ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01236378
Conditions: Transplant Rejection Renal Transplantation
Keywords: Organ Transplants Anti-Rejection Therapy Pharmacokinetics
Sponsor: Pfizer
Start date: 2010-12-01; Completion date: 2011-04-01
Enrollment: 24 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Sirolimus, 1 mg, white, triangular tablets (Rapamune®) was approved on 03 April 2007 in China for prophylaxis of organ rejection in renal transplantation. A pharmacokinetic (PK) study to be conducted in renal allograft recipients was requested by State Food and Drug Administration (SFDA) to provide further guidance for clinical use.

To minimize risk to patients, this study is designed to collect blood PK samples from renal allograft recipients who are currently under sirolimus (1 mg tablets) treatment with or without concomitant medication(s). PK samples will be collected from these patients to characterize the steady state PK of sirolimus during sirolimus maintenance therapy. This study will not involve any changes to the established treatment regimen for the patients who enroll in the study

Detailed description:

Arms: arm 1: Subjects must be taking sirolimus (1 mg tablet formulation) with or without concomitant medications, unless specifically excluded below, for prophylaxis of renal rejection.
Interventions: intervention 1: Sirolimus
Intervention descriptions: intervention 1: Sirolimus, 1 mg, white, triangular tablets, daily dose, dosages of any of these medications must be stable for at least 2 weeks prior to screening and continue with no change until completion of the last PK sample collection.

Protocol documents:
Clinical trial NCT01241435
Conditions: Depressive Disorder, Major
Sponsor: Eli Lilly and Company
Start date: 2010-10-01; Completion date: 2011-04-01
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the effect of liver function on how much of the study drug (LY2216684) 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.

The duration of participation in this study is approximately 12 days, not including the screening visit. This study requires 1 clinic confinement of 5 days/4 nights followed by 1 out-patient follow-up visit. A screening visit is required within 30 days prior to the start of the study. This research study will be an open-label study.

The study involves a single oral dose of 18 milligrams (mg) LY2216684 given as 2 tablets.

Detailed description:

Arms: arm 1: LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with normal hepatic function, mild hepatic impairment (Child-Pugh A), moderate hepatic impairment (Child-Pugh B), or severe hepatic impairment (Child-Pugh C)
Interventions: intervention 1: LY2216684
Intervention descriptions: intervention 1: Administered orally

Protocol documents:
Clinical trial NCT01247350
Conditions: Healthy Volunteer
Sponsor: Eli Lilly and Company
Start date: 2010-11-01; Completion date: 2011-04-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the safety and tolerability of LY3009104 when given orally as single and multiple doses in Japanese healthy subjects.

Detailed description:

Arms: arm 1: 2mg administered once on day 1 (single dose) arm 2: 5mg administered once on day 1 (single dose) arm 3: 10 mg administered on day 1 (single dose) and following a 7 day washout period, administered once daily for 10 days (multiple dose) arm 4: 14 mg administered on day 1 (single dose) and following a 7 day washout period, administered once daily for 10 days (multiple dose) arm 5: administered on day 1 (single dose) and following a 7 day washout period, administered once daily for 10 days (multiple dose)
Interventions: intervention 1: LY3009104 intervention 2: Placebo
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally

Protocol documents:
Clinical trial NCT01255670
Conditions: Peritonsillar Abscess
Keywords: Peritonsillar Abscess Quinsy Penicillin Metronidazole Recurrence
Sponsor: Helsinki University Central Hospital
Start date: 2010-02-01; Completion date: 2011-04-01
Enrollment: 200 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Treatment of peritonsillar abscess varies. To study whether broad spectrum antibiotics are required in addition to abscess drainage, a prospective, double blind, placebo-controlled, randomized study on 200 adult patients with peritonsillar abscess is performed. 100 patients are given penicillin and metronidazole and 100 patients get penicillin and placebo. Recovery and recurrence are analyzed.

Detailed description:

Arms: arm 1: After incision and drainage 100 randomized patients receive penicillin and metronidazole as treatment of peritonsillar abscess arm 2: After incision and drainage 100 randomized patients receive penicillin and placebo as treatment of peritonsillar abscess
Interventions: intervention 1: penicillin and metronidazole in peritonsillar abscess
Intervention descriptions: intervention 1: Peroral Penicillin: 1000 000 IU 3 times a day for 10 days Peroral metronidazole: 500 mg 3 times a day for 7 days

Protocol documents:
Clinical trial NCT01263925
Conditions: Stage II Peripheral Arterial Occlusive Disease Intermittent Claudication Fontaine Stage II PAOD
Keywords: Alprostadil Prostaglandin E1 Prostavasin® PAOD
Sponsor: UCB Pharma
Start date: 2001-04-01; Completion date: 2011-04-01
Enrollment: 561 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Investigate, under outpatient conditions, both the effect of 4 weeks of daily treatment with Prostaglandin E1 and that of 4 weeks of interval treatment (two infusions per week) on the pain-free walking distance in patients with Intermittent Claudication.

Detailed description:

Arms: arm 1: Alprostadil (Prostaglandin E1) intravenous and matching Placebo to Pentoxifylline oral arm 2: Pentoxifylline oral and matching Placebo to Alprostadil (Prostaglandin E1) intravenous
Interventions: intervention 1: Alprostadil (Prostaglandin E1) intervention 2: Pentoxifylline intervention 3: Placebo to Pentoxifylline oral intervention 4: Placebo to Alprostadil (Prostaglandin E1) intravenous
Intervention descriptions: intervention 1: 4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 µg) of Prostaglandin E1 (total 60 µg) in 50 - 250 ml physiological saline solution over 2 hours.

4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 µg) of Prostaglandin E1 (total 60 µg) in 50 - 250 ml physiological saline solution over 2 hours. intervention 2: 4-week Daily Treatment Period 1: 4 weeks of 2 x daily (including weekends) 600 mg Pentoxifylline tablets.

4-week Interval Treatment Period 2: 4 weeks of 2 x daily (including weekends) 600 mg Pentoxifylline tablets. intervention 3: 4-week Daily Treatment Period 1: 4 weeks of 2 x daily (including weekends) matching Placebo to Pentoxifylline tablets.

4-week Interval Treatment Period 2: 4 weeks of 2 x daily (including weekends) matching Placebo to Pentoxifylline tablets. intervention 4: 4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours.

4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours.

Protocol documents:
Clinical trial NCT01265394
Conditions: Healthy
Keywords: Amyloid Magnetic resonance imaging Positron Emission Tomography Standard uptake value ratios Healthy Subjects
Sponsor: GE Healthcare
Start date: 2010-12-01; Completion date: 2011-04-01
Enrollment: 218 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Amyloid is an abnormal chemical found in the brain of patients with Alzheimer's Disease (AD). The study drug helps produce pictures of amyloid in the brain. The purpose of this study is to determine how well the study drug performs in young healthy subjects.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: [18F] Flutemetamol
Intervention descriptions: intervention 1: Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.

Protocol documents:
Clinical trial NCT01265446
Conditions: Sore Throat Due to a Common Cold
Keywords: Sore throat, upper respiratory tract infection, lozenge with lidocaine and cetylpyridinium chloride.
Sponsor: Novartis
Start date: 2010-12-01; Completion date: 2011-04-01
Enrollment: 250 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the efficacy and safety of a single dose of a lidocaine 8 mg + cetylpyridimium chloride (CPC) 2 mg lozenge with a single dose of a lidocaine 1 mg + CPC 2 mg lozenge in the treatment of sore throat due to a common cold.

Detailed description:

Arms: arm 1: one single dose arm 2: one single dose
Interventions: intervention 1: Lidocaine 8mg + CPC 2mg intervention 2: Lidocaine 1mg + CPC 2mg
Intervention descriptions: intervention 1: one single dose intervention 2: one single dose

Protocol documents:
Clinical trial NCT01287364
Conditions: Perennial Allergic Rhinitis
Keywords: perennial allergic rhinitis PAR
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2011-02-01; Completion date: 2011-04-01
Enrollment: 185 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is an open-label, randomized, multicenter, 2-way crossover study in subjects 12 years or older with perennial allergic rhinitis (PAR) to evaluate the psychometric properties of a novel-patient administered assessment of treatment satisfaction with and preference of an Internasal Corticosteroid (INCS)

Detailed description:
This is an open-label, randomized, multicenter, 2-way crossover study in subjects 12 years or older with perennial allergic rhinitis (PAR) to evaluate the psychometric properties of a novel-patient administered assessment of treatment satisfaction with and preference of an INCS. Subjects will be randomized to 1 of 2 treatment sequences:

Sequence 1: Treatment Period 1 = ciclesonide hydrofluoroalkane (HFA) nasal aerosol 80 μg once daily; Treatment Period 2 = mometasone nasal inhalation 200 μg once daily

Sequence 2: Treatment Period 1 = mometasone nasal inhalation 200 μg once daily; Treatment Period 2 = ciclesonide HFA nasal aerosol 80 μg once daily

Total study participation will be approximately 8 weeks including a 3-week screening/baseline phase, a 1-week treatment period, a 1- to 2- week washout phase between treatments, a second 1-week treatment period consisting of the alternate treatment, and an additional 1-week follow up period after the last dose of study drug to assess safety. Subjects are required to continue to meet eligibility criteria for the second treatment period.

Nasal symptoms will be evaluated daily from 7 days prior to the first dose of study drug in Treatment Period 1 through the last dose of study drug in Treatment Period 2. The Allergic Rhinitis Satisfaction and Preference (ARTSP) and other Modules from the Phase V® e-Health Outcomes Information System (Phase V Technologies, Wellesley MA) will be completed two times during each treatment period (before the first dose and on the day after the last dose) via the internet at the clinical site. Patient preference will be evaluated at the day after last dose only.

Arms: arm 1: ciclesonide hydrofluoroalkane (HFA) nasal aerosol 80 μg once daily in first intervention period, followed by a 7-14 day washout period, after which the second intervention of mometasone nasal inhalation 200 μg once daily will be administered. arm 2: mometasone nasal inhalation 200 μg once daily in first intervention period followed by a 7-14 day washout period after which the second intervention of ciclesonide hydrofluoroalkane (HFA) nasal aerosol 80 μg once daily will be administered
Interventions: intervention 1: ciclesonide hydrofluoroalkane (HFA) nasal aerosol intervention 2: mometasone nasal inhalation
Intervention descriptions: intervention 1: ciclesonide hydrofluoroalkane (HFA) nasal aerosol 80 μg once daily for one week. intervention 2: mometasone nasal inhalation 200 μg once daily for one week

Protocol documents:
Clinical trial NCT01287520
Conditions: Advanced Cancer
Sponsor: Eli Lilly and Company
Start date: 2007-11-01; Completion date: 2011-04-01
Enrollment: 41 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine a recommended Phase 2 dose and dosing regimen of LY2090314 in combination with pemetrexed and carboplatin in patients with advanced/metastatic cancer. Part A of this study will consist of dose escalation of the study regimen, and Part B will consist of an expanded cohort to confirm the dose provided from Part A.

Detailed description:

Arms: arm 1: Part A, Cycle 1 (28 days): Intravenous doses of LY2090314 starting at 10 milligram (mg) were given on Day 1 followed by 10 mg LY2090314, 500 milligram per square meter (mg/m\^2) pemetrexed (intravenous dose), and 5 or 6 area under the concentration-time curve (AUC) intravenous dose of carboplatin on Day 8.

Part A, Cycle 2 (21 days): Pemetrexed and carboplatin given on Day 1 at the same dose administered in Cycle 1.

Part A, Cycle 3 (21 days) and beyond: LY2090314, Pemetrexed and carboplatin were given on Day 1 at the same dose administered in Cycle 1. LY2090314 doses were escalated until the maximum tolerated dose (MTD) was reached.

Part B: Dose determined in Part A was administered. Participants were allowed to continue the combination treatment if they were receiving therapeutic benefit until they fulfilled one of the criteria for discontinuation.
Interventions: intervention 1: LY2090314 intervention 2: pemetrexed intervention 3: Carboplatin intervention 4: ranitidine
Intervention descriptions: intervention 1: Administered intravenously intervention 2: Administered intravenously intervention 3: Administered intravenously intervention 4: Per I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine given as pretreatment to LY2090314 for stomach pain.

Protocol documents:
Clinical trial NCT01289431
Conditions: Conjunctivitis, Allergic
Sponsor: Bausch & Lomb Incorporated
Start date: 2011-02-01; Completion date: 2011-04-01
Enrollment: 236 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the dose response, and efficacy of Mapracorat ophthalmic formulation compared to its vehicle for the prevention of symptoms and signs associated with allergic conjunctivitis using a conjunctival allergen challenge (CAC) model.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Mapracorat intervention 2: Vehicle
Intervention descriptions: intervention 1: administered daily to each eye for 2 weeks following allergen challenge using a CAC model intervention 2: administered daily to each eye for 2 weeks following allergen challenge using a CAC model

Protocol documents:
Clinical trial NCT01290757
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2011-01-01; Completion date: 2011-04-01
Enrollment: 180 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of this Phase I trial is to demonstrate the bioequivalence of two capsules of dabigatran etexilate made from two different drug product batches.

The reference batch is dabigatran etexilate hard capsules 150 mg using the currently approved capsule shell (Qualicaps). The test batch is dabigatran etexilate 150 mg hard capsules using a new capsule shell (Capsugel). The test batch is the drug product intended for future commercial use.

Detailed description:

Arms: arm 1: Capsugel (T), oral administration arm 2: Qualicaps (R), oral administration
Interventions: intervention 1: Dabigatran etexilate intervention 2: Dabigatran etexilate
Intervention descriptions: intervention 1: 150 mg Capsugel (T) intervention 2: 150 mg Qualicaps (R)

Protocol documents:
Clinical trial NCT01297595
Conditions: Healthy
Keywords: relative bioavailability pharmacokinetics crizotinib oral liquid formulation formulated capsule
Sponsor: Pfizer
Start date: 2011-03-01; Completion date: 2011-04-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will be an open-label, randomized, 2-period, 2-treatment, 2-sequence, cross-over single-dose study employing administration of two oral formulations of crizotinib (OLF and FC) in the fasted state to healthy adult subjects. Twenty-two (22) subjects will be enrolled to obtain at least 20 evaluable subjects who complete the study. Each subject will receive two treatments (A and B) with a washout period of at least 14 days between each treatment.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: crizotinib
Intervention descriptions: intervention 1: Each subject will receive 250 mg single oral doses of oral liquid formulation and formulated capsule of crizotinib separated by at least 14 days.

Protocol documents:
Clinical trial NCT01303445
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2011-03-01; Completion date: 2011-04-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of the current study is to investigate if a drug-drug interaction occurs with the administration of omeprazole 80 mg q.d. at steady state on the pharmacokinetics of dipyridamole and the pharmacodynamics of ASA-induced platelet aggregation inhibition (components of Aggrenox®) when administered every 12 hours at steady state.

Detailed description:
Purpose:

Arms: arm 1: Aggrenox alone arm 2: Aggrenox and omeprazole arm 3: Omeprazole alone arm 4: Aggrenox and omeprazole
Interventions: intervention 1: Aggrenox alone intervention 2: Aggrenox and omeprazole intervention 3: Aggrenox and omeprazole intervention 4: Omeprazole alone
Intervention descriptions: intervention 1: Aggrenox 1 capsule twice daily for 7 days intervention 2: Aggrenox 1 capsule twice daily and omeprazole 80mg once daily for 7 days intervention 3: Aggrenox 1 capsule twice daily and omeprazole 80mg once daily for 7 days intervention 4: omeprazole 80 once daily for 7 days

Protocol documents:
Clinical trial NCT01303627
Conditions: Urinary Tract Problem
Keywords: Remifentanil Laryngeal mask airway removal Hemodynamic changing Infusion Ureterorenoscopy
Sponsor: Diskapi Teaching and Research Hospital
Start date: 2011-02-01; Completion date: 2011-04-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The effect of maintenance remifentanil infusion with target controlled infusion during laryngeal mask airway removal on hemodynamic parameters and emergence quality is going to be investigated.

Detailed description:
In all patients (control group and remifentanil group induction of anesthesia will be achieved with desflurane and remifentanil.Anesthesia will be maintained with remifentanil (1-4 ng/mL) by TCI target controlled infusion, and desflurane . Throughout the surgery hemodynamic parameters are going to be recorded. As soon as the surgery has been finished, in control group remifentanil infusion and desflurane inhalation is going to be stopped.In remifentanil group,desflurane inhalation is going to be stopped and remifentanil infusion will be maintained until the removal of LMA. During the emergence period the time of eye opening, hemodynamic parameters and emergence quality (score 1-2)are going to be recorded.

Arms: arm 1: Remifentanil:1.5ng/ml remifentanil infusion maintained at the end of the surgery arm 2: Control:Remifentanil stopped at the end of the surgery
Interventions: intervention 1: remifentanil
Intervention descriptions: intervention 1: 1-4 ng/mL i.v. infusion during the surgery, maintenance dosage till LMA removal is 1.5 ng/mL.

Protocol documents:
Clinical trial NCT01304329
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2011-02-01; Completion date: 2011-04-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of the study is to investigate the drug-drug interaction potential between BI 10773 and simvastatin.

Detailed description:

Arms: arm 1: 1 tablet BI 10773, oral administration with 240 ml water arm 2: 1 tablet simvastatin, oral administration with 240 ml water arm 3: 1 tablet BI 10773 + 1 tablet simvastatin, oral administration with 240 ml water
Interventions: intervention 1: BI 10773 intervention 2: simvastatin intervention 3: simvastatin intervention 4: BI 10773
Intervention descriptions: intervention 1: Medium dose oral administration intervention 2: Medium dose oral administration intervention 3: Medium dose oral administration intervention 4: Medium dose oral administration

Protocol documents:
Clinical trial NCT01306175
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2011-02-01; Completion date: 2011-04-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of the study is to investigate the relative bioavailability of digoxin after concomitant multiple oral administration of BI 10773 and a single dose of digoxin in comparison to digoxin given alone to healthy male and female subjects.

Detailed description:

Arms: arm 1: Tablet, oral administration with 240 mL water arm 2: Tablets, oral administration with 240 mL water
Interventions: intervention 1: Digoxin plus BI 10773 intervention 2: Digoxin
Intervention descriptions: intervention 1: Digoxin 0.5 mg as single dose, BI 10773 medium dose once daily intervention 2: Digoxin 0.5 mg as single dose

Protocol documents:
Clinical trial NCT01313286
Conditions: Healthy Volunteers
Keywords: Diabetes Mellitus, Type 2
Sponsor: Eli Lilly and Company
Start date: 2011-03-01; Completion date: 2011-04-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to compare 2 formulations of the study drug (LY2608204) in terms of how much 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.

Detailed description:

Arms: arm 1: Single oral 80 mg dose of LY2608204 reference formulation in period 1; single oral 80 mg dose of LY2608204 test formulation in period 2. There is a washout period of at least 14 days between dosing periods. arm 2: Single oral 80 mg dose of LY2608204 test formulation in period 1; single oral 80 mg dose of LY2608204 reference formulation in period 2. There is a washout period of at least 14 days between dosing periods.
Interventions: intervention 1: LY2608204 Reference intervention 2: LY2608204 Test
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally.

Protocol documents:
Clinical trial NCT01314703
Conditions: Antimicrobial Effectiveness
Sponsor: CareFusion
Start date: 2011-03-01; Completion date: 2011-04-01
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to measure the antimicrobial effectiveness of ChloraPrep one-Step.

Detailed description:

Interventions: intervention 1: ChloraPrep One-Step intervention 2: 70% isopropyl alcohol
Intervention descriptions: intervention 1: 10.5 ml applicator preoperative skin preparation intervention 2: 10.5 ml applicator

Protocol documents: