ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00769886
Conditions: Allergic Conjunctivitis
Sponsor: Bausch & Lomb Incorporated
Start date: 2008-10-01; Completion date: 2009-06-01
Enrollment: 144 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to establish the safety and efficacy of ketotifen/naphazoline ophthalmic solution compared to vehicle and its individual components in alleviating the signs and symptoms of conjunctival allergen challenge (CAC)-induced allergic conjunctivitis.

Detailed description:

Arms: arm 1: KetoNaph (ketotifen fumarate 0.025%, naphazoline HCl 0.05%) ophthalmic solution arm 2: Naphazoline HCl 0.05% ophthalmic solution arm 3: Ketotifen fumarate 0.025% ophthalmic solution arm 4: Vehicle of KetoNaph ophthalmic solution
Interventions: intervention 1: Ketotifen/naphazoline intervention 2: Ketotifen intervention 3: Naphazoline intervention 4: Vehicle
Intervention descriptions: intervention 1: One drop of ketotifen/naphazoline in study eye at visit 3 and visit 4. intervention 2: One drop of Ketotifen in study eye at visit 3 and visit 4. intervention 3: One drop of naphazoline in study eye at vist 3 and visit 4. intervention 4: One drop of vehicle in study eye at visit 3 and visit 4.

Protocol documents:
Clinical trial NCT00770328
Conditions: Obesity
Keywords: Plasma PAI-1 level at 0, 4, 8 weeks Plasma hsCRP level at 0, 4, 8 weeks Plasma TNF-a level at 0, 4, 8 weeks
Sponsor: Vanderbilt University
Start date: 2003-05-01; Completion date: 2009-06-01
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
PAI-1 is elevated in obese individuals. TNF-alpha, an inflammatory mediator is believed to play a role in obesity mediated elevations in PAI-1 levels. TNF-alpha blockade with antibodies and the drug pentoxifylline have been shown to lower PAI-1 levels in animal models. This study tests the hypothesis that pentoxifylline will lower PAI-1 levels in human subjects.

Detailed description:
Obese individuals with elevated PAI-1 levels (greater than 10 ng/ml) are randomized to pentoxifylline 400mg, three times a day (TID) or placebo for 8 weeks. PAI-1, TNF-a and high sensitivity C-Reactive Protein are measured at week 0, 4 and 8.

Arms: arm 1: Patients receive Pentoxifylline 400 mg po TID for 8 weeks. arm 2: Patients take a placebo TID for 8 weeks.
Interventions: intervention 1: Pentoxifylline intervention 2: Placebo
Intervention descriptions: intervention 1: 400mg PO TID x 8 weeks intervention 2: PO TID x 8 weeks

Protocol documents:
Clinical trial NCT00771316
Conditions: Urinary Tract Infections
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-12-01; Completion date: 2009-06-01
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to demonstrate that MK0826 is comparable to Meropenem in the treatment of complicated Urinary Tract Infections (UTIs) in adults.

Detailed description:

Arms: arm 1: MK0826 (ertapenem) arm 2: meropenem
Interventions: intervention 1: MK0826 (ertapenem) intervention 2: Comparator: meropenem
Intervention descriptions: intervention 1: A single dose of 1.0g IV infused over a 30 minute interval at hour 0 intervention 2: 500 mg IV infused over a 30 minute interval at hours 0, 8, and 16 for at least 4 days

Protocol documents:
Clinical trial NCT00775528
Conditions: Cystic Fibrosis Pancreatic Exocrine Insufficiency
Keywords: Cystic Fibrosis Pancreatic Exocrine Insufficiency
Sponsor: Solvay Pharmaceuticals
Start date: 2009-04-01; Completion date: 2009-06-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess the safety and tolerability of pancrelipase delayed release capsules in subjects up to 6 years of age with Pancreatic Exocrine Insufficiency (PEI) due to Cystic Fibrosis.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Pancrelipase Delayed Release
Intervention descriptions: intervention 1: 3,000, 6,000 and 12,000 unit Lipase Capsules

Protocol documents:
Clinical trial NCT00778921
Conditions: Hypertension
Keywords: Aliskiren Amlodipine Non-responder to Amlodipine
Sponsor: Novartis
Start date: 2008-10-01; Completion date: 2009-06-01
Enrollment: 847 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients with hypertension not adequately controlled with amlodipine alone.

Detailed description:

Arms: arm 1: Amlodipine 10 mg arm 2: Aliskiren/Amlodipine 150/10 mg arm 3: Aliskiren/Amlodipine 300/10 mg
Interventions: intervention 1: Amlodipine 10 mg intervention 2: Aliskiren 150 intervention 3: Amlodipine 300
Intervention descriptions: intervention 1: Amlodipine 10 mg intervention 2: Aliskiren/Amlodipine 150/10 mg intervention 3: Aliskiren/Amlodipine 300/10 mg

Protocol documents:
Clinical trial NCT00780143
Conditions: Relapsed/Refractory Leukemia
Keywords: Tumor Leukemia Plitidepsin Aplidin
Sponsor: PharmaMar
Start date: 2007-11-01; Completion date: 2009-06-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase I/II study to determine the safety, tolerability and to identify the MTD and DLT of Plitidepsin in combination with a fixed dose of Cytarabine in patients with relapsed/refractory leukemia and to determine the response rate of the combination of Plitidepsin with Cytarabine in patients with relapsed/refractory AML treated at the MTD.

Detailed description:
This is a Phase I/II study to determine:

* the safety, tolerability and to identify the MTD and DLT of Plitidepsin in combination with a fixed dose of Cytarabine in patients with relapsed/refractory leukemia and to determine the response rate of the combination of Plitidepsin with Cytarabine in patients with relapsed/refractory AML treated at the MTD.
* the pharmacokinetic parameters of Plitidepsin in combination with Cytarabine.
* whether Plitidepsin in combination with Cytarabine exerts antiangiogenic effects as measured by reduction in microvessel density and VEGFR-1 expression in bone marrow biopsies of patients with relapsed/refractory leukemia.
* whether measurement of free serum VEGF levels, soluble circulating VEGF Receptor and Peripheral Progenitor Endothelial cells provide an early marker of response to Plitidepsin.
* the effects of Plitidepsin and Cytarabine on cytidine deaminase activity and correlate results with Cytarabine drug resistance.
* changes in leukemic gene expression as a result of Plitidepsin and Cytarabine administration.
* tumor response duration.
* progression free survival and overall survival.

Arms: arm 1: Plitidepsin in combination with Cytarabine
Interventions: intervention 1: Plitidepsin plus Cytarabine
Intervention descriptions: intervention 1: Plitidepsin 0.54 mg /m2 (initial dose)daily x 5 one hour infusion every 3 weeks plus Cytarabine 1 g/m2 daily for 5 days.

Protocol documents:
Clinical trial NCT00786188
Conditions: Hot Flashes
Keywords: Menopause Vasomotor Symptoms Hot flash Perimenopause Nonhormonal therapies Climacteric symptoms Mesafem Low-Dose Mesylate salt of Paroxetine (LDMP)
Sponsor: Noven Therapeutics
Start date: 2008-11-01; Completion date: 2009-06-01
Enrollment: 102 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an exploratory 8-week, multicenter, double-blind, randomized, placebo-controlled study of Brisdelle (paroxetine mesylate) Capsules 7.5 mgin subjects with moderate to severe postmenopausal vasomotor symptoms (VMS), defined as follows:

* Moderate VMS: Sensation of heat with sweating, able to continue activity
* Severe VMS: Sensation of heat with sweating, causing cessation of activity

Detailed description:
Eligible subjects will be entered into a 1-week observation period followed by a 1-week run-in period. Following completion of the run-in period, eligible subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo in a 1:1 ratio. Study drug will be administered once daily at bedtime. Symptom assessment questionnaires will be administered at baseline and at Day 28 and Day 57 visits.

Arms: arm 1: Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg. arm 2: Eligible subjects will be randomized to receive a sugar pill.
Interventions: intervention 1: Brisdelle (paroxetine mesylate) intervention 2: Sugar pill
Intervention descriptions: intervention 1: Eligible subjects will be randomized to receive Brisdelle™ (paroxetine mesylate) Capsules 7.5 mg. intervention 2: Subjects will receive a sugar pill.

Protocol documents:
Clinical trial NCT00793182
Conditions: Renal Impairment
Keywords: Renal Kidney Contrast Induced Nephropathy
Sponsor: Guerbet
Start date: 2009-01-01; Completion date: 2009-06-01
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the contrast-induced nephropathy (CIN) rate in subjects randomized to receive either Ioversol or Iodixanol for contrast-enhanced computed tomography.

Detailed description:
Contrast-induced nephropathy (CIN) is an acute decline in renal function after the administration of iodinated contrast agents. CIN is commonly defined as an increase in post contrast serum creatinine (SCr) greater than or equal to 25% or an absolute increase greater than or equal to 0.5 mg/dL from pre contrast baseline values. Study will evaluate and compare the effects of two (2) contrast media products on renal function in subjects with stable reduced renal function while undergoing contrast-enhanced computed tomography.

Arms: arm 1: Ioversol 320 mgI/mL arm 2: Iodixanol 320 mgI/mL
Interventions: intervention 1: Ioversol 320 mgI/mL intervention 2: Iodixanol 320 mgI/mL
Intervention descriptions: intervention 1: 125 mL of Ioversol administered in the vein intervention 2: 125 mL of Iodixanol administered in the vein

Protocol documents:
Clinical trial NCT00793585
Conditions: IgA Nephropathy
Keywords: IgA nephropathy
Sponsor: Sun Yat-sen University
Start date: 2007-07-01; Completion date: 2009-06-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This prospective, randomized controlled study will evaluate the effect of uric acid on the progression of IgA nephropathy.

Detailed description:
It has been reported that hyperuricemia is a risk factor for progression of IgAN. This will be a prospective, randomized study. Eligible IgAN patients will be randomized into the treatment group and the control group. Patients in treatment group will receive allopurinol and usual therapy. Patients in control group will receive usual therapy with placebo. If with hypertension, add the CCB and the β-blocker. Fasting uric acid, serum creatinine, albumin, routine blood test, urine microscopy and dipstick, proteinuria of 24 hours and blood pressure will be measured every month. After followed-up for 6 months, the curative effect of Allopurinol on blood pressure, proteinuria and the progression of IgA nephropathy will be evaluated.

Arms: arm 1: Allopurinol group:allopurinol, 100-300mg/d according to the levels of Scr(serum creatinine) and UA(uric acid), for those Scr \< 1.5mg/dl (133 umol/L) at the baseline, allopurinol was given 100 mg three times daily.Patients diagnosed with hypertension received antihypertensive drugs with titration of CCB and β-blocker during the follow-up.The target of BP is less than 130/80mmHg. arm 2: Control group:(patient in this group were received health education and were encouraged to adhere to a low-purine diet and continue their usual therapy.Patients diagnosed with hypertension received antihypertensive drugs with titration of CCB and β-blocker during the follow-up.The target of BP is less than 130/80mmHg.
Interventions: intervention 1: allopurinol intervention 2: continue their usual therapy
Intervention descriptions: intervention 1: Patients will receive the lifestyle modification and treatment of allopurinol (300 mg /d) and lifestyle modification for 4 weeks; when the UA level \< 6mg/dl , the dosage changed to 200mg/d. intervention 2: Patients will receive lifestyle modification and continue their usual therapy.

Protocol documents:
Clinical trial NCT00796315
Conditions: Allergic Rhinitis Upper Respiratory Infection
Keywords: Pharmacokinetic study
Sponsor: Procter and Gamble
Start date: 2008-12-01; Completion date: 2009-06-01
Enrollment: 41 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary goal of this study is to characterize the pharmacokinetics of doxylamine succinate in children ages 2 to \< 18 years. Once characterized, these pediatric pharmacokinetic data will be pooled with historical adult PK data from other studies to assess whether the existing Over-the-Counter (OTC)doses provide comparable systemic drug exposure as that associated with efficacy in adults.

Detailed description:

Arms: arm 1: Doxylamine Succinate United States Pharmacopeia (USP)
Interventions: intervention 1: Doxylamine Succinate USP
Intervention descriptions: intervention 1: One dose of liquid, dosing range 3.125mg/7.5mL - 12.5mg/30mL

Protocol documents:
Clinical trial NCT00799409
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD Attention Deficit Hyperactivity Disorder
Sponsor: Ortho-McNeil Janssen Scientific Affairs, LLC
Start date: 2008-12-01; Completion date: 2009-06-01
Enrollment: 78 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this trial is to determine if the study medication, CONCERTA (methylphenidate HCl), is safe and effective in improving academic performance and behavior in children with attention deficit hyperactivity disorder (ADHD), when compared to placebo.

Detailed description:
The hypothesis is that CONCERTA (methylphenidate HCl) is safe and effective in improving academic performance and behavior in children with ADHD, when compared to placebo as demonstrated using specified study measures. This is a double-blind (neither participant nor investigator knows the name of the assigned study drug), randomized (study drug assigned by chance), placebo-controlled, crossover study evaluating the academic, behavioral, and cognitive effects of CONCERTA (methylphenidate HCl) on older children with ADHD. This means that all eligible children will receive treatment with methylphenidate HCl throughout the study (the titration and assessment periods) and inactive pill (placebo) on one of the two laboratory classroom days. On the other laboratory classroom day they will receive their regular dose of methylphenidate HCl. The primary efficacy variable in this study is the Permanent Product Math Test (PERMP) attempted score. Secondary Measures include: SKAMP (Swanson, Kotkin, Agler, M-Flynn, and Pelham), tests of inattention, reading fluency and comprehension, and memory. Assessments will be completed during each of the laboratory assessment days (12.5 hours). Participants will be assessed for adverse events throughout the study. Patients will initiate treatment with oral CONCERTA (methylphenidate HCl) 18 mg at baseline and continue morning dosing with increases every 3 to 7 days until an optimal dose is achieved, up to the maximum of 54 mg/day. Eligible patients will remain in the study for a maximum of 8 weeks.

Arms: arm 1: CONCERTA (methylphenidate HCl) / Placebo Optimal Subject Dose (18 mg-54 mg) once daily during Lab School Day #1 and Placebo once daily on Lab School Day #2 arm 2: Placebo/ CONCERTA (methylphenidate HCl) Placebo once daily on Lab School Day #1 and Optimal Subject Dose (18 mg-54 mg) once daily during Lab School Day #2
Interventions: intervention 1: Placebo/ CONCERTA (methylphenidate HCl) intervention 2: CONCERTA (methylphenidate HCl) / Placebo
Intervention descriptions: intervention 1: Placebo once daily on Lab School Day #1 and Optimal Subject Dose (18 mg-54 mg) once daily during Lab School Day #2 intervention 2: Optimal Subject Dose (18 mg-54 mg) once daily during Lab School Day #1 and Placebo once daily on Lab School Day #2

Protocol documents:
Clinical trial NCT00803595
Conditions: Influenza, Human
Keywords: Influenza Neuraminidase inhibitor
Sponsor: Daiichi Sankyo Co., Ltd.
Start date: 2008-11-01; Completion date: 2009-06-01
Enrollment: 1002 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to confirm the efficacy of CS-8958 administered as a single inhaled low dose or single inhaled high dose by showing non-inferiority to oseltamivir phosphate using the time to alleviation of influenza illness. For safety evaluation, between-group comparisons will be made with regard to incidence of adverse events and other safety measures.

In a secondary objective, the optimum dosage of CS-8958 for this indication will be evaluated based on the efficacy and safety of single inhaled low or high dose.

Detailed description:

Arms: arm 1: CS-8958 powder to be inhaled - low-dose arm arm 2: CS-8958 powder to be inhaled - high-dose arm arm 3: oseltamivir phosphate oral capsules
Interventions: intervention 1: CS-8958 intervention 2: CS-8958 intervention 3: oseltamivir phosphate
Intervention descriptions: intervention 1: CS-8958 powder 20 mg to be inhaled one time. Oseltamivir phosphate placebo capsules 2 times per day for 5 days intervention 2: CS-8958 powder 40 mg to be inhaled one time. Oseltamivir phosphate placebo capsules 2 times per day for 5 days intervention 3: CS-8958 placebo powder to be inhaled one time. Oseltamivir phosphate oral capsules taken twice daily for 5 days.

Protocol documents:
Clinical trial NCT00812955
Conditions: Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia
Keywords: Dyslipidemia Hypercholesterolemia Hypertriglyceridemia
Sponsor: AstraZeneca
Start date: 2008-11-01; Completion date: 2009-06-01
Enrollment: 474 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to test the effect and safety of three different doses of ABT-143 compared to simvastatin in subjects with elevated levels of low density lipoprotein cholesterol ("bad cholesterol") and triglycerides.

Detailed description:
There are 4 treatment groups in the study: ABT-143 capsules 20/135 mg, ABT-143 capsules 10/135 mg, ABT-143 5/135 mg, and simvastatin capsules 40 mg. The primary outcome measure only compares 2 of these groups: ABT-143 capsules 20/135 mg and the simvastatin capsules 40 mg groups, therefore there are only results for these 2 groups and not all 4 groups for this outcome measure . Secondary outcome measure (mean percent change in LDL-C comparing ABT-143 capsules 10/135 mg to simvastatin capsules 40 mg) only compares these 2 groups: ABT-143 capsules 10/135 mg and simvastatin capsules 40 mg, therefore there are only results for these 2 groups and not all 4 groups for this outcome measure. Secondary outcome measure (mean percent change in LDL-C comparing ABT-143 capsules 5/135 mg to simvastatin capsules 40 mg) only compares these 2 groups: ABT-143 capsules 5/135 mg and simvastatin capsules 40 mg, therefore there are only results for these 2 groups and not all 4 groups for this outcome measure. For the other pre-specified outcome measures, median percent change in triglycerides from baseline to the final visit and mean percent change in HDL-C from baseline to the final visit for the full analysis sets, all 3 ABT-143 capsules 20/135 mg, 10/135 mg, and 5/135 mg groups were compared to the simvastatin capsules 40 mg group, therefore there are results for all 4 treatment groups for these outcome measures.

Arms: arm 1: ABT-143 capsules 5/135 mg - ABT-143 (rosuvastatin 5 mg in combination with fenofibric acid 135 mg) once daily for 8 weeks arm 2: ABT-143 capsules 10/135 mg - ABT-143 (rosuvastatin 10 mg in combination with fenofibric acid 135 mg) once daily for 8 weeks arm 3: ABT-143 capsules 20/135 mg - ABT-143 (rosuvastatin 20 mg in combination with fenofibric acid 135 mg) once daily for 8 weeks arm 4: Simvastatin capsules 40 mg daily for 8 weeks
Interventions: intervention 1: ABT-143 intervention 2: simvastatin
Intervention descriptions: intervention 1: Once daily for 8 weeks intervention 2: Once daily for 8 weeks simvastatin capsules 40 mg

Protocol documents:
Clinical trial NCT00818337
Conditions: Heart Disease
Sponsor: Creighton University
Start date: 2008-11-01; Completion date: 2009-06-01
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this pilot study is to evaluate the prevalence of biological aspirin resistance in women at risk for CHD taking low dose (81 mg) aspirin. Aspirin responsiveness will be measured with the VerifyNow device (Accumetrics; San Diego, CA). Those women identified as biologically resistant will be switched to aspirin 325 mg for 14 days and then re-tested for aspirin responsiveness.

Detailed description:

Arms: arm 1: Resistant
Interventions: intervention 1: Aspirin
Intervention descriptions: intervention 1: Aspirin 81mg and Aspirin 325mg, non-enteric coated, take one tablet by mouth daily

Protocol documents:
Clinical trial NCT00822692
Conditions: Abscess Methicillin-Resistant Staphylococcus Aureus Infection
Keywords: Abscess Cellulitis Antibiotics MRSA
Sponsor: 59th Medical Wing
Start date: 2008-07-01; Completion date: 2009-06-01
Enrollment: 139 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Patients will be enrolled in a multi-center study (Wilford Hall Medical Center and Brooke Army Medical Center) to prospectively evaluate outcome after treatment for an uncomplicated skin abscess.

Detailed description:
All patients will receive incision and drainage and wound cultures. Patients will then be randomized to 1) septa double strength two pills orally twice a day x 7 days or 2)placebo. Patients will then return to the emergency room on days 3 and 7 for wound repacking and evaluation. The primary outcome recurrence rates within 30 days of treatment. Patients who are not improving at the following visit will then be treated with additional antibiotics if needed. Data will be analyzed both by initial randomization and intention to treat.

Arms: arm 1: Trim/sulfa (800/160) two tablets orally (PO) twice a day (BID) x 7 days arm 2: matched placebo 2 pills orally (PO) twice a day (BID) x 7 days
Interventions: intervention 1: Trim/ Sulfa DS intervention 2: placebo
Intervention descriptions: intervention 1: bactrim DS (800/160) two tablets PO BID x 7 days intervention 2: matched placebo 2 pills PO BID x 7 days

Protocol documents:
Clinical trial NCT00832572
Conditions: Coronary Artery Disease Pain Peripheral Nervous System Diseases Polyneuropathy
Keywords: Coronary Artery Disease Pain Peripheral Neuropathy Polyneuropathy
Sponsor: Gilead Sciences
Start date: 2009-01-01; Completion date: 2009-06-01
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study was to determine whether ranolazine was effective in the treatment of neuropathic pain in patients with coronary artery disease.

Eligibility required neurological examination by the study doctor and assessment of the patient's pain. Eligible participants were randomized to receive blinded study medication for a total of 12 weeks.

Detailed description:

Arms: arm 1: Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6, then ranolazine during Weeks 7 to 12. arm 2: Participants were randomized to receive ranolazine during Weeks 1 to 6, then placebo to match ranolazine during Weeks 7 to 12.
Interventions: intervention 1: Ranolazine intervention 2: Placebo
Intervention descriptions: intervention 1: Ranolazine ER tablet administered orally for 6 weeks (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks). intervention 2: Placebo to match ranolazine administered twice a day for 6 weeks

Protocol documents: