ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01454063
Conditions: Intraocular Lens Replacement
Keywords: cataract lens replacement
Sponsor: Omeros Corporation
Start date: 2011-09-01; Completion date: 2012-03-01
Enrollment: 405 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety and efficacy of OMS302 (the study drug) for maintaining intraoperative mydriasis in individuals undergoing Intraocular Lens Replacement (ILR) surgery.

Detailed description:

Arms: arm 1: OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery. arm 2: Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
Interventions: intervention 1: OMS302 intervention 2: Placebo
Intervention descriptions: intervention 1: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL solution containing 60.75 millimolar (mM) phenylephrine hydrochloride (HCl) and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product is added to a 500 mL bottle of commercially available balanced salt solution (BSS) through a syringe filter. This will achieve 4.0 mL of the drug product in a 500 mL bottle of BSS. intervention 2: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product is added to a 500 mL bottle of commercially available BSS through a syringe filter. This will achieve 4.0 mL of the drug product in a 500 mL bottle of BSS.

Protocol documents:
Clinical trial NCT01454505
Conditions: Nasal Allergies Allergies
Keywords: Healthy subjects Nasal allergies Allergies Environmental Exposure Chamber EEC Ragweed
Sponsor: Alcon Research
Start date: 2011-10-01; Completion date: 2012-03-01
Enrollment: 110 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to determine the maximum tolerated dose of AL-53817 (Stage A) and evaluate the safety and efficacy of AL-53817 for the treatment of allergic rhinitis (Stage B).

Detailed description:
Stage A was a 1-day, single ascending dose study utilizing 7 separate cohorts of unique subjects (healthy normal volunteers). Each cohort was administered a different dose of AL-53817 Nasal Spray Solution in order to determine the maximum tolerated dose (MTD).

In Stage B, 2 different cohorts of unique, ragweed-sensitive subjects were administered the MTD for up to 5 days twice a day to determine the safety and efficacy of AL-53817 Nasal Spray Solution for the treatment of allergic rhinitis. Subjects were required to meet minimum allergic rhinitis scores at two qualifying EEC visits to participate in the study. Subjects were continually housed in clinic during the 5-day treatment period.

Arms: arm 1: Stage B: AL-53817 nasal spray solution, 1 spray to each nostril twice a day for 4 days. On Day 5, 1 spray to each nostril 60 minutes before entering the EEC. arm 2: Stage B: Vehicle nasal spray, 1 spray to each nostril twice a day for 4 days. On Day 5, 1 spray to each nostril 60 minutes before entering the EEC.
Interventions: intervention 1: AL-53817 nasal spray solution intervention 2: Vehicle nasal spray
Intervention descriptions: intervention 1: Active ingredients administered in 1 of 3 concentrations during Stage A to determine maximum tolerated dose (MTD), and administered at maximum tolerated dose during Stage B. intervention 2: Inactive ingredients used as placebo comparator during Stage A and Stage B.

Protocol documents:
Clinical trial NCT01460368
Conditions: Diabetes Mellitus, Type 2
Sponsor: Eli Lilly and Company
Start date: 2011-10-01; Completion date: 2012-03-01
Enrollment: 67 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Part A: The purpose of Part A of the study is to look at the electrocardiogram (ECG) effects due to blood sugar changes after a meal compared to when LY2409021 is also given with a meal.

Part B: The purpose of Part B is to evaluate the effect of LY2409021, when given at a dose level much higher than what would normally be given, on the electrical activity of the heart as measured by ECG in relation to placebo and moxifloxacin.

Detailed description:
This is a 2 part study. Part A is a single-dose study to compare the effects of a meal on glucose, insulin and QT in healthy participants with and without LY2409021. Part B of this study is a randomized, 3-period, crossover design, in which participants and investigators are blinded to placebo and LY2409021, and will assess the electrophysiological effects of a single supratherapeutic dose of LY2409021 compared to a positive control (moxifloxacin) and placebo.

Arms: arm 1: Participants will receive 2 standard meals; one alone without LY2409021, and one along with a single dose of 300 milligrams (mg) LY2409021 administered orally. Participants enrolled in Part A will not be allowed to participate in Part B. arm 2: 300 milligrams (mg) LY2409021 administered orally as a single dose on Day 1 of the relevant treatment period. The treatment and washout period was a total of 15 days in length. arm 3: Administered orally as a single dose on Day 1 of the relevant treatment period. The treatment and washout period was a total of 15 days in length. arm 4: 400 milligrams (mg) Moxifloxacin administered orally as a single dose on Day 1 of the relevant treatment period. The treatment and washout period was a total of 15 days in length.
Interventions: intervention 1: LY2409021 intervention 2: Placebo intervention 3: Moxifloxacin
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally intervention 3: Administered orally

Protocol documents:
Clinical trial NCT01473953
Conditions: Diabetes Diabetes Mellitus, Type 2 Healthy
Sponsor: Novo Nordisk A/S
Start date: 2011-10-01; Completion date: 2012-03-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in the United States of America (USA). The aim of this trial is to investigate the safety, tolerability and pharmacokinetics (exposure in the body) of liraglutide-depot in healthy subjects.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: liraglutide-depot intervention 2: placebo
Intervention descriptions: intervention 1: Subjects will be randomised to receive a single dose of liraglutide-depot, at increasing dose levels, injected s.c./subcutaneously (under the skin). Progression to next dose level (max. 8) will be based on safety evaluation. intervention 2: Subjects will be randomised to receive a single dose of liraglutide-depot placebo, at increasing dose levels, injected s.c./subcutaneously (under the skin).

Protocol documents:
Clinical trial NCT01477567
Conditions: Diabetes Mellitus, Type 2
Sponsor: Eli Lilly and Company
Start date: 2011-11-01; Completion date: 2012-03-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to determine the safety of LY3009385 in healthy participants. The study drug is given as a single dose, by injections under the skin. Side effects will be documented. This study is approximately 28 days not including screening. Screening is required within 28 days prior to the start of the study.

Detailed description:
This is a single ascending dose study that examines the safety and tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) effects of single doses of LY3009385 administered subcutaneously to healthy participants. The planned dose levels are 0.3, 1, 3, 9, 27, and 54 milligrams (mg). Within each dose level, participants are randomized to receive either LY3009385 or Placebo.

Adjustments to the dose levels were permitted after review of emerging safety, PK, and glycemic data.

The actual LY3009385 dose levels tested during this study were 0.3, 1, 3, 9, 22, and 54 mg.

Arms: arm 1: LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 arm 2: LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 arm 3: LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 arm 4: LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 arm 5: LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 arm 6: LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 arm 7: Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
Interventions: intervention 1: LY3009385 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01479374
Conditions: Allergic Conjunctivitis
Keywords: Allergic Conjunctivitis Ocular Allergy
Sponsor: Alcon Research
Start date: 2012-01-01; Completion date: 2012-03-01
Enrollment: 397 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to assess the safety and efficacy of AL-4943A ophthalmic solution for the treatment of ocular itching associated with allergic conjunctivitis using the Conjunctival Allergen Challenge (CAC) model.

Detailed description:
This study consisted of 5 Visits. Eligible patients underwent allergy testing using the Conjunctival Allergen Challenge (CAC) model, which reproduces the signs and symptoms of Seasonal Allergic Conjunctivitis by replicating the natural disease process. Patients demonstrating a positive reaction to the CAC at Visit 1 (screening) and Visit 2 (confirmatory) were randomized to treatment at Visit 3 (Day 0). The test article was instilled at Visit 3, with treatment efficacy CAC performed at 24 hours duration of action. The test article was instilled again at Visit 4 (Day 14), with treatment efficacy CAC performed at 16 hours duration of action. The test article was instilled a final time at Visit 5 (Day 21), with treatment efficacy performed at onset of action.

Arms: arm 1: AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days arm 2: AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days arm 3: Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
Interventions: intervention 1: AL-4943A ophthalmic solution intervention 2: AL-4943A vehicle intervention 3: Olopatadine hydrochloride ophthalmic solution, 0.2%
Intervention descriptions: intervention 1: None intervention 2: Inactive ingredients used as placebo intervention 3: None

Protocol documents:
Clinical trial NCT01484951
Conditions: Glaucoma
Keywords: Open-angle glaucoma Ocular hypertension Pigment dispersion glaucoma
Sponsor: Alcon Research
Start date: 2011-05-01; Completion date: 2012-03-01
Enrollment: 74 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to assess the safety and efficacy of switching to Azarga from prior pharmacotherapy in patients with open-angle glaucoma.

Detailed description:

Arms: arm 1: Brinzolamide 1% and timolol 0.5% fixed combination eye drops, one drop administered to the study eye(s) twice daily (8:00 am and 8:00 pm) for up to 8 weeks.
Interventions: intervention 1: Brinzolamide 1% and timolol 0.5% fixed combination eye drops
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01485588
Conditions: Neovascular Age-Related Macular Degeneration
Sponsor: Iconic Therapeutics, Inc.
Start date: 2010-12-01; Completion date: 2012-03-01
Enrollment: 18 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
Phase 1: The purpose of this study is to evaluate the safety and tolerability of single ascending doses of hI-con1™ for subjects with Age-Related Macular Degeneration.

Phase 2: The purpose of this study is to evaluate the safety of 3 injections of hI-con1™ at 2 different dose levels.

Detailed description:

Arms: arm 1: Phase 1- This is a dose escalation study (60µl, 150µl, or 300 µl) given at baseline and then the subject is followed up to week 24. arm 2: Phase 1- This is a dose escalation study (60µl, 150µl, or 300 µl) given at baseline and then the subject is followed up to week 24. arm 3: Phase 1- This is a dose escalation study (60µl, 150µl, or 300 µl) given at baseline and then the subject is followed up to week 24.
Interventions: intervention 1: hI-con1™ 60µl intervention 2: hI-con1™ 150µl intervention 3: hI-con1™ 300µl
Intervention descriptions: intervention 1: Phase 1: 60µl, 150µl, or 300µl per injection (in the eye) on Day 1 only intervention 2: Phase 1: 60µl, 150µl, or 300µl per injection (in the eye) on Day 1 only intervention 3: Phase 1: 60µl, 150µl, or 300µl per injection (in the eye) on Day 1 only

Protocol documents:
Clinical trial NCT01535638
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2012-02-01; Completion date: 2012-03-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of the current study is to investigate the relative bioavailability of three trial formulations of BI 207127, the trial formulation 2 (TFII), the final formulation (FF), and a FF modified formulation. All formulations are supplied as film-coated Tablets and administered as single dose treatments of BI 207127 (3 film-coated Tablets) in healthy volunteers, with the aim to compare the bioavailability of the three formulations. All treatments will be applied fed, 30 minutes after start of the intake of a standard normal breakfast.

Detailed description:

Arms: arm 1: Film-coated tablet for oral administration arm 2: Film-coated tablet for oral administration arm 3: Film-coated tablet for oral administration
Interventions: intervention 1: BI 207127 intervention 2: BI 207127 intervention 3: BI 207127
Intervention descriptions: intervention 1: Medium dose film-coated tablet intervention 2: Medium dose film-coated tablet intervention 3: Medium dose film-coated tablet

Protocol documents:
Clinical trial NCT01537666
Conditions: Healthy Cystic Fibrosis
Sponsor: Savara Inc.
Start date: 2011-11-01; Completion date: 2012-03-01
Enrollment: 25 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is carried out to evaluate the safety, tolerability and pharmacokinetics of AeroVanc inhalation powder in healthy volunteers, and in patients with cystic fibrosis.

Detailed description:
The study has three main objectives:

* To evaluate the safety, and tolerability of AeroVanc inhalation powder in healthy volunteers, and in patients with CF.
* To determine the systemic bioavailability of vancomycin in healthy volunteers following single dose pulmonary administration of 16 mg, 32 mg, and 80 mg doses of AeroVanc in comparison with a 250 mg dose of vancomycin administered intravenously.
* To estimate the lung sputum concentrations of vancomycin in patients with cystic fibrosis (CF) following single dose pulmonary administration of 32 mg and 80 mg doses of AeroVanc.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None
Interventions: intervention 1: AeroVanc intervention 2: IV vancomycin hydrochloride
Intervention descriptions: intervention 1: Vancomycin hydrochloride dry powder for inhalation intervention 2: Vancomycin hydrochloride solution for intravenous administration

Protocol documents:
Clinical trial NCT01540773
Conditions: Growth Hormone Amino Acid
Keywords: growth hormone
Sponsor: Pennington Biomedical Research Center
Start date: 2011-10-01; Completion date: 2012-03-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of the study is to confirm the results of a prior study that demonstrated pills containing two amino acids which are in foods increased growth hormone and insulin-like growth factor-1.

Detailed description:
Oral supplementation with a key combination of derivatives that has been shown to increase human growth hormone in healthy volunteers peaking at 90 minutes and IGF-1 at 8 hours post-administration.

Arms: arm 1: supplements with the proprietary amino acid derivative blend. arm 2: Non-Active
Interventions: intervention 1: Amino acid supplement intervention 2: Placebo
Intervention descriptions: intervention 1: An orally administered supplement of the proprietary amino acid derivative intervention 2: A non-active orally administered supplement of the proprietary amino acid derivative

Protocol documents:
Clinical trial NCT01543828
Conditions: COPD
Keywords: COPD Indacatarol placebo crossover patient perception
Sponsor: Novartis Pharmaceuticals
Start date: 2012-01-01; Completion date: 2012-03-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a phase IV study of indacaterol 75 μg single-dose compared to placebo in moderate-severe COPD patients with breathing symptoms to assess time to patient's perception of onset of effect.

Detailed description:

Arms: arm 1: In treatment 1: participants received indacaterol 75 µg one dose delivered via single-dose dry-powder inhaler (SDDPI) followed by treatment 2: placebo one dose via SDDPI between day 7 and 10. Albuterol was available for use as rescue medication. arm 2: In treatment 1, participants received placebo one dose delivered via SDDPI followed by treatment 2: indacaterol 75 µg one dose delivered via SDDPI between Day 7 and Day 10. Albuterol was available for use as rescue medication.
Interventions: intervention 1: indacaterol intervention 2: placebo
Intervention descriptions: intervention 1: delivered via single-dose dry-powder inhaler intervention 2: delivered via single-dose dry-powder inhaler

Protocol documents:
Clinical trial NCT01551888
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD Chronic Obstructive Pulmonary Disease Chronic Bronchitis Emphysema Airflow Obstruction, Chronic Chronic Airflow Obstruction Chronic Obstructive Airway Disease Chronic Obstructive Lung Disease
Sponsor: AstraZeneca
Start date: 2012-01-01; Completion date: 2012-03-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this Phase II study is to evaluate the pharmacokinetics, safety, and tolerability of aclidinium/formoterol fixed dose combination (FDC 400/12 μg via the Almirall Inhaler and formoterol 12 μg via the Foradil® Aerolizer®, both administered twice daily for five days to patients with moderate to severe COPD.

Detailed description:

Arms: arm 1: Aclidinium/formoterol 400/12μg fixed-dose combination (FDC), one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) on Day 5 via the Almirall inhaler arm 2: Formoterol 12μg one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) on Day 5 via the Foradil® Aerolizer®
Interventions: intervention 1: Aclidinium/formoterol 400/12μg intervention 2: Formoterol
Intervention descriptions: intervention 1: Aclidinium/formoterol 400/12μg fixed dose combination (FDC), one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) on Day 5 via the Almirall inhaler intervention 2: Formoterol 12 μg one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) on Day 5 via the Foradil® Aerolizer®

Protocol documents:
Clinical trial NCT01632215
Conditions: Carpal Tunnel Syndrome
Keywords: gabapentine postoperative pain
Sponsor: Federal University of São Paulo
Start date: 2010-03-01; Completion date: 2012-03-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to evaluate the postoperative analgesic effect of preoperative gabapentine for carpal tunnel syndrome surgery.

Detailed description:
There was studied 40 patients. Group 1 patients received 600 mg of gabapentin 1 hour before surgery; G2 received placebo 1 hour before surgery.

Anesthesia was regional intravenous block. Postoperative analgesia when needed was with acetaminophen. If needed was administered codeine. The evaluation of neuropathic pain was made by DN4 questionnaire. Pain intensity was assessed by numeric scale at block and after 30min, 1h, 2h, 2wk, 4wk, 6m. It was noted the duration of analgesia, and the amount of acetaminophen and codeine.

The statistical program used for analysis of the results was the Instat Graph

Arms: arm 1: Gabapentine arm 2: Placebo group
Interventions: intervention 1: Gabapentine intervention 2: Sugar pill
Intervention descriptions: intervention 1: Gabapentine 600 mg 01 dose intervention 2: Sugar pill 01 dose

Protocol documents:
Clinical trial NCT01634178
Conditions: Healthy Volunteer
Keywords: Apremilast, pharmacokinetic safety Safety and pharmacokinetics in healthy volunteer subjects
Sponsor: Amgen
Start date: 2012-02-01; Completion date: 2012-03-01
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of the study is to evaluate the effects of a high fat meal on the pharmacokinetics of a single dose of 30 mg apremilast in healthy adults.

Detailed description:
Participants will be randomized to receive a single dose of 30 mg apremilast during each of the 2 periods; once under fasting conditions and once after a high fat meal. Participants will be randomly assigned to receive apremilast either fasted first, then fed, or fed first then fasted. Participants will check into the study center on Day -1 of each period, will be dosed on Day 1, and discharged from the study center on Day 3 after all scheduled pharmacokinetic blood draws and safety evaluations. After a washout of 5 to 10 days, participants will return for period 2 during which they will receive apremilast according to their assigned sequence.

Arms: arm 1: In Period 1 participants will receive a single 30 mg apremilast tablet administered under fasted conditions and in Period 2 participants will receive a single 30 mg apremilast tablet administered after a high fat meal. arm 2: In Period 1 participants will receive a single 30 mg apremilast tablet administered after a high fat meal and in Period 2 participants will receive a single 30 mg apremilast tablet administered under fasted conditions.
Interventions: intervention 1: Apremilast
Intervention descriptions: intervention 1: Tablet for oral administration

Protocol documents:
Clinical trial NCT01660321
Conditions: Pediculosis
Keywords: Pediculosis capitis Head Lice
Sponsor: ParaPRO LLC
Start date: 2011-09-01; Completion date: 2012-03-01
Enrollment: 26 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A pharmacokinetic and tolerance study of Natroba (spinosad) Topical Suspension, 0.9% in pediatric subjects 6 months to 4 years of age with an active head lice infestation.

Detailed description:
A Postmarketing Requirement Protocol, multicenter, open-label study in pediatric subjects 6 months to 4 years of age with an active head lice infestation designed to determine the topical absorption and safety of Natroba (spinosad) Topical Suspension, 0.9% for a single, 10 minute treatment for spinosad (Spinosyn A and Spinosyn D) and benzyl alcohol.

Arms: arm 1: Natroba (Spinosad) Topical Suspension, 0.9%
Interventions: intervention 1: spinosad
Intervention descriptions: intervention 1: A sufficient amount of Natroba Topical Suspension was applied to completely cover the scalp, worked out to the ends of the hair, and left in place for 10 minutes (±30 seconds), followed by a complete rinse and shampoo.

Protocol documents: