ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01736241
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2012-12-01; Completion date: 2013-07-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study was to evaluate the safety and tolerability of the study drug known as LY3053102 in healthy participants. The study also investigated how much of the study drug entered the blood stream and how long it took the body to dispose of the study drug. Information about any side effects that occurred was also collected. The study was expected to last approximately 8 weeks for each participant (up to 4 weeks from screening to the administration of study drug and an additional 4 weeks of follow up).

Detailed description:

Arms: arm 1: A single 2-, 7-, 20-, 50-, 150-, or 405-milligrams (mg) dose of LY3053102 was subcutaneously administered to newly randomized participants in 6 escalating dose level cohorts. The dose was escalated based on the safety results over at least a 7-day evaluation period postdose. The dose escalation occurred over 13 weeks proceeding according to tolerability at each dose level. arm 2: A single dose of LY3053102-matching placebo was administered subcutaneously to 1 newly randomized participant in each LY3053102-dose level cohort over 13 weeks.
Interventions: intervention 1: LY3053102 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01737879
Conditions: Anemia
Keywords: Anemia, Chronic Kidney Disease, End Stage Renal Disease, erythropoiesis-stimulating agents, Hemodialysis, Hemoglobin
Sponsor: Amgen
Start date: 2012-10-01; Completion date: 2013-07-01
Enrollment: 41 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate whether hemodialysis patients on peginesatide can be converted to epoetin alfa by using a predefined conversion table while achieving a stable hemoglobin.

Detailed description:
This is a phase 4, multicenter, single-arm, open-label study designed to evaluate whether patients receiving hemodialysis and treated with peginesatide can be converted to epoetin alfa using a predefined conversion table while achieving stable hemoglobin. The study will be conducted in two phases. Hemodialysis patients treated with epoetin alfa 3 times a week (TIW) will first be converted to peginesatide administered every 4 weeks (Q4W). After 24 weeks, these participants will be converted back to epoetin alfa administered TIW for 32 weeks. The primary endpoint will be the mean hemoglobin during the last 8 weeks of the epoetin alfa period.

Arms: arm 1: Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
Interventions: intervention 1: Peginesatide intervention 2: Epoetin alfa
Intervention descriptions: intervention 1: All participants will receive peginesatide for the first 24 weeks. intervention 2: All participants converted to epoetin alfa at week 25 for a total of 32 weeks

Protocol documents:
Clinical trial NCT01743027
Conditions: Allergic Conjunctivitis
Keywords: Allergic conjunctivitis Olopatadine HCl solution Conjunctival Allergen Challenge Itching eyes Ocular allergies PATADAY PATANOL
Sponsor: Alcon Research
Start date: 2013-01-01; Completion date: 2013-07-01
Enrollment: 902 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate an ophthalmic solution for the treatment of ocular itching associated with allergic conjunctivitis using the Conjunctival Allergen Challenge (CAC) model.

Detailed description:
Enrolled participants will be tested for the presence of common allergies using the Conjunctival Allergen Challenge (CAC) model. Drops of increasing concentration of a solubilized allergen will be instilled in both eyes until a positive reaction occurred. The test will be repeated to confirm the allergic reaction. Participants with confirmed reactions will be administered the test article (Day 0) and undergo a CAC 24 hours post-instillation (Day 1). On Day 14, participants will be administered the test article and undergo an additional CAC.

Arms: arm 1: AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14 arm 2: Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14 arm 3: Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14 arm 4: AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
Interventions: intervention 1: AL-4943A ophthalmic solution intervention 2: Olopatadine hydrochloride ophthalmic solution, 0.2% intervention 3: Olopatadine hydrochloride ophthalmic solution, 0.1% intervention 4: AL-4943A ophthalmic solution vehicle
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01749826
Conditions: Inflammation
Keywords: Inflammation, opioids, immune system
Sponsor: Stanford University
Start date: 2010-01-01; Completion date: 2013-07-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
We aim to examine the extent to which inflammation is affected by acute and chronic opioid exposure.

Detailed description:
We are interested in learning how the immune system and the inflammation process is effected by acute and chronic opioid exposure. Preliminary evidence in animal models show that acute opioid exposure leads to decreased inflammatory responses, while chronic opioid exposure causes increased inflammatory responses, as measured by local cytokine release at the site of injury. Translating these findings to humans will lead to important new mechanistic knowledge that may ultimately improve our ability to treat pain.

Arms: arm 1: 15mg sustained release morphine sulfate, with a maximum dose of 120mg. Patients will be titrated up to a maximum dose of 8 pills a day for one month. arm 2: 15mg sustained release morphine sulfate, with a maximum dose of 120mg. Patients will be titrated up to a maximum dose of 8 pills a day for one month.
Interventions: intervention 1: Morphine Sulfate
Intervention descriptions: intervention 1: 15mg sustained release morphine sulfate, with a maximum dose of 120mg. Patients will be titrated up to a maximum dose of 8 pills a day for one month.

Protocol documents:
Clinical trial NCT01765179
Conditions: Male Hypogonadism
Keywords: testosterone male hypogonadism low testosterone
Sponsor: Clarus Therapeutics, Inc.
Start date: 2013-01-01; Completion date: 2013-07-01
Enrollment: 144 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to determine if oral testosterone undecanoate is effective and safe in the treatment of low testosterone in men.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Oral testosterone undecanoate
Intervention descriptions: intervention 1: Initial dose 200 mg T, BID; dose titration Days 42 and/or 84 based on serum T levels obtained 3-5 hours post AM dose on Days 30 and 72. Dosages increased or decreased in 50 mg increments.

Protocol documents:
Clinical trial NCT01774045
Conditions: Major Depressive Disorder
Keywords: Major depressive disorder Depression
Sponsor: BioLite, Inc.
Start date: 2012-11-01; Completion date: 2013-07-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety of PDC-1421 Capsule in healthy subject, find the effective adequate dose for the next stage of the study, and accumulate information of possible mechanism of its anti-depressive effect.

Detailed description:
Outcome measures: Physical examination, Vital sign, Electrocardiograph (ECG), Hematology, Blood chemistry, AEs/SAEs monitoring and Columbia-Suicide Severity Rating Scale (C-SSRS)

Arms: arm 1: Dosage form: 380mg PDC-1421 per Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observing for three Days. arm 2: Dosage form: Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observing for three Days.
Interventions: intervention 1: PDC-1421 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01783860
Conditions: Posterior Blepharitis
Keywords: Azithromycin Doxycycline Posterior Blepharitis
Sponsor: Tehran University of Medical Sciences
Start date: 2013-01-01; Completion date: 2013-07-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
One hundred patients with the diagnosis of posterior blepharitis based on history taking and proper physical examinations by two experienced ophthalmologists will include in the study.

Patients will diagnose with posterior blepharitis if they score at least one in two symptoms (based on a subjective grading scale) and two signs (based on an objective grading scale) of posterior blepharitis according to study criteria. Patients will exclude if they have the following criteria: age\< 12 years old,history of previous ocular or lacrimal surgery,previous usage of contact lenses,any history of ocular allergy,history of systemic diseases with ocular involvement (except rosacea), history of usage of topical or systemic antibiotic in the last month, pregnancy or lactating mothers, liver failure and any history of sensitivity to cyclines.

Qualified patients then randomly receive oral azithromycin (2 of 250 mg capsules for the first day and 250mg for the next 4 days) or oral doxycycline (100mg capsule every 12 hours for one month) in a double-blinded fashion. each patients in both treatment groups will accurately instruct to apply warm compress and eyelid scrubbing 2 times a day for 5 minutes each in the treatment period. Symptoms and signs were recorded for each patient in two treatment groups at baseline visit (before treatment) and then in the days 7, 31, 37 and 61 after treatment.

Detailed description:

Arms: arm 1: Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days. arm 2: Oral doxycycline 100mg capsule every 12 hours for one month
Interventions: intervention 1: Azithromycin intervention 2: Doxycycline
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01818245
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2013-03-01; Completion date: 2013-07-01
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will include 2 groups (cohorts) of participants:

In Cohort A, this study will look at the amount of LY2605541 that is present in the body after it is injected in 3 different locations in the body of the same participant. At least 16 days will pass between each injection.

In Cohort B, the study will look at how the body absorbs, distributes, and disposes of LY2605541 in participants aged 65 and over.

Participants may enroll in only one cohort.

Detailed description:

Arms: arm 1: Participants ≤55 years of age will receive 1 subcutaneous (SC) injection of 0.5 Units per kilogram (U/kg) of LY2605541 in the abdominal wall on Day 1 in 1 of 3 treatment periods. There was a washout period of 16-28 days between each treatment period. arm 2: Participants ≤55 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the upper arm on Day 1 in 1 of 3 treatment periods. There was a washout period of 16-28 days between each treatment period. arm 3: Participants ≤55 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the thigh on Day 1 in 1 of 3 treatment periods. There was a washout period of 16-28 days between each treatment period. arm 4: Participants ≥65 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the abdominal wall on Day 1.
Interventions: intervention 1: LY2605541
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01838785
Conditions: Healthy
Keywords: 18F-DTBZ AV-133 imaging
Sponsor: Chang Gung Memorial Hospital
Start date: 2012-07-01; Completion date: 2013-07-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A total 25 healthy subjects will be included in this study. Subjects between 20 and 80 years of age may be eligible for this study. Candidates are screened with a medical history and physical examination, and blood test.

Detailed description:
The primary objective of this protocol is to assess the possible age-dependent decline in striatal 18F-DTBZ uptake of healthy subjects.

This study is expected to be completed in a period of 2 years.

Arms: arm 1: 18F-DTBZ AV-133 imaging
Interventions: intervention 1: 18F-DTBZ AV-133
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01844830
Conditions: Anesthesia
Keywords: operative dental procedure
Sponsor: St. Renatus, LLC
Start date: 2013-05-01; Completion date: 2013-07-01
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy of Kovacaine Mist, and Placebo for inducing pulpal anesthesia of the maxillary teeth in pediatric patients.

Detailed description:
The study will employ a multi-center, randomized, double-blind, placebo-controlled, parallel-groups design to demonstrate the safety and efficacy of Kovacaine Mist delivered intranasally for inducing pulpal anesthesia of maxillary permanent teeth numbers 4 to 13 (maxillary right second premolar to maxillary left second premolar) or maxillary primary teeth numbers A to J (maxillary right second primary molar to maxillary left second primary molar) sufficient to allow completion of the Study Dental Procedure. The maxillary teeth will be categorized in two subsets, anterior teeth (permanent teeth numbers 6 to 11 and primary teeth numbers C to H) and posterior teeth (permanent teeth numbers 4, 5, 12, 13 and primary teeth numbers A, B, I, J).

The intent is to treat 90 male and female subjects aged 3 to 17 years, inclusive, at 3 study sites, 2:1 randomization within each study site, and an overall goal of 60 subjects treated with Kovacaine Mist and 30 treated with placebo. Subjects will receive Kovacaine Mist or placebo (2:1) according to the kit randomization plan within three dosing strata (100 µL, 200 µL or 400 µL) based on subject weight at entry: subjects weighing 10 to \<20 kg, 20 to \<40 kg and ≥ 40 kg will be assigned to the 100 µL, 200 µL or 400 µL dose group, respectively. Recruitment will be from diverse pediatric dental patient populations. To ensure adequate representation in the 3 dose/weight groups, each stratum will contain at least 25% of subjects.

Arms: arm 1: Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total); arm 2: Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Interventions: intervention 1: Tetracaine HCl 3% and Oxymetazoline HCl 0.05% intervention 2: Placebo
Intervention descriptions: intervention 1: Intranasally administered regional anesthetic intervention 2: Inactive ingredients supplied in identical nasal sprayer

Protocol documents:
Clinical trial NCT01849848
Conditions: Relapsed/Refractory Multiple Myeloma
Sponsor: SymBio Pharmaceuticals
Start date: 2011-11-01; Completion date: 2013-07-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the antitumor efficacy and safety of bendamustine (SyB L-0501: 90 mg/m\^2/day) for a maximum of 6 cycles (1 cycle: intravenous administration for 2 consecutive days and 26-day observation period) in patients with relapsed/refractory multiple myeloma.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: SyB L-0501
Intervention descriptions: intervention 1: The administration of SyB L-0501 at 90 mg/m\^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.

Protocol documents:
Clinical trial NCT01852019
Conditions: Coronary Artery Disease
Keywords: CAD
Sponsor: The Medicines Company
Start date: 2013-06-01; Completion date: 2013-07-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To demonstrate that patients treated with cangrelor can be directly switched to oral prasugrel and that patients treated with prasugrel can be switched to cangrelor without a significant decrease in the extent of inhibition of platelet aggregation.

Detailed description:

Arms: arm 1: Cangrelor IV + Oral prasugrel (60mg) administered within 5 minutes after cangrelor IV discontinuation arm 2: Prasugrel discontinued 48h (n=6) prior to initiation of cangrelor infusion (2h) arm 3: Cangrelor IV + oral prasugrel (60mg) administered at 1.5h after the cangrelor infusion start time. arm 4: Cangrelor IV + oral prasugrel (60mg) administered at 1.0h after the cangrelor infusion start time. arm 5: Prasugrel discontinued 24h prior to initiation of cangrelor infusion (2h)
Interventions: intervention 1: Cangrelor intervention 2: Prasugrel
Intervention descriptions: intervention 1: Cangrelor IV administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8 intervention 2: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.

Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.

Protocol documents:
Clinical trial NCT01853475
Conditions: Malaria
Keywords: pharmacokinetics safety tolerability bioavailability
Sponsor: Medicines for Malaria Venture
Start date: 2013-04-01; Completion date: 2013-07-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Piperaquine tablets (coated) + OZ439 granules + TPGS granules will be co-administered in Phase IIb (adults). However, safety and PK data (for OZ439 plus piperaquine) were obtained using piperaquine tablets plus OZ439 as Powder in Bottle with milk. Piperaquine has not yet been administered together with TPGS. Co-administration of piperaquine plus OZ439 as Powder in Bottle (PIB) with milk results in an increase in OZ439 exposure (current estimate \~ 70% due to a small drug drug interaction).

This study investigates the exposure of piperaquine and OZ439 when co-administered as piperaquine phosphate tablets and OZ439 + TPGS prototype (a formulation close to that of Phase IIb, but not identical), in order to select the appropriate doses for Phase IIb. The reference treatment is piperaquine phosphate tablets + OZ439 Powder in Bottle + full fat milk

Detailed description:
Objectives:

1. To evaluate the piperaquine and OZ439 pharmacokinetics when administered as a combination of piperaquine phosphate tablets with OZ439 / TPGS formulation in the fasted state
2. To evaluate the piperaquine and OZ439 pharmacokinetics of a reference free combination formulation: piperaquine phosphate tablets with OZ439 powder in bottle (PIB) given with full fat milk
3. To determine safety and tolerability of OZ439 and piperaquine phosphate when co-administered.

Arms: arm 1: PQP tablets 1440mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted. arm 2: PQP tablets 960mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted. arm 3: PQP Tablets 1440 mg and OZ439 PIB 800mg + full fat cow's milk
Interventions: intervention 1: PQP tablets 960mg intervention 2: PQP tablets 1440mg intervention 3: OZ439+TPGS 800mg intervention 4: OZ439 PIB 800mg
Intervention descriptions: intervention 1: Piperaquine phosphate tablets 960mg intervention 2: Piperaquine phosphate tablets 1440mg intervention 3: OZ439+TPGS prototype formulation 800mg intervention 4: OZ439 Powder in Bottle Aqueous Solution 800mg

Protocol documents:
Clinical trial NCT01854710
Conditions: Healthy Volunteers
Keywords: ADASUVE inhaled loxapine thorough QT/QTc study
Sponsor: Alexza Pharmaceuticals, Inc.
Start date: 2013-05-01; Completion date: 2013-07-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Assess the potential effects on the QT interval of 2 consecutive doses of ADASUVE administered 2 hours apart, in relation to placebo and an active control in healthy volunteers.

Detailed description:
It has been shown in a pre-marketing clinical study that clinically relevant QT prolongation does not appear to be associated with a single dose of ADASUVE. The potential risk of QTc prolongation following repeat dosing is unknown. Therefore the current study will assess the potential effects on the QT interval of 2 consecutive doses of ADASUVE administered 2 hours apart, in relation to placebo and an active control in healthy volunteers.

The study hypothesis H0: Placebo-subtracted max mean dQTc \> 10 msec

Arms: arm 1: Treatment: A = Inhaled loxapine (2 doses of 10 mg 2 hours apart) + oral placebo, B = Inhaled placebo + oral placebo, C = Oral moxifloxacin 400 mg + Inhaled placebo arm 2: Treatment: A = Inhaled loxapine (2 doses of 10 mg 2 hours apart) + oral placebo, B = Inhaled placebo + oral placebo, C = Oral moxifloxacin 400 mg + Inhaled placebo arm 3: Treatment: A = Inhaled loxapine (2 doses of 10 mg 2 hours apart) + oral placebo, B = Inhaled placebo + oral placebo, C = Oral moxifloxacin 400 mg + Inhaled placebo arm 4: Treatment: A = Inhaled loxapine (2 doses of 10 mg 2 hours apart) + oral placebo, B = Inhaled placebo + oral placebo, C = Oral moxifloxacin 400 mg + Inhaled placebo arm 5: Treatment: A = Inhaled loxapine (2 doses of 10 mg 2 hours apart) + oral placebo, B = Inhaled placebo + oral placebo, C = Oral moxifloxacin 400 mg + Inhaled placebo arm 6: Treatment: A = Inhaled loxapine (2 doses of 10 mg 2 hours apart) + oral placebo, B = Inhaled placebo + oral placebo, C = Oral moxifloxacin 400 mg + Inhaled placebo
Interventions: intervention 1: ADASUVE 10 mg 2 doses 2 hours apart intervention 2: Inhaled Placebo intervention 3: Oral moxifloxacin 400 mg intervention 4: Oral placebo
Intervention descriptions: intervention 1: Inhaled loxapine 10 mg 2 doses 2 hours apart intervention 2: Staccato placebo via inhalation x 2 at 2 hours apart intervention 3: Oral moxifloxacin 400 mg single dose intervention 4: Oral capsule identical in appearance to moxifloxacin

Protocol documents: