ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00539006
Conditions: Rhinitis, Allergic, Perennial
Keywords: fluticasone propionate seasonal allergic rhinitis fluticasone furoate experience GW685698X preference
Sponsor: GlaxoSmithKline
Start date: 2007-08-01; Completion date: 2007-11-01
Enrollment: 377 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this replicate study to FFU105927 is to provide data on subject preference of FFNS as compared with FPNS.

Detailed description:
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 Seasonal Allergic Rhinitis (FFU105924)

Arms: arm 1: active compound arm 2: active compound arm 3: placebo arm arm 4: placebo arm
Interventions: intervention 1: FPNS intervention 2: FFNS intervention 3: placebo FPNS intervention 4: placebo FFNS
Intervention descriptions: 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

Protocol documents:
Clinical trial NCT00564954
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD children laboratory classroom Attention Deficit Hyperactivity Disorder
Sponsor: Novartis Pharmaceuticals
Start date: 2007-10-01; Completion date: 2007-11-01
Enrollment: 86 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study compared the efficacy of dex-methylphenidate extended release 20 mg versus placebo during an 8-hour laboratory classroom day.

Detailed description:

Arms: arm 1: 20 mg capsule orally once a day for 7 days arm 2: orally once a day for 7 days
Interventions: intervention 1: Dex-methylphenidate hydrochloride extended-release (Focalin XR) intervention 2: Placebo
Intervention descriptions: intervention 1: 20 mg capsule orally once a day for 7 days intervention 2: orally once a day for 7 days

Protocol documents:
Clinical trial NCT00591760
Conditions: Heart Failure Growth Hormone Deficiency Ischemic Heart Disease
Keywords: Heart Failure Growth Hormone Anabolism Anabolic Deficiency Hormone replacement
Sponsor: Federico II University
Start date: 2004-12-01; Completion date: 2007-11-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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.

Detailed description:
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 group support the concept that a considerable amount of CHF-patients have a coexisting Growth Hormone Deficiency (GHD), defined by current guidelines(GH stimulation test).

Our study hypothesis is that correction of GH deficiency in patients with chronic heart failure may exert a beneficial effect on their cardiac function and remodeling, performance status and quality-of-life.

Since this was a preliminary study, no sample size calculation was performed; treatment effects from were sought in left ventricular function (as assessed by cardiac MRI), cardiopulmonary exercise performance, clinical status, vascular reactivity, biochemistry and neurohumoral markers of disease (NT-proBNP).

Arms: 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
Interventions: intervention 1: Somatotropin
Intervention descriptions: intervention 1: Subcutaneous Somatotropin (recombinant human Growth Hormone) 0.012 mg/kg every second day for 6 months

Protocol documents:
Clinical trial NCT00669916
Conditions: Plaque Psoriasis
Keywords: Plaque psoriasis
Sponsor: Novartis Pharmaceuticals
Start date: 2007-02-01; Completion date: 2007-11-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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 baseline and subjects will be observed for up to 26 weeks following the infusion.

Detailed description:

Arms: arm 1: AIN457A 3mg/kg was administered intravenously as a single dose. arm 2: Placebo was administered intravenously as a single dose.
Interventions: intervention 1: AIN457 intervention 2: Placebo
Intervention descriptions: intervention 1: single infusion of 3 mg/kg intervention 2: single infusion of placebo

Protocol documents:
Clinical trial NCT00719862
Conditions: Seasonal Allergic Rhinitis
Sponsor: Meda Pharmaceuticals
Start date: 2007-08-01; Completion date: 2007-11-01
Enrollment: 481 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The Purpose of this study is to determine if one allergy medication (0.15% azelastine hydrochloride) is more effective than Placebo alone

Detailed description:

Arms: arm 1: 0mg Placebo Nasal Spray arm 2: 0.15% azelastine hydrochloride
Interventions: intervention 1: Placebo nasal spray intervention 2: 0.15% azelastine hydrochloride Nasal Spray
Intervention descriptions: intervention 1: Placebo intervention 2: 0.15% azelastine hydrochloride 822 mcg

Protocol documents:
Clinical trial NCT00720278
Conditions: Seasonal Allergic Rhinitis
Sponsor: Meda Pharmaceuticals
Start date: 2007-08-01; Completion date: 2007-11-01
Enrollment: 526 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to determine if two allergy medications are more effective than placebo.

Detailed description:

Arms: arm 1: Placebo nasal spray arm 2: 0.1% azelastine hydrochloride nasal spray arm 3: 0.15% azelastine hydrochloride nasal spray
Interventions: intervention 1: 0.15% azelastine hydrochloride 1644 mcg daily intervention 2: 0.1% azelastine hydrochloride 1096 mcg daily intervention 3: Placebo
Intervention descriptions: intervention 1: 0.15% azelastine hydrochloride 1644 mcg daily intervention 2: 0.1% azelastine hydrochloride 1096 mcg daily intervention 3: 0 mcg Placebo daily

Protocol documents:
Clinical trial NCT00758394
Conditions: Dental Plaque
Sponsor: Colgate Palmolive
Start date: 2007-09-01; Completion date: 2007-11-01
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This clinical study was to evaluate the control of dental plaque formation after toothbrushing for 4 days with each of the 4 study toothpastes.

Detailed description:
Evaluation of dental plaque control for two prototype toothpastes will be determined by comparison to two control toothpastes.

Arms: arm 1: Fluoride only toothpaste arm 2: Triclosan/fluoride toothpaste arm 3: toothpaste containing amino acid #1 arm 4: toothpaste containing amino acid/bicarbonate
Interventions: intervention 1: Fluoride intervention 2: Triclosan/Fluoride intervention 3: Triclosan/Fluoride intervention 4: Triclosan/Fluoride
Intervention descriptions: 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

Protocol documents:
Clinical trial NCT00775203
Conditions: Major Depressive Disorder
Keywords: Unipolar
Sponsor: Labopharm Inc.
Start date: 2007-06-01; Completion date: 2007-11-01
Enrollment: 412 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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).

Detailed description:
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 approximately 11 weeks; the total duration of the randomized phase was 8 weeks (titration: 2 weeks + treatment: 6 weeks).

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Trazodone Hydrochloride (HCl) Extended-Release Tablets intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00779558
Conditions: Thrombosis
Sponsor: Stanford University
Start date: 2005-11-01; Completion date: 2007-11-01
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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 thrombosis, compared to a normal saline infusion, in patients less than one year of age after cardiac surgery?

Detailed description:
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, pulmonary) Need for therapeutic heparinization ECMO

Randomization and blinding are performed in the Pharmacy. The intervention is initiated at the intensive care unit physician's discretion, generally within the 1st 24 hours post-operatively. The study is terminated when all catheters have been discontinued or at POD #14, whichever occurs first.

Thrombosis is demonstrated by echocardiogram or ultrasound performed at

1 - 3 days, 5 - 7 days, and 10 - 14 days after initiation of the study drug.

The following are calculations for statistical analysis:

Sample size determination - Using 2 - sided alpha = 0.05 and Beta = 0.2, and assuming a baseline thrombosis incidence of 20%, 160 patients are required to detect an effect size of 15%.

Arms: arm 1: Heparin sulfate infusion at 10 units/kg/hour arm 2: Placebo - normal saline infusion
Interventions: intervention 1: Heparin sulfate infusion at 10 units/kg/hour intervention 2: Placebo infusion
Intervention descriptions: intervention 1: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery intervention 2: Infusion of normal saline

Protocol documents:
Clinical trial NCT00960687
Conditions: Healthy
Keywords: healthy pharmacokinetics therapeutic equivalency
Sponsor: Mutual Pharmaceutical Company, Inc.
Start date: 2007-10-01; Completion date: 2007-11-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
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.

Detailed description:
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. Additionally, the safety and tolerability of this dosing regimen will be evaluated. Fifty-four healthy, non-smoking, non-obese, 18-45 year old, male and female volunteers will be randomly assigned in a crossover fashion to receive each of two dosing regimens (fenofibric acid and fenofibrate) in sequence with a 7 day washout period between dosing periods. On the morning of Day 1, subjects will receive either a single oral dose of the test formulation, fenofibric acid (1 x 105 mg tablet) or a single oral dose of the reference formulation, fenofibrate (1 x 145 mg tablet) 30 minutes after the initiation of a standard breakfast. After a 7 day washout period, on the morning of Day 8, subjects will receive the alternate regimen 30 minutes after the initiation of a standard breakfast. Fasting will continue for 4 hours after each dose. Blood samples will be drawn from all participants before dosing and for 72 hours post dose at times sufficient to adequately define the pharmacokinetics of fenofibric acid. Subjects will be monitored throughout their participation for adverse reactions to the study drug and/or procedures. Seated blood pressure and pulse will be measured prior to each dose and approximately 2 hours post-dose. All adverse experiences, whether elicited by query, spontaneously reported, or observed by clinic staff, will be documented in the subject's case report form.

Arms: 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.
Interventions: intervention 1: Fenofibric Acid (Fibricor™) 105 mg Tablet intervention 2: Fenofibrate (Tricor®) 145 mg Tablet
Intervention descriptions: 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.

Protocol documents:
Clinical trial NCT01021007
Conditions: Dental Plaque
Sponsor: Colgate Palmolive
Start date: 2007-10-01; Completion date: 2007-11-01
Enrollment: 67 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluate the efficacy of an oral rinse on dental plaque and gingival inflammation

Detailed description:

Arms: arm 1: control mouthrinse arm 2: new prototype mouthrinse
Interventions: intervention 1: Iodine intervention 2: water
Intervention descriptions: intervention 1: Rinse 2 times per day for 6 weeks intervention 2: Use 2 times per day for 6 weeks

Protocol documents:
Clinical trial NCT01101178
Conditions: Healthy
Keywords: Healthy subjects Opioid Healthy volunteers
Sponsor: Purdue Pharma LP
Start date: 2007-08-01; Completion date: 2007-11-01
Enrollment: 79 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
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.

Detailed description:
Oxycodone hydrochloride (oxycodone) is a semi-synthetic opioid analgesic that is effective in the relief of moderate to severe malignant and non-malignant pain.

Arms: arm 1: Reformulated OXY 80 mg x 1 dose arm 2: Original OxyContin® (OXY) 80 mg x 1 dose
Interventions: intervention 1: Reformulated OXY (oxycodone HCl) intervention 2: Original OxyContin® (OXY) (oxycodone HCl)
Intervention descriptions: 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.

Protocol documents:
Clinical trial NCT01332318
Conditions: Restless Legs Syndrome
Sponsor: XenoPort, Inc.
Start date: 2007-04-01; Completion date: 2007-11-01
Enrollment: 130 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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 XP13512 1800 mg for 16 days. On Day 16, one of the placebo groups also received one 50 mg dose of diphenhydramine (DPH) to assess the effects of an agent known to have sedative properties, while the other 3 groups received a DPH placebo.

Detailed description:
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) XP13512 1800 mg/day + Diphenhydramine Placebo (1800 mg) D) XP13512 Placebo + 50 mg Diphenhydramine (Pbo/DPH)

Arms: 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
Interventions: intervention 1: XP13512 intervention 2: Diphenhydramine intervention 3: Placebo
Intervention descriptions: 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

Protocol documents:
Clinical trial NCT01924767
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2007-07-01; Completion date: 2007-11-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
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.

Detailed description:

Arms: arm 1: multiple doses as tablet arm 2: multiple doses as tablet arm 3: multiple doses as tablet arm 4: multiple doses as tablet
Interventions: 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
Intervention descriptions: 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: po taken fasting with 240 mL water intervention 8: po taken fasting with 240 mL water

Protocol documents:
Clinical trial NCT02284828
Conditions: Epilepsy
Sponsor: Bial - Portela C S.A.
Start date: 2007-09-01; Completion date: 2007-11-01
Enrollment: 26 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
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.

Detailed description:
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 to assess the ESL acute response relationship with respect to cognitive and motor skill performance, and the multiple doses were chosen to further characterize the ESL dose response relationship with respect to cognitive and motor skill performance.

Arms: 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.
Interventions: intervention 1: BIA 2-093
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00769132
Conditions: Hypercholesterolemia
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-08-03; Completion date: 2007-11-06
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
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.

Detailed description:

Arms: 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
Interventions: intervention 1: Comparator: niacin + laropiprant intervention 2: Comparator: niacin intervention 3: Comparator: laropiprant intervention 4: Comparator: placebo
Intervention descriptions: 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

Protocol documents:
Clinical trial NCT00684515
Conditions: Cerebral Infarction
Sponsor: Merck Sharp & Dohme LLC
Start date: 2006-09-21; Completion date: 2007-11-08
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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.

Detailed description:

Arms: 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
Interventions: intervention 1: Vorapaxar 2.5 mg intervention 2: Vorapaxar 1 mg intervention 3: Placebo intervention 4: Aspirin 75-150 mg
Intervention descriptions: 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

Protocol documents:
Clinical trial NCT00402987
Conditions: Pharyngitis
Keywords: sore throat acute pain
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2006-12-04; Completion date: 2007-11-15
Enrollment: 269 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Celecoxib intervention 2: Celecoxib intervention 3: celecoxib intervention 4: placebo
Intervention descriptions: 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 later by dose 2 placebo

Protocol documents: