ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00548145
Conditions: Alzheimer Disease Hypercholesterolemia
Keywords: Pitavastatin Statins Donepezil Alzheimer's Disease Hypercholesterolemia ADAS-Jcog Alzheimer Disease (MMSE 15-23 and CDR1 or 2)
Sponsor: Osaka University
Start date: 2007-11-01; Completion date: 2012-03-01
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Some studies suggest that statin medications may be effective against Alzheimer's disease. However, this has not been proven. The purpose of this study is to evaluate the efficacy of pitavastatin in patients with mild to moderate Alzheimer's disease and hypercholesterolemia.

Detailed description:
The PIT-ROAD study will include 50 patients who have taken donepezil more than 3 months stably. This study will see how the use of a particular statin medication, pitavastatin, affects ADAS-Jcog score etc. and cholesterol.

Participants will be given a full information of the study and written informed consent should be obtained before entering the study. Participants will take part in 5 visits over the course of 12 months. If participants have taken cholesterol lowering drug, they will have wash-out period at least 4weeks. Participants will undergo 8 tests (ADAS-Jcog etc., baseline and month 12 visits), complete a medical history questionnaire (baseline), complete medication side effect review through questionnaire and/or blood sample (all visits). Participants will be randomly assigned to receive either pitavastatin or other cholesterol lowering medication for 12 months.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Pitavastatin intervention 2: cholesterol-lowering medicine other than statin(e.g.,Ezetimibe,Colestimide)
Intervention descriptions: intervention 1: 2 mg by orally/day Duration: 12 months intervention 2: duration: 12 months

Protocol documents:
Clinical trial NCT00572156
Conditions: Insulin-like Growth Factor-1 Deficiency
Keywords: IGF-1 Deficiency growth ISS Constitutional growth delay Primary IGFD Primary IGF Deficiency
Sponsor: Ipsen
Start date: 2007-12-01; Completion date: 2012-03-01
Enrollment: 106 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
IGF-1 (insulin-like growth factor-1) is a hormone that is normally produced in the body in response to another hormone called growth hormone. Growth Hormone is produced by a small gland at the base of the brain (the pituitary). Together IGF-1 and GH are large contributors to growth during infancy, childhood, and adolescence.

Children with IGF Deficiency are short and have an imbalance in the levels of growth hormone and IGF-1 that their body produces. Their growth hormone levels are normal or even high, but IGF-1 levels do not increase normally in response to growth hormone. As a result, they have a type of growth hormone insensitivity and an inability to grow normally.

This study is a test to see whether daily dosing with a combination of rhIGF-1 and rhGH will help children with IGFD grow taller more quickly than children treated with rhGH alone. The study medications, rhIGF-1 and rhGH, are approved by the US Food and Drug Administration (FDA) for use in some growth disorders in children, but the combination of rhIGF-1 and rhGH in children with IGF-1 deficiency (IGFD) is investigational.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: NutropinAq® (Somatropin [rDNA origin]) intervention 2: Increlex® (Mecasermin [rDNA origin] injection) + NutropinAq® (Somatropin [rDNA origin]) intervention 3: Increlex® (Mecasermin [rDNA origin] injection) + NutropinAq® (Somatropin [rDNA origin]) intervention 4: Increlex® (Mecasermin [rDNA origin] injection) + NutropinAq® (Somatropin [rDNA origin])
Intervention descriptions: intervention 1: rhGH (Somatropin) 45µg/kg once daily injection intervention 2: rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection intervention 3: rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections intervention 4: rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections

Protocol documents:
Clinical trial NCT00581542
Conditions: Conjunctivitis
Sponsor: University of Rochester
Start date: 2007-03-01; Completion date: 2012-03-01
Enrollment: 124 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to compare the effect of Polytrim Ophthalmic Solution and Moxifloxacin Ophthalmic Solution in treating your child's pink eye. Both these medications are approved by the Food and Drug Administration, for treatment of conjunctivitis. This study will investigate if both of the medications are equally good.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: moxifloxacin intervention 2: polytrim
Intervention descriptions: intervention 1: 1-2 drops three times a day for 8-10 days. intervention 2: 1-2 drops four times a day for 8-10 days.

Protocol documents:
Clinical trial NCT00581971
Conditions: Cancer
Keywords: Radiosensitization COX-2 inhibitor Celecoxib Head and Neck Cancer Chemoradiation
Sponsor: University of Alabama at Birmingham
Start date: 2002-09-01; Completion date: 2012-03-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a single-institution, open-label, non-randomized phase IB/II trial of celecoxib administered concurrently with carboplatin, paclitaxel, and radiation therapy in patients with locally advanced or recurrent squamous cell carcinoma of the head and neck.

Detailed description:
Treatment for this protocol consists of radiotherapy, 70.2Gy, at 1.8Gy qd, Monday through Friday.Celecoxib 400mg bid is taken during radiotherapy, starting 1 week before radiotherapy. Carboplatin IV, AUC 2.0, weekly for weeks 1 through 7,Paclitaxel 45 mg/m2, weekly for weeks 1 through 7, and Celecoxib 400mg bid, continuing after therapy for two years or until disease progression.

Arms: arm 1: None
Interventions: intervention 1: celecoxib intervention 2: Carboplatin intervention 3: Paclitaxel intervention 4: Radiation Therapy
Intervention descriptions: intervention 1: 400mg bid starting 1 week before radiotherapy and taken through radiotherapy. intervention 2: IV, AUC 2.0, weekly for weeks 1 through 7 intervention 3: IV 30 mg/m2, weekly for weeks 1 through 7 intervention 4: 70.2Gy, at 1.8Gy qd, Monday through Friday

Protocol documents:
Clinical trial NCT00585533
Conditions: Lung Cancer
Sponsor: University of Utah
Start date: 2004-06-01; Completion date: 2012-03-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate Tarceva in a selected population of patients with untreated advanced non-small cell lung cancer who are anticipated to have a relatively good (indolent) prognosis based on clinical criteria. It is anticipated that selection will enrich for tumor characteristic that are likely to be benefited by EGFR inhibitor treatment (survival greater than 90 days). The goal of this strategy is to provide a less toxic, oral treatment for patients with advanced NSCLC that will not interfere with patients receiving chemotherapy at some point in the future and may prolong the time to chemotherapy related progression.

Patients will remain on study until disease progresses, a decline in performance status, if patient cannot tolerate the side effects or develops symptoms requiring conventional chemotherapy.

Detailed description:
Primary Objective To determine Time to Chemotherapy Progression (ie includes time on Tarceva monotherapy and chemotherapy) in advanced NSCLC

Secondary Objectives To evaluate survival and response rate associated with Tarceva treatment To study the frequency of symptom improvement (Lung Cancer Subscale)

Arms: arm 1: None
Interventions: intervention 1: Erlotinib (Tarceva)
Intervention descriptions: intervention 1: Erlotinib

Protocol documents:
Clinical trial NCT00595361
Conditions: Asthma
Keywords: asthma exercise induced asthma exercise induced bronchoconstriction long acting beta agonist salmeterol exercise challenge bronchoprotection beta 2 adrenergic receptor polymorphisms pharmacogenetics
Sponsor: Brigham and Women's Hospital
Start date: 2008-01-01; Completion date: 2012-03-01
Enrollment: 30 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to find out how well a long-acting beta agonist like salmeterol works in people with different forms of the same gene. Our hypothesis is that asthmatics with the Arg/Arg genotype will have loss of bronchoprotection against exercise-induced asthma with regular salmeterol treatment, as compared to asthmatics with the Gly/Gly genotype.

Detailed description:
In many patients with asthma, exercise-induced bronchoconstriction is a common and oftentimes limiting characteristic. Inhaled β2-adrenoreceptor agonists like albuterol are the most effective treatments available for the relief of acute asthma symptoms. However, there is evidence that regular use may lead to adverse effects in some patients. Previous studies have shown that polymorphisms of the β2-adrenergic receptor can influence airway responses to regular inhaled beta-agonist treatment.

Pharmacogenetics is the study of how genetic differences influence the variability in patients' responses to therapy, both therapeutic and adverse. Genetic susceptibility and environmental factors both play major roles in the etiology of asthma. The strong familial clustering of asthma has lead to a surge of research into the genetic predisposition of asthma. The aim of the present study is to utilize a double-blinded prospective cohort study to investigate whether genotype-specific effects occur when assessing the duration of protection conferred against exercise-induced bronchoconstriction by regular salmeterol treatment.

Arms: arm 1: Arg/Arg subjects on 2 week salmeterol treatment arm 2: Gly/Gly subjects on 2 week salmeterol treatment
Interventions: intervention 1: salmeterol
Intervention descriptions: intervention 1: salmeterol 50 micrograms twice daily for 2 weeks

Protocol documents:
Clinical trial NCT00602420
Conditions: Musculoskeletal Complications Pain Unspecified Adult Solid Tumor, Protocol Specific
Keywords: pain musculoskeletal complications unspecified adult solid tumor, protocol specific
Sponsor: Gary Morrow
Start date: 2008-06-01; Completion date: 2012-03-01
Enrollment: 510 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Naproxen may help prevent or lessen bone pain caused by pegfilgrastim. It is not yet known whether naproxen is more effective than a placebo in preventing bone pain caused by pegfilgrastim in patients with non-hematologic cancer undergoing chemotherapy.

PURPOSE: This randomized phase III trial is studying naproxen to see how well it works compared with a placebo in preventing bone pain caused by pegfilgrastim in patients with non-hematologic cancer undergoing chemotherapy.

Detailed description:
OBJECTIVES:

Primary

* To compare the efficacy of daily administration of naproxen vs placebo in preventing or reducing the severity and duration of pegfilgrastim-induced bone pain (PIBP) in patients with non-hematologic malignancies undergoing chemotherapy.

Secondary

* To identify potential risk factors for the development of PIBP.
* To identify potential clinical predictors for the response or failure to respond to naproxen in preventing PIBP.
* To assess the toxicity of naproxen when administered in the preventive setting.

OUTLINE: This is a multicenter study. Patients are stratified by Clinical Community Oncology Program (CCOP) site. Patients are randomized to 1 treatment arm vs placebo.

* Arm I: Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.
* Arm II: Patients receive matching placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.

Arms: arm 1: Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days. arm 2: Patients receive an oral placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.
Interventions: intervention 1: naproxen intervention 2: placebo
Intervention descriptions: intervention 1: Oral naproxen twice daily for 5-8 days. intervention 2: Oral placebo twice daily for 5-8 days.

Protocol documents:
Clinical trial NCT00619099
Conditions: Myelodysplastic Syndrome
Keywords: Myelodysplastic Syndrome Decitabine Dacogen MGI PHARMA, Inc.
Sponsor: Eisai Inc.
Start date: 2008-05-01; Completion date: 2012-03-01
Enrollment: 67 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effectiveness and safety of two different dose schedules of DACOGEN® (decitabine) for Injection in patients with Myelodysplastic Syndromes (MDS).

Detailed description:
This is a randomized open-label Phase 2 efficacy and safety study of two (2) subcutaneous (SQ) dosing schedules of decitabine in subjects with Low or Intermediate 1 Risk MDS. This study will be conducted in up to 6 study centers in the United States.

The primary efficacy outcome is the overall improvement rate. These two doses will be administered subcutaneously. The probability that one schedule is superior to the other will be estimated, and the level of toxicity for each schedule will also be evaluated.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: decitabine intervention 2: decitabine
Intervention descriptions: intervention 1: Schedule A: decitabine will be administered subcutaneously (SQ) daily for 3 consecutive days (Days 1 to 3) every 28 days. The dose will be 20 mg/m\^2/day. One course will be considered 28 days. intervention 2: Schedule B: decitabine will be administered SQ every 7 days for 21 days (Days 1, 8, and 15) followed by 7 days without an administration of decitabine. The dose will be 20 mg/m\^2/day. One course will be considered 28 days.

Protocol documents:
Clinical trial NCT00644878
Conditions: Chronic Myelogenous Leukemia - Chronic Phase
Keywords: leukemia chronic myelogenous leukemia chronic phase molecular response nilotinib ENABL
Sponsor: Novartis Pharmaceuticals
Start date: 2008-10-01; Completion date: 2012-03-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This exploratory study will evaluate the change in molecular response in chronic myelogenous leukemia - chronic phase patients with a complete cytogenetic response and have a suboptimal molecular response to imatinib

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Nilotinib
Intervention descriptions: intervention 1: Nilotinib 300 mg is taken by mouth twice a day at 12 hour intervals. Nilotinib is to be taken with water on an empty stomach. No food two hours prior to the dose of nilotinib and for one hour following the dose.

Protocol documents:
Clinical trial NCT00651482
Conditions: Kidney Neoplasms Kidney (Renal Cell) Cancer
Sponsor: Sandy Srinivas
Start date: 2008-08-01; Completion date: 2012-03-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To determine the safety and efficacy of the combination of bevacizumab and everolimus (RAD001) for the treatment of metastatic renal cell cancer

Detailed description:

Arms: arm 1: Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles

Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)

Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)
Interventions: intervention 1: Everolimus intervention 2: Bevacizumab
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00652340
Conditions: Recurrent Non Small Cell Lung Cancer
Sponsor: Tragara Pharmaceuticals, Inc.
Start date: 2008-04-01; Completion date: 2012-03-01
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the anti-tumor efficacy of apricoxib and erlotinib with placebo and erlotinib as measured by time to disease progression to test the hypothesis that down regulation of COX-2 and EGFR pathways in patients with up-regulated COX-2 expression in tumor will have a clinical benefit compared with erlotinib alone.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: apricoxib/erlotinib intervention 2: erlotinib/placebo
Intervention descriptions: intervention 1: apricoxib: 100 mg tablets, 400mg/day

erlotinib: per package insert intervention 2: erlotinib: per package insert

placebo: 100 mg tablets, 400 mg/day

Protocol documents:
Clinical trial NCT00668785
Conditions: Proliferative Diabetic Retinopathy Macular Edema
Keywords: Ranibizumab Proliferative Diabetic Retinopathy Macular Edema following Panretinal Photocoagulation Safety and Efficacy Intravitreal Injection
Sponsor: Jumper, J. Michael, M.D.
Start date: 2007-03-01; Completion date: 2012-03-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a randomized, open-label Phase II study evaluating the safety and efficacy of intravitreally administered ranibizumab 0.5mg in subjects with Proliferative Diabetic Retinopathy experiencing post- Panretinal Photocoagulation (PRP) macular edema.

Detailed description:
Levels of VEGF are elevated in eyes wth Diabetic Macular Edema and the expression of VEGF was found to be elevated temporarily following the photocoagulation of human Retinal Pigment Epithelial (RPE) cells. Ranibizumab (Lucentis TM, Genentech) is an anti-VEGF antibody shown to have properties to prevent macular edema. We hypothesize that VEGF inhibition can effectively treat PRP-induced macular edema, thereby minimizing post-PRP vision loss.

Subjects who meet eligibility criteria will receive 0.5mg ranibizumab administered 7-14 days post-PRP. Additional intravitreal injections of 0.5 mg of ranibizumab at Day 30 and/or Day 60 may be also be administered. All subjects will be followed for 90 days for safety and efficacy assessments. There is no placebo or sham arm of this trial.

Arms: arm 1: Ranibizumab is being used off-label to test the safety and efficacy of its use in Diabetic Macular Edema post panretinal photocoagulation. Ranibizumab 0.5mg at baseline and then again at 30 days and/or 60 days after PRP as deemed appropriate by the Investigator.
Interventions: intervention 1: ranibizumab
Intervention descriptions: intervention 1: Ranibizumab 0.5mg at baseline and then again at 30 days and/or 60 days after PRP as deemed appropriate by the Investigator.

Protocol documents:
Clinical trial NCT00702364
Conditions: Traumatic Brain INjury
Keywords: Attention Traumatic Brain INjury Atomoxetine Strattera
Sponsor: Craig Hospital
Start date: 2008-01-01; Completion date: 2012-03-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Atomoxetine is the only medication that is currently approved by the FDA for the treatment of attention deficit hyperactivity disorder in adults. It has gained recent interest as an alternative medication for treating attentional problems related to traumatic brain injury (TBI), but it's effectiveness in this population has not been studied. There are a number of advantages of Atomoxetine over traditional neuro-stimulant medications currently used for attentional disorders after traumatic brain injury. This study will use a randomized double-blind placebo-controlled crossover design to investigate the efficacy of atomoxetine to improve attention, behavioral function, and depression in adults with TBI

Detailed description:

Arms: arm 1: 40mg atomoxetine twice a day for 2 weeks arm 2: Placebo twice a day for two weeks
Interventions: intervention 1: atomoxetine intervention 2: placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00724282
Conditions: Sleep Insomnia Insulin Resistance
Keywords: sleep eszopiclone insulin secretion insulin action glucose tolerance
Sponsor: University of Chicago
Start date: 2008-04-01; Completion date: 2012-03-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Available data suggest that obtaining adequate sleep is associated with a better ability of the body to use carbohydrates as a source of energy and a lower risk of developing diabetes. The sleeping pill, Eszopiclone (Lunesta), has been approved by the Food and Drug Administration for the treatment of people who complain of trouble falling or staying asleep. This study will examine the hypothesis that the use of Eszopiclone (Lunesta) to improve the sleep of people with insomnia may also improve the use of sugar in their body.

Detailed description:
Study participants will complete a set of oral and intravenous glucose (sugar) tolerance tests, which will be performed on two separate occasions in random order: once after a week of treatment with Eszopiclone (Lunesta) and once again after a week of receiving placebo.

Arms: arm 1: Subjects receive either eszopiclone or placebo for 9 days, followed by 3 week washout, then crossover to opposite treatment. Treatment is double-blinded.
Interventions: intervention 1: Eszopiclone intervention 2: Placebo
Intervention descriptions: intervention 1: Eszopiclone 3 mg by mouth daily at bedtime for 9 days intervention 2: Placebo by mouth daily at bedtime for 9 days

Protocol documents:
Clinical trial NCT00730171
Conditions: Irritable Bowel Syndrome With Constipation Chronic Constipation
Sponsor: Ironwood Pharmaceuticals, Inc.
Start date: 2008-09-01; Completion date: 2012-03-01
Enrollment: 1743 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study is to assess the long-term safety of linaclotide administered to patients with chronic constipation (CC) or irritable bowel syndrome with constipation (IBS-C).

Detailed description:
Participants include randomization-ineligible (RI) patients from the lead-in double-blind trials MCP-103-302 (NCT00938717) or MCP-103-303 (NCT00730015), or rollover (RO) patients from the lead-in double-blind trials MCP-103-302 (NCT00938717), MCP-103-303 (NCT00730015), and from the Phase 2 double-blind studies MCP-103-004 (NCT00306748), MCP-103-005 (NCT00258193), and MCP-103-201 (NCT00402337), or MCP-103-202 (NCT00460811).

Arms: arm 1: Linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator.
Interventions: intervention 1: Linaclotide
Intervention descriptions: intervention 1: Linaclotide capsules, oral, once daily each morning at least 30 minutes before breakfast for the duration of the study.

Protocol documents: