ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02148107
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2014-05-01; Completion date: 2014-08-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
It is the objective of this MRD trial to investigate pharmacokinetics, pharmcodynamics, safety and tolerability of rising doses BI 691751 over a treatment period of 14 days to support the further clinical development of this LTA4H-inhibitor. Special emphasis will be given to detect potential effects of BI 691751 on heart rate.

Detailed description:

Arms: arm 1: multiple dose given over 14 days arm 2: multiple dose given over 14 days arm 3: multiple dose given over 14 days arm 4: multiple dose given over 14 days arm 5: multiple dose given over 14 days arm 6: multiple dose given over 14 days arm 7: Placebo
Interventions: intervention 1: BI 691751 intervention 2: BI 691751 intervention 3: BI 691751 intervention 4: BI 691751 intervention 5: BI 691751 intervention 6: BI 691751 intervention 7: Placebo
Intervention descriptions: intervention 1: BI 691751 Dose 1 intervention 2: BI 691751 Dose 2 intervention 3: BI 691751 Dose 3 intervention 4: BI 691751 Dose 4 intervention 5: BI 691751 Dose 5 intervention 6: BI 691751 Dose 6 intervention 7: Placebo

Protocol documents:
Clinical trial NCT02159547
Conditions: Migraine
Keywords: migraine, emergency department, dexketoprofen, placebo
Sponsor: Akdeniz University
Start date: 2014-05-01; Completion date: 2014-08-01
Enrollment: 224 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
H0 hypothesis: IV dexketoprofen is equivalent to placebo in ceasing migraine attack in emergency department.

H1 hypothesis: IV dexketoprofen is not equivalent (superior) to placebo in ceasing migraine attack in emergency department.

Detailed description:
Migraine attack is one of the most leading causes presentations to emergency department. Patients with migraine attack seek urgent care to cease their pain. There are so many interventions defined in the medical literature that can be used in migraine attacks. However, as a IV drug, dexketoprofen; little known whether IV dexketoprofen is superior to placebo or not. In the present study we aimed to determine the effects of IV dexketoprofen in migraine attack in emergency department.

Arms: arm 1: 50 mg intravenous dexketoprofen in 50 ml normal saline in 5 minutes infusion. arm 2: 50 ml normal saline
Interventions: intervention 1: Dexketoprofen intervention 2: Normal Saline
Intervention descriptions: intervention 1: 50 mg intravenous arveles in 50 ml saline in 5 minutes intervention 2: 50 ml normal saline

Protocol documents:
Clinical trial NCT02193165
Conditions: Dental Plaque Gingivitis
Sponsor: Colgate Palmolive
Start date: 2014-07-01; Completion date: 2014-08-01
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this clinical research study is to assess the efficacy of three oral hygiene multi-component regimens encompassing the use of a manual toothbrush, toothpaste and a mouthwash in controlling established dental plaque and gingivitis.

Detailed description:

Arms: arm 1: triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash arm 2: stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash arm 3: fluoride toothpaste + fluoride Mouthwash
Interventions: intervention 1: triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash intervention 2: stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash intervention 3: fluoride toothpaste + fluoride Mouthwash
Intervention descriptions: intervention 1: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds. intervention 2: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds. intervention 3: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds.

Protocol documents:
Clinical trial NCT02195583
Conditions: Oral Hygiene
Sponsor: GlaxoSmithKline
Start date: 2014-06-01; Completion date: 2014-08-01
Enrollment: 62 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will evaluate the effect of experimental sodium fluoride-silica dentifrice formulations, with and without zinc, on remineralization of enamel in situ. Following the remineralization phase, the acid resistance of the new mineral formed will be assessed. Fluoride uptake during the remineralization phase will also be measured.

Detailed description:

Arms: arm 1: Non-zinc, 1426ppm fluoride as sodium fluoride in a silica gel base arm 2: Non-zinc, 1150ppm fluoride as sodium fluoride in a silica gel base arm 3: Non-zinc, 250ppm fluoride as sodium fluoride in a silica gel base arm 4: Zinc base A, 1426ppm fluoride as sodium fluoride in a silica gel base arm 5: Zinc base B, 1426ppm fluoride as sodium fluoride in a silica gel base arm 6: Non-zinc, 0ppm fluoride in a silica gel base
Interventions: intervention 1: Sodium fluoride (1426 ppm) intervention 2: Sodium fluoride (1150 ppm) intervention 3: Sodium fluoride (250 ppm) intervention 4: Sodium fluoride (1426 ppm) + zinc base A intervention 5: Sodium fluoride (1426 ppm) + zinc base B intervention 6: Fluoride (0 ppm)
Intervention descriptions: intervention 1: Non-zinc, 1426ppm fluoride as sodium fluoride in a silica gel base intervention 2: Non-zinc, 1150ppm fluoride as sodium fluoride in a silica gel base intervention 3: Non-zinc, 250ppm fluoride as sodium fluoride in a silica gel base intervention 4: Zinc base A, 1426ppm fluoride as sodium fluoride in a silica gel base intervention 5: Zinc base B, 1426ppm fluoride as sodium fluoride in a silica gel base intervention 6: Non-zinc, 0ppm fluoride in a silica gel base

Protocol documents:
Clinical trial NCT02213055
Conditions: Head Lice
Keywords: Lice
Sponsor: Hackensack Meridian Health
Start date: 2009-05-01; Completion date: 2014-08-01
Enrollment: 97 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
* To evaluate the efficacy of LiceMD for the treatment of head lice in a pediatric population.
* To evaluate the safety of LiceMD in a pediatric population.

Detailed description:
Head lice, or Pediculus humanus capitis, cause an estimated 6 to 12 million infestations per year in the U.S., most commonly affecting children 3 to 11 years of age. Despite common perceptions, head lice crawl, and cannot hop or fly. For this reason, transmission occurs most often by human head-to-head contact, and much less commonly by the sharing of personal items such as hats, coats, combs, or towels. Because head lice feed on human blood, they cannot live on pets and are only viable 1-2 days on surfaces other than the human head.

Arms: arm 1: Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment. arm 2: Parents/guardians who do not agree to use the investigational product and choose a standard head lice treatment will be asked to participate in the comparison arm of the study.
Interventions: intervention 1: LICEMD intervention 2: Standard Head lice product
Intervention descriptions: intervention 1: Parents/guardians of infested children will provide consent for their child's participation. Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment. Participants will be examined for lice count and scalp irritation the day after the first application, and one and two weeks after the first application. intervention 2: The most common treatments are pesticide-based, over-the-counter remedies of permethrin (1%), or pyrethrin-based products.After baseline scalp exam for lice count and preexisting signs of irritation, parents who agree to the comparison arm may purchase any other head lice treatment of their choice. All treatments are to be done at home by a parent or guardian. All participants will be examined for lice count and scalp irritation the day after the first application, and one and two weeks after the first application. Participants may also be examined by parents or the school nurse at any time if signs of irritation or re-infestation occur. If the child is still found to be infested during any examination, the school nurse will instruct the parent/guardian to retreat.

Protocol documents:
Clinical trial NCT02264821
Conditions: Post Caesarean Analgesia
Keywords: analgesia caesarean wound infiltration intrathecal morphine.
Sponsor: Dr Madeleine Wilwerth
Start date: 2012-02-01; Completion date: 2014-08-01
Enrollment: 192 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study is to compare effective analgesia with continuous wound infiltration of ropivacaine through multi-holed catheter or with morphine 100 mcg added intrathecally to spinal anesthesia, after elective Caesarean delivery.

Detailed description:
Double blind, 3 groups

* Control group: Rachi 0,1 ml saline, Infusion 300ml saline
* Group rachi-morphine: 0,1ml =100µg morphine/300ml saline
* Group KT: 0,1 ml saline/300 ml naropin 0.2%

Arms: arm 1: ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline arm 2: 100 µg intrathecal morphine and saline infiltration arm 3: intrathecal saline and saline infiltration
Interventions: intervention 1: ropivacaine infiltration intervention 2: intrathecal morphine intervention 3: placebo
Intervention descriptions: intervention 1: wound infiltration intervention 2: 100 µg added to the spinal anaesthesia intervention 3: placebo in spinal anaesthesia and in wound infiltration

Protocol documents:
Clinical trial NCT02360995
Conditions: Dental Plaque Gingivitis
Sponsor: Colgate Palmolive
Start date: 2014-06-01; Completion date: 2014-08-01
Enrollment: 129 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this clinical research study is to evaluate clinical efficacy of Colgate Total Toothpaste as compared to Crest Pro-Health Toothpaste and Crest Pro-Health Mouthwash, and Crest Cavity Protection Toothpaste and Crest Fluoride Mouthwash in reducing gingivitis and dental plaque in adults in a six-week clinical study.

Detailed description:

Arms: arm 1: Triclosan/fluoride toothpaste arm 2: Stannous fluoride toothpaste \& cetylpyridinium chloride Mouthwash arm 3: fluoride toothpaste +fluoride mouthwash
Interventions: intervention 1: Triclosan/fluoride toothpaste intervention 2: stannous fluoride toothpaste intervention 3: fluoride toothpaste intervention 4: Fluoride Mouthwash intervention 5: cetylpyridinium chloride Mouthwash
Intervention descriptions: intervention 1: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration). intervention 2: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). intervention 3: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). intervention 4: Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time. intervention 5: Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time.

Protocol documents:
Clinical trial NCT02396537
Conditions: Pain
Keywords: Children Midazolam Lidocaine Intranasal
Sponsor: University of Alabama at Birmingham
Start date: 2014-01-01; Completion date: 2014-08-01
Enrollment: 77 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to establish whether premedication with topical lidocaine would reduce the pain associated with IN midazolam administration in children. The study was designed to be a double-blinded, randomized, placebo-controlled trial performed in an urban, academic pediatric emergency department.

Detailed description:
This was a double-blinded, randomized, placebo-controlled trial performed in an urban, academic pediatric emergency department with an annual census of 67,000 patients. Children 6-12 years old for whom IN midazolam was ordered were eligible for enrollment. Patients were randomly assigned an identical intranasal medication (4% Lidocaine or 0.9% saline). Patients were administered the study drug followed by IN midazolam. Patients then assigned a pain score for midazolam administration using the Wong-Baker FACES Pain Rating scale. The primary endpoint of pain score was analyzed with a two-tailed Mann-Whitney U test, with P \< 0.05 considered statistically significant.

Arms: arm 1: Patient to receive 4% lidocaine intranasally prior to midazolam arm 2: Patient to receive 0.9% Saline intranasally prior to midazolam
Interventions: intervention 1: Lidocaine intervention 2: Midazolam intervention 3: 0.9% Saline
Intervention descriptions: intervention 1: Administered intranasally prior to Midazolam administration. intervention 2: Administered to all patients immediately after study drug (Lidocaine or Placebo) administered. intervention 3: Administered intranasally prior to Midazolam administration.

Protocol documents:
Clinical trial NCT02402296
Conditions: Localized Aggressive Periodontitis
Sponsor: Al-Azhar University
Start date: 2013-01-01; Completion date: 2014-08-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
combining the non-surgical therapy with a well-tolerated substance that can stimulate protective immune responses like B-glucan, might effectively mount resolution pathways contributing to resolving of the chronic lesion observed in aggressive forms of periodontal disease.

Detailed description:
Aim: To investigate the efficacy of β-glucan supplementation to non-surgical periodontal therapy in localized aggressive periodontitis (LAP) patients.

Method: 30 subjects were randomly and equally assigned to receive scaling and root planing; either with placebo pills (Group I) or β-glucan (100 mg/once a day) (Group II), for 40 days. Subjects were clinically monitored on day 0 and day 91. Gingival samples were harvested from hopeless teeth sites to be investigated histologically and immunohistochemically using matrix metalloproteinase (MMP)-1 and 9 antibodies form each patient; at the same time intervals.

Arms: arm 1: Included those patients who received a systemic β-1,3/1,6-D-glucan (100 mg capsule) once/ day for 40 days after scaling and root planing. arm 2: Was assigned for patients who had scaling and root planing and empty capsules filled with carbohydrates (placebo) for 40 days.
Interventions: intervention 1: β-1,3/1,6-D-glucan intervention 2: Placebo
Intervention descriptions: intervention 1: 15 patients (in group II) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of β-1,3/1,6-D-glucan oral supplementation for 40 days. intervention 2: 15 patients (in group I) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of placebo capsules oral supplementation for 40 days.

Protocol documents:
Clinical trial NCT02770625
Conditions: Gaucher Disease, Type 1
Keywords: Type I Gaucher ISU302 Imiglucerase
Sponsor: ISU Abxis Co., Ltd.
Start date: 2011-09-01; Completion date: 2014-08-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of ISU302 in patients with Type 1 Gaucher disease.

Detailed description:
The objectives of this clinical study were to evaluate the efficacy and safety of every other week (EOW) dosing of ISU302 at a dose of 60 U/kg as an effective glucocerebrosidase enzyme replacement therapeutic product in patients with Type 1 Gaucher disease (GD). Primary efficacy endpoint was the difference in hemoglobin concentration between baseline and Week 24. Secondary efficacy endpoints included assessment of platelet counts, spleen and liver volume, and biomarker levels in plasma at Week 24 compared to baseline; skeletal change and bone mineral density (BMD); and single-dose pharmacokinetic (PK) analysis. Secondary safety endpoints included the assessment of adverse events (AEs), vital signs, physical examination, and electrocardiogram (ECG); clinical safety laboratory analyses included serum chemistry, urinalysis, hematology and coagulation, and the measurement of anti-ISU302 antibodies.

Arms: arm 1: 60 U/kg (once every 2 weeks for 6 months)
Interventions: intervention 1: ISU302
Intervention descriptions: intervention 1: 60 U/kg given intravenously

Protocol documents:
Clinical trial NCT02792829
Conditions: Healthy Volunteers
Keywords: Bioavailability of Lenvatinib suspension Palatability of Lenvatinib suspension Lenvatinib Lenvima E7080 Capsule formulation Healthy volunteers
Sponsor: Eisai Inc.
Start date: 2014-08-01; Completion date: 2014-08-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The study will be conducted in adult healthy participants and will consist of two phases: Prerandomization and Randomization. The Prerandomization Phase will consist of 2 periods: a Screening Period and a Baseline Period. The Randomization Phase will consist of 2 Periods (each 6 days long) separated by a 1-day long Baseline Period and End of Treatment (EOT) Period. A total of 60 participants will be enrolled into one of three arms. Arms 1 and 3 consist of 2 sequences, and Arm 2 consists of 4 sequences (as this is an incomplete block design with 2 factors \[number of capsules and whether water or apple juice is used as vehicle\]). Each participant will be randomized into one of 8 sequences.

Detailed description:

Arms: arm 1: Arm 1 will have 2 sequences:

1. Sequence 1 - Treatment Period 1: 11 mg suspension (2 capsules, 1 x 10 mg and 1 x 1 mg); Treatment Period 2: 11 mg capsules (2 capsules, 1 x 10 mg and 1 x 1 mg)
2. Sequence 2 - Treatment Period 1: 11 mg capsules (2 capsules, 1 x 10 mg and 1 x 1 mg); Treatment Period 2: 11 mg suspension (2 capsules, 1 x 10 mg and 1 x 1 mg) arm 2: Arm 2 will have 4 sequences:

1. Sequence 3 - Treatment Period 1: 11 mg suspension (5 capsules, 2 x 4 mg and 3 x 1 mg) WATER; Treatment Period 2: 11 mg suspension (2 capsules, 1 x 10 mg and 1 x 1 mg) APPLE JUICE
2. Sequence 4 - Treatment Period 1: 11 mg suspension (5 capsules, 2 x 4 mg and 3 x 1 mg capsules) APPLE JUICE; Treatment Period 2: 11 mg suspension (2 capsules, 1 x 10 mg and 1 x 1 mg capsules) WATER
3. Sequence 5 - Treatment Period 1: 11 mg suspension (2 capsules, 1 x 10 mg and 1 x 1 mg capsules) WATER; Treatment Period 2: 11 mg suspension (5 capsules, 2 x 4 mg and 3 x 1 mg capsules) APPLE JUICE
4. Sequence 6 - Treatment Period 1: 11 mg suspension (2 capsules, 1 x 10 mg and 1 x 1 mg capsules) APPLE JUICE; Treatment Period 2: 11 mg suspension (5 capsules, 2 x 4 mg and 3 x 1 mg capsules) WATER arm 3: Arm 3 will have 2 sequences:

1. Sequence 7 - Treatment Period 1: 23 mg suspension (5 capsules, 2 x 10 mg and 3 x 1 mg capsules) taken 23 hours after preparation; Treatment Period 2: 23 mg suspension (5 capsules, 2 x 10 mg and 3 x 1 mg capsules) taken 2 hours after preparation
2. Sequence 8 - Treatment Period 1: 23 mg suspension (5 capsules, 2 x 10 mg and 3 x 1 mg capsules) taken 2 hours after preparation; Treatment Period 2: 23 mg suspension (5 capsules, 2 x 10 mg and 3 x 1 mg capsules) taken 23 hours after preparation
Interventions: intervention 1: Lenvatinib
Intervention descriptions: intervention 1: All participants will receive one single dose in each of the 2 treatment periods (total of 2 doses). The total duration of the treatment periods is 12 days (6 days per period) in healthy adult volunteers.

Protocol documents:
Clinical trial NCT02806960
Conditions: Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2
Sponsor: Eli Lilly and Company
Start date: 2014-06-01; Completion date: 2014-08-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will investigate how the body processes nasal glucagon and the effect of nasal glucagon on the body. After an 8-hour overnight fast and 4 hours after the start of a low-carbohydrate breakfast, the study drug will be delivered into the participant's nostril(s) (intranasally) once or twice in each of four study periods. The study is open to adults with type 1 or type 2 diabetes and is expected to last about 50 days for each participant.

Detailed description:

Arms: arm 1: Treatment 1, single nasal glucagon (NG) dose of 3 milligram (mg). arm 2: Treatment 2, NG dose of 3 mg plus 3 mg NG dose in same nostril 15 minutes later. arm 3: Treatment 3, NG dose of 3 mg plus 3 mg NG dose in the opposite nostril 15 minutes later. arm 4: Treatment 4, NG dose of 3 mg then immediately 3 mg NG dose in the opposite nostril.
Interventions: intervention 1: Nasal Glucagon
Intervention descriptions: intervention 1: Administered intranasally.

Protocol documents: