervical Cancer Cervical Intraepithelial Neoplasia Grade 1 Human Papilloma Virus Infection
null
2
arm 1: Patients receive oral green tea extract once daily for 16 weeks in the absence of unacceptable toxicity. arm 2: Patients receive oral placebo once daily for 16 weeks in the absence of unacceptable toxicity.
[ 0, 2 ]
3
[ 0, 7, 10 ]
intervention 1: Given orally intervention 2: Given orally intervention 3: Correlative studies
intervention 1: placebo intervention 2: defined green tea catechin extract intervention 3: laboratory biomarker analysis
1
Tucson | Arizona | United States | -110.92648 | 32.22174
98
0
0
0
NCT00303823
1COMPLETED
2011-02-01
2005-09-01
National Cancer Institute (NCI)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
143
RANDOMIZED
FACTORIAL
0TREATMENT
4QUADRUPLE
true
0ALL
null
Smoking is often a problem for alcohol dependent individuals. Many people who seek treatment for alcohol dependence are unable to quit smoking. The purpose of this study is to evaluate the effectiveness of bupropion, an antidepressant medication, in treating smokers receiving treatment for alcohol dependence.
Past research suggests that over 75% of alcohol dependent individuals in early alcohol recovery smoke cigarettes; smoking-related mortality exceeds alcohol-related mortality in this population. Many alcohol dependent individuals in early recovery are interested in smoking cessation treatment; however, studies indicate ...
Smoking Cessation Alcohol-Related Disorders
null
2
arm 1: participants in this arm receive bupropion arm 2: placebo
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 300 mg QD intervention 2: placebo
intervention 1: Bupropion intervention 2: placebo
1
Bedford | Massachusetts | United States | -71.27617 | 42.49065
143
0
0
0
NCT00304707
1COMPLETED
2011-02-01
2005-04-01
National Institute on Drug Abuse (NIDA)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
37
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
null
This phase II trial is studying how well ABI-007 works in treating patients with persistent or recurrent cervical cancer. Drugs used in chemotherapy, such as ABI-007, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
OBJECTIVES: I. Estimate the antitumor activity of ABI-007 in patients with persistent or recurrent squamous or nonsquamous cell carcinoma of the cervix who have failed on higher-priority treatment protocols. II. Determine the nature and degree of toxicity of ABI-007 in this cohort of patients. III. To determine the ...
Cervical Adenocarcinoma Cervical Adenosquamous Carcinoma Cervical Small Cell Carcinoma Cervical Squamous Cell Carcinoma Recurrent Cervical Carcinoma
null
1
arm 1: Patients receive ABI-007 IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
[ 0 ]
2
[ 0, 10 ]
intervention 1: Given IV intervention 2: Correlative studies
intervention 1: Paclitaxel Albumin-Stabilized Nanoparticle Formulation intervention 2: Laboratory Biomarker Analysis
26
Aurora | Colorado | United States | -104.83192 | 39.72943 Chicago | Illinois | United States | -87.65005 | 41.85003 Urbana | Illinois | United States | -88.20727 | 40.11059 Des Moines | Iowa | United States | -93.60911 | 41.60054 Des Moines | Iowa | United States | -93.60911 | 41.60054 Des Moines | Iowa | United States...
35
0
0
0
NCT00309959
1COMPLETED
2011-02-01
2006-11-01
Gynecologic Oncology Group
5NETWORK
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
26
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to t...
OBJECTIVES: Primary * Improve median progression-free survival of patients with unresectable hepatocellular cancer treated with bevacizumab and transarterial chemoembolization therapy. Secondary * Characterize the safety and toxicity of this regimen in these patients. * Determine the response rate in patients treat...
Liver Cancer
localized unresectable adult primary liver cancer adult primary hepatocellular carcinoma advanced adult primary liver cancer recurrent adult primary liver cancer
null
1
arm 1: None
[ 0 ]
4
[ 2, 0, 0, 3 ]
intervention 1: None intervention 2: None intervention 3: None intervention 4: None
intervention 1: bevacizumab intervention 2: chemotherapy intervention 3: embolization therapy intervention 4: hepatic artery infusion
1
Baltimore | Maryland | United States | -76.61219 | 39.29038
26
0
0
0
NCT00335829
1COMPLETED
2011-02-01
2006-05-01
Yale University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
56
RANDOMIZED
PARALLEL
2DIAGNOSTIC
4QUADRUPLE
false
0ALL
true
This study measures the occurrence of certain side effects linked to antidepressant use and evaluates the effectiveness of the medication sertraline plus cognitive behavioral therapy to treat people with obsessive-compulsive disorder.
Obsessive-compulsive disorder (OCD) is an anxiety disorder that is associated with recurring repetitive behaviors and persistent unwanted thoughts. People with OCD often carry out ritual-like behaviors such as counting, cleaning, or washing their hands in order to momentarily ease their anxiety. A current treatment for...
Obsessive-Compulsive Disorder
OCD Antidepressive Agents, Second-Generation Placebos Cognitive Behavior Therapy Child Psychiatry Activation Syndrome Psychometrics
null
3
arm 1: Regular titration of Sertraline plus cognitive behavioral therapy. The titration schedule used a flexible upward titration from 25 mg/day to 200 mg/day over 9 weeks unless higher doses were not tolerated, after which the dosage was adjusted as a function of tolerability. If tolerated, maximum dose could be achie...
[ 0, 2, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Sertraline will be administered in standard dosing. Treatment with sertraline will last 18 weeks. intervention 2: The placebo will be administered in the same manner as sertraline. Treatment with placebo will last 18 weeks. intervention 3: Sertraline will be administered in slow titration. Treatment wit...
intervention 1: Regular Titration intervention 2: Placebo intervention 3: Slow Titration
2
Gainesville | Florida | United States | -82.32483 | 29.65163 Tampa | Florida | United States | -82.45843 | 27.94752
56
0
0
0
NCT00382291
1COMPLETED
2011-02-01
2009-02-01
University of Florida
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
576
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
Primary purpose of this study is to compare the efficacy and safety of two different nevirapine (Viramune) dosing regimens (once daily (QD) and twice daily (BID) application) and of atazanavir/ritonavir (Reyataz/Norvir), all on an emtricitabine/tenofovir disoproxil fumarate (DF) (Truvada) background. Patients will rece...
null
HIV Infections
null
3
arm 1: nevirapine (NVP) 200 mg BID in combination with emtricitabine (FTC) and tenofovir DF (TDF) arm 2: nevirapine (NVP) 400 mg QD in combination with emtricitabine (FTC) and tenofovir DF (TDF) arm 3: ritonavir-boosted atazanavir in combination with emtricitabine (FTC) and tenofovir DF (TDF)
[ 1, 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: nevirapine twice daily intervention 2: nevirapine once daily intervention 3: atazanavir once daily
intervention 1: nevirapine bid intervention 2: nevirapine qd intervention 3: atazanavir
68
Capital Federal | N/A | Argentina | N/A | N/A Córdoba | N/A | Argentina | -64.18853 | -31.40648 Mar del Plata | N/A | Argentina | -57.5562 | -38.00042 Rosario | N/A | Argentina | -60.63932 | -32.94682 Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.52437 Bochum | N/A | Germany | 7.21...
569
0
0
0
NCT00389207
1COMPLETED
2011-02-01
2006-10-01
Boehringer Ingelheim
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
50
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
false
The purpose of this study is to evaluate the safety and tolerability of weekly ABI-007 in combination with bevacizumab. The evaluation of progression-free survival of weekly ABI-007 in combination with bevacizumab for patients with previously untreated advanced/metastatic breast cancer.
null
Metastatic Breast Cancer
Metastatic breast cancer, Abraxane, Bevacizumab
null
1
arm 1: ABI-007 is administered on days 1, 8 and 15 at 125 mg/m\^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued ...
[ 0 ]
2
[ 0, 0 ]
intervention 1: 125 mg/m\^2 of ABI-007 administered by intravenously (IV) over 30 minutes on days 1, 8 and 15 of each 28 day cycle. intervention 2: Bevacizumab administered once every 2 weeks (10 mg/kg) by IV infusion after ABI-007 has been given. The first dose is one Day 1, cycle 1.
intervention 1: ABI-007 intervention 2: Bevacizumab
20
Melbourne | Florida | United States | -80.60811 | 28.08363 Ocoee | Florida | United States | -81.54396 | 28.56917 Niles | Illinois | United States | -87.80284 | 42.01892 Terre Haute | Indiana | United States | -87.41391 | 39.4667 Columbia | Maryland | United States | -76.83942 | 39.24038 Westminister | Maryland | Unite...
50
0
0
0
NCT00394082
1COMPLETED
2011-02-01
2006-06-01
Celgene
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
48
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
false
The purpose of this study is to evaluate the effectiveness and tolerability of the combination of bevacizumab and Abraxane in the treatment of women with epithelial ovarian cancer or peritoneal cancer. The study will also evaluate how the patient's quality of life is during their treatment.
null
Epithelial Ovarian Cancer Primary Peritoneal Carcinoma
null
0
null
null
2
[ 0, 0 ]
intervention 1: Bevacizumab will be given via IV infusion at 10mg/kg given on days 1 and 15 of a 28-day cycle. intervention 2: Abraxane will be given via IV infusion at 100mg/m²over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
intervention 1: Bevacizumab intervention 2: Abraxane
11
Little Rock | Arkansas | United States | -92.28959 | 34.74648 La Verne | California | United States | -117.76784 | 34.10084 Athens | Georgia | United States | -83.37794 | 33.96095 Atlanta | Georgia | United States | -84.38798 | 33.749 Coeur d'Alene | Idaho | United States | -116.78047 | 47.67768 Billings | Montana | Un...
48
0
0
0
NCT00407563
1COMPLETED
2011-02-01
2007-01-01
Accelerated Community Oncology 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
[ 4 ]
220
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
The purpose of this study is to evaluate if pregabalin relieves nerve pain associated with spinal cord injury compared to placebo (pill that contains no active medicine). This study will also evaluate the safety of pregabalin in this patient population.
null
Neuralgia Spinal Cord Injuries
Pain central neuropathic pain
null
2
arm 1: None arm 2: flexible dosing over 4 weeks followed by 12 weeks maintenance and one week taper period
[ 2, 0 ]
2
[ 0, 0 ]
intervention 1: Placebo intervention 2: Pregabalin capsules taken twice daily up to 17 weeks (150-600 mg/day)
intervention 1: placebo intervention 2: pregabalin
67
Phoenix | Arizona | United States | -112.07404 | 33.44838 Phoenix | Arizona | United States | -112.07404 | 33.44838 Phoenix | Arizona | United States | -112.07404 | 33.44838 Fresno | California | United States | -119.77237 | 36.74773 Napa | California | United States | -122.28553 | 38.29714 Northridge | California | Un...
219
0
0
0
NCT00407745
1COMPLETED
2011-02-01
2007-01-01
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
89
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
1FEMALE
true
Lymphangioleiomyomatosis (LAM) is a rare lung disease of women that is caused by genetic mutations. It results in the uncontrolled growth of an unusual type of smooth muscle cell in the lung. These cells invade lung tissue, including the airways, blood vessels, and lymph vessels, and restrict the flow of air, blood, an...
LAM is an uncommon, progressive, cystic lung disease that predominantly affects young women. The disease is caused by mutations in tuberous sclerosis complex (TSC) genes, which regulate cellular pathways that control nutrient sensing, cell size, cell migration, and cell proliferation. Individuals with LAM often experie...
Lymphangioleiomyomatosis
Lymphangiomyomatosis mTOR
null
2
arm 1: Participants receive sirolimus daily for 1 year and are followed with serial pulmonary function tests, 6-minute walk tests, and symptom and QOL questionnaires over a 2-year period. arm 2: Participants receive placebo daily for 1 year and followed with serial pulmonary function tests, 6-minute walk tests, and sym...
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: A sirolimus dose of 2 tablets (1 mg/tablet) per day for 1 year. intervention 2: A placebo dose of 2 tablets per day for 1 year.
intervention 1: Sirolimus intervention 2: Placebo
13
Los Angeles | California | United States | -118.24368 | 34.05223 Denver | Colorado | United States | -104.9847 | 39.73915 Gainesville | Florida | United States | -82.32483 | 29.65163 Bethesda | Maryland | United States | -77.10026 | 38.98067 Boston | Massachusetts | United States | -71.05977 | 42.35843 Cincinnati | Ohi...
89
0
0
0
NCT00414648
1COMPLETED
2011-02-01
2006-12-01
University of Cincinnati
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
42
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
This is a phase II study of biweekly (every other week) bevacizumab followed by gemcitabine then infusional 5-fluorouracil in patients with stage III or IV pancreatic cancer. Patients' response will be evaluated every 8 weeks using usual CT scanning techniques. RECIST (Response Evaluation Criteria in Solid tumors) crit...
Rationale: Research indicates that the vascular endothelial growth factor (VEGF), or a substance made by cells that stimulates new blood vessel formation, plays an important role in the growth and metastasis of many cancers, including pancreatic carcinoma. Both VEGF and its receptors are overexpressed in pancreatic can...
Pancreatic Cancer
Advanced Pancreatic Cancer
null
1
arm 1: None
[ 0 ]
3
[ 0, 0, 0 ]
intervention 1: 1000 mg/m2 over 100 minutes every 2 weeks. intervention 2: 10 mg/kg every 2 weeks. intervention 3: 2400 mg/m2 over 48 hours every 2 weeks.
intervention 1: Gemcitabine intervention 2: Bevacizumab intervention 3: Infusional 5-Fluorouracil
2
Ann Arbor | Michigan | United States | -83.74088 | 42.27756 Columbus | Ohio | United States | -82.99879 | 39.96118
42
0
0
0
NCT00417976
1COMPLETED
2011-02-01
2006-12-01
Tony Bekaii-Saab
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
1,234
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
To determine if treatment with BG00012 can decrease the number of MS relapses during a certain time period. To determine if, over time, BG00012 treatment can decrease the number of certain types of brain lesions commonly seen in MS patients and slow down the time it takes for the disease to get worse. The purpose of t...
null
Relapsing-Remitting Multiple Sclerosis
relapsing oral remitting multiple sclerosis
null
3
arm 1: Participants received two placebo capsules orally three times daily (TID) arm 2: Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD) arm 3: Participants received two 120 mg BG00012 capsules orally three times daily (TID)
[ 2, 0, 0 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: BG00012 intervention 2: Placebo
159
Gilbert | Arizona | United States | -111.78903 | 33.35283 Phoenix | Arizona | United States | -112.07404 | 33.44838 San Francisco | California | United States | -122.41942 | 37.77493 New Haven | Connecticut | United States | -72.92816 | 41.30815 Washington D.C. | District of Columbia | United States | -77.03637 | 38.89...
2,060
0
0
0
NCT00420212
1COMPLETED
2011-02-01
2007-01-01
Biogen
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 1 ]
81
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
Hypothesis: We hypothesize that resuscitation regimens which minimize the total volume of resuscitation fluid, while restoring organ perfusion, will lead to lower morbidity and mortality in critically ill patients following trauma.
null
Injuries Shock, Traumatic
null
2
arm 1: Vasopressin arm 2: bolus of NS (normal saline) followed by continuous infusion of NS, no vasopressin added
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: no vasopressin added to bolus or 5 hour continuous infusion intervention 2: vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours
intervention 1: normal saline control intervention 2: vasopressin
1
San Antonio | Texas | United States | -98.49363 | 29.42412
81
0
0
0
NCT00420407
6TERMINATED
2011-02-01
2007-02-01
The University of Texas Health Science Center at San Antonio
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 ]
181
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
1FEMALE
false
The primary objective of this study is to determine whether overall response to cetuximab combined with cisplatin is better than overall response to cisplatin alone together with showing that the overall response for cetuximab and cisplatin was above a pre-specified threshold of 0.2 in the treatment of "triple negative...
null
Breast Neoplasm
cancer breast metastatic triple negative
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Subjects will receive an initial dose of cetuximab 400 milligram per square meter (mg/m\^2) followed by weekly doses of 250 mg/m\^2. All doses will be given by intravenous (IV) infusion. Subjects will receive cisplatin (75 mg/m\^2 IV on Day 1) every 3 weeks, with a maximum of 6 cycles. Administration ...
intervention 1: cetuximab, cisplatin intervention 2: cisplatin
46
Campbelltown | New South Wales | Australia | 150.81667 | -34.06667 Liverpool | New South Wales | Australia | 150.92588 | -33.91938 Wollongong | New South Wales | Australia | 150.89345 | -34.424 Malvern | Victoria | Australia | 145.02811 | -37.86259 Perth | Western Australia | Australia | 115.8614 | -31.95224 Bludesch-G...
202
0
0
0
NCT00463788
1COMPLETED
2011-02-01
2007-06-01
Merck KGaA, Darmstadt, Germany
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
2
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
true
0ALL
true
This study was designed to determine whether post-operative pain following a tonsillectomy can be reduced by adding an antacid-like medication to the medications taken after surgery. It is hypothesized that even a small amount of stomach acid backing up and entering the mouth can increase post-tonsillectomy pain. There...
This study has been limited to children and adolescents ages 5-18 who are undergoing tonsillectomy for an indication of obstructive sleep disturbance (snoring, choking/gasping or pauses in breathing during sleep.) Study participants will be randomized to two groups: study medication (Lansoprazole) or an inactive subst...
Post-tonsillectomy Pain Post-tonsillectomy Activity Post-tonsillectomy Hydration
Tonsillectomy Pain
null
2
arm 1: Post-operative administration of Lansoprazole arm 2: Placebo
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: If weight is less than 30 kg, 15 mg of Lansoprazole twice daily will be administered. If weight is greater than or equal to 30 kg, 30 mg of Lansoprazole twice daily will be administered. intervention 2: Placebo will also be administered based on weight.
intervention 1: Lansoprazole intervention 2: Placebo
2
Boston | Massachusetts | United States | -71.05977 | 42.35843 Boston | Massachusetts | United States | -71.05977 | 42.35843
0
0
0
0
NCT00472186
6TERMINATED
2011-02-01
2008-06-01
Boston Children's Hospital
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
9
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
true
0ALL
true
The purpose of this study is to compare two standard treatments for pemphigus to determine which more effectively improves the clinical manifestations of the disease and decreases serum level of the autoantibodies which cause the disease.
Pemphigus is a serious and life-threatening autoimmune disease characterized by blisters and erosions that occur on the skin and oral mucosa. It is caused by autoantibodies that attack desmoglein 1 and 3, adhesion molecules that are present on the surface of the cells (keratinocytes) that make up the superficial layer ...
Pemphigus Vulgaris
pemphigus vulgaris IVIg cyclophosphamide treatment pemphigus antibodies
null
2
arm 1: IVIg alone (intravenous immunoglobulin) arm 2: IVIg with cyclophosphamide
[ 1, 0 ]
2
[ 0, 0 ]
intervention 1: Gamunex 10% 500/mg/kg/day x four days per cycle total of four cycles intervention 2: cyclophosphamide dose of 2mg/kg/day divided into three-times daily oral administration
intervention 1: intravenous immunoglobulin intervention 2: cyclophosphamide
1
New York | New York | United States | -74.00597 | 40.71427
9
0
0
0
NCT00483119
6TERMINATED
2011-02-01
2007-04-01
NYU Langone Health
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
33
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, oxaliplatin, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial...
OBJECTIVES: Primary * Compare the response rate in patients with "good risk" genotype (TSER\*2/\*2 or TSER\*2/\*3 genotype \[low TS expression\]) to historical control response rates in non-genotype selected patients. OUTLINE: This is a multicenter study. Patients receive oxaliplatin IV over 2 hours, leucovorin cal...
Gastric Cancer
adenocarcinoma of the stomach stage IV gastric cancer recurrent gastric cancer
null
1
arm 1: None
[ 0 ]
7
[ 0, 0, 0, 6, 6, 6, 10 ]
intervention 1: Given through a vein over 5 minutes and then continuously over 46 hours on days 1 and 15. intervention 2: through a vein over 2 hours on days 1 and 15. intervention 3: 500 ml D5W through a vein over 2 hours on days 1 and 15. intervention 4: Blood collection intervention 5: Blood collection intervention ...
intervention 1: fluorouracil intervention 2: leucovorin calcium intervention 3: oxaliplatin intervention 4: gene expression analysis intervention 5: polymorphism analysis intervention 6: protein expression analysis intervention 7: pharmacological study
5
St Louis | Missouri | United States | -90.19789 | 38.62727 Chapel Hill | North Carolina | United States | -79.05584 | 35.9132 Nashville | Tennessee | United States | -86.78444 | 36.16589 Nashville | Tennessee | United States | -86.78444 | 36.16589 Nashville | Tennessee | United States | -86.78444 | 36.16589
24
0
0
0
NCT00514020
1COMPLETED
2011-02-01
2007-08-01
Vanderbilt-Ingram Cancer Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
59
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This clinical trial is studying the side effects of Erwinia asparaginase and what happens to the drug in the body in treating young patients with acute lymphoblastic leukemia who are allergic to PEG-asparaginase. Drugs used in chemotherapy, such as Erwinia asparaginase, work in different ways to stop the growth of canc...
PRIMARY OBJECTIVES: I. To determine if the 48-hour trough serum asparaginase activity is ? 0.1 IU/mL in young patients with acute lymphoblastic leukemia treated with Erwinia asparaginase after allergy to PEG-asparaginase. II. To determine the frequency of asparaginase-related toxicity in these patients. III. To char...
Adult Acute Lymphoblastic Leukemia Childhood Acute Lymphoblastic Leukemia
null
1
arm 1: Patients receive 6 doses of Erwinia asparaginase IM on a Monday/Wednesday/Friday schedule as a replacement for each scheduled dose of PEG-asparaginase remaining on the original treatment protocol. All other chemotherapy continues according to the original treatment protocol.
[ 0 ]
3
[ 0, 10, 10 ]
intervention 1: Given IM intervention 2: Correlative studies intervention 3: Correlative studies
intervention 1: Asparaginase intervention 2: Laboratory Biomarker Analysis intervention 3: Pharmacological Study
43
Birmingham | Alabama | United States | -86.80249 | 33.52066 Phoenix | Arizona | United States | -112.07404 | 33.44838 Downey | California | United States | -118.13257 | 33.94001 Los Angeles | California | United States | -118.24368 | 34.05223 Madera | California | United States | -120.06072 | 36.96134 Orange | Californ...
55
0
0
0
NCT00537030
1COMPLETED
2011-02-01
2008-02-11
Children's Oncology Group
5NETWORK
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
323
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
A study to assess the safety and efficacy of Alefacept in de novo kidney transplant patients.
This is a 4 arm (all active) study to determine the safety and efficacy of Alefacept in de novo kidney transplant recipients.
Kidney Transplantation
kidney transplant alefacept
null
4
arm 1: Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months. arm 2: ...
[ 1, 0, 0, 0 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: Administered as a 7.5 mg intravenous bolus on day 0 (intraoperatively, prior to kidney revascularization) and Day 3; subsequently administered subcutaneously either weekly or every 2 weeks. intervention 2: The initial dose of tacrolimus was administered orally within 48 hours post-transplant. Subsequent...
intervention 1: Alefacept intervention 2: tacrolimus intervention 3: basiliximab intervention 4: mycophenolate mofetil intervention 5: Corticosteroids
38
Loma Linda | California | United States | -117.26115 | 34.04835 Los Angeles | California | United States | -118.24368 | 34.05223 Los Angeles | California | United States | -118.24368 | 34.05223 Sacramento | California | United States | -121.4944 | 38.58157 San Diego | California | United States | -117.16472 | 32.71571 ...
309
0
0
0
NCT00543569
1COMPLETED
2011-02-01
2008-02-01
Astellas Pharma Inc
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
194
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This study is a randomized, blinded, placebo-controlled clinical efficacy trial to assess the duration and severity of influenza symptoms, and duration of viral shedding, in influenza patients receiving oseltamivir early and late relative to placebo. There are two main hypotheses in this study: 1. The duration of inf...
In the past decade influenza has become increasingly recognized as a serious disease and pandemic threat. Elderly persons, young children, and individuals with chronic medical conditions have the greatest risk for complications or death from influenza infection. Neuraminidase inhibitors are currently licensed for the t...
Influenza
randomized blinded controlled efficacy
null
2
arm 1: Adults and adolescents weighing greater than 88 pounds will receive one 75 mg oseltamivir capsule twice daily, with or without food for a total of 5 days (10 doses). Participants one year of age and older up to a maximum weight of 88 pounds will receive a liquid form of study medication containing oseltamivir at...
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Adults and adolescents weighing greater than 88 pounds will receive one 75 mg oseltamivir capsule twice daily, with or without food for a total of 5 days (10 doses). Participants one year of age and older up to a maximum weight of 88 pounds will receive a liquid form of study medication containing oselt...
intervention 1: Oseltamivir intervention 2: Placebo
1
Marshfield | Wisconsin | United States | -90.1718 | 44.66885
165
0
0
0
NCT00555893
1COMPLETED
2011-02-01
2008-01-01
Marshfield Clinic Research Foundation
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 ]
43
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
P-cadherin may play a part in tumor growth; PF-03732010 is a new drug that inhibits P-cadherin. This study will test how well the drug is tolerated, and what effects there might be. Blood will also be taken to measure the amount of drug in blood.
null
Neoplasms
null
1
arm 1: Single Arm study
[ 0 ]
1
[ 0 ]
intervention 1: IV infusion. Escalating dose levels, starting at 0.5 mg/kg to Maximum Tolerated Dose. Cycle length of 4 weeks for first cycle, and 2 weekly for subsequently cycles was originally explored, yet based on emerging PK data the Cycle 1 duration is 2 weeks and then weekly. Number of Cycles: Until Progression ...
intervention 1: PF-03732010
3
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 Parkville | Victoria | Australia | 144.95 | -37.78333 Seoul | N/A | South Korea | 126.9784 | 37.566
43
0
0
0
NCT00557505
1COMPLETED
2011-02-01
2007-12-01
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 ]
1,353
RANDOMIZED
PARALLEL
1PREVENTION
2DOUBLE
false
0ALL
null
The primary efficacy objective is to evaluate whether dabigatran etexilate is superior to placebo in the long-term prevention of recurrent symptomatic venous thrombo-embolism (VTE) in patients with symptomatic deep-vein thrombosis (DVT) or pulmonary embolism (PE) who completed 6 to 18 months of treatment with vitamin K...
null
Venous Thromboembolism
null
2
arm 1: Patient to receive dabigatran etexilatate capsules 150 mg twice daily arm 2: Patient to receive dabigatran extexilate matching placebo capsules twice daily
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: dabigatran etexilate capsules 150 mg BID intervention 2: Matching placebo BID
intervention 1: dabigatran etexilate 150 mg twice daily (BID) intervention 2: matching placebo twice daily (BID)
147
Birmingham | Alabama | United States | -86.80249 | 33.52066 Huntsville | Alabama | United States | -86.58594 | 34.7304 Laguna Hills | California | United States | -117.71283 | 33.61252 Colorado Springs | Colorado | United States | -104.82136 | 38.83388 Jacksonville | Florida | United States | -81.65565 | 30.33218 Key W...
1,343
0
0
0
NCT00558259
1COMPLETED
2011-02-01
2007-11-01
Boehringer Ingelheim
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
12
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This phase II trial is studying saracatinib to see how well it works in treating patients with metastatic or locally advanced breast cancer that cannot be removed by surgery. Saracatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
PRIMARY OBJECTIVES: I. To estimate the disease control rate of AZD0530 (saracatinib) in patients with metastatic breast cancer. SECONDARY OBJECTIVES: I. To estimate the efficacy of AZD0530 in terms of overall response rate (complete and partial response) and progression free survival. II. To describe the toxicity p...
Estrogen Receptor-negative Breast Cancer Male Breast Cancer Progesterone Receptor-negative Breast Cancer Recurrent Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Stage IV Breast Cancer
null
1
arm 1: Patients receive saracatinib PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
[ 0 ]
2
[ 0, 10 ]
intervention 1: None intervention 2: Correlative studies
intervention 1: saracatinib intervention 2: laboratory biomarker analysis
1
New York | New York | United States | -74.00597 | 40.71427
9
0
0
0
NCT00559507
1COMPLETED
2011-02-01
2007-10-01
National Cancer Institute (NCI)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
16
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to determine the safety and tolerability of dasatinib with bortezomib in the treatment of relapsed or refractory multiple myeloma.
null
Multiple Myeloma
null
1
arm 1: Phase I dose escalation study
[ 0 ]
3
[ 0, 0, 0 ]
intervention 1: Tablets; oral; approximately 2 years on study, depending on response; 50 mg once daily (QD), 100 mg QD, 140 mg QD intervention 2: Powder; intravenous; approximately 2 years on study, depending on response; 1.0 mg/m\^2 QD, 1.3 mg/m\^2 QD intervention 3: Tablets; oral; approximately 2 years on study, depe...
intervention 1: Dasatinib intervention 2: Bortezomib intervention 3: Dexamethasone
7
Orlando | Florida | United States | -81.37924 | 28.53834 Atlanta | Georgia | United States | -84.38798 | 33.749 Nantes | Cedex 1 | France | -1.55336 | 47.21725 Lille | N/A | France | 3.05858 | 50.63297 Bari | N/A | Italy | 16.86982 | 41.12066 Bologna | N/A | Italy | 11.33875 | 44.49381 Salamanca | N/A | Spain | -5.6638...
14
0
0
0
NCT00560352
6TERMINATED
2011-02-01
2008-02-01
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
[ 4 ]
69
RANDOMIZED
CROSSOVER
4SUPPORTIVE_CARE
2DOUBLE
false
2MALE
true
Aprepitant is currently approved for prophylaxis of acute and delayed CINV for highly emetogenic chemotherapy regimens, including cisplatin; however, it has not yet been studied in multiple-day chemotherapy treatment programs. This study will compare the addition of aprepitant compared to placebo administered on days 3...
OUTLINE: This is a multi-center trial. Subjects will be stratified prior to randomization based on previous administration of chemotherapy. Subjects will randomize to aprepitant or placebo with their first study cycle of chemotherapy and then cross over to opposite treatment with the second study cycle. Cisplatin-ba...
Germ Cell Tumors
null
2
arm 1: Participants first received Aprepitant 125mg PO day 3 then 80mg on days 4 and 7 during study cycle 1, then received matched placebo PO daily on days 3 through 7 during study cycle 2 arm 2: Participants first received matched placebo PO daily on days 3 through 7 during study cycle 1, then received Aprepitant 125m...
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Subjects will be randomized to receive aprepitant 125mg PO day 3 then 80mg on days 4-7 on either cycle 1 or cycle 2. intervention 2: Subjects will be randomized to receive placebo on days 3-7 on either cycle 1 or cycle 2.
intervention 1: Aprepitant intervention 2: Placebo
6
Indianapolis | Indiana | United States | -86.15804 | 39.76838 Muncie | Indiana | United States | -85.38636 | 40.19338 St Louis | Missouri | United States | -90.19789 | 38.62727 Portland | Oregon | United States | -122.67621 | 45.52345 Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 Milwaukee | Wiscon...
69
0
0
0
NCT00572572
1COMPLETED
2011-02-01
2007-12-01
Hoosier Cancer 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 ]
42
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
Researchers want to see whether Sho-saiko-to (SST) can help in patients with chronic hepatitis C. Chronic hepatitis C may cause swelling within the liver and this can lead to scar tissue. In some patients, severe scarring of the liver, liver failure and liver cancer can occur. Standard treatment for chronic hepatitis C...
Chronic hepatitis C affects nearly three million Americans. Of these, 15% will develop liver cirrhosis and approximately 5% will progress to hepatocellular carcinoma. Treatment for chronic hepatitis C is limited to interferon-based therapy. Many patients decline or cannot tolerate interferon because of its serious side...
Hepatitis C
Hepatitis C Sho-saiko-to SST Interferon Therapy
null
1
arm 1: All patients will receive treatment with 2.5grams of SST as granules in packet form by mouth three times a day every day for 52 weeks unless occurrence of unacceptable adverse events or patient withdrawal.
[ 0 ]
1
[ 0 ]
intervention 1: All patients will receive treatment with 2.5grams of SST as granules in packet form by mouth three times a day every day for 52 weeks unless occurrence of unacceptable adverse events or patient withdrawal. Patients will be seen for clinical follow-up at three month intervals: at 3, 6, 9, and 12 months, ...
intervention 1: Sho-saiko-to
1
New York | New York | United States | -74.00597 | 40.71427
24
0
0
0
NCT00590564
1COMPLETED
2011-02-01
2002-10-01
Memorial Sloan Kettering Cancer Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
209
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This study will evaluate the effect of atomoxetine in treating Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms in children and adolescents with ADHD and comorbid reading disability (dyslexia)
null
Attention Deficit Hyperactivity Disorder Dyslexia
null
2
arm 1: Atomoxetine will be administered at 1.0 to 1.4 milligram/kilogram/day (mg/kg/day) given orally once daily in the morning. All eligible patients who complete the double-blind study period will have the option of participating in a 16-week open-label extension period in which patients will be treated with atomoxet...
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Atomoxetine will be administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 to 32 weeks intervention 2: oral, daily, for 16 weeks
intervention 1: Atomoxetine intervention 2: Placebo
16
Irvine | California | United States | -117.82311 | 33.66946 Palo Alto | California | United States | -122.14302 | 37.44188 San Francisco | California | United States | -122.41942 | 37.77493 New Haven | Connecticut | United States | -72.92816 | 41.30815 Tampa | Florida | United States | -82.45843 | 27.94752 Libertyville...
209
0
0
0
NCT00607919
1COMPLETED
2011-02-01
2008-03-01
Eli Lilly and Company
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
3
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
Background: * gp100 is a protein that is often found in melanoma tumors. * An experimental procedure developed for treating patients with melanoma uses anti-gp100 cells designed to destroy their tumors. The anti-gp100 cells are created in the laboratory using the patient's own tumor cells or blood cells. * The treatme...
Background: * We have engineered human peripheral blood lymphocytes (PBLs) to express a T-cell receptor that recognizes an human leukocyte antigens (HLAA) 0201 restricted epitope derived from the gp100 protein. * We constructed a single retroviral vector that contains both alpha and infinity chains and can mediate gen...
Metastatic Melanoma Skin Cancer
Metastatic Melanoma Immunotherapy Vaccination Tumor Regression Skin Cancer
null
1
arm 1: ALVAC plus anti-gp100:154-162 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + high dose (HD) interleukin-2 (IL-2): ALVAC vaccine two hours prior to cell infusion patients will receive 0.5 ml containing a target dose of 10\^7 cell culture infectious dose 50% (CCID50) (with a range of approximately 10\^...
[ 0 ]
5
[ 0, 0, 2, 2, 2 ]
intervention 1: 60 mg/kg day x 2 days intravenous in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg day x 2 days over 1 hour intervention 2: 25 mg/m\^2 day intravenous piggy back over 30 minutes for 5 days intervention 3: 720,000 IU/kg intravenously over 15 minutes every 8 hours (+/- 1 hour) for up to 5 days. in...
intervention 1: cyclophosphamide intervention 2: fludarabine phosphate intervention 3: Aldesleukin intervention 4: ALVAC gp100 Vaccine intervention 5: anti-gp100:154-162 Tcell receptor (TCR) peripheral blood lymphocyte (PBL)
1
Bethesda | Maryland | United States | -77.10026 | 38.98067
3
0
0
0
NCT00610311
6TERMINATED
2011-02-01
2008-01-01
National Cancer Institute (NCI)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
16
RANDOMIZED
CROSSOVER
null
3TRIPLE
true
0ALL
false
This study tests the hypothesis that extrasynaptic mechanisms are critically linked with cognitive effects of NMDA antagonism as evidenced by event-related potentials (ERPs) in healthy humans.
null
Cognitive Dysfunction
NMDA glutamate N-acetylcysteine P3
null
2
arm 1: The NAC capsules were administered orally in divided doses: 2000 mg followed by 1000 mg 2 hours later. Each morning, 165 min after NAC administration, subjects received a 1-min bolus of normal saline, followed by a 70-minlong saline infusion during which behavioral, cognitive, and ERP data were collected. Ketami...
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Active drug (N-acetylcysteine) intervention 2: placebo N-acetylcysteine
intervention 1: N-acetylcysteine and ketamine intervention 2: placebo and ketamine
1
West Haven | Connecticut | United States | -72.94705 | 41.27065
16
0
0
0
NCT00611897
1COMPLETED
2011-02-01
2006-01-01
Yale University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
119
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This research is being done because people with schizophrenia often have problems with thinking including learning, remembering, paying attention, and problem solving. During this study, we will test if cognitive remediation (computer games made to improve thinking), used along with a drug called atomoxetine, may help ...
Persons with schizophrenia in a stable and residual antipsychotic- treated clinical condition for at least 8 weeks will be recruited from several public mental health treatment settings into the UTSW Schizophrenia Research Clinic. Each volunteer will receive information about the protocol and its risks and benefits. If...
Cognition in Schizophrenia
Cognition schizophrenia Atomoxetine Strattera cognitive remediation
null
4
arm 1: Patients are given the drug Atomoxetine and Cognitive Remediation training. arm 2: Patients are given the drug Atomoxetine and Remediation Control training. arm 3: Patients are given a Placebo and Cognitive Remediation training. arm 4: Patients are given Placebo and Remediation Control training.
[ 5, 5, 5, 5 ]
2
[ 0, 0 ]
intervention 1: 40mg 2po qam intervention 2: 40mg 2po qam
intervention 1: Atomoxetine intervention 2: Placebo
1
Dallas | Texas | United States | -96.80667 | 32.78306
40
0
0
0
NCT00628394
1COMPLETED
2011-02-01
2003-09-01
University of Texas Southwestern Medical Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
35
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to determine whether or not the injection site of cytokines, or growth factors, has an effect on peripheral blood stem cell collection.
The purpose of this study is to determine the preferred injection site for G-CSF and GM-CSF, which are cytokines, or growth factors. The doctor may also choose to use these growth factors in combination with chemotherapy to increase the number of stem cells in the blood. Both options are established and are effective i...
Cytokines
null
2
arm 1: These subjects will have their cytokine injections administered only to their abdomen. arm 2: The extremity arm will have their injections administered to their upper and/or lower extremities.
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: Injection site Extremities: G-CSF injections will commence on the day after completion of mobilization chemotherapy, at least 24 hours after completion of the last chemotherapy dose. On the seventh day of cytokine administration, GMCSF injections will be started, and patients will maintain a twice daily...
intervention 1: G-CSF, GM-CSF administered at extremities intervention 2: G-CSF and GMCSF administered at abdomen
1
Atlanta | Georgia | United States | -84.38798 | 33.749
35
0
0
0
NCT00646763
6TERMINATED
2011-02-01
2008-04-01
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
[ 3 ]
18
NA
SINGLE_GROUP
9OTHER
0NONE
false
0ALL
false
Preterm babies are at risk of brain injury. Melatonin, a naturally occurring hormone, may reduce this risk. The unborn baby receives melatonin from the mother but following premature delivery there maybe a period of prolonged melatonin deficiency. This deficiency may be harmful because studies suggest that melatonin is...
PURPOSE OF THE STUDY AND OBJECTIVES The overall purpose is to investigate whether melatonin, on achieving adult maternal peak blood levels in preterm infants, will reduce brain injury and white matter disease as defined by specialised magnetic resonance imaging (MRI) at term. Before testing this hypothesis in a clinica...
Premature Birth Brain Injury
Premature Birth Brain injury Neuroprotection Melatonin Pharmacokinetics
null
1
arm 1: Infants born less than 31 weeks gestation who are less than 7 days old
[ 0 ]
1
[ 0 ]
intervention 1: A single intravenous infusion of melatonin will be given to each infant over 6 hours so that successive groups will receive increasing doses until the correct dose for age is found. Based on the pharmacokinetics and clearance of melatonin in adults an approximate dose has been calculated. The starting ...
intervention 1: Melatonin injection
2
Bolton | N/A | United Kingdom | -2.43333 | 53.58333 London | N/A | United Kingdom | -0.12574 | 51.50853
18
0
0
0
NCT00649961
1COMPLETED
2011-02-01
2010-05-01
Imperial College London
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 ]
18
RANDOMIZED
PARALLEL
null
0NONE
false
0ALL
false
This pilot study focuses on the persistence of central nervous system (CNS) immune activation that has been observed in the presence of 'effective' combination antiretroviral therapy (cART). Attention to this issue is based on the fear that chronic CNS immunoactivation can cause indolent brain injury that will eventual...
null
HIV Infections
raltegravir central nervous system (CNS) HIV-1 AIDS cerebrospinal fluid (CSF) immunoactivation antiretroviral therapy suppression
null
2
arm 1: The raltegravir dosing will be 400mg twice daily by mouth. Subjects will continue all of their regular medications throughout the protocol. arm 2: Subjects randomized not to receive augmented treatment will continue in the study with their regular antiretroviral regimen.
[ 0, 4 ]
1
[ 0 ]
intervention 1: 400 mg two times daily for three months
intervention 1: raltegravir
1
San Francisco | California | United States | -122.41942 | 37.77493
24
0
0
0
NCT00672932
1COMPLETED
2011-02-01
2008-04-01
University of California, San Francisco
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
2
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
This open-label study will pilot the use of systemic sunitinib malate, a dual inhibitor of vascular endothelial growth factor (VEGF) and platelet derived growth factor (PDGF), in five participants with Von Hippel-Lindau (VHL) to investigate its potential efficacy as a treatment for retinal angiomas. Participants will h...
null
Von Hippel-Lindau Syndrome
Von Hippel Lindau Sunitinib Malate Sutent Von Hippel-Lindau Syndrome VHL
null
1
arm 1: Participants were expected to receive 9 months of sunitinib malate therapy administered in 6 cycles. Each cycle consisted of a daily oral dose of 50 mg sunitinib malate for 4 weeks followed by a 2-week rest period).
[ 0 ]
1
[ 0 ]
intervention 1: Participants were expected to receive 9 months of sunitinib malate therapy administered in 6 cycles. Each cycle consisted of a daily oral dose of 50 mg sunitinib malate for 4 weeks followed by a 2-week rest period).
intervention 1: Sunitinib Malate
1
Bethesda | Maryland | United States | -77.10026 | 38.98067
2
0
0
0
NCT00673816
6TERMINATED
2011-02-01
2008-05-01
National Eye Institute (NEI)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
550
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of this study is to assess long-term ocular safety of fluticasone furoate nasal spray in adult and adolescent subjects diagnosed with perennial allergic rhinitis.
null
Rhinitis, Allergic, Perennial
Perennial Allergic Rhinitis fluticasone furoate ocular safety
null
2
arm 1: None arm 2: None
[ 2, 1 ]
2
[ 0, 0 ]
intervention 1: fluticasone furoate nasal spray intervention 2: placebo
intervention 1: fluticasone furoate nasal spray intervention 2: vehicle placebo nasal spray
56
Oxford | Alabama | United States | -85.83496 | 33.61427 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Fresno | California | United States | -119.77237 | 36.74773 Huntington Beach | California | United States | -117.99923 | 33.6603 Los Angeles | California | United States | -118.24368 | 34.05223 Mission ...
548
0
0
0
NCT00682643
1COMPLETED
2011-02-01
2008-06-01
GlaxoSmithKline
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
261
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
The objective of this study is to compare the efficacy of peginterferon alfa-2b (PegIFN-2b) monotherapy administered at a dose of 0.5 ug/kg vs stronger neo minophagen C (SNMC) in participants with chronic hepatitis C (CHC) and liver fibrosis (Metavir fibrosis score of F2 and F3) who were previously treated with interfe...
null
Hepatitis C, Chronic
hepatitis C
null
2
arm 1: Participants receiving PegIFN-2b at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks. arm 2: Participants receiving SNMC 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up to 156 weeks.
[ 0, 1 ]
2
[ 2, 0 ]
intervention 1: PegIFN-2b administered at a dose of 0.5 ug/kg SC once a week for 156 weeks intervention 2: SNMC (as glycyrrhizin-containing compound) administered at 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for 156 weeks .
intervention 1: Peginterferon alfa-2b (PegIFN-2b) intervention 2: Comparator: Stronger neo minophagen C (SNMC)
0
null
252
0
0
0
NCT00686881
6TERMINATED
2011-02-01
2006-12-01
Merck Sharp & Dohme LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
843
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
The purpose of the trial was to evaluate the efficacy, safety, and tolerability of an intramuscular depot formulation of aripiprazole as maintenance treatment in patients with schizophrenia. The trial was designed into 4 treatment phases. Phase 1 was designed to allow for a patient to be converted from their current a...
This was a randomized, double-blind, placebo-controlled study consisting of a screening phase and 4 treatment phases. Eligibility was determined during a screening phase of 2 to 42 days. Patients receiving oral treatment with an antipsychotic other than non-generic aripiprazole entered Phase 1. Patients with a lapse in...
Schizophrenia
Aripiprazole Intramuscular (IM) depot Schizophrenia
null
2
arm 1: Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks. arm 2: Patients received placebo intramuscularly every 28 days for 52 weeks.
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Aripiprazole depot was supplied in 400 mg lyophilized vials. Patients received aripiprazole 300 mg if they were unable to tolerate aripiprazole 400 mg. intervention 2: Placebo depot was supplied in 400 mg lyophilized vials.
intervention 1: Aripiprazole depot intervention 2: Placebo depot
110
Chandler | Arizona | United States | -111.84125 | 33.30616 Anaheim | California | United States | -117.9145 | 33.83529 National City | California | United States | -117.0992 | 32.67811 Oceanside | California | United States | -117.37948 | 33.19587 San Diego | California | United States | -117.16472 | 32.71571 Santa Ana...
2,320
0
0
0
NCT00705783
1COMPLETED
2011-02-01
2008-07-01
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