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 ]
158
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
true
0ALL
false
The primary objective is to compare the effectiveness and tolerance of the medication named lubiprostone plus a large volume liquid laxative versus placebo which is a look alike medication that has no effect such as a sugar pill plus a large volume liquid laxative as a bowel cleaning preparation for colonoscopy to see ...
The study is a double blind placebo controlled study of lubiprostone in 4 doses vs look alike placebo in 4 doses before bowel preparation for outpatient screening, surveillance and diagnostic colonoscopy. Patients with severe underlying medical conditions were excluded. Patients with inflammatory bowel disease, frequen...
Colonoscopy
Routine screening colonoscopy Colonoscopy Preparation Amitiza GoLYTELY Pegylated Electrolytes Preparation Solution Colonoscopy Solution
null
2
arm 1: First dose of lubiprostone 24 micrograms or placebo was administered 2 nights before colonoscopy and subsequent doses at breakfast, lunch, and dinner on the day before the procedure. Patients were on a clear liquid diet on the day before the procedure and were instructed to initiate drinking PEG (immediately aft...
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: 24 mcg administered 4 times over the two days before the colonoscopy. 96 mcg total intervention 2: Amitiza Placebo
intervention 1: lubiprostone (Amitiza) intervention 2: Placebo
3
Detroit | Michigan | United States | -83.04575 | 42.33143 Novi | Michigan | United States | -83.47549 | 42.48059 West Bloomfield | Michigan | United States | -83.38356 | 42.56891
123
0
0
0
NCT00645801
1COMPLETED
2011-07-01
2008-03-01
Henry Ford 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 ]
23
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
Pemphigus is a severe autoimmune blistering disease mediated by circulating antibodies against certain proteins important for maintaining skin integrity. Protein A immunoadsorption is a dialysis-like technique selectively removing the antibodies from patient's blood. Rituximab is a synthetic antibody capable of destroy...
null
Pemphigus
pemphigus rituximab immunoadsorption dexamethasone treatment management
null
1
arm 1: None
[ 5 ]
1
[ 0 ]
intervention 1: Protein A Immunoadsorption: performed on 3 consecutive days every 3 weeks Rituximab: 1000 mg i.v. given twice at a 2-week interval Dexamethasone pulse therapy: 100 mg i.v. given on 3 consecutive days every 3 weeks Azathioprine: 2.5 mg/kg body weight daily p.o.
intervention 1: Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine
1
Lübeck | Schleswig-Holstein | Germany | 10.68729 | 53.86893
23
0
0
0
NCT00656656
1COMPLETED
2011-07-01
2008-01-01
University of Luebeck
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 ]
95
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
2MALE
true
This randomized, double-blind phase II trial is to assess the efficacy and safety of bicalutamide (Casodex® ) associated to ZD6474 (Zactima™ ) or to placebo in patients with castration-refractory metastatic prostate cancer without any clinical symptom related to disease progression. The study is blinded, and subjects w...
null
Prostate Cancer
null
2
arm 1: Bicalutamide 150mg + ZD6474 300mg arm 2: Bicalutamide 150mg + placebo
[ 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: 300mg orally, once daily intervention 2: 150mg orally, once daily intervention 3: orally, once daily
intervention 1: ZD6474 (Vandetanib) intervention 2: Bicalutamide intervention 3: Placebo
5
Bordeaux | N/A | France | -0.5805 | 44.84044 Créteil | N/A | France | 2.46569 | 48.79266 Paris | N/A | France | 2.3488 | 48.85341 Reims | N/A | France | 4.02853 | 49.26526 Villejuif | N/A | France | 2.35992 | 48.7939
95
0
0
0
NCT00659438
1COMPLETED
2011-07-01
2008-02-01
Genzyme, a Sanofi Company
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
50
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This study assessed the efficacy and safety of Avastin in combination with docetaxel and cisplatin as first-line treatment of patients with metastatic or locally advanced non-small cell lung cancer. Patients received Avastin 15 mg/kg intravenously (IV), docetaxel 75 mg/m\^2, and cisplatin 75 mg/m\^2 on Day 1 of each 3-...
null
Non-small Cell Lung Cancer
null
1
arm 1: Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m\^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease ...
[ 0 ]
3
[ 0, 0, 0 ]
intervention 1: Bevacizumab was supplied as a sterile liquid in glass vials. intervention 2: Bevacizumab was supplied as a sterile liquid in glass vials. intervention 3: Bevacizumab was supplied as a sterile liquid in glass vials.
intervention 1: Bevacizumab intervention 2: Cisplatin intervention 3: Docetaxel
14
Palma de Mallorca | Balearic Islands | Spain | 2.65024 | 39.56939 Cadiz | Cadiz | Spain | -6.2891 | 36.52672 Castellon | Castellon | Spain | -0.04935 | 39.98567 Donostia / San Sebastian | Guipuzcoa | Spain | -1.97499 | 43.31283 Alcalá de Henares | Madrid | Spain | -3.35996 | 40.48205 Madrid | Madrid | Spain | -3.70256 ...
49
0
0
0
NCT00661778
1COMPLETED
2011-07-01
2007-07-01
Hoffmann-La Roche
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
25
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
true
0ALL
false
This research is being done to study how the immune system in the small intestine improves after taking antiretroviral (anti-HIV) medications. The main purpose is to measure the increase in the numbers of immune cells in the intestine to see if one type of HIV medication gives different results than other types of HIV ...
While the world-wide AIDS epidemic continues to impact millions of individuals, effective anti-HIV medications have substantially reduced morbidity and mortality for those patients able to adhere to combination regimens. Despite improved survival, durable virologic suppression, and increases in peripheral CD4+T-cell co...
HIV Infections AIDS
HIV Positive AIDS Antiretroviral Therapy Gastrointestinal-Associated Lymphoid Tissue Immune Reconstitution treatment experienced
null
3
arm 1: HIV Negative volunteers arm 2: HIV-Positive volunteers taking raltegravir in combination with two other nucleoside reverse transcriptase inhibitors (NRTI) medications arm 3: HIV-Positive volunteers taking efavirenz or any other non-nucleoside reverse transcriptase inhibitors (NNRTI) in combination with two other...
[ 4, 1, 1 ]
2
[ 0, 0 ]
intervention 1: 400mg tablet twice daily by mouth for nine months intervention 2: 600mg capsule once daily by mouth without regard to food
intervention 1: raltegravir intervention 2: efavirenz
2
Sacramento | California | United States | -121.4944 | 38.58157 Sacramento | California | United States | -121.4944 | 38.58157
25
0
0
0
NCT00661960
1COMPLETED
2011-07-01
2008-03-01
University of California, Davis
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
42
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
Background: In order to survive, brain tumors must have a network of blood vessels to supply it with oxygen and nutrients. The tumors produce substances that enable new blood vessels to form. Tandutinib and Bevacizumab are experimental drugs that may prevent new blood vessel formation and thereby slow or stop tumor g...
Background Bevacizumab is a monoclonal antibody directed against vascular- endothelial growth factor (VEGF), the major angiogenesis factor involved in high-grade glioma-mediated angiogenesis. Preclinical studies in our laboratory and others have shown potent antiglioma activity in vivo and early clinical trials of bev...
Glioblastoma Gliosarcoma Anaplastic Astrocytoma Anaplastic Oligodendroglioma Anaplastic Mixed Oligoastrocytoma
Brain Tumor Chemotherapy Radiation Anti-Angiogenesis Glioblastoma Glioma
null
2
arm 1: GBM (glioblastoma multiforme) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks. arm 2: AG (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, and malignant astrocytoma NOS (not otherwise specified)) Tandutin...
[ 0, 0 ]
3
[ 2, 0, 3 ]
intervention 1: Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks. intervention 2: Tandutinib 500 mg by mouth daily dose twice a day. intervention 3: Forty-five one-sentence questionnaire to assess health related quality of life in patients with brain cancer.
intervention 1: Bevacizumab intervention 2: MLN-518 (Tandutinib) intervention 3: Quality-of-life assessment
1
Bethesda | Maryland | United States | -77.10026 | 38.98067
42
0
0
0
NCT00667394
1COMPLETED
2011-07-01
2008-04-01
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
[ 3 ]
30
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This phase II trial studies how well cilengitide works in treating younger patients with recurrent or progressive high-grade glioma that has not responded to standard therapy. Cilengitide may stop the growth of tumor cells by blocking blood flow to the tumor.
PRIMARY OBJECTIVES: I. To determine the objective response rate to cilengitide in younger patients with recurrent or progressive high-grade glioma that is refractory to standard therapy. SECONDARY OBJECTIVES: I. To estimate the distribution of time to progression, time to treatment failure, and time to death in thes...
Childhood High-grade Cerebellar Astrocytoma Childhood High-grade Cerebral Astrocytoma Recurrent Childhood Anaplastic Astrocytoma Recurrent Childhood Anaplastic Oligoastrocytoma Recurrent Childhood Anaplastic Oligodendroglioma Recurrent Childhood Brain Tumor Recurrent Childhood Cerebellar Astrocytoma Recurrent Childhood...
null
1
arm 1: Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
[ 0 ]
3
[ 0, 10, 10 ]
intervention 1: Given IV intervention 2: Correlative studies intervention 3: Correlative studies
intervention 1: cilengitide intervention 2: laboratory biomarker analysis intervention 3: pharmacological study
20
Oakland | California | United States | -122.2708 | 37.80437 San Francisco | California | United States | -122.41942 | 37.77493 Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 Chicago | Illinois | United States | -87.65005 | 41.85003 Boston | Massachusetts | United States | -71.05977 | 42.3...
29
0
0
0
NCT00679354
1COMPLETED
2011-07-01
2008-06-01
National Cancer Institute (NCI)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
13
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of this study is to determine whether abatacept at a dose 30 mg/kg via intravenous infusion is safe and well tolerated in the treatment of lupus nephritis in mainland Chinese subjects with systemic lupus erythematosus (SLE)
null
Lupus Nephritis
null
3
arm 1: None arm 2: None arm 3: Open-label long-term extension phase
[ 2, 1, 5 ]
3
[ 0, 0, 0 ]
intervention 1: Infusion, Intravenous, single dose, Day 1 intervention 2: Infusion, Intravenous, 30mg/kg, single dose, Day 1 intervention 3: Infusion, intravenous, 10 mg/kg, administered on Days 15 and 29 followed by doses every 4 weeks until the end of the study
intervention 1: Placebo intervention 2: Abatacept intervention 3: Abatacept
1
Shanghai | Shanghai Municipality | China | 121.45806 | 31.22222
9
0
0
0
NCT00705367
1COMPLETED
2011-07-01
2008-08-01
Bristol-Myers Squibb
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
57
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
The purpose of this study is to explore the impact of vitamin D3 on the expression of alpha interferon (IFN alpha) expression in systemic lupus erythematosus (SLE) patients with vitamin D deficiency.
Systemic Lupus Erythematosus (SLE) is an autoimmune disease characterized by the production of autoantibodies with subsequent immune complex deposition and tissue inflammation. The role of interferon (IFN) alpha in the development of SLE has been repeatedly documented. Vitamin D deficiency is common among lupus patient...
Systemic Lupus Erythematosus SLE Lupus
Systemic lupus erythematosus SLE Vitamin D3 Vitamin D deficiency IFN alpha expression
null
3
arm 1: Participants in this arm take a vitamin D3 dose of 2000 international units (IU) daily by mouth for a duration of 12 weeks. arm 2: Participants in this arm take a vitamin D3 dose of 4000 international units (IU) daily by mouth for a duration of 12 weeks. arm 3: Participants in this arm take a vitamin D3 placebo ...
[ 0, 0, 2 ]
2
[ 0, 0 ]
intervention 1: 8% vitamin D3 powder, 84% microcrystalline cellulose, 8% fumed silica by weight intervention 2: 86% microcrystalline cellulose, 14% fumed silica by weight
intervention 1: Vitamin D3 intervention 2: Vitamin D3 placebo
8
Birmingham | Alabama | United States | -86.80249 | 33.52066 San Francisco | California | United States | -122.41942 | 37.77493 Boston | Massachusetts | United States | -71.05977 | 42.35843 Manhassett | New York | United States | N/A | N/A Rochester | New York | United States | -77.61556 | 43.15478 Durham | North Caroli...
54
0
0
0
NCT00710021
1COMPLETED
2011-07-01
2008-11-01
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 ]
87
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
This 2 arm study will compare the efficacy and safety of switching to CellCept combined with different regimens of reduced calcineurin inhibitors (CNI) in patients with liver transplants. Patients currently receiving CNI treatment will be randomized into one of 2 groups to receive either 1) CellCept 2.0g/day po bid + 5...
null
Liver Transplantation
null
2
arm 1: Participants received mycophenolate mofetil (MMF), 1.5 to 2.0 grams (g) daily, orally (PO), twice per day (BID) from baseline (BL) to Week 52. Participants also received a 50 percent (%) reduced dose of calcineurin inhibitor (CNI) from BL to Week 52. arm 2: Participants received MMF, 1.5 to 2.0 g daily, PO, BID ...
[ 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: 1.5 to 2.0 g daily PO BID intervention 2: 50% reduction from BL intervention 3: ≥75% reduction from BL
intervention 1: Mycophenolate mofetil intervention 2: CNI (50%) intervention 3: CNI (≥75%)
11
Beijing | N/A | China | 116.39723 | 39.9075 Beijing | N/A | China | 116.39723 | 39.9075 Changsha | N/A | China | 112.97087 | 28.19874 Chengdu | N/A | China | 104.06667 | 30.66667 Chongqing | N/A | China | 106.55771 | 29.56026 Guangzhou | N/A | China | 113.25 | 23.11667 Jiangsu | N/A | China | N/A | N/A Shanghai | N/A |...
83
0
0
0
NCT00717314
1COMPLETED
2011-07-01
2008-05-01
Hoffmann-La Roche
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
14
RANDOMIZED
CROSSOVER
0TREATMENT
4QUADRUPLE
false
0ALL
true
The purpose of this study is to determine whether eculizumab is safe and effective in the treatment of patients with generalized myasthenia gravis despite treatment with various immunosuppressants, such as prednisone, methotrexate, Cellcept, cyclosporine, and cyclophosphamide, that are currently available.
null
Myasthenia Gravis
null
2
arm 1: eculizumab arm 2: Placebo
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses intervention 2: Placebo IV weekly for 4 doses then every two weeks for 7 doses
intervention 1: eculizumab intervention 2: Placebo
25
Birmingham | Alabama | United States | -86.80249 | 33.52066 Orange | California | United States | -117.85311 | 33.78779 Sacramento | California | United States | -121.4944 | 38.58157 Jacksonville | Florida | United States | -81.65565 | 30.33218 Atlanta | Georgia | United States | -84.38798 | 33.749 Indianapolis | India...
26
0
0
0
NCT00727194
6TERMINATED
2011-07-01
2008-10-01
Alexion Pharmaceuticals, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
101
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
The hope of this study is to gather data and information about the tolerability and effectiveness of Lexiva versus Sustiva in patients who have have been generally underrepresented in clinical trials.
The objective of this study is to gain tolerability and efficacy data for Norvir-boosted Lexiva versus Sustiva, both used in combination with Epzicom, as components of a first-line, once daily regimen for the treatment of HIV-1 infection in a patient population that is underrepresented in US clinical research.
Human Immunodeficiency Virus Infections
null
2
arm 1: Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg). arm 2: QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg) The intervention may be switched for the following reasons: * To resolve a Grade 3 or 4 Adverse Event * The subject experienced a virologic failure (as defined in section 3.6.2) * The investigator believes the sub...
intervention 1: Efavirenz 600mg intervention 2: Boosted Lexiva
1
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
101
0
0
0
NCT00727597
1COMPLETED
2011-07-01
2008-07-01
Georgetown 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
true
Obsessive-compulsive disorder (OCD) is a common psychiatric illness that affects up to 2-3% of the population. People with OCD experience anxiety-provoking, intrusive thoughts, known as obsessions, and feel compelled to perform repetitive behaviors, or compulsions. The only medications proven effective for OCD are sero...
null
Obsessive Compulsive Disorder
OCD
null
1
arm 1: Minocycline (NPL-2003)
[ 0 ]
1
[ 0 ]
intervention 1: Minocycline (NPL-2003) daily for 12 weeks
intervention 1: NPL-2003
1
New York | New York | United States | -74.00597 | 40.71427
9
0
0
0
NCT00728923
1COMPLETED
2011-07-01
2008-08-01
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
[ 4 ]
48
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
true
0ALL
false
This study involves research. Pregabalin is a Food and Drug Administration (FDA) medication approved in the United States for the treatment of nerve pain related to diabetes and post-herpetic neuralgia "shingles", and for seizures in adults. The purpose of this research is to study the effect of oral Pregabalin on spin...
Gabapentin and the related more potent compound pregabalin have been shown to reduce postoperative pain in animal models (1). Pregabalin given before and after surgery reduced opioid use following spinal fusion surgery (2). Studies have identified the alpha 2 delta auxiliary subunit of voltage-gated calcium channels as...
PAIN
Pregabalin CSF Neurotransmitter
null
3
arm 1: Group 1 (n=16, multi-dose pregabalin): patients receive pregabalin 150 mg orally 1 hour prior to surgery and then repeat 150 mg doses at 12 and 24 hours after initial dose. arm 2: Group 2 (n=16, single dose pregabalin): patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses at ...
[ 0, 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Group 1 (n=16, multi-dose pregabalin): patients receive pregabalin 150 mg orally 1 hour prior to surgery and then repeat 150 mg doses at 12 and 24 hours after initial dose. Group 2 (n=16, single dose pregabalin): patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses ...
intervention 1: Pregabalin intervention 2: Pregabalin intervention 3: Placebo
1
Chicago | Illinois | United States | -87.65005 | 41.85003
48
0
0
0
NCT00729690
1COMPLETED
2011-07-01
2008-08-01
Asokumar Buvanendran
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 ]
94
RANDOMIZED
FACTORIAL
null
4QUADRUPLE
true
2MALE
false
This study will explore the hypothesis that effects of alcohol are in part mediated by increased production of neuroactive steroids, which interact with GABAA-receptors. We propose to study non-dependent drinkers using a 4-session within-subjects design in which alcohol / placebo is paired with dutasteride / placebo pr...
Alcohol has multiple pharmacological effects, though which of these effects relate to the risk of alcohol dependence is not clear. Animal studies indicate that the neuroactive steroid allopregnanolone is an alcohol-modulated endogenous agonist at GABAA receptors and that genetic variation in steroid 5a-reductase type I...
Alcohol Related Disorders Alcoholism Alcohol Abuse
steroid 5Alpha Reductase dutasteride neuroactive steroid
null
4
arm 1: None arm 2: None arm 3: None arm 4: None
[ 2, 0, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 4 mg dutasteride administered 2-4 days prior to ingestion of 0.8 mg/kg ethanol divided between three drinks consumed over 36 minutes intervention 2: placebo medication administered 2-4 days prior to ingestion of 0.8 gr/kg ethanol divided between three drinks consumed over 36 minutes intervention 3: 4 mg...
intervention 1: dutasteride + ethanol intervention 2: placebo medication + ethanol intervention 3: dutasteride + placebo alcohol intervention 4: placebo medication + placebo alcohol
1
Farmington | Connecticut | United States | -72.83204 | 41.71982
320
0
0
0
NCT00734656
1COMPLETED
2011-07-01
2007-03-01
UConn 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
[ 0 ]
32
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
true
0ALL
false
The overall goal of the present project is to investigate whether lisdexamphetamine (LDX; Vyvanse) is an effective adjunct to nicotine replacement therapy (NRT) to promote smoking cessation in patients with comorbid Attention Deficit Hyperactivity Disorder (ADHD) and nicotine dependence. The investigators hypothesized ...
This will be a 2-group, parallel, placebo-controlled, double blind study. Regular, nicotine dependent individuals with ADHD will receive NRT pretreatment for 2 weeks prior to an identified quit date.At the quit date, subjects will be randomized into one of two groups. * The first group will begin treatment for 1 week ...
Attention Deficit Hyperactivity Disorder Nicotine Dependence
ADHD Smoking
null
2
arm 1: The first group will receive LDX/SPD489 titrated up to 70 mg qd for 4 weeks after the identified quit date. Subjects will continue to receive NRT 21 mg at week 1 post quit date, then 14mg at week 2 post quit date and 7 at weeks 3 and 4 post quit date. arm 2: The second group will receive matching placebo and NRT...
[ 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: All subjects will lreceive transdermal nicotine patch during beginning at Visit 0 (quit smoke date). The dose will be tapered down from 21 mg to 14mg after week 1,vthen to 7 mg after week 2. Subjects will remain at 7mg until the 4th week. intervention 2: Subjects on this arm will receive Lis-dexamphetam...
intervention 1: Transdermal Nicotine Patch intervention 2: Lis-dexamphetamine (Vyvanse) intervention 3: Placebo
1
Durham | North Carolina | United States | -78.89862 | 35.99403
32
0
0
0
NCT00736255
1COMPLETED
2011-07-01
2007-12-01
Duke University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
46
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to determine whether raltegravir 400 mg b.i.d. in a boosted PI regimen is as efficacious and safe as the NRTI backbone in a boosted PI regimen.
null
Virus Diseases HIV
Safety
null
2
arm 1: Group 1 Raltegravir 400 mg PO b.i.d. + their current boosted PI regimen Subjects in this study are HIV-Infected Patients who are on a stable boosted PI regimen; in this group are assigned to switched from their NRTIs as a Backbone to Raltegravir arm 2: Group 2 Continue the same regimen without change
[ 0, 4 ]
1
[ 0 ]
intervention 1: This is a multicenter, pilot randomized, controlled study to evaluate the safety and efficacy of raltegravir in patients switched from a stable boosted PI-based regimen with a NRTI backbone to raltegravir instead of their current NRTIs. A stable boosted PI-based regimen is defined as having a documented...
intervention 1: Switch NRTIs as a Backbone to Raltegravir
1
Tampa | Florida | United States | -82.45843 | 27.94752
46
0
0
0
NCT00749580
1COMPLETED
2011-07-01
2008-11-01
University of South Florida
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
1,681
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This open-label, single arm study will investigate the safety, tolerability and efficacy of tocilizumab monotherapy, or combination therapy with non-biologic disease modifying antirheumatic drugs (DMARDs), in patients with severe active RA. Patients will receive tocilizumab 8mg/kg iv as a 60 minute infusion every 4 wee...
null
Rheumatoid Arthritis
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: 8mg/kg iv (60 minute infusion)
intervention 1: tocilizumab [RoActemra/Actemra]
282
Canberra | Australian Capital Territory | Australia | 149.12807 | -35.28346 Coffs Harbour | New South Wales | Australia | 153.11351 | -30.29626 Kogarah | New South Wales | Australia | 151.13564 | -33.9681 Parramatta Park | New South Wales | Australia | N/A | N/A Adelaide | South Australia | Australia | 138.59863 | -34....
1,681
0
0
0
NCT00750880
1COMPLETED
2011-07-01
2008-09-01
Hoffmann-La Roche
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
515
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
The primary objective was to demonstrate the superiority of insulin glargine over sitagliptin in reducing Glycosylated Hemoglobin A1c (HbA1c) from baseline to the end of the treatment period. Secondary objective was to assess the effect of insulin glargine in comparison with sitagliptin on: * HbA1c level * Fasting Pl...
null
Diabetes Mellitus, Type 2
null
2
arm 1: Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL\<FPG≤100mg/dL (3.9mmol/L\<FPG≤5.5mmol/L). arm 2: Dose of 100 mg once a day administered with or without...
[ 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Subcutaneous injection. 100 Units/mL solution for injection in a pre-filled SoloStar® pen (3 mL). intervention 2: Oral administration. 100 mg film-coated tablets. intervention 3: Patients continued with metformin as usual oral anti-diabetic treatment.
intervention 1: Insulin Glargine intervention 2: Sitagliptin intervention 3: Metformin
17
Bridgewater | New Jersey | United States | -74.64815 | 40.60079 Vienna | N/A | Austria | 16.37208 | 48.20849 São Paulo | N/A | Brazil | -46.63611 | -23.5475 Bogotá | N/A | Colombia | -74.08175 | 4.60971 Cairo | N/A | Egypt | 31.24967 | 30.06263 Kallithea | N/A | Greece | 23.7 | 37.95 Hong Kong | N/A | Hong Kong | 114.1...
501
0
0
0
NCT00751114
1COMPLETED
2011-07-01
2008-11-01
Sanofi
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
44
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The primary objective of this study is to prescribe oral domperidone for patients with gastroparesis who have failed or suffered adverse effects from standard medical therapy.
null
Gastroparesis
null
1
arm 1: None
[ 5 ]
1
[ 0 ]
intervention 1: 10 mg 4 times daily 20 mg 4 times daily 30 mg 4 times daily
intervention 1: Domperidone
1
New Haven | Connecticut | United States | -72.92816 | 41.30815
44
0
0
0
NCT00760461
6TERMINATED
2011-07-01
2008-10-01
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 ]
8
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Kaletra (a combination drug with lopinavir and ritonavir) is one of a few effective medications that are approved and available for young children who are HIV+. The liquid form is reported to have a very nasty taste and presents difficulties for the children who must take the medication twice a day and for their parent...
null
HIV Infections
HIV Kaletra treatment Experienced
null
1
arm 1: Patients will serve as their own controls as they are switched from the baseline treatment with liquid Kaletra to the study intervention treatment with Low Dose Tablet Kaletra (100mg/25mg)
[ 0 ]
1
[ 0 ]
intervention 1: Lopinavir/Ritonavir tablets 100mg/25mg
intervention 1: Low dose Kaletra tablets
1
Phoenix | Arizona | United States | -112.07404 | 33.44838
8
0
0
0
NCT00762320
1COMPLETED
2011-07-01
2008-10-01
Phoenix Children's Hospital
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
501
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
1FEMALE
true
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about differences in DNA and predict how well patients will respond to treatment and plan better treatment. PURPOSE: This clinical trial is studying blood samples from women with breast cancer or ductal carcino...
OBJECTIVES: Primary * To evaluate the change in endoxifen levels after an increase in tamoxifen citrate dose from 20 mg to 40 mg in women with breast cancer or ductal breast carcinoma in situ with intermediate-metabolizing CYP2D6 genotypes. Secondary * To evaluate the tolerability of increasing the dose of tamoxife...
Breast Cancer Menopausal Symptoms
menopausal symptoms recurrent breast cancer stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer ductal breast carcinoma in situ breast cancer in situ
null
2
arm 1: One arm, containing the ultra-rapid and extensive metabolizer genotypes, continues treatment with tamoxifen at 20mg. arm 2: This arm, containing the intermediate and poor metabolizer genotypes, receives escalated treatment with tamoxifen at 40mg.
[ 0, 1 ]
5
[ 0, 6, 10, 10, 3 ]
intervention 1: Women found to be IM or PM will undergo increased tamoxifen to 40 mg/day (20 mg bid). Drug is given orally on a daily basis. intervention 2: Genetic analysis of blood sample. intervention 3: Genetic analysis of blood sample. intervention 4: Questionnaire called the survey of participants. Questionnaires...
intervention 1: tamoxifen citrate intervention 2: gene expression analysis intervention 3: pharmacogenomic studies intervention 4: questionnaire administration intervention 5: quality-of-life assessment
7
Chapel Hill | North Carolina | United States | -79.05584 | 35.9132 Charlotte | North Carolina | United States | -80.84313 | 35.22709 Durham | North Carolina | United States | -78.89862 | 35.99403 Greensboro | North Carolina | United States | -79.79198 | 36.07264 Greenville | North Carolina | United States | -77.36635 |...
480
0
0
0
NCT00764322
1COMPLETED
2011-07-01
2008-06-18
UNC Lineberger Comprehensive Cancer Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
10
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Part I evaluates the safety, tolerability and pharmacokinetics (PK) of vorinostat in Japanese patients with relapsed or refractory CTCL. Part II evaluates the safety of vorinostat in Japanese pts. with relapsed or refractory CTCL. Relapsed or refractory CTCL patients will be newly enrolled in Part II.
null
Lymphoma
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Parts I \& II: Vorinostat (400 mg) Oral, daily (QD). Treatment period is 28 days per cycle.
intervention 1: vorinostat
0
null
10
0
0
0
NCT00771472
1COMPLETED
2011-07-01
2008-08-01
Merck Sharp & Dohme LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
459
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
The trial is a randomised, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of 5 µg tiotropium over a 48-week treatment period as compared to placebo. Tiotropium inhalation solution delivered by the Respimat® inhaler will be examined as add-on controller therapy on top of usual...
null
Asthma
null
2
arm 1: patient to receive double-blind treatment with either 5mcg/day tiotropium inhalation solution or placebo inhalation solution arm 2: patient to receive double-blind treatment with either 5mcg/day tiotropium inhalation solution or placebo inhalation solution
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Intervention = randomisation: Patient to receive double-blind treatment with either 5mcg/day tiotropium inhalation solution or placebo intervention 2: Matching placebo
intervention 1: tiotropium 5mcg/day intervention 2: placebo
73
Birmingham | Alabama | United States | -86.80249 | 33.52066 Los Angeles | California | United States | -118.24368 | 34.05223 Los Angeles | California | United States | -118.24368 | 34.05223 Riverside | California | United States | -117.39616 | 33.95335 San Diego | California | United States | -117.16472 | 32.71571 Waln...
459
0
0
0
NCT00772538
1COMPLETED
2011-07-01
2008-10-01
Boehringer Ingelheim
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
148
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This study will evaluate the effect of treprostinil diethanolamine (UT-15C) sustained release tablets(compared to placebo) on digital ulcers in patients with scleroderma. Treprostinil diethanolamine is an analog of prostacyclin. Prostacyclin is a naturally occuring substance produced by the cells of blood vessels that ...
null
Systemic Sclerosis Scleroderma
Scleroderma, Diffuse Scleroderma, Limited Scleroderma, Systemic Ulcer prostacyclin
null
2
arm 1: Treprostinil diethanolamine sustained release tablet initiated at 0.25 mg BID and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose. arm 2: Matching placebo sustained release tablet initiated at 0.25 mg BID and titrated up to a maximum dose of 16 mg BID or the individual's max...
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: oral sustained release tablet. Maximum tolerable dose not exceeding 16 mg twice daily (BID) intervention 2: None
intervention 1: treprostinil diethanolamine intervention 2: placebo
30
Birmingham | Alabama | United States | -86.80249 | 33.52066 Scottsdale | Arizona | United States | -111.89903 | 33.50921 Los Angeles | California | United States | -118.24368 | 34.05223 Palo Alto | California | United States | -122.14302 | 37.44188 Aurora | Colorado | United States | -104.83192 | 39.72943 Farmington | ...
147
0
0
0
NCT00775463
1COMPLETED
2011-07-01
2009-05-01
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
[ 4 ]
453
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
The trial is a randomised, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of 5 µg tiotropium over a 48-week treatment period as compared to placebo. Tiotropium inhalation solution delivered by the Respimat® inhaler will be examined as add-on controller therapy on top of usual...
null
Asthma
null
2
arm 1: patient to receive double-blind treatment with either 5mcg/day tiotropium inhalation solution or placebo inhalation solution arm 2: patient to receive double-blind treatment with either 5mcg/day tiotropium inhalation solution or placebo inhalation solution
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Intervention = Randomisation: patient to receive double-blind treatment with either 5mcg/day tiotropium inhalation solution or placebo inhalation solution intervention 2: Intervention = Randomisation: patient to receive double-blind treatment with either 5mcg/day tiotropium inhalation solution or placeb...
intervention 1: tiotropium 5mcg/day intervention 2: placebo
75
Fountain Valley | California | United States | -117.95367 | 33.70918 Fresno | California | United States | -119.77237 | 36.74773 Stockton | California | United States | -121.29078 | 37.9577 Waterbury | Connecticut | United States | -73.0515 | 41.55815 Pensacola | Florida | United States | -87.21691 | 30.42131 Chicago |...
453
0
0
0
NCT00776984
1COMPLETED
2011-07-01
2008-10-01
Boehringer Ingelheim
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
148
RANDOMIZED
PARALLEL
1PREVENTION
4QUADRUPLE
false
0ALL
true
The purpose of this study is to determine the ability of 3 commercially available phosphorus binders (calcium acetate, sevelamer carbonate, and lanthanum carbonate) to achieve and maintain a phosphorus level in the normal range in patients with chronic kidney disease.
It is the specific aim of this pilot study to assess the feasibility of achieving and maintaining a serum P less than or equal to 3.5 mg/dL (1.13 mmol/L) in patients with eGFR \>20 and \<45 mL/min with any of the 3 commercially available P lowering agents (calcium acetate, sevelamer carbonate, or lanthanum carbonate). ...
Chronic Kidney Disease
phosphorus secondary hyperparathyroidism vascular calcification
null
4
arm 1: 667 mg with meals arm 2: 500 mg with meals arm 3: 800 mg with meals arm 4: with meals
[ 1, 1, 1, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: None intervention 4: None
intervention 1: Calcium acetate intervention 2: Lanthanum Carbonate intervention 3: Sevelamer Carbonate intervention 4: Placebo
1
Denver | Colorado | United States | -104.9847 | 39.73915
145
0
0
0
NCT00785629
1COMPLETED
2011-07-01
2009-02-01
Denver Nephrologists, P.C.
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
240
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe as compared with quetiapine XR long term among schizophrenic outpatients with chronic schizophrenia.
null
Chronic Schizophrenia
Schizophrenia SM-13496 Latuda Lurasidone
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Lurasidone 40-160 mg/day flexibly dosed. intervention 2: Quetiapine XR 200-800 mg/day flexibly dosed.
intervention 1: Lurasidone HC1 intervention 2: Quetiapine XR
65
Little Rock | Arkansas | United States | -92.28959 | 34.74648 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Cerritos | California | United States | -118.06479 | 33.85835 Costa Mesa | California | United States | -117.91867 | 33.64113 Escondido | California | United States | -117.08642 | 33.11921 Garden ...
292
0
0
0
NCT00789698
1COMPLETED
2011-07-01
2008-12-01
Sumitomo Pharma America, 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 ]
32
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
This trial will test the hypothesis that CF102 can safely and effectively suppress viral load in patients with chronic hepatitis C and high circulating levels of virus. The trial will monitor the safety of twice-daily oral dosing with CF102 over a 16-week period; will measure changes in viral load during therapy; and w...
This is a Phase 1/2, randomized, double-blind, placebo-controlled, dose-escalation study of subjects with chronic hepatitis C genotype 1. Eligible subjects will be assigned in a 3:1 ratio (8 subjects in each cohort) to receive qd or bid treatment for 15 days with oral CF-102 or with placebo. Dose escalation will occur ...
Chronic Hepatitis C
Hepatitis C Viral hepatitis
null
4
arm 1: CF102 1 mg qd arm 2: CF102 1 mg bid arm 3: CF102 1 mg bid; 16 weeks arm 4: None
[ 0, 0, 0, 2 ]
2
[ 0, 0 ]
intervention 1: Oral capsules intervention 2: Matching placebo capsules
intervention 1: CF 102 intervention 2: Placebo
1
Tel Aviv | N/A | Israel | 34.78057 | 32.08088
32
0
0
0
NCT00790673
1COMPLETED
2011-07-01
2009-07-01
Can-Fite BioPharma
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
16
RANDOMIZED
CROSSOVER
0TREATMENT
4QUADRUPLE
false
0ALL
true
N-methyl-D-aspartate (NMDA)-type glutamate receptors are thought to play a pivotal role in neurocognitive dysfunction associated with schizophrenia. Further, several novel glutamate-based classes of compound are presently in development as potential novel treatments for persistent negative and cognitive symptoms. The s...
16 in- or outpatients with DSM-IV-TR schizophrenia or schizoaffective disorder and prominent negative symptoms will be recruited for this study. This study will consist of a randomized trial of D-serine (60 mg/kg/d) vs. placebo using a crossover design with a 2-week baseline lead-in, and two 6-week intervention arms se...
Schizophrenia Schizoaffective Disorder
biomarker EEG schizophrenia NMDA D-serine
null
2
arm 1: 60 mg/kg/day arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 60 mg/kg/day intervention 2: oral
intervention 1: D Serine intervention 2: Placebo
1
Orangeburg | New York | United States | -73.94958 | 41.04649
16
0
0
0
NCT00817336
1COMPLETED
2011-07-01
2009-06-01
Nathan Kline Institute for Psychiatric Research
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
32
RANDOMIZED
CROSSOVER
5SCREENING
0NONE
true
0ALL
true
This study will measure the percentage of platelet aggregation inhibition with a loading dose of clopidogrel (300 mg) using the VerifyNow Assay System in healthy volunteers who have drank 11 oz of grapefruit juice. It will also measure the percentage of platelet aggregation inhibition with a maintenance dose of clopido...
This study will examine the effect of GFJ on the loading dose (300 mg) of clopidogrel and will evaluate the effect of GFJ on the maintenance dose (75 mg/day) of clopidogrel. Subjects will be randomized to either initially receive GFJ prior to their loading dose of clopidogrel or receive GFJ prior to their second loadin...
Healthy
Platelet Aggregation Inhibition
null
2
arm 1: Participants received a 300 mg dose of clopidogrel with or without GFJ. arm 2: Participants received clopidogrel 75 mg/day for 7 days with or without GFJ
[ 0, 0 ]
3
[ 7, 0, 0 ]
intervention 1: Participants received grapefruit juice during 1 of the 2 periods. intervention 2: None intervention 3: None
intervention 1: Grapefruit juice intervention 2: Clopidogrel 75 mg/day intervention 3: Clopidogrel 300 mg
1
Omaha | Nebraska | United States | -95.94043 | 41.25626
32
0
0
0
NCT00817999
1COMPLETED
2011-07-01
2008-11-01
Creighton University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
602
RANDOMIZED
PARALLEL
1PREVENTION
3TRIPLE
false
0ALL
true
Pancreatitis (inflammation of the pancreas) is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP), a procedure for the diagnosis and treatment of disorders of the pancreas and bile duct. Preliminary data has shown that non-steroidal antiinflammatory drugs, when administered rectally,...
This study is a multi-center, randomized, placebo-controlled, double-blinded clinical trial of rectal indomethacin in the prevention of post-ERCP pancreatitis in high risk patients.
Post-ERCP Pancreatitis
null
2
arm 1: Indomethacin suppository arm 2: Placebo suppository
[ 1, 2 ]
2
[ 0, 10 ]
intervention 1: 100 mg PR once at the time of ERCP intervention 2: 2 placebo suppositories at the time of ERCP
intervention 1: Indomethacin intervention 2: Placebo suppositories
4
Indianapolis | Indiana | United States | -86.15804 | 39.76838 Lexington | Kentucky | United States | -84.47772 | 37.98869 Ann Arbor | Michigan | United States | -83.74088 | 42.27756 Cleveland | Ohio | United States | -81.69541 | 41.4995
602
0
0
0
NCT00820612
6TERMINATED
2011-07-01
2009-01-01
University of Michigan
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
19
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
1FEMALE
false
The study examined the effects of adding the sleep aid eszopiclone to Lexapro on mood and levels of the neurotransmitters glutamate, glutamine, and GABA in women with depression, anxiety, and insomnia. Specifically, the objective was to determine the role of glutamate, glutamine, and GABA in mediating the response the ...
null
Depression Anxiety Insomnia
Magnetic Resonance Spectroscopy Glutamate Glutamine GABA Lexapro Lunesta Escitalopram Eszopiclone
null
2
arm 1: Lexapro for 10 weeks together with eszopiclone. arm 2: Lexapro for 10 weeks together with placebo.
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Subjects receive 10 mg escitalopram daily for four weeks and 10 or 20 mg for an additional six weeks. Subjects also receive 3 mg eszopiclone. intervention 2: Subjects receive 10 mg of escitalopram daily for four weeks followed by 10 or 20 mg for an additional six weeks. Subjects also receive placebo for...
intervention 1: Eszopiclone intervention 2: Placebo
1
Boston | Massachusetts | United States | -71.05977 | 42.35843
19
0
0
0
NCT00826111
1COMPLETED
2011-07-01
2007-08-01
Steward St. Elizabeth's Medical Center of Boston, 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
[ 3 ]
129
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
This is a pilot study to examine if the novel treatment regimen maraviroc plus boosted atazanavir can be expected to be safe and efficacious in treatment naive HIV infected patients. Based on the results from this study, a confirmatory phase 3 study may be conducted.
null
Human Immunodeficiency Virus-1
CCR5-tropic HIV-1 virus
null
2
arm 1: maraviroc (Selzentry, Celsentri) 150 mg QD + atazanavir (Reyataz) /ritonavir (Norvir) 300/100mg QD Subjects experiencing unconjugated hyperbilirubinemia attributable to atazanavir (Reyataz) /ritonavir (Norvir) without any other etiology of hyperbilirubinemia, responding to the therapy without virologic failure, ...
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: maraviroc (Selzentry, Celsentri) 150mg QD + atazanavir (Reyataz) /ritonavir (Norvir) (300/100mg) QD OR maraviroc (Selzentry, Celsentri) 150mg QD+ darunavir (Prezista)/ritonavir (Norvir) (800/100 mg) QD (if atazanavir (Reyataz) /ritonavir (Norvir) is replaced by darunavir (Prezista)/ritonavir (Norvir)) O...
intervention 1: maraviroc intervention 2: maraviroc
39
Los Angeles | California | United States | -118.24368 | 34.05223 Los Angeles | California | United States | -118.24368 | 34.05223 Los Angeles | California | United States | -118.24368 | 34.05223 Los Angeles | California | United States | -118.24368 | 34.05223 Norwalk | Connecticut | United States | -73.4079 | 41.1176 W...
121
0
0
0
NCT00827112
1COMPLETED
2011-07-01
2009-03-01
ViiV Healthcare
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
50
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The purpose of this study is to examine the effects of propranolol versus placebo on responses to cocaine cues in cocaine dependent individuals.
This study will employ cocaine-dependent individuals to investigate the acute effects of propranolol vs. placebo, administered immediately after a retrieval session of cocaine cue exposure, on the subjective and physiological responses occurring during a subsequent test session of cocaine cue exposure. Participants (N=...
Cocaine Dependence
cocaine cocaine-dependent propranolol craving beta-blockade cue exposure drug addiction memory addictive behavior
null
2
arm 1: None arm 2: None
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: 40 mg administered once intervention 2: administered once
intervention 1: Propranolol intervention 2: Placebo
1
Charleston | South Carolina | United States | -79.93275 | 32.77632
51
0
0
0
NCT00830362
1COMPLETED
2011-07-01
2009-02-01
Medical University of South Carolina
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
6
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
1.1 Primary Objective To evaluate the effects of short course preoperative erlotinib treatment in a panel of predictive biomarkers from a group of patients who undergo resection of pancreatic adenocarcinoma with curative intent. 1.2 Secondary Objectives 1.2.1 To analyze the effects of short course preoperative erlot...
Our current clinical trial proposal includes a short course of pre-operative, single agent erlotinib followed by post-operative erlotinib-gemcitabine in a neo-adjuvant/adjuvant approach to the treatment of patients with resectable pancreatic adenocarcinoma. The short course pre-operative erlotinib treatment serves two ...
Pancreatic Cancer
Pancreatic Cancer Assay Biomarkers
null
1
arm 1: 150 mg of erlotinib for 7 days prior to surgery,then in the adjuvant stage the subject will receive 100mg of erlotinib and gemcitabine 1000mg/2 for 6 cycles
[ 0 ]
1
[ 0 ]
intervention 1: Preoperative dosing of 150 mg oral erlotinib for 7 days before surgery. followed by erlotinib 100 mg daily 6 month/6 chemotherapy cycles. Gemcitabine 1000 m2 weekly after surgery for 6 cycles.
intervention 1: erlotinib
1
Birmingham | Alabama | United States | -86.80249 | 33.52066
19
0
0
0
NCT00841035
6TERMINATED
2011-07-01
2009-02-01
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 ]
16
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
true
0ALL
false
This research is designed to assess the impact of pretreatment with puerarin (NPI-031G), a major ingredient in the plant kudzu, on alcohol drinking. Hypothesis: Short-term treatment with this compound will reduce alcohol self-administration in a simulated natural settings laboratory.
Participants will have an opportunity to drink up to 6 beers, plus water and juice, during a 90 minute afternoon drinking session in our simulated apartment room laboratory. Drinking sessions will be conducted in the afternoon after participants take puerarin or placebo for 7 days.
Alcohol Abuse
null
2
arm 1: None arm 2: Sugar beet filler in capsule
[ 1, 2 ]
1
[ 0 ]
intervention 1: 400 mg, three times a day for 7 days
intervention 1: Puerarin, Placebo
1
Belmont | Massachusetts | United States | -71.17867 | 42.39593
16
0
0
0
NCT00854724
1COMPLETED
2011-07-01
2009-02-01
Mclean Hospital
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
1
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
false
ON 01910.Na has undergone preclinical and clinical phase I studies showing activity in patients with progressing ovarian cancer resistant to platinum-based chemotherapies. This study will look at a larger population of patients to determine whether treatment with ON 01910.Na has an effect on progression free survival r...
This is a Phase II single arm study of ON 01910.Na to be administered as a 2-hour infusion biweekly to patients with progressive ovarian cancer resistant to platinum-based therapy. The primary objective is to evaluate progression-free survival (PFS). The secondary objectives are to document other measures of outcome \...
Ovarian Cancer
Ovarian Cancer Cisplatin Carboplatin
null
1
arm 1: 3200 mg ON 01910.Na administered intravenously over 2 hours on days 1, 4, 8, 11, 15, and 18 of 28-day cycle
[ 0 ]
1
[ 0 ]
intervention 1: None
intervention 1: ON 01910.Na
1
Indianapolis | Indiana | United States | -86.15804 | 39.76838
1
0
0
0
NCT00856791
1COMPLETED
2011-07-01
2009-03-01
Traws Pharma, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
486
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
A multi center, randomized study to evaluate the efficacy and safety of eszopiclone compared to placebo in children (6-11 years of age, inclusive) and adolescents (12-17 years of age, inclusive) with attention deficit/hyperactivity disorder (ADHD) associated insomnia.
This is a multi center, randomized, double blind, placebo controlled, fixed dose study of eszopiclone in pediatric subjects 6-17 years of age, inclusive, with ADHD associated insomnia. Subjects will be randomized at approximately 1:1:1 to either low dose oral eszopiclone (1 mg for children ages 6-11 years, 2 mg for ado...
Insomnia Attention Deficit Hyperactivity Disorder
Hypnotic Eszopiclone Attention Deficit/Hyperactivity Disorder Insomnia Children Adolescent Polysomnography Actigraphy
null
3
arm 1: 1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years arm 2: 2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years arm 3: Placebo 6-17 years
[ 0, 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: 1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years intervention 2: 2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years intervention 3: 1 tablet per day for 12 weeks
intervention 1: eszopiclone intervention 2: eszopiclone intervention 3: Placebo
73
Birmingham | Alabama | United States | -86.80249 | 33.52066 Dothan | Alabama | United States | -85.39049 | 31.22323 Chandler | Arizona | United States | -111.84125 | 33.30616 Phoenix | Arizona | United States | -112.07404 | 33.44838 Tucson | Arizona | United States | -110.92648 | 32.22174 Little Rock | Arkansas | Unite...
483
0
0
0
NCT00856973
1COMPLETED
2011-07-01
2009-05-01
Sumitomo Pharma America, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
141
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The primary rationale for this study is to evaluate the effect of once daily montelukast on duration of acute illness in infants with first-time bronchiolitis.
null
Bronchiolitis
Bronchiolitis montelukast leukotriene inhibitor
null
2
arm 1: 4mg granules PO QD for 14 days arm 2: Sucrose granules PO QD for 14 days
[ 0, 2 ]
2
[ 0, 10 ]
intervention 1: 4mg granules daily for 14 days intervention 2: table sugar as placebo daily for 14 days
intervention 1: montelukast sodium intervention 2: sucrose
1
Milwaukee | Wisconsin | United States | -87.90647 | 43.0389
141
0
0
0
NCT00863317
1COMPLETED
2011-07-01
2008-12-01
Medical College of Wisconsin
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 ]
8
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This study will test the efficacy of a systematic, multi-modal intervention protocol designed to improve sleep functioning and subsequent alleviation of daytime cognitive and behavioral difficulties among children diagnosed with ADHD. It is hypothesized that children receiving behavioral and (if necessary) pharmacologi...
Parents, researchers, and clinicians have long suspected that inadequate sleep in many children diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) can exacerbate symptoms of hyperactivity and inattentiveness, leading to further cognitive and behavioral disruptions. Extant sleep studies report that upwards o...
Attention Deficit Hyperactivity Disorder
Attention Deficit Hyperactivity Disorder (ADHD)
null
2
arm 1: Children will receive behavioral sleep interventions and, if needed, melatonin, to improve sleep functions. arm 2: Children will only receive sleep behavior interventions for the first four weeks of the trial. Treatment with study drug will be delayed to the 5th week.
[ 0, 0 ]
2
[ 5, 0 ]
intervention 1: A structured sleep protocol is taught to parents, use of a white noise generator intervention 2: Body Weight \<40mg will be given 3mg at bedtime for two weeks Body Weight \>40mg will be given 6 mg at bedtime for two weeks
intervention 1: Sleep Intervention intervention 2: Melatonin
1
Cincinnati | Ohio | United States | -84.51439 | 39.12711
8
0
0
0
NCT00867451
1COMPLETED
2011-07-01
2010-01-01
Children's Hospital Medical Center, Cincinnati
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
15
RANDOMIZED
PARALLEL
1PREVENTION
4QUADRUPLE
false
0ALL
false
This study will determine the effectiveness of antidepressant medication in preventing depression and improving recovery in people who have been supported by mechanical ventilators in an intensive care unit (ICU).
More than one third of all people admitted to ICUs in hospitals require mechanical ventilation for respiratory failure. Many people who survive after being on mechanical ventilation for a prolonged time have significant issues with recovery and quality of life when discharged from the ICU. They are also more prone to d...
Depression
Critical Illness Intensive Care Unit Acute Respiratory Failure Prolonged Mechanical Ventilation
null
2
arm 1: Participants will receive 8 weeks of escitalopram treatment. arm 2: Participants will receive 8 weeks of placebo pills.
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 10 mg of escitalopram administered enterally with the option for dose escalation to 20 mg after 3 to 5 weeks if the medical condition is stable and no liver disease presents intervention 2: Placebo pills for 8 weeks
intervention 1: Escitalopram intervention 2: Placebo
1
Minneapolis | Minnesota | United States | -93.26384 | 44.97997
15
0
0
0
NCT00872027
1COMPLETED
2011-07-01
2009-04-01
University of Minnesota
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
176
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
This study evaluates the efficacy and safety of Cyclosporine 0.010% eye drops in the treatment of Atopic Keratoconjunctivitis (chronic and severe inflammation of the eye). The study consists of a double-masked phase, and open-labeled phase, and an open-labeled maintenance phase. For the first 3 months of the study, pat...
null
Atopic Conjunctivitis
null
2
arm 1: Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day. arm 2: Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months followed by cyclosporine ophthalmic solution ...
[ 0, 5 ]
2
[ 0, 0 ]
intervention 1: Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months. intervention 2: Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.
intervention 1: Cyclosporine Vehicle intervention 2: Cyclosporine 0.010%
12
Bakersfield | California | United States | -119.01871 | 35.37329 Randwick | New South Wales | Australia | 151.24895 | -33.91439 Ottawa | Ontario | Canada | -75.69812 | 45.41117 Prague | N/A | Czechia | 14.42076 | 50.08804 Dijon | Burgundy | France | 5.01667 | 47.31667 Munich | Bavaria | Germany | 11.57549 | 48.13743 Ba...
258
0
0
0
NCT00884585
1COMPLETED
2011-07-01
2009-05-01
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
[ 4 ]
310
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
This study is an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who are currently receiving approved therapy for their PAH (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor). Study visits will occur at 4 week intervals for 16 weeks with the ...
null
Pulmonary Hypertension
null
2
arm 1: Identical placebo tablets to UT-15C, doses were titrated in the same manner arm 2: Doses were initiated at 0.25 mg BID and increased by 0.25 mg BID every three days (as clinically indicated based on tolerability and symptoms of PAH), to a max dose of 16 mg BID.
[ 2, 0 ]
2
[ 0, 0 ]
intervention 1: treprostinil diolamine sustained release tablets intervention 2: None
intervention 1: UT-15C SR intervention 2: Placebo
62
Birmingham | Alabama | United States | -86.80249 | 33.52066 Phoenix | Arizona | United States | -112.07404 | 33.44838 Fresno | California | United States | -119.77237 | 36.74773 La Jolla | California | United States | -117.2742 | 32.84727 Los Angeles | California | United States | -118.24368 | 34.05223 Sacramento | Cal...
310
0
0
0
NCT00887978
1COMPLETED
2011-07-01
2009-06-01
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
[ 4 ]
557
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A (onabotulinumtoxinA) in treating patients with idiopathic overactive bladder with urinary incontinence.
null
Overactive Bladder
null
2
arm 1: OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable). arm 2: Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botuli...
[ 0, 5 ]
2
[ 2, 0 ]
intervention 1: OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable). Or, if placebo is administered at Day 1, onabotulinumtoxinA 100 U injected after a minimum of 12 weeks (if applic...
intervention 1: onabotulinumtoxinA intervention 2: normal saline
2
Newport Beach | California | United States | -117.92895 | 33.61891 Victoria | British Columbia | Canada | -123.35155 | 48.4359
550
0
0
0
NCT00910845
1COMPLETED
2011-07-01
2009-09-01
Allergan
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
24
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
2MALE
false
The primary objective was to evaluate efficacy of a single dose of Liproca Depot in patients with localized prostate cancer. Primary efficacy variable was the proportion of patients showing PSA nadir. 24 Caucasian men, with a mean age at inclusion of 68.4 years, with localized prostate cancer were injected once with a ...
Patients with localized prostate cancer were followed to progression or maximum 24 weeks after a single injection in one lobe of 2-8 mL ready-made paste (corresponding to 400-1600 mg 2-Hydroxyflutamid). Progression was defined as an increase in PSA by \> 25% over baseline or on-treatment nadir.Among the 24 patients the...
Prostate Cancer
Prostate cancer
null
1
arm 1: Single injection of 2-Hydroxyflutamide (2-8mL ready-made paste)in one prostate lobe
[ 0 ]
2
[ 0, 0 ]
intervention 1: Ready made paste including 600 mg 2-HOF for injection as a single dose intervention 2: The Product consists of two sterile components, one aqueous liquid and a dry powder, containing the active drug 2-Hydroxyflutamide (2-HOF. The two components were mixed under aceptic conditions to a paste prior to adm...
intervention 1: 2-hydroxyflutamide (2-HOF) [Liproca Depot] intervention 2: 2-Hydroxyflutamide
2
Tampere | N/A | Finland | 23.78712 | 61.49911 Tampere | N/A | Finland | 23.78712 | 61.49911
24
0
0
0
NCT00913263
1COMPLETED
2011-07-01
2009-06-01
Lidds AB
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
24
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
false
0ALL
true
To assess and compare the pharmacokinetics of Melphalan HCL for Injection (Propylene Glycol-Free) versus Alkeran for Injection in multiple myeloma (MM) patients undergoing autologous stem cell transplant (ASCT).
This study will be a multicenter, open-label, randomized, comparative, cross-over study of high-dose Melphalan HCl for Injection (Propylene Glycol-Free) and Alkeran for Injection conducted in 24 patients who have symptomatic MM and qualify for ASCT. During the Study Period, patients will be randomized to receive 100mg...
Multiple Myeloma
autologous stem cell transplantation
null
2
arm 1: Subjects begin with treatment Melphalan and crossover to treatment Alkeran arm 2: Subjects begin with treatment Alkeran and crossover to treatment Melphalan.
[ 5, 5 ]
2
[ 0, 0 ]
intervention 1: Patients will be randomized to receive 100 mg/m2 of Melphalan HCL for Injection (Propylene Glycol-Free) on Day -3 and Alkeran for Injection on Day -2 prior to ASCT. intervention 2: Patients will be randomized to receive 100 mg/m2 of Alkeran for Injection on Day -3 and Melphalan HCL for Injection (Propyl...
intervention 1: Melphalan HCL for Injection (Propylene Glycol-Free)/Alkeran for Injection intervention 2: Alkeran for Injection/Melphalan HCL for Injection (Propylene Glycol-Free)
1
Kansas City | Kansas | United States | -94.62746 | 39.11417
24
0
0
0
NCT00925782
1COMPLETED
2011-07-01
2010-01-01
Acrotech Biopharma Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
10
RANDOMIZED
PARALLEL
null
2DOUBLE
false
0ALL
true
We will prospectively study 2 groups of diabetic patients treated with pioglitazone or placebo for 26 weeks. Bone marrow aspirates will be obtained from these patients at baseline and after 26 weeks of treatment, and hBMCs will be isolated from these bone marrow aspirations. The ability of hBMCs to differentiate into o...
E2a. Screening: Prescreening of electronic medical records will be used as much as possible to reduce screen failure rates. Patients will undergo a full history (with special focus on inclusion and exclusion criteria), physical exam, and blood draw. Lab work will consist of CBC, PT, PTT, CMP, HbA1c, PTH, serum beta-HCG...
Osteoblast Adipocytes Bone Density Osteocalcin Adiponectin Mesenchymal Stem Cells
pioglitazone human bone marrow stem cells adipocytes osteoblasts bone mineral density adiponectin leptin CTX P1NP Osteocalcin
null
2
arm 1: half of the diabetic patients will be randomized to pioglitazone treatment for 6 months starting out with 15mg qd for 4 weeks and dose increased to 30mg (2 tablets) qday if no adverse effects noted at the four week mark by study physician. arm 2: The other half will be randomized to placebo for 6 months. The pla...
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: 6 month treatment with pioglitazone 15mg for four weeks with dose increased to 30mg if no adverse effects (swelling of lower extremities, liver enzyme elevation) noted at the four week mark. intervention 2: The placebo pills also start out with one ("15mg") pill qday and are increased to 2 tablets ("30m...
intervention 1: Pioglitazone intervention 2: Placebo
1
Atlanta | Georgia | United States | -84.38798 | 33.749
10
0
0
0
NCT00927355
1COMPLETED
2011-07-01
2009-04-01
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
[ 4 ]
427
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The objectives of this clinical trial are to compare the effects of exenatide once weekly and insulin glargine on blood glucose control, body weight, lipids, safety, and tolerability.
null
Type 2 Diabetes Mellitus
diabetes; exenatide once weekly; Byetta; glargine; Lantus; Amylin; Lilly
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: subcutaneous injection, 2.0mg, once a week; intervention 2: subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
intervention 1: exenatide once weekly intervention 2: insulin glargine
22
Aomori | N/A | Japan | 140.73333 | 40.81667 Chiba | N/A | Japan | 140.11667 | 35.6 Ehime | N/A | Japan | N/A | N/A Fukuoka | N/A | Japan | 130.41667 | 33.6 Gunma | N/A | Japan | N/A | N/A Hiroshima | N/A | Japan | 132.45 | 34.4 Hokkaido | N/A | Japan | N/A | N/A Hyōgo | N/A | Japan | 144.43333 | 43.36667 Ibaraki | N/A ...
427
0
0
0
NCT00935532
1COMPLETED
2011-07-01
2009-07-01
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 ]
32
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The primary objective of this pilot study is to evaluate the effect of the HPV vaccine Gardasil on anal condylomata recurrence and persistence rates in HIV positive patients.
A quadrivalent human papilloma virus (HPV) vaccine called Gardasil had recently (at start of study) been developed and approved by the FDA for the prevention of cervical HPV infection and cervical cancer, which is associated with infection from this virus. It is unknown whether the same vaccine could also be of benefit...
HIV Positive Anal Condylomata Anal Warts HIV Infections
HIV HPV Anal condylomata Vaccine HIV positive patients Anal condylomata or anal warts
null
2
arm 1: Patients who are in the control group received a placebo of saline in the upper extremity at initial visit, 2 months and 6 months after enrollment. arm 2: The treatment group received a 0.5mL intramuscular injection of Gardasil (quadrivalent HPV vaccine) in their upper extremity at initial visit, and again at tw...
[ 2, 1 ]
2
[ 0, 0 ]
intervention 1: 0.5 ml intervention 2: 0.5mL intramuscular injection of Gardasil (quadrivalent HPV vaccine) in their upper extremity initially and again at two months and six months after enrollment.
intervention 1: Saline intervention 2: Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine
1
St Louis | Missouri | United States | -90.19789 | 38.62727
0
0
0
0
NCT00941889
1COMPLETED
2011-07-01
2007-07-01
Washington University School of Medicine
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
103
RANDOMIZED
CROSSOVER
0TREATMENT
3TRIPLE
false
0ALL
true
1. to examine the non-inferiority of Dysport in the clinical efficacy and safety in comparison with Botox®, assuming a bioequivalence ratio of 2.5:1 units, in the treatment of Cervical dystonia. 2. double blind, randomised, multi center, crossover study
1. Prospective, randomized, head-to-head, double-blind, cross-over study. 2. Total patients: A group 51, B group 51 3. Study duration: 16 + 4 + 16 weeks. Eligible patients will be randomised at baseline to receive either Dysport® or Botox® and monitored at weeks 2, 4, 8, 12, 16 weeks. After 4 weeks of wash out period, ...
Cervical Dystonia
cervical dystonia botulinum toxin
null
2
arm 1: Dysport® injection in first intervention period and Botox® in second intervention period (after washout period) cross over injection of Dysport® (abobotulinumtoxinA) and Botox® (onabotulinumtoxinA) arm 2: Botox® injection in first intervention period and Dysport® in second intervention period (after washout peri...
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Cross over injection of Dysport® (\<500IU), Botox® (200IU)assuming a bioequivalence ratio of 2.5:1 units intervention 2: Cross over injection of Dysport® (\<500IU), Botox® (200IU)assuming a bioequivalence ratio of 2.5:1 units
intervention 1: Dysport® (abobotulinumtoxinA) intervention 2: Botox® (onabotulinumtoxinA)
7
Seongnam-si | Gyeonggi-do | South Korea | 127.13778 | 37.43861 Busan | N/A | South Korea | 129.03004 | 35.10168 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Kore...
188
0
0
0
NCT00950664
1COMPLETED
2011-07-01
2009-08-01
Seoul National University Hospital
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
145
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
This study will test the effectiveness of warfarin in patients with IPF. Approximately 256 patients will be randomized 1:1 to either warfarin or placebo. Patients will return at week 1 for a safety review and every 16 weeks for 48 weeks. The primary endpoint in the study is the time to either death, non-bleeding/non-el...
Study design: ACE-IPF was a double-blind, randomized, placebo-controlled trial of an oral warfarin dose adjusted to an international normalized ratio (INR) response of 2.0 to 3.0, compared with a sham dose-adjusted placebo. The trial was originally designed as an event-driven study with a treatment period of up to 144...
Idiopathic Pulmonary Fibrosis
IPF Warfarin
null
2
arm 1: Oral warfarin titrated to an international normalization ratio (INR) of 2-3 arm 2: Oral placebo (1mg or 2.5mg)
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3. intervention 2: Oral placebo (1mg or 2.5mg)
intervention 1: warfarin intervention 2: placebo
22
Birmingham | Alabama | United States | -86.80249 | 33.52066 Los Angeles | California | United States | -118.24368 | 34.05223 San Francisco | California | United States | -122.41942 | 37.77493 Denver | Colorado | United States | -104.9847 | 39.73915 New Haven | Connecticut | United States | -72.92816 | 41.30815 Miami | ...
145
0
0
0
NCT00957242
6TERMINATED
2011-07-01
2009-10-01
Duke University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
7
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
To assess the efficacy and safety of oral rosuvastatin in patients with suspected or confirmed influenza who require intensive care unit (ICU) admission due to respiratory distress.
Hypothesis: Rosuvastatin therapy will improve mortality and reduce the need for mechanical ventilation in patients experiencing respiratory distress as a complication of influenza.
Acute Respiratory Distress Syndrome Influenza H1N1 Influenza
ARDS H1N1 Influenza Statin
null
2
arm 1: Placebo arm 2: Experimental arm
[ 2, 0 ]
2
[ 0, 0 ]
intervention 1: 20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge intervention 2: Placebo tablet identical to active therapy. 1 tablet per day
intervention 1: Rosuvastatin (crestor) intervention 2: Placebo
21
Little Rock | Alaska | United States | N/A | N/A Phoenix | Arizona | United States | -112.07404 | 33.44838 Stanford | California | United States | -122.16608 | 37.42411 Chicago | Illinois | United States | -87.65005 | 41.85003 Iowa City | Iowa | United States | -91.53017 | 41.66113 Baltiomore | Maryland | United States...
7
0
0
0
NCT00970606
6TERMINATED
2011-07-01
2009-10-01
Gordon Bernard
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 ]
30
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to assess the effect of treatment with Advair Diskus on depression using the Cornell depression scale in COPD patients in the nursing home.
We are studying 35 residents in the ECF with a diagnosis of COPD. We are evaluating them for depressive symptoms using the Cornell Depression Scale and the MDS 3.0 section D. We are selecting patients who are not currently on treatment with Advair and starting them on Advair Diskus50/250 1 inhalation bid for a period o...
Chronic Obstructive Pulmonary Disease Depression
COPD Depression Nursing Home
null
1
arm 1: open label treatment with Advair diskus in COPD patients
[ 0 ]
1
[ 0 ]
intervention 1: Advair diskus 50/250 1 inhalation bid for 16 weeks
intervention 1: Advair diskus
2
Brooksville | Florida | United States | -82.38991 | 28.55554 Centerville | Ohio | United States | -84.15938 | 39.62839
27
0
0
0
NCT00974246
1COMPLETED
2011-07-01
2009-10-01
Valley Medical Research
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
29
RANDOMIZED
PARALLEL
7BASIC_SCIENCE
4QUADRUPLE
false
0ALL
false
To explore the effect of CP-690,550 on blood and synovial markers in subjects with rheumatoid arthritis. To evaluate the safety, tolerability and efficacy of CP-690,550.
null
Rheumatoid Arthritis
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: CP-690,550 dose is 10 mg twice daily, oral tablets, for 4 weeks Methotrexate dose is ≥ 7.5 mg / week and ≤ 25 mg / week intervention 2: Methotrexate dose is ≥ 7.5 mg / week and ≤ 25 mg / week
intervention 1: CP-690,550 + methotrexate intervention 2: Placebo + Methotrexate
15
Birmingham | Alabama | United States | -86.80249 | 33.52066 Birmingham | Alabama | United States | -86.80249 | 33.52066 Birmingham | Alabama | United States | -86.80249 | 33.52066 La Jolla | California | United States | -117.2742 | 32.84727 Frederick | Maryland | United States | -77.41054 | 39.41427 Battle Creek | Mich...
29
0
0
0
NCT00976599
1COMPLETED
2011-07-01
2009-11-01
Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
20
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
Attention Deficit Hyperactivity Disorder (ADHD) is a neurobiological disorder characterized by lifelong issues of inattention, distraction, organizational difficulties, forgetfulness, restlessness, talking out of turn, difficulty waiting and interrupting others. ADHD is the second most common neuropsychiatric disorder ...
This will be a 12-week study of twenty enrolled participants with the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV) criteria adult ADHD (age 18-55), with a goal of completing twenty participants in the trial. The primary objective of this study is to determine the effect of droxidopa th...
Attention Deficit Hyperactivity Disorder
Attention Deficit Hyperactivity Disorder ADHD Adult ADHD Adult Attention Deficit Hyperactivity Disorder
null
2
arm 1: 3 weeks of open label droxidopa (200, 400, or 600 milligrams \[mg\] three times daily \[TID\]) monotherapy followed by 3 weeks of droxidopa in combination with carbidopa (25 mg or 50 mg TID). arm 2: 2 week double-blind period in which participants either continued to receive droxidopa+carbidopa treatment or plac...
[ 0, 2 ]
1
[ 0 ]
intervention 1: 3 weeks of open label droxidopa (L-dihydroxyphenylserine (L-DOPS)) (200, 400, or 600mgs TID) monotherapy followed by 3 weeks of droxidopa in combination with carbidopa (25mg or 50mg TID) followed by 2 weeks of double blind continued droxidopa+carbidopa or placebo
intervention 1: Droxidopa+Carbidopa
1
New York | New York | United States | -74.00597 | 40.71427
31
0
0
0
NCT00983814
1COMPLETED
2011-07-01
2009-10-01
Chelsea 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
[ 0 ]
5
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
true
RATIONALE: Metformin hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying how well metformin hydrochloride works in treating women with stage I or stage II breast cancer that can be removed by surgery.
OBJECTIVES: Primary * To determine the in situ effects of metformin hydrochloride on proliferation (Ki67) and apoptosis (caspase-3) in women with operable stage I or II breast cancer. Secondary * To determine the in situ biologic effect of metformin hydrochloride on the AMP kinase, MTOR/PI3K, and IGF pathways in br...
Breast Cancer
stage I breast cancer stage II breast cancer
null
1
arm 1: Metformin: 850 mg orally (PO) twice daily (BID) for 7-21 days, discontinued 24-36 hrs prior to surgery
[ 0 ]
2
[ 0, 10 ]
intervention 1: Metformin: 850 mg orally (PO) twice daily (BID) for 7-21 days, discontinued 24-36 hrs prior to surgery intervention 2: Blood and tissue collection to determine the in situ biologic effect of metformin
intervention 1: metformin hydrochloride intervention 2: laboratory biomarker analysis
3
Atlanta | Georgia | United States | -84.38798 | 33.749 Nashville | Tennessee | United States | -86.78444 | 36.16589 Nashville | Tennessee | United States | -86.78444 | 36.16589
5
0
0
0
NCT00984490
6TERMINATED
2011-07-01
2009-09-01
Vanderbilt-Ingram Cancer Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
86
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to evaluate the safety of long-term treatment with HZT-501, a fixed-dose combination oral tablet of 800 mg ibuprofen and 26.6 mg famotidine for patients that require long-term NSAID treatment.
HZT-501, a fixed-dose combination of ibuprofen, a pain and inflammation relieving non-steroidal anti-inflammatory drug (NSAID), and famotidine, a histamine type 2 receptor antagonist (H2RA), is being developed for the treatment of patients with signs and symptoms of osteoarthritis, rheumatoid arthritis, mild to moderat...
Osteoarthritis Rheumatoid Arthritis Chronic Low Back Pain Chronic Regional Pain Syndrome Chronic Soft Tissue Pain
NSAID Chronic Pain Osteoarthritis Rheumatoid Arthritis
null
1
arm 1: Open-label treatment with HZT-501
[ 0 ]
1
[ 0 ]
intervention 1: Fixed-dose combination oral tablet 800mg Ibuprofen/26.6 mg Famotidine taken three times per day
intervention 1: HZT-501
4
Chicago | Illinois | United States | -87.65005 | 41.85003 Morton Grove | Illinois | United States | -87.78256 | 42.04059 Duncansville | Pennsylvania | United States | -78.4339 | 40.42341 Dallas | Texas | United States | -96.80667 | 32.78306
86
0
0
0
NCT00984815
1COMPLETED
2011-07-01
2009-09-01
Amgen
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
263
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to test the hypothesis that the HumaPen Memoir with memory function, when used over 24 weeks for prandial insulin injections achieves superior glycemic control, when compared to the conventional HumaPen Luxura without memory function.
null
Diabetes Mellitus, Type 1
null
2
arm 1: Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks arm 2: Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
[ 0, 0 ]
4
[ 0, 0, 1, 1 ]
intervention 1: subcutaneously, daily (as determined by patient's blood glucose), for 24 weeks intervention 2: subcutaneously, daily (as determined by patient's blood glucose), for 24 weeks intervention 3: subcutaneously, daily for 24 weeks intervention 4: subcutaneously, daily for 24 weeks
intervention 1: Insulin Lispro intervention 2: Huminsulin Regular intervention 3: HumaPen Memoir intervention 4: HumaPen Luxura
29
Aschaffenburg | N/A | Germany | 9.15214 | 49.97704 Aßlar | N/A | Germany | 8.46273 | 50.59163 Bad Mergentheim | N/A | Germany | 9.77361 | 49.4925 Berlin | N/A | Germany | 13.41053 | 52.52437 Bosenheim | N/A | Germany | 7.91382 | 49.84472 Diez | N/A | Germany | 8.00735 | 50.37419 Dresden | N/A | Germany | 13.73832 | 51....
261
0
0
0
NCT00985712
1COMPLETED
2011-07-01
2009-10-01
Eli Lilly and Company
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
20
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Some patients who need kidney transplants have high levels of antibodies that make them incompatible with most potential deceased donor kidney offers. These patients are considered highly-sensitized and are very difficult to transplant because the likelihood that they will receive a compatible organ is very low. There ...
null
Kidney Failure
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: A maximum of four doses (each single dose being 2gm/kg) of IVIg will be administered over a four-month period, with one dose administered each month. Each single dose of 2gm/kg will be administered in two half-doses (1gm/kg each) to be given one day apart, with one day of hemodialysis on the intervening...
intervention 1: IVIg and rituximab
1
Baltimore | Maryland | United States | -76.61219 | 39.29038
0
0
0
0
NCT00986947
6TERMINATED
2011-07-01
2009-09-01
Johns Hopkins University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
46
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
2MALE
true
The purpose of this study is to determine the safety and effectiveness of the study drug carlumab in participants with metastatic castrate-resistant prostate cancer (cancer of the gland that makes fluid that aids movement of sperm).
This is an open-label (all people know the identity of the intervention), multicenter trial (conducted in more than one center) in participants with metastatic castrate-resistant prostate cancer. The trial consists of 3 phases: screening period, treatment period of approximately 4 months, and a follow-up period (Week 1...
Prostate Cancer
Prostate cancer Infusion Carlumab CNTO 888
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Carlumab diluted in 5 percent (%) dextrose administered at the dose of 15 milligram per kilogram (mg/kg) by intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) at a constant rate over a 90 minute period once every 2 weeks until disease progression.
intervention 1: Carlumab
13
Orange City | Florida | United States | -81.29867 | 28.94888 Ann Arbor | Michigan | United States | -83.74088 | 42.27756 Charleston | South Carolina | United States | -79.93275 | 32.77632 Antwerp | N/A | Belgium | 4.40026 | 51.22047 Brussels | N/A | Belgium | 4.34878 | 50.85045 Wilrijk | N/A | Belgium | 4.39513 | 51.16...
46
0
0
0
NCT00992186
1COMPLETED
2011-07-01
2009-09-01
Centocor Research & Development, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
464
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
This study will assess the efficacy, safety, and tolerability of ACT-128800 in patients with relapsing-remitting multiple sclerosis.
null
Multiple Sclerosis
null
4
arm 1: ACT-128800 Dose 1 arm 2: ACT-128800 Dose 2 arm 3: ACT-128800 Dose 3 arm 4: Matching placebo
[ 0, 0, 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: ACT-128800 (Dose 1) administered orally once daily intervention 2: Matching placebo administered orally once daily intervention 3: ACT-128800 (Dose 2) administered orally once daily intervention 4: ACT-128800 (Dose 3) administered orally once daily
intervention 1: ACT-128800 Dose 1 intervention 2: Placebo intervention 3: ACT-128800 Dose 2 intervention 4: ACT-128800 Dose 3
115
Scottsdale | Arizona | United States | -111.89903 | 33.50921 Tucson | Arizona | United States | -110.92648 | 32.22174 Sacramento | California | United States | -121.4944 | 38.58157 Stanford | California | United States | -122.16608 | 37.42411 Sarasota | Florida | United States | -82.53065 | 27.33643 Indianapolis | Indi...
462
0
0
0
NCT01006265
1COMPLETED
2011-07-01
2009-10-01
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
[ 4 ]
322
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The purpose of this study is to evaluate the efficacy (good or bad effects) and safety of ustekinumab in the treatment of patients with moderate to severe psoriasis in China.
In this study, 220 patients will be divided into two groups randomly (by chance), like flipping a coin. Each group will receive a different treatment. The results for each group are compared to each other. There are 2 treatment groups in this study, Group 1 and Group 2. Group 1 will receive placebo at Weeks 0 and 4, us...
Psoriasis
psoriasis asian patients Chinese ustekinumab CNTO 1275 Stelara
null
2
arm 1: placebo Subcutaneous injection at Week 0 and 4,ustekinumab 45 mg subcutaneous injection at Week 12 and 16 arm 2: placebo Subcutaneous injection at Week 12,ustekinumab 45 mg subcutaneous injection at Week 0 4 and 16
[ 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Subcutaneous injection at Week 0 and 4 intervention 2: 45 mg subcutaneous injection at Week 12 and 16 intervention 3: Subcutaneous injection at Week 12 intervention 4: 45 mg subcutaneous injection at Week 0, 4 and 16
intervention 1: placebo intervention 2: ustekinumab intervention 3: placebo intervention 4: ustekinumab
9
Beijing | N/A | China | 116.39723 | 39.9075 Chongqing | N/A | China | 106.55771 | 29.56026 Dalian | N/A | China | 121.60222 | 38.91222 Guangzhou | N/A | China | 113.25 | 23.11667 Hangzhou | N/A | China | 120.16142 | 30.29365 Nanjing | N/A | China | 118.77778 | 32.06167 Shanghai | N/A | China | 121.45806 | 31.22222 Shen...
638
0
0
0
NCT01008995
1COMPLETED
2011-07-01
2009-10-01
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
[ 3 ]
30
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
The objectives of the study are to evaluate the pharmacokinetics (PK), safety, and efficacy of WR 279,396 (Paromomycin + Gentamicin Topical Cream) and Paromomycin Topical Cream in subjects with cutaneous leishmaniasis (CL).
This study is a single-site, randomized, double-blind, two group trial assessing the PK, safety and efficacy of WR 279,396 Topical Cream and Paromomycin Topical Cream in subjects with CL. Subjects will be screened over a period up to 28 days for eligibility including parasitology for confirmation of ulcerative CL. Subj...
Leishmaniasis, Cutaneous
leishmaniasis cutaneous WR 279,396 paromomycin gentamicin pharmacokinetics safety efficacy
null
2
arm 1: None arm 2: None
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: topical application to CL lesions once daily for 20 days intervention 2: topical application to CL lesions once daily for 20 days
intervention 1: WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream) intervention 2: Paromomycin Alone Cream (15% paromomycin topical cream)
1
Lima | N/A | Peru | -77.02824 | -12.04318
30
0
0
0
NCT01032382
1COMPLETED
2011-07-01
2010-01-01
U.S. Army Medical Research and Development Command
1FED
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
160
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
true
0ALL
false
The purpose of this study is to compare different medication combinations used in a periarticular injection after total knee replacement surgery(TKR). A periarticular injection is an injection that is given into the tissues surrounding the knee joint. The injection is given while the patient is still in surgery. The s...
Data Collection: Data will be collected from the patient's pre-operative office visit, up to six weeks post-operatively. Variables Pre-operative Collection: * Vital signs * Hb/Hct * Age * Sex * BMI * WOMAC Score - Screen Failure at 36 or 12 * Visual Analog Scale (VAS) Intra-operative Collection: * Duration of sur...
Osteoarthritis,Knee
Analgesia postoperative pain periarticular arthroplasty pain management
null
4
arm 1: Ropivacaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml) arm 2: Ropivacaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) arm 3: Ropivacaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml) ...
[ 1, 1, 1, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Ropivacaine 5mg/ml (49.25 ml) intervention 2: Toradol 30mg/ml (1 ml) intervention 3: Clonidine 0.1 mg/ml (0.08mg - 0.8 ml) intervention 4: Epinephrine 1 mg/ml (0.5 ml)
intervention 1: Ropivacaine intervention 2: Toradol intervention 3: Clonidine intervention 4: Epinephrine
0
null
160
0
0
0
NCT01042093
1COMPLETED
2011-07-01
2010-01-01
Towson Orthopaedic Associates
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 ]
251
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
This study is a multicentre, open, randomised, parallel-group study with formoterol 9 μg one inhalation b.i.d, or standard COPD therapy. Standard (reference) COPD treatment arm should be the group to refer to when safety results of formoterol arm will be evaluated. 240 patients with moderate-to-severe COPD will be rand...
null
Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease COPD Japanese Phase 3 Safety OT Oxis
null
1
arm 1: Formoterol 9 μg/dose
[ 0 ]
1
[ 0 ]
intervention 1: 9 μg/dose, Inhaled, twice daily for 52 weeks
intervention 1: Formoterol (OT)
27
Nagoya | Aichi-ken | Japan | 136.90641 | 35.18147 Akita | Akita | Japan | 140.11667 | 39.71667 Fukuoka | Fukuoka | Japan | 130.41667 | 33.6 Chitose | Hokkaido | Japan | 141.65222 | 42.81944 Obihiro | Hokkaido | Japan | 143.20444 | 42.91722 Sapporo | Hokkaido | Japan | 141.35 | 43.06667 Ako | Hyōgo | Japan | 134.37035 |...
251
0
0
0
NCT01047553
1COMPLETED
2011-07-01
2009-12-01
AstraZeneca
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
229
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The primary objective is to determine the efficacy of AMR101 (ethyl icosapentate) compared to placebo in lowering fasting triglyceride levels in patients with very high fasting triglyceride levels ≥ 500 and ≤ 2000 mg/dL.
null
Hypertriglyceridemia
hypertriglyceridemia omega-3 fatty acids statin triglycerides lipids EPA docosahexaenoic acid fish fatty acids fibrates niacin lipid atorvastatin Lovaza simvastatin lovastatin pravastatin fluvastatin rosuvastatin Trilipix Vytorin Simcor ezetimibe Zetia ethyl-EPA ethyl icosapentate Crestor Zocor Lipitor Niaspan LDL HDL ...
null
3
arm 1: None arm 2: None arm 3: None
[ 2, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks (Weeks 1-12) intervention 2: AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks (Weeks 1-12) intervention 3: Placebo 4 capsules/day for 12 weeks (Weeks 1-12)
intervention 1: AMR101 (ethyl icosapentate) - 4 g/day intervention 2: AMR101 (ethyl icosapentate) - 2 g/day intervention 3: Placebo
60
Sacramento | California | United States | -121.4944 | 38.58157 Golden | Colorado | United States | -105.2211 | 39.75554 Miami | Florida | United States | -80.19366 | 25.77427 Miami | Florida | United States | -80.19366 | 25.77427 Ocala | Florida | United States | -82.14009 | 29.1872 Addison | Illinois | United States |...
229
0
0
0
NCT01047683
1COMPLETED
2011-07-01
2009-12-01
Amarin Pharma Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
244
null
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to evaluate the effects of risperidone compared with other atypical antipsychotic drugs on the physical maturity, growth and development of children, and the risk of prolactin-related adverse events (side effects) associated to these drugs.
This is a study to find out what the effects are of long-term use of atypical antipsychotics (drugs used to treat mental health and some behavior disorders) in children and adolescents on their growth and physical maturity. Atypical antipsychotics are used in the treatment of a wide range of disorders in children and a...
Schizophrenia Bipolar Disorder Autistic Disorder Conduct and Other Disruptive Behavior Disorders
Schizophrenia Bipolar Disorder Autistic Disorder Conduct and Other Disruptive Behavior Disorders Risperidone RISPERDAL Antipsychotic Agents Prolactin Pediatrics
null
2
arm 1: Risperidone as per local prescribing practices arm 2: Other atypical antipsychotic drugs as per local prescribing practices
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: As per local prescribing practices intervention 2: As per local prescribing practices
intervention 1: Risperidone intervention 2: Other atypical antipsychotic drugs
28
San Francisco | California | United States | -122.41942 | 37.77493 Aurora | Colorado | United States | -104.83192 | 39.72943 Altamonte Springs | Florida | United States | -81.36562 | 28.66111 Gainesville | Florida | United States | -82.32483 | 29.65163 Smyrna | Georgia | United States | -84.51438 | 33.88399 Naperville ...
184
0
0
0
NCT01050582
1COMPLETED
2011-07-01
2009-10-01
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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 ]
323
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine monotherapy versus placebo for the treatment of acute manic or mixed episodes associated with bipolar I disorder.
null
Bipolar Disorder Mania
Acute Mania Bipolar I Disorder
null
2
arm 1: Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks. arm 2: Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine. intervention 2: Patients who meet eligibility criteria will be administered a once daily oral dose of placebo.
intervention 1: Cariprazine intervention 2: Placebo
28
Long Beach | California | United States | -118.18923 | 33.76696 Riverside | California | United States | -117.39616 | 33.95335 San Diego | California | United States | -117.16472 | 32.71571 Chicago | Illinois | United States | -87.65005 | 41.85003 Lake Charles | Louisiana | United States | -93.2044 | 30.21309 Flowood |...
312
0
0
0
NCT01058096
1COMPLETED
2011-07-01
2010-02-01
Forest Laboratories
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
30
NON_RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
The objectives of the study are to evaluate the pharmacokinetics (PK), safety, and efficacy of WR 279,396 (Paromomycin + Gentamicin Topical Cream) and Paromomycin Topical Cream in subjects with cutaneous leishmaniasis (CL).
This study is a single-site, randomized, double-blind, two group trial assessing the PK, safety and efficacy of WR 279,396 Topical Cream and Paromomycin Topical Cream in subjects with CL. Subjects will be screened over a period up to 28 days for eligibility including parasitology for confirmation of ulcerative CL. Subj...
Leishmaniasis, Cutaneous
leishmaniasis cutaneous WR 279,396 paromomycin gentamicin pharmacokinetics safety efficacy
null
2
arm 1: Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated cutaneous leishmaniasis (CL) lesions once daily for 20 days arm 2: WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: topical application to CL lesions once daily for 20 days intervention 2: topical application to CL lesions once daily for 20 days
intervention 1: WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream) intervention 2: Paromomycin Alone Cream (15% paromomycin topical cream)
1
Panama City | N/A | Panama | -79.51973 | 8.9936
30
0
0
0
NCT01083576
1COMPLETED
2011-07-01
2010-03-01
U.S. Army Medical Research and Development Command
1FED
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
86
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
This extension study will assess the safety and efficacy of AIN457 versus placebo for maintaining uveitis suppression when reducing systemic immunosuppression
null
Non-infectious Uveitis
Quiescent uveitis intermediate uveitis panuveitis posterior uveitis uveitis NVS Definition: Words or phrases that best describe the protocol. Keywords help users find studies in the database. Avoid acronyms, abbreviations and trade names. Examples: Heart failure, aliskiren, heart attack, cardiovascular diseases Psorias...
null
4
arm 1: AIN457 300 mg subcutaneous (s.c.) weekly for 3 weeks followed by AIN457 300 mg s.c. every 2 weeks arm 2: AIN457 300 mg s.c. at baseline for Week 2 followed by AIN457 300 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly arm 3: AIN457 150 mg s.c. and placebo s.c. at Baseline and Wee...
[ 0, 0, 0, 2 ]
2
[ 0, 0 ]
intervention 1: AIN457 150 mg powder for solution was provided in glass vials each containing 150 mg AIN457 as a lyophilized cake intervention 2: Matching placebo to AIN457
intervention 1: AIN457 intervention 2: Placebo
35
Beverly Hills | California | United States | -118.40036 | 34.07362 Atlanta | Georgia | United States | -84.38798 | 33.749 Louisville | Kentucky | United States | -85.75941 | 38.25424 Baltimore | Maryland | United States | -76.61219 | 39.29038 Cambridge | Massachusetts | United States | -71.10561 | 42.3751 Teaneck | New...
124
0
0
0
NCT01090310
6TERMINATED
2011-07-01
2010-08-01
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 ]
10
NA
SINGLE_GROUP
2DIAGNOSTIC
0NONE
false
0ALL
false
This is an open label phase 2 pilot study designed to evaluate the safety, tolerability and device performance of the GeNO nitrosyl delivery system during right heart catheterization (RHC) in participants with pulmonary arterial hypertension (PAH). All participants will receive inhaled nitric oxide in oxygen or nitric ...
TREATMENT/FOLLOW-UP: Participants meeting eligibility criteria will receive open label nitric oxide at 80 ppm via a nasal cannula. Hemodynamic clinical laboratory and clinical assessment data will be collected at baseline, after 15 minutes of inhaled nitric oxide administration, post RHC procedure and at hospital disc...
Pulmonary Arterial Hypertension
Diagnostic Techniques and Procedures
null
1
arm 1: Nitric Oxide via GeNO Nitrosyl system
[ 0 ]
1
[ 0 ]
intervention 1: single short-term exposure to inhaled nitric oxide using the GeNO nitrosyl delivery system.
intervention 1: Nitric Oxide generated by the GeNO nitrosyl delivery system
3
Boston | Massachusetts | United States | -71.05977 | 42.35843 Cleveland | Ohio | United States | -81.69541 | 41.4995 Dallas | Texas | United States | -96.80667 | 32.78306
0
0
0
0
NCT01092559
1COMPLETED
2011-07-01
2010-10-01
Geno 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
[ 0 ]
61
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
This study will assess the effects of colesevelam, alone or in combination with sitagliptin, on glucose metabolism in subjects with T2DM inadequately controlled by diet and exercise
The hypothesis is that co-administrationof colesevelam plus sitagliptin results in a greater reduction in HbA1c compared to colesevelam HCl treatment by 1. improving the effects of colesevelam on fasting glucose metabolism 2. improving the effects of colsevelam on postprandial glucose metabolism
Diabetes Mellitus, Type 2
Colesevelam type 2 diabetes sitagliptin glucose metabolism
null
2
arm 1: Subjects will be given 3.75 g/day. Subjects will be given 3 tablets (625mg each) with breakfast and 3 tablets (625mg) with dinner for 12 weeks. arm 2: Colesevelam: Subjects will be given 3.75 g/day. Subjects will be given 3 tablets (625mg each) with breakfast and 3 tablets (625mg) with dinner for 12 weeks. Sita...
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: Subjects will be given 3.75 g/day. Subjects will be given 3 tablets (625mg each) with breakfast and 3 tablets (625mg) with dinner for 12 weeks. intervention 2: Subjects will be given 100mg/day. Subjects will be given 1 tablet (100mg) with breakfast for 12 weeks.
intervention 1: Colesevelam HCl intervention 2: Sitagliptin
3
San Francisco | California | United States | -122.41942 | 37.77493 Miami | Florida | United States | -80.19366 | 25.77427 San Antonio | Texas | United States | -98.49363 | 29.42412
61
0
0
0
NCT01092663
1COMPLETED
2011-07-01
2010-03-01
KineMed
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 ]
40
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
true
0ALL
false
The purpose of this study is to investigate the utility of post-session administration of D-cycloserine to enhance fear extinction in a sample of people with acrophobia who will be treated with CBT.
null
Phobic Disorders
Phobias Anxiety Disorders D-Cycloserine Phobic Disorders Mental Disorders Heights Acrophobia
null
2
arm 1: Participants will receive placebo augmented cognitive behavioral therapy arm 2: Participants will receive D-Cycloserine augmented cognitive behavioral therapy
[ 2, 0 ]
3
[ 5, 0, 0 ]
intervention 1: The aim of CBT is to help participants become more comfortable with heights situations. Participants will receive 2 sessions over two weeks of individual CBT. intervention 2: D-Cycloserine intervention 3: Sugar Pill
intervention 1: Individual Cognitive Behavioral Therapy (CBT) intervention 2: D-Cycloserine intervention 3: Placebo
1
Dallas | Texas | United States | -96.80667 | 32.78306
58
0
0
0
NCT01102803
1COMPLETED
2011-07-01
2010-04-01
Southern Methodist University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
35
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The objectives of this study would be to see if the addition of vitamin D to fluticasone propionate provides greater symptomatic relief in patients with seasonal allergic rhinitis compared to fluticasone propionate treatment alone.
null
Seasonal Allergic Rhinitis
null
2
arm 1: Subjects will be treated with fluticasone propionate and Vitamin D once daily for 2 weeks during allergy season arm 2: Subjects will be treated with fluticasone propionate and placebo for Vitamin D once daily for 2 weeks during allergy season
[ 1, 2 ]
3
[ 0, 0, 0 ]
intervention 1: 4000 IU once daily intervention 2: Placebo taken once daily intervention 3: 200 mcg daily, intranasal
intervention 1: Vitamin D3 intervention 2: Placebo intervention 3: Fluticasone Propionate
1
Chicago | Illinois | United States | -87.65005 | 41.85003
35
0
0
0
NCT01103934
1COMPLETED
2011-07-01
2010-06-01
University of Chicago
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
33
RANDOMIZED
CROSSOVER
null
0NONE
true
0ALL
false
The purpose of this study is to determine the pharmacogenetics, pharmacokinetics, and drug-drug interactions of sitagliptin therapy.
null
Healthy
Healthy volunteers
null
3
arm 1: ABCB1 CGC/CGC genetic make-up; sitagliptin 100 mg x 1 dose; atorvastatin 40 mg x 5 doses arm 2: ABCB1 CGC/TTT genetic make-up; sitagliptin 100 mg x 1 dose; atorvastatin 40 mg x 5 doses arm 3: ABCB1 TTT/TTT genetic make-up; sitagliptin 100 mg x 1 dose; atorvastatin 40 mg x 5 doses
[ 0, 0, 0 ]
2
[ 0, 0 ]
intervention 1: sitagliptin 100 mg x 1 dose intervention 2: atorvastatin 40 mg x 5 doses
intervention 1: Sitagliptin intervention 2: atorvastatin
1
Aurora | Colorado | United States | -104.83192 | 39.72943
33
0
0
0
NCT01112670
1COMPLETED
2011-07-01
2009-11-01
University of Colorado, Denver
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
63
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
An international, multi-centre, prospective, randomised, double-blind, 4-arm, placebo controlled, parallel group study with 12 weeks once daily oral treatment in subjects with psoriasis vulgaris.
null
Psoriasis Vulgaris
Psoriasis Vulgaris Systemic Anti-psoriatic
null
4
arm 1: LEO 22811 0.5 mg: Oral solution arm 2: LEO 22811 1.5 mg: Oral solution arm 3: LEO 22811 3.0 mg: Oral solution arm 4: Placebo: Oral solution
[ 1, 1, 1, 2 ]
2
[ 0, 0 ]
intervention 1: Oral solution intervention 2: Placebo
intervention 1: LEO 22811 intervention 2: Placebo
2
Québec | N/A | Canada | -71.21454 | 46.81228 Paris | N/A | France | 2.3488 | 48.85341
63
0
0
0
NCT01116895
1COMPLETED
2011-07-01
2010-05-01
LEO Pharma
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
128
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
This study was designed to confirm the efficacy and safety of laser photocoagulation as adjunctive therapy to ranibizumab 0.5 mg versus laser monotherapy in patients with visual impairment due to Diabetic Macular Edema. A subgroup of patients with Proliferative Diabetic Retinopathy were included to evaluate the efficac...
null
Visual Impairment Due to Diabetic Macular Edema
Diabetic macular edema DME Proliferative diabetic retinopathy PDR ranibizumab laser
null
2
arm 1: Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment. Ranibizumab intravitreal injection given at baseline, at 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment. arm 2: Active laser tre...
[ 0, 1 ]
3
[ 3, 0, 0 ]
intervention 1: Active laser photocoagulation procedure at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment. intervention 2: Sham intravitreal injections at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment. inter...
intervention 1: Active laser photocoagulation intervention 2: Sham injections intervention 3: Ranibizumab 0.5 mg
34
Aschaffenburg | N/A | Germany | 9.15214 | 49.97704 Berlin | N/A | Germany | 13.41053 | 52.52437 Bonn | N/A | Germany | 7.09549 | 50.73438 Bremen | N/A | Germany | 8.80717 | 53.07582 Chemnitz | N/A | Germany | 12.92922 | 50.8357 Cologne | N/A | Germany | 6.95 | 50.93333 Darmstadt | N/A | Germany | 8.65027 | 49.87167 Des...
128
0
0
0
NCT01131585
6TERMINATED
2011-07-01
2010-06-01
Novartis Pharmaceuticals
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
810
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of the study is to compare the efficacy and safety of fluticasone furoate/vilanterol (GW642444) inhalation powder administered once daily with fluticasone propionate/salmeterol administered twice daily in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a 24-week...
null
Asthma
Salmeterol fluticasone furoate Vilanterol fluticasone propionate GW642444
null
2
arm 1: Fluticasone furoate/vilanterol inhalation powder once daily + placebo inhalation powder twice daily for 24 weeks arm 2: Fluticasone propionate/salmeterol inhalation powder twice daily + placebo inhalation powder once daily for 24 weeks
[ 0, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Fluticasone furoate/Vilanterol Inhalation Powder inhaled orally once daily for 24 weeks intervention 2: Fluticasone propionate/salmeterol Inhalation Powder inhaled orally twice daily for 24 weeks intervention 3: Inhalation powder inhaled orally once daily for 24 weeks intervention 4: Inhalation powder i...
intervention 1: Fluticasone furoate/Vilanterol Inhalation Powder intervention 2: Fluticasone propionate/salmeterol Inhalation Powder intervention 3: Placebo (1) intervention 4: Placebo (2)
63
Huntington Beach | California | United States | -117.99923 | 33.6603 Los Angeles | California | United States | -118.24368 | 34.05223 Los Angeles | California | United States | -118.24368 | 34.05223 Riverside | California | United States | -117.39616 | 33.95335 Rolling Hills Estates | California | United States | -118....
806
0
0
0
NCT01147848
1COMPLETED
2011-07-01
2010-06-01
GlaxoSmithKline
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
71
RANDOMIZED
PARALLEL
7BASIC_SCIENCE
2DOUBLE
false
0ALL
false
The purpose of the study is to find out if AZD2423 can reduce inflammation in the lungs of patients with mild COPD.
null
Chronic Obstructive Pulmonary Disease Lung Disease
Respiratory disease chronic obstructive pulmonary disease
null
2
arm 1: Oral treatment arm 2: Oral treatment
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 100mg Oral dose od intervention 2: Oral dose od
intervention 1: AZD2423 intervention 2: AZD2423 Placebo
1
Hanover | Hannover | Germany | 9.73322 | 52.37052
44
0
0
0
NCT01153321
1COMPLETED
2011-07-01
2010-10-01
AstraZeneca
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
169
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
null
The purpose of this study was to determine whether, in patients with mild to moderate knee osteoarthritis, canakinumab is safe and tolerable when injected intra-articularly.
This is a randomized, double-blind, parallel group, placebo controlled 18 weeks study, consisting of two parts: 1. Part A: an ascending single dose part in which the safety and tolerability of up to 4 different canakinumab doses are studied (starting dose 150 mg, maximum dose 600 mg). 2. Part B: a double-dummy, active...
Osteoarthritis
Osteo arthritis pain control intra- articular injections Knee OA
null
5
arm 1: In this ascending dose part, participants received a single intra-articular injection of canakinumab. The beginning dose was 150 mg, escalating to the 300 mg dose and then to 600 mg. arm 2: Participants received a single intra-articular injection of canakinumab-matching placebo. arm 3: Participants received a si...
[ 0, 2, 0, 2, 1 ]
4
[ 2, 0, 0, 0 ]
intervention 1: Intra-articular injection intervention 2: Intra-articular injection intervention 3: Tablets for oral administration intervention 4: Tablets for oral administration
intervention 1: Canakinumab intervention 2: Placebo to canakinumab intervention 3: Naproxen intervention 4: Placebo to Naproxen
13
Anniston | Alabama | United States | -85.83163 | 33.65983 Mesa | Arizona | United States | -111.82264 | 33.42227 San Diego | California | United States | -117.16472 | 32.71571 Westlake Village | California | United States | -118.80565 | 34.14584 Chicago | Illinois | United States | -87.65005 | 41.85003 Topeka | Kansas ...
169
0
0
0
NCT01160822
1COMPLETED
2011-07-01
2010-04-01
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
[ 3 ]
356
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The objective of this study is to identify the concentration and daily dosing frequency of BOL-303242-X ophthalmic suspension in treating dry eye syndrome over a 12 week dosing period.
null
Dry Eye Syndrome
null
6
arm 1: 0.3% BOL-303242-X ophthalmic suspension arm 2: 2% BOL-303242-X ophthalmic suspension arm 3: Vehicle twice daily (BID) arm 4: 1% BOL-303242-X ophthalmic suspension arm 5: 2% BOL-303242-X ophthalmic suspension in the morning (AM) and vehicle in the afternoon (PM) arm 6: Vehicle in the AM and 2% BOL-303242-X ophtha...
[ 0, 0, 2, 0, 0, 0 ]
6
[ 0, 0, 0, 0, 0, 0 ]
intervention 1: 0.3% BOL-303242-X ophthalmic suspension BID for 12 weeks. intervention 2: 2% BOL-303242-X ophthalmic suspension BID for 12 weeks. intervention 3: Placebo Comparator: Vehicle BID for 12 weeks. intervention 4: 1% BOL-303242-X ophthalmic suspension BID for 12 weeks. intervention 5: 2% BOL-303242-X ophthalm...
intervention 1: 0.3% BOL-303242-X ophthalmic suspension intervention 2: 2% BOL-303242-X ophthalmic suspension intervention 3: Placebo Comparator: Vehicle intervention 4: 1% BOL-303242-X ophthalmic suspension intervention 5: 2% BOL-303242-X ophthalmic suspension AM intervention 6: 2% BOL-303242-X ophthalmic suspension P...
1
Rochester | New York | United States | -77.61556 | 43.15478
351
0
0
0
NCT01163643
1COMPLETED
2011-07-01
2010-07-01
Bausch & Lomb Incorporated
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 ]
43
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
false
The purpose of this study is to determine whether the investigational lotion is an effective treatment of moderate to severe plaque psoriasis in comparison to an approved cream.
null
Plaque Psoriasis
null
2
arm 1: Subjects randomized to receive lotion arm 2: Subjects randomized to receive cream
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Apply 3.5 grams twice daily for 1-2 weeks intervention 2: Apply 3.5 grams twice daily for 1-2 weeks
intervention 1: Halobetasol Proprionate Lotion 0.05% intervention 2: Halobetasol Proprionate Cream 0.05%
5
San Diego | California | United States | -117.16472 | 32.71571 Clinton Township | Michigan | United States | -82.91992 | 42.58698 Troy | Michigan | United States | -83.14993 | 42.60559 Charlotte | North Carolina | United States | -80.84313 | 35.22709 Austin | Texas | United States | -97.74306 | 30.26715
43
0
0
0
NCT01166646
1COMPLETED
2011-07-01
2010-07-01
Therapeutics, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
136
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
true
0ALL
false
A major limitation to the widespread acceptance of colonoscopy as a procedure to screen for colorectal cancer is the laxative preparation. Phosphate-based preps (e.g. Fleets Phosphosoda) are now used on a limited basis because of their known association with renal injury. Polyethylene glycol (PEG) mixed with a balanced...
Objective To determine whether Miralax is as efficacious for bowel cleansing as standard Golytely for screening colonoscopy. This study is designed and powered to be an non-inferiority study. Primary aim: To compare the quality of bowel preparation between Miralax and Golytely Secondary Aims: * compare patient comfo...
Colon Cancer
PEG-3350, polyethylene glycol, colonoscopy
null
2
arm 1: 255 miralax with 64 oz gatorade. arm 2: Golytely 4 Liters
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: 255 grams of miralax mixed with 64 ounces gatorade for colonoscopy preparation. intervention 2: Golytely 4 liters
intervention 1: PEG-3350 and Gatorade intervention 2: Golytely 4 liters
1
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
136
0
0
0
NCT01170754
1COMPLETED
2011-07-01
2010-04-01
Temple 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 ]
3
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
true
0ALL
false
This will be a randomized two arm prospective study to evaluate postoperative ureteral stent pain. One arm will be given 3 days of preoperative darifenacin and the control group will have the standard of care which is no preoperative anticholinergic medication. The primary endpoints will be decreased pain scores and le...
The purpose of the study is to determine if preoperative dosing of darifenacin will assist in postoperative ureteral stent pain. This will be a randomized two arm prospective study to evaluate postoperative ureteral stent pain. One arm will be given 3 days of preoperative darifenacin and the control group will have the...
Overactive Bladder Renal Colic Pain, Postoperative
Stents [E07.695.750] Darifenacin (C101207) Kidney calculi
null
2
arm 1: 3 days of preoperative darifenacin anticholinergic medication arm 2: The control group will have the standard of care which is no preoperative anticholinegic medication.
[ 1, 4 ]
1
[ 0 ]
intervention 1: an M3 selective anticholinergic medication. M3 muscarinic receptors are felt to be related to bladder and ureteral contractility. The ureteral and bladder spasms related to ureteral stents are felt to be due to inappropriate contractions. By using a selective M3 receptor, it is felt that there will be f...
intervention 1: Darifenacin
1
Columbia | Missouri | United States | -92.33407 | 38.95171
0
0
0
0
NCT01189071
6TERMINATED
2011-07-01
2009-08-01
University of Missouri-Columbia
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 ]
446
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This study will evaluate the safety and efficacy of botulinum toxin Type A compared to placebo for the treatment of Crow's Feet Lines (Lateral Canthal Rhytides).
null
Lateral Canthus Rhytides Crow's Feet Lines
null
2
arm 1: 24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1. arm 2: normal saline injected into bilateral Crow's Feet Line areas on Day 1.
[ 0, 2 ]
2
[ 2, 0 ]
intervention 1: 24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1 intervention 2: Injected into bilateral Crow's Feet Line areas on Day 1
intervention 1: onabotulinumtoxinA intervention 2: normal saline
4
Newport Beach | California | United States | -117.92895 | 33.61891 Aalst | N/A | Belgium | 4.0355 | 50.93604 Vancouver | British Columbia | Canada | -123.11934 | 49.24966 Sutton Coldfield | England | United Kingdom | -1.81667 | 52.56667
444
0
0
0
NCT01189747
1COMPLETED
2011-07-01
2010-10-01
Allergan
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
16
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The primary objectives of this study are to evaluate the safety and tolerability of CS-7017 administered orally twice a day in combination with carboplatin and paclitaxel, and to assess the pharmacokinetics of CS-7017 in combination with carboplatin and paclitaxel.
null
Carcinoma, Non-Small-Cell Lung
PPAR gamma agonist Tumor Cancer Antineoplastic Agent Respiratory Tract Neoplasms Carboplatin Paclitaxel Neoplasms
null
1
arm 1: Drug: CS-7017 from 0.25 mg twice a day (BID) to 0.50 mg BID for up to 4\~6 cycles (1 cycle: 3 weeks) Drug: Carboplatin IV, Area under the curve (AUC) of 6 mg/mL\*min, once every three weeks for up to 4\~6 cycles (1 cycle: 3 weeks) Drug: Paclitaxel IV, 200mg/m\^2, once every three weeks for up to 4\~6 cycles (1...
[ 0 ]
3
[ 0, 0, 0 ]
intervention 1: Drug: CS-7017 from 0.25 mg BID to 0.50 mg BID for up to 4\~6 cycles (1 cycle: 3 weeks) intervention 2: Drug: Carboplatin IV, AUC of 6 mg/mL\*min, once every three weeks for up to 4\~6 cycles (1 cycle: 3 weeks) intervention 3: Drug: Paclitaxel IV, 200mg/m\^2, once every three weeks for up to 4\~6 cycles ...
intervention 1: CS-7017 intervention 2: Carboplatin intervention 3: Paclitaxel
1
Seoul | Gangnam-gu | South Korea | 126.9784 | 37.566
16
0
0
0
NCT01199055
1COMPLETED
2011-07-01
2010-03-01
Daiichi Sankyo Co., Ltd.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
27
RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
The primary objectives of this trial is to evaluate the changes from baseline (Visit 2) in the 24-hour Ambulatory Blood Pressure Monitoring mean (relative to dose time) for diastolic blood pressure and systolic blood pressure after 8 weeks of treatment with Telmisartan 80mg/Amlodipine 5mg in patients with moderate to s...
null
Hypertension
null
1
arm 1: Patients will be given placebo for 2 weeks for wash-out, then qualified patients will be administered Telmisartan 80mg/Amlodipine 5mg for 8 weeks.
[ 0 ]
1
[ 0 ]
intervention 1: after 2 weeks placebo wash-out, patients will be administered Telmisartan 80mg/Amlodipine 5mg for 8 weeks.
intervention 1: telmisartan+amlodipine fixed dose combination
1
Shanghai | N/A | China | 121.45806 | 31.22222
27
0
0
0
NCT01204398
1COMPLETED
2011-07-01
2010-11-01
Boehringer Ingelheim
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
11
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
Erlotinib attacks a part of cancer cells that helps them live and grow. Studies done in human beings show that this drug can make a difference in the way anti-estrogens work in hormone-sensitive breast cancers. OSI-906 attacks a different part of the cancer cell that helps them live and grow. Studies done in the labora...
The safety run component of this trial is to determine the safety profile of the OSI-906, erlotinib and anti-endocrine treatment combination. The phase II component evaluates the antitumor activity of the combination OSI-906, erlotinib and endocrine therapy.
Hormone-sensitive Metastatic Breast Cancer
null
1
arm 1: * OSI-906 in a pill form, by mouth, twice a day (12 hours a part) * Erlotinib in a pill form, by mouth, once a day * Letrozole in a pill form, by mouth, once a day * Goserelin, by injection once per month for women who are pre-menopausal
[ 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: In a pill form by mouth, twice a day (12 hours apart) During the safety run portion of the study" * Dose level 2 = 150 mg twice a day * Dose level 1 = 100 mg twice a day * Dose level -1 = 100 mg twice a day * Dose level -2 = 100 mg twice a day intervention 2: During the safety run phase of the study: ...
intervention 1: OSI-906 intervention 2: Erlotinib intervention 3: Letrozole intervention 4: Goserelin
3
Franklin | Tennessee | United States | -86.86889 | 35.92506 Nashville | Tennessee | United States | -86.78444 | 36.16589 Nashville | Tennessee | United States | -86.78444 | 36.16589
11
0
0
0
NCT01205685
6TERMINATED
2011-07-01
2010-05-01
Vanderbilt-Ingram Cancer Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
69
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
The aim of this study will be to determine the efficacy of this novel, lipid-containing artificial tear on the signs and symptoms of meibomian gland disease.
This investigation will involve approximately 90 MGD subjects, randomly assigned to either the Systane Balance treatment group or a control group using Optive™ Lubricant Eyedrops (Allergan), a low-viscosity artificial tear. Both arms will dose the drops four times per day and the treatment trial will be conducted for 6...
Meibomian Gland Dysfunction
dry eye, MGD, tear film break up time
null
2
arm 1: Artificial tear emulsion arm 2: Artificial tear
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Artificial tear emulsion drop intervention 2: Artificial tear eye drop
intervention 1: Systane Balance intervention 2: Optive Lubricant Eye Drops
1
Fullerton | California | United States | -117.92534 | 33.87029
69
0
0
0
NCT01207752
1COMPLETED
2011-07-01
2010-09-01
Southern California College of Optometry at Marshall B. Ketchum University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
38
RANDOMIZED
SINGLE_GROUP
0TREATMENT
4QUADRUPLE
false
0ALL
false
The primary purpose of this Study is to help answer the following research question(s). * How does LY2189265 affect gastric emptying (the speed at which food and drink leaves the stomach) in patients with Type 2 diabetes? * How does LY2189265 affect how the body handles metformin (a drug used to treat Type 2 diabetes)...
null
Diabetes Mellitus, Type 2
null
2
arm 1: Each participant will receive placebo on Week 1. Participants randomized to placebo will receive once-weekly doses of placebo on Weeks 2 to 5. Placebo will be administered by single subcutaneous injection into the skin of the abdominal wall. Participants regularly taking metformin will continue their normal do...
[ 2, 0 ]
2
[ 2, 0 ]
intervention 1: 1.5 mg administered subcutaneously intervention 2: Administered subcutaneously
intervention 1: LY2189265 intervention 2: Placebo
1
Glasgow | N/A | United Kingdom | -4.25763 | 55.86515
62
0
0
0
NCT01215968
1COMPLETED
2011-07-01
2010-09-01
Eli Lilly and Company
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
71
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
Primary Objective: To demonstrate that use of glucose sparing prescriptions, Dianeal, Extraneal, Nutrineal (D-E-N) versus Dianeal only, in diabetic (Type 1 and Type 2) Continuous Ambulatory Peritoneal Dialysis (CAPD) patients leads to improved metabolic control as measured by the magnitude of change from the baseline v...
null
End Stage Renal Disease (ESRD) Diabetes CAPD
ESRD Diabetes CAPD
null
2
arm 1: Dianeal only arm 2: Dianeal, Extraneal, Nutrineal
[ 1, 0 ]
2
[ 0, 0 ]
intervention 1: Dianeal 1.5% dextrose, 2.5% dextrose, 4.25% dextrose intervention 2: Dianeal 1.5% dextrose, 2.5% dextrose, 4.25% dextrose, Nutrineal 1.1% Amino Acids, Extraneal 7.5% Icodextrin
intervention 1: Dianeal intervention 2: Dianeal, Extraneal, Nutrineal
16
Armenia | N/A | Colombia | -75.67263 | 4.53656 Barranquilla | N/A | Colombia | -74.78132 | 10.96854 Bogotá | N/A | Colombia | -74.08175 | 4.60971 Bucaramanga | N/A | Colombia | -73.11895 | 7.125 Cartagena | N/A | Colombia | -75.49328 | 10.39817 Cúcuta | N/A | Colombia | -72.5049 | 7.90745 Girardot | N/A | Colombia | -7...
251
0
0
0
NCT01219959
1COMPLETED
2011-07-01
2010-10-01
Vantive Health LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
30
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
1FEMALE
false
This is a multi-center, open-label, drug-drug interaction study in postmenopausal women with osteoporosis.
Approximately 27 subjects (Group A: 18; Group B: 9) will receive a 2 mg oral dose of midazolam on day 1 followed by a 24 hour PK collection. Subjects randomized to Group A will receive a single 60 mg subcutaneous (SC) dose of denosumab on day 2 administered in the abdomen. On study day 16, another 2 mg oral dose of mid...
Postmenopausal Osteoporosis
Amgen Phase 1 Postmenopausal Osteoporosis
null
2
arm 1: All 27 subjects will receive midazolam. arm 2: Eighteen (18) subjects will receive denosumab.
[ 5, 1 ]
2
[ 0, 0 ]
intervention 1: Eighteen (18) subjects will receive 1 fixed dose administration of denosumab. intervention 2: All subjects will receive two oral dose administrations of midazolam.
intervention 1: Denosumab intervention 2: Midazolam
0
null
79
0
0
0
NCT01221727
1COMPLETED
2011-07-01
2010-11-01
Amgen
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
8
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The primary objective of the study is to compare the efficacy of duloxetine 60 mg by mouth daily with placebo in the prevention of depression associated with mild/moderate traumatic brain injury and to enhance cognitive function.
The primary objective of the study is to compare the efficacy of duloxetine 60 mg by mouth daily with placebo in the prevention of depression associated with mild/moderate traumatic brain injury and to enhance cognitive function. Research exploring the use of selective serotonin reuptake inhibitors in the treatment of ...
Traumatic Brain Injury Depression
Depression Traumatic brain injury Duloxetine Cymbalta impaired cognitive function
null
2
arm 1: Duloxetine 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously. arm 2: Sugar pills 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Duloxetine 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously. intervention 2: Sugar pills 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months p...
intervention 1: Duloxetine intervention 2: Sugar pill
1
Indianapolis | Indiana | United States | -86.15804 | 39.76838
8
0
0
0
NCT01223001
6TERMINATED
2011-07-01
1996-09-01
Rehabilitation Hospital of Indiana
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 ]
6
NA
SINGLE_GROUP
0TREATMENT
0NONE
true
0ALL
false
In this study the investigators will test a nutritional supplement called betaine hydrochloride to see if it can temporarily increase the stomach acid in healthy volunteers who have decreased stomach acid because they take a medicine called rabeprazole.
Investigators will evaluate the extent and time course of gastric re-acidification after oral betaine HCl in healthy volunteers with pharmacologically-induced hypochlorhydria. After betaine HCl dose, gastric pH will be continuously monitored for 2 hours.
Pharmacodynamic
null
1
arm 1: None
[ 0 ]
2
[ 7, 0 ]
intervention 1: betaine hydrochloride 1500mg po x 1 on day 5 intervention 2: rabeprazole po daily x 5 days
intervention 1: betaine hydrochloride intervention 2: Rabeprazole
1
San Francisco | California | United States | -122.41942 | 37.77493
6
0
0
0
NCT01237353
1COMPLETED
2011-07-01
2011-03-01
University of California, San Francisco
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
7
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The primary objective of this study is to determine the pharmacokinetic profile of a 50 mg/kg loading dose of intravenous levetiracetam (LEV) in term and late preterm infants with seizures. Secondary objectives are to evaluate the safety and efficacy of a 50 mg/kg loading dose of levetiracetam in term and preterm infan...
null
Seizures
seizures neonate levetiracetam Epilepsy central nervous system diseases anticonvulsants
null
0
null
null
1
[ 0 ]
intervention 1: 50 mg/kg single loading dose of IV levetiracetam
intervention 1: levetiracetam
1
Cincinnati | Ohio | United States | -84.51439 | 39.12711
7
0
0
0
NCT01239212
1COMPLETED
2011-07-01
2010-09-01
Children's Hospital Medical Center, Cincinnati
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
36
RANDOMIZED
CROSSOVER
null
2DOUBLE
true
0ALL
true
Nanotechnology is the controlled generation and manipulation of matter in dimensions less than 100 nm. Silver has been used for its bactericidal properties. The investigators propose to study the American Biotech Laboratory 32 ppm silver solution over a 14-day period in human volunteers to determine the toxicity and to...
null
Healthy
null
2
arm 1: Oral Dose of 10ppm arm 2: Oral Dose of 32ppm
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Silver nanoparticles at 10ppm intervention 2: Silver nanoparticles at 32ppm
intervention 1: 10ppm Oral Silver Particle intervention 2: 32ppm Oral Silver Particle
1
Salt Lake City | Utah | United States | -111.89105 | 40.76078
60
0
0
0
NCT01243320
1COMPLETED
2011-07-01
2010-12-01
University of Utah
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 ]
70
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
false
The purpose of the study is to compare safety and efficacy of Fibrin Sealant (FS) Vapor Heated (VH) S/D 500 s-apr with manual compression as a supportive treatment of local bleeding (i.e. oozing) in hepatic resection surgery when standard surgical techniques are insufficient.
null
Bleeding (Oozing) in Hepatic Resection
null
2
arm 1: Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant. Hemostasis will be assessed at 4, 6, 8 and 10 minutes after application of the study treatment. arm 2: A dry surgical gauze swab will be used to apply...
[ 0, 1 ]
2
[ 0, 10 ]
intervention 1: Dosage form: spray application; dosage frequency: single application intervention 2: Dosage form: surgical gauze swab; dosage frequency: single application
intervention 1: Fibrin Sealant (FS) VH S/D 500 s-apr intervention 2: Manual compression
7
Berlin | N/A | Germany | 13.41053 | 52.52437 Essen | N/A | Germany | 7.01228 | 51.45657 Hanover | N/A | Germany | 9.73322 | 52.37052 Heidelberg | N/A | Germany | 8.69079 | 49.40768 Jena | N/A | Germany | 11.5899 | 50.92878 Leipzig | N/A | Germany | 12.37129 | 51.33962 Tübingen | N/A | Germany | 9.05222 | 48.52266
70
0
0
0
NCT01244425
1COMPLETED
2011-07-01
2010-11-01
Baxter Healthcare 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
[ 5 ]
9
RANDOMIZED
FACTORIAL
9OTHER
0NONE
false
0ALL
true
Heparin/Platelet Factor 4 (PF4) antibody testing will be performed in subjects who have just undergone coronary artery bypass grafting (CABG) surgery. 30 subjects with a positive antibody result and no signs or symptoms of Heparin Induced Thrombocytopenia (HIT) will be randomized to receive argatroban and warfarin. 30 ...
This is a prospective, randomized, single center study. Patients scheduled for CABG will be screened and enrolled. Subjects positive for heparin/PF4 antibody within 24 h after CABG and without clinical suspicion of HIT will be randomized into one of two groups. An additional 30 patients with negative antibody titers wi...
Coronary Artery Bypass Graft Surgery Presence of Heparin/Platelet Factor 4 Antibody
null
3
arm 1: Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive argatroban and warfarin arm 2: Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive no medication arm 3: Post-CABG heparin PF4 antibody negative with no signs or symptoms of HI...
[ 0, 4, 4 ]
1
[ 0 ]
intervention 1: Subjects with the presence of heparin PF4 antibodies without signs or symptoms of HIT post CABG will be randomized to receive argatroban and warfarin or no drug for one month.
intervention 1: Argatroban and warfarin
1
Boston | Massachusetts | United States | -71.05977 | 42.35843
8
0
0
0
NCT01246011
6TERMINATED
2011-07-01
2010-11-01
Massachusetts General Hospital
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
6
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
null
The purpose of the protocol is to determine the effect of BN83495 on the progression of endometrial cancer with estrogen receptor in post menopausal women who had previously received chemotherapy.
null
Endometrial Cancer
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
intervention 1: BN83495
9
Augusta | Georgia | United States | -81.97484 | 33.47097 Minneapolis | Minnesota | United States | -93.26384 | 44.97997 Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 Upland | Pennsylvania | United States | -75.38269 | 39.85261 London | Ontario | Canada | -81.23304 | 42.98339 Ottawa | Ontario | Cana...
6
0
0
0
NCT01251354
6TERMINATED
2011-07-01
2010-11-01
Ipsen
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0