ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00814658
Conditions: Dementia
Keywords: Dementia Mixed Dementia Galantamine Reminyl ER Nimodipine
Sponsor: Janssen-Cilag Farmaceutica Ltda.
Start date: 2008-06-01; Completion date: 2009-10-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the combination of galantamine with nimodipine in patients with mixed dementia on cognition and quality of life.

Detailed description:
A double-blind (neither the patient nor the physician know the name of the study drug), 6-month, multicenter, placebo-controlled trial to evaluate the combination of galantamine with nimodipine in patients with mixed dementia on cognition and quality of life. The target dose of galantamine is 24 mg/day and nimodipine will be taken in fixed doses of 90 mg/day. Primary outcomes will be measured by a computerized battery of neuropsychological tests and Quality of Life (QoL) scores. Secondary outcomes will be measured by ADAS-cog, Clinical Global Impression (CGI) and Neuropsychiatric Inventory (NPI). Mixed dementia (Alzheimer's Disease (AD) associated with cerebrovascular disease) is one of the most common causes of dementia, which remain largely underdiagnosed. Little is known about specific treatments for this condition. Ischemic lesions by themselves seem to play an important role in cognitive impairment, even in the presence of AD pathology. Hypotheses: - Galantamine 16-24 mg/day in combination with nimodipine 90 mg/day is superior to galantamine monotherapy (16-24 mg/day) in improving or stabilizing cognition in patients with AD associated with cerebrovascular disease (mixed dementia), as measured by the CNTB at 6 months. - Galantamine 16-24 mg/day in combination with nimodipine 90 mg/day is superior to galantamine monotherapy (16-24 mg/day) on QoL measures in this population as measured by QoL - AD at 6 months. Group 1: galantamine oral 8mg/day for a month, 16mg/day for 4 weeks and after 24mg/day until end of study plus nimodipine oral 30mg tid during all study. Group 2: Group 1: galantamine oral 8mg/day for a month, 16mg/day for 4 weeks and after 24mg/day until end of study plus placebo oral 30mg tid during all study.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Galantamine intervention 2: Nimodipine intervention 3: Placebo
Intervention descriptions: intervention 1: Galantamine 8 mg/day for one month, followed by 4 weeks of galantamine 16 mg/day. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day. intervention 2: Nimodipine 30 mg 3 times a day (tid). intervention 3: Matching placebo three times a day (tid).

Protocol documents:
Clinical trial NCT00818363
Conditions: Postoperative Pain
Keywords: Postoperative pain shoulder surgery opioid
Sponsor: Durect
Start date: 2008-12-01; Completion date: 2009-10-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a research study testing SABER-Bupivacaine (an experimental pain-relieving medication). SABER-Bupivacaine is designed to continuously deliver bupivacaine, a common local anesthetic, for a few days in order to treat local post-surgical pain.

The purpose of this study is to investigate safety (if there are any side effects) associated with the use of SABER-Bupivacaine and how well it works in reducing pain and opioid-related side effects following shoulder surgery.

Detailed description:

Arms: arm 1: 5.0 mL SABER-Bupivacaine/Once arm 2: 5.0 mL SABER-Placebo/Once
Interventions: intervention 1: SABER-Bupivacaine intervention 2: SABER-Placebo
Intervention descriptions: intervention 1: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once intervention 2: Injectable Solution; 5.0 mL SABER-Placebo/Once

Protocol documents:
Clinical trial NCT00819767
Conditions: Hypertension
Keywords: hypertension systolic blood pressure exercise test cardiovascular disease aliskiren valsartan
Sponsor: Novartis
Start date: 2009-02-01; Completion date: 2009-10-01
Enrollment: 68 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study compared the blunting effect of aliskiren and valsartan monotherapies on exercise-induced rises in systolic blood pressure in patients with mild to moderate essential hypertension.

Detailed description:

Arms: arm 1: For the first week of the 8 week treatment period, patients received aliskiren 150 mg, placebo to aliskiren, and 2 capsules of placebo to valsartan. For the remaining 7 weeks of the study, patients received aliskiren 300 mg (two 150 mg tablets) and 2 capsules of placebo to valsartan. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days). arm 2: For the first week of the 8 week treatment period, patients received valsartan 160 mg, placebo to valsartan, and 2 tablets of placebo to aliskiren. For the remaining 7 weeks of the study, patients received valsartan 320 mg (two 160 mg capsules) and 2 tablets of placebo to aliskiren. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
Interventions: intervention 1: Aliskiren intervention 2: Valsartan intervention 3: Placebo to aliskiren intervention 4: Placebo to valsartan
Intervention descriptions: intervention 1: Aliskiren was supplied in 150 mg tablets. intervention 2: Valsartan was supplied in 160 mg capsules. intervention 3: Placebo to aliskiren was supplied in tablets matching aliskiren 150 mg. intervention 4: Placebo to valsartan was supplied in capsules matching valsartan 160 mg.

Protocol documents:
Clinical trial NCT00821093
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: respiratory dyspnea breathlessness COPD indacaterol long-acting β2-agonist
Sponsor: Novartis Pharmaceuticals
Start date: 2009-01-01; Completion date: 2009-10-01
Enrollment: 1123 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study compared the safety and efficacy of indacaterol 150 µg taken once daily (o.d.) versus salmeterol 50 µg taken twice daily (b.i.d) in patients 40 years old or older with chronic obstructive pulmonary disease.

Detailed description:

Arms: arm 1: Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Patients also inhaled placebo to salmeterol twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, \[DISKUS\]) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. arm 2: Patients inhaled salmeterol 50 μg twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, \[DISKUS\]) for 12 weeks. Patients also inhaled placebo to indacaterol once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Interventions: intervention 1: Indacaterol 150 µg intervention 2: Salmeterol 50 µg intervention 3: Placebo to indacaterol intervention 4: Placebo to salmeterol
Intervention descriptions: intervention 1: Indacaterol 150 μg was provided in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI). intervention 2: Salmeterol 50 μg was provided in the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, \[DISKUS\]). intervention 3: Placebo to indacaterol was provided in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI). intervention 4: Placebo to salmeterol was provided in the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, \[DISKUS\]).

Protocol documents:
Clinical trial NCT00851747
Conditions: Obesity
Sponsor: The Cleveland Clinic
Start date: 2009-02-01; Completion date: 2009-10-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to determine the efficacy of phosphatidylcholine and deoxycholate subcutaneous injections for localized fat removal.

Subcutaneous injections of the study drug will be efficacious in decreasing localized fat deposits due to the known fat necrosis effects on fat tissue after study drug tissue incubation.

Detailed description:
This study is a randomized, double-blind study of 21 subjects. Participants in this study will be healthy, non-obese (BMI \<30) subjects over 25 with two localized, symmetrical, and contralateral areas of fat deposition on the abdomen or flanks and on the buttocks or thighs that have proven resistant to diet and exercise. Each participant will be randomized to one of three groups and will receive 4 series of injections two weeks apart. Multiple injections will be placed in the subdermal fat layer from 1-1.5 cm apart depending on the size of the treatment area.

Group A will serve as a control and will receive only injections of saline as a placebo. Group B will receive saline injections on one side of the body and receive study drug injections on the contralateral side. Group C will receive only study drug injections. The study sites will include a symmetric, contralateral area of localized fat deposit on both the upper and lower torso. Clinical evaluations will be performed at each visit. Hematologic and ultrasonographic evaluations will be performed at baseline, at the 3rd treatment (Week 4), and at 6 month follow-up. Histologic evaluations will be performed on select individuals at baseline and at the 3rd treatment (Week 4) visit.

Arms: arm 1: Phosphatidylcholine Deoxycholate Injections. Group C will receive only study drug injections arm 2: Group A will serve as a control and will receive only injections of saline as a placebo. arm 3: Group B will receive saline injections on one side of the body and receive study drug injections on the contralateral side.
Interventions: intervention 1: Phosphatidylcholine Deoxycholate intervention 2: Saline
Intervention descriptions: intervention 1: Group A will serve as a control and will receive only injections of saline as a placebo. Group B will receive saline injections on one side of the body and receive study drug injections on the contralateral side. Group C will receive only study drug injections intervention 2: Group A will serve as a control and will receive only injections of saline as a placebo. Group B will receive saline injections on one side of the body and receive study drug injections on the contralateral side. Group C will receive only study drug injections

Protocol documents:
Clinical trial NCT00862641
Conditions: Asthma Coronary Artery Disease Pulmonary Disease, Chronic Obstructive
Keywords: regadenoson CVT 3146 asthma coronary artery disease pulmonary disease, chronic obstructive
Sponsor: Astellas Pharma Inc
Start date: 2009-04-01; Completion date: 2009-10-01
Enrollment: 1009 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is intended to determine the safety and tolerance of regadenoson in subjects with asthma or chronic obstructive pulmonary disease.

Detailed description:

Arms: arm 1: Matching intravenous (IV) bolus injection, subjects with Asthma arm 2: 0.4mg / 5mL intravenous bolus injection, subjects with Asthma arm 3: Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD) arm 4: 0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
Interventions: intervention 1: Regadenoson intervention 2: Placebo
Intervention descriptions: intervention 1: IV intervention 2: IV

Protocol documents:
Clinical trial NCT00872729
Conditions: Cystinosis
Keywords: cystinosis cysteamine inheritable disease orphan disease CTNS protein, human nephropathic cystinosis
Sponsor: Amgen
Start date: 2009-05-01; Completion date: 2009-10-01
Enrollment: 9 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Cystinosis is an inheritable disease that if untreated, results in kidney failure as early as the first decade of life. The current marketed therapy is Cystagon® (cysteamine bitartrate) which must be taken every six hours for the rest of the patient's life to prevent complications of cystinosis. RP103 is a formulation of cysteamine bitartrate that is being studied to see if it may be able to be given less frequently, once every 12 hours, and have similar results.

Detailed description:
This is a single-dose, open-labeled, non-randomized, two-period study of Cysteamine Bitartrate Delayed-release Capsules (RP103) and Cystagon® in up to 10 patients (male or female) with nephropathic cystinosis under fasting conditions. It will involve a 4 night check-in to a clinical research center.

Study with completed results acquired from Horizon in 2024

Arms: arm 1: Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg arm 2: Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg
Interventions: intervention 1: Cystagon® intervention 2: RP103
Intervention descriptions: intervention 1: Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.

Duration of Treatment and Dose: Reference Period up to four doses Q6H. intervention 2: Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.

Duration of treatment and Dose: Single dose of Test Product at dose equivalent to Reference Product.

Protocol documents:
Clinical trial NCT00874887
Conditions: Anti-biotic Resistance
Sponsor: Allergan
Start date: 2009-03-01; Completion date: 2009-10-01
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess if the presence of BAK in a fluoroquinolone in the study eye affects the development of resistant bacteria on the conjunctiva based upon changes in the surface flora over the course of 2 weeks of topical treatment in healthy adult subjects.

Detailed description:

Arms: arm 1: moxifloxacin 0.5% (m mg/mL), boric acid, sodium chloride, and purified water arm 2: gatifloxacin 0.3% (3 mg/mL), benzalkonium chloride 0.005%, edetate disodium; purified water and sodium chloride
Interventions: intervention 1: moxifloxacin 0.5% HCI ophthalmic solution intervention 2: gatifloxacin ophthalmic solution 0.3%
Intervention descriptions: intervention 1: 1 drop in study eye three times a day for 14 days intervention 2: 1 drop in study eye four times a day for 14 days

Protocol documents:
Clinical trial NCT00885118
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2009-04-01; Completion date: 2009-10-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this trial is to evaluate the pharmacodynamics, pharmacokinetics, safety, and tolerability of once daily oral administration of BI 10773 administered for 28 days in Japanese patients with T2DM.

Detailed description:

Arms: arm 1: patient to receive a BI 10773 low dose tablet and a placebo tablet once daily arm 2: patient to receive a BI 10773 middle dose tablet and a placebo tablet once daily arm 3: patient to receive two tablets of BI 10773 middle dose once daily arm 4: patient to receive a BI 10773 high dose tablet and a placebo tablet once daily arm 5: patient to receive two tablets of placebo once daily
Interventions: intervention 1: Placebo (middle dose) intervention 2: Placebo intervention 3: BI 10773 intervention 4: BI 10773 intervention 5: BI 10773 intervention 6: Placebo (high dose) intervention 7: BI 10773 intervention 8: Placebo (low dose)
Intervention descriptions: intervention 1: Placebo tablets once a day intervention 2: Placebo tablets once a day intervention 3: BI 10773 middle dose tablets once a day intervention 4: BI 10773 high dose tablets once a day intervention 5: BI 10773 middle dose tablets once a day intervention 6: Placebo tablets once a day intervention 7: BI 10773 low dose tablets once a day intervention 8: Placebo tablets once a day

Protocol documents:
Clinical trial NCT00892281
Conditions: Rosacea
Sponsor: Galderma R&D
Start date: 2009-04-01; Completion date: 2009-10-01
Enrollment: 1421 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to assess the effectiveness, safety, subject satisfaction and quality of life with Oracea® when used as monotherapy or as add-on therapy to existing topical regimens for the treatment of rosacea.

Detailed description:

Arms: arm 1: Oracea as monotherapy arm 2: Oracea® as add-on Therapy (Oracea® + Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides
Interventions: intervention 1: doxycycline (Oracea®) 40 mg modified release as monotherapy intervention 2: doxycycline (Oracea®) 40 mg modified release as add-on therapy
Intervention descriptions: intervention 1: Take once daily in the morning intervention 2: Take once daily in the morning

Protocol documents:
Clinical trial NCT00911534
Conditions: Symptomatic Gastroesophageal Reflux Disease (sGERD)
Keywords: Gastroesophageal Reflux Disease GERD
Sponsor: Eisai Inc.
Start date: 2009-01-01; Completion date: 2009-10-01
Enrollment: 305 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy, safety and tolerability of rabeprazole extended release (ER) 50 mg with placebo in subjects with symptomatic gastroesophageal reflux disease (sGERD).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: rabeprazole sodium intervention 2: Placebo
Intervention descriptions: intervention 1: One rabeprazole extended release (ER) 50 mg capsule daily; rescue medication will be provided to subjects to take as needed. intervention 2: One rabeprazole placebo capsule daily; rescue medication will be provided to subjects to take as needed.

Protocol documents:
Clinical trial NCT00918749
Conditions: Postmenopausal Osteoporosis
Sponsor: Warner Chilcott
Start date: 2009-05-01; Completion date: 2009-10-01
Enrollment: 205 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Randomized, multicenter, double-blind, double-dummy, active-controlled, parallel-design study in approximately 201 postmenopausal women. A subset of subjects (approximately 102) will also participate in a pharmacokinetic (PK) component of the study. Each subject will be randomized to 1 of 3 treatment regimens for 3 months.

Detailed description:

Arms: arm 1: 150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast. arm 2: 75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast arm 3: 100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
Interventions: intervention 1: 150 mg intervention 2: 75 mg intervention 3: 100 mg
Intervention descriptions: intervention 1: 150 mg immediate release (IRBB) risedronate tablet administered orally at least 30 minutes before breakfast. intervention 2: 75 mg delayed release (DRFB) risedronate tablet administered orally immediately after ingesting breakfast intervention 3: 100 mg delayed release (DRFB) risedronate tablet administered orally immediately after ingesting breakfast

Protocol documents:
Clinical trial NCT00919763
Conditions: Atopic Dermatitis
Keywords: Dermatitis, Atopic
Sponsor: Galderma R&D
Start date: 2009-05-21; Completion date: 2009-10-01
Enrollment: 102 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a multi-center, randomized, double-blind, parallel group study. Efficacy Objectives: To evaluate the efficacy of CD2027 ointment 3 mcg/g applied twice daily over 4 weeks versus its vehicle in adult participants with at least moderate atopic dermatitis.

Safety objective: To evaluate safety of CD2027 ointment 3 mcg/g when applied twice daily over 4 weeks versus its vehicle on 5 percent (%) - 20% involved Body Surface Area (BSA) (excluding Head/Neck) in adult participants with at least moderate atopic dermatitis.

Detailed description:

Arms: arm 1: Participants applied 3 mcg/g CD2027 Ointment (up to 10 gram per application) topically, twice daily (at least 8 hours apart) over 4 weeks on atopic dermatitis lesions. arm 2: Participants applied Vehicle Ointment (up to 10 gram per application) topically, twice daily (at least 8 hours apart) over 4 weeks on atopic dermatitis lesions.
Interventions: intervention 1: CD2027 Ointment 3 mcg/g, twice daily intervention 2: Vehicle Ointment, twice daily
Intervention descriptions: intervention 1: Topical Ointment intervention 2: Topical Ointment

Protocol documents:
Clinical trial NCT00935259
Conditions: Hypercholesterolemia, Dyslipidemia
Keywords: Hypercholesterolemia, Dyslipidemia, simvastatin, Zocor
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-07-01; Completion date: 2009-10-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study was to provide human lipidomics standards with simvastatin treatment that were to be used for comparison with similar preclinical studies.

Detailed description:

Arms: arm 1: Simvastatin 40 mg tablets once daily for 2 weeks followed by placebo for 2 weeks arm 2: Placebo for 2 weeks followed by simvastatin 40 mg once daily for 2 weeks
Interventions: intervention 1: Simvastatin intervention 2: Placebo
Intervention descriptions: intervention 1: 40 mg once daily for 2 weeks intervention 2: Placebo, matching the simvastatin (40 mg) tablet as a single oral daily dose for 2 weeks

Protocol documents:
Clinical trial NCT00941681
Conditions: Heart Failure
Keywords: omecamtiv mecarbil
Sponsor: Cytokinetics
Start date: 2009-04-01; Completion date: 2009-10-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to understand the pharmacokinetics of different oral formulations of CK-1827452 being considered for future studies in patients with heart failure. This study will compare the pharmacokinetics and safety and tolerability of both modified-release (MR) and immediate-release (IR) oral formulations of CK-1827452.

Detailed description:

Arms: arm 1: Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days. arm 2: Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days. arm 3: Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
Interventions: intervention 1: CK-1827452 intervention 2: CK-1827452 intervention 3: CK-1827452
Intervention descriptions: intervention 1: 50 mg MR CK-1827452 BID for 10 days intervention 2: 37.5 mg IR CK-1827452 TID for 10 days intervention 3: 100 mg MR CK-1827452 BID for 10 days

Protocol documents: