ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00701220
Conditions: Cardiovascular Disease Cardiomyopathy Heart Disease Myocardial Disease Myocardial Ischemia
Keywords: Cardiovascular Disease Cardiomyopathy Heart Disease Myocardial Disease Myocardial Ischemia
Sponsor: Philip Binkley
Start date: 2007-04-01; Completion date: 2010-12-01
Enrollment: 9 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to see if taking a cholesterol lowering drug Lipitor (Atorvastatin Calcium)will increase the number of endothelial progenitor cells (EPC's) circulating in the blood of heart failure patients taking this cholesterol-lowering drug, and if this will also show an improvement in the damaged areas of the patient's hearts as documented by MRI scans.

Detailed description:
This study involves the testing of blood for cholesterol levels and flow cytometry tests to count the number of EPC's in your blood. These tests are routinely performed to gain knowledge about a person's health. If any incidental findings are identified as a result of your participation in this research study, you will be notified and referred to your doctor or appropriate health care professional.

You are being asked to provide a blood sample that will be used to determine the usual numbers of EPC's circulating in the blood of healthy people who have no risk factors for heart disease. Your results will be compared with those of patients who have heart failure.

Flow cytometry is a special laboratory test that can count, separate, and detect characteristics of cells in blood. Your blood sample will be analyzed using flow cytometry. Endothelial progenitor cells (EPC's) are immature cells that are necessary for new blood vessel formation. EPC's will be separated by flow cytometry and counted. You will not be given the results of your flow cytometry study.

Arms: arm 1: Patients with Ischemic Cardiomyopathy receiving Lipitor (Atorvastatin calcium). arm 2: NonIschemic Cardiomyopathy receiving Lipitor (Atorvastatin calcium) treatment arm 3: Healthy subjects with no history of high cholesterol, heart disease, or heart attacks
Interventions: intervention 1: Atorvastatin Calcium
Intervention descriptions: intervention 1: Atorvastatin Calcium starting at a 10 mg dose and may be increased up to 40 mg dose until cholesterol is lowered to an acceptable range. Blood will drawn every 2 weeks for the first 12 weeks to check the cholesterol level and adjust medication dosage. Cardiac MRI will be performed at the beginning and at the end of the 6 month study to measure the physical changes of the heart.

Protocol documents:
Clinical trial NCT00701558
Conditions: Non-small Cell Lung Cancer Metastatic
Sponsor: Hoffmann-La Roche
Start date: 2008-08-01; Completion date: 2010-12-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will assess the efficacy and safety of erlotinib + gemcitabine in chemotherapy-naive participants with unresectable, advanced and/or metastatic non-small cell lung cancer. Participants will receive erlotinib 150 mg orally (po) daily, in combination with gemcitabine 1000 mg/m\^2 intravenously (iv) weekly for 3 weeks of each 4 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.

Detailed description:

Arms: arm 1: Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m\^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death.
Interventions: intervention 1: Erlotinib intervention 2: Gemcitabine
Intervention descriptions: intervention 1: 150 mg po daily intervention 2: 1000 mg/m\^2 iv on days 1, 8, 15 of each 4 week cycle for 6 cycles

Protocol documents:
Clinical trial NCT00702507
Conditions: Diaper Rash
Keywords: Diaper dermatitis complicated by candidiasis
Sponsor: Stiefel, a GSK Company
Start date: 2007-05-01; Completion date: 2010-12-01
Enrollment: 200 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether repeated use of 0.25% miconazole nitrate ointment in newborns and infants with a yeast infection in the diaper area causes the yeast to become resistant to the drug.

Detailed description:
The objective of this study is to investigate the potential for the development of resistance in Candida spp. after repeated treatment courses of 0.25% miconazole nitrate ointment in neonates and infants up to one year of age.

Arms: arm 1: None
Interventions: intervention 1: 0.25 % Miconazole Nitrate Ointment
Intervention descriptions: intervention 1: Topical Application

Protocol documents:
Clinical trial NCT00725361
Conditions: n Ulcer Scleroderma, Systemic
Sponsor: Stanford University
Start date: 2008-06-01; Completion date: 2010-12-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a research study of an investigational drug called ambrisentan (Letairis) in the treatment and prevention of digital ulcers in patients with systemic sclerosis.

Detailed description:
Ambrisentan is an endothelin blocker approved for the treatment of pulmonary arterial hypertension. Patients with systemic sclerosis can have damage to their blood vessels, resulting in increased levels of endothelin in their bloodstream that then causes decreased blood flow to the digits. This can result in very painful digital ulcers. We hope to learn whether blocking the action of endothelin with ambrisentan will be helpful in the treatment and prevention of digital ulcers in patients with systemic sclerosis. This therapy is not approved for the treatment of systemic sclerosis, but this study will help us learn whether ambrisentan is safe and effective in the treatment and prevention of digital ulcers in patients with systemic sclerosis.

Arms: arm 1: Ambrisentan
Interventions: intervention 1: Ambrisentan
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00728481
Conditions: Eosinophilic Esophagitis Gastroesophageal Reflux Disease EE GERD
Sponsor: Mayo Clinic
Start date: 2008-05-01; Completion date: 2010-12-01
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary aim of this study was to determine the proportion of patients with esophageal eosinophilic infiltration that have objective (measurable) evidence of gastroesophageal reflux disease (GERD).

This study was also done to see if patients that have eosinophilic esophagitis (EE) and GERD would receive relief from taking the medication Nexium or a steroid called Pulmicort.

The study also evaluated the accuracy of pH monitoring (acid exposure) within the esophagus as a predictor of endoscopic, histological and symptomatic response in patients with EE.

Detailed description:
Hypotheses:

1. There is a subset of patients with the diagnosis of EE who also have GERD.
2. Patients with both EE and GERD will respond symptomatically and histologically to aggressive gastric acid suppression with a proton pump inhibitor as monotherapy.
3. Swallowed budesonide suspension is effective in treating patients with EE who do not have evidence of GERD.

Participants were randomized based on results of a 24 hour pH study, which determined the average percent time the distal esophagus was exposed to a pH of less than than 4. Subjects with a positive pH result were randomized to esomeprazole or randomized to budesonide, if there was a negative pH result. Studies were interpreted by a single gastroenterologist experienced in reading esophageal pH studies. The percent time the pH monitor detected a pH less than 4 was recorded and an esophageal pH of less than 4 for 4% or greater of the study time was considered abnormal. Note: pH is a measure of acidity or alkalinity (lower numbers are more acid, higher numbers are more alkaline).

Those subjects with GERD (positive pH result) received gastric acid-suppressing medication (esomeprazole 40 mg, twice daily) for 6 weeks. Subjects who did not have GERD (negative pH result) were treated with a corticosteroid designed to coat the esophagus (budesonide suspension 1 mg twice daily) for six weeks. Response to treatment was assessed by esophageal histology and symptoms.

Arms: arm 1: Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks for subjects with positive 24 hour pH study (GERD) arm 2: Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose \[Splenda-registered trademark\]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)
Interventions: intervention 1: Esomeprazole intervention 2: Budesonide
Intervention descriptions: intervention 1: Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks intervention 2: Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose \[Splenda-registered trademark\]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)

Protocol documents:
Clinical trial NCT00732303
Conditions: Non-Small Cell Lung Cancer
Sponsor: Hoosier Cancer Research Network
Start date: 2009-01-01; Completion date: 2010-12-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Pemetrexed is approved for second line therapy in metastatic NSCLC. Given the single-agent activity of pemetrexed and the tolerability of pemetrexed in combination with radiation, this study will evaluate survival rates and toxicities in patients with poor risk stage III NSCLC.

Detailed description:
OUTLINE: This is a multi-center study.

* Pemetrexed (Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles
* Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.

The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks.

Performance Status: ECOG performance status 2

Life Expectancy: Not specified

Hematopoietic:

* Platelets ≥ 100 K/mm3
* Absolute Neutrophil Count (ANC) ≥ 2.0 K/mm3

Hepatic:

* Aspartate transaminase (AST) ≤ 2.5 x ULN.
* Alanine transaminase (ALT) ≤ 2.5 x ULN.
* Total bilirubin ≤ 1.5 x ULN

Renal:

* Calculated creatinine clearance (using Cockcroft-Gault formula) ≥ 45 cc/min

Cardiovascular:

* No significant history of cardiac disease. Must not have unstable angina (anginal symptoms at rest).

Pulmonary:

* Forced expiratory volume in 1 second (FEV1) greater than 1L

Arms: arm 1: * Pemetrexed (Alimta) 500mg/m\^2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles
* Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.

The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks.
Interventions: intervention 1: Pemetrexed intervention 2: Radiation Therapy
Intervention descriptions: intervention 1: Pemetrexed (Alimta) 500mg/\^2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles intervention 2: Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.

The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks.

Protocol documents:
Clinical trial NCT00736099
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2008-08-01; Completion date: 2010-12-01
Enrollment: 2122 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the current study is to investigate the safety and tolerability of BI 1356 (5 mg / once daily) given for 78 weeks in different modalities of treatment.

The treatment modalities are determined by the treatment in the blinded trial in which every patient was included previously as BI 1356 in monotherapy (patients in 1218.16 trial), BI 1356 in combination with pioglitazone (patients in 1218.15 trial), BI 1356 added to metformin background (patients in 1218.17 trial) or BI 1356 added to a background therapy of metformin in combination with a sulphonylurea (patients in 1218.18 study)

Detailed description:

Arms: arm 1: open label arm 2: open label
Interventions: intervention 1: linagliptine 5 mg intervention 2: linagliptine 5 mg and pioglitazone 30 mg
Intervention descriptions: intervention 1: safety and efficacy of linagliptine 5 mg open label intervention 2: efficacy and safety of the combination linagliptine and pioglitazone

Protocol documents:
Clinical trial NCT00741819
Conditions: Pulmonary Arterial Hypertension
Keywords: pulmonary arterial hypertension PAH treprostinil sodium inhalation ventavis iloprost
Sponsor: United Therapeutics
Start date: 2008-09-01; Completion date: 2010-12-01
Enrollment: 73 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a 24-month, multi-center, prospective, open-label, safety evaluation in PAH subjects following transition from a stable dose of inhaled iloprost (Ventavis).

Subjects are to be evaluated for safety throughout the course of the study while secondary assessments will be conducted at Baseline, Week 6, Week 12, and Months 6, 12, 18 and 24 following initiation of treprostinil sodium.

Detailed description:

Arms: arm 1: Solution for oral inhalation treprostinil (0.6 mg/mL). Inhaled via an ultrasonic nebulizer which provides a dose of 6mcg of treprostinil per breath. Doses are titrated up to 12 breaths four times daily.
Interventions: intervention 1: Inhaled treprostinil
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00750061
Conditions: Spinal Cord Injury
Keywords: Spinal Cord Injury
Sponsor: China Spinal Cord Injury Network
Start date: 2008-08-01; Completion date: 2010-12-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, placebo-controlled, double-blinded trial. Forty patients will be randomized into two groups. The subjects in the Treatment Group will be administered with lithium carbonate, while the Control Group will receive placebo.

Each subject will receive oral lithium carbonate or placebo for six weeks. In the treatment group, the dose will be adjusted according to the serum lithium level while in the control group there will be a sham adjustment.

The outcomes will be assessed 6 weeks and 6 months after the onset of the medication. The outcomes will be compared with baseline pre-treatment data to obtain "neurological change scores." The efficacy and safety will be analyzed comparing the results of the treatment group with those of the control group.

Detailed description:

Arms: arm 1: Placebo tablet arm 2: Lithium Carbonate tablet, 250mg
Interventions: intervention 1: Lithium Carbonate intervention 2: Placebo
Intervention descriptions: intervention 1: The subject start at a dosage regime of three times a day and one tablet of lithium carbonate, 250mg/table, oral administration each time for three days. The daily dose will be adjusted according to the serum lithium level and the clinical findings. Target serum lithium level is 0.6-1.2mM.

The course of medication is 6 weeks. intervention 2: Matching placebo

Protocol documents:
Clinical trial NCT00777556
Conditions: Emergency Contraception
Sponsor: Duramed Research
Start date: 2008-10-01; Completion date: 2010-12-01
Enrollment: 343 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a non-comparative case series study to assess the ability of females 11-16 years of age, inclusive, who are requesting emergency contraception (EC) to use the study product, DR-104 (Plan B® 1.5), appropriately and safely without provider counseling.

Detailed description:
To simulate an over-the-counter (OTC) setting, each potential subject was expected to read the label text on the outside of the study package and determine whether and how to use the study product without provider direction or assistance. The study product, Plan B® 1.5, was to be dispensed only to those subjects who appropriately self-selected and indicated that they wanted to participate in the study and receive study product. Subjects could also appropriately self-select not to use the study product.

Follow-up contact was to be conducted at approximately one, four, and eight weeks following the date the subject was dispensed study product. At these contacts, subjects answered questions regarding product use, health problems since last contact, and pregnancy status. Subjects were not to be permitted to enroll more than once in this Actual Use Study, however to assess repeat use of emergency contraceptives (EC) (use in addition to the study product) subjects were also queried at the one-, four-, and eight-week follow-up contacts regarding use of additional EC.

Arms: arm 1: One tablet for emergency contraception
Interventions: intervention 1: DR-104
Intervention descriptions: intervention 1: One 1.5 mg tablet of levonorgestrel for emergency contraception within 72 hours following unprotected sexual intercourse.

Protocol documents:
Clinical trial NCT00785928
Conditions: Rheumatoid Arthritis
Keywords: Arthritis
Sponsor: Eli Lilly and Company
Start date: 2008-10-01; Completion date: 2010-12-01
Enrollment: 158 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the efficacy of LY2127399 versus placebo using American College of Rheumatology (ACR)50 response scale at 24 weeks

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None
Interventions: intervention 1: LY2127399 intervention 2: Placebo
Intervention descriptions: intervention 1: Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20). intervention 2: Administered subcutaneously (SC) every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).

Protocol documents:
Clinical trial NCT00789867
Conditions: Cystic Fibrosis
Keywords: Single dose Pilot Safety Gene expression Tolerability CFTR gene Cystic fibrosis Non-viral
Sponsor: Imperial College London
Start date: 2008-11-01; Completion date: 2010-12-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study objectives are to assess safety, tolerability and gene expression after a single dose of non-viral CFTR gene therapy (pGM169/GL67A) administered to the nose and lungs of patients with cystic fibrosis.

Detailed description:
The trial is designed as single administration to nose and lung. Initially, in Part A, 3 patients will be dosed individually one week apart with 10 ml (26.5mg pDNA) via nebuliser and a nasal dose equivalent to 10% of this (based on relative surface area calculations: conducting airways approximate 540 cm2; nasal epithelium from both nostrils approximately 40 cm2). Based on our previous study, we do not expect any side effects of the nasal dose, but we are taking this opportunity, as this group will not be undergoing bronchoscopic efficacy measures, to assess gene transfer to the nasal epithelium. A further group of 3 patients will then be treated in exactly the same way with 20 ml nebulised and a 2 ml nasal dose.

Subsequently, patients will receive doses of 2 ml (nasal) and 20 ml (nebulised). These patients will undergo more intensive monitoring for gene expression both before and after administration.

In Part B of the protocol, we will test combinations of delivery conditions and dose in an attempt to identify the maximal tolerated dose. We may also use Ibuprofen or Prednisolone in standard clinical doses around the dosing period to reduce the inflammatory response. Delivery conditions include: standard nebulisation (each 5 ml over 25 minutes as in Part A), slow (each 5 ml over 75-150 minutes) and divided (standard rate delivery with a period of up to 6 hours between aliquots). With these conditions we will test the following doses until a tolerable dose is reached: 20 ml (no standard delivery as sufficient data already available from Part A); 10 ml; 5 ml; 2.5 ml. Each dosing strategy will initially be performed in a cohort of 3 patients although numbers may need to be increased to 6 if data are inconclusive. Once a satisfactory Single dose of pGM169/GL67A in CF patients; cro851 Version 10; 16.08.2010 10 dose and nebulisation strategy has been identified, the numbers receiving this will be increased to 6. The maximum number of patients recruited to this arm of the study will be 30. Part B will also allow either these subjects or others to receive a 2 ml nasal dose with both pre and post-measurements of nasal PD.

Arms: arm 1: Received a nebulized dose 20ml via an breath-actuated nebulizer arm 2: Received a nebulized dose 10ml via an breath-actuated nebulizer arm 3: Received a nebulized dose 5ml via an breath-actuated nebulizer
Interventions: intervention 1: pGM169/GL67A
Intervention descriptions: intervention 1: Received a nebulized dose via an breath-actuated nebulizer

Protocol documents:
Clinical trial NCT00791102
Conditions: Allergic Rhinitis
Sponsor: University of Chicago
Start date: 2010-01-01; Completion date: 2010-12-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to see whether ASP-1001 when given as a nasal spray is safe and can reduce the signs and symptoms of allergic rhinitis (hayfever) following nasal challenge with antigen.

Detailed description:

Arms: arm 1: Topical ASP-1001 arm 2: Placebo for Topical ASP-1001
Interventions: intervention 1: ASP-1001 nasal spray intervention 2: Placebo for ASP-1001
Intervention descriptions: intervention 1: 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge. intervention 2: 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.

Protocol documents: