ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01854593
Conditions: Proliferative Diabetic Retinopathy Diabetic Traction Retinal Detachment Vitreous Hemorrhage
Sponsor: Nihon University
Start date: 2012-05-01; Completion date: 2014-03-01
Enrollment: 69 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
We hypothesized that to reduce the adverse effects of intravitreal bevacizumab on ocular tissue and whole body, intravitreal injection of a low concentration of bevacizumab and conducting vitrectomy shortly after the injection is useful. In the present prospective, double-masked, randomized, controlled study, we aimed to verify the usefulness of intravitreal injection of 0.16 mg/0.05 ml bevacizumab one day before conducting vitrectomy for PDR.

Detailed description:
Early postoperative hemorrhage in proliferative diabetic retinopathy (PDR) patients is a major complication. Intravitreal injection of anti-vascular endothelial growth factor (VEGF) has reported to reduce vitreous hemorrhage. Recently, numerous reports have shown the efficacy of reducing neovascularization activity before vitrectomy by preoperative intravitreal injection of anti-VEGF agents. When intravitreal bevacizumab (IVB) injection is used as an adjunct therapy, a shortterm effect is needed. Because it is reported some adverse events caused by bevacizumab injection. Hattori et al reported intravitreal injection of 0.16 mg/0.05 ml bevacizumab in PDR patients marked blockage of intravitreal VEGF concentrations in the pilot study. The purpose of this study is to evaluate low dose of intravitreal bevacizumab as a preoperative adjunct therapy reduce the postoperative vitreous hemorrhage. This study involves PDR patients who underwent vitrectomy between May 2012 and August 2013 at Surugadai Hospital of Nihon University. The risks to participants are accompanied by the intravitreal injection of bevacizumab (especially the possibility of endophthalmitis and thromboembolic events).

Between June 2012 and August 2013, one investigator (AM) randomized PDR patients with an indication for primary 25-gauge vitrectomy into a sham group and an IVB group. One day after injection, three surgeons except AM conducted the surgeries. Vitreous samples were collected at the start of surgery, and intraoperative and postoperative complications were evaluated.

Arms: arm 1: 0.16 mg/0.05 ml bevacizumab intravitreal injection one day before vitrectomy. arm 2: Sham injection one day before vitrectomy.
Interventions: intervention 1: Bevacizumab intervention 2: Vitrectomy intervention 3: Sham injection
Intervention descriptions: intervention 1: 0.16 mg/0.05 ml bevacizumab (single injection on 1 day before operation) intervention 2: vitrectomy of 25 gauge system. intervention 3: Sham injection one day before vitrectomy

Protocol documents:
Clinical trial NCT01856595
Conditions: Diabetes Mellitus, Type 2
Sponsor: Pfizer
Start date: 2013-05-13; Completion date: 2014-03-01
Enrollment: 117 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of PF-06291874 in Type 2 Diabetes patients.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: PF-06291874 intervention 2: Placebo
Intervention descriptions: intervention 1: The dosing schedule is 5, 15, 50, 100 and 150 mg QD for 14 days for the first 5 cohorts in Part A. The dosing schedule for the first cohort in Part B is 15 mg QD for 14 days and 30 mg QD for 28 days intervention 2: Placebo tablets will be administered QD in each of the cohorts for 14 days (Part A cohorts 1- 5 and Part B cohort 1) or 28 days (Part B cohort 2).

Protocol documents:
Clinical trial NCT01856764
Conditions: Atopic Dermatitis
Keywords: Atopic dermatitis
Sponsor: AstraZeneca
Start date: 2013-06-01; Completion date: 2014-03-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effect of topical roflumilast on the reduction of atopic dermatitis lesions in adults with atopic dermatitis.

Detailed description:

Arms: arm 1: Roflumilast 0.5%, cream, topically, twice daily for up to 15 days. arm 2: Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days.
Interventions: intervention 1: 0.5% Roflumilast Cream intervention 2: Vehicle Cream
Intervention descriptions: intervention 1: Roflumilast 0.5% cream intervention 2: Roflumilast formulation vehicle

Protocol documents:
Clinical trial NCT01864005
Conditions: Non-ST or ST Elevation Acute Coronary Syndromes
Keywords: Non-ST or ST Elevation Acute Coronary Syndromes, Ticagrelor, Clopidogrel, Antiplatelet Effect
Sponsor: AstraZeneca
Start date: 2013-05-01; Completion date: 2014-03-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test the hypothesis that the onset of the antiplatelet effect of ticagrelor is more rapid and greater than clopidogrel in Chinese patients with ACS.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ticagrelor intervention 2: Clopidogrel
Intervention descriptions: intervention 1: 90mg tablets. loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. Duration of treatment: 6 weeks. intervention 2: 75mg capsule. loading dose of 600mg clopidogrel capsules (eight 75mg capsules) taken orally, follow by 75mg of clopidogrel capsules orally od. Duration of treatment: 6 weeks.

Protocol documents:
Clinical trial NCT01880320
Conditions: Acne Vulgaris
Sponsor: Galderma R&D
Start date: 2013-07-01; Completion date: 2014-03-01
Enrollment: 503 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study hypothesis are based on the assumption that :

* CD0271 0.3%/CD1579 2.5% Gel provides superior clinical efficacy compared with Topical Gel Vehicle in the overall population and in the subgroup of severe Subjects
* CD0271 0.3%/CD1579 2.5% Gel applied once daily for up to 12 weeks has an acceptable safety and tolerability profile

Detailed description:

Arms: arm 1: active arm arm 2: Comparator arm arm 3: Placebo arm
Interventions: intervention 1: CD0271 0.3% / CD1579 2.5% intervention 2: CD0271 0.1% / CD1579 2.5% intervention 3: Topical Gel Vehicle
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01882647
Conditions: Plaque Psoriasis
Keywords: psoriasis lotion investigator's global assessment
Sponsor: Therapeutics, Inc.
Start date: 2013-06-01; Completion date: 2014-03-01
Enrollment: 222 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase 3 study has been designed to determine and compare the efficacy and safety of 000-0551 Lotion and Vehicle Lotion applied twice daily for two weeks in subjects with plaque psoriasis.

Detailed description:

Arms: arm 1: Topical lotion, applied twice daily arm 2: Topical lotion, applied twice daily
Interventions: intervention 1: 000-0551 Lotion intervention 2: Vehicle Lotion
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01924871
Conditions: Deep Extubation
Sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Start date: 2013-07-01; Completion date: 2014-03-01
Enrollment: 62 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
It has been reported that deep extubation can reduce cardiopulmonary complication against endotracheal tube extubation during emergence from general anesthesia. The investigators hypothesized that using desflurane with target controlled infusion of remifentanil is more effective than using desflurane alone during deep extubation. The purpose of this study is to evaluate the effect of remifentanil to prevent respiratory complication (etc. coughing) during emergence from general anesthesia.

Detailed description:

Arms: arm 1: 1.5 MAC desflurane until extubation arm 2: 1.0 MAC desflurane with 1.0ng/ml targeted concentration infusion of remifentanil
Interventions: intervention 1: Desflurane with remifentanil intervention 2: Desflurane
Intervention descriptions: intervention 1: During the emergence from anesthesia,extubation was performed under 1.0 MAC desflurane with 1.0ng/ml remifentanil intervention 2: During the emergence from anesthesia,extubation was performed under 1.5 MAC desflurane

Protocol documents:
Clinical trial NCT01929031
Conditions: Pain, Postoperative Tooth Diseases
Sponsor: Boehringer Ingelheim
Start date: 2013-08-01; Completion date: 2014-03-01
Enrollment: 562 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to compare the efficacy of a combination product containing ibuprofen 400 mg and caffeine 100 mg versus either ingredient alone as well as placebo for the treatment of post-surgical dental pain over an eight-hour period followed by a single dose of study medication (study stage 1). A secondary objective is to evaluate efficacy of multiple doses of the combination in comparison to ibuprofen alone over a 5-day post-surgical period (study stage 2).

Detailed description:

Arms: arm 1: Study Stage 1: One Caffeine 100 mg tablet after dental surgery; Arm Type: Active Comparator - Study Stage 2: Subsequent to Stage 1, every 6-8 hours one ibuprofen 400 mg tablet, while awake, over 5 days; Arm Type: Active Comparator arm 2: Study Stage 1: One Placebo tablet after dental surgery Arm Type: Placebo Comparator - Study Stage 2: Subsequent to Stage 1, every 6-8 hours one Ibuprofen 400 mg/Caffeine tablet, while awake, over 5 days; Arm Type: Experimental arm 3: Study Stage 1: One Ibuprofen 400 mg/Caffeine 100 mg tablet after dental surgery: Arm Type Experimental - Study Stage 2: Subsequent to Stage 1, every 6-8 hours one Ibuprofen 400 mg/Caffeine 100 mg tablet, while awake, over 5 days; Arm Type Experimental arm 4: Study Stage 1: One Ibuprofen 400 mg tablet after dental surgery; Arm Type Active Comparator - Study Stage 2: Subsequent to stage 1, every 6-8 hours one Ibuprofen 400 mg tablet, while awake, over 5 days; Arm type; Active Comparator arm 5: Study Stage 1: One Caffeine 100 mg tablet after dental surgery. Arm Type; Active Comparator - Study Stage 2: Subsequent to Stage 1, every 6-8 hours one Ibuprofen 400mg/Caffeine 100 mg tablet, while awake, over 5 days; Arm Type: Experimental arm 6: Study Stage 1: One Placebo tablet after dental surgery Arm Type: Placebo Comparator - Study Stage 2: Subsequent to Stage 1, every 6-8 hours one Ibuprofen 400 mg tablet, while awake over 5 days; Arm Type: Active Comparator
Interventions: intervention 1: ibuprofen + caffeine intervention 2: ibuprofen intervention 3: ibuprofen intervention 4: caffeine intervention 5: ibuprofen + caffeine intervention 6: placebo intervention 7: placebo intervention 8: caffeine intervention 9: ibuprofen intervention 10: ibuprofen + caffeine
Intervention descriptions: intervention 1: FDC tablet intervention 2: tablet. intervention 3: tablet intervention 4: tablet intervention 5: Fixed Dose Combination (FDC) tablet intervention 6: tablet intervention 7: tablet intervention 8: tablet intervention 9: tablet intervention 10: FDC tablet

Protocol documents:
Clinical trial NCT01933672
Conditions: Type 2 Diabetes Mellitus
Keywords: Phase 1b type 2 diabetes metformin background PF-04937319
Sponsor: Pfizer
Start date: 2013-10-01; Completion date: 2014-03-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Study B1621019 will assess efficacy and safety of two different dosing regimens of an investigational agent (PF-04937319) compared to an approved drug (sitagliptin) in patients with type 2 diabetes

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: PF-04937319 once-daily intervention 2: PF-04937319 split-dose intervention 3: Sitagliptin once-daily
Intervention descriptions: intervention 1: Tablets, 300 mg once-daily with breakfast, 14-days intervention 2: tablets, 150 mg with breakfast plus 100 mg with lunch, 14-days intervention 3: tablets, 100 mg once-daily with breakfast, 14-days

Protocol documents:
Clinical trial NCT01951417
Conditions: Acne
Sponsor: Galderma R&D
Start date: 2013-10-01; Completion date: 2014-03-01
Enrollment: 81 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, multi-center study to be conducted in the United States. The study will examine the change in lesion count in subjects using Epiduo® Gel Pump (once daily) in conjunction with Cetaphil® DermaControl™ Foam Wash (twice daily) and Moisturizer SPF 30 (once daily). Subjects with a clinical diagnosis of mild or moderate acne who are eligible for treatment with Epiduo® in accordance with the currently approved product labeling and who meet other inclusion/exclusion criteria are to be enrolled in the study and receive the study products for 8 weeks. Efficacy and safety assessments include: complete lesion counts, cutaneous irritation assessment, end of study treatment questionnaire, photographic evaluation for oiliness, skin tone, and P Acnes, hydration assessment, barrier function assessment, treatment compliance, and adverse event assessment.

Detailed description:

Arms: arm 1: Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
Interventions: intervention 1: Adapalene/BPO Gel intervention 2: Moisturizer SPF 30 intervention 3: Foam Wash
Intervention descriptions: intervention 1: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily) intervention 2: Moisturizer SPF 30 (once daily) intervention 3: Foam Wash (twice daily)

Protocol documents:
Clinical trial NCT01961349
Conditions: Sedation to be Moderate for a Diagnostic Gastrointestinal Endoscopy and Gastrointestinal Endoscopic Polypectomy
Keywords: sedation, propofol, gastrointestinal endoscopy
Sponsor: AstraZeneca
Start date: 2013-10-01; Completion date: 2014-03-01
Enrollment: 279 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed as a multi-centre, randomised, parallel-group, placebo-controlled, phase III confirmatory study. The study will be partially double-blinded: the comparison between Group 1 (placebo group) and Group 2 (ICI35,868 without EES0000645/A) will be carried out in double-blind, but the comparison between Group 1 (placebo group) and Group 3 (ICI35,868 with EES0000645/A) will be carried out in single-blind.

The efficacy and safety of ICI35,868 with and without EES0000645/A for the sedation to be moderate for a diagnostic gastrointestinal endoscopy and gastrointestinal endoscopic polypectomy will be evaluated.

Detailed description:

Arms: arm 1: Group 1 (placebo group) is treated by Anaesthesiologist arm 2: Group 2 (ICI35,868 without EES0000645/A) is treated by Anaesthesiologist arm 3: Group 3 (ICI35,868 with EES0000645/A) is treated by Endoscopist
Interventions: intervention 1: Intralipid intervention 2: ICI35,868 (Diprivan) intervention 3: ICI35,868 (Diprivan) + EES0000645/A (SDS)
Intervention descriptions: intervention 1: Treated by Anaesthesiologist. (Intralipid is being used as a placebo for Diprivan.) intervention 2: Treated by Anaesthesiologist intervention 3: Treated by Endoscopist with EES0000645/A(SDS)

Protocol documents:
Clinical trial NCT01978600
Conditions: Open-Angle Glaucoma Ocular Hypertension
Keywords: Open-Angle Glaucoma Ocular Hypertension Simbrinza™ Intraocular Pressure
Sponsor: Alcon Research
Start date: 2013-10-01; Completion date: 2014-03-01
Enrollment: 89 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate intraocular pressure (IOP) over a 24-hour period using Simbrinza™ topical ophthalmic suspension.

Detailed description:
This study consisted of two phases, a Screening/Eligibility Phase and a Treatment Phase. Both phases required the patient to complete an overnight stay.

Arms: arm 1: Brinzolamide 1%/Brimonidine 0.2% ophthalmic suspension, 1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks arm 2: Timolol Maleate 0.5%, 1 drop twice a day (8AM, 8PM) in each eye for 4 weeks
Interventions: intervention 1: Brinzolamide 1%/Brimonidine 0.2% ophthalmic suspension intervention 2: Timolol Maleate 0.5%
Intervention descriptions: intervention 1: Commercially marketed and approved for lowering IOP in patients with open-angle glaucoma and ocular hypertension. intervention 2: Commercially marketed and approved for lowering IOP in patients with open-angle glaucoma and ocular hypertension.

Protocol documents:
Clinical trial NCT01984229
Conditions: Healthy Volunteer
Sponsor: Hoffmann-La Roche
Start date: 2013-12-01; Completion date: 2014-03-01
Enrollment: 23 participants; Allocation: NON_RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This open-label study will investigate whether multiple oral doses of posaconazole affect the single dose pharmacokinetics of alectinib in healthy volunteers.

Detailed description:

Arms: arm 1: There will be 3 dosing periods in the study: Period 1 (Days 1 to 7), Period 2 (Days 8 to 14), and Period 3 (Days 15 to 18). Alectinib will be administered as a 40 milligrams (mg) single oral dose on Day 1 (Period 1) and Day 15 (Period 3) with an identical standardized meal (identical meal on Day 1 and Day 15 across all participants). On Days 8 to 14 (Period 2) and Days 15 to 18 (Period 3) posaconazole will be administered as a 400-mg twice daily (BID) oral dose after a high-fat meal. The follow-up assessments will occur within 10 to 14 days after the last dose of posaconazole. arm 2: There will be 3 dosing periods in the study: Period 1 (Days 1 to 7), Period 2 (Days 8 to 14), and Period 3 (Days 15 to 21). Alectinib will be administered as a single oral dose at the dose selected based on Cohort A data on Day 1 (Period 1) and Day 15 (Period 3) with an identical standardized meal (identical meal on Day 1 and Day 15 across all participants). On Days 8 to 14 (Period 2) and Days 15 to 21 (Period 3) posaconazole will be administered as a 400-mg BID oral dose after a high-fat meal. The follow-up assessments will occur within 10 to 14 days after the last dose of posaconazole.
Interventions: intervention 1: Alectinib intervention 2: Posaconazole
Intervention descriptions: intervention 1: Alectinib will be administered as a single oral dose on Day 1 (Period 1) and Day 15 (Period 3) with an identical standardized meal (identical meal on Day 1 and Day 15 across all participants). intervention 2: Posaconazole will be administered as a 400-mg BID oral dose after a high-fat meal on Days 8 to 14 (Period 2) and Days 15 to 18 or 21 (Period 3).

Protocol documents:
Clinical trial NCT01989455
Conditions: Healthy Volunteers
Keywords: Healthy Deferiprone DFP L1
Sponsor: ApoPharma
Start date: 2013-11-01; Completion date: 2014-03-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Single center, randomized, double-blind, placebo-controlled, adaptive sequential ascending-dose study for the evaluation of the safety, tolerability, and pharmacokinetics of single doses of deferiprone administered by intravenous infusion to healthy males and females. A bioavailability comparison will be included.

Detailed description:

Arms: arm 1: Single dose of 500mg deferiprone or placebo administered via intravenous infusion.

First 2 subjects to enroll: 1 will be randomized to receive deferiprone and the other to receive placebo.

Next 14 subjects enrolled: 13 will be randomized to receive deferiprone and 1 to receive placebo. arm 2: Single dose of 1000mg deferiprone or placebo administered via intravenous infusion and oral solution.

Randomization will be done for all 16 subjects at the same time: 14 will be randomized to receive deferiprone and 2 to receive placebo.

Subjects enrolled to cohort 2 will receive an oral dose of deferiprone. arm 3: Single dose of 1500mg deferiprone or placebo administered via intravenous infusion.

Randomization will be done for all 16 subjects at the same time, 14 will be randomized to receive deferiprone and 2 to receive placebo. arm 4: Single dose of 2000mg deferiprone or placebo administered via intravenous infusion.

First 2 subjects to enroll: 1 will be randomized to receive deferiprone and the other to receive placebo.

Next 14 subjects enrolled: 13 will be randomized to receive deferiprone and 1 to receive placebo.
Interventions: intervention 1: Deferiprone intervention 2: Placebo
Intervention descriptions: intervention 1: Deferiprone for infusion, 10mg/mL for intravenous infusion.

Oral dose of deferiprone: 80mg/mL oral solution. (Cohort 2) intervention 2: Placebo: normal saline solution.

Protocol documents:
Clinical trial NCT02000973
Conditions: General Anesthesia Propofol Target-controlled Infusion Thoracic Epidural Anesthesia
Sponsor: First Hospital of China Medical University
Start date: 2013-11-01; Completion date: 2014-03-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators designed a prospective, randomized, placebo-controlled study to determine whether thoracic epidural anesthesia(TEA) with different local anesthetics has different influences on the propofol dose during induction.

Detailed description:

Arms: arm 1: General anesthesia combined with thoracic epidural 0.9% normal saline 8ml arm 2: General anesthesia combined with thoracic epidural 1% lidocaine 8ml arm 3: General anesthesia combined with thoracic epidural 0.25% bupivacaine 8ml arm 4: General anesthesia combined with thoracic epidural 0.3% ropivacaine 8ml
Interventions: intervention 1: Lidocaine intervention 2: Bupivacaine intervention 3: Ropivacaine intervention 4: Normal Saline
Intervention descriptions: intervention 1: General anesthesia combined with thoracic epidural 1% lidocaine intervention 2: General anesthesia combined with thoracic epidural 0.25% bupivacaine intervention 3: General anesthesia combined with thoracic epidural 0.3% ropivacaine intervention 4: General anesthesia combined with thoracic epidural 0.9% normal saline

Protocol documents:
Clinical trial NCT02018315
Conditions: Glucose Transporter Type 1 Deficiency Syndrome GLUT1 Deficiency Syndrome
Keywords: G1D Glut1 Disorder Glucose Transporter Type 1 Disorder Glucose Transporter Type I Disorder
Sponsor: Juan Pascual
Start date: 2012-01-01; Completion date: 2014-03-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this trial is to determine if an alternative energy source will impact brain metabolism in a disorder characterized by glucose metabolism failure in the brain.

The central hypothesis tested in this investigation is whether circumventing impaired glucose metabolism is feasible, safe and potentially promising by supplying anaplerotic precursors through metabolism of odd-carbon fatty acids that can enter the citric acid cycle (CAC) through alternative metabolic pathways.

Detailed description:
Triheptanoin, a nutritional supplement long used in other metabolic disorders and also added to foods and cosmetics, will be used to complement any diet that G1D patients may be receiving at enrollment with the exception of the ketogenic diet.

Arms: arm 1: Triheptanoin (C7 oil, liquid) dosed at 1 g/kg body weight divided and administered 4 times per day via mouth or g-tube for 3 months.
Interventions: intervention 1: Triheptanoin
Intervention descriptions: intervention 1: Triheptanoin is a 7-carbon medium chain triglyceride

Protocol documents: