ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01129622
Conditions: Breast Cancer
Keywords: Letrozole Breast MRI Postmenopausal women
Sponsor: Mount Sinai Hospital, Canada
Start date: 2008-10-01; Completion date: 2010-09-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is a primary investigation to determine the usefulness and safety of a short course of a relatively high dose of letrozole (a medication used to decrease the female hormone estrogen which is produced locally inside the breast after menopause) in improving the performance of of breast MRI (Magnetic Resonance Imaging). The inhibition of estrogen in the breast by letrozole might help better identifying of suspicious areas in the breast and could assist radiologists in distinguishing between benign breast areas and cancer tissue. This might help reducing the rate of call backs and unnecessary biopsies for patients. We expect to enroll 20 healthy postmenopausal women in this study.

Detailed description:
A breast MRI will be performed in the standard way for diagnosis and to serve as a baseline. A second MRI will be performed within a month and following administration of letrozole 12.5 mg daily for three days to reduce breast estrogen levels and in anticipation of lowering breast gadolinium dye uptake.

Arms: arm 1: Single arm of healthy postmenopausal women who received baseline diagnostic MRI will receive letrozole of 12.5 mg/day orally for three successive days. A second post treatment breast MRI is done right after receiving the three days of letrozole treatment and within one month after the first MRI .
Interventions: intervention 1: letrozole
Intervention descriptions: intervention 1: Letrozole (12.5 mg/day ) which is higher than the dose routinely used for therapeutic indications is given for a brief duration (3 successive days) aiming to promote acute aromatase inhibition suitable for pre-diagnostic regimens.

Protocol documents:
Clinical trial NCT01130597
Conditions: Heart Failure
Keywords: HF Heart failure hyperkalemia chronic kidney disease prevention of hyperkalemia in heart failure participants
Sponsor: Relypsa, Inc.
Start date: 2010-05-01; Completion date: 2010-09-01
Enrollment: 63 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to evaluate the feasibility of individualized titration of patiromer according to serum potassium. This study also assessed the safety and tolerability of patiromer and the effects of patiromer on serum potassium in heart failure (HF) participants with chronic kidney disease (CKD).

Detailed description:
This was an open-label, single-arm study to evaluate a titration regimen for patiromer in approximately 63 HF participants with CKD receiving one or more of the following: angiotensin-converting enzyme inhibitors (ACEIs), angiotensin II receptor blockers (ARBs), or beta blockers (BBs). This study was considered to be exploratory.

Upon successful completion of screening evaluations (-10 to -5 days prior to enrollment), all eligible participants were assigned at Baseline (Day 0 visit) to an initial dose of patiromer (20 g/day) and spironolactone (25 mg/day).

Study visits for enrolled participants were scheduled for Days 3, 7, 14, 21, 28, 35, 42, 49 and 56. A follow-up visit occurred on Day 63.

At selected study visits, patiromer or spironolactone doses may have been titrated. The study dosing algorithm was designed to maintain an individual's serum potassium value in the range of 4.0 - 5.1 mEq/L (based on local lab data).

Any participant with a local laboratory serum potassium value \< 3.5 or \> 5.5 mEq/L on two consecutive scheduled study visits, despite titration of patiromer or spironolactone, were withdrawn from the study, permanently discontinued patiromer and spironolactone, and returned for a follow-up visit within 7 days.

Arms: arm 1: spironolactone + patiromer
Interventions: intervention 1: patiromer intervention 2: spironolactone
Intervention descriptions: intervention 1: Active investigational drug intervention 2: None

Protocol documents:
Clinical trial NCT01133626
Conditions: Perennial Allergic Rhinitis
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2010-06-01; Completion date: 2010-09-01
Enrollment: 107 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the effects of BDP HFA Nasal Aerosol on HPA-axis function.

Detailed description:

Arms: arm 1: Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone. arm 2: Participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily each morning for 6 weeks (42 days). During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone. arm 3: Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a 10/mg a day prednisone capsule.
Interventions: intervention 1: Placebo Nasal Aerosol intervention 2: Prednisone capsules intervention 3: Placebo Prednisone Capsules intervention 4: Beclomethasone dipropionate
Intervention descriptions: intervention 1: Placebo nasal aerosol administered daily for 42 days of treatment intervention 2: Prednisone 10 mg capsule taken each day on the last 7 days of treatment intervention 3: Placebo prednisone capsule taken each day on the last 7 days of treatment intervention 4: Total daily dose of 320 micrograms per day of beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) applied as a nasal aerosol each morning for 42 days.

Protocol documents:
Clinical trial NCT01149785
Conditions: Healthy
Keywords: crizotinib healthy volunteers ketoconazole pharmacokinetics single dose
Sponsor: Pfizer
Start date: 2010-07-01; Completion date: 2010-09-01
Enrollment: 15 participants; Allocation: NON_RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to estimate the effect of multiple doses of ketoconazole on the single dose pharmacokinetics of crizotinib in healthy volunteers.

Detailed description:

Arms: arm 1: There should be at least 14-day washout period between treatment A and B.
Interventions: intervention 1: crizotinib intervention 2: ketoconazole intervention 3: crizotinib
Intervention descriptions: intervention 1: Treatment A: a single 150-mg dose of crizotinib will be administered in the fasted state on Day 1 as 1 × 50-mg and 1 × 100-mg Immediate Release Tablets. intervention 2: Treatment B: 200 mg twice a day (approximately 12 hrs apart) doses of ketoconazole will be administered orally on an empty stomach from Day 1 to Day 16. intervention 3: Treatment B: A single 150-mg dose of crizotinib will be administered in the fasted state on Day 4 as 1 × 50-mg and 1 × 100-mg Immediate Release Tablets.

Protocol documents:
Clinical trial NCT01154634
Conditions: Reflux
Keywords: Pharmacodynamic effect Reflux inhibition
Sponsor: AstraZeneca
Start date: 2010-05-01; Completion date: 2010-09-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to investigate the pharmacodynamic effect of AZD2516 in healthy male subjects.

Detailed description:
A double-blind, randomized, placebo-controlled, two-centre, phase IIa pharmacodynamic cross-over study to assess the effect of AZD2516 on the total number of reflux episodes in healthy male volunteers.

Arms: arm 1: period 1: AZD2516 5 mg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD2516 16 mg, period 6: washout, period 7: AZD2516 40 mg. arm 2: period 1: AZD2516 40 mg, period 2: washout, period 3: AZD2516 16 mg, period 4: washout, period 5: placebo, period 6: washout, period 7: AZD2516 5 mg. arm 3: period 1: AZD2516 16 mg, period 2: washout, period 3: AZD2516 5 mg, period 4: washout, period 5: AZD2516 40 mg, period 6: washout, period 7: placebo. arm 4: period 1: placebo, period 2: washout, period 3: AZD2516 40 mg, period 4: washout, period 5: AZD2516 5 mg, period 6: washout, period 7: AZD2516 16 mg
Interventions: intervention 1: AZD2516, 5 mg intervention 2: AZD2516, 16 mg intervention 3: AZD2516, 40 mg intervention 4: Placebo
Intervention descriptions: intervention 1: Capsule, oral intervention 2: Capsule, oral intervention 3: Capsule, oral intervention 4: Capsule, oral

Protocol documents:
Clinical trial NCT01156389
Conditions: Malaria
Keywords: malaria artemisinin-based combination therapy (ACT) antimalarial pyronaridine artesunate (Pyramax)
Sponsor: Medicines for Malaria Venture
Start date: 2010-07-01; Completion date: 2010-09-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to determine any drug interaction between the antimalarial Pyramax (pyronaridine artesunate) and the protease inhibitor ritonavir in healthy subjects. The secondary objective of the study is to assess further the safety of Pyramax in this setting.

Detailed description:
This is a phase I, open label, randomized study to determine any drug interaction between Pyramax (pyronaridine/artesunate) and the protease inhibitor ritonavir in healthy volunteers. A total of 34 healthy volunteers (17 per treatment arm) will be enrolled in the study so that at least 30 (15 per treatment arm) will complete it. Subjects will be randomly assigned in a 1:1 ratio to receive either ritonavir (100 mg) twice daily for 17 days from Day 1-17 plus Pyramax (180:60 mg) once daily for 3 days from Day 8-10 in Arm A or pyronaridine/artesunate (180:60 mg) alone once daily for 3 days from Day 1-3 in Arm B.

Subjects will come to the clinic the evening before first dosing of Pyramax / ritonavir. If enrolled, and according to the treatment arm, subjects will stay in the clinic and attend subsequent visits as follows:

Arm A:

* Inpatient day -1 (evening) to day 17
* Ambulatory clinic visit once daily (morning) on day 22, 29, 36, 43 and 50 (end of study visit)

Arm B:

* Inpatient day -1 (evening) to day 4 (morning),
* Ambulatory clinic visit once daily (morning) on Day 5, 6, 8, 15, 22, 29, 36, and 43.(end of study visit) The subjects will be evaluated for pharmacokinetic parameters and safety/tolerability.

Arms: arm 1: 7 days of ritonavir followed by 3 days of ritonavir plus Pyramax followed by 7 days of ritonavir followed by a 33 day follow-up period (40 days since last Pyramax dosing) and a study completion evaluation. arm 2: 3 day treatment course of Pyramax, followed by a follow up period of 40 days since last Pyramax dosing and a study completion evaluation.
Interventions: intervention 1: Ritonavir and Pyramax intervention 2: Pyramax
Intervention descriptions: intervention 1: 100 mg ritonavir (one soft gelatin capsule twice per day over 17 days, the evening capsule on day 1 will be omitted) and Pyramax (pyronaridine/artesunate) 180:60 mg (3 to 4 tablets once per day according to weight for 3 days). intervention 2: Pyramax (pyronaridine/artesunate) 180:60 mg (3 to 4 tablets once per day according to weight for 3 days).

Protocol documents:
Clinical trial NCT01161472
Conditions: Healthy
Sponsor: Pfizer
Start date: 2010-07-01; Completion date: 2010-09-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The study is designed to evaluate elements of cognitive function in subjects receiving either fesoterodine or alprazolam.

Detailed description:
Evaluation of cognitive function

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: 4mg fesoterodine intervention 2: 8mg fesoterodine intervention 3: alprazolam 1mg intervention 4: Placebo
Intervention descriptions: intervention 1: 4mg tablet once daily for 6 days intervention 2: 4mg tablet once daily for 3 days followed by 8mg tablet once daily for 3 days intervention 3: 1mg tablet once on last day of treatment period at clinic intervention 4: Placebo tablet for fesoterodine once daily for 6 days and placebo tablet for alprazolam once on last day of treatment period at clinic

Protocol documents:
Clinical trial NCT01168934
Conditions: Healthy
Keywords: healthy volunteers crizotinib absolute bioavailability pharmacokinetics
Sponsor: Pfizer
Start date: 2010-08-01; Completion date: 2010-09-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will be an open-label, randomized, 2-period, 2-treatment, 2-sequence, cross-over single-dose study to test the absolute bioavailability of oral crizotinib formulation to IV formulation in healthy adult volunteers. Fourteen (14) subjects will be enrolled to obtain at least 12 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:
evaluate the absolute bioavailability of oral crizotinib to IV crizotinib.

Arms: arm 1: Each subject will receive single oral and IV doses of crizotinib separated by at least 14 days.
Interventions: intervention 1: crizotinib intervention 2: crizotinib
Intervention descriptions: intervention 1: Treatment A: Intravenous dose of 50 mg crizotinib will be administered as directed. intervention 2: Treatment B: Oral dose of 250 mg crizotinib as 1 × 50-mg Immediate Release Tablet and 2 × 100-mg Immediate Release Tablets will be administered in the fasted state as directed.

Protocol documents:
Clinical trial NCT01170884
Conditions: Glaucoma Ocular Hypertension
Sponsor: Allergan
Start date: 2009-12-01; Completion date: 2010-09-01
Enrollment: 121 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Comparing Safety and Efficacy of Combigan® and Lumigan® with Lumigan® Alone in Glaucoma or Ocular Hypertension Subjects Treated with Xalatan®.

Detailed description:

Arms: arm 1: COMBIGAN® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution) adjunctive to LUMIGAN® (bimatoprost 0.03% ophthalmic solution) arm 2: LUMIGAN® (bimatoprost 0.03% ophthalmic solution) plus Gen Teal® Mild (hypromellose 0.2% eye drops) used for masking purposes
Interventions: intervention 1: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution; bimatoprost 0.03% ophthalmic solution intervention 2: bimatoprost 0.03% ophthalmic solution; hypromellose 0.2% eyedrops
Intervention descriptions: intervention 1: 1 drop of fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution (Combigan®) taken approximately 12 hours apart, up to 2 times a day and 1 drop of bimatoprost 0.03% ophthalmic solution (Lumigan®) taken once every 24 hours. intervention 2: 1 drop of bimatoprost 0.03% ophthalmic solution (Lumigan®) taken approximately every 24 hours; mild lubricant eyedrops (Gen Teal® Mild) for masking purposes

Protocol documents:
Clinical trial NCT01177800
Conditions: Psoriasis
Keywords: Psoriasis Infliximab Remicade
Sponsor: Xian-Janssen Pharmaceutical Ltd.
Start date: 2009-02-01; Completion date: 2010-09-01
Enrollment: 129 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the superiority and efficacy of infliximab induction therapy in chinese participants with moderate to severe plaque-type psoriasis (scaly skin rash) compared with placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial).

Detailed description:
This is a double-blind (neither physician nor participant knows the treatment that the participant receives), multicenter (when more than one hospital or medical school team work on a medical research study) and placebo-controlled study of infliximab in participants with moderate to severe plaque-type psoriasis. All the eligible participants will be randomly assigned to infliximab and placebo groups. The infliximab group will receive 5 milligram per kilogram (mg/kg) infliximab infusions (a fluid or a medicine delivered into a vein by way of a needle) intravenously (into a vein) at Week 0, 2 and 6 in the induction treatment phase followed by maintenance regimen of the intervention every 8 weeks up to 26 weeks. Placebo infusions will also be given at Week 10, 12 and 16. The placebo group will receive placebo infusion at Week 0, 2, 6, 14 and 22. At Week 10, participants in placebo group will then receive infliximab induction therapy. Efficacy of the participants will primarily be evaluated by percentage of participants who achieve a Psoriasis Area and Severity Index 75 (PASI) response at Week 10. Participants' safety will be monitored throughout the study.

Arms: arm 1: 5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab will be given at Week 10, 12 and 16. Total duration of treatment will be 26 weeks. arm 2: Placebo infusion, matched to infliximab will be given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants will receive 5 mg/kg infliximab intravenously. Placebo infusion will be again given at Week 14 and 22. Total duration of treatment will be 26 weeks.
Interventions: intervention 1: Placebo intervention 2: Infliximab
Intervention descriptions: intervention 1: Placebo matched to infliximab given at Weeks 10, 12 and 16 in Infliximab arm and at Weeks 0, 2 and 6 in Placebo arm intervention 2: 5 mg/kg infusion given intravenously at Week 0,2,6 (induction treatment phase) and at Week 14 and 22 in maintenance phase in infliximab arm and at Week 12 and 16 in Placebo arm.

Protocol documents:
Clinical trial NCT01191723
Conditions: Healthy
Keywords: Healthy Volunteers
Sponsor: Allergan
Start date: 2010-08-01; Completion date: 2010-09-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Compare the acute effect on the QT interval of MAP0004 (Dihydroergotamine Mesylate delivered by Oral Inhalation) with Moxifloxacin and Placebo.

Detailed description:

Arms: arm 1: There was 48 hour wash-out between treatment visits. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 2.

Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 3. Treatment C = inhaler placebo and placebo capsules at Visit 4. Tablets were orally administered after oral inhalation dosing. arm 2: There was 48 hour wash-out between treatment visits. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 2.

Treatment C = inhaler placebo and placebo capsules at Visit 3. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 4. Tablets were orally administered after oral inhalation dosing. arm 3: There was 48 hour wash-out between treatment visits. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 2. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 3.

Treatment C = inhaler placebo and placebo capsules at Visit 4. Tablets were orally administered after oral inhalation dosing. arm 4: There was 48 hour wash-out between treatment visits. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 2. Treatment C = inhaler placebo and placebo capsules at Visit 3. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 4.

Tablets were orally administered after oral inhalation dosing. arm 5: There was 48 hour wash-out between treatment visits. Treatment C = inhaler placebo and placebo capsules at Visit 2. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 3.

Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 4. Tablets were orally administered after oral inhalation dosing. arm 6: There was 48 hour wash-out between treatment visits.

Treatment C = inhaler placebo and placebo capsules at Visit 2. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 3. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 4.

Tablets were orally administered after oral inhalation dosing.
Interventions: intervention 1: MAP0004 intervention 2: Inhaler Placebo intervention 3: Moxifloxacin intervention 4: Placebo Capsule
Intervention descriptions: intervention 1: 3.0mg orally inhaled MAP0004 administered in Treatment B as per protocol intervention 2: Placebo for Inhaler administered in Treatments A and C intervention 3: 400mg encapsulated tablet administered in Treatment A as per protocol intervention 4: Placebo for Moxifloxacin administered in Treatment B and Treatment C

Protocol documents:
Clinical trial NCT01201785
Conditions: Type 2 Diabetes Mellitus Coronary Artery Disease
Keywords: diabetes mellitus, coronary artery disease, aspirin therapy
Sponsor: University of Florida
Start date: 2009-01-01; Completion date: 2010-09-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Since diabetic platelets are characterized by an enhanced turnover rate, it may be hypothesized that an increase in the frequency, rather than the dose, of drug administration may be a more effective strategy to inhibit platelet reactivity in diabetic patients as this may enable COX-1 blockade of newly generated platelets. However, how different dosing regimens impact the pharmacodynamic effects of aspirin selectively in diabetes mellitus has been poorly explored. Therefore, the aim of the present pilot investigation was to evaluate how increasing the frequency of aspirin administration, remaining within the daily recommended therapeutic doses, affects antiplatelet responsiveness in diabetic patients with coronary artery disease.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Aspirin
Intervention descriptions: intervention 1: After having been on aspirin 81mg/daily for at least one-week, patients switched their aspirin regimen on a weekly basis according to the following scheme: aspirin 81mg twice daily (bid) for one week; aspirin 162 mg once daily (od) for one week; aspirin 162 mg bid for one week; aspirin 325 mg od for one week. Pharmacodynamic assessments were made after each sequence (5 time-points). Afterward, patients resumed the dose of aspirin that they were on prior to entering the study.

Protocol documents:
Clinical trial NCT01215110
Conditions: Pulmonary Tuberculosis
Keywords: Bedaquiline Sirturo Early Bactericidal Activity EBA Pulmonary Tuberculosis TMC207
Sponsor: Global Alliance for TB Drug Development
Start date: 2010-04-01; Completion date: 2010-09-01
Enrollment: 68 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of TMC207 at multiple doses as determined by the rate of change of log10 colony forming units (CFU) per ml sputum over the time period Day 7-14 in participants with smear positive pulmonary tuberculosis (TB). A control group will receive standard treatment.

Detailed description:

Arms: arm 1: TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14 arm 2: TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14. arm 3: TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14 arm 4: TMC207- 200 mg Day 1 and 100 mg Days 2-14 arm 5: Rifafour e-275 mg
Interventions: intervention 1: TMC207 intervention 2: Rifafour e-275 mg
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: