ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01124045
Conditions: Cataracts Inflammation
Keywords: Pediatric Cataracts Inflammation Durezol Pred Forte Difluprednate Prednisolone
Sponsor: Alcon Research
Start date: 2010-08-01; Completion date: 2012-04-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study was to compare the safety and efficacy of Durezol™ compared to Pred Forte™ for the treatment of inflammation following cataract surgery in a pediatric population 0 to 3 years of age.

Detailed description:
Parents or guardians instilled patients' assigned study medications once on the day of surgery (Day 0) and 4 times daily (QID) beginning on the day after surgery (Day 1) for 14 days followed by a tapering period of 14 days (dependent upon the Investigator's determination of adequate response to treatment). Patients were evaluated for safety and efficacy on the following visits: Day 0 (day of surgery), Day 1, Day 8 ± 1 day, Day 15 ± 2 days and Day 29 ± 2 days (end of study drug treatment). Additional safety visits occurred at 1 week after the last dose + 2 days and at 3 Months + 1 week. No inferential statistical analysis was planned for this study. Data was summarized using descriptive statistics.

Arms: arm 1: Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment arm 2: Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
Interventions: intervention 1: Difluprednate ophthalmic emulsion, 0.05% intervention 2: Prednisolone acetate ophthalmic suspension, 1.0%
Intervention descriptions: intervention 1: Topical ocular administration intervention 2: Topical ocular administration

Protocol documents:
Clinical trial NCT01124097
Conditions: Post Herpetic Neuralgia
Keywords: post herpetic neuralgia
Sponsor: Bial - Portela C S.A.
Start date: 2010-09-01; Completion date: 2012-04-01
Enrollment: 240 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to assess the efficacy of Eslicarbazepine acetate (ESL) as therapy in subjects with Post-herpetic Neuralgia (PHN) over a 15 week treatment phase.

Detailed description:
Post-herpetic neuralgia (PHN) is a syndrome of intractable pain following an acute infection of herpes zoster (shingles).

Treatment for PHN is often suboptimal. More than 50% of the subjects fail to respond to pharmacological treatments or experience intolerable side effects.

The clinical development of ESL to treat neuropathic pain is based on its chemical and pharmacodynamic relationship to sodium channel blockers, including carbamazepine, which is effective for treating some neuropathic pain conditions. Preclinical data supports the theoretical background.

This study will examine the efficacy, safety, tolerability and pharmacokinetics of Eslicarbazepine acetate for the treatment of post herpetic neuralgia.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Eslicarbazepine acetate (BIA 2-093) intervention 2: Placebo
Intervention descriptions: intervention 1: Tablets will be used. intervention 2: Tablets will be used.

Protocol documents:
Clinical trial NCT01129960
Conditions: Painful Diabetic Neuropathy
Keywords: Diabetic Neuropathic Pain
Sponsor: Bial - Portela C S.A.
Start date: 2010-11-01; Completion date: 2012-04-01
Enrollment: 332 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to assess the efficacy of Eslicarbazepine acetate (ESL) as therapy in subjects with Diabetic Neuropathic Pain (DNP) over a 15 week treatment phase.

Detailed description:
Diabetic neuropathic pain (DNP) is one of the most common complications of diabetes mellitus. It currently affects about 1% of the population but its prevalence is expected to increase in coming years (European Medicines Agency 2007) in step with the increase in diabetes mellitus prevalence, which is expected to affect 220 million people by 2010

The clinical development of ESL to treat neuropathic pain is based on its chemical and pharmacodynamic relationship to sodium channel blockers, including carbamazepine, which is effective for treating some neuropathic pain conditions. Preclinical data supports the theoretical background.

This study will examine the efficacy, safety, tolerability and pharmacokinetics of Eslicarbazepine acetate for the treatment of diabetic neuropathic pain.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Eslicarbazepine acetate (BIA 2-093) intervention 2: Placebo
Intervention descriptions: intervention 1: Tablets will be used. intervention 2: Tablets will be used.

Protocol documents:
Clinical trial NCT01137786
Conditions: Coronary Artery Stenosis
Sponsor: Bracco Diagnostics, Inc
Start date: 2010-12-01; Completion date: 2012-04-01
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a pilot study, randomized, double-blind, parallel group comparison of two iodinated contrast agents used during percutaneous coronary intervention (PCI). All patients enrolled must have normal eGFR. Statistical summaries will be presented to analyse the various laboratory tests for the two groups.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Non ionic contrast media comparator intervention 2: Non ionic contrast media comparator
Intervention descriptions: intervention 1: One time administration for PCI intervention 2: one time administration for PCI

Protocol documents:
Clinical trial NCT01148511
Conditions: Age-related Macular Degeneration
Keywords: Macula degeneration Ranibizumab Choroidal neovascularisation Treat and extend Treat and observe
Sponsor: Novartis Pharmaceuticals
Start date: 2010-02-01; Completion date: 2012-04-01
Enrollment: 99 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study was to compare 2 treatment regimens for patients suffering from choroidal neovascularisation secondary to age-related macular degeneration (AMD). The first treatment regimen was the approved AMD treatment of 1 injection each month for 3 months and than re-treatment of patients who have a visual loss of more than 5 letters with monthly control (Treat and Observe). The second treatment regimen was 1 injection each month for 3 months and than extending the control period if the macula is dry during the monthly control (Treat and Extend). If the "Treat and Extend" regimen is found effective and safe, the number of ranibizumab injections, the number of patient visits, the risk of adverse events due to the intravitreal injections, and policlinic occupation number could all be reduced.

Detailed description:

Arms: arm 1: Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over. arm 2: Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.
Interventions: intervention 1: Ranibizumab 0.5 mg
Intervention descriptions: intervention 1: Ranibizumab was supplied as a sterile solution in sealed glass vials.

Protocol documents:
Clinical trial NCT01157065
Conditions: Exudative Age-Related Macular Degeneration
Keywords: Wet AMD Intravitreal Injection Macular Degeneration VEGF treatment
Sponsor: Alcon Research
Start date: 2011-06-01; Completion date: 2012-04-01
Enrollment: 99 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study was to demonstrate a biological effect of AL-78898A, as measured by change (reduction) in central subfield (CSF) retinal thickness 4 weeks after a single intravitreal injection, as compared to LUCENTIS.

Detailed description:
The study consisted of a Screening Visit (Visit 1), a Day 0 visit (Visit 2), 6 on-therapy visits at Day 1, Weeks 1, 2, 3, 4, and 8 (Visits 3-8), and an Exit Visit at Week 12 (Visit 9). Patients who met all inclusion and exclusion criteria at Visit 1 were randomized in a 3:1 ratio to receive either AL-78898A or LUCENTIS as a single 50-μL injection in the study eye. Additionally, patients received standard therapy for exudative AMD beginning at Week 2/Visit 5 if the patient was not improving per protocol-specified criteria. Beginning at Week 4/Visit 7, patients not improving received standard therapy for exudative AMD at the investigator's discretion.

Arms: arm 1: Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up arm 2: Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
Interventions: intervention 1: AL-78898A intervention 2: Ranibizumab
Intervention descriptions: intervention 1: Investigational treatment intervention 2: Anti-vascular endothelial growth factor (VEGF) treatment

Protocol documents:
Clinical trial NCT01181050
Conditions: Inflammation Rheumatoid Arthritis
Sponsor: Janssen Research & Development, LLC
Start date: 2010-08-01; Completion date: 2012-04-01
Enrollment: 63 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Europe. The aim of this trial is to evaluate the clinical efficacy of a single dose of NNC0142-0002 administered to subjects with active rheumatoid arthritis (RA).

Detailed description:

Arms: arm 1: Subjects received a single dose of 4 mg/kg NNC0142-0002 arm 2: Subjects received a single dose of placebo
Interventions: intervention 1: NNC0142-0002 intervention 2: placebo
Intervention descriptions: intervention 1: A single dose of 4 mg NNC 0142-0000-0002/kg bodyweight. Administered subcutaneously (s.c., under the skin). intervention 2: A single dose of 4 mg NNC 0142-0000-0002 placebo/kg bodyweight. Administered subcutaneously (s.c., under the skin).

Protocol documents:
Clinical trial NCT01184508
Conditions: Migraine Headache
Keywords: classic with aura common without aura migraine headache
Sponsor: Eli Lilly and Company
Start date: 2011-01-01; Completion date: 2012-04-01
Enrollment: 87 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to measure the change in frequency of migraine attacks per 28 days in migraine patients being treated orally with LY2300559 for 12 weeks.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Placebo intervention 2: LY2300559
Intervention descriptions: intervention 1: Administered orally, once daily, for 12 weeks intervention 2: 300 milligrams (mg) administered orally, once daily, for 12 weeks

Protocol documents:
Clinical trial NCT01188551
Conditions: Chronic Otitis Media
Keywords: myringotomy pressure equalization tubes
Sponsor: Nationwide Children's Hospital
Start date: 2011-01-01; Completion date: 2012-04-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study to compare intranasal dexmedetomidine to intranasal fentanyl following anesthesia induction in patients undergoing myringotomy and placement of pressure equalization (PE) tubes in providing analgesia and smoothing emergence from general anesthesia.

Detailed description:

Arms: arm 1: Midazolam 0.5 mg/kg given orally pre-op and 1 dose of dexmedetomidine 1mcg/kg given intranasally in OR. arm 2: Midazolam 0.5 mg/kg given orally pre-op and 1 dose of fentanyl 2mcg/kg given intranasally in OR. arm 3: 1 dose of dexmedetomidine 1mcg/kg given intranasally in OR without any pre-medication. arm 4: 1 dose of fentanyl 2mcg/kg given intranasally in the OR without any pre-medication.
Interventions: intervention 1: Dexmedetomidine intervention 2: Fentanyl intervention 3: Midazolam
Intervention descriptions: intervention 1: dexmedetomidine (1 µg/kg) will be administered intranasally intervention 2: fentanyl (2 µg/kg) will be administered intranasally intervention 3: Sedative given pre-op.

Protocol documents:
Clinical trial NCT01195090
Conditions: Type 2 Diabetes
Keywords: sitagliptin pioglitazone type 2 diabetes
Sponsor: Sung-Chen Liu
Start date: 2009-10-01; Completion date: 2012-04-01
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 24-weeks study will to compare the glycemic efficacy and safety of sitagliptin with pioglitazone in patients with type 2 diabetes who had inadequate glycemic control despite dual therapy with metformin and a sulfonylurea.

Detailed description:
This is a prospective, open-label, randomized, parallel, 24-week study. Inclusion criteria: type 2 diabetes patients who were treated with stable doses of sulfonylurea and metformin to their half maximally dose (sulfonylureas \> half maximal dose, and metformin \> 1500 mg/d) for \> 10 weeks. \> 20 years old; A1C:\> 7.0 % and \< 11% Exclusion criteria: insulin use within 12 weeks of the screening visit, any contraindications for use of sitagliptin or pioglitazone, impaired renal function (serum creatinine \> 1.4 mg/dl), alanine aminotransferase (ALT) or aspartate aminotransferase levels (AST) \> 2.5 times the upper limit of normal (ULN), current or prepare to pregnancy and lactation.

Primary Purpose:

compare the change in hemoglobin A1c and the proportion of patients achieving A1C \< 7% between the 2 groups

Secondary Purposes:

1. Changes in fasting plasma glucose, high sensitive C-reactive protein (hsCRP)
2. Homeostasis model assessment-β cell function(HOMA-β) will be calculated to assess changes in β-cell function and HOMA-insulin resistance(HOMA-IR)to assess changes in insulin resistance
3. Body weight change, proportion of side effects

Arms: arm 1: add sitagliptin100mg/d to pre-study OADs arm 2: add pioglitazone 30mg/d to pre-study OADs
Interventions: intervention 1: Sitagliptin intervention 2: pioglitazone
Intervention descriptions: intervention 1: add sitagliptin100mg/d to pre-study OADs intervention 2: add pioglitazone 30mg/d to pre-study OADs

Protocol documents:
Clinical trial NCT01195116
Conditions: Interstitial Cystitis
Keywords: Post-operative pain management Pain Management Painful bladder syndrome frequency and urgency Dexmedetomidine hydrodistension
Sponsor: University of Rochester
Start date: 2010-05-01; Completion date: 2012-04-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the effects of dexmedetomidine while patients undergo treatment for Interstitial Cystitis (IC). The investigators goal is to demonstrate in patients with IC undergoing bladder hydrodistension that the use of dexmedetomidine as a supplemental anesthetic agent will result in better postoperative pain management.

Detailed description:
Inclusion Criteria: Patients with a clinical diagnosis of IC scheduled for cystoscopy and hydrodistension for both diagnostic and therapeutic indications.

Data collected will include:

I. Postoperative Outcomes i. Pain Reported (Visual Analogue Scale) ii. Post-operative opiate use iii. Time in PACU iv. Time until discharge v. Adverse Events (i.e. nausea/vomiting, nursing intervention) II. Intermediate-term Outcomes (4-6 weeks) i. Interstitial Cystitis Symptom \& Problem Index ii. Revised McGill Pain Score

Arms: arm 1: Dexmedetomidine is a FDA-approved medication that is a highly selective, short acting, alpha-2 adrenoreceptor agonist. To date, its safety and efficacy is well studied and established.It produces sedative, anxiolytic, and analgesic effects when used while patients undergo procedures and surgical operations.Interstitial Cystitis, as a chronic visceral pain syndrome, has the potential to have a neuropathic component for which an alpha-2 adrenergic agonist may be more effective than other classes, including opioids or NSAIDs. arm 2: None
Interventions: intervention 1: Dexmedetomidine intervention 2: Normal Saline
Intervention descriptions: intervention 1: 1 mcg/kg/hour intervention 2: 1mcg/kg/hr

Protocol documents:
Clinical trial NCT01200524
Conditions: Nerve Pain
Keywords: Analgesic effect
Sponsor: AstraZeneca
Start date: 2010-10-01; Completion date: 2012-04-01
Enrollment: 133 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to investigate the analgesic efficacy of AZD2423 compared with placebo after 28 days treatment in patients with posttraumatic neuralgia.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: Tablet to match the 20 mg and 50 mg AZD2423 active tablet
Interventions: intervention 1: AZD2423 intervention 2: AZD2423 intervention 3: Placebo
Intervention descriptions: intervention 1: 20 mg tablet intervention 2: 50 mg tablet intervention 3: Placebo

Protocol documents:
Clinical trial NCT01210001
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2010-09-01; Completion date: 2012-04-01
Enrollment: 499 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate the efficacy and safety of BI 10773 in type 2 diabetic patients in order to provide these data for approval for BI 10773 by regulatory authorities as an antidiabetic agent as add-on therapy to pioglitazone alone or in combination with metformin.

Detailed description:

Arms: arm 1: BI 10773 tablets once daily arm 2: BI 10773 tablets once daily arm 3: Placebo tablets matching BI 10773
Interventions: intervention 1: Placebo intervention 2: BI 10773 intervention 3: Placebo intervention 4: Placebo intervention 5: Placebo intervention 6: BI 10773
Intervention descriptions: intervention 1: Placebo tablets matching BI 10773 low dose intervention 2: BI 10773 tablets once daily intervention 3: Placebo tablets matching BI 10773 high dose intervention 4: Placebo tablets matching BI 10773 high dose intervention 5: Placebo tablets matching BI 10773 high dose intervention 6: BI 10773 tablets once daily

Protocol documents:
Clinical trial NCT01215097
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2010-10-01; Completion date: 2012-04-01
Enrollment: 306 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In this randomised, double-blind, parallel group trial, the safety and efficacy of 5 mg of Linagliptin administered orally once daily will be compared with a placebo after 24 weeks of treatment as add-on therapy to metformin in patients with type 2 diabetes and insufficient glycaemic control.

Detailed description:

Arms: arm 1: once a day arm 2: once a day
Interventions: intervention 1: Linagliptin intervention 2: placebo
Intervention descriptions: intervention 1: once a day intervention 2: once a day

Protocol documents:
Clinical trial NCT01215513
Conditions: Prostate Cancer
Sponsor: Ferring Pharmaceuticals
Start date: 2010-09-01; Completion date: 2012-04-01
Enrollment: 127 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, multi-centre single arm trial to investigate long-term safety and tolerability of degarelix in Korean patients with prostate cancer.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Degarelix
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01221298
Conditions: Hepatitis C HCV Chronic Hepatitis C Infection Hepatitis C Genotype 1
Sponsor: AbbVie (prior sponsor, Abbott)
Start date: 2010-10-01; Completion date: 2012-04-01
Enrollment: 11 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of ABT-450 with ritonavir (ABT-450/r) dosed in combination with ABT-072 and ribavirin (RBV) in treatment-naïve participants with genotype 1 chronic hepatitis C virus (HCV) infection.

Detailed description:
This was a Phase 2a multicenter, open-label, single arm, combination treatment study of a regimen of ABT-450/r/ABT-072, and ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-(1a or 1b) infected treatment-naïve participants.

Arms: arm 1: ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
Interventions: intervention 1: ABT-450 intervention 2: ABT-072 intervention 3: Ribavirin intervention 4: Ritonavir
Intervention descriptions: intervention 1: tablets intervention 2: tablets intervention 3: tablets intervention 4: capsules

Protocol documents:
Clinical trial NCT01224171
Conditions: Crohn's Disease
Sponsor: Millennium Pharmaceuticals, Inc.
Start date: 2010-11-01; Completion date: 2012-04-01
Enrollment: 416 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study in patients with moderately to severely active Crohn's disease is designed to establish the efficacy and safety of vedolizumab for the induction of clinical response and remission.

Detailed description:
After completing the study, patients were eligible to enroll in a long term safety study with continued access to vedolizumab (study C13008; NCT00790933) if study drug was well tolerated, and no major surgical intervention for Crohn's disease occurred or was required.

Participants who did not enroll in Study C13008 were to complete the Final Safety visit (16 weeks after the last dose of study drug) for a maximum time on study of 22 weeks.

Arms: arm 1: Participants received placebo intravenous infusion at Weeks 0, 2 and 6. arm 2: Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
Interventions: intervention 1: vedolizumab intervention 2: Placebo
Intervention descriptions: intervention 1: Vedolizumab for intravenous infusion intervention 2: Placebo intravenous infusion

Protocol documents: