FEATURE_phases
list
FEATURE_enrollmentCount
int64
FEATURE_allocation
string
FEATURE_interventionModel
string
FEATURE_primaryPurpose
class label
FEATURE_masking
class label
FEATURE_healthyVolunteers
bool
FEATURE_sex
class label
FEATURE_oversightHasDmc
bool
FEATURE_briefSummary
string
FEATURE_detailedDescription
string
FEATURE_conditions
string
FEATURE_conditionsKeywords
string
FEATURE_protocolPdfText
string
FEATURE_numArms
int64
FEATURE_armDescriptions
string
FEATURE_armGroupTypes
list
FEATURE_numInterventions
int64
FEATURE_interventionTypes
list
FEATURE_interventionDescriptions
string
FEATURE_interventionNames
string
FEATURE_numLocations
int64
FEATURE_locationDetails
string
LABEL_ct_level_ade_population
int64
LABEL_sum_dosing_errors
int64
LABEL_dosing_error_rate
float32
LABEL_wilson_label
int64
METADATA_nctId
string
METADATA_overallStatus
class label
METADATA_completionDate
date32
METADATA_startDate
date32
METADATA_leadSponsorName
string
METADATA_leadSponsorClass
class label
METADATA_hasProtocol
bool
METADATA_hasSap
bool
METADATA_hasIcf
bool
METADATA_protocolPdfLinks
string
METADATA_count_Accidental drug intake by child
int64
METADATA_count_Accidental overdose
int64
METADATA_count_Accidental overdose (therapeutic agent)
int64
METADATA_count_Accidental underdose
int64
METADATA_count_Deliberate overdose
int64
METADATA_count_Dose calculation error
int64
METADATA_count_Drug administration error
int64
METADATA_count_Drug overdose
int64
METADATA_count_Drug overdose accidental
int64
METADATA_count_Extra dose administered
int64
METADATA_count_Incorrect dosage administered
int64
METADATA_count_Incorrect dose administered
int64
METADATA_count_Incorrect drug administration duration
int64
METADATA_count_Incorrect drug administration rate
int64
METADATA_count_Incorrect product administration duration
int64
METADATA_count_Intentional overdose
int64
METADATA_count_Medication error
int64
METADATA_count_Medication monitoring error
int64
METADATA_count_Multiple drug overdose
int64
METADATA_count_Multiple drug overdose accidental
int64
METADATA_count_Multiple drug overdose intentional
int64
METADATA_count_Multiple use of single-use product
int64
METADATA_count_Non-accidental overdose
int64
METADATA_count_Overdose
int64
METADATA_count_Overdose NOS
int64
METADATA_count_Overmedication
int64
METADATA_count_Prescribed overdose
int64
METADATA_count_Treatment noncompliance
int64
METADATA_count_Underdose
int64
METADATA_count_Unintentional medical device removal
int64
METADATA_count_Unintentional medical device removal by patient
int64
METADATA_wilson_lower_bound
float32
[ 5 ]
20
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
false
0ALL
false
The aim of the study is to investigate meal-related treatment with either premixed Insulin Aspart 30, Aspart 70 and Aspart with regard to postprandial glucose, triglyceride and free fatty acids excursions after a standard breakfast and lunch.
Whereas the effects of each of the established types of insulin (remixed Insulin Aspart 30, Aspart 70 and Aspart) have been shown before, their specific glucose and lipid lowering capacities have so far not been investigated in a simulated physiological situation.
Type 2 Diabetes
insulin aspart 30 insulin aspart 70 insulin aspart postprandial glucose and lipid metabolism consecutive mixed meals
null
3
arm 1: 35% of their usual total daily insulin dose before the standardized breakfast and 25% prior to lunch arm 2: 35% of their usual total daily insulin dose before the standardized breakfast and 25% prior to lunch arm 3: 35% of their usual total daily insulin dose before the standardized breakfast and 25% prior to lu...
[ 1, 1, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Patients received insulin aspart before breakfast and before lunch. intervention 2: Patients received biphasic insulin aspart 30 before breakfast and before lunch. intervention 3: Patients received biphasic insulin aspart 70 before breakfast and before lunch.
intervention 1: Insulin Aspart intervention 2: Insulin Aspart 30 intervention 3: Insulin Aspart 70
1
Graz | N/A | Austria | 15.45 | 47.06667
60
0
0
0
NCT01293396
1COMPLETED
2011-03-01
2010-06-01
Medical University of Graz
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 ]
6
NA
SINGLE_GROUP
9OTHER
0NONE
true
2MALE
false
This is a single dose study of radiolabeled \[14C\]-LY3009104 in healthy male volunteers to study the absorption, distribution, metabolism, and elimination of LY3009104. This study requires minimum of 7 days and maximum of 22 days stay. This study is for research purposes only and is not intended to treat any medical c...
null
Healthy Volunteers
Absorption Distribution Metabolism Excretion Mass balance Metabolic profile Radiolabeled study 14C
null
1
arm 1: Single 10-milligram (mg) oral dose containing 100 microcuries of 14C-labeled LY3009104
[ 0 ]
1
[ 0 ]
intervention 1: Administered orally
intervention 1: LY3009104
1
Madison | Wisconsin | United States | -89.40123 | 43.07305
6
0
0
0
NCT01299285
1COMPLETED
2011-03-01
2011-02-01
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
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
The interest in using L-asparaginase in pancreatic cancer arose from in vitro and in vivo studies data showing an anti-neoplastic effect on pancreatic tumor cell lines. Interestingly, these studies suggest an additional effect of L-asparaginase associated to gemcitabine.GRASPA is a suspension of red blood cells encapsu...
null
Pancreatic Cancer
pancreatic cancer asparaginase
null
4
arm 1: None arm 2: None arm 3: None arm 4: None
[ 0, 0, 0, 0 ]
1
[ 0 ]
intervention 1: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose
intervention 1: GRASPA
0
null
12
0
0
0
NCT01523808
1COMPLETED
2011-03-01
2009-11-01
ERYtech Pharma
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
96
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
Vitamin D (Vit D) status is an emerging risk marker of great interest in cardiovascular disease (CVD). Lower serum levels of Vit D are associated with both cardiac risk factors and prevalent cardiovascular disease. Vit D insufficiency remains very prevalent in free living populations in the United States especially in ...
100 subjects with angiographically documented CAD and Vit D deficiency will be randomized to 50,000 IU oral ergocalciferol (active treatment group) or placebo (delayed intervention group) once a week for 12 weeks. The investigators will measure endothelial function at randomization and week 12 using RH-PAT and serologi...
Vitamin D Deficiency Coronary Artery Disease Endothelial Dysfunction Inflammation
vitamin D, vitamin D deficiency coronary artery disease ergocalciferol endothelial function adhesion molecules inflammation IL-12 interferon-gamma CXCL-10 reactive hyperemia peripheral arterial tonometry endothelial dysfunction cytokines chemokines
null
2
arm 1: 50,000 units of ergocalciferol once a week for 12 weeks arm 2: None
[ 1, 2 ]
2
[ 0, 10 ]
intervention 1: Oral capsule, 50,000 units, once a week, 12 weeks intervention 2: Oral capsule, once a week, 12 weeks
intervention 1: Ergocalciferol intervention 2: Sugar pill
2
The Bronx | New York | United States | -73.86641 | 40.84985 The Bronx | New York | United States | -73.86641 | 40.84985
90
0
0
0
NCT01570309
1COMPLETED
2011-03-01
2008-08-01
Seth I. Sokol, M.D.
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
1,137
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This study will evaluate bimatoprost 0.01% (LUMIGAN® RC) in patients with elevated intraocular pressure (IOP) due to primary open angle glaucoma (POAG) or ocular hypertension (OHT) in a clinical setting.
null
Glaucoma, Primary Open Angle Ocular Hypertension
null
1
arm 1: Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
[ 0 ]
1
[ 0 ]
intervention 1: Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
intervention 1: Bimatoprost 0.01%
1
Barrie | Ontario | Canada | -79.66634 | 44.40011
1,137
0
0
0
NCT01833741
1COMPLETED
2011-03-01
2009-12-01
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
[ 0 ]
36
RANDOMIZED
PARALLEL
1PREVENTION
2DOUBLE
true
0ALL
true
The purpose of this study is to see if salsalate, an Nuclear factor-kappaB (NF-κB) mediated inflammation inhibitor, or carvedilol, an α- and β-blocker, will protect against free fatty acid induced hypertension, insulin resistance, endothelial dysfunction, inflammation and oxidative stress, and autonomic dysfunction in ...
During postprandial lipemia, dietary triglycerides transported by intestinal chylomicrons are hydrolyzed by lipoprotein lipase lining the vascular bed, with subsequent release of FFA for transport across the endothelium. Whether the intermittent flux of FFA has the same impact as the i.v. lipid infusion will be examine...
Hypertension Diabetes
null
3
arm 1: Obese, normotensive, healthy subjects will receive an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject has no side effects, the dose will be increased to two salsalate 750 mg tablets twice daily for the remaining four w...
[ 0, 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Salsalate 750 mg intervention 2: Carvedilol 3.125 mg intervention 3: One tablet intervention 4: 24-hour infusion of Intralipid 20% solution at 20 mL/h (96 g/24 h)
intervention 1: Salsalate intervention 2: Carvedilol intervention 3: Placebo intervention 4: Intralipid 20%
1
Atlanta | Georgia | United States | -84.38798 | 33.749
36
0
0
0
NCT02406586
1COMPLETED
2011-03-01
2009-07-01
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 ]
187
RANDOMIZED
CROSSOVER
0TREATMENT
3TRIPLE
false
0ALL
true
The purpose of this study is to evaluate the effectiveness and safety of subcutaneous (under the skin) administration of anti-interleukin-6 monoclonal antibody (CNTO 136) in reducing signs and symptoms of participants with active rheumatoid arthritis (RA) with methotrexate (MTX) therapy.
This is a multicenter, double-blind (neither physician nor participants knows the treatment that the participant receives), randomized (study medication is assigned by chance), placebo-controlled (an inactive substance is compared with a medication to test whether the medication has a real effect in a clinical study) s...
Arthritis, Rheumatoid
Arthritis, Rheumatoid Rheumatoid Arthritis Active Rheumatoid Arthritis CNTO 136 Interleukin-6 Anti-interleukin-6 monoclonal antibody Methotrexate Placebo
null
7
arm 1: Participants will receive placebo (Week 0 to Week 10) and later CNTO 136 100 mg (Week 12 to Week 22) every 2 weeks. Stable dose of methotrexate will be maintained through Week 24. arm 2: Participants will receive CNTO 136 100 mg (Week 0 to Week 10) and later placebo (Week 12 to Week 22) every 2 weeks. Stable dos...
[ 0, 0, 0, 0, 0, 0, 0 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: CNTO 136 100 mg will be administered subcutaneously (under the skin) every 2 or 4 weeks as per the appropriate randomized arm. intervention 2: CNTO 136 50 mg will be administered subcutaneously every 4 weeks from Week 0 to Week 24. intervention 3: CNTO 136 25 mg will be administered subcutaneously every...
intervention 1: CNTO 136 100 mg intervention 2: CNTO 136 50 mg intervention 3: CNTO 136 25 mg intervention 4: Placebo intervention 5: Methotrexate
38
Aventura | Florida | United States | -80.13921 | 25.95648 Lexington | Kentucky | United States | -84.47772 | 37.98869 Frederick | Maryland | United States | -77.41054 | 39.41427 Kalamazoo | Michigan | United States | -85.58723 | 42.29171 Charlotte | North Carolina | United States | -80.84313 | 35.22709 Winston-Salem | ...
247
0
0
0
NCT00718718
1COMPLETED
2011-03-03
2008-08-11
Centocor, 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 ]
3
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This study will evaluate the hepatic (liver) and plasma pharmacokinetics of Vaniprevir (MK-7009) by evaluation of ribonucleic acid (RNA) of the hepatitis C virus (HCV) in genotype 1, HCV-infected participants.
null
Chronic Hepatitis C Infection
Hepatitis C Virus (HCV) Vaniprevir MK-7009
null
1
arm 1: For each participant in period 1, 600 mg of Vaniprevir was taken twice daily on Days 1-3 and a single dose of Vaniprevir 600 mg was taken on Day 4. Period 1 was followed by a minimum 30-day, up to approximately 140 day, washout interval. In period 2, 300 mg of Vaniprevir was taken twice daily by each participant...
[ 0 ]
1
[ 0 ]
intervention 1: Period 1: Vaniprevir 600 mg twice daily on Days 1-3 and a single dose of Vaniprevir 600 mg on Day 4. Period 2: Vaniprevir 300 mg twice daily on Days 1-3 and a single dose of Vaniprevir 300 mg on Day 4. There was at least a 30-day (up to approximately 140-day) washout interval between periods 1 and 2.
intervention 1: Vaniprevir
0
null
6
0
0
0
NCT00954993
6TERMINATED
2011-03-04
2010-01-13
Merck Sharp & Dohme LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
3
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
2MALE
null
This study aims to evaluate the effect of afamelanotide on the facial inflammatory acne-related lesions in patients with mild to moderate acne vulgaris, including tolerability of afamelanotide by patients with moderate acne vulgaris and effects of the treatment on quality of life in eligible patients.
null
Acne Vulgaris
null
2
arm 1: None arm 2: None
[ 0, 0 ]
1
[ 0 ]
intervention 1: Group A is administered afamelanotide implant on Days 0, 21 and 42; Group B is administered afamelanotide implant on Days 0 and 28.
intervention 1: Afamelanotide
0
null
3
0
0
0
NCT04943159
1COMPLETED
2011-03-08
2010-08-24
Clinuvel Pharmaceuticals Limited
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
32
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This study has been designed to evaluate the side effects of Gleevec when given in combination with Temzolomide; and to learn more about how these drugs work in the body and whether this combination is useful in treating patients with melanoma.
null
Melanoma Advanced Melanoma
Temzolomide Gleevec Melanoma Advanced melanoma Phase II
null
1
arm 1: Temozolomide plus imatinib
[ 0 ]
2
[ 0, 0 ]
intervention 1: Gleevec (600 mg) daily. intervention 2: Temzolomide (1000 mg/m2) over 5 days on a 28 day cycle.
intervention 1: Gleevec intervention 2: Temodar
1
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
28
0
0
0
NCT00667953
6TERMINATED
2011-03-09
2003-01-01
Abramson Cancer Center at Penn 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
[ 4 ]
129
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of the study is to compare sitagliptin and glipizide in lowering blood sugar in participants with type-2 diabetes mellitus (T2DM) and end-stage renal disease on dialysis who do not have adequate glycemic control.
null
Diabetes Mellitus, Type 2 End-Stage Kidney Disease
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: 25 mg (one 25-mg tablet) once daily intervention 2: 2.5 mg (1/2 of a 5-mg tablet) once daily, up to 10 mg twice daily (four 5-mg tablets), for a maximum of 20 mg
intervention 1: Sitagliptin intervention 2: Glipizide
0
null
129
0
0
0
NCT00509236
1COMPLETED
2011-03-14
2007-10-19
Merck Sharp & Dohme LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
6
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study was to demonstrate that participants with Paget's disease of the bone who had responded to zoledronic acid treatment as participants in the core registration studies CZOL446K2304 and CZOL446K2305 and later experienced a relapse can be successfully treated with a 5 milligram (mg) infusion of zo...
Uncontrolled study
Paget's Disease of the Bone
Paget's Disease Zoledronic acid Reclast®/Aclasta® Infusion Re-treatment Re-lapse
null
1
arm 1: Participants received single re-treatment dose of zoledronic acid 5 mg intravenous (IV) infusion.
[ 0 ]
1
[ 0 ]
intervention 1: Zoledronic acid 5 mg intravenous infusion once
intervention 1: Zoledronic Acid
11
Brussels | N/A | Belgium | 4.34878 | 50.85045 Montreal | N/A | Canada | -73.58781 | 45.50884 Québec | N/A | Canada | -71.21454 | 46.81228 Auckland | N/A | New Zealand | 174.76349 | -36.84853 Cape Town | N/A | South Africa | 18.42322 | -33.92584 Barcelona | N/A | Spain | 2.15899 | 41.38879 Madrid | N/A | Spain | -3.7025...
6
0
0
0
NCT00740129
1COMPLETED
2011-03-14
2008-10-21
Novartis Pharmaceuticals
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
118
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This phase I/II trial is studying the side effects and best dose of motexafin gadolinium when given together with temozolomide and radiation therapy and to see how well they work in treating patients with newly diagnosed supratentorial glioblastoma multiforme or gliosarcoma. Drugs used in chemotherapy, such as temozolo...
PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose of motexafin gadolinium (MGd) when given concurrently with temozolomide and radiotherapy in patients with newly diagnosed supratentorial glioblastoma multiforme (GBM) or gliosarcoma. II. Estimate the overall survival of patients treated with concurrent radio...
Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma
null
4
arm 1: Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over...
[ 0, 0, 0, 1 ]
3
[ 4, 0, 0 ]
intervention 1: Undergo radiotherapy intervention 2: Given IV intervention 3: Given orally
intervention 1: 3-Dimensional Conformal Radiation Therapy intervention 2: Motexafin Gadolinium intervention 3: Temozolomide
106
Mobile | Alabama | United States | -88.04305 | 30.69436 Scottsdale | Arizona | United States | -111.89903 | 33.50921 Tucson | Arizona | United States | -110.92648 | 32.22174 Castro Valley | California | United States | -122.08635 | 37.6941 Castro Valley | California | United States | -122.08635 | 37.6941 Castro Valley ...
103
0
0
0
NCT00305864
1COMPLETED
2011-03-15
2006-02-09
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 ]
336
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
null
The main aim of this study is to see if giving LDX to children and adolescents aged 6-17 years with ADHD decreases symptoms of ADHD.
null
ADHD
null
3
arm 1: Overencapsulated LDX 30, 50, or 70mg arm 2: Overencapsulated Concerta 18, 36, or 54mg arm 3: Overencapsulated Placebo
[ 0, 1, 2 ]
3
[ 0, 0, 0 ]
intervention 1: 30, 50 or 70mg capsule once per day (Overencapsulated) intervention 2: 18, 36, or 54mg tablet one per day (Overencapsulated) intervention 3: Placebo capsule once per day (Overencapsulated)
intervention 1: Lisdexamfetamine Dimesylate (LDX) intervention 2: Methylphenidate Hydrochloride intervention 3: Placebo
49
Hoboken | Antwerp | Belgium | 4.34844 | 51.17611 Ghent | East Flanders | Belgium | 3.71667 | 51.05 Leuven | N/A | Belgium | 4.70093 | 50.87959 Nice | Cedex 03 | France | 7.26608 | 43.70313 Bordeaux Cédex | N/A | France | N/A | N/A Montpellier | N/A | France | 3.87635 | 43.61093 Paris | Île-de-France Region | France | 2...
332
1
0.003012
1
NCT00763971
1COMPLETED
2011-03-16
2008-11-17
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
1
0
0
0
0
0
0
0
0.000532
[ 4 ]
426
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
The purpose of the study is to compare how sitagliptin and glipizide lower blood glucose levels in participants with moderate or severe renal insufficiency.
null
Diabetes Mellitus, Type 2 Renal Insufficiency, Chronic
null
2
arm 1: Sitagliptin + Placebo for Glipizide arm 2: Glipizide + Placebo for Sitagliptin
[ 0, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Participants with moderate renal insufficiency will receive two sitagliptin 25 mg tablets orally daily; participants with severe renal insufficiency will receive one sitagliptin 25 mg tablet orally daily intervention 2: Participants will receive glipizide 2.5 mg (1/2 tablet) orally once daily up to 20 m...
intervention 1: Sitagliptin intervention 2: Glipizide intervention 3: Placebo for Sitagliptin intervention 4: Placebo for Glipizide
0
null
422
0
0
0
NCT00509262
1COMPLETED
2011-03-16
2007-10-09
Merck Sharp & Dohme LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
-0
[ 3 ]
116
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
Vicriviroc (vye-kri-VYE-rock) is an investigational drug that belongs to a new class of drugs, called C-C chemokine receptor type 5 (CCR5) receptor blockers. This group of drugs blocks one of the ways human immunodeficiency virus (HIV) enters T-cells (the cells that fight infection). The purpose of this 48-week study i...
This is a randomized, double-blind, placebo controlled, parallel-group, multi-center study of vicriviroc maleate in participants with HIV infected with CCR5-tropic virus only for whom standard antiretroviral treatment (ART) has failed. The study will evaluate the antiviral efficacy of two doses of vicriviroc (20 mg onc...
HIV Infections
null
4
arm 1: Vicriviroc 30 mg once daily (QD), orally (PO), plus an open-label optimized antiretroviral therapy (ART) regimen containing a ritonavir-boosted protease inhibitor (PI/r) for 48 weeks. arm 2: Vicriviroc 20 mg QD, PO, plus an open-label optimized ART regimen containing a PI/r for 48 weeks. arm 3: Placebo QD, PO, p...
[ 0, 0, 2, 0 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: Three tablets of vicriviroc 10 mg once daily for 48 weeks (Double-blind Period) or for up to 45 months (Open Label Period). intervention 2: Two tablets of vicriviroc 10 mg once daily for 48 weeks. intervention 3: Three tablets of placebo once daily for 48 weeks. intervention 4: Two tablets of placebo on...
intervention 1: Vicriviroc 30 mg intervention 2: Vicriviroc 20 mg intervention 3: Placebo intervention 4: Placebo intervention 5: Background ART Regimen
0
null
199
0
0
0
NCT00243230
1COMPLETED
2011-03-17
2005-09-19
Merck Sharp & Dohme LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
474
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The primary objective of this study is to characterize, as accurately as possible, the estimation of the difference in pre-pubescent growth velocities between subjects treated continuously for one year with FFNS 110mcg QD, the highest dose approved for pediatric use in the US, and placebo nasal spray as determined by s...
null
Rhinitis, Allergic, Perennial
allergic rhinitis fluticasone furoate nasal spray growth
null
2
arm 1: None arm 2: None
[ 2, 0 ]
2
[ 0, 0 ]
intervention 1: Fluticasone furoate nasal spray 110mg QD intervention 2: Placebo nasal spray
intervention 1: Fluticasone furoate nasal spray intervention 2: Placebo nasal spray
74
Oxford | Alabama | United States | -85.83496 | 33.61427 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Huntington Beach | California | United States | -117.99923 | 33.6603 Long Beach | California | United States | -118.18923 | 33.76696 Long Beach | California | United States | -118.18923 | 33.76696 River...
474
0
0
0
NCT00570492
1COMPLETED
2011-03-17
2007-11-26
GlaxoSmithKline
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
12
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
Many patients with schizophrenia and schizoaffective disorder have symptoms that persist, including hallucinations or delusions, despite adequate pharmacotherapy with antipsychotic drug. Glutamate is a major excitatory neurotransmitter in the brain that has been implicated in several brain diseases. NMDA antagonist dru...
Patients will be screened over the telephone. Information will be gathered from the mental health treatment team and the patient. Most patients who come to this study have had an inadequate or insufficient improvement with clozapine. Upon arrival at the NYS Psychiatric Institute, they review and sign consent to make su...
Psychosis Schizophrenia Schizoaffective Disorder
Ceftriaxone Psychosis Schizophrenia Schizoaffective Disorder
null
2
arm 1: IV Ceftriaxone 2 grams/day arm 2: IV Placebo (Normal Saline)
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 2 grams of ceftriaxone given daily, Monday to Friday, excluding major holidays, for a total of 40 doses intervention 2: 50 cc of normal saline, daily, Monday through Friday, except for major holidays, for a total of 40 normal saline infusions.
intervention 1: ceftriaxone intervention 2: Normal Saline
1
New York | New York | United States | -74.00597 | 40.71427
10
0
0
0
NCT00591318
6TERMINATED
2011-03-17
2007-10-10
Research Foundation for Mental Hygiene, Inc.
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 ]
214
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
1FEMALE
false
This study will evaluate the safety and treatment effect of 50 mg odanacatib (MK-0822) with Vitamin D versus placebo with Vitamin D in postmenopausal women with low bone density. The primary efficacy hypothesis is that odanacatib will increase aBMD at the lumbar spine compared to placebo at 12 months.
null
Osteoporosis
null
2
arm 1: Participants receive 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also receive 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg. arm 2: Participants receive matching placebo to odanacatib and open-label...
[ 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Odanacatib 50 mg tablets, taken orally once weekly for 24 months. intervention 2: Matching placebo tablets to odanacatib taken orally once weekly for 24 months. intervention 3: Vitamin D3 tablets (5600 IU) taken orally once weekly for 24 months. intervention 4: Calcium supplement 500 mg tablet taken ora...
intervention 1: Odanacatib intervention 2: Placebo intervention 3: Vitamin D3 intervention 4: Calcium supplement
0
null
214
0
0
0
NCT00729183
1COMPLETED
2011-03-21
2008-10-02
Merck Sharp & Dohme LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
72
RANDOMIZED
SINGLE_GROUP
0TREATMENT
3TRIPLE
false
0ALL
false
The primary objective of the study is to evaluate the safety of single doses of oral naldemedine in adults physically dependent on opioids.
A single dose of naldemedine or matching placebo will be administered orally to each cohort of 12 participants (9 treatments, 3 placebos) in the morning of Day 15 under fasted conditions. The first cohort will receive a 0.1 mg dose. Cohorts will continue to be enrolled at the next higher dose level until the highest do...
Opioid Induced Bowel Dysfunction
Chronic pain Opioid physical dependence
null
6
arm 1: In this cohort 9 participants received one 0.1 mg naldemedine tablet and 3 participants received matching placebo administered on Day 15 under fasted conditions. arm 2: In this cohort 9 participants received a single dose of 0.3 mg naldemedine tablets and 3 participants received matching placebo tablets administ...
[ 0, 0, 0, 0, 0, 0 ]
2
[ 0, 0 ]
intervention 1: Tablets or solution for oral administration intervention 2: Tablets or solution for oral administration
intervention 1: Naldemedine intervention 2: Placebo
1
Salt Lake City | Utah | United States | -111.89105 | 40.76078
72
0
0
0
NCT01122030
1COMPLETED
2011-03-22
2010-05-19
Shionogi
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
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 ]
1,615
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
A study to evaluate the efficacy and safety of sitagliptin and pioglitazone co-administration in comparison with sitagliptin and pioglitazone monotherapy in patients with type 2 diabetes.
null
Type 2 Diabetes Mellitus
null
7
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None
[ 0, 0, 0, 0, 0, 0, 0 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: Sitagliptin 100 mg tablet (blinded) orally once daily for 54 weeks. intervention 2: Pioglitazone 15 mg, 30 mg, or 45 mg tablets or capsules (blinded) orally once daily for 54 weeks. Participants randomized to receive pioglitazone 45 mg as monotherapy or in combination with sitagliptin were to start on p...
intervention 1: Sitagliptin phosphate intervention 2: Pioglitazone hydrochloride intervention 3: Matching placebo to sitagliptin intervention 4: Matching placebo to pioglitazone intervention 5: Metformin
0
null
1,615
0
0
0
NCT00722371
1COMPLETED
2011-03-25
2008-09-05
Merck Sharp & Dohme LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
122
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
A Phase 2, multicenter, prospective, randomized, double-blind study of CXA-101/ tazobactam (1000/500 mg q8h) and metronidazole (500 mg q8h) IV infusion vs. meropenem IV infusion (1000 mg q8h) and a matching saline placebo (q8h) in the treatment of cIAI in adult subjects. Dose adjustments for subjects with mild renal im...
null
Complicated Intra-abdominal Infection
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: CXA-101/tazobactam (1000/500 mg q8h) plus metronidazole (500 mg q8h) administered via IV infusion intervention 2: meropenem IV infusion (1000 mg q8h) plus a matching saline placebo (q8h) administered via IV infusion
intervention 1: CXA-101/ tazobactam and metronidazole intervention 2: meropenem plus saline placebo
33
Orange | California | United States | -117.85311 | 33.78779 Torrance | California | United States | -118.34063 | 33.83585 Aurora | Colorado | United States | -104.83192 | 39.72943 Newark | Delaware | United States | -75.74966 | 39.68372 Pensacola | Florida | United States | -87.21691 | 30.42131 Detroit | Michigan | Uni...
121
0
0
0
NCT01147640
1COMPLETED
2011-03-25
2010-06-25
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
389
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
This is a 6 week study to investigate the effectiveness and safety of BI 671800 ED in patients with asthma who do not take inhaled corticosteroids.
null
Asthma
null
5
arm 1: Patients receive BI 671800 (low dose) capsules twice daily arm 2: Patients inhale from Fluticasone propionate metered dose inhaler (MDI) twice daily arm 3: Patients receive placebo capsules twice daily arm 4: Patients receive BI 671800 (medium dose) capsules twice daily arm 5: Patients receive BI 671800 (high do...
[ 0, 1, 2, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: BI 671800 intervention 2: Placebo matching Fluticasone propionate intervention 3: Fluticasone propionate intervention 4: Placebo matching BI 671800
intervention 1: BI 671800 intervention 2: Fluticasone propionate placebo intervention 3: Fluticasone propionate intervention 4: BI 671800 Placebo
92
Tucson | Arizona | United States | -110.92648 | 32.22174 Cypress | California | United States | -118.03729 | 33.81696 Los Angeles | California | United States | -118.24368 | 34.05223 Palmdale | California | United States | -118.11646 | 34.57943 San Jose | California | United States | -121.89496 | 37.33939 Stockton | Ca...
388
0
0
0
NCT01092143
1COMPLETED
2011-03-26
2010-03-18
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
[ 5 ]
125
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to determine how clobetasol proprionate foam works against a placebo foam in the treatment of hand dermatitis.
Topical corticosteroids have anti-inflammatory, immunosuppressive and antiproliferative properties. Clobetasol propionate foam 0.05% (Olux-E), a Class 1 corticosteroid, is formulated in an ethanol free petrolatum base that provides the benefits of a super-potent corticosteroid combined with moisturizing ingredients in ...
Dermatitis, Chronic
null
2
arm 1: None arm 2: None
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: 2 times a day, 14 total days study treatment intervention 2: 2 times a day, 14 total days of study treatment
intervention 1: clobetasol propionate 0.05% intervention 2: Vehicle / Placebo
10
San Diego | California | United States | -117.16472 | 32.71571 Boynton Beach | Florida | United States | -80.06643 | 26.52535 West Palm Beach | Florida | United States | -80.05337 | 26.71534 Louisville | Kentucky | United States | -85.75941 | 38.25424 Louisville | Kentucky | United States | -85.75941 | 38.25424 Bellevi...
125
0
0
0
NCT01323673
1COMPLETED
2011-03-29
2010-11-15
Stiefel, a GSK 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 ]
121
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
The object of this study is to assess the efficacy and safety of zonisamide as adjunctive therapy in patients with uncontrolled partial epilepsy.
The object of this study is to assess the efficacy and safety of zonisamide as adjunctive therapy in patients with uncontrolled partial epilepsy. Subject takes zonisamide for 16 weeks (4 weeks-titration period, 8 weeks maintenance period). Dose range of zonisamide is 100 \~ 400 mg/day and target dose is 300 mg/day. Aft...
Epilepsy
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: zonisamide 100 mg tablet
intervention 1: zonisamide
10
Busan | N/A | South Korea | 129.03004 | 35.10168 Busan | N/A | South Korea | 129.03004 | 35.10168 Daegu | N/A | South Korea | 128.59111 | 35.87028 Daegu | N/A | South Korea | 128.59111 | 35.87028 Daegu | N/A | South Korea | 128.59111 | 35.87028 Incheon | N/A | South Korea | 126.70515 | 37.45646 Koyang | N/A | South Kor...
121
0
0
0
NCT01140867
1COMPLETED
2011-03-31
2008-02-29
Eisai Korea 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 ]
106
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
The study hypothesis is that single and multiple doses of ibuprofen 600 mg ER caplets provide analgesic efficacy superior to placebo over 12-hour dosing intervals.
null
Pain
dental pain multiple dose ibuprofen third molar extraction
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: One 600 mg caplet dosed at 0, 12, 24 and 36 hours intervention 2: One placebo caplet dosed at times 0, 12, 24 and 36 hours
intervention 1: Ibuprofen 600 mg ER intervention 2: Placebo
2
Austin | Texas | United States | -97.74306 | 30.26715 Austin | Texas | United States | -97.74306 | 30.26715
106
0
0
0
NCT01266161
1COMPLETED
2011-03-31
2010-11-22
Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
112
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
This study was designed to evaluate and compare the safety and tolerability of tenofovir disoproxil fumarate (TDF), emtricitabine (FTC)/TDF, and entecavir (ETV) in the treatment of hepatitis B patients with decompensated liver disease. Safety was assessed by evaluating adverse events (AEs) and laboratory abnormalities....
null
Chronic Hepatitis B
Hepatitis; Hepatitis B virus; Tenofovir
null
3
arm 1: TDF 300 mg + FTC/TDF placebo + ETV placebo once daily (QD) arm 2: FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo QD arm 3: ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo QD
[ 0, 0, 0 ]
6
[ 0, 0, 0, 0, 0, 0 ]
intervention 1: 300-mg tablet QD intervention 2: FTC 200 mg/TDF 300 mg fixed-dose combination (FDC) tablet QD intervention 3: 0.5-mg or 1-mg tablet QD intervention 4: Placebo to match TDF QD intervention 5: Placebo to match FTC/TDF QD intervention 6: Placebo to match ETV QD
intervention 1: Tenofovir disoproxil fumarate (tenofovir DF; TDF) intervention 2: Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) intervention 3: Entecavir (ETV) intervention 4: TDF placebo intervention 5: FTC/TDF placebo intervention 6: ETV placebo
38
Los Angeles | California | United States | -118.24368 | 34.05223 San Francisco | California | United States | -122.41942 | 37.77493 Miami | Florida | United States | -80.19366 | 25.77427 Chicago | Illinois | United States | -87.65005 | 41.85003 Detroit | Michigan | United States | -83.04575 | 42.33143 New York | New Yo...
217
2
0.009217
1
NCT00298363
1COMPLETED
2011-04-01
2006-04-01
Gilead Sciences
4INDUSTRY
false
false
false
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
0.002531
[ 3 ]
92
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
1FEMALE
false
Evaluate the percentage of clinical objective responses (cOR) in patients with HER2 negative early breast cancer treated with pre operative (neoadjuvant)lapatinib and letrozole
null
Neoplasms, Breast
neo-adjuvant letrozole lapatinib primary breast cancer
null
2
arm 1: Letrozole 2.5 mg administered orally fro 6 mos. plus placebo 1500 mg administered orally throughout the study until definitive surgery arm 2: Letrozole 2.5 mg administered orally fro 6 mos. plus lapatinib 1500 mg administered orally throughout the study until definitive surgery
[ 2, 0 ]
3
[ 0, 0, 10 ]
intervention 1: 1500 mg administered orally daily intervention 2: 2.5 mg administered orally daily intervention 3: 1500 mg administered orally daily
intervention 1: lapatinib intervention 2: letrozole intervention 3: placebo
14
Brindisi | Apulia | Italy | 17.93607 | 40.63215 Carpi (MO) | Emilia-Romagna | Italy | 10.8777 | 44.78237 Forlì | Emilia-Romagna | Italy | 12.04144 | 44.22177 Modena | Emilia-Romagna | Italy | 10.92539 | 44.64783 Piacenza | Emilia-Romagna | Italy | 9.69342 | 45.05242 Rimini | Emilia-Romagna | Italy | 12.56528 | 44.05755...
92
1
0.01087
1
NCT00422903
1COMPLETED
2011-04-01
2007-04-01
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
1
0
0
0
0
0
0
0
0.001921
[ 4 ]
214
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purpose of the study is to evaluate the safety, tolerability and activity of Fampridine-SR when administered for up to 36 additional months in patients who previously participated in the MS-F204 study or until it becomes commercially available, whichever comes first.
Multiple sclerosis (MS) is a disorder of the body's immune system that affects the central nervous system (CNS). Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. In people with MS, the fatty sheath that surrounds and insulates the...
Multiple Sclerosis
multiple sclerosis MS walking leg strength demyelination
null
0
null
null
1
[ 0 ]
intervention 1: Tablets, 10 mg, BID (twice daily)
intervention 1: Fampridine-SR
42
Phoenix | Arizona | United States | -112.07404 | 33.44838 Phoenix | Arizona | United States | -112.07404 | 33.44838 Fayetteville | Arkansas | United States | -94.15743 | 36.06258 Berkeley | California | United States | -122.27275 | 37.87159 Los Angeles | California | United States | -118.24368 | 34.05223 Sacramento | C...
214
2
0.009346
1
NCT00649792
1COMPLETED
2011-04-01
2007-08-01
Acorda Therapeutics
4INDUSTRY
false
false
false
null
0
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
0
0
0
0
0
0
0
0.002567
[ 5 ]
312
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This protocol describes a prospective, randomized, open-label, multicenter study to evaluate the safety and efficacy of switching from fixed dose abacavir (ABC)/lamivudine (3TC) to fixed dose emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) in virologically suppressed, human immunodeficiency virus type 1 (HIV-1)...
This protocol describes a prospective, randomized, open-label, multicenter study to evaluate the safety and efficacy of switching from fixed dose ABC/3TC to fixed dose FTC/TDF in virologically suppressed, HIV-1 infected subjects maintained on a PI/r-containing ARV regimen. Subjects were stratified based on the PI/r (i...
HIV Infection
HIV HIV 1
null
2
arm 1: Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada \[TVD\]) for 48 weeks. The prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study. arm 2: Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as...
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: FTC 200 mg/TDF 300 mg tablet, once a day intervention 2: ABC 600 mg/3TC 300 mg tablet, once a day
intervention 1: emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) intervention 2: abacavir (ABC)/lamivudine (3TC)
80
Little Rock | Arkansas | United States | -92.28959 | 34.74648 Beverly Hills | California | United States | -118.40036 | 34.07362 Beverly Hills | California | United States | -118.40036 | 34.07362 Beverly Hills | California | United States | -118.40036 | 34.07362 Fountain Valley | California | United States | -117.95367...
311
1
0.003215
1
NCT00724711
1COMPLETED
2011-04-01
2008-07-01
Gilead Sciences
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0.000568
[ 4 ]
678
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of the study is to evaluate the efficacy, safety and tolerability of nalmefene in the treatment of alcohol dependence.
Alcohol dependence is a maladaptive pattern of alcohol use, leading to clinically significant impairment or distress, as manifested by at least three of a number of criteria such as tolerance, withdrawal symptoms, frequent use of alcohol in larger amounts or over longer periods than was intended, and others. Excessive ...
Alcohol Dependence
Pharmacologic Actions Alcohol-Related Disorders Alcoholism Mental Disorders Central Nervous System Agents
null
2
arm 1: None arm 2: None
[ 2, 0 ]
2
[ 0, 0 ]
intervention 1: as-needed use, tablets, orally, 6 months intervention 2: 18.06 mg, as-needed use, tablets, orally, 6 months. 18.06 mg nalmefene equals 20 mg nalmefene hydrochloride.
intervention 1: Placebo intervention 2: Nalmefene
57
Assebroek | N/A | Belgium | 3.2623 | 51.19367 Bruges | N/A | Belgium | 3.22424 | 51.20892 Charleroi | N/A | Belgium | 4.44448 | 50.41136 Kortenberg | N/A | Belgium | 4.54353 | 50.88982 Liège | N/A | Belgium | 5.56749 | 50.63373 Mechelen | N/A | Belgium | 4.47762 | 51.02574 Ostend | N/A | Belgium | 2.927 | 51.21551 Lito...
678
4
0.0059
1
NCT00812461
1COMPLETED
2011-04-01
2009-03-01
H. Lundbeck A/S
4INDUSTRY
false
false
false
null
0
1
0
0
0
0
0
0
0
0
0
0
0
0
0
3
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0.002297
[ 4 ]
605
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to evaluate the safety, tolerability and efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe, stable chronic obstructive pulmonary disease. The study will be 56 weeks in duration; a 2-week rin-in period, a 52-week treatment period and a 2-week follo...
null
Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease COPD Chronic Bronchitis Emphysema Airflow Obstruction, Chronic Chronic Airflow Obstruction Chronic Obstructive Airway Disease Chronic Obstructive Lung Disease
null
2
arm 1: aclidinium bromide, inhaled, 52 weeks of treatment arm 2: aclidinium bromide, inhaled, 52 weeks of treatment
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: aclidinium bromide 200 μg, oral inhalation twice per day for 52 weeks of treatment intervention 2: aclidinium bromide 400 μg, oral inhalation twice per day for 52 weeks of treatment
intervention 1: Aclidinium Bromide 200 µg intervention 2: Aclidinium Bromide 400 µg
113
Birmingham | Alabama | United States | -86.80249 | 33.52066 Mobile | Alabama | United States | -88.04305 | 30.69436 Scottsdale | Arizona | United States | -111.89903 | 33.50921 Tempe | Arizona | United States | -111.90931 | 33.41477 Tucson | Arizona | United States | -110.92648 | 32.22174 Buena Park | California | Unit...
602
1
0.001661
1
NCT01044459
1COMPLETED
2011-04-01
2009-11-01
AstraZeneca
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
0
0
0
0
0
0
0
0
0
0
0
0
0.000293
[ 5 ]
684
NA
SINGLE_GROUP
4SUPPORTIVE_CARE
0NONE
false
0ALL
false
The purpose of the research study is to find out if opioid dependent chronic pain patients who are judged by their physician to be eligible to change their current opioid medicine and to participate in this study can be successfully adjusted to a stable dose of EMBEDA (morphine sulfate and naltrexone hydrochloride). Th...
The decision to terminate the trial was based on a lack of study drug supply. The decision was not based on any safety concerns. The termination letter was sent on 11March2011.
Chronic Disease Pain
chronic pain Embeda opioid moderate pain severe pain conversion converting switching morphine aberrant behavior Pain (DT) + Chronic Disease (DT)
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Capsules in dose strengths ranging from 20 to 100 mg morphine sulfate with 0.8 to 4 mg of naltrexone hydrochloride taken either once or twice daily with a starting dose calculated using the total daily dose of the current opioid being converted from until a stable dose is achieved or six weeks which eve...
intervention 1: morphine sulfate and naltrexone hydrochloride (EMBEDA)
166
Adamsville | Alabama | United States | -86.95611 | 33.60094 Birmingham | Alabama | United States | -86.80249 | 33.52066 Huntsville | Alabama | United States | -86.58594 | 34.7304 Huntsville | Alabama | United States | -86.58594 | 34.7304 Mobile | Alabama | United States | -88.04305 | 30.69436 Montgomery | Alabama | Uni...
684
1
0.001462
1
NCT01179191
6TERMINATED
2011-04-01
2010-08-01
Pfizer
4INDUSTRY
false
false
false
null
0
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0.000258
[ 3 ]
1,053
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to provide entecavir to participants who have completed another entecavir trial without achieving virologic response or who relapsed during postdosing follow-up.
null
Hepatitis B Virus HBV
null
1
arm 1: None
[ 0 ]
2
[ 0, 0 ]
intervention 1: Tablets, Oral, 1.0 mg, once daily intervention 2: Oral, 100 mg, daily
intervention 1: Entecavir intervention 2: Lamivudine
0
null
1,051
5
0.004757
1
NCT01438424
1COMPLETED
2011-04-01
2001-01-01
Bristol-Myers Squibb
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
0
0
0
0
0
0
4
0
0
0
0
0
0
0
0.002034
[ 4 ]
503
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
This randomized phase III trial studies how well gefitinib works in treating patients with stage IB, II, or IIIA non-small cell lung cancer that was completely removed by surgery. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known if gefitinib may be...
PRIMARY OBJECTIVES: I. To assess, in comparison with placebo, the impact of adjuvant therapy with two years of daily oral ZD1839 (IRESSA) (gefitinib) on the overall survival of patients with completely resected (T1N1-2, T2N0-2, T3N0-2) non-small cell lung cancer (NSCLC). SECONDARY OBJECTIVES: I. To compare the disea...
Adenocarcinoma of the Lung Adenosquamous Cell Lung Cancer Bronchoalveolar Cell Lung Cancer Large Cell Lung Cancer Squamous Cell Lung Cancer Stage IB Non-small Cell Lung Cancer Stage IIA Non-small Cell Lung Cancer Stage IIB Non-small Cell Lung Cancer Stage IIIA Non-small Cell Lung Cancer
null
2
arm 1: Patients receive gefitinib PO QD for 2 years in the absence of disease progression or unacceptable toxicity. arm 2: Patients receive placebo PO QD for 2 years in the absence of disease progression or unacceptable toxicity.
[ 0, 2 ]
3
[ 0, 10, 10 ]
intervention 1: Given PO intervention 2: Given PO intervention 3: Correlative studies
intervention 1: gefitinib intervention 2: placebo intervention 3: laboratory biomarker analysis
1
Kingston | Ontario | Canada | -76.48098 | 44.22976
492
0
0
0
NCT00049543
1COMPLETED
2011-04-01
2002-09-01
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 ]
172
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
null
The core study looked at the effect of Zoledronic Acid given once as an intravenous (i.v.) infusion compared to 60 days of oral Risedronate in patients with Paget's disease of bone. The effect was demonstrated in the reduction of serum alkaline phosphatase (SAP). The extended observation period included participants of...
null
Paget's Disease of Bone
Bisphosphonate SAP SAP excess non-inferiority therapeutic response extended observation period
null
2
arm 1: Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period. arm ...
[ 0, 1 ]
5
[ 0, 0, 0, 0, 7 ]
intervention 1: Zoledronic acid 5 mg in 5 mL of sterile water intravenous infusion. intervention 2: Oral risedronate 30 mg capsules. intervention 3: Oral placebo of risedronate capsules. intervention 4: 5 mL of sterile water one dose intravenous infusion. intervention 5: Calcium and vitamin D supplements were supplied.
intervention 1: Zoledronic Acid intervention 2: Risedronate intervention 3: Placebo to Risedronate intervention 4: Placebo to Zoledronic Acid intervention 5: Calcium and Vitamin D
34
Santa Monica | California | United States | -118.49138 | 34.01949 Lakewood | Colorado | United States | -105.08137 | 39.70471 Boca Raton | Florida | United States | -80.0831 | 26.35869 Miami | Florida | United States | -80.19366 | 25.77427 Maywood | Illinois | United States | -87.84312 | 41.8792 Worcester | Massachuset...
171
0
0
0
NCT00051636
1COMPLETED
2011-04-01
2001-01-01
Novartis Pharmaceuticals
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
36
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This phase II trial is studying how well CCI-779 works in treating patients with progressive metastatic neuroendocrine tumors. Drugs used in chemotherapy, such as CCI-779, work in different ways to stop tumor cells from dividing so they stop growing or die.
OBJECTIVES: I. To assess the objective tumor response rate (i.e. partial or complete responses as defined by the RECIST criteria) in patients with progressive metastatic neuroendocrine tumours given CCI-779. II. To assess the stable disease rate and duration, time to progression, median survival time, 1-year survival...
Metastatic Gastrointestinal Carcinoid Tumor Pulmonary Carcinoid Tumor Recurrent Gastrointestinal Carcinoid Tumor Recurrent Islet Cell Carcinoma
null
1
arm 1: Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.
[ 0 ]
2
[ 0, 10 ]
intervention 1: Given IV intervention 2: Correlative studies
intervention 1: temsirolimus intervention 2: laboratory biomarker analysis
1
Toronto | Ontario | Canada | -79.39864 | 43.70643
36
0
0
0
NCT00093782
1COMPLETED
2011-04-01
2003-12-01
National Cancer Institute (NCI)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3, 4 ]
474
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
Maraviroc (UK-427,857), a selective and reversible CCR5 coreceptor antagonist, has been shown to be active in vitro against a wide range of clinical isolates (including those resistant to existing classes). In HIV-1 infected patients, maraviroc (UK-427,857) given as monotherapy for 10 days reduced HIV-1 viral load by u...
null
HIV Infections
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 2, 0 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone. intervention 2: \[OBT (3-6 drugs based on treatment history and resistance testing)\] intervention 3: maraviroc (UK-427,857) 150 mg taken twice daily intervention 4: \[OBT (3-6 drugs base...
intervention 1: Maraviroc (UK-427,857) intervention 2: optimized background therapy intervention 3: Maraviroc (UK-427,857) intervention 4: optimized background therapy intervention 5: optimized background therapy
172
Hobson City | Alabama | United States | -85.84413 | 33.62149 Garden Grove | California | United States | -117.94145 | 33.77391 Los Angeles | California | United States | -118.24368 | 34.05223 Oakland | California | United States | -122.2708 | 37.80437 Palm Springs | California | United States | -116.54529 | 33.8303 Tar...
1,056
0
0
0
NCT00098722
1COMPLETED
2011-04-01
2004-12-01
ViiV Healthcare
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
134
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
This Phase II trial is studying how well giving epratuzumab together with an established chemotherapy platform works in treating young patients with relapsed acute lymphoblastic leukemia. Monoclonal antibodies, such as epratuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to gro...
PRIMARY OBJECTIVES: I. Determine the feasibility of epratuzumab administered alone and in combination with re-induction combination chemotherapy in pediatric patients with relapsed CD22-positive acute lymphoblastic leukemia. II. Determine the toxic effects of this regimen in these patients. III. Determine the antitu...
Recurrent Childhood Acute Lymphoblastic Leukemia
null
2
arm 1: Four weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 8, 15, 22. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, high-dose (HD) methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabin...
[ 0, 0 ]
14
[ 0, 0, 0, 0, 2, 0, 0, 0, 0, 0, 0, 0, 0, 2 ]
intervention 1: Given IM intervention 2: Given IV intervention 3: 40 mg/m2/day PO divided BID or TID intervention 4: Given IV intervention 5: Given IV intervention 6: Given IT intervention 7: Given orally intervention 8: Given IM intervention 9: Given IV intervention 10: Given IT intervention 11: Given IV intervention ...
intervention 1: L-asparaginase intervention 2: doxorubicin hydrochloride intervention 3: therapeutic hydrocortisone intervention 4: vincristine sulfate intervention 5: epratuzumab intervention 6: cytarabine intervention 7: prednisone intervention 8: pegaspargase intervention 9: dexrazoxane hydrochloride intervention 10...
46
Birmingham | Alabama | United States | -86.80249 | 33.52066 Loma Linda | California | United States | -117.26115 | 34.04835 Long Beach | California | United States | -118.18923 | 33.76696 Los Angeles | California | United States | -118.24368 | 34.05223 Los Angeles | California | United States | -118.24368 | 34.05223 Ma...
114
0
0
0
NCT00098839
1COMPLETED
2011-04-01
2005-02-01
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
[ 4 ]
185
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
null
The primary objective of this core study was to show non-inferiority of zoledronic acid to risedronate, with respect to the proportion of patients who achieved therapeutic response. The extended observation period included participants of the core study who responded to treatment.
null
Paget's Disease of Bone
Zoledronic acid, risedronate, Paget's disease of bone
null
2
arm 1: Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period. arm 2: Participants received 60 day...
[ 0, 1 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: 5 mg zoledronic acid in 5 mL of sterile water for infusion intervention 2: 5 mL of sterile water for infusion intervention 3: 30mg oral tablets overencapsulated to match the placebo capsules intervention 4: oral capsules intervention 5: Calcium and vitamin D supplements were supplied
intervention 1: zoledronic acid intervention 2: placebo to zoledronic acid intervention 3: Risedronate intervention 4: Placebo to risedronate intervention 5: Calcium and vitamin D supplements
41
Tucson | Arizona | United States | -110.92648 | 32.22174 Colorado Springs | Colorado | United States | -104.82136 | 38.83388 Indianapolis | Indiana | United States | -86.15804 | 39.76838 New Orleans | Louisiana | United States | -90.07507 | 29.95465 Boston | Massachusetts | United States | -71.05977 | 42.35843 Syracuse...
178
0
0
0
NCT00103740
1COMPLETED
2011-04-01
2002-04-01
Novartis Pharmaceuticals
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
22
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
null
This study will look at the safety, tolerability and effectiveness of cidofovir in kidney transplant patients who have been diagnosed with BK virus nephropathy (BKVN), a viral condition that can cause patients to reject transplanted kidneys. Up to 48 adult (age 18 years and older) kidney or pancreas transplant recipien...
The primary objectives of this randomized, double-blind, placebo-controlled, dose-escalation study are to evaluate the safety and tolerability of 3 dose levels of cidofovir when administered to renal transplant recipients with BK virus nephropathy and to identify the maximum tolerated doses (MTD) among the 3 dose level...
BK Virus (Nephropathy)
Vistide®, Cidofovir, renal transplant, BK Virus Nephropathy
null
2
arm 1: 32 subjects will be randomized to 1 of 3 possible cohorts. Cohort I will receive dose 0.25 mg/kg; Cohort II will receive 0.5 mg/kg, Cohort III will receive 1.0 mg/kg. Maximum tolerated dose is to be determined. arm 2: 16 subjects to receive placebo.
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Cidofovir is a marketed product for treatment of Cytomegalovirus disease (retinitis) in human immunodeficiency virus (HIV) infected patients. It is packaged as a sterile, hypertonic aqueous solution for intravenous infusion only. Dosages: 0.25 mg/kg, 0.5 mg/kg, and 1.0 mg/kg. intervention 2: The control...
intervention 1: Cidofovir intervention 2: Placebo
12
Birmingham | Alabama | United States | -86.80249 | 33.52066 San Francisco | California | United States | -122.41942 | 37.77493 San Francisco | California | United States | -122.41942 | 37.77493 Aurora | Colorado | United States | -104.83192 | 39.72943 Chicago | Illinois | United States | -87.65005 | 41.85003 Chicago | ...
22
0
0
0
NCT00138424
6TERMINATED
2011-04-01
2006-05-01
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
[ 5 ]
77
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
The primary objective of this study is to collect health economic data depicting the initial levels and natural progression over time of resource usage, Parkinson's disease (PD)-related costs, and health related quality of life (HRQoL) for a cohort of advanced PD patients treated with Duodopa (levodopa-carbidopa in an ...
null
Advanced Idiopathic Parkinson's Disease
Health economics,Quality of life
null
3
arm 1: Duodopa-naïve participants titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-20...
[ 0, 0, 0 ]
4
[ 0, 1, 1, 1 ]
intervention 1: None intervention 2: None intervention 3: None intervention 4: None
intervention 1: Levodopa-carbidopa intestinal gel (LCIG) intervention 2: CADD-Legacy® 1400 ambulatory infusion pump intervention 3: percutaneous endoscopic gastrostomy tube (PEG tube) intervention 4: jejunal extension tube (J-tube)
0
null
76
0
0
0
NCT00141518
1COMPLETED
2011-04-01
2006-03-01
AbbVie (prior sponsor, Abbott)
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
20
NON_RANDOMIZED
PARALLEL
null
0NONE
true
2MALE
true
The objective of this study is to determine whether subjects with negative symptoms of schizophrenia have abnormal functioning of brain circuits relevant to reward processing, and to determine whether any such abnormalities are normalized by treatment with aripiprazole.
TITLE: Aripiprazole effects on reward processing in deficit syndrome schizophrenia Principal Investigator: Erica Duncan, M.D. Background- This is a study of the way people with schizophrenia may feel when they get rewards. Certain parts of the brain play a part in people feeling happy when they win some sort of reward...
Schizophrenia
schizophrenia reward fMRI
null
1
arm 1: Patients to be switched from baseline medication to aripiprazole, and fMRI measured at baseline and after med switch.
[ 0 ]
2
[ 10, 0 ]
intervention 1: fMRI scanning during behavioral reward task intervention 2: 30 mg by mouth once daily
intervention 1: fMRI intervention 2: Aripiprazole
1
Decatur | Georgia | United States | -84.29631 | 33.77483
20
0
0
0
NCT00209027
6TERMINATED
2011-04-01
2005-04-01
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 ]
30
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
true
The purpose of this study is to determine if acquired hormone therapy resistance can be reversed by Avastin (Bevacizumab), as measured by time to disease progression and evaluate toxicity of the combination of hormone treatment plus Avastin (Bevacizumab).
This is a single institution, open-label study designed to evaluate safety and efficacy of Avastin (Bevacizumab) combined with an endocrine agent in patients with estrogen and/or progesterone receptor positive metastatic breast carcinoma who have acquired resistance to at least one hormonal agent. Patients will be trea...
Metastatic Breast Cancer
Breast cancer Metastatic breast cancer Hormonal therapy Bevacizumab
null
1
arm 1: The patient will continue the same hormonal therapy used prior to study enrollment but will combine it with Avastin.
[ 0 ]
2
[ 0, 0 ]
intervention 1: All patients will received Avastin 15 mg/kg IV every three weeks. The first evaluation will be done at Week 6. Patients with objective response or stable disease will continue therapy with restaging every 6 weeks until evidence of disease progression. Patients with progression of disease will be taken o...
intervention 1: Avastin intervention 2: Hormonal therapy
1
Birmingham | Alabama | United States | -86.80249 | 33.52066
30
0
0
0
NCT00240071
1COMPLETED
2011-04-01
2005-10-01
University of Alabama at Birmingham
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 ]
119
RANDOMIZED
FACTORIAL
0TREATMENT
4QUADRUPLE
false
0ALL
null
The purpose of this study is to determine whether doses of 30 mg and 45 mg AZD2171 can be well tolerated without significant drug withdrawal when accompanied by a suitable hypertension management strategy or dose reduction.
null
Tumors
Advanced Solid Tumours phase II Hypertension RECENTIN
null
2
arm 1: 30 mg AZD2171 arm 2: 45 mg AZD2171
[ 0, 0 ]
1
[ 0 ]
intervention 1: 30 mg \& 45 mg oral tablet
intervention 1: AZD2171
6
Freiburg im Breisgau | N/A | Germany | 7.85222 | 47.9959 Hamburg | N/A | Germany | 9.99302 | 53.55073 Amsterdam | N/A | Netherlands | 4.88969 | 52.37403 Nijmegen | N/A | Netherlands | 5.85278 | 51.8425 Utrecht | N/A | Netherlands | 5.12222 | 52.09083 Surrey | N/A | United Kingdom | N/A | N/A
119
0
0
0
NCT00264004
1COMPLETED
2011-04-01
2005-11-01
AstraZeneca
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
47
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to evaluate the tolerability and safety of 25 percent human albumin therapy in patients with subarachnoid hemorrhage.
An estimated 37,500 people in the United States have subarachnoid hemorrhage (SAH) every year. SAH is usually secondary to a brain aneurysm that has burst. In SAH the bleeding accumulates around the lining of the brain. SAH is associated with a 51percent mortality rate, and one third of survivors are left functionally ...
Subarachnoid Hemorrhage
subarachnoid hemorrhage SAH human albumin HA cerebral vasospasm aneurysm neuroprotective
null
4
arm 1: 0.625 g/kg 25% human albumin arm 2: 1.25 g/kg 25% human albumin arm 3: 1.875 g/kg 25% human albumin arm 4: 2.5 g/kg 25% human albumin
[ 1, 1, 1, 1 ]
1
[ 0 ]
intervention 1: 25% human albumin: after approval by the Data and Safety Monitoring Board dosage tier would be escalated to the subsequent higher level sequentially.
intervention 1: 25% human albumin
6
Baltimore | Maryland | United States | -76.61219 | 39.29038 Hershey | Pennsylvania | United States | -76.65025 | 40.28592 Charleston | South Carolina | United States | -79.93275 | 32.77632 Houston | Texas | United States | -95.36327 | 29.76328 Calgary | Alberta | Canada | -114.08529 | 51.05011 Toronto | Ontario | Canad...
47
0
0
0
NCT00283400
6TERMINATED
2011-04-01
2006-01-01
Baylor College of Medicine
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
349
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
This study was an international, multicenter, randomized (2:1 active:placebo), double-blind, placebo-controlled study in subjects with PAH who were NOT currently receiving approved therapy for their PAH. Study visits occurred at 4 week intervals for 12 weeks (with an additional visit at Week 11) with the key measure of...
null
Pulmonary Hypertension
Pulmonary Arterial Hypertension
null
2
arm 1: Subjects receive UT-15C (oral treprostinil) twice daily. arm 2: Subjects receive placebo (sugar pill) twice daily.
[ 1, 2 ]
2
[ 0, 10 ]
intervention 1: Sustained release oral tablet, twice daily intervention 2: Placebo oral tablet twice daily
intervention 1: Oral treprostinil (UT-15C) Sustained Release Tablets intervention 2: Placebo
77
Birmingham | Alabama | United States | -86.80249 | 33.52066 Phoenix | Arizona | United States | -112.07404 | 33.44838 Phoenix | Arizona | United States | -112.07404 | 33.44838 Fresno | California | United States | -119.77237 | 36.74773 Los Angeles | California | United States | -118.24368 | 34.05223 Sacramento | Califo...
228
0
0
0
NCT00325403
1COMPLETED
2011-04-01
2006-10-01
United Therapeutics
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
281
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
This study evaluated the safety, tolerability and effect on MRI lesion parameters of FTY720 in patients with relapsing multiple sclerosis.
null
Multiple Sclerosis
FTY720 MS Multiple Sclerosis RRMS
null
3
arm 1: Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation. arm 2: Core study:...
[ 0, 2, 0 ]
2
[ 0, 0 ]
intervention 1: FTY720 capsule was taken orally once a day intervention 2: Placebo 1.25 mg capsule was given once daily
intervention 1: FTY720 intervention 2: Placebo
26
Montreal | N/A | Canada | -73.58781 | 45.50884 Ottawa | N/A | Canada | -75.69812 | 45.41117 Toronto | N/A | Canada | -79.39864 | 43.70643 Vancouver | N/A | Canada | -123.11934 | 49.24966 Copenhagen | N/A | Denmark | 12.56553 | 55.67594 Helsinki | N/A | Finland | 24.93545 | 60.16952 Turku | N/A | Finland | 22.26869 | 60...
281
0
0
0
NCT00333138
1COMPLETED
2011-04-01
2003-05-01
Novartis
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
83
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
true
1FEMALE
true
Skeletal buffering of chronic acid loads may contribute to a significant amount of bone loss over time. Evidence from a few small short-term studies suggests that basic compounds, namely potassium citrate and potassium bicarbonate may reduce bone loss and improve bone density. The purpose of this study is to evaluate ...
Participants were recruited from a single academic center. Subjects underwent screening at the Clinical Translational Science Center (CTSC) at Weill Cornell Medical College (WCMC). Study visits occurred at the CTSC where investigators administered and monitored questionnaires, compliance, adverse events, and endpoint m...
Bone Diseases, Metabolic Osteoporosis, Postmenopausal
postmenopausal osteopenia treatment bone loss
null
2
arm 1: Potassium Citrate 20 meq twice daily arm 2: Placebo
[ 0, 2 ]
1
[ 0 ]
intervention 1: 20 meq by mouth in capsule form twice daily
intervention 1: potassium citrate
1
New York | New York | United States | -74.00597 | 40.71427
83
0
0
0
NCT00357331
1COMPLETED
2011-04-01
2006-08-01
Weill Medical College of Cornell 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 ]
9
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
FR901228 may stop the growth of cancer cells by blocking some of the enzymes needed for cell to grow and by blocking blood flow to the cancer. This phase II trial is studying how well FR901228 works in treating patients with relapsed or refractory non-Hodgkin's lymphoma.
OBJECTIVES: I. Determine the response rate (complete and partial) to FR901228 in patients with relapsed or refractory mantle cell or diffuse large cell non-Hodgkin's lymphoma. II. Evaluate the safety and feasibility of FR901228, in terms of the incidence of toxicity and maximum grade observed and courses delayed or d...
Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Mantle Cell Lymphoma
null
1
arm 1: Patients receive FR901228 IV over 4 hours on days 1, 8, and 15.
[ 0 ]
1
[ 0 ]
intervention 1: Given IV
intervention 1: romidepsin
1
Houston | Texas | United States | -95.36327 | 29.76328
9
0
0
0
NCT00383565
6TERMINATED
2011-04-01
2006-09-01
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 ]
24
RANDOMIZED
PARALLEL
4SUPPORTIVE_CARE
3TRIPLE
false
0ALL
true
RATIONALE: Escitalopram may help improve depression and quality of life in patients with advanced lung or gastrointestinal cancer. It is not yet known whether escitalopram is more effective than a placebo in treating depression in patients with advanced lung or gastrointestinal cancer. PURPOSE: This randomized clinica...
OBJECTIVES: * Compare the efficacy of escitalopram oxalate vs placebo in treating major depressive disorder in patients with advanced lung or gastrointestinal cancer. * Compare the side effect burden of escitalopram oxalate vs placebo in these patients. * Determine potential moderators of the efficacy of escitalopram ...
Colorectal Cancer Depression Esophageal Cancer Extrahepatic Bile Duct Cancer Fatigue Gallbladder Cancer Gastric Cancer Liver Cancer Lung Cancer Pancreatic Cancer
fatigue psychosocial effects of cancer and its treatment stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer extensive stage small cell lung cancer advanced adult primary liver cancer depression stage III pancreatic cancer stage IV pancreatic cancer stage IV esophageal cancer stage IV gastric canc...
null
3
arm 1: Participants in this arm were randomized to receive placebo once daily for the first 4 weeks and placebo once daily for the second 4 weeks arm 2: Participants in this arm were randomized to receive placebo once daily for the first 4 weeks and escitalopram oxalate 10 mg once daily for the second 4 weeks arm 3: Pa...
[ 2, 5, 5 ]
2
[ 0, 0 ]
intervention 1: escitalopram oxalate 10 mg once daily for 4 weeks intervention 2: one placebo pill identical in appearance to the escitalpram pill once daily
intervention 1: escitalopram oxalate intervention 2: Placebo
1
Boston | Massachusetts | United States | -71.05977 | 42.35843
24
0
0
0
NCT00387348
6TERMINATED
2011-04-01
2006-03-01
Massachusetts General Hospital
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
39
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
2MALE
true
Primary Objective: * To assess the possible improvement in prostate specific antigen (PSA) outcome of short course androgen suppression therapy in conjunction with dose-escalation intensity modulated radiation therapy (IMRT), 3D conformal radiation therapy (3D-CRT), or proton therapy over IMRT, 3D-CRT, or proton thera...
Prior patient studies have shown that short-term hormone therapy (about 4 months) before and during radiation therapy can benefit patients with bulky tumors or locally-advanced prostate tumors. These prior results have been used to justify a potential benefit for using short-term hormone therapy combined with radiation...
Prostate Cancer
Prostate Cancer External Beam Radiotherapy Radiation Therapy Hormone Therapy Bicalutamide Casodex Leuprolide Lupron Goserelin Zoladex Flutamide EBRT
null
2
arm 1: Radiation Therapy (RT) over 8 1/2 weeks: 42 treatments, 5 days per week with 2 days rest in between. arm 2: Radiation Therapy over 8 1/2 weeks; + Hormone Therapy (Bicalutamide 50 mg orally/day or Flutamide 250 mg orally 3 times daily on first 21-30 Days) + Leuprolide (22.5 mg Intramuscularly (IM)/every 3 months ...
[ 1, 1 ]
6
[ 3, 0, 0, 0, 0, 5 ]
intervention 1: Radiation treatment given over about 8 1/2 weeks; 42 treatments, 5 days per week with 2 days rest in between. intervention 2: 50 mg By Mouth (PO) Daily intervention 3: 22.5 mg Intramuscularly (IM) Every 3 Months or 7.5 mg IM Every 1 Month intervention 4: 10.8 mg Subcutaneously Every 3 Months or 3.6 mg S...
intervention 1: Radiation Therapy intervention 2: Bicalutamide intervention 3: Leuprolide intervention 4: Goserelin intervention 5: Flutamide intervention 6: Questionnaire
1
Houston | Texas | United States | -95.36327 | 29.76328
38
0
0
0
NCT00388804
6TERMINATED
2011-04-01
2005-02-01
M.D. Anderson Cancer Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
11
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
There is a subgroup of children with autism that appears to develop typically for a period of time, and then loses social or language skills, or regresses. A recent study by Vargas and co-workers at Johns Hopkins has demonstrated that this regressive type of autism is associated with chronic brain inflammation as shown...
Autism is a neurodevelopmental disorder that results in abnormalities of social and language development and is associated with rigid and repetitive behaviors. Although there is strong evidence of heritability, the involved genes have not been identified. The prevalence of autism spectrum disorders may be as common as ...
Autism Minocycline Regressive Autism
Immunology Microglia NF-Kappa-B Antibiotic Autism Minocycline Regressive Autism
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: None
intervention 1: Minocycline
2
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 Bethesda | Maryland | United States | -77.10026 | 38.98067
11
0
0
0
NCT00409747
1COMPLETED
2011-04-01
2006-11-01
National Institute of Mental Health (NIMH)
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 ]
180
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
In patients with Alzheimer's disease (AD) who respond to antipsychotic treatment of psychosis and/or agitation/aggression, the relapse risk after discontinuation is not established. AD patients with psychosis and/or agitation/aggression receive 16 weeks of open risperidone treatment (Phase A). Responders are then rando...
This multicenter study (6 academic sites and 2 non-academic sites) involves treating AD patients (assisted living or nursing home patients, and outpatients) using an atypical antipsychotic, risperidone. In Phase A, 180 AD patients with psychosis and/or agitation/aggression receive open treatment with risperidone for 16...
Alzheimer Disease Psychotic Disorders Agitation Aggression
Risperidone treatment, psychosis, agitation, aggression, discontinuation, placebo
null
3
arm 1: Risperidone for 16 weeks followed by risperidone for 16 weeks arm 2: Risperidone for 16 weeks followed by placebo for 16 weeks arm 3: Placebo for 16 weeks followed by placebo for 16 weeks
[ 5, 5, 5 ]
1
[ 0 ]
intervention 1: Risperidone open label flexible dose 0.25 to 3 mg daily for first 16 weeks; dose at 16 weeks then fixed for randomized trial
intervention 1: risperidone
7
Tuscaloosa | Alabama | United States | -87.56917 | 33.20984 Los Angeles | California | United States | -118.24368 | 34.05223 Norwalk | Connecticut | United States | -73.4079 | 41.1176 Iowa City | Iowa | United States | -91.53017 | 41.66113 New York | New York | United States | -74.00597 | 40.71427 New York | New York |...
163
0
0
0
NCT00417482
1COMPLETED
2011-04-01
2004-08-01
New York State Psychiatric Institute
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
40
NON_RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
false
0ALL
null
This study will determine the maximum tolerated dose of oral ixabepilone administered for 5 successive days every 21 days in participants with advanced cancer. The safety, tolerability, and pharmacokinetics of ixabepilone in the body will be studied. In addition, this study will assess preliminary evidence of the effec...
null
Cancer
null
8
arm 1: If none of first 3 participants experiences a dose-limiting toxicity (DLT) during the first 21-day cycle, a new cohort is opened at the next dose level (5-mg increments). If 2 or more of the first 3 participants experience a DLT within the first 21-day course, the dose level will be considered above the maximum ...
[ 0, 0, 0, 0, 0, 0, 0, 0 ]
8
[ 0, 0, 0, 0, 0, 0, 0, 0 ]
intervention 1: Ixabepilone, 5 mg, administered orally once daily on Days 1 through 5 every 21 days. Dose increased by 5 mg for each subsequent treatment group until disease progression, unacceptable toxicity, or participant refusal. No dose escalation within each treatment group. On all dosing days in Cycle 1, partici...
intervention 1: Ixabepilone, 5 mg/d intervention 2: Ixabepilone, 10 mg/d intervention 3: Ixabepilone, 15 mg/d intervention 4: Ixabepilone, 20 mg/d intervention 5: Ixabepilone, 25 mg/d intervention 6: Ixabepilone, 30 mg/d intervention 7: Ixabepilone, 25 mg, with famotidine intervention 8: Ixabepilone, 25 mg, with food
2
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 Detroit | Michigan | United States | -83.04575 | 42.33143
44
0
0
0
NCT00422097
1COMPLETED
2011-04-01
2007-01-01
R-Pharm
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
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
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
To determine the overall safety of PF-00477736 when given in combination with gemcitabine, a chemotherapy agent, in patients with advanced solid tumors and determine the maximum dose of PF-00477736 that can be safely given in combination with gemcitabine. This is the first study of PF-00477736 in humans.
The study was closed to enrollment as of 17 May 2010 due to business reasons. The patient on study continued treatment until 19 April 2011 when stopped for complete response. Premature closure was not prompted by any safety or efficacy concerns.
Neoplasms
Advanced cancer
null
1
arm 1: None
[ 0 ]
2
[ 0, 0 ]
intervention 1: * Escalating doses of PF-00477736 will be administered intravenously on Days 2 and 9 and gemcitabine will be administered intravenously on Days 1 and 8 of a 21-day cycle (doses to be evaluated range from 750 to 1250 mg/m2 in three separated cohorts). * If a patient is administered Cycle 0 - only PF-0047...
intervention 1: PF-00477736 intervention 2: gemcitabine
7
Los Angeles | California | United States | -118.24368 | 34.05223 Los Angeles | California | United States | -118.24368 | 34.05223 Santa Monica | California | United States | -118.49138 | 34.01949 Santa Monica | California | United States | -118.49138 | 34.01949 New York | New York | United States | -74.00597 | 40.71427...
43
0
0
0
NCT00437203
6TERMINATED
2011-04-01
2006-12-01
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 ]
102
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
To determine the best dose of this investigational agent AG-013736 in combination with various standard of care treatments for advanced solid tumors.
null
Neoplasms
axitinib chemotherapy anti-angiogenesis VEGF inhibition
null
1
arm 1: The following separate groups were included: axitinib 1. plus carboplatin/paclitaxel in three different schedules 2. plus paclitaxel 3. plus docetaxel/carboplatin 4. plus docetaxel 5. plus capecitabine 6. plus gemcitabine/cisplatin 7. plus pemetrexed/cisplatin
[ 0 ]
10
[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]
intervention 1: Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclit...
intervention 1: Axitinib + Paclitaxel + Carboplatin (Cohort 1) intervention 2: Axitinib + Paclitaxel + Carboplatin (Cohort 2) intervention 3: Axitinib + Paclitaxel + Carboplatin (Cohort 3) intervention 4: Axitinib + Paclitaxel (Cohort 4) intervention 5: Axitinib + Docetaxel + Carboplatin (Cohort 4a) intervention 6: Axi...
13
Augusta | Georgia | United States | -81.97484 | 33.47097 Augusta | Georgia | United States | -81.97484 | 33.47097 Harvey | Illinois | United States | -87.64671 | 41.61003 Harvey | Illinois | United States | -87.64671 | 41.61003 Tinley Park | Illinois | United States | -87.78449 | 41.57337 Hobart | Indiana | United Stat...
98
0
0
0
NCT00454649
1COMPLETED
2011-04-01
2005-12-01
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
[ 3 ]
18
RANDOMIZED
CROSSOVER
0TREATMENT
3TRIPLE
false
0ALL
true
To evaluate the efficacy and safety of cholic acid therapy in treating lipodystrophy patients with hepatic steatosis. This is a randomized, double-blind, placebo-controlled cross-over study.
Lipodystrophies are rare disorders characterized by selective loss of adipose tissue and predisposition to develop insulin resistance and its associated metabolic complications such as dyslipidemia, diabetes mellitus and hepatic steatosis. Nonalcoholic hepatic steatosis or steatohepatitis caused by excessive accumulati...
Hepatic Steatosis
lipodystrophy
null
2
arm 1: Cholic Acid weight based dose for 6 months double-blind arm 2: Placebo for Cholic Acid for 6 months double-blind
[ 0, 2 ]
1
[ 0 ]
intervention 1: Capsules of active Cholic Acid or matching placebo, total dose is 15 mg/kg per day, maximum dose of 1500 mg per day, taken PO, BID.
intervention 1: Cholic Acid
1
Dallas | Texas | United States | -96.80667 | 32.78306
29
0
0
0
NCT00457639
1COMPLETED
2011-04-01
2006-04-01
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 ]
45
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or stopping them from dividin...
OBJECTIVES: * Determine the efficacy and safety of bortezomib, pegylated doxorubicin hydrochloride liposome, and dexamethasone followed by thalidomide and dexamethasone with or without bortezomib in patients with symptomatic high-risk or primary resistant multiple myeloma. OUTLINE: Patients receive BDD comprising bor...
Multiple Myeloma and Plasma Cell Neoplasm
stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma refractory multiple myeloma
null
1
arm 1: Combination therapy with bortezomib, pegylated liposomal doxorubicin and dexamethasone (BDD) followed by either thalidomide and dexamethasone (TD) or bortezomib, thalidomide and dexamethasone in patients with symptomatic untreated high-risk or primary resistant multiple myeloma. Three cycles of BDD will be admin...
[ 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: None intervention 4: None
intervention 1: bortezomib intervention 2: dexamethasone intervention 3: pegylated liposomal doxorubicin hydrochloride intervention 4: thalidomide
1
New York | New York | United States | -74.00597 | 40.71427
45
0
0
0
NCT00458705
1COMPLETED
2011-04-01
2006-11-01
Memorial Sloan Kettering Cancer Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
25
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This phase II trial is studying how well dasatinib works in treating patients with advanced liver cancer that cannot be removed by surgery. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES: I. Determine the progression-free survival (PFS) rate and response rate (complete and partial response) at 4 months in patients with unresectable advanced hepatocellular carcinoma treated with dasatinib. SECONDARY OBJECTIVES: I. Determine the median PFS and overall survival of patients treated wi...
Adult Primary Hepatocellular Carcinoma Advanced Adult Primary Liver Cancer Recurrent Adult Primary Liver Cancer
null
1
arm 1: Patients receive oral dasatinib at 70 mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
[ 0 ]
1
[ 0 ]
intervention 1: Given orally
intervention 1: dasatinib
1
Los Angeles | California | United States | -118.24368 | 34.05223
25
0
0
0
NCT00459108
6TERMINATED
2011-04-01
2007-04-01
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 ]
39
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This single arm study will assess the efficacy and safety of subcutaneous Mircera for correction of anemia in participants with chronic kidney disease who are not on dialysis and are not treated with erythropoiesis-stimulating agents (ESA). Eligible participants will receive Mircera by monthly subcutaneous injections, ...
null
Anemia
null
1
arm 1: Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose will be 1.2 micrograms per kilogram (mcg/kg) body weight. Thereafter, throughout the duration of study the dose adjustments will be performed depending on the h...
[ 0 ]
1
[ 0 ]
intervention 1: Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose will be 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments will be performed depending on the hemoglobin value.
intervention 1: Methoxy Polyethylene Glycol-epoetin Beta
22
Tallinn | N/A | Estonia | 24.75353 | 59.43696 Tallinn | N/A | Estonia | 24.75353 | 59.43696 Tartu | N/A | Estonia | 26.72509 | 58.38062 HUS | N/A | Finland | N/A | N/A Joensuu | N/A | Finland | 29.76316 | 62.60118 Jyväskylä | N/A | Finland | 25.72088 | 62.24147 Kajaani | N/A | Finland | 27.72846 | 64.22728 Kotka | N/A ...
39
0
0
0
NCT00462384
6TERMINATED
2011-04-01
2008-02-01
Hoffmann-La Roche
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
62
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to find out what effects (both good and bad) that capecitabine has on you and your breast cancer when given in a novel schedule in combination with the antibody therapy, bevacizumab. Capecitabine (Xeloda®) is an anticancer drug that was approved by FDA in 1998 for treating metastatic breast...
A. Primary Objectives: • To estimate the efficacy of every other week capecitabine and bevacizumab in patients with metastatic breast cancer in terms of overall response rate (complete response (CR) + partial response (PR)) when administered at the MTD of capecitabine determined by the phase I portion of this trial. ...
Breast Cancer
Breast cancer Metastatic breast cancer Breast Metastatic
null
1
arm 1: The Phase II trial has a Simon mini-max two-stage design. Twenty-seven patients will be enrolled to the first stage of the Phase II trial, with a target accrual of 40 patients. The treatment dose of capecitabine as determined in the Phase I portion of this trial will be administered orally in two divided doses d...
[ 0 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: Capecitabine intervention 2: Bevacizumab
5
Basking Ridge | New Jersey | United States | -74.54932 | 40.70621 Commack | New York | United States | -73.29289 | 40.84288 New York | New York | United States | -74.00597 | 40.71427 Rockville Centre | New York | United States | -73.64124 | 40.65871 Sleepy Hollow | New York | United States | -73.85847 | 41.08565
63
0
0
0
NCT00468585
1COMPLETED
2011-04-01
2005-06-01
Memorial Sloan Kettering Cancer Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
53
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
RATIONALE: Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide toge...
OBJECTIVES: Primary \* Assess the response rate in patients with newly diagnosed active multiple myeloma treated with lenalidomide, cyclophosphamide, and dexamethasone. Secondary * Assess the toxicity of this regimen in these patients. * Determine the time to progression in patients treated with this regimen. OUTLI...
Multiple Myeloma and Plasma Cell Neoplasm
stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma
null
1
arm 1: None
[ 0 ]
3
[ 0, 0, 0 ]
intervention 1: 300 mg/m2 administrated by PO (with food)on Days 1, 8, 15 (up to 12 cycles) OR 300 mg administrated by PO (with food)on Days 1, 8, 15 (up to 12 cycles) intervention 2: 40 mg administrated by PO (with food)on Days 1, 8, 15 \& 22 intervention 3: 25 mg administrated by PO (with food)on Days 1-21
intervention 1: cyclophosphamide intervention 2: dexamethasone intervention 3: lenalidomide
2
Scottsdale | Arizona | United States | -111.89903 | 33.50921 Rochester | Minnesota | United States | -92.4699 | 44.02163
53
0
0
0
NCT00478218
1COMPLETED
2011-04-01
2006-07-01
Mayo Clinic
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
37
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
This study will evaluate the pharmacokinetics, safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema
null
Diabetic Macular Edema
null
2
arm 1: None arm 2: None
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: 0.5 mg fluocinolone acetonide intravitreal insert intervention 2: 0.2 mg fluocinolone acetonide intravitreal insert
intervention 1: Fluocinolone Acetonide intervention 2: Fluocinolone Acetonide
1
Baltimore | Maryland | United States | -76.61219 | 39.29038
37
0
0
0
NCT00490815
1COMPLETED
2011-04-01
2007-08-01
Alimera Sciences
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
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 ]
91
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The principal aim of the project is to conduct an off-label adjunctive clinical trial evaluating varenicline as a treatment for core neurobiological and clinical deficits in schizophrenia, in addition to evaluating for smoking cessation in schizophrenia patients.
This is a double-blind, placebo controlled clinical trial in schizophrenia patients. Outcome measures include biomarkers and clinical symptoms and functions, and smoking cessation. Neurobiological and cognitive markers will be measured for short term (2 weeks) and longer-term (8 weeks). Current schizophrenia treatments...
Schizophrenia Schizoaffective Disorder Schizophreniform Disorder
Varenicline Neurobiology clinical trial cognitive deficits Schizophreniform Disorder
null
2
arm 1: Varenicline arm 2: Placebo
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Varenicline 0.5mg po qd x 7 days then titrated to Varenicline 0.5mg po bid x 7 weeks intervention 2: Placebo 0.5mg po qd x 7 days then titrated to Placebo 0.5mg po bid x 7 weeks
intervention 1: Varenicline intervention 2: Placebo
3
Baltimore | Maryland | United States | -76.61219 | 39.29038 Baltimore | Maryland | United States | -76.61219 | 39.29038 Baltimore | Maryland | United States | -76.61219 | 39.29038
69
0
0
0
NCT00492349
1COMPLETED
2011-04-01
2007-05-01
University of Maryland, Baltimore
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 ]
41
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
true
RATIONALE: Oxidized glutathione (NOV-002) may stimulate the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from ...
OUTLINE: This is a multicenter study. Patients receive oxidized glutathione (NOV-002) IV twice on day -1 of course 1 and once on day 1 of courses 2-8. Patients receive NOV-002 subcutaneously once daily on days 2-21 of courses 1-8. Patients also receive chemotherapy comprising doxorubicin hydrochloride IV and cyclophos...
Breast Cancer
stage II breast cancer stage IIIC breast cancer inflammatory breast cancer
null
1
arm 1: * NOV-002: * Cycle 1, Day -1 only: 60 mg intravenously (IV) x 2, 3 hours (+/- 30 minutes) apart * Cycles 1 - 8, Day 1: 60 mg IV, 1 hour (+/- 30 minutes) prior to chemotherapy administration * Cycle 1 - 8, Days 2 - 21: 60 mg subcutaneous injections * Cyclophosphamide: 600 mg/m2 IV, Cycles 1 - 4, Day 1 * Do...
[ 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: None intervention 4: None
intervention 1: Cyclophosphamide intervention 2: Docetaxel intervention 3: Doxorubicin intervention 4: NOV 002
2
Miami | Florida | United States | -80.19366 | 25.77427 Charleston | South Carolina | United States | -79.93275 | 32.77632
41
0
0
0
NCT00499122
1COMPLETED
2011-04-01
2007-06-04
University of Miami
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 ]
38
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
true
1FEMALE
false
The primary hypothesis is that continuous administration of an OCP (CCOCP regimen) will result in more pain relief than a traditional 21/7 administration in primary dysmenorrhea (PD) patients.
It is well established that excess prostaglandin production in primary dysmenorrhea (PD) leads to ischemia of the uterine muscle, which consequently causes pelvic pain. A large number of drugs have been studied for pain relief in dysmenorrhea patients with non-steroid anti-inflammatory drugs (NSAIDs) being the most eff...
Dysmenorrhea
Dysmenorrhea continuous OCP
null
2
arm 1: treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for 168 continuous days through six cycles arm 2: treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for traditional (21 active days/7 inactive days) regimen through six cycles.
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: (CCOCP) continuous treatment with Monophasic oral gestodene/ethinyl estradiol intervention 2: (traditional OCP) (21 active days/7 inactive days) treatment regimen
intervention 1: CCOCP intervention 2: Traditional OCP
1
Strossmayerova 17 | N/A | Croatia | N/A | N/A
38
0
0
0
NCT00517556
1COMPLETED
2011-04-01
2007-08-01
Milton S. Hershey 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 ]
48
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The primary objective is to determine the progression free survival with pemetrexed, and gemcitabine plus bevacizumab as first-line chemotherapy in elderly patients with Stage IIIB/IV non-small cell lung cancer (NSCLC). The secondary objectives are to determine the overall response rate; overall survival; chemotherapy...
null
Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer
null
0
null
null
1
[ 0 ]
intervention 1: Bevacizumab 10 mg/kg will be given intravenously according to weight. Pemetrexed 500 mg/m\^2 and gemcitabine 1500 mg/m\^2 will be given intravenously according to weight and height. All agents are administered every 2 weeks.
intervention 1: Pemetrexed and Gemcitabine plus Bevacizumab
10
Waterbury | Connecticut | United States | -73.0515 | 41.55815 Augusta | Georgia | United States | -81.97484 | 33.47097 Macon | Georgia | United States | -83.6324 | 32.84069 Marietta | Georgia | United States | -84.54993 | 33.9526 Billings | Montana | United States | -108.50069 | 45.78329 Canton | Ohio | United States |...
48
0
0
0
NCT00517595
1COMPLETED
2011-04-01
2007-08-01
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
[ 3 ]
30
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to find out what effects (good and bad) the combination of the chemotherapy drugs gemcitabine, capecitabine, and bevacizumab has on a patient and kidney cancer.
* to determine the objective response rate and estimate the time to progression of combination gemcitabine, capecitabine, and bevacizumab in patients with metastatic clear cell renal cell cancer; * to determine survival of combination gemcitabine, capecitabine, and bevacizumab in patients with metastatic cell renal cel...
Carcinoma, Renal Cell
metastatic renal cell kidney neoplasm
null
1
arm 1: Combination of gemcitabine, capecitabine, and bevacizumab gemcitabine 1000 mg/m\^2 d1, 8, capecitabine 1000 mg (flat dose) po bid d1-14, and bevacizumab 15 mg/kg d 1, on a 21 day cycle
[ 0 ]
1
[ 0 ]
intervention 1: gemcitabine 1000 mg/m\^2 d1, 8, capecitabine 1000 mg (flat dose) po bid d1-14, and bevacizumab 15 mg/kg d 1, on a 21 day cycle
intervention 1: combination of gemcitabine, capecitabine, and bevacizumab
1
Chicago | Illinois | United States | -87.65005 | 41.85003
29
0
0
0
NCT00523640
6TERMINATED
2011-04-01
2005-03-01
University of Chicago
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
10
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
Obsessive-compulsive disorder (OCD) affects 2-3% of the population and leads to a great deal of suffering. Many patients benefit from established treatments, the mainstay of which are cognitive behavioral therapy and a group of antidepressant medications known as serotonin reuptake inhibitors. However, 20-30% of patien...
Due to limited participation, this study has closed.
Obsessive-Compulsive Disorder
obsessive-compulsive disorder OCD glutamate N-Acetylcysteine augmentation
null
2
arm 1: Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose titrated to 3000 mg within the first week, in addition to the medication regimen they are on at enrollment arm 2: Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcy...
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 3000 mg by mouth PO (1200 mg AM, 1800 mg PM), 12 weeks intervention 2: placebo, 2 capsules PO AM, 3 capsules PO PM, 12 weeks
intervention 1: N-Acetylcysteine intervention 2: placebo
0
null
7
0
0
0
NCT00539513
6TERMINATED
2011-04-01
2006-06-01
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
[ 0 ]
45
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
false
Sorafenib is being looked at in a number of solid tumor settings including breast cancer. This trial is designed as a pilot study to assess the safety and tolerability of a novel oral agent in combination with standard chemotherapy in the treatment of early stage node positive or otherwise high-risk breast cancer. If t...
Primary Objectives The primary objective is to assess the safety and tolerability of doxorubicin / cyclophosphamide followed by paclitaxel in combination with sorafenib in patients with early stage node positive or otherwise high-risk breast cancer. Secondary Objectives The secondary objectives are to assess activity ...
Breast Cancer
Breast Cancer Early Stage High Risk Node Positive Doxorubicin Cyclophosphamide Paclitaxel Sorafenib
null
1
arm 1: All patients received doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 (AC) both administered intravenously day 1 every 3 weeks for four cycles, followed by paclitaxel 175 mg/m2 intravenously day 1 every 3 weeks for four cycles or 80 mg/m2 for twelve weeks (physician discretion), combined with sorafenib 400 m...
[ 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: None intervention 4: None
intervention 1: Doxorubicin intervention 2: Cyclophosphamide intervention 3: Paclitaxel intervention 4: Sorafenib
8
Jacksonville | Florida | United States | -81.65565 | 30.33218 Orlando | Florida | United States | -81.37924 | 28.53834 Louisville | Kentucky | United States | -85.75941 | 38.25424 Grand Rapids | Michigan | United States | -85.66809 | 42.96336 Omaha | Nebraska | United States | -95.94043 | 41.25626 Chattanooga | Tenness...
45
0
0
0
NCT00544167
1COMPLETED
2011-04-01
2007-05-01
SCRI Development Innovations, LLC
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
16
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The purpose of this proposed pilot study is to examine the use of varenicline in people with schizophrenia to specifically assess tolerability and efficacy for smoking cessation. Specifically, The primary objective of this pilot study is to determine if taking of varenicline along with an individual smoking cessation s...
The primary objective of the data analysis will be to measure the rate of smoking cessation in the two treatment groups. Smoking cessation will be measured weekly through a composite measure of self-reported abstinence, end expired carbon monoxide (CO) of less than C10 ppm and urine cotinine dipstick measure of \< 30 n...
Cigarette Smoking Schizophrenia
null
2
arm 1: None arm 2: None
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence throug...
intervention 1: varenicline intervention 2: placebo
0
null
8
0
0
0
NCT00554840
1COMPLETED
2011-04-01
2007-11-01
University of Maryland, Baltimore
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
12
RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The primary objective of this study is to compare the effectiveness of a dose-escalation regimen (400 to 800mg bid) relative to the standard dosing regimen (400mg bid) of sorafenib given in patients with metastatic RCC. The secondary objectives are to evaluate the effects of the dose-escalation regimen on the quality ...
null
Renal Cell Carcinoma
Renal Cell Carcinoma Kidney Cancer
null
2
arm 1: Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (...
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12. intervention 2: Patients randomized to Group B will receive Dose Level 1...
intervention 1: Sorafenib Escalated Dose intervention 2: Sorafenib Standard Dose
13
Jonesboro | Arkansas | United States | -90.70428 | 35.8423 La Verne | California | United States | -117.76784 | 34.10084 Miami | Florida | United States | -80.19366 | 25.77427 Athens | Georgia | United States | -83.37794 | 33.96095 Atlanta | Georgia | United States | -84.38798 | 33.749 Macon | Georgia | United States |...
18
0
0
0
NCT00557830
6TERMINATED
2011-04-01
2008-01-01
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 ]
29
RANDOMIZED
PARALLEL
6HEALTH_SERVICES_RESEARCH
0NONE
false
0ALL
true
This protocol is designed to assess the efficacy and safety of inotuzumab ozogamicin given with rituximab compared to a defined investigator's choice therapy. Subjects will be randomized to one of these two arms of the study.
On January 14th 2009, enrollment in the study was discontinued because of poor enrollment and because it was unlikely that the study would meet the estimated enrollment of approximately 978 subjects. The decision was not prompted by the identification of any safety signals in this or other studies. Active treatment and...
Lymphoma, Follicular
null
2
arm 1: Subjects will receive rituximab intravenously at a dose level of 375 mg/m² on day 1 of each cycle followed by inotuzumab ozogamicin administered intravenously at a dose level of 1.8 mg/m2 on day 2. The sequence will be repeated every 28 days. arm 2: Subjects will receive the investigator's choice from the follow...
[ 0, 1 ]
9
[ 0, 0, 0, 0, 0, 0, 0, 0, 0 ]
intervention 1: IV administration, 1.8mg/m² on day 2 of each cycle every 28 days, for up to 8 cycles. intervention 2: IV administration, 375 mg/m² on day 1 of each cycle every 28 days, for up to 8 cycles. intervention 3: intravenous rituximab at a dose of 375 mg/m2 on day 1 intervention 4: intravenous cyclophosphamide ...
intervention 1: inotuzumab ozogamicin intervention 2: rituximab intervention 3: rituximab intervention 4: cyclophosphamide intervention 5: vincristine intervention 6: prednisone/prednisolone intervention 7: mitoxantrone intervention 8: fludarabine intervention 9: dexamethasone
39
Mission Hills | California | United States | -120.43683 | 34.68609 Evansville | Indiana | United States | -87.55585 | 37.97476 Baltimore | Maryland | United States | -76.61219 | 39.29038 Novi | Michigan | United States | -83.47549 | 42.48059 Southfield | Michigan | United States | -83.22187 | 42.47337 Saint Louis Park ...
28
0
0
0
NCT00562965
6TERMINATED
2011-04-01
2007-11-01
Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
33
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
To determine whether using a long-acting insulin analog at the time of diagnosis, instead of intermediate-acting insulin, affects the rate of loss of the body's ability to make insulin in children with newly diagnosed type 1 diabetes.
BACKGROUND: Type 1 diabetes (or insulin dependent diabetes mellitus (IDDM)) is a very common disorder affecting 1/400 persons by the age of 18 years and over 1 million people in the United States alone. An autoimmune disorder affecting the endocrine pancreas, it causes, in the untreated state, high blood glucose levels...
Type 1 Diabetes
type 1 diabetes, basal-bolus, honeymoon, C-peptide
null
3
arm 1: 24 subjects randomized to therapy with a combination of insulins detemir and aspart at diagnosis of diabetes. arm 2: 24 subjects randomized to therapy with a combination of insulins glargine and aspart at diagnosis of diabetes. arm 3: 24 subjects randomized to therapy with a combination of insulins NPH and aspar...
[ 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Dosage adjusted to meet age-specific glycemic goals throughout course of study. intervention 2: Dosage to be adjusted to meet age-specific glycemic goals throughout course of study. intervention 3: Dosage to be adjusted to meet age specific glycemic goals throughout course of study.
intervention 1: Insulin detemir intervention 2: Glargine intervention 3: NPH
1
Dallas | Texas | United States | -96.80667 | 32.78306
33
0
0
0
NCT00564018
6TERMINATED
2011-04-01
2006-09-01
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
[ 0 ]
57
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The goal of this study is to determine if one dose of simvastatin will decrease the inflammatory response to coronary intervention. Also to determine if one dose of simvastatin affects endothelial function (activity of the artery) as measured by noninvasive peripheral artery tonography.
The objective of this study is to determine if acute pretreatment with simvastatin, an HMG-CoA reductase inhibitor will reduce the post inflammatory response after percutaneous coronary interventions (PCI), and/or change endothelial function as assessed by peripheral arterial tomography (PAT). Percutaneous coronary int...
Coronary Artery Disease
null
2
arm 1: Subjects randomized to this arm will be pretreated with 80 mg (2 pills) simvastatin approximately one hour prior to percutaneous coronary intervention. arm 2: Subjects randomized to this arm will be pretreated with 2 placebo pills approximately one hour prior to percutaneous coronary intervention.
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Subjects randomized to this arm will be pretreated with 80 mg (2 pills) simvastatin approximately one hour prior to percutaneous coronary intervention. intervention 2: Subjects randomized to this arm will be pretreated with 2 placebo pills approximately one hour prior to percutaneous coronary interventi...
intervention 1: Simvastatin intervention 2: Placebo
1
Rochester | Minnesota | United States | -92.4699 | 44.02163
57
0
0
0
NCT00588471
6TERMINATED
2011-04-01
2002-11-01
Mayo Clinic
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
11
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
true
The goal of this trial is to determine the activity of erlotinib in a rationally selected population of women with ER-negative, PR-negative, HER2/neu-negative, EGFR-positive breast cancer. If erlotinib is shown to have activity, this could identify a form of targeted therapy for this specific subset of breast cancer pa...
This is a Phase II, open-label, single institution trial of treatment with single agent erlotinib. The purpose of the research is to determine the effects erlotinib has on the breast cancer tumors in women with metastatic hormone receptor negative and HER2-negative breast cancer. The Federal Drug Administration (FDA) h...
Metastatic Breast Cancer
Metastatic breast cancer ER and PR hormone receptor negative HER2/neu negative EGFR positive
null
1
arm 1: Open label; In this open label study, all enrolled subjects receive active drug, Erlotinib
[ 0 ]
1
[ 0 ]
intervention 1: During the treatment period, subjects will receive single agent erlotinib, 150mg/day.
intervention 1: Erlotinib
1
Chicago | Illinois | United States | -87.65005 | 41.85003
11
0
0
0
NCT00597597
6TERMINATED
2011-04-01
2007-04-01
Rush University Medical Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
50
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to examine whether the medication pramipexole (Mirapex) may be able to improve cognitive problems (i.e. difficulties with thinking, memory, and concentration) that may be associated with bipolar disorder.
To address the primary aim, the study is an eight-week, randomized, double-blind, placebo-controlled treatment trial of pramipexole in 50 euthymic bipolar I and II disorder (BPD) patients, who demonstrate cognitive impairment.
Bipolar Disorder
null
2
arm 1: Day 1: Random assignment to drug or placebo and dosage starting at 0.125 mg BID, which will be increased every week to a target dose of 1.5 mg/day. Targeted maximum dose of 1.5 mg/day is expected to be reached by week 4, however, dosing will be flexible based upon side effects reported. The maximum dose will be ...
[ 0, 2 ]
1
[ 0 ]
intervention 1: po pramipexole versus matching placebo minimum 0.125 mg bid and maximum 0.75 mg bid
intervention 1: pramipexole
1
Glen Oaks | New York | United States | -73.71152 | 40.74705
45
0
0
0
NCT00597896
1COMPLETED
2011-04-01
2005-10-01
Northwell 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 ]
20
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
Cisplatin or Carboplatin will be given on day 1 every 21 days for 6 cycles; Gemcitabine will be given on day 1 and day 8 every 21 days for 6 cycles. Those patients that do not progress on GC after 6 cycles of chemotherapy will be started on erlotinib daily until disease progression. A cycle of erlotinib will be 28 days...
null
Nasopharyngeal Cancer
gemcitabine carboplatin cisplatin erlotinib tarceva nasopharyngeal
null
1
arm 1: Eligible patients are treated with cisplatin/carboplatin and gemcitabine (GC) for 6 cycles of therapy followed by maintenance erlotinib. Those patients achieving SD or PR with chemotherapy will be started on maintenance erlotinib until disease progression. Those patients achieving CR with chemotherapy will be st...
[ 0 ]
3
[ 0, 0, 0 ]
intervention 1: 1000mg/m\^2 intravenous (IV) day 1 and day 8 intervention 2: Area under curve (AUC)=5 (Carboplatin) or 70mg/m\^2 (Cisplatin) intravenous (IV) day 1 intervention 3: 150mg daily (post GC therapy)
intervention 1: Gemcitabine intervention 2: Carboplatin/Cisplatin intervention 3: erlotinib
1
Toronto | Ontario | Canada | -79.39864 | 43.70643
20
0
0
0
NCT00603915
1COMPLETED
2011-04-01
2006-06-01
University Health Network, Toronto
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 ]
58
RANDOMIZED
PARALLEL
2DIAGNOSTIC
3TRIPLE
false
0ALL
false
Parkinson's disease is a common progressive degenerative disease affecting 3% of all patients over the age of 65. Given their age and frailty, these patients frequently require surgical procedures with general anesthesia. However, after surgery, patients with Parkinson's disease have longer hospital stays and a greater...
We will compare the groups in terms of postoperative delirium, and cognitive and motor function changes. Patients randomized to an inhaled anesthetic will receive a standard anesthetic mix: an inhaled anesthetic with intravenous agents for rapid induction of anesthesia, narcotics for postoperative pain relief, and musc...
Parkinson's Disease
Parkinson's Disease Deep brain stimulation (DBS) Subthalamic Nucleus Total Intravenous Anesthesia Inhalational Anesthesia
null
2
arm 1: Inhaled Anesthesia - isoflurane arm 2: Intravenous Anesthesia - propofol, remifentanil
[ 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Group 1 Inhaled anesthesia Patients will be maintained on 50% oxygen in air and isoflurane 0 to 4%, titrated as needed to maintain a standard blood pressure (standard practice). If needed, muscle relaxation will be provided by additional boluses or an infusion of mivacurium (4-10 ug/kg/min). interventio...
intervention 1: Isoflurane intervention 2: Remifentanil intervention 3: Propofol
1
New York | New York | United States | -74.00597 | 40.71427
58
0
0
0
NCT00615472
6TERMINATED
2011-04-01
2003-10-01
Columbia 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, 4 ]
24
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
Does a new add on (or adjunctive) therapy used in glaucoma surgery improve the success of trabeculectomy? Ranibizumab may offer benefit similar to mitomycin C in preventing epi-scleral fibrosis while avoiding the well known complications of mytomycin C which include late bleb leaks, hypotony and infection.
This is an open-label, single center trial with two arms for patients who underwent guarded filtration surgery to control glaucoma. The control will consist of patients randomly assigned to receive inter-operative mitomycin C 0.4 mg/ml which is applied in a standard fashion with a soaked pledget inserted in the sub-ten...
Glaucoma
glaucoma glucoma filtering surgery ranibizumab mitomycin C patients requiring first time glaucoma filtering surgery
null
2
arm 1: Ranibizumab 0.5mg (0.05mL) injection at end of trabeculectomy surgery. This intra-operative adjunct therapy was administered sub-conjunctivally 8-10mm posteriorly to the limbus as an antifibrotic agent. arm 2: Mitomycin C 0.4 mg/ml soaked sponge applied to sclera (for up to 2 min) after flap is made during trabe...
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery intervention 2: Mitomycin (MMC) C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery.
intervention 1: Ranibizumab intervention 2: Mitomycin (MMC)
1
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
24
0
0
0
NCT00626782
1COMPLETED
2011-04-01
2008-01-01
Wills Eye
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 ]
39
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
The major goal of this project is to investigate established insomnia treatments in a schizophrenia population to see if the improved sleep leads to overall better quality of life. In addition, we hypothesize that the insomnia treatment may also lead to observed improvements in other symptoms associated with schizophre...
The primary aim of this study is to investigate the clinical efficacy of eszopiclone for the treatment of schizophrenia-related insomnia over 8 weeks. A two-week, single-blind placebo phase followed the double-blind phase to evaluate rebound and withdrawal effects after abrupt discontinuation.
Insomnia Schizophrenia Schizoaffective Disorder Sleep Disorders
null
2
arm 1: Participants assigned to this arm will receive Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks. arm 2: Participants assigned to this arm will receive placebo (an inactive substance or a "sugar pill") to be taken each night for all weeks of the study.
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks. intervention 2: Placebo or inactive substance ("sugar pill")taken each night for all weeks of the study
intervention 1: Eszopiclone intervention 2: Placebo
1
New Haven | Connecticut | United States | -72.92816 | 41.30815
36
0
0
0
NCT00645944
1COMPLETED
2011-04-01
2008-04-01
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
[ 4 ]
147
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
Prospective, randomized multicenter study to determine the safety and effectiveness of performing cornea collagen cross-linking (CXL) using riboflavin and UVA light in eyes with progressive keratoconus.
This was a sham controlled study for the first three months. Patients had one eye designated as the study eye and were randomized to receive one of two study treatments (CXL or sham) in their study eye. The patients were evaluated at 1, 3, 6, and 12 months. At month 3 or later patients had the option of receiving CXL t...
Progressive Keratoconus
keratoconus cross-linking riboflavin UVA light cornea
null
2
arm 1: riboflavin ophthalmic solution and UVA irradiation arm 2: riboflavin ophthalmic solution without UVA irradiation.
[ 1, 3 ]
2
[ 0, 1 ]
intervention 1: riboflavin 0.1% ophthalmic solution (approximately 32 drops, or 1.6 mL) intervention 2: UVA light (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
intervention 1: riboflavin ophthalmic solution intervention 2: UVA Irradiation
10
La Jolla | California | United States | -117.2742 | 32.84727 San Diego | California | United States | -117.16472 | 32.71571 Miami | Florida | United States | -80.19366 | 25.77427 Indianapolis | Indiana | United States | -86.15804 | 39.76838 Kansas City | Kansas | United States | -94.62746 | 39.11417 Baltimore | Marylan...
147
0
0
0
NCT00647699
1COMPLETED
2011-04-01
2007-12-01
Glaukos Corporation
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
177
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to evaluate the long-term safety, tolerability and activity of Fampridine-SR in subjects with multiple sclerosis who have previously participated in either an Acorda Therapeutics or an Elan Corporation sponsored protocol. Subjects are eligible regardless of whether they received active drug...
Under the original protocol, patients were to have their treatment dose titrated upwards from a starting dose of 10mg b.i.d. to 15mg b.i.d. and then to a stable (maintenance) dose of 20mg b.i.d. The protocol was subsequently revised to lower the maximum maintenance dose. In the most current protocol, all patients were ...
Multiple Sclerosis
multiple sclerosis MS walking leg strength demyelination
null
0
null
null
1
[ 0 ]
intervention 1: Dosage form - tablets.
intervention 1: Fampridine-SR b.i.d. (Twice Daily)
22
Phoenix | Arizona | United States | -112.07404 | 33.44838 Los Angeles | California | United States | -118.24368 | 34.05223 Atlanta | Georgia | United States | -84.38798 | 33.749 Chicago | Illinois | United States | -87.65005 | 41.85003 Baltimore | Maryland | United States | -76.61219 | 39.29038 Golden Valley | Minnesot...
177
0
0
0
NCT00654927
1COMPLETED
2011-04-01
2003-11-01
Acorda Therapeutics
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
110
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
Study of trastuzumab emtansine (T-DM1) administered to patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer.
null
Metastatic Breast Cancer
HER2-positive breast cancer HER2 MBC Trastuzumab emtansine
null
1
arm 1: Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
[ 0 ]
1
[ 0 ]
intervention 1: Intravenous repeating dose
intervention 1: Trastuzumab emtansine [Kadcyla]
0
null
110
0
0
0
NCT00679211
1COMPLETED
2011-04-01
2008-08-01
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 ]
280
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
null
The objective of this study is to evaluate the safety and efficacy of the combination of ABT-335 plus rosuvastatin in dyslipidemic subjects with Chronic Kidney Disease (CKD) Stage 3.
null
Dyslipidemia Kidney Disease
Dyslipidemia Kidney Disease
null
2
arm 1: ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks arm 2: Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks intervention 2: Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
intervention 1: ABT-335 plus rosuvastatin intervention 2: Rosuvastatin
114
Birmingham | Alabama | United States | -86.80249 | 33.52066 Huntsville | Alabama | United States | -86.58594 | 34.7304 Madison | Alabama | United States | -86.74833 | 34.69926 Montgomery | Alabama | United States | -86.29997 | 32.36681 Chula Vista | California | United States | -117.0842 | 32.64005 Fountain Valley | Ca...
280
0
0
0
NCT00680017
1COMPLETED
2011-04-01
2008-06-01
AstraZeneca
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3, 4 ]
44
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
1FEMALE
true
This study will test in several innovative ways, several different combinations of PTH and oral monthly ibandronate for the treatment of osteoporosis in postmenopausal women. The intension is to provide other options for treatment than the current standard 2 year course of drug therapy. These options may lead to treatm...
This randomized double-blind clinical trial for the treatment of postmenopausal osteoporosis will be conducted and coordinated by study investigators who also participated in the investigator-initiated PaTH study. Final data analysis will compare the results from this trial with those from the PaTH study. In the PaTH s...
Osteoporosis
Combination of PTH and ibandronate Bone marker formation Postmenopausal Trabecular spine BMD
null
2
arm 1: Group A will receive 6 months of monthly oral ibandronate 150 mg, plus daily PTH 1-84, 1.4 mg; followed by 18 months of ibandronate only. Placebo injections will be given months 13-15. Calcium + Vitamin D supplements, plus multivitamins are provided. arm 2: Group B will receive 3 months of daily PTH 1-84, 1.4 mg...
[ 1, 1 ]
4
[ 0, 0, 10, 10 ]
intervention 1: 1.4 mg injected subcutaneously (in the abdomen) daily intervention 2: 150mg by mouth once monthly intervention 3: Daily injections as placebo for PTS 1-84 intervention 4: Monthly pills as placebo for oral ibandronate
intervention 1: PTH(1-84) intervention 2: Ibandronate intervention 3: Placebo injection intervention 4: Placebo pills
1
San Francisco | California | United States | -122.41942 | 37.77493
44
0
0
0
NCT00683163
1COMPLETED
2011-04-01
2008-05-01
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
[ 3 ]
162
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
It has been shown in previous studies that the ability to treat lung cancer could be significantly improved by not only targeting the tumor cells directly with chemotherapy, but also by cutting off the blood supply to the cancer cells. Blood vessels that supply the tumor are formed through a process called angiogenesis...
Lung cancer is the number one cause of cancer-related mortality in the United States, with an estimated 160,390 deaths in 2007. Over 80% of these patients will have non-small cell lung cancer (NSCLC), and the majority of these patients have advanced disease at the time of diagnosis. Patients with advanced disease who ...
Lung Cancer Non Small Cell Lung Cancer
Stage IIIB Non Small Cell Lung Cancer Stage IV Non Small Cell Lung Cancer Vandetanib Docetaxel plus carboplatin
null
2
arm 1: Docetaxel day 1, carboplatin day 1 + vandetanib induction days 1 through 21 (daily) of a 28-day cycle for 4 cycles. If free of disease progression after 4 cycles, vandetanib maintenance daily until progression. arm 2: Docetaxel day 1, carboplatin day 1 + vandetanib induction days 1 through 21 (daily) of a 28-day...
[ 1, 2 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: 100 mg daily by mouth intervention 2: (75mg/m2) IV (in the vein) on day 1 of a 21-day cycle for 4 cycles or until disease progression intervention 3: IV (in the vein) to area under the curve (AUC) of 6 on day 1 of a 21 day cycle, for 4 cycles or until disease progression intervention 4: None interventio...
intervention 1: vandetanib induction intervention 2: Docetaxel intervention 3: Carboplatin intervention 4: Placebo intervention 5: Vandetanib maintenance
30
Boca Raton | Florida | United States | -80.0831 | 26.35869 Lakeland | Florida | United States | -81.9498 | 28.03947 Rockford | Illinois | United States | -89.094 | 42.27113 Wichita | Kansas | United States | -97.33754 | 37.69224 New Orleans | Louisiana | United States | -90.07507 | 29.95465 Baltimore | Maryland | Unite...
215
0
0
0
NCT00687297
1COMPLETED
2011-04-01
2008-04-01
PrECOG, LLC.
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
154
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
true
1FEMALE
true
The purpose of this study is to determine the subjective response of iron substitution (Tardyferon®) on fatigue in women blood donors with a mean serum ferritin \< 30ng/ml and to assess variation of ferritin and hemoglobin after a blood donation.
* Actually, there's no recommendation to check ferritin level in blood donors, even if several studies pointed out the high prevalence of iron deficiency after a blood donation. Furthermore, some clinical trials showed that non-anaemic women with unexplained fatigue may benefit from iron supplementation. * The purpose ...
Fatigue Iron Deficiency
Fatigue Blood donation Iron deficiency Ferrous sulphate Donation Donors Iron Ferritin Hemoglobin Anemia Anaemia Haemoglobin Don Women blood donors
null
2
arm 1: None arm 2: None
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Volunteers will receive 80 mg/day oral ferrous sulphate (Tardyferon®) for four weeks. Visual analogical scales and questionnaires will be performed at day 0 and 30 to quantify fatigue (" Fatigue Severity Scale"). We will also check depression and anxiety symptoms (" Prime MD ") and health survey (" SF-1...
intervention 1: Ferrous sulphate intervention 2: Placebo
1
Lausanne | Bugnon 44 | Switzerland | 6.63282 | 46.516
145
0
0
0
NCT00689793
1COMPLETED
2011-04-01
2008-11-01
University of Lausanne
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 ]
15
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Our hypothesis is that IV or SQ Treprostinil can improve 6 minute walk distance, hemodynamics and quality of life in patients with interstitial lung disease and severe secondary pulmonary arterial hypertension.
Patients with pulmonary hypertension (PH) complicating pulmonary fibrosis are at increased risk of death. There are no therapies proven to be effective in this population, targeting the pulmonary hypertension. The purpose of this study is to evaluate parenteral treprostinil in an open-label fashion in patients with pul...
Pulmonary Arterial Hypertension Interstitial Lung Disease Idiopathic Pulmonary Fibrosis
pulmonary hypertension pulmonary fibrosis interstitial lung disease
null
1
arm 1: Patients with pulmonary fibrosis with an advanced pulmonary hypertension phenotype will be treated with parenteral treprostinil in an open-label fashion
[ 0 ]
1
[ 0 ]
intervention 1: For both SQ and IV routes, treprostinil will be started in the hospital at 1ng/kg/min and titrated up by 1ng/kg/min every 1-3 days as tolerated
intervention 1: Treprostinil
1
Los Angeles | California | United States | -118.24368 | 34.05223
15
0
0
0
NCT00705133
1COMPLETED
2011-04-01
2008-07-01
Rajan Saggar
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 ]
89
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
false
The purpose of this study is to study changes in skin color that may be caused by using one of the three eye medicines: Xalatan, Travatan or Lumigan.
One uncommon side effect of prostaglandin eye drops is a change in color of the skin around the eyes, which is reversible. There are three different brands of the medicine which are equally effective in lowering eye pressure but their likelihood of changing skin color is unknown. Qualifying patients will be randomly as...
Glaucoma Application Site Pigmentation Changes
periocular skin pigmentation Lumigan Travatan Xalatan latanoprost bimatoprost travoprost
null
3
arm 1: Patients assigned to Lumigan/bimatoprost one drop before bedtime (qhs) to affected eye(s) arm 2: Patients assigned to Xalatan/latanoprost one drop before bedtime (qhs) to affected eye(s) arm 3: Patients assigned to Travatan/travoprost one drop before bedtime (qhs) to affected eye(s)
[ 1, 1, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Xalatan/latanoprost 0.005% ophthalmic solution one drop qhs for one year intervention 2: Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year intervention 3: Travatan/travoprost 0.004% ophthalmic solution one drop qhs for one year
intervention 1: latanoprost intervention 2: bimatoprost intervention 3: travoprost
2
Arlington Heights | Illinois | United States | -87.98063 | 42.08836 Akron | Ohio | United States | -81.51901 | 41.08144
89
0
0
0
NCT00705757
1COMPLETED
2011-04-01
2008-03-01
Summa Health System
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
14
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
2MALE
true
The primary objective of this study is to test the feasibility of a large-scale clinical trial of once-daily prophylaxis. The secondary objectives are to collect clinical efficacy outcomes so that we can better plan a large-scale study; we will estimate the effect size and variability of effect and resource utilization...
Hemophilia is an important and costly disorder; if left untreated, it may have serious consequences. The greatest impact of hemophilia occurs from recurrent bleeding into joints. The consequences of joint bleeding include pain associated with acute bleeding and later chronic arthropathy. Half of affected children with ...
Hemophilia A
Hemophilia Prophylaxis Youth Young Adults Feasibility
null
1
arm 1: Low dose daily prophylaxis using FVIII products (e.g.Kogenate FS, Advate, or Humate-P, Recombinate, Helixate FS)
[ 0 ]
1
[ 0 ]
intervention 1: Starting at the 4-month visit, subjects will receive 250 units per day (if their weight is \< 50 kg.) or 500 units per day (weight ≥ 50 kg.) of their usual preparation of factor VIII.
intervention 1: Kogenate FS, Advate, or Humate-P, Recombinate, Helixate FS
3
Toronto | Ontario | Canada | -79.39864 | 43.70643 Toronto | Ontario | Canada | -79.39864 | 43.70643 Montreal | Quebec | Canada | -73.58781 | 45.50884
14
0
0
0
NCT00717626
1COMPLETED
2011-04-01
2008-07-01
The Hospital for Sick Children
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 ]
82
RANDOMIZED
PARALLEL
7BASIC_SCIENCE
4QUADRUPLE
true
0ALL
true
The main objective of the Atopic Dermatitis and Vaccinia Immunization Network (ADVN) is to reduce the risk of the fatal reaction, eczema vaccinatum (EV), to the smallpox vaccination in those with atopic dermatitis (AD). Since vaccination with live vaccinia virus (VV) in individuals with AD increases the risk of EV, a y...
AD is a chronic inflammatory skin disorder characterized by recurrent viral skin infections. The purpose of this study is to understand the immune response to a yellow fever vaccine in adults with AD. This study will provide substantial information about normal and defective cutaneous immunity in participants with AD i...
Atopic Dermatitis
Yellow Fever Vaccine Scarification Method Atopic Dermatitis IgG antibodies
null
2
arm 1: Participants will be randomized within each atopic dermatitis (AD) severity subgroup or as non-atopic controls to either subcutaneous (SC) or transcutaneous (TC) vaccine administration. In this arm, participants will receive a standard vaccine dose (5.5x10\^4 Plaque Forming Units) of YFV-17D administered subcuta...
[ 0, 0 ]
2
[ 2, 0 ]
intervention 1: None intervention 2: None
intervention 1: Live Yellow Fever Vaccine (YFV-17D) intervention 2: YFV-17D Placebo
3
San Diego | California | United States | -117.16472 | 32.71571 Denver | Colorado | United States | -104.9847 | 39.73915 Portland | Oregon | United States | -122.67621 | 45.52345
82
0
0
0
NCT00723489
1COMPLETED
2011-04-01
2008-08-01
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 ]
63
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
A Phase IIIb, Multicenter, Open-Label Study of Patients With Pulmonary Arterial Hypertension Treated With Iloprost(Inhalation)Evaluating Safety and Inhalation Times When Converting From Power Disc-6 to Power Disc-15 With the I-neb® Adaptive Aerosol Delivery® System (I-neb® AAD®)
null
Pulmonary Arterial Hypertension
pulmonary arterial hypertension inhaled therapy power disc-15
null
1
arm 1: The study enrolled patients who were already using iloprost with PD-6 without any safety or tolerability concerns, thereby facilitating a direct comparison of the PD-15 to the PD-6. The single-arm design allowed each patient to serve as his/her own control
[ 0 ]
2
[ 0, 0 ]
intervention 1: Period 1 (PD-6): study period defined as the 14 days prior to the first dose of study iloprost inhalation with PD-15. Commercial iloprost inhalation solution delivered using the Power Disc-6 with the I-neb® Adaptive Aerosol Delivery (AAD®) system administered 6 to 9 times per day intervention 2: Period ...
intervention 1: Iloprost PD-6 intervention 2: Iloprost PD-15
36
Mobile | Alabama | United States | -88.04305 | 30.69436 Phoenix | Arizona | United States | -112.07404 | 33.44838 Los Angeles | California | United States | -118.24368 | 34.05223 Los Angeles | California | United States | -118.24368 | 34.05223 Santa Barbara | California | United States | -119.69819 | 34.42083 Gainesvil...
63
0
0
0
NCT00723554
6TERMINATED
2011-04-01
2008-07-01
Actelion
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
47
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study was to evaluate the safety of Dasatininb in the treatment of scleroderma pulmonary interstitial fibrosis.
null
Scleroderma
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Tablets, Oral, 100 mg, once daily, 6 months
intervention 1: dasatinib
13
Scottsdale | Arizona | United States | -111.89903 | 33.50921 Los Angeles | California | United States | -118.24368 | 34.05223 Farmington | Connecticut | United States | -72.83204 | 41.71982 Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 Chicago | Illinois | United States | -87.65005 | 41....
31
0
0
0
NCT00764309
1COMPLETED
2011-04-01
2009-01-01
Bristol-Myers Squibb
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
113
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The investigational product, ibalizumab, is a humanized IgG4 monoclonal antibody administered via intravenous infusion at 800 mg every 2 weeks or at 2000 mg every 4 weeks. In addition to study drug, all patients will receive an optimized background regimen (OBR), which is a standard-of-care regimen selected by the inve...
The primary objectives of this study are to: * Evaluate the dose-response relationship of antiviral activity of the ibalizumab dose regimens at Week 24 in order to determine the optimal dose and regimen. The primary evaluation of effectiveness will be based on the proportion of patients achieving undetectable viral lo...
HIV
HIV CD4 experienced resistant resistance monoclonal antibody infusion ibalizumab TNX355 TNX-355 TMB355 TMB-355
null
2
arm 1: every 2 weeks, combined with an Optimized Background Regimen arm 2: every 4 weeks, combined with an Optimized Background Regimen
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: Ibalizumab 800 mg IV every 2 weeks intervention 2: Ibalizumab 2000 mg IV every 4 weeks
intervention 1: Ibalizumab intervention 2: Ibalizumab
30
Beverly Hills | California | United States | -118.40036 | 34.07362 Long Beach | California | United States | -118.18923 | 33.76696 Los Angeles | California | United States | -118.24368 | 34.05223 San Francisco | California | United States | -122.41942 | 37.77493 San Francisco | California | United States | -122.41942 |...
113
0
0
0
NCT00784147
1COMPLETED
2011-04-01
2008-08-01
TaiMed Biologics Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
-0
[ 3 ]
4
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The study is to see whether treatment with Sunitinib decreases the accumulation of ascites in patients with refractory malignant ascites.
This is a single arm, non-randomized, phase II pilot study in patients who have stopped cytotoxic and biologic therapy for their neoplasms and are suffering from malignant ascites that requires drainage for comfort. The study will employ a Simon 2-stage optimal design. Initially up to 17 patients would be enrolled. If ...
Ascites
malignant ascites
null
1
arm 1: Sunitinib (50mg PO daily x 4 wks + 2 wks rest x 3 cycles if able to tolerate tx
[ 0 ]
1
[ 0 ]
intervention 1: Patients will be given Sunitinib 50 mg orally daily for four weeks, followed by a two week holiday. For patients tolerating treatment, three cycles of treatment will be given (18 weeks total).
intervention 1: Sunitinib
1
Hershey | Pennsylvania | United States | -76.65025 | 40.28592
3
0
0
0
NCT00796861
6TERMINATED
2011-04-01
2007-05-01
Milton S. Hershey 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
[ 0 ]
251
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to evaluate if post-operative antibiotic prophylaxis decreases infectious complications when compared to pre-operative antibiotics alone, in patients undergoing elective thoracic surgery requiring tube thoracostomy (chest tube).
There is currently no evidence-based standard for the extended use of prophylactic antibiotics in patients receiving thoracic surgery that results in the placement of a tube thoracostomy (chest tube). The rationale for this prophylaxis is that antibiotics directed at typical skin flora may reduce the rate of infectious...
Antibiotic Prophylaxis
Thoracic Surgery Antibiotic Prophylaxis Chest Tube
null
2
arm 1: Participants received intravenous (IV) cefazolin or vancomycin (for participants allergic to cephalosporin) immediately following surgery for 48 hours or until all chest tubes were removed, whichever occurred first. arm 2: Participants received IV placebo-matching antibiotics immediately following surgery for 48...
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were penicillin-allergic received 1 ...
intervention 1: cefazolin or vancomycin intervention 2: Placebo
1
Boston | Massachusetts | United States | -71.05977 | 42.35843
245
0
0
0
NCT00818766
1COMPLETED
2011-04-01
2008-03-01
Brigham and Women's Hospital
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
27
RANDOMIZED
CROSSOVER
0TREATMENT
3TRIPLE
true
2MALE
false
Escitalopram (Lexapro) and citalopram (Celexa) are similar selective serotonin reuptake inhibitors that alter blood flow to the amygdala and other brain structures involved in regulating mood. Escitalopram consists of S-citalopram while citalopram contains both S-citalopram and R-citalopram (racemic citalopram). There ...
null
Antidepressant Activity in Healthy Volunteers
Citalopram Escitalopram Celexa Lexapro fMRI antidepressant healthy volunteers
null
3
arm 1: One week of escitalopram at 10 mg followed by one week at 20 mg in healthy volunteers. arm 2: One week of citalopram at 20 mg followed by one week at 40 mg in healthy volunteers. arm 3: Two weeks of placebo in healthy volunteers.
[ 1, 1, 2 ]
3
[ 0, 0, 0 ]
intervention 1: One week of escitalopram taken orally at 10 mg followed by one week at 20 mg daily. intervention 2: One week of citalopram taken orally at 20 mg followed by one week at 40 mg daily. intervention 3: Two weeks of placebo taken orally.
intervention 1: Escitalopram intervention 2: Citalopram intervention 3: Placebo
1
Boston | Massachusetts | United States | -71.05977 | 42.35843
64
0
0
0
NCT00825825
1COMPLETED
2011-04-01
2007-05-01
Michael Henry, MD
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3, 4 ]
53
RANDOMIZED
PARALLEL
null
2DOUBLE
true
0ALL
false
The purpose of this research study is to examine if a combination of a cholesterol lowering-drug, simvastatin, with a sugar-lowering drug called rosiglitazone is more effective in improving vascular inflammation (irritation of the vessels that transport your blood) and other cardiovascular risk factors than the taking ...
Age 21-75 years Metabolic syndrome (must have 3 of the 5 components) elevated waist circumference \>40inches in men, \>35 inches in women elevated triglycerides \>150mg/dL reduced HDL \<40mg/dL in men\<50 in women elevated blood pressure \>130mmHg systolic, or \>85mmHg diastolic elevated fasting glucose \>100mg/dL
Pre-diabetes
null
2
arm 1: Subjects will receive 40 mg Simvastatin + 1 tab Placebo Rosiglitazone daily arm 2: Subjects will receive 40 mg Simvastatin + 4 mg Rosiglitazone once daily
[ 1, 1 ]
3
[ 0, 0, 0 ]
intervention 1: 4 mg daily intervention 2: 1 tab daily intervention 3: 40 mg daily
intervention 1: Rosiglitazone intervention 2: Placebo Rosiglitazone intervention 3: Simvastatin
1
Chicago | Illinois | United States | -87.65005 | 41.85003
43
0
0
0
NCT00831129
1COMPLETED
2011-04-01
2006-09-01
University of Chicago
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0