ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02495623
Conditions: Irritable Bowel Syndrome With Constipation (IBS-C)
Sponsor: Theriva Biologics, Inc.
Start date: 2015-06-01; Completion date: 2015-11-01
Enrollment: 63 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multi-Dose Study of the Effect of Two Dosage Strengths of SYN-010 Compared with Placebo on Breath Methane Production in Breath Methane-Positive Subjects with Irritable Bowel Syndrome with Constipation (IBS-C)

Detailed description:
This is a Phase 2, randomized, multi-center, multi-dose study. Sixty subjects with irritable bowel syndrome with constipation who are between the ages of 18 and 65, inclusive, will be enrolled. The entire duration of the study may be up to 43 days (from Screening to the post end-of-study \[EOS\] visit telephone call).

Arms: arm 1: 21 mg SYN-010 arm 2: 42 mg SYN-010 arm 3: Placebo
Interventions: intervention 1: SYN-010 21 mg intervention 2: SYN-010 42 mg intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02497391
Conditions: Healthy
Sponsor: Eli Lilly and Company
Start date: 2015-07-01; Completion date: 2015-11-01
Enrollment: 95 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine if there is any difference in the way the body handles 3 types of evacetrapib tablets with different particle sizes. Information about any side effects will also be collected. This study will consist of 3 study periods. Participants will be dosed 3 times during the entire study. Each study period will consist of an inpatient stay for 3 days - the day before dosing (Day -1), dosing day (Day 1) and the day after dosing (Day 2). Then participants will be asked to return to the clinical research unit (CRU) daily for outpatient appointments up to Day 8. The overall length of this study is about 7 weeks from first dose to end of study. Screening will take place within 28 days prior to the first dose of evacetrapib and follow-up will take place 21 days after the last dose of evacetrapib.

Detailed description:

Arms: arm 1: Single oral dose of 130 mg evacetrapib tablet given one time during one study period. arm 2: Single oral dose of 130 mg evacetrapib tablet given one time during one study period. arm 3: Single oral dose of 130 mg evacetrapib tablet given one time during one study period.
Interventions: intervention 1: Evacetrapib
Intervention descriptions: intervention 1: administered orally

Protocol documents:
Clinical trial NCT02511561
Conditions: Otitis Externa
Keywords: Otitis externa Swimmer's ear Ear infection
Sponsor: Otonomy, Inc.
Start date: 2015-07-01; Completion date: 2015-11-01
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 1-month, multicenter, open-label study in subjects with unilateral otitis externa. Eligible subjects will receive a single dose of 6 mg OTO-201 to the affected ear. The study is designed to characterize safety, procedural factors and clinical effect of OTO-201 administered in subjects with otitis externa.

Detailed description:

Arms: arm 1: Ciprofloxacin arm 2: Ciprofloxacin arm 3: Ciprofloxacin
Interventions: intervention 1: OTO-201 (ciprofloxacin)
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02540265
Conditions: Pain, Post-operative
Keywords: Bunion Bunionectomy Pain Analgesia N1539
Sponsor: Baudax Bio
Start date: 2015-08-01; Completion date: 2015-11-01
Enrollment: 59 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the safety of N1539 in subjects with acute moderate to severe pain following unilateral bunionectomy.

Detailed description:

Arms: arm 1: N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses. arm 2: N1539 (Intravenous meloxicam) 60mg every 24 hours for up to 3 doses. arm 3: IV Placebo every 24 hours for up to 3 doses.
Interventions: intervention 1: N1539 intervention 2: Intravenous Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02555228
Conditions: Lesion of Stomach
Keywords: simethicone gastroscopy McNalley score
Sponsor: Changi General Hospital
Start date: 2015-08-01; Completion date: 2015-11-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A randomized controlled and endoscopist-blinded study which compares the efficacy of liquid simethicone (100mg) in 5 mls water, versus placebo ( 5mls of water), as premedication (given at least 30 minutes) before gastroscopy towards improvement of the total mucosal visibility score.

Detailed description:
Excessive bubbles or foam during gastroscopy is a common problem which can cause significant hindrance to an optimal evaluation of the gastric mucosa, prolong the procedure time, and contribute to poor patient tolerance during the scope.

Simethicone, with or without N-acetylcysteine, has been extensively evaluated to improve mucosal visibility. However, the volume of simethicone preparation and the timing of ingesting this solution before gastroscope varied significantly across different studies. In general, it appeared that a larger volume of simethicone solution, given earlier before the gastroscopy, may yield better results. However, allowing a patient to ingest a large volume of liquid before a gastroscopy under sedation brings forth the risk of aspiration. A recent Taiwanese study published in 2014 \[1\] showed that the subgroup with 100mg of simethicone in just 5ml of water, did achieve a good total mucosal visibility score, if the solution was ingested more than 30 minutes before the gastroscope. This may be because a longer time allows the simethicone to coat more of the mucosa. However, this study did not compare this preparation against a placebo.

In Changi General Hospital, many gastroscopies are done daily with no premedication. Also, there is no protocol for premedication before gastroscopes. This study hopes to prove that a low volume of simethicone solution, given at an ample time (more than 30 minutes) before the scope, can significantly improve overall endoscopy performance compared to no premedication at all.

Arms: arm 1: Liquid simethicone (1ml volume) in 5mls of water arm 2: Just 5 mls of water
Interventions: intervention 1: Simethicone intervention 2: Water
Intervention descriptions: intervention 1: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy. intervention 2: 5mls of water is given at least 30 minutes before the gastroscopy.

Protocol documents:
Clinical trial NCT02555449
Conditions: Healthy
Sponsor: Eli Lilly and Company
Start date: 2015-09-01; Completion date: 2015-11-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to measure how much of the specially prepared study drug, LY3202626, containing radiolabeled carbon \[¹⁴C\] gets into the blood stream and how long it takes the body to get rid of it.

Information about any side effects that may occur will also be collected.

Participants will stay at a clinical research unit (CRU). The study will last about 28 days (check in to follow-up) for each participant.

This study is for research purposes only and is not intended to treat any medical condition.

Detailed description:

Arms: arm 1: Single oral dose of LY3202626 containing 100 micro curies of radioactivity
Interventions: intervention 1: [¹⁴C]-LY3202626
Intervention descriptions: intervention 1: Administered as solution by mouth

Protocol documents:
Clinical trial NCT02572752
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2015-08-01; Completion date: 2015-11-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To establish the bioequivalence of 1 soft gelatine capsule containing 200 mg nintedanib compared to 2 soft gelatine capsules containing 100 mg nintedanib

Detailed description:

Arms: arm 1: Nintedanib, 1 capsule, oral with 240 mL of water arm 2: Nintedanib, 2 capsules, oral with 240 mL of water arm 3: Nintedanib, 2 capsules, oral with 240 mL of water
Interventions: intervention 1: Nintedanib intervention 2: Nintedanib intervention 3: Nintedanib
Intervention descriptions: intervention 1: 1 soft gelatine capsule, single dose, oral intervention 2: Nintedanib, 2 soft gelatine capsules, single dose, oral intervention 3: None

Protocol documents:
Clinical trial NCT02595684
Conditions: Obesity
Keywords: Obesity Tadalfil Insulin secretion Insulin sensitivity
Sponsor: University of Guadalajara
Start date: 2015-08-01; Completion date: 2015-11-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Obesity is a chronic disease of multifactorial etiology that develops from the interaction of the influence of nutritive , metabolic , cellular and molecular psychological factors.

Tadalafil is Is a drug inhibiting the enzyme phosphodiesterase-5 (PDE-5), responsible for inactivating the vasodilator nitric oxide. USING paragraph was mainly treat erectile dysfunction, and recently approved for the treatment of pulmonary hypertension , it is innovative because of its longer life means, provides efficacy after 36 hours and the highest selectivity.

The aim of this study is to evaluate the effect of tadalafil on insulin sensitivity and insulin secretion in obese men.

The investigators hypothesis is that the administration of tadalafil improve the insulin sensitivity and insulin secretion in obese men.

Detailed description:
A randomized, double-blind, placebo-controlled clinical trial in 18 men aged between 30 and 50 years with obesity (BMI 30-39.9) according to the World Health Organization (WHO) criteria without treatment.

They will be assigned randomly in two groups of 9 patients, each to receive 5 mg of tadalafil or placebo every day at night during 28 days.

There will be evaluated Insulin secretion, both first phase of insulin secretion by Stumvoll Inex as well as Total Insulin Secretion by Area Under the Curve of glucose and insulin and Insulinogenic Index, and Insulin sensitivity by Matsuda index.

Waist circumference, glucose and insulin levels, lipid profile and blood pressure are going to be load will be evaluated before and after intervention in both groups.

Statistical analysis will be presented through measures of central tendency and dispersion, average and deviation standard for quantitative variables; frequencies and percentages for variable qualitative. Qualitative variables will be analyzed by X2, will be used for differences inter-group Mann-Whitney U Test and Wilcoxon Test for the within-groups differences. Will be considered statistical significance p ≤0.05.

This protocol was approved by a local Ethics Committee and written informed consent will be obtained from all volunteers.

Arms: arm 1: Tadalafil capsules arm 2: Calcined magnesia capsules
Interventions: intervention 1: Tadalafil intervention 2: Placebo
Intervention descriptions: intervention 1: Tadalafil capsules: 5 mg, one per day, at night, during 28 days. intervention 2: Calcined magnesia capsules: one per day, at night, during 28 days.

Protocol documents:
Clinical trial NCT02596620
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori Proton pump inhibitor Eradication
Sponsor: Chang Gung Memorial Hospital
Start date: 2013-10-01; Completion date: 2015-11-01
Enrollment: 164 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Asia Pacific Consensus states that levofloxacin-based triple therapy as an alternative second-line therapy after Helicobacter pylori (H. pylori) eradication failure when bismuth salts are not available. The investigators compare the efficacies of 10-day levofloxacin-based sequential therapy and 10-day triple therapy in the treatment for patients after failure of standard triple therapy and to determine what clinical and bacterial factors influencing the efficacy of salvage regimens.

Detailed description:
In this randomized-controlled trial , the investigator recruited participants with H pylori infection after failure of first line standard triple therapy. Using a computer-generated randomization sequence, the investigators randomly allocated patients to either 10-day levofloxacin-containing sequential (EALM, esomeprazole 40 mg b.d., amoxicillin 1 g b.d.for 5 days and followed by esomeprazole 40 mg b.d., levofloxacin 500 mg qd and metronidazole for 5 days) or 10-day levofloxacin-containing triple therapy (EAL, esomeprazole 40 mg b.d., amoxicillin 1 g b.d., and levofloxacin 500 mg qd) at a 1:1 ratio. The primary outcome was the eradication rate by intention-to-treat and per-protocol analyses.

Arms: arm 1: Esomeprazole (Nexium)(40 mg) 1 tablet twice daily, amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 5 days followed by esomeprazole (Nexium) (40 mg) twice daily, levofloxacin(Cravit)(500 mg), 1 tablet once daily and metronidazole (Flagyl)(250 mg) 2 tablets three times daily for 5 days arm 2: Esomeprazole (Nexium)(40 mg) 1 tablet twice daily; amoxicillin (Amolin)(500 mg) 2 tablets twice daily and levofloxacin(Cravit)(500 mg), 1 tablet once daily for 10 days
Interventions: intervention 1: Nexium intervention 2: Amolin intervention 3: Cravit intervention 4: Flagyl
Intervention descriptions: intervention 1: Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms intervention 2: Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for the first 5 days in the Sequential arm; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 10 days for triple therapy arm intervention 3: Levofloxacin(Cravit)(500 mg) 1 tablet once dialy for the last 5 days in the sequential arm and 1 tablets once daily for 10 days in the triple therapy arm intervention 4: Metronidazole (Flagyl)(250 mg) 2 # tid for the last 5 days in the sequential arm

Protocol documents:
Clinical trial NCT02616614
Conditions: Acne Vulgaris
Sponsor: Actavis Inc.
Start date: 2015-05-01; Completion date: 2015-11-01
Enrollment: 862 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Actavis has developed a generic formulation of clindamycin 1.2% and benzoyl peroxide 3.75% gel. This study is designed to evaluate the safety and efficacy of this formulation in subjects with Acne Vulgaris

Detailed description:
This is a randomized, double blind, three-arm, parallel group, placebo control bioequivalence study with clinical endpoint, at multiple study sites, designed to establish bioequivalence of clindamycin 1.2% and benzoyl peroxide 3.75% gel of Actavis and Onexton® (clindamycin 1.2% and benzoyl peroxide 3.75%) gel in the treatment of subjects with Acne Vulgaris.

The primary objective is to evaluate the bioequivalence of a generic of clindamycin 1.2% and benzoyl peroxide 3.75% gel to Onexton® in the treatment of subjects with acne vulgaris.

Arms: arm 1: Clindamycin 1.2% and benzoyl peroxide 3.75% topical gel Applied a thin film of medication onto 6 areas of the face (chin, left cheek, right cheek, nose, left forehead, and right forehead) once daily arm 2: Generic clindamycin 1.2% and benzoyl peroxide 3.75% topical gel. Applied a thin film of medication onto 6 areas of the face (chin, left cheek, right cheek, nose, left forehead, and right forehead) once daily arm 3: A vehicle gel. Applied a thin film of medication onto 6 areas of the face (chin, left cheek, right cheek, nose, left forehead, and right forehead) once daily
Interventions: intervention 1: Onexton intervention 2: Clindamycin/benzoyl peroxide gel intervention 3: Placebo
Intervention descriptions: intervention 1: Topical gel for treating acne intervention 2: Generic Clindamycin/benzoyl peroxide gel for treating acne intervention 3: Vehicle gel used as a placebo

Protocol documents:
Clinical trial NCT02624843
Conditions: Head Lice
Sponsor: Akorn, Inc.
Start date: 2015-08-01; Completion date: 2015-11-01
Enrollment: 239 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To establish the therapeutic equivalence and safety of a generic Benzyl Alcohol Lotion 5% with Ulesfia Lotion 5% in eradication of head lice in the study subjects.

Detailed description:

Arms: arm 1: Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out. arm 2: Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out. arm 3: Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out.
Interventions: intervention 1: Benzyl Alcohol Lotion 5% intervention 2: Ulesfia (benzyl alcohol lotion) 5% intervention 3: Placebo
Intervention descriptions: intervention 1: White topical lotion intervention 2: White topical lotion intervention 3: White topical lotion

Protocol documents:
Clinical trial NCT02631954
Conditions: Aspergillus Infections Candida Infections Fungal Infections
Sponsor: Chong Kun Dang Pharmaceutical
Start date: 2015-09-01; Completion date: 2015-11-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Phase I Clinical Trial for Comparison of Pharmacokinetic Characteristics of Vorico Injection 200mg(Voriconazole) and Vfend® IV 200mg for Single Dose Crossover Intravenous Infusion in Healthy Volunteers

Detailed description:
To healthy volunteers subjects of twenty four(24), following treatments are administered dosing in each period injected wash-out period is a minimum of 7days. Treatment A(Test Drug): Vorico Injection 200mg(Voriconazole) for Single Dose Treatment B(Reference Drug): Vfend® IV 200mg for Single Dose Pharmacokinetic blood samples are collected up to 24hrs.

Safety and pharmacokinetic are assessed.

Arms: arm 1: Test drug: Vorico Injection 200mg(Voriconazole) Wash out: 7 days Reference drug: Vfend® IV 200mg arm 2: Reference drug: Vfend® IV 200mg Wash out: 7 days Test drug: Vorico Injection 200mg(Voriconazole)
Interventions: intervention 1: Vorico Injection 200mg(Voriconazole) intervention 2: Vfend®(Voriconazole) IV 200mg
Intervention descriptions: intervention 1: Vorico Injection 200mg(Voriconazole) to administered intravenously once intervention 2: Vfend®(Voriconazole) IV 200mg to administered intravenously once

Protocol documents:
Clinical trial NCT02760862
Conditions: Headache
Sponsor: Ain Shams University
Start date: 2014-10-01; Completion date: 2015-11-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Fifty patients of both sex, aged 18-50 years and ASA I and II undergoing elective lower abdominal and pelvic surgery under spinal anesthesia were included in this randomized double-blind study. Patients were randomly divided into 2 groups 25 each; group (I) received intravenous hydrocortisone 100mg every 8 hours for 48 hours and group (II) received intravenous infusion of mannitol 20% 100ml over 30 minutes followed by 100ml every 12hours. Mean (+/- SD) of headache intensity at 0, 6, 12, 24 and 48 hours after beginning of treatment was assessed using visual analog scale.

Detailed description:

Arms: arm 1: Group (I), received hydrocortisone 100mg, dissolved in 2ml normal saline, intravenously/8 hours for 48 hours (Hydrocortisone as sodium succinate, vial, equivalent to hydrocortisone 100mg, Egyptian INT, Pharmaceutical Industries CO. ARE,EIPICO.EGYPT). arm 2: group (II), received mannitol 20% intravenous fluid (100ml intravenously which was given over 30 minutes and followed by 100 ml on a 12hour basis for 48 hours) (Manufactured by Allmed Middle East, Egypt).
Interventions: intervention 1: hydrocortisone 100mg. intervention 2: mannitol 20% intravenous fluid
Intervention descriptions: intervention 1: Group (I), received hydrocortisone 100mg, dissolved in 2ml normal saline, intravenously/8 hours for 48 hours intervention 2: group (II), received mannitol 20% 100ml intravenously which was given over 30 minutes and followed by 100 ml on a 12hour basis. Urinary catheter was inserted for patients in group (II) under complete aseptic conditions by the anesthesia resident before the start of mannitol infusion and removed after its discontinuation, accompanied by the intravenous fluid infusion over 48 hours of 500ml of normal saline or Ringer's solution every 8 hours and the input/output fluid chart for evaluation of fluid balance.

Protocol documents:
Clinical trial NCT02829983
Conditions: Aggressive Periodontitis
Keywords: clarithromycin periodontal debridement aggressive periodontitis
Sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho
Start date: 2014-03-01; Completion date: 2015-11-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the periodontal clinical response and the possible adverse effects of the clarithromycin combined to periodontal mechanical therapy in the treatment of patients with generalized aggressive periodontitis.

Detailed description:
To assess the periodontal clinical response and the possible adverse effects of the clarithromycin combined to periodontal mechanical therapy in the treatment of patients with generalized aggressive periodontitis.Forty patients were select and randomly assigned into two groups: Group clarithromycin with 20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg - 12/12 hours) for 3 days; group placebo with 20 subjects that received FMUD associated with placebo. Probing depth (PD), gain in clinical attachment level (CAL) and bleeding on probing (BOP) were evaluated at baseline, 3 and 6 months post- operatively.

Arms: arm 1: 20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg - 12/12 hours) for 3 days. arm 2: 20 subjects that received FMUD associated with placebo (members took with placebo 500 mg b.i.d. for 3 days).
Interventions: intervention 1: Clarithromycin intervention 2: Placebo intervention 3: One-stage full-mouth ultrasonic debridement (FMUD)
Intervention descriptions: intervention 1: Use of 500mg of Clarithromycin twice a day for 3 days intervention 2: Use of placebo tablets twice a day for 3 days. intervention 3: One session of Periodontal debridement using ultrasonic device.

Protocol documents:
Clinical trial NCT01405053
Conditions: Lennox-Gastaut Syndrome
Keywords: Central Nervous System
Sponsor: Eisai Inc.
Start date: 2011-06-16; Completion date: 2015-11-02
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was designed to evaluate the cognitive effect, safety, and pharmacokinetics (PK) of rufinamide on Lennox-Gastaut Syndrome (LGS) inadequately controlled in pediatric participants already taking other anti-epileptic drugs.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Rufinamide intervention 2: Any other approved Antiepileptic Drug
Intervention descriptions: intervention 1: Rufinamide up to 45 mg/kg/day, in 2 divided doses, administered as oral suspension (40 mg/mL) as an add-on to the subject's existing regimen of 1-3 antiepileptic drugs (AEDs) intervention 2: Any other approved AED: any other approved AED of the investigator's choice as an add-on to the subject's existing regimen of 1-3 anti-epileptic drugs (AEDs)

Protocol documents: