ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01010633
Conditions: Inflammation Pain
Sponsor: Bausch & Lomb Incorporated
Start date: 2009-11-01; Completion date: 2010-08-01
Enrollment: 406 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being conducted to compare the safety and efficacy of loteprednol etabonate compared to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.

Detailed description:

Arms: arm 1: Loteprednol etabonate arm 2: Vehicle of loteprednol etabonate
Interventions: intervention 1: Vehicle of Loteprednol Etabonate intervention 2: Loteprednol Etabonate
Intervention descriptions: intervention 1: 1 to 2 drops of vehicle administered into the study eye, 4 times a day for approximately 14 days. intervention 2: 1 to 2 drops of study drug administered into the study eye, 4 times a day for approximately 14 days.

Protocol documents:
Clinical trial NCT01018810
Conditions: Psoriasis
Keywords: Psoriasis
Sponsor: Eli Lilly and Company
Start date: 2009-12-01; Completion date: 2010-08-01
Enrollment: 8 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In this study, we will evaluate clinical activity, safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of 5 LY2525623 dosing groups compared to placebo in adults with plaque psoriasis.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None
Interventions: intervention 1: LY2525623 Intravenous intervention 2: LY2525623 Subcutaneous intervention 3: Placebo Intravenous intervention 4: Placebo Subcutaneous
Intervention descriptions: intervention 1: administered intravenously at randomization and every 2 weeks for 6 weeks intervention 2: administered subcutaneously at randomization and every 2 weeks for 6 weeks intervention 3: administered intravenously at randomization and every 2 weeks for 6 weeks intervention 4: administered subcutaneously at randomization and every 2 weeks for 6 weeks

Protocol documents:
Clinical trial NCT01023516
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Chronic obstructive pulmonary lung respiratory disease efficacy placebo-controlled COPD FEV1 St Georges Respiratory Questionnaire
Sponsor: AstraZeneca
Start date: 2009-11-01; Completion date: 2010-08-01
Enrollment: 615 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is to evaluate the efficacy of AZD9668 compared with placebo in symptomatic COPD patients by assessing the effects on lung function and symptoms of COPD

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: AZD9668 intervention 2: Placebo
Intervention descriptions: intervention 1: 2 x 30 mg oral tablets bd for 12 weeks intervention 2: 2 x matched placebo to oral tablet bd for 12 weeks

Protocol documents:
Clinical trial NCT01025635
Conditions: Papulopustular Rosacea
Keywords: rosacea papulopustular azelaic acid foam
Sponsor: LEO Pharma
Start date: 2009-12-01; Completion date: 2010-08-01
Enrollment: 401 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate the safety and efficacy of a new formulation of an existing medication for the treatment of papulopustular rosacea. The study will test the active ingredient plus foam against foam alone.

Detailed description:

Arms: arm 1: Participants received azelaic acid foam, 15% topically twice daily for 12 weeks arm 2: Participants received vehicle foam topically twice daily for 12 weeks
Interventions: intervention 1: Azelaic acid foam 15% intervention 2: Vehicle foam
Intervention descriptions: intervention 1: Applied topically twice daily for 12 weeks intervention 2: Applied topically twice daily for 12 weeks

Protocol documents:
Clinical trial NCT01027793
Conditions: Stretch Marks Striae Treatment
Keywords: Stretch marks Striae Tretinoin Superficial dermabrasion
Sponsor: Brazilan Center for Studies in Dermatology
Start date: 2009-03-01; Completion date: 2010-08-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study aims to evaluate head-to-head the effectiveness of tretinoin 0.5% and superficial dermabrasion in subjects that have recent stretch marks.

Detailed description:
Healthy female subjects, from 11 t0 25 years old, that have thin (1-5mm) recent(less than 6 months of evolution),reddish or purple line stretch marks. The striae should be symmetrical and it could be located in the abdomen,breasts, upper arms, thighs (both inner and outer), hips, and buttocks.

Thirty subjects will be randomly divided in two groups:

Group 1 will receive tretinoin cream that should be applied daily in areas affected by stretch marks.

Group 2 will receive 16 sessions of dermabrasion that would be held in the research center.

Subjects will be evaluated by pictures, measurement of width and length of stretch marks, using Mirror System(Canfield).

Biopsy to quantify alterations of epidermis and dermis of treated area, will be held pre-treatment and 2 weeks after the conclusion of treatment. For biopsy will be used a punch of 3mm.

The results will be evaluated two weeks after the conclusion of the interventions. An independent dermatologist, blinded for intervention, will analyse pictures pre and post treatment. This subjective evaluation will be performed using Global Aesthetic Improvement Scale.

Safety and adverse events will be assessed each visit.

Arms: arm 1: Group 1 will receive tretinoin cream 0.05%(Vitanol A, Stiefel) that should be applied daily in areas affected by stretch marks, in both sides, for a period of 16 weeks. arm 2: Group 2 will receive 16 sessions of dermabrasion that would be held in the research center.
Interventions: intervention 1: Tretinoin cream 0.005% intervention 2: Superficial Dermabrasion
Intervention descriptions: intervention 1: Group 1 will receive tretinoin cream 0.05%(Vitanol A, Stiefel) that should be applied daily in areas affected by stretch marks, in both sides, for a period of 16 weeks. intervention 2: Group 2 will receive 16 sessions of dermabrasion that would be held in the research center

Protocol documents:
Clinical trial NCT01049360
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease COPD Chronic Bronchitis Emphysema Airflow Obstruction, Chronic Chronic Airflow Obstruction Chronic Obstructive Airway Disease Chronic Obstructive Lung Disease
Sponsor: AstraZeneca
Start date: 2009-12-01; Completion date: 2010-08-01
Enrollment: 128 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate the efficacy of this multicenter, randomized, double-blind, placebo-controlled, 4-period, incomplete-block crossover, dose-ranging study comparing 2 fixed dose combinations (FDCs) of aclidinium bromide with formoterol fumarate or with placebo, aclidinium bromide and formoterol fumarate, all administered twice a day (BID) in patients with stable, moderate to severe chronic obstructive pulmonary disease (COPD) beginning with a 2-week run-in period and with a 7-10 day washout each between treatment period.

Detailed description:

Arms: arm 1: Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID) arm 2: Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID) arm 3: Aclidinium bromide 400 μg administered twice-daily (BID) arm 4: Formoterol fumarate 12 μg twice-daily arm 5: Placebo twice-daily
Interventions: intervention 1: Aclidinium 400 μg / Formoterol 12 μg intervention 2: Aclidinium 400 μg / Formoterol 6 μg intervention 3: Aclidinium 400 μg intervention 4: Formoterol 12 μg intervention 5: Placebo
Intervention descriptions: intervention 1: Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID) for a 14 day period within four different treatment periods. intervention 2: Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID) for a 14 day period within four different treatment periods. intervention 3: Aclidinium bromide 400 μg administered twice-daily (BID) for a 14 day period within four different treatment periods. intervention 4: Formoterol fumarate 12 μg twice-daily for a 14 day period within four different treatment periods. intervention 5: Placebo twice-daily delivered by inhalation for a 14 day period within four different treatment periods.

Protocol documents:
Clinical trial NCT01053312
Conditions: Normal Pressure Hydrocephalus
Keywords: Amyloid NPH Normal pressure hydrocephalus PET Positron Emission Tomography SUVR Standard uptake value ratios
Sponsor: GE Healthcare
Start date: 2009-12-01; Completion date: 2010-08-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will determine the level of association between the quantitative estimates of brain uptake of \[18F\]flutemetamol and the quantitative immunohistochemical estimates of amyloid levels in biopsy samples previously obtained during shunt placement in patients who have normal pressure hydrocephalus (NPH).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: [18F] Flutemetamol
Intervention descriptions: intervention 1: All subjects will receive an intravenous (IV) dose of \[18F\]flutemetamol (less than 10µg flutemetamol). The nominal activity of a single administration of \[18F\]flutemetamol will be 185 megabecquerels (MBq).

Protocol documents:
Clinical trial NCT01053962
Conditions: Chronic Idiopathic Constipation
Keywords: Chronic Idiopathic Constipation Constipation Irritable Bowel Syndrome
Sponsor: Bausch Health Americas, Inc.
Start date: 2010-03-01; Completion date: 2010-08-01
Enrollment: 84 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 2a, randomized, double-blind, placebo-controlled, 14-day repeat oral, dose ranging study to determine the safety, pharmacokinetics (PK) and pharmacodynamics (PD) effects of SP-304 in patients with chronic idiopathic constipation.

Detailed description:
This is a Phase 2a, randomized, double-blind, placebo-controlled, 14-day repeat oral, dose ranging study to determine the safety, PK and PD effects of SP-304 in patients with chronic idiopathic constipation. Patients diagnosed with chronic idiopathic constipation (CIC) will be screened for the anticipated 4 cohorts, to yield 80 randomized patients for enrollment. Four dose cohorts are planned (0.3 mg, 1.0 mg, 3.0mg, and 9.0 mg) with 20 patients per dose cohort \[randomization ratio 3:1 (15 receive SP-304:5 receive placebo)\]. Patients who continue to meet all the entry criteria and complete the pre-treatment bowel movement (BM) diary will receive, in a double-blind, randomized fashion, SP-304 or matching placebo. It is expected that each patient will complete all 14 days of dosing (including making accurate BM diary entries for all 14 days in the treatment period). All patients receiving at least one dose of SP-304 or matching placebo will be considered evaluable for the safety endpoints. If a patient receives at least 5 doses per treatment week (1 dose per day for 7 days) and has completed BM diary entries for those 5 dosing days in each corresponding treatment week, he/she will be considered evaluable.

Arms: arm 1: SP-304 0.3 mg tablet by mouth once daily for 14 consecutive days. arm 2: SP-304 1.0 mg tablet by mouth once daily for 14 consecutive days. arm 3: SP-304 3.0 mg tablet by mouth once daily for 14 consecutive days arm 4: SP-304 9.0 mg tablet by mouth once daily for 14 consecutive days. arm 5: Placebo tablet by mouth once daily for 14 consecutive days
Interventions: intervention 1: SP-304 0.3 mg intervention 2: SP-304 1.0 mg intervention 3: SP-304 3.0 mg intervention 4: SP-304 9.0 mg intervention 5: Placebo
Intervention descriptions: intervention 1: SP-304 0.3 mg intervention 2: SP-304 1.0 mg intervention 3: SP-304 3.0 mg intervention 4: SP-304 9.0 mg intervention 5: Placebo

Protocol documents:
Clinical trial NCT01062113
Conditions: Pain
Keywords: Acute pain after oral surgery lateral mandibular Impacted third molar tooth extraction
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2010-04-01; Completion date: 2010-08-01
Enrollment: 255 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate efficacy and safety of additional dose of celecoxib, as compared to placebo, in patients with post lateral mandibular impacted third molar tooth extraction pain.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Celecoxib intervention 2: Celecoxib intervention 3: Placebo
Intervention descriptions: intervention 1: Initial dose: Celecoxib 200mg tablet x 2 will be administrated during a period from 1 to 2 hours post lateral mandibular impacted third molar tooth extraction in subjects with "moderate pain" or "severe pain"rated as 45.0 mm or more on the VAS intervention 2: Additional dose: Celecoxib 200mg tablet x 1 will be administrated during a period from 5 to 12 hours post-initial dose of Celecoxib 400mg in subjects who require an additional analgesic dose for any pain intervention 3: Additional dose: Placebo (tablet) will be administrated during a period from 5 to 12 hours post-initial dose of Celecoxib 400mg in subjects who require an additional analgesic dose for any pain

Protocol documents:
Clinical trial NCT01072331
Conditions: Type 2 Diabetes Mellitus
Keywords: insulin resistance
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2010-02-01; Completion date: 2010-08-01
Enrollment: 99 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effect of MP-513 on 24-h glycemic control in patients with type 2 Diabetes for 4 weeks administration.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: MP-513 intervention 2: MP-513 intervention 3: Placebo of MP-513
Intervention descriptions: intervention 1: MP-513 10 mg, once a day, for 4 weeks intervention 2: MP-513 20 mg, once a day, for 4 weeks intervention 3: MP-513 placebo, once a day, for 4 weeks

Protocol documents:
Clinical trial NCT01072526
Conditions: Dry Eye Syndromes
Keywords: Dry Eye Syndromes Lacrimal Apparatus Diseases
Sponsor: University of Missouri-Columbia
Start date: 2007-12-01; Completion date: 2010-08-01
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether a homeopathic therapy in combination with cyclosporin (Restasis) is more effective than cyclosporin (Restasis) alone in the treatment of dry eye disease.

Detailed description:
Dry eye disease affects millions of people world-wide, and presents with symptoms of blurred vision, discharge from the eyes, eye discomfort, burning, redness, sandy and gritty feeling in the eyes, and sensitivity to light. Topical eye drops for eye lubrication (i.e., artificial tear solutions) and controlling ocular inflammation through the use of topical immunomodulatory agents (i.e., cyclosporine \[Restasis\]) have been shown to be effective for treating dry eye syndrome, but are not curative. Recently, we have evaluated a few patients who had discontinued using Restasis as they had obtained better relief of their dry eye symptoms with a homeopathic therapy.

Potential participants will undergo an eye examination consisting of medical history and physical examination (i.e., visual acuity, pupillary exam, examination of the lids, slit-lamp examination of the conjunctiva, cornea, anterior chamber, iris, and lens, and funduscopic examination). Participants qualifying for the study will then stop all eye medications and will use a common artificial tear solution for 2 weeks prior to the baseline examination. We will evaluate 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film to break-up; 2) staining of the cornea by fluorescein stain; 3) measurement of tear production over 5 minutes by Schirmer's test; and 4) the Ocular Surface Disease Index (OSDI).

Arms: arm 1: Subjects will receive Euphrasia-based homeopathic therapy (Artificial Tears) in combination with cyclosporin solution (Restasis) . arm 2: Subjects will receive placebo in combination with cyclosporin solution (Restasis) .
Interventions: intervention 1: Euphrasia-based homeopathic therapy intervention 2: Cyclosporin solution
Intervention descriptions: intervention 1: ophthalmic solution; 1 drop both eyes twice daily intervention 2: Cyclosporin solution; 1 drop both eyes twice daily

Protocol documents:
Clinical trial NCT01098747
Conditions: Pain
Keywords: Pain following third molar extraction
Sponsor: Pfizer
Start date: 2010-04-01; Completion date: 2010-08-01
Enrollment: 335 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the pain relieving effect of a single-dose of a novel ibuprofen formulation to placebo and two formulations of standard ibuprofen in the treatment of post-surgical dental pain following "wisdom" tooth (third molar) removal.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Novel Ibuprofen intervention 2: Standard Ibuprofen intervention 3: Standard Ibuprofen intervention 4: Placebo
Intervention descriptions: intervention 1: Single-dose of novel ibuprofen (equal to 400 mg ibuprofen) intervention 2: Single-dose of standard ibuprofen (400mg) intervention 3: Single-dose of standard ibuprofen (400mg) intervention 4: Single-dose of placebo

Protocol documents:
Clinical trial NCT01100112
Conditions: Colitis, Ulcerative
Keywords: ulcerative colitis Budesonide
Sponsor: Bausch Health Americas, Inc.
Start date: 2010-02-01; Completion date: 2010-08-01
Enrollment: 61 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Open-label, 8 week study, to assess the efficacy and safety of oral Budesonide-MMX 9 mg Extended-release Tablets in patients with mild to moderate, active ulcerative colitis who are not in remission based on the Ulcerative Colitis Disease Activity Index in study CB-01-02/01 (parent study \[NCT00679432\]).

Detailed description:
Patients who complete the parent study and who do not achieve clinical remission will be eligible to receive 8 weeks of open-label treatment with Budesonide-MMX 9mg if they satisfy the entry criteria for this study.

Arms: arm 1: Budesonide-MMX 9 mg tablet
Interventions: intervention 1: Budesonide
Intervention descriptions: intervention 1: One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks.

Protocol documents:
Clinical trial NCT01107405
Conditions: Allergic Conjunctivitis
Sponsor: Bausch & Lomb Incorporated
Start date: 2010-04-01; Completion date: 2010-08-01
Enrollment: 101 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy of loteprednol etabonate ophthalmic base, compared to loteprednol etabonate ophthalmic suspension, and vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in a modified Conjunctival Allergen Challenge model and in an environmental model during pollen season. Comparisons will be made following 2 weeks of dosing.

Detailed description:

Arms: arm 1: Loteprednol etabonate ophthalmic base dosed once/day. arm 2: Loteprednol etabonate ophthalmic base dosed two times/day arm 3: Loteprednol etabonate ophthalmic base dosed four times/day. arm 4: Loteprednol etabonate ophthalmic suspension dosed four times/day arm 5: Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
Interventions: intervention 1: Loteprednol etabonate base (QD) intervention 2: Loteprednol etabonate base (BID) intervention 3: Loteprednol etabonate base (QID) intervention 4: Loteprednol etabonate suspension intervention 5: Vehicle of loteprednol etabonate
Intervention descriptions: intervention 1: Loteprednol Etabonate ophthalmic base once daily dosing for 2 weeks intervention 2: Loteprednol etabonate ophthalmic base BID dosing for 2 weeks intervention 3: Loteprednol Etabonate ophthalmic base four times/day dosing for 2 week intervention 4: Loteprednol etabonate ophthalmic suspension dosed four times daily for 2 weeks. intervention 5: Vehicle of loteprednol etabonate ophthalmic dosed once, twice or four times daily for 2 weeks.

Protocol documents:
Clinical trial NCT01120093
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
Sponsor: AstraZeneca
Start date: 2010-05-01; Completion date: 2010-08-01
Enrollment: 79 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The present trial is conducted to further assess the efficacy by means of serial spirometry, safety and tolerability of three doses of aclidinium bromide administered twice a day compared to previously approved BID drug, formoterol 12 µg, and placebo in patients with moderate to severe chronic obstructive pulmonary disease (COPD).after 7 days on treatment. Every treatment period is 7-days long and there is a 5 to 7-days wash-out period in between them. The trial starts with a run in phase of 11 to 17-days duration and it ends up with a follow up contact 14-days after last treatment dose.

Detailed description:

Arms: arm 1: Aclidininum bromide 100 μg twice daily by inhalation arm 2: Aclidininum bromide 200 μg twice daily by inhalation arm 3: Aclidininum bromide 400 μg twice daily by inhalation arm 4: Placebo twice-daily by inhalation arm 5: Formoterol 12 μg twice daily by inhalation
Interventions: intervention 1: Aclidinium bromide 100 μg bid intervention 2: Aclidinium bromide 200 μg bid intervention 3: Aclidininum bromide 400 μg bid intervention 4: Placebo intervention 5: Formoterol 12 μg bid
Intervention descriptions: intervention 1: Aclidinium bromide 100 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days intervention 2: Aclidinium bromide 200 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days intervention 3: Aclidinium bromide 400 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days intervention 4: Placebo via inhalation in the morning and evening for 7 days intervention 5: Formoterol 12 μg twice-daily via inhalation by Aerolizer® dry powder inhaler: 1 puff in the morning and evening for 7 days

Protocol documents:
Clinical trial NCT01133392
Conditions: Healthy Volunteers
Keywords: insulin lispro
Sponsor: Eli Lilly and Company
Start date: 2010-05-01; Completion date: 2010-08-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will compare how the body treats 2 different forms of insulin lispro and how they affect blood sugar levels.

Detailed description:
The 2 formulations of insulin lispro will be referred to here as:

Lispro A

Lispro B

Arms: arm 1: 20 units (U) subcutaneously (SC) arm 2: 20 units (U) subcutaneously (SC)
Interventions: intervention 1: Insulin lispro A intervention 2: Insulin lispro B
Intervention descriptions: intervention 1: 20 units (U) subcutaneously (SC). intervention 2: 20 U subcutaneously (SC).

Protocol documents:
Clinical trial NCT01153711
Conditions: Healthy Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2010-05-01; Completion date: 2010-08-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This clinical trial is intended to investigate a possible effect of the p-gp inhibitor ketoconazole on the bioavailability of olodaterol

Detailed description:

Arms: arm 1: solution for oral inhalation arm 2: tablet
Interventions: intervention 1: BI 1744 intervention 2: BI 1744 intervention 3: Ketoconazole intervention 4: Ketoconazole
Intervention descriptions: intervention 1: 10 mcg solution for oral inhalation intervention 2: 10 mcg solution for oral inhalation intervention 3: 400 mg tablet intervention 4: 400 mg tablet

Protocol documents: