ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00372424
Conditions: Breast Cancer
Keywords: Breast cancer over-expressing HER2. First-line treatment with sunitinib/docetaxel/trastuzumab.
Sponsor: Pfizer
Start date: 2006-12-01; Completion date: 2011-09-01
Enrollment: 26 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is an exploratory trial evaluating the tolerability and preliminary anti-tumor activity of SU011248 combined with docetaxel and trastuzumab in patients with locally recurrent or metastatic breast cancer over-expressing Her-2, who have not received chemotherapy treatment in the advanced disease setting.

Detailed description:

Arms: arm 1: Combination of SU011248 (37.5 mg once daily \[Schedule 2/1\]) with docetaxel (75 mg/m2 every 3 weeks) and trastuzumab (therapeutic dose)
Interventions: intervention 1: Herceptin intervention 2: Sunitinib intervention 3: Taxotere
Intervention descriptions: intervention 1: Trastuzumab will be administered intravenously on Day 1 before docetaxel - loading dose of 4 mg/kg over 90-minute on Day 1 followed by weekly maintenance doses of 2 mg/kg on Days 1, 8, 15 given as 30-minute infusions if the initial loading dose was well tolerated. Loading dose of 8 mg/kg over 90-minute on Day 1 followed by 3-weekly maintenance doses of 6 mg/kg given as 90-minute infusions. The administration of 6 mg/kg will be repeated on Day 1 every 3 weeks. intervention 2: SU011248 will be administered at 37.5 mg once daily for 2 weeks every 3 weeks (Schedule 2/1) starting from Day 2, when in combination with docetaxel. SU011248 will be administered at the starting dose of 37.5 mg daily in a continuous regimen when docetaxel is discontinued. intervention 3: The starting dose of docetaxel will be 75 mg/m2 every 3 weeks, administered on Day 1 of each cycle as a 1-hour IV infusion.

Protocol documents:
Clinical trial NCT00448123
Conditions: Kidney Stones Ureteral Stones
Keywords: Kidney Stones Ureteral Stones Flomax Emergency Medicine Urology
Sponsor: Robert Swor
Start date: 2007-02-01; Completion date: 2011-09-01
Enrollment: 127 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine if emergency department patients with acute ureteral colic pain due to a ureteral stone who are treated with tamsulosin, versus placebo, will experience a shorter time to passage of their stone or resolution of their pain. A secondary study objective will be to determine if there is a relationship between response to tamsulosin and stone size or position in the ureter.

Detailed description:
This is a prospective randomized placebo controlled study of tamsulosin alone, vs placebo, to determine its effect on the rates of stone passage and resolution of pain in patients with acute renal colic pain that present to the emergency department. The study will be conducted in the Emergency Department (ED)and Emergency Department Observation Unit (EDOU) of William Beaumont Hospital, a high volume, university affiliated 952 bed suburban teaching hospital.

Patients will be given a seven-day supply of tamsulosin (0.4mg daily) or placebo. They will also be given a prescription for Vicodin (30 pills) and Ibuprofen (600mg, 30 pills). They will be called on days 1, 2, 3, 7, and 10 following the index visit regarding passage of stone or 48 hours without pain. Patients will be asked to call in if they pass their stone or are without pain for 48 hours. Related return visits to Royal Oak or Troy Beaumont within 30 days of their index visit will be followed by chart review.

The study will be limited to patients presenting to the emergency department with acutely symptomatic renal colic pain. Confirmation of a symptomatic stone will be made by imaging (helical CT scan or intravenous pyelogram).

Study exclusion criteria:

* Stone not documented on imaging
* Stones \>10mm
* Pregnancy
* Age \<18 years
* Evidence of infection with an obstructing stone
* Obstructing stone in a solitary kidney
* Currently taking tamsulosin, vardenafil, nifedipine, or steroids
* Contraindications or allergy to tamsulosin
* Ureteral surgery
* Patients that are unable to understand consent
* Patients that are unable to comply with follow-up

Arms: arm 1: Placebo arm 2: Intervention - Tamsulosin
Interventions: intervention 1: Tamsulosin intervention 2: Placebo
Intervention descriptions: intervention 1: Study Drug intervention 2: Placebo

Protocol documents:
Clinical trial NCT00528580
Conditions: Sepsis
Keywords: Sepsis Statin Infection Immunomodulatory
Sponsor: University of Chicago
Start date: 2008-02-01; Completion date: 2011-09-01
Enrollment: 68 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
We propose a Phase II, randomized, placebo-controlled clinical trial to test the hypothesis that treatment with once-daily statins has a beneficial effect on inflammatory cytokines and clinical outcomes in adults hospitalized with sepsis. As our animal models suggest pretreatment with statins are required for their beneficial effects, we propose a study design intended to identify patients and initiate treatment early in their hospital stay. This Phase II study is intended to assess the feasibility of conducting a large-scale investigator-initiated translational research protocol that involves multiple clinical services within the Department of Medicine.

Detailed description:

Arms: arm 1: Simvastatin 80 mg once daily PO (or via NG or G-tube) arm 2: Identical-appearing placebo PO (or via NG or G-tube)
Interventions: intervention 1: Simvastatin intervention 2: Identical-appearing placebo
Intervention descriptions: intervention 1: 80 mg once daily PO/NG x 4 days intervention 2: once daily x 4 days

Protocol documents:
Clinical trial NCT00570401
Conditions: Lung Cancer
Keywords: adenocarcinoma of the lung stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer recurrent non-small cell lung cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2006-06-01; Completion date: 2011-09-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well dasatinib works in treating patients with advanced lung cancer that is no longer responding to erlotinib or gefitinib.

Detailed description:
OBJECTIVES:

Primary

* To determine the overall response rate (complete response and partial response) in patients with acquired erlotinib hydrochloride- or gefitinib-resistant advanced adenocarcinoma of the lung treated with dasatinib.

Secondary

* To determine the progression-free survival and overall survival of patients treated with this drug.
* To determine the overall response rate in patients with EGFR T790M lung adenocarcinomas treated with this drug.
* To determine the progression-free survival and overall survival of patients with EGFR T790M lung adenocarcinomas treated with this drug.
* To determine the toxicity profile of dasatinib in these patients.

OUTLINE: Beginning 1 week after completion of erlotinib hydrochloride or gefitinib therapy, patients receive oral dasatinib twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Response is assessed by CT scan at 4 weeks, 8 weeks, and then every 8 weeks thereafter.

Arms: arm 1: Beginning 1 week after completion of erlotinib hydrochloride or gefitinib therapy, patients receive oral dasatinib twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Response is assessed by CT scan at 4 weeks, 8 weeks, and then every 8 weeks thereafter.
Interventions: intervention 1: dasatinib
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00588146
Conditions: Anemia Liver Disease Hypoxemia
Keywords: anemia HHT Liver disease Hypoxemia Iron deficiency anemia Liver disease with high cardiac output Diffuse pulmonary AVMs with hypoxemia
Sponsor: Mayo Clinic
Start date: 2007-01-01; Completion date: 2011-09-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of the study is to evaluate the safety and tolerability of pegylated interferon alpha-2b (PEG-Intron) in patients with severe complications related to Hereditary hemorrhagic telangiectasia (HHT).

Funding Source - FDA Office of Orphan Products Development (OOPD)

Detailed description:
The objective of this study is to evaluate the safety and tolerability of pegylated interferon alpha-2b (PEG-Intron) in patients with severe complications related to Hereditary Hemorrhagic Telangiectasia (HHT). Participants will be randomized to the treatment arm or control arm and then crossed over to the alternate arm at 6 months for the remainder of the 12-month study. Study treatment will consist of weekly subcutaneous injections of pegylated interferon alpha-2b (PEG-Intron), 1 microgram/kilogram/week. Adverse events as well as monitoring and treatment of toxicities will be followed as stated in the protocol. Adverse events will be graded according to the Modified NCI Common Toxicity Criteria. After every five participants have completed one month of treatment, an independent data safety monitoring board will review any adverse events.

Arms: arm 1: Weekly subcutaneous injection of pegylated interferon alpha2b 1 microgram/kg/week for 6 months, then standard care for 6 months. arm 2: Standard care for 6 months, then weekly subcutaneous injection of pegylated interferon alpha2b 1 microgram/kg/week for 6 months.
Interventions: intervention 1: Pegylated Interferon Alpha2b intervention 2: Standard care
Intervention descriptions: intervention 1: Weekly subcutaneous injection of 1 microgram/kg/week intervention 2: Standard care

Protocol documents:
Clinical trial NCT00612430
Conditions: Glioblastoma Gliosarcoma
Keywords: Glioblastoma Gliosarcoma GBM MG Brain tumor Bevacizumab Avastin Etoposide VP-16 Etopophos Toposar VePesid Glioblastoma multiforme Recurrent GBM Anaplastic astrocytoma Malignant glioma
Sponsor: Duke University
Start date: 2007-03-01; Completion date: 2011-09-01
Enrollment: 59 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Primary Objective to estimate 6-month progression free survival probability of patients with recurrent malignant glioma treated with Etoposide + Bevacizumab.

Secondary Objectives To evaluate safety \& tolerability of Etoposide + Bevacizumab among patients with recurrent malignant glioma (RMG).

To evaluate radiographic response, progression free survival \& overall survival of patients with recurrent malignant glioma treated with Etoposide + Bevacizumab.

Detailed description:
Exploratory, single-arm, ph II study designed to assess anti-tumor activity of combinatorial regimen consisting of Etoposide + Bevacizumab among patients with RMG. Primary endpoint of study is probability of progression-free survival at 6 months. Important secondary objective is to further assess safety of Etoposide \& Bevacizumab for patients with recurrent malignant glioma.

If study demonstrates that combinatorial regimen of Etoposide + Bevacizumab is associated with encouraging anti-tumor activity among patients with RMG, further assessment of regimen in additional phase II \& possibly phase III studies, will be considered.

Arms: arm 1: Grade III and IV patients will receive: Bevacizumab administered intravenously at dose 10 mg/kg every two weeks. If patient tolerates 1st bevacizumab dose, subsequent doses may be given by local oncologists under direct supervision of Duke investigators. Etoposide administered orally, once daily for 1st 21 days of each 28-day treatment cycle. Dose of Etoposide will be 50 mg/m2/day.
Interventions: intervention 1: Bevacizumab and Etoposide
Intervention descriptions: intervention 1: 32 pts w recurrent WHO grade III MG \& 27 pts w recurrent WHO grade IV MG will be enrolled in this study. Estimated rate of accrual is 10 pts per month. The estimated date of study completion is 6-9 months from study initiation. Bevacizumab administered intravenously at dose 10 mg/kg every two weeks. If pt tolerates 1st bevacizumab dose, subsequent doses may be given by local oncologists under direct supervision of Duke investigators. Etoposide administered orally, once daily for 1st 21 days of each 28-day treatment cycle. Dose of Etoposide will be 50 mg/m2/day. The Duke investigators will review all la data \& order treatment. Treatment will continue until either evidence of progressive disease, unacceptable toxicity, non-compliance w study follow-up, or withdrawal of consent.

Protocol documents:
Clinical trial NCT00662311
Conditions: Stage IIIA Non-small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer
Sponsor: University of Washington
Start date: 2008-03-01; Completion date: 2011-09-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase I/II trial studies the side effects and best dose of vorinostat when given together with paclitaxel and radiation therapy and to see how well it works in treating patients unable to tolerate cisplatin with stage III non-small cell lung cancer (NSCLC) that cannot be removed by surgery. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving vorinostat together with paclitaxel and radiation therapy may kill more tumor cells

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the maximum tolerated dose (MTD) of vorinostat when administered in combination with paclitaxel and thoracic radiation therapy in patients with locally advanced NSCLC.

SECONDARY OBJECTIVES:

I. To assess the safety and toxicity of vorinostat when administered in combination with paclitaxel and thoracic radiation therapy in patients with locally advanced NSCLC.

II. To determine the radiological response rate, by computed tomography (CT) scan, of vorinostat when administered in combination with paclitaxel and thoracic radiation therapy in patients with locally advanced NSCLC.

III. To describe the progression free survival (PFS) and overall survival (OS) of this regiment over 3 years of follow up.

OUTLINE: This is a phase I, dose-escalation study of vorinostat followed by a phase II study.

Patients receive vorinostat orally (PO) once daily (QD), 5 days a week and paclitaxel intravenously (IV) over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days, 12 weeks, every 3 months for 2 years, and then every 6 months for 1 year.

Arms: arm 1: Patients receive vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: vorinostat intervention 2: paclitaxel intervention 3: radiation therapy
Intervention descriptions: intervention 1: Given PO intervention 2: Given IV intervention 3: Undergo radiation therapy

Protocol documents:
Clinical trial NCT00670956
Conditions: Congenital Cystic Adenomatoid Malformation
Keywords: prenatal steroids hydrops congenital cystic adenomatoid malformation of the lung prenatal intervention betamethasone prenatal diagnosis
Sponsor: University of California, San Francisco
Start date: 2008-04-01; Completion date: 2011-09-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Congenital cystic adenomatoid malformations (CCAMs) are theorized to be growing immature lung tissue. Administration of maternal steroids in the mid-trimester may stop the growth or decrease the size of the CCAM, thus increasing normal lung tissue and improving survival in fetuses with large CCAMs. This is a prospective, blinded, randomized trial comparing administration of a single course of antenatal steroids (Betamethasone) to control (i.e., placebo). The primary outcome variable will be incidence of hydrops. One month postnatal survival and relative size of the CCAM as determined by CCAM volume:head circumference ratio (CVR) between treatment/no treatment groups will be secondary outcome variables. Change in size of CCAM will be serially followed for both groups with individual growth curves being plotted prenatally and these will be compared with pathology weigh and volume to evaluate treatment effect. Other prenatal data collected will include: incidence of polyhydramnios, incidence of premature rupture of membranes, incidence of material complications. We will also compare mode of delivery, postnatal respiratory compromise, need for resection in the first week of life, and occurrence of complications during newborn administration

Detailed description:

Arms: arm 1: STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart arm 2: PLACEBO: IM x 2 doses 24 hours apart
Interventions: intervention 1: Betamethasone intervention 2: Placebo
Intervention descriptions: intervention 1: 12 mg intramuscularly x 2 doses 24 hours apart intervention 2: PLACEBO: IM x 2 doses 24 hours apart

Protocol documents:
Clinical trial NCT00673439
Conditions: Heparin-Induced Thrombocytopenia
Keywords: heparin-induced thrombocytopenia thrombocytopenia HIT thrombosis blood clot blood thinner anticoagulant heparin warfarin fondaparinux Arixtra
Sponsor: University of Louisville
Start date: 2007-11-01; Completion date: 2011-09-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine how safe and effective fondaparinux is in treating patients with suspected or confirmed heparin-induced thrombocytopenia (HIT).

Detailed description:
Currently, standard treatment of HIT involves the transition from a direct thrombin inhibitor (a type of anticoagulant or "blood thinner") to warfarin, a different type of anticoagulant. Direct thrombin inhibitors (DTIs) require IV administration and frequent blood draws for dose adjustments, which can lead to prolonged hospitalization. DTIs also affect blood test measurements, making it difficult to determine proper dosages of warfarin.

Fondaparinux is a drug that is approved by the FDA for the treatment of blood clots in deep veins and in the lungs. Fondaparinux is not FDA approved for the treatment of HIT. However, an increasing number of doctors are using fondaparinux instead of DTIs to treat HIT. Although fondaparinux appears to be more convenient and predictable than DTI medications, more research is needed to support its use as a treatment for HIT.

Arms: arm 1: daily subcutaneous injection of fondaparinux (7.5-10 mg)
Interventions: intervention 1: fondaparinux intervention 2: warfarin
Intervention descriptions: intervention 1: Dosage form: subcutaneous injection; dosage: 7.5 to 10.0 mg; frequency and duration: daily until blood test results rule out confirmed HIT - for patients with confirmed HIT, continue daily until INR (blood clotting) measurement rises to at least 2 intervention 2: Dosage form: oral; dosage: 2.5 to 5.0 mg; frequency and duration: (for confirmed HIT only) once daily, to begin when blood platelet count reaches at least 100,000, and continue for approximately 4 weeks

Protocol documents:
Clinical trial NCT00702780
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease escitalopram MRI
Sponsor: Seoul National University Hospital
Start date: 2008-11-01; Completion date: 2011-09-01
Enrollment: 74 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study aimed to test whether escitalopram would slow the brain atrophy in patients with mild to moderate AD over the 52-week period.

Detailed description:
* Study institutions: Four university hospitals in Korea
* Design: Multi-center, randomized, placebo-controlled, double-blind clinical trial
* Subjects: 74 probable Alzheimer's disease patients who have been taking donepezil at stable dose within 2 months (Escitalopram 37 : Placebo 37)

Arms: arm 1: Escitalopram 20mg tablet by mouth once a day arm 2: Placebo 20mg tablet by mouth once a day
Interventions: intervention 1: escitalopram intervention 2: placebo
Intervention descriptions: intervention 1: 5 mg/day for 2 weeks, 10 mg/day for 2 weeks and 20 mg/day for 48 weeks (maintaining donepezil at the previous stable dose during the whole trial period) intervention 2: 5mg/day for 2 weeks, 10mg/day for 2 weeks and 20mg/day for 48 weeks (maintaining donepezil at the previous stable dose during the whole trial period)

Protocol documents:
Clinical trial NCT00722553
Conditions: Carcinoma, Transitional Cell Bladder Cancer Bladder Neoplasm
Keywords: Transitional Cell Carcinoma of the Urinary Bladder Transitional Cell Carcinoma Bladder Cancer Urinary Bladder Cancer Bladder Carcinoma Urinary Metastatic Relapsed
Sponsor: Acrotech Biopharma Inc.
Start date: 2008-07-01; Completion date: 2011-09-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether pralatrexate, given with vitamin B12 and folic acid, is effective in the treatment of advanced or metastatic bladder cancer. The study will also investigate the safety of pralatrexate with vitamin B12 and folic acid in this patient population. Additionally, this study includes the collection of blood samples to investigate the pharmacokinetics (PK) of pralatrexate in this patient population (PK is the activity of a drug in the body over a period of time, including how the drug is absorbed, distributed in the body, localized in the tissues, and excreted from the body).

Detailed description:

Arms: arm 1: Vitamin B12 : 1 mg intramuscular injection Administered within 10 weeks of enrollment, every 8-10 weeks throughout the study and for at least 30 days after last dose of pralatrexate.

Folic Acid: 1-1.25 mg orally Administered daily for at least 7 days prior to enrollment, throughout the study and for at least 30 days after last dose of pralatrexate.
Interventions: intervention 1: Pralatrexate Injection intervention 2: Vitamin B12 intervention 3: Folic Acid
Intervention descriptions: intervention 1: Intravenous (IV) push administration over 3-5 minutes via a peripheral IV line containing normal saline (0.9% sodium chloride).

Initial dose: 190 mg/m2

Dose reductions per protocol: 150 mg/m2, 120 mg/m2 and 100 mg/m2 will be allowed for defined toxicity.

Administered on days 1 and 15 of a 4-week cycle (every 2 weeks) until criteria for discontinuation per the protocol are met. intervention 2: 1 mg intramuscular injection

Administered within 10 weeks of enrollment, every 8-10 weeks throughout the study and for at least 30 days after last dose of pralatrexate. intervention 3: 1-1.25 mg orally

Administered daily for at least 7 days prior to enrollment, throughout the study and for at least 30 days after last dose of pralatrexate.

Protocol documents: