ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01285492
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD QVA149 NVA237 indacaterol combination bronchodilator
Sponsor: Novartis Pharmaceuticals
Start date: 2011-01-01; Completion date: 2012-09-01
Enrollment: 160 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 52-week treatment, multi-center, randomized, open label, parallel group study to assess the long term safety and tolerability of once-daily QVA149 (indacaterol and NVA237 (\[glycopyrronium bromide\]) using tiotropium as an active control in Japanese patients with moderate to severe chronic obstructive pulmonary disease (COPD).

Detailed description:

Arms: arm 1: QVA149 110/50 μg once a day (o.d) arm 2: tiotropium 18 μg o.d.
Interventions: intervention 1: QVA149 intervention 2: Tiotropium
Intervention descriptions: intervention 1: QVA149 (110 μg indacaterol / 50 μg glycopyrronium o.d.), delivered via Concept1 intervention 2: Tiotropium (18 μg o.d.), delivered via Handihaler®

Protocol documents:
Clinical trial NCT01294436
Conditions: Type2 Diabetes High Blood Sugar
Keywords: Phase3 Clinical trial Type 2 Diabetes Mellitus
Sponsor: AstraZeneca
Start date: 2011-02-01; Completion date: 2012-09-01
Enrollment: 728 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a long term, single arm, open label study to evaluate the safety and efficacy of dapagliflozin as monotherapy or in combination therapy with other anti diabetic drug in Japanese subjects with type 2 diabetes mellitus who have inadequate blood sugar control on diet and exercise or on other anti-diabetic treatment will be included in this study.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Dapagliflozin
Intervention descriptions: intervention 1: Oral Dose 5 or 10 mg

Protocol documents:
Clinical trial NCT01301833
Conditions: Type 2 Diabetes Mellitus
Keywords: insulin resistance
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2011-02-01; Completion date: 2012-09-01
Enrollment: 462 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) as monotherapy or in combination with oral antihyperglycaemic agent in patients with type 2 Diabetes for 52 weeks administration.

Detailed description:

Arms: arm 1: teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) arm 2: teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide arm 3: teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide arm 4: teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
Interventions: intervention 1: teneligliptin intervention 2: glinide intervention 3: biguanide intervention 4: alpha-glucosidase inhibitor
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01304589
Conditions: Vestibulodynia Vulvodynia
Keywords: provoked vestibulodynia vulvodynia PVD
Sponsor: University of Tennessee
Start date: 2010-10-01; Completion date: 2012-09-01
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary aim of this study is to determine the efficacy of milnacipran in reducing pain in women with provoked vestibulodynia (PVD), a centrally mediated pain syndrome similar to fibromyalgia, that is characterized by severe pain in the vestibule (outer vagina). The investigators will also determine whether associated symptoms in PVD, including psychological distress, impairment of sexual function, physical function, and quality of life, are correlated with a reduction in vulvar pain.

Detailed description:
This is an 18-week, open-label, flexible-dose "proof of concept" trial where women with a diagnosis of vestibulodynia will be evaluated at baseline for eligibility. Eligible patients will be openly treated with 200 mg/d milnacipran (or the maximum tolerated dose) for a total of 12 weeks. The study design involves 4 phases: screening and washout, baseline assessment, dose escalation, and stable-dose phase (Figure 1). After completing a 2-week washout of prohibited medications, patients will enter a 2-week baseline period, where they will be trained in the use of daily diaries and the tampon test, and baseline safety and efficacy data will be recorded. Patients who continue to meet the eligibility criteria at the end of the baseline period will begin a 6-week period of dose escalation. All patients will be scheduled to receive a total of 12 weeks of stable dose treatment after the 6-week dose-escalation period for a total of 18 weeks of drug exposure.

Arms: arm 1: This was an 18-week, open-label, flexible-dose exploratory trial where eligible patients were treated with 200 mg/day of milnacipran (or the maximum tolerated dose) for a total of 12 weeks. The study design involved 3 phases: screening and baseline assessment, dose escalation and stable-dose phase. All women received 12 weeks of stable dose treatment after a 6-week dose-escalation period for a total of 18 weeks of drug exposure.
Interventions: intervention 1: Milnacipran
Intervention descriptions: intervention 1: 6-week titration period starting at 12.5mg daily and moving up to 200mg daily (or maximum tolerated dose) for 12 weeks - total treatment period is 18 weeks

Protocol documents:
Clinical trial NCT01313182
Conditions: Surgical Site Infection
Sponsor: Solventum US LLC
Start date: 2011-03-01; Completion date: 2012-09-01
Enrollment: 1874 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
We hypothesize the application of mupirocin or povidone-iodine to the nares is equally effective in short term Staphylococcus aureus(SA)suppression. Our overall study objective is to measure the rate of deep and superficial Surgical Site Infections (SSIs) after primary hip, knee, shoulder and elbow arthroplasty surgery and primary spinal fusion surgery requiring implantation of prosthetic material, when the patient receives either nasal mupirocin or nasal povidone-iodine prior to surgery.

Secondary study objectives include:

1. Measure hospital length of stay and re-admission rates in the mupirocin and povidone-iodine groups.
2. Measure adverse events related to mupirocin and povidone-iodine.
3. Measure rate of SA resistance to mupirocin.

Detailed description:
We hypothesize the application of mupirocin or povidone-iodine to the nares is equally effective in short term Staphylococcus aureus(SA)suppression. Our overall study objective is to measure the rate of deep and superficial Surgical Site Infections (SSIs) after primary hip, knee, shoulder and elbow arthroplasty surgery and primary spinal fusion surgery requiring implantation of prosthetic material, when the patient receives either nasal mupirocin or nasal povidone-iodine prior to surgery.

Arms: arm 1: Povidone-iodine solution 5% w/w (0.5% available iodine) USP Patient Preoperative Skin Preparation arm 2: Mupirocin calcium ointment, 2%
Interventions: intervention 1: mupirocin calcium ointment, 2% intervention 2: 3M Skin and Nasal Antiseptic
Intervention descriptions: intervention 1: Approximately one-half of the ointment from the single-use tube should be applied into 1 nostril and the other half into the other nostril twice daily (morning and evening) for 5 days.

After application, the nostrils should be closed by pressing together and releasing the sides of the nose repetitively for approximately 1 minute. This will spread the ointment throughout the nares. intervention 2: The solution is applied to for 30 seconds to each nostril twice for a total of 2 minutes. The solution is applied by rotating the applicator around the circumference of the nostril for 15 seconds and then rotating the applicator in the anterior nares for 15 seconds.

Protocol documents:
Clinical trial NCT01325181
Conditions: Chronic Central Serous Chorioretinopathy
Keywords: Chronic central serous chorioretinopathy Ranibizumab Photodynamic therapy
Sponsor: Jang Won Heo
Start date: 2009-07-01; Completion date: 2012-09-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy and safety of intravitreal ranibizumab injection versus low-fluence PDT in the treatment of chronic CSC.

Detailed description:
Central serous chorioretinopathy (CSC) is characterized by serous detachment of the neurosensory retina. The pathophysiology of CSC is not certain and various theories are proposed including impaired function of retinal pigment epithelium (RPE), choroidal ischemia and choroidal hyperpermeability leading to RPE damage. Acute CSC with monofocal or paucifocal changes of RPE usually shows spontaneous resolution and has a favorable visual outcome. Chronic CSC is characterized by multifocal or diffuse decompensation of RPE associated with persistent detachment of neurosensory retina. This might lead to cystoid macular degeneration, foveal atrophy and damage to the foveal photoreceptor layer, consequently resulting in irreversible significant visual loss. Photodynamic therapy (PDT) was proposed for the treatment of chronic CSC. Modified parameters of PDT such as shortening of the time of laser emission and reduction of a total light energy have been suggested to reduce the irreversible damages induced by conventional PDT. Recently, intravitreal injection of antibody to vascular endothelial growth factor(VEGF) was proposed as a new treatment option based on the effect of anti-permeability. Several reports demonstrated acceptable outcomes after intravitreal bevacizumab injection, one of anti-VEGF agent. But the clinical results with ranibizumab are not reported yet. The purpose of this study is to compare the efficacy and safety of intravitreal ranibizumab injection versus low-fluence PDT in the treatment of chronic CSC.

Arms: arm 1: Half the regular laser fluence PDT(Visudyne®; Novartis); a total light energy of 25J/cm2, a light dose rate of 300mW/cm2. If subretinal fluid was sustained after primary treatment, rescue treatment(ranibizumab injection) was considered arm 2: Consecutive Intravitreal injection of ranibizumab(Lucentis®, Novartis) 0.5mg/0.05ml for the first 3 months. If subretinal fluid was sustained after primary treatment, rescue treatment(low-fluence photodynamic therapy) was considered
Interventions: intervention 1: Verteporfin intervention 2: ranibizumab
Intervention descriptions: intervention 1: a 6mg/m2 infusion of verteporfin(Visudyne; Novartis)over 10 minutes followed by laser delivery intervention 2: Consecutive intravitreal injection of ranibizumab(Lucentis®, Novartis) 0.5mg/0.05ml for the first 3 months

Protocol documents:
Clinical trial NCT01325337
Conditions: Alopecia Alopecia, Androgenetic Baldness
Sponsor: Allergan
Start date: 2011-06-01; Completion date: 2012-09-01
Enrollment: 307 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of 3 doses of bimatoprost solution compared with vehicle and over-the-counter (OTC) minoxidil 5% solution in men with androgenic alopecia. All treatments will be provided in a double-blinded fashion except for minoxidil 5% solution which will be provided open-label.

Detailed description:

Arms: arm 1: Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. arm 2: Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. arm 3: Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. arm 4: Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. arm 5: Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
Interventions: intervention 1: bimatoprost Formulation A intervention 2: bimatoprost Formulation B intervention 3: bimatoprost Formulation C intervention 4: bimatoprost vehicle solution intervention 5: minoxidil 5% solution
Intervention descriptions: intervention 1: Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. intervention 2: Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. intervention 3: Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. intervention 4: Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. intervention 5: Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.

Protocol documents:
Clinical trial NCT01325350
Conditions: Alopecia Baldness
Sponsor: Allergan
Start date: 2011-06-01; Completion date: 2012-09-01
Enrollment: 306 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of 3 doses of bimatoprost solution compared with vehicle and over-the-counter (OTC) minoxidil 2% solution in women with female pattern hair loss. All treatments will be provided in a double-blinded fashion except for minoxidil 2% solution which will be provided open-label.

Detailed description:

Arms: arm 1: Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. arm 2: Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. arm 3: Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. arm 4: Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. arm 5: Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
Interventions: intervention 1: bimatoprost Formulation A intervention 2: bimatoprost Formulation B intervention 3: bimatoprost Formulation C intervention 4: bimatoprost vehicle solution intervention 5: minoxidil 2% solution
Intervention descriptions: intervention 1: Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. intervention 2: Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. intervention 3: Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. intervention 4: Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. intervention 5: Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.

Protocol documents:
Clinical trial NCT01325493
Conditions: Idiopathic Scoliosis Spondylolisthesis
Keywords: opioid tolerance hyperalgesia scoliosis pupillometry
Sponsor: Julia Finkel
Start date: 2010-01-01; Completion date: 2012-09-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to:

1\. Establish whether ketamine can decrease opioid consumption and modulate the onset of opioid tolerance and prevent opioid-induced hyperalgesia in pediatric subjects, ages 10 years to 18 years, undergoing posterior spinal fusion and instrumentation.

Detailed description:

Arms: arm 1: Normal Saline given 0.5mg/kg intravenous (IV) load followed by an intraoperative continuous infusion at 0.25mg/kg/h and a postoperative infusion at 0.1mg/kg/h arm 2: ketamine 0.5mg/kg intravenous (IV) load followed by an intraoperative continuous infusion at 0.25mg/kg/h and a postoperative infusion at 0.1mg/kg/h
Interventions: intervention 1: Ketamine intervention 2: Normal Saline
Intervention descriptions: intervention 1: ketamine 0.5mg/kg intravenous (IV) load followed by an intraoperative continuous infusion at 0.25mg/kg/h and a postoperative infusion at 0.1mg/kg/h intervention 2: Normal saline given 0.5mg/kg intravenous (IV) load followed by an intraoperative continuous infusion at 0.25mg/kg/h and a postoperative infusion at 0.1mg/kg/h

Protocol documents:
Clinical trial NCT01326845
Conditions: Myelodysplastic Syndrome Transfusional Iron Overload
Keywords: Gastrointestinal adverse events, myelodysplastic syndrome, transfusional iron overload diarrhea, constipation abdominal pain, vomiting
Sponsor: Novartis Pharmaceuticals
Start date: 2011-12-01; Completion date: 2012-09-01
Enrollment: 12 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the study is to evaluate and compare the frequency and severity of GI adverse events in different dose administration regimens. The patient population consists of low or intermediate (int-1) risk myelodysplastic syndrome (MDS) patients with transfusional iron overload. The study patients are randomized to either a morning dose of 20 mg/kg/day deferasirox or an evening dose of the same. Patients are then followed up for 6 months for any GI events and are assessed using patient reported outcomes tools e.g. a patient diary.

Detailed description:

Arms: arm 1: Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food arm 2: Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
Interventions: intervention 1: Deferasirox
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01342081
Conditions: Open Angle Glaucoma Ocular Hypertension
Keywords: Primary open angle glaucoma or ocular hypertension
Sponsor: Santen Pharmaceutical Co., Ltd.
Start date: 2011-05-01; Completion date: 2012-09-01
Enrollment: 489 participants; Allocation: ; Intervention model: PARALLEL

Brief summary:
DE-111 ophthalmic solution will be evaluated for superiority in comparison with Tafluprost 0.0015% ophthalmic solution, or for non-inferiority in comparison with Tafluprost 0.0015% and Timolol ophthalmic solution 0.5% used concomitantly, in IOP(intraocular pressure) -lowering effect in primary open-angle glaucoma or ocular hypertension patients, in a multicenter, randomized, double-masked, parallel-group comparison study. Safety will be compared and evaluated as well.

Detailed description:

Arms: arm 1: DE-111 ophthalmic solution arm 2: Tafluprost ophthalmic solution 0.0015% arm 3: Concomitant use of tafluprost ophthalmic solution 0.0015% plus timolol ophthalmic solution 0.5%
Interventions: intervention 1: DE-111 ophthalmic solution intervention 2: Tafluprost ophthalmic solution 0.0015% intervention 3: Concomitant use of tafluprost ophthalmic solution 0.0015% plus timolol ophthalmic solution 0.5%
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01342094
Conditions: Open Angle Glaucoma Ocular Hypertension
Keywords: Primary open angle glaucoma or ocular hypertension
Sponsor: Santen Pharmaceutical Co., Ltd.
Start date: 2011-05-01; Completion date: 2012-09-01
Enrollment: 166 participants; Allocation: ; Intervention model: PARALLEL

Brief summary:
DE-111 ophthalmic solution will be evaluated for superiority in comparison with Timolol ophthalmic solution 0.5%, in IOP(intraocular pressure ) -lowering effect in primary open-angle glaucoma or ocular hypertension patients, in a multicenter, randomized, double-masked, parallel-group comparison study. Safety will be compared and evaluated as well.

Detailed description:

Arms: arm 1: DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes. arm 2: Timolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes.
Interventions: intervention 1: DE-111 ophthalmic solution intervention 2: Timolol ophthalmic solution 0.5% intervention 3: Placebo ophthalmic solution
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01346371
Conditions: Allergic Conjunctivitis
Keywords: Allergic conjunctivitis Allergic conjunctivitis
Sponsor: Minnesota Eye Consultants, P.A.
Start date: 2011-05-01; Completion date: 2012-09-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to compare the effect of Bepreve® with an artificial-tear eye drop on the quality of your tears.

Detailed description:
This is a single-center, randomized, parallel group, placebo-controlled study to evaluate the effect of BEPREVE compared to a placebo eye drop on the measurement of tear film osmolarity and tear film lipid layer in patients with allergic conjunctivitis.

Subjects will be screened for this study on day one of dosing with the test article. Subjects who sign the informed consent form and who meet all inclusion/exclusion criteria will be eligible for participation in this study. They will be assigned sequentially, according to a computer generated randomization list, in a ratio of 1:1 to receive either BEPREVE™ (bepotastine besilate ophthalmic solution) 1.5% or REFRESH TEARS® Lubricant Eye Drops (1:1). Subjects will instill one drop of test article either BEPREVE™ or REFRESH TEARS® into the study eyes twice daily for a maximum of 60 days. Subjects will be seen for evaluation on Days 0, 28±3, and 56±3 following randomization.

Arms: arm 1: Must add drops twice a day every day during trial enrollment. arm 2: Must add drops twice a day every day while enrolled in trial.
Interventions: intervention 1: Refresh Tears 0.5% Lubricant Eye Drops intervention 2: Bepreve 1.5% Ophthalmic Solution
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01356602
Conditions: Acute Gouty Arthritis
Keywords: Gout arthritis gout flare acute gout gouty rheumatic disease uric acid
Sponsor: Novartis Pharmaceuticals
Start date: 2011-05-01; Completion date: 2012-09-01
Enrollment: 397 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study assessed the safety and efficacy of canakinumab pre-filled syringes in comparison to triamcinolone acetonide 40 mg and canakinumab lyophilizate in patients that have frequent flares of acute gouty arthritis.

Detailed description:

Arms: arm 1: Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug. arm 2: The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized powder and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug. arm 3: The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
Interventions: intervention 1: Canakinumab pre-filled syringe intervention 2: Canakinumab lyophilized powder intervention 3: Triamcinolone Acetonide intervention 4: Placebo
Intervention descriptions: intervention 1: Canakinumab pre-filled syringe intervention 2: Canakinumab lyophilized powder intervention 3: Triamcinolone Acetonide intervention 4: Matching placebo to Canakinumab (PFS), Canakinumab (LYO) and Triamcinolone Acetonide

Protocol documents:
Clinical trial NCT01363713
Conditions: Allergic Conjunctivitis
Sponsor: Santen Pharmaceutical Co., Ltd.
Start date: ; Completion date: 2012-09-01
Enrollment: 130 participants; Allocation: ; Intervention model: 

Brief summary:
Safety and efficacy of DE-114 ophthalmic solution will be evaluated in patients with allergic conjunctivitis, in an open-label, multicenter study.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: DE-114 ophthalmic solution
Intervention descriptions: intervention 1: None

Protocol documents: