ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00141297
Conditions: Neoplasms Lymphoma, Non-Hodgkin
Keywords: Advanced cancer
Sponsor: Pfizer
Start date: 2004-09-01; Completion date: 2014-12-01
Enrollment: 74 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
PD-0332991 may work in cancer by stopping cancer cells from multiplying. PD-0332991 is in a new class of drugs called cyclin-dependent kinase (CDK inhibitors). This research study is the first time that PD-0332991 will be given to people. PD-0332991 is taken by mouth daily.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: PD-0332991
Intervention descriptions: intervention 1: Dose ranging study - evaluating two oral schedule: (1) 3/1 Schedule - PD-0332991 administered days 1-21 of a 28-day schedule, doses ranging from 25 to 150 mg once daily; (2) 2/1 Schedule - PD-0332991 administered days 1-14 of a 21-days schedule, doses ranging from 100 to 225 mg once daily

Protocol documents:
Clinical trial NCT00334282
Conditions: Carcinoma, Renal Cell
Keywords: Metastatic Anti-angiogenesis GW786034 Pazopanib
Sponsor: GlaxoSmithKline
Start date: 2006-04-01; Completion date: 2014-12-01
Enrollment: 435 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate efficacy and safety of pazopanib compared to placebo in patients with locally advanced and/ or metastatic renal cell carcinoma (RCC). Approximately 350-400 eligible patients will be stratified and randomized in a 2:1 ratio to receive either 800 mg pazopanib once daily or matching placebo. The study treatment will continue until patients experience disease progression, unacceptable toxicity or death. Primary objective of the study is to evaluate and compare the two treatment arms for progression-free survival. Principal secondary objective is to evaluate and compare the two treatment arms with respect to overall survival. Other objectives are overall response rate \[complete response (CR) + partial response (PR)\], rate of CR + PR + 6 months stable disease, and the incidence, severity and causality of adverse events and serious adverse events. Safety and efficacy assessments will be regularly performed on all patients. An Independent Data Monitoring Committee will be established to monitor safety during the course of the study and to evaluate interim efficacy data on overall survival.

Detailed description:

Arms: arm 1: matching placebo (800 mg tablet) once daily arm 2: Oral pazopanib tablet 800 mg once daily continuously
Interventions: intervention 1: Pazopanib intervention 2: placebo
Intervention descriptions: intervention 1: Oral pazopanib tablet 800 mg once daily continuously intervention 2: matching placebo (800 mg tablet) once daily

Protocol documents:
Clinical trial NCT00420381
Conditions: Ovarian Cancer Neoplasms Carcinoma
Keywords: Recurrent Cancer
Sponsor: Eli Lilly and Company
Start date: 2007-01-01; Completion date: 2014-12-01
Enrollment: 28 participants; Allocation: NA; Intervention model: SEQUENTIAL

Brief summary:
The purpose is to assess the efficacy and toxicity of the study agent, enzastaurin, in participants with recurrent or persistent ovarian cancer.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: enzastaurin
Intervention descriptions: intervention 1: 1125 mg loading dose then 500 mg, oral, daily, until progressive disease

Protocol documents:
Clinical trial NCT00424827
Conditions: Pancreatic Cancer
Keywords: pancreatic cancer, gemcitabine, 5-FU, cetuximab, radiation
Sponsor: University of Massachusetts, Worcester
Start date: 2006-06-01; Completion date: 2014-12-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, non-randomized, combination study of cetuximab, gemcitabine, 5-FU, and external beam radiotherapy in patients with locally advanced, non-metastatic pancreatic cancer.

Detailed description:
During cycle I (chemoradiation), gemcitabine (200 mg/m2) and cetuximab 400mg/m2 initial dose followed by 250mg/m2 IV weekly will be given with continuous infusion 5-FU (200 mg/m2/day) delivered 5 of every 7 days and concurrent external beam radiation therapy. Cetuximab, gemcitabine and 5-FU will begin on the first week of external beam radiotherapy and will continue throughout the course of external beam radiation therapy, and will be discontinued following the conclusion of external beam radiation therapy. All patients will have a central venous access device placed to facilitate chemotherapy administration.

During cycles 2 through 5 (chemotherapy), gemcitabine will be administered at a dose of 1000 mg/m2 over 30 minutes followed by cetuximab at a dose of 250mg/m2 over 30 minutes weekly for 3 weeks followed by one-week rest for four cycles.

Arms: arm 1: This protocol will assess the antitumor activity of Gemcitabine/Fluorouracil with External Beam Radiation in patients with non-metastatic, locally advanced pancreatic carcinoma.
Interventions: intervention 1: Gemcitabine/Fluorouracil with External Beam Radiation
Intervention descriptions: intervention 1: This protocol will assess the antitumor activity of gemcitabine (200 mg/m2 per week) and cetuximab (400mg/m2 loading dose followed by 250 mg/m2 weekly) when given with continuous infusion 5-FU (200 mg/m2/day/M-F) and daily concurrent external beam radiation therapy (50.4 Gy) in patients with non-metastatic, locally advanced pancreatic carcinoma.

Protocol documents:
Clinical trial NCT00454363
Conditions: Gastrin-Producing Neuroendocrine Tumor Lung Carcinoid Tumor Metastatic Digestive System Neuroendocrine Tumor G1 Multiple Endocrine Neoplasia Type 1 Pancreatic Glucagonoma Pancreatic Insulinoma Pancreatic Polypeptide Tumor Recurrent Digestive System Neuroendocrine Tumor G1 Recurrent Pancreatic Neuroendocrine Carcinoma Regional Digestive System Neuroendocrine Tumor G1 Somatostatin-Producing Neuroendocrine Tumor
Sponsor: National Cancer Institute (NCI)
Start date: 2007-03-01; Completion date: 2014-12-01
Enrollment: 52 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well pazopanib hydrochloride works in treating patients with advanced neuroendocrine cancer. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Detailed description:
PRIMARY OBJECTIVE:

I. To determine the objective response rate (ORR) (complete and partial response) of GW786034 (pazopanib hydrochloride) 800 mg administered orally once daily in patients with advanced low or intermediate grade carcinoid tumors (in carcinoid cohort).

II. To determine the objective response rate (ORR) (complete response and partial response) of GW786034 800mg administered orally once daily in patients with advanced low or intermediate grade pancreatic islet cell carcinoma (in islet cell cohort).

SECONDARY OBJECTIVES:

I. To determine the progression free survival (PFS) duration of GW786034 800mg administered orally once daily in patients with low grade neuroendocrine carcinoma.

II. To determine the safety and tolerability of GW786034 800mg administered orally once daily in patients with low grade neuroendocrine carcinoma.

III. To explore the effect on tumor blood flow as determined by functional computed tomography (CT) of GW786034 800 mg orally once daily in patients with low grade neuroendocrine carcinoma.

IV. To assess the trough level of GW786034 800 mg orally once daily in patients with low grade neuroendocrine carcinoma.

OUTLINE:

Patients receive pazopanib hydrochloride orally (PO) once daily (QD) on days 1-28. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 90 days for up to 18 months.

Arms: arm 1: Patients receive pazopanib hydrochloride PO QD on days 1-28. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Laboratory Biomarker Analysis intervention 2: Pazopanib Hydrochloride intervention 3: Pharmacological Study
Intervention descriptions: intervention 1: Correlative studies intervention 2: Given PO intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT00489866
Conditions: PTSD
Keywords: PTSD Antidepressant Aripiprazole OEF OIF
Sponsor: Durham VA Medical Center
Start date: 2007-03-01; Completion date: 2014-12-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The proposed investigation will determine the therapeutic potential of aripiprazole augmentation to a stable antidepressant regimen for reducing posttraumatic stress disorder (PTSD) symptoms, cognitive symptoms, psychotic symptoms, and depressive symptoms in veterans with PTSD.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Aripiprazole intervention 2: Placebo
Intervention descriptions: intervention 1: Aripiprazole: 5 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-10 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-15 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-20 mg taken once a day orally for 2 weeks intervention 2: Same as active drug.

Protocol documents:
Clinical trial NCT00506142
Conditions: Metastatic Malignant Uveal Melanoma
Sponsor: Spectrum Pharmaceuticals, Inc
Start date: 2007-11-01; Completion date: 2014-12-01
Enrollment: 54 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
Marqibo (liposomal vincristine) is a form of vincristine preparation. Vincristine is designed to interfere with the multiplication of cancer cells, which may slow or stop their growing and spreading throughout the body. This may cause the cancer cells to die. Liposomal vincristine is formed when vincristine is placed inside of oil droplets called liposomes, which may help to improve the delivery of drug to the tumor site. The liposomal formulation results in a slow, steady release of vincristine in the tumor metastasis, exposing the cancer cells to vincristine continuously.

The goal of this clinical research study is to learn if Marqibo (liposomal vincristine) can help to control metastatic uveal melanoma. The safety of liposomal vincristine will also be studied.

Approximately 50 patients will take part in this study.

Detailed description:

Arms: arm 1: Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks. arm 2: Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week.
Interventions: intervention 1: Marqibo® (vincristine sulfate liposomes injection)
Intervention descriptions: intervention 1: Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks.

Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week.

Protocol documents:
Clinical trial NCT00530855
Conditions: Epilepsy
Keywords: Epilepsy Partial-onset Seizures Lacosamide Monotherapy Vimpat
Sponsor: UCB Pharma
Start date: 2008-02-01; Completion date: 2014-12-01
Enrollment: 322 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open-label extension trial will assess the long-term use of Lacosamide monotherapy and safety of Lacosamide monotherapy and adjunctive therapy in subjects with partial-onset seizures who were previously enrolled in the conversion to monotherapy trial (SP902).

Detailed description:

Arms: arm 1: Lacosamide tablets for dosing 100 -800 mg/day
Interventions: intervention 1: Lacosamide
Intervention descriptions: intervention 1: 50 mg and 100 mg Lacosamide tablets taken for 50 -400 mg twice daily dosing for up to 2 years

Protocol documents:
Clinical trial NCT00556049
Conditions: Renal Cell Carcinoma Neoplasm Metastases
Keywords: mRCC sunitinib gemcitabine
Sponsor: Massachusetts General Hospital
Start date: 2007-12-01; Completion date: 2014-12-01
Enrollment: 72 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to determine if the combination of sunitinib and gemcitabine is effective in treating patients with metastatic renal cell carcinoma. The safety of this combination will also be studied. Sunitinib is approved by the FDA for the treatment of renal cell carcinoma. However, some patients' cancers do not respond to treatment or stops responding after initially responding. Gemcitabine is a chemotherapy drug that is approved by the FDA for the treatment of pancreatic cancer and several other cancers. It is not approved for the treatment of renal cell carcinoma. Previous research has suggested that combining gemcitabine with sunitinib may have some effectiveness in treating metastatic renal cell carcinoma.

Detailed description:
* Participants will receive study treatment as an outpatient. Study treatment will be given in 3-week cycles.
* Sunitinib will be taken orally once per day for the first two weeks (days 1-14) of each treatment cycle.
* Gemcitabine will be given intravenously at the study clinic on days 1 and 8 of each treatment cycle.
* Before receiving sunitinib and gemcitabine on day 1 of each cycle the following will be performed: physical exam, performance status assessment and blood work. Before receiving gemcitabine on day 8 the following will be performed: physical exam, performance status assessment and blood work. Every 3 cycles a CT scan will be performed to measure the tumor.

Arms: arm 1: Sunitinib and gemcitabine
Interventions: intervention 1: Gemcitabine intervention 2: Sunitinib
Intervention descriptions: intervention 1: Intravenously on days 1 and 8 of each 21-day treatment cycle. intervention 2: Orally on days 1-14 of each 21-day treatment cycle

Protocol documents:
Clinical trial NCT00571324
Conditions: Congenital Hyperinsulinism
Keywords: hyperinsulinism hypoglycemia KATP channel Kir6.2
Sponsor: Diva De Leon
Start date: 2007-08-01; Completion date: 2014-12-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine if Exendin-(9-39), an antagonist of the glucagon-like peptide-1 (GLP-1) receptor with effects on the pancreatic beta cell, increases fasting blood glucose levels in subjects with congenital hyperinsulinism.

Detailed description:
This is an open-label, pilot study , to determine if Exendin-(9-39), an antagonist of the glucagon-like peptide-1 (GLP-1) receptor with effects on the pancreatic beta cells, increases fasting blood glucose levels in subjects with congenital hyperinsulinism. Our overall hypothesis is that abnormal GLP-1 secretion resulting from dysfunctional nutrient sensing in intestinal L-cells plays a role in the dysregulated insulin secretion characteristic of this disorder, and that antagonism of the GLP-1 receptor will increase fasting blood glucose levels.

Aim 1. To evaluate the dose of exendin-(9-39) required to elevate fasting blood glucose levels in subjects with congenital hyperinsulinism due to KATP channel mutations.

Aim 2. To determine therapeutic plasma levels, plasma half-life and pharmacokinetics of exendin-(9-39) during an intravenous short-term infusion in subjects with congenital hyperinsulinism due to Adenosine triphosphate (ATP)-sensitive potassium channel (KATP) mutations.

Arms: arm 1: Exendin-(9-39) will be administered intravenously (IV) after an overnight fast. Exendin-(9-39) will be infused over 6 hours with the dose slowly escalating from 100pmol/kg/min for 2 hours, then 300pmol/kg/min for another 2 hours followed by 500pmol/kg/min for the last 2 hours of the infusion. The following day, after another overnight fast, normal saline (control) vehicle infusion will be administered intravenously (IV) over 6 hours. During both infusions, blood glucose levels will be measured every 20 minutes. arm 2: Normal saline vehicle infusion will be administered intravenously (IV) after an overnight fast. The infusion will be given over 6 hours. The following day, after another overnight fast, Exendin-(9-39) will be infused over 6 hours with the dose slowly escalating from 100pmol/kg/min for 2 hours, then 300pmol/kg/min for another 2 hours followed by 500pmol/kg/min for the last 2 hours of the infusion. During both infusions, blood glucose levels will be measured every 20 minutes.
Interventions: intervention 1: Exendin-(9-39) intervention 2: Vehicle
Intervention descriptions: intervention 1: A short term intravenous infusion of the study drug, exendin-(9-39), will be given over 6 hours. intervention 2: A short term intravenous infusion of normal saline, or the vehicle, will be given over 6 hours.

Protocol documents:
Clinical trial NCT00601640
Conditions: Other Benign Neoplasm of Skin, Unspecified
Keywords: skin cancer
Sponsor: University of Arizona
Start date: 2007-01-01; Completion date: 2014-12-01
Enrollment: 184 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of eflornithine and diclofenac may stop cancer from growing in patients with sun-damaged skin.

PURPOSE: This randomized phase II trial is studying the side effects and how well eflornithine works compared with diclofenac, given alone or together, in treating patients with sun-damaged skin.

Detailed description:
OBJECTIVES:

Primary

* To determine if combination therapy with topical eflornithine hydrochloride ointment and topical diclofenac sodium gel over 3-months increases the efficacy versus either agent used alone in the treatment of moderately sun-damaged skin.

Secondary

* To evaluate the safety of sequential administration of topical eflornithine hydrochloride ointment and topical diclofenac sodium gel.
* To determine the correlation of karyometric changes with histopathologic, immunohistochemical, clinical, and genetic polymorphism data.
* To obtain materials for microarray analysis.

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

* Eflornithine hydrochloride : Patients apply topical eflornithine hydrochloride ointment to their left forearm twice daily on days 1-90.
* Diclofenac sodium : Patients apply topical diclofenac sodium gel to their left forearm once daily on days 1-90.
* Eflornithine hydrochloride/Diclofenac sodium : Patients apply topical eflornithine hydrochloride ointment as in arm I twice daily and topical diclofenac sodium gel as in arm II once daily on days 1-90.

Prior to treatment, three 4-mm punch biopsies are taken from the skin of the left lateral forearm for assessment of histopathology, the cyclooxygenase-2 enzyme and p53 expression, apoptosis, and nuclear chromatin karyometry. Tissue is also obtained for future use in microarray analysis. Blood is drawn for assessment of ornithine decarboxylase polymorphisms and for banking for subsequent studies. Biopsies are repeated 2-3 weeks after completion of treatment.

Digital photographs are taken at baseline and 1-2 weeks after completion of study therapy to document improvement of sun damage, appearance of new skin lesions, and toxicity.

Arms: arm 1: Patients apply Eflornithine HCL ointment to their left forearm twice daily on days 1-90. arm 2: Patients apply topical Diclofenac Na gel to their left forearm once daily on days 1-90. arm 3: Eflornithine HCl ointment and Diclofenac Na gel applied twice and once daily, respectively on days 1-90.
Interventions: intervention 1: Diclofenac Na gel intervention 2: Eflornithine HCL ointment
Intervention descriptions: intervention 1: Given topically twice daily on days 1-90 intervention 2: Given topically twice daily on days 1-90

Protocol documents:
Clinical trial NCT00663234
Conditions: HIV Infections Hyperlipidemia
Keywords: Treatment Experienced
Sponsor: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Start date: 2009-08-01; Completion date: 2014-12-01
Enrollment: 28 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Treatment of HIV with combination antiretroviral regimens frequently results in the suppression of HIV viral load, significant immune recovery, and delayed disease progression. However, treatment with these regimens, particularly protease inhibitors (PIs), has been associated with significant increases in cholesterol and triglycerides in HIV-infected adults and children. The purpose of this study was to evaluate the safety and effectiveness of escalating doses of atorvastatin, a FDA-approved drug which lowers cholesterol and triglyceride levels, in HIV-infected children receiving stable antiretroviral regimens.

Detailed description:
Antiretroviral regimens, particularly those containing PIs, often cause hyperlipidemia, which is an increase in the amount of fat (such as cholesterol and triglycerides) in the blood. These increases can lead to heart disease and pancreatitis. Although the mechanism by which PIs cause hyperlipidemia is not clearly understood, there are medications to combat this side effect. The primary purpose of this study was to evaluate the safety and effectiveness of escalating doses of atorvastatin, based on low-density lipoprotein cholesterol (LDL-C) levels, in HIV-infected children receiving stable antiretroviral therapy.

Participants were assigned to one of two groups based on age (10 to 14 years or 15 to 23 years) and were treated for a maximum of 48 weeks. The first six participants enrolled in the study were in the 15 to 23 year old age group. Once safety data through week 8 on these 6 participants was analyzed, the remaining participants were enrolled. All participants received atorvastatin in combination with a stable antiretroviral regimen. Each participant was followed independently according to a dose escalation algorithm for atorvastatin. Participants began dosing at 10 mg daily. If efficacy criteria were not met, dosing increased to 20 mg daily at week 8. Since dose escalations were done within subject, safety and efficacy rates were presented for the dose-escalation strategy overall and not for individual doses. Atorvastatin was provided by the study, but antiretrovirals were not.

Study visits occurred at study entry and weeks 4, 8, 12, 24, 36, and 48. Safety labs were collected at all study visits. Blood collection for lipid measurements occurred at weeks 4, 12, 24 and 48.

Arms: arm 1: Participants ages 10 to 14 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen arm 2: Participants ages 15 to 23 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen
Interventions: intervention 1: Atorvastatin
Intervention descriptions: intervention 1: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.

Protocol documents: