ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00804999
Conditions: Normal Contact Lens Wear
Keywords: confocal microscopy contact lens wear contact lens solutions sodium fluorescein
Sponsor: Christine Sindt
Start date: 2008-11-01; Completion date: 2009-03-01
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Assess the usefulness of using confocal microscopy to examine changes to the structure of the cornea and to identify any potential consequences of contact lens wear and/or solution use.

Detailed description:
Several types of solutions are used in contact lens wear.

Each contact lens solution used to disinfect contacts have different ingredients even though they all disinfect the contacts.

The objective of this study is to examine the layers of the cornea via HRT in order to assess the usefulness of this technology and to identify any potential consequences of contact lens wear and/or care solution used.

Arms: arm 1: Subjects that have never worn contacts with no ocular problems were selected. A baseline HRT was performed. Trial contact lenses were soaked in clear care solution for 10 hours. After 10 hours of the lenses soaking in clear care the subject returned. The contacts lenses that were soaked in clear care were inserted onto the patients eyes. The patient then wore the contacts for two hours. After two hours the contact lenses were removed. An HRT was performed immediately after removing the contact lenses. The HRT scans were analyzed for dendritic cell migration, basal cell epithelial density and nerve density and tortuosity. arm 2: Subjects that had worn contacts for at least two weeks without incident were selected. A baseline HRT was performed.Trial contacts lenses were soaked in ReNu contact solution for 10 hours. After 10 hours of the lenses soaking in ReNu the subject returned. The contacts were inserted onto the patients eyes. The patient then wore the contacts for two hours. After two hours the contacts lenses were removed. An HRT both with and without sodium fluorescein was performed immediately after removing the contact lenses.The HRT scans were analyzed for dendritic cell migration, basal cell epithelial density and nerve density and tortuosity. arm 3: Subjects that had worn contacts for at least two weeks without incident were selected. A baseline HRT was performed.Trial contacts lenses were soaked in Optifree Replenish contact solution for 10 hours. After 10 hours of the lenses soaking in Optifree Replenish the subject returned. The contacts were inserted onto the patients eyes. The patient wore contacts the for two hours. After two hours the contacts were removed. An HRT both with and without sodium fluorescein was performed immediately after removing the contact lenses.The HRT scans were analyzed for dendritic cell migration, basal cell epithelial density and nerve density and tortuosity.
Interventions: intervention 1: Clear Care intervention 2: ReNu intervention 3: OPTI-FREE
Intervention descriptions: intervention 1: neutralized Clear Care intervention 2: overnight soak in solution intervention 3: overnight soak in solution

Protocol documents:
Clinical trial NCT00809185
Conditions: Myelodysplastic Syndromes
Keywords: de novo myelodysplastic syndromes secondary myelodysplastic syndromes previously treated myelodysplastic syndromes
Sponsor: Case Comprehensive Cancer Center
Start date: 2005-11-01; Completion date: 2009-03-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: RAD001(Everolimus) may stop the growth of cancer cells by blocking some of the enzymes needed for their growth and by blocking blood flow to the cancer.

PURPOSE: This phase II trial is studying how well RAD001(everolimus) works in treating patients with myelodysplastic syndromes.

Detailed description:
OBJECTIVES:

Primary

* Determine the clinical activity (improvement in erythroid response and/or improvement in other cytopenias, bone marrow morphology/cytogenetics) of RAD001(everolimus) in patients with low or intermediate-1 risk myelodysplastic syndromes.
* Assess the toxicity of this drug in these patients.

Secondary

* Examine laboratory correlates (S6K1 levels, angiogenesis pre- and post-treatment) and determine how these correlates correspond to dosing and clinical activity of RAD001(everolimus).
* Evaluate the presence of HLA-DR15 and cytotoxic T-cell populations in patients pre- and post-treatment and correlate this with response to treatment.
* Examine the incidence of the null GSTT-1 phenotype in myelodysplastic syndromes patients and correlate this with response to RAD001(everolimus).

OUTLINE: Patients receive oral RAD001(everolimus) once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or relapse.

Blood samples are collected periodically during study. Samples are analyzed for S6K1 activity, effector T cells by flow cytometry, GSTT-1 by PCR, and HLA-DR15 levels.

Arms: arm 1: RAD001 (everolimus) at 10mg/day with Bone marrow aspirate/biopsy and other laboratory biomarker analysis
Interventions: intervention 1: everolimus intervention 2: laboratory biomarker analysis intervention 3: Bone marrow aspirate/biopsy
Intervention descriptions: intervention 1: Patients will receive monotherapy with RAD001(everolimus)for 21 days within the 28 day cycle. intervention 2: Laboratory correlates (cytotoxic t cell populations, S6K1 levels, GSTT-1 mutations, and the presence or absence of HLA-DR15) will be assessed to see if any of these correlates correspond to response. intervention 3: Bone marrow aspirate and biopsy with cytogenetics should be obtained within 4 weeks prior to starting drug and at week 33. A bone marrow aspirate and biopsy should also be obtained for patients going off study prior to week 33 (including cytogenetics). The percentage of blasts on the aspirate should be used to determine the IPSS score.

Protocol documents:
Clinical trial NCT00839072
Conditions: Healthy
Keywords: bioavailability pharmacokinetics healthy crossover trazodone
Sponsor: Labopharm Inc.
Start date: 2009-02-01; Completion date: 2009-03-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of the study is to compare the pharmacokinetic profiles of extended-release and immediate-release trazodone formulations

Detailed description:
The bioavailability of once-daily trazodone extended-release 300 mg caplets (test product) and trazodone immediate-release 100 mg tablets administered q8h (reference product) will be compared in healthy adult volunteers in a randomized, crossover fashion. Morning doses will be administered after an overnight fast. Blood samples will be collected predose and at pre-defined times over 72 hours following the morning dose. Pharmacokinetic parameters will be analyzed using ANOVA. Comparative bioavailability will be assessed on the basis of the ratio of least-squares means and/or 90% confidence interval criteria.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Trazodone HCl intervention 2: Trazodone HCl
Intervention descriptions: intervention 1: 100 mg immediate-release tablet, dosing q8h intervention 2: 300 mg extended-release caplet, single dose

Protocol documents:
Clinical trial NCT00847886
Conditions: Rheumatoid Arthritis
Sponsor: Lexicon Pharmaceuticals
Start date: 2009-02-01; Completion date: 2009-03-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the effect of LX3305 on methotrexate (MTX) pharmacokinetics and to evaluate the safety and tolerability of LX3305 given over 14 days in subjects with stable rheumatoid arthritis that are receiving stable doses of MTX.

Detailed description:

Arms: arm 1: Daily oral intake of LX3305 for 14 days. arm 2: Matching placebo dosing with daily oral intake for 14 days.
Interventions: intervention 1: LX3305 intervention 2: LX3305 Placebo intervention 3: Methotrexate
Intervention descriptions: intervention 1: Daily oral intake of LX3305 for 14 days. intervention 2: Matching placebo dosing with daily oral intake for 14 days. intervention 3: Once weekly stable-dose methotrexate.

Protocol documents:
Clinical trial NCT00884377
Conditions: Cutaneous Leishmaniasis
Sponsor: U.S. Army Medical Research and Development Command
Start date: 2004-02-01; Completion date: 2009-03-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study serves to compare the effectiveness of treating cutaneous leishmaniasis with either intravenous sodium stibogluconate or direct heat therapy using the ThermoMed-TM device.

Detailed description:
A total of 56 Department of Defense health care beneficiaries, 18 years of age or older and diagnosed with cutaneous leishmaniasis, were planned to be treated with either intravenous sodium stibogluconate (Pentostam-TM) or the ThermoMed-TM device of Thermosurgery Technologies, Inc. at the Walter Reed Army Medical Center. Pentostam is the standard of care for this disease, but the i.v. administration and the many known side effects prompt the search for an improved method of treating this disease, especially for milder cases. This study compares the safety and efficacy of these two treatment approached.

Arms: arm 1: 20 mg/kg/day Sodium stibogluconate intravenous arm 2: ThermoMed device, single heat treatment at 50 degrees Celsius
Interventions: intervention 1: Sodium stibogluconate (Pentostam) intervention 2: ThermoMed
Intervention descriptions: intervention 1: intravenous 20 mg/kg/day for 10 days intervention 2: ThermoMed heat treatment device, one treatment

Protocol documents:
Clinical trial NCT01000818
Conditions: HIV-1 Infection HIV Infections
Keywords: Treatment experienced
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-06-01; Completion date: 2009-03-01
Enrollment: 18 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
An open-label, 3-period, fixed-sequence study in a panel of 18 HIV-infected patients on MK0518 as part of a stable treatment regimen for HIV.

Detailed description:

Arms: arm 1: MK0518 arm 2: famotidine + MK0518 arm 3: omeprazole + MK0518
Interventions: intervention 1: MK0518 (Raltegravir) intervention 2: famotidine intervention 3: omeprazole
Intervention descriptions: intervention 1: 400 mg oral tablet of MK0518 once every 12 hours. Period 1 duration is one day, Period 2 duration is one day, Period 3 duration is five days. intervention 2: Single 20 mg famotidine oral tablet taken 2 hours prior to administration of AM dose of MK0518 intervention 3: 20 mg oral tablet of omeprazole, once daily for 5 days

Protocol documents:
Clinical trial NCT01005966
Conditions: Caries
Keywords: remineralization enamel in situ fluoride caries
Sponsor: GlaxoSmithKline
Start date: 2008-11-01; Completion date: 2009-03-01
Enrollment: 65 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is to evaluate the effect of fluoride dentrifrices on enamel with artificial caries lesions in an in situ model

Detailed description:

Arms: arm 1: Placebo arm 2: Sodium fluoride toothpaste arm 3: Amine Fluoride arm 4: Dose response arm 5: Sodium monofluorophosphate/sodium fluoride Toothpaste arm 6: None
Interventions: intervention 1: Sodium Fluoride Toothpaste intervention 2: Amine Fluoride Toothpaste intervention 3: Sodium monofluorophosphate/Sodium Fluoride Toothpaste intervention 4: Placebo intervention 5: 675 ppmf toothpaste
Intervention descriptions: intervention 1: Test product intervention 2: Test product intervention 3: test product intervention 4: placebo and washout treatment intervention 5: dose response

Protocol documents:
Clinical trial NCT01048242
Conditions: Insomnia Obstructive Sleep Apnea
Sponsor: University of Pennsylvania
Start date: 2006-07-01; Completion date: 2009-03-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the study is to determine if treatment with Ramelteon will help to improve insomnia in older adults with co-existent insomnia and sleep apnea. The primary study objective is sleep latency (a measure of insomnia). The hypothesis is that sleep latency will be reduced in subjects taking Ramelteon relative to the placebo arm. The secondary study objective is to determine if subject compliance with CPAP treatment of their sleep apnea is improved in subjects taking Ramelteon (their compliance may be improved because they would have less insomnia due to Ramelteon treatment when using their CPAP). The hypothesis is that compliance with CPAP will be improved in subjects taking Ramelteon relative to the placebo arm.

Detailed description:
Randomized, double-blind, placebo-controlled, parallel arm clinical trial with two study arms.

Arms: arm 1: Ramelteon 8 mg oral before bedtime arm 2: None
Interventions: intervention 1: rozerem intervention 2: Placebo
Intervention descriptions: intervention 1: Ramelteon (rozerem) 8mg oral before bedtime intervention 2: placebo

Protocol documents:
Clinical trial NCT01077076
Conditions: Intragastric Acidity
Keywords: Gastric Acid Human Experimentation
Sponsor: Bayer
Start date: 2008-12-01; Completion date: 2009-03-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This randomized, crossover study is to evaluate the early effectiveness, defined as effect on intragastric pH during the first 4 hours after dosing, of Zegerid, Prilosec over-the-counter (OTC) Tablets, and placebo on the 4th day of treatment to inhibit acid secretion. Additional purposes are to:

1. provide pharmacodynamic evidence comparing 24-hr inhibition of acid secretion on the 1st, 4th, and 11th days of dosing with each of the indicated treatments;
2. compare Zegerid and Prilosec OTC for achieving their steady-state effects for controlling 24-hr gastric acidity at steady-state on the 4th and 11th day of dosing.
3. evaluate early effectiveness, defined as effect on intragastric pH during the first 4 hours after administration, of Zegerid, Prilosec OTC Tablets, and placebo on acid inhibition at steady-state when administered on the 11th day of dosing.

Detailed description:
Participants were randomized in a 3-way crossover design and received, in random order, Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate), Prilosec OTC Tablets (20 mg-equivalent omeprazole), and Placebo Capsules. Participants received each treatment for 11 days. There was a minimum of a 2-week washout period between treatment arms.

Arms: arm 1: 20 mg omeprazole and 1100 mg sodium bicarbonate arm 2: 20.6 mg omeprazole-magnesium complex. arm 3: Inert substance
Interventions: intervention 1: Zegerid intervention 2: Prilosec OTC™ Tablets intervention 3: Placebo
Intervention descriptions: intervention 1: Zegerid taken once daily for 11 days. intervention 2: Prilosec OTC™ Tablets taken once daily for 11 days. intervention 3: Placebo taken once daily for 11 days.

Protocol documents:
Clinical trial NCT01084148
Conditions: Uremic Xerosis
Sponsor: Orfagen
Start date: 2007-01-01; Completion date: 2009-03-01
Enrollment: 237 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary objective:

To demonstrate the long-term efficacy (response to treatment during initial therapy, time to relapse without treatment, durability and lesional recurrence during maintenance therapy) of V0034 CR 01B cream on uraemic xerosis in the real-life setting.

Secondary objectives:

1. To assess the local tolerance of V0034 CR 01B after long-term use
2. To assess the patient benefit and acceptability of V0034 CR 01B

Detailed description:

Arms: arm 1: cream arm 2: cream
Interventions: intervention 1: V0034CR01B intervention 2: V0034CR01B vehicle
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01225159
Conditions: Nosocomial Infection External Causes of Morbidity and Mortality Hypoglycemia
Keywords: tight glycemic control cardiac surgery
Sponsor: Prince of Songkla University
Start date: 2008-09-01; Completion date: 2009-03-01
Enrollment: 200 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine whether intraoperative tight glycaemic control can reduce postoperative infection, morbidity and mortality

Detailed description:
Hyperglycaemia develops frequently in patients undergoing cardiac surgery, especially following cardiopulmonary bypass (CPB). Recent evidence suggests that acute hyperglycaemia adversely affects immune function, wound healing and cardiovascular function.

Arms: arm 1: TGC used hyperinsulinaemic normoglycaemic clamp with modified glucose-insulin-potassium to control blood sugar. The insulin (HumulinTM R, Lilly pharma, Germany) was diluted with normal saline to the concentration 1 IU. mL-1 and was infused continuously throughout the operations at a fixed rate of 0.3 IU. kg-1.h-1 but the maximal rate was 20 IU/ h. A separate mixture of glucose 25% (A.N.B Laboratories, Thailand) 50 mL, potassium chloride (Nida pharma, Thailand) 20 mEq and magnesium sulfate (Atlantic, Thailand) 2 gm was infused at 0.75 mL.kg-1.h-1 and was adjusted to maintain blood glucose levels 80-150 mg/dL. arm 2: Conventional glycaemic control aims to control blood sugar less than 250 mg%. Insulin was given bolusly if the blood sugar more than 250 mg%.
Interventions: intervention 1: TGC intervention 2: Conventional glycaemic control
Intervention descriptions: intervention 1: TGC used hyperinsulinaemic normoglycaemic clamp with modified glucose-insulin-potassium to control blood sugar. The insulin (HumulinTM R, Lilly pharma, Germany) was diluted with normal saline to the concentration 1 IU. mL-1 and was infused continuously throughout the operations at a fixed rate of 0.3 IU. kg-1.h-1 but the maximal rate was 20 IU/ h. A separate mixture of glucose 25% (A.N.B Laboratories, Thailand) 50 mL, potassium chloride (Nida pharma, Thailand) 20 mEq and magnesium sulfate (Atlantic, Thailand) 2 gm was infused at 0.75 mL.kg-1.h-1 and was adjusted to maintain blood glucose levels 80-150 mg/dL. intervention 2: Conventional glycaemic control aims to control blood sugar less than 250 mg%. Insulin was given bolusly if the blood sugar more than 250 mg%.

Protocol documents:
Clinical trial NCT01798992
Conditions: Idiopathic Dilated Cardiomyopathy
Keywords: ejection fraction beta-blocker carvedilol metoprolol myocardial gene expression human heart ventricular remodeling wall stress adrenergic signaling myosin heavy chain
Sponsor: University of Colorado, Denver
Start date: 2000-09-01; Completion date: 2009-03-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary goal of the study is to measure in the intact human heart, the alterations in gene expression over time that are associated with reverse remodeling in response to β-blockade. The second goal is to investigate the signaling mechanisms which in turn are responsible for these changes in gene expression, and the third goal is to determine the relationship between intrinsic systolic dysfunction and remodeling of the left ventricle. This will be accomplished by measuring ventricular size, function, and gene expression in myocardial tissue samples obtained by percutaneous biopsy prior to initiation of β-blockade and at 3 and 12 months after start of therapy. The specific Aims and Hypotheses to be tested are:

1. Aim: Determine the changes in gene expression associated with changes in intrinsic systolic function and with functional decompensation in the intact, failing human heart.

   a. Hypothesis: Changes in the expression of select genes precede or accompany changes in left ventricular systolic function in humans with idiopathic dilated cardiomyopathy (IDC).
2. Aim: Identify signaling mechanisms responsible for alterations in expression of key genes involved in mediation of ventricular hypertrophy or contractile dysfunction.

   a. Hypothesis: Myocardial-failure-associated regulation of select messenger ribonucleic acids and proteins are related to left ventricular wall stress and neurohormonal signaling.
3. Aim: In the relationship between contractile dysfunction and dilatation/remodeling, determine the relationship between contractile dysfunction and structural remodeling.

   b. Hypothesis: the contractile dysfunction is primary and structural remodeling secondary.

Detailed description:

Arms: arm 1: Patients with normal ejection fraction who underwent a single myocardial biopsy and received no β-blocker therapy arm 2: Idiopathic dilated cardiomyopathy patients randomized to metoprolol succinate titrated to a goal of 200 mg by mouth daily for 18 months arm 3: Idiopathic dilated cardiomyopathy patients who were randomized to receive metoprolol succinate and doxazosin titrated to a goal of 200 mg and 8 mg by mouth daily for 18 months arm 4: Idiopathic dilated cardiomyopathy patients who were randomized to receive carvedilol titrated to a goal of 25 mg by mouth twice daily for 18 months
Interventions: intervention 1: Carvedilol intervention 2: Metoprolol succinate intervention 3: Metoprolol succinate + doxazosin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02150954
Conditions: Induction of Labor
Keywords: induction of labor pitocin foley bulb
Sponsor: Duke University
Start date: 2007-12-01; Completion date: 2009-03-01
Enrollment: 121 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to compare induction of labor using a foley catheter bulb with a low dose of oxytocin versus a foley catheter bulb with an increasing dose of oxytocin. A foley catheter bulb with or without oxytocin is a common method of labor induction in patients whose cervix is not significantly dilated or thinned out (effaced). Oxytocin (pitocin) is a medicine used to increase the number and strength of the womb's contractions.

Detailed description:

Arms: arm 1: Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes. arm 2: Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.
Interventions: intervention 1: pitocin
Intervention descriptions: intervention 1: None

Protocol documents: