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string
interventionModel
string
primaryPurpose
class label
masking
class label
healthyVolunteers
bool
sex
class label
oversightHasDmc
bool
briefSummary
string
detailedDescription
string
conditions
string
conditionsKeywords
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protocolPdfText
string
numArms
int64
armDescriptions
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armGroupTypes
list
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nctid
string
[ 5 ]
360
RANDOMIZED
CROSSOVER
0TREATMENT
3TRIPLE
false
0ALL
false
The purpose of this replicate study to FFU105924 is to provide data on subject preference of FFNS as compared with FPNS.
A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, One-Week, Cross-Over, Multicenter Study to Evaluate the Efficacy, Patient Preference and Experience of One-Daily, Intranasal Administration of 110mcg Fluticasone Furoate Nasal Spray and 200mcg Fluticasone Propionate Nasal Spray in Adult Subjects with Se...
Rhinitis, Allergic, Perennial
experience GW685698X fluticasone furoate preference seasonal allergic rhinitis fluticasone propionate
null
4
arm 1: fluticasone furoate nasal spray, fluticasone propionate nasal spray arm 2: fluticasone propionate nasal spray, fluticasone furoate nasal spray arm 3: placebo nasal spray matching fluticasone furoate nasal spray, placebo nasal spray matching fluticasone propionate nasal spray arm 4: placebo nasal spray matching f...
[ 1, 1, 2, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: fluticasone propionate nasal spray intervention 2: fluticasone furoate nasal spray intervention 3: placebo nasal spray matching fluticasone furoate nasal spray intervention 4: placebo nasal spray matching fluticasone propionate nasal spray
intervention 1: FPNS intervention 2: FFNS intervention 3: placebo FFNS intervention 4: placebo FPNS
28
Birmingham | Alabama | United States | -86.80249 | 33.52066 Phoenix | Arizona | United States | -112.07404 | 33.44838 Long Beach | California | United States | -118.18923 | 33.76696 Los Angeles | California | United States | -118.24368 | 34.05223 San Diego | California | United States | -117.16472 | 32.71571 San Diego ...
0
NCT00519636
[ 5 ]
377
RANDOMIZED
CROSSOVER
0TREATMENT
3TRIPLE
false
0ALL
null
The purpose of this replicate study to FFU105927 is to provide data on subject preference of FFNS as compared with FPNS.
A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, One-Week, Cross-Over, Multicenter Study to Evaluate the Efficacy, Patient Preference and Experience of One-Daily, Intranasal Administration of 110mcg Fluticasone Furoate Nasal Spray and 200mcg Fluticasone Propionate Nasal Spray in Adult Subjects with Se...
Rhinitis, Allergic, Perennial
fluticasone propionate seasonal allergic rhinitis fluticasone furoate experience GW685698X preference
null
4
arm 1: active compound arm 2: active compound arm 3: placebo arm arm 4: placebo arm
[ 1, 1, 2, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: fluticasone propionate nasal spray intervention 2: fluticasone furoate nasal spray intervention 3: placebo nasal spray matching fluticasone propionate nasal spray intervention 4: placebo nasal spray matching fluticasone furoate nasal spray
intervention 1: FPNS intervention 2: FFNS intervention 3: placebo FPNS intervention 4: placebo FFNS
24
Scottsdale | Arizona | United States | -111.89903 | 33.50921 Fresno | California | United States | -119.77237 | 36.74773 Huntington Beach | California | United States | -117.99923 | 33.6603 Long Beach | California | United States | -118.18923 | 33.76696 Mission Viejo | California | United States | -117.672 | 33.60002 O...
0
NCT00539006
[ 5 ]
86
RANDOMIZED
CROSSOVER
0TREATMENT
3TRIPLE
false
0ALL
null
This study compared the efficacy of dex-methylphenidate extended release 20 mg versus placebo during an 8-hour laboratory classroom day.
null
Attention Deficit Hyperactivity Disorder
ADHD children laboratory classroom Attention Deficit Hyperactivity Disorder
null
2
arm 1: 20 mg capsule orally once a day for 7 days arm 2: orally once a day for 7 days
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 20 mg capsule orally once a day for 7 days intervention 2: orally once a day for 7 days
intervention 1: Dex-methylphenidate hydrochloride extended-release (Focalin XR) intervention 2: Placebo
5
Little Rock | Arkansas | United States | -92.28959 | 34.74648 Winter Park | Florida | United States | -81.33924 | 28.6 Las Vegas | Nevada | United States | -115.13722 | 36.17497 Houston | Texas | United States | -95.36327 | 29.76328 Lubbock | Texas | United States | -101.85517 | 33.57786
0
NCT00564954
[ 3 ]
56
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
false
The aim of this study is to investigate the potential benefits of the correction of growth hormone (GH) deficiency with GH replacement therapy in patients with chronic heart failure due to left ventricular systolic dysfunction.
To date, a wide range of alterations in the GH/IGF-1 axis have been described in patients with chronic heart failure (CHF): reductions in GH levels, reductions in IGF-1 and a pattern of peripheral resistance to GH, in particular in patients with severe heart failure and cardiac cachexia. Unpublished experience of our g...
Heart Failure Growth Hormone Deficiency Ischemic Heart Disease
Heart Failure Growth Hormone Anabolism Anabolic Deficiency Hormone replacement
null
2
arm 1: Patients will receive 6 months of substitutive somatotropin (growth hormone) therapy at a dose of 0.012 mg/kg every second day, added to their background optimized CHF therapy arm 2: PLacebo will be admistred with the same devices of GH, also on top of Optimal CHF treatment
[ 0, 4 ]
1
[ 0 ]
intervention 1: Subcutaneous Somatotropin (recombinant human Growth Hormone) 0.012 mg/kg every second day for 6 months
intervention 1: Somatotropin
0
null
0
NCT00591760
[ 2, 3 ]
36
RANDOMIZED
PARALLEL
7BASIC_SCIENCE
2DOUBLE
false
0ALL
false
This is a two-arm, parallel group, double-blind, placebo-controlled proof-of-concept study comparing 3 mg/kg of AIN457 to placebo. Subjects with a diagnosis of moderate to severe stable plaque psoriasis will be randomized to receive either AIN457 or placebo. AIN457 or placebo will be administered by single infusion at ...
null
Plaque Psoriasis
Plaque psoriasis
null
2
arm 1: AIN457A 3mg/kg was administered intravenously as a single dose. arm 2: Placebo was administered intravenously as a single dose.
[ 0, 2 ]
2
[ 2, 0 ]
intervention 1: single infusion of 3 mg/kg intervention 2: single infusion of placebo
intervention 1: AIN457 intervention 2: Placebo
0
null
0
NCT00669916
[ 4 ]
481
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
1FEMALE
false
The Purpose of this study is to determine if one allergy medication (0.15% azelastine hydrochloride) is more effective than Placebo alone
null
Seasonal Allergic Rhinitis
null
2
arm 1: 0mg Placebo Nasal Spray arm 2: 0.15% azelastine hydrochloride
[ 2, 1 ]
2
[ 0, 0 ]
intervention 1: Placebo intervention 2: 0.15% azelastine hydrochloride 822 mcg
intervention 1: Placebo nasal spray intervention 2: 0.15% azelastine hydrochloride Nasal Spray
34
Huntington Beach | California | United States | -117.99923 | 33.6603 Long Beach | California | United States | -118.18923 | 33.76696 San Diego | California | United States | -117.16472 | 32.71571 San Jose | California | United States | -121.89496 | 37.33939 Stockton | California | United States | -121.29078 | 37.9577 L...
0
NCT00719862
[ 4 ]
526
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study was to determine if two allergy medications are more effective than placebo.
null
Seasonal Allergic Rhinitis
null
3
arm 1: Placebo nasal spray arm 2: 0.1% azelastine hydrochloride nasal spray arm 3: 0.15% azelastine hydrochloride nasal spray
[ 2, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: 0.15% azelastine hydrochloride 1644 mcg daily intervention 2: 0.1% azelastine hydrochloride 1096 mcg daily intervention 3: 0 mcg Placebo daily
intervention 1: 0.15% azelastine hydrochloride 1644 mcg daily intervention 2: 0.1% azelastine hydrochloride 1096 mcg daily intervention 3: Placebo
29
Oxford | Alabama | United States | -85.83496 | 33.61427 Encinitas | California | United States | -117.29198 | 33.03699 Los Angeles | California | United States | -118.24368 | 34.05223 Mission Viejo | California | United States | -117.672 | 33.60002 San Diego | California | United States | -117.16472 | 32.71571 Colorado...
0
NCT00720278
[ 4 ]
29
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
true
0ALL
false
This clinical study was to evaluate the control of dental plaque formation after toothbrushing for 4 days with each of the 4 study toothpastes.
Evaluation of dental plaque control for two prototype toothpastes will be determined by comparison to two control toothpastes.
Dental Plaque
null
4
arm 1: Fluoride only toothpaste arm 2: Triclosan/fluoride toothpaste arm 3: toothpaste containing amino acid #1 arm 4: toothpaste containing amino acid/bicarbonate
[ 2, 1, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Brush two times a day for 4 days. intervention 2: Brush two times daily for 4 days intervention 3: Brush twice daily for 4 days intervention 4: Brush twice daily for 4 days
intervention 1: Fluoride intervention 2: Triclosan/Fluoride intervention 3: Triclosan/Fluoride intervention 4: Triclosan/Fluoride
1
New York | New York | United States | -74.00597 | 40.71427
0
NCT00758394
[ 4 ]
412
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
null
The purpose of this study was to demonstrate efficacy, safety and clinical benefit of Trazodone Contramid® OAD (Once A Day) in the treatment of Unipolar Major Depressive Disorder (MDD).
This two-arm, multicentre, randomized, placebo-controlled, double-blind, parallel-design study consisted of a baseline phase (screening and wash-out) and a double-blind randomized phase (randomization to Trazodone Contramid® OAD or placebo). The total study duration including wash-out of prohibited medications was appr...
Major Depressive Disorder
Unipolar
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: Trazodone Hydrochloride (HCl) Extended-Release Tablets intervention 2: Placebo
36
Birmingham | Alabama | United States | -86.80249 | 33.52066 Mesa | Arizona | United States | -111.82264 | 33.42227 Beverly Hills | California | United States | -118.40036 | 34.07362 Burbank | California | United States | -118.30897 | 34.18084 San Diego | California | United States | -117.16472 | 32.71571 Denver | Color...
0
NCT00775203
[ 0 ]
90
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
Heparin is frequently used in central venous catheters (CVCs) in post-operative cardiac patients. It remains unclear if a heparin infusion, compared to a normal saline infusion, prevents thrombosis of CVCs after surgery. This study will answer the question: does a low-dose heparin infusion (10 units/kg/h) prevent throm...
Patients are contacted pre-operatively and their parents consented. The following criteria apply: Inclusion criteria: All infants \< 1 year of age undergoing cardiac surgery at Lucile Packard Children's Hospital Exclusion Criteria: Known coagulopathy History of clinically significant bleeding (GI, cranial, pulmonar...
Thrombosis
null
2
arm 1: Heparin sulfate infusion at 10 units/kg/hour arm 2: Placebo - normal saline infusion
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery intervention 2: Infusion of normal saline
intervention 1: Heparin sulfate infusion at 10 units/kg/hour intervention 2: Placebo infusion
1
Stanford | California | United States | -122.16608 | 37.42411
0
NCT00779558
[ 2 ]
54
RANDOMIZED
CROSSOVER
7BASIC_SCIENCE
0NONE
true
0ALL
false
This study will evaluate the bioequivalence of 105 mg fenofibric acid tablets relative to 145 mg fenofibrate tablets in healthy volunteers when administered following a breakfast of standard composition. Safety and tolerability of this regimen will also be evaluated.
Fenofibrate is rapidly and completely hydrolyzed to fenofibric acid, the active moiety. The primary objective of this study is to evaluate the bioequivalence of 105 mg fenofibric acid tablets relative to 145 mg fenofibrate tablets in healthy volunteers when administered following a breakfast of standard composition. Ad...
Healthy
healthy pharmacokinetics therapeutic equivalency
null
2
arm 1: 1 x 105 mg fenofibric acid (Fibricor™)tablet administered 30 minutes after the initiation of a standard breakfast. arm 2: 1 x 145 mg fenofibrate (Tricor®) tablet administered 30 minutes after the initiation of a standard breakfast.
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: 1 x 105 mg fenofibric acid (Fibricor™) tablet administered 30 minutes after the initiation of a standard breakfast. intervention 2: 1 x 145 mg Fenofibrate (Tricor®) tablet administered 30 minutes after the start of a standard breakfast.
intervention 1: Fenofibric Acid (Fibricor™) 105 mg Tablet intervention 2: Fenofibrate (Tricor®) 145 mg Tablet
0
null
0
NCT00960687
[ 2 ]
40
RANDOMIZED
CROSSOVER
7BASIC_SCIENCE
0NONE
true
0ALL
false
The primary objective of this study is to characterize the single-dose pharmacokinetic profile of fenofibric acid (105 mg tablets) and the effect of food of various calorie/fat compositions on the rate and extent of absorption. Additionally, the safety and tolerability of this dose and regimen of fenofibric acid will b...
The primary objective of this study is to determine the single-dose pharmacokinetic profile of fenofibric acid (105 mg tablets) and the effect of food of various calorie/fat compositions on the rate and extent of absorption. Forty healthy, non-smoking, non-obese, non-pregnant adult volunteers between the ages of 18 and...
Healthy
pharmacokinetics
null
4
arm 1: Fenofibric Acid 105 mg tablet administered 30 minutes after the initiation of a low-fat breakfast. arm 2: Fenofibric Acid 105 mg tablet administered 30 minutes after the initiation of a standard breakfast. arm 3: Fenofibric Acid 105 mg tablet administered 30 minutes after the initiation of a high-fat/high-calori...
[ 0, 0, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: One 105 mg tablet administered 30 minutes after the initiation of a low-fat breakfast. intervention 2: One 105 mg tablet administered 30 minutes after the initiation of a standard breakfast intervention 3: One 105 mg tablet administered 30 minutes after the initiation of a high-fat/high-calorie breakfas...
intervention 1: Fenofibric Acid 105 mg Tablet intervention 2: Fenofibric Acid 105 mg Tablet intervention 3: Fenofibric Acid 105 mg Tablet intervention 4: Fenofibric Acid 105 mg Tablet
1
Fargo | North Dakota | United States | -96.7898 | 46.87719
0
NCT00960856
[ 4 ]
67
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
true
0ALL
false
Evaluate the efficacy of an oral rinse on dental plaque and gingival inflammation
null
Dental Plaque
null
2
arm 1: control mouthrinse arm 2: new prototype mouthrinse
[ 2, 0 ]
2
[ 0, 10 ]
intervention 1: Rinse 2 times per day for 6 weeks intervention 2: Use 2 times per day for 6 weeks
intervention 1: Iodine intervention 2: water
1
Northfield | New Jersey | United States | -74.55015 | 39.37039
0
NCT01021007
[ 2 ]
79
RANDOMIZED
CROSSOVER
null
0NONE
true
0ALL
false
The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80 mg) relative to the original OxyContin® (OXY) formulation (80 mg) in the fed state.
Oxycodone hydrochloride (oxycodone) is a semi-synthetic opioid analgesic that is effective in the relief of moderate to severe malignant and non-malignant pain.
Healthy
Healthy subjects Opioid Healthy volunteers
null
2
arm 1: Reformulated OXY 80 mg x 1 dose arm 2: Original OxyContin® (OXY) 80 mg x 1 dose
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Reformulated OXY 80-mg tablet x 1 dose taken with food. intervention 2: Original OxyContin® (OXY) 80-mg tablet x 1 dose taken with food.
intervention 1: Reformulated OXY (oxycodone HCl) intervention 2: Original OxyContin® (OXY) (oxycodone HCl)
1
Madison | Wisconsin | United States | -89.40123 | 43.07305
0
NCT01101178
[ 3 ]
130
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
This study was a multi center, randomized, double blind, active and placebo controlled, parallel group study to assess simulated driving performance in XP13512 treated subjects with Restless Legs Syndrome (RLS). Eligible subjects were randomized to receive a once daily dose of placebo (2 groups), XP13512 1200 mg, or XP...
This study was a multicenter, randomized, double blind, active and placebo controlled, parallel group study. Eligible subjects were randomized in a 1:1:1:1 ratio to 1 of the following 4 treatment groups: A) XP13512 Placebo + Diphenhydramine Placebo (Pbo) B) XP13512 1200 mg/day + Diphenhydramine Placebo (1200 mg) C) XP...
Restless Legs Syndrome
null
4
arm 1: XP13512 Placebo + Diphenhydramine Placebo arm 2: XP13512 1200 mg/day + Diphenhydramine Placebo arm 3: XP13512 1800 mg/day + Diphenhydramine Placebo arm 4: XP13512 Placebo + 50 mg Diphenhydramine
[ 2, 0, 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: XP13512 once daily for 16 days intervention 2: one 50 mg dose of diphenhydramine (DPH) on day 16 intervention 3: XP13512 placebo once daily for 16 days
intervention 1: XP13512 intervention 2: Diphenhydramine intervention 3: Placebo
1
Albuquerque | New Mexico | United States | -106.65114 | 35.08449
0
NCT01332318
[ 2 ]
48
RANDOMIZED
SINGLE_GROUP
0TREATMENT
2DOUBLE
false
0ALL
null
To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 10773 with repeat dosing for eight days and the exploration of the pharmacokinetics and pharmacodynamics of BI 10773 after multiple dosing, including dose proportionality and assessment of steady state.
null
Diabetes Mellitus, Type 2
null
4
arm 1: multiple doses as tablet arm 2: multiple doses as tablet arm 3: multiple doses as tablet arm 4: multiple doses as tablet
[ 0, 0, 0, 0 ]
8
[ 0, 0, 0, 0, 0, 0, 0, 0 ]
intervention 1: po taken fasting with 240 mL water intervention 2: po taken fasting with 240 mL water intervention 3: po taken fasting with 240 mL water intervention 4: po taken fasting with 240 mL water intervention 5: po taken fasting with 240 mL water intervention 6: po taken fasting with 240 mL water intervention 7...
intervention 1: BI 10773 Placebo intervention 2: BI 10773 intervention 3: BI 10773 Placebo intervention 4: BI 10773 intervention 5: BI 10773 Placebo intervention 6: BI 10773 Placebo intervention 7: BI 10773 intervention 8: BI 10773
1
Neuss | N/A | Germany | 6.68504 | 51.19807
0
NCT01924767
[ 2 ]
26
NA
SINGLE_GROUP
0TREATMENT
1SINGLE
true
0ALL
false
Single-blind, single-centre, fixed-order study to evaluate the PD effects of a single oral dose and multiple oral doses of ESL (BIA 2-093) in healthy volunteers.
Single-blind, single-centre, fixed-order study to evaluate the PD effects of a single oral dose and multiple oral doses of ESL (BIA 2-093) in healthy volunteers. A single dose of oral ESL 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg each given QD. The single dose was chosen ...
Epilepsy
null
1
arm 1: A single dose of oral ESL 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
[ 0 ]
1
[ 0 ]
intervention 1: None
intervention 1: BIA 2-093
0
null
0
NCT02284828
[ 3 ]
24
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
false
0ALL
false
GSK573719 is a high-affinity specific muscarinic receptor (mAChR) antagonist which is being developed for once daily treatment of chronic obstructive pulmonary disease (COPD). The long duration of action of GSK573719 when administered via inhalation in animal models supports the potential for use as a once-daily bronch...
A randomised, double blind, placebo-controlled, double dummy, 4-way cross-over, dose ascending study to assess the safety, tolerability, pharmacodynamics and pharmacokinetics of single inhaled doses of GSK573719 (3 escalating mcg doses will be used) and tiotropium bromide (18µg) via DPI in COPD patients
Pulmonary Disease, Chronic Obstructive
chronic obstructive pulmonary disease, GSK573719, muscarinic receptor antagonist
null
12
arm 1: Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: umeclidinium bromide (UMEC) 250 micrograms (µg), UMEC 500 µg, Tiotropium 18 µg and placebo. Treatment periods were seperated by a washout period of at least 14 days. arm 2: Participants received single doses ...
[ 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1 ]
2
[ 0, 0 ]
intervention 1: 250 micrograms (μg) per blister, administered via dry powder inhaler, dose-ascending study doses began at 250 ug, then 500 ug, and 1000 μg intervention 2: strips of five capsules, each containing 18 μg administered via dry powder inhaler
intervention 1: GSK573719 intervention 2: Tiotropium
3
Hanover | Lower Saxony | Germany | 9.73322 | 52.37052 Berlin | N/A | Germany | 13.41053 | 52.52437 Hamburg | N/A | Germany | 9.99302 | 53.55073
0
NCT00515502
[ 2 ]
26
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
true
0ALL
null
The purpose of this study is to evaluate the potential effects of ER niacin/laropiprant, ER niacin, laropiprant, and placebo over the course of seven days on urinary levels of a metabolite of thromboxane A2 (TxA2), as a marker of in vivo platelet reactivity.
null
Hypercholesterolemia
null
4
arm 1: ER niacin/laropiprant + Placebo to laropiprant arm 2: ER niacin + Placebo to laropiprant arm 3: laropiprant + Placebo to ER niacin/laropiprant arm 4: Placebo
[ 0, 1, 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: ER niacin 2 g/laropiprant 40 mg tablet once daily for 7 days intervention 2: ER niacin 2 g tablet once daily for 7 days intervention 3: laropiprant 40 mg once daily for 7 days intervention 4: matching placebo tablets for each of the interventions once daily for 7 days
intervention 1: Comparator: niacin + laropiprant intervention 2: Comparator: niacin intervention 3: Comparator: laropiprant intervention 4: Comparator: placebo
0
null
0
NCT00769132
[ 3 ]
90
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The study is designed to assess safety of Vorapaxar when added to standard of care (aspirin) in Japanese subjects with cerebral infarction. The study will assess incidence and tolerability of bleeding, major adverse cardiac events, all adverse events, and effect on expression of markers of inflammation.
null
Cerebral Infarction
null
3
arm 1: Vorapaxar oral tablets; once daily for 60 days + Aspirin. arm 2: Vorapaxar oral tablets; once daily for 60 days + Aspirin. arm 3: Placebo oral tablets; once daily for 60 days + Aspirin
[ 0, 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Oral tablets; once daily for 60 days. intervention 2: Oral tablets; once daily for 60 days intervention 3: oral tablets; once daily for 60 days intervention 4: oral tablets; once daily for 60 days
intervention 1: Vorapaxar 2.5 mg intervention 2: Vorapaxar 1 mg intervention 3: Placebo intervention 4: Aspirin 75-150 mg
0
null
0
NCT00684515
[ 4 ]
269
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
We are proposing a study in which we utilize and augment the sore throat pain model to assess the analgesic effectiveness of celecoxib compared to placebo in patients with painful pharyngitis under randomized, double-blind, placebo-controlled conditions.
null
Pharyngitis
sore throat acute pain
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: dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg intervention 2: dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo intervention 3: dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg intervention 4: dose 1 placebo followed 6-12 hours la...
intervention 1: Celecoxib intervention 2: Celecoxib intervention 3: celecoxib intervention 4: placebo
1
Storrs | Connecticut | United States | -72.24952 | 41.80843
0
NCT00402987
[ 4 ]
397
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
1FEMALE
false
Clinical trial objectives are to investigate the efficacy and safety of a single injection of 100 μg Org 36286 in women weighing 60 kg or less to induce multifollicular development for controlled ovarian stimulation (COS), using daily recFSH as a reference.
This is a randomized, double-blind, active-controlled, equivalence clinical trial investigating the efficacy and safety of a new treatment regimen with Org 36286, a recombinant gonadotropin applied to initiate and sustain follicular stimulation in COS for Assisted Reproductive Technology (ART). For this regimen, patien...
Infertility
In vitro fertilization Pharmacological effects of drugs Hormones Hormone Substitutes and Hormone Antagonists Pharmacological Actions Randomized Multi-center Multi-national Double-blind Active-controlled Equivalence
null
2
arm 1: Participants received a single subcutaneous (SC) injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recombinant Follicle Stimulating Hormone (recFSH) injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also recei...
[ 0, 1 ]
8
[ 0, 0, 0, 0, 2, 0, 0, 2 ]
intervention 1: 100 µg corifollitropin alfa subcutaneous (SC) injection intervention 2: 150 IU recFSH SC injection intervention 3: GnRH antagonist (ganirelix) administered SC at a dose of 0.25 mg/day intervention 4: hCG 5,000 IU or 10,000 IU administered SC intervention 5: Progesterone was started on the day of oocyte ...
intervention 1: corifollitropin alfa (Org 36286) intervention 2: recFSH (follitropin beta) intervention 3: gonadatropin releasing hormone (GnRH) antagonist (ganirelix) intervention 4: human chorion gonadatropin (hCG) intervention 5: progesterone intervention 6: placebo-recFSH (follitropin alfa) intervention 7: placebo-...
0
null
0
NCT00702845
[ 4 ]
15
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This study will evaluate the efficacy and safety of MabThera/Rituxan plus methotrexate in patients with active rheumatoid arthritis who have had an inadequate response to at least 1 DMARD treatment. All patients will receive MabThera (1000mg iv infusion) on days 1 and 15, and methotrexate (10-25mg po) weekly. The antic...
null
Rheumatoid Arthritis
null
1
arm 1: None
[ 0 ]
3
[ 0, 0, 0 ]
intervention 1: 1000 mg iv Days 1 and 15 intervention 2: 10 - 25 mg/week intervention 3: iv administration on Day 1 and 15 prior to MabThera/Rituxan infusion
intervention 1: rituximab [MabThera/Rituxan] intervention 2: methotrexate intervention 3: methylprednisolone
3
Belgrade | N/A | Serbia | 20.46513 | 44.80401 Niška Banja | N/A | Serbia | 22.0057 | 43.29507 Nova Sad | N/A | Serbia | N/A | N/A
0
NCT02006706
[ 3 ]
31
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to evaluate the objective tumor response rate (based on the RECIST criteria) to SNS-595 as a second-line therapy in patients with advanced NSCLC.
Other objectives of this study are to assess the safety, tumor response, time to disease progression, survival rate and to explore several potential biomarkers to see how these levels change after administration of SNS-595.
Carcinoma, Non-Small-Cell Lung
Lung Squamous Cell Large Cell Adenocarcinoma Carcinoma Cancer
null
1
arm 1: Patients are treated with 48 mg/m2 of the drug SNS-595 injection once every 21 days for up to 6 cycles as a second -line therapy to patients with advanced non-small cell lung cancer (NSCLC)
[ 0 ]
1
[ 0 ]
intervention 1: Vosaroxin (formerly voreloxin or SNS-595) is a first in class anticancer quinolone derivative, non anthracycline topoisomerase II inhibitor. It induces replication dependent DNA damage by intercalating DNA and inhibiting topoisomerase II, leading to apoptosis.
intervention 1: SNS-595 Injection
4
Scottsdale | Arizona | United States | -111.89903 | 33.50921 Louisville | Kentucky | United States | -85.75941 | 38.25424 Durham | North Carolina | United States | -78.89862 | 35.99403 Nashville | Tennessee | United States | -86.78444 | 36.16589
0
NCT00252382
[ 4 ]
559
RANDOMIZED
PARALLEL
1PREVENTION
4QUADRUPLE
false
0ALL
false
The purpose of this study is to determine if risperidone is effective and safe in the prevention of mood episodes in patients with bipolar 1 disorder.
RISPERDAL CONSTA (risperidone long-acting injection) may provide substantial improvement, by reducing patient non-compliance, in the long-term treatment of bipolar I disorder. This is a randomized (patients are assigned different treatments based on chance), double-blind, (neither the patient nor the physician knows wh...
Bipolar Disorder
Mood episodes Bipolar 1 disorder Intramuscular Injectable risperidone safety and efficacy
null
2
arm 1: Risperdal Consta 12.5 25 37.5 or 50mg intramuscular (IM) injection every 2 weeks arm 2: Placebo Matching placebo intramuscular (IM) injection every 2 weeks
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 12.5, 25, 37.5 or 50mg intramuscular (IM) injection every 2 weeks intervention 2: Matching placebo intramuscular (IM) injection every 2 weeks
intervention 1: Risperdal Consta intervention 2: Placebo
51
Little Rock | Arkansas | United States | -92.28959 | 34.74648 La Mesa | California | United States | -117.02308 | 32.76783 National City | California | United States | -117.0992 | 32.67811 Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 Bradenton | Florida | United States | -82.57482 | 27....
1
NCT00132678
[ 4 ]
77
NON_RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The primary objective of this trial was to characterize the long-term (up to 40 weeks) safety and tolerability of asenapine in bipolar I disorder subjects who had not completely responded to continuing treatment with lithium or valproic acid (VPA) for the treatment of an acute manic or mixed episodes upon enrollment in...
null
Bipolar Disorder
null
2
arm 1: Asenapine arm 2: Placebo
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Asenapine 5 or 10 mg twice daily (BID) sublingually for 40 weeks intervention 2: Fast-dissolving tablet; twice daily (BID) sublingually for 40 weeks
intervention 1: Asenapine intervention 2: Placebo
0
null
1
NCT00145509
[ 4 ]
154
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
1FEMALE
true
A randomized, controlled trial in girls with Turner syndrome at least 7 years old and younger than 13 at study entry, to determine the efficacy and safety of Humatrope (somatropin) treatment in promoting linear growth to final height.
A randomized, controlled trial of Humatrope (somatropin) treatment in girls with Turner syndrome at least 7 years old and younger than 13 at study entry. Core study objectives are to determine the efficacy of Humatrope in promoting linear growth to final height in girls with Turner syndrome, and to assess the safety o...
Turner Syndrome
syndrome Turner Turner's height growth growth hormone somatropin short stature short hearing glucose metabolism
null
2
arm 1: Control arm; untreated with Humatrope. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height). arm 2: Humatrope (0.05 mg/kg/dose) by su...
[ 4, 0 ]
3
[ 0, 0, 0 ]
intervention 1: 0.05 mg/kg/dose by subcutaneous injection 6 times per week, until Core study completion criteria are met (protocol final height). intervention 2: escalating doses 2.5-20.0 mcg tablets daily after age 13 and at least one year on study, continuing until Core study completion criteria are met. intervention...
intervention 1: Somatropin intervention 2: Ethinyl estradiol intervention 3: Medroxyprogesterone acetate
14
Calgary | Alberta | Canada | -114.08529 | 51.05011 Edmonton | Alberta | Canada | -113.46871 | 53.55014 Vancouver | British Columbia | Canada | -123.11934 | 49.24966 Winnipeg | Manitoba | Canada | -97.14704 | 49.8844 Halifax | Nova Scotia | Canada | -63.57688 | 44.64269 Hamilton | Ontario | Canada | -79.84963 | 43.25011...
1
NCT00191113
[ 4 ]
381
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
The purpose of this study is to demonstrate the efficacy and safety of quetiapine fumarate (SEROQUEL) in the treatment of adolescent patients with schizophrenia and bipolar I disorder.
null
Schizophrenia Bipolar I Disorder
Schizophrenia Bipolar I Disorder
null
0
null
null
1
[ 0 ]
intervention 1: Oral dosing, flexible dosing
intervention 1: quetiapine fumarate
48
Dothan | Alabama | United States | -85.39049 | 31.22323 Scottsdale | Arizona | United States | -111.89903 | 33.50921 Cerritos | California | United States | -118.06479 | 33.85835 Riverside | California | United States | -117.39616 | 33.95335 Sacramento | California | United States | -121.4944 | 38.58157 San Diego | Cal...
1
NCT00227305
[ 4 ]
280
RANDOMIZED
PARALLEL
1PREVENTION
0NONE
false
0ALL
null
This is a randomized, multi-center, open-label, parallel group study with three arms: * Rasburicase alone * Rasburicase followed by Allopurinol * Allopurinol alone The primary objective is to compare the adequacy of control of plasma uric acid concentration and the safety profile among the three arms.
After signing the informed consent and having met the inclusion criteria, patients will be randomized to 1 of the 3 arms and treated for a total duration of 5 days. Patients in all arms will receive chemotherapy beginning 4-24 hours after the first dose of rasburicase or allopurinol.
Tumor Lysis Syndrome Cancer Hyperuricemia
Hyperuricemia Tumor lysis syndrome Leukemia Lymphoma Myelodysplastic Syndromes Solid tumor cancers Solid Tumor cancers with hyperuricemia Hyperuricemia (cancer patients only) Tumor lysis syndrome (cancer patients only)
null
3
arm 1: Rasburicase alone given as a single agent for 5 days arm 2: Rasburicase alone given as a single agent from Day 1 through Day 3, followed by oral allopurinol given from Day 3 through Day 5 (Day 3 is an overlap) arm 3: Oral allopurinol alone given as a single agent for 5 days
[ 0, 0, 1 ]
2
[ 0, 0 ]
intervention 1: 30-min IV infusion intervention 2: Oral administration
intervention 1: Rasburicase (SR29142) intervention 2: Allopurinol
15
Berkeley | California | United States | -122.27275 | 37.87159 Los Angeles | California | United States | -118.24368 | 34.05223 Denver | Colorado | United States | -104.9847 | 39.73915 Jacksonville | Florida | United States | -81.65565 | 30.33218 New Orleans | Louisiana | United States | -90.07507 | 29.95465 Boston | Ma...
1
NCT00230178
[ 4 ]
260
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
This 2 arm study will compare 'time and motion' (provider time spent on anemia management) and effect on hemoglobin (Hb) levels, of methoxy polyethylene glycol-epoetin beta (Mircera) and epoetin alfa, in anemic patients with chronic kidney disease (CKD) on hemodialysis. Patients stable on intravenous (iv) epoetin alfa ...
null
Anemia
null
2
arm 1: 120-360 micrograms (iv) monthly, starting dose arm 2: As prescribed, (iv), 3 times weekly
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: 120-360 micrograms intravenous (iv) monthly, starting dose intervention 2: As prescribed, iv, 3 times weekly
intervention 1: methoxy polyethylene glycol-epoetin beta intervention 2: Epoetin alfa
44
Birmingham | Alabama | United States | -86.80249 | 33.52066 Rainbow City | Alabama | United States | -86.04192 | 33.95482 Hot Springs | Arizona | United States | N/A | N/A Fairfield | California | United States | -122.03997 | 38.24936 Los Alamitos | California | United States | -118.07256 | 33.80307 Los Angeles | Calif...
1
NCT00422513
[ 4 ]
680
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin infections in adults.
Additional purpose of this study is to compare ceftaroline effectivity versus Vancomycin plus Aztreonam in the treatment of complicated skin infections in adults.
Bacterial Infections
Abscess Antibacterial Antibiotic Antimicrobial Bacterial infection, skin Ceftaroline Ceftaroline acetate Cellulitis Cephalosporin Complicated skin and skin structure infection (cSSSI) cSSSI Intravenous Methicillin-resistant Staphylococcus Aureus (MRSA) PPI-0903 Prodrug Skin disease, bacterial Skin infection Staphylococ...
null
2
arm 1: Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours. arm 2: Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours.
[ 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: 600 mg parenteral infused over 60 minutes, every 12 hours for 5 to 14 days intervention 2: vancomycin at 1 g parenteral infused over 60 minutes followed by aztreonam 1 g infused over 60 minutes, every 12 hours, for 5 to 14 days. intervention 3: Ceftaroline fosamil 600 mg administered intravenously over ...
intervention 1: ceftaroline intervention 2: vancomycin plus aztreonam intervention 3: Placebo
54
Buena Park | California | United States | -117.99812 | 33.86751 Hawaiian Gardens | California | United States | -118.07284 | 33.8314 Los Angeles | California | United States | -118.24368 | 34.05223 Pasadena | California | United States | -118.14452 | 34.14778 San Diego | California | United States | -117.16472 | 32.715...
1
NCT00423657
[ 3 ]
12
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This study will test the safety and effectiveness of two drugs, Sirolimus and Thymoglobulin, for preventing rejection of transplanted kidneys. Standard anti-rejection therapy uses a combination of drugs, such as cyclosporine, tacrolimus, azathioprine, steroids, and others, that are taken daily for life. However, even w...
This protocol will test a novel dual agent combination therapy for its ability to prevent human renal allograft rejection. Thymoglobulin (Sangstat), a FDA-approved polyclonal rabbit-IgG antithymocyte preparation, will be given for ten days at the time of transplantation to achieve profound lymphocyte depletion. This wi...
Kidney Failure
Renal Failure Anti-rejection Apoptosis Polyclonal Antibody Kidney Transplant
null
1
arm 1: Thymoglobulin (Sangstat), a FDA-approved polyclonal rabbit-IgG antithymocyte preparation, will be given for ten days at the time of transplantation to achieve profound lymphocyte depletion. This will be paired with chronic therapy with Sirolimus (rapamycin, Wyeth-Ayerst), an oral immunosuppressant agent recently...
[ 0 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: Sirolimus intervention 2: Thymoglobulin
1
Bethesda | Maryland | United States | -77.10026 | 38.98067
0
NCT00006178
[ 4 ]
330
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The purpose of this multicenter study is to determine if insulin-like growth factor-1 (IGF-I) slows the progressive weakness in amyotrophic lateral sclerosis (ALS) patients. Study participants will be followed for 2 years once enrolled. They will receive either placebo or the active IGF-I. Examinations will take place ...
The objective of this trial was to determine whether IGF-1 (MyotrophinTM) slows progression of weakness in amyotrophic lateral sclerosis (ALS). Three hundred thirty patients with ALS from 20 medical centers participated in this double blind, placebo-controlled two-year study. Half the patients received IGF-1 and the ot...
Amyotrophic Lateral Sclerosis
amyotrophic lateral sclerosis ALS progressive weakness insulin-like growth factor-1 IGF-I Myotrophin
null
2
arm 1: Insulin like growth factor, type 1 will be given 0.05 mg per kg body weight subcutaneously twice daily arm 2: Placebo arm
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: 0.05 mg per kg body weight given subcutaneously twice daily intervention 2: The placebo represented the inert suspension vehicle for the IGF-1. It was given as equal volume as the active drug based upon body weight, subcutaneously twice daily.
intervention 1: Insulin like growth factor, type 1 intervention 2: Placebo
20
Scottsdale | Arizona | United States | -111.89903 | 33.50921 San Francisco | California | United States | -122.41942 | 37.77493 Jacksonville | Florida | United States | -81.65565 | 30.33218 Atlanta | Georgia | United States | -84.38798 | 33.749 Indianapolis | Indiana | United States | -86.15804 | 39.76838 Ann Arbor | M...
0
NCT00035815
[ 5 ]
65
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
This study will determine whether adding the drug risperidone (Risperdal®) is more effective than placebo in treating schizophrenic patients who are taking the drug clozapine.
Clozapine is the only antipsychotic drug that has been approved for treatment resistant patients with schizophrenia. However, up to 50% of patients treated with clozapine fail to respond and continue to exhibit clinically significant residual positive and negative symptoms and cognitive impairments. An emerging trend i...
Schizophrenia
null
2
arm 1: Participants assigned to risperidone arm 2: Participants assigned to placebo
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Placebo capsule daily for 16 weeks intervention 2: Risperdal 4 mg per day for 16 weeks
intervention 1: Placebo intervention 2: Risperdal
1
Catonsville | Maryland | United States | -76.73192 | 39.27205
0
NCT00056498
[ 3 ]
148
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
This study will examine whether interleukin-2 (IL-2) given before the interruption of antiretroviral (ARV) treatment could significantly extend the period of time that a patient is temporarily not taking ARV treatment and also preserve CD4 counts above 350 cells per microliter. There will be an evaluation of the toxici...
The use of antiretroviral (ARV) medications has greatly improved morbidity and mortality of HIV-infected patients but long-term use of these agents has been associated with significant toxicities and medication fatigue that can lead to problems with adherence and eventual development of virologic resistance. The spectr...
HIV Infections
Interleukin 2 Treatment Interruption HIV
null
2
arm 1: HAART (standard of care) and three cycles of IL-2 arm 2: HAART alone
[ 1, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Three cycles of IL-2 (6 MUI bid during 5 days = one cycle) intervention 2: HAART from week 0 to week 24 intervention 3: HAART is interrupted from week 24 in both arms
intervention 1: Interleukin 2 intervention 2: HAART intervention 3: Treatment interruption
2
Bethesda | Maryland | United States | -77.10026 | 38.98067 Créteil | N/A | France | 2.46569 | 48.79266
0
NCT00071890
[ 4 ]
74
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This study will evaluate the safety and blood levels of a new pediatric formulation of Famvir in children 1-12 years of age. In Part A, patients will receive a single dose of famciclovir (12.5 mg/kg) to assess pharmacokinetics (PK) and safety. In Part B, patients will receive multiple doses of famciclovir alone or with...
null
Herpes Simplex
herpes simplex cold sores fever blisters children Famvir famciclovir
null
1
arm 1: single-arm
[ 0 ]
1
[ 0 ]
intervention 1: Famciclovir sprinkle capsules, 25 mg and 100 mg, using OraSweet® syrup vehicle
intervention 1: Famciclovir
13
Birmingham | Alabama | United States | -86.80249 | 33.52066 Denver | Colorado | United States | -104.9847 | 39.73915 Chicago | Illinois | United States | -87.65005 | 41.85003 Louisville | Kentucky | United States | -85.75941 | 38.25424 New York | New York | United States | -74.00597 | 40.71427 Stony Brook | New York | ...
0
NCT00098059
[ 4 ]
298
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
null
The purpose of this study is to determine whether the combination of AMD3100 (plerixafor) and granulocyte colony-stimulating factor (G-CSF or generic name filgrastim) is better than G-CSF alone to mobilize and collect the optimal number of stem cells in non-Hodgkin's lymphoma patients for autologous transplantation.
A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. Currently filgrastim (G-CSF), a colony stimulating factor, is used to cause the growth and mobilization of stem cells from bone marrow to peripheral blood, which can then be collected from the peripheral bl...
Lymphoma, Non-Hodgkin
Non-Hodgkin's lymphoma Stem cell mobilization
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Participants underwent mobilization with granulocyte colony-stimulating factor (G-CSF) (10 µg/kg/day) for 4 days, administered by subcutaneous (SC) injection. On the evening of Day 4, participants received plerixafor (240 µg/kg), administered by SC injection. On Day 5, participants received a morning do...
intervention 1: Granulocyte colony-stimulating factor plus plerixafor intervention 2: Granulocyte colony-stimulating factor plus placebo
32
Phoenix | Arizona | United States | -112.07404 | 33.44838 Duarte | California | United States | -117.97729 | 34.13945 Denver | Colorado | United States | -104.9847 | 39.73915 New Haven | Connecticut | United States | -72.92816 | 41.30815 Gainesville | Florida | United States | -82.32483 | 29.65163 Tampa | Florida | Uni...
0
NCT00103610
[ 0 ]
146
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
true
0ALL
false
This study compares two types of diet interventions: a low carbohydrate ketogenic diet (Atkins) and a low-fat diet combined with a medication (Orlistat).
Overweight and obesity are increasingly prevalent in the veteran population as well as the general public. For patients with obesity-associated illnesses, there are few effective treatment options available after failed attempts at diet and exercise, even though weight loss has been shown to alleviate these conditions....
Diabetes Mellitus Obesity
anti-obesity agents diet therapy diet, reducing obesity overweight risk factors weight loss
null
2
arm 1: Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake. arm 2: Participants receive counseling on a low fat diet over 48 weeks aimed at reducing fat and calorie intake, and additionally receive Orlistat taken 3 times daily.
[ 0, 1 ]
3
[ 5, 0, 5 ]
intervention 1: A low-carb diet limits carbohydrates - such as grains, starchy vegetables and fruit - and emphasizes dietary protein and fat. intervention 2: In addition to the low fat diet, Orlistat is taken 3 times daily. intervention 3: Participants receive counseling on a low fat diet over 48 weeks aimed at reducin...
intervention 1: Low carbohydrate ketogenic diet intervention 2: Orlistat intervention 3: Low-fat diet
1
Durham | North Carolina | United States | -78.89862 | 35.99403
0
NCT00108524
[ 4 ]
59
NON_RANDOMIZED
SINGLE_GROUP
null
0NONE
false
0ALL
null
This is a long-term, open-label, extension of the OMC-SXB-7 trial. Participants from the OMC-SXB-7 open-label trial may be entered without any requirement as to length of participation in that trial. Approximately 70 patients are expected to participate at up to 6 investigative centers located in Canada. The trial wil...
This trial will be conducted as a long-term, open-label, extension of the OMC-SXB-7 trial. Participants from the OMC-SXB-7 open-label trial may be entered without any requirement as to length of participation in that trial. Approximately 70 patients are expected to participate at up to 6 investigative centers located ...
Narcolepsy
Narcolepsy Cataplexy
null
0
null
null
1
[ 0 ]
intervention 1: Xyrem (sodium oxybate) oral solution
intervention 1: Xyrem (sodium oxybate) oral solution
1
Toronto | Ontario | Canada | -79.39864 | 43.70643
0
NCT00132873
[ 4 ]
241
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
To evaluate the efficacy of pregabalin, using a flexible, optimized dose schedule with dose adjustment based on Daily Pain Rating Scale (DPRS), compared to placebo in subjects with peripheral neuropathic pain.
null
Diabetic Neuropathies Neuralgia
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 150-600mg/day, BID intervention 2: Placebo
intervention 1: pregabalin intervention 2: Placebo
10
Sungnam-si | Gyeonggi-do | South Korea | N/A | N/A Suwon | Gyeonggi-do | South Korea | 127.00889 | 37.29111 Busan | N/A | South Korea | 129.03004 | 35.10168 Daegu | N/A | South Korea | 128.59111 | 35.87028 Gwangju | N/A | South Korea | 126.91556 | 35.15472 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | Sou...
0
NCT00141219
[ 5 ]
194
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
This study will evaluate the lipid-lowering effect and safety of colesevelam therapy administered to heterozygous familial pediatric patients 10 through 17 years of age who are on a stable dose of a pediatric-approved statin monotherapy (atorvastatin, lovastatin, simvastatin or pravastatin), or who are treatment naive ...
null
Hypercholesterolemia
Pediatric hypercholesterolemia colesevelam
null
3
arm 1: colesevelam HCl 3.750 g arm 2: Low dose colesevelam 1.875 g arm 3: placebo comparator
[ 0, 0, 2 ]
2
[ 0, 0 ]
intervention 1: Tablets intervention 2: Matching Tablets
intervention 1: colesevelam HCl intervention 2: placebo
25
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 St Louis | Missouri | United States | -90.19789 | 38.62727 New Hyde Park | New York | United States | -73.68791 | 40.7351 New York | New York | United States | -74.00597 | 40.71427 The Bronx | New York | United States | -73.86641 | 40.84985 C...
0
NCT00145574
[ 5 ]
171
RANDOMIZED
FACTORIAL
1PREVENTION
0NONE
null
0ALL
null
The purpose of this study is to determine whether cyclosporine A (in a micro emulsion formulation) monitored by sample taken 2 hour after oral dose (C-2h) will show equivalent or superior efficacy compared to tacrolimus monitored by pre-dose blood concentration (C-0h). In addition this study will assess the safety and ...
null
Liver Transplant
Liver transplant, adults, C2 monitoring
null
2
arm 1: Cyclosporine A was given in a twice-daily schedule at 12-hour intervals. It was administered within the first 4 hours post-operatively (study day 1), at an initial dose of 10-15mg/kg/day in two doses, as close as possible to 15mg/kg/day. After the first oral administration, the dose of Cyclosporine A was adjuste...
[ 0, 1 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: Each patient was given two 20mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. intervention 4: Methylprednisolone was given as an intravenous bolus of 500mg during transplant surgery intervention 5: Post-operative...
intervention 1: Cyclosporine A intervention 2: Tacrolimus intervention 3: Basiliximab intervention 4: Methylprednisolone intervention 5: Prednisone
1
Basel | N/A | Switzerland | 7.57327 | 47.55839
0
NCT00149994
[ 3 ]
51
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
1FEMALE
true
The purpose of this study is to determine whether a commercially available anti-digoxin antibody, Digibind, can delay delivery in patients with severe pre-eclampsia. If so, this would allow more time for maternally administered steroids to prevent the development of respiratory complications in premature infants.
Preeclampsia (PE) is a serious complication of third trimester pregnancy manifested by high blood pressure, proteinuria, edema, encephalopathy sometimes with seizures, and hepatic failure. There is no known specific treatment, although palliative measures such as antihypertensive drugs, magnesium, steroids and early de...
Pre-eclampsia
Pre-eclampsia Hypertension Endogenous digitalis-like factor Anti-digoxin antibody Digibind
null
2
arm 1: Digibind treatment plus standard of care arm 2: None
[ 1, 2 ]
2
[ 0, 10 ]
intervention 1: intravenous administered, dose based on weight (assuming 4ng/mL EDLF concentration). Dose every 6 hours x 48 hours. intervention 2: None
intervention 1: Anti-digoxin antibody (FAB fragment) intervention 2: sodium chloride
8
Mobile | Alabama | United States | -88.04305 | 30.69436 Phoenix | Arizona | United States | -112.07404 | 33.44838 Orlando | Florida | United States | -81.37924 | 28.53834 Shreveport | Louisiana | United States | -93.75018 | 32.52515 St Louis | Missouri | United States | -90.19789 | 38.62727 Charleston | South Carolina ...
0
NCT00158743
[ 0 ]
64
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
It is a common belief that patients with MOH rarely respond of preventative medications whilst overusing acute medications. However, no randomized trial has been done previously to prove such statement. Based on some clinical experiences, our hypothesis are patients with probably MOH may benefit from use of preventive ...
This randomized multi-centre study started January 2004, and patients with probably MOH have been included from five different University hospitals in Norway. The last patient was included November 9th 2006, final inclusion date was December 31th 2006. At this time a total of 64 patients with probable MOH according to ...
Headache
Medication-overuse headache preventative medication controls follow-up randomized abrupt withdrawal
null
3
arm 1: Use of preventive drugs from the start without abrupt withdrawal arm 2: Device: Abrupt withdrawal. Standard out-patients detoxication program including telephone call after 2 weeks and rescue medicine up to 2 days/week arm 3: Active control: No instruction for abrupt withdrawal or prophylactic treatment. The con...
[ 1, 5, 5 ]
1
[ 0 ]
intervention 1: Several preventive drugs based on each individual regarding type of original headache type (i.e angiotensin II blockers, betablockers, valproate, tricyclic antidepressants or gabapentin)
intervention 1: Betablockers or other preventive drugs based on primary headache type
1
Trondheim | N/A | Norway | 10.39506 | 63.43049
0
NCT00159588
[ 5 ]
121
RANDOMIZED
CROSSOVER
0TREATMENT
4QUADRUPLE
true
0ALL
false
To test the hypothesis that a 4 week treatment with atomoxetine is more effective than placebo in patients with combined type Attention Deficit/Hyperactivity Disorder (ADHD), patients with only Reading Disorder, and patients with combined type ADHD and Reading Disorder.
null
Attention Deficit Hyperactivity Disorder Reading Disorder
null
4
arm 1: Atomoxetine, 1.2 mg/kg/day, by mouth (PO) for 4 weeks, 2 week washout period and cross-over to placebo, every day (QD), PO for 4 weeks arm 2: Placebo, every day (QD), by mouth (PO) for 4 weeks, 2 week washout period and cross-over to atomoxetine 1.2 mg/kg/day, PO for 4 weeks arm 3: Normal controls were children ...
[ 0, 0, 4, 4 ]
2
[ 0, 0 ]
intervention 1: Atomoxetine, 1.2 mg/kg/day, by mouth (PO) intervention 2: Placebo, every day (QD), by mouth (PO)
intervention 1: Atomoxetine Hydrochloride intervention 2: placebo
5
Ghent | N/A | Belgium | 3.71667 | 51.05 Almere Stad | N/A | Netherlands | 5.21413 | 52.37025 Amsterdam | N/A | Netherlands | 4.88969 | 52.37403 Breda | N/A | Netherlands | 4.77596 | 51.58656 Vught | N/A | Netherlands | 5.2875 | 51.65333
0
NCT00191906
[ 5 ]
171
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
This 2 arm study will evaluate the efficacy and safety of a single intravenous injection of Kytril in preventing postoperative nausea and vomiting (PONV) in children. Patients will be randomized to receive a single dose of either 20 micrograms or 40 micrograms Kytril intravenously (iv) 15 minutes prior to the end of su...
null
Post-Operative Nausea and Vomiting
null
2
arm 1: None arm 2: None
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: 20 micrograms intravenously (iv) 15 min prior to end of surgery intervention 2: 40 micrograms intravenously (iv) 15 min prior to end of surgery
intervention 1: granisetron intervention 2: granisetron
11
Fresno | California | United States | -119.77237 | 36.74773 Stanford | California | United States | -122.16608 | 37.42411 Hartford | Connecticut | United States | -72.68509 | 41.76371 Miami | Florida | United States | -80.19366 | 25.77427 Atlanta | Georgia | United States | -84.38798 | 33.749 Indianapolis | Indiana | U...
0
NCT00231478
[ 3 ]
26
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
AZD2171 (cediranib maleate) may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. This phase II trial is studying how well AZD2171 works in treating patients with refractory stage IV breast cancer
PRIMARY OBJECTIVES: I. Evaluation of the fraction of patients with increased levels of circulating endothelial cells after 3 weeks of treatment with AZD2171. II. Estimation of the objective response rate (ORR = CR + PR) among patients with refractory breast cancer receiving AZD2171. SECONDARY OBJECTIVES: I. Estimat...
Male Breast Cancer Recurrent Breast Cancer Stage IV Breast Cancer
null
1
arm 1: Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
[ 0 ]
2
[ 0, 10 ]
intervention 1: Given orally intervention 2: Correlative studies
intervention 1: cediranib maleate intervention 2: laboratory biomarker analysis
1
Boston | Massachusetts | United States | -71.05977 | 42.35843
0
NCT00244881
[ 5 ]
121
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This is a multicenter clinical trial designed to compare the efficacy of 48 weeks of therapy with pegylated (PEG)-Interferon/ribavirin in Southeastern Asian patients with genotype 1 chronic hepatitis C with 48 weeks of therapy with PEG-Interferon/ribavirin in Caucasian patients with genotype 1 chronic hepatitis C. This...
null
Hepatitis C, Chronic
chronic hepatitis C pegylated interferon alfa-2b ribavirin Asia
null
4
arm 1: Genotype 1 hepatitis C virus (HCV)-infected Southeastern Asian (SEA) subjects treated for up to 48 weeks with PEG-Intron (peginterferon alfa-2b; PEG-IFN) REDIPEN and REBETOL (ribavirin; RIB) combination therapy arm 2: Genotype 1 HCV-infected Caucasian subjects treated for up to 48 weeks with PEG-Intron REDIPEN a...
[ 1, 1, 0, 1 ]
4
[ 2, 0, 2, 0 ]
intervention 1: Powder for injection in Redipen (50, 80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 weeks intervention 2: 200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg daily for up to 48 weeks intervention 3: Powder for injection in Redipen (...
intervention 1: peginterferon alfa-2b intervention 2: ribavirin intervention 3: peginterferon alfa-2b intervention 4: ribavirin
0
null
0
NCT00255008
[ 4 ]
447
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to evaluate the long-term safety of almotriptan malate (a migraine headache medication) in the treatment of migraine headaches in adolescents for up to one year.
Almotriptan malate, and several other treatments for migraine headaches, known as triptans, are approved for the treatment of migraine headaches in adults. To date, none of these have been approved by the Food and Drug Administration (FDA) for use in adolescents. This is an open-label, multi-center study that will enro...
Migraine
Migraine Almotriptan Malate Headache Triptan
null
1
arm 1: Patients will take one 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain
[ 0 ]
1
[ 0 ]
intervention 1: Patients will take one 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain
intervention 1: Almotriptan Malate
49
Mobile | Alabama | United States | -88.04305 | 30.69436 Montgomery | Alabama | United States | -86.29997 | 32.36681 Oxford | Alabama | United States | -85.83496 | 33.61427 Mesa | Arizona | United States | -111.82264 | 33.42227 Phoenix | Arizona | United States | -112.07404 | 33.44838 Jonesboro | Arkansas | United State...
0
NCT00257010
[ 4 ]
826
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
1FEMALE
null
The purpose of this study is to determine whether ospemifene is more effective than placebo in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women.
null
Atrophy Vaginal Diseases
Urogenital atrophy Vaginal atrophy Vulvar and vaginal atrophy in postmenopausal women Menopausal symptoms
null
3
arm 1: Subjects will receive a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2. arm ...
[ 0, 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 1 tablet (dose 30 mg/day) taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12). intervention 2: 1 tablet (dose 60 mg/day) taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12). intervention 3: 1 tablet taken e...
intervention 1: Ospemifene 30 mg intervention 2: Ospemifene 60 mg intervention 3: Placebo intervention 4: Nonhormonal vaginal lubricant
0
null
0
NCT00276094
[ 4 ]
494
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of the study was to assess the efficacy and safety of NGX-4010 applied for 30 or 60 minutes for the treatment of painful HIV-associated neuropathy.
Study C119 was a multicenter, randomized, double-blind, controlled evaluation of the efficacy and safety of NGX-4010 for the treatment of painful HIV-associated neuropathy. Eligible subjects had painful HIV-associated neuropathy resulting from HIV disease and/or antiretroviral drug exposure in both feet, with average n...
Pain HIV Infections Peripheral Nervous System Diseases
Analgesics Capsaicin Neuropathic pain Neuropathy Distal sensory polyneuropathy Peripheral neuropathy Dermal assessment Pain measurement
null
4
arm 1: None arm 2: None arm 3: None arm 4: None
[ 0, 0, 5, 5 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Up to 4 NGX-4010 patches of 280 cm\^2 each were applied to the feet (2 per foot) for 60 minutes. intervention 2: Up to 4 control patches of 280 cm\^2 each were applied to the feet (2 per foot) for 60 minutes. intervention 3: Up to 4 NGX-4010 patches of 280 cm\^2 each were applied to the feet (2 per foot...
intervention 1: NGX-4010, 8% capsaicin patch intervention 2: 0.04% capsaicin patch intervention 3: NGX-4010, 8% capsaicin patch intervention 4: 0.04% capsaicin patch
0
null
0
NCT00321672
[ 5 ]
219
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
The primary objective is to compare buprenorphine transdermal delivery system (BTDS) with standard- treatment in subjects with osteoarthritis (OA).
null
Osteoarthritis
OA Elderly Pain OA of the hips and/or knees
null
2
arm 1: Buprenorphine transdermal 7 day analgesic patch arm 2: codeine paracetamol combination tablets
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: buprenorphine transdermal system 5, 10 and 20 mg intervention 2: combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500
intervention 1: Buprenorphine intervention 2: Codeine paracetamol
1
Cambridge | N/A | United Kingdom | 0.11667 | 52.2
0
NCT00324038
[ 3 ]
34
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
5-aza is a chemotherapy drug with activity in leukemia and myelodysplastic syndromes (MDS). Researchers hope that valproic acid (VPA) and all-trans retinoic acid (ATRA)will increase the effects of 5-aza. The goal of this clinical research study is to find the highest safe dose of valproic acid (VPA) that can be given i...
Recent studies have shown synergy between demethylating agents and histone deacetylase inhibitors. In my laboratory, we have developed in vitro models using HL-60 and MOLT4 leukemic cells to study the effects of the combination of decitabine (a 5-azacytidine analogue) and valproic acid. Valproic acid is an antiepilepti...
Myelodysplastic Syndrome Acute Myelogenous Leukemia
Combination Chemotherapy MDS High-Risk Myelodysplastic Syndrome AML Acute myelogenous leukemia valproic acid VPA Depakene 5-azacytidine 5-aza Azacitidine 5-AZC Vidaza AZA-CR Ladakamycin NSC-102816 All-trans retinoic acid ATRA Tretinoin Vesanoid
null
1
arm 1: Daily for 7 days, Valproic acid (VPA) starting dose 75 mg/m\^2 subcutaneously in combination with 5-azacytidine (5-aza) 50 mg/kg orally; and all-trans retinoic acid (ATRA) 45 mg/m\^2 orally daily (in two divided doses) for 5 days starting on day 3.
[ 0 ]
3
[ 0, 0, 0 ]
intervention 1: Start at 75 mg/m\^2 subcutaneously daily for 7 days. intervention 2: 50 mg/kg daily by mouth for 7 days, same days as 5-aza. intervention 3: 45 mg/m\^2 orally daily (in two divided doses) for 5 days starting on day 3 of the administration of 5-aza and VPA.
intervention 1: 5-Azacytidine (5-aza) intervention 2: Valproic Acid intervention 3: All-Trans Retinoic Acid (ATRA)
1
Houston | Texas | United States | -95.36327 | 29.76328
0
NCT00326170
[ 3, 4 ]
123
NON_RANDOMIZED
SINGLE_GROUP
2DIAGNOSTIC
0NONE
false
0ALL
null
Very often patients receive medications before a diagnostic, therapeutic, or surgical procedure to help them relax, keep them calm, and to relieve them from pain. This is called procedural sedation. With respect to minimal-to-moderate procedural sedation for minor surgical procedures, a patient is first given a pain-re...
This is a Phase 3 open-label, single-arm study designed to evaluate the safety of AQUAVAN following pretreatment with an analgesic, fentanyl, in patients who are undergoing minor surgical procedures that require minimal-to-moderate sedation. All patients will be placed on supplemental oxygen via nasal cannula and an el...
Procedural Sedation
Arthroscopy AV Shunt Bunion Dilatation and Curettage Esophagogastroduodenoscopy Hysteroscopy Lithotripsy Rotator Cuff/ Shoulder Transesophageal Echocardiography Ureteroscopy AQUAVAN Sedation
null
0
null
null
1
[ 0 ]
intervention 1: None
intervention 1: AQUAVAN® (fospropofol disodium) Injection
15
Phoenix | Arizona | United States | -112.07404 | 33.44838 Jacksonville | Florida | United States | -81.65565 | 30.33218 Louisville | Kentucky | United States | -85.75941 | 38.25424 Slidell | Louisiana | United States | -89.78117 | 30.27519 Slidell | Louisiana | United States | -89.78117 | 30.27519 Chevy Chase | Marylan...
0
NCT00327392
[ 4 ]
367
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to test in patients who have had hip replacement surgery the effectiveness (level of pain control) and the safety of 3 different dose levels of CG5503 compared with placebo and with 10-mg oxycodone during the 72-hour double-blind period and to assess the safety of the drug for 9 days after ...
Patients undergoing hip replacement often experience moderate to severe acute pain post-surgery. Normally such pain is controlled when patients receive repeated doses of opioid analgesics. However, opioid therapy is commonly associated with side effects such as nausea, vomiting, sedation, constipation, addiction, toler...
Arthroplasty
Arthralgia Pain Pain Assessment Hip Replacement Tapentadol
null
4
arm 1: Placebo Fixed Dose Matching placebo for 3 days arm 2: Oxycodone HCL IR Fixed Dose 10 mg BID for 3 days arm 3: Tapentadol IR (CG5503) Fixed Dose 50, 75, \& 100 mg BID for 3 days arm 4: Tapentadol IR (CG5503) Flexible Dose q4-6 hr Tapentadol IR 50 \& 100 mg BID for 9 days
[ 2, 1, 0, 5 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Fixed Dose 50, 75, \& 100 mg BID for 3 days intervention 2: Fixed Dose Matching placebo for 3 days intervention 3: Fixed Dose 10 mg BID for 3 days intervention 4: Flexible Dose q4-6 hr Tapentadol IR 50 \& 100 mg BID for 9 days
intervention 1: Tapentadol IR (CG5503) intervention 2: Placebo intervention 3: Oxycodone HCL IR intervention 4: Tapentadol IR (CG5503)
77
Birmingham | Alabama | United States | -86.80249 | 33.52066 Mobile | Alabama | United States | -88.04305 | 30.69436 Sheffield | Alabama | United States | -87.69864 | 34.76509 Phoenix | Arizona | United States | -112.07404 | 33.44838 Fort Smith | Arkansas | United States | -94.39855 | 35.38592 Little Rock | Arkansas | U...
0
NCT00364533
[ 4 ]
325
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The primary objective of this trial is to assess the efficacy of XP13512 taken once daily compared to placebo for the treatment of patients suffering from Restless Legs Syndrome (RLS).
This was a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy and safety of XP13512 in subjects with Restless Legs Syndrome (RLS). Eligible subjects were randomized to receive 1 of 3 once daily oral doses of XP13512 1200 mg, XP13512 600 mg, or placebo. The pr...
Restless Legs Syndrome
null
3
arm 1: XP13512 600MG ONCE DAILY arm 2: XP13512 1200MG ONCE DAILY arm 3: PLACEBO ONCE DAILY
[ 0, 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: XP13512 600MG ONCE DAILY intervention 2: XP13512 1200MG ONCE DAILY intervention 3: PLACEBO ONCE DAILY
intervention 1: XP13512 600MG intervention 2: XP13512 1200MG intervention 3: PLACEBO
0
null
0
NCT00365352
[ 5 ]
49
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
true
1FEMALE
false
This study will look at colonic mucosal blood flow in subjects who have taken alosetron vs placebo and healthy volunteers vs diarrhea-predominant Irritable Bowel Syndrome (d-IBS) patients.
null
Irritable Colon
mucosal blood flow d-IBS
null
0
null
null
1
[ 0 ]
intervention 1: None
intervention 1: alosetron
1
London | N/A | United Kingdom | -0.12574 | 51.50853
0
NCT00370032
[ 3 ]
107
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
null
This is a study comparing the activity of lapatinib versus placebo followed by chemoradiation. This study is designed to explore the effects of lapatinib monotherapy on apoptosis/necrosis, in pre-treatment and post-treatment tumour tissue samples in subjects with locally advanced squamous cell carcinoma of head and nec...
null
Squamous Cell Carcinoma of Head and Neck
squamous cell carcinoma of head and neck lapatinib ErbB1/ErbB2 inhibitor apoptosis
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: Lapatinib oral tablets intervention 2: Placebo
9
Caen | N/A | France | -0.35912 | 49.18585 Montpellier | N/A | France | 3.87635 | 43.61093 Villejuif | N/A | France | 2.35992 | 48.7939 Athens | N/A | Greece | 23.72784 | 37.98376 Bangalore | N/A | India | 77.59369 | 12.97194 Thiruvananthapuram | N/A | India | 76.94924 | 8.4855 Lima | Lima Province | Peru | -77.02824 | ...
0
NCT00371566
[ 5 ]
9
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Objective: This study is designed to determine whether growth hormone treatment in children 8 to 18 years of age alters function of the lining of the arteries. This may play a role in increasing or decreasing the risk of heart disease. Methods. Twenty children, for whom growth hormone therapy will be otherwise provide...
The purpose of the research is to learn more about how the lining of arteries in the body (called the endothelium) is affected by growth hormone treatment in children and adolescents. Poor function by the blood vessels is associated with increased risk of heart disease or stroke. This research is being done because gro...
Growth Hormone Deficiency Panhypopituitarism Short Stature
growth hormone endothelial function
null
1
arm 1: Growth hormone treatment 0.3 mg/kg/min
[ 0 ]
1
[ 0 ]
intervention 1: Growth Hormone treatment
intervention 1: growth hormone
1
Columbus | Ohio | United States | -82.99879 | 39.96118
0
NCT00373386
[ 1 ]
11
NA
SINGLE_GROUP
null
1SINGLE
true
0ALL
true
Study consists of an eight day inpatient visit on the General Clinical Research Center. The investigators' specific aims are to: 1. To define the maximum safe dose of a seven day continuous administration of parathyroid hormone \[PTH(1-34)\] in healthy human volunteers. 2. To estimate the effect of a seven day continu...
This study will expand upon earlier infusions studies that demonstrated: 1) There is a dose-related increase in 1,25 (OH)2 vitamin D in response to PTHrP and PTH over multiple days. 2) There is a markedly attenuated vitamin D response to PTHrP compared to PTH, particularly during the second 24 hours. 3) The increase in...
Osteoporosis Bone Diseases, Endocrine Hyperparathyroidism
Endocrine System Diseases MusculoSkeletal System Disease Hormone Physiologic Properties
null
2
arm 1: Parathyroid Hormone (PTH) (1-34) 2 picomols/kg/hr for one week. arm 2: Parathyroid Hormone (PTH) (1-34)4 picomols/kg/hr for one week.
[ 0, 0 ]
1
[ 0 ]
intervention 1: PTH(1-34) IV given over a one week period
intervention 1: Parathyroid Hormone (1-34)
1
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
0
NCT00377312
[ 4 ]
338
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
The primary purpose of this study is to evaluate whether treatment with (SEROQUEL SR) quetiapine fumarate sustained release (SR) for 9 weeks compared to placebo will improve depressive symptoms in elderly patients with major depressive disorder. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. T...
null
Major Depressive Disorder
Major Depressive Disorder MDD
null
0
null
null
1
[ 0 ]
intervention 1: None
intervention 1: Quetiapine
43
Birmingham | Alabama | United States | -86.80249 | 33.52066 San Diego | California | United States | -117.16472 | 32.71571 Fort Myers | Florida | United States | -81.84059 | 26.62168 Gainsville | Florida | United States | N/A | N/A Sarasota | Florida | United States | -82.53065 | 27.33643 Roswell | Georgia | United Sta...
0
NCT00388973
[ 3 ]
22
RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
This study evaluates the safety and efficacy of plerixafor given in addition to granulocyte-colony stimulating factor (G-CSF) for collection of peripheral blood stem cells (PBSCs) for autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) and multiple myeloma (MM). Efficacy outcomes include evaluation...
Participants with NHL and MM who have undergone prior cyto-reductive chemotherapy, are to be autologously transplanted, and meet the inclusion/exclusion criteria are eligible to enter the study. The only change to the standard of care is the addition of plerixafor to a granulocyte colony-stimulating factor (G-CSF) mobi...
Multiple Myeloma Lymphoma, Non-Hodgkin
Non-Hodgkin's Lymphoma Multiple Myeloma stem cell mobilization AMD3100 autologous transplantation
null
2
arm 1: Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for u...
[ 0, 0 ]
1
[ 0 ]
intervention 1: Participants underwent mobilization with G-CSF 10 µg/kg/day for 4 days, administered by subcutaneous injection (SC) injection each morning. On the evening of Day 4, participants received a dose of plerixafor 240 µg/kg, administered by SC injection. On Day 5, participants returned to the clinic and recei...
intervention 1: G-CSF Plus Plerixafor
2
Calgary | Alberta | Canada | -114.08529 | 51.05011 Vancouver | British Columbia | Canada | -123.11934 | 49.24966
0
NCT00396266
[ 4 ]
30
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
false
0ALL
null
This study evaluated the effect of valsartan on small vessel blood flow in patients with mild-to-moderate hypertension in direct comparison to atenolol and hydrochlorothiazide.
null
Hypertension
hypertension valsartan atenolol hydrochlorothiazide microcirculation arterial compliance pulse wave analysis
null
2
arm 1: After a 2-week washout period, patients were treated with valsartan for 20 weeks followed by one week in which it was tapered off. Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film...
[ 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: 100 mg tablets orally once a day (od) in the morning. intervention 2: 12.5 or 25 mg tablets orally once a day (od) in the morning. intervention 3: 80 mg, 160 mg, or 320 mg tablets orally once a day in the morning
intervention 1: Atenolol intervention 2: Hydrochlorothiazide (HCTZ)) intervention 3: Valsartan
2
Investigative Centers | N/A | Germany | N/A | N/A Basel | N/A | Switzerland | 7.57327 | 47.55839
0
NCT00396656
[ 5 ]
192
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This study will examine the ability of olmesartan medoxomil to lower the blood pressure of patients with Type II diabetes and high blood pressure. The medication being tested has been approved by the FDA for the treatment of high blood pressure.
null
Hypertension
Hypertension Angiotensin Receptor Blocker Calcium Channel Blocker Angiotensin Converting Enzyme Inhibitor Hydrochlorothiazide Stage I and II Hypertension Type II Diabetes
null
1
arm 1: Blood pressure (BP) measurements were taken every three weeks for 12 weeks. In accordance with their BP results, participants either stayed on their current medication or were started on the next higher regimen at the 3, 6, or 9 week visits. All participants began at 20 mg olmesartan, once daily for 3 weeks. The...
[ 0 ]
2
[ 0, 0 ]
intervention 1: Olmesartan medoxomil tablets, once daily intervention 2: Olmesartan medoxomil and hydrochlorothiazide combination tablets, once daily, if necessary
intervention 1: olmesartan medoxomil intervention 2: Olmesartan medoxomil plus Hydrochlorothiazide
27
Birmingham | Alabama | United States | -86.80249 | 33.52066 Mesa | Arizona | United States | -111.82264 | 33.42227 Searcy | Arkansas | United States | -91.73625 | 35.25064 Los Angeles | California | United States | -118.24368 | 34.05223 Roseville | California | United States | -121.28801 | 38.75212 Tustin | California ...
0
NCT00403481
[ 3 ]
42
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
true
The purpose of this study is to investigate whether heliox-powered albuterol nebulizer therapy will result in reduced inpatient length of stay in children hospitalized with acute asthma exacerbations.
We hypothesize that heliox-powered albuterol nebulizer therapy will result in reduced inpatient length of stay in children hospitalized with acute asthma exacerbations. Severity of asthma will be characterized using a modified Becker Clinical Asthma Score (CAS) based upon the acuity of physical signs for four clinical ...
Status Asthmaticus
Status asthmaticus Asthma Helium Children
null
2
arm 1: Group 1 (Heliox-Powered Albuterol) patients will receive all albuterol nebulizer treatments, including continuous therapy, powered by 70:30 Heliox. arm 2: Group 2 (Oxygen-Powered Albuterol) patients will receive all albuterol nebulizer treatments, including continuous therapy, powered by 100% oxygen per usual st...
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Subjects will be treated with continuous albuterol nebs with Heliox intervention 2: Subjects will be treated with continuous albuterol nebs in oxygen
intervention 1: Helium-oxygen-driven albuterol nebulizer intervention 2: Oxygen
1
Cincinnati | Ohio | United States | -84.51439 | 39.12711
0
NCT00410150
[ 4 ]
1,670
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
null
This is a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations will be performed at Screening (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment evaluators and lesion counters must be trained and ...
null
Acne Vulgaris
Acne vulgaris Adapalene Benzoyl Peroxide
null
4
arm 1: Adapalene/Benzoyl Peroxide Topical Gel arm 2: Adapalene Topical Gel arm 3: Benzoyl Peroxide Topical Gel arm 4: Topical Gel Vehicle
[ 0, 1, 1, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Topical Gel, One application daily in the evening for 12 weeks intervention 2: Topical Gel,One application daily in the evening for 12 weeks intervention 3: Topical Gel, one application daily in the evening for 12 weeks intervention 4: Topical Gel Vehicle,one application daily in the evening for 12 week...
intervention 1: Adapalene/Benzoyl Peroxide intervention 2: Adapalene intervention 3: Benzoyl Peroxide intervention 4: Topical Gel Vehicle
62
Huntsville | Alabama | United States | -86.58594 | 34.7304 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Fresno | California | United States | -119.77237 | 36.74773 Irvine | California | United States | -117.82311 | 33.66946 Los Angeles | California | United States | -118.24368 | 34.05223 Marina del Rey...
0
NCT00421993
[ 4 ]
429
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
Multinational, multicentre, randomised, prospective, open, parallel group study directly comparing two glycoprotein-IIb/IIIa inhibitors, abciximab and eptifibatide, added early to standard treatment before primary PCI of STEMI patients with respect to effect on sum-ST-resolution after 60 minutes post-procedure and othe...
null
Infarction, Myocardial
Eptifibatide ST-elevation Myocardial Infarction STEMI Abciximab
null
2
arm 1: Intravenous bolus of 0.25 mg/kg followed by continuous intravenous infusion of 0.125 mcg/kg/min (max. 10 mcg/min) for 12 h after PCI. arm 2: Intravenous bolus of 180 mcg/kg followed immediately by a continuous infusion of 2.0 mcg/kg/ min for 20-24 h after end of PCI, and a second bolus of 180 mcg/kg administered...
[ 1, 0 ]
2
[ 0, 0 ]
intervention 1: Intravenous bolus of 0.25 mg/kg followed by continuous intravenous infusion of 0.125 mcg/kg/min (max. 10 mcg/min) for 12 h after PCI. intervention 2: Intravenous bolus of 180 mcg/kg followed immediately by a continuous infusion of 2.0 mdg/kg/ min for 20-24 h after end of PCI, and a second bolus of 180 m...
intervention 1: Abciximab intervention 2: Eptifibatide
24
Alençon | N/A | France | 0.09311 | 48.43476 Bordeaux | N/A | France | -0.5805 | 44.84044 Caen | N/A | France | -0.35912 | 49.18585 Créteil | N/A | France | 2.46569 | 48.79266 Lille | N/A | France | 3.05858 | 50.63297 Melun | N/A | France | 2.65356 | 48.5457 Melun | N/A | France | 2.65356 | 48.5457 Nancy | N/A | France ...
0
NCT00426751
[ 4 ]
150
RANDOMIZED
CROSSOVER
0TREATMENT
1SINGLE
false
0ALL
null
This study evaluated the safety and clinical effect of treatment with methylphenidate under different breakfast conditions (minimal breakfast versus standard continental breakfast) in children with Attention-Deficit Hyperactivity Disorder (ADHD).
null
Attention Deficit Hyperactivity Disorder
ADHD methylphenidate children food effect Attention-Deficit Hyperactivity Disorder (ADHD) in children
null
2
arm 1: Very light breakfast (VLB) for one week then crossover to standard breakfast (SB) for one week while taking either 1 or 2 20 mg capsules of methylphenidate once per day based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for chil...
[ 0, 0 ]
1
[ 0 ]
intervention 1: None
intervention 1: Methylphenidate 20 mg long-acting capsules
1
Freiburg im Breisgau | N/A | Germany | 7.85222 | 47.9959
0
NCT00428792
[ 4 ]
1,703
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
The purpose of this study is to investigate the efficacy and safety of MK0974 compared to a placebo for acute migraine.
null
Migraine
null
4
arm 1: MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack arm 2: MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack arm 3: MK0974 300 mg; ...
[ 0, 0, 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: None intervention 4: MK0974 50 mg soft gel capsule Placebo; MK0974 150 mg soft gel capsule Placebo; MK0974 300 mg soft gel capsule Placebo.
intervention 1: MK0974 50 mg intervention 2: MK0974 150 mg intervention 3: MK0974 300 mg intervention 4: Comparator: Placebo
0
null
0
NCT00432237
[ 3 ]
85
RANDOMIZED
PARALLEL
1PREVENTION
1SINGLE
true
1FEMALE
false
The main purpose of this clinical research study is to investigate if degarelix can synchronise the growth of the egg sacs in the ovaries and if degarelix has any effect on the lining of the womb.
For the primary end-point (data collected on Stimulation Day 1), the study will compare degarelix 2.5 mg administered in the mid-luteal phase to placebo administered in the mid-luteal phase. After Stimulation Day 1 the placebo group will be split into two groups: a degarelix 2.5 mg follicular group and a ganirelix 0.2...
Infertility, Female
Assisted Reproductive Technology (ART) oocyte donors undergoing controlled ovarian hyperstimulation for assisted reproductive technologies
null
2
arm 1: Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1. arm 2: Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stim...
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1. intervention 2: Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be i...
intervention 1: Degarelix mid-luteal, 2.5 mg intervention 2: Placebo
4
Brussels | N/A | Belgium | 4.34878 | 50.85045 Prague | N/A | Czechia | 14.42076 | 50.08804 Madrid | N/A | Spain | -3.70256 | 40.4165 Valencia | N/A | Spain | -0.37966 | 39.47391
0
NCT00434122
[ 2 ]
27
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
A Phase I Trial of GW572016, Gemcitabine and Oxaliplatin for Metastatic Pancreaticobiliary Cancer Schema
The primary objective of this phase I study is to determine the safety, tolerability and optimal tolerated regimen of GW572016 when combined with gemcitabine and with the combination of gemcitabine and oxaliplatin. Three to six patients will be treated at each dose level to assess toxicity. To better assess the safety ...
Metastatic Pancreatic Cancer
Pancreatic Cancer
null
4
arm 1: Weekly gem + GW572016, 1000mg/day (combination) arm 2: Weekly gem + GW572016, 1500 mg/day (combination) arm 3: GEMOX + GW572016 1000 mg/day (combination) arm 4: GEMOX + GW572016 1500 mg/day (combination)
[ 0, 0, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Weekly gem + GW572016, 1000mg/day (combination) intervention 2: Weekly gem + GW572016, 1500 mg/day (combination) intervention 3: GEMOX + GW572016 1000 mg/day (combination) intervention 4: GEMOX + GW572016 1500 mg/day (combination)
intervention 1: cohort 1 intervention 2: cohort 2 intervention 3: cohort 3 intervention 4: cohort 4
1
Providence | Rhode Island | United States | -71.41283 | 41.82399
0
NCT00439179
[ 3 ]
60
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
The primary objective of this study is to evaluate if adjunctive armodafinil treatment can improve the cognitive deficits in patients with schizophrenia
null
Schizophrenia
null
4
arm 1: Armodafinil or placebo was provided in 50 mg tablet form and subjects were instructed to take 4 tablets orally once daily in the morning. Subjects randomized to the 50 mg/day armodafinil treatment arm for the double-blind treatment period of the study took one 50 mg armodafinil tablet plus three placebo tablets ...
[ 1, 1, 1, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 50 mg/day armodafinil intervention 2: 100 mg/day armodafinil intervention 3: 200 mg/day armodafinil intervention 4: placebo
intervention 1: armodafinil intervention 2: armodafinil intervention 3: armodafinil intervention 4: placebo
12
Garden Grove | California | United States | -117.94145 | 33.77391 National City | California | United States | -117.0992 | 32.67811 Paramount | California | United States | -118.15979 | 33.88946 Pico Rivera | California | United States | -118.09673 | 33.98307 San Diego | California | United States | -117.16472 | 32.715...
0
NCT00487942
[ 5 ]
793
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
1FEMALE
null
This study will evaluate the efficacy of acetaminophen or fluvastatin in reducing the rate of occurrence and the severity of post dose symptoms that may occur during the 3 day period following a zoledronic acid infusion in post menopausal women with low bone mass.
null
Osteoporosis
zoledronic acid post dose symptoms transient acetaminophen fluvastatin
null
3
arm 1: 2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceedin...
[ 0, 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: None
intervention 1: Placebo intervention 2: Acetaminophen intervention 3: Fluvastatin
1
Http://www.osteoporosisclinicalresearch.com | New Jersey | United States | N/A | N/A
0
NCT00489424
[ 3 ]
168
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
true
0ALL
false
The objective of this trial is to assess the efficacy and safety of Staccato Loxapine in patients with migraine headache with or without aura in a clinical setting.
This study will enroll male and female patients with migraine headache with or without aura. The study will randomize \~160 patients, 1:1:1:1 to receive one of the following treatments: 1.25 mg Staccato Loxapine; 2.5 mg Staccato Loxapine; 5 mg Staccato Loxapine; Staccato Placebo.
Migraine
Staccato® Loxapine, Migraine
null
4
arm 1: 1.25 mg ADASUVE, single dose arm 2: 2.5 mg ADASUVE, single dose arm 3: 5 mg ADASUVE, single dose arm 4: Staccato Placebo, 0 mg
[ 0, 0, 0, 0 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: Placebo aerosol inhalation (0mg)
intervention 1: Staccato Loxapine intervention 2: Staccato Placebo
1
Wellesley Hills | Massachusetts | United States | -71.27867 | 42.30843
0
NCT00489476
[ 2 ]
12
RANDOMIZED
PARALLEL
null
4QUADRUPLE
true
0ALL
null
This study will examine the effects of oral dronabinol tetrahydrocannabinol (THC) on withdrawal symptoms in marijuana dependent volunteers, and evaluate the safety, pharmacokinetics (PK), and cardiovascular effects of the combination of oral dronabinol and smoked marijuana to determine if there are potential significan...
null
Marijuana Dependence
Marijuana dependence
null
2
arm 1: None arm 2: None
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: Placebo intervention 2: Dronabinol
1
Bethesda | Maryland | United States | -77.10026 | 38.98067
0
NCT00490269
[ 3 ]
83
RANDOMIZED
CROSSOVER
0TREATMENT
4QUADRUPLE
false
0ALL
null
This study will assess the efficacy and safety of glycopyrronium bromide (NVA237) in patients with stable COPD, in comparison to an active comparator.
null
Chronic Obstructive Pulmonary Disease
COPD, Age≥40 yrs, Glycopyrronium Bromide
null
6
arm 1: 12.5 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence. arm 2: 25 µg daily via single-dose dry-powder inhaler (SDDPI). At basel...
[ 0, 0, 0, 0, 2, 1 ]
3
[ 0, 0, 0 ]
intervention 1: single-dose dry-powder inhaler (SDDPI) intervention 2: single-dose dry-powder inhaler (SDDPI) intervention 3: Handihaler inhaler
intervention 1: NVA237 intervention 2: Placebo intervention 3: Tiotropium
3
Vilvoorde | N/A | Belgium | 4.42938 | 50.92814 Rueil-Malmaison | N/A | France | 2.18967 | 48.8765 Tokyo | N/A | Japan | 139.69171 | 35.6895
0
NCT00501852
[ 3 ]
40
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The primary aim of the study is to demonstrate a reduction in circulating interleukin 6 levels at 4 and 24 hours after completion of lobectomy (either VATS or open). The null hypothesis (H0) is thus that there is no difference in circulating interleukin 6 levels when patients are given either ketamine or placebo (0.9% ...
This study is designed to be a phase 2 (efficacy) randomized controlled clinical trial of ketamine versus placebo in 40 patients undergoing lobectomy by VATS or open approach, at Duke University. We selected a single dose regimen of 0.5mg/kg IV ketamine given at induction of anesthesia, as this is the dose that previou...
Lung Cancer
Lobectomy VATS
null
2
arm 1: Single bolus 0.5mg/kg ketamine IV after induction of anesthesia arm 2: 0.9 % saline bolus of equivalent volume
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Interventional intervention 2: placebo
intervention 1: Ketamine intervention 2: 0.9% saline
1
Durham | North Carolina | United States | -78.89862 | 35.99403
0
NCT00504725
[ 4 ]
257
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This study will evaluate the efficacy and safety of valsartan and amlodipine in fixed dose combination in adults with moderate, inadequately controlled hypertension. There was an optional study extension for eligible patients who wanted to participate that contains the triple therapy (ie, hydrochlorothiazide+ amlodipin...
Title of study extension: An open-label, multicenter extension to evaluate the efficacy and tolerability of a 4 week therapy with hydrochlorothiazide 12.5 mg plus amlodipine 10 mg/valsartan 160 mg in hypertensive patients not adequately responding to a 4 week therapy each with the combinations of olmesartan 20 mg plus ...
Hypertension
hypertension, valsartan, amlodipine
null
1
arm 1: During the Treatment Phase 1, participants received 1 week of treatment with olmesartan 10 mg and amlodipine 5 mg once daily in free combination, followed by three weeks of treatment with olmesartan 20 mg plus amlodipine 10 mg once daily in free combination. During the treatment Phase 2 of the study participants...
[ 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Amlodipine supplied as 5 mg tablets, taken orally once a day during Treatment Phase 1 only. intervention 2: Olmesartan medoxomil supplied as 10 mg tablets taken once a day during Treatment Phase 1 only. intervention 3: Fixed-dose combination of amlodipine 10 mg plus valsartan 160 mg tablet taken orally ...
intervention 1: Amlodipine intervention 2: Olmesartan medoxomil intervention 3: Amlodipine+valsartan intervention 4: Hydrochlorothiazide
2
Schwerin | N/A | Germany | 11.41316 | 53.62937 N/A | N/A | N/A | N/A | N/A
0
NCT00523744
[ 2 ]
48
RANDOMIZED
CROSSOVER
0TREATMENT
4QUADRUPLE
true
0ALL
false
To assess the safety of Staccato Prochlorperazine on cardiac repolarization (QTc interval duration) at 2 dose levels compared to placebo in healthy volunteers.
The planned study is a single dose, double-blind, double-dummy, active and placebo controlled, randomized, 4-period cross-over study investigating investigating 2 doses levels of Staccato Prochlorperazine, a positive control with known QT/QTc prolongation (oral moxifloxacin), and placebo.
Cardiotoxicity
Inhaled prochlorperazine, Thorough Qt/QTc,
null
4
arm 1: Treatment Sequence ABCD where Treatment: A = Inhaled prochlorperazine (10 mg) + oral placebo, B = Inhaled prochlorperazine (5 mg) + oral placebo, C = Inhaled placebo + oral placebo, D = Inhaled placebo + oral moxifloxacin 400 mg arm 2: Treatment Sequence BDAC where Treatment: A = Inhaled prochlorperazine (10 mg)...
[ 5, 5, 5, 5 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: Inhaled Staccato placebo (0 mg) intervention 2: Oral placebo (identical to 400 mg moxifloxacin) intervention 3: Staccato prochlorperazine 5 mg, single dose intervention 4: Inhaled prochlorperazine 10 mg, single dose intervention 5: Oral moxifloxacin 400 mg, si/ngle dose
intervention 1: Inhaled placebo intervention 2: Oral placebo intervention 3: Inhaled prochlorperazine 5 mg intervention 4: Inhaled prochlorperazine 10 mg intervention 5: Oral moxifloxacin
1
Evansville | Indiana | United States | -87.55585 | 37.97476
0
NCT00543062
[ 5 ]
48
RANDOMIZED
PARALLEL
4SUPPORTIVE_CARE
0NONE
true
0ALL
null
The purpose of this study is to evaluate the drug concentrations of AzaSite™ compared to Vigamox at various time points in conjunctiva tissue of healthy volunteers
null
Bacterial Infections Eye Infections
null
8
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None arm 8: None
[ 0, 0, 0, 0, 0, 0, 0, 0 ]
2
[ 0, 0 ]
intervention 1: azithromycin topical solution 1% given as a single drop in a single eye intervention 2: Moxifloxacin topical solution given as a single drop in a single eye
intervention 1: Azithromycin intervention 2: Moxifloxacin
0
null
0
NCT00564447
[ 2 ]
33
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
false
0ALL
null
The purpose of the study is to see if generic ibuprofen has an effect on osteoarthritis knee pain during a series of timed walks on a treadmill.
null
Osteoarthritis, Knee
null
3
arm 1: Ibuprofen arm 2: Placebo 1 arm 3: Placebo 2
[ 1, 2, 2 ]
2
[ 0, 0 ]
intervention 1: Patients will receive 800 mg ibuprofen in one of the three treatment periods. intervention 2: Patients will receive placebo to ibuprofen in two of the three treatment periods.
intervention 1: ibuprofen intervention 2: Placebo
0
null
0
NCT00565084
[ 3 ]
69
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of PA-824 at 200, 600, 1000 and 1200 mg per day in adult patients with newly diagnosed, uncomplicated, smear positive tuberculosis. A control group will receive standard TB treatment.
null
Pulmonary Tuberculosis
Early Bactericidal Activity EBA pulmonary tuberculosis PA-824 Pretomanid CL-007
null
5
arm 1: PA-824 200 mg/qd arm 2: PA-824 600 mg/qd arm 3: PA-824 1000 mg/qd arm 4: PA-824 1200 mg/qd arm 5: Rifafour e-275 mg
[ 0, 0, 0, 0, 1 ]
1
[ 0 ]
intervention 1: 200 mg, 600 mg, 100 mg, 1200 mg qd
intervention 1: PA-824
2
Cape Town | Cape Province | South Africa | 18.42322 | -33.92584 Cape Town | Cape Province | South Africa | 18.42322 | -33.92584
0
NCT00567840
[ 4 ]
124
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
true
0ALL
false
This is a Phase 3b, open-label, multicenter trial to assess the safety and tolerability of switching from ropinirole therapy to the rotigotine transdermal system and its effect on symptoms in subjects with idiopathic Parkinson's disease
null
Parkinson's Disease
Rotigotine NEUPRO Switching trial from ropinirole to rotigotine, safety and tolerability Parkinson disease
null
1
arm 1: Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
[ 0 ]
1
[ 0 ]
intervention 1: Strength: 2,4,6,and 8mg/24h, form: transdermal application, once daily application
intervention 1: Rotigotine
0
null
0
NCT00593606
[ 2 ]
26
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
true
0ALL
null
The purpose of this study is to evaluate the potential effects of ER niacin/laropiprant, ER niacin, laropiprant, and placebo over the course of seven days on urinary levels of a specific metabolite (which is a marker of in vivo platelet reactivity).
Subjects will receive 1 of 4 treatments per period and will eventually receive all 4 treatments: Treatment A: ER niacin 2g/laropiprant 40 mg daily + Placebo to laropiprant for 7 days Treatment B: ER niacin 2 g daily + Placebo to laropiprant for 7 days Treatment C: laropiprant 40 mg daily + Placebo to ER niacin/laro...
Type 2 Diabetes Mellitus
null
4
arm 1: Arm A: ER niacin/laropiprant + Placebo to laropiprant arm 2: Arm B: ER niacin + Placebo to laropiprant arm 3: Arm C: laropiprant + Placebo to ER Niacin/laropiprant arm 4: Arm D: Placebo
[ 0, 0, 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: ER niacin 2 g/ laropiprant 40 mg daily for 7 days. intervention 2: ER niacin 2 g daily for 7 days. intervention 3: laropiprant 40 mg daily for 7 days. intervention 4: matching placebo tablets for each of the interventions once daily for 7 days
intervention 1: Comparator: ER niacin (+) laropiprant intervention 2: Comparator: ER niacin intervention 3: Comparator: laropiprant intervention 4: Comparator: placebo
0
null
0
NCT00618995
[ 2 ]
18
NA
SINGLE_GROUP
0TREATMENT
0NONE
true
0ALL
true
Intraject is a needle-free, single use, disposable, subcutaneous delivery system pre-filled with 6 mg sumatriptan. Healthy Individuals will be enrolled for a series of 3 injections over 2 days. Assessment of Local Site Signs will be recorded for up to 5 days, as needed.
This study will evaluate the extent, persistence, and any cumulative effects on skin tissue by assessing local injection site reactions (bleeding, swelling, erythema, bruising) following repeated administrations of needle-free Intraject sumatriptan to the same anatomic site.
Healthy
sumatriptan Intraject Local Site Reactions
null
0
null
null
1
[ 0 ]
intervention 1: injection
intervention 1: Sumatriptan
0
null
0
NCT00620425
[ 3 ]
414
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Leishmanias is a disease caused by the bite of sandflies and is found in many parts of the world including the Europe, Southwest Asia, Africa and the Middle East. This disease is a threat for military soldiers in areas where this disease is found. Sodium stibogluconate (SSG) or Pentostam (Glaxo Smith Kline, United King...
Leishmaniasis is a protozoal disease transmitted by sandflies and is endemic in many parts of the world including Central and South America, Europe, Southwest Asia, Africa, and the Middle East. Infected humans may develop cutaneous (Old or New World), mucocutaneous (New World), or visceral leishmaniasis. The disease is...
Leishmaniasis
Leishmaniasis Sodium stibogluconate Pentostam sand fly
null
1
arm 1: All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with 20 mg/kg once daily intravenously with SSG.
[ 0 ]
1
[ 0 ]
intervention 1: 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days for less responsive; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal...
intervention 1: Sodium Stibogluconate (SSG)
1
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
0
NCT00662012
[ 5 ]
60
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This study is designed to determine if opioid dependent subjects who are already receiving Subutex® prefer the Suboxone® tablet over the Subutex® tablet after switching from Subutex® to Suboxone®. Subjects who are selected to participate in this study will continue their prescribed dose of Subutex® (buprenorphine 2 to ...
null
Opiate-related Disorders Opiate Dependence Drug Abuse
Suboxone Subutex Buprenorphine Naloxone
null
1
arm 1: Subutex® for first two days of study followed by Suboxone® for last 3 days of study
[ 0 ]
2
[ 0, 0 ]
intervention 1: 2 mg buprenorphine and 8 mg buprenorphine tablets at doses from 2 to 16 mg buprenorphine daily for first two days of study intervention 2: 2/0.5 mg buprenorphine/naloxone and 8/2 mg buprenorphine/naloxone tablets at doses from 2/0.5 mg buprenorphine/naloxone to 16/4 mg buprenorphine/naloxone daily for l...
intervention 1: buprenorphine intervention 2: buprenorphine/naloxone
0
null
0
NCT00684073
[ 5 ]
21
RANDOMIZED
PARALLEL
4SUPPORTIVE_CARE
2DOUBLE
false
1FEMALE
true
This trial is part of a larger, longitudinal study of symptoms that occur in the breast surgical scar area and/or ipsilateral arm following breast cancer surgery. Women who develop pain in the breast scar area or ipsilateral arm will be randomized to a placebo patch or a lidocaine patch that they will wear on a daily b...
null
Neuropathic Pain Postmastectomy Pain
breast cancer neuropathic pain topical lidocaine postmastectomy pain breast symptoms breast pain
null
2
arm 1: Drug: lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.), 1 patch was applied topically to the affected site(s) for 12 hours each day. arm 2: Drug: placebo patch, 1 patch was applied topically to the affected site(s) for 12 hours each day.
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: 1 patch was applied topically to the affected site(s) for 12 hours each day. intervention 2: 1 patch was applied topically to the affected site(s) for 12 hours each day.
intervention 1: Lidoderm patch intervention 2: Placebo patch
1
San Francisco | California | United States | -122.41942 | 37.77493
0
NCT00686127
[ 4 ]
43
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
true
1FEMALE
false
A 24 week study to compare the use of Metformin, birth control pills and a carefully planned intensive lifestyle program that includes weight loss and exercise. These approaches will be compared to placebo (a pill that contains no active substances. Metformin, birth control pills and the lifestyle management program wi...
Polycystic ovary syndrome (PCOS) is a condition associated with irregular menstrual cycles, (due to lack of regular ovulation), and evidence of elevated androgen (male hormone) levels, such as unwanted hair growth or acne. This condition often becomes recognized at the time of puberty. The standard treatment for this c...
Polycystic Ovary Syndrome
Polycystic Ovary Syndrome Overweight Adolescent Girls Irregular Menstrual Cycles
null
4
arm 1: Metformin arm 2: Oral Contraceptive Pills arm 3: lifestyle modification program arm 4: placebo to active metformin arm
[ 0, 0, 1, 2 ]
4
[ 0, 0, 5, 0 ]
intervention 1: Metformin 425mg. capsules, 2 capsules BID x 24 weeks intervention 2: Yasmin oral contraceptive tabs; 1 tab daily x 24 weeks intervention 3: weekly classes x 24 weeks for training in diet, exercise and behavior modification skills intervention 4: placebo to the active metformin arm. 2 capsules BID x 24 w...
intervention 1: Metformin intervention 2: Oral Contraceptive Pills (Yasmin) intervention 3: Lifestyle Modification intervention 4: placebo
0
null
0
NCT00714233
[ 4 ]
120
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
true
0ALL
false
The objective of this study is to evaluate the performance of two toothpastes in controlling established gingivitis and dental plaque in adults.
null
Gingivitis
Gingivitis and Plaque
null
2
arm 1: triclosan/copolymer/fluoride toothpaste arm 2: sodium fluoride only toothpaste (placebo)
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Six Month study, brush twice daily intervention 2: twice daily usage
intervention 1: Triclosan, fluoride intervention 2: Fluoride
1
Barcelona | N/A | Spain | 2.15899 | 41.38879
0
NCT00926328
[ 5 ]
29
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
true
1FEMALE
false
The objective of this study is to compare the action halos of the botulinum toxins (Dysport® and Botox®) using two equivalence-ratios and to gather supportive information, such as more detailed data on the effectiveness in reduction of wrinkles and duration of action on the upper part of the face of both products, trou...
This was a monocentric, prospective, randomized and double-blind study. Fifty nine female patients, presenting with moderate to severe forehead wrinkles, with sweating ability who had never undergone previous BoNT-A injections were enrolled. There were two randomizations, one related to the dose-equivalence (2:1U and 2...
Wrinkles in Frontal Area
Muscular activity wrinkles in frontal area action halos
null
2
arm 1: BoNT A1 (4U): Botulinum toxin A (Dysport®)4 units arm 2: BoNT-A2(2U): Botulinum toxin A (Botox®) 2 units
[ 1, 1 ]
1
[ 0 ]
intervention 1: On Visit 1 (Day 0): Botulinum toxin A (Dysport® and Botox®) will be administered according to an equivalence ratio of 2:1. Both reconstituted in the same volume per point, injected in the forehead determined site. * Dysport®: 4 units will be injected in the left or right forehead side. * Botox® : 2 un...
intervention 1: BOTULINUM TOXIN TYPE-A
1
Porto Alegre | Rio Grande do Sul | Brazil | -51.23019 | -30.03283
0
NCT00959907
[ 4 ]
22
RANDOMIZED
CROSSOVER
0TREATMENT
1SINGLE
true
0ALL
false
Research study to compare the effects of brushing with two commercially available toothpastes on salivary bacteria after brushing
null
Salivary Bacteria Levels
null
2
arm 1: fluoride toothpaste control arm 2: triclosan/fluoride toothpaste
[ 2, 1 ]
2
[ 0, 0 ]
intervention 1: Whole mouth brushing for 7 days intervention 2: Brush whole mouth twice daily for 7 days
intervention 1: Fluoride intervention 2: Triclosan/Fluoride
1
Mumbai | N/A | India | 72.88261 | 19.07283
0
NCT00981825
[ 5 ]
29
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
true
1FEMALE
false
The objective of this study is to compare the field of effects of the botulinum toxins (Dysport® and Botox®) using two equivalence-ratios and to gather supportive information, such as more detailed data on the effectiveness in reduction of wrinkles and duration of action on the upper part of the face of both products, ...
This was a monocentric, prospective, randomized and double-blind study. Twenty nine female patients, presenting with moderate to severe forehead wrinkles, with sweating ability who had never undergone previous BoNT-A injections were enrolled. Subjects have received botulinum toxin type-A injections in two forehead site...
Wrinkles in Frontal Area
Botulinum toxin type A field effects dose-equivalence anhydrotic action halos
null
1
arm 1: Dysport® compared to Botox®
[ 0 ]
3
[ 0, 0, 0 ]
intervention 1: Botulinum toxin A (Dysport®)will be administered according to an equivalence ratio of 2,5:1. Both reconstituted in the same volume per point, injected in the forehead determined site. -Dysport®: 5 units will be injected in the left or right forehead side. intervention 2: 2 units will be injected in the...
intervention 1: Botulinum Toxin Type A (Dysport®) intervention 2: Botulinum Toxin Type A/Botox® intervention 3: Botulinum Toxin Type A/Dysport®
1
Porto Alegre | Rio Grande do Sul | Brazil | -51.23019 | -30.03283
0
NCT00989768
[ 2 ]
28
RANDOMIZED
CROSSOVER
7BASIC_SCIENCE
0NONE
true
0ALL
false
This randomized, single dose, three-way crossover study will evaluate the bioequivalence of two formulations of colchicine, the test product (colchicine 0.6mg Mutual) and a marketed combination product (colchicine 0.5 mg with probenecid 500 mg), administered under fasting conditions. It will also determine the bioavail...
This randomized, single dose, three-way crossover study will evaluate the bioequivalence of two formulations of colchicine, the test product (colchicine 0.6mg Mutual) and a marketed combination product (colchicine 0.5mg with probenecid 500mg), administered under fasting conditions. It will also determine the bioavailab...
Healthy
bioequivalence fasting fed healthy
null
3
arm 1: Colchicine (fasted) arm 2: Colchicine (fed) arm 3: Colchicine/Probenecid (fasted)
[ 0, 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: 0.6mg tablet administered after a fast of at least 10 hours intervention 2: 0.6mg tablet administered after a standardized high-fat, high-calorie breakfast intervention 3: 0.5mg/500mg tablet administered after a fast of at least 10 hours
intervention 1: Colchicine intervention 2: Colchicine intervention 3: Colchicine/Probenecid
1
Fargo | North Dakota | United States | -96.7898 | 46.87719
0
NCT01021020
[ 4 ]
60
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
true
0ALL
false
Clinical research for the treatment of mucositis subjects who have dental implants for a minimum of one-year.
null
Mucositis
null
2
arm 1: Triclosan/copolymer/fluoride toothpaste arm 2: Fluoride Toothpaste
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Brush twice daily intervention 2: Brush twice daily
intervention 1: Triclosan and Fluoride intervention 2: Fluoride
1
Rimini | N/A | Italy | 12.56528 | 44.05755
0
NCT01072201
[ 0 ]
42
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
Chlamydia trachomatis is one of the major causes of sexually transmitted disease and also the leading infectious cause of blindness in the world.Treatment of C. trachomatis eye infection has involved for a long time. The efficacy of single dose azithromycin has already been demonstrated as effective in the treatment of...
Medical records of patients with clinically suspected chlamydial conjunctivitis between January 1, 2006 and December 31, 2006 at one cornea specialist's (Y.C.H) out-patient clinic were retrospectively reviewed. At this clinic, patients of both sexes with acute, chronic or recurrent follicular conjunctivitis with the sy...
Chlamydial Conjunctivitis
Oral Azithromycin Chlamydial Conjunctivitis
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Oral Azithromycin in the Treatment of Chlamydial Conjunctivitis
intervention 1: Azithromycin
1
Taipei | N/A | Taiwan | 121.52639 | 25.05306
0
NCT01178762
[ 4 ]
300
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
1FEMALE
true
Efficacy and safety studies in the past have suggested that a starting dose of 75 International Unit (IU) of SJ-0021, and an increase in the dose by 37.5 IU every 7 days, are safe for treatment of subjects with ovulatory disorders who are infertile due to hypothalamic or pituitary dysfunction and have amenorrhea I or a...
Follicle stimulating hormone (FSH) is a heterodimeric glycoprotein wherein an alfa subunit and a beta subunit are noncovalently bonded. Follicle stimulating hormone is one of the key hormones regulating reproductive functions in both female and male mammals, including humans. In females, it stimulates the development o...
Infertility Ovulation Induction
Infertility Ovulation induction Gonalef® (Follitropin alfa) Purified pituitary gonadotropin (Fertinorm-P®) gonadotropin Reproductive technologies, assisted Polycystic ovary syndrome
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Subcutaneous administration of follitropin alfa at a dose of 75 IU/day was started on dosing Day 1 and the same daily dose was maintained for the first 7 days of the treatment period. Dose increment by 37.5 IU was permitted on dosing Day 8, Day 15 and Day 22 if the dosage increase criterion was met. int...
intervention 1: Gonalef® (Follitropin alfa) intervention 2: Purified pituitary gonadotropin (Fertinorm-P®)
1
Tokyo | N/A | Japan | 139.69171 | 35.6895
0
NCT01185782
[ 3 ]
480
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study was to evaluate the dose-response relationships of alogliptin, once daily (QD) to an α-glucosidase inhibitor, three times daily (TID), to determine the optimal clinical dose for type 2 diabetic patients.
Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus. Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV)...
Diabetes Mellitus, Type 2
Diabetes Mellitus - Type 2 Diabetes Mellitus Drug Therapy
null
6
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None
[ 2, 0, 0, 0, 0, 1 ]
6
[ 0, 0, 0, 0, 0, 0 ]
intervention 1: Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks intervention 2: Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks. intervention 3: Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks. intervention 4: Alogliptin 50 mg, tablets, orally, once daily for up to...
intervention 1: Alogliptin intervention 2: Alogliptin intervention 3: Alogliptin intervention 4: Alogliptin intervention 5: Voglibose intervention 6: Placebo
1
Okayama | N/A | Japan | 133.93333 | 34.65
0
NCT01263470
[ 3 ]
43
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
1FEMALE
false
This is a 4-week study to examine the effects of a new experimental medication on women with breast cancer and established bone metastases. This study will enroll approximately 45 women. The primary hypotheses are: (1) odanacatib will result in a substantial suppression of urinary N-telopeptide of type I collagen (u-NT...
null
Breast Cancer Metastatic Bone Disease
null
2
arm 1: Participants will receive a single IV infusion of ZA 4 mg at the start of treatment and a once-daily odanacatib matching placebo tablet for 4 weeks. arm 2: Participants will receive a once-daily odanacatib 5 mg tablet for 4 weeks and a single IV infusion of ZA matching placebo at the start of treatment.
[ 1, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Single ZA 4 mg IV infusion at the start of treatment intervention 2: Once-daily odanacatib 5 mg tablet for 4 weeks intervention 3: Once-daily odanacatib matching placebo for 4 weeks intervention 4: Single IV infusion of ZA matching placebo given at the start of treatment
intervention 1: ZA intervention 2: Odanacatib intervention 3: Odanacatib matching placebo intervention 4: ZA matching placebo
0
null
0
NCT00399802
[ 4 ]
129
RANDOMIZED
CROSSOVER
0TREATMENT
4QUADRUPLE
false
0ALL
null
The primary objective of this study is to assess the time of onset of Vyvanse compared to placebo, in the analog classroom as measured by the Swanson, Kotkin, Agler, M. Flynn and Pelham (SKAMP) deportment scale in children (aged 6-12) diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD).
null
ADHD
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Following completion of the 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). intervention 2: Placebo
intervention 1: Vyvanse (lisdexamfetamine dimesylate) intervention 2: Placebo
9
Little Rock | Arkansas | United States | -92.28959 | 34.74648 Irvine | California | United States | -117.82311 | 33.66946 Wildomar | California | United States | -117.28004 | 33.59891 Overland Park | Kansas | United States | -94.67079 | 38.98223 Las Vegas | Nevada | United States | -115.13722 | 36.17497 Durham | North ...
0
NCT00500149