ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01801735
Conditions: Osteoarthritis
Sponsor: Iroko Pharmaceuticals, LLC
Start date: 2013-03-01; Completion date: 2014-08-01
Enrollment: 600 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety of Meloxicam SoluMatrix Capsules for up to 52 weeks in subjects with pain due to osteoarthritis (OA) of the knee or hip

Detailed description:

Arms: arm 1: One Capsule QD
Interventions: intervention 1: Meloxicam Test Capsules
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01820260
Conditions: Actinic Keratosis
Sponsor: LEO Pharma
Start date: 2013-04-01; Completion date: 2014-08-01
Enrollment: 395 participants; Allocation: RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
To identify the Maximum Tolerated Dose levels of ingenol mebutate gel after once daily treatment for 2 or 3 consecutive days and to evaluate efficacy of ingenol mebutate gel in different doses after once daily treatment for 2 or 3 consecutive days compared to vehicle gel

Detailed description:

Arms: arm 1: Open-label, dose escalation, 3 days treatment arm 2: Randomized, 3 days treatment arm 3: Randomized 2 days treatment arm 4: Randomized 3 days treatment arm 5: Randomized 2 days treatment arm 6: Randomized 3 days treatment arm 7: Randomized 2 days treatment arm 8: Open-label, dose escalation, 3 days treatment arm 9: Open-label, dose escalation, 3 days treatment arm 10: Open-label, dose escalation, 3 days treatment arm 11: Open-label, dose escalation, 3 days treatment arm 12: Open-label, dose escalation, 2 days treatment arm 13: Open-label, dose escalation, 3 days treatment arm 14: Open-label, dose escalation, 2 days treatment
Interventions: intervention 1: Ingenol mebutate gel intervention 2: placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01838590
Conditions: Hepatitis C Virus
Keywords: Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action HCV genotype 4 (GT-4) HCV Sustained Virologic Response Direct Acting Antiviral Combination Therapy GS-7977 Ribavirin Open Label Sofosbuvir Additional relevant MeSH terms: Hepatitis Hepatitis, Chronic Hepatitis C Hepatitis C, Chronic
Sponsor: Gilead Sciences
Start date: 2013-03-01; Completion date: 2014-08-01
Enrollment: 103 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to to evaluate the safety, tolerability, and efficacy of sofosbuvir (SOF) plus ribavirin (RBV) in Egyptian adults with genotype 4 hepatitis C virus (HCV) infection.

Detailed description:

Arms: arm 1: Participants will receive SOF+RBV for 12 weeks. arm 2: Participants will receive SOF+RBV for 24 weeks.
Interventions: intervention 1: SOF intervention 2: RBV
Intervention descriptions: intervention 1: Sofosbuvir (SOF) 400 mg tablet administered orally once daily intervention 2: Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Protocol documents:
Clinical trial NCT01844856
Conditions: Complicated Intra-abdominal Infections
Sponsor: Tetraphase Pharmaceuticals, Inc
Start date: 2013-08-01; Completion date: 2014-08-01
Enrollment: 541 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety, and pharmacokinetics of eravacycline compared with ertapenem in the treatment of adult complicated intra-abdominal infections (cIAI).

Detailed description:

Arms: arm 1: Eravacycline was administered intravenously (IV) at a dose of 1.0 milligram per kilogram of body weight (mg/kg) every 12 hours (q12h) for a minimum of 4 days and a maximum of 14 days. Eravacycline treatment was to be stopped when symptoms of complicated intra-abdominal infection (cIAI) resolved, there was treatment failure, or the maximum allowed number of infusion days was reached. arm 2: Ertapenem was administered IV at a dose of 1.0 gram (g) every 24 hours (q24h) for a minimum of 4 days and a maximum of 14 days. Ertapenem treatment was to be stopped when symptoms of cIAI resolved, there was treatment failure, or the maximum allowed number of infusion days was reached.
Interventions: intervention 1: Eravacycline intervention 2: Ertapenem intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: Administered IV to maintain the blind.

Protocol documents:
Clinical trial NCT01849770
Conditions: Sporadic Amyotrophic Lateral Sclerosis
Keywords: SALS Mexiletine Safety
Sponsor: University of Washington
Start date: 2013-07-01; Completion date: 2014-08-01
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research is to find out if mexiletine is safe and effective in people with Amyotrophic Lateral Sclerosis (ALS). In this trial, participants will be taking either 300 milligrams per day of mexiletine, 900 milligrams per day of mexiletine or placebo (non-active study drug). The safety and efficacy of these doses will be compared to see if one dose is better than the other.

Detailed description:
Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disorder affecting primarily motor neurons, for which treatment designed to slow or arrest progression remains lacking. Mexiletine is a use-dependent sodium channel blocker that has been FDA-approved for decades for the treatment of cardiac arrhythmias and more recently to treat neuropathic pain in diabetic polyneuropathy. Mexiletine has been shown also to be protective of neurons following spinal cord, head injury, and cerebral ischemia, largely by blocking excitotoxicity. Based on previous studies, mexiletine appears to penetrate into the central nervous system at concentrations sufficient to confer significant protection. Recent unpublished studies in the laboratory of Dr. Robert Brown at the University of Massachusetts have also demonstrated that mexiletine ingestion in mice genetically engineered to express high levels of mutant cytosolic copper-zinc superoxide dismutase-1 (SOD1) transgene prolongs survival in these animals. As mexiletine already has FDA-approval as an anti-arrhythmic agent, much is known about the pharmacology and safety of this drug in non-ALS patients. We anticipate that by excluding subjects with a known history of cardiac disease and with the known neuroprotectant properties of this medication, mexiletine is a good choice for further study in an ALS clinical trial.

Arms: arm 1: Mexiletine, 300 milligrams by mouth per day for 12 weeks. arm 2: Mexiletine, 900 milligrams by mouth per day for 12 weeks. arm 3: Placebo, by mouth per day for 12 weeks.
Interventions: intervention 1: Mexiletine intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01854944
Conditions: Schizophrenia
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2013-09-01; Completion date: 2014-08-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine how low and high does of brexpiprazole binds to certain receptors in the brain. This will be determined by PET scans taken pre-dose and post-dose.

Detailed description:

Arms: arm 1: Three cohorts of subjects will be evaluated:

\- Cohorts 1 and 3 will receive high doses of brexpiprazole, and Cohort 2 will receive low doses of brexpiprazole.
Interventions: intervention 1: Brexpiprazole 1mg to 4mg
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01858766
Conditions: Hepatitis C
Keywords: Hepatitis HCV Genotype 1 HCV Genotype 2 HCV Genotype 3 HCV Genotype 4 HCV Genotype 5 HCV Genotype 6 treatment naive
Sponsor: Gilead Sciences
Start date: 2013-04-01; Completion date: 2014-08-01
Enrollment: 379 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV) in treatment-naive adults with chronic genotype (GT) 1, 2, 3, 4, 5, or 6 hepatitis C virus (HCV) infection.

Detailed description:

Arms: arm 1: Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 12 weeks. arm 2: Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 12 weeks. arm 3: Participants with genotype 2, 4, 5, or 6 HCV infection will receive SOF+VEL 25 mg for 12 weeks. arm 4: Participants with genotype 2, 4, 5, or 6 HCV infection will receive SOF+VEL 100 mg for 12 weeks. arm 5: Participants with genotype 3 HCV infection will receive SOF+VEL 25 mg for 12 weeks. arm 6: Participants with genotype 3 HCV infection will receive SOF+VEL 100 mg for 12 weeks. arm 7: Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 8 weeks. arm 8: Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg plus RBV for 8 weeks. arm 9: Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 8 weeks. arm 10: Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg plus RBV for 8 weeks. arm 11: Participants with genotype 2 HCV infection will receive SOF+VEL 25 mg for 8 weeks. arm 12: Participants with genotype 2 HCV infection will receive SOF+VEL 25 mg plus RBV for 8 weeks. arm 13: Participants with genotype 2 HCV infection will receive SOF+VEL 100 mg for 8 weeks. arm 14: Participants with genotype 2 HCV infection will receive SOF+VEL 100 mg plus RBV for 8 weeks.
Interventions: intervention 1: SOF intervention 2: VEL intervention 3: RBV
Intervention descriptions: intervention 1: 400 mg tablet administered orally once daily intervention 2: Tablet administered orally once daily intervention 3: 200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Protocol documents:
Clinical trial NCT01860989
Conditions: Cure Rate
Keywords: parasitemia
Sponsor: Novartis Pharmaceuticals
Start date: 2013-07-01; Completion date: 2014-08-01
Enrollment: 11 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria patients with acute P. falciparum infection after single dose with KAE609 at 75 mg, 150mg, 225mg and 300mg/day

Detailed description:
the study is comprised of 4 sequential cohorts, in total there will be up to 48 patients enrolled in the study.

cohort 1: 6-12 patients receive 75mg single dose. cohort 2: 6-12 patients receive 150mg single dose. cohort 3: 6-12 patients receive 225mg single dose. cohort 4: 6-12 patients receive 300mg single dose. After approximately every 6 patients in any cohort have been treated with a given dose and complete the first 15 days, a safety and tolerability data review will be conducted by a Data Monitoring Committee(DMC). Consensus agreement of DMC is required to either escalate to the next dose level or expand a given cohort with an additional 6 patients in order to obtain more safety data.

Arms: arm 1: 6-12 subjects with Plasmodium falciparum malaria will receive 75 mg KAE609 as a single dose arm 2: 6-12 subjects with Plasmodium falciparum malaria will receive 150 mg KAE609 as a single dose arm 3: 6 to 12 subjects with Plasmodium falciparum malaria will receive 225 mg KAE609 as a single dose arm 4: 6- 12 subjects with Plasmodium falciparum malaria will receive 300 mg KAE609 as a single dose
Interventions: intervention 1: KAE609 intervention 2: KAE609 intervention 3: KAE609 intervention 4: KAE609
Intervention descriptions: intervention 1: KAE609 75mg single dose intervention 2: KAE609 150mg single dose intervention 3: KAE609 225mg single dose intervention 4: KAE609 300mg single dose

Protocol documents:
Clinical trial NCT01876368
Conditions: Hypertension
Keywords: hypertension, LCZ696, olmesartan
Sponsor: Novartis Pharmaceuticals
Start date: 2013-09-01; Completion date: 2014-08-01
Enrollment: 376 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the efficacy and safety of LCZ696 in comparison to olmesartan in essential hypertensive patients not adequately responsive to olmesartan

Detailed description:

Arms: arm 1: Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks. arm 2: Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
Interventions: intervention 1: LCZ696 intervention 2: Olmesartan intervention 3: Placebo of LCZ696 intervention 4: Placebo of Olmesartan
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01880840
Conditions: Allergic Rhinitis
Sponsor: Meda Pharmaceuticals
Start date: 2013-06-01; Completion date: 2014-08-01
Enrollment: 191 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to compare the safety of 2 different doses of the investigational use of an allergy medication (Astepro Nasal Spray) in the treatment of allergic rhinitis (AR). This is an open-label study; that is, parent and child will know which group each is in.

Detailed description:
Approximately 200 subjects, between the ages of ≥ 6 months to \< 6 years of age who have a history of AR will participate in this study.

The study will be conducted at about 20 research centers in the United States. Each research center will enroll approximately 2 to 10 subjects.

The study will involve at least 4 office visits over at least a 4-week period. You will need to keep the appointments as scheduled by the study personnel.

Some medications or therapies could interfere with the safety evaluations conducted in this study. If your child is currently taking any of these medications or therapies, they will need to discontinue them in order to be eligible for this study. Your study doctor will discuss this with you along with information on how this could affect your child's health. If you and the study doctor decide this is appropriate, there is a specific time period that these will need to be discontinued before your child can proceed in study evaluation.

If your child is eligible for study participation, he/she will be randomly assigned (by chance, like the flip of a coin) to one of the following two study drug groups:

* Astepro (azelastine hydrochloride) 0.15% Nasal Spray, 822 mcg (total daily dose); OR
* Astepro (azelastine hydrochloride) 0.1% Nasal Spray, 548 mcg (total daily dose)

The following are being performed for the purposes of this study and are not considered standard care:

* Your child will be placed in one of the two study drug groups by chance.
* You will complete questionnaires about your child's allergy symptoms.
* You will complete diary cards each morning recording your child's allergy symptoms over the previous 24 hours.
* Your child will have his/her vital signs measured (blood pressure, pulse, temperature and breathing rate).
* You and your child will be asked questions regarding your child's use of any medication or supplements and how your child has felt since his/her last visit.
* Blood and urine samples will be collected to assess the safety of taking the study drug.

Arms: arm 1: Nasal Spray at a dosage of 1 spray per nostril twice daily arm 2: Nasal Spray at a dosage of 1 spray per nostril twice daily
Interventions: intervention 1: 205.5 mcg of azelastine hydrochloride intervention 2: 137 mcg of azelastine hydrochloride
Intervention descriptions: intervention 1: nasal spray intervention 2: nasal spray

Protocol documents:
Clinical trial NCT01890148
Conditions: Asthma
Keywords: Asthma
Sponsor: AstraZeneca
Start date: 2014-03-01; Completion date: 2014-08-01
Enrollment: 13 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Distribution of neutrophils in bronchial mucosal tissue in asthma patients before and after 4 wk treatment with AZD 5069

Detailed description:
The purpose is to investigate the bronchial tissue neutrophil counts and distribution in asthma patients after 4 week oral treatment with AZD 5069

Arms: arm 1: oral BD administration of 45 mg AZD5069
Interventions: intervention 1: AZD5069
Intervention descriptions: intervention 1: oral BD administration of 45 mg AZD5069

Protocol documents:
Clinical trial NCT01893905
Conditions: Knee Osteoarthritis
Sponsor: Tedec-Meiji Farma, S.A.
Start date: 2013-06-01; Completion date: 2014-08-01
Enrollment: 158 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main objective is to assess the efficacy of a new formulation containing chondroitin sulfate and glucosamine sulfate (CS+GS) compared with placebo in patients with primary osteoarthritis of the knee.

Detailed description:
The purpose of this study is to determine whether a new combination of chondroitin sulfate and glucosamine sulfate administered once a day is superior to placebo in the treatment of patients with moderate to severe knee osteoarthritis. Eligible patients will be randomized 1:1 and the treatments will be administered for 24 weeks. Clinical efficacy at the end of treatment will be evaluated. Safety will be evaluated through adverse events recoding during the study period.

Arms: arm 1: Chondroitin sulfate 1200mg+ glucosamine sulfate 1500mg orally administered once a day for 24 weeks arm 2: Placebo of chondroitin sulfate + glucosamine sulfate orally administered once a day for 24 weeks
Interventions: intervention 1: CS+SG intervention 2: Placebo
Intervention descriptions: intervention 1: Chondroitin sulfate+glucosamine sulfate orally administered once a day for 24 weeks. intervention 2: Placebo of chondroitin sulfate+glucosamine sulfate orally administered once a day for 24 weeks.

Protocol documents:
Clinical trial NCT01894555
Conditions: Atherothrombosis
Keywords: Platelet Transcriptome Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Aspirin
Sponsor: Johns Hopkins University
Start date: 2013-01-01; Completion date: 2014-08-01
Enrollment: 33 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This clinical trial is examining the effect of 4-week aspirin therapy on platelet transcriptome in persons at high-risk for myocardial infarction or stroke due to family history of early-onset coronary artery disease.

Detailed description:
Platelet aggregation can initiate thrombosis on ulcerated arterial plaques resulting in acute coronary syndrome (ACS). There is large variation in platelet aggregation between individuals. As the genetic message to the cell machinery is conveyed through its transcriptome, we hypothesize that much of the variability in platelet function can be explained by transcriptome changes including differences in gene or isoform expression, altered splicing events, or allele-specific expression. Moreover, aspirin modifies gene expression in several cells, but whether it also affects platelet transcriptome has not yet been studied. Our goal is to characterize the platelet transcriptome and identify genes that are up- or down-regulated after 4-week aspirin therapy. A major strength of our study is that it enrolls individuals from European Americans and African Americans and thus will have the ability to study similarities and differences between the two. The study will produce innovative comparative genomic/platelet phenotype data and will provide a potential pharmacogenomic and diagnostic template for the future discovery of novel antiplatelet regimens to prevent thrombosis-related cardiovascular disease events.

Arms: arm 1: Participants treated with aspirin - there is no control group. Participant's baseline will act as their control.
Interventions: intervention 1: Aspirin
Intervention descriptions: intervention 1: 81 mg daily for 4 weeks

Protocol documents:
Clinical trial NCT01895322
Conditions: Chronic Renal Failure
Keywords: Tolvaptan dialysis
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2013-07-01; Completion date: 2014-08-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To investigate the efficacy, pharmacokinetics, pharmacodynamics, and safety of OPC-41061 in patients with chronic renal failure who are undergoing peritoneal dialysis, using daily urine volume, body weight, and edematous conditions as parameters and conducting dose escalation every 2 days until reaching the dose that achieves urine volume increase and then performing 5-day repeated administration at the fixed dose, the final dose used in the dose escalation period.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: OPC-41061
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01901393
Conditions: Pain
Keywords: Post Operative Pain, Pail relief
Sponsor: Cumberland Pharmaceuticals
Start date: 2013-07-01; Completion date: 2014-08-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy of intravenous ibuprofen compared to ketorolac for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS)

Detailed description:

Arms: arm 1: 800mg ibuprofen arm 2: 30mg ketorolac
Interventions: intervention 1: IV ibuprofen intervention 2: Ketorolac
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01908140
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Sponsor: AstraZeneca
Start date: 2013-09-01; Completion date: 2014-08-01
Enrollment: 933 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to compare the efficacy, safety and tolerability of aclidinium bromide/formoterol fumarate and salmeterol/fluticasone propionate in patients with chronic obstructive pulmonary disease (COPD)

Detailed description:

Arms: arm 1: Aclidinium Bromide 400 μg / Formoterol Fumarate 12 μg BID for 24 Weeks arm 2: Salmeterol 50 μg / Fluticasone propionate 500 μg BID for 24 Weeks
Interventions: intervention 1: Aclidinium Bromide / Formoterol Fumarate intervention 2: Salmeterol / Fluticasone
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01908803
Conditions: Acute Otitis Media
Keywords: AOMT tympanostomy tubes Otorrhea anti-infective
Sponsor: Alcon Research
Start date: 2013-12-01; Completion date: 2014-08-01
Enrollment: 84 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate a single application of AL-60371/AL-817 Otic Suspension relative to ototopical CIPRODEX for sustained clinical cure, microbiological success, and time to cessation of otorrhea.

Detailed description:
The results at the time of the interim analysis met the futility criteria and the study was subsequently stopped.

Arms: arm 1: AL-60371/AL-817 otic suspension, 200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1) arm 2: Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension, 4 drops in affected ear(s) twice daily through tympanostomy tube for 7 days
Interventions: intervention 1: AL-60371/AL-817 otic suspension intervention 2: Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension
Intervention descriptions: intervention 1: None intervention 2: CIPRODEX®

Protocol documents: