ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01551056
Conditions: Allergic Conjunctivitis
Sponsor: Aciex Therapeutics, Inc.
Start date: 2012-03-01; Completion date: 2012-06-01
Enrollment: 91 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the onset and duration of action of AC-170 0.24% compared to vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in the conjunctival allergen challenge (CAC) model.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: AC-170 0.24% intervention 2: AC-170 0%
Intervention descriptions: intervention 1: 1 drop in each eye at 2 separate times during a 14 day period intervention 2: 1 drop in each eye at 2 separate times during a 14 day period

Protocol documents:
Clinical trial NCT01552343
Conditions: Nocturia
Sponsor: Ferring Pharmaceuticals
Start date: 2012-03-01; Completion date: 2012-06-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess psychometric properties (reliability and validity) of the Nocturia Impact (NI) diary.

To assess the association between reduction of number of nocturnal voids and the mean changes in NI scores (sensitivity of the NI total score to change in nocturia).

To assess which NI diary items account for the main difference in change in total NI score in treatment versus placebo.

Detailed description:

Arms: arm 1: Female participants took 1 tablet of 25 μg every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month. arm 2: Female participants took 1 tablet of placebo every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month. arm 3: Male participants took 1 tablet 75 μg every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month. arm 4: Male participants took 1 tablet of placebo every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
Interventions: intervention 1: Desmopressin intervention 2: Placebo
Intervention descriptions: intervention 1: Desmopressin orally disintegrating tablets. Female participants took a 25 μg tablet and male participants took a 75 μg tablet one hour prior to bedtime for one month. intervention 2: Placebo to match the 25 μg tablet of active drug taken by female participants or the 75 μg tablet taken by males. One placebo tablet taken one hour prior to bedtime for one month.

Protocol documents:
Clinical trial NCT01556633
Conditions: Healthy Volunteer
Sponsor: Hoffmann-La Roche
Start date: 2012-03-01; Completion date: 2012-06-01
Enrollment: 16 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This open-label, prospective, single dose study will evaluate the pharmacokinetics and safety of Tamiflu (oseltamivir) in volunteers on dialysis and in volunteers with a creatinine clearance from 10 to 30 mL/min. Volunteers will receive a single oral dose of Tamiflu.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Tamiflu (oseltamivir) intervention 2: Tamiflu (oseltamivir)
Intervention descriptions: intervention 1: Single dose of Tamiflu in volunteers on dialysis intervention 2: Single dose of Tamiflu in volunteers with creatinine clearance from 10 to 30 mL/min

Protocol documents:
Clinical trial NCT01579084
Conditions: Rosacea Erythema
Sponsor: Allergan
Start date: 2012-04-01; Completion date: 2012-06-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and tolerability of AGN-199201 for the treatment of erythema associated with rosacea.

Detailed description:

Arms: arm 1: AGN-199201 Formulation A applied to one side of the face and Formulation B applied to the other side of the face twice daily. arm 2: AGN-199201 Formulation B applied to one side of the face and Formulation C applied to the other side of the face twice daily. arm 3: AGN-199201 Formulation C applied to one side of the face and Formulation A applied to the other side of the face twice daily. arm 4: AGN-199201 Formulation A applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily. arm 5: AGN-199201 Formulation B applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily. arm 6: AGN-199201 Formulation C applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily. arm 7: AGN-199201 Formulation A applied to both sides of the face twice daily. arm 8: AGN-199201 Formulation B applied to both sides of the face twice daily. arm 9: AGN-199201 Formulation C applied to both sides of the face twice daily. arm 10: AGN-199201 Vehicle (Placebo) applied to both sides of the face twice daily.
Interventions: intervention 1: AGN-199201 Formulation A intervention 2: AGN-199201 Formulation B intervention 3: AGN-199201 Formulation C intervention 4: AGN-199201 Vehicle
Intervention descriptions: intervention 1: AGN-199201 Formulation A applied to the face as per protocol twice daily. intervention 2: AGN-199201 Formulation B applied to the face as per protocol twice daily. intervention 3: AGN-199201 Formulation C applied to the face as per protocol twice daily. intervention 4: AGN-199201 vehicle (placebo) applied to the face as per protocol twice daily.

Protocol documents:
Clinical trial NCT01580306
Conditions: Hepatitis C
Sponsor: Boehringer Ingelheim
Start date: 2012-04-01; Completion date: 2012-06-01
Enrollment: 32 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main objective of this study is to investigate the influence of mild, moderate and severe renal impairment on the pharmacokinetics and safety of BI 201335 in comparison to a control group with normal renal function after single dose of BI 201335.

Detailed description:

Arms: arm 1: Capsule for oral administration arm 2: Capsule for oral administration
Interventions: intervention 1: BI 201335 intervention 2: BI 201335
Intervention descriptions: intervention 1: Relevant treatment dose capsule (A) for oral administration intervention 2: Relevant treatment dose capsule (B) for oral administration

Protocol documents:
Clinical trial NCT01580488
Conditions: Psoriasis Vulgaris
Sponsor: LEO Pharma
Start date: 2012-04-01; Completion date: 2012-06-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to evaluate the anti-psoriatic effect of LEO 35299 in different formulations, compared to Daivonex® ointment and Daivonex® ointment vehicle, using the psoriasis plaque test modified from the method developed by KJ Dumas and JR Scholtz.

Detailed description:

Interventions: intervention 1: B LEO 35299 20 mg/g cream intervention 2: C LEO 35299 20 mg/g cream intervention 3: E LEO 35299 10 mg/g solution intervention 4: F LEO 35299 10 mg/g solution intervention 5: Daivonex® ointment intervention 6: Daivonex® ointment vehicle
Intervention descriptions: intervention 1: once daily application, 3 weeks intervention 2: once daily application, 3 weeks intervention 3: once daily application, 3 weeks intervention 4: once daily application, 3 weeks intervention 5: once daily application, 3 weeks intervention 6: once daily application, 3 weeks

Protocol documents:
Clinical trial NCT01581931
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2012-04-01; Completion date: 2012-06-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To establish bioequivalence (BE) under fed conditions between metformin in linagliptin/metformin fixed dose combination tablet and metformin reference product administered in free combination togther with linagliptin

Detailed description:

Arms: arm 1: fixed dose combination tablet (FDC) arm 2: single tablets
Interventions: intervention 1: Linagliptin/metformin intervention 2: Metformin intervention 3: Linagliptin
Intervention descriptions: intervention 1: FDC intervention 2: single tablet Metformin intervention 3: single tablet Linagliptin

Protocol documents:
Clinical trial NCT01595282
Conditions: Pain
Keywords: pain suction curettage
Sponsor: Planned Parenthood League of Massachusetts
Start date: 2011-06-01; Completion date: 2012-06-01
Enrollment: 94 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study is to compare the effect of pre-procedural ketorolac to ibuprofen on immediate post-procedural pain scores in patients undergoing first trimester suction curettage with local anesthesia only.

Our primary hypothesis is that IM ketorolac compared to oral ibuprofen will result in an approximate 30% reduction in pain scores on a 21-point numerical rating scale immediately after the procedure.

Secondary hypotheses include:

* Pain scores on the 21-point scale will also be significantly lower in the ketorolac group immediately after cervical dilation and 15 minutes post-procedure.
* Fewer patients in the ketorolac group will rate their pain as "severe" on a subjective pain rating scale.
* Patients in the ketorolac group will be more satisfied with their pain control.
* Side effects will be similar between groups.

Detailed description:

Arms: arm 1: Intramuscular injection of ketorolac 60 mg in 2cc -plus- placebo tablet (calcium carbonate 600 mg tablet). For subjects who are 50 kg or less, intramuscular injection of ketorolac 30 mg in 1cc -plus- placebo tablet (calcium carbonate 600 mg tablet) arm 2: Ibuprofen 800 mg tablet -plus- intramuscular injection of 2cc saline placebo. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet -plus- intramuscular injection of 2cc saline placebo
Interventions: intervention 1: Ketorolac intervention 2: Ibuprofen
Intervention descriptions: intervention 1: For subjects weighing over 50 kg, ketorolac 60 mg in 2cc administered via intramuscular injection 30-60 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ketorolac 30 mg in 1 cc administered via intramuscular injection 30-60 minutes before suction curettage procedure intervention 2: For subjects weighing over 50 kg, ibuprofen 800 mg tablet administered orally 60-90 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet administered orally 60-90 minutes before suction curettage procedure.

Protocol documents:
Clinical trial NCT01595854
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2012-05-01; Completion date: 2012-06-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Evaluation of potential ticagrelor effects on dabigatran exposure and evaluation of two new pharmacodynamic methods

Detailed description:

Arms: arm 1: low dose dabigatran + high dose ticagrelor arm 2: high dose ticagrelor arm 3: medium dose dabigatran arm 4: low dose dabigatran
Interventions: intervention 1: dabigatran etexilate intervention 2: Ticagrelor intervention 3: Ticagrelor intervention 4: dabigatran etexilate intervention 5: dabigatran etexilate
Intervention descriptions: intervention 1: medium dose dabigatran intervention 2: high dose ticagrelor intervention 3: high dose ticagrelor intervention 4: low dose dabigatran intervention 5: medium dose dabigatran

Protocol documents:
Clinical trial NCT01605461
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2012-05-01; Completion date: 2012-06-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Phase 1 study to assess the pharmacokinetics and routes of elimination of a single oral dose of \[14C\]-BI 207127 and to characterize the metabolic profile following single dose administration.

Detailed description:

Arms: arm 1: Single oral solution dose of BI 207127 NA combined with \[14C\]-BI 207127 NA
Interventions: intervention 1: BI 207127 NA
Intervention descriptions: intervention 1: Single oral solution dose of BI 207127 NA combined with \[14C\]-BI 207127 NA

Protocol documents:
Clinical trial NCT01631825
Conditions: Parkinson's Disease
Keywords: SPM 962 rotigotine Parkinson's disease concomitant use of L-dopa
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2009-10-01; Completion date: 2012-06-01
Enrollment: 321 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
* To investigate the safety of once-daily repeated transdermal administration of SPM 962 within a dose range of 4.5 to 36.0 mg/day (54-week treatment period) in Parkinson's disease (PD) patients treated concomitantly with L-dopa in a multi-center, open-label uncontrolled study.
* To investigate efficacy of SPM 962 in an exploratory manner.

Detailed description:

Arms: arm 1: SPM 962 transdermal patch
Interventions: intervention 1: SPM 962
Intervention descriptions: intervention 1: SPM 962 transdermal patch once a daily up to 36.0 mg/day

Protocol documents:
Clinical trial NCT01665157
Conditions: Dietary Modification
Keywords: Diet Control before Colonoscopy
Sponsor: National Taiwan University Hospital
Start date: 2011-11-01; Completion date: 2012-06-01
Enrollment: 180 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and the acceptability of low-residue diet package (Enimaclin®) as diet control before colonoscopy.

Detailed description:
In this study, we investigate a randomized, single-blinded, comparative study to evaluate the efficacy and the acceptability of low-residue diet package (Enimaclin®) as diet control before colonoscopy.

Arms: arm 1: Low-residue diet package with normal amount 2L PEG-ELS arm 2: Self-controlled diet with normal amount of 2L PEG-ELS arm 3: Low-residue diet package with low volume 1.5L PEG-ELS
Interventions: intervention 1: Enimaclin® intervention 2: Self-controlled diet intervention 3: 2L PEG-ELS intervention 4: low volume 1.5L PEG-ELS
Intervention descriptions: intervention 1: Enimaclin Colomil ® (Glico Co., Japan Osaka)，a low-residue diet package for each meal.

The duration of study is one day before colonoscopy. intervention 2: Self-controlled low residue diet. intervention 3: Normal volume of PEG-ELS intervention 4: Low volume PEG-ELS

Protocol documents:
Clinical trial NCT01755637
Conditions: Helminthiasis
Sponsor: GlaxoSmithKline
Start date: 2012-04-01; Completion date: 2012-06-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of the study is to compare the pharmacokinetic profiles of two Albendazole tablet formulations manufactured under the different granulation processes in healthy Chinese adult males.

Detailed description:
Due to the product manufacture process change in Albendazole oral formulation from ethanol based granulation process to aqua based granulation process, State Food and Drug Administration officially requested Tianjin Smith Kline and French Laboratories to carry out a Bioequivalence study to demonstrate bioequivalence between the manufacturing processes. This trial will be conducted to support the official requirement via the comparison of the pharmacokinetic profiles between both the drugs manufactured under the different processes.

After oral administration, Albendazole is quickly oxidized into its pharmacologically active metabolite, Albendazole sulphoxide (ABZ-SO. Due to extensive metabolism and limited absorption, plasma concentration of ABZ after oral administration was found to be too low to be measured. Thus, this trial will also compare the pharmacokinetic profiles of ABZ-SO manufactured using different solvents.

Arms: arm 1: Albendazole tablets 400 milligram (mg) manufactured under aqua based solvent condition taken orally with 200 millilitre (mL) of water as single dose treatment. arm 2: Albendazole tablets 400 mg manufactured under ethanol based solvent condition taken orally with 200 mL of water as single dose treatment.
Interventions: intervention 1: Albendazole
Intervention descriptions: intervention 1: Albendazole tablets 400 mg

Protocol documents:
Clinical trial NCT03776747
Conditions: Radiation Exposure
Sponsor: Eric A. Hoffman
Start date: 2008-07-22; Completion date: 2012-06-01
Enrollment: 18 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The main purpose of this study is to assess and test the reproducibility and results of hyperpolarized 3-Helium gas as a contrast agent with Magnetic Resonance Imaging (MRI) of the lungs in healthy adult subjects.

Detailed description:
New CT imaging techniques often expose the patient to higher doses of radiation. There is a great deal of concern about effects of medical radiation exposure on the general public and regulations are becoming stricter on the radiation doses that are allowed.

One novel procedure that has been developed to evaluate the function and structure of the lung is the use of hyperpolarized gases with MRI scanners. We want to compare the lung imaging techniques that we have developed in our lab to a technique that uses hyperpolarized 3-Helium gas with MRI. This technique is free from radiation and less invasive than many lung imaging techniques.

Hyperpolarized gas MRI is based on the introduction of spins into the lungs, allowing imaging to take place. The use of hyperpolarized 3-Helium has a few advantages:

1. it allows us to see the microstructure of the lungs through diffusion imaging (apparent diffusion coefficient) which correlates with the size of airways and alveolar space.
2. it allows us to see ventilation, or how air moves in the lungs, at a high resolution.
3. it is capable of ultra fast imaging which will help us assess gas flow patterns within the airways.

and 4) the speed of depolarization lets us measure the partial pressure of oxygen and associated gas exchange mechanisms.

Arms: arm 1: Subjects will have vitals, pulmonary function tests, initial proton MRI scan, prone hyperpolarized 3 helium gas scan arm 2: Subjects will have vitals, pulmonary function tests, initial protocol MRI scan, supine hyperpolarized 3 helium gas scan
Interventions: intervention 1: Prone hyperpolarized 3 helium gas scan intervention 2: Supine hyperpolarized 3 helium gas scan intervention 3: Vitals intervention 4: Pulmonary Function Tests intervention 5: Initial protocol MRI scan
Intervention descriptions: intervention 1: Hyperpolarized gas used as a contrast agent to test reproducibility of MRI of the lungs/Images done while subject is prone. intervention 2: Hyperpolarized gas used as a contrast agent to test reproducibility of MRI of the lungs/Images done while subject is supine. intervention 3: None intervention 4: Pre and post spirometry, diffuse lung carbon monoxide (DLCO), lung volumes intervention 5: Initial scan to determine placement

Protocol documents:
Clinical trial NCT01268683
Conditions: Ischemic Stroke
Sponsor: Remedy Pharmaceuticals, Inc.
Start date: 2011-05-26; Completion date: 2012-06-07
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to assess the feasibility of enrolling, evaluating, and treating with glyburide for injection severe anterior circulation ischemic stroke participants, whether or not treated with standard of care intravenous (IV) recombinant tissue plasminogen activator (rtPA). Participants must be between 18-80 years of age, must have a baseline diffusion weighted image (DWI) lesion volume 82 -210 centimeters cubed (cm3), and time from symptom onset to start of study infusion must be ≤10 hour(hr). The secondary objectives are to assess the initial safety and tolerability, and pharmacokinetics (PK) /pharmacodynamics (PD) of glyburide in severe stroke participants, as well as to compare the clinical and magnetic resonance imaging (MRI) outcome data to benchmark data derived from published literature.

Detailed description:
This is a multi-center, prospective, open label, phase IIa trial of glyburide for injection in 10 participants with a severe anterior circulation ischemic stroke who are likely to experience clinically significant brain swelling.

Participants will receive glyburide, delivered as an IV bolus followed by an IV infusion for 72 hours.

Participants will have a baseline (pretreatment) MRI scan as standard of care, and three follow up MRI scans (at 24+12 hours, 48+12 hours, and 72±12 hours). Since recanalization may have an effect on outcome, the results of vascular studies, obtained as part of standard of care and defined as CTA, MRA or catheter angiography of the head and neck, will be recorded. Additionally, clinical endpoints such as the National Institutes of Health Stroke Scale (NIHSS), Glasgow Coma Scale (GCS) and Full Outline of UnResponsiveness Score (FOUR) Score (baseline, 24±12 hour, 48±12 hour, 72±12 hour and 7±1 days) and Modified Rankin Scale (mRS) (30±5 days and 90±7 days) will be assessed. Safety parameters will be assessed through Day 7 or discharge (whichever is sooner), and then again at Day 30±5 and Day 90±7.

Study participation is expected to last 90±7 days.

Arms: arm 1: This arm is administered a glyburide bolus followed by continuous infusion of glyburide for 72 hours
Interventions: intervention 1: Glyburide for Injection
Intervention descriptions: intervention 1: Administered as specified in the treatment arm.

Protocol documents:
Clinical trial NCT01107392
Conditions: Benign Prostatic Hyperplasia
Sponsor: Allergan
Start date: 2010-08-01; Completion date: 2012-06-08
Enrollment: 315 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of intraprostatic administration of botulinum toxin Type A (BOTOX®) compared with placebo to treat urinary tract symptoms due to benign prostatic hyperplasia.

Detailed description:

Arms: arm 1: botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe. arm 2: Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
Interventions: intervention 1: botulinum toxin Type A intervention 2: Normal saline
Intervention descriptions: intervention 1: botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe. intervention 2: Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.

Protocol documents:
Clinical trial NCT00548093
Conditions: Carcinoma, Non Small Cell Lung
Keywords: non-small cell lung cancer advanced previously treated
Sponsor: Pfizer
Start date: 2008-04-29; Completion date: 2012-06-11
Enrollment: 66 participants; Allocation: NON_RANDOMIZED; Intervention model: 

Brief summary:
To assess the antitumor efficacy measured by the objective response rate of oral PF-00299804 taken daily, as single agent in patients with advanced NSCLC who failed at least one chemotherapy + erlotinib.

Detailed description:

Arms: arm 1: descriptive: adenocarcinoma histology arm 2: descriptive: non-adenocarcinoma histology
Interventions: intervention 1: PF-00299804 intervention 2: PF-00299804
Intervention descriptions: intervention 1: PF-00299804 orally at 45 mg daily, on continuous schedule intervention 2: PF-00299804 orally at 45 mg daily, on continuous schedule

Protocol documents: