ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00527592
Conditions: Open-Angle Glaucoma Ocular Hypertension
Keywords: Comfort
Sponsor: Alcon Research
Start date: 2007-05-01; Completion date: 2008-08-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to compare the comfort of Travatan Z in one eye and Xalatan in the opposite eye in patients with primary open-angle glaucoma or ocular hypertension.

Detailed description:

Arms: arm 1: Travoprost assigned to one eye, with latanoprost assigned to the fellow eye for intra-individual control. One drop, single dose. The eye, and the order in which the first test medicine was instilled (either travoprost or latanoprost), was randomly assigned. arm 2: Latanoprost assigned to one eye, with travoprost assigned to the fellow eye for intra-individual control. One drop, single dose. The eye, and the order in which the first test medicine was instilled (either travoprost or latanoprost), was randomly assigned.
Interventions: intervention 1: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®) intervention 2: Latanoprost ophthalmic solution 0.005% (XALATAN®)
Intervention descriptions: intervention 1: Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop, single dose. Referred to as travoprost. intervention 2: Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop, single dose. Referred to as latanoprost.

Protocol documents:
Clinical trial NCT00529529
Conditions: Asthma
Keywords: asthma QAB149 indacaterol
Sponsor: Novartis Pharmaceuticals
Start date: 2007-09-01; Completion date: 2008-08-01
Enrollment: 805 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was designed to assess the safety of indacaterol (300 µg and 600 µg (2 x 300 μg capsules) once daily \[od\]), compared with salmeterol (50 μg twice a day \[b.i.d.\]), over 26 weeks, in patients with moderate to severe persistent asthma.

Detailed description:

Arms: arm 1: Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 07:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). 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 received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 07:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). 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 3: Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 07:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. 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 300 μg intervention 2: Salmeterol 50 μg intervention 3: Placebo to indacaterol intervention 4: Placebo to salmeterol
Intervention descriptions: intervention 1: Indacaterol was supplied as powder filled capsules together with a single dose dry powder inhaler (SDDPI). intervention 2: Salmeterol was supplied as powder filled capsules together with the manufacturer's proprietary dry powder inhalation device. intervention 3: Placebo to indacaterol was supplied as powder filled capsules together with a single dose dry powder inhaler (SDDPI). intervention 4: Placebo to salmeterol was supplied as powder filled capsules together with the manufacturer's proprietary dry powder inhalation device.

Protocol documents:
Clinical trial NCT00541242
Conditions: Ocular Hypertension Glaucoma
Sponsor: Allergan
Start date: 2007-12-01; Completion date: 2008-08-01
Enrollment: 586 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will compare the safety and efficacy of Bimatoprost and Latanoprost in patients with glaucoma or ocular hypertension

Detailed description:

Arms: arm 1: bimatoprost 0.03% eye drops arm 2: latanoprost 0.005% eye drops
Interventions: intervention 1: bimatoprost 0.03% eye drops intervention 2: latanoprost 0.005% eye drops
Intervention descriptions: intervention 1: Open-labeled latanoprost 0.005% 1 drop into each eye every evening for 6 weeks followed by a masked randomized treatment of bimatoprost 0.03% 1 drop every evening for 12 weeks intervention 2: Open-labeled latanoprost 0.005% 1 drop into each eye every evening for 6 weeks followed by a masked randomized treatment of latanoprost 0.005% 1 drop every evening for 12 weeks

Protocol documents:
Clinical trial NCT00542880
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD Symbicort Seretide
Sponsor: AstraZeneca
Start date: 2007-09-01; Completion date: 2008-08-01
Enrollment: 442 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is to assess the effects with two different inhaled respiratory medications with regards to improvement of lung function, symptoms and morning activities.

Detailed description:

Arms: arm 1: Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg First, then Seretide Diskus (salmeterol/fluticasone) 50/500 μg arm 2: Seretide Diskus (salmeterol/fluticasone) 50/500 μg First, then Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
Interventions: intervention 1: Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg intervention 2: Seretide Diskus (salmeterol/fluticasone) 50/500 μg
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00555750
Conditions: Primary Insomnia
Keywords: sleep metabolism insulin glucose actigraphy diary volumetry GABA
Sponsor: Brigham and Women's Hospital
Start date: 2006-03-01; Completion date: 2008-08-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test the effects of sleep and eszopiclone, a drug that helps people sleep, on how the body processes glucose (sugar). Eszopiclone is approved by the U.S. Food and Drug Administration (FDA) for sale for the treatment of insomnia. It is marketed in the United States as LUNESTA.

Main Hypothesis: Primary insomnia is associated with impairments of glucose metabolism that can be reversed by two months of eszopiclone for the primary insomnia

Detailed description:
Insomnia is the most common sleep disorder, affecting nearly one-third of all adults in any given year, and chronically affecting 10-15% of the adult population. Reduced sleep time, independent of insomnia, has been associated with a variety of deleterious long term effects, including an increased risk of incident myocardial infarction and symptomatic diabetes. Chronic partial sleep loss or insomnia may impair glucose metabolism in the short term and are associated with the development of diabetes in the long term. Although the extent of sleep loss is more acute in the laboratory-based 'sleep debt' studies of healthy volunteers, chronic primary insomnia patients exhibit 'hyperarousal' (hypercortisolemia in the afternoon and evening, accelerated metabolism) similar to that seen with acute sleep deprivation. In addition, degradations of sleep quantity and quality in primary insomnia have been attributed to cognitive and somatic hyperarousal in the sleep setting. study examines and quantifies in adult men and women the link between primary insomnia and impaired glucose tolerance. This study examines the extent which adequate treatment of primary insomnia reverses impairments of glucose metabolism. If abnormalities of glucose metabolism are reversible, this study will demonstrate the importance of treatment of chronic primary insomnia.

Arms: arm 1: active medication (eszopiclone 3mg tablet) by mouth nightly 30 min before bed arm 2: identical placebo tablet by mouth nightly 30 min before bed
Interventions: intervention 1: eszopiclone intervention 2: placebo
Intervention descriptions: intervention 1: 3mg tablet, by mouth nightly 30 min before bed, for two months intervention 2: inactive placebo tablet, by mouth nightly 30 minutes before bed, for two months

Protocol documents:
Clinical trial NCT00557362
Conditions: Fungal Keratitis
Keywords: Keratitis Eye Infection, Fungal Fungal Eye Infection Ocular Infection, Fungal Fungal Keratitis Mycotic Infections, Ocular Voriconazole Natamycin
Sponsor: University of California, San Francisco
Start date: 2007-11-01; Completion date: 2008-08-01
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
We evaluated whether voriconazole is a superior treatment to natamycin for filamentous fungal keratitis in a randomized, masked, controlled trial. This is a therapeutic exploratory study to investigate the safety and feasibility of conducting a larger study and to generate preliminary data.

Detailed description:
Fungal ulcers tend to have very poor outcomes with the most common treatments, amphotericin B and natamycin. There has been only a single randomized trial of anti-fungal therapy for fungal ulcers and no new medications have been approved by the FDA since the 1960s. There are studies that indicate that the newer triazoles, such as voriconazole, are more effective in vitro against filamentous fungi such as Aspergillus spp., a common cause of fungal keratitis1-3. Despite a number of case reports and in vitro studies, there has been no systematic attempt to determine whether it is more or less effective clinically than natamycin, the only commercially available FDA-approved agent. There is little data available for physicians to make an informed, evidence-based decision on choice of antifungal.

We evaluated whether voriconazole is a superior treatment to natamycin for filamentous fungal keratitis in a randomized, masked, controlled trial. This is a therapeutic exploratory study to investigate the safety and feasibility of conducting a larger study and to generate preliminary data. The primary outcome is visual acuity at 3 months from enrollment. A subset of patients will be followed at 4 years from enrollment.

Arms: arm 1: Topical voriconazole with corneal de-epithelialization arm 2: Topical voriconazole without corneal de-epithelialization arm 3: Topical natamycin with corneal de-epithelialization arm 4: Topical natamycin without corneal de-epithelialization
Interventions: intervention 1: Natamycin 5% intervention 2: Voriconazole intervention 3: Corneal de-epithelialization
Intervention descriptions: intervention 1: One drop of medication will be given every one hour while awake for one week. For another 2 weeks, one drop of medication should be given every 2 hours while awake intervention 2: Voriconazole (VFEND® I.V., Pfizer, New York, NY) will be prepared as a 1% solution.

One drop of medication should be given every one hour while awake for one week. For another 2 weeks, one drop of medication should be given every 2 hours while awake intervention 3: Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications.

Protocol documents:
Clinical trial NCT00562120
Conditions: Allergic Rhinitis
Sponsor: Pfizer
Start date: 2007-12-01; Completion date: 2008-08-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
An H3 receptor antagonist should reduce the congestion associated with allergic rhinitis. A nasal allergen challenge will be given to patients to induce rhinitis symptoms and acoustic rhinometry will be used to measure the congestion.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Placebo intervention 2: Allegra intervention 3: Allegra-D intervention 4: PF-03654746
Intervention descriptions: intervention 1: A single oral dose of Placebo is dosed during the study in order to ascertain the effect of placebo on measures and in order to maintain the blind of the other drugs. intervention 2: A single oral dose of Allegra is dosed to subjects in combination with PF-03654746. intervention 3: A single oral dose of Allegra-D is dosed to subjects as an active comparator. intervention 4: A single oral dose of PF-03654746 is the investigational drug being studied.

Protocol documents:
Clinical trial NCT00566150
Conditions: Bipolar Depression
Keywords: Keppra Levetiracetam Anticonvulsant Depression Bipolar Disorder Affective Disorders Mood Disorders Double Blind Acute Antidepressant Effects
Sponsor: Yale University
Start date: 2005-10-01; Completion date: 2008-08-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A 6-week outpatient, double-blind, placebo-controlled, add-on trial to investigate the effects of levetiracetam on depressive symptoms in bipolar depressed patients.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Levetiracetam intervention 2: Placebo
Intervention descriptions: intervention 1: Flexible dose up to 2500mg per day, for 6 weeks. intervention 2: Flexible dose up to 2500mg per day, for 6 weeks.

Protocol documents:
Clinical trial NCT00569803
Conditions: Transplantation
Sponsor: Bristol-Myers Squibb
Start date: 2007-12-01; Completion date: 2008-08-01
Enrollment: 153 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Pharmacokinetics, Bioavailability, Safety and Immunogenicity of Single Doses of Belatacept Administered Subcutaneously to Healthy Subjects

Detailed description:

Arms: arm 1: Belatacept 50 mg subcutaneous (SC) injection arm 2: Belatacept 100 mg SC injection arm 3: Belatacept 125 mg SC injection arm 4: 2 SC injections of 75 mg Belatacept arm 5: 2 SC injections of 100 mg Belatacept arm 6: 2 SC injections of 125 mg Belatacept arm 7: 125 mg Belatacept intravenous (IV) injection arm 8: SC injection of placebo solution
Interventions: intervention 1: belatacept intervention 2: Placebo
Intervention descriptions: intervention 1: single dose, 116 days intervention 2: Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)

Protocol documents:
Clinical trial NCT00580294
Conditions: Pain
Keywords: Sciatica Diabetic Neuropathies Complex Regional Pain Syndromes Low Back Pain Neck Pain Headache Back Pain Arthritis Brachial Plexus Injury (stinger/burner) Chronic Pain Contractures Diabetes Fibromyalgia Foot Pain Fracture Hip Herpes Zoster (shingles) Migraine Neuropathic Pain Osteoarthritis Osteoporosis Rheumatoid Arthritis Scoliosis Nerve pain Opana Opioid Opioid Rotation Oxymorphone Morphine neuropathic oxycodone
Sponsor: Icahn School of Medicine at Mount Sinai
Start date: 2007-11-01; Completion date: 2008-08-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to see if changing from one pain medication like morphine or oxycodone to another pain medication, oxymorphone (OPANA®), will be helpful to patients. This study will examine if the switching from one pain medication to another can be done over a 24 hour period. Oxymorphone, the drug being studied, is an FDA approved drug for treatment of severe pain.

Detailed description:

Arms: arm 1: participants switched to oxymorphone extended release (ER) via both oral and intravenous patient-controlled analgesia (IV-PCA) oxymorphone. After 24 hours, participants were discharged with oral oxymorphone ER and oxymorphone immediate release (IR) as needed
Interventions: intervention 1: Oxymorphone
Intervention descriptions: intervention 1: IV PO

Protocol documents:
Clinical trial NCT00590044
Conditions: Diabetic Ketoacidosis
Keywords: Diabetic ketoacidosis insulin therapy DKA
Sponsor: Emory University
Start date: 2007-12-01; Completion date: 2008-08-01
Enrollment: 74 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is a multicenter, randomized controlled trial to compare the safety and efficacy of insulin analogs and human insulins both during acute intravenous treatment and during the transition to subcutaneous insulin in patients with diabetic ketoacidosis (DKA).

Detailed description:
Diabetic ketoacidosis (DKA) is the most serious emergency in patients with diabetes. With an estimated 100,000 admissions per year in the United States, DKA is also the leading cause of death in children with type 1 diabetes, and accounts for a significant proportion of admissions in adult patients with type 1 and type 2 diabetes. The mainstay in the treatment of DKA involves the continuous intravenous (IV) infusion of regular insulin or the frequent subcutaneous (SC) injections of regular or rapid-acting insulin analogs. Multiple studies have reported successful protocols for insulin administration during the acute management of DKA, but they have failed to address the transition phase from IV to SC maintenance insulin regimen. The American Diabetes Association (ADA) position statement recommends the use of split-mixed insulin combination of regular and intermediate-acting insulin (NPH). This regimen, however, are associated with a high rate of hyperglycemia shortly after discontinuation of IV insulin and a risk of hypoglycemia during the hospital stay. Recently, the long-acting "basal" insulin glargine (Lantus®, Sanofi Aventis Pharmaceuticals) has been shown to facilitate glycemic control with lower rate of hypoglycemic events than intermediate-acting insulin in subjects with type 1 and type 2 diabetes. This study aims i) to determine the effects of giving a dose of glargine insulin shortly after starting an intravenous insulin infusion on glycemic control, time to resolve DKA, and rate of hypoglycemia in patients with DKA, and ii) to compare the safety and efficacy of basal/bolus (glargine/glulisine) insulin versus the standard split-mixed insulin regimen of NPH and regular insulin after the resolution of DKA. The hypothesis is that basal (lantus®) insulin as compared to NPH insulin shortly after the start of insulin infusion will improve inpatient glycemic control in patients with DKA.

Arms: arm 1: Daily insulin glargine + glulisine before meals arm 2: Split-mixed NPH + Regular insulin twice daily
Interventions: intervention 1: insulin glargine+ glulisine intervention 2: NPH + Regular insulin
Intervention descriptions: intervention 1: Daily insulin glargine + glulisine before meals intervention 2: Split-mixed NPH + Regular insulin twice daily

Protocol documents:
Clinical trial NCT00602927
Conditions: Nicotine Dependence
Keywords: Varenicline, Imaging, fMRI
Sponsor: University of Pennsylvania
Start date: 2007-11-01; Completion date: 2008-08-01
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This project aims to define mechanisms through which varenicline might be an effective smoking cessation medication.

Detailed description:
Thirty treatment seeking smokers will be recruited to complete a 40-day within-subject (cross-over), double-blind study that will assess effects of varenicline on brain activation while performing certain tasks. Prior to beginning the study, participants will complete an health and physical screening to determine final eligibility. Following a medication run-up and a 3.5 day abstinence period, participants will complete study period 1 (an fMRI scan while performing attention, working memory and emotion tasks). After a 14 to 21-day washout period the study procedures will be repeated with placebo (order of study medication counterbalanced). After completion of both study periods, all participants will be offered a 13-week quit smoking program with varenicline.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Varenicline intervention 2: Placebo
Intervention descriptions: intervention 1: Day 1 - Day 3 0.5mg once daily Day 4 - Day 7 0.5mg twice daily Day 8 - Day 13 1.0mg twice daily intervention 2: Participants will take placebo pills for 13 days using the same regimen as the varenicline study period.

Protocol documents:
Clinical trial NCT00611884
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2008-01-01; Completion date: 2008-08-01
Enrollment: 245 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Africa, Asia and North America. The aim of this trial is to compare two insulin degludec (NN1250, SIBA) formulations with each other and with insulin glargine, all in combination with metformin in insulin naive subjects with type 2 diabetes.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: insulin glargine intervention 2: insulin degludec intervention 3: insulin degludec intervention 4: insulin degludec intervention 5: metformin
Intervention descriptions: intervention 1: Treat-to-target dose titration scheme, s.c. injection. intervention 2: Formulation D: Treat-to-target dose titration scheme, s.c. injection, once daily intervention 3: Formulation E: Treat-to-target dose titration scheme, s.c. injection, once daily intervention 4: Formulation D: Treat-to-target dose titration scheme, s.c. injection, 3 times weekly intervention 5: Tablets, 1500-2000 mg/day

Protocol documents:
Clinical trial NCT00613379
Conditions: HIV Infections
Keywords: HIV treatment naïve
Sponsor: CytoDyn, Inc.
Start date: 2007-12-01; Completion date: 2008-08-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is:

1. To assess and characterize the PK and PD of PRO 140 administered IV
2. To assess the antiviral activity of PRO 140
3. To assess the safety and tolerability of PRO 140

Detailed description:

Arms: arm 1: 10 mg/kg PRO 140, one IV dose (N=10) arm 2: 5 mg/kg PRO 140, one IV dose (N=10) arm 3: Placebo, one IV dose (N=10)
Interventions: intervention 1: PRO 140 intervention 2: PRO 140 intervention 3: Placebo
Intervention descriptions: intervention 1: 10 mg/kg PRO 140, one IV dose (N=10) intervention 2: 5 mg/kg PRO 140, one IV dose (N=10) intervention 3: PBO, one IV dose (N=10)

Protocol documents:
Clinical trial NCT00613951
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2008-01-01; Completion date: 2008-08-01
Enrollment: 182 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Europe. The aim of this trial is to compare two NN5401 (Soluble Insulin Analogue Combination \[SIAC\], insulin degludec/insulin aspart) formulations with each other and with biphasic insulin aspart 30, all in combination with metformin in insulin naive subjects with type 2 diabetes.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: insulin degludec/insulin aspart intervention 2: insulin degludec/insulin aspart intervention 3: biphasic insulin aspart intervention 4: metformin
Intervention descriptions: intervention 1: Formulation B: Treat-to-target dose titration scheme, injection s.c., twice daily intervention 2: Formulation B: Treat-to-target dose titration scheme, injection s.c., twice daily intervention 3: Treat-to-target dose titration scheme, injection s.c., twice daily intervention 4: Tablets, 1500-2000 mg/daily

Protocol documents: