ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01872910
Conditions: Acute Pain
Keywords: Wisdom tooth extraction
Sponsor: Eli Lilly and Company
Start date: 2013-06-01; Completion date: 2013-10-01
Enrollment: 124 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to test if a single dose of LY3023703 relieves pain after wisdom teeth removal. The study will last about one week for each participant, not including screening.

Detailed description:

Arms: arm 1: Part A: Single oral administration of placebo matching corresponding LY3023703 dose administered orally once as a capsule post dental surgery.

Part B: Single oral administration of placebo matching corresponding LY3023703 administered orally once as a capsule, post dental surgery and post dialysate probe placement.

Part B of this study assessed whether LY3023703 selectively inhibited the prostaglandin E(PGE) surge in the wound dialysate during the postoperative period. arm 2: Part A: Single oral administration of 30 milligrams (mg) LY3023703 administered orally once as a 30-milligrams (mg) capsule post dental surgery.

Part B: Single oral administration of 30 milligrams (mg) LY3023703 administered orally once as a 30-mg capsule, post dental surgery and post dialysate probe placement.

Part B of this study assessed whether LY3023703 selectively inhibited the prostaglandin E(PGE) surge in the wound dialysate during the postoperative period. arm 3: Part A: Single oral administration of 400 mg celecoxib (Positive control) administered orally once as two 200-mg capsules post dental surgery (Positive control).

Participants received two 200-mg celecoxib capsules during Pre-Part B.The purpose of Pre-Part B was to develop proficiency in the dialysate placement, collection, and maintenance techniques before moving to Part B.

Celecoxib was not administered in Part B.

Part B of this study assessed whether LY3023703 selectively inhibited the prostaglandin E(PGE) surge in the wound dialysate during the postoperative period.
Interventions: intervention 1: Placebo intervention 2: LY3023703 intervention 3: Celecoxib
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally intervention 3: Administered orally

Protocol documents:
Clinical trial NCT01881113
Conditions: Allergic Conjunctivitis
Sponsor: Aciex Therapeutics, Inc.
Start date: 2013-06-01; Completion date: 2013-10-01
Enrollment: 101 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the onset and duration of action of AC-170 0.24% compared to vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in the conjunctival allergen challenge (CAC) model.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: AC-170 0.24% intervention 2: AC-170 0%
Intervention descriptions: intervention 1: 1 drop in each eye at 2 separate times during a 14 day period intervention 2: 1 drop in each eye at 2 separate times during a 14 day period

Protocol documents:
Clinical trial NCT01885104
Conditions: Constipation
Sponsor: Bayer
Start date: 2013-04-01; Completion date: 2013-10-01
Enrollment: 65 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the safety and tolerability of oral ingestion of PEG 3350 solution concentrate to oral ingestion of a placebo solution concentrate, in participants with constipation.

Detailed description:
This was a randomized, single-blind, placebo-controlled study to evaluate the proportion of participants with abnormalities of the oral mucosa detected by visual examination of the oral cavity in the polyethylene glycol (PEG) 3350 group compared with the placebo group. The study was also to evaluate the proportion of participants with abnormalities of the esophageal mucosa detected by endoscopic examination of the esophagus in the PEG 3350 group compared with the placebo group, and to compare the safety and tolerability by evaluation of the proportion of participants with the occurrence of adverse events (AEs) or adverse drug reactions.

Arms: arm 1: Participants will receive a 17 g dose of PEG 3350 solution concentrate in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, will be provided for use as a rescue medication if a participant has not had a bowel movement for 72 hours after start of treatment. arm 2: Participants will receive a 17 g dose of Placebo solution concentrate in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, will be provided for use as a rescue medication if a participant has not had a bowel movement for 72 hours after start of treatment.
Interventions: intervention 1: Polyethylene Glycol (PEG 3350) intervention 2: Placebo intervention 3: Bisacodyl laxative tablets (rescue medication)
Intervention descriptions: intervention 1: Oral 17 g dose of PEG 3350 solution concentrate in a volume of approximately 30 mL, once a day, for 14 days. intervention 2: Oral 17 g dose of Placebo solution concentrate in a volume of approximately 30 mL, once a day, for 14 days. intervention 3: 5.0 mg tablets, 1 to 3 tablets in a single daily dose, to be provided for use as rescue medication if participant has not had bowel movement for 72 hours after start of treatment.

Protocol documents:
Clinical trial NCT01887470
Conditions: Colonoscopy Preparation
Keywords: Bowel Evacuation Colonoscopy Preparation
Sponsor: Cumberland Pharmaceuticals
Start date: 2013-07-01; Completion date: 2013-10-01
Enrollment: 55 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine the efficacy of 2 regimens of lactulose as a preparation for colonoscopy.

Detailed description:
A full-dose regimen of lactulose for oral solution, where all dosing is completed the evening prior to the colonoscopy procedure, will be studied and compared to a split-dose regimen, where three doses are taken on the prior evening, and one dose is taken the morning of the procedure.

Arms: arm 1: Four hourly doses of lactulose for oral solution are taken in the evening. The colonoscopy is initiated prior to noon on the following day. arm 2: Four hourly doses of lactulose for oral solution are taken in the evening. The colonoscopy is initiated after noon on the following day. arm 3: Three hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure; one dose is taken on the morning of the procedure. The colonoscopy is initiated prior to noon. arm 4: Three hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure; one dose is taken on the morning of the procedure. The colonoscopy is initiated after noon.
Interventions: intervention 1: Full dose preparation intervention 2: Split dose preparation
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01893567
Conditions: Plaque Psoriasis
Sponsor: Galderma R&D
Start date: 2013-07-01; Completion date: 2013-10-01
Enrollment: 28 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The aim of this study is to investigate the utility of a technological based rating scale for assessing improvement in plaque psoriasis with Clobex spray treatment.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Clobex Spray
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01894503
Conditions: Chronic Sinusitis
Sponsor: Intersect ENT
Start date: 2013-06-01; Completion date: 2013-10-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to assess the safety and performance of the steroid-releasing S8 Sinus Implant when used in post-sinus surgery patients who presented with recurrent sinus obstruction.

Detailed description:
The S8 PK study was a single-center, open label study treating 5 adult (18 years or older) patients diagnosed with chronic sinusitis, who had undergone prior bilateral total ethmoidectomy and later presented with recurrent nasal obstruction/congestion symptoms and bilateral ethmoid polyposis. The S8 PK study assessed the safety, implant delivery to the ethmoid sinus, and systemic exposure to mometasone furoate (MF) by measuring plasma MF and cortisol concentrations through 30 days post-procedure.

Arms: arm 1: Bilateral in-office placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
Interventions: intervention 1: S8 Sinus Implant (mometasone furoate, 1350 mcg)
Intervention descriptions: intervention 1: Bioabsorbable sinus implant with 1350 mcg of mometasone furoate released over 90 days

Protocol documents:
Clinical trial NCT01896726
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2013-07-01; Completion date: 2013-10-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The main purpose of this study is to find out how the body absorbs and breaks down a common birth control pill called Microgynon when it is given with the study drug called baricitinib. Safety and the body's ability to tolerate baricitinib and Microgynon will also be studied. The study will last approximately 6 weeks for each participant.

Detailed description:

Arms: arm 1: Microgynon \[30 micrograms (µg) ethinyl estradiol and 150 µg levonorgestrel\] administered orally, once daily (QD), on Days 1 and 29. Baricitinib, 10 milligrams (mg), administered orally QD on Days 23 through 30.
Interventions: intervention 1: Baricitinib intervention 2: Microgynon
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally

Protocol documents:
Clinical trial NCT01907360
Conditions: Attention-Deficit Hyperactivity Disorder
Sponsor: Ironshore Pharmaceuticals and Development, Inc
Start date: 2013-08-01; Completion date: 2013-10-01
Enrollment: 29 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
This study was designed to assess the pharmacokinetic effects of a single dose of HLD200 (methylphenidate hydrochloride) in children and adolescents with ADHD.

Detailed description:
This study utilized a single-center, open-label, single-treatment, fasted design to examine the rate and extent of absorption of evening-administered HLD200 in children (6-12 years) and adolescents (13-17 years) with ADHD.

Following a screening period that included five days washout to allow for clearance of any prior ADHD medications, subjects were domiciled in-clinic and administered HLD200 (B-formulation; 54 mg; oral capsule) at 9 pm under fasted conditions. Subjects were then observed for safety and tolerability and a total of 18 blood samples collected during a 48 hour period (at t=0, 4, 6, 8, 9, 10, 11, 12, 13, 14, 15, 16, 18, 20, 22, 24, 36 and 48 hours post-dosing). These samples were then assayed for methylphenidate plasma concentrations and this data used for calculation of pharmacokinetic parameters.

Arms: arm 1: HLD200 (B formulation, 54 mg, oral capsules) administered as a single treatment in the evening to children aged 13-17 years. arm 2: HLD200 (B formulation, 54 mg, oral capsules) administered as a single treatment in the evening to children aged 6-12 years.
Interventions: intervention 1: HLD200 (methylphenidate hydrochloride)
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01910311
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2013-08-01; Completion date: 2013-10-01
Enrollment: 18 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purposes of this study are to look at what effect multiple doses of rifampicin have on a single dose of baricitinib and to look at the safety and tolerability of these drugs. Side effects will be documented. The study will last approximately 31 days from the first dose to the end of the study.

Detailed description:

Arms: arm 1: Single oral dose of 10 milligrams (mg) baricitinib on Day 1. arm 2: Oral doses of 600 mg rifampicin once daily on Days 3 to 11, with a single oral dose of 10 mg baricitinib co-administered on Day 10.
Interventions: intervention 1: Baricitinib intervention 2: Rifampicin
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally

Protocol documents:
Clinical trial NCT01913314
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2013-08-01; Completion date: 2013-10-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This type of study is called a radiolabeled study. For this study, LY2835219 (study drug) has been specially prepared to contain radiolabeled carbon \[\^14C\]. \[\^14C\] is a naturally occurring radioactive form of the element carbon. This study will help understand how the drug appears in the blood, urine, and stool after it is administered.

In addition, this study will also evaluate the safety and tolerability of a single dose of LY2835219 when given to healthy participants. Information about any side effects that may occur will also be collected.

This study will last about 3 weeks for each participant, not including screening.

Detailed description:

Arms: arm 1: Single 150 milligram (mg) oral dose solution of LY2835219 containing 5 micro-curies of (µCi) \[\^14C\] labeled drug
Interventions: intervention 1: [^14C]-LY2835219
Intervention descriptions: intervention 1: Administered as oral solution

Protocol documents:
Clinical trial NCT01929876
Conditions: Healthy Participants
Sponsor: Genentech, Inc.
Start date: 2013-07-01; Completion date: 2013-10-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open-label, 2-period, fixed sequence, drug interaction study will investigate the effect of co-administration of itraconazole on the pharmacokinetics of cobimetinib in healthy participants. Participants will receive multiple repeating doses of cobimetinib and itraconazole.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Cobimetinib intervention 2: Itraconazole
Intervention descriptions: intervention 1: 10 milligram (mg) (2\* 5 mg capsules) will be administered orally on Day 1 of Period 1 and Day 4 of Period 2 intervention 2: 200 mg oral solution will be administered once daily from Day 1 to Day 14 of Period 2

Protocol documents:
Clinical trial NCT01933048
Conditions: Influenza
Keywords: influenza
Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
Start date: 2012-09-01; Completion date: 2013-10-01
Enrollment: 1077 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this prospective, open-label clinical trial is to evaluate the immunogenicity of self-administered (SA) live, attenuated influenza vaccine (LAIV) in comparison with healthcare worker administered (HCWA) LAIV and to evaluate the feasibility of group self-administration of LAIV.

Detailed description:
This Phase IV, open-label, prospective clinical trial assesses SA-LAIV, testing whether the immunogenicity of SA-LAIV is non-inferior to that of HCWA-LAIV, as well as evaluating the feasibility of utilizing group administration for SA-LAIV. Subjects will be enrolled into one of two major treatment arms: HCWA-LAIV (Estimated N = 550) and SA-LAIV (Estimated N = 550). Enrollment into each major treatment arm will be stratified by study site. Enrollment in the HCWA-LAIV and SA-LAIV treatment arms may occur concurrently at each site. Subjects enrolling in the study will be randomized to HCWA or SA, and within the SA arm to either individual self-administration, or group administration. Specifically, following self-administration of LAIV to 190 individual subjects, 180 subjects will be vaccinated in 36 groups of 5 and 180 subjects will be vaccinated in 18 groups of 10. All vaccinations in the SA-LAIV arm will be given under the direction and supervision of a research staff member who is trained to administer LAIV vaccines. Following immunization all subjects will return for one visit at approximately 28 (± 7) days for follow-up.

Arms: arm 1: FluMist administered by a Healthcare Worker arm 2: FluMist self-administered by subject
Interventions: intervention 1: FluMist
Intervention descriptions: intervention 1: FluMist Intranasal Vaccine

Protocol documents:
Clinical trial NCT01940510
Conditions: Healthy Volunteer
Sponsor: Hoffmann-La Roche
Start date: 2013-10-01; Completion date: 2013-10-01
Enrollment: 24 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This single center, open-label, 3-period, fixed-sequence study will evaluate the effect of multiple oral doses of rifampin on the pharmacokinetics of a single oral dose of RO5424802 in healthy volunteers. Subjects will receive a single dose of RO5424802 on Days 1 and 17 and rifampin daily from Days 8 to Day 20.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: RO5424802 intervention 2: rifampin
Intervention descriptions: intervention 1: Single dose without (Day 1) and with (Day 17) co-administration of rifampin intervention 2: Multiple doses Days 8-16 and Days 17-20

Protocol documents:
Clinical trial NCT01965782
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2013-10-01; Completion date: 2013-10-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This type of study is called a radiolabeled study. For this study, LY3023703 (study drug) has been specially prepared to contain radiolabeled carbon \[14C\]. \[14C\] is a naturally occurring radioactive form of the element carbon. This study will help understand how the drug appears in the blood, urine, and stool after it is administered to healthy men. Information about any side effects that may occur will also be collected. This study will last up to 15 days for each participant, not including screening. Screening is required within 28 days prior to the start of the study.

Detailed description:

Arms: arm 1: Single oral dose of 15 mg LY3023703, containing approximately 100 µCi \[\^14C\] labeled drug, administered as an oral solution.
Interventions: intervention 1: [^14C]-LY3023703
Intervention descriptions: intervention 1: Administered orally

Protocol documents:
Clinical trial NCT01995825
Conditions: Epilepsy
Keywords: bioequivalence lamotrigine epilepsy
Sponsor: University of Maryland, Baltimore
Start date: 2012-05-01; Completion date: 2013-10-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
In this study, brand name lamotrigine (LAMICTAL) and generic lamotrigine will be compared in patients with epilepsy. Both the brand name and generic lamotrigine are approved by the Food and Drug Administration (FDA) and are commonly used to treat epilepsy. Some physicians and patients with epilepsy have believed that brand and generic lamotrigine have had clinically significant differences in efficacy and tolerability. The brand name and generic tablets have been shown to be the same when blood levels were measured in healthy volunteers without epilepsy, but these drugs have not yet been compared in patients with epilepsy. This study will do this comparison, by switching patients between brand and generic in a very structured manner, and seeing if the drugs are the same, primarily in terms of blood levels. Other comparisons will also be made secondarily, looking for any differences in adverse effects and seizure control.

Detailed description:
As is commonly done in a bioequivalence study, the null hypothesis is that the generic (i.e. test) is bioINequivalent to the brand name (i.e. reference). Hence, the alternative hypothesis is that the generic is bioequivalent to the brand name.

Arms: arm 1: Crossover trial. Each arm will receive Brand lamotrigine tablet for two periods and Generic lamotrigine for two periods. arm 2: Crossover trial. Each arm will receive Generic lamotrigine tablet for two periods and Brand lamotrigine for two periods.
Interventions: intervention 1: Brand lamotrigine intervention 2: Generic lamotrigine
Intervention descriptions: intervention 1: Brand lamotrigine tablet 100mg tablets (1-3 either once or twice a day) for two weeks intervention 2: Generic lamotrigine tablet 100mg tablets (1-3 either once or twice a day) for two weeks

Protocol documents:
Clinical trial NCT02080780
Conditions: CLARITHROMYCIN/DILTIAZEM [VA Drug Interaction]
Sponsor: Ventrus Biosciences, Inc
Start date: 2013-09-01; Completion date: 2013-10-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the drug-drug interaction potential of clarithromycin XL on Diltiazem hydrochloride (DTZ) 2% cream.

Detailed description:
This study was designed to investigate the potential effect of clarithromycin XL at steady state (administered orally, once daily on Days 4 through 9 as 2 x 500 mg tablets, 1000 mg per day, for a total of 6000 mg) on the PK of a single topical dose of diltiazem hydrochloride 2% cream applied to the perianal area (\~2.5 cm \[1 inch\]; \~8.5 mg). This was a Phase 1 study with a single treatment arm. Efficacy was not assessed; therefore the study was of open-label design.

Arms: arm 1: 3 parts:

1. \- Single Dose, Diltiazem (Day 1)
2. \- Multiple Dose, Clarithromycin XL (Days 4-9)
3. \- Single Dose, Diltiazem (Day 8)
Interventions: intervention 1: Clarithromycin XL intervention 2: 2% Diltiazem
Intervention descriptions: intervention 1: Clarithromycin XL administered once daily on Days 4 through 9 as 2 x 500 mg tablets, 1000 mg per day, for a total of 6000 mg intervention 2: 2% Diltiazem Hydrochloride Cream applied on Day 1 \& Day 8 to the perianal area (\~2.5 cm \[1 inch\]; \~8.5 mg)

Protocol documents:
Clinical trial NCT02082769
Conditions: Gout
Keywords: Gout Uric Acid Xanthine oxidase Febuxostat
Sponsor: Xijing Hospital
Start date: 2011-07-01; Completion date: 2013-10-01
Enrollment: 504 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare febuxostat allopurinol in subjects with gout.

Detailed description:
A randomized, double-blind, multicenter, allopurinol-controlled and parallel-assigned study comparing 40 mg, 80 mg of febuxostat, and allopurinol 300 mg in subjects with gout. Subjects will receive treatment for 24 weeks.

Arms: arm 1: Febuxostat 40 mg, orally, once daily for up to 24 weeks arm 2: Febuxostat 80 mg, orally, once daily for up to 24 weeks arm 3: Allopurinol 100mg, orally, three times daily for up to 24 weeks
Interventions: intervention 1: Febuxostat intervention 2: Allopurinol
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: