ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02014649
Conditions: Influenza
Keywords: Influenza treatment pediatric laninamivir
Sponsor: Biota Scientific Management Pty Ltd
Start date: 2013-11-01; Completion date: 2014-05-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase 1/2 protocol is designed to collect safety, tolerability and pharmacokinetic data of two doses of Laninamivir Octanoate in children and adolescents. The protocol will also explore virology and efficacy endpoints.

Detailed description:
Approximately 48 subjects aged 5-17 years inclusive will be randomised into the study.

Subjects with recent onset of presumptive influenza will have influenza A or B infection confirm by Rapid Antigen Test.

The study will be conducted on an outpatient basis. The dose is administered in a single session in the clinic on Day 1. The subject will return to the clinic for assessments and follow up.

Arms: arm 1: Dry Powder plus placebo arm 2: Dry Powder
Interventions: intervention 1: 20 mg laninamivir octanoate intervention 2: Placebo intervention 3: 40 mg laninamivir octanoate
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02038829
Conditions: COPD
Keywords: COPD
Sponsor: Sunovion Respiratory Development Inc.
Start date: 2014-01-01; Completion date: 2014-05-01
Enrollment: 96 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Study for subjects 40 to 65 years-old with a diagnosis of moderate to severe COPD. Aclidinium bromide 400 mcg 2x a day will be given as an active comparator.

Detailed description:
This is a randomized, six-way crossover study to determine the efficacy and dose-response profile of SUN101. The study population will consist of subjects 40 to 65 years-old (inclusive), with a diagnosis of moderate to severe COPD. Aclidinium bromide 400 mcg bid will be given as an active comparator. The study will be double-blind for SUN-101 and placebo and will be open-label for aclidinium.

Arms: arm 1: Placebo bid arm 2: SUN-101 3 mcg bid arm 3: SUN-101 6.25 mcg bid arm 4: SUN-101 12.5 mcg bid arm 5: SUN-101 50 mcg bid arm 6: Aclidinium 400 mcg bid
Interventions: intervention 1: Placebo intervention 2: SUN101 3 mcg intervention 3: SUN-101 6.25 mcg intervention 4: SUN-101 12.5 mcg intervention 5: SUN-101 50 mcg intervention 6: Aclidinium
Intervention descriptions: intervention 1: Placebo intervention 2: SUN-101 3 mcg bid intervention 3: SUN-101 6.25 mcg bid intervention 4: SUN-101 12.5 mcg bid intervention 5: SUN-101 50 mcg bid intervention 6: Aclidinium 400 mcg bid

Protocol documents:
Clinical trial NCT02044393
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2014-01-01; Completion date: 2014-05-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Investigation of the relative bioavailability of a single dose of BI 691751 when given alone and together with itraconazole; safety and tolerability

Detailed description:

Arms: arm 1: single dose BI 691751 arm 2: multiple doses of itraconazole + single dose BI 691751
Interventions: intervention 1: itraconazole intervention 2: BI 691751 intervention 3: BI 691751
Intervention descriptions: intervention 1: multiple doses of itraconazole given as capsules intervention 2: single dose BI 691751 given as tablet intervention 3: single dose BI 691751 given as tablet

Protocol documents:
Clinical trial NCT02052752
Conditions: Skin Diseases
Sponsor: GlaxoSmithKline
Start date: 2014-02-01; Completion date: 2014-05-01
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
5 Day study to assess how quickly a topical acne product begins to work.

Detailed description:

Arms: arm 1: Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3. arm 2: The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3. arm 3: A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
Interventions: intervention 1: 3% Benzoyl Peroxide intervention 2: 3% Benzoyl Peroxide Placebo intervention 3: Neutrogena Rapid Clear®
Intervention descriptions: intervention 1: Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3. intervention 2: The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3. intervention 3: A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.

Protocol documents:
Clinical trial NCT02057835
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2014-03-01; Completion date: 2014-05-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
BI 691751 is currently being developed to inhibit growth and prevent rupture of atherosclerotic plaques and to consequently reduce the risk of major cardiovascular events in patients with established atherosclerotic disease. 1334.5 is a Pan Asian Phase 1 study to investigate safety, tolerability and pharmacokinetics of BI 691751 in healthy Chinese and Japanese male volunteers.

Detailed description:

Arms: arm 1: BI 691751 low dose 1 arm 2: BI 691751 low dose 2 arm 3: BI 691751 middle dose arm 4: BI 691751 high dose
Interventions: intervention 1: Placebo to BI 691751 intervention 2: BI 691751 high dose intervention 3: BI 691751 middle dose intervention 4: Placebo to BI 691751 intervention 5: BI 691751 low dose 1 intervention 6: Placebo to BI 691751 intervention 7: Placebo to BI 691751 intervention 8: BI 691751 low dose 2
Intervention descriptions: intervention 1: Placebo to BI 691751 intervention 2: BI 691751 high dose intervention 3: BI 691751 middle dose intervention 4: Placebo to BI 691751 intervention 5: BI 691751 low dose 1 intervention 6: Placebo to BI 691751 intervention 7: Placebo to BI 691751 intervention 8: BI 691751 low dose 2

Protocol documents:
Clinical trial NCT02061813
Conditions: Head Lice
Keywords: Hatchtech
Sponsor: Dr. Reddy's Laboratories Limited
Start date: 2014-01-01; Completion date: 2014-05-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine the irritation potential of repeat applications of abametapir lotion on normal skin.

Detailed description:
This will be a randomized, evaluator-blind, single-center, controlled, within-subject comparison study of the investigational products (abametapir lotion) and its vehicle lotion and positive and negative controls under occlusive conditions in healthy volunteers. All subjects will have the investigational product (abametapir lotion), the vehicle product, the positive control patch, and negative control patch applied to 4 randomly assigned, adjacent skin sites on the infrascapular area of their back, for the purpose of determining irritation potential.

The investigational products, vehicle, and controls will be applied to one side of the infrascapular area of the back. Evaluation of dermal reactions at the application sites will be assessed clinically using a visual scale that rates the degree of erythema, edema, and other signs of cutaneous irritation (see Section 3.5.5).

A total of 21 applications of each product will be made.

Arms: arm 1: Applied 0.2 mL topically under occlusive condition arm 2: Applied 0.2 mL topically under occlusive condition arm 3: Positive control applied 0.2 mL topically under occlusive condition arm 4: Negative control applied 0.2 mL topically under occlusive condition
Interventions: intervention 1: Abametapir Lotion 0.74% w/w intervention 2: Sodium Lauryl Sulfate intervention 3: Saline 0.9% intervention 4: Placebo
Intervention descriptions: intervention 1: applied 0.2 mL topically under occlusive condition intervention 2: Sodium Lauryl Sulfate is prepared as a 0.2% aqueous solution by the site for topical administration, and applied 21 times over consecutive days under occlusive conditions, will serve as a positive control. intervention 3: A solution of 0.9% saline for topical administration, applied 21 times over consecutive days under occlusive conditions, will serve as a negative control intervention 4: None

Protocol documents:
Clinical trial NCT02062177
Conditions: Sedation Endoscopy
Sponsor: Università Vita-Salute San Raffaele
Start date: 2014-02-01; Completion date: 2014-05-01
Enrollment: 140 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Many studies address safety of non-anesthesiologist propofol sedation (NAPS) for gastrointestinal endoscopy. Target Controlled Infusion (TCI) is a sophisticated tool for providing optimal sedation regimen and avoiding under or oversedation. The objective of the study is to compare standard moderate sedation during upper endoscopy and colonoscopy versus propofol NAPS.

Detailed description:

Arms: arm 1: 70 patients (35 upper endoscopy - 35 colonoscopy) arm 2: 70 patients (35 upper endoscopy - 35 colonoscopy)
Interventions: intervention 1: Propofol intervention 2: Midazolam
Intervention descriptions: intervention 1: 70 patients (35 upper endoscopy - 35 colonoscopy) are sedated with propofol TCI (Target Controlled Infusion) pump (concentration 1.2-1.6 mcg/ml). intervention 2: 70 patients (35 upper endoscopy - 35 colonoscopy) in group midazolam are sedated with midazolam 0.04 mg/Kg if aged \< 70, 0.03 mg/Kg if aged \> 70.

Protocol documents:
Clinical trial NCT02066727
Conditions: Nerve Block
Keywords: Dexmedetomidine obturator nerve block lidocaine EC50
Sponsor: Guolin Wang
Start date: 2014-02-01; Completion date: 2014-05-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Hypothesis: Dexmedetomidine as an adjuvant of lidocaine can decrease the median effective concentration(EC50) of lidocaine for obturator nerve block during transurethral resection of bladder tumor

Detailed description:
A selective obturator nerve block(ONB) is an effective alternative to suppress the obturator nerve reflex which is defined as a sudden, violent adductor muscle spasm when the obturator nerve is stimulated directly by the electronic resector during transurethral resection of the tumor on the lateral bladder wall. Studies showed Dexmedetomidine as an adjuvant to local anesthetic prolongs peripheral nerve block duration without any nerve toxicity. In the following randomized, non-crossover study, the investigators test if Dexmedetomidine as an adjuvant can decrease the median effective concentration(EC50) of lidocaine for obturator nerve block during transurethral resection of bladder tumor.

Arms: arm 1: Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg. arm 2: Normal Saline is administrated as an adjuvant of lidocaine.
Interventions: intervention 1: Dexmedetomidine intervention 2: Normal Saline
Intervention descriptions: intervention 1: Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg. intervention 2: Normal Saline is administrated as an adjuvant of lidocaine.

Protocol documents:
Clinical trial NCT02087748
Conditions: Pain Delayed Onset Muscle Soreness
Keywords: DOMS
Sponsor: Lotus Clinical Research, LLC
Start date: 2014-03-01; Completion date: 2014-05-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate analgesic efficacy of Topical Voltaren Gel (diclofenac sodium gel) 1% applied QID compared to Placebo in Subjects Experiencing Delayed Onset Muscle Soreness.

Detailed description:
The purpose of this randomized, double-blind, placebo controlled, within-subject study is to evaluate the efficacy of topical diclofenac sodium gel (DSG) 1% in reducing pain associated with delayed onset muscle soreness (DOMS). Following exercise, subjects reporting significant DOMS received topical DSG 1% applied to 1 leg and placebo applied to the other every 6 hours for 48 hours.

Arms: arm 1: Diclofenac sodium 1% gel 4 grams applied topically Q6 hour for 48 hours arm 2: Placebo gel 4gm applied topically Q6 hour for 48 hours
Interventions: intervention 1: 1% diclofenac sodium gel intervention 2: Placebo
Intervention descriptions: intervention 1: Diclofenac sodium 1% gel 4 grams applied topically Q6 hour for 48 hours intervention 2: Placebo gel 4gm applied topically Q6 hour for 48 hours

Protocol documents:
Clinical trial NCT02100826
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2014-04-01; Completion date: 2014-05-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to compare two different preparations of an antibiotic called cephalexin to determine if they are essentially the same. The study has two periods. Participants will receive one preparation of cephalexin in each period. At least 7 hours will pass between the study periods. The study is expected to last about 2 days for each participant, not including screening or follow-up.

Detailed description:

Arms: arm 1: Cephalexin manufactured in Italy by Facta administered once orally in one of two study periods. arm 2: Cephalexin manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
Interventions: intervention 1: Cephalexin
Intervention descriptions: intervention 1: Administered orally.

Protocol documents:
Clinical trial NCT02101112
Conditions: Thrombosis
Sponsor: Bristol-Myers Squibb
Start date: 2014-03-01; Completion date: 2014-05-01
Enrollment: 69 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine whether the bioavailability of apixaban crushed tablets suspended in water or mixed with applesauce is similar to the bioavailability of apixaban whole tablets administered orally.

Detailed description:
This study will investigate the bioavailability of apixaban administered as crushed tablets suspended in water and as crushed tablets mixed with applesauce compared with that of whole tablets. The study results may allow enhancement of the apixaban label to include alternative methods of apixaban administration, which may be of benefit to patients who have difficulty swallowing.

Arms: arm 1: Participants received a single dose of apixaban, 10 mg, given orally as 2 5-mg whole commercial tablets (reference) arm 2: Participants received a single dose of apixaban, 10 mg, given by mouth as 2 5-mg whole commercial tablets crushed and suspended in 30 mL of water arm 3: Participants received a single dose of 10 mg, given by mouth as 2 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
Interventions: intervention 1: Apixaban
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02107599
Conditions: Alzheimer's Disease
Sponsor: Avid Radiopharmaceuticals
Start date: 2014-03-01; Completion date: 2014-05-01
Enrollment: 96 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate whether the addition of quantitation as an adjunct to visual interpretations significantly improves the accuracy of Amyvid scan interpretation.

Detailed description:

Arms: arm 1: Physician readers will interpret Amyvid scans using qualitative analysis followed by the use of quantitation. No subjects will be exposed to Florbetapir(18F) as part of this study.
Interventions: intervention 1: Florbetapir (18F)
Intervention descriptions: intervention 1: No Florbetapir (18F) will be administered in this study.

Protocol documents:
Clinical trial NCT02123446
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2014-04-01; Completion date: 2014-05-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to compare two different preparations of an antibiotic called cephalexin in capsules to determine if they are essentially the same. The study has two periods. Participants will receive one preparation of cephalexin in each period. At least 7 hours will pass between the study periods. The study is expected to last about 2 days for each participant, not including screening or follow-up.

Detailed description:

Arms: arm 1: Cephalexin manufactured in Mexico by Eli Lilly administered once orally in one of two study periods. arm 2: Cephalexin manufactured in Italy by Facta administered once orally in one of two study periods.
Interventions: intervention 1: Cephalexin
Intervention descriptions: intervention 1: Administered orally.

Protocol documents:
Clinical trial NCT02123459
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2014-05-01; Completion date: 2014-05-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to compare two different preparations of an antibiotic called cephalexin to determine if they are essentially the same. The study has two periods. Participants will receive one preparation of cephalexin in each period. At least 7 hours will pass between the study periods. The study is expected to last about 2 days for each participant, not including screening or follow-up.

Detailed description:

Arms: arm 1: Cephalexin manufactured in Mexico by Eli Lilly administered once orally in one of two study periods arm 2: Cephalexin manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods
Interventions: intervention 1: Cephalexin
Intervention descriptions: intervention 1: Administered orally

Protocol documents:
Clinical trial NCT02123472
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2014-05-01; Completion date: 2014-05-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to compare two different preparations of an antibiotic called cephalexin to determine if they are essentially the same. The study has two periods. Participants will receive one preparation of cephalexin in each period. At least 7 hours will pass between the study periods. The study is expected to last about 2 days for each participant, not including screening or follow-up.

Detailed description:

Arms: arm 1: Cephalexin manufactured in Italy by Facta administered once orally in one of two study periods. arm 2: Cephalexin manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
Interventions: intervention 1: Cephalexin
Intervention descriptions: intervention 1: Administered Orally

Protocol documents:
Clinical trial NCT02130999
Conditions: Non-24-Hour-Sleep-Wake Disorder
Keywords: Non-24 absolute bioavailability tasimelteon Hetlioz™
Sponsor: Vanda Pharmaceuticals
Start date: 2014-05-01; Completion date: 2014-05-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Hetlioz™ (tasimelteon) is used in the treatment of Non-24-Hour-Sleep-Wake Disorder (Non-24). Non-24 is very common in people who are totally blind because light can not reset their body clock. This causes the internal sleep-wake cycle to be out of sync with the 24-hour day-night. Non-24 is a serious, chronic circadian rhythm disorder in the blind that causes nighttime sleep problems and a wide range of daytime difficulties, including an overwhelming urge to nap.

Tasimelteon will be given in two ways; orally (by mouth) as a 20 mg capsule and intravenously (I.V.) by infusion through a catheter (not an injection) into a vein. The oral administration is approved by the FDA. The I.V. administration is considered investigational as it has not been approved by the FDA. This will be the first time tasimelteon will be given to humans by intravenous (I.V.) injection.

The purposes of this research study are to:

* assess how quickly a single 20 mg oral dose of tasimelteon is absorbed into the body;
* evaluate the single-dose pharmacokinetics of tasimelteon after a single 20 mg oral dose and after a single 2 mg I.V. dose;
* evaluate the single-dose pharmacokinetics of tasimelteon metabolites after a single 20 mg oral dose and after a single 2 mg I.V. dose;
* evaluate the safety and tolerability of a single 20 mg oral dose of tasimelteon; and
* evaluate the safety and tolerability of a single 2 mg I.V. dose of tasimelteon.

Pharmacokinetics (PK) is the study of how a drug is absorbed, distributed, metabolized, and eventually eliminated by the body. Pharmacokinetics is what the body does to the drug. Blood samples will be taken throughout the study for PK analysis.

Detailed description:

Arms: arm 1: * Single oral dose of tasimelteon 20 mg on Day 1
* Single I.V. dose of tasimelteon 2 mg on Day 6 arm 2: * Single I.V. dose of tasimelteon 2 mg on Day 1
* Single oral dose of tasimelteon 20 mg on Day 6
Interventions: intervention 1: tasimelteon 20 mg capsule intervention 2: tasimelteon 2 mg I.V.
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: