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list
enrollmentCount
int64
allocation
string
interventionModel
string
primaryPurpose
class label
masking
class label
healthyVolunteers
bool
sex
class label
oversightHasDmc
bool
briefSummary
string
detailedDescription
string
conditions
string
conditionsKeywords
string
protocolPdfText
string
numArms
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armDescriptions
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armGroupTypes
list
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numLocations
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target
int64
nctid
string
[ 3 ]
76
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
This study will test the hypothesis that CF101, which is under development to treat other immune-mediated inflammatory diseases, will provide clinical benefits in the treatment of chronic plaque psoriasis. Patients with psoriasis who qualify for the study will be treated every 12 hours (q12h) with CF101 capsules, or pl...
This is a Phase 2, multicenter, randomized, double-blind, dose-ranging, placebo-controlled, study in adult males and females, ages 18 to 70 years, inclusive, with a diagnosis of moderate-to-severe chronic plaque psoriasis. At the Screening Visit, patients who provide written informed consent will have screening procedu...
Plaque Psoriasis
Psoriasis
null
4
arm 1: None arm 2: None arm 3: None arm 4: None
[ 0, 0, 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: CF101 1 mg q12 hours for 12 weeks intervention 2: CF101 2 mg q12 hours for 12 weeks intervention 3: CF101 4 mg q12 hours for 12 weeks intervention 4: Placebo tablets q12 hours for 12 weeks
intervention 1: CF101 1mg intervention 2: CF101 2mg intervention 3: CF101 4mg intervention 4: Placebo
4
Afula | N/A | Israel | 35.2892 | 32.60907 Holon | N/A | Israel | 34.77918 | 32.01034 Petah Tikva | N/A | Israel | 34.88747 | 32.08707 Tel Litwinsky | N/A | Israel | 34.84588 | 32.05096
0
NCT00428974
[ 3 ]
256
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
This was a double-blind, placebo-controlled, parallel-arm, multicentre, prospective dose-finding trial of the safety and efficacy of atacicept in subjects with active rheumatoid arthritis who had failed a three month therapeutic trial with a tumor necrosis factor alpha (TNFa) antagonist due to lack of efficacy.
null
Rheumatoid Arthritis
atacicept arthritis
null
4
arm 1: None arm 2: None arm 3: None arm 4: None
[ 0, 0, 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks. intervention 2: Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose,...
intervention 1: Atacicept intervention 2: Atacicept intervention 3: Atacicept intervention 4: Placebo matched to atacicept
2
Rockland | Massachusetts | United States | -70.91616 | 42.13066 Canada | N/A | Canada | N/A | N/A
0
NCT00430495
[ 4 ]
207
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
null
To evaluate the efficacy of teriparatide based on measurements of bone mineral density at lumbar spine
null
Osteoporosis
null
2
arm 1: 20 micrograms for 104 weeks arm 2: Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: daily, subcutaneous intervention 2: daily, subcutaneous
intervention 1: Teriparatide intervention 2: Placebo
16
Aichi | N/A | Japan | 130.62158 | 32.51879 Fukuoka | N/A | Japan | 130.41667 | 33.6 Hokkaido | N/A | Japan | N/A | N/A Hyōgo | N/A | Japan | 144.43333 | 43.36667 Kagoshima | N/A | Japan | 130.55 | 31.56667 Kanagawa | N/A | Japan | 139.91667 | 37.58333 Nagano | N/A | Japan | 138.18333 | 36.65 Nagasaki | N/A | Japan | 12...
0
NCT00433160
[ 4 ]
1,197
RANDOMIZED
PARALLEL
1PREVENTION
4QUADRUPLE
false
0ALL
false
This is a multicenter, randomized, double-blind, placebo-controlled, event-driven, superiority study for efficacy. Patients with confirmed symptomatic DVT (deep vein thrombosis) or PE (pulmonary embolism) who completed 6 or 12 months of treatment with rivaroxaban or VKA (vitamin K antagonist) are eligible for this tria...
Within the US 'Johnson \& Johnson Pharmaceutical Research \& Development, L.L.C.' is sponsor. The treatment period was followed by an observational period of 30 days starting the day after the last intake of study medication, regardless of the actual duration of study drug administration. Participants who did not comp...
Venous Thromboembolism
null
2
arm 1: Participants were to receive rivaroxaban 20 mg oral tablet once daily arm 2: Participants were to receive matching placebo oral tablet once daily
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Patients randomized to rivaroxaban will receive rivaroxaban 20 mg once-daily. intervention 2: Patients allocated to placebo will receive a matching placebo tablet once daily.
intervention 1: Rivaroxaban (Xarelto, BAY59-7939) intervention 2: Placebo
322
Little Rock | Arkansas | United States | -92.28959 | 34.74648 Los Angeles | California | United States | -118.24368 | 34.05223 Redlands | California | United States | -117.18254 | 34.05557 Bay Pines | Florida | United States | -82.77816 | 27.81419 Melbourne | Florida | United States | -80.60811 | 28.08363 Miami | Flori...
0
NCT00439725
[ 0 ]
74
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
null
We are testing the hypothesis that subjects in the treatment group will experience fewer fasting induced headaches as compared to those in the placebo group.In our clinical experience, we estimate that approximately 25% of our headache population experiences fasting-induced migraine or hunger-induced migraine. With a g...
null
Migraine
null
2
arm 1: 5.0 mg of Frovatriptan given as single dose arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Frovatriptan 5.0 mg orally one time at the start of the 20 hour fast intervention 2: Inert tab identical in appearance to Frovatriptan
intervention 1: Frovatriptan intervention 2: Placebo
1
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
0
NCT00440232
[ 3 ]
32
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
false
0ALL
false
This study will examine the efficacy and safety of lapatinib in patients with ErbB2 positive ovarian, gastric/esophageal adenocarcinoma, uterine serous papillary, or bladder cancers.
null
Cancer
Ovarian Cancer Bladder Cancer ErbB2 positive Lapatinib Gastric/Esophageal Cancer Uterine Serous Papillary Cancer
null
2
arm 1: None arm 2: None
[ 0, 2 ]
1
[ 0 ]
intervention 1: Subjects administered open label lapatinib, 1500 mg to be taken orally once a day, for 12 weeks. After 12 weeks, subjects with a partial or complete response per Response Evaluation Criteria in Solid Tumors (RECIST) will continue to receive open label lapatinib (1500 mg/day orally) until disease progres...
intervention 1: Oral lapatinib tablets or placebo tablets
20
Denver | Colorado | United States | -104.9847 | 39.73915 Indianapolis | Indiana | United States | -86.15804 | 39.76838 Overland Park | Kansas | United States | -94.67079 | 38.98223 Minneapolis | Minnesota | United States | -93.26384 | 44.97997 St Louis | Missouri | United States | -90.19789 | 38.62727 Las Vegas | Nevad...
0
NCT00447226
[ 3 ]
114
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study was to evaluate the long term safety and tolerability of peginesatide for the maintenance of hemoglobin in participants with chronic kidney disease (CKD) who had received at least 24 weeks of peginesatide treatment in an earlier study.
Anemia associated with chronic kidney disease is due to several factors, primarily the inability of the diseased kidneys to produce adequate amounts of endogenous erythropoietin. Ancillary factors include the shortened lifespan of red blood cells, iron and other nutritional deficiencies, infection, and inflammation. Th...
Chronic Renal Failure Chronic Kidney Disease Anemia
anemia chronic kidney disease CKD chronic renal failure CRF dialysis erythropoietin EPO erythropoiesis stimulating agent ESA Hematide™ hemodialysis hemoglobin Hb Hgb Omontys peginesatide red blood cell red blood cell production
null
2
arm 1: Participants were from a prior Affymax peginesatide treatment study conducted in participants who were on dialysis and had been on Epoetin at study entry, and who were switched to peginesatide (NCT00434330). This group is categorized as "Maintenance Switch in Dialysis Participants" regardless of dialysis status ...
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Participants received the same initial peginesatide dose via the same route, intravenously or subcutaneously, as was administered at the end of the previous peginesatide treatment study in which the participant was enrolled. The median first dose at study start was 0.044 milligram per kilogram (mg/kg) w...
intervention 1: peginesatide intervention 2: peginesatide
20
Burgas | N/A | Bulgaria | 27.46781 | 42.50606 Pleven | N/A | Bulgaria | 24.61667 | 43.41667 Plovdiv | N/A | Bulgaria | 24.75 | 42.15 Rousse | N/A | Bulgaria | 25.9534 | 43.84872 Varna | N/A | Bulgaria | 27.91667 | 43.21667 Veliko Tarnovo | N/A | Bulgaria | 25.62904 | 43.08124 Bialystok | N/A | Poland | 23.16433 | 53.13...
0
NCT00453973
[ 5 ]
40
NA
SINGLE_GROUP
0TREATMENT
0NONE
true
0ALL
false
This study will evaluate changes in brain gamma-aminobutyric acid (GABA) levels due to treatment with escitalopram in people with major depressive disorder.
Major depressive disorder (MDD) is a severe form of depression. MDD can significantly interfere with an individual's thoughts, behavior, mood, and physical health. People who suffer from MDD often experience feelings of worthlessness; they may feel hopeless and may be unable to cope with problems in their life. In addi...
Major Depressive Disorder
depression biology
null
1
arm 1: single arm
[ 5 ]
1
[ 0 ]
intervention 1: Dose determined per clinical discretion. All participants begin on 10mg po qd of escitalopram, and can increase the dose to 30mg po qd over the 12 weeks of the study.
intervention 1: Escitalopram
1
Boston | Massachusetts | United States | -71.05977 | 42.35843
0
NCT00464711
[ 4 ]
147
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
true
0ALL
true
This study is designed to test whether treatment of depressive symptoms using escitalopram improves adherence to Buprenorphine and reduces symptoms of depression for individuals receiving Buprenorphine through their medical provider.
Participants interested in receiving Buprenorphine will be offered the opportunity to enroll in this study. Enrolled study participants will complete interviews at baseline and again every two weeks for a total of 8 interviews over 3 months. In this double-blind randomized controlled trial, participants will either rec...
Opiate Dependence Depression
opiate use depression buprenorphine escitalopram
null
2
arm 1: None arm 2: None
[ 2, 1 ]
2
[ 0, 0 ]
intervention 1: 10mg escitalopram/day for 3 months intervention 2: placebo capsule/day for 3 months
intervention 1: escitalopram intervention 2: placebo
1
Providence | Rhode Island | United States | -71.41283 | 41.82399
0
NCT00475878
[ 3 ]
59
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
To determine the pharmacokinetic profile and to evaluate the safety and tolerability of ascending multiple doses of tigecycline in patients aged 8 to 11 years with selected serious infections; complicated intra-abdominal infections (cIAI), complicated skin and skin structure infections (cSSSI), or community-acquired pn...
null
Bacterial Infections Intra-Abdominal Infection Pneumonia, Bacterial Skin Diseases, Bacterial Skin Diseases, Infectious
cIAI cSSSI CAP Child
null
3
arm 1: 0.75 mg/kg (up to a maximum dose of 50 mg for each dose) of tigecycline every 12 hours infused over approximately 30 minutes. Escalation to next dose cohort will occur only after safety and tolerability at preceding dose have been established by sponsor (after tigecycline LDOT data are received) and if at least ...
[ 0, 0, 0 ]
1
[ 0 ]
intervention 1: None
intervention 1: Tygacil
36
Long Beach | California | United States | -118.18923 | 33.76696 Oakland | California | United States | -122.2708 | 37.80437 Orange | California | United States | -117.85311 | 33.78779 San Diego | California | United States | -117.16472 | 32.71571 Tampa | Florida | United States | -82.45843 | 27.94752 Louisville | Kentu...
0
NCT00488345
[ 3 ]
63
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
Patients with schizophrenia are characterized by a broad range of neurocognitive abnormalities. These include impairments in attention, including abnormalities in sensory gating; executive function; visual and verbal learning and memory; working memory; processing speed; and social cognition (Nuechterlein et al, 2004)....
The proposed study is a multicenter, randomized, double blind comparison of MK-0777 GEM 3 mg BID, MK-0777 GEM 8 mg BID, and placebo. The total sample will consist of 90 clinically stable patients with DSM IV TR schizophrenia, with 30 subjects randomized to each group. A best estimate diagnostic approach will be utilize...
Schizophrenia
Cognition Schizophrenia
null
3
arm 1: MK-0777 8 mg tablet by mouth twice daily for 4 weeks arm 2: MK-0777 3 mg tablet by mouth twice daily for 4 weeks arm 3: Placebo tablet by mouth twice daily for 4 weeks
[ 0, 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: MK-0777 GEM, 8 mg BID intervention 2: MK-0777 GEM, 3 mg BID intervention 3: 2 tablets placebo BID
intervention 1: MK-0777 intervention 2: MK-0777 intervention 3: placebo
8
Los Angeles | California | United States | -118.24368 | 34.05223 Catonsville | Maryland | United States | -76.73192 | 39.27205 Boston | Massachusetts | United States | -71.05977 | 42.35843 Boston | Massachusetts | United States | -71.05977 | 42.35843 St Louis | Missouri | United States | -90.19789 | 38.62727 New York |...
0
NCT00505076
[ 4 ]
245
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
This is a phase III multi-centre study in three periods: the first period is a phosphate binder washout for 4 weeks, the second period is an open-label, flexible dose titration, the third period is a placebo-controlled withdrawal comparing MCI-196 with placebo for 4 weeks.
null
Chronic Kidney Disease Dialysis Hyperphosphatemia
Chronic Kidney Disease Dialysis Hyperphosphatemia Phosphate binder
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose (Open-label) and 4 weeks of double blind intervention 2: 3g to 15g/day (3 times a day), Tablet, 4 weeks of double blind
intervention 1: MCI-196 intervention 2: Placebo
39
Glendale | Arizona | United States | -112.18599 | 33.53865 Tempe | Arizona | United States | -111.90931 | 33.41477 Hot Springs | Arkansas | United States | -93.05518 | 34.5037 Paragould | Arkansas | United States | -90.49733 | 36.0584 Pine Bluff | Arkansas | United States | -92.0032 | 34.22843 Fountain Valley | Califor...
0
NCT00506441
[ 4 ]
55
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
This study is designed to evaluate the effectiveness of treatment of residual amblyopia in children ages 3 to \< 10 years with visual acuity of 20/32 to 20/63 in the amblyopic eye. The study is a randomized clinical trial comparing intensive treatment (42 hours per week of patching plus daily atropine) with a control g...
Amblyopia is the most common cause of monocular visual impairment in both children and young and middle-aged adults. Both patching and atropine are accepted treatment modalities for the management of moderate amblyopia in children. Despite best efforts with conventional treatment, some patients fail to achieve normal v...
Amblyopia
Amblyopia Atropine Patching
null
2
arm 1: 42 hours per week of patching combined with atropine (1%) once daily in the sound eye, with spectacle correction (if needed) arm 2: For patients currently patching, reduce patching to two hours daily for four weeks, then no treatment thereafter except spectacle correction (if needed). For patients currently usin...
[ 1, 1 ]
4
[ 1, 0, 1, 0 ]
intervention 1: 42 hours per week of patching intervention 2: daily atropine (1%) intervention 3: two hours of daily patching for 4 weeks, then no treatment intervention 4: once weekly atropine for 4 weeks, then no treatment
intervention 1: Patching intervention 2: Atropine intervention 3: Patching intervention 4: Atropine
1
Durham | North Carolina | United States | -78.89862 | 35.99403
0
NCT00506675
[ 3 ]
6
RANDOMIZED
PARALLEL
1PREVENTION
0NONE
false
0ALL
false
The purpose of this study is to investigate the prevention of Restenosis following Revascularization of the superficial Femoral Artery (SFA)
null
Vascular Disease, Peripheral
Restenosis Superficial Femoral Artery Prevention of restenosis Revascularization of the superficial Femoral Artery
null
4
arm 1: Following revascularization, participants did not receive any study drug treatment. arm 2: Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m\^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m\^2 at 7 days....
[ 4, 0, 0, 0 ]
1
[ 0 ]
intervention 1: Nanoparticle albumin-bound paclitaxel, 45 mg/m\^2.
intervention 1: Nanoparticle Paclitaxel
7
Sacramento | California | United States | -121.4944 | 38.58157 Gainsville | Florida | United States | N/A | N/A Davenport | Iowa | United States | -90.57764 | 41.52364 Flint | Michigan | United States | -83.68746 | 43.01253 Teaneck | New Jersey | United States | -74.01597 | 40.8976 Cincinnati | Ohio | United States | -...
0
NCT00518284
[ 0 ]
1
RANDOMIZED
PARALLEL
1PREVENTION
3TRIPLE
false
0ALL
true
A total of 50 patients \>40 yrs of age with an expected hospital stay in the Medical Intensive Care or Regional Heart Unit at LVH Muhlenberg of 6 days or longer will be enrolled. The patient and study team will be blinded to which drug they are receiving (either Arixtra or Lovenox). Subjects will be examined for any bl...
A total of 50 patients will be enrolled in this double-blinded, randomized, controlled trial. Inclusion criteria: subjects\>40 yrs of age with an expected hospital stay in the Medical Intensive Care or Regional Heart Unit at LVH Muhlenberg of 6 days or longer (4 days bedridden) will be enrolled. Total drug treatment wi...
Venous Thrombosis
Bleeding rates Prophylaxis for deep vein thrombosis
null
2
arm 1: Arixtra (Fondaparinox) 2.5 mg SC Daily arm 2: Lovenox 40mg SC Daily
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: Patients will be randomized to receive Arixtra 2.5mg once a day if randomized to this arm intervention 2: Patients will be randomized to receive Lovenox 40mg SC Daily if randomized to this arm
intervention 1: Arixtra (Fondaparinox) 2.5 mg SC Daily intervention 2: Lovenox 40mg SC Daily
1
Bethlehem | Pennsylvania | United States | -75.37046 | 40.62593
0
NCT00521885
[ 4 ]
52
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The primary objective of this study is: To assess the virologic effect of changing enfuvirtide to MK-0518(raltegravir) in human immunodeficiency virus type 1(HIV-1) infected patients who have an undetectable level of serum human immunodeficiency virus(HIV) (\< 75 copies/ml by branch deoxyribonucleic acid (bDNA) assay,...
Human immunodeficiency virus type 1(HIV-1) infected patients who have had an undetectable viral load on an enfuvirtide containing regimen at the Kaiser Permanente Hayward, Los Angeles, San Francisco, and Santa Clara Medical Centers will be enrolled. Patients will receive open label MK-0518 (raltegravir) 400mg orally tw...
HIV Infections
Treatment Experience On enfuvirtide
null
1
arm 1: Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide.
[ 0 ]
1
[ 0 ]
intervention 1: This is a single-arm, open-label, non-randomized pilot study in human immunodeficiency virus type 1 (HIV-1) positive patients who have an undetectable viral load on their current enfuvirtide containing medication regimen. The treatment regimen will consist of replacing enfuvirtide with MK-0518 400 mg tw...
intervention 1: raltegravir
8
Anaheim | California | United States | -117.9145 | 33.83529 Hayward | California | United States | -122.0808 | 37.66882 Los Angeles | California | United States | -118.24368 | 34.05223 Los Angeles | California | United States | -118.24368 | 34.05223 Panorama City | California | United States | -118.44981 | 34.22473 San...
0
NCT00529243
[ 4 ]
345
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The purpose of the study is to investigate the efficacy and safety of a grass sublingual tablet in children and adolescents with a history of grass-pollen induced rhinoconjunctivitis with or without asthma.
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study in participants aged 5 to \<18 years of either sex, and of any race with a history of grass pollen induced rhinoconjunctivitis with or without asthma. While receiving treatment, participants will receive either grass sublingual ta...
Rhinoconjunctivitis Rhinitis Conjunctivitis Allergy
rhinoconjunctivitis rhinitis conjunctivitis allergy allergen immunotherapy
null
2
arm 1: Matching Placebo arm 2: Grass Sublingual Tablet (Phleum pratense extract)
[ 2, 0 ]
9
[ 0, 2, 0, 0, 0, 0, 0, 0, 0 ]
intervention 1: Placebo sublingual tablet, once daily intervention 2: Grass sublingual tablet, once daily intervention 3: Loratadine Syrup 1 mg/mL was dosed orally once daily at a dose of 5 mg for children aged 5 to \<6 years of age and at a dose of 10 mg for children aged 6 to \<18 years of age as rescue medication fo...
intervention 1: Placebo intervention 2: SCH 697243 intervention 3: Loratadine Syrup 1 mg/mL Rescue Treatment intervention 4: Loratadine 10 mg Rescue Treatment intervention 5: Olopatadine 0.1% Rescue Treatment intervention 6: Mometasone furoate 50 mcg Rescue Treatment intervention 7: Albuterol 108 mcg Rescue Treatment i...
0
null
0
NCT00550550
[ 4 ]
208
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This single-arm study will assess the efficacy and safety of intravenous (IV) Mircera when administered for the maintenance of hemoglobin (Hb) levels in participants with chronic renal anemia. Individuals currently receiving maintenance treatment with epoetin alfa or darbepoetin alfa will receive monthly injections of ...
null
Chronic Renal Anemia
null
1
arm 1: Participants with chronic renal anemia who have been previously treated with erythropoiesis-stimulating agent (ESA) therapy will receive IV Mircera every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg will be determined by the dose of ESA received prior to admini...
[ 0 ]
1
[ 0 ]
intervention 1: Participants will receive a starting dose of 120, 200, or 360 mcg via IV injection. Thereafter, the once-monthly dose will be titrated to achieve target Hb concentrations.
intervention 1: Methoxy polyethylene glycol-epoetin beta
24
Aigáleo | N/A | Greece | 23.68333 | 37.98333 Athens | N/A | Greece | 23.72784 | 37.98376 Athens | N/A | Greece | 23.72784 | 37.98376 Athens | N/A | Greece | 23.72784 | 37.98376 Athens | N/A | Greece | 23.72784 | 37.98376 Athens | N/A | Greece | 23.72784 | 37.98376 Athens | N/A | Greece | 23.72784 | 37.98376 Athens | N/...
0
NCT00550680
[ 4 ]
425
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
2MALE
false
The purpose of this study is to test whether pregabalin added to the standard of care with dosing starting preoperatively and continuing for 1 week post surgery will decrease the intensity of acute post-operative pain following inguinal hernia repair.
null
Pain, Postoperative Hernia, Inguinal
postoperative pain chronic pain
null
4
arm 1: None arm 2: None arm 3: None arm 4: None
[ 0, 2, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 150 mg BID intervention 2: Placebo intervention 3: 75 mg BID intervention 4: 25 mg BID
intervention 1: Pregabalin intervention 2: placebo intervention 3: Pregabalin intervention 4: Pregabalin
42
Birmingham | Alabama | United States | -86.80249 | 33.52066 Glendale | California | United States | -118.25508 | 34.14251 Laguna Hills | California | United States | -117.71283 | 33.61252 Pasadena | California | United States | -118.14452 | 34.14778 Lake Worth | Florida | United States | -80.07231 | 26.61708 Pensacola ...
0
NCT00551135
[ 3 ]
2
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
Src expression has been identified in a majority of Non-Small Cell Lung Cancer (NSCLC) cell lines and there is preclinical evidence that Src family kinases may be important in hypoxic growth and angiogenesis in NSCLC. We hypothesize that the inhibition of Src pathway with dasatinib will demonstrate anti-tumor activity ...
This is a phase II study of dasatinib, a targeted biologic agent, known to inhibit Src. It is difficult to assess outcome in phase II adjuvant trials because there is no measurable disease to evaluate efficacy and there are many variables that could confound comparing survival of subjects on trial to historical control...
Carcinoma, Non-Small-Cell Lung
Non Small Cell Lung Cancer (NSCLC) carcinoma dasatinib neoadjuvant adjuvant resection genomic signature predictor microarray
null
1
arm 1: Neoadjuvant dasatinib is to be administered as an oral dose of 70 mg PO twice daily on a continuous basis for 3 weeks prior to surgery. Patients will begin adjuvant dasatinib (70 mg PO twice daily) between 4-6 weeks after standard adjuvant therapy is complete or 4-8 weeks after surgery for those patients that do...
[ 0 ]
1
[ 0 ]
intervention 1: Fresh frozen tumor tissue must be available prior to initiating dasatinib. Eligible patients will receive neoadjuvant dasatinib 70 mg PO twice daily for 3 weeks followed by surgery. The surgical specimen will be evaluated for pathologic response. The second tumor sample will be obtained after 3 weeks of...
intervention 1: Dasatinib
1
Durham | North Carolina | United States | -78.89862 | 35.99403
0
NCT00564876
[ 3 ]
37
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The purpose of this study is to determine whether varenicline (Chantix), is effective for the treatment of cocaine dependence.
The purpose of study is to determine if Varenicline (Chantix™) promotes cocaine abstinence in cocaine dependent individuals. Varenicline (Chantix™) (2.0 mg/day) or placebo will be administered in a 9-week double-blind trial to patients meeting diagnostic criteria for cocaine dependence.
Cocaine Dependence
cocaine crack cocaine cocaine-related disorders substance-related disorders alpha4beta2 nicotinic acetylcholine receptor
null
2
arm 1: Varenicline (Chantix) arm 2: Placebo
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 1.0 mg BID for 8 weeks intervention 2: placebo BID for 8 weeks
intervention 1: varenicline intervention 2: placebo
1
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
0
NCT00567008
[ 4 ]
94
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
true
0ALL
false
Prior studies in animal models have established that the pathogenesis of alcoholic liver disease (ALD) is regulated in part by the effects of chronic alcohol abuse on hepatic methionine metabolism. The hypothesis of the clinical study was that provision of the methionine metabolite S-adenosylmethionine (SAM) would corr...
We assessed a total of 297 potential ALD candidates, from whom 40 were enrolled in the study. In addition, we enrolled 26 gender matched active alcohol drinkers without liver disease (AD) and 28 age and gender matched healthy control subjects (HS). Of the original 40 ALD subjects who provided initial enrollment data, 3...
Liver Disease, Alcoholic
Alcoholic Liver Disease (ALD) S-adenosylmethionine SAMe
null
2
arm 1: Alcoholic liver disease patients receiving S-adenosylmethionine (SAMe)at 400 mg capsule three times daily for 24 weeks arm 2: ALD subjects receiving Placebo three times daily for 24 weeks.
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Alcoholic liver disease patients received drug at dose of 400 mg three times daily for 24 weeks. intervention 2: Alcoholic liver disease patients received identical size and shape sugar pill placebo three times daily for 24 weeks.
intervention 1: S-adenosylmethionine intervention 2: Placebo
1
Sacramento | California | United States | -121.4944 | 38.58157
0
NCT00573313
[ 2, 3 ]
5
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to discover whether children and adults with Fanconi anemia (FA) can be safely and effectively transplanted with Human Leukocyte Antigen (HLA) mismatched (up to one haplotype), HLA-matched sibling, or unrelated donor stem cells, when leukocytolytic monoclonal antibodies are the sole conditi...
If clinically feasible (no aplasia, no active malignancy), the recipients marrow will be harvested and cryopreserved as a back up for use if non-engraftment/rejection is followed by failure to undergo autologous reconstitution. For HLA Mismatched donors, harvested peripheral blood stem cells will be enriched for CD34 ...
Fanconi Anemia Severe Aplastic Anemia
Allogeneic Stem Cell Transplant Fanconi Anemia Severe Aplastic Anemia fludarabine campath anti-CD45
null
1
arm 1: CAMPATH-1H Anti-CD45 Fludarabine Stem Cell Infusion
[ 0 ]
4
[ 2, 2, 0, 3 ]
intervention 1: Given intravenous on days -8, -7, and -6 intervention 2: Given intravenous on days -5, -4, -3 and -2 dose is 400 micrograms/kg intervention 3: Given intravenous on days -8, -7, -6, -5 and -4 Dose is 30 mg/m2 intervention 4: Stem cells are infused on day 0
intervention 1: CAMPATH-1H intervention 2: Anti-CD45 intervention 3: Fludarabine intervention 4: Stem cell infusion
2
Houston | Texas | United States | -95.36327 | 29.76328 Houston | Texas | United States | -95.36327 | 29.76328
0
NCT00590460
[ 2, 3 ]
13
RANDOMIZED
CROSSOVER
0TREATMENT
4QUADRUPLE
false
0ALL
false
This placebo-controlled study investigates acetyl-L-carnitine in the treatment of septic shock requiring vasopressors.
This is a cross-over study which infuses ALC for 12 out of 18 hours (and placebo the other 6). Patients must have vasopressor-dependent septic shock and be free from renal failure, hepatic failure, and seizures to be eligible.
Septic Shock
Septic shock Acetyl-L-carnitine
null
2
arm 1: Placebo for first 6 hours then Acetyl-L-Carnitine (ALC) for 12 hours arm 2: Acetyl-L-Carnitine (ALC) for first 12 hours then placebo for next 6 hours
[ 5, 5 ]
1
[ 0 ]
intervention 1: Acetyl-L-Carnitine - 4 g IV over 30 minutes, then 8 g iv over the next 12 hours
intervention 1: Acetyl-L-Carnitine
1
Nashville | Tennessee | United States | -86.78444 | 36.16589
0
NCT00592488
[ 4 ]
395
NON_RANDOMIZED
SINGLE_GROUP
1PREVENTION
0NONE
false
0ALL
false
The purpose of this study is to assess the Safety and tolerability of D961H (Esomeprazole) 20 mg once daily for up to 52 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating AE, clinical laboratory value ...
null
Gastric Ulcer Duodenal Ulcer Rheumatoid Arthritis Osteoarthritis Lumbago
gastrointestinal GI NSAID Japan Japanese Gastric ulcer duodenal ulcer
null
1
arm 1: Esomeprazole 20 mg once daily
[ 0 ]
1
[ 0 ]
intervention 1: Esomeprazole 20 mg once daily
intervention 1: Esomeprazole 20 mg
3
Ōita | N/A | Japan | 131.6 | 33.23333 Saitama | N/A | Japan | 139.65657 | 35.90807 Tokyo | N/A | Japan | 139.69171 | 35.6895
0
NCT00595517
[ 0 ]
6
NA
SINGLE_GROUP
null
0NONE
false
0ALL
true
Short-daily hemodialysis is increasingly becoming a preferred alternative to the conventional intermittent (three times per week) hemodialysis schedule. Studies have shown that short-daily dialysis improves a patient's quality of life, high blood pressure, anemia and calcium-phosphorus balance. Infection, however, will...
Despite improvements in dialysis machine and filter technology and refinements in providing an adequate "dose" of HD, patients receiving thrice-weekly hemodialysis (HD) have an alarming 20% annual mortality rate. Concomitant with this high mortality rate, patients with end stage renal disease (ESRD) also endure poorer ...
End Stage Renal Disease Infection
Short-daily hemodialysis pharmacokinetics levofloxacin gentamicin vancomycin
null
1
arm 1: Intervention: administer intravenous vancomycin, gentamicin and levofloxacin. This study will determine the pharmacokinetics of intravenous vancomycin, gentamicin and levofloxacin in subjects receiving short-daily hemodialysis. There will not be a control arm for this study. The intervention for this arm will be...
[ 0 ]
1
[ 0 ]
intervention 1: Each subject will receive a single dose of 15 mg/kg vancomycin; 2 mg/kg gentamicin and 250 mg levofloxacin administered intravenously over a one-hour infusion period through the venous limb of their HD access (or tunneled catheter) via an IV pump.
intervention 1: Intravenous antibiotics
1
Indianapolis | Indiana | United States | -86.15804 | 39.76838
0
NCT00596167
[ 2, 3 ]
6
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
The purpose of this study is to determine if nikkomycin Z is safe when administered at different dose levels for 14 days. The study will also determine blood levels and urinary excretion of nikkomycin Z in relation to dose administered. Patients with mild forms of Valley Fever pneumonia will be eligible to participate ...
Every year there are 50,000 new U.S. cases of coccidioidomycosis (Valley Fever). The majority of these illnesses occur as a result of endemic exposure in Arizona and California. The benefits of antifungal therapy for uncomplicated disease are not currently established. Current therapies for serious and complicated form...
Coccidioidomycosis
coccidioidomycosis Valley Fever nikkomycin Z
null
5
arm 1: nikkomycin Z 50 mg BID x 14 days arm 2: nikkomycin Z nikkomycin Z 250 mg BID x 14 days arm 3: nikkomycin Z 500 mg BID x 14 days arm 4: nikkomycin Z 750 BID x 14 days arm 5: placebo BID x 14 days
[ 0, 0, 0, 0, 2 ]
2
[ 0, 0 ]
intervention 1: Stage I: Multiple rising doses. Doses packaged on a unit dose basis in 50 and 250 mg capsules. Subjects take 1-3 capsules per dosing block for 14 days unless ADE or study withdrawal. Dose escalation unless a dose-limiting adverse effect is noted. Subjects assigned to BID dosing will receive 28 doses and...
intervention 1: nikkomycin Z intervention 2: Placebo
1
Tucson | Arizona | United States | -110.92648 | 32.22174
0
NCT00614666
[ 3 ]
218
RANDOMIZED
PARALLEL
1PREVENTION
4QUADRUPLE
false
0ALL
true
The purpose of this study is to determine whether alefacept is effective and well tolerated when used with a combination of tacrolimus, mycophenolate mofetil and steroids versus a combination therapy of placebo, tacrolimus and steroids in the prevention of kidney transplant rejection.
null
De Novo Kidney Transplantation
kidney transplant alefacept
null
2
arm 1: Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment. arm 2: Participants received 7.5 mg a...
[ 2, 0 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: IV and subcutaneous injection intervention 2: IV and subcutaneous injection intervention 3: The initial daily dose was 0.2 mg/kg orally given in 2 doses commencing 24 hours after completion of surgery. intervention 4: Mycophenolic mofetil was administered as 750 mg twice per day orally intervention 5: M...
intervention 1: Alefacept intervention 2: placebo intervention 3: Tacrolimus intervention 4: Mycophenolate Mofetil intervention 5: Steroids
33
Vienna | N/A | Austria | 16.37208 | 48.20849 Brussels | N/A | Belgium | 4.34878 | 50.85045 Brussels | N/A | Belgium | 4.34878 | 50.85045 Ghent | N/A | Belgium | 3.71667 | 51.05 Leuven | N/A | Belgium | 4.70093 | 50.87959 Liège | N/A | Belgium | 5.56749 | 50.63373 Prague | N/A | Czechia | 14.42076 | 50.08804 Créteil | N...
0
NCT00617604
[ 5 ]
52
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
true
To show that the use of intravenous levetiracetam(LEV;Keppra)for seizure prevention in patients in the Neuroscience Intensive Care Unit will result in fewer side effects compared to the current standard of care anticonvulsant and will be at least as effective as the current standard of care in preventing clinical and s...
To show that the use of intravenous levetiracetam(LEV;Keppra)for seizure prophylaxis in the Neuroscience Intensive Care Unit will result in fewer adverse effects compared to the current standard of care anticonvulsant(phenytoin) and will be at least as effective as phenytoin in preventing clinical and sub-clinical seiz...
Traumatic Brain Injury Subarachnoid Hemorrhage
Seizures Traumatic Brain Injury Subarachnoid Hemorrhage
null
2
arm 1: Group 1 - The levetiracetam (Keppra®) group will receive a loading dose of 20 mg/kg IV over 15 minutes (rounded to the nearest 250mg) up to a maximum of 2000 mg, then started on maintenance dose (1000 mg, IV BID)as prophylaxis for 7 days. arm 2: Group 2-The phenytoin group will receive a loading dose of 20 mg/kg...
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: Levetiracetam group will receive a loading dose of 20 mg/kg IV(rounded to nearest 250mg) to a maximum of 2000mg, then started on maintenance dose (1000 mg,IV q 12h) as prophylaxis for seven days. intervention 2: The group will receive a loading dose of fosphenytoin 20 mg/kg IV to a maximum of 2000 mg, t...
intervention 1: Levetiracetam intervention 2: Phenytoin
1
Cincinnati | Ohio | United States | -84.51439 | 39.12711
0
NCT00618436
[ 0 ]
3
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
To determine whether sorafenib is able to change pre-cancerous cells in a way that we believe is important in the progression of cancer.
To characterize the effects of sorafenib on specific molecular markers in patients with Barrett's esophagus and high grade intraepithelial neoplasia (HGIN) or carcinoma in situ (CIS).
Esophageal Cancer
Esophageal cancer
null
1
arm 1: sorafenib 2 tablets by mouth
[ 0 ]
1
[ 0 ]
intervention 1: 2 tablets with water by mouth twice a day for two weeks.
intervention 1: sorafenib
1
Chicago | Illinois | United States | -87.65005 | 41.85003
0
NCT00619242
[ 4 ]
439
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to evaluate the long-term safety and efficacy of lubiprostone administration in participants with opioid-induced bowel dysfunction.
null
Opioid-Induced Bowel Dysfunction
null
1
arm 1: Lubiprostone: 24 mcg capsule twice daily (BID) for 36 weeks
[ 0 ]
1
[ 0 ]
intervention 1: 24 mcg capsules for oral administration
intervention 1: Lubiprostone 24
123
Birmingham | Alabama | United States | -86.80249 | 33.52066 Hueytown | Alabama | United States | -86.99666 | 33.45122 Mobile | Alabama | United States | -88.04305 | 30.69436 Mesa | Arizona | United States | -111.82264 | 33.42227 Phoenix | Arizona | United States | -112.07404 | 33.44838 Phoenix | Arizona | United States...
0
NCT00620061
[ 4 ]
146
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This trial is conducted in Europe. The aim of this research is to assess the safety of continuous treatment with insulin detemir following participation in trial NN304-1689 (NCT00435019) on antibody development.
null
Diabetes Diabetes Mellitus, Type 1
null
1
arm 1: Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
[ 0 ]
2
[ 0, 0 ]
intervention 1: Treat-to-target dose titration scheme (individually adjusted), injection s.c. (under the skin), once or twice daily. intervention 2: Treat-to target dose titration scheme (individually adjusted), injection s.c. (under the skin), at larger meals.
intervention 1: insulin detemir intervention 2: insulin aspart
32
Pleven | N/A | Bulgaria | 24.61667 | 43.41667 Sofia | N/A | Bulgaria | 23.32415 | 42.69751 Varna | N/A | Bulgaria | 27.91667 | 43.21667 Olomouc | N/A | Czechia | 17.25175 | 49.59552 Pardubice | N/A | Czechia | 15.77659 | 50.04075 Prague | N/A | Czechia | 14.42076 | 50.08804 Glostrup Municipality | N/A | Denmark | 12.40...
0
NCT00623194
[ 4 ]
310
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
2MALE
false
To assess the efficacy and safety of 2 new formulations of leuprolide acetate 45 mg 6-month depot, Formulation A or Formulation B, for the treatment of patients with prostate cancer. A formulation will be deemed successful if the percentage of subjects with suppression of testosterone to \<= 50 ng/dL from Week 4 to Wee...
A total of 300 male subjects were planned to be enrolled. Subjects were to receive a total of 2 intramuscular (IM) injections of the same formulation, either Formulation A or Formulation B, administered 24 weeks apart. The first 150 subjects were to receive Formulation A for both injections and the next 150 subjects we...
Prostate Cancer
Lupron Depot prostate cancer leuprolide acetate
null
2
arm 1: Leuprolide acetate 45 mg, 6-month depot arm 2: Leuprolide acetate, 45 mg, 6-month depot
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Leuprolide acetate was administered as 2 intramuscular (IM) injections of Formulation A, 45 mg 6 month depot, 24 weeks apart. intervention 2: Leuprolide acetate was administered as 2 intramuscular (IM) injections of Formulation B, 45 mg 6 month depot, 24 weeks apart.
intervention 1: Leuprolide acetate - Formulation A intervention 2: Leuprolide acetate - Formulation B
63
Birmingham | Alabama | United States | -86.80249 | 33.52066 Homewood | Alabama | United States | -86.80082 | 33.47177 Anchorage | Alaska | United States | -149.90028 | 61.21806 Phoenix | Arizona | United States | -112.07404 | 33.44838 Sierra Vista | Arizona | United States | -110.30369 | 31.55454 Tucson | Arizona | Uni...
0
NCT00626431
[ 3 ]
5
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to test the hypothesis that the combination of gemcitabine and doxil will have clinical activity in patients with metastatic renal cell carcinoma.
Patients with metastatic renal cell carcinoma who have received prior therapy with sorafenib, sunitinib or temsirolimus and have progressive disease may participate in this study if all eligibility criteria are met. Doxil will be administered on day 1 and gemcitabine on day 1 and 8 of a 21 day cycle. Tumor responses wi...
Metastatic Renal Cell Carcinoma
Renal cell carcinoma Kidney Cancer Gemcitabine Doxil Chemotherapy
null
1
arm 1: Patients will receive 3 cycles of therapy as an outpatient. Each 21-day cycle of therapy will comprise: Gemcitabine: IV on days 1 and 8. Doxil: on day 1. Patients with either responding or stable disease will continue to receive additional 3 cycles of therapy with gemcitabine and Doxil until there is radiologica...
[ 0 ]
2
[ 0, 0 ]
intervention 1: 800 mg IV day 1 and 8 intervention 2: 24 mg/m2 every 21 days IV
intervention 1: Gemcitabine intervention 2: Doxil
1
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
0
NCT00630409
[ 3 ]
367
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
This is a 24 week study comparing the efficacy of four dose levels of INT131 besylate with pioglitazone HCl in patients with type 2 diabetes. Eligible patients will be men and women (of non-childbearing potential or using dual barrier methods of contraception) between 30 and 75 years of age who are minimally responsive...
null
Type 2 Diabetes Mellitus
Type 2 diabetes diabetes diabetes mellitus diabetes mellitus, type 2 non-TZD thiazolidinedione selective peroxisome proliferator-activated receptor gamma modulator SPPARM peroxisome proliferator-activated receptor gamma PPAR gamma insulin sensitizer glucose control endocrinopathy hypoglycemic agent sulfonylurea metform...
null
6
arm 1: INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone HCl. arm 2: INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone HCl arm 3: INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone HCl arm 4: INT131 besylate 3 mg admini...
[ 0, 0, 0, 0, 1, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Once-daily, oral intervention 2: Once-daily, oral intervention 3: Once-daily, oral
intervention 1: INT131 besylate intervention 2: Pioglitazone HCl intervention 3: Placebo
66
Carmichael | California | United States | -121.32828 | 38.61713 Los Angeles | California | United States | -118.24368 | 34.05223 San Diego | California | United States | -117.16472 | 32.71571 Santa Ana | California | United States | -117.86783 | 33.74557 Colorado Springs | Colorado | United States | -104.82136 | 38.833...
0
NCT00631007
[ 5 ]
774
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
This study will evaluate the long-term gastrointestinal (GI) safety and efficacy of aliskiren (300 mg) compared to ramipril (10mg) in patients ≥ 50 years with essential hypertension.
null
Hypertension
Hypertension, aliskiren, ramipril, colonoscopy
null
2
arm 1: For the first 2 weeks of the study, participants received aliskiren 150 mg once a day and were then forced titrated to aliskiren 300 mg once a day for 52 weeks. Participants also received a placebo capsule to match ramipril once a day for the study duration. arm 2: For the first 2 weeks of the study participants...
[ 0, 1 ]
4
[ 0, 0, 10, 10 ]
intervention 1: Aliskiren 300 mg once a day intervention 2: Ramipril 10 mg once a day intervention 3: Placebo capsules to match ramipril. intervention 4: Placebo tablets to match aliskiren.
intervention 1: Aliskiren intervention 2: Ramipril intervention 3: Placebo to Ramipril intervention 4: Placebo to Aliskiren
7
Kansas City | Missouri | United States | -94.57857 | 39.09973 Investigative Site | N/A | Argentina | N/A | N/A Investigative Site | Colombia | Colombia | N/A | N/A Investigative Site | N/A | France | N/A | N/A Investigative Site | N/A | Germany | N/A | N/A Investigative Site | N/A | India | N/A | N/A Investigative Site...
0
NCT00631917
[ 5 ]
32
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
2MALE
false
A prospective study to evaluate the effect of rFVIII-FS in different prophylactic regimens on bleeding events frequency and development of arthropathy in Previously Treated and Minimally treated Hemophilia A pediatric population.
null
Hemophilia A
Kogenate, Children, Factor VIII, Hemophilia A, Prophylactic
null
3
arm 1: rFVIII-FS (Octocog-alfa, antihemophilic factor \[recombinant\]) 70 IU/kg, dosing by injection once per week \[qw\] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a ...
[ 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: rFVIII-FS (Octocog-alfa, antihemophilic factor \[recombinant\]) 70 IU/kg, dosing by injection once per week (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times ...
intervention 1: rFVIII-FS (Kogenate FS, BAY14-2222) 70 IU/kg, dosing once per week intervention 2: rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg twice per week (30 IU/kg + 40 IU/kg) intervention 3: rFVIII-FS (Kogenate FS, BAY14-2222) 75 IU/kg, dosing three times per week (3 x 25 IU/kg)
4
Kirov | N/A | Russia | 49.66007 | 58.59665 Moscow | N/A | Russia | 37.61556 | 55.75222 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Yekaterinburg | N/A | Russia | 60.6122 | 56.8519
0
NCT00632814
[ 4 ]
181
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The purpose of this study is to see whether droxidopa is effective in treating symptoms of neurogenic orthostatic hypotension in patients with Primary Autonomic Failure (Pure Autonomic Failure, Multiple System Atrophy, Parkinson's Disease), Non-diabetic neuropathy, or Beta Hydroxylase deficiency.
Systolic blood pressure is transiently and minimally decreased in healthy individuals upon standing. Normal physiologic feedback mechanisms work through neurally-mediated pathways to maintain the standing blood pressure, and thus maintain adequate cerebral perfusion. The compensatory mechanisms that regulate blood pres...
Symptomatic Neurogenic Orthostatic Hypotension (NOH) Non-diabetic Neuropathy Primary Autonomic Failure Dopamine Beta Hydroxylase Deficiency
NOH Neurogenic Orthostatic Hypotension Orthostatic hypotension PAF Pure Autonomic Failure MSA Multiple System Atrophy Neuropathy Autonomic Failure Parkinson Dopamine Deficiency Dopamine Droxidopa
null
2
arm 1: Double-blind arm 2: Double-blind
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day intervention 2: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, th...
intervention 1: Placebo intervention 2: Droxidopa
54
Birmingham | Alabama | United States | -86.80249 | 33.52066 Litchfield Park | Arizona | United States | -112.35794 | 33.49337 Phoenix | Arizona | United States | -112.07404 | 33.44838 Sun City | Arizona | United States | -112.27182 | 33.59754 Fountain Valley | California | United States | -117.95367 | 33.70918 Oxnard |...
0
NCT00633880
[ 4 ]
452
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
Gabapentin and pregabalin are treatments for some types of neuropathic pain, including postherpetic neuralgia (PHN). However, these treatments usually need to be taken 3 times a day for effective pain control. The purpose of this study is to determine whether a new gabapentin tablet, which only needs to be taken once a...
The primary study objective is to assess the relative efficacy of G-ER dosed once daily (1800 mg following the evening meal), versus placebo in reducing the mean daily pain score from the baseline week to the end of the efficacy treatment period (Treatment Week 10) in patients with PHN. Secondary efficacy measures wil...
Neuralgia,Postherpetic
Postherpetic Neuralgia (PHN), shingles
null
2
arm 1: Gabapentin - Extended Release arm 2: Sugar pill
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Once-Daily; 300 mg and 600 mg tablets intervention 2: Once daily; 300 mg and 600 mg tablets
intervention 1: Gabapentin Extended Release tablets intervention 2: Placebo
39
Birmingham | Alabama | United States | -86.80249 | 33.52066 Tuscaloosa | Alabama | United States | -87.56917 | 33.20984 Phoenix | Arizona | United States | -112.07404 | 33.44838 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Lancaster | California | United States | -118.13674 | 34.69804 Los Angeles | Cal...
0
NCT00636636
[ 3 ]
32
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
This study is designed to evaluate whether or not oral viscous budesonide is effective in treating children with Eosinophilic Esophagitis.
null
Eosinophilic Esophagitis
Eosinophils Esophagitis Microscopy
null
2
arm 1: oral viscous budesonide plus Prevacid arm 2: placebo plus Prevacid
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Budesonide is taken daily for three months. In addition, Prevacid is taken twice daily for three months. intervention 2: Placebo is taken daily for three months. In addition, Prevacid is taken twice daily for three months.
intervention 1: Budesonide plus Prevacid intervention 2: placebo plus Prevacid
1
San Diego | California | United States | -117.16472 | 32.71571
0
NCT00638456
[ 2 ]
23
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This study is to demonstrate the safety, tolerability, pharmakokinetic and pharmacodynamic effect of a single oral dose of BAY63-2521 in patients with pulmonary hypertension due to chronic obstructive pulmonary disease (COPD).
In addition to the pharmacodynamic and pharmacokinetic variables, the following laboratory variables were assessed: * Hematology: Leucocytes, erythrocytes, hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), platelets, white blood ...
Hypertension, Pulmonary Pulmonary Disease, Chronic Obstructive
Chronic obstructive pulmonary disease COPD Pulmonary hypertension
null
2
arm 1: Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3. arm 2: Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: 1.0 mg BAY63-2521 will be given twice per subject, as single dose administration during the hemodynamic investigation (on study day 1) and during the lung function testing (on study day 3). intervention 2: 2.5 mg BAY63-2521 will be given twice per subject, as single dose administration during the hemody...
intervention 1: Riociguat (Adempas, BAY63-2521) 1.0 mg intervention 2: Riociguat (Adempas, BAY63-2521) 2.5 mg
7
Heidelberg | Baden-Wurttemberg | Germany | 8.69079 | 49.40768 Löwenstein | Baden-Wurttemberg | Germany | 9.38 | 49.09558 München | Bavaria | Germany | 13.46314 | 48.69668 Bad Nauheim | Hesse | Germany | 8.73859 | 50.36463 Giessen | Hesse | Germany | 8.67554 | 50.58727 Greifswald | Mecklenburg-Vorpommern | Germany | 13....
0
NCT00640315
[ 3 ]
255
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
To evaluate the safety and tolerability of atacicept and to explore if atacicept reduces central nervous system inflammation in subjects with relapsing multiple sclerosis (RMS) as assessed by frequent magnetic resonance imaging (MRI). This study is randomised. Study medication is administered via subcutaneous (under th...
null
Relapsing Multiple Sclerosis
Relapsing Multiple Sclerosis Atacicept
null
4
arm 1: None arm 2: None arm 3: None arm 4: None
[ 0, 0, 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Atacicept will be administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks. intervention 2: Atacicept will be administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loadi...
intervention 1: Atacicept intervention 2: Atacicept intervention 3: Atacicept intervention 4: Placebo matched to atacicept
50
Phoenix | Arizona | United States | -112.07404 | 33.44838 Atlanta | Georgia | United States | -84.38798 | 33.749 Northbrook | Illinois | United States | -87.82895 | 42.12753 East Lansing | Michigan | United States | -84.48387 | 42.73698 Jefferson | New Hampshire | United States | -71.47453 | 44.41895 Cleveland | Ohio |...
0
NCT00642902
[ 2, 3 ]
15
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to determine whether control of inflammatory pathways mediated by IL-1 beta using the IL-1 receptor antagonist anakinra will yield measurable decreases in expression of genes that are otherwise overexpressed as a consequence of IL-1 beta effects in children with newly diagnosed type 1 diabe...
Type 1 diabetes mellitus (T1D) is caused by autoimmune and autoinflammatory destruction of the insulin-producing beta cells in the pancreatic islets of Langerhans. Historically, treatment for this condition has consisted of insulin replacement therapy and dietary modification. Recent studies have demonstrated the poten...
Type 1 Diabetes Mellitus
Type 1 diabetes mellitus IL1 beta Anakinra
null
1
arm 1: After study enrollment, all subjects started anakinra (Kineret™; Amgen, Thousand Oaks, CA, USA) as a subcutaneous daily injection. Subjects weighing \>25 kg at the time of enrollment received 100 mg daily, whereas those weighing \<25 kg received 50 mg daily. Anakinra was continued for 28 d with no dose adjustmen...
[ 0 ]
1
[ 0 ]
intervention 1: Patients will receive daily anakinra therapy for 28 days
intervention 1: Anakinra
1
Dallas | Texas | United States | -96.80667 | 32.78306
0
NCT00645840
[ 5 ]
12
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This study will evaluate the effectiveness of propranolol in reducing symptoms of distress in people with post-traumatic stress disorder.
Post-traumatic stress disorder (PTSD) is a common and disabling condition, with about 10% of people having experienced PTSD at some point during their lives. The diagnosis of PTSD requires certain criteria: exposure to a severe psychological trauma and the persistent presence of three symptom clusters that include re-e...
Post-Traumatic Stress Disorder
Propanolol Beta Blockers Reconsolidation Cognitive Therapy PTSD
null
2
arm 1: Participants will take propranolol for 14 weeks. Medication will be self-administered times they experience acute onset of hyperarousal symptoms, not more than twice per day. arm 2: Participants will take placebo for 14 weeks. Medication will be self-administered times they experience acute onset of hyperarousal...
[ 0, 2 ]
3
[ 0, 0, 5 ]
intervention 1: Participants will take a 40-mg dose of propranolol immediately after they experience a traumatic memory associated with strong hyperarousal symptoms. Participants may take up to two doses a day, if the doses are separated by at least 6 hours. intervention 2: Participants will take a single dose of place...
intervention 1: Propanolol intervention 2: Placebo intervention 3: Cognitive therapy workbook
1
New York | New York | United States | -74.00597 | 40.71427
0
NCT00648375
[ 5 ]
30
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this research study is to better understand how the study drug works when people use it to treat atopic dermatitis.
To evaluate adherence to topical therapy using adherence data collected by the MEMS cap (Medication Electronic Monitoring System) in pediatric patients with atopic dermatitis (AD) and the impact of a return visit.
Atopic Dermatitis
atopic dermatitis eczema
null
1
arm 1: tacrolimus ointment
[ 0 ]
1
[ 0 ]
intervention 1: tacrolimus ointment to be applied twice daily to affected areas during duration of study
intervention 1: tacrolimus ointment
1
Winston-Salem | North Carolina | United States | -80.24422 | 36.09986
0
NCT00654355
[ 4 ]
100
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purpose of the trial is to evaluate the safety of intravenous (iv) lacosamide delivered in a single dose followed by 6.5 days of oral lacosamide treatment in subjects with partial-onset seizures.
This multicenter, open-label trial examined safety and tolerability of rapid initiation of adjunctive lacosamide via a single intravenous loading dose followed by oral maintenance treatment in subjects 16 - 60 years of age with partial-onset seizures. Three consecutive 25-subject cohorts were given a progressively incr...
Partial Epilepsies Partial Onset Seizures
epilepsy seizures Lacosamide Vimpat intravenous
null
3
arm 1: Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily arm 2: Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily arm 3: Single loading dose of intravenous (iv) lacosamide 400 mg fo...
[ 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Single loading intravenous (iv) lacosamide 200 mg dose administered over a 15 minute infusion duration followed by oral lacosamide 200 mg/day (100 mg twice daily) for 6.5 days intervention 2: Single loading intravenous (iv) lacosamide 300 mg dose administered over a 15 minute infusion duration followed ...
intervention 1: lacosamide intervention 2: lacosamide intervention 3: lacosamide
7
Phoenix | Arizona | United States | -112.07404 | 33.44838 Baltimore | Maryland | United States | -76.61219 | 39.29038 Chesterfield | Missouri | United States | -90.57707 | 38.66311 Columbus | Ohio | United States | -82.99879 | 39.96118 Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 Dallas | Texas | ...
0
NCT00655551
[ 4 ]
2,055
RANDOMIZED
PARALLEL
1PREVENTION
2DOUBLE
false
0ALL
null
The primary objective of the trial is to demonstrate non-inferiority of 220 mg oral dabigatran etexilate compared to 40 mg subcutaneous enoxaparin administered once daily. Safety and efficacy will be compared between the treatment groups.
null
Venous Thromboembolism
null
2
arm 1: 220 mg once daily arm 2: 40 mg once daily
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: 40 mg once daily intervention 2: 220 mg once daily
intervention 1: Enoxaparin intervention 2: Dabigatran etexilate
108
La Jolla | California | United States | -117.2742 | 32.84727 Aurora | Colorado | United States | -104.83192 | 39.72943 Englewood | Colorado | United States | -104.98776 | 39.64777 Clearwater | Florida | United States | -82.8001 | 27.96585 Lexington | Kentucky | United States | -84.47772 | 37.98869 Missoula | Montana | ...
0
NCT00657150
[ 4 ]
1,397
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
The purpose of this study is to investigate the efficacy and safety of Rabeprazole (RAB) Extended-Release (ER) 50 mg versus Esomeprazole (ESO) 40 mg in subjects with erosive gastroesophageal reflux disease (eGERD).
This is a multicenter, randomized, double-blind, double-dummy, parallel-group study. Subjects who meet all the inclusion/exclusion criteria will be randomly assigned to 1 of 2 treatment groups, Rabeprazole Extended-Release (RAB ER) 50 mg or Esomeprazole (ESO) 40 mg for the treatment of mild to moderate erosive Gastroes...
Gastroesophageal Reflux Disease (GERD)
GERD erosive GERD erosive esophagitis
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Rabeprazole ER 50 mg capsule, once daily for 4-8 weeks. intervention 2: Esomeprazole 40 mg capsule, once daily for 4-8 weeks.
intervention 1: Rabeprazole sodium intervention 2: Esomeprazole
85
Huntsville | Alabama | United States | -86.58594 | 34.7304 Tucson | Arizona | United States | -110.92648 | 32.22174 Tucson | Arizona | United States | -110.92648 | 32.22174 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Sherwood | Arkansas | United States | -92.22432 | 34.81509 Anaheim | California | Uni...
0
NCT00658632
[ 4 ]
570
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to evaluate the efficacy and safety in adult patients who have inadequate glycaemic control when treated with metformin in addition to diet and exercise.
null
Type 2 Diabetes
DPP-4 inhibitors HbA1c Incretins
null
2
arm 1: Metformin + Saxagliptin arm 2: Metformin + Placebo
[ 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Oral tablet, once daily for 24 weeks intervention 2: oral tablet, once daily for 24 weeks intervention 3: oral tablet, once daily for 24 weeks
intervention 1: Saxagliptin intervention 2: Placebo intervention 3: Metformin
30
Hefei | Anhui | China | 117.28083 | 31.86389 Beijing | China | China | 116.39723 | 39.9075 Chongqing | China | China | 106.55771 | 29.56026 Guangzhou | Guangdong | China | 113.25 | 23.11667 Shijiazhuang | Hebei | China | 114.47861 | 38.04139 Ha'er Bing | Hei Longjiang | China | N/A | N/A Wuhan | Hubei | China | 114.266...
0
NCT00661362
[ 5 ]
32
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of this study is to find out how an anti-anxiety drug or placebo affects the activity of your brain when you are at rest and when you are viewing emotional material, such as, emotional faces and pictures.
This is an exploratory study to evaluate the usefulness of fMRI as a biomarker to measure the response to a known, FDA approved marketed anxiolytic. As such, this is not a study testing safety and efficacy of an approved medicine; it is a study to evaluate the usefulness of fMRI (a non-significant risk device procedure...
Generalized Anxiety Disorder
Anxiety disorders Generalized anxiety
null
2
arm 1: Alprazolam, an FDA-approved drug, will be administered to 24 patients with generalized anxiety disorder. arm 2: A placebo comparator will be administered to 12 patients with generalized anxiety disorder
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Drug dose will be fixed across patients: alprazolam 0.5 mg b.i.d escalating to 1.0 mg b.i.d. The treatment duration will be approximately 28 days (4 weeks). intervention 2: Placebo, bid, p.o. for 28 +/- 2 days.
intervention 1: Alprazolam (Xanax) intervention 2: Placebo
1
San Diego | California | United States | -117.16472 | 32.71571
0
NCT00662259
[ 5 ]
39
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This study is being done to see if the blood pressure lowering effect of an approved drug nebivolol is comparable to that of another approved drug carvedilol for the treatment of hypertension in patients who have coronary artery disease.
null
Hypertension Coronary Artery Disease
carvedilol Coreg (TM) hypertension blood pressure coronary artery disease Nebivolol BYSTOLIC (TM)
null
2
arm 1: Encapsulated Nebivolol arm 2: Encapsulated Carvedilol
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration once daily intervention 2: Encapsulated Carvedilol 12.5 mg, 25 mg, 50 mg total daily dosage, oral administration twice daily
intervention 1: Nebivolol intervention 2: Carvedilol
34
Birmingham | Alabama | United States | -86.80249 | 33.52066 Peoria | Arizona | United States | -112.23738 | 33.5806 Buena Park | California | United States | -117.99812 | 33.86751 Los Angeles | California | United States | -118.24368 | 34.05223 Orange | California | United States | -117.85311 | 33.78779 Santa Ana | Cal...
0
NCT00673075
[ 5 ]
17
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The primary objective of this trial is to assess the continued efficacy of Omacor co-administered with simvastatin for lowering non-high-density lipoprotein cholesterol (non-HCL-C) levels.
The present trial is an open-label, uncontrolled extension to the previous trial (PRV-06009) which utilized a randomized,double-blind, two-period crossover design with eight clinic visits. The current trial consists of nine clinic visits over 104 weeks. There will be two treatment periods in this study: * Phase I: Al...
Dyslipidemias
cholesterol dyslipidemia omega 3
null
1
arm 1: Subjects who had successfully completed a 12-wk double-blind crossover study of P-OM3 plus simvastatin 20 mg/d were eligible for the open-label extension study. Omacor 4 grams/day plus simvastatin 80 mg/day. Simvastatin dose adjusted at Investigator discretion after week 6.
[ 5 ]
1
[ 0 ]
intervention 1: Omacor 4 grams/day plus simvastatin 80 mg/day. Simvastatin dose adjusted at Investigator discretion after week 6.
intervention 1: Omacor + simvastatin
0
null
0
NCT00678743
[ 4 ]
225
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to determine whether a reduced dose of aripiprazole is effective in treating patients with major depressive disorder
This is a 60-day, multi-center, double-blind, placebo-controlled study on the efficacy of aripiprazole (Abilify) augmentation of selective serotonin reuptake inhibitors (SSRIs) or selective serotonin norepinephrine uptake inhibitors (SNRIs) venlafaxine in patients with MDD who have responded inadequately to treatment w...
Major Depressive Disorder
Depression
null
3
arm 1: patients randomly assigned to the drug/drug sequence, the dose of aripiprazole will be 2 mg/day during the first phase of the study, and 5 mg/day in the second phase. arm 2: For patients randomly assigned to the placebo/drug sequence, the dose of aripiprazole will be 2 mg/day during the second phase of the study...
[ 1, 1, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Tablet dose of aripiprazole will be 2 mg/day during the first phase (30 days) of the study, and 5 mg/day in the second phase (30 days) intervention 2: For patients randomly assigned to the placebo/drug sequence, the dose of aripiprazole will be 2 mg/day during the second phase of the study (30 days) int...
intervention 1: Aripiprazole 5mg intervention 2: Aripiprazole 2mg intervention 3: Placebo
1
Boston | Massachusetts | United States | -71.05977 | 42.35843
0
NCT00683852
[ 2 ]
12
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to determine the maximum tolerated dose, dose-limiting toxicity, and recommended Phase II dose of ixabepilone in combination with carboplatin in patients with non-small cell lung cancer.
null
Non-small Cell Lung Cancer (NSCLC)
null
2
arm 1: None arm 2: None
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: On Day 1 of each 21-day cycle, ixabepilone, 32 mg/m\^2, intravenous (IV) solution administered as a 3-hour infusion; 30 minutes after the end of ixabepilone infusion, carboplatin, 5 mg/min/mL, intravenous IV solution infused over 30 minutes. Repeated once every 3 weeks, for a maximum of 6 cycles. interv...
intervention 1: Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/min/mL intervention 2: Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/min/mL
1
Chuo-Ku | Tokyo | Japan | N/A | N/A
0
NCT00683904
[ 5 ]
385
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Open label, 12-week clinical trial to assess efficacy, safety, treatment adherence and Quality of Life impact of Mometasone Furoate dry powder 400 mcg once-daily in persistent mild-moderate asthmatic patients at least 12 years old. Protocol deviations may have occurred that resulted in quality issues associated with r...
null
Asthma
null
1
arm 1: Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
[ 0 ]
1
[ 0 ]
intervention 1: Mometasone Furoate 400 mcg once daily, in the evening through 12 weeks.
intervention 1: Mometasone Furoate
0
null
0
NCT00687531
[ 4 ]
35
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The HIP study is designed to follow the clinical experience of young hypertensive children receiving candesartan cilexetil (Atacand) who are between the ages of 1 and less than 11 years old. The study is open label with no concurrent control group. To be eligible for HIP, children must have completed Study 328 without ...
null
Hypertension
pediatric renal disease high blood pressure
null
1
arm 1: investigator determines efficacious dose based on child's BP response.
[ 0 ]
1
[ 0 ]
intervention 1: 0.05, 0.2, 0.4 mg/kg, oral solution, single daily dose
intervention 1: candesartan cilexetil
13
Edegem | Belgium | Belgium | 4.44504 | 51.15662 Ghent | Belgium | Belgium | 3.71667 | 51.05 Strasbourg | N/A | France | 7.74553 | 48.58392 Erlangen | N/A | Germany | 11.00783 | 49.59099 Heidelberg | N/A | Germany | 8.69079 | 49.40768 Marburg | N/A | Germany | 8.77069 | 50.80904 Rostock | N/A | Germany | 12.14049 | 54.0...
0
NCT00690612
[ 3 ]
56
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purpose of this research study is to find out how well cetuximab works in treating NSCLC in patients who have been previously treated with a class of drug called tyrosine kinase inhibitor (TKI). Cetuximab is a protein that is designed to block a substance in cancer cells called "epidermal growth factor receptor" or...
* Participants on this study will receive cetuximab by infusion intravenously once per week and may continue to receive weekly cetuximab infusions until their disease progresses or they experience unacceptable side effects. * The following will be performed every 4 weeks while they are receiving study treatments: Physi...
Non-small Cell Lung Cancer
cetuximab tyrosine kinase inhibitor
null
1
arm 1: 400mg/m2 IV x 1 and then 250mg/m2 IV weekly
[ 0 ]
1
[ 0 ]
intervention 1: Given intravenously once per week.
intervention 1: Cetuximab
3
Boston | Massachusetts | United States | -71.05977 | 42.35843 Boston | Massachusetts | United States | -71.05977 | 42.35843 Boston | Massachusetts | United States | -71.05977 | 42.35843
0
NCT00694603
[ 3 ]
60
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to assess the efficacy of addition of zometa to anti-neoplastic treatment compared with anti-neoplastic treatment alone, as measured by the primary efficacy variable of SREs (Skeletal Related Events) and to assess the safety in nasopharyngeal patients with bone metastases randomized to rece...
null
Nasopharyngeal Cancer
null
2
arm 1: Zometa (zoledronic acid) 4 mg over 15 min IV infusion, every 4 week Anti-neoplastic therapy .Patients can receive concomitant cycles of chemotherapy or radiotherapy. arm 2: Anti-neoplastic therapy alone. Patients can receive concomitant cycles of chemotherapy or radiotherapy.
[ 0, 4 ]
1
[ 0 ]
intervention 1: Zometa 4 mg IV infusion every 4 weeks for 24 months. Co-administration with Zometa: Calcium 500 mg + vitamin D 400-500 IU daily
intervention 1: Zometa (zoledronic acid)
1
Guangzhou | Guangdong | China | 113.25 | 23.11667
0
NCT00697619
[ 5 ]
42
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
Generalized anxiety disorder (GAD) is a very common disorder in the geriatric population with prevalence rates reaching 7% and even higher rates of 8% among elderly veterans. However, despite such high prevalence treating clinicians are presently forced to address treatment issues in this population without the guidanc...
Generalized anxiety disorder (GAD) is a serious and distinct illness that occurs in significant numbers, affecting at least 7 million people in the United States alone. The prevalence of GAD is higher in the primary care setting with rates twice as high as the rates reported in community samples. GAD is a life-long dis...
Generalized Anxiety Disorder
sertraline pharmacotherapy geriatric
null
3
arm 1: sertraline 50 mg daily arm 2: sertraline 100mg daily arm 3: placebo 50 or 100mg
[ 0, 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: 50 mg daily intervention 2: 100 mg daily intervention 3: 50mg or 100mg matching placebo
intervention 1: sertraline 50 mg daily intervention 2: sertraline 100 mg daily intervention 3: Placebo 50 or 100 mg
3
Tuscaloosa | Alabama | United States | -87.56917 | 33.20984 Miami | Florida | United States | -80.19366 | 25.77427 Charleston | South Carolina | United States | -79.93275 | 32.77632
0
NCT00701675
[ 5 ]
311
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
To compare the efficacy of SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily (bid) to that of budesonide inhalation powder DPI 180 μg x 2 inhalations bid, in African American(self-reported) subjects with inhaled corticosteroid (ICS) dependent asthma.
null
Asthma
Asthma
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: 160/4.5 μg x 2 actuations twice daily (bid) intervention 2: inhalation powder 180 μg x 2 inhalations bid (PULMICORT)
intervention 1: Budesonide / formoterol fumarate (SYMBICORT) intervention 2: Budesonide
57
Pell City | Alabama | United States | -86.28609 | 33.58621 Bentonville | Arkansas | United States | -94.20882 | 36.37285 Hot Springs | Arkansas | United States | -93.05518 | 34.5037 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Malvern | Arkansas | United States | -92.81295 | 34.36231 Huntington Park | ...
0
NCT00702325
[ 4 ]
34
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
false
0ALL
false
The hypothesis is that pseudoephedrine, a sympathomimetic amine commonly used as a decongestant, will decrease nasal congestion leading to increased patency of the nose and a decrease in nighttime sleep fragmentation in individuals with year round perennial allergic rhinitis (PAR). This decrease in sleep fragmentation ...
The hypothesis is that pseudoephedrine, a sympathomimetic amine commonly used as a decongestant, will decrease nasal congestion leading to increased patency of the nose and a decrease in nighttime sleep fragmentation in individuals with year round perennial allergic rhinitis (PAR). This decrease in sleep fragmentation ...
Rhinitis Sleep
Sleep, Pseudoephedrine
null
2
arm 1: Placebo arm 2: Pseudoephedrine is a 240 mg PO per day
[ 2, 1 ]
1
[ 0 ]
intervention 1: Pseudoephedrine is a 240 mg PO per day
intervention 1: Pseudoephedrine
1
Hershey | Pennsylvania | United States | -76.65025 | 40.28592
0
NCT00704496
[ 5 ]
50
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
false
0ALL
false
This study will evaluate whether patients have an overall preference for Kristalose® or liquid lactulose based on taste, consistency, and portability.
This study will evaluate whether patients have an overall preference for Kristalose® or liquid lactulose based on taste, consistency, and portability.
Constipation
constipation laxative lactulose Kristalose®
null
2
arm 1: Kristalose®, as prescribed, for 7 days. arm 2: Liquid lactulose, as prescribed, for 7 days.
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Crystals to be dissolved in water and taken as prescribed. intervention 2: Liquid to be taken as prescribed.
intervention 1: lactulose (Kristalose®) intervention 2: liquid lactulose
3
Brooklyn | New York | United States | -73.94958 | 40.6501 Raleigh | North Carolina | United States | -78.63861 | 35.7721 Cleveland | Ohio | United States | -81.69541 | 41.4995
0
NCT00712543
[ 2 ]
8
RANDOMIZED
CROSSOVER
0TREATMENT
4QUADRUPLE
false
0ALL
true
More people worldwide use amphetamine-type stimulants than any illicit drug besides cannabis, and methamphetamine (MA) abuse and dependence is the fastest growing drug problem in the United States. Much work remains in identifying an effective pharmacotherapy for MA dependence. The neurobiological actions produced by M...
Study Procedures: Study participants are those who meet criteria for MA dependence, who are not seeking treatment, and who also meet criteria for nicotine dependence. Participants will be asked to wear a telemetry device during screening and throughout the study that records heart rate and body temperature. Participan...
Methamphetamine Addiction Crystal Meth Addiction Amphetamine Addiction
methamphetamine varenicline Chantix stimulant crystal meth
null
2
arm 1: Sugar pill (placebo) drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition. arm 2: Varenicline dosing will begin at 0.5 mg once daily for the first ...
[ 2, 1 ]
2
[ 0, 0 ]
intervention 1: Subjects receive MA infusions on certain days first under varenicline (10 days) then under placebo (8 days) after a 14-24 day washout in order to determine study medication safety and tolerability intervention 2: Subjects receive MA infusions on certain days first under placebo (10 days) then under vare...
intervention 1: Varenicline, then placebo intervention 2: Placebo, then varenicline
1
Los Angeles | California | United States | -118.24368 | 34.05223
0
NCT00713479
[ 2 ]
41
null
null
0TREATMENT
null
false
0ALL
null
The primary objective of this trial is to evaluate the long-term safety of BIBF 1120 in terms of incidence and intensity of Adverse Events and changes in safety laboratory parameters. Secondary objectives are the collection of further safety data (vital signs), efficacy data and the determination of pharmacokinetic ch...
null
Neoplasms
null
0
null
null
1
[ 0 ]
intervention 1: None
intervention 1: BIBF 1120
11
Bordeaux | N/A | France | -0.5805 | 44.84044 Clichy | N/A | France | 2.30952 | 48.90018 Clichy | N/A | France | 2.30952 | 48.90018 Paris | N/A | France | 2.3488 | 48.85341 Paris | N/A | France | 2.3488 | 48.85341 Paris | N/A | France | 2.3488 | 48.85341 Paris | N/A | France | 2.3488 | 48.85341 Freiburg/Breisgau | N/A |...
0
NCT00715403
[ 0 ]
1,931
RANDOMIZED
PARALLEL
1PREVENTION
0NONE
true
0ALL
false
Background: In developing countries, many babies are born at home and the umbilical cord commonly becomes infected during the first week after birth, and can be deadly. Cleansing of the cord with a low-cost antiseptic like chlorhexidine may reduce the risk of these infections. Little is known, however, about the freque...
null
Infection
chlorhexidine umbilical cord
null
3
arm 1: Chlorhexidine cleansing of the cord for seven days arm 2: Chlorhexidine cleansing of the cord for 1 day arm 3: Dry cord care, as recommended by WHO
[ 0, 0, 2 ]
2
[ 0, 5 ]
intervention 1: Solution (4.0%, 7.1% CHX-D) intervention 2: Educational messages regarding clean cord care
intervention 1: Chlorhexidine 4.0% intervention 2: Dry Cord Care
3
Baltimore | Maryland | United States | -76.61219 | 39.29038 Sylhet | Sylhet Division | Bangladesh | 91.87198 | 24.89904 Dhaka | N/A | Bangladesh | 90.40744 | 23.7104
0
NCT00719329
[ 4 ]
637
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
To evaluate the efficacy of a 14-day course of rifaximin given 3 times a day vs. placebo in providing adequate relief of IBS symptoms.
null
Non-Constipation Irritable Bowel Syndrome
Diarrhea Rifaximin IBS Abdominal pain Bloating
null
2
arm 1: Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period. arm 2: Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
[ 2, 0 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: Rifaximin intervention 2: Placebo
88
Anniston | Alabama | United States | -85.83163 | 33.65983 Birmingham | Alabama | United States | -86.80249 | 33.52066 Huntsville | Alabama | United States | -86.58594 | 34.7304 Tempe | Arizona | United States | -111.90931 | 33.41477 Anaheim | California | United States | -117.9145 | 33.83529 Carmichael | California | U...
0
NCT00724126
[ 4 ]
623
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
To evaluate the efficacy of a 14-day course of rifaximin given 3 times a day vs. placebo in providing adequate relief of IBS symptoms.
null
Non-Constipation Irritable Bowel Syndrome
IBS Abdominal pain Bloating Diarrhea Rifaximin
null
2
arm 1: Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period. arm 2: Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
[ 2, 0 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: Rifaximin intervention 2: Placebo
96
Hueytown | Alabama | United States | -86.99666 | 33.45122 Phoenix | Arizona | United States | -112.07404 | 33.44838 Sierra Vista | Arizona | United States | -110.30369 | 31.55454 Tucson | Arizona | United States | -110.92648 | 32.22174 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Little Rock | Arkansas...
0
NCT00731679
[ 5 ]
42
NA
SINGLE_GROUP
7BASIC_SCIENCE
1SINGLE
false
0ALL
true
This is a single-blind, Investigator Initiated study to evaluate the safety and efficacy of Vyvanse™ and provide pilot data in two areas: (1) on the use of Near-Infrared Spectroscopy to detect medication effects in children with ADHD; and (2) on the influence of Vyvanse ™ on reading fluency and comprehension, over a pe...
This is a single-blind study to evaluate the safety and efficacy of Vyvanse™ and provide pilot data in two areas: (1) on the use of Near-Infrared Spectroscopy to detect medication effects in children with ADHD; and (2) on the influence of Vyvanse ™ on reading fluency and comprehension over a period of approximately 6 w...
Attention Deficit/Hyperactivity Disorder
Attention Deficit Hyperactivity Disorder ADHD ADD reading brain hemodynamics brain imaging attention Near-Infrared Spectroscopy NIRS MSIT
null
1
arm 1: All subjects were tested at baseline before medication and then titrated to best dose and retested on Vyvanse Medication.
[ 0 ]
1
[ 0 ]
intervention 1: Subjects will participate in an open-label dose optimization period and successful titration to an optimal dose of Vyvanse™, subjects will take their optimized dose of Vyvanse™ (30, 50 or 70 mg/day) during the week leading up to their final visit. During the study subjects will take their prescribed dos...
intervention 1: Vyvanse
1
Irvine | California | United States | -117.82311 | 33.66946
0
NCT00733356
[ 4 ]
378
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
false
2MALE
false
The primary purpose of the study is to help answer whether tadalafil taken once a day can help improve the psychological outcomes (such as sexual self confidence, spontaneity and time concerns) compared to sildenafil taken as needed in patients with erectile dysfunction (ED).
null
Erectile Dysfunction
null
6
arm 1: Tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks arm 2: Tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks,...
[ 0, 0, 0, 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: 5 mg tablet taken once a day (OaD) by mouth for 8 weeks intervention 2: 100 mg tablet taken as needed (PRN) by mouth for 8 weeks intervention 3: 20 mg tablet taken as needed (PRN) by mouth for 8 weeks
intervention 1: tadalafil once a day [T(OaD)] intervention 2: sildenafil citrate as needed [S(PRN)] intervention 3: tadalafil as needed [T(PRN)]
37
Huntsville | Alabama | United States | -86.58594 | 34.7304 Newport Beach | California | United States | -117.92895 | 33.61891 Middlebury | Connecticut | United States | -73.12761 | 41.52787 Plantation | Florida | United States | -80.23184 | 26.13421 Knoxville | Tennessee | United States | -83.92074 | 35.96064 San Anton...
0
NCT00734604
[ 3 ]
23
RANDOMIZED
CROSSOVER
7BASIC_SCIENCE
2DOUBLE
true
0ALL
false
In heavy marijuana smokers, opioid receptor blockade increases the subjective and cardiovascular effects of marijuana. The current study was designed to clarify opioid-cannabinoid interactions by assessing how naltrexone shifts the dose-response function for marijuana-elicited effects in heavy marijuana smokers. For th...
null
Marijuana Smoking
naltrexone smoked marijuana marijuana use
null
6
arm 1: Placebo naltrexone capsules (0mg), inactive marijuana (0% THC). Each study participant underwent 8 conditions in a randomized order. arm 2: Placebo naltrexone capsules (0mg), active marijuana (5.5% THC). Each study participant underwent 8 conditions in a randomized order. arm 3: Placebo naltrexone capsules (0mg)...
[ 2, 2, 2, 0, 0, 2 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: Marijuana cigarette containing 0% THC intervention 2: Marijuana cigarette containing 5.5% THC intervention 3: Marijuana cigarette containing 6.2% THC intervention 4: Naltrexone (12mg/70kg) intervention 5: Naltrexone (0mg)
intervention 1: Inactive Marijuana (0% THC) intervention 2: Active Marijuana (5.5% THC) intervention 3: Active Marijuana (6.2% THC) intervention 4: Naltrexone intervention 5: Placebo naltrexone
1
New York | New York | United States | -74.00597 | 40.71427
0
NCT00743145
[ 4 ]
115
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
1FEMALE
true
The purpose of this study is to determine whether combination oral contraceptive pill of norethindrone and ethinyl estradiol is effective in the treatment of primary dysmenorrhea.
null
Dysmenorrhea
null
2
arm 1: ethinyl estradiol 0.035mg and norethisterone 1mg arm 2: Placebo for ethinyl estradiol 0.035mg and norethisterone 1mg
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: ethinyl estradiol 0.035mg and norethisterone 1mg intervention 2: Placebo for ethinyl estradiol 0.035mg and norethisterone 1mg
intervention 1: IKH-01 intervention 2: Placebo
0
null
0
NCT00746096
[ 0 ]
42
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
1FEMALE
false
There are many ways to perform a suprapubic approach pubovaginal sling. Some surgeons inject local pain medical into the retropubic space before placing the sling, others do not. This study is to determine if injection of local pain medication into the retropubic space before placing a mid-urethral sling for urinary st...
To evaluate if an injection in the retropubic space with a local acting anesthetic, Marcaine, (bupivacaine) at the time of mid-urethral sling placement will improve patients' reported post operative pain and decrease the use of narcotic pain medication. This study will include all female patients age 18 and older who w...
Stress Urinary Incontinence
mid-urethral sling pubovaginal sling postoperative pain visual analog scale suprapubic approach SPARC sling
null
2
arm 1: Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach. a...
[ 0, 4 ]
1
[ 0 ]
intervention 1: Patients randomized to the intervention arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the s...
intervention 1: 0.125% Marcaine
1
Chapel Hill | North Carolina | United States | -79.05584 | 35.9132
0
NCT00746863
[ 3, 4 ]
15
RANDOMIZED
CROSSOVER
7BASIC_SCIENCE
4QUADRUPLE
true
0ALL
false
The purpose of this study is to figure out how decreasing the activity of 11-beta hydroxysteroid dehydrogenase (11-beta HSD) will affect your blood vessel function. 11-beta HSD, which is found in the kidneys and blood vessels, is a natural protein that when active helps to keep your blood pressure under control.
This study intends to determine whether activation of mineralocorticoid receptors affects vascular function. Vascular function relies on two components of the blood vessel: the inner lining (endothelium) and the vascular smooth muscle. In specific aim 1, we seek to determine if that inhibition of the enzyme 11-beta hyd...
Apparent Mineralocorticoid Excess (AME)
null
2
arm 1: Glycyrrhetic Acid arm 2: Placebo
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: 130 mg daily for fourteen days intervention 2: Placebo daily for fourteen days
intervention 1: Glycyrrhetic Acid intervention 2: Placebo
1
Boston | Massachusetts | United States | -71.05977 | 42.35843
0
NCT00759525
[ 4 ]
705
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of the study is to compare two ophthalmic solutions in patients with open-angle glaucoma or ocular hypertension.
null
Open-angle Glaucoma Ocular Hypertension
Open-angle glaucoma ocular hypertension
null
2
arm 1: One drop self-administered in the study eye(s) once daily for 90 days arm 2: One drop self-administered in the study eye(s) once daily for 90 days
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 90 days. Referred to as travoprost. intervention 2: Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 90 days. R...
intervention 1: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®) intervention 2: Latanoprost ophthalmic solution 0.005% (XALATAN®)
0
null
0
NCT00761319
[ 4 ]
1,315
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
This is a Randomized, Double-Blind, Controlled Study to evaluate the Safety and Efficacy of a clindamycin / benzoyl peroxide gel in Subjects with Acne Vulgaris
A multicenter, randomized, double-blind, comparator and vehicle-controlled study in subjects with acne vulgaris. Approximately 1320 subjects will be enrolled. Subjects will be randomized to 1 of 4 parallel study groups in a 1:1:1:1 ratio (clindamycin / benzoyl peroxide gel:clindamycin gel:BPO gel:vehicle gel).
Acne Vulgaris
Acne Vulgaris Acne
null
4
arm 1: clindamycin / benzoyl peroxide gel arm 2: Clindamycin gel arm 3: BPO gel arm 4: vehicle gel
[ 0, 1, 1, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Once a day application to the face intervention 2: Once a day application to the face intervention 3: Once a day application to the face intervention 4: Once a day application to the face
intervention 1: clindamycin / benzoyl peroxide gel intervention 2: clindamycin gel intervention 3: BPO gel intervention 4: vehicle gel
24
San Diego | California | United States | -117.16472 | 32.71571 Santa Monica | California | United States | -118.49138 | 34.01949 Denver | Colorado | United States | -104.9847 | 39.73915 Boca Raton | Florida | United States | -80.0831 | 26.35869 Miami | Florida | United States | -80.19366 | 25.77427 Miami Beach | Florid...
0
NCT00776919
[ 5 ]
100
RANDOMIZED
PARALLEL
4SUPPORTIVE_CARE
0NONE
false
0ALL
false
The goal of the proposed study is to evaluate the effectiveness of intraoperative, strict glycemic control to improve survival and infection rates following liver transplantation in a randomized, prospective trial.Primary objective: To determine if strict intraoperative blood glucose control, when compared to standard ...
Approximately 2.1 million patients in the United States acquire infections during medical care every year. For example, 9%-30% patients who undergo surgery acquire nosocomial infections, which increase mortality and morbidity over that expected normally expected and increase the cost of care by several billion dollars....
Liver Transplant
liver transplant blood sugar
null
2
arm 1: strict glycemic control (80 to 110 mg/dl) arm 2: standard of care insulin dosing
[ 0, 4 ]
1
[ 0 ]
intervention 1: bolus or infusion 80 to 110 mg/dl
intervention 1: insulin
1
Ann Arbor | Michigan | United States | -83.74088 | 42.27756
0
NCT00780026
[ 5 ]
4
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
Studying the effectiveness of a functional rehabilitation protocol (FRP) in early Relapsing Remitting Multiple Sclerosis (RRMS) patients treated with Betaferon by comparing the physical ability of patients with and without FRP.
null
Multiple Sclerosis, Relapsing-Remitting
KineSEP Rehabilitation Betaferon
null
2
arm 1: Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization arm 2: Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, ad...
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Treatment by Interferon beta-1b (Betaseron, BAY86-5046) for 3 month and beginning of the Functional Rehabilitation Program starting within 6 weeks after randomization intervention 2: Treatment by Interferon beta-1b (Betaseron, BAY86-5046) for 3 month and beginning of the Functional Rehabilitation Progra...
intervention 1: Interferon beta-1b, FRP within 15 days after randomization intervention 2: Interferon beta-1b, FRP about 6 weeks after randomization
10
Rennes | Brittany Region | France | -1.67429 | 48.11198 Avignon | N/A | France | 4.80892 | 43.94834 Lille | N/A | France | 3.05858 | 50.63297 Lomme | N/A | France | 2.98715 | 50.64358 Montpellier | N/A | France | 3.87635 | 43.61093 Mulhouse | N/A | France | 7.32866 | 47.75205 Nîmes | N/A | France | 4.35788 | 43.83665 Q...
0
NCT00780455
[ 5 ]
23
RANDOMIZED
PARALLEL
2DIAGNOSTIC
3TRIPLE
false
0ALL
false
The purpose of this study is to compare the incidence of contrast-induced nephropathy (CIN) following the administration of iopamidol-370 (Iopamiro-370) and iodixanol-320 (Visipaque 320) in patients with moderate-to-severe chronic kidney disease and diabetes mellitus undergoing cardiac angiography.
This was a Phase IV, multicenter, randomized, double-blind, parallel-group comparison of iopamidol-370 and iodixanol-320 in patients at high risk for CIN, i.e., patients with: * Stage 3 or 4 CKD (SCr level of ≥ 1.5 mg/dL for men and ≥1.3 mg/dL for women or eGFR between 15 and 50 mL/min, and * Diabetes mellitus who wou...
Chronic Renal Impairment Diabetes Mellitus
null
2
arm 1: None arm 2: None
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: Iopamiro-370 (Iopamidol injection 76%) is provided in single dose bottles/vials, ready to use, aqueous, nonpyrogenic, colorless to pale yellow sterile solution intervention 2: Visipaque 320 (iodixanol) injection is provided in bottles/flexible containers, ready to use sterile, pyrogen-free colorless to ...
intervention 1: Iopamidol injection 76% intervention 2: iodixanol
1
Princeton | New Jersey | United States | -74.65905 | 40.34872
0
NCT00782639
[ 5 ]
500
RANDOMIZED
PARALLEL
6HEALTH_SERVICES_RESEARCH
0NONE
false
0ALL
false
With the advances of flexible bronchoscopy, like metallic stent, electrocautery and real time endobronchial ultrasound, the complexity and duration of procedures are increasing. So, adequate sedation and analgesia is important for both patients and bronchoscopist. Clinical-judged midazolam administration is the curren...
It is well known that patients undergoing bronchoscopy could be less suffering and the procedures could be carried on more smoothly if the patients have adequate sedation and analgesia. The preferred sedative and analgesic drugs are Midazolam and opioid, like Alfentanil or Morphine, which were titrated according to phy...
Flexible Bronchoscopy
flexible bronchoscopy sedation bispectral index
null
2
arm 1: In the study group, induction was started using alfentanil 4\~5μg/kg bolus following repeated propofol boluses (0.5\~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3\~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated t...
[ 1, 1 ]
2
[ 1, 0 ]
intervention 1: Induction: Alfentanil: 5μg/kg slowly push. Propofol: 0.5-1.5mg/kg slowly push till BIS value 70. Maintenance: Propofol infusion (3\~12 mg/kg/hour) to maintain BIS around 65\~75. Alfentanil: 5μg/kg slowly push Q15min prn if severe cough. intervention 2: Induction: Alfentanil: 5μg/kg slowly push. Mida...
intervention 1: Bispectral index guide propofol infusion intervention 2: Clinical-judged midazolam administration
1
Taoyuan | N/A | Taiwan | 121.29696 | 24.99368
0
NCT00789815
[ 2 ]
14
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
false
0ALL
null
A 2-period crossover study to assess the safety, tolerability and glucose-lowering effects of MK8245.
Hypothesis: Multiple doses of MK-8245 are sufficiently safe and well tolerated in patients with Type 2 diabetes based on an assessment of clinical and laboratory adverse experiences (AEs), to permit continued clinical investigation.
Type 2 Diabetes
null
2
arm 1: MK8245 arm 2: Placebo Comparator
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: MK8245 50 mg capsules twice daily for 13 days. On Day 14, only the morning dose of study medication will be taken. There will be a 14 day washout period. Patients will then crossover to MK8245 placebo capsules twice daily for 13 days. On Day 14, only the morning dose of study drug will be taken. interve...
intervention 1: MK8245 intervention 2: Comparator: Placebo
0
null
0
NCT00790556
[ 5 ]
999
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The initial 12 week portion of this 20 week study will examine the ability of a combination of olmesartan medoxomil and amlodipine to lower the blood pressure of patients with high blood pressure who have not had sufficient blood pressure reduction using one anti-hypertension drug (monotherapy). The final 8 weeks of th...
null
Hypertension
null
1
arm 1: Azor tablets and hydrochlorothiazide tablets (if necessary) will be administered for up to 20 weeks
[ 0 ]
2
[ 0, 0 ]
intervention 1: amlodipine and olmesartan medoxomil tablets administered orally, once daily for up to 20 weeks intervention 2: hydrochlorothiazide tablets may be administered orally, if necessary once daily, for up to 8 weeks
intervention 1: amlodipine and olmesartan medoxomil tablets intervention 2: hydrochlorothiazide tablets
72
Birmingham | Alabama | United States | -86.80249 | 33.52066 Green Valley | Arizona | United States | -110.9937 | 31.85425 Mesa | Arizona | United States | -111.82264 | 33.42227 Sierra Vista | Arizona | United States | -110.30369 | 31.55454 Tempe | Arizona | United States | -111.90931 | 33.41477 Tucson | Arizona | Unite...
0
NCT00791258
[ 3 ]
14
RANDOMIZED
CROSSOVER
0TREATMENT
1SINGLE
false
0ALL
false
This study aims to test an insulin and glucagon delivery algorithm designed to be used in conjunction with a continuous glucose monitoring system. This combined glucose sensing/hormone delivery approach is a step on the way to eventual development of an artificial (or automated) pancreas. The insulin and glucagon deliv...
The objective of the current human study is to compare glycemic control in persons with Type 1 Diabetes using the FMPD Insulin plus Glucagon Delivery Algorithm vs. the FMPD Insulin-Alone Algorithm. Subjects will undergo two 28-hour sensor-augmented glycemic control studies. Each subject will be fitted with two short te...
Type 1 Diabetes
diabetes pancreas beta cell glucagon insulin hypoglycemia
null
3
arm 1: Glycemic control of subject participants was managed by the closed-loop system which delivered insulin and normal saline (instead of glucagon) as a placebo, based upon algorithm calculations. arm 2: Glycemic control of subject participants was managed by the system which delivered insulin and glucagon based upon...
[ 2, 1, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Insulin dosing and frequency calculated by Fading Memory Proportional Derivative algorithm intervention 2: During incipient hypoglycemia, glucagon was given in an attempt to prevent overt hypoglycemia. Dosing and frequency was calculated by the Fading Memory Proportional Derivative algorithm interventio...
intervention 1: Insulin, Asp(B28)- intervention 2: Glucagon intervention 3: Placebo
1
Portland | Oregon | United States | -122.67621 | 45.52345
0
NCT00797823
[ 5 ]
336
NA
SINGLE_GROUP
1PREVENTION
0NONE
true
0ALL
false
We hypothesize that when offered influenza vaccine at little or no cost, in a setting where the value of the vaccine is connected to one's high risk child, vaccination rates for parents will approach 90-95%, similar to rates obtained in the Neonatal Intensive Care Unit environment.
null
Influenza
Influenza prevention
null
0
null
null
1
[ 0 ]
intervention 1: 0.5 mL Deltoid Intramuscular Injection X 1
intervention 1: Influenzae vaccine
1
Akron | Ohio | United States | -81.51901 | 41.08144
0
NCT00812110
[ 3 ]
226
null
CROSSOVER
0TREATMENT
null
false
0ALL
null
The primary goal of this trial is to compare the efficacy and safety of COMBIVENT CFC MDI with albuterol HFA MDI, the current standard reliever medication in asthma. In the first cross-over part of the study (Treatment Phases 1 and 2) the marketed product, COMBIVENT CFC MDI will be used. In the second, parallel group p...
null
Asthma
null
0
null
null
3
[ 0, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: None
intervention 1: Combivent CFC MDI intervention 2: Albuterol HFA MDI intervention 3: Respimat Combivent
41
Birmingham | Alabama | United States | -86.80249 | 33.52066 Los Angeles | California | United States | -118.24368 | 34.05223 Los Angeles | California | United States | -118.24368 | 34.05223 Palmdale | California | United States | -118.11646 | 34.57943 San Diego | California | United States | -117.16472 | 32.71571 Stock...
0
NCT00818454
[ 2 ]
32
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This study will assess the pharmacokinetics of MK-0941 in participants with varying degrees of renal insufficiency.
null
Type 2 Diabetes
null
5
arm 1: MK-0941 20 mg administered to participants with mild renal insufficiency and type 2 diabetes. arm 2: MK-0941 20 mg administered to participants with moderate renal insufficiency and type 2 diabetes. arm 3: MK-0941 5 mg administered to participants with severe renal insufficiency and type 2 diabetes. arm 4: MK-09...
[ 0, 0, 0, 0, 0 ]
2
[ 0, 0 ]
intervention 1: Two 10-mg tablets of MK-0941 administered as a single oral dose. intervention 2: MK-0941 administered as one single 5-mg tablet.
intervention 1: MK-0941 20 mg intervention 2: MK-0941 5 mg
0
null
0
NCT00830791
[ 5 ]
171
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
null
A 12-week evaluation of the safety and efficacy of dapsone gel 5% when used with tazarotene cream 0.1% compared with tazarotene cream 0.1% monotherapy in treating moderate to severe facial acne vulgaris
null
Acne Vulgaris
null
2
arm 1: Dapsone Gel 5% and Tazarotene Cream 0.1% arm 2: Tazarotene Cream 0.1%
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: Dapsone topical gel 5%, 1 pea-size amount BID x 12 weeks and Tazarotene Cream 0.1%, 1 pea-size amount QD x 12 weeks intervention 2: Tazarotene Cream 0.1%, 1 pea-size amount QD x 12 weeks
intervention 1: Dapsone intervention 2: Tazarotene
1
Fremont | California | United States | -121.98857 | 37.54827
0
NCT00834210
[ 4 ]
485
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
null
This study will compare the blood pressure (BP) lowering effect of the combination of aliskiren/amlodipine 300/10 mg versus amlodipine 10 mg monotherapy in patients with moderate to severe hypertension by testing the hypothesis that the combination of aliskiren/amlodipine produces a superior reduction from baseline in ...
null
Moderate to Severe Hypertension
Hypertension systolic blood pressure cardiovascular disease aliskiren amlodipine
null
2
arm 1: Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg. arm 2: Amlodipine treatment regimen: At randomization, patients were tre...
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Each dose was taken by mouth with water at approximately 8:00 in the morning with or without food, except on the morning of the next office/clinic visit, when the medication was taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to...
intervention 1: Aliskiren/amlodipine 300/10 mg tablet intervention 2: Amlodipine 10 mg capsule
6
Berlin | N/A | Germany | 13.41053 | 52.52437 Manila | N/A | Philippines | 120.9822 | 14.6042 Bucharest | N/A | Romania | 26.10626 | 44.43225 Moscow | N/A | Russia | 37.61556 | 55.75222 Singapore | N/A | Singapore | 103.85007 | 1.28967 Madrid | N/A | Spain | -3.70256 | 40.4165
0
NCT00841672
[ 3 ]
191
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This study will evaluate the lipid-modifying effect and tolerability of MK1903 when compared to placebo in patients with dyslipidemia who are not on a statin or other lipid-modifying therapy.
null
Dyslipidemia
null
2
arm 1: MK1903 arm 2: Placebo to MK1903
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period. intervention 2: Three 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
intervention 1: MK1903 intervention 2: Comparator: Placebo
0
null
0
NCT00847197
[ 2 ]
36
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to asses the pharmacokinetics and safety of dexlansoprazole modified release (MR), once daily (QD), in adolescent subjects (age 12-17 years old) with Symptomatic Gastroesophageal Reflux Disease.
Gastroesophageal reflux disease is a condition of multifactorial etiology resulting in the reflux of gastric contents into the esophagus through the lower esophageal sphincter. The prevalence of Gastroesophageal reflux disease in the pediatric population is becoming increasingly recognized and documented. It is a chron...
Gastroesophageal Reflux
Esophageal Reflux Gastro-Esophageal Reflux Gastroesophageal Reflux Disease GERD Regurgitation, Gastric Heartburn Drug Therapy Adolescent
null
2
arm 1: None arm 2: None
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days. intervention 2: Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
intervention 1: Dexlansoprazole MR intervention 2: Dexlansoprazole MR
3
Anaheim | California | United States | -117.9145 | 33.83529 Cypress | California | United States | -118.03729 | 33.81696 Overland Park | Kansas | United States | -94.67079 | 38.98223
0
NCT00847210
[ 5 ]
18
NA
SINGLE_GROUP
0TREATMENT
0NONE
true
1FEMALE
null
The primary objective of this study is to determine the efficacy and longevity of the use of Restylane® and Perlane® in combination for the rejuvenation of the infraorbital hollows and to measure patient satisfaction with this treatment
This study will examine the effectiveness of using Restylane® and Perlane® together in the treatment of the hollows in the under eye area. The combination of these treatments for use in the under eye area is considered investigational. An investigational therapy is a therapy that is not approved by the US Food and Drug...
Infraorbital Hollows
null
1
arm 1: One syringe of Perlane® (1.0cc) and one syringe of Restylane® (1.0cc) will be used total for both tear trough areas.
[ 0 ]
2
[ 0, 0 ]
intervention 1: one syringe of Restylane® (1.0cc) will be used total for both tear trough areas. intervention 2: One syringe of Perlane® (1.0cc) will be used total for both tear trough areas.
intervention 1: Restalyne intervention 2: Perlane
1
Cleveland | Ohio | United States | -81.69541 | 41.4995
0
NCT00852241
[ 2 ]
46
NON_RANDOMIZED
PARALLEL
null
0NONE
true
0ALL
false
The purpose of this study is to assess the effects of hepatic impairment on the single dose pharmacokinetics of BMS-790052.
null
Hepatic Insufficiency
null
4
arm 1: None arm 2: None arm 3: None arm 4: None
[ 1, 1, 1, 1 ]
1
[ 0 ]
intervention 1: Capsules, Oral, 30 mg, single dose, one day
intervention 1: BMS-790052
2
Anaheim | California | United States | -117.9145 | 33.83529 Orlando | Florida | United States | -81.37924 | 28.53834
0
NCT00859053
[ 3 ]
34
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to assess the safety, pharmacokinetics and efficacy of 3 fixed doses of MP-214 orally administered once daily to patients with schizophrenia. MP-214 tablets will be administered to patients starting at an initial dose, followed by up-titration to a fixed dose (low, medium or high) for 14 da...
null
Schizophrenia
schizophrenia antipsychotics dopamine D3/D2 antagonist
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: None
intervention 1: Cariprazine 3 mg intervention 2: Cariprazine 6 mg intervention 3: Cariprazine 12.5 mg
1
Kure | Hiroshima | Japan | 132.56658 | 34.23222
0
NCT00862992
[ 2 ]
84
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
true
0ALL
false
This Phase 1 study will evaluate safety, tolerability, PK and PD of AMG 827 when administered as a single SC or IV dose.
This Phase 1 study will evaluate safety, tolerability, PK and PD of AMG 827 when administered as a single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).
Psoriasis
null
4
arm 1: Placebo treatment arm 2: 140 mg SC PsO arm 3: 350 mg SC PsO arm 4: 700 mg IV PsO
[ 2, 0, 1, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B). intervention 2: single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B). intervention 3: single SC or IV dose in healthy subjects (Part A) and subj...
intervention 1: 700 mg IV intervention 2: 350 mg SC intervention 3: Placebo intervention 4: 140 mg SC
0
null
0
NCT00867100
[ 3 ]
100
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
The purpose of this study was to assess the safety and efficacy of CNS 7056 as a procedural sedative at three dose levels compared to midazolam during a diagnostic upper GI endoscopy.
This was a randomized, double-blind, parallel-group, dose-finding study assessing the safety and efficacy of three dose levels of CNS 7056 compared with midazolam in patients undergoing diagnostic upper GI endoscopy. Patients who met all study entry criteria and completed screening procedures were randomly assigned to...
Procedural Sedation Endoscopy
CNS 7056 Procedural Sedation Sedation Endoscopy
null
4
arm 1: Remimazolam (CNS 7056) 0.10 mg/kg iv arm 2: Remimazolam (CNS 7056) 0.15 mg/kg iv arm 3: Remimazolam (CNS 7056) 0.20 mg/kg iv arm 4: Midazolam 0.075 mg/kg iv
[ 0, 0, 0, 0 ]
2
[ 0, 0 ]
intervention 1: Administered as a single intravenous injection by a syringe driver over 1 minute intervention 2: Administered as a single intravenous injection by a syringe driver over 1 minute
intervention 1: CNS 7056 intervention 2: Midazolam
7
Sheffield | Alabama | United States | -87.69864 | 34.76509 Phoenix | Arizona | United States | -112.07404 | 33.44838 Anaheim | California | United States | -117.9145 | 33.83529 South Miami | Florida | United States | -80.29338 | 25.7076 Stony Brook | New York | United States | -73.14094 | 40.92565 Raleigh | North Carol...
0
NCT00869440
[ 3 ]
41
RANDOMIZED
PARALLEL
4SUPPORTIVE_CARE
4QUADRUPLE
false
0ALL
false
Pain is a most common symptom and it has a high impact on quality of life in cancer patients. Many cancer patients have received opioid therapy, but also many of them have suffered from side effects of opioids. Drowsiness and confusion are common side effects of opioids. Caffeine is a well known psychostimulant,and it ...
Previous studies on cancer pain lacked assessment of quality of life. And most of previous studies on cancer pain did not give attention to symptoms accompanied with pain. We include such variables as outcome measures, and aimed to evaluate the efficacy and the safety of intravenous caffeine in advanced cancer inpatien...
Cancer Pain
Pain Cancer patients Caffeine Adjuvant analgesics Sedation Confusion Quality of life Fatigue
null
2
arm 1: Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour arm 2: Intravenous injections of 100ml of normal saline over 1 hour
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Intravenous injection of caffeine 200mg with 100ml of normal saline over 1 hour, once a day, for two days. intervention 2: Intravenous injections of 100ml of normal saline over 1 hour, once a day, for two days
intervention 1: Caffeine intervention 2: Normal saline
2
Goyang-si | Gyeonggi-do | South Korea | 126.835 | 37.65639 Seoul | N/A | South Korea | 126.9784 | 37.566
0
NCT00879775
[ 4 ]
123
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
false
The purpose of this study is to compare the tolerability of 3 treatment regimens containing Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel with that of Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 weeks in the treatment of acne vulgaris. The efficacy of the four treatment regimens w...
null
Acne
Acne
null
4
arm 1: Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks arm 2: Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily applica...
[ 0, 0, 0, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week intervention 2: Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks intervention 3: Adapalen...
intervention 1: Adapalene BPO Gel standard daily overnight application intervention 2: Adapalene-BPO 3-hour daily application before bedtime intervention 3: Adapalene-BPO Gel every other day application intervention 4: Adapalene-BPO Gel standard+Cetaphil® Moisturizing Lotion
2
Windsor | Ontario | Canada | -83.01654 | 42.30008 Montreal | Quebec | Canada | -73.58781 | 45.50884
0
NCT00883233
[ 3 ]
40
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to evaluate the safety and effectiveness of a study medication that contains a combination of a pain medication, sufentanil, and a sedative, triazolam. This drug is being designed to provide mild sedation as well as reduce anxiety and pain before and during a procedure (in this case electiv...
null
Sedation Anxiety Pain
procedural sedation
null
2
arm 1: single dose of sublingual Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™ arm 2: single dose of sublingual Placebo NanoTab™
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Single dose of sublingual Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™ intervention 2: Single dose of sublingual placebo NanoTab™
intervention 1: Sublingual Sufentanil/Triazolam NanoTab™ (ARX-F03) intervention 2: Placebo NanoTab™
1
Pasadena | California | United States | -118.14452 | 34.14778
0
NCT00894699
[ 5 ]
99
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
The investigators hypothesize that pregabalin will decrease post-operative pain scores and analgesic use following robot-assisted endoscopic thyroidectomy compared to placebo. The primary outcome will be acute postoperative pain, measured by a verbal numerical rating score (VNRS) and total analgesic consumption during ...
null
Pain, Postoperative
thyroidectomy pain, postoperative pregabalin
null
2
arm 1: Patients receive oral Placebo 150 mg 1 hour prior to surgery, and 12 hours later arm 2: Patients receive oral pregabalin 150 mg 1 hour prior to surgery, and 12 hours later
[ 2, 0 ]
2
[ 0, 0 ]
intervention 1: Pregabalin 150 mg orally intervention 2: Vitamin Complex 150 mg orally
intervention 1: Pregabalin intervention 2: Vitamin Complex (placebo)
1
Seoul | N/A | South Korea | 126.9784 | 37.566
0
NCT00905580
[ 5 ]
247
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
false
A study to determine if using 2 acne products in the morning is as safe and efficacious as using one product in the morning and one product in the evening.
Approximately 240 subjects will be enrolled in this randomized, multi-center study. Following satisfaction of entry criteria and screening procedures, all subjects will receive RETIN-A MICRO PUMP 0.04% and a 5% Benzoyl Peroxide wash (OTC) for the entire 12-week treatment period. Subjects will be randomized to either bo...
Acne Vulgaris
acne irritation objective sensory methods
null
2
arm 1: 5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day arm 2: 5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: 5% benzoyl peroxide wash intervention 2: 0.04% tretinoin gel
intervention 1: benzoyl peroxide wash intervention 2: Tretinoin gel
12
Boca Raton | Florida | United States | -80.0831 | 26.35869 Miami | Florida | United States | -80.19366 | 25.77427 Snellville | Georgia | United States | -84.01991 | 33.85733 Louisville | Kentucky | United States | -85.75941 | 38.25424 Fridley | Minnesota | United States | -93.26328 | 45.08608 Albuquerque | New Mexico |...
0
NCT00907257
[ 4 ]
278
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
This Phase III study is designed to assess the efficacy and safety of PEP005 Gel, 0.015% when applied to an area of skin containing 4-8 AK lesions on the face or scalp.
null
Actinic Keratosis
Peplin Actinic keratosis PEP005
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: once daily for 3 consecutive days intervention 2: once daily for 3 consecutive days
intervention 1: PEP005 (Ingenol Mebutate) gel, 0.015% intervention 2: Vehicle Gel
21
Hot Springs | Arizona | United States | N/A | N/A Fremont | California | United States | -121.98857 | 37.54827 Jacksonville | Florida | United States | -81.65565 | 30.33218 Arlington Heights | Illinois | United States | -87.98063 | 42.08836 Carmel | Indiana | United States | -86.11804 | 39.97837 Evansville | Indiana | ...
0
NCT00915551