FEATURE_phases
list
FEATURE_enrollmentCount
int64
FEATURE_allocation
string
FEATURE_interventionModel
string
FEATURE_primaryPurpose
class label
FEATURE_masking
class label
FEATURE_healthyVolunteers
bool
FEATURE_sex
class label
FEATURE_oversightHasDmc
bool
FEATURE_briefSummary
string
FEATURE_detailedDescription
string
FEATURE_conditions
string
FEATURE_conditionsKeywords
string
FEATURE_protocolPdfText
string
FEATURE_numArms
int64
FEATURE_armDescriptions
string
FEATURE_armGroupTypes
list
FEATURE_numInterventions
int64
FEATURE_interventionTypes
list
FEATURE_interventionDescriptions
string
FEATURE_interventionNames
string
FEATURE_numLocations
int64
FEATURE_locationDetails
string
LABEL_ct_level_ade_population
int64
LABEL_sum_dosing_errors
int64
LABEL_dosing_error_rate
float32
LABEL_wilson_label
int64
METADATA_nctId
string
METADATA_overallStatus
class label
METADATA_completionDate
date32
METADATA_startDate
date32
METADATA_leadSponsorName
string
METADATA_leadSponsorClass
class label
METADATA_hasProtocol
bool
METADATA_hasSap
bool
METADATA_hasIcf
bool
METADATA_protocolPdfLinks
string
METADATA_count_Accidental drug intake by child
int64
METADATA_count_Accidental overdose
int64
METADATA_count_Accidental overdose (therapeutic agent)
int64
METADATA_count_Accidental underdose
int64
METADATA_count_Deliberate overdose
int64
METADATA_count_Dose calculation error
int64
METADATA_count_Drug administration error
int64
METADATA_count_Drug overdose
int64
METADATA_count_Drug overdose accidental
int64
METADATA_count_Extra dose administered
int64
METADATA_count_Incorrect dosage administered
int64
METADATA_count_Incorrect dose administered
int64
METADATA_count_Incorrect drug administration duration
int64
METADATA_count_Incorrect drug administration rate
int64
METADATA_count_Incorrect product administration duration
int64
METADATA_count_Intentional overdose
int64
METADATA_count_Medication error
int64
METADATA_count_Medication monitoring error
int64
METADATA_count_Multiple drug overdose
int64
METADATA_count_Multiple drug overdose accidental
int64
METADATA_count_Multiple drug overdose intentional
int64
METADATA_count_Multiple use of single-use product
int64
METADATA_count_Non-accidental overdose
int64
METADATA_count_Overdose
int64
METADATA_count_Overdose NOS
int64
METADATA_count_Overmedication
int64
METADATA_count_Prescribed overdose
int64
METADATA_count_Treatment noncompliance
int64
METADATA_count_Underdose
int64
METADATA_count_Unintentional medical device removal
int64
METADATA_count_Unintentional medical device removal by patient
int64
METADATA_wilson_lower_bound
float32
[ 3 ]
10
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The investigators hypothesize that, in addition to its apoptotic effect, clofarabine induces DNA hypomethylation. If the investigators' hypothesis is correct, findings from the present proposal will not only contribute to information relating to the mechanisms of action of clofarabine but also provide the opportunity f...
Study Overview This study will recruit patients who have received at least six cycles of 5-azacytidine without response or whose disease has progressed or relapsed while on 5-azacytidine. The first cohort of patients will receive clofarabine 10 mg/m2/day for five days and the second cohort of patients 5 mg/m2/day for ...
Myelodysplastic Syndromes
Myelodysplastic Syndromes
null
2
arm 1: Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progress...
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: 10 mg/m2 x 5 days per 4 to 6 week cycles intervention 2: 5 mg/m2 x 5 days per 4 to 6 week cycles
intervention 1: Clofarabine intervention 2: Clofarabine
1
Amarillo | Texas | United States | -101.8313 | 35.222
10
0
0
0
NCT00700011
6TERMINATED
2010-03-01
2008-03-01
Texas Oncology Cancer Center
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 ]
59
RANDOMIZED
PARALLEL
1PREVENTION
1SINGLE
false
0ALL
true
This study is to investigate the effect of Sodium Bicarbonate bolus injection in patients undergoing an emergent coronary procedure for prevention of contrast-induced nephropathy.
This study is to investigate the effect of Sodium Bicarbonate bolus injection in patients undergoing an emergent coronary procedure for prevention of contrast-induced nephropathy.The End point is development of contrast-induced nephropathy.
Emergent Coronary Procedure
Patients undergoing an emergent coronary procedure
null
2
arm 1: None arm 2: None
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: 8.4%sodium bicarbonate 0.5ml/kg bolus injection before procedure and hydration with 154mEq/l sodium bicarbonate 1ml/kg/Hr for 6 hours after the procedure intervention 2: 8.4%sodium bicarbonate 0.5ml/kg bolus injection before procedure and hydration with 154mEq/l sodium bicarbonate 1ml/kg/Hr for 6 hours ...
intervention 1: Sodium bicarbonate intervention 2: Sodium Chloride
1
Osaka | N/A | Japan | 135.50107 | 34.69379
59
0
0
0
NCT00700375
1COMPLETED
2010-03-01
2008-07-01
Osaka General Medical Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
2
NA
SINGLE_GROUP
0TREATMENT
0NONE
true
1FEMALE
true
The purpose of this study is to determine whether 6 months of fiber supplementation will improve ovulation in women with polycystic ovary syndrome (PCOS).
We hypothesize that 6 months of fiber supplementation will improve ovulation in women with PCOS by improving insulin sensitivity independent of weight loss. In this pilot study, we will determine the feasibility of conducting a larger double-blind, randomized trial in women with PCOS to test this hypothesis. We will ev...
PCOS
null
1
arm 1: 2 tablespoons daily
[ 0 ]
1
[ 0 ]
intervention 1: Liquid fiber supplement, 2 tablespoons twice daily.
intervention 1: Fiber-Stat
1
Richmond | Virginia | United States | -77.46026 | 37.55376
2
0
0
0
NCT00703092
6TERMINATED
2010-03-01
2008-02-01
Virginia Commonwealth 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 ]
115
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
true
0ALL
true
The purpose of this study is to compare the incidence of nausea, vomiting, need for rescue medication, prolonged PACU time, and unplanned hospital admission in patients with high risk for post-operative nausea and vomiting (PONV) treated with oral aprepitant with or without transdermal scopolamine preoperatively.
Aprepitant, a selective antagonist of neurokinin-1 (NK-1) receptors, blocks the emetic effects of substance P. NK-1 receptors are found on vagal afferents in the gastrointestinal tract and in the nucleus tractus solitaries in the brain. Substance P action on the NK-1 receptors in the central nervous system (CNS) is one...
Nausea Vomiting
postoperative nausea and vomiting
null
2
arm 1: Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a...
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia intervention 2: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery
intervention 1: Aprepitant intervention 2: Scopolamine
1
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
115
0
0
0
NCT00717054
1COMPLETED
2010-03-01
2008-02-01
Drexel 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 ]
42
NON_RANDOMIZED
PARALLEL
7BASIC_SCIENCE
0NONE
true
0ALL
true
We propose to study and compare measures of brain energy metabolism in geriatric bipolar individuals and healthy older adults. We would also like to investigate changes in brain energy metabolites and in vivo creatine kinase (CK) enzymatic activity associated with CoQ10 administration in older bipolar individuals.
Hypotheses 1. At baseline, the forward rate constant (kfor) of CK enzymatic activity in the frontal lobe of older subjects with bipolar depression will be significantly decreased relative to that of age-matched healthy controls. 2. After 8 weeks of treatment, bipolar depression subjects will demonstrate an increase in...
Bipolar Depression
Bipolar depression elderly Coenzyme Q10 Magnetic resonance spectroscopy
null
2
arm 1: Open Label Study arm 2: Healthy controls completed all study procedures completed by the CoQ10 group but did not receive any study medication.
[ 0, 4 ]
1
[ 0 ]
intervention 1: CoEnzyme Q10 with dosage range from 400 mg to 1200 mg per day
intervention 1: CoEnzyme Q10
1
Belmont | Massachusetts | United States | -71.17867 | 42.39593
19
0
0
0
NCT00720369
1COMPLETED
2010-03-01
2008-07-01
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 ]
35
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of this study is to further assess the potency of PF-00868554, an HCV polymerase inhibitor, in subjects chronically infected with HCV by evaluating the antiviral activity of PF-00868554 in combination with current standard of care therapy, pegylated interferon-alpha2a (PEGASYS) and ribavirin (COPEGUS).
null
Hepatitis C
null
4
arm 1: 500 mg BID arm 2: 300 mg BID arm 3: 200 mg BID arm 4: Placebo
[ 0, 0, 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 500 mg BID administered as 5x100 mg tablets for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks. intervention 2: 300 mg BID administered as 3x100 mg tablets for 4 weeks in combination with standard of care; standard of care continued for an additional ...
intervention 1: PF-00868554 intervention 2: PF-00868554 intervention 3: PF-00868554 intervention 4: Placebo
10
La Jolla | California | United States | -117.2742 | 32.84727 San Francisco | California | United States | -122.41942 | 37.77493 Orlando | Florida | United States | -81.37924 | 28.53834 Springfield | Massachusetts | United States | -72.58981 | 42.10148 New York | New York | United States | -74.00597 | 40.71427 New York ...
35
0
0
0
NCT00720434
1COMPLETED
2010-03-01
2008-08-01
Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
158
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of this study is to evaluate the safety and efficacy of ustekinumab (CNTO 1275) compared with placebo in participants with moderate to severe plaque type psoriasis.
This is a multicenter (involving more than 1 study center), randomized (study medication assigned by chance), double-blind (neither the invesitigator nor the participant knows the identity of the study medication), placebo- controlled (1 of the study medications is inactive), parallel-group comparative study (different...
Psoriasis
Psoriasis Ustekinumab CNTO 1275
null
7
arm 1: Placebo 0.5 ml and 1.0 ml will be administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12). arm 2: Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) will be administered SC on Weeks 0 and 4 during controlled period (Weeks 0-12). arm 3: Ustekinumab 90 mg (1.0 ml) and ...
[ 2, 1, 1, 2, 2, 1, 1 ]
7
[ 0, 0, 0, 0, 0, 0, 0 ]
intervention 1: Placebo 0.5 ml and 1.0 ml will be administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12). intervention 2: Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) will be administered SC on Weeks 0 and 4 during controlled period (Weeks 0-12). intervention 3: Uste...
intervention 1: Placebo (CP) intervention 2: Ustekinumab 45 mg (CP) intervention 3: Ustekinumab 90 mg (CP) intervention 4: Placebo A (After CP) intervention 5: Placebo B (After CP) intervention 6: Ustekinumab 45 mg (After CP) intervention 7: Ustekinumab 90 mg (After CP)
27
Asahikawa | N/A | Japan | 142.36489 | 43.77063 Chitose | N/A | Japan | 141.65222 | 42.81944 Chūō | N/A | Japan | 139.77544 | 35.67004 Fukuoka | N/A | Japan | 130.41667 | 33.6 Fushimi | N/A | Japan | 138.89742 | 35.11426 Isehara | N/A | Japan | 139.31019 | 35.39932 Kanazawa | N/A | Japan | 136.61667 | 36.6 Kurume | N/A ...
312
0
0
0
NCT00723528
1COMPLETED
2010-03-01
2008-03-01
Janssen Pharmaceutical K.K.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
28
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
Paclitaxel is known to be active as a single and combination agent in esophageal cancer, and has also been demonstrated to have anti-angiogenic properties in weekly dosing regimens. Sunitinib malate is an anti-angiogenic drug with the potential to improve responses when combined with chemotherapy, as demonstrated with ...
OUTLINE: This is a multi-center study. Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle. * Paclitaxel ...
Esophageal Cancer
null
1
arm 1: Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle. * Paclitaxel 90 mg/m2 IV on days 1, 8 and 15. ...
[ 0 ]
2
[ 0, 0 ]
intervention 1: Sunitinib malate 37.5 mg orally, daily intervention 2: Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.
intervention 1: Sunitinib malate intervention 2: Paclitaxel
15
Chicago | Illinois | United States | -87.65005 | 41.85003 Chicago | Illinois | United States | -87.65005 | 41.85003 Galesburg | Illinois | United States | -90.37124 | 40.94782 Bloomington | Indiana | United States | -86.52639 | 39.16533 Evansville | Indiana | United States | -87.55585 | 37.97476 Fort Wayne | Indiana | ...
28
0
0
0
NCT00730353
1COMPLETED
2010-03-01
2008-08-01
Hoosier Cancer Research Network
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
121
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
The purpose of this study is to evaluate the efficacy and safety of Ustekinumab in the treatment of patients with moderate to severe psoriasis in South Korea and Taiwan.
This is phase 3, multicenter, randomized, placebo-controlled double-blind, parallel study of subcutaneous injection of placebo and ustekinumab 45mg in Taiwanese and Korean patients with moderate to severe plaque psoriasis. Ustekinumab is an experimental medicine that is being tested to see if it may be useful in treati...
Psoriasis
Psoriasis Psoriatic Arthritis Ustekinumab CNTO 1275
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: Placebo, Weeks 0-12 intervention 2: Ustekinumab 45 mg, Weeks 0-12 intervention 3: Placebo at Weeks 0 and 4, then ustekinumab 45 mg at Week 12 and Week 16 intervention 4: Ustekinumab 45 mg at Weeks 0 and 4, then placebo at Week 12 and ustekinumab 45 mg at Week 16
intervention 1: Placebo - Controlled Period (CP) intervention 2: Ustekinumab 45 mg - CP intervention 3: Placebo to ustekinumab 45 mg - after CP intervention 4: Ustekinumab 45 mg - after CP
5
Anyang | N/A | South Korea | 127.1464 | 36.9577 Seoul | N/A | South Korea | 126.9784 | 37.566 Changhua | N/A | Taiwan | 120.5512 | 24.0692 Kaohsiung County | N/A | Taiwan | N/A | N/A Taipei | N/A | Taiwan | 121.52639 | 25.05306
235
0
0
0
NCT00747344
1COMPLETED
2010-03-01
2008-12-01
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
[ 2 ]
112
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This study will asses the safety, tolerability, multiple-dose pharmacokinetics and pharmacodynamics of MK1006 in participants with type 2 diabetes.
null
Type 2 Diabetes
null
10
arm 1: After a 2-week run-in/wash-off period, participants received single daily doses (q.d.) of 20 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU). arm 2: After a 2-week run-in/wash-off period, participants received single daily doses of 40 mg MK-1006 over ...
[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 2 ]
2
[ 0, 0 ]
intervention 1: MK-1006 capsules (10 mg and 20 mg) administered orally from 20 mg to 120 mg per dose over a multiple dosing period. intervention 2: Dose-matched MK-1006 placebo capsules (1 mg, 10 mg and 20 mg) administered orally over a multiple dosing period.
intervention 1: MK-1006 intervention 2: Comparator: Placebo comparator
0
null
112
0
0
0
NCT00758680
6TERMINATED
2010-03-01
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 ]
1,179
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to evaluate the safety and efficacy of Moxifloxacin AF Ophthalmic Solution compared to Moxifloxacin AF Vehicle in the treatment of bacterial conjunctivitis in patients one month of age or older.
null
Bacterial Conjunctivitis
pink eye conjunctivitis moxifloxacin fluoroquinolone
null
2
arm 1: Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5%, 1 drop in each eye twice daily for 3 days arm 2: Moxifloxacin AF vehicle, 1 drop in each eye twice daily for 3 days
[ 0, 2 ]
2
[ 0, 10 ]
intervention 1: Eye drops intervention 2: Inactive ingredients used as a placebo for masking purposes
intervention 1: Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5% intervention 2: Moxifloxacin AF Vehicle
0
null
1,179
0
0
0
NCT00759148
1COMPLETED
2010-03-01
2008-10-01
Alcon Research
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
29
NON_RANDOMIZED
CROSSOVER
null
0NONE
true
0ALL
false
This study will evaluate what effect renal dysfunction has on a drug that has an intravenous (CP-70,429) and an oral form (PF-03709270).
To evaluate the pharmacokinetics and safety.
Pneumonia
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Study Periods 1 and 2 will be separated by a minimum of 14 days. In Period 1, subjects will receive a single dose of CP-70429 (800 mg given as a 1.5 hour intravenous infusion), while in Period 2, subjects will receive a single oral dose of PF-03709270 (1000 mg).
intervention 1: CP-70,429 and PF-03709270
2
Indianapolis | Indiana | United States | -86.15804 | 39.76838 Brussels | N/A | Belgium | 4.34878 | 50.85045
57
0
0
0
NCT00759564
1COMPLETED
2010-03-01
2008-11-01
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 ]
32
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This is a phase II, open-label, multicenter, dual-strata study designed to evaluate the efficacy and safety of IV romidepsin given in combination with IV bortezomib for multiple myeloma (MM) patients with refractory or relapsed disease. Patients will be enrolled into one of two strata, bortezomib-resistant or bortezomi...
null
Multiple Myeloma
Multiple Myelonoma Romidepsin Bortezomib
null
1
arm 1: Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period. Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles.
[ 0 ]
2
[ 0, 0 ]
intervention 1: Bortezomib was administered at a dose of 1.0 mg/m\^2 as an intravenous (IV) push over 3 to 5 seconds twice weekly for 2 consecutive weeks (Days 1, 4, 8 and 11) of each 28-day cycle. On days that bortezomib and romidepsin were administered together, bortezomib was administered prior to the romidepsin inf...
intervention 1: Bortezomib intervention 2: Romidepsin
12
Loma Linda | California | United States | -117.26115 | 34.04835 Rancho Mirage | California | United States | -116.41279 | 33.73974 Santa Barbara | California | United States | -119.69819 | 34.42083 West Hollywood | California | United States | -118.36174 | 34.09001 Atlanta | Georgia | United States | -84.38798 | 33.749...
32
0
0
0
NCT00765102
6TERMINATED
2010-03-01
2008-09-01
Celgene
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3, 4 ]
337
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
The purpose of this study is to evaluate the efficacy and safety of E3810 tablets in patients with Proton Pump Inhibitor-resistant reflux esophagitis.
This is a multicenter, randomized, double-blinded study. The efficacy with E3810 20 mg once daily is compared with E3810 20 mg twice daily and 10 mg twice daily using endoscopic recovery. The frequency of adverse event, etc., will be compared among 3 groups for safety assessment.
Refractory Reflux Esophagitis
reflux esophagitis rabeprazole GERD Japan
null
3
arm 1: None arm 2: None arm 3: None
[ 1, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: 20 mg taken orally, once a day for 8 weeks. intervention 2: 10 mg, taken orally, twice a day for 8 weeks. intervention 3: 20 mg taken orally, twice a day for 8 weeks.
intervention 1: E3810 intervention 2: E3810 intervention 3: E3810
54
Nagakute | Aichi-ken | Japan | 137.05667 | 35.17325 Nagoya | Aichi-ken | Japan | 136.90641 | 35.18147 Akita | Akita | Japan | 140.11667 | 39.71667 Abiko | Chiba | Japan | 140.01667 | 35.86667 Kashiwa | Chiba | Japan | 139.97732 | 35.86224 Yachiyo | Chiba | Japan | 140.12445 | 35.73531 Chikushino-shi | Fukuoka | Japan |...
337
0
0
0
NCT00770913
1COMPLETED
2010-03-01
2008-10-01
Eisai Co., Ltd.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
140
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This single arm study will assess the long term maintenance of hemoglobin (Hb) levels, safety and tolerability of once monthly subcutaneous methoxy polyethylene glycol-epoetin beta (CERA) in predialysis participants with chronic renal anemia. Participants currently receiving subcutaneous darbopoetin alfa maintenance tr...
null
Anemia
null
1
arm 1: Participants will receive methoxy polyethylene glycol-epoetin beta once monthly by subcutaneous (SC) injection for 28 weeks.
[ 0 ]
1
[ 0 ]
intervention 1: 120, 200 or 360 micrograms every 4 weeks by subcutaneous injection.
intervention 1: Methoxy Polyethylene Glycol-Epoetin Beta
34
Barletta | Apulia | Italy | 16.28165 | 41.31429 Molfetta (Ba) | Apulia | Italy | 16.59905 | 41.20036 Putignano | Apulia | Italy | 17.1219 | 40.85106 Caserta | Campania | Italy | 14.33231 | 41.07262 Eboli | Campania | Italy | 15.05693 | 40.61747 Napoli | Campania | Italy | 14.5195 | 40.87618 Nola | Campania | Italy | 14...
111
0
0
0
NCT00773968
1COMPLETED
2010-03-01
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 ]
27
RANDOMIZED
SINGLE_GROUP
0TREATMENT
1SINGLE
false
0ALL
false
The purpose of this study is to determine if use of topical imiquimod cream after cryotherapy of actinic keratoses reduces the total number of lesions (those treated with cryotherapy and new ones) at follow-up.
Actinic keratoses are common skin lesions associated with excess sun exposure. Over time, there is a small risk a lesion may progress to skin cancer. Since one can not predict which actinic keratosis will progress, the standard of care is to treat the lesions. The most commonly used method to treat actinic keratoses in...
Actinic Keratoses
Combination treatment Imiquimod Cryotherapy
null
2
arm 1: Imiquimod 5% cream, 1 packet (250 mg cream), applied to left or right treatment area on the face and/or balding scalp arm 2: No treatment of treatment area on the other half of the face and/or balding scalp
[ 0, 4 ]
1
[ 0 ]
intervention 1: 1 packet (250 mg cream) 3 times per week for 4 weeks
intervention 1: imiquimod 5% cream
3
St. Petersburg | Florida | United States | -82.67927 | 27.77086 Henderson | Nevada | United States | -114.98194 | 36.0397 New York | New York | United States | -74.00597 | 40.71427
27
0
0
0
NCT00774787
1COMPLETED
2010-03-01
2008-10-01
Rigel Dermatology
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
4
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
1FEMALE
false
The purpose of the study is to assess the benefit of panobinostat monotherapy given either orally or i.v. to women with HER2-positive locally recurrent or metastatic breast cancer
null
Breast Cancer
null
2
arm 1: None arm 2: None
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Solution for infusion - 25mg/5ml intervention 2: Hard gelatine capsules - 5mg and 20 mg
intervention 1: Panobinostat - LBH589 intervention 2: Panobinostat - LBH589
1
Los Angeles | California | United States | -118.24368 | 34.05223
4
0
0
0
NCT00777335
6TERMINATED
2010-03-01
2009-02-01
Translational Research in Oncology
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 ]
72
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
Little is known about the support needed to improve compliance with Chantix for smoking cessation. This is a two arm pilot study of African American smokers to provide varying levels of side effect management and compliance support during a 12 week treatment period. The primary aim of the study is to estimate the effec...
null
Smokers
African american smokers smoking cessation African American smokers
null
2
arm 1: Chantix for 3 months and Standard Counseling arm 2: Chantix for 3 months and Adherence Counseling
[ 1, 0 ]
3
[ 0, 5, 5 ]
intervention 1: Chantix 0.5 mg once daily on days 1-3, 0.5 mg twice daily on days 4-7, and 1 mg twice daily on day 8 through end of treatment at month 3 intervention 2: Induction Support counseling on days 8, 12, 20 and months 1 and 2. Adherence counseling based on the Information-Motivation-Behavioral Skills model of ...
intervention 1: Chantix intervention 2: Adherence Counseling intervention 3: Standard Counseling
1
Kansas City | Kansas | United States | -94.62746 | 39.11417
72
0
0
0
NCT00781599
1COMPLETED
2010-03-01
2008-10-01
Nikki Nollen, PhD, MA
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
48
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to evalute the response and toxicity of metastatic colorectal cancer patients to the regimen of gamma interferon added to bolus and infusional 5-fluorouracil and leucovorin (GFL) with or without bevacizumab.
null
Colorectal Cancer
Gamma Interferon 5-FU LV
null
2
arm 1: Patients in stratum 1 have not received prior chemotherapy in the metastatic setting. arm 2: Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting.
[ 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 5-FU bolus was administered at 400mg/m\^2 on day 1 and day 2 of each cycle. 5-FU at 600 mg/m\^2 infusion was administered over 22 hours on day 1 and day 2 of each cycle. intervention 2: Leucovorin 200mg/m\^2 was administered over 2 hours on day 1 and day 2 of each cycle. intervention 3: Gamma-Interferon...
intervention 1: 5-Fluorouracil intervention 2: Leucovorin (LV) intervention 3: Gamma-Interferon-1b (IFN-γ) intervention 4: Bevacizumab
1
Memphis | Tennessee | United States | -90.04898 | 35.14953
47
0
0
0
NCT00786643
1COMPLETED
2010-03-01
2006-02-01
Accelerated Community Oncology Research Network
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
101
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
true
0ALL
false
Varenicline (Champix) is a relatively new medicine that is effective in helping people to quit smoking. It is normally started 1-week before stopping smoking and used for up to 12-24 weeks. We are trying to find out if using varenicline for an extended time (4-weeks) before stopping smoking is better than the standard ...
null
Tobacco Dependence Smoking Cessation
Smoking cessation Tobacco dependence Varenicline Preloading
null
2
arm 1: Participants will use varenicline (1mg BD) 4-weeks prior to quitting arm 2: Participants will use 3 weeks of placebo, followed by 1 week of varenicline, prior to quitting
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Varenicline 1mg twice daily intervention 2: Placebo 1mg BD
intervention 1: Varenicline intervention 2: Placebo
1
London | N/A | United Kingdom | -0.12574 | 51.50853
101
0
0
0
NCT00789074
1COMPLETED
2010-03-01
2009-07-01
Queen Mary University of London
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
11
RANDOMIZED
CROSSOVER
4SUPPORTIVE_CARE
3TRIPLE
false
0ALL
true
The primary objective of the study is to evaluate thyrotropin releasing hormone (TRH) as a treatment for cancer-related fatigue. The central hypothesis of this pilot study is that TRH is more efficacious than placebo in alleviating cancer-related fatigue in patients with breast or prostate cancer.
null
Cancer-related Fatigue
cancer fatigue
null
2
arm 1: TRH arm 2: Placebo
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 0.5mg and 1.5mg intervention 2: Saline
intervention 1: Thyrotropin releasing hormone (TRH) intervention 2: Placebo
1
Farmington | Connecticut | United States | -72.83204 | 41.71982
16
0
0
0
NCT00790296
6TERMINATED
2010-03-01
2006-12-01
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
[ 3 ]
109
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
This is a Phase II screening study of lithium carbonate in ALS. The purpose of this study is to find out if lithium carbonate is safe to be used in people with ALS and if it can slow the progression of the disease. Since there is no placebo in this study, all patients will be taking lithium carbonate.
This is a Phase II Screening study. There is no placebo (inactive or 'fake' drug) in this study, meaning that all participants will be taking lithium carbonate. The purpose of this study is to find out if lithium carbonate is safe to be used in people with ALS and if it can slow the progression of the disease. A recen...
Amyotrophic Lateral Sclerosis
ALS Amyotrophic Lateral Sclerosis Lou Gehrig's Disease Lithium Lithium Carbonate
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: The dosage of lithium carbonate will be adjusted for each individual. The maximum dose is 450mg/day.
intervention 1: lithium carbonate
10
Scottsdale | Arizona | United States | -111.89903 | 33.50921 Los Angeles | California | United States | -118.24368 | 34.05223 Orange | California | United States | -117.85311 | 33.78779 San Francisco | California | United States | -122.41942 | 37.77493 Kansas City | Kansas | United States | -94.62746 | 39.11417 St Loui...
358
0
0
0
NCT00790582
1COMPLETED
2010-03-01
2008-05-01
Forbes Norris MDA/ALS Research Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
63
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
Objectives: Primary objective: Evaluate toxicity of rapamycin when used for post-bone marrow transplant graft vs. host disease prophylaxis in children with acute lymphoblastic leukemia (ALL). Investigator initiated; four participating institutions; Phase II pilot study
Objectives: Primary objective: Evaluate toxicity of rapamycin when used for post-bone marrow transplant graft vs. host disease prophylaxis in children with acute lymphoblastic leukemia (ALL). Rapamycin Rapamycin (RAPA, RapamuneR) (sirolimus) is an immunosuppressive agent that was approved by the FDA in 1999. It is a ...
Acute Lymphoblastic Leukemia
ALL Cancer Stem Cell Transplant
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Rapamycin (RAPA, RapamuneR) (sirolimus) is an immunosuppressive agent that was approved by the FDA in 1999. It is a macrocyclic lactone that is structurally similar to Tacrolimus (FK506) and binds to the same intracellular protein as FK506, FKBP1,2,3, but it has an entirely different mechanism of action...
intervention 1: RAPAMYCIN
1
Salt Lake City | Utah | United States | -111.89105 | 40.76078
63
0
0
0
NCT00795886
1COMPLETED
2010-03-01
2005-08-01
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 ]
1
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to evaluate if the combination of oral budesonide and rectal hydrocortisone improves symptoms in patients with active ulcerative colitis. Also, we would like to determine if oral budesonide and rectal hydrocortisone has fewer and less severe side effects compared to standard steroids (predn...
Ulcerative colitis (UC) is a common chronic inflammatory condition of the intestines that results in bloody diarrhea, abdominal pain, and extraintestinal manifestations of disease. The disease course is typically chronic, characterized by periodic exacerbations followed by symptom- free intervals; less commonly symptom...
Inflammatory Bowel Disease Ulcerative Colitis
Inflammatory Bowel Disease Ulcerative Colitis Budesonide Corticosteroids
null
1
arm 1: See intervention
[ 0 ]
1
[ 0 ]
intervention 1: Budesonide 9 mg PO (oral) daily and hydrocortisone 100 mL PR (enema) for an 8-week period. The doses of each drug to be used in the pilot study are standard doses used in clinical practice. After 8-weeks, the budesonide will be tapered in the following manner: 1) budesonide 6 mg PO daily and hydrocortis...
intervention 1: Combination Oral Budesonide and Rectal Hydrocortisone
1
Baltimore | Maryland | United States | -76.61219 | 39.29038
1
0
0
0
NCT00805285
6TERMINATED
2010-03-01
2008-10-01
University of Maryland, Baltimore
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
102
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Azithromycin has high rates of clinical response and eradication, wide spectrum of activity, so we suppose the development of the azithromycin injectable formulation in Japan would deliver benefit to patients of community acquired pneumonia.
null
Community Acquired Pneumonia (CAP)
null
1
arm 1: Azithromycin switch therapy (switch from intravenous to oral)
[ 0 ]
1
[ 0 ]
intervention 1: The intravenous formulation 500 mg is administered once daily for 2-5 days; followed by the oral formulation 500 mg will be given once daily to complete a 7 to 10-day course of therapy.
intervention 1: Azithromycin
34
Seto-shi | Aichi-ken | Japan | N/A | N/A Touon | Ehime | Japan | N/A | N/A Chikushino-shi | Fukuoka | Japan | 130.5156 | 33.49631 Fukuoka | Fukuoka | Japan | 130.41667 | 33.6 Koga | Fukuoka | Japan | 130.46667 | 33.73333 Yanagawa | Fukuoka | Japan | 130.4 | 33.16667 Higashihiroshima | Hiroshima | Japan | 132.73682 | 34...
102
0
0
0
NCT00809328
1COMPLETED
2010-03-01
2009-02-01
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
[ 5 ]
840
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This study investigates two different approaches to the change in antidepressant treatment when an initial treatment is not effective: early intervention or delayed intervention. Two hypothesis will be tested: 1. that time to confirmed response is shorter in the early intervention strategy vs. delayed intervention st...
null
Major Depressive Disorder
Major Depressive Disorder MDD Depression
null
2
arm 1: Escitalopram 10 milligrams per day for 4 weeks (one 10 milligram \[mg\]-capsule) followed by Duloxetine flexible dose (60 or 120 mg daily) for 12 weeks. arm 2: Escitalopram 10 mg per day for 4 weeks (one 10 mg-capsule) followed by Escitalopram 10 to 20 mg per day for 4 weeks (one or two 10 mg capsule\[s\]). Then...
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Flexible dose of 60 or 120 mg daily intervention 2: 10 mg in both Early and Delayed Intervention. Flexible dose of 10 to 20 mg daily in Delayed Intervention.
intervention 1: Duloxetine Hydrochloride intervention 2: Escitalopram
60
Copenhagen | N/A | Denmark | 12.56553 | 55.67594 Angoulême | N/A | France | 0.15345 | 45.64997 Arcachon | N/A | France | -1.17255 | 44.66126 Dole | N/A | France | 5.48966 | 47.09225 Gujan-Mestras | N/A | France | -1.06815 | 44.636 Marseille | N/A | France | 5.38107 | 43.29695 Montpellier | N/A | France | 3.87635 | 43.6...
1,654
0
0
0
NCT00810069
1COMPLETED
2010-03-01
2008-11-01
Eli Lilly and Company
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
63
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this multicenter, open label study, is to evaluate the safety and efficacy of a 12-week treatment with Posaconazole Oral Suspension in participants with IFI
null
Fungal Infection
refractory or first line medication intolerable invasive fungal infection
null
1
arm 1: Posaconazole 400 mg twice a day (BID) oral suspension for 12 weeks
[ 0 ]
1
[ 0 ]
intervention 1: 400mg BID oral suspension for 12 weeks
intervention 1: Posaconazole
0
null
62
0
0
0
NCT00811642
1COMPLETED
2010-03-01
2008-11-01
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 ]
382
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to evaluate how tapentadol immediate release (IR) and oxycodone IR treat moderate to severe post-operative pain after elective arthroscopic shoulder surgery.
This is a double-blind (neither the patient nor the study doctor knows the name of the assigned study drug during the study), randomized (study drug selected by chance like flipping a coin), active-comparator (patient will get active drug and there is no inactive drug), outpatient study to evaluate efficacy and how wel...
Postoperative Pain
analgesia postoperative pain opioid rotator cuff repair labral tear repair Bankart procedure oxycodone tapentadol arthroscopic shoulder surgery
null
2
arm 1: Tapentadol IR First dose: one 50 mg capsule (a re-dose of 50 mg is permitted as soon as one hour after the first dose on Day 1 if needed) Subsequent doses: one or two capsules (50 mg or 100 mg) every 4 to 6 hours as needed arm 2: Oxycodone IR First dose: one 5 mg capsule (a re-dose of 5 mg is permitted as soon a...
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: First dose: one 50 mg capsule (a re-dose of 50 mg is permitted as soon as one hour after the first dose on Day 1, if needed) Subsequent doses: one or two capsules (50 mg or 100 mg) every 4 to 6 hours as needed intervention 2: First dose: one 5 mg capsule (a re-dose of 5 mg is permitted as soon as one ho...
intervention 1: Tapentadol IR intervention 2: Oxycodone IR
0
null
378
0
0
0
NCT00814580
1COMPLETED
2010-03-01
2008-12-01
Ortho-McNeil Janssen Scientific Affairs, LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
1
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to determine whether the biologic medication alefacept (Amevive) is effective and safe in the treatment of Pityriasis Rubra Pilaris.
Pityriasis Rubra Pilaris (PRP) is a therapeutic challenge, and many different medication regimens exist to treat the condition. Clinical response is variable, and no single treatment has emerged as a leading therapy. Biologic agents have emerged as effective treatments for many skin diseases, including psoriasis. Given...
Pityriasis Rubra Pilaris
PRP Pityriasis Rubra Pilaris Amevive Alefacept Biologic Immunosuppressant Severe skin disease
null
1
arm 1: Treatment Group (only one group)
[ 0 ]
1
[ 0 ]
intervention 1: 15mg intramuscular injection weekly for 12 weeks
intervention 1: Alefacept
1
New York | New York | United States | -74.00597 | 40.71427
0
0
0
0
NCT00815633
6TERMINATED
2010-03-01
2008-12-01
Joshua Zeichner
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 ]
97
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The primary objective is to evaluate the efficacy of rosuvastatin therapy on plasma lipid profile (Low Density Lipoprotein (LDL), High-Density Lipoprotein (HDL), total cholesterol, triglyceride) in patients with metabolic syndrome.
null
Metabolic Syndrome
plasma lipid profile metabolic syndrome
null
1
arm 1: medication start dose is 10mg. After 6 weeks of treatment will be force-titrated to 20mg.
[ 0 ]
1
[ 0 ]
intervention 1: medication start dose is 10mg. After 6 weeks of treatment will be force-titrated to 20mg.
intervention 1: rosuvastatin
6
Ankara | Besevler | Turkey (Türkiye) | 32.85427 | 39.91987 Kayseri | Erciyes | Turkey (Türkiye) | 35.48528 | 38.73222 Istanbul | Haseki | Turkey (Türkiye) | 28.94966 | 41.01384 Kocaeli | Umuttepe | Turkey (Türkiye) | 27.51145 | 39.62497 Izmir | N/A | Turkey (Türkiye) | 27.13838 | 38.41273 Trabzon | N/A | Turkey (Türkiy...
97
0
0
0
NCT00815659
1COMPLETED
2010-03-01
2008-12-01
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
[ 5 ]
146
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
This study will test the usefulness of the medication metformin in treating people with schizophrenia or schizoaffective disorder who are overweight and also taking antipsychotic medications.
Schizophrenia is a chronic mental disorder that is characterized, in part, by psychotic symptoms. Psychotic symptoms include hallucinations and delusions, in which a person has abnormal experiences or beliefs, and are commonly treated with antipsychotic medications. Unfortunately, a side effect of many antipsychotics i...
Schizophrenia
Schizoaffective Disorder
null
2
arm 1: Encapsulated metformin 1000-2000 mg/day arm 2: Matching placebo capsules 2-4 daily
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 500 mg to 1,000 mg taken twice daily for 16 weeks intervention 2: 1 to 2 placebo capsules taken twice daily for 16 weeks
intervention 1: Metformin intervention 2: Placebo
16
Palo Alto | California | United States | -122.14302 | 37.44188 Boca Raton | Florida | United States | -80.0831 | 26.35869 Iowa City | Iowa | United States | -91.53017 | 41.66113 Wichita | Kansas | United States | -97.33754 | 37.69224 Glen Burnie | Maryland | United States | -76.62469 | 39.16261 Boston | Massachusetts |...
146
0
0
0
NCT00816907
1COMPLETED
2010-03-01
2009-01-01
National Institute of Mental Health (NIMH)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
328
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL inhalation solution delivered by the Respimat inhaler once daily for 4 weeks in Japanese patients with chronic obstructive pulmonary disease (COPD). The selection of the optimum dose(s) will be based on bronchodilator efficacy, safety...
null
Pulmonary Disease, Chronic Obstructive
null
4
arm 1: 2 puffs of 2.5 µg/actuation arm 2: 2 puffs of 5 µg/actuation arm 3: 2 puffs arm 4: 2 puffs of 1 µg/actuation
[ 0, 0, 2, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 2 puffs of 1 µg/actuation delivered by the Respimat® inhaler intervention 2: 2 puffs of 2.5 µg/actuation delivered by the Respimat® inhaler intervention 3: 2 puffs of 5 µg/actuation delivered by Respimat® intervention 4: 2 puffs delivered by the Respimat® inhaler
intervention 1: BI 1744 CL 2 µg intervention 2: BI 1744 CL 5 µg intervention 3: BI 1744 CL 10 µg intervention 4: Placebo
48
Asahikawa, Hokkaido | N/A | Japan | 142.36489 | 43.77063 Bunkyo-ku, Tokyo | N/A | Japan | N/A | N/A Chiba, Chiba | N/A | Japan | N/A | N/A Fukuoka, Fukuoka | N/A | Japan | N/A | N/A Fukuoka, Fukuoka | N/A | Japan | N/A | N/A Himeji, Hyogo | N/A | Japan | N/A | N/A Himeji, Hyogo | N/A | Japan | N/A | N/A Hiroshima, Hiro...
328
0
0
0
NCT00824382
1COMPLETED
2010-03-01
2009-01-01
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 ]
154
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to investigate the ability of different doses of PA21 to lower serum phosphate levels, in patients with chronic kidney disease on maintenance hemodialysis.
null
Chronic Kidney Disease
Hemodialysis
null
6
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None
[ 0, 0, 0, 0, 0, 0 ]
6
[ 0, 0, 0, 0, 0, 0 ]
intervention 1: Daily dose of 1.25 g PA21 (1 tablet/day) for 6 weeks. One PA21 tablet will be taken orally with the largest meal of the day. intervention 2: Daily dose of 5.0 g PA21 (4 tablets/day) for 6 weeks. Two PA21 tablets will be taken orally with the largest meal of the day, and one PA21 tablet will be taken ora...
intervention 1: 1.25 g PA21 (250 mg iron) intervention 2: 5.0 g PA21 (1,000 mg iron) intervention 3: 7.5 g PA21 (1,500 mg iron) intervention 4: 10.0 g PA21 (2,000 mg iron) intervention 5: 12.5 g PA21 (2,500 mg iron) intervention 6: Sevelamer hydrochloride
60
Arvada | Colorado | United States | -105.08748 | 39.80276 Denver | Colorado | United States | -104.9847 | 39.73915 Pembroke Pines | Florida | United States | -80.22394 | 26.00315 Kansas City | Kansas | United States | -94.62746 | 39.11417 Fresh Meadows | New York | United States | -73.79347 | 40.73482 Cleveland | Ohio ...
154
0
0
0
NCT00824460
1COMPLETED
2010-03-01
2008-12-01
Vifor 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
[ 3 ]
34
RANDOMIZED
CROSSOVER
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this research study was to evaluate ARX-F02 (Sufentanil NanoTab) versus placebo ("sugar" pill or inactive substance) in the management of breakthrough pain in cancer patients.
null
Cancer Pain
Cancer breakthrough pain
null
1
arm 1: During the Titration Phase, patients titrated to the effective dosage of sublingual sufentanil NanoTab™(20, 30, 40, 60 or 80 mcg). One sublingual sufentanil NanoTab™ was taken as needed for breakthrough pain. During the Double-Blind Phase, patients were then randomized to one of six treatment sequences, each of...
[ 0 ]
1
[ 0 ]
intervention 1: During the Titration Phase, patients titrated to the dose of sufentanil that provided adequate pain relief without intolerable side effects. Dosages were 20, 30, 40, 60 and 80 mcg. During the Double Blind Phase, patients were randomized to one of six sequences and took 7 doses of sufentanil (dosage dete...
intervention 1: Sublingual sufentanil NanoTabs™ and placebo NanoTabs™
13
Montebello | California | United States | -118.10535 | 34.00946 Jacksonville | Florida | United States | -81.65565 | 30.33218 Lakeland | Florida | United States | -81.9498 | 28.03947 Sarasota | Florida | United States | -82.53065 | 27.33643 Venice | Florida | United States | -82.45426 | 27.09978 Marietta | Georgia | Un...
34
0
0
0
NCT00833040
1COMPLETED
2010-03-01
2009-04-01
Talphera, 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 ]
2
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to find out if a program of intensive chemotherapy with gemcitabine, docetaxel and capecitabine followed by an advanced form of focused radiation aimed at the patient's tumor followed by more chemotherapy can increase the chances that the patient's pancreatic tumor can be removed completely...
* Cycle 1 and 2: * Days 4, 11 and 25, 32 ....gemcitabine 750 mg/m\^2 intravenous piggy back (IVPB) over 30 min * Days 4, 11 and 25, 32 ....docetaxel 30 mg/m\^2 IVPB over 1 hour * Days 1-14 and 22-35 ....capecitabine 750 mg/m\^2 oral twice daily * Each cycle is 21 days long * SRS: Day 43 ....25 Gy single fracti...
Pancreatic Neoplasms
stereotactic radiosurgery borderline resectable pancreatic cancer gastrointestinal pancreas
null
1
arm 1: GTX-SRS: Gemcitabine, Taxotere, Xeloda (GTX)-Stereotactic Radiosurgery (SRS)
[ 0 ]
2
[ 0, 4 ]
intervention 1: GTX: 21 day cycle x 2 Gemcitabine 750mg/m2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m2 on days 1-14 intervention 2: stereotactic body radiation therapy (SBRT) 25
intervention 1: GTX (gemcitabine, docetaxel and capecitabine) intervention 2: stereotactic body radiation therapy
1
Tampa | Florida | United States | -82.45843 | 27.94752
2
0
0
0
NCT00833859
6TERMINATED
2010-03-01
2009-03-01
H. Lee Moffitt Cancer Center and Research Institute
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
17
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The purpose of this grant is to collect pilot data to assess the amount of botulinum toxin that needs to be injected into the calf muscles of subjects with diabetes mellitus, peripheral neuropathy, and a plantar ulcer to decrease muscle strength. We hypothesize that a decrease in plantar flexor muscle strength will tem...
Please read "Brief Summary"
Diabetes Mellitus Peripheral Neuropathy Plantar Ulcers
Diabetes mellitus plantar ulcers peripheral neuropathy
null
3
arm 1: Placebo (saline) injections into 6 sites in the calf muscle arm 2: Total 200 units of Botulinum Toxin injected into 6 sites into the calf muscles. arm 3: 300 units of botulinum toxin injected into 6 sites in the calf muscle
[ 2, 1, 1 ]
2
[ 0, 0 ]
intervention 1: 200 units of botulinum toxin, and 300 units of botulinum toxin. Injection are given at one session. 2 injections into the medial gastrocnemius, 2 injections into the lateral gastrocnemius, and 2 injections into the soleus intervention 2: Placebo (saline) (3cc). Injection are given at one session. 2 inje...
intervention 1: Botulinum Toxin intervention 2: Saline
1
St Louis | Missouri | United States | -90.19789 | 38.62727
17
0
0
0
NCT00845897
1COMPLETED
2010-03-01
2005-03-01
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
[ 4 ]
1,134
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
This study assessed the efficacy and safety of indacaterol (150 µg once daily \[od\]) when combined with tiotropium (18 µg od) versus tiotropium (18 µg od) treatment alone in patients with chronic obstructive pulmonary disease (COPD)
null
Chronic Obstructive Pulmonary Disease (COPD)
chronic obstructive pulmonary disease COPD indacaterol tiotropium bronchodilation
null
2
arm 1: Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Dai...
[ 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device. intervention 2: Tiotropium was supplied in powder filled capsules together the manufacture's proprietary inhalation device (HandiHaler®). intervention 3: Placebo to indacaterol was supplied ...
intervention 1: Indacaterol 150 μg intervention 2: Tiotropium 18 μg intervention 3: Placebo to indacaterol
137
Birmingham | Alabama | United States | -86.80249 | 33.52066 Mobile | Alabama | United States | -88.04305 | 30.69436 Scottsdale | Arizona | United States | -111.89903 | 33.50921 Tucson | Arizona | United States | -110.92648 | 32.22174 Tucson | Arizona | United States | -110.92648 | 32.22174 Pine Bluff | Arkansas | Unite...
1,131
0
0
0
NCT00846586
1COMPLETED
2010-03-01
2009-03-01
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
[ 5 ]
249
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
The purpose of this study is to evaluate in patients with Chronic Obstructive Pulmonary Disease (COPD) if Advair DISKUS™ 250/50mcg BID modifies arterial stiffness which is a measure associated with risk of heart disease.
This is a multicenter, randomized, double-blind, placebo controlled study to evaluate the effect of Fluticasone Propionate/Salmeterol DISKUS 250/50mcg (FSC) BID on arterial stiffness in COPD subjects. Following a 1 to 14 day run-in period, approximately 250 subjects will be randomly assigned to double-blind treatment f...
Pulmonary Disease, Chronic Obstructive
Chronic Obstructive Pulmonary Disease arterial stiffness Computed Tomography pulse wave velocity Pulse wave analysis
null
2
arm 1: Subjects receive blinded Fluticasone Propionate/Salmeterol. At 4 months subjects will receive open label SPIRIVA HANDIHALER arm 2: Subjects will receive placebo ADVAIR DISKUS. At 4 months subjects will receive open label SPIRIVA HANDIHALER
[ 1, 2 ]
2
[ 0, 10 ]
intervention 1: ADVAIR DISKUS™ 250/50mcg is indicated for the twice-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. ADVAIR DISKUS™ 250/50mcg is also indicated to reduce exacerbations of COPD in patients with...
intervention 1: ADVAIR DISKUS™ 250/50mcg intervention 2: Placebo
24
Birmingham | Alabama | United States | -86.80249 | 33.52066 Jasper | Alabama | United States | -87.27751 | 33.83122 Mobile | Alabama | United States | -88.04305 | 30.69436 Phoenix | Arizona | United States | -112.07404 | 33.44838 San Diego | California | United States | -117.16472 | 32.71571 Torrance | California | Uni...
249
0
0
0
NCT00857766
1COMPLETED
2010-03-01
2009-03-01
GlaxoSmithKline
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
-0
[ 4 ]
64
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study was to determine whether patients with schizophrenia, schizoaffective disorder, or bipolar I disorder who also have metabolic syndrome have a larger decrease in fasting non-high density lipoprotein (non-HDL) cholesterol levels with aripiprazole than with their current atypical antipsychotic tr...
null
Schizophrenia Schizoaffective Disorder Bipolar I Disorder Metabolic Syndrome
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Aripiprazole administered orally as tablets, 5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days within a range of 10 to 30 mg daily, for 16 weeks intervention 2: Oanzapine, risperidone, or quetiapine administered orally as t...
intervention 1: Aripiprazole intervention 2: Oanzapine, risperidone, or quetiapine
14
Calgary | Alberta | Canada | -114.08529 | 51.05011 Pentincton | British Columbia | Canada | N/A | N/A Vancouver | British Columbia | Canada | -123.11934 | 49.24966 Hamilton | Ontario | Canada | -79.84963 | 43.25011 London | Ontario | Canada | -81.23304 | 42.98339 Markham | Ontario | Canada | -79.2663 | 43.86682 Mississ...
26
0
0
0
NCT00857818
6TERMINATED
2010-03-01
2009-04-01
Otsuka Pharmaceutical Development & Commercialization, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
260
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The primary objective of this study is to demonstrate the superiority of MCI-196 over placebo and non-inferiority with simvastatin in reducing serum low-density lipoprotein (LDL)-cholesterol in subjects with chronic kidney disease Stage V on dialysis. This study incorporates a Washout Period and two treatment periods -...
null
Chronic Kidney Disease
Chronic Kidney Disease Dialysis Dyslipidemia Bile acid sequestrant
null
4
arm 1: None arm 2: None arm 3: None arm 4: None
[ 0, 2, 1, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Tablets of 3 g to 12 g/day (3 times a day) with dose escalation design during 16 weeks of Active Comparison Phase, and 4 weeks of fixed dose during Withdrawal Phase (Week 16 to Week 20) intervention 2: Tablets once a day, for 16 weeks of Active Comparison Phase, and 4 weeks of fixed dose during Withdraw...
intervention 1: MCI-196 intervention 2: Placebo of Simvastatin intervention 3: Simvastatin intervention 4: Placebo of MCI-196
39
Brest | N/A | Belarus | 23.71749 | 52.10894 Grodno | N/A | Belarus | 23.8942 | 53.62865 Homyel | N/A | Belarus | 30.9754 | 52.4345 Minsk | N/A | Belarus | 27.56653 | 53.90019 Vitebsk | N/A | Belarus | 30.2049 | 55.1904 Gabrovo | N/A | Bulgaria | 25.33417 | 42.87472 Plovdiv | N/A | Bulgaria | 24.75 | 42.15 Sofia | N/A |...
259
0
0
0
NCT00858637
1COMPLETED
2010-03-01
2009-03-01
Mitsubishi Tanabe Pharma Corporation
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
16
RANDOMIZED
CROSSOVER
0TREATMENT
1SINGLE
false
0ALL
true
This research is a prospective, randomized, cross-over study that is being done to compare the effect of morning only, evening only and twice daily insulin glargine (Lantus®) on hypoglycemia (blood glucose level \<70 mg/dL) as measured by continuous glucose monitoring (CGM) in patients with type 1 diabetes.
Over the course of the 6 week study, patients will take insulin glargine in each of 3 different times: only in the morning, only at night, and half in the morning, half at night. After 2 weeks taking the insulin in one regimen, patients will be switched to another regimen. Through the whole study, patients will be inje...
Type 1 Diabetes Hypoglycemia
hypoglycemia type 1 diabetes split dosing insulin glargine continuous glucose monitoring
null
3
arm 1: Morning only administration of insulin glargine arm 2: Evening only administration of insulin glargine arm 3: Split dose administration of insulin glargine, half dose in morning, half dose in evening
[ 1, 1, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Evening only administration of insulin glargine, with normal saline injection administered in the morning. intervention 2: Morning only administration of insulin glargine, with normal saline injection administered at night. intervention 3: split dose of insulin glargine, half administered in the morning...
intervention 1: Evening only administration of insulin glargine intervention 2: Morning only administration of insulin glargine intervention 3: split dose insulin glargine
1
Baltimore | Maryland | United States | -76.61219 | 39.29038
0
0
0
0
NCT00869414
6TERMINATED
2010-03-01
2009-07-01
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
[ 5 ]
271
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
This study will evaluate the effect of omalizumab on markers of impairment in patients with inadequately controlled persistent allergic asthma on Step 4 or above therapy as defined in the 2007 National Heart, Lung, and Blood Institute (NHBLI) Guidelines
null
Persistent Allergic Asthma
Asthma; asthma management; asthma impairment ; Xolair ; omalizumab
null
2
arm 1: The determined dose (at least 0.016 mg/kg/IgE (IU/mL) was administered subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used. arm 2: Placebo was administered subcutaneously every 2 weeks or e...
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Omalizumab was supplied as a lyophilized, sterile powder in a single-use, 5 mL vial. The vial was designed to deliver 150 mg (1.2 mL) of omalizumab for subcutaneous (s.c.) administration after reconstitution with 1.4 mL sterile water for injection. Doses of more than 150 mg were divided among multiple i...
intervention 1: Omalizumab intervention 2: Placebo
50
Jasper | Alabama | United States | -87.27751 | 33.83122 Anchorage | Alaska | United States | -149.90028 | 61.21806 Scottsdale | Arizona | United States | -111.89903 | 33.50921 Encinitas | California | United States | -117.29198 | 33.03699 Fresno | California | United States | -119.77237 | 36.74773 Huntington Beach | Ca...
271
0
0
0
NCT00870584
1COMPLETED
2010-03-01
2009-03-01
Novartis Pharmaceuticals
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
64
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
false
0ALL
false
This study will measure and compare changes in insulin production and sensitivity using the hyperglycemic clamp technique in obese patients with impaired glucose tolerance and hypertension treated with placebo, isosorbide mononitrate (ISMN) or hydrochlorothiazide (HCTZ).
null
Hypertension
null
4
arm 1: Placebo in Period 1 followed by HCTZ in Period 2 arm 2: HCTZ in Period 1, followed by placebo in Period 2 arm 3: Placebo in Period 1, followed by ISMN in Period 2 arm 4: ISMN in Period 1, followed by placebo in Period 2
[ 0, 0, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: HCTZ 50 mg (two 25 mg capsules) once daily for 4 weeks per treatment period. intervention 2: Placebo to HCTZ two 0 mg capsules once daily for 4 weeks per treatment period intervention 3: ISMN 60 mg extended release capsule once daily for 4 weeks per treatment period intervention 4: Placebo to ISMN 0 mg ...
intervention 1: Hydrochlorothiazide (HCTZ) intervention 2: Comparator: Placebo to HCTZ intervention 3: Isosorbide mononitrate (ISMN) intervention 4: Comparator: Placebo to ISMN
0
null
128
0
0
0
NCT00871871
1COMPLETED
2010-03-01
2009-03-01
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
[ 2 ]
28
RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
true
0ALL
true
This is a Phase 1 study to assess the pharmacokinetics (PK) of IK-1001 (sodium sulfide) in healthy volunteers as well as in subjects with varying degrees of impaired renal function. A total of 28 subjects will be enrolled into the study over a 6 month period. There will be 4 cohorts. The first cohort will consist of su...
This is a Phase 1 pharmacokinetic study to assess the pharmacokinetics of IK-1001 in healthy volunteers as well as subjects with varying degrees of impaired renal function following a single intravenous infusion. A total of 28 subjects will be enrolled into the study, including 6 normal subjects (Creatinine Clearance ...
Renal Impairment
Renal Impairment Renal Disease Sodium Sulfide
null
4
arm 1: Mild renal impairment (RI) Cohort administered 1.5 mg/kg/hr infusion of Sodium sulfide intravenously for 3 hours. arm 2: Healthy subjects received sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours arm 3: Moderate RI cohort received sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours arm 4: Severe RI ...
[ 0, 0, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Sodium sulfide administered intravenously at 1.5 mg/kg/hr for 3 hours intervention 2: Sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours intervention 3: Sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours intervention 4: Sodium sulfide intravenously at 1.0 mg/kg/hr for 3 hours
intervention 1: Sodium Sulfide intervention 2: Sodium Sulfide intervention 3: Sodium Sulfide intervention 4: Sodium Sulfide
1
Minneapolis | Minnesota | United States | -93.26384 | 44.97997
28
0
0
0
NCT00879645
6TERMINATED
2010-03-01
2009-08-01
Mallinckrodt
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 ]
60
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purposes of this study are: 1. To understand whether the use of HIV therapy in persons with more advanced HIV disease results in greater side effects. 2. To determine whether these side effects can be related to greater activation of the immune system.
1. To compare the incidence and severity of self-reported symptoms in persons with CD4 counts \<100 cells/mm3 versus those with CD4 counts ≥ 100 cells/mm3 who are initiating antiretroviral therapy. 2. To determine the relationship between self-reported symptoms and levels of T cells, HIV RNA, activation marker cytokine...
HIV Infections
HIV immune reconstitution treatment naive
null
2
arm 1: All participants were treated but at baseline by design were divided based upon their CD4 count at baseline measurement. Group with CD4\<100 cells/cu mm arm 2: All participants were treated but at baseline by design were divided based upon their CD4 count at baseline measurement. Group with CD4\>/=100 cells/cu m...
[ 5, 5 ]
2
[ 0, 0 ]
intervention 1: Tenofovir/emtricitabine fixed dose combination once daily intervention 2: Lopinavir/ritonavir 400/100 mg twice daily
intervention 1: Truvada (tenofovir/emtricitabine) intervention 2: Kaletra (lopinavir/ritonavir)
1
Cincinnati | Ohio | United States | -84.51439 | 39.12711
60
0
0
0
NCT00885664
1COMPLETED
2010-03-01
2005-10-01
University of Cincinnati
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
200
RANDOMIZED
PARALLEL
1PREVENTION
4QUADRUPLE
true
0ALL
true
The aim of the study is to see if lozenges containing a low dose of interferon-alpha can prevent and/or reduce the severity of colds and flu. Starting about 1 month before the expected start of the winter colds and flu season in Perth, Australia, healthy volunteers will allow a lozenge containing interferon, or a lozen...
null
Upper Respiratory Tract Infections
Prophylaxis Treatment Symptoms Winter Colds and Flu
null
2
arm 1: 150 international units of interferon-alpha arm 2: placebo lozenges
[ 0, 2 ]
2
[ 0, 10 ]
intervention 1: a lozenge for oral dissolution containing 150 international units of human interferon-alpha taken once daily for 16 weeks intervention 2: placebo lozenges for oral dissolution taken once daily for 16 weeks
intervention 1: interferon-alpha intervention 2: placebo
1
Nedlands | Western Australia | Australia | 115.8073 | -31.98184
198
0
0
0
NCT00895947
1COMPLETED
2010-03-01
2009-04-01
Ainos, Inc. (f/k/a Amarillo Biosciences 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 ]
30
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to evaluate the effect of escitalopram after 12 weeks of treatment in patients with Social Anxiety Disorder (SAD), to evaluate proportion of patients who respond to escitalopram during the treatment period, and to evaluate safety of escitalopram.
The study will be performed in Russia, as an open-label, uncontrolled, one arm trial. The patients will receive escitalopram for 12 weeks. Start and maintenance dosages as well as dose titration will be left to the investigators' decision (5 to 20 mg/day), in accordance with the national Summary of Products Characteris...
Social Anxiety Disorder
Social Anxiety Disorder SAD Antidepressant Anxiolytic
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Flexible-dosed (5 to 20 mg Oral Tablets Daily)
intervention 1: Escitalopram
1
Moscow | N/A | Russia | 37.61556 | 55.75222
30
0
0
0
NCT00902226
1COMPLETED
2010-03-01
2009-03-01
H. Lundbeck A/S
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
30
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to evaluate the effect of escitalopram after 8 weeks of treatment in patients with Generalized Anxiety Disorder (GAD), to evaluate proportion of patients who respond to escitalopram during the treatment period, and to evaluate safety of escitalopram.
The study will be performed in Russia, as an open-label, uncontrolled, one arm trial. The patients will receive escitalopram for 8 weeks. Start and maintenance dosages as well as dose titration will be left to the investigators' decision (5 to 20 mg/day), in accordance with the national Summary of Products Characterist...
Generalized Anxiety Disorder
Generalized Anxiety Disorder GAD Antidepressant Anxiolytic
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Flexible-dosed (5 to 20 mg Oral Tablets Daily)
intervention 1: Escitalopram
1
Moscow | N/A | Russia | 37.61556 | 55.75222
30
0
0
0
NCT00902564
1COMPLETED
2010-03-01
2009-03-01
H. Lundbeck A/S
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
47
RANDOMIZED
CROSSOVER
9OTHER
0NONE
true
2MALE
false
The purpose of this study is to perform a relative bioavailability study between two formulations of sildenafil citrate.
Bio-equivalence between two formulations of sildenafil citrate
Erectile Dysfunction
Sildenafil Bio-equivalence
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: sildenafil citrate 100 mg CT, single dose without water intervention 2: sildenafil citrate 100 mg CT, single dose with water intervention 3: sildenafil citrate 100 mg film-coated tablet (Viagra®), single dose
intervention 1: sildenafil citrate 100 mg CT intervention 2: sildenafil citrate 100 mg CT intervention 3: Viagra®
1
Bragança Paulista | São Paulo | Brazil | -46.54418 | -22.9527
188
0
0
0
NCT00904748
1COMPLETED
2010-03-01
2010-01-01
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
239
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
NXN-188 Dihydrochloride is being developed as an immediate release oral product for the treatment of acute migraine. This study is being conducted to evaluate NXN-188 in subjects with a migraine history of aura.
This was a multicenter, double-blind, parallel group, active and placebo-controlled, three arm study of a single oral dose of NXN-188 for the treatment of acute migraine headache with aura. After study eligibility was confirmed, subjects were randomized to NXN-188 600 mg, sumatriptan 100 mg, or placebo in a 1:1:1 rati...
Migraine With Aura
Migraine aura
null
3
arm 1: NXN-188, 600 mg, PRN arm 2: Sumatriptan, 100 mg, PRN arm 3: matching, PRN
[ 0, 1, 2 ]
3
[ 0, 0, 0 ]
intervention 1: NXN-188 hard gelatin capsules, 600 mg administered as three 200 mg capsules intervention 2: administered as 3 placebo hard gelatin capsules intervention 3: administered in a hard gelatin capsule with 2 capsules of placebo
intervention 1: NXN-188 intervention 2: placebo intervention 3: sumatriptan succinate
16
Newport Beach | California | United States | -117.92895 | 33.61891 Oceanside | California | United States | -117.37948 | 33.19587 San Francisco | California | United States | -122.41942 | 37.77493 Santa Monica | California | United States | -118.49138 | 34.01949 St. Petersburg | Florida | United States | -82.67927 | 27...
185
0
0
0
NCT00920686
1COMPLETED
2010-03-01
2009-06-01
NeurAxon 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 ]
1
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Background: * Pioglitazone is a drug that belongs to the class of antidiabetic agents called thiazolidinediones. It is approved for treatment of type 2 diabetes mellitus. * Research suggests that the thiazolidinediones may have anticancer activity that can reduce cancer risk or cause tumors to shrink. Objectives: -T...
Background: Lung cancer is the leading cause of cancer deaths in the United States (US). Chemoprevention is an active area of investigation for reducing the burden of this disease. However, the choice of chemopreventive targets requires sufficient human data to justify extensive clinical interventions. Peroxisome pro...
Non-Small-Cell Lung Cancer
NSCLC Stage Ia-IIb Resectable NSCLC Non-Small Cell Lung Cancer NSCLC
null
1
arm 1: 45 mg tablet daily by mouth for six weeks
[ 0 ]
1
[ 0 ]
intervention 1: 45 mg tablet daily by mouth for six weeks
intervention 1: Pioglitazone
2
Bethesda | Maryland | United States | -77.10026 | 38.98067 New York | New York | United States | -74.00597 | 40.71427
1
0
0
0
NCT00923949
6TERMINATED
2010-03-01
2008-08-01
National Cancer Institute (NCI)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
329
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to investigate the efficacy, safety and tolerability of 4 weeks treatment with AZD3199 in moderate to severe COPD.
null
COPD
COPD Efficacy Safety Inhalation
null
5
arm 1: AZD3199 low dose arm 2: AZD3199 intermediate dose arm 3: AZD3199 high dose arm 4: Formoterol 2x4.5 microgram bid arm 5: Placebo
[ 0, 0, 0, 1, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Dry powder for inhalation, o.d., 4 weeks intervention 2: Dry powder for inhalation, b.i.d., 4 weeks intervention 3: Dry powder for inhalation, b.i.d., 4 weeks
intervention 1: AZD3199 intervention 2: formoterol intervention 3: Placebo
38
Blagoevgrad | N/A | Bulgaria | 23.1 | 42.01667 Pleven | N/A | Bulgaria | 24.61667 | 43.41667 Rousse | N/A | Bulgaria | 25.9534 | 43.84872 Sofia | N/A | Bulgaria | 23.32415 | 42.69751 Varna | N/A | Bulgaria | 27.91667 | 43.21667 Moncton | New Brunswick | Canada | -64.7965 | 46.09454 St. John's | Newfoundland and Labrado...
329
0
0
0
NCT00929708
1COMPLETED
2010-03-01
2009-06-01
AstraZeneca
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
10
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The objective of this study is to evaluate the efficacy of apremilast in patients with recalcitrant atopic or contact dermatitis.
Atopic Dermatitis (AD) is a chronic, inflammatory skin disease characterized by dry, red, and itchy patches that can become thickened and lichenified with time. Contact Dermatitis, or Allergic Contact Dermatitis (ACD), is an eczematous reaction in response to an environmental allergen. The etiology of Atopic Dermatiti...
Atopic Dermatitis Allergic Contact Dermatitis
eczema dermatitis TNF blockade PDE4 inhibitor T cell inhibitor
null
1
arm 1: Apremilast is being evaluated at daily doses of 20 mg by mouth (PO) twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type Atopic Dermatitis (AD) or Allergic Contact Ddermatitis (ACD).
[ 0 ]
1
[ 0 ]
intervention 1: Apremilast is being evaluated at daily doses of 20 mg by mouth (PO) twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type Atopic Dermatitis (AD) or Allergic Contact Ddermatitis (ACD).
intervention 1: Apremilast
1
Boston | Massachusetts | United States | -71.05977 | 42.35843
12
0
0
0
NCT00931242
1COMPLETED
2010-03-01
2009-06-01
Tufts Medical Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
107
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this trial is to study the efficacy and safety of Visonac PDT in patients from 9 to 35 years old with Aktilite® CL512. Patients was randomized to Visonac or vehicle cream without occlusion and red light(dose: 37J/cm2)
Double blinded, prospective, randomized, stratified, placebo-controlled, multi-center study in patients with moderate to severe acne vulgaris. Patients with facial severity grades 3 to 4 on the Investigator's Global Assessment (IGA) scale will be included. Each patient will be classified according to age in the two age...
Acne Vulgaris
Acne Vulgaris Moderate to severe
null
2
arm 1: Active treatment, Light dose 37 J/cm2. arm 2: Placebo treatment, Light dose 37 J/cm2.
[ 0, 2 ]
3
[ 0, 0, 3 ]
intervention 1: Cream application followed by illumination with red light. intervention 2: Cream application followed by illumination with red light. intervention 3: Photodynamic Therapy - Light dose 37 J/cm2
intervention 1: Visonac PDT (MAL PDT) intervention 2: Vehicle cream (placebo) intervention 3: PDT
11
San Diego | California | United States | -117.16472 | 32.71571 Chicago | Illinois | United States | -87.65005 | 41.85003 Naperville | Illinois | United States | -88.14729 | 41.78586 Fridley | Minnesota | United States | -93.26328 | 45.08608 Rochester | New York | United States | -77.61556 | 43.15478 Hershey | Pennsylva...
107
0
0
0
NCT00933543
1COMPLETED
2010-03-01
2009-08-01
Photocure
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 ]
412
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
The purpose of the study is to compare the combination of aliskiren, amlodipine and Hydrochlorothiazide (HCTZ) versus the combination of aliskiren and amlodipine as therapy in minority Stage 2 hypertensive patients.
null
Hypertension
Hypertension Aliskiren Amlodipine HCTZ Systolic blood pressure Diastolic blood pressure Stage II Combination
null
2
arm 1: At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25...
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Amlodipine capsule (5 mg) Aliskiren/Amlodipine tablets (150/5 mg, 300/5 mg, 300/10 mg) intervention 2: Aliskiren/Amlodipine tablets (150/5 mg, 300/5 mg, 300/10 mg) HCTZ capsule (12.5 mg, 25mg)
intervention 1: Aliskiren/Amlodipine intervention 2: Aliskiren/Amlodipine and Hydrochlorothiazide (HCTZ)
5
Little Rock | Arkansas | United States | -92.28959 | 34.74648 South Miami | Florida | United States | -80.29338 | 25.7076 Mattapan | Massachusetts | United States | -71.087 | 42.27232 Manassas | Virginia | United States | -77.47527 | 38.75095 Seattle | Washington | United States | -122.33207 | 47.60621
411
0
0
0
NCT00942994
1COMPLETED
2010-03-01
2009-06-01
Novartis
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
163
RANDOMIZED
PARALLEL
1PREVENTION
0NONE
false
0ALL
true
The study will assess the use of paliperidone palmitate compared with oral risperidone in delaying time to relapse in patients recently diagnosed with schizophrenia who are at high risk of relapse.
This is a Prospective, Randomized, Active-controlled, Rater-blinded Study to to assess the efficacy of paliperidone palmitate compared with oral risperidone in delaying time to relapse in patients recently diagnosed with schizophrenia who are at high risk of relapse. Recently diagnosed is defined as first diagnosis of ...
Schizophrenia
Schizophrenia Risperidone Risperdal Paliperidone Palmitate Invega Sustenna
null
2
arm 1: paliperidone palmitate 50 75 100 or 150 mg eq. monthly injection for 2 years arm 2: oral risperidone 2 4 6 or 8 mg tabs once daily for two years
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: 50, 75, 100, or 150 mg eq. monthly injection for 2 years intervention 2: 2, 4, 6, or 8 mg tabs once daily for two years
intervention 1: paliperidone palmitate intervention 2: oral risperidone
72
Little Rock | Arkansas | United States | -92.28959 | 34.74648 Garden Grove | California | United States | -117.94145 | 33.77391 San Diego | California | United States | -117.16472 | 32.71571 Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 Kissimmee | Florida | United States | -81.41667 | 2...
162
0
0
0
NCT00946985
6TERMINATED
2010-03-01
2009-06-01
Ortho-McNeil Janssen Scientific Affairs, LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
12
RANDOMIZED
PARALLEL
6HEALTH_SERVICES_RESEARCH
2DOUBLE
true
0ALL
false
This research is being done to evaluate the effect of glucagon-like peptide-1 (GLP-1, a naturally occurring hormone) on insulin release and to examine whether there is extra insulin release when GLP-1 is not allowed to be rapidly inactivated.
The purpose of the present proposal is to 1) examine the role of dipeptidyl peptidase (DPP-4) inhibition on insulin release during a hyperglycemic clamp while GLP-1 is being infused and, 2) further elucidate the role of the metabolite of GLP-1, that is GLP-1 9-36 amide (GLP-1m). During stable and very reproducible elev...
Glucose Homeostasis
Healthy volunteers GLP-1 Januvia Sitagliptin
null
2
arm 1: None arm 2: None
[ 2, 1 ]
2
[ 0, 0 ]
intervention 1: 1 tablet 100 mg once a day intervention 2: 1 tablet 100 mg once a day
intervention 1: Placebo intervention 2: Januvia
1
Baltimore | Maryland | United States | -76.61219 | 39.29038
0
0
0
0
NCT00947011
6TERMINATED
2010-03-01
2009-03-01
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 ]
195
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This is a a multi-center, randomized, double-blind, parallel group, and placebo controlled, two-arm study of a single oral dose of NXN-188 for the treatment of acute migraine headache without aura. Up to 120 migraineurs will be enrolled. Approximately 60 subjects having a headache history of migraine without aura will ...
After study eligibility was confirmed and all screening procedures completed, subjects were randomized at Visit 1 to receive either NXN-188 600 mg or placebo in a 1:1 ratio. Study drug and diaries were dispensed, and subjects were instructed regarding when to dose with study drug. Subjects were also trained regarding t...
Migraine Without Aura
migraine
null
2
arm 1: 3 x 200 mg capsules, PRN arm 2: 3 x 0 mg capsules, PRN
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 200 mg capsules, 600 mg, PRN intervention 2: 200 mg capsules with no active ingredient designed to match the NXN-188 capsules
intervention 1: NXN-188 intervention 2: Placebo
4
St. Petersburg | Florida | United States | -82.67927 | 27.77086 Atlanta | Georgia | United States | -84.38798 | 33.749 Mount Vernon | New York | United States | -73.83708 | 40.9126 Salt Lake City | Utah | United States | -111.89105 | 40.76078
174
0
0
0
NCT00959751
1COMPLETED
2010-03-01
2009-07-01
NeurAxon 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 ]
25
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
To study how the body absorbs, distributes, metabolises and eliminates Keppra XR in both children (12 to 16 years old) and adults (18 to 55 years old) with epilepsy.
null
Epilepsy
Levetiracetam Epilepsy Children Adults
null
2
arm 1: None arm 2: None
[ 0, 0 ]
1
[ 0 ]
intervention 1: Keppra XR 500 mg tablets and Keppra XR 750 mg tablets Dosage: Keppra XR 1000-3000 mg/day taken once daily. Duration: 4-7 days
intervention 1: Keppra XR
6
Mobile | Alabama | United States | -88.04305 | 30.69436 Phoenix | Arizona | United States | -112.07404 | 33.44838 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Fairfield | Connecticut | United States | -73.26373 | 41.14121 Bethesda | Maryland | United States | -77.10026 | 38.98067 Dallas | Texas | Unite...
25
0
0
0
NCT00961441
1COMPLETED
2010-03-01
2009-09-01
UCB BIOSCIENCES, 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 ]
403
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
false
In this study, Malathion Gel 0.5% will be compared to Nix (permethrin 1%) as a treatment for head lice in patients 2 years of age and older. Malathion Gel 0.5% is a new formulation of an established head lice treatment. The new formulation has been evaluated in 2 previous studies of patients 2 years of age and older.
This is a Phase III, multi-center, investigator-blinded, two-arm, randomized, parallel group study, evaluating the safety and efficacy of a Malathion Gel, 0.5% formulation, manufactured by Taro. The objective is to show superiority of the novel product to an active control, Nix® Crème Rinse, manufactured by Insight Pha...
Pediculosis
Head Lice
null
2
arm 1: Malathion gel 0.5% 30 minute application arm 2: Nix Crème Rinse applied to scalp for 10 minutes
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present. intervention 2: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head head lice are still present.
intervention 1: Malathion gel 0.5% intervention 2: Permethrin 1% rinse (Nix Crème)
7
Hot Springs | Arkansas | United States | -93.05518 | 34.5037 Sacramento | California | United States | -121.4944 | 38.58157 Kissimmee | Florida | United States | -81.41667 | 28.30468 Miami | Florida | United States | -80.19366 | 25.77427 Ormond Beach | Florida | United States | -81.05589 | 29.28581 Picayune | Mississip...
403
0
0
0
NCT00963508
1COMPLETED
2010-03-01
2009-08-01
Sun Pharmaceutical Industries, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
13
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to see if escitalopram (Lexapro) improves symptoms of major depressive disorder in patients who have ALS or MS.
This eight-week study aims to assess the effectiveness and tolerability of escitalopram in improving symptoms of Major Depression in patients with Amyotrophic Lateral Sclerosis (ALS) or Multiple Sclerosis (MS) as measured by the HAM-D. In addition, the study will assess improvement in the quality of life in patients wi...
Major Depression Multiple Sclerosis Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis ALS Multiple Sclerosis MS Major Depression Depression Major Depressive Disorder antidepressants Escitalopram Lexapro
null
1
arm 1: All patients will receive escitalopram 20 mg daily.
[ 0 ]
1
[ 0 ]
intervention 1: After confirmation of diagnoses and safety screening escitalopram will be started at 10 mg per day and augmented weekly in 10 mg per day increments, the maximum dose being 20 mg per day. The dose will be titrated upward or downward based on clinical response and tolerability. No other psychotropic medic...
intervention 1: escitalopram
1
Columbia | South Carolina | United States | -81.03481 | 34.00071
14
0
0
0
NCT00965497
1COMPLETED
2010-03-01
2009-07-01
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
[ 5 ]
51
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of this study is to assess the safety and efficacy of Travoprost 0.004% and Tafluprost 0.0015% in patients with primary open angle glaucoma or ocular hypertension when both medications are administered in the evening.
null
Glaucoma
Glaucoma IOP Travoprost
null
2
arm 1: Travoprost first, with tafluprost second. Each product dosed for six weeks. arm 2: Tafluprost first, with travoprost second. Each product dosed for six weeks.
[ 5, 5 ]
2
[ 0, 0 ]
intervention 1: One drop in the qualifying eye(s) each evening at 6:00 PM for 6 weeks, topical administration intervention 2: One drop in the qualifying eye(s) each evening at 6:00 PM for 6 weeks, topical administration
intervention 1: Travoprost 0.004% ophthalmic solution (TRAVATAN) intervention 2: Tafluprost 0.0015% ophthalmic solution
0
null
99
0
0
0
NCT00966940
1COMPLETED
2010-03-01
2009-09-01
Alcon Research
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
3
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
1FEMALE
false
The treatment of cervical cancer with chemotherapy and radiation will make women post menopausal (no estrogen from the ovaries), if a woman is not already in menopause. Estrogen plays a key role in maintaining bone health. Therefore, these women are at higher risk of getting osteoporosis (decrease minerals in the bone)...
OBJECTIVES * To determine the incidence of disseminated tumor cells (DTCs) in bone marrow and circulating tumor cells (CTCs) in the blood of women with cervical cancer at diagnosis and 3 to 9 months after chemotherapy and pelvic radiation with and without Zometa. * To determine the change in biochemical markers of bon...
Uterine Cervical Neoplasms
Uterine Cervical Cancer Cancer of Cervix Cervix Cancer
null
2
arm 1: Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care. arm 2: Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about...
[ 4, 0 ]
1
[ 0 ]
intervention 1: None
intervention 1: Zoledronic acid
1
St Louis | Missouri | United States | -90.19789 | 38.62727
3
0
0
0
NCT00966992
6TERMINATED
2010-03-01
2009-08-01
Washington University School of Medicine
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3, 4 ]
184
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
This is a controlled trial of amantadine to improve level of function following severe traumatic brain injury. The purpose of this study is: 1. To determine whether amantadine hydrochloride, given in a dose of 200-400 mg, improves functional recovery from the vegetative and minimally conscious states 2. To determine ...
Severe traumatic brain injury may result in severe disorders of consciousness (DOC), including coma, the vegetative state (VS) and the minimally conscious state (MCS). The longer the duration of impaired consciousness, the worse the ultimate functional prognosis, with only about half of those individuals who remain unc...
Traumatic Brain Injury
Traumatic Brain Injury Rehabilitation Disorders of Consciousness Functional Outcome Amantadine Hydrochloride
null
2
arm 1: 100mg BID administered for 2 weeks, then increased to 150mg BID in week 3 if change on primary outcome measure (ie Disability Rating Scale, DRS) was less than 2 points after week 2. If change in DRS score remained less than 2 points after week 3, dose was increased to 200mg BID in week 4. arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 184 patients who remain in VS or MCS 4 - 16 weeks post-TBI will be randomized in a stratified fashion to 4 weeks of amantadine (200 - 400 mg/day) followed by a 2-week washout period. The Disability Rating Scale (DRS) will be the primary dependent variable with the Coma Recovery Scale-Revised (CRS-R) ser...
intervention 1: Amantadine Hydrochloride intervention 2: Placebo
11
Braintree | Massachusetts | United States | -71.00215 | 42.20384 Jackson | Mississippi | United States | -90.18481 | 32.29876 New York | New York | United States | -74.00597 | 40.71427 Schenectady | New York | United States | -73.93957 | 42.81424 Charlotte | North Carolina | United States | -80.84313 | 35.22709 Elkins ...
184
0
0
0
NCT00970944
1COMPLETED
2010-03-01
2003-02-01
JFK Medical Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
138
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
false
This clinical trial will evaluate the efficacy and safety of Clobex® (clobetasol propionate) Spray 0.05% and Vectical™ (calcitriol) Ointment 3 µg/g over a four week period of use in one of two different regimens: 1. Vectical™ Ointment treatment, twice daily on weekdays (Mon - Fri) and Clobex® Spray treatment twice dai...
null
Plaque Psoriasis
null
2
arm 1: Vectical™ Ointment weekdays \& Clobex® Spray weekends regimen arm 2: Clobex® Spray morning and Vectical™ Ointment evening regimen
[ 5, 5 ]
2
[ 0, 0 ]
intervention 1: Vectical™ Ointment 3 µg/g, topical, apply twice daily on weekdays (Mon-Fri) and Clobex® Spray 0.05% twice daily on weekends (Sat-Sun) for 28 days intervention 2: Clobex® Spray 0.05%, topical, apply once each morning and Vectical™ Ointment 3 µg/g, topical, apply once each evening for 28 days
intervention 1: Vectical™ Ointment weekdays and Clobex® Spray weekends regimen intervention 2: Clobex® Spray morning and Vectical™ Ointment evening regimen
6
Los Angeles | California | United States | -118.24368 | 34.05223 San Diego | California | United States | -117.16472 | 32.71571 Evansville | Indiana | United States | -87.55585 | 37.97476 Fridley | Minnesota | United States | -93.26328 | 45.08608 Dallas | Texas | United States | -96.80667 | 32.78306 Waterloo | Ontario ...
138
0
0
0
NCT00988637
1COMPLETED
2010-03-01
2009-10-01
Galderma R&D
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
4
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
2MALE
true
The primary objectives of this study are to evaluate the safety and best dose of a regimen including bevacizumab and erlotinib in combination with docetaxel and prednisone. In addition, the investigators wish to evaluate how well these drugs might work against this disease. Bevacizumab and erlotinib are novel drugs tha...
In this Phase I/Phase II study, the primary objectives are to establish the maximum tolerated dose of docetaxel, erlotinib, bevacizumab, and prednisone in patients with metastatic hormone refractory prostate cancer and to determine the efficacy of this regimen for treatment of metastatic HRPC. In the phase I portion of...
Prostate Cancer
null
1
arm 1: Bevacizumab, Erlotinib, Docetaxel, Prednisone (dose escalation) Phase I: * Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid * Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab...
[ 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Phase I: * Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle * Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle * Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle intervention 2: 15mg/kg of Bevacizumab every 3 weeks intervention 3: 200 mg of Erlotinib PO daily days 2-16 intervention 4: 5 mg ...
intervention 1: Docetaxel intervention 2: Bevacizumab intervention 3: Erlotinib intervention 4: Prednisone
1
New York | New York | United States | -74.00597 | 40.71427
0
0
0
0
NCT00996502
6TERMINATED
2010-03-01
2006-07-01
Columbia University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
54
RANDOMIZED
CROSSOVER
0TREATMENT
4QUADRUPLE
false
0ALL
null
This study compared the effects of a single dose of indacaterol with that of a single dose of tiotropium on inspiratory capacity.
null
Chronic Obstructive Pulmonary Disease
COPD indacaterol tiotropium
null
3
arm 1: Patients received indacaterol 150 μg once. After a 5-9 days washout period, patients received tiotropium 18 μg once. After a second 5-9 days washout period, patients received placebo (matching indacaterol) once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agoni...
[ 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device. intervention 2: Tiotropium was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device. intervention 3: Placebo (matching indacaterol) was supplied i...
intervention 1: Indacaterol 150 μg intervention 2: Tiotropium 18 μg intervention 3: Placebo
11
Bergamo | N/A | Italy | 9.66721 | 45.69601 Brescia | N/A | Italy | 10.21472 | 45.53558 Cava de' Tirreni | N/A | Italy | 14.70773 | 40.69954 Genova | N/A | Italy | 11.87211 | 45.21604 Milan | N/A | Italy | 12.59836 | 42.78235 Orbassano | N/A | Italy | 7.53813 | 45.00547 Pavia | N/A | Italy | 9.15917 | 45.19205 Reggio Em...
157
0
0
0
NCT00999908
1COMPLETED
2010-03-01
2009-10-01
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 ]
21
RANDOMIZED
CROSSOVER
0TREATMENT
3TRIPLE
false
0ALL
false
Respiratory diseases including Asthma are high prevalent among preschool children. Specific treatment, nowadays, include steroid inhalers and anti leukotrienes. It is known that the amount of the drug reaching small airways and lungs is bigger how much smaller the particles liberated by inhalers. Beclometasone is being...
26 - 30 patients, between 3 -6 years old, mild asthmatics, with positive adenosine challenge test, will received in a randomized, double blind, cross over assignment Beclometasone dipropionate (100µg twice a day) or placebo, through an inhaler (autohaler) device, attached to a spacer device, during four consecutive wee...
Asthma Bronchial Hyperresponsiveness
asthma preschool children bronchial hyperresponsiveness beclometasone dipropionate - HFA Qvar Adenosine Challenge test
null
2
arm 1: Controlled or partially controlled multiple trigger wheezing children received 4 weeks of placebo, preceded and succeeded by AMP challenge test, arm 2: Patients will receive 4 weeks of inhale QVAR (HFA beclomethasone) 100µg through a spacer device, twice a day
[ 2, 1 ]
2
[ 0, 0 ]
intervention 1: 100µg twice a day, through inhaler autohaler, using a spacer device, preceded and followed by adenosine challenge test intervention 2: inhalation twice a day for one month, preceded and followed by adenosine challenge test
intervention 1: Beclomethasone dipropionate HFA intervention 2: placebo
1
Haifa | N/A | Israel | 34.99928 | 32.81303
21
0
0
0
NCT01006655
1COMPLETED
2010-03-01
2009-03-01
Rambam Health Care Campus
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 ]
258
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of this study is to evaluate the efficacy and safety of fentanyl in opioid-naive participants with post-herpetic neuralgia, complex regional pain syndrome or post-operative pain syndrome who cannot obtain a sufficient analgesic effect by the treatment of non-opioid analgesics (drug used to control pain).
This is a multi-center (conducted in more than one center), double-blind (neither the participant nor the physician knows the assigned study drug), randomized (participants assigned study drug by chance), withdrawal study in opioid-naive participants with post-herpetic neuralgia (intense, typically intermittent pain al...
Postherpetic Neuralgia Complex Regional Pain Syndromes (CRPS) Postoperative Pain
Postherpetic Neuralgia Complex Regional Pain Syndromes (CRPS) Postoperative Pain Fentanyl Patch, transdermal Opioid analgesics
null
3
arm 1: One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2...
[ 0, 0, 2 ]
2
[ 0, 0 ]
intervention 1: One-day adhesive transdermal patch containing fentanyl 12.5 to 50 mcg/hr applied to chest, abdomen, upper arm and thigh and replaced every day. intervention 2: Placebo patch indistinguishable from one-day adhesive transdermal patch containing fentanyl 12.5 to 50 mcg/hr applied to chest, abdomen, upper a...
intervention 1: Fentanyl intervention 2: Placebo
79
Aichi | N/A | Japan | 130.62158 | 32.51879 Amagasaki | N/A | Japan | 135.41667 | 34.71667 Asahikawa | N/A | Japan | 142.36489 | 43.77063 Bunkyō City | N/A | Japan | 139.4217 | 35.5331 Chigasaki | N/A | Japan | 139.40434 | 35.33638 Chūō | N/A | Japan | 139.77544 | 35.67004 Ebetsu | N/A | Japan | 141.55056 | 43.10806 Fuj...
421
0
0
0
NCT01008553
1COMPLETED
2010-03-01
2008-12-01
Janssen Pharmaceutical K.K.
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 ]
35
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
false
0ALL
null
This study assessed the efficacy, safety, tolerability, and pharmacokinetics of two different formulations of indacaterol, one administered via the Concept1 device and one administered via the Simoon device. The study aimed to determine whether the novel formulation (Simoon) had a similar profile to that of the establi...
This study was double-blind with regards to the Concept1, where placebo for the lactose-blended indacaterol was available. However, with regards to the Simoon, neither the subject nor the investigator was blinded due to lack of a placebo to the PulmoSphere formulation. Hence, the overall designation of the study was pa...
Asthma
asthma QAB149 indacaterol pulmonary function
null
4
arm 1: In treatment period 1, patients received indacaterol 150 μg via the Concept1 dry-powder inhaler (DPI); in treatment period 2, patients received placebo to indacaterol via the Concept1 DPI; in treatment period 3, patients received indacaterol 60 μg via the Simoon DPI; and in treatment period 4, patients received ...
[ 0, 0, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Indacaterol maleate 150 μg was provided in powder filled capsules with the Concept1 dry-powder inhaler. intervention 2: Indacaterol 60 μg was provided in powder filled capsules with the Simoon dry-powder inhaler. intervention 3: Indacaterol 120 μg was provided in powder filled capsules with the Simoon d...
intervention 1: Indacaterol 150 μg via the Concept1 dry-powder inhaler intervention 2: Indacaterol 60 μg via the Simoon dry-powder inhaler intervention 3: Indacaterol 120 μg via the Simoon dry-powder inhaler intervention 4: Placebo to indacaterol via the Concept1 dry-powder inhaler
4
Berlin | N/A | Germany | 13.41053 | 52.52437 Groningen | N/A | Netherlands | 6.56667 | 53.21917 Belfast | N/A | United Kingdom | -5.92541 | 54.59682 Manchester | N/A | United Kingdom | -2.23743 | 53.48095
135
0
0
0
NCT01012739
1COMPLETED
2010-03-01
2009-10-01
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
[ 5 ]
2
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
null
The purpose of this study is to assess if a single dose of Diclofenac potassium (0.5 mg/kg) is more or as effective as a single dose of Acetaminophen (10 mg/kg) in the reduction of fever during 2 hours, in the treatment of febrile children with acute upper respiratory infections. This is a comparative double blind, do...
null
Fever
Antipyretics fever diclofenac acetaminophen children acute upper respiratory tract infections
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Diclofenac potassium intervention 2: Acetaminophen
intervention 1: Diclofenac potassium intervention 2: Acetaminophen
2
Caracas | N/A | Venezuela | -66.87919 | 10.48801 Estado Carabobo | N/A | Venezuela | N/A | N/A
0
0
0
0
NCT01019980
6TERMINATED
2010-03-01
2010-03-01
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 ]
357
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
false
This study is to evaluate the safety and efficacy of loteprednol etabonate \[LE\] and tobramycin ophthalmic suspension versus tobramycin and dexamethasone ophthalmic suspension in the treatment of ocular inflammation associated with blepharokeratoconjunctivitis (BKC).
null
Conjunctivitis Keratitis Blepharitis
Blepharokeratoconjunctivitis
null
2
arm 1: Loteprednol etabonate and tobramycin ophthalmic suspension arm 2: Tobramycin and dexamethasone ophthalmic suspension
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Loteprednol etabonate and tobramycin ophthalmic suspension administered to study eye 4 times a day (QID) for 14 days. intervention 2: Tobramycin and dexamethasone ophthalmic suspension administered to study eye 4 times a day (QID) for 14 days.
intervention 1: Loteprednol and tobramycin intervention 2: Tobramycin and dexamethasone
1
Singapore | N/A | Singapore | 103.85007 | 1.28967
354
0
0
0
NCT01028027
1COMPLETED
2010-03-01
2009-10-01
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
[ 4 ]
618
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
2MALE
false
Randomized, placebo-controlled, double-blind, parallel design, Phase 3 study to evaluate the safety and efficacy of udenafil, an orally administered, potent and selective inhibitor of PDE-5 versus placebo for the treatment of subjects with erectile dysfunction (ED).
null
Erectile Dysfunction
null
4
arm 1: None arm 2: None arm 3: None arm 4: None
[ 2, 0, 0, 0 ]
2
[ 0, 0 ]
intervention 1: Tablets via oral administration before an attempt at sexual intercourse. intervention 2: Tablets via oral administration before an attempt at sexual intercourse.
intervention 1: Udenafil intervention 2: Placebo
36
Birmingham | Alabama | United States | -86.80249 | 33.52066 Homewood | Alabama | United States | -86.80082 | 33.47177 Mesa | Arizona | United States | -111.82264 | 33.42227 Phoenix | Arizona | United States | -112.07404 | 33.44838 Tucson | Arizona | United States | -110.92648 | 32.22174 Laguna Hills | California | Unit...
616
0
0
0
NCT01037244
1COMPLETED
2010-03-01
2009-09-01
Warner Chilcott
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 ]
378
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
This is an exploratory, multicenter, randomized, blinded, placebo-controlled study of Mucinex in patients with colds. Patients will receive 7 days of treatment with either Mucinex or placebo. The study will assess the effects of Mucinex on sputum and cold symptoms.
null
Common Cold
common cold
null
2
arm 1: None arm 2: None
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: bid 7 days intervention 2: bid 7 days
intervention 1: guaifenesin (Mucinex) intervention 2: placebo
1
Bellevue | Nebraska | United States | -95.89084 | 41.13667
377
0
0
0
NCT01046136
1COMPLETED
2010-03-01
2009-12-01
Reckitt Benckiser 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 ]
123
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Although approved for minor strains, sprains and contusions, FLECTOR Patch has not been studied extensively in the setting of acute back strain. This study is being conducted as an initial step in demonstrating the benefit of FLECTOR Patch specifically for back strain. In particular, this study is expected to provide i...
null
Acute Back Strain
FLECTOR® Patch acute back strain
null
1
arm 1: One patch applied every 12 hours
[ 0 ]
1
[ 0 ]
intervention 1: One FLECTOR Patch applied to the most painful area on the subject's back every 12 hours for up to 14 days.
intervention 1: FLECTOR® Patch (diclofenac epolamine topical patch) 1.3%
0
null
123
0
0
0
NCT01054820
1COMPLETED
2010-03-01
2010-01-01
Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
50
RANDOMIZED
CROSSOVER
7BASIC_SCIENCE
0NONE
true
2MALE
false
The major aim of this study is to investigate and compare the drug amount delivered to the body after sequential application of two Rotigotine patches of two different formulations
null
Healthy Volunteers
Rotigotine Neupro® Transdermal Patch
null
2
arm 1: Rotigotine transdermal patch 4.5 mg/10 cm\^2, test drug product PR2.2.1 followed by Rotigotine transdermal patch 4.5 mg/10 cm\^2, reference drug product PR2.1.1 separated by a washout phase of at least 5 days arm 2: Rotigotine transdermal patch 4.5 mg/10 cm\^2, reference drug product PR2.1.1 followed by Rotigoti...
[ 0, 0 ]
1
[ 0 ]
intervention 1: Rotigotine 4.5 mg/10 cm\^2 patch applied for 24 hours
intervention 1: Rotigotine transdermal patch
1
Mönchengladbach | North Rhine-Westphalia | Germany | 6.44172 | 51.18539
98
0
0
0
NCT01059903
1COMPLETED
2010-03-01
2010-01-01
UCB 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
[ 3 ]
25
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
true
1FEMALE
false
The purpose of this study was to assess the safety and efficacy of a new metallic cannula to inject hyaluronic acid for dermal augmentation in the nasolabial folds compared to standard needle.
This was a monocentric, prospective, randomized, phase II and double-blind study. At the baseline visits, one investigator rated the severity of nasolabial folds on both left and right sides according to the mentioned scale, and a standard set of six photographs of the face (frontal, left side and right side for both ...
Wrinkles
metallic cannula Hyaluronic acid
null
2
arm 1: Nasolabial Fold with metallic cannula and hyaluronic acid injected. hyaluronic acid with metallic cannula or standard needle. Hyaluronic acid injected with the new tool arm 2: Nasolabial Fold with standard needle and hyaluronic acid injected. hyaluronic acid with metallic cannula or standard needle.
[ 0, 1 ]
2
[ 3, 0 ]
intervention 1: The sides of injection were randomized and both the subject and the evaluator were blind to it. The injections were performed according through two different devices: * In one of the sides, the hyaluronic acid (Restylane®) was injected in its conventional pharmaceutical presentation, with a standard ne...
intervention 1: hyaluronic acid with metallic cannula or standard needle. intervention 2: Hyaluronic acid injected with the new tool.
2
Porto Alegre | Rio Grande do Sul | Brazil | -51.23019 | -30.03283 Porto Alegre | N/A | Brazil | -51.23019 | -30.03283
50
0
0
0
NCT01066026
1COMPLETED
2010-03-01
2009-07-01
Brazilan Center for Studies in Dermatology
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
27
RANDOMIZED
CROSSOVER
null
0NONE
true
0ALL
false
To demonstrate the bioequivalence of a 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) tablet to that of 2.5-mg saxagliptin (Onglyza) and 500-mg metformin (Glucophage, marketed in Canada by Sanofi-Aventis) tablets coadministered to healthy participants in the fasted and fed states.
null
Type 2 Diabetes Mellitus
null
4
arm 1: Single oral doses of saxagliptin, 2.5 mg, and metformin, 500 mg, administered together as tablets in the fasted state arm 2: Single oral dose of a 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) tablet administered in the fasted state arm 3: Single oral doses of saxagliptin, 2.5 mg, and metformi...
[ 5, 5, 5, 5 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin, once daily, 1 week intervention 2: Tablets, oral, 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC), once daily, 1 week intervention 3: Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin, once daily, 1 week intervention 4: Tablet...
intervention 1: Saxagliptin, 2.5 mg + Metformin, 500 mg (fasted state) intervention 2: Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fasted state) intervention 3: Saxagliptin, 2.5 mg + Metformin, 500 mg (fed state) intervention 4: Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fed state)
1
Austin | Texas | United States | -97.74306 | 30.26715
105
0
0
0
NCT01068717
1COMPLETED
2010-03-01
2010-03-01
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
[ 2 ]
24
RANDOMIZED
CROSSOVER
null
0NONE
true
0ALL
false
To demonstrate bioequivalence of a 2.5 mg saxagliptin/850 mg metformin fixed dose combination (FDC) tablet relative to the 2.5 mg saxagliptin tablet and 850 mg metformin (Glucophage Marketed by Merck-Serono) tablet co-administered to healthy subjects in the fasted and fed condition.
null
Type 2 Diabetes Mellitus
null
4
arm 1: A single oral dose of 2.5-mg Onglyza tablet and 850-mg Glucophage (marketed by Merck Serono) tablet administered together in the fasted condition. arm 2: A single oral dose of 2.5-mg saxagliptin/850-mg metformin fixed dose combination (FDC) administered in the fasted condition. arm 3: A single oral dose of 2.5-m...
[ 5, 5, 5, 5 ]
3
[ 0, 0, 0 ]
intervention 1: Tablets, Oral, 2.5 mg, once daily, single dose intervention 2: Tablets, Oral, 850 mg, once daily, single dose intervention 3: Tablet, oral, (saxagliptin 2.5 mg) (metformin 850 mg), once daily, single dose
intervention 1: saxagliptin intervention 2: metformin intervention 3: saxagliptin + metformin (FDC tablet)
1
Austin | Texas | United States | -97.74306 | 30.26715
94
0
0
0
NCT01068743
1COMPLETED
2010-03-01
2010-02-01
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
[ 5 ]
401
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
GlaxoSmithKline will be conducting this trial to compare analgesic efficacy of paracetamol 1000 mg vs 650 mg. The post-surgical dental pain model will be used to evaluate the analgesic efficacy of paracetamol. Each subject will be enrolled in the study for up to six weeks. The duration of the entire study will be appro...
null
Post-surgical Dental Pain
dental pain paracetamol Post-surgical dental pain
null
3
arm 1: Paracetamol 1000mg arm 2: Paracetamol 650 mg arm 3: Placebo
[ 0, 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Paracetamol 1000mg intervention 2: Paracetamol 650 mg intervention 3: Placebo
intervention 1: Paracetamol 1000 mg intervention 2: Paracetamol 650 mg intervention 3: Placebo
1
Salt Lake City | Utah | United States | -111.89105 | 40.76078
401
0
0
0
NCT01075243
1COMPLETED
2010-03-01
2009-11-01
GlaxoSmithKline
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
300
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
GlaxoSmithKline will be conducting this trial to compare analgesics efficacy of paracetamol 1000mg vs 500mg . The post-surgical dental pain model will be used to evaluate the analgesic efficacy of paracetamol. Each subject will be enrolled in the study for up to six weeks. The duration of the entire study will be appro...
null
Post-surgical Dental Pain
paracetamol dental pain Post-surgical dental pain
null
3
arm 1: Paracetamol 1000 mg arm 2: Paracetamol 500 mg arm 3: Placebo
[ 0, 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Paracetamol 1000 mg intervention 2: Paracetamol 500 mg intervention 3: Placebo
intervention 1: Paracetamol 1000 mg intervention 2: Paracetamol 500 mg intervention 3: Placebo
2
Austin | Texas | United States | -97.74306 | 30.26715 Salt Lake City | Utah | United States | -111.89105 | 40.76078
300
0
0
0
NCT01082081
1COMPLETED
2010-03-01
2009-10-01
GlaxoSmithKline
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
153
RANDOMIZED
PARALLEL
1PREVENTION
2DOUBLE
false
0ALL
false
The purposes of this study are to document the antiemetic efficacy of multimodal antiemetic protocol in patient after Total Knee Arthroplasty using regional anesthesia, midazolam \& propofol, hydration \& oxygen supplement, preemptive \& multimodal contemporary pain management and to determine whether Ramosetron prophy...
Immediate postoperative pain after Total Knee Arthroplasty(TKA) remains an unsolved problem, and a substantial proportion of patients experience moderate to severe postoperative pain. Patient controlled analgesia(PCA) using opioid is an effective and safe modality for postoperative pain relief after TKA and remains an ...
Osteoarthritis, Knee
postoperative nausea and vomiting
null
2
arm 1: ramosetron prophylaxis at the end of surgery with starting PCA and 1 day after surgery arm 2: no antiemetic prophylaxis
[ 0, 4 ]
1
[ 0 ]
intervention 1: ramosetron intravenous injection, 0.3mg, 1 time/day for 2 days
intervention 1: Ramosetron
1
Seongnam-si | Gyeonggi-do | South Korea | 127.13778 | 37.43861
142
0
0
0
NCT01102491
1COMPLETED
2010-03-01
2009-09-01
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
[ 2 ]
13
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This study will evaluate the safety and tolerability of single doses of MK-0941 based on assessment of clinical and laboratory adverse experiences
null
Type 2 Diabetes
null
4
arm 1: Period 1: Placebo - Period 2: 80 mg - Period 3: 100 mg - Period 4: Placebo - Period 5: 140 mg arm 2: Period 1: 60 mg - Period 2: 80 mg - Period 3: 100 mg - Period 4: 120 mg - Period 5: Placebo arm 3: Period 1: 60 mg - Period 2: Placebo - Period 3: 100 mg - Period 4: 120 mg - Period 5: 140 mg arm 4: Period 1: 60 ...
[ 0, 0, 0, 0 ]
2
[ 0, 0 ]
intervention 1: A single 60, 80, 100, 120 or 140 mg oral dose of MK-0941 will be administered in each period intervention 2: a single oral placebo will be administered in the designated period (Periods 1-5)
intervention 1: MK-0941 intervention 2: Comparator: Placebo
0
null
59
0
0
0
NCT01106287
1COMPLETED
2010-03-01
2009-10-01
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
[ 5 ]
55
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
The purpose of this study is to determine whether the combinational use of ammonium lactate lotion 12% (Lac-Hydrin) and halobetasol propionate ointment 0.05% (Ultravate) is safe and effective in the initial treatment and long-term maintenance of psoriasis. Patients will use both medications continuously for two weeks a...
This is a randomized, double-blind, placebo-controlled, clinical trial assessing the efficacy of Ultravate ointment in combination with Lac-Hydrin lotion in the treatment of plaque psoriasis. In the first phase, patients will be treated for two weeks with combination therapy using Ultravate ointment twice daily along w...
Plaque Psoriasis
plaque psoriasis lac-hydrin ammonium lactate Ultravate halobetasol propionate weekend only application topical therapy topical corticosteroid class I steroid
null
2
arm 1: Lac-Hydrin lotion twice daily everyday + Ultravate ointment twice daily on weekends only arm 2: Lac-Hydrin lotion twice daily everyday + placebo ointment twice daily on weekends only
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Steroid on weekends only group intervention 2: Placebo on weekends only group
intervention 1: Lac-Hydrin lotion (ammonium lactate lotion 12%) ; UItravate ointment (halobetasol propionate ointment 0.05%) intervention 2: Lac-Hydrin lotion (ammonium lactate lotion 12%); placebo ointment
1
New York | New York | United States | -74.00597 | 40.71427
41
0
0
0
NCT01111123
1COMPLETED
2010-03-01
2009-01-01
Icahn School of Medicine at Mount Sinai
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 ]
11
RANDOMIZED
CROSSOVER
4SUPPORTIVE_CARE
3TRIPLE
false
0ALL
false
The purpose of this prospective study is to compare pain levels and pain medication dose requirements in patients with topical negative pressure (TNP) dressings removed in a standard manner (i.v. or p.o. pain meds) compared to dressings removed with lidocaine analgesia, via injection retrograde up the suction tube into...
null
Pain
Wound Vacuum Assisted Dressings Lidocaine Dressing change Pain management palliative care
null
2
arm 1: None arm 2: None
[ 2, 1 ]
2
[ 0, 0 ]
intervention 1: Interventional dressing change: iv or po pain medication with injection of 1% lidocaine retrograde up the suction tube into the sponge. intervention 2: Control dressing change: iv or po pain medication and injection of 0.9% normal saline retrograde up the suction tube.
intervention 1: Lidocaine intervention 2: Placebo-Saline
1
Salt Lake City | Utah | United States | -111.89105 | 40.76078
21
0
0
0
NCT01126359
1COMPLETED
2010-03-01
2008-08-01
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
[ 0 ]
107
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
true
0ALL
false
Introduction Numerous drugs and combinations of drugs are used for procedural sedation and analgesia (PSA) in Emergency Departments, including propofol, ketamine, benzodiazepines, narcotics, barbiturates, and others, but propofol has gained popularity despite its potential to cause cardiac and respiratory depression. ...
Introduction Numerous drugs and combinations of drugs are used for procedural sedation and analgesia (PSA) in Emergency Departments, including propofol, ketamine, benzodiazepines, narcotics, barbiturates, and others, but propofol has gained popularity despite its potential to cause cardiac and respiratory depression. ...
Procedural Sedation and Analgesia
null
2
arm 1: Participants received 0.5-1.5 micrograms/kg Fentanyl, followed 0.5 mg/kg Ketamine infusion, followed by propofol to maintain sedation. arm 2: Participants received 0.5-1.5 micrograms/kg Fentanyl, followed by placebo infusion, followed by propofol to maintain sedation.
[ 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Ketamine was given as a 0.5mg / Kg bolus. intervention 2: Placebo given as an bolus to control group. intervention 3: Fentanyl 0.5 - 1.5 micrograms given to both arms prior to Ketamine or placebo intervention 4: Propofol given to both arms to maintain sedation throughout procedure.
intervention 1: Ketamine intervention 2: Placebo intervention 3: Fentanyl intervention 4: Propofol
1
Columbia | Missouri | United States | -92.33407 | 38.95171
0
0
0
0
NCT01126957
6TERMINATED
2010-03-01
2007-05-01
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
[ 5 ]
83
RANDOMIZED
CROSSOVER
1PREVENTION
2DOUBLE
true
0ALL
false
This study will use an oral in-situ caries model to study remineralization of enamel due to the action of different combinations of fluoride salts delivered from dentifrices.
null
Dental Caries
Enamel remineralization Fluoride caries
null
4
arm 1: Fluoride toothpaste containing sodium fluoride (NaF) arm 2: Fluoride toothpaste containing stannous fluoride (SnF) and NaF. arm 3: Fluoride toothpaste containing sodium monofluorophosphate (NaMFP) and NaF. arm 4: Low fluoride toothpaste containing NaF
[ 0, 0, 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Fluoride toothpaste containing sodium fluoride as 1450 parts per million (ppm) F, 675 ppmF, 450 ppmF, 350ppmF. intervention 2: Fluoride toothpaste containing stannous fluoride (1100 ppmF) intervention 3: Fluoride toothpaste containing sodium monofluorophosphate (1000 ppmF)
intervention 1: NaF intervention 2: SnF intervention 3: NaMFP
1
Indianapolis | Indiana | United States | -86.15804 | 39.76838
318
0
0
0
NCT01128946
1COMPLETED
2010-03-01
2009-11-01
GlaxoSmithKline
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
50
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
1FEMALE
null
The purpose of this study is to specifically investigate the efficacy of an alternative pharmacologic cervical ripening agent, misoprostol, versus the standard oxytocin, as an adjunct to Foley balloon for induction of the unfavorable cervix.
The design of this study is a randomized, controlled study with two arms. Both groups will undergo placement of a Foley catheter, through the external and internal os of the cervix, according to standard practice. In group A, receiving intravenous infusion of oxytocin, will serve as the control group as it is standard ...
Induction of Labor
Cervical Ripening Rate of Cesearean Section
null
2
arm 1: Foley balloon placement with intravenous low dose oxytocin administration starting 2 milliunits per minute. arm 2: Misoprostol, 25 mcg, is placed intravaginally into the posterior fornix of the vagina in conjunction with Foley balloon placement
[ 1, 0 ]
2
[ 0, 0 ]
intervention 1: Foley balloon placement with intravenous low dose oxytocin administration starting 2 milliunits per minute. intervention 2: Misoprostol, 25 mcg, is placed intravaginally into the posterior fornix of the vagina in conjunction with Foley balloon placement
intervention 1: Oxytocin intervention 2: Misoprostol
1
Canton | Ohio | United States | -81.37845 | 40.79895
50
0
0
0
NCT01139801
1COMPLETED
2010-03-01
2009-09-01
Aultman Health Foundation
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
610
RANDOMIZED
PARALLEL
1PREVENTION
4QUADRUPLE
false
0ALL
null
The objective of this study is to assess the efficacy and safety of DU-176b compared with enoxaparin sodium for the prevention of venous thromboembolism in patients after elective total hip arthroplasty.
null
Prevention Venous Thromboembolism
Anticoagulants Venous thromboembolism Thromboembolism Thrombosis enoxaparin sodium Embolism Deep vein thrombosis DU-176b edoxaban factor Xa total hip arthroplasty
null
2
arm 1: DU-176b oral tablets, 30 mg., taken once daily for 2 weeks, initiated within 6 to 24 hours after surgery. arm 2: enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks, initiated within 24 to 36 hours after surgery.
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: edoxaban intervention 2: enoxaparin sodium
2
Osaka | N/A | Japan | 135.50107 | 34.69379 Tokyo | N/A | Japan | 139.69171 | 35.6895
604
0
0
0
NCT01181167
1COMPLETED
2010-03-01
2009-05-01
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
[ 0 ]
102
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
Intravenous phenobarbital in combination with a symptom-guided standardized lorazepam-based alcohol withdrawal protocol will be associated with decreased need for ICU admission, continuous lorazepam infusion and will not be associated with increased adverse events.
null
Alcohol Withdrawal
null
2
arm 1: 10 mg/kg IV phenobarbital in 100 ml saline arm 2: 100 ml saline
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: 10 mg/kg IV phenobarbital in 100 ml saline intervention 2: 100 m l saline
intervention 1: 10 mg/kg IV phenobarbital in 100 ml saline intervention 2: placebo
1
Oakland | California | United States | -122.2708 | 37.80437
102
0
0
0
NCT01184417
1COMPLETED
2010-03-01
2009-01-01
Jonathan Rosenson
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 ]
22
RANDOMIZED
PARALLEL
9OTHER
0NONE
true
0ALL
false
The purpose of this study is to find out if presurgical antiseptic preparations affect how well surgical drapes adhere to skin.
Adhesive incise drapes are often used to provide a physical sterile barrier between the surrounding skin and the open wound at the beginning of a surgery. This study sought to determine the effect of presurgical skin antiseptic preparation on the adhesion of various incise drapes to the skin.
Healthy
null
2
arm 1: Applied ChloraPrep on the application site per manufacturer's instruction arm 2: Apply DuraPrep to the application site per manufacturer's instruction
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: The application sites (subjects' backs) will be prepped with ChloraPrep according to manufacturer's instruction. Samples of 3 surgical incise drapes will be applied to the prepped sites according to randomization schedule intervention 2: The application sites (subjects' backs) will be prepped with DuraP...
intervention 1: ChloraPrep intervention 2: DuraPrep
1
Broomall | Pennsylvania | United States | -75.35658 | 39.9815
22
0
0
0
NCT01290978
1COMPLETED
2010-03-01
2010-02-01
Solventum US LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
133
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to evaluate the effectiveness and safety of paliperidone extended release (ER) in symptomatic participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) who wer...
This is an open-label (all people know the identity of the intervention), multi-centric (conducted in more than one center) and non-comparative study of paliperidone ER in participants with schizophrenia who have a previous history of bad adherence to the antipsychotic treatment because of insufficient efficacy and sid...
Schizophrenia
Schizophrenia Paliperidone
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Participants will be administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose will be increased or decreased as per Investigator's discretion.
intervention 1: Paliperidone ER
0
null
132
0
0
0
NCT01362439
1COMPLETED
2010-03-01
2009-01-01
Janssen-Cilag S.p.A.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
31
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to compare serum concentrations of inflammatory cytokines, interleukin 6 (IL-6), High-sensitivity C-reactive protein (hs-CRP), adiponectin, and tumour necrosis factor alpha (TNFα), before and after three months treatment with metformin in obese adolescents with insulin resistance (IR).
The increased prevalence of obesity in pediatric patients is a public health problem particularly because of the difficulties involved with changing lifestyles. Current studies of obese children and adolescents show increased insulin resistance (IR) and chronic inflammatory states. These conditions increase the risk of...
Obesity
Metformin Obesity Insulin resistance Interleukin six Adiponectin High sensitivity C reactive protein. Tumour Necrosis Factor alpha
null
2
arm 1: Tablet of 500 mg metformin, oral every 12 hours (total metformin dose of 1 g/day) for 3 months. arm 2: Tablet of 500 mg oral placebo every 12 hours for 3 months.
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Tablet of 500 mg metformin, oral every 12 hours (total metformin dose of 1 g/day) for 3 months. intervention 2: Tablet of 500 mg oral placebo every 12 hours for 3 months.
intervention 1: Metformin intervention 2: Placebo
2
León | Guanajuato | Mexico | -101.67374 | 21.12908 Mexico City | Mexico City | Mexico | -99.12766 | 19.42847
31
0
0
0
NCT01410604
1COMPLETED
2010-03-01
2007-01-01
Hospital Regional de Alta Especialidad del Bajio
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 ]
201
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
1FEMALE
false
The purpose of this study is to evaluate the efficacy and safety of Ethinyl estradiol and Norgestimate (EE/NGM) compared to Ethinyl estradiol and Desogestrel (EE/DSG), for treatment of female participants with mild to moderate acne vulgaris (pimples).
This is a single-blind (physician does not know the name of the assigned drug) and randomized (study drug assigned by chance) study to compare the effectiveness and safety of EE/NGM and EE/DSG in female participants using oral contraceptive and have mild to moderate acne vulgaris. Tablets of EE/NGM and EE/DSG will be a...
Acne Vulgaris
Acne Vulgaris Ethinyl estradiol Norgestimate Desogestrel Tricilest Oilezz
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Ethinyl estradiol/Norgestimate encapsulated oral tablet will be administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each. interven...
intervention 1: Ethinyl estradiol/Norgestimate (EE/NGM) intervention 2: Ethinyl estradiol/Desogestrel (EE/DSG)
3
Bangkok | N/A | Thailand | 100.50144 | 13.75398 Bangkok | N/A | Thailand | 100.50144 | 13.75398 Chiang Mai | N/A | Thailand | 98.98468 | 18.79038
201
0
0
0
NCT01466673
1COMPLETED
2010-03-01
2008-12-01
Janssen-Cilag Ltd.,Thailand
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
52
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
true
0ALL
false
To investigate the effect of BIA 9-1067 in steady-state conditions on the levodopa pharmacokinetics
Single centre, randomized, double-blind, gender-balanced, placebo-controlled study in 4 groups of healthy subjects
Parkinson Disease
Parkinson Disease BIA 9-1067
null
4
arm 1: 5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28 arm 2: Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28. arm 3: 15 mg BI...
[ 0, 0, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: None intervention 4: None
intervention 1: BIA 9-1067 intervention 2: Placebo intervention 3: levodopa/carbidopa intervention 4: levodopa/benserazide
1
Mount Royal | Quebec | Canada | -73.64918 | 45.51675
52
0
0
0
NCT01533116
1COMPLETED
2010-03-01
2009-03-01
Bial - Portela C S.A.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
59
RANDOMIZED
PARALLEL
7BASIC_SCIENCE
2DOUBLE
true
1FEMALE
false
The purpose of this study is to assess the safety and side effects of multiple doses of LY2541546 in postmenopausal women when given subcutaneously (injection just under the skin) and intravenously (directly into a vein). The study will also test how long it takes the study drug to get into the body, how long it takes ...
null
Healthy
Postmenopausal females Volunteers
null
6
arm 1: 180 milligram (mg) LY2541546 administered subcutaneous (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind. arm 2: 270 mg LY2541546 administered (SC) once every 2 weeks (Q2W) for 8 weeks. arm 3: 270 mg LY2541546 administered (SC) once every 4 weeks (Q4W) for ...
[ 0, 0, 0, 0, 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Administered SC intervention 2: Administered IV intervention 3: Administered SC intervention 4: Administered IV
intervention 1: LY2541546 - SC intervention 2: LY2541546 - IV intervention 3: Placebo - SC intervention 4: Placebo - IV
5
Daytona Beach | Florida | United States | -81.02283 | 29.21081 Honolulu | Hawaii | United States | -157.85833 | 21.30694 Evansville | Indiana | United States | -87.55585 | 37.97476 Austin | Texas | United States | -97.74306 | 30.26715 Dallas | Texas | United States | -96.80667 | 32.78306
59
0
0
0
NCT01742091
1COMPLETED
2010-03-01
2009-09-01
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
[ 3, 4 ]
66
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
false
0ALL
false
This study will compare a fast-absorbing paracetamol plus caffeine formula with placebo and an over-the-counter dose of paracetamol and ibuprofen to treat episodic tension headache.
null
Headache, Tension-Type
caffeine paracetamol tension headache
null
4
arm 1: Placebo arm 2: paracetamol marketed forumulation arm 3: ibuprofen marketed formulation arm 4: experimental paracetamol + caffeine formulation
[ 2, 1, 1, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Placebo intervention 2: experimental paracetamol + caffeine formulation intervention 3: ibuprofen marketed formulation intervention 4: Paracetamol marketed formulation
intervention 1: Placebo intervention 2: Experimental paracetamol + caffeine formulation intervention 3: ibuprofen marketed formulation intervention 4: Paracetamol marketed formulation
7
Pembroke Pines | Florida | United States | -80.22394 | 26.00315 Springfield | Massachusetts | United States | -72.58981 | 42.10148 Wellesley Hills | Massachusetts | United States | -71.27867 | 42.30843 Lake Success | New York | United States | -73.71763 | 40.77066 Mount Vernon | New York | United States | -73.83708 | 4...
187
0
0
0
NCT01755702
6TERMINATED
2010-03-01
2009-07-01
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
[ 2 ]
24
RANDOMIZED
CROSSOVER
null
2DOUBLE
true
0ALL
false
The aim of this study is to learn how different doses of LY2624803 affect sleep in healthy Japanese participants. The study has four treatment periods. Participants will receive a single dose of LY2624803 or placebo in each treatment period.
null
Sleep Initiation and Maintenance Disorders
null
5
arm 1: Single dose of 0.1 mg LY2624803 administered orally in up to 2 of 4 treatment periods arm 2: Single dose of 1.0 mg LY2624803 administered orally in up to 2 of 4 treatment periods arm 3: Single dose of 3.0 mg LY2624803 administered orally in up to 2 of 4 treatment periods arm 4: Single dose of 6.0 mg LY2624803 ad...
[ 0, 0, 0, 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Administered orally as reconstituted solution intervention 2: Administered orally as a capsule intervention 3: Administered orally as solution intervention 4: Administered orally as a capsule
intervention 1: LY2624803 - Solution intervention 2: LY2624803 - Capsule intervention 3: Placebo - Solution intervention 4: Placebo - Capsule
1
Sagamihara | N/A | Japan | 139.24167 | 35.56707
91
0
0
0
NCT01784614
1COMPLETED
2010-03-01
2009-09-01
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
[ 3, 4 ]
60
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Alzheimer's disease (AD), the most common dementing disorder of later life, is a major cause of disability and death in the elderly. Although a number of theoretical causes exist, the etiology of AD is still unknown. Consequently, the focus of treatments has been palliative, designed to ameliorate AD symptoms. Recent e...
The study is conducted in a sample of 35 elderly (50-90 years old) outpatients who meet study inclusion criteria for depression (DEP) (DSM-IV criteria for major depression, dysthymic disorder, or depression NOS) and mild cognitive impairment (MCI; e.g. operationally defined as between "normal" and "dementia"), i.e., De...
Mild Cognitive Impairment Major Depressive Disorder Alzheimer's Disease
Memory Decline Depression Elderly Antidepressants Treatment memantine
null
1
arm 1: concurrent es-citalopram plus memantine were administered for 48 weeks.
[ 0 ]
2
[ 0, 0 ]
intervention 1: es-citalopram 10mg/day will be given for the first week, and 20mg/day starting at week 2. intervention 2: After two weeks on Lexapro, Memantine 5mg will be added. The dose will increase to 10mg for the second week and will be increased at a rate of 5mg per week. Memantine dosage will not exceed 20mg.
intervention 1: es-citalopram intervention 2: Memantine
1
New York | New York | United States | -74.00597 | 40.71427
35
0
0
0
NCT01876823
1COMPLETED
2010-03-01
2006-04-01
New York State Psychiatric Institute
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
48
RANDOMIZED
CROSSOVER
7BASIC_SCIENCE
0NONE
true
0ALL
false
The purpose of this study is to assess the oral bioavailability of Apixaban solution formulation (Treatment B, 10 mg as 25 mL x 0.4 mg/mL) relative to Apixaban tablets (Treatment A, 10 mg as 2 x 5 mg tablets) in healthy subjects.
null
Healthy Volunteers
null
2
arm 1: Apixaban Film coated Tablet Single dose 10 mg orally arm 2: Apixaban Solution Single dose 10 mg orally
[ 0, 0 ]
1
[ 0 ]
intervention 1: None
intervention 1: Apixaban
1
Neptune City | New Jersey | United States | -74.02792 | 40.20011
27
0
0
0
NCT02034565
1COMPLETED
2010-03-01
2010-02-01
Bristol-Myers Squibb
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0