ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01399008
Conditions: Gout
Keywords: Hyperuricemia
Sponsor: Gilead Sciences
Start date: 2011-06-01; Completion date: 2012-02-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy, safety and tolerability of MBX-102 in combination with allopurinol compared to allopurinol alone when administered orally once a day for four weeks to gout patients with an inadequate hypouricemic response to allopurinol alone.

Detailed description:

Arms: arm 1: Arhalofenate 400 mg plus allopurinol 300 mg arm 2: Arhalofenate 600 mg plus allopurinol 300 mg arm 3: Placebo plus Allopurinol 300 mg
Interventions: intervention 1: Arhalofenate intervention 2: Allopurinol intervention 3: Colchicine intervention 4: Placebo
Intervention descriptions: intervention 1: Arhalofenate 400 and 600 mgs over-encapsulated tablets once daily for 4 weeks or Allopurinol 300 mg once daily for 4 weeks intervention 2: Allopurinol 300 mg as active comparator intervention 3: 0.6 mg colchicine daily as flare prophylaxis intervention 4: Placebo

Protocol documents:
Clinical trial NCT01401010
Conditions: Febrile Neutropenia
Keywords: neutropenia doripenem
Sponsor: Gary E. Stein, Pharm.D.
Start date: 2010-08-01; Completion date: 2012-02-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Primary: To determine the serum pharmacokinetics (PK) of doripenem in febrile neutropenic patients.

Secondary: Monte Carlo Simulations Tested Against Various Gram-negative Isolates and Reported as Probability of Target Attainment (40% Time (fT)\> minimum inhibitory concentration (MIC))

Detailed description:
Background: Doripenem is a group 2 carbapenem with enhanced in vitro activity against Gram-negative bacteria including Pseudomonas aeruginosa. Currently, there is a paucity of pharmacokinetic/pharmacodynamic data on doripenem in patients with febrile neutropenia.

Objectives: To conduct a pharmacokinetic and safety evaluation of two doses of doripenem in febrile neutropenic patients and provide probability estimates of attaining effective drug exposure against common Gram-negative pathogens.

Methods: We obtained multiple blood samples from 12 adult patients with febrile neutropenia who were receiving either 500 mg or 1000 mg of doripenem IV over 4-hours every 8 hours. Following at least 2 doses, serum concentrations were measured in each subject at 1, 4, 6 and 8 hours after initiation of a dose by a validated HPLC assay. The derived pharmacokinetic (PK) parameters from these serum levels were utilized to perform a 5000 patient Monte Carlo simulation against bacteria with minimal inhibitory concentrations (MICs) of 0.008 to 64 mg/L to determine probability estimates of time of free drug concentration \> MIC (fT\>MIC).

Results: The mean PK parameters in these patients were a volume of distribution (Vd) of 43.9L, an elimination rate constant (k) of 0.37 hr -1, a total clearance (Cl) of 14.4 L/h, and an area under the concentration-time curve (AUC) of 57.6 mg∙h/L. An optimal probability of target attainment (40% fT\>MIC) of 90% was obtained against bacteria with MICs ≤ 2.0 and ≤ 4.0 mg/L with 500 mg and 1000 mg doses, respectively. Adverse events associated with doripenem were not observed in these patients.

Conclusions: The findings from this analysis of doripenem suggest that higher doses as well as prolonged infusions may be necessary to optimally treat selected Gram-negative bacteria (eg. Pseudomonas aeruginosa) in patients with febrile neutropenia

Arms: arm 1: pharmacokinetics/pharmacodynamics arm 2: pharmacokinetics/pharmacodynamics
Interventions: intervention 1: Doripenem intervention 2: doripenem
Intervention descriptions: intervention 1: 500 mg every 8 hours intervention 2: 1000 mg every 8 hours

Protocol documents:
Clinical trial NCT01407523
Conditions: Epilepsy Partial Onset Seizures
Keywords: Levetiracetam Infusion Epilepsy Partial Onset Seizures
Sponsor: UCB Japan Co. Ltd.
Start date: 2011-07-01; Completion date: 2012-02-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate the safety of Levetiracetam IV 15-minute infusion administered every 12 hours as adjunctive treatment in subjects with Partial Onset Seizures after switching from the equivalent Levetiracetam oral dose.

Detailed description:

Arms: arm 1: Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.
Interventions: intervention 1: Levetiracetam
Intervention descriptions: intervention 1: * Formulation: concentrate for solution for infusion
* Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)
* Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day
* Frequency: twice daily

Protocol documents:
Clinical trial NCT01414010
Conditions: Human Gut Microbiota
Keywords: healthy volunteers gut microbiota gut microbiome prebiotic probiotic antibiotic antibiotic-associated diarrhea intestinal bacterial overgrowth
Sponsor: Beth Israel Deaconess Medical Center
Start date: 2011-08-01; Completion date: 2012-02-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare and contrast the effects of a prebiotic (Trametes Versicolor), a probiotic (Saccharomyces boulardii) and an antibiotic (amoxicillin) on the gut microbiota of healthy volunteers. It is expected that treatment will result in the rapid and reproducible alterations in fecal microbiota that will spontaneously reverse in the weeks after treatment is discontinued.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: Control group, no intervention given.
Interventions: intervention 1: Trametes versicolor extract intervention 2: Saccharomyces boulardii intervention 3: Amoxicillin
Intervention descriptions: intervention 1: 1,200 mg, 3 times daily on an empty stomach for 14 days intervention 2: 250 mg, 3 times daily on an empty stomach for 14 days intervention 3: 250 mg 3 times daily at least 1 hour before meals for 7 days

Protocol documents:
Clinical trial NCT01425801
Conditions: Asthma
Keywords: COPD
Sponsor: AstraZeneca
Start date: 2011-08-01; Completion date: 2012-02-01
Enrollment: 62 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate the pharmacodynamics of single doses of inhaled LAS100977 QD in patients with persistent asthma.

Detailed description:

Arms: arm 1: Single-dose LAS100977 0.625 μg, during double-blind treatment period arm 2: Single-dose LAS100977 1.25 μg, during double-blind treatment period arm 3: Single-dose LAS100977 2.5 μg, during double-blind treatment period arm 4: Single-dose salbutamol 400 μg, during double-blind treatment period arm 5: Placebo to LAS100977, and placebo to salbutamol arm 6: Single-dose LAS100977 0.313 μg, during double-blind treatment period
Interventions: intervention 1: LAS100977 0.313 μg intervention 2: LAS100977 0.625 μg intervention 3: LAS100977 1.25 μg intervention 4: LAS100977 2.5 μg intervention 5: Salbutamol 400 μg intervention 6: Salbutamol placebo intervention 7: LAS100977 placebo
Intervention descriptions: intervention 1: Dry powder inhalation, once-daily, single-dose intervention 2: Dry powder inhalation, once-daily, single-dose intervention 3: Dry powder inhalation, once-daily, single-dose intervention 4: Dry powder inhalation, once-daily, single-dose intervention 5: Pressurized inhalation suspension, once-daily, single-dose intervention 6: Pressurized inhalation, once-daily intervention 7: Dry powder inhalation, once-daily

Protocol documents:
Clinical trial NCT01433107
Conditions: Tinea Pedis
Keywords: Tinea pedis Terbinafine film forming solution
Sponsor: Novartis
Start date: 2011-08-01; Completion date: 2012-02-01
Enrollment: 290 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the efficacy and safety of a single dose of terbinafine film forming solution 1% with a single dose of placebo film forming solution in the treatment of tinea pedis.

Detailed description:

Arms: arm 1: Drug arm 2: Drug
Interventions: intervention 1: Terbinafine intervention 2: Terbinafine Placebo
Intervention descriptions: intervention 1: 1% single application intervention 2: single application

Protocol documents:
Clinical trial NCT01435577
Conditions: Bunion Pain
Keywords: Bunionectomy Postsurgical Pain Acute Pain
Sponsor: Grünenthal GmbH
Start date: 2011-09-01; Completion date: 2012-02-01
Enrollment: 177 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to established the safety and efficacy of multiple dose treatment with tapentadol IV in an adult population with moderate to severe pain following bunionectomy.

Detailed description:

Arms: arm 1: Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone. arm 2: Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
Interventions: intervention 1: Tapentadol intervention 2: Matching Placebo
Intervention descriptions: intervention 1: 30 mg per administration, maximum 12 administrations over 48 hours intervention 2: Maximum 12 administrations over 48 hours

Protocol documents:
Clinical trial NCT01447433
Conditions: Obesity Overweight
Keywords: Calcium Carbonate Vitamin D Body weight Body fat Metabolic parameters Energy restriction Very-low calcium consumers Obesity Overweight
Sponsor: Changhai Hospital
Start date: 2011-04-01; Completion date: 2012-02-01
Enrollment: 53 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine whether calcium plus vitamin D supplementation is conducive to weight and fat loss during energy restriction in very-low calcium consumers.

Detailed description:
Due to the contradicting findings in the hypothesis of calcium supplementation on weight and fat loss, which might be explained by the difference in initial calcium intake, the present study is aimed to evaluate the effect of calcium plus vitamin D supplementation on accelerating weight and fat loss in overweight or obese subjects with very-low calcium consumption(\<600mg/day).

The hypotheses to be tested are:

Calcium plus vitamin D supplementation is conducive to body weight and fat loss in overweight or obese young adults during energy restriction 12 weeks after randomization.

Arms: arm 1: Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure. arm 2: A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
Interventions: intervention 1: Calcium Carbonate intervention 2: Energy restriction
Intervention descriptions: intervention 1: tablet, 600mg elemental calcium and 125IU vitamin D, once daily, for 12 weeks intervention 2: A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.

Protocol documents:
Clinical trial NCT01458210
Conditions: Diabetes Mellitus, Type 2
Sponsor: Eli Lilly and Company
Start date: 2011-10-01; Completion date: 2012-02-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to look at how the body processes oral contraceptive (OC), using Ortho-Cyclen, as a commonly prescribed combination oral contraceptive in healthy female participants, and the effect of dulaglutide on how Ortho-Cyclen is processed by the body. Information about any side effects that may occur will also be collected.

Detailed description:

Arms: arm 1: Ortho-Cyclen (OC) (0.25 milligram \[mg\] norelgestromin \[NGMN\] + 0.035 mg ethinyl estradiol \[EE\] \[active tablets\] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 1 sample was taken during the first 28-day course and the Period 2 sample was taken during the second 28-day course.

Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2.
Interventions: intervention 1: Ortho-Cyclen intervention 2: Dulaglutide
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered subcutaneously

Protocol documents:
Clinical trial NCT01471093
Conditions: Dry Eye Syndromes
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2011-11-01; Completion date: 2012-02-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to assess the safety of OPC-12759 ophthalmic solution in healthy subjects.

Detailed description:

Arms: arm 1: A single dose of OPC-12759 Ophthalmic solution for two-day treatment arm 2: A single dose of OPC-12759 Ophthalmic suspension for two-day treatment
Interventions: intervention 1: OPC-12759 Ophthalmic solution intervention 2: OPC-12759 Ophthalmic suspension
Intervention descriptions: intervention 1: 2％ OPC-12759 Ophthalmic solution intervention 2: 2％ OPC-12759 Ophthalmic suspension

Protocol documents:
Clinical trial NCT01495858
Conditions: Pain, Postoperative
Keywords: Naproxen sodium Diphenhydramine
Sponsor: Bayer
Start date: 2011-12-01; Completion date: 2012-02-01
Enrollment: 267 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the study is to evaluate the efficacy and safety of a single oral dose of naproxen sodium 440 mg in combination with DPH (diphenhydramine) 25 mg in subjects with postsurgical dental pain and phase advanced sleep.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111) intervention 2: Naproxen Sodium 440 mg (BAYH6689) intervention 3: DPH 50 mg
Intervention descriptions: intervention 1: Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally. intervention 2: Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally. intervention 3: Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.

Protocol documents:
Clinical trial NCT01534195
Conditions: Allergic Conjunctivitis
Sponsor: ORA, Inc.
Start date: 2012-01-01; Completion date: 2012-02-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effectiveness of the modified Conjunctival Allergen Challenge (CAC) and observe how the produced allergic inflammation reacts to treatment with a proven ocular anti-inflammatory medication,

Prednisolone, assessed by the following measures:

* Ocular itching
* Conjunctival redness

Detailed description:
Prospective, single center, randomized, double-masked, placebo controlled study. Subjects will be randomized to one of the following treatment arms to dose four times per day (QID) for 8 days between Visits 4 and 5.

* Prednisolone phosphate
* Tears Naturale II Ophthalmic Solution (Placebo)

Duration:

Approximately 19 days

Controls:

Artificial Tears (Tears Naturale® II)

Arms: arm 1: Prednisolone Sodium Phosphate Ophthalmic Solution, 1% arm 2: Tears Naturale II Ophthalmic Solution, 1%
Interventions: intervention 1: Prednisolone Sodium Phosphate Ophthalmic Solution 1% intervention 2: Tears Naturale II Ophthalmic Solution
Intervention descriptions: intervention 1: One drop in each eye, four times/day for 8 days. intervention 2: one drop in each eye, four times/ day (QID) for 8 days

Protocol documents:
Clinical trial NCT01587027
Conditions: Mountain Sickness
Keywords: Altitude Sickness High Altitude Sickness
Sponsor: Poudre Valley Health System
Start date: 2011-12-01; Completion date: 2012-02-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This safety study is the first in a series of studies testing the application of the combination of aminophylline and methazolamide.

Detailed description:
After successful completion of this safety trial, our goal will be to evaluate the safety of this combination in healthy individuals exposed to hypoxia and exercise. Subsequently, an efficacy study will clarify whether this drug combination improves physical and mental functions in human subjects under high altitude conditions.

Arms: arm 1: Aminophylline, Methazolamide, Aminophylline and Methazolamide arm 2: Methazolamide, Aminophylline, Aminophylline and Mathazolamide
Interventions: intervention 1: Aminophylline intervention 2: Methazolamide intervention 3: Aminophylline and Methazolamide
Intervention descriptions: intervention 1: Aminophylline dosage form-tablet dosage-500mg intervention 2: Methazolamide dosage form-tablet dosage-250mg intervention 3: Aminophylline 500mg orally and Methazolamide 250mg orally

Protocol documents:
Clinical trial NCT01610596
Conditions: Psoriasis Plaque Psoriasis
Keywords: Psoriasis Skin Diseases Halobetasol Vasoconstrictor Agents Therapeutic Uses Pharmacologic Actions Anti-Inflammatory Agents Physiological Effects of Drugs
Sponsor: Therapeutics, Inc.
Start date: 2011-11-01; Completion date: 2012-02-01
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a double-blind, multicenter, vehicle-controlled, parallel group comparison study to determine and compare the efficacy and safety of HBP Lotion 0.05% and Vehicle Lotion applied twice daily for two weeks in subjects with moderate to severe plaque psoriasis. Eligible subjects will be randomized (1:1) to one of two treatment groups - HBP Lotion 0.05% or Vehicle Lotion. The maximum amount of test article to be applied per week should not exceed 50 grams.

Detailed description:

Arms: arm 1: Topical lotion, applied twice daily arm 2: Topical lotion, applied twice daily
Interventions: intervention 1: Halobetasol Propionate Lotion 0.05% intervention 2: Placebo
Intervention descriptions: intervention 1: Apply twice daily for 1-2 weeks, not to exceed 50 grams per week intervention 2: None

Protocol documents:
Clinical trial NCT01657903
Conditions: Dental Erosion Acid Wear
Sponsor: GlaxoSmithKline
Start date: 2011-11-01; Completion date: 2012-02-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to compare and evaluate the ability of two European Union (EU) regulated gel to foam toothpaste formulations versus a non-fluoride toothpaste using a modified in-situ model of dental erosion and remineralization. A positive control i.e fluoride containing toothpaste marketed in EU will also be compared to non-fluoride toothpaste.

Detailed description:
The aim of this study is to assess the remineralization effects of two EU gel to foam toothpaste formulations with 1450 parts per million (ppm) of fluoride as sodium fluoride (NaF) and 5% potassium nitrate (KNO3) versus a non-fluoride (0 ppm F)/KNO3 toothpaste as a negative control. The two experimental gel to foam toothpaste formulations differ in their relative dentine abrasivity (RDA) values which is an in-vitro measure of a toothpaste abrasivity to the dentinal tissues. A marketed toothpaste containing NaF and KNO3 will serve as a positive control.

Arms: arm 1: Participants to brush with 1.5 g of low RDA gel to foam toothpaste containing 1450 ppm F - EU level as NaF. All study treatments contain 5% weight by weight (w/w) KNO3. arm 2: Participants to brush with 1.5 g of medium RDA gel to foam toothpaste containing 1450 ppm F - EU level as NaF. All study treatments contain 5% w/w KNO3. arm 3: Participants to brush with 1.5 g of NaF/KNO3 toothpaste containing 1450 ppm F - EU level as NaF. All study treatments contain 5% w/w KNO3. arm 4: Participants to brush with a fluoride free toothpaste (0 ppmF). All study treatments contain 5% w/w KNO3.
Interventions: intervention 1: Sodium Fluoride intervention 2: Potassium nitrate
Intervention descriptions: intervention 1: Toothpaste containing 1450 ppm F - EU level as NaF. intervention 2: All study treatments contain 5% w/w KNO3.

Protocol documents:
Clinical trial NCT01728337
Conditions: Sun-induced Wrinkles
Keywords: botulinum toxin, wrinkles
Sponsor: Brazilan Center for Studies in Dermatology
Start date: 2011-07-01; Completion date: 2012-02-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
this study was proposed to provide more scientific and objective data on the clinical and aesthetic effects of these two toxins (Dysport and Xeomin).

Detailed description:
Subjects will perform 6 (six) visits during the study:

Screening visit, performed 30 to 1 day before the visit 1, when eligible subjects will be recruited and first evaluations will be performed; visit 1, which is the baseline and when the injections will be performed; visit 2, 30 +/- 3 days after the injections, when evaluations will be performed; visit 3, 90 +/- 3 days after the injections, when evaluations will be performed; 4, 120 +/- 3 days after the injections, when evaluations will be performed; visit 5, 150 +/- 3 days after the injections, when evaluations will be performed.

Assessment of percentage (%) of responders, after 5 months of injection, to the effects of two BT-A preparations, Dysport® and Xeomin®, by measuring frontalis m. wrinkle intensity at maximum contraction, as measured by visual Wrinkles Severity Scale (WSS).

Arms: arm 1: 30 U of Dysport® was injected on the right side of the forehead and 12 U Xeomin® was injected on the left side of the forehead (dose-equivalence 2.5:1). arm 2: 30 U Dysport® was injected on the left side of the forehead and 12 U Xeomin® was injected on the right side of the forehead (dose-equivalence 2.5:1).
Interventions: intervention 1: Dysport intervention 2: Xeomin
Intervention descriptions: intervention 1: Dysport® was injected on the right side of the forehead and Xeomin® was injected on the left side of the forehead. intervention 2: Xeomin® was injected on the right side of the forehead and Dysport® was injected on the left side of the forehead

Protocol documents: