ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02230696
Conditions: Seasonal Allergic Rhinitis
Sponsor: Padagis LLC
Start date: 2014-08-01; Completion date: 2015-02-01
Enrollment: 951 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare safety and efficacy of Perrigo's steroid drug product compared with an FDA approved steroid drug product in the treatment of subjects with seasonal allergic rhinitis.

Detailed description:

Arms: arm 1: Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray - Perrigo arm 2: Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray - Meda arm 3: Placebo nasal spray
Interventions: intervention 1: Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray intervention 2: Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray intervention 3: Placebo nasal spray
Intervention descriptions: intervention 1: 137 micro-grams Azelastine Hydrochloride, 50 micro-grams Fluticasone Propionate intervention 2: 137 micro-grams Azelastine Hydrochloride, 50 micro-grams Fluticasone Propionate intervention 3: Placebo nasal spray

Protocol documents:
Prot_001.pdf: 
 
 
NCT02230696 
 
09-02-2014 

















































































































SAP_000.pdf: 
 
 
NCT02230696 
 
09-02-2014
Clinical trial NCT02246166
Conditions: Common Cold
Sponsor: GlaxoSmithKline
Start date: 2015-01-01; Completion date: 2015-02-01
Enrollment: 53 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This phase IV multi-centre, randomised, double-blind, placebo-controlled, parallel-group, single-dose study will assess the efficacy and tolerability of the active tablets versus placebo in participants suffering from cold and influenza. Eligible participants will be randomly assigned to one of 2 treatment groups (active or placebo tablets) and enter a four-hour (hr) treatment phase. Each participant will be administered only once during each study period. Participants will use a questionnaire to record the symptom severity scores as described, as well as time.

Detailed description:

Arms: arm 1: Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg). arm 2: Matching placebo tablet
Interventions: intervention 1: Test tablet intervention 2: Placebo
Intervention descriptions: intervention 1: The active tablet will be administered orally. Product administration will occur within 30mins of the baseline assessment of symptom severity intervention 2: The placebo tablet will be administered orally. Product administration will occur within 30mins of the baseline assessment of symptom severity

Protocol documents:
Clinical trial NCT02249104
Conditions: Acne Vulgaris
Sponsor: Galderma R&D
Start date: 2014-08-01; Completion date: 2015-02-01
Enrollment: 28 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this study is to evaluate a complete topical acne regimen consisting of a prescription acne medication (Epiduo® Gel) and an acne-specific cleanser (Cetaphil® DermaControl™ Foam Wash) and moisturizer with sunscreen (Cetaphil® DermaControl™ Moisturizer SPF 30) for safety, efficacy and patient satisfaction in student athletes with acne vulgaris.

Detailed description:
The overall purpose of this study was to demonstrate lesion count reduction from baseline, subject satisfaction, and compliance with a regimen of adapalene BPO used in conjunction with a foam wash and moisturizer with sunscreen in student athletes. The study hypothesis was that this regimen would reduce total lesion count (inflammatory and noninflammatory) relative to baseline. The objective of this study was to evaluate the change in lesion count (total, inflammatory, and noninflammatory) in subjects using the CoMMPlete regimen.

Arms: arm 1: Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily

Cetaphil Acne Regimen:

Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application

Cetaphil® DermaControl™ Foam Wash, at least twice daily
Interventions: intervention 1: Adapalene/benzoyl peroxide gel, 0.1%/2.5% intervention 2: Cetaphil Acne Regimen
Intervention descriptions: intervention 1: Topical AV therapy intervention 2: Cleanse, Moisturize, and Protect

Protocol documents:
Clinical trial NCT02256553
Conditions: Rhinitis, Allergic, Seasonal
Sponsor: ALK-Abelló A/S
Start date: 2014-10-01; Completion date: 2015-02-01
Enrollment: 102 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the safety and tolerability of MK-3641 (short ragweed \[Ambrosia artemisiifolia\] extract, SCH 039641, RAGWITEK®) sublingual tablets and MK-7243 (Timothy grass \[Phleum pratense\] extract, SCH 697243, GRASTEK®) sublingual tablets co-administered in participants 18 through 65 years of age with both ragweed- and grass polled-induced allergic rhinitis, with or without conjunctivitis and with or without asthma. The primary endpoint is the percentage of participants who experience at least one event of local swelling after co-administration of MK-3641 and MK-7243 sublingual tablets.

Detailed description:
Events of local swelling include pharyngeal edema, laryngeal edema, mouth edema, oropharyngeal swelling, palatal edema, tongue swelling/edema or throat tightness.

Arms: arm 1: Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
Interventions: intervention 1: MK-3641 12 Amb a 1-U (short ragweed extract) intervention 2: MK-7243 2800 BAU (Timothy grass extract) intervention 3: Rescue Medication
Intervention descriptions: intervention 1: 12 units of Ambrosia artemisiifolia major allergen number 1 (Amb a 1-U) extract sublingual tablets intervention 2: 2800 bioequivalent allergen units (BAU) of Phleum pratense extract sublingual tablets intervention 3: Self-injectable epinephrine, to be administered for an anaphylactic reaction, including symptoms/signs of upper airway obstruction.

Protocol documents:
Clinical trial NCT02258412
Conditions: Hand Hygiene Effectiveness
Keywords: antimicrobial efficacy hand hygiene bacteria
Sponsor: Solventum US LLC
Start date: 2014-10-01; Completion date: 2015-02-01
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will evaluate the immediate antimicrobial efficacy and persistence of two hand hygiene products on ICU Health Care Worker's skin flora by measuring bacterial organisms on hands using the hand print method. It is hypothesized that the product containing Chlorhexidine gluconate will provide more persistence than the alcohol product, resulting in less bacterial growth on the hand print plates. In addition, environmental monitoring for cleanliness will be captured from high touch surfaces in ICU patient rooms and common areas using Rodac plates and adenosine triphosphate tests.

Detailed description:
Crossover study with 50 Health care workers using each product with a minimum of 3 days in between. Products will be applied twice as per manufacturer's instructions for a Healthcare Personnel Handwash followed by immediate hand print. Persistent hand prints will be collected after exposure to environmental contaminants in the common areas. Hand prints will also be collected from one hand of 60 patients cared for by a participating Health Care Worker and gloved hand of Health Care Worker. All media contain neutralizers to inactivate active ingredients in each product and on surfaces. Each hand print plate's area of growth will be measured for Colony Forming Units using computerized software.

Arms: arm 1: Alcohol foam hand sanitizer applied with 1 pump into hands, spread over hands up to the wrist and rubbed until dry. Foam will be applied twice approximately 15-30 minutes apart on one day. arm 2: Hand antiseptic is applied by dispensing 1 pump into hands, spreading over the hands up to the wrist, and rubbing until dry. Hand antiseptic will be used twice approximately 15-30 minutes apart on one day.
Interventions: intervention 1: hand antiseptic with CHG and alcohol intervention 2: Alcohol hand sanitizer foam
Intervention descriptions: intervention 1: HCWs will be randomized to use one product on one day and the other product on another day at least 3 days apart. Each product will be applied using 1 pump from its dispenser and rubbed over the hands until dry. Gloves will be worn while the HCW is in the patient room. Upon exit from the room, HCW will washoout with that same product. One imprint will be made of the non-dominant hand onto media containing neutralizers. That hand will be gloved with a white cotton glove. The HCW will work in the common areas with timing recorded. Upon leaving the common area, the dominant ungloved hand will be imprinted onto a fresh media plate containing neutralizers. intervention 2: Alcohol foam hand sanitizer applied with 1 pump into hands, spread over hands up to the wrist and rubbed until dry. Foam will be applied twice approximately 15-30 minutes apart on one day

Protocol documents:
Clinical trial NCT02268656
Conditions: Igel
Sponsor: Gachon University Gil Medical Center
Start date: 2014-10-01; Completion date: 2015-02-01
Enrollment: 40 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Before anethetic induction, infuse dexmedetomidine 0.5 mcg/kg for 2 minutes and after injection of lidocaine 30 mg, propofol infusion by using target controlled infusion (TCI) pump. Effect site concentraion of propofol start from 5 and changes the concentration as previous response to i-gel insertion as up and down methods

Detailed description:
Before anethetic induction, infuse dexmedetomidine 0.5 mcg/kg for 2 minutes and after injection of lidocaine 30 mg, propofol infusion by using target controlled infusion (TCI) pump. Effect site concentraion of propofol start from 5 and changes the concentration as previous response to i-gel insertion as up and down methods. Failure of previous subjects are defined as difficulty to mouth open, severe nausea and couph and laryngeal spasm, and not loss of consciousness.

Arms: arm 1: after infusion of dexmedetomidine dexmedetomidine 0.5 mcg/kgfor 2 min, infusion of propofol as using target controlled infusion pump. Effect site concentration would be changed as the response to i-gel insertion as up and down method in male arm 2: after infusion of dexmedetomidine dexmedetomidine 0.5 mcg/kgfor 2 min, infusion of propofol as using target controlled infusion pump. Effect site concentration would be changed as the response to i-gel insertion as up and down method in female
Interventions: intervention 1: propofol concentration
Intervention descriptions: intervention 1: First subjects start from effect site concentraion of 5ug/ml propofol, after insertion of i-gel, determine the next subjects' effect site concentraion would be increae or decrease 0.5 ug/ml as up and down method

Protocol documents:
Clinical trial NCT02269488
Conditions: Healthy Japanese Children Age 2 Years Through 6 Years
Keywords: Safety Tolerability MEDI3250 Japanese children
Sponsor: AstraZeneca
Start date: 2014-11-01; Completion date: 2015-02-01
Enrollment: 100 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This open-label, single arm, multicenter study will enroll approximately 100 subjects. The study is designed to gather the safety and tolerability data in Japanese children 2 to 6 years of age that would support approval of MEDI3250 in Japan.

Detailed description:
For children age 2 years through 6 years, the recommended dosage schedule for intranasal administration is 0.2 mL (0.1 mL per nostril). For children not previously vaccinated against seasonal influenza, a second dose should be given after an interval of at least 4 weeks.

For the safety and tolerability endpoint, data will be gathered on solicited symptoms, AEs and SAEs.

Arms: arm 1: MEDI3250 Nasal spray
Interventions: intervention 1: MEDI3250
Intervention descriptions: intervention 1: MEDI3250

Protocol documents:
Clinical trial NCT02289755
Conditions: Hyperoxaluria Nephrolithiasis
Keywords: Urine Oxalate Nephrolithiasis Kidney Stones Hyperoxaluria Enteric Hyperoxaluria Idiopathic Hyperoxaluria Urological Diseases Kidney Diseases
Sponsor: Allena Pharmaceuticals
Start date: 2014-09-01; Completion date: 2015-02-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the effect of ALLN-177 to reduce urinary oxalate excretion in patients with recurring kidney stones and enteric or idiopathic hyperoxaluria.

Detailed description:
A multi-center, open-label, single arm study to evaluate the safety and the effect of ALLN-177 to reduce urinary oxalate excretion in recurrent kidney stone formers with associated hyperoxaluria. The study design includes a screening period to confirm eligibility, followed by a 3-day baseline period, 4-day open label treatment period with ALLN-177 and 4-day follow up period.

Arms: arm 1: Recurrent Calcium Oxalate Stone Formers with Hyperoxaluria Subjects with Enteric or Idiopathic hyperoxaluria

Dosing: 5 capsules of ALLN-177 orally (p.o.) up to 3 times daily (TID) with meals for 4 consecutive days.
Interventions: intervention 1: ALLN-177
Intervention descriptions: intervention 1: ALLN-177 is orally administered oxalate decarboxylase (OxDc). The goal of oral therapy with ALLN-177 is to enzymatically degrade both dietary oxalate and endogenously produced oxalate secreted in the gastrointestinal tract resulting in decreased absorption and reduced urinary oxalate excretion.

Protocol documents:
Clinical trial NCT02308501
Conditions: Allergic Conjunctivitis
Sponsor: ORA, Inc.
Start date: 2014-12-01; Completion date: 2015-02-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A Single-Center Evaluation of the Anti-Inflammatory Effects of Lastacaft ® as Measured by In-Vivo Confocal Microscopy

Detailed description:

Arms: arm 1: One drop Lastacaft ® in right eye or left eye based on randomization list once on Day 1 and once on Day 2 arm 2: One drop Tears Naturale ® in right eye or left eye based on randomization list once on Day 1 and once on Day 2
Interventions: intervention 1: Lastacaft ® intervention 2: Tears Naturale ® (Placebo)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02318303
Conditions: Seasonal Allergic Rhinitis
Sponsor: Glenmark Pharmaceuticals Ltd. India
Start date: 2014-12-01; Completion date: 2015-02-01
Enrollment: 1111 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study to evaluate the two different strengths and dose regimen of GSP 301 to be effective in treatment of seasonal allergic rhinitis.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None
Interventions: intervention 1: GSP 301-1 NS (QD) intervention 2: GSP 301-2 NS (BID) intervention 3: GSP 301 Placebo NS intervention 4: Olopatadine HCl-1 NS (QD) intervention 5: Olopatadine HCl-2 NS (BID) intervention 6: Mometasone Furoate-1 NS (QD) intervention 7: Mometasone Furoate-2 NS (BID)
Intervention descriptions: intervention 1: GSP 301-1 NS (665 μg olopatadine hydrochloride/50 μg mometasone furoate) administered as 2 sprays/nostril intervention 2: GSP 301-2 NS (665 μg olopatadine hydrochloride/25 μg mometasone furoate) administered as 2 sprays/nostril intervention 3: GSP 301 placebo NS administered as 2 sprays/nostril intervention 4: Olopatadine HCl-1 NS (665 μg) administered as 2 sprays/nostril intervention 5: Olopatadine HCl-2 NS (665 μg) administered as 2 sprays/nostril intervention 6: Mometasone furoate -1 NS (50 μg) administered as 2 sprays/nostril intervention 7: Mometasone furoate-2 NS (25 μg) administered as 2 sprays/nostril

Protocol documents:
Clinical trial NCT02327143
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2015-01-01; Completion date: 2015-02-01
Enrollment: 11 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The aim of this study is to compare how much of the study drug gets into the blood stream when it is given as a single oral dose and as an intravenous infusion (given directly into a vein via a small needle).

The study will also provide information on how well the study drug is tolerated when given as a capsule in combination with giving it intravenously, and information on any changes in heart function.

The study will last about 10 days. Screening is required within 28 days before study drug is given.

Detailed description:

Arms: arm 1: 200 mg LY2835219 administered orally on day 1. arm 2: 0.4 mg ¹³C₈-LY2835219 given intravenously (IV) for 15 minutes, starting approximately 6 hours after the oral dose.
Interventions: intervention 1: LY2835219 intervention 2: ¹³C₈-LY2835219
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered IV

Protocol documents:
Clinical trial NCT02338713
Conditions: Healthy Volunteers
Keywords: Drug therapy
Sponsor: Takeda
Start date: 2015-01-01; Completion date: 2015-02-01
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to demonstrate that the intestinal absorption of calcium from a novel calcium carbonate-vitamin D3 chewable tablet formulation (calcium 500 milligrams (mg) and vitamin D3 1000 International Units (IU)) increases the amount of calcium excreted in urine and decreases parathyroid hormone (PTH) in serum as compared with Baseline.

Detailed description:
The drug being tested in this study was called Calcichew D3. Calcichew D3 was being tested to assess how it is processed by the body in healthy men and postmenopausal women. This study looked at lab results in people who take Calcichew D3.

The study enrolled approximately 27 participants. All participants received the same treatment:

• Calcichew D3 (calcium 500 mg and vitamin D3 1000 IU) chewable tablets All participants were asked to take one tablet each morning of the treatment period.

This single-centre trial was conducted in France. The overall time to participate in this study was up to 44 days. Participants made 2 visits to the clinic, including one 7-day period of confinement to the clinic, and were contacted by telephone 14 days after last dose of study drug for a follow-up assessment.

Arms: arm 1: Noncarbonated water 200 milliliter (mL), orally, once daily on Days 1, 2 and 3 in period 1 (dummy treatment period) followed by Calcichew D3 500 milligram (mg)/1000 international units (IU) (Calcium 500 mg, chewable tablets and vitamin D3 1000 IU, chewable tablets), orally, once daily on Days 4, 5 and 6 in period 2 (study treatment period) of 6 days treatment period.
Interventions: intervention 1: Calcichew D3 intervention 2: Noncarbonated Water
Intervention descriptions: intervention 1: Calcium 500 mg and vitamin D3 1000 IU chewable tablets intervention 2: Noncarbonated water 200 mL

Protocol documents:
Clinical trial NCT02340104
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2015-01-01; Completion date: 2015-02-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to compare how much baricitinib (study drug) gets into the blood stream when it is given as a single dose (in tablet form) and as an intravenous infusion (injection given directly into a vein via a small needle). Each participant in the study will make four visits to the investigator site over the course of about 6 weeks.

Detailed description:

Arms: arm 1: Single oral dose of baricitinib and single intravenous (IV) infusion of \[\^13C4D3\^15N\]-baricitinib over 1.5 hours.
Interventions: intervention 1: Baricitinib intervention 2: [^13C4D3^15N]-baricitinib
Intervention descriptions: intervention 1: 4 milligrams (mg) administered orally intervention 2: 4 micrograms (μg) administered intravenously (IV)

Protocol documents:
Clinical trial NCT02359435
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori Proton pump inhibitor Eradication
Sponsor: Kaohsiung Veterans General Hospital.
Start date: 2012-10-01; Completion date: 2015-02-01
Enrollment: 440 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Reverse hybrid therapy is a one-step two-phase treatment for Helicobacter pylori infection with less cost than standard triple therapy. Whether reverse hybrid therapy can replace standard triple therapy as the recommended first-line treatment is unknown. The investigators compared the efficacy of 12-day reverse hybrid therapy and 12-day standard triple therapy in first-line treatment.

Detailed description:
For this multicentre, single-blind, and randomized-controlled trial (REHYTRI study), the investigator recruited patients with H pylori infection. Using a computer-generated randomization sequence, the investigator randomly allocated patients to either 12-day reverse hybrid therapy (pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg for the first 7 days, followed by pantoprazole 40 mg, amoxicillin 1 g for another 5 days; with all drugs given twice daily) or a 12-day standard triple therapy (pantoprazole 40 mg, clarithromycin 500 mg, amoxicillin 1 g for 12 days; with all drugs given twice daily) at a 1:1 ratio. Our primary outcome was the eradication rate by intention-to-treat and per-protocol analyses.

Arms: arm 1: pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg for the first 7 days, followed by pantoprazole 40 mg and amoxicillin 1 g for another 5 days; with all drugs given twice daily arm 2: pantoprazole 40 mg, clarithromycin 500 mg, and amoxicillin 1 g for 12 days; with all drugs given twice daily
Interventions: intervention 1: Reverse hybrid therapy intervention 2: Standard triple therapy
Intervention descriptions: intervention 1: pantoprazole 40 mg b.d., amoxicillin 1 g b.d., clarithromycin 500 mg b.d. and metronidazole 500 mg b.d. for the first 7 days, followed by pantoprazole 40 mg b.d. and amoxicillin 1 g b.d. for another 5 days intervention 2: pantoprazole 40 mg b.d., clarithromycin 500 mg b.d., and amoxicillin 1 g b.d. for 12 days

Protocol documents:
Clinical trial NCT02707640
Conditions: Idiopathic Pulmonary Fibrosis
Sponsor: Hoffmann-La Roche
Start date: 2013-08-01; Completion date: 2015-02-01
Enrollment: 123 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 2, randomized, double-blind, placebo-controlled safety and tolerability study of N-acetylcysteine or placebo in participants with mild to moderate idiopathic pulmonary fibrosis (IPF) receiving background pirfenidone therapy.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: Background therapy
Interventions: intervention 1: Matching Placebo intervention 2: N-acetylcysteine intervention 3: Pirfenidone
Intervention descriptions: intervention 1: Matching Placebo, oral administration, three times daily for 24 weeks. intervention 2: N-acetylcysteine, 600 mg, oral administration, three times daily for 24 weeks. intervention 3: Pirfenidone, at least 1602 mg/day, oral administration, for 32 weeks, during the wash-out and screening period and for at least 8 weeks prior to randomization.

Protocol documents: