ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02073461
Conditions: Acne Vulgaris
Keywords: Acne Vulgaris
Sponsor: Galderma R&D
Start date: 2014-03-01; Completion date: 2014-10-01
Enrollment: 236 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to assess the efficacy and safety of two concentrations of CD1579 (2.5% and 5%) versus vehicle in the treatment of acne vulgaris in the Japanese patients.

Detailed description:

Arms: arm 1: Benzoyl Peroxide 2.5% arm 2: Benzoyl Peroxide 5% arm 3: Vehicle
Interventions: intervention 1: CD1579 2.5% intervention 2: CD1579 5% intervention 3: Vehicle
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02084511
Conditions: Pain, Postoperative
Sponsor: Boehringer Ingelheim
Start date: 2014-03-01; Completion date: 2014-10-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate the effectiveness of BI 1026706 powder for reconstitution of an oral solution compared to placebo and the relative effectiveness compared to Celecoxib.

Detailed description:

Arms: arm 1: BI 1026706 low dose arm 2: BI 1026706 high dose arm 3: Placebo reference arm 4: Celecoxib capsule
Interventions: intervention 1: Placebo to BI 1026706 solution intervention 2: BI 1026706 intervention 3: Placebo to BI 1026706 tablet intervention 4: Celecoxib
Intervention descriptions: intervention 1: Placebo to BI 1026706 solution intervention 2: BI 1026706 intervention 3: Placebo to BI 1026706 tablet intervention 4: Celecoxib capsule

Protocol documents:
Clinical trial NCT02088957
Conditions: Nonconvulsive Electrographic Seizures
Keywords: Brivaracetam Phenytoin Nonconvulsive electrographic seizures
Sponsor: UCB BIOSCIENCES, Inc.
Start date: 2014-03-01; Completion date: 2014-10-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to compare the efficacy of Brivaracetam and Phenytoin, both administered intravenously, in adult subjects experiencing nonconvulsive electrographic seizures.

Detailed description:

Arms: arm 1: Subjects will receive an acute intravenous (iv) dose of Brivaracetam (BRV) 200 mg as a bolus on Day 1. If seizures recur, a second iv bolus of BRV 100 mg can be given no sooner than 15 minutes after the first bolus. If the second acute bolus is not needed within12 hours after first iv bolus, BRV will be continued as 100 mg iv dose every 12 hours (bid). The total dose for the first 24 hours of treatment should not exceed a maximum dose of 400 mg. The rate of bolus administration is 50 mg (5 mL) undiluted BRV/min. On study Day 5 (or earlier), subjects will transition from iv to oral formulation, at comparable dosing for a maximum of 6 months.

Subjects should transition to oral medication as soon as they are able to swallow tablets. arm 2: Subjects will receive an acute intravenous (iv) dose of Phenytoin (PHT) 20 mg/kg at a rate of 50 mg/min on Day 1. If seizures recur, a second acute dose of PHT iv will be given no sooner than 15 minutes after the first dose. Treatment with PHT iv will be continued with at least 2 daily divided doses according to site practice. Daily PHT dose can be adapted according to investigator's clinical judgment. On study Day 5 (or earlier), subjects will transition from iv to oral formulation at comparable dosing for a maximum of 6 months.

Subjects should transition to oral medication as soon as they are able to swallow tablets.
Interventions: intervention 1: Brivaracetam intravenous solution intervention 2: Brivaracetam oral tablets intervention 3: Phenytoin intravenous solution intervention 4: Phenytoin oral tablets
Intervention descriptions: intervention 1: * Active Substance: Brivaracetam
* Pharmaceutical Form: Solution for infusion
* Concentration: 10 mg/mL
* Route of Administration: Intravenous bolus use intervention 2: * Active Substance: Brivaracetam
* Pharmaceutical Form: Film-coated tablet
* Concentration: 10 mg and 25 mg tablets; Daily Dose: 200 mg/day (100 mg bid)
* Route of Administration: Oral use intervention 3: * Active Substance: Phenytoin
* Pharmaceutical Form: Solution for infusion
* Concentration: 50 mg/mL
* Route of Administration: Intravenous use intervention 4: * Active Substance: Phenytoin
* Pharmaceutical Form: Tablet
* Concentration: Weight based
* Route of Administration: Oral use

Protocol documents:
Clinical trial NCT02097485
Conditions: Head Lice Infestation
Sponsor: Dr. Reddy's Laboratories Limited
Start date: 2014-05-01; Completion date: 2014-10-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study was to evaluate ovicidal efficacy of a single application of abametapir lotion 0.74% w/w intended for the treatment of head lice.

Detailed description:
This was a double-blind, randomised, vehicle-controlled, parallel group study in males and females, aged three years and older with active head lice infestation. The study was designed to assess the ovicidal efficacy of a single application of abametapir lotion 0.74% w/w compared to a vehicle control, when applied to the scalp and hair for 10 minutes at the study site. This study used an ex vivo method of assessment for ovicidal efficacy.

Arms: arm 1: Topically administered to hair and scalp for 10 minutes application. arm 2: Administered to scalp and hair for 10 minutes application.
Interventions: intervention 1: Abametapir Lotion 0.74% w/w intervention 2: Vehicle Lotion
Intervention descriptions: intervention 1: 200mL abametapir lotion topically administered to the scalp and hair and once fully saturated left for 10 minutes and then washed out thoroughly with warm water. intervention 2: control to abametapir: 200mL Vehicle Lotion topically administered to the scalp and hair and once fully saturated left for 10 minutes and then washed out thoroughly with warm water.

Protocol documents:
Clinical trial NCT02100748
Conditions: Acute Pain
Keywords: moderate to severe acute pain bunionectomy
Sponsor: Trevena Inc.
Start date: 2014-04-01; Completion date: 2014-10-01
Enrollment: 333 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with placebo in patients with acute postoperative pain after bunionectomy.

Detailed description:
The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with placebo in patients with acute postoperative pain after bunionectomy. The results section also includes data from the morphine arms.

Arms: arm 1: TRV130 1 mg IV Q4H x 48 h arm 2: TRV130 2 mg IV Q4H x 48 h arm 3: TRV130 3 mg IV Q4H x 48 h arm 4: TRV130 4 mg IV Q4H x 48 h arm 5: Morphine 4 mg IV Q4H x 48 h arm 6: Placebo (D5W) IV Q4H x 48 h
Interventions: intervention 1: TRV130 intervention 2: Morphine intervention 3: Placebo
Intervention descriptions: intervention 1: TRV130 1 - 4 mg will be administered every 4 hours intervention 2: Morphine 4 mg will be administered every 4 hours intervention 3: Placebo will be administered every 4 hours

Protocol documents:
Clinical trial NCT02109172
Conditions: Chronic Obstructive Pulmonary Disease COPD
Keywords: Chronic Obstructive Pulmonary Disease COPD
Sponsor: Mylan Inc.
Start date: 2014-04-01; Completion date: 2014-10-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study evaluated the safety and efficacy of once and twice daily TD-4208 and placebo when administered using a jet nebulizer for 7 days in a cross-over design to patients with moderate to severe chronic obstructive pulmonary disease.

Detailed description:

Arms: arm 1: TD-4208 inhalation solution 44 mcg twice daily for 7 days arm 2: Placebo inhalation solution twice daily for 7 days arm 3: TD-4208 inhalation solution 175 mcg once daily, placebo once daily
Interventions: intervention 1: TD-4208 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02132169
Conditions: Atopic Disease (Including Allergic Conjunctivitis)
Sponsor: Aciex Therapeutics, Inc.
Start date: 2014-05-01; Completion date: 2014-10-01
Enrollment: 512 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety of AC-170 0.24% used twice daily in Healthy Adult Subjects and in Pediatric subjects with a history or family history of atopic disease (including allergic conjunctivitis).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Drug: AC-170 0.24% intervention 2: AC-170 0%
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02142153
Conditions: Invasive Aspergillosis
Keywords: First in man Antifungal Intravenous infusion Healthy volunteers
Sponsor: F2G Biotech GmbH
Start date: 2014-08-01; Completion date: 2014-10-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
F901318 is a potent new antifungal agent for the treatment of systemic fungal infections. This study will test it for the first time in man with the objective of assessing its safety, tolerability and pharmacokinetic profile.

Detailed description:
Double blind, placebo controlled, ascending single intravenous dose, sequential group study. Forty subjects will be studied in 5 cohorts (Groups A to E), each group consisting of 8 subjects. Each subject will be on study for approximately 6 weeks. Each subject will participate in one treatment cohort only, residing at the Clinical Research Unit (CRU) from Day -1 (the day before dosing) to Day 6 (120 hours post-dose). Each cohort will be dosed in a leading edge design in which two subjects will receive study drug (1 active and 1 placebo) on the first dosing day, and the last 6 will receive study drug (active or placebo) on the second dosing day.

All subjects will return for a post-study visit 8 to 10 days after the dose of study medication.

Cohorts will be dosed at 2 weekly intervals. There will be a review of safety and pharmacokinetic data prior to each dose escalation.

Arms: arm 1: Single intravenous infusion over 4 hours arm 2: Single intravenous infusion over 4 hours arm 3: Single intravenous infusion over 4 hours arm 4: Single intravenous infusion over 4 hours arm 5: Single intravenous infusion over 4 hours arm 6: Single intravenous infusion over 4 hours arm 7: Single intravenous infusion over 4 hours arm 8: Single intravenous infusion over 4 hours arm 9: Single intravenous infusion over 4 hours arm 10: Single intravenous infusion over 4 hours
Interventions: intervention 1: F901318 intervention 2: Placebo
Intervention descriptions: intervention 1: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.

Pharmacokinetic profile intervention 2: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities

Protocol documents:
Clinical trial NCT02147899
Conditions: Bacterial Vaginosis
Sponsor: Symbiomix Therapeutics
Start date: 2014-05-01; Completion date: 2014-10-01
Enrollment: 215 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to test the safety and effectiveness of the oral investigational new drug, SYM-1219, for the treatment of bacterial vaginosis.

Detailed description:
:This was a Phase 2, multi-center, prospective, randomized, double-blind, placebo-controlled study to evaluate the effectivenessand safety of SYM-1219 in women with bacterial vaginosis. Patients determined to be eligible for the study were randomized to one of the following treatments: SYM-1219 1 gram orallyas a single dose;SYM-1219 2 grams orally as a single dose;or matching placebo. Patients determined to be eligible based on the clinical assessments at the Baseline visit (Day 1) were randomized in a 1:1:1 ratio and received a singledose of the assigned study treatment on Day 1 under fasted conditions (i.e., no food 2 hours prior to or 1 hour after dosing). The centralized randomization was stratified by the number of reported episodes of BV in the past 12 months (including the current episode): 3 or fewer episodes versus 4 or more episodes. Patients were asked to complete a daily telephone questionnaire on Days1to7 and at the Test of Cure (TOC)/End of Study (EOS)visit. Patients were also contacted by telephone once on Day 8 to 10 to inquire about possible adverse events (AEs). A TOC visit was conducted between Day 21 and 30; or at EOSif the final visit was notconducted between Day 21and30

Arms: arm 1: Administered orally arm 2: Administered orally arm 3: Administered orally
Interventions: intervention 1: SYM-1219 intervention 2: Placebo
Intervention descriptions: intervention 1: Oral intervention 2: Oral

Protocol documents:
Clinical trial NCT02169336
Conditions: Pain, Post-operative
Keywords: Bunion Bunionectomy Pain Analgesia dexmedetomidine intranasal
Sponsor: Baudax Bio
Start date: 2014-06-01; Completion date: 2014-10-01
Enrollment: 95 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the analgesic efficacy of two dose levels of DEX-IN compared with placebo, using the summed pain intensity difference over the first 48 hours (SPID48) in subjects with acute moderate to severe pain following unilateral bunionectomy.

Detailed description:

Arms: arm 1: DEX-IN 35mcg every 6 hours for 48 hours. DEX-IN 35mcg PRN for up to 3 additional days. arm 2: DEX-IN 50mcg every 6 hours for 48 hours. DEX-IN 50mcg PRN for up to 3 additional days. arm 3: IN Placebo every 6 hours for 48 hours. IN Placebo PRN for up to 3 additional days.
Interventions: intervention 1: Intranasal Dexmedetomidine intervention 2: Intranasal Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02183675
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2014-07-01; Completion date: 2014-10-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To assess drug drug interaction through pharmacokinetics investigation at steady state of Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ) given as three different formulations in healthy Japanese male subjects

Detailed description:

Arms: arm 1: Telmisartan/Amlodipine/HCTZ fixed-dose combination arm 2: Telmisartan/Amlodipine fixed-dose combination arm 3: Telmisartan/HCTZ fixed-dose combination
Interventions: intervention 1: Telmisartan/Amlodipine intervention 2: Telmisartan/Amlodipine/HCTZ intervention 3: Telmisartan/HCTZ
Intervention descriptions: intervention 1: Telmisartan/Amlodipine fixed-dose combination intervention 2: Telmisartan/Amlodipine/HCTZ fixed-dose combination intervention 3: Telmisartan/HCTZ fixed-dose combination

Protocol documents:
Clinical trial NCT02221349
Conditions: Dentin Sensitivity
Keywords: Sensitivity
Sponsor: Procter and Gamble
Start date: 2014-08-01; Completion date: 2014-10-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the safety and effectiveness of normal oral hygiene with two different marketed dentifrices, on longer term dentinal hypersensitivity response following use of potassium oxalate desensitizers.

Detailed description:

Arms: arm 1: Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Stannous fluoride paste, self applied arm 2: Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Sodium fluoride paste, self applied
Interventions: intervention 1: Potassium oxalate intervention 2: Sodium fluoride paste intervention 3: Stannous fluoride paste
Intervention descriptions: intervention 1: Professionally applied (liquid) and self applied (gel) intervention 2: Toothpaste used by subject intervention 3: Toothpaste used by subject

Protocol documents:
Clinical trial NCT02230995
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2014-09-01; Completion date: 2014-10-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose combination (FDC) tablet containing empagliflozin and metformin extended release compared to the free combination of empagliflozin and metformin extended release under fed conditions.

Detailed description:

Arms: arm 1: Single dose empagliflozin/metformin arm 2: single doses empagliflozin and metformin
Interventions: intervention 1: metformin intervention 2: empagliflozin/metformin intervention 3: empagliflozin
Intervention descriptions: intervention 1: single dose of metformin given as tablets intervention 2: Single dose empagliflozin/metformin given as fixed-dose combination tablet intervention 3: single dose of empagliflozin given as tablet

Protocol documents:
Clinical trial NCT02252354
Conditions: Healthy Volunteers
Keywords: Drug therapy
Sponsor: Takeda
Start date: 2014-09-01; Completion date: 2014-10-01
Enrollment: 12 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this 2 part study is to look at how TAK-385 is taken up, broken down and removed from the body when given as a radiolabelled oral solution (by mouth) or as an oral tablet (by mouth) followed by a radiolabelled intravenous (IV) infusion (into the arm vein).

Detailed description:
The study will consist of 2 parts involving up to 12 healthy male participants. In Part 1, up to 6 participants will receive a single 80 mg dose of \[14C\]-TAK-385 administered as an oral solution. In Part 2, up to 6 participants will receive a single oral 80 mg dose of TAK-385 administered as two 40 mg tablets and an 80 μg intravenous (into a vein) dose of \[14C\]-TAK-385 (containing not more than 37.0kBq \[1000 nCi\] 14C).

This single centre study will take place in the United Kingdom.

Arms: arm 1: \[14C\]-TAK-385 80 mg, solution, orally, once on Day 1. arm 2: TAK-385 80 mg, tablets, orally, and \[14C\]-TAK-385 80 μg, infusion, intravenous once on Day 1.
Interventions: intervention 1: [14C]-TAK-385 Oral Solution intervention 2: TAK-385 Tablets intervention 3: [14C]-TAK-385 Solution for Intravenous Infusion
Intervention descriptions: intervention 1: TAK-385 oral radiolabelled solution intervention 2: TAK-385 tablets 2 X 40 mg intervention 3: TAK-385 intravenous (IV) radiolabelled solution

Protocol documents:
Clinical trial NCT02255513
Conditions: Attention Deficit Hyperactivity Disorder
Sponsor: Ironshore Pharmaceuticals and Development, Inc
Start date: 2014-05-01; Completion date: 2014-10-01
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will examine the efficacy and safety of HLD200 in patients age 6-12 years with ADHD using a classroom study design.

Detailed description:
The study consists of two distinct treatment phases. The first is the 6-week open-label, treatment optimization phase during which subjects are titrated to an optimal daily dose of HLD200. Subjects are then randomized to receive either optimal HLD200 or matched placebo treatment for an additional week prior to final testing during a laboratory school day.

Arms: arm 1: HLD200 (methylphenidate hydrochloride) 20, 40, 60, 80, or 100 mg capsules

Subjects were allowed to titrate to their optimal HLD200 dose during a 6 week open-label, treatment optimization phase before being randomized to continue their HLD200 treatment over an one week double-blind, placebo-controlled phase. HLD200 was administered orally, once daily each evening. arm 2: Placebo capsules (dose matched to HLD200 capsules)

Subjects were allowed to titrate to their optimal HLD200 dose during a 6 week open-label, treatment optimization phase before being randomized to receive placebo treatment over a one week double-blind, placebo-controlled phase. Treatments were administered orally, once daily each evening.
Interventions: intervention 1: HLD200 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02274311
Conditions: Acromegaly
Keywords: Acromegaly SERM Clomiphene
Sponsor: Felipe Henning Gaia Duarte
Start date: 2011-01-01; Completion date: 2014-10-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To assess the impact of clomiphene citrate on serum insulin like growth factor 1 and testosterone levels in male acromegalic patients not controlled by surgery, radiotherapy and/or medical treatments (somatostatin analogues, dopamine agonists and/or growth hormone receptor antagonist)

Detailed description:
Acromegaly, a disease caused by a growth hormone secreting pituitary adenoma, results in reduced life span. Despite the many modalities available to treat this disease,as surgery, medical treatment and radiotherapy, uncontrolled disease persists in a significant portion of patients

Oral estrogens, alone or in combination with somatostatin receptor analogues, have been shown to control acromegaly in women. Selective estrogen receptor modulators (SERMs) resulted in similar effects in both genders. Clomiphene citrate, a SERM that increases luteinizing hormone and follicle stimulating hormone secretion, improves hypogonadism and fertility outcomes.

The aim of this study is to assess the impact of clomiphene citrate on serum insulin like growth factor 1 and testosterone levels in male acromegalic patients not controlled by surgery, radiotherapy and/or medical treatment.

In this prospective, open label, single center trial, sixteen male patients were studied. Clomiphene citrate (50 mg/day) was added to previous medical treatment for 3 months and hormonal assessment was performed prior to and during the intervention. Hormones included: growth hormone, insulin like growth factor, total testosterone, follicle stimulating hormone, luteinizing hormone and prostate-specific antigen.

Arms: arm 1: Patients receiving clomiphene citrate
Interventions: intervention 1: Clomiphene Citrate
Intervention descriptions: intervention 1: Clomiphene citrate, 50 mg, orally for three months

Protocol documents:
Clinical trial NCT02277249
Conditions: Abortion, Induced
Sponsor: University of California, Los Angeles
Start date: 2012-10-01; Completion date: 2014-10-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Current practice for the provision of late second trimester abortion (dilation and evacuation, or D\&E) often involves the administration of digoxin into the fetal compartment to induce fetal demise prior to the procedure. Digoxin may be administered transabdominally or transvaginally into the fetal compartment. Both modes of administration have been shown in prospective studies to be highly effective and safe. Both modes of administration are considered standard of care. This pilot study will directly compare transabdominal and transvaginal digoxin with respect to patient preference (i.e, patient pain score describing discomfort with injection).

Detailed description:

Arms: arm 1: Transvaginal administration of digoxin for inducing fetal death prior to second-trimester abortion arm 2: Transabdominal administration of digoxin for inducing fetal death prior to second-trimester abortion
Interventions: intervention 1: Digoxin (transvaginal administration) intervention 2: Digoxin (transabdominal administration)
Intervention descriptions: intervention 1: Transvaginal digoxin administration prior to second-trimester abortion. This is only listed as a "Procedure/Surgery" type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied. intervention 2: Transabdominal digoxin administration prior to second-trimester abortion. This is only listed as a "Procedure/Surgery" type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied.

Protocol documents: